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<1>
Accession Number
608722173
Title
Multivessel versus culprit lesion only percutaneous revascularization plus
potential staged revascularization in patients with acute myocardial
infarction complicated by cardiogenic shock: Design and rationale of
CULPRIT-SHOCK trial.
Source
American Heart Journal. 172 (pp 160-169), 2016. Date of Publication:
February 2016.
Author
Thiele H.; Desch S.; Piek J.J.; Stepinska J.; Oldroyd K.; Serpytis P.;
Montalescot G.; Noc M.; Huber K.; Fuernau G.; De Waha S.; Meyer-Saraei R.;
Schneider S.; Windecker S.; Savonitto S.; Briggs A.; Torremante P.; Vrints
C.; Schuler G.; Ceglarek U.; Thiery J.; Zeymer U.
Institution
(Thiele, Desch, Fuernau, De Waha, Meyer-Saraei) University Heart Center
Luebeck, Luebeck, Germany
(Thiele, Desch, Fuernau, De Waha, Meyer-Saraei) German Center for
Cardiovascular Research (DZHK), Luebeck, Germany
(Piek) Academic Medical Center, Amsterdam, Netherlands
(Stepinska) Institute of Cardiology, Warsaw, Poland
(Oldroyd) Western Infirmary, Glasgow, United Kingdom
(Serpytis) Vilnius University Hospital, Vilnius, Lithuania
(Montalescot) ACTION Study Group, Centre Hospitalier, Universitaire
Pitie-Salpetriere, Paris, France
(Noc) University Medical Center Ljubljana, Ljubljana, Slovenia
(Huber) Wilhelminenspital der Stadt Wien, Vienna, Austria
(Schneider, Zeymer) Institut fur Herzinfarktforschung, Ludwigshafen,
Germany
(Windecker) University of Bern, Inselspital, Bern, Switzerland
(Savonitto) Manzoni Hospital, Lecco, Italy
(Briggs) Institute of Health and Wellbeing, University of Glasgow,
Glasgow, United Kingdom
(Torremante) GABO:milliarium MbH and Co KG, Munich, Germany
(Vrints) Universitair Ziekenhuis Antwerp, Antwerp, Belgium
(Schuler) University of Leipzig-Heart Center, Leipzig, Germany
(Ceglarek, Thiery) University of Leipzig-Institute of Laboratory Medicine,
Leipzig, Germany
(Zeymer) Klinikum Ludwigshafen, Ludwigshafen, Germany
Publisher
Mosby Inc. (E-mail: customerservice@mosby.com)
Abstract
Background In acute myocardial infarction complicated by cardiogenic shock
(CS), up to 80% of patients present with multivessel coronary artery
disease. Currently, the best revascularization strategy is unknown.
Therefore, a prospective randomized adequately powered clinical trial is
warranted. Study design The CULPRIT-SHOCK study is a 706-patient
controlled, international, multicenter, randomized, open-label trial. It
is designed to compare culprit lesion only percutaneous coronary
intervention (PCI) with possible staged non-culprit lesion
revascularization versus immediate multivessel PCI in patients with CS
complicating acute myocardial infarction. Patients will be randomized in a
1:1 fashion to one of the two treatment arms. The primary efficacy
endpoint of CULPRIT-SHOCK is 30-day mortality and severe renal failure
requiring renal replacement therapy. Secondary outcome measures such as
hemodynamic, laboratory, and clinical parameters will serve as surrogate
endpoints for prognosis. Furthermore, an intermediate- and long-term
follow-up at 6 and 12 months will be performed. Safety endpoints include
the assessment of bleeding and stroke. Conclusions The CULPRIT-SHOCK trial
will address the question of optimal revascularization strategy in
patients with multivessel disease and acute myocardial infarction
complicated by CS. Copyright © 2015 Elsevier Inc. All rights
reserved.

<2>
Accession Number
606892408
Title
Colchicine for postoperative pericardial effusion: A multicentre,
double-blind, randomised controlled trial.
Source
Heart. 101 (21) (pp 1711-1716), 2015. Date of Publication: 01 Nov 2015.
Author
Meurin P.; Lelay-Kubas S.; Pierre B.; Pereira H.; Pavy B.; Iliou M.C.;
Bussiere J.L.; Weber H.; Beugin J.P.; Farrokhi T.; Bellemain-Appaix A.;
Briota L.; Tabet J.Y.
Institution
(Meurin, Weber, Tabet) Department of Cardiology, Les Grands Pres (CRCB),
27 rue Sainte Christine, Villeneuve Saint Denis 77174, France
(Lelay-Kubas) Centre de Readaptation Bois Gibert, Ballan Mire, France
(Pierre) IRIS, Marcy l'etoile, France
(Pereira) Assistance Publique, Hopitaux de Paris, Hopital Europeen
Georges-Pompidou, Unite D'epidemiologie et de Recherche Clinique, Paris,
France
(Pereira) INSERM, Centre D'Investigation Clinique 1418, Module
epidemiologie Clinique, Paris, France
(Pavy) Centre Hospitalier Loire Vendee Ocean, Machecoul, France
(Iliou) Corentin-Celton Hospital, Issy Les Moulineaux, France
(Bussiere) Clinique de Chatillon, Chatillon, France
(Beugin) Clinique de la Mitterie, 195 rue Adolphe Defrenne, Lomme, France
(Farrokhi) Bligny Hospital, Briis-sous-Forges, France
(Bellemain-Appaix) La Maison du Mineur, Vence, France
(Briota) Centre Dieuleufit Sante, Dieulefit, France
(Tabet) Private Hospital Jacques Cartier, Institut Cardiovasculaire Paris
Sud, Massy, France
Publisher
BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com)
Abstract
Objectives Pericardial effusion is common after cardiac surgery. Growing
evidence suggests that colchicine may be useful for acute pericarditis,
but its efficacy in reducing pericardial effusion volume postoperatively
has not been assessed. Methods This randomised, double-blind,
placebocontrolled study conducted in 10 centres in France included 197
patients at high risk of tamponade (ie, with moderate to large-sized
persistent effusion (echocardiography grades 2, 3 or 4 on a scale of 0-4))
at 7-30 days after cardiac surgery. Patients were randomly assigned to
receive colchicine, 1 mg daily (n=98), or a matching placebo (n=99). The
main end point was change in pericardial effusion grade after 14-day
treatment. Secondary end points included frequency of late cardiac
tamponade. Results The placebo and the colchicine groups showed a similar
mean baseline pericardial effusion grade (2.9 +/-0.8 vs 3.0+/-0.8) and
similar mean decrease from baseline after treatment (-1.1+/-1.3 vs
-1.3+/-1.3 grades). The mean difference in grade decrease between groups
was -0.19 (95% CI -0.55 to 0.16, p=0.23). In total, 13 cases of cardiac
tamponade occurred during the 14-day treatment (7 and 6 in the placebo and
colchicine groups, respectively; p=0.80). At 6-month follow-up, all
patients were alive and had undergone a total of 22 (11%) drainages: 14 in
the placebo group and 8 in the colchicine group ( p=0.20). Conclusions In
patients with pericardial effusion after cardiac surgery, colchicine
administration does not reduce the effusion volume or prevent late cardiac
tamponade.

<3>
Accession Number
626925100
Title
Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic
Acid in Open Cardiac Surgery (DEPOSITION) study: Results of a pilot study.
Source
Journal of Cardiac Surgery. 34 (5) (pp 305-311), 2019. Date of
Publication: May 2019.
Author
Habbab L.M.; Hussain S.; Power P.; Bashir S.; Gao P.; Semelhago L.;
VanHelder T.; Parry D.; Chu V.; Lamy A.
Institution
(Habbab, Hussain, Power, Bashir, Gao, Semelhago, VanHelder, Parry, Chu,
Lamy) Division of Cardiac Surgery, David Braley Cardiac, Vascular and
Stroke Research Institute, Hamilton General Hospital, McMaster University,
Hamilton, ON, Canada
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Background: Cardiac surgery patients are at high risk for postoperative
bleeding. Intravenous (IV) tranexamic acid (TxA) is a commonly used
antifibrinolytic drug, but is associated with postoperative seizures. We
conducted this pilot randomized controlled trial (RCT) to determine the
feasibility of a larger trial that will be designed to investigate the
impact of TxA administration route, intrapericardial (IP) vs IV, on
postoperative bleeding and seizures. Method(s): In this
single-center, double-blinded, pilot RCT we enrolled adult patients
undergoing nonemergent on-pump cardiac operations through a median
sternotomy. Participants were randomized to IP or IV TxA groups. The
primary outcomes were cumulative chest tube drainage, transfusion
requirements, and incidence of postoperative seizures. Result(s): A
total of 97 participants were randomized to the intervention and control
groups. Baseline characteristics were similar in both groups. Most
participants underwent a CABG and/or aortic valve replacement. There was
no statistical difference. The IP TxA group was found to have a tendency
for less chest tube drainage in comparison to the IV TxA group, 500.5
(370.0-700.0) and 540.0 (420.0-700.0) mL, respectively, which was not
statistically significant (P = 0.2854). Fewer participants in the IP TxA
group with cardiac tamponade and/or required a reoperation for bleeding
and fewer packed red blood cell transfusions. None of the IP TxA group
developed seizure vs one from the IV TxA group. Conclusion(s): This
is the first known pilot RCT to investigate the role of TxA route of
administration in open cardiac surgery. Intrapericardial TxA shows
promising results with decreased bleeding, transfusion requirements,
reoperations, and postoperative seizures. A larger RCT is needed to
confirm these results and lead to a change in practice. Copyright
© 2019 Wiley Periodicals, Inc.

<4>
Accession Number
2003424367
Title
Genetic determinants of responsiveness to mesenchymal stem cell injections
in non-ischemic dilated cardiomyopathy.
Source
EBioMedicine. 48 (pp 377-385), 2019. Date of Publication: October 2019.
Author
Rieger A.C.; Myerburg R.J.; Florea V.; Tompkins B.A.; Natsumeda M.; Premer
C.; Khan A.; Schulman I.H.; Vidro-Casiano M.; DiFede D.L.; Heldman A.W.;
Mitrani R.; Hare J.M.
Institution
(Rieger, Florea, Tompkins, Natsumeda, Premer, Khan, Schulman,
Vidro-Casiano, DiFede, Hare) Interdisciplinary Stem Cell Institute,
University of Miami Miller School of Medicine, Miami, FL, United States
(Myerburg, Heldman, Mitrani, Hare) Cardiovascular Division, University of
Miami Miller School of Medicine, Miami, FL, United States
(Tompkins) Department of Surgery, University of Miami Miller School of
Medicine, Miami, FL, United States
(Schulman) Katz Family Division of Nephrology and Hypertension, University
of Miami Miller School of Medicine, Miami, FL, United States
Publisher
Elsevier B.V.
Abstract
Background: Non-ischemic dilated cardiomyopathy (NIDCM) responds variably
to intramyocardial injection of mesenchymal stem cells (MSCs). We
hypothesized that NIDCM genotype may influence responsiveness to MSC
therapy and performed genotyping on all patients in the POSEIDON-DCM
trial. Method(s): POSEIDON-DCM patients (n = 34) underwent genetic
sequence analysis and deletion/duplication testing. The results were
classified as positive for pathological variants (PV+; n = 8), negative
for any variants (V-; n = 6), or as variants of uncertain significance
(VUS; n = 20). All outcomes of therapy were analysed for each category of
genetic results. Finding(s): The 3 groups were indistinguishable at
baseline with regard to ejection fraction (EF), demographics, medication
use, or functional parameters. V- patients had an increase in EF at 12
months: +13.6% (IQR = +7.8%; +20.5%; p = 0.002), compared with VUS (+6.5%;
IQR = +0.9%, +11.1%; p = 0.005) and PV+(-5.9%; IQR = -12.7%, +1.0; p =
0.2; p = 0.01 between groups). Six-minute walk distance improved in V-
patients, but not in VUS and PV+. V- patients improved MLHFQ, compared to
the other 2 groups, which did not improve over time. EPC[sbnd]CFUs
increased by 9.7 +/- 1.9 in V- (p = 0.009) compared to VUS and PV+
patients. V- patients had one-year survival (100%) compared with VUS (85%)
and PV+ (40%; p = 0.015 log-rank). Similarly, MACE rates were lower in V-
(0%) than PV+ (61.9%) or VUS (42.2%; p = 0.021 log-rank).
 Interpretation(s): Our findings support the concept that the genetic
profile of NIDCM patients plays a role in responsiveness to MSC therapy,
with V- patients more likely to benefit and the converse for PV+. This
observation emphasizes the need for further genetic studies, because of
important implications for the management of NIDCM
syndromes. Copyright © 2019

<5>
Accession Number
2003409935
Title
The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous
Mitral Annuloplasty in Functional Mitral Regurgitation.
Source
JACC: Heart Failure. 7 (11) (pp 945-955), 2019. Date of Publication:
November 2019.
Author
Witte K.K.; Lipiecki J.; Siminiak T.; Meredith I.T.; Malkin C.J.; Goldberg
S.L.; Stark M.A.; von Bardeleben R.S.; Cremer P.C.; Jaber W.A.; Celermajer
D.S.; Kaye D.M.; Sievert H.
Institution
(Witte, Malkin) Leeds Institute for Cardiovascular and Metabolic Medicine,
University of Leeds, Leeds, United Kingdom
(Lipiecki) Clinique Pole Sanioyte Republique, Clermont Ferrand, France
(Siminiak) Poznan University of Medical Sciences, HCP Medical Center,
Poznan, Poland
(Meredith) Faculty of Medicine, Nursing and Health Sciences, Monash
University, Melbourne, Australia
(Goldberg) Tyler Heart Institute at Community Hospital of the Monterey
Peninsula, Monterey, CA, United States
(Goldberg, Stark) Cardiac Dimensions, Kirkland, WA, United States
(von Bardeleben) Department of Cardiology, University Medical Centre
Mainz, Mainz, Germany
(Cremer, Jaber) Department of Cardiovascular Medicine, Cleveland Clinic,
Cleveland, OH, United States
(Celermajer) Faculty of Medicine and Health, University of Sydney, New
South Wales, Australia
(Kaye) Department of Cardiology, Alfred Hospital, Melbourne, Victoria,
Australia
(Sievert) CardioVascular Center Sankt Katherinen, Frankfurt, Germany
(Sievert) Anglia Ruskin University, Chelmsford, United Kingdom
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Objectives: This study sought to evaluate the effects of the Carillon
device on mitral regurgitation severity and left ventricular remodeling.
 Background(s): Functional mitral regurgitation (FMR) complicates
heart failure with reduced ejection fraction and is associated with a poor
prognosis. Method(s): In this blinded, randomized, proof-of-concept,
sham-controlled trial, 120 patients receiving optimal heart failure
medical therapy were assigned to a coronary sinus-based mitral annular
reduction approach for FMR or sham. The pre-specified primary endpoint was
change in mitral regurgitant volume at 12 months, measured by quantitative
echocardiography according to an intention-to-treat analysis.
 Result(s): Patients (69.8 +/- 9.5 years of age) were randomized to
either the treatment (n = 87) or the sham-controlled (n = 33) arm. There
were no significant differences in baseline characteristics between the
groups. In the treatment group, 73 of 87 (84%) had the device implanted.
The primary endpoint was met, with a statistically significant reduction
in mitral regurgitant volume in the treatment group compared to the
control group (decrease of 7.1 ml/beat [95% confidence interval [CI]:
-11.7 to -2.5] vs. an increase of 3.3 ml/beat [95% CI: -6.0 to 12.6],
respectively; p = 0.049). Additionally, there was a significant reduction
in left ventricular volumes in patients receiving the device versus those
in the control group (left ventricular end-diastolic volume decrease of
10.4 ml [95% CI: -18.5 to -2.4] vs. an increase of 6.5 ml [95% CI: -5.1 to
18.2]; p = 0.03 and left ventricular end-systolic volume decrease of 6.2
ml [95% CI: -12.8 to 0.4] vs. an increase of 6.1 ml [95% CI: -1.42 to
13.6]; p = 0.04). Conclusion(s): The Carillon device significantly
reduced mitral regurgitant volume and left ventricular volumes in
symptomatic patients with functional mitral regurgitation receiving
optimal medical therapy. (Carillon Mitral Contour System for Reducing
Functional Mitral Regurgitation [REDUCE FMR]; NCT02325830) Copyright
© 2019 The Authors

<6>
Accession Number
628822329
Title
Update in Cardiac Sarcoidosis.
Source
Annals of the American Thoracic Society. 16 (11) (pp 1341-1350), 2019.
Date of Publication: 01 Nov 2019.
Author
Ribeiro Neto M.L.; Jellis C.L.; Joyce E.; Callahan T.D.; Hachamovitch R.;
Culver D.A.
Institution
(Ribeiro Neto, Culver) Department of Pulmonary and Critical Care Medicine
(Jellis, Callahan, Hachamovitch) Department of Cardiovascular Medicine,
and Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio; and
(Joyce) Department of Cardiology, Mater Misericordiae University Hospital,
Dublin, Ireland
Publisher
NLM (Medline)
Abstract
Increasing awareness of cardiac manifestations of sarcoidosis and the
widespread availability of advanced imaging tests have led to a tidal wave
of interest in a condition that was once considered rare. In this Focused
Review, we explore important clinical questions that may confront
specialists faced with possible cardiac involvement. In the absence of an
ideal reference standard, three main sets of clinical criteria exist: the
Japanese Ministry of Health and Welfare, the Heart Rhythm Society, and the
World Association for Sarcoidosis and Other Granulomatous Disorders
criteria. Once cardiac sarcoidosis is suspected, clinicians should be
familiar with the prevalence of the disease in different clinical
scenarios. Before obtaining advanced cardiac imaging, electrocardiogram,
ambulatory electrocardiogram, echocardiogram, and B-type natriuretic
peptide may be useful. The available therapies for cardiac sarcoidosis
include immunosuppression, antiarrhythmic medications, heart failure
medications, device therapy, ablation therapy, and heart transplantation.
Contemporary data suggest that long-term survival in cardiac sarcoidosis
is better than previously believed. There is no randomized controlled
trial demonstrating benefits of screening, but screening is recommended
based on observational data.

<7>
Accession Number
629094153
Title
Radial Versus Femoral Approach in Women Undergoing Coronary Angiography: A
Meta-Analysis of Randomized Controlled Trials.
Source
The Journal of invasive cardiology. 31 (11) (pp 335-340), 2019. Date of
Publication: 01 Nov 2019.
Author
Al Halabi S.; Burke L.; Hussain F.; Lopez J.; Mathew V.; Bernat I.; Shroff
A.
Institution
(Shroff) Division of Cardiology, Department of Medicine University of
Illinois Hospital & Health Sciences System, 740 West Taylor Street,
Chicago
Publisher
NLM (Medline)
Abstract
OBJECTIVES: We sought to compare outcomes with radial vs femoral approach
in female patients undergoing coronary angiography. BACKGROUND: Women
undergoing cardiac procedures have increased risk of bleeding and vascular
complications, but are under-represented in randomized clinical trials
(RCTs) involving coronary angiography. METHOD(S): We performed a
meta-analysis of RCTs comparing outcomes in women undergoing angiography
with radial vs femoral approaches. The primary outcome was non-coronary
artery bypass graft (CABG) related bleeding at 30 days. Secondary outcomes
included major adverse cardiovascular or cerebrovascular events (MACCE; a
composite of death, stroke or myocardial infarction), vascular
complications, procedure duration, and access-site crossover.
 RESULT(S): Four studies (n = 6041 female patients) met the inclusion
criteria. In female patients undergoing coronary angiography, radial
access decreased non-CABG related bleeding (odds ratio [OR], 0.56; 95%
confidence interval [CI], 0.44-0.72; P<.001), MACCE (OR, 0.73; 95% CI,
0.58-0.93; P=.01), vascular complications (OR, 0.49; 95% CI, 0.32-0.75;
P<.001) with no significant difference in procedure time (mean difference,
0.04; 95% CI, -0.97 to 0.89; P=.93). There was an increase in access-site
crossover using the radial approach (OR, 2.86; 95% CI, 2.24-3.63; P<.001).
Patients undergoing radial approach were more likely to prefer radial
access for the next procedure (OR, 6.96; 95% CI, 5.70-8.50; P<.001).
 CONCLUSION(S): In female patients undergoing coronary angiography or
intervention, the radial approach is associated with decreased bleeding,
MACCE, and vascular complications. These data suggest that radial access
should be the preferred approach for women.

<8>
Accession Number
626662994
Title
Time course of the survival advantage of transcatheter over surgical
aortic valve replacement: Interplay between sex and patient risk profile.
Source
Catheterization and Cardiovascular Interventions. 94 (5) (pp 746-752),
2019. Date of Publication: 01 Nov 2019.
Author
Ueshima D.; Masiero G.; Schiavo A.; Badawy M.R.A.; Fraccaro C.; Napodano
M.; Brener S.J.; Tarantini G.
Institution
(Ueshima, Masiero, Schiavo, Badawy, Fraccaro, Napodano, Tarantini)
Department of Cardiac, Thoracic and Vascular Sciences, University of Padua
Medical School, Padua, Italy
(Badawy) Department of Cardiology, Faculty of Medicine, Minia University,
Minya, Egypt
(Brener) Department of Medicine, Cardiac Catheterization Laboratory, New
York Methodist Hospital, New York, NY, United States
Publisher
John Wiley and Sons Inc. (P.O.Box 18667, Newark NJ 07191-8667, United
States)
Abstract
Objectives: The aim of this study was to explore the time course of
survival advantage of TAVR over SAVR as function of the patients' risk and
sex. Background(s): Women have been reported to have better survival
than men undergoing transcatheter aortic valve replacement (TAVR).
However, scant data on the sex-based survival benefit of TAVR over
surgical aortic valve replacement (SAVR) are available. Method(s): A
systematic review of studies reporting clinical outcomes of men and women
undergoing TAVR or SAVR was performed. Studies were divided into two
groups according to average patient's risk score and the interplay of
surgical risk and sex on outcomes were analyzed. Result(s): Eight
studies involving 6,596 women and 7,204 men patients were extracted.
Unlike mens, women patients had survival advantage from TAVR over SAVR
that became substantial at 1 year from index procedure and persisted at
2-year of follow-up. Moreover, this sex-based TAVR survival advantage was
mainly observed in higher surgical risk patients. Men showed a
significantly lower rate of residual paravalvular leak after SAVR.
 Conclusion(s): Women patients had a selective mortality benefit from
TAVR compared to SAVR. This sex-based TAVR benefit was mainly observed in
high surgical risk patients beyond 1 year from procedure. Copyright
© 2019 Wiley Periodicals, Inc.

<9>
Accession Number
2003395091
Title
Hybrid Coronary Artery Revascularization: A Review and Current Evidence.
Source
Innovations: Technology and Techniques in Cardiothoracic and Vascular
Surgery. 14 (5) (pp 394-404), 2019. Date of Publication: 01 Oct 2019.
Author
Kiaii B.; Teefy P.
Institution
(Kiaii) Department of Cardiac Surgery, London Health Sciences Centre,
London, ON, Canada
(Teefy) Department of Cardiology, London Health Sciences Centre, London,
ON, Canada
Publisher
SAGE Publications Ltd (E-mail: info@sagepub.co.uk)
Abstract
Objective: The role of hybrid coronary revascularization (HCR), which
utilizes the combination of minimally invasive surgical coronary artery
bypass grafting of the left anterior descending artery and percutaneous
coronary intervention (PCI) of non-left anterior descending vessels to
treat multivessel coronary artery disease, is expanding. We set out to
provide a review of this technology. Method(s): We conducted a
retrospective analysis of all minimally invasive hybrid operations
performed at our institution from September 2004 to December 2018. An
effective analysis comparing patients undergoing HCR vs off-pump or
on-pump surgical coronary artery revascularization was undertaken using an
adjusted analysis with inverse-probability weighting based on the
propensity score. Outcomes that were assessed include death, myocardial
infarction, stroke, atrial fibrillation, renal failure, requirement of
blood transfusion, conversion to open procedure (in the hybrid group),
length of stay in intensive care unit, and total length of stay in
hospital. Intention-to-treat analysis was performed. An up-to-date
literature review of HCR complements this study. Result(s): Since
2004 a total of 191 consecutive patients (61.4+/-11.1 years; 142 males and
49 females) underwent HCR (robotic-assisted coronary artery bypass graft
of the left internal thoracic artery to the left anterior descending
coronary artery (LAD) and PCI of a non-LAD vessel) in a single- or
double-stage fashion. Successful HCR occurred in 183 of the 191 patients
(8 patients required intraoperative conversion to conventional coronary
bypass). From our comparative analysis and literature review we found no
significant difference between HCR and coronary artery bypass grafting
groups with respect to in-hospital and 1-year follow-up.
 Conclusion(s): Current evidences suggest that HCR is a feasible,
safe, and effective coronary artery revascularization strategy in selected
patients with multivessel coronary artery disease. Copyright ©
The Author(s) 2019.

<10>
Accession Number
623950147
Title
Point-of-care viscoelastic hemostatic testing in cardiac surgery patients:
a systematic review and meta-analysis.
Source
Canadian Journal of Anesthesia. 65 (12) (pp 1333-1347), 2018. Date of
Publication: 01 Dec 2018.
Author
Lodewyks C.; Heinrichs J.; Grocott H.P.; Karkouti K.; Romund G.; Arora
R.C.; Tangri N.; Rabbani R.; Abou-Setta A.; Zarychanski R.
Institution
(Lodewyks, Arora) Department of Surgery, Section of Cardiac Surgery, Max
Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada
(Lodewyks, Tangri, Rabbani, Abou-Setta, Zarychanski) Department of
Community Health Sciences, Max Rady College of Medicine, University of
Manitoba, Winnipeg, MB, Canada
(Heinrichs, Grocott) Department of Anesthesia and Perioperative Medicine,
Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada
(Karkouti) Department of Anesthesia, Institute of Health Policy,
Management, and Evaluation, and Peter Munk Cardiac Centre, University of
Toronto, Toronto, ON, Canada
(Romund) Neil John Maclean Library, University of Manitoba, Winnipeg, MB,
Canada
(Rabbani, Abou-Setta, Zarychanski) George & Fay Yee Center for Healthcare
Innovation, University of Manitoba/Winnipeg Regional Health Authority,
Winnipeg, MB, Canada
(Arora, Tangri, Zarychanski) Department of Internal Medicine, Max Rady
College of Medicine, University of Manitoba, Winnipeg, MB, Canada
(Lodewyks) Y3505-409 Tache Avenue, Winnipeg, MB R2H 2A6, Canada
Publisher
Springer New York LLC (E-mail: barbara.b.bertram@gsk.com)
Abstract
Purpose: Thromboelastography and rotational thromboelastometry are
point-of-care (POC) viscoelastic tests used to help guide blood product
administration. It is unclear whether these tests improve clinical or
transfusion-related outcomes. The objective of this study was to appraise
data from randomized trials evaluating the benefit of POC testing in
cardiac surgery patients. Primary outcomes were the proportion of patients
transfused with blood products and all-cause mortality. Source: Medline
(Ovid), EMBASE (Ovid), CENTRAL (the Cochrane Library-Wiley), Web of
Science, Biosis, Scopus, and CINAHL databases, as well as clinical trial
registries and conference proceedings were queried from inception to
February 2018. Principal findings: We identified 1,917 records, 11 of
which were included in our analysis (8,294 patients). Point-of-care
testing was not associated with a difference in the proportion of patients
transfused with any blood product (risk ratio [RR], 0.90; 95% confidence
interval [CI], 0.79 to 1.02; I2 = 51%; four trials, 7,623
patients), or all-cause mortality (RR, 0.73; 95% CI, 0.47 to 1.13;
I2 = 5%; six trials, 7,931 patients). Nevertheless, POC testing
was weakly associated with a decrease in the proportion of patients
receiving red blood cells (RBC) (RR, 0.91; 95% CI, 0.85 to 0.96;
I2 = 0%; seven trials, 8,029 patients), and heterogeneous
reductions in frozen plasma (FP) (RR, 0.58; 95% CI, 0.34 to 0.99;
I2 = 87%; six trials, 7,989 patients) and platelets (RR, 0.66;
95% CI, 0.49 to 0.90; I2 = 65%; seven trials, 8,029 patients).
Meta-analysis of the number of units of RBCs and FP was not possible due
to heterogeneity in reporting, however POC testing significantly reduced
the units of platelets transfused (standard mean difference, -0.09; 95%
CI, -0.18 to 0.00; four trials, 7,643 patients). Conclusion(s): Our
review indicates that in cardiac surgery patients, POC viscoelastic
hemostatic testing is not associated with a reduction in the proportion of
patients receiving any blood product or all-cause mortality. However,
viscoelastic testing is weakly associated with a reduction in proportion
of patients transfused with specific blood products. Presently, the
benefits associated with viscoelastic testing in cardiac surgery patients
are insufficiently robust to recommend routine implementation of this
technology. Trial registration: PROSPERO (CRD4201706577). Registered 11
May 2017. Copyright © 2018, Canadian Anesthesiologists' Society.

<11>
Accession Number
2003647557
Title
P1.16-A Surgical Therapy for Malignant Pleural Mesothelioma in Mexican
Population.
Source
Journal of Thoracic Oncology. Conference: 2019 Latin America Conference on
Lung Cancer. Mexico. 14 (11 Supplement 2) (pp S1180), 2019. Date of
Publication: November 2019.
Author
Torres M.E.M.; Saldana R.B.; Mejia J.A.B.
Institution
(Torres, Saldana) National Institute of Respiratory Disease, Mexico City,
Mexico
(Mejia) Thoracic Surgery, ISSEMYM Medical Center Toluca, Metepec, Mexico
Publisher
Elsevier Inc.
Abstract
Background: Malignant pleural mesothelioma (MPM) remains an aggressive
thoracic malignancy associated with poor prognosis. There is no standard
treatment regimen, and particularly, the impact of radical surgery remains
controversial. The main goal of our retrospective single-centre study was
to evaluate the surgical treatment at our division regarding their effect
on the patient's survival. Method(s): We retrospectively reviewed
data from 23 consecutive patients with histologically proven MPM, treated
from 2012 to 2015 in National Institute of Respiratory Disease. Mexico
City. The program was used: SPSS 20 SPSS Inc, Chicago, IL. Statistical
tests were considered significant for P values <0.05. Result(s):
There were 9 women (39%) and 14 men (61%) with a mean age of 57.6 years.
Epitheloid subtype was found in 23 patients (100%). Extended
pleurectomy/decortication was performed in 9 (39%) and extrapleural
pneumonectomy in 10 (43.4), in 4 (17.3) cases the procedure could not be
completed. Clinical staging was: IIB in 6(26.1%) and III in 12 (52.2%).
Frecuency of complications was 12 (52.2%). 30-day mortality rate was
4.34%. Mean survival time for the collective was 25.4 months. Median
survival of patients undergoing surgical resection with complete trimodal
therapy was significantly longer tan that of patients undergoing surgery
only (36.1 versus 18.5 months; p <0.05). [Figure presented]
 Conclusion(s): Our data suggest that patients undergoing surgical
resection with adjuvant therapy was longer survival. A large multicenter,
randomized trial, testing P/D after induction chemotherapy versus
chemotherapy alone in MPM patients with good prognostic factors, is
needed. Keywords: Malignant pleural mesothelioma, Extrapleural
pneumonectomy, Extended pleurectomy/decortication, Thoracic
surgery Copyright © 2019

<12>
Accession Number
629733782
Title
Trials Focusing on Prevention and Treatment of Delirium After Cardiac
Surgery: A systematic Review of Randomized Evidence.
Source
Journal of cardiothoracic and vascular anesthesia. (no pagination), 2019.
Date of Publication: 24 Sep 2019.
Author
Pieri M.; De Simone A.; Rose S.; De Domenico P.; Lembo R.; Denaro G.;
Landoni G.; Monaco F.
Institution
(Pieri, De Domenico, Lembo, Denaro, Landoni, Monaco) Department of
Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute,
Milan, Italy
(De Simone) Department of Neonatal Intensive Care Unit, IRCCS San Raffaele
Scientific Institute, Milan, Italy
(Rose) Department of Neurology Rehabilitation, IRCCS San Raffaele
Scientific Institute, Milan, Italy
Publisher
NLM (Medline)
Abstract
BACKGROUND: Delirium after cardiac surgery is associated with adverse
outcomes, including prolonged hospital stay, prolonged intensive care unit
stay, and increased mortality. Effective preventive interventions and
treatments still are largely unknown. AIM: This systematic review aimed to
gather and summarize the existing evidence from randomized trials
concerning interventions studied in the prevention or treatment of
delirium in adult patients undergoing cardiac surgery. METHOD(S): A
systematic review of the literature using a key word strategy and Boolean
operators was performed. PubMed and the Cochrane and Scopus databases were
searched for pertinent studies until July 2018 (no inception limit).
 RESULT(S): Of 2,556 articles identified, 56 studies met the inclusion
criteria and were included in the review-39 addressed pharmacologic
strategies and 17 nonpharmacologic interventions. Interestingly, 51 (91%)
trials focused on delirium prevention and only 5 (9%) on delirium
treatment. Most of the analyzed studies were recent double-blind,
single-center trials conducted in Europe or North America, with a low risk
of bias. Overall, 38 different interventions were identified: 15 (26%)
interventions were performed before surgery, 20 (36%) in the operating
room, and 21 (38%) after surgery. The most frequently analyzed strategies
were the administration of dexmedetomidine, ketamine, antipsychotics,
glucocorticoids, propofol, opioids, volatile anesthetics, local
anesthetics, and remote ischemic preconditioning. The analyzed strategies
were extremely heterogenous, and dexmedetomidine was the most promising
measure able to prevent the development of postoperative delirium.
 CONCLUSION(S): In the present systematic review of 56 randomized
controlled trials that examined 38 interventions, the authors found that
dexmedetomidine was the most frequently studied agent and that it might
reduce the occurrence of delirium after cardiac surgery. Copyright
© 2019 Elsevier Inc. All rights reserved.

<13>
Accession Number
629733728
Title
A randomized control trial comparing prophylactic dexmedetomidine versus
clonidine on rates and duration of delirium in older adult patients
undergoing coronary artery bypass grafting.
Source
Journal of clinical anesthesia. (pp 109622), 2019. Date of Publication: 23
Oct 2019.
Author
Shokri H.; Ali I.
Institution
(Shokri, Ali) Ain Shams University, Cairo, Egypt
Publisher
NLM (Medline)
Abstract
STUDY OBJECTIVE: Postoperative delirium occurs in 20-50% of elderly
patients undergoing cardiac surgery and increases morbidity and mortality.
We investigated whether prophylactic dexmedetomidine could reduce delirium
incidence in elderly patients after coronary artery bypass grafting
(CABG), compared with clonidine. DESIGN: Prospective observational trial.
SETTING: Academic university hospital. PARTICIPANTS: Patients (60-70years
old) who underwent CABG and received either dexmedetomidine or clonidine
infusion postoperatively. INTERVENTIONS: Patients were randomly allocated
to dexmedetomidine or clonidine groups. In the dexmedetomidine group,
patients received an initial infusion of 0.7-1.2mug/kg/h; sedation and
analgesia were evaluated after 45-60min. If the Richmond assessment
sedation score (RASS) increased from +1 to +4, the infusion rate was
increased by 0.1-0.2mug/kg/h every 30min, up to 1-1.4mug/kg body-weight/h.
Dexmedetomidine infusion was not discontinued pre-extubation; thereafter,
infusion was reduced by 0.1mug/kg/h until 0.2mug/kg/h. The maximum
infusion duration was 72h. In the clonidine group, patients received an
initial infusion of 0.5mug/kg, followed by 1-2mug/kg/h, if the RASS
changed from +1 to +4. This was continued throughout mechanical
ventilation. MEASUREMENTS: Patients were followed up to 5days
post-surgery. Delirium incidence, extubation time, lengths of intensive
care unit (ICU) and hospital stay, need for inotropic support or
vasopressors, mean arterial blood pressure and heart rate, hospital
mortality rate, total postoperative morphine dose, number of patients
receiving haloperidol, and adverse events were recorded. MAIN RESULTS:
Two-hundred-and-eighty-six patients (dexmedetomidine, 144; clonidine, 142)
were studied. Dexmedetomidine was associated with lower risk and duration
of delirium, shorter mechanical ventilation duration and ICU stay, lower
mortality rate, and lower morphine consumption than the clonidine group.
Dexmedetomidine significantly decreased heart rates after ICU admission.
 CONCLUSION(S): Postoperative infusion of dexmedetomidine provides a
feasible option for postoperative control of delirium after CABG in adult
patients. Copyright © 2019 Elsevier Inc. All rights reserved.

<14>
Accession Number
629732064
Title
A meta-analysis of >=5-year mortality after transcatheter versus surgical
aortic valve replacement.
Source
The Journal of cardiovascular surgery. (no pagination), 2019. Date of
Publication: 25 Oct 2019.
Author
Takagi H.; Hari Y.; Nakashima K.; Kuno T.; Ando T.
Institution
(Takagi) Department of Cardiovascular Surgery, Shizuoka Medical Center,
Shizuoka, Japan
(Takagi) Department of Cardiovascular Surgery, Kitasato University School
of Medicine, Sagamihara, Japan
(Hari, Nakashima) Department of Cardiovascular Surgery, Shizuoka Medical
Center, Shizuoka, Japan
(Hari, Nakashima) Department of Cardiovascular Surgery, Kitasato
University School of Medicine, Sagamihara, Japan
(Kuno) Department of Medicine, Mount Sinai Beth Israel Medical Center, NY,
NY, United States
(Ando) Department of Cardiology, Detroit Medical Center, MI, Detroit,
United States
Publisher
NLM (Medline)
Abstract
BACKGROUND: It remains unclear whether long-term survival is superior
following transcatheter aortic valve implantation (TAVI) than following
surgical aortic valve replacement (SAVR). We performed a meta-analysis of
mortality with >=5-year follow- up in randomized controlled trials (RCTs)
and propensity-score matched (PSM) studies of TAVI versus SAVR.
 METHOD(S): MEDLINE, EMBASE, and the Cochrane Central Register of
Controlled Trials were searched through March 2019. Eligible studies were
RCTs or PSM studies of TAVI versus SAVR enrolling patients with severe
aortic stenosis and reporting all- cause mortality with >=5-year follow-up
as an outcome. A hazard ratio of mortality for TAVI versus SAVR was
extracted from each individual study. RESULT(S): Study-specific
estimates were combined in the random-effects model. Our search identified
3 RCTs and 7 PSM studies enrolling 5498 patients. A pooled analysis of all
10 studies demonstrated a statistically significant 38% increase in
mortality with TAVI relative to SAVR. A subgroup meta-analysis showed no
statistically significant difference between TAVI and AVR in RCTs and a
statistically significant 68% increase with TAVI relative to SAVR in PSM
studies. CONCLUSION(S): On the basis of a meta-analysis of 7 PSM
studies, TAVI is associated with greater all-cause mortality with >=5-year
follow-up than SAVR. However, another meta-analysis of 3 RCTs suggests no
difference in mortality between TAVI and SAVR.

<15>
Accession Number
629730852
Title
Cardiovascular outcomes with transcatheter vs. surgical aortic valve
replacement in low-risk patients: An updated meta-analysis of randomized
controlled trials.
Source
Cardiovascular revascularization medicine : including molecular
interventions. (no pagination), 2019. Date of Publication: 15 Aug 2019.
Author
Kundu A.; Sardar P.; Malhotra R.; Qureshi W.T.; Kakouros N.
Institution
(Kundu, Malhotra, Qureshi, Kakouros) Division of Cardiovascular Medicine,
University of Massachusetts Medical School, MA, Worcester, United States
(Sardar) Division of Cardiology, Brown University, Rhode Island Hospital,
Providence, RI, United States
Publisher
NLM (Medline)
Abstract
BACKGROUND: TAVR is an established treatment option in high and
intermediate-risk patients with severe AS. There is less data regarding
the efficacy of TAVR in low-risk patients. This meta-analysis evaluated
efficacy and safety outcomes of transcatheter aortic valve replacement
(TAVR) in comparison to surgical aortic valve replacement (SAVR) in
low-risk patients with severe aortic stenosis (AS). METHOD(S):
Databases were searched for randomized controlled trials (RCTs) that
compared TAVR with SAVR for the treatment of low-risk patients with severe
AS. We calculated pooled odds ratios (ORs) and 95% confidence intervals
(CIs) using the random-effects model. RESULT(S): The final analysis
included 2953 patients from 5 studies. Compared to SAVR, TAVR was
associated with similar mid-term mortality [OR 0.67; 95% CI 0.37-1.21;
p=0.18], as well as similar short-term mortality [OR 0.51; 95% CI
0.24-1.11; p=0.09]. Randomization to TAVR was associated with a reduced
risk of developing acute kidney injury [OR 0.26; 95% CI 0.13-0.52;
p<0.001], short-term major bleeding [OR 0.27; 95% CI 0.12-0.60; p<0.001]
and new-onset atrial fibrillation [OR 0.17; 95% CI 0.14-0.21; p<0.001].
However, TAVR was associated with a higher risk of requiring permanent
pacemaker implantation [OR 4.25; 95% CI 1.86-9.73; p<0.001]. There was no
significant difference in the risk of myocardial infarction, stroke,
endocarditis or aortic valve re-intervention between the two groups.
 CONCLUSION(S): Our meta-analysis showed that TAVR has similar
clinical efficacy to SAVR, with a more favorable safety profile, in
patients with severe AS who are at low-surgical risk. Copyright ©
2019 Elsevier Inc. All rights reserved.

<16>
Accession Number
629739325
Title
Safety and Efficacy of Enoxaparin in Pregnancy: A Systematic Review and
Meta-Analysis.
Source
Advances in therapy. (no pagination), 2019. Date of Publication: 31 Oct
2019.
Author
Jacobson B.; Rambiritch V.; Paek D.; Sayre T.; Naidoo P.; Shan J.;
Leisegang R.
Institution
(Jacobson) Department of Haematology and Molecular Medicine, University of
Witwatersrand, 1 Jan Smuts Ave, Johannesburg, South Africa
(Rambiritch) Department of Pharmacology, University of KwaZulu-Natal,
University Rd, Westville, South Africa
(Paek, Sayre) Doctor Evidence, 301 Arizona Ave, Santa Monica, CA, USA
(Naidoo) Sanofi Affiliate, Medical, Bond St, Grand Central, Midrand, South
Africa
(Naidoo) Department of Health Informatics, School of Health Professions,
Rutgers, State University of New Jersey, 57 US Highway 1, NB, United
States
(Shan) Sanofi Global, Medical, Paris, France
(Leisegang) Department of Pharmaceutical Biosciences, Uppsala University,
Uppsala 752 36, Sweden
(Leisegang) FAMCRU, Department of Paediatrics & Child Health, Stellenbosch
University, Tygerberg, Cape Town, South Africa
Publisher
NLM (Medline)
Abstract
INTRODUCTION: International guidelines support the use of low molecular
weight heparins for the treatment of thromboembolism and
thromboprophylaxis during pregnancy. However, evidence of the benefit and
harm associated with specific low molecular weight heparins such as
enoxaparin is dated. No current systematic review and meta-analysis
describing the safety and efficacy of enoxaparin for thromboembolism and
thromboprophylaxis during pregnancy exists. METHOD(S): PubMed,
Embase, and Cochrane databases were searched on August 17, 2018 for
clinical trials or observational studies in pregnant women receiving
enoxaparin; patients with a prosthetic heart valve were excluded. Risk
ratios (RR) with 95% confidence intervals (CI) were calculated using a
random effects model, and heterogeneity was measured using the I2
statistic. RESULT(S): Of the 485 records identified in the search, 24
studies published clinical trials, and observational studies were found
dating back to 2000. Only one observational cohort and one randomized
control trial focused on the use of enoxaparin for thromboprophylaxis and
therefore efficacy was not assessed; the other studies included women with
recurrent pregnancy loss (15 studies), history of placental vascular
complications (five studies), and recurrent in vitro fertilization failure
(two studies) and were therefore analyzed in terms of safety only.
Bleeding events were non-significantly more often reported for enoxaparin
compared to untreated controls (RR 1.35 [0.88-2.07]) but less often
reported for enoxaparin versus aspirin (RR 0.93 [0.62-1.39]);
thromboembolic events, thrombocytopenia, and teratogenicity were rarely
reported events; in patients with a history of recurrent pregnancy loss,
encouragingly the rates of pregnancy loss were significantly lower for
enoxaparin compared to untreated controls (RR 0.58 [0.34-0.96]) and
enoxaparin+aspirin versus aspirin alone (RR 0.42 [0.32-0.56]) as well as
observably lower for enoxaparin versus aspirin alone (RR 0.39
[0.15-1.01]), though significant heterogeneity was observed (I2>60).
 CONCLUSION(S): Literature on the efficacy and safety of enoxaparin
for thromboembolism and thromboprophylaxis remains scanty, and therefore
efficacy was not assessed; in terms of safety, when including other
indications for enoxaparin in pregnancy, we found that enoxaparin was
associated with significantly lower complications than aspirin. Given
differences in study design and study heterogeneity, pregnancy loss
results should be interpreted with caution. Moreover, reports of
thromboembolic events, thrombocytopenia, and congenital malformations were
rare.Sanofi.

<17>
Accession Number
629738717
Title
A meta-analysis comparing aspirin alone versus dual antiplatelet therapy
for the prevention of venous graft failure following coronary artery
bypass surgery.
Source
Cardiovascular revascularization medicine : including molecular
interventions. (no pagination), 2019. Date of Publication: 25 Oct 2019.
Author
Hesterberg K.; Rawal A.; Khan S.; Rashid A.; Jones D.; Siddiqui T.; Khader
T.A.; Nayyar M.; Shah R.
Institution
(Hesterberg, Rawal, Jones, Khader, Nayyar) Department of Medicine,
University of Tennessee, TN, Memphis, United States
(Khan) Department of Medicine, Aga Khan University, Pakistan
(Rashid) Jackson Clinic, University of Tennessee, TN, Jackson, United
States
(Siddiqui) Department of Medicine, Texas Tech University Health Sciences
Center El Paso, TX, United States
(Shah) Department of Medicine, University of Tennessee, Memphis, TN, USA;
Department of Cardiology, Gulf Coast Regional Medical Center, Panama City,
FL, USA
Publisher
NLM (Medline)
Abstract
BACKGROUND: Aspirin (ASA) monotherapy is the current standard of care
after coronary artery bypass grafting (CABG) to prevent saphenous vein
graft (SVG) failure. Several small, randomized clinical trials (RCTs) have
suggested that dual antiplatelet therapy (DAPT) may be more effective at
preventing SVG failure than ASA alone; however, it is unclear whether some
P2Y12 inhibitors are more effective than others for the prevention of SVG
failure. METHOD(S): Scientific databases and websites were searched
to find RCTs. Both traditional pairwise meta-analysis using random-effect
model and network meta-analysis using mixed-treatment comparison models
were performed to compare the efficacy of various anti-platelet strategies
for the prevention of SVG failure. RESULT(S): Nine RCTs, which
included a total of 1677 patients, were analyzed. Compared to ASA alone,
DAPT decreased the risk of graft failure by 37% (RR: 0.63, 95% CI:
0.47-0.86; p=0.003). In the moderator analysis, the decreased risk of
graft failure with DAPT was not significantly different in the
ASA+clopidogrel group than in the ASA+ticagrelor group
(P-interaction=0.17). The results of the network meta-analysis were
consistent with those from pairwise analyses. The risk of major bleeding
was not statistically significantly different between DAPT and ASA alone
(RR: 1.35, 95% CI: 0.62-2.94; p=0.45). CONCLUSION(S): In post-CABG
patients, DAPT seems to be more effective at preventing graft failure than
ASA alone. This strategy does not seem to significantly increase major
bleeding risk. Clopidogrel- and ticagrelor-based DAPT seem to be equally
effective for this indication. Copyright © 2019. Published by
Elsevier Inc.

<18>
Accession Number
629738381
Title
Transcatheter versus surgical aortic valve replacement in low surgical
risk patients: A meta-analysis of randomized-controlled trials and
propensity-matched studies.
Source
Cardiovascular revascularization medicine : including molecular
interventions. (no pagination), 2019. Date of Publication: 24 Oct 2019.
Author
Rawasia W.F.; Usman M.S.; Mujeeb F.A.; Zafar M.; Khan S.U.; Alkhouli M.
Institution
(Rawasia, Khan, Alkhouli) West Virginia University, Heart and Vascular
Institute, Morgantown, United States
(Usman, Mujeeb, Zafar) Dow University of Health Sciences, Karachi,
Pakistan
Publisher
NLM (Medline)
Abstract
BACKGROUND: We performed a meta-analysis of randomized trials (RCT) and
propensity-matched (PSM) studies comparing transcatheter aortic valve
implantation (TAVI) with surgical aortic valve replacement (SAVR) in low
surgical risk patients. METHOD(S): Published studies including
low-risk patients who underwent TAVI (n=9068) or SAVR (n=17,388) were
included. Outcomes of interest were short-term (30-day) and mid-term
(1-year) mortality and major complications. RESULT(S): Short-term
mortality was lower with TAVI vs. SAVR (1.8% vs. 2.8%, RR=0.67,
[0.56-0.80]). TAVI was associated with lower risk of atrial fibrillation
(7.4% vs. 36.5%, RR=0.21, [0.14-0.31]), and kidney injury (5.3% vs. 9%,
RR=0.45, [0.26-0.80]), but had higher incidence of vascular complications
(5.5% vs. 1.4%, RR=4.88 [1.47-16.18]), and permanent pacemaker
implantation (14.9% vs. 3.4%, RR=4.94 [3.03-8.08]). Stroke rates were
similar between both interventions (1.7% vs. 2.2%, RR=0.80 [0.54-1.18]).
Mid-term all-cause mortality was similar in the pooled analysis for TAVI
vs. SAVR (8.6% vs. 8.4%, RR=0.90 [0.66-1.24]), but was lower with TAVI in
RCTs (2.1% vs. 3.5%, RR=0.61 [0.39-0.95]). Cardiovascular mortality was
lower with TAVI (1.6% vs. 2.9%, RR=0.55 [0.33-0.90]), but stroke (3% vs.
4.2%, RR=0.69, [0.45-1.06]) and valve re-interventions rates (0.8% vs.
0.6%, RR=1.28 [0.52-3.17]) were similar between both strategies.
 CONCLUSION(S): TAVI in low surgical risk patients is associated with
lower short-term morbidity and mortality compared with SAVR. Copyright
© 2019 Elsevier Inc. All rights reserved.

<19>
Accession Number
629697604
Title
Combined proximal descending aortic endografting plus distal bare metal
stenting (Petticoat technique) versus conventional proximal descending
aortic stent graft repair for complicated type b aortic dissections.
Source
Cochrane Database of Systematic Reviews. 2019 (10) (no pagination), 2019.
Article Number: CD013149. Date of Publication: 30 Oct 2019.
Author
Rong D.; Ge Y.; Liu J.; Liu X.; Guo W.
Institution
(Rong, Ge, Liu, Liu, Guo) Department of Vascular and Endovascular Surgery,
Chinese PLA General Hospital, Beijing, China
Publisher
John Wiley and Sons Ltd (Southern Gate, Chichester, West Sussex PO19 8SQ,
United Kingdom. E-mail: vgorayska@wiley.com)
Abstract
Background Aortic dissection is a separation of the aortic wall, caused by
blood flowing through a tear in the inner layer of the aorta. Aortic
dissection is an infrequent but life-threatening condition. The incidence
of aortic dissection is 3 to 6 per 10,000 per year in the Western
population, and can be up to 43 per 10,000 per year in the Eastern
population. Over 20% of people with an aortic dissection do not reach a
hospital alive. After admission, the mortality rates for people with an
aortic dissection are between 10% and 20% for those who received
endovascular treatment, and between 20% and 30% for those who had open
surgery. Thoracic endovascular aortic repair (TEVAR) is the standard
endovascular method to treat complicated type B aortic dissection (aortic
dissections without involvement of the ascending aorta). Although TEVAR is
less invasive than open surgery and has a better long-term aortic
remodeling effect than conservative medical treatment, favourable aortic
remodelling is usually limited to the thoracic aortic segment. TEVAR
cannot be extended into the abdominal aorta because it could cover the
ostia of the reno-visceral arteries. Thus, the abdominal aorta is still at
risk of progressive aneurysmal degeneration. The PETTICOAT (provisional
extension to induce complete attachment) technique, with proximal
endograft and distal bare metal stent, was proposed in 2006 to address
this issue. The concept of this technique was to implant a distal bare
metal stent into the aortic true lumen, distal to the proximal endograft,
to stabilize the distal collapsed intimal flap, while allowing blood flow
to reno-visceral arteries. Therefore, the PETTICOAT technique was
considered to be related to a more extensive aortic remodelling for people
with type B aortic dissection, especially in the area of the abdominal
aorta. However, it is still unclear whether the PETTICOAT technique is
superior to standard TEVAR. Objectives To assess the effects of combined
proximal descending aortic endografting plus distal bare metal stenting
versus conventional proximal descending aortic stent graft repair for
treating complicated type B aortic dissections. Search methods The
Cochrane Vascular Information Specialist searched the Cochrane Vascular
Specialised Register, Cochrane Central Register of Controlled Trials
(CENTRAL), MEDLINE, Embase and Cumulative Index to Nursing and Allied
Health Literature (CINAHL) databases, and the World Health Organization
International Clinical Trials Registry Platform and ClinicalTrials.gov
trials registers to 5 November 2018. We also undertook reference checking
and citation searching to identify additional studies. Selection criteria
We considered all randomised controlled trials which compared the outcome
of complicated type B aortic dissection, when treated by combined proximal
descending aortic endografting plus distal bare metal stenting (PETTICOAT
technique) versus conventional proximal descending aortic stent graft
repair. Data collection and analysis Two independent review authors
assessed all references identified by the Cochrane Vascular Information
Specialist. We planned to undertake data collection and analysis in
accordance with recommendations described in the Cochrane Handbook for
Systematic Reviews of Interventions. Main results We found no trials that
met the inclusion criteria for this review. Authors' conclusions We
identified no randomised controlled trials and therefore cannot draw any
definite conclusion on this topic. Evidence from non-ran-domised studies
appears to be favourable in the short-term, for combined proximal
descending aortic endografting plus distal bare metal stenting (PETTICOAT
technique) to solve the problem of unfavourable distal aortic remodeling.
Randomised controlled trials are warranted to provide solid evidence on
this topic. Evidence from cohort studies with large sample sizes would
also be helpful in guiding clinical practice. Copyright © 2019
The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

<20>
Accession Number
2003464680
Title
Cost-Effectiveness of Transcatheter Aortic Valve Implantation Using a
Balloon-Expandable Valve in Japan: Experience From the Japanese Pilot
Health Technology Assessment.
Source
Value in Health Regional Issues. 21 (pp 82-90), 2020. Date of Publication:
May 2020.
Author
Inoue S.; Nakao K.; Hanyu M.; Hayashida K.; Shibahara H.; Kobayashi M.;
Asaoka M.; Nishikawa K.; Clancy S.; Koshiishi J.; Sakamaki H.
Institution
(Inoue, Shibahara, Kobayashi) CRECON Medical Assessment Inc, Tokyo, Japan
(Nakao) Division of Cardiology, Cardiovascular Center, Saiseikai Kumamoto
Hospital, Kumamoto, Japan
(Hanyu) Cardiovascular Center, Kitano Hospital, Osaka, Japan
(Hayashida) Department of Cardiology, Keio University School of Medicine,
Tokyo, Japan
(Asaoka, Nishikawa) Edwards Lifesciences Limited, Tokyo, Japan
(Clancy) Edwards Lifesciences Corporation, Irvine, CA, United States
(Koshiishi) Abbott Vascular Japan Co, Ltd, Tokyo, Japan
(Sakamaki) Graduate School of Health Innovation, Kanagawa University of
Human Services, Kanagawa, Japan
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Background: Transcatheter aortic valve implantation (TAVI) is an
innovative and effective treatment in high-surgical-risk (HR) and
inoperable patients with symptomatic severe aortic stenosis.
 Objective(s): This cost-effectiveness analysis of transfemoral TAVI
(TF-TAVI) compared with surgical aortic valve replacement (SAVR) conforms
with the methodological guidelines for cost-effectiveness evaluation by
the Ministry of Health, Labor, and Welfare in Japan. Method(s): The
cost-effectiveness of TF-TAVI using SAPIEN XT was evaluated using a
lifetime Markov simulation from the national payer perspective.
Comparators were SAVR for HR patients and standard of care (SOC) for
inoperable patients. A systematic literature review for clinical evidence
of TF-TAVI and comparators was conducted. The evidence for TF-TAVI was
derived from the SOURCE XT registry and Japanese post marketing
surveillance. Because there was no literature directly or indirectly
comparing TF-TAVI using SAPIEN XT with comparators, the comparator data
were selected from relevant published studies, considering the similarity
of study eligibility criteria and patient backgrounds (eg, age and
surgical risk scores). Sensitivity analyses were used to validate the
robustness of results. Result(s): The incremental cost-effectiveness
ratio of TF-TAVI versus SAVR for HR patients was 1.3
million/quality-adjusted life-years (QALYs). The incremental
cost-effectiveness ratio of TF-TAVI versus SOC for inoperable patients was
3.5 million/QALY. Conclusion(s): TF-TAVI was cost-effective when
compared with SAVR for HR patients and when compared with SOC for
inoperable patients, using a threshold of 5 million/QALY. Copyright
© 2019 ISPOR-The professional society for health economics and
outcomes research

<21>
Accession Number
626156595
Title
Chronic kidney disease is associated with increased mortality and
procedural complications in transcatheter aortic valve replacement: a
systematic review and meta-analysis.
Source
Catheterization and Cardiovascular Interventions. 94 (3) (pp E116-E127),
2019. Date of Publication: 01 Sep 2019.
Author
Rattanawong P.; Kanitsoraphan C.; Kewcharoen J.; Riangwiwat T.;
Chongyangyuenvong P.; Vutthikraivit W.; Mannem S.R.; Chung E.H.
Institution
(Rattanawong, Kanitsoraphan, Kewcharoen) Department of Internal Medicine,
University of Hawaii Internal Medicine Residency Program, Honolulu, HI,
United States
(Rattanawong, Chongyangyuenvong) Department of Internal Medicine, Faculty
of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
(Riangwiwat) Geisinger Commonwealth School of Medicine, Scranton, PA,
United States
(Vutthikraivit) Department of Internal Medicine, Texas Tech University
Health Sciences Center, Lubbock, TX, United States
(Mannem) Division of Cardiology, Queen's Medical Center, Honolulu, HI,
United States
(Chung) Department of Internal Medicine, Michigan Medicine, University of
Michigan, Ann Arbor, MI, United States
Publisher
John Wiley and Sons Inc. (P.O.Box 18667, Newark NJ 07191-8667, United
States)
Abstract
Objective: We performed a systematic review and meta-analysis to explore
the association between chronic kidney disease (CKD) and mortality and
procedural complications in transcatheter aortic valve replacement (TAVR).
 Background(s): The impact of varying stages of CKD or end-stage renal
disease (ESRD) on patients receiving TAVR is not clearly identified.
 Method(s): We searched the databases of MEDLINE and EMBASE from
inception to May 2018. Included studies were published TAVR studies that
compared the risk of mortality and procedural complications in CKD
patients compared to control patients. Data from each study were combined
using the random-effects model. Result(s): Twelve studies (42,703 CKD
patients and 51,347 controls) were included. Compared with controls, CKD
patients had a significantly higher risk of 30-day overall mortality (risk
ratio [RR] = 1.56, 95% confidence interval [CI]: 1.34-1.80, I2
= 60.9), long-term cardiovascular mortality (RR = 1.44, 95% CI: 1.22-1.70,
I2 = 36.2%), and long-term overall mortality (RR = 1.66, 95%
CI: 1.45-1.91, I2 = 80.3), as well as procedural complications
including pacemaker requirement (RR = 1.20, 95% CI: 1.03-1.39,
I2 = 56.1%) and bleeding (RR = 1.60, 95% CI: 1.26-2.02,
I2 = 86.0%). Risk of mortality and procedural complications
increased with severity of CKD for stages 3, 4, and 5, respectively, in
terms of long-term overall mortality (RR = 1.28, 1.82, and 2.12), 30-day
overall mortality (RR = 1.26, 1.89, and 1.93), 30-day cardiovascular
mortality (RR = 1.18, 1.75, and 2.50), and 30-day overall bleeding (RR =
1.19, 1.63, and 2.12). Conclusion(s): Our meta-analysis demonstrates
a significant increased risk of mortality and procedural complications in
patients with CKD who underwent TAVR compared to controls. Copyright
© 2019 Wiley Periodicals, Inc.

<22>
Accession Number
2001807204
Title
High Transpulmonary Artery Gradient Obtained at the Time of Left
Ventricular Assist Device Implantation Negatively Affects Survival After
Cardiac Transplantation.
Source
Journal of Cardiac Failure. 25 (10) (pp 777-784), 2019. Date of
Publication: October 2019.
Author
Uriel N.; Imamura T.; Sayer G.; Agarwal R.; Sims D.B.; Takayama H.; John
R.; Pagani F.D.; Naka Y.; Sundareswaran K.S.; Farrar D.J.; Jorde U.P.
Institution
(Uriel, Imamura, Sayer) Division of Cardiology, Department of Medicine,
University of Chicago Medical Center, Chicago, IL, United States
(Agarwal) Division of Cardiovascular Medicine, Cardiovascular Institute,
Allegheny Health Network, Pittsburgh, PA, United States
(Sims, Jorde) Division of Cardiology, Department of Medicine, Montefiore
Medical Center, Albert Einstein College of Medicine, Bronx, United States
(Takayama, Naka) Division of Cardiothoracic Surgery, Department of
Surgery, Columbia University Medical center, New York, United States
(John) Department of Surgery, University of Minnesota, Minneapolis, MN,
United States
(Pagani) Department of Surgery, University of Michigan, Ann Arbor, MI,
United States
(Sundareswaran, Farrar) Abbott, Pleasanton, CA, United States
Publisher
Churchill Livingstone Inc.
Abstract
Aim: Preoperatively elevated pulmonary vascular resistance (PVR) is a
contraindication to heart transplantation (HT). Transpulmonary pressure
gradient (TPG) is one of the main variables used in PVR determination (ie,
PVR = TPG/cardiac output). Unlike PVR, which is subject to the shortcoming
of cardiac output estimation, TPG is directly measured. We aimed to
evaluate the relationship of TPG obtained before left ventricular assist
device (LVAD) implantation on post-HT survival. Methods and Results:
A total of 490 patients were implanted with Heartmate II LVADs in the
multicenter Heartmate II Bridge-to-Transplantation clinical trial, and
416/490 had pre-LVAD TPG data available. Outcomes during LVAD support and
after HT stratified by both PVR and TPG were studied. The median pre-LVAD
TPG was 10 mm Hg. Baseline demographic and clinical characteristics were
similar for patients with and without TPG >10 mm Hg. Outcomes during LVAD
support (ie, recovery to LVAD explantation, HT, or ongoing device support)
for patients below and above the median TPG were similar. However, post-HT
1-year survival rate was significantly higher for patients with TPG <=10
mm Hg compared with those with TPG >10 mm Hg (91% vs 80%; P = .016).
Analysis based on the median PVR of 2.68 Wood units did not stratify
post-HTx 1-year survival rates between the groups (89% vs 83%; P = .25).
 Conclusion(s): Elevated TPG, rather than high PVR, before LVAD
implantation was associated with increased mortality following HT.
Pre-LVAD TPG may be useful to identify a cohort that requires close
follow-up with serial hemodynamic monitoring before HT. Copyright
© 2019 Elsevier Inc.

<23>
Accession Number
2003460303
Title
Diagnostic Value of Advanced Imaging Modalities for the Detection and
Differentiation of Prosthetic Valve Obstruction: A Systematic Review and
Meta-Analysis.
Source
JACC: Cardiovascular Imaging. 12 (11P1) (pp 2182-2192), 2019. Date of
Publication: November 2019.
Author
Kim J.Y.; Suh Y.J.; Han K.; Kim Y.J.; Choi B.W.
Institution
(Kim) Department of Radiology, Dongsan Medical Center, Keimyung University
College of Medicine, Daegu, Korea, South Korea
(Suh, Han, Kim, Choi) Department of Radiology, Research Institute of
Radiological Science, Severance Hospital, Yonsei University College of
Medicine, Seoul, Korea, South Korea
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Objectives: This meta-analysis investigated the diagnostic values of
transthoracic echocardiography (TTE), 2-dimensional (2D) and 3-dimensional
(3D) transesophageal echocardiography (TEE), and multidetector-row
computed tomography (MDCT) in patients with suspected mechanical
prosthetic valve obstruction (PVO) for detecting subprosthetic mass and
differentiating its causes. Background(s): Diagnostic values of
advanced imaging modalities, such as MDCT and TEE, for the detection and
differentiation of PVO have not been investigated. Method(s): PubMed
and EMBASE were systematically searched for studies that evaluated PVO
using imaging modalities. The modified Quality Assessment of Diagnostic
Accuracy Studies-2 tool was used to evaluate study quality. Pooled
sensitivity of each modality for PVO detection and pooled diagnostic
accuracy of TEE and MDCT for differentiating the causes of PVO were
analyzed. Study heterogeneity was also assessed. Result(s): Seventeen
studies (229 patients) that used at least 1 index tool among TTE, TEE, or
MDCT were included. For detecting a subprosthetic mass that caused PVO, 3D
TEE and MDCT showed a higher sensitivity of 81% (95% confidence interval
[CI]: 40% to 95%) and 88% (95% CI: 81% to 93%), respectively, compared
with TTE (20%; 95% CI: 7% to 47%) and 2D TEE (68%; 95% CI: 46% to 84%).
Pooled sensitivity and specificity for diagnosing thrombus as a cause of
PVO was 75% (95% CI: 54% to 88%) and 75% (95% CI: 40% to 93%),
respectively, for TEE and 45% (95% CI: 16% to 77%) and 90% (95% CI: 77% to
96%), respectively, for MDCT. Pooled sensitivity for diagnosing pannus as
a cause of PVO was 62% (95% CI: 46% to 76%) for TEE and 85% (95% CI: 70%
to 93%) for MDCT. Conclusion(s): This meta-analysis suggested that
MDCT and 3D TEE have higher sensitivity than do TTE and 2D TEE, and can be
reliable imaging modalities for detecting a subprosthetic mass that causes
PVO. Moreover, MDCT can more accurately differentiate the cause of PVO
than does TEE. Copyright © 2019 American College of Cardiology
Foundation

<24>
Accession Number
2003460299
Title
Meta-Analysis of the Prognostic Role of Late Gadolinium Enhancement and
Global Systolic Impairment in Left Ventricular Noncompaction.
Source
JACC: Cardiovascular Imaging. 12 (11P1) (pp 2141-2151), 2019. Date of
Publication: November 2019.
Author
Grigoratos C.; Barison A.; Ivanov A.; Andreini D.; Amzulescu M.-S.;
Mazurkiewicz L.; De Luca A.; Grzybowski J.; Masci P.G.; Marczak M.;
Heitner J.F.; Schwitter J.; Gerber B.L.; Emdin M.; Aquaro G.D.
Institution
(Grigoratos, Barison, De Luca, Emdin, Aquaro) Fondazione Gabriele
Monasterio CNR/Regione Toscana, Pisa, Italy
(Grigoratos, Emdin) Institute of Life Sciences, Scuola Superiore
Sant'Anna, Pisa, Italy
(Ivanov, Heitner) Department of Cardiology, New York Methodist Hospital,
Brooklyn, NY, United States
(Andreini) Centro Cardiologico Monzino, IRCCS, Milan, Italy
(Andreini) Department of Clinical Sciences and Community Health,
Cardiovascular Section, University of Milan, Milan, Italy
(Amzulescu, Gerber) Division of Cardiology, Department of Cardiovascular
Diseases Cliniques St. Luc and Pole de Recherche Cardiovasculaire,
Institut de Recherche Experimentale et Clinique, Universite Catholique de
Louvain, Brussels, Belgium
(Mazurkiewicz, Grzybowski) Department of Cardiomyopathies, Institute of
Cardiology, Warsaw, Poland
(Mazurkiewicz, Marczak) CMR Unit, Institute of Cardiology, Warsaw, Poland
(Masci, Schwitter) Division of Cardiology and CMR-Center, University
Hospital Lausanne, Lausanne, Switzerland
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Objectives: The objective of this meta-analysis was to assess the
predictive value of late gadolinium enhancement (LGE) and global systolic
impairment for future major adverse cardiovascular events in left
ventricular noncompaction (LVNC). Background(s): The prognosis of
patients with LVNC, with and without left ventricular dysfunction and LGE,
is still unclear. Method(s): A systematic review of published
research and a meta-analysis reporting a combined endpoint of hard
(cardiac death, sudden cardiac death, appropriate defibrillator firing,
resuscitated cardiac arrest, cardiac transplantation, assist device
implantation) and minor (heart failure hospitalization and thromboembolic
events) events was performed. Result(s): Four studies with 574
patients with LVNC and 677 with no LVNC and an average follow-up duration
of 5.2 years were analyzed. In patients with LVNC, LGE was associated with
the combined endpoint (pooled odds ratio: 4.9; 95% confidence interval:
1.63 to 14.6; p = 0.005) and cardiac death (pooled odds ratio: 9.8; 95%
confidence interval: 2.44 to 39.5; p < 0.001). Preserved left ventricular
systolic function was found in 183 patients with LVNC: 25 with positive
LGE and 158 with negative LGE. In LVNC with preserved ejection fraction,
positive LGE was associated with hard cardiac events (odds ratio: 6.1; 95%
confidence interval: 2.1 to 17.5; p < 0.001). No hard cardiac events were
recorded in patients with LVNC, preserved ejection fraction, and negative
LGE. Conclusion(s): Patients with LVNC but without LGE have a better
prognosis than those with LGE. When LGE is negative and global systolic
function is preserved, no hard cardiac events are to be expected.
Currently available criteria allow diagnosis of LVNC, but to further
define the presence and prognostic significance of the disease, LGE and/or
global systolic impairment must be considered for better risk
stratification. Copyright © 2019 American College of Cardiology
Foundation

<25>
Accession Number
627212102
Title
Clinical and genetic insights into non-compaction: a meta-analysis and
systematic review on 7598 individuals.
Source
Clinical Research in Cardiology. 108 (11) (pp 1297-1308), 2019. Date of
Publication: 01 Nov 2019.
Author
Kayvanpour E.; Sedaghat-Hamedani F.; Gi W.-T.; Tugrul O.F.; Amr A.; Haas
J.; Zhu F.; Ehlermann P.; Uhlmann L.; Katus H.A.; Meder B.
Institution
(Kayvanpour, Sedaghat-Hamedani, Gi, Tugrul, Amr, Haas, Zhu, Ehlermann,
Katus, Meder) Department of Medicine III, Institute for Cardiomyopathy,
University of Heidelberg, INF 410, Heidelberg 69120, Germany
(Kayvanpour, Sedaghat-Hamedani, Gi, Tugrul, Amr, Haas, Katus, Meder) DZHK
(German Centre for Cardiovascular Research), Berlin, Germany
(Uhlmann) Institute of Medical Biometry and Informatics, University of
Heidelberg, Heidelberg, Germany
(Zhu) Department of Cardiology, Institute of Cardiology, Union Hospital,
Tongji Medical College, Huazhong University of Science and Technology,
Wuhan 430022, China
(Meder) Department of Genetics, Stanford Genome Technology Center,
Stanford University School of Medicine, Stanford, CA, United States
Publisher
Dr. Dietrich Steinkopff Verlag GmbH and Co. KG
Abstract
Background: Left ventricular non-compaction has been increasingly
diagnosed in recent years. However, it is still debated whether
non-compaction is a pathological condition or a physiological trait. In
this meta-analysis and systematic review, we compare studies, which
investigated these two different perspectives. Furthermore, we provide a
comprehensive overview on the clinical outcome as well as genetic
background of left ventricular non-compaction cardiomyopathy in adult
patients. Methods and Results: We retrieved PubMed/Medline
literatures in English language from 2000 to 19/09/2018 on clinical
outcome and genotype of patients with non-compaction. We summarized and
extensively reviewed all studies that passed selection criteria and
performed a meta-analysis on key phenotypic parameters. Altogether, 35
studies with 2271 non-compaction patients were included in our
meta-analysis. The mean age at diagnosis was the mid of their fifth
decade. Two-thirds of patients were male. Congenital heart diseases
including atrial or ventricular septum defect or Ebstein anomaly were
reported in 7% of patients. Twenty-four percent presented with family
history of cardiomyopathy. The mean frequency of neuromuscular diseases
was 5%. Heart rhythm abnormalities were reported frequently: conduction
disease in 26%, supraventricular tachycardia in 17%, and sustained or
non-sustained ventricular tachycardia in 18% of patients. Three important
outcome measures were reported including systemic thromboembolic events
with a mean frequency of 9%, heart transplantation with 4%, and adequate
ICD therapy with 15%. Nine studies investigated the genetics of
non-compaction cardiomyopathy. The most frequently mutated gene was TTN
with a pooled frequency of 11%. The average frequency of MYH7 mutations
was 9%, for MYBPC3 mutations 5%, and for CASQ2 and LDB3 3% each. TPM1,
MIB1, ACTC1, and LMNA mutations had an average frequency of 2% each.
Mutations in PLN, HCN4, TAZ, DTNA, TNNT2, and RBM20 were reported with a
frequency of 1% each. We also summarized the results of eight studies
investigating the non-compaction in altogether 5327 athletes, pregnant
women, patients with sickle cell disease, as well as individuals from
population-based cohorts, in which the presence of left ventricular
hypertrabeculation ranged from 1.3 to 37%. Conclusion(s): The
summarized data indicate that non-compaction may lead to unfavorable
outcome in different cardiomyopathy entities. The presence of key features
in a multimodal diagnostic approach could distinguish between benign
morphological trait and manifest cardiomyopathy. Copyright ©
2019, Springer-Verlag GmbH Germany, part of Springer Nature.

<26>
Accession Number
2002675314
Title
One year experience with fast track algorithm in patients with refractory
out-of-hospital cardiac arrest.
Source
Resuscitation. 144 (pp 157-165), 2019. Date of Publication: November 2019.
Author
Adler C.; Paul C.; Michels G.; Pfister R.; Sabashnikov A.; Hinkelbein J.;
Braumann S.; Djordjevic L.; Blomeyer R.; Krings A.; Bottiger B.W.; Baldus
S.; Stangl R.
Institution
(Adler, Michels, Pfister, Braumann, Baldus) Department of Internal
Medicine III, Division of Cardiology, Pneumology, Angiology and Intensive
Care, University of Cologne, Cologne, Germany
(Adler, Paul, Blomeyer, Krings, Stangl) Department of Emergency Medicine,
Fire Department City of Cologne, Cologne, Germany
(Hinkelbein, Bottiger) Department of Anaesthesiology and Intensive Care
Medicine, University Hospital Cologne, Cologne, Germany
(Sabashnikov, Djordjevic) Department of Cardiothoracic Surgery, Heart
Center of the University of Cologne, Cologne, Germany
Publisher
Elsevier Ireland Ltd
Abstract
Background: Overall prognosis in patients with out-of-hospital cardiac
arrest (OHCA) remains poor, especially when return of spontaneous
circulation (ROSC) cannot be achieved at the scene. It is unclear if rapid
transport to the hospital with ongoing cardiopulmonary resuscitation (CPR)
improves outcome in patients with refractory OHCA (rOHCA). The aim of this
study was to evaluate the effect of a novel fast track algorithm (FTA) in
patients with rOHCA. Method(s): This prospective single-center study
analysed outcome in rOHCA patients treated with FTA. Historical patients
before FTA-implementation served as controls. rOHCA was defined as:
persistent shockable rhythm after three shocks and 300 mg of amiodarone or
persistent non-shockable rhythm and continuous CPR for 10 min without ROSC
after exclusion of treatable arrest causes. Result(s): 110
consecutive patients with rOHCA (mean age 56 +/- 14 years) were included.
40 patients (36%) were treated with FTA, 70 patients (64%) served as
historical controls. Pre-hospital time was significantly shorter after FTA
implementation (69 +/- 18 vs. 79 +/- 24 min, p = 0.02). Favourable
neurological outcome (defined as cerebral performance categories Score 1
or 2) was significantly more frequent in FTA patients (27.5% vs. 11.4%, p
= 0.038). FTA-implementation showed a trend towards improved mortality
(70.0% vs. 82.9%, p = 0.151). Extracorporeal Life Support was similar
between the two groups. Conclusion(s): Our study suggests that a
rapid transport algorithm with ongoing CPR is feasible, improves
neurological outcome and may improve survival in carefully selected
patients with rOHCA. Copyright © 2019 Elsevier B.V.

<27>
Accession Number
2003333412
Title
Preoperative anemia and postoperative mortality in patients with aortic
stenosis treated with transcatheter aortic valve implantation (TAVI): A
systematic review and meta-analysis.
Source
Medical Science Monitor. 25 (pp 7251-7257), 2019. Date of Publication: 27
Sep 2019.
Author
Lv Z.; Zhou B.; Yang C.; Wang H.
Institution
(Lv, Zhou, Wang) Department of Cardiovascular Surgery, Qingdao Fuwai
Hospital, Qingdao, Shandong, China
(Yang) Department of Cardiovascular Medicine, Qingdao Fuwai Hospital,
Qingdao, Shandong, China
Publisher
International Scientific Information, Inc. (E-mail:
iza.pranga@isl-science.com)
Abstract
Background: Patients with severe aortic stenosis who have comorbidities
that prevent general anesthesia and open cardiothoracic surgery are
candidates for transcatheter aortic valve implantation (TAVI). However,
TAVI can result in patient mortality following the procedure. This
systematic review of the literature and meta-analysis aimed to determine
the relationship between preoperative anemia and postoperative mortality
in patients following TAVI. Material/Methods: PubMed, EMBASE, the Cochrane
Library, and the Web of Science were systematically searched from their
inception to February 2019 for relevant published studies that included
patients with bicuspid aortic valve stenosis and tricuspid aortic valve
stenosis who underwent TAVI and who had preoperative data on hemoglobin
levels. The pooled odds ratios (OR) and 95% confidence interval (CI) were
calculated using a random-effects generic inverse variance method.
 Result(s): Six published studies that involved 6,406 patients with
aortic stenosis were included in the meta-analysis. There was no
significant difference observed for the final pooled result for patients
with and without anemia for the short-term 30-day postoperative mortality
(OR, 1.34; 95% CI, 0.77-2.35). However, long-term mortality rates were
significantly worse in patients with preoperative anemia compared with
those without anemia (OR, 1.77; 95% CI, 1.34-2.35). Conclusion(s):
Systematic review of the literature and meta-analysis showed that
pre-procedural anemia reduced long-term mortality following TAVI. This
finding supports the need to correct preoperative anemia in patients with
aortic stenosis to improve patient outcome following TAVI. Copyright
© Med Sci Monit, 2019.

<28>
Accession Number
2003583404
Title
Predicting mortality with cardiac troponins: Recent insights from
meta-analyses.
Source
Diagnosis. (no pagination), 2019. Date of Publication: 2019.
Author
Lippi G.; Cervellin G.; Sanchis-Gomar F.
Institution
(Lippi) Section of Clinical Biochemistry, University of Verona, Piazzale
LA Scuro, Verona 37134, Italy
(Cervellin) Emergency Department, University Hospital of Parma, Parma,
Italy
(Sanchis-Gomar) Department of Physiology, Faculty of Medicine, University
of Valencia, INCLIVA Biomedical Research Institute, Valencia, Spain
Publisher
Walter de Gruyter GmbH
Abstract
The introduction of cardiac troponin (cTn) testing in clinical practice
has been one of the most important breakthroughs that have occurred in the
recent history of laboratory medicine. Although it is now uncontestable
that cTn values are essential for diagnosing acute coronary syndrome
(ACS), solid evidence is also emerging that assessment of either cardiac
troponin I (cTnI) or T (cTnT) may provide valuable prognostic information
in the general healthy population, as well as in patients with a vast
array of cardiac and extra-cardiac diseases. We have hence performed a
critical review of the scientific literature for identifying meta-analyses
which have investigated the potential contribution of cTns in predicting
the risk of death in health and disease. According to the articles
identified with our research, we can conclude that increased cTn values
may be considered independent risk factors for all-cause mortality in the
general population, as well as in patients with ACS, in those undergoing
revascularization procedures, or with stable coronary artery disease
(CAD), heart failure (HF) and atrial fibrillation (AF). Measurement of cTn
may then be helpful for stratifying the mortality risk in non-cardiac
hospitalized patients, in those with critical illness or sepsis, syncope,
stroke, acute aortic dissection, pulmonary diseases, brain injury, renal
failure, vascular and non-cardiac surgery. Although this evidence has
notable clinical implications, the cost-effectiveness of population
screening with high-sensitivity (hs) cTn immunoassays has not been proven
so far. Copyright ©2019 Walter de Gruyter GmbH, Berlin/Boston
2019.

<29>
Accession Number
2003581529
Title
Volatile anesthetics versus total intravenous anesthesia in patients
undergoing coronary artery bypass grafting: An updated metaanalysis and
trial sequential analysis of randomized controlled trials.
Source
PLoS ONE. 14 (10) (no pagination), 2019. Article Number: e0224562. Date of
Publication: 2019.
Author
Jiao X.-F.; Lin X.-M.; Ni X.-F.; Li H.-L.; Zhang C.; Yang C.-S.; Song
H.-X.; Yi Q.-S.; Zhang L.-L.
Institution
(Jiao, Ni, Li, Zhang, Yang, Song, Yi, Zhang) Department of Pharmacy, West
China Second University Hospital, Sichuan University, Sichuan, China
(Jiao, Ni, Li, Zhang, Yang, Song, Yi, Zhang) Evidence-Based Pharmacy
Center, West China Second University Hospital, Sichuan University,
Sichuan, China
(Jiao, Lin, Ni, Li, Zhang, Yang, Song, Yi, Zhang) Key Laboratory of Birth
Defects and Related Diseases of Women and Children, Sichuan University,
Ministry of Education, Sichuan, China
(Jiao, Ni, Yi) West China School of Medicine, Sichuan University, Sichuan,
China
(Lin) Department of Anesthesiology, West China Second University Hospital,
Sichuan University, Sichuan, China
Publisher
Public Library of Science (E-mail: plos@plos.org)
Abstract
Background The benefits of volatile anesthetics in coronary artery bypass
grafting (CABG) patients remain controversial. We aimed to conduct an
updated meta-analysis to assess whether the use of volatile anesthetics
during CABG could reduce mortality and other outcomes. Methods We searched
eight databases from inception to June 2019 and included randomized
controlled trials (RCTs) comparing the effects of volatile anesthetics
versus total intravenous anesthesia (TIVA) in CABG patients. The primary
outcomes were operative mortality and one-year mortality. The secondary
outcomes included the length of stay in the intensive care unit (ICU) and
hospital and postoperative safety outcomes (myocardial infarction, heart
failure, arrhythmia, stroke, delirium, postoperative cognitive impairment,
acute kidney injury, and the use of intra-aortic balloon pump (IABP) or
other mechanical circulatory support). Trial sequential analysis (TSA) was
performed to control for random errors. Results A total of 89 RCTs
comprising 14,387 patients were included. There were no significant
differences between the volatile anesthetics and TIVA groups in operative
mortality (relative risk (RR) = 0.92, 95% confidence interval (CI):
0.68-1.24, p = 0.59, I2 = 0%), one-year mortality (RR = 0.64, 95% CI:
0.32-1.26, p = 0.19, I2 = 51%), or any of the postoperative safety
outcomes. The lengths of stay in the ICU and hospital were shorter in the
volatile anesthetics group than in the TIVA group. TSA revealed that the
results for operative mortality, one-year mortality, length of stay in the
ICU, heart failure, stroke, and the use of IABP were inconclusive.
Conclusions Conventional meta-analysis suggests that the use of volatile
anesthetics during CABG is not associated with reduced risk of mortality
or other postoperative safety outcomes when compared with TIVA. TSA shows
that the current evidence is insufficient and inconclusive. Thus, future
large RCTs are required to clarify this issue. Copyright © 2019
Jiao et al. This is an open access article distributed under the terms of
the Creative Commons Attribution License, which permits unrestricted use,
distribution, and reproduction in any medium, provided the original author
and source are credited.

<30>
Accession Number
2003451981
Title
Efficacy and safety of tacrolimus in de novo pediatric transplant
recipients randomized to receive immediate- or prolonged-release
tacrolimus.
Source
Clinical Transplantation. 33 (10) (no pagination), 2019. Article Number:
e13698. Date of Publication: 01 Oct 2019.
Author
Vondrak K.; Parisi F.; Dhawan A.; Grenda R.; Webb N.J.A.; Marks S.D.;
Debray D.; Holt R.C.L.; Lachaux A.; Kelly D.; Kazeem G.; Undre N.
Institution
(Vondrak) University Hospital Motol, Prague, Czechia
(Parisi) Ospedale Pediatrico Bambino Gesu, Rome, Italy
(Dhawan) King's College Hospital, London, United Kingdom
(Grenda) The Children's Memorial Health Institute, Warsaw, Poland
(Webb) Manchester University Foundation Trust, Manchester, United Kingdom
(Marks) Great Ormond Street Hospital for Children, NHS Foundation Trust,
London, United Kingdom
(Debray) APHP-Hopital Universitaire Necker, Paris, France
(Holt) Alder Hey Children's Hospital, Liverpool, United Kingdom
(Lachaux) Universite Lyon 1 et Hospices Civils de Lyon, Lyon, France
(Kelly) Birmingham Women's & Children's Hospital, Birmingham, United
Kingdom
(Kazeem, Undre) Astellas Pharma Europe Ltd, Chertsey, United Kingdom
(Kazeem) BENKAZ Consulting Ltd, Cambridge, United Kingdom
Publisher
Blackwell Publishing Ltd
Abstract
Background and aims: This multicenter trial compared immediate-release
tacrolimus (IR-T) vs prolonged-release tacrolimus (PR-T) in de novo
kidney, liver, and heart transplant recipients aged <16 years. Each
formulation had similar pharmacokinetic (PK) profiles. Follow-up efficacy
and safety results are reported herein. Material(s) and Method(s):
Patients, randomized 1:1, received once-daily, PR-T or twice-daily, IR-T
within 4 days of surgery. After a 4-week PK assessment, patients continued
randomized treatment for 48 additional weeks. At Year 1, efficacy
assessments included the number of clinical acute rejections,
biopsy-confirmed acute rejection (BCAR) episodes (including severity),
patient and graft survival, and efficacy failure (composite of death,
graft loss, BCAR, or unknown outcome). Adverse events were assessed
throughout. Result(s): The study included 44 children. At Year 1,
mean +/- standard deviation tacrolimus trough levels were 6.6 +/- 2.2 and
5.4 +/- 1.6 ng/mL, and there were 2 and 7 acute rejection episodes in the
PR-T and IR-T groups, respectively. No cases of graft loss or death were
reported during the study. The overall efficacy failure rate was 18.2%
(PR-T n = 1; IR-T n = 7). Conclusion(s): In pediatric de novo solid
organ recipients, the low incidence of BCAR and low efficacy failure rate
suggest that PR-T-based immunosuppression is effective and well tolerated
to 1-year post-transplantation. Copyright © 2019 The Authors.
Clinical Transplantation published by John Wiley & Sons Ltd

<31>
Accession Number
629725262
Title
The serratus plane block for postoperative analgesia in breast and
thoracic surgery: A systematic review and meta-Analysis.
Source
Regional Anesthesia and Pain Medicine. (no pagination), 2019. Date of
Publication: 2019.
Author
Chong M.; Berbenetz N.; Kumar K.; Lin C.
Institution
(Chong, Kumar, Lin) Department of Anesthesia and Perioperative Medicine,
Western University, London, ON N6A 3K7, Canada
(Berbenetz) Department of Medicine, Queen's University, Kingston, ON,
Canada
Publisher
BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com)
Abstract
Background and objectives: The serratus plane block (SPB) is a novel chest
wall interfascial plane block. Its analgesic efficacy compared with
non-block care and paravertebral block (PVB) is unestablished.
 Method(s): We conducted a random-effects meta-Analysis of randomized
controlled trials (RCTs) recruiting adult surgical patients that compared
a SPB to non-block care or PVB for postoperative analgesia. Visual analog
scale pain scores were the primary outcome. Database sources were Medline,
Embase, the Cochrane Library, and Google Scholar searched up to July 29,
2019 without language restriction. Risk of bias was assessed using
Cochrane methodology. Result(s): Nineteen RCTs that comprised 1260
patients were included. Six trials involved thoracic surgery patients and
13 studied breast surgery patients. SPB reduced pain scores 0 hour
postoperatively (-1.62 cm; 99% CI-2.43 to-0.81; p<0.001;
I2=92%), at 2-4 hours (-1.29 cm; 99% CI-2.08 to-0.49; p<0.001;
I2=92%), at 6 hours (-1.69 cm; 99% CI-3.19 to-0.20; p=0.004;
I2=99%), and up to 24 hours compared with non-block care. SPB
also prolonged the time to first analgesic request (193.2 min; 95% CI 7.2
to 379.2 min; p=0.04; I2=99%), reduced 24-hour postoperative
opioid consumption (-11.27 mg of IV morphine equivalent;-17.36 to-5.18 mg;
p<0.001), and reduced postoperative nausea and vomiting (RR 0.51; 95% CI
0.38 to 0.68; p<0.001; I2=12%). In contrast, no meaningful
differences were detected in any of the outcomes for the SPB versus PVB
data. Conclusion(s): SPB reduced postoperative pain scores (Grading
of Recommendations Assessment, Development, and Evaluation rating: low;
due to heterogeneity and deficiencies in blinding) in breast and thoracic
surgery patients compared with non-block care. Based on five trials only,
SPB was not appreciably different from PVB. Copyright © American
Society of Regional Anesthesia & Pain Medicine 2019. No commercial re-use.
See rights and permissions. Published by BMJ.

<32>
Accession Number
2002348198
Title
Vitamin B12 for the treatment of vasoplegia in cardiac surgery and liver
transplantation: a narrative review of cases and potential biochemical
mechanisms.
Source
Canadian Journal of Anesthesia. 66 (12) (pp 1501-1513), 2019. Date of
Publication: 01 Dec 2019.
Author
Charles F.-G.; Murray L.J.; Giordano C.; Spiess B.D.
Institution
(Charles, Giordano, Spiess) Department of Anesthesiology, University of
Florida College of Medicine, 1600 SW Archer Road, PO Box 100254,
Gainesville, FL 32610, United States
(Murray) Department of Chemistry, Center for Catalysis and Florida Center
for Heterocyclic Compounds, University of Florida, Gainesville, FL, United
States
Publisher
Springer New York LLC (E-mail: barbara.b.bertram@gsk.com)
Abstract
Purpose: Hydroxocobalamin, or vitamin B12 (V-B12), is frequently used to
treat smoke inhalation and cyanide poisoning. Recent reports have also
described its use to treat vasoplegia in cardiac surgery and liver
transplantation. This narrative review discusses this "off-label"
indication for V-B12, focusing on the potential biochemical mechanisms of
its actions. Source: PubMed, Cochrane, and Web of Science databases were
searched for clinical reports on the use of V-B12 for vasoplegia in
cardiac surgery and liver transplantation, with the biochemical mechanisms
discussed being based on a survey of the related biochemistry literature.
Principal findings: Forty-four patients have been treated with V-B12 for
vasoplegia in various isolated case reports and one series. Although 75%
of patients have increased blood pressure in response to V-B12, there were
some "non-responders". The true efficacy remains unknown because clinical
trials have not been performed, and significant reporting bias likely
exists. Plausible biochemical explanations exist for the potential
beneficial effects of V-B12 in treating vasoplegia, including binding
nitric oxide and other gasotransmitters. Additional research is required
to clarify if and how these mechanisms are causally involved in effective
clinical responders and non-responders. Conclusion(s): Although
anecdotal reports utilizing V-B12 for vasoplegia are available, no
higher-level evidence exists. Future work is necessary to further
understand the dosing, timing, adverse events, and biochemical mechanisms
of V-B12 compared with other therapies such as methylene
blue. Copyright © 2019, Canadian Anesthesiologists' Society.

<33>
Accession Number
2002700619
Title
Intra-aortic balloon pump in acute chest pain and cardiogenic shock-a
long-term follow-up.
Source
Scandinavian Cardiovascular Journal. 53 (6) (pp 337-341), 2019. Date of
Publication: 02 Nov 2019.
Author
Bendz B.; Gude E.; Ragnarsson A.; Endresen K.; Aaberge L.; Geiran O.;
Simonsen S.
Institution
(Bendz, Gude, Ragnarsson, Endresen, Aaberge, Simonsen) Department of
Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway
(Geiran) Department of Cardio-Thoracic Surgery, Heart-Lung Clinic, Oslo
University Hospital, Rikshospitalet, Oslo, Norway
(Bendz, Geiran) Institute of Clinical Medicine, University of Oslo, Oslo,
Norway
Publisher
Taylor and Francis Ltd
Abstract
Objectives. Coronary revascularisation and intra-aortic balloon pump
(IABP) has been considered the gold standard treatment of acute coronary
syndrome with cardiogenic shock, recently challenged by the SHOCK II
study. The aim of this non-randomised study was to investigate the long
term prognosis after immediate IABP supported angiography, in patients
with acute chest pain and cardiogenic shock, treated with percutaneous
coronary intervention (PCI), cardiac surgery or optimal medical treatment.
We assessed data from 281 consecutive patients admitted to our department
from 2004 to 2010. Results. Mean (+/-SD) age was 63.8 +/- 11.5 (range
30-84) years with a follow-up of 5.6 +/- 4.4 (0-12.7) years. Acute
myocardial infarction was the primary diagnosis in 93% of the patients, 4%
presented with unstable angina pectoris and 3% cardiomyopathy or
arrhythmias of non-ischemic aetiology. Systolic blood pressure at
admittance was 85 +/- 18 mmHg and diastolic 55 +/- 18 mmHg. Thirty day,
one- and five-year survival was 71.2%, 67.3% and 57.7%, respectively. PCI
was performed immediately in 70%, surgery was done in 17%, and 13% were
not eligible for any revascularisation. Independent variables predicting
mortality were medical treatment vs revascularisation, out-of-hospital
cardiac arrest, and advanced age. Three serious non-fatal complications
occurred due to IABP treatment, i.e. 0.001 per treatment day. Conclusions.
We report the use of IABP in patients with acute chest pain admitted for
angiography. Long-term survival is acceptable and discriminating factors
were no revascularisation, out-of-hospital cardiac arrest and age. IABP
was safe and feasible and the complication rate was low. Copyright
© 2019, © 2019 Informa UK Limited, trading as Taylor & Francis
Group.

<34>
Accession Number
628374630
Title
Outcomes of Vocal Fold Motion Impairment and Dysphagia after Pediatric
Cardiothoracic Surgery: A Systematic Review.
Source
Otolaryngology - Head and Neck Surgery (United States). 161 (5) (pp
754-763), 2019. Date of Publication: 01 Nov 2019.
Author
Orzell S.; Joseph R.; Ongkasuwan J.; Bedwell J.; Shin J.; Raol N.
Institution
(Orzell) Department of Otolaryngology, SUNY Upstate Medical Center,
Syracuse, NY, United States
(Joseph) School of Medicine, Emory University, Atlanta, GA, United States
(Ongkasuwan, Bedwell) Department of Otolaryngology, Baylor College of
Medicine, Houston, TX, United States
(Shin) Department of Otolaryngology, Harvard Medical School, Boston, MA,
United States
(Raol) Department of Otolaryngology-Head and Neck Surgery, School of
Medicine, Emory University, Atlanta, GA, United States
Publisher
SAGE Publications Inc. (E-mail: claims@sagepub.com)
Abstract
Objective: The objective of this study was to systematically review the
literature regarding vocal fold motion impairment (VFMI), respiratory
outcomes, and swallowing outcomes in children following congenital heart
surgery (CHS). Data Sources: PubMed, Embase, Medline, and CINAHL
databases. Review Methods: Data sources were searched from inception to
November 30, 2018. Studies that described recovery of VFMI and swallowing
function following CHS were included, and a qualitative analysis was
performed. Result(s): A total of 1371 studies were identified, of
which 8 met inclusion criteria for VFMI and 5 met inclusion criteria for
swallowing outcomes. Studies including patients who underwent isolate
patent ductus arteriosus ligation were excluded. VFMI was present in 8% to
59% of subjects, and rates of recovery ranged from 9% to 96% at 6 months
to 6 years of follow-up. Inability to maintain an oral diet occurred in
14% to 100% of subjects with VFMI and 11% to 61% without VFMI following
surgery. Tolerance of an oral diet without tube feeding was present in 66%
to 75% of subjects with VFMI and 88% to 100% without VFMI at 24 days to
3.2 years of follow-up. Limited data suggest that time to extubation is
longer in VFMI subjects, but overall hospital length of stay and mortality
may not be affected by VFMI status. Conclusion(s): Data evaluating
dysphagia and VFMI after CHS are limited. Most studies suggest significant
improvement in swallowing function, while rate of recovery of VFMI is
variable. Future prospective studies with standardized screening and
follow-up are needed to better elucidate outcomes to help develop
algorithms for identification and management of VFMI after
CHS. Copyright © American Academy of Otolaryngology-Head and Neck
Surgery Foundation 2019.

<35>
Accession Number
628862252
Title
A Systematic Review and Meta-Analysis of del Nido Versus Conventional
Cardioplegia in Adult Cardiac Surgery.
Source
Innovations: Technology and Techniques in Cardiothoracic and Vascular
Surgery. 14 (5) (pp 385-393), 2019. Date of Publication: 01 Oct 2019.
Author
An K.R.; Rahman I.A.; Tam D.Y.; Ad N.; Verma S.; Fremes S.E.; Latter D.A.;
Yanagawa B.
Institution
(An, Rahman, Tam, Verma, Latter, Yanagawa) Division of Cardiac Surgery, Li
Ka Shing Knowledge Institute, St Michael's Hospital, University of
Toronto, ON, Canada
(Ad) Division of Cardiac Surgery, University of Maryland School of
Medicine, Baltimore, United States
(Fremes) Division of Cardiac Surgery, Department of Surgery, Schulich
Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto,
ON, Canada
Publisher
SAGE Publications Ltd (E-mail: info@sagepub.co.uk)
Abstract
Objective: Del Nido cardioplegia (DC) has been used extensively in
pediatric cardiac surgery but the efficacy and safety in adults remains
uncertain. Our objective was to perform a systematic review and
meta-analysis comparing DC and blood cardioplegia (BC) in our primary
endpoint of 30-day or in-hospital mortality as well as other efficacy and
safety endpoints. Method(s): Both MEDLINE and EMBASE were searched
from 1996 to 2017 for studies comparing DC and BC. Data were extracted by
2 independent investigators and aggregated in a random effects model.
 Result(s): One randomized controlled trial (n = 89), 7 adjusted (n =
1,104), and 5 unadjusted observational studies (n = 717) were included.
There was no difference in in-hospital mortality between DC and BC
(relative risk:0.67, 95% confidence interval [CI]: 0.22, 2.07; P = 0.49).
DC reduced cardioplegia volume requirements (mean difference [MD]:-1.1 L,
95% CI, -1.6, -0.6; P < 0.0001), aortic cross-clamp time (MD: -8 minutes,
95% CI, -12, -3; P = 0.0004), and cardiopulmonary bypass (CPB) times (MD:
-8 minutes, 95% CI, -14, -3; P = 0.03). DC reduced troponin release
(standardized MD: -0.3, 95% CI, -0.5, -0.1; P = 0.001). In-hospital
outcomes of stroke, atrial fibrillation, acute kidney injury/dialysis, low
cardiac output state, blood transfusion, reoperation rate, postoperative
left ventricular EF, intensive care unit length of stay (LOS), and
in-hospital LOS were comparable between groups. Conclusion(s): DC is
a safe alternative to BC in routine adult cardiac surgery. Its use is
associated with reduction in CPB and aortic cross-clamp times and may
potentially offer improved myocardial protection. Copyright © The
Author(s) 2019.

<36>
Accession Number
2003397064
Title
Reducing blood loss in pediatric craniosynostosis surgery by use of
tranexamic acid.
Source
Neurochirurgie. 65 (5) (pp 302-309), 2019. Date of Publication: November
2019.
Author
Eustache G.; Riffaud L.
Institution
(Eustache) Rennes University, CHU of Rennes, Department of Anesthesiology,
Rennes 35000, France
(Riffaud) Rennes University, CHU of Rennes, Department of Neurosurgery,
Rennes 35000, France
(Riffaud) INSERM MediCIS, Unit U1099 LTSI, Rennes 1 University, Rennes,
35000, France
Publisher
Elsevier Masson SAS (62 rue Camille Desmoulins, Issy les Moulineaux Cedex
92442, France)
Abstract
Introduction: Craniosysnostosis surgical corrections are routine
procedures in the pediatric neurosurgical field. However, these procedures
result in significant blood loss. Tranexamic acid (TXA) is an
antifibrinolytic drug, which has demonstrated a significant reduction in
perioperative blood loss in many pediatric surgical procedures such as
cardiac surgery and scoliosis surgery. We conducted a systematic review to
evaluate protocols of TXA use in pediatric craniosynostosis procedures and
its effect on intraoperative blood loss and transfusions. Material(s)
and Method(s): A comprehensive literature review of the National Library
of Medicine (PubMed) database was performed to identify relevant studies.
We included any clinical study reporting on blood loss or blood
transfusion for pediatric craniosynostosis surgery with intraoperative use
of tranexamic acid, with the following limits: publication date from
inception to May 2019; reports in English. Result(s): Thirteen
studies were eligible for our review. Of the 13 studies, 4 were
prospective, randomised, double-blind controlled trials, 9 were
retrospective studies, tailored as a "before-after" studies, comparing
blood loss and transfusion without/with TXA. TXA significantly decreases
the number and volume of packed red blood cell transfusions and the rate
of transfusion in children undergoing craniosynostosis surgery.
Significantly fewer fresh frozen plasma transfusions were required in the
TXA groups in 2 randomised studies. Length of stay in hospital was
significantly lower with the use of TXA in three studies. Advantages of
TXA administration also include an excellent patient tolerance of side
effects, ease of administration and low cost. Conclusion(s): TXA
significantly reduces blood loss and the need for transfusions in children
undergoing craniosynostosis surgery. TXA administration should be a
routine part of strategy to reduce blood loss and limit transfusions in
these procedures. Copyright © 2019 Elsevier Masson SAS

<37>
Accession Number
629719360
Title
The safe addition of nitric oxide into the sweep gas of the extracorporeal
circuit during cardiopulmonary bypass and extracorporeal life support.
Source
Journal of Extra-Corporeal Technology. 50 (4) (pp 260-264), 2018. Date of
Publication: 2018.
Author
Bennett M.; Thuys C.; Augustin S.; Schultz B.; Bottrell S.; Horton A.;
Bednarz A.; Horton S.
Institution
(Bennett, Thuys, Augustin, Schultz, Bottrell, Horton, Horton) Department
of Cardiac Surgery, Royal Children's Hospital Melbourne, Flemington Road,
Parkville, VIC 3052, Australia
(Bednarz) Department of Biomedical Engineering, Royal Children's Hospital,
Parkville, VIC, Australia
(Horton) Faculty of Medicine, Department of Paediatrics, University of
Melbourne, Parkville, VIC, Australia
(Horton) Murdoch Children's Research Institute, Parkville, VIC, Australia
Publisher
American Society of Extra-Corporeal Technology (E-mail: donna@amsect.org)
Abstract
Low cardiac output syndrome and the systemic inflammatory response are
consequences of the cardiac surgical perioperative course. The mechanisms
responsible are multifactorial, but recent studies have shown that nitric
oxide (NO) may be a key component in mitigating some of these processes.
Following on from literature reports detailing the use of inhaled NO added
to the gas phase of the extracorporeal circuit, we set about developing a
technique to perform this addition safely and efficiently. In the setting
of cardiopulmonary bypass, the technique was validated in a randomized
prospective trial looking at 198 children. The benefits observed in this
trial then stimulated the incorporation of NO into all extracorporeal life
support (ECLS) circuits. This required additional hardware modifications
all of which were able to be performed safely. Initial results from the
first series of ECLS patients using NO also appear
promising. Copyright © 2018 American Society of Extra-Corporeal
Technology. All rights reserved.

<38>
Accession Number
629727412
Title
Aminoglycosides for infective endocarditis: time to say goodbye?.
Source
Clinical microbiology and infection : the official publication of the
European Society of Clinical Microbiology and Infectious Diseases. (no
pagination), 2019. Date of Publication: 24 Oct 2019.
Author
Lebeaux D.; Fernandez-Hidalgo N.; Pilmis B.; Tattevin P.; Mainardi J.-L.
Institution
(Lebeaux, Mainardi) Service de Microbiologie, Unite Mobile
d'Infectiologie, AP-HP, Hopital Europeen Georges Pompidou, Centre
Universite de Paris, Universite de Paris, Paris, France
(Fernandez-Hidalgo) Servei de Malalties Infeccioses, Hospital Universitari
Vall d'Hebron, Universitat Autonoma de Barcelona. Barcelona, Spain;
Spanish Network for Research in Infectious Diseases (REIPI), Instituto de
Salud Carlos III, Madrid, Spain
(Pilmis) Service de Microbiologie et Plateforme de dosage des
anti-infectieux, Equipe mobile de microbiologie Clinique, Groupe
Hospitalier Paris Saint-Joseph, Paris, France
(Tattevin) Infectious Diseases and Intensive Care Unit, Pontchaillou
University Hospital, Rennes, France
Publisher
NLM (Medline)
Abstract
BACKGROUND: Based on experimental studies showing synergism with
beta-lactams and glycopeptides, aminoglycosides have long been considered
essential in the treatment of infective endocarditis (IE). However, their
use is associated with a high risk of renal failure, especially in elderly
patients. OBJECTIVE(S): The aim of this narrative review was to
summarize the evidence to support reducing or even avoiding the use of
aminoglycosides for the treatment of IE. We also analysed data supporting
the use of aminoglycosides in specific subgroup of IE patients. SOURCES:
PubMed database was searched up to July 2019 to identify relevant studies.
CONTENTS: Recent European Guidelines reduced the use of aminoglycosides in
IE, no longer recommended in Staphylococcus aureus native-valve IE, and
shortened to 2 weeks for IE related to Enterococcus faecalis and
streptococci with penicillin MIC > 0.125 mug/mL. In addition, alternative
regimen without aminoglycosides (ampicillin or amoxicillin plus
ceftriaxone) is proposed for E. faecalis. Observational studies suggested
that gentamicin would not be necessary in the case of staphylococcal
prosthetic-valve IE as long as rifampicin is maintained. Recent clinical
studies showed that for streptococcal IE, gentamicin could be restricted
to isolates with penicillin MIC > 0.5 mug/mL. For the empirical and
definitive treatment of E. faecalis IE, amoxicillin or ampicillin plus
ceftriaxone may be considered, irrespective of high-level of
aminoglycoside resistance. IMPLICATIONS: In a scenario of progressive
increase in the age and frailty of IE patients, the use of aminoglycosides
can be reduced or avoided in ~90% cases. This should result in reduced
incidence of renal failure, an important prognostic factor in
IE. Copyright © 2019 European Society of Clinical Microbiology
and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

<39>
Accession Number
629726971
Title
Comparison of ProGlide vs. Prostar in patients undergoing transcatheter
aortic valve implantation.
Source
Minerva cardioangiologica. (no pagination), 2019. Date of Publication: 25
Oct 2019.
Author
Giordano A.; Corcione N.; Ferraro P.; Morello A.; Conte S.; Testa L.;
Iadanza A.; Sardella G.; Mancone M.; Berti S.; Petronio A.S.; Romagnoli
E.; Pepe M.; Frati G.; Biondi-Zoccai G.
Institution
(Giordano, Corcione, Morello) Unita Operativa di Interventistica
Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Caserta, Italy
(Ferraro, Conte) Unita Operativa di Emodinamica, Santa Lucia Hospital, San
Giuseppe Vesuviano, Naples, Italy
(Testa) Department of Cardiology, IRCCS Policlinico San Donato, San Donato
Milanese, Milan, Italy
(Iadanza) Divisione di Emodinamica, Dipartimento di Scienze Cardiache,
Toraciche e Vascolari, Policlinico Santa Maria alle Scotte, Siena, Italy
(Sardella, Mancone) Department of Cardiovascular, Respiratory, Anaesthetic
and Geriatric Sciences, Sapienza University of Rome, Policlinico Umberto
I, Rome, Italy
(Berti) Fondazione C.N.R. G. Monasterio Ospedale del Cuore, Massa, Italy
(Petronio) Department of Cardiology, University Hospital, Pisa, Italy
(Romagnoli) Institute of Cardiology, Fondazione Policlinico Universitario
A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy
(Pepe) Division of Cardiology, Department of Emergency and Organ
Transplantation, University of Bari, Bari, Italy
(Frati) Department of Medico-Surgical Sciences and Biotechnologies,
Sapienza University of Rome, Latina, Italy
(Frati) IRCCS NEUROMED, Italy
(Biondi-Zoccai) Department of Medico-Surgical Sciences and
Biotechnologies, Sapienza University of Rome, Latina, Italy
Publisher
NLM (Medline)
Abstract
BACKGROUND: Expanding indications to transcatheter aortic valve
implantation (TAVI) warrant meticolous vascular management and
minimization of access site complications. Two leading vascular closure
devices (VCD) are currently used for TAVI, Proglide vs Prostar, but their
comparative effectiveness and safety are debated. We aimed at comparing
acute and 1-month outcomes of patients undergoing TAVI using as VCD either
ProGlide (Perclose) or Prostar (XL). METHOD(S): The prospective
RISPEVA database was queried for baseline, procedural, and outcome details
of patients undergoing TAVI and in whom either ProGlide or Prostar had
been used as VCD. Outcomes of interest were death, vascular complication,
and bleeding, distinguishing specific subtypes. Outcomes were adjudicated
according to current Valve Academic Research Consortium definitions.
 RESULT(S): A total of 1987 subjects were included, 913 (46.0%)
receiving ProGlide, and 1074 receiving Prostar (54.0%). Several baseline
and procedural differences were evident, including surgical risk,
concomitant coronary artery disease, sheath size, use of predilation, and
chosen TAVI device (all p<0.05). Peri-procedurally, despite similar rates
of device success (p=0.262), Prostar was associated with a lower risk of
vascular stenosis (p=0.005), but a higher rate of device malfunction
(p=0.028). Unadjusted analysis for 1-month outcomes suggested higher rates
of major adverse events, any bleeding, major bleeding, and renal failure
in patients receiving Prostar (all p<0.05). However, propensity
score-adjusted analysis did not confirm any significant differences,
suggesting that confounding factors mostly drove unadjusted differences.
 CONCLUSION(S): Use of ProGlide and Prostar as VCD of choice for TAVI
appears similarly safe and effective, despite some potential benefits
associated with Proglide. Further randomized trials are warranted to
confirm or disprove these findings.

<40>
Accession Number
629726679
Title
A Novel Patient-Specific Model for Predicting Severe Oliguria; Development
and Comparison With Kidney Disease: Improving Global Outcomes Acute Kidney
Injury Classification.
Source
Critical care medicine. (no pagination), 2019. Date of Publication: 29 Oct
2019.
Author
Howitt S.H.; Oakley J.; Caiado C.; Goldstein M.; Malagon I.; McCollum C.;
Grant S.W.
Institution
(Howitt, Oakley, Malagon, McCollum, Grant) Division of Cardiovascular
Sciences, University of Manchester, ERC, Manchester University Hospitals
Foundation Trust, Manchester, United Kingdom
(Howitt, Malagon) Department of Cardiothoracic Anaesthesia and Critical
Care, Wythenshawe Hospital, Manchester University Hospitals Foundation
Trust, Manchester, United Kingdom
(Oakley, Caiado, Goldstein) Department of Mathematical Sciences, Durham
University, Durham, United Kingdom
Publisher
NLM (Medline)
Abstract
OBJECTIVES: The Kidney Disease: Improving Global Outcomes urine output
criteria for acute kidney injury lack specificity for identifying patients
at risk of adverse renal outcomes. The objective was to develop a model
that analyses hourly urine output values in real time to identify those at
risk of developing severe oliguria. DESIGN: This was a retrospective
cohort study utilizing prospectively collected data. SETTING: A cardiac
ICU in the United Kingdom. PATIENTS: Patients undergoing cardiac surgery
between January 2013 and November 2017.None. MEASUREMENT AND MAIN RESULTS:
Patients were randomly assigned to development (n = 981) and validation (n
= 2,389) datasets. A patient-specific, dynamic Bayesian model was
developed to predict future urine output on an hourly basis. Model
discrimination and calibration for predicting severe oliguria (< 0.3
mL/kg/hr for 6 hr) occurring within the next 12 hours were tested in the
validation dataset at multiple time points. Patients with a high risk of
severe oliguria (p > 0.8) were identified and their outcomes were compared
with those for low-risk patients and for patients who met the Kidney
Disease: Improving Global Outcomes urine output criterion for acute kidney
injury. Model discrimination was excellent at all time points (area under
the curve > 0.9 for all). Calibration of the model's predictions was also
excellent. After adjustment using multivariable logistic regression,
patients in the high-risk group were more likely to require renal
replacement therapy (odds ratio, 10.4; 95% CI, 5.9-18.1), suffer prolonged
hospital stay (odds ratio, 4.4; 95% CI, 3.0-6.4), and die in hospital
(odds ratio, 6.4; 95% CI, 2.8-14.0) (p < 0.001 for all). Outcomes for
those identified as high risk by the model were significantly worse than
for patients who met the Kidney Disease: Improving Global Outcomes urine
output criterion. CONCLUSION(S): This novel, patient-specific model
identifies patients at increased risk of severe oliguria. Classification
according to model predictions outperformed the Kidney Disease: Improving
Global Outcomes urine output criterion. As the new model identifies
patients at risk before severe oliguria develops it could potentially
facilitate intervention to improve patient outcomes.

<41>
Accession Number
629726620
Title
Outcome Measures in Gender-Confirming Chest Surgery: A Systematic Scoping
Review.
Source
Aesthetic plastic surgery. (no pagination), 2019. Date of Publication: 29
Oct 2019.
Author
Tolstrup A.; Zetner D.; Rosenberg J.
Institution
(Tolstrup, Zetner, Rosenberg) Centre for Perioperative Optimisation,
Department of Surgery, Herlev Hospital, University of Copenhagen,
Copenhagen, Denmark
Publisher
NLM (Medline)
Abstract
BACKGROUND: The aim of this scoping review was to provide an overview of
outcome measures in gender-confirming chest surgery. METHOD(S): A
comprehensive literature search was performed in PubMed, EMBASE, CINAHL,
PsycINFO, Scopus and the Cochrane Library to find studies evaluating
gender-confirming chest surgery in a non-cis gender population. The
systematic scoping review followed the PRISMA extension for scoping
reviews. Data were charted for outcome measures including complications,
reoperations, revision surgery, aesthetic outcome and patient-reported
outcome measures. RESULT(S): Our search yielded 849 records, which
were screened on title, abstract and full text. Of these, 47 were included
in the review. Feminising gender-confirming chest surgery was evaluated in
11 studies, and masculinising gender-confirming chest surgery was
evaluated in 39 studies. Clinician-reported outcome categories were used
in 40 studies and included complications, reoperation, revision surgery
and aesthetic outcome. Categories of patient-reported outcomes were used
in 29 studies and included aesthetic outcome, functional outcome and
mental health parameters. The summary of outcome domains and
classifications showed that there are large variations in outcome
evaluation between studies. Although several studies reported on similar
outcome categories, there was a high level of heterogeneity of domains and
classifications of outcomes. CONCLUSION(S): Evaluation of outcomes in
gender-confirming chest surgery showed large variations in reporting, and
further streamlining of reporting is therefore required to be able to
compare surgical outcomes between studies. LEVEL OF EVIDENCE III: This
journal requires that authors assign a level of evidence to each article.
For a full description of these Evidence-Based Medicine ratings, please
refer to the Table of Contents or the online Instructions to Authors
www.springer.com/00266 .

<42>
Accession Number
629725159
Title
Prevalence and Impact of Treatment Crossover in Cardiac Surgery Randomized
Trials: A Meta-Epidemiologic Study.
Source
Journal of the American Heart Association. 8 (21) (pp e013711), 2019. Date
of Publication: 05 Nov 2019.
Author
Gaudino M.; Fremes S.E.; Ruel M.; Di Franco A.; Di Mauro M.; Chikwe J.;
Frati G.; Girardi L.N.; Taggart D.P.; Biondi-Zoccai G.
Institution
(Gaudino, Di Franco, Girardi) Department of Cardiothoracic Surgery Weill
Cornell Medicine New York NY
(Fremes) Schulich Heart Centre Division of Cardiac Surgery Department of
Surgery Sunnybrook Health Sciences Centre University of Toronto Ontario
Canada
(Ruel) University of Ottawa Heart Institute University of Ottawa Ontario
Canada
(Di Mauro) Heart Department SS Annunziata Hospital Chieti Italy
(Chikwe) Department of Cardiothoracic Surgery Stony Brook School of
Medicine New York NY
(Chikwe) Department of Cardiothoracic Surgery Mount Sinai Hospital New
York NY
(Frati, Biondi-Zoccai) Department of Medico-Surgical Sciences and
Biotechnologies Sapienza University of Rome Latina Italy
(Frati) Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.)
Neuromed Pozzilli Italy
(Taggart) Nuffield Department of Surgical Sciences University of Oxford
United Kingdom
(Biondi-Zoccai) Mediterranea Cardiocentro Napoli Italy
Publisher
NLM (Medline)
Abstract
Background Crossover dilutes treatment effect and reduces statistical
power of intention-to-treat analysis. We examined incidence and impact on
cardiac surgery randomized controlled trial (RCT) outcomes of crossover
from experimental to control interventions, or vice versa. Methods and
Results MEDLINE, EMBASE, and Cochrane Library were searched, and RCTs
(>=100 patients) comparing >=2 adult cardiac surgical interventions were
included. Crossover from the initial treatment assignment and relative
risks (RRs) for each trial's primary end point and mortality at longest
available follow-up were extracted. All RRs were calculated as >1 favored
control group and <1 favored experimental arm. Primary outcome was the
effect estimate for primary end point of each RCT, and secondary outcome
was all-cause mortality; both were appraised as RR at the longest
follow-up available. Sixty articles reporting on 47 RCTs (25 440 patients)
were identified. Median crossover rate from experimental to control group
was 7.0% (first quartile, 2.0%; third quartile, 9.7%), whereas from
control to experimental group, the rate was 1.3% (first quartile, 0%;
third quartile, 3.6%). RRs for primary end point and mortality were higher
in RCTs with higher crossover rate from experimental to control group (RR,
1.01 [95% CI, 0.94-1.07] versus RR, 0.80 [95% CI, 0.66-0.97] and RR, 1.02
[95% CI, 0.95-1.11] versus RR, 0.94 [95% CI, 0.82-1.07], respectively).
Crossover from control to experimental group did not alter effect
estimates for primary end point or mortality (RR, 0.82 [95% CI, 0.63-1.05]
versus RR, 0.95 [95% CI, 0.86-1.04] and RR, 0.88 [95% CI, 0.73-1.07]
versus RR, 1.02 [95% CI, 0.95-1.09], respectively). Conclusions Crossover
from experimental to control group is associated with outcomes of cardiac
surgery RCTs. Crossover should be minimized at designing stage and
carefully appraised after study completion.

<43>
Accession Number
622224611
Title
Effects of perioperative statins on patient outcomes after noncardiac
surgery: a meta-analysis.
Source
Annals of Medicine. 50 (5) (pp 402-409), 2018. Date of Publication: 04 Jul
2018.
Author
Ma B.; Sun J.; Diao S.; Zheng B.; Li H.
Institution
(Ma, Sun, Diao, Zheng) Department of Cardiology, The Affiliated Hospital
of Binzhou Medical University, Binzhou, Shandong, China
(Li) Department of Oncology, The Affiliated Hospital of Binzhou Medical
University, Binzhou, Shandong, China
Publisher
Taylor and Francis Ltd
Abstract
Background: Cardiovascular complications are strongly correlated with a
higher risk of mortality during follow-up after noncardiac surgery.
However, controversy remains regarding whether perioperative
administration of hydroxymethylglutaryl-CoA reductase inhibitors (statins)
has a beneficial effect on patient outcomes. Objective(s): We
performed a meta-analysis to validate the hypothesis that perioperative
statins improve patient outcomes after noncardiac surgery. Method(s):
Electronic databases (PubMed, Web of Science, EMBASE, and the Cochrane
Library) were searched for randomized controlled trials (RCTs) published
up to 10 November 2017. RCTs were eligible for inclusion if they compared
perioperative statin treatment with control treatment in patients
scheduled for noncardiac surgery and reported data pertaining to clinical
outcomes. Result(s): Twelve RCTs involving 4707 patients (2371 in the
perioperative statin group and 2336 in the control group) were ultimately
included in this meta-analysis. The incidences of postoperative myocardial
infarction, composite of death/myocardial infarction/stroke and new cases
of atrial fibrillation were all lower in patients treated with statins
than in control group patients, as shown by the fixed-effects model (odds
ratio (OR) = 0.460, 95% confidence interval (CI) = 0.324-0.653, p = 0 for
myocardial infarction; OR = 0.617, 95% CI = 0.476-0.801, p = 0 for
composite of death/myocardial infarction/stroke; OR = 0.406, 95% CI =
0.247-0.666, p = 0 for new atrial fibrillation). No significant
differences in the incidences of stroke or transient ischemic attack,
all-cause mortality and cardiovascular mortality were observed between the
statin and control arms. Conclusion(s): This meta-analysis supports
the hypothesis that perioperative statins effectively reduce the
incidences of postoperative myocardial infarction, composite of
death/myocardial infarction/stroke and new cases of atrial fibrillation in
patients undergoing noncardiac surgery.Key Messages Cardiovascular
complications are strongly correlated with a higher risk of mortality
during follow-up after noncardiac surgery. We performed a meta-analysis to
confirm the hypothesis that perioperative statins improve patient outcomes
after noncardiac surgery. Copyright © 2018, © 2018 Informa
UK Limited, trading as Taylor & Francis Group.

<44>
Accession Number
2003205625
Title
Effect of open-lung vs conventional perioperative ventilation strategies
on postoperative pulmonary complications after on-pump cardiac surgery:
the PROVECS randomized clinical trial.
Source
Intensive Care Medicine. 45 (10) (pp 1401-1412), 2019. Date of
Publication: 01 Oct 2019.
Author
Lagier D.; Fischer F.; Fornier W.; Huynh T.M.; Cholley B.; Guinard B.;
Heger B.; Quintana G.; Villacorta J.; Gaillat F.; Gomert R.; Degirmenci
S.; Colson P.; Lalande M.; Benkouiten S.; Minh T.H.; Pozzi M.; Collart F.;
Latremouille C.; Vidal Melo M.F.; Velly L.J.; Jaber S.; Fellahi J.-L.;
Baumstarck K.; Guidon C.
Institution
(Lagier, Guinard, Quintana, Villacorta, Gaillat, Gomert, Degirmenci,
Velly, Guidon) Departement d'Anesthesie et Reanimation (SAR 2), CHU La
Timone, Assistance Publique des Hopitaux de Marseille, Marseille, France
(Collart) Service de Chirurgie Cardiaque, CHU La Timone, Assistance
Publique des Hopitaux de Marseille, Marseille, France
(Lagier) C2VN, Inserm 1263, Inra 1260, Aix Marseille Universite,
Marseille, France
(Velly) INT, Aix Marseille Universite, Marseille, France
(Fischer, Heger) Departement d'Anesthesie et Reanimation, Nouvel Hopital
Civil, Hopitaux Universitaires de Strasbourg, Strasbourg, France
(Minh) Service de Chirurgie Cardiaque, Nouvel Hopital Civil, Strasbourg,
France
(Fornier, Fellahi) Service d'Anesthesie et Reanimation, Hospices Civils de
Lyon, Hopital Louis Pradel, Lyon, France
(Pozzi) Service de Chirurgie Cardiaque, Hospices Civils de Lyon, Hopital
Louis Pradel, Lyon, France
(Fellahi) IHU OPERA, Inserm 1060, Faculte de Medecine Lyon Est, Universite
Claude Bernard Lyon 1, Lyon, France
(Fornier) Centre d'Investigation Clinique de Lyon, INSERM 1407, Lyon,
France
(Huynh, Cholley) Service d'Anesthesie et Reanimation, Hopital Europeen
Georges Pompidou, AP-HP, Paris, France
(Huynh, Cholley, Latremouille) Service de Chirurgie Cardiaque, Hopital
Europeen Georges Pompidou, AP-HP, Paris, France
(Huynh, Cholley, Latremouille) Universite Paris Descartes-Sorbonne
Paris-Cite, Paris, France
(Colson, Lalande) CHU de Montpellier, Departement d'Anesthesie et
Reanimation, Hopital Arnaud de Villeneuve, Montpellier, France
(Jaber) Departement d'Anesthesie et Reanimation, Hopital Saint-Eloi,
Montpellier, France
(Colson) IGF, Cnrs, Inserm, Universite de Montpellier, Montpellier, France
(Jaber) UMR CNRS 9214-Inserm U1046, Universite de Montpellier,
Montpellier, France
(Vidal Melo) Department of Anesthesia, Critical Care and Pain Medicine,
Massachusetts General Hospital, Harvard Medical School, Boston, United
States
(Benkouiten) Direction de la Recherche en Sante de l'Assistance Publique
des Hopitaux de Marseille, Marseille, France
(Baumstarck) Centre d'Etudes et de Recherches sur les Services de Sante et
Qualite, Faculte de Medecine, Aix-Marseille Universite, Marseille, France
Publisher
Springer Verlag (E-mail: service@springer.de)
Abstract
Purpose: To evaluate whether a perioperative open-lung ventilation
strategy prevents postoperative pulmonary complications after elective
on-pump cardiac surgery. Method(s): In a pragmatic, randomized,
multicenter, controlled trial, we assigned patients planned for on-pump
cardiac surgery to either a conventional ventilation strategy with no
ventilation during cardiopulmonary bypass (CPB) and lower perioperative
positive end-expiratory pressure (PEEP) levels (2 cm H<inf>2</inf>O) or an
open-lung ventilation strategy that included maintaining ventilation
during CPB along with perioperative recruitment maneuvers and higher PEEP
levels (8 cm H<inf>2</inf>O). All study patients were ventilated with
low-tidal volumes before and after CPB (6 to 8 ml/kg of predicted body
weight). The primary end point was a composite of pulmonary complications
occurring within the first 7 postoperative days. Result(s): Among 493
randomized patients, 488 completed the study (mean age, 65.7 years; 360
(73.7%) men; 230 (47.1%) underwent isolated valve surgery). Postoperative
pulmonary complications occurred in 133 of 243 patients (54.7%) assigned
to open-lung ventilation and in 145 of 245 patients (59.2%) assigned to
conventional ventilation (p = 0.32). Open-lung ventilation did not
significantly reduce the use of high-flow nasal oxygenotherapy (8.6% vs
9.4%; p = 0.77), non-invasive ventilation (13.2% vs 15.5%; p = 0.46) or
new invasive mechanical ventilation (0.8% vs 2.4%, p = 0.28). Mean alive
ICU-free days at postoperative day 7 was 4.4 +/- 1.3 days in the open-lung
group vs 4.3 +/- 1.3 days in the conventional group (mean difference, 0.1
+/- 0.1 day, p = 0.51). Extra-pulmonary complications and adverse events
did not significantly differ between groups. Conclusion(s): A
perioperative open-lung ventilation including ventilation during CPB does
not reduce the incidence of postoperative pulmonary complications as
compared with usual care. This finding does not support the use of such a
strategy in patients undergoing on-pump cardiac surgery. Trial
registration: Clinicaltrials.gov Identifier: NCT 02866578.
https://clinicaltrials.gov/ct2/show/NCT02866578. Copyright ©
2019, Springer-Verlag GmbH Germany, part of Springer Nature.

<45>
Accession Number
629599809
Title
Protocol for the electroencephalography guidance of anesthesia to
alleviate geriatric syndromes (Engages-canada) study: A pragmatic,
randomized clinical trial [version 1; peer review: 2 approved].
Source
F1000Research. 8 (no pagination), 2019. Article Number: 1165. Date of
Publication: 2019.
Author
Deschamps A.; Saha T.; El-Gabalawy R.; Jacobsohn E.; Overbeek C.; Palermo
J.; Robichaud S.; Dumont A.A.; Djaiani G.; Carroll J.; Kavosh M.S.;
Tanzola R.; Schmitt E.M.; Inouye S.K.; Oberhaus J.; Mickle A.; Abdallah
A.B.; Avidan M.S.
Institution
(Deschamps) Department of Anesthesiology and Pain Medicine, Montreal Heart
Institute and Universite de Montreal, Montreal, QC H1T 1C8, Canada
(Saha, Tanzola) Department of Anesthesiology and Perioperative Medicine,
Queen's University, Kingston, Kingston, ON, Canada
(El-Gabalawy) Department of Clinical Health Psychology, Anesthesiology,
Perioperative and Pain Medicine, University of Manitoba, Winnipeg, MB,
Canada
(Jacobsohn) Departments of Anesthesia and Internal Medicine, University of
Manitoba, Winnipeg, MB, Canada
(Overbeek, Palermo) Department of Anesthesiology and Pain Medicine,
University of Montreal, Montreal, QC, Canada
(Robichaud) Montreal Heart Institute, Montreal, QC H1T 1C8, Canada
(Dumont) Montreal Health Innovation Coordinating Center, Montreal Heart
Institute, Montreal, QC, Canada
(Djaiani, Carroll) Department of Anesthesia, University of Toronto,
Toronto, ON, Canada
(Kavosh) Department of Anesthesiology, Perioperative and Pain Medicine,
Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada
(Schmitt, Inouye) Department of Medicine, Beth Israel Deaconess Medical
Center, Boston, Massachussetts, United States
(Oberhaus, Mickle, Abdallah, Avidan) Department of Anesthesiology,
Washington University School of Medicine, St-Louis, MO, United States
Department of Anesthesia, University of Manitoba, Winnipeg, MB, Canada
Publisher
F1000 Research Ltd
Abstract
Background: There is some evidence that electroencephalography guidance of
general anesthesia can decrease postoperative delirium after non-cardiac
surgery. There is limited evidence in this regard for cardiac surgery. A
suppressed electroencephalogram pattern, occurring with deep anesthesia,
is associated with increased incidence of postoperative delirium (POD) and
death. However, it is not yet clear whether this electroencephalographic
pattern reflects an underlying vulnerability associated with increased
incidence of delirium and mortality, or whether it is a modifiable risk
factor for these adverse outcomes. Method(s): The
Electroencephalography Guidance of Anesthesia to Alleviate Geriatric
Syndromes (ENGAGES-Canada) is an ongoing pragmatic 1200 patient trial at
four Canadian sites. The study compares the effect of two anesthetic
management approaches on the incidence of POD after cardiac surgery. One
approach is based on current standard anesthetic practice and the other on
electroencephalography guidance to reduce POD. In the guided arm,
clinicians are encouraged to decrease anesthetic administration, primarily
if there is electroencephalogram suppression and secondarily if the EEG
index is lower than the manufacturers recommended value (bispectral index
(BIS) or WAVcns below 40 or Patient State Index below 25). The aim in the
guided group is to administer the minimum concentration of anesthetic
considered safe for individual patients. The primary outcome of the study
is the incidence of POD, detected using the confusion assessment method or
the confusion assessment method for the intensive care unit; coupled with
structured delirium chart review. Secondary outcomes include unexpected
intraoperative movement, awareness, length of intensive care unit and
hospital stay, delirium severity and duration, quality of life, falls, and
predictors and outcomes of perioperative distress and dissociation.
 Discussion(s): The ENGAGES-Canada trial will help to clarify whether
or not using the electroencephalogram to guide anesthetic administration
during cardiac surgery decreases the incidence, severity, and duration of
POD. Registration: ClinicalTrials.gov (NCT02692300)
26/02/2016. Copyright © 2019 Deschamps A et al.

<46>
Accession Number
2003557185
Title
The utility of traditional Chinese medicine (Shenmai) in the cardiac
rehabilitation after coronary artery bypass grafting: A single-center
randomized clinical trial.
Source
Complementary Therapies in Medicine. 47 (no pagination), 2019. Article
Number: 102203. Date of Publication: December 2019.
Author
Zhang C.; Zheng Y.; Chen T.; Wang S.; Xu M.
Institution
(Zhang, Wang, Xu) Department of Cardiovascular Surgery, Beijing Anzhen
Hospital, Capital Medical University, Beijing, China
(Zheng) The University of Pittsburgh School of Nursing, Pittsburgh, PA,
United States
(Chen) Department of Clinical Sciences, Liverpool School of Tropical
Medicines, Pembroke Pl, Liverpool L3 5QA, United Kingdom
Publisher
Churchill Livingstone
Abstract
Objective: examine the efficacy and safety of Shenmai to the cardiac
rehabilitation in patients received coronary artery bypass grafting.
 Design(s): a single-center randomized, single blind clinical trial.
 Setting(s): Department of Cardiovascular Surgery, Beijing Anzhen
Hospital, Capital Medical University, Beijing, China. Subjects: Patients
with coronary artery disease who received coronary artery bypass grafting
in our center were studied. They must be competent to complete the
6-minute walking test without any assistance and without any severe
comorbidity. Intervention(s): in Shemmai group, the participants were
treated with Shenmai injection (100 ml/day) right after the surgery to
discharge for 9.28 +/- 3.75 days and then capsule (3.6 g/day) sequentially
for 30 days in addition to the cardiac rehabilitation. In control group,
only cardiac rehabilitation was conducted. Main measures: the 6-Minute
Walking Test was measured at three time points: one day before operation,
on the day of discharge and 30 days follow up. Result(s): The sample
(n = 166) was predominately male (84%), with mean age was 61.12 +/- 9.13
years. There was no significant difference between groups in baseline
characteristics and the procedural characteristics. There was one death in
control group and one stroke in Shenmai group right after the surgery.
Overall, there was group (p =.005) and time effect (p <.001) on the
6-minute walking distance. Participants in the Shenmai group walked longer
distance in meters compared with control group on the day of discharge
(314.54 +/- 64.14 vs. 271.29 +/- 76.82, P <.001), while no significant
differences before operation (399.72 +/- 93.19 vs. 403.67 +/- 91.99, p
=.78) and on 30-day follow up (436.54 +/- 67.64 vs. 421.64 +/- 83.53, p
=.21). Conclusion(s): Shenmai improves the exercise tolerance in the
early stage of the cardiac rehabilitation for patients received coronary
artery bypass grafting. Copyright © 2019 Elsevier Ltd

<47>
Accession Number
629676474
Title
Right Ventricular Electrical Activation in Patients with Repaired
Tetralogy of Fallots: Insights from Electroanatomical Mapping and
High-Resolution Magnetic Resonance Imaging.
Source
Circulation: Arrhythmia and Electrophysiology. 12 (6) (no pagination),
2019. Article Number: e007141. Date of Publication: 01 Jun 2019.
Author
Jalal Z.; Sacher F.; Fournier E.; Cochet H.; Derval N.; Haissaguerre M.;
Fernandez E.T.; Iriart X.; Denis A.; Ploux S.; Pillois X.; Bordachar P.;
Thambo J.-B.
Institution
(Jalal, Fournier, Iriart, Thambo) Department of Pediatric and Adult
Congenital Cardiology, Bordeaux University Hospital (CHU), Ave Magellan,
Pessac 33600, France
(Sacher, Derval, Haissaguerre, Denis, Ploux, Bordachar) Electrophysiology
and Ablation Unit, Bordeaux University Hospital (CHU), Pessac, France
(Cochet, Fernandez) Department of Radiology, Bordeaux University Hospital
(CHU), Pessac, France
(Jalal, Sacher, Cochet, Derval, Haissaguerre, Fernandez, Iriart, Denis,
Ploux, Pillois, Bordachar, Thambo) IHU Liryc, Electrophysiology and Heart
Modeling Institute, Foundation Bordeaux Universite, Pessac-Bordeaux,
France
(Jalal, Sacher, Cochet, Derval, Haissaguerre, Fernandez, Denis, Bordachar,
Thambo) INSERM, Centre de Recherche Cardio-Thoracique de Bordeaux, France
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)

<48>
Accession Number
629676148
Title
Interventional Therapy Versus Medical Therapy for Secundum Atrial Septal
Defect: A Systematic Review (Part 2) for the 2018 AHA/ACC Guideline for
the Management of Adults with Congenital Heart Disease A Report of the
American College of Cardiology/American Heart Association Task Force on
Clinical Practice Guidelines.
Source
Circulation. 139 (14) (pp E814-E830), 2019. Date of Publication: 02 Apr
2019.
Author
Oster M.; Ami B.A.; Zaragoza-Macias E.; Dendukuri N.; Marelli A.
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
Secundum atrial septal defect (ASD) is the most common adult congenital
heart defect and can present with wide variation in clinical findings.
With the intention of preventing morbidity and mortality associated with
late presentation of ASD, consensus guidelines have recommended surgical
or percutaneous ASD closure in adults with right heart enlargement, with
or without symptoms. The aim of the present analysis was to determine if
the protective effect of secundum ASD closure in adults could be qualified
by pooling data from published studies. A systematic review and
meta-analysis were performed by using EMBASE, MEDLINE (through PubMed),
and the Cochrane Library databases to assess the effect of secundum ASD
percutaneous or surgical closure in unoperated adults 18 years of age.
Data were pooled across studies with the DerSimonian-Laird random-effects
model or a Bayesian meta-analysis model. Between-study heterogeneity was
assessed with Cochrans Q test. Bias assessment was performed with the
Newcastle- Ottawa Scale and the Cochrane Risk of Bias Tool, and
statistical risk of bias was assessed with Begg and Mazumdars test and
Egger?s test. A total of 11 nonrandomized studies met the inclusion
criteria, contributing 603 patients. Pooled analysis showed a protective
effect of ASD closure on New York Heart Association functional class and
on right ventricular systolic pressure, volumes, and dimensions. Two
additional studies comprising 652 patients were reviewed separately for
mortality outcome and primary outcome of interest because they did not
meet the inclusion criteria. Those studies showed that ASD closure was
associated with a weak protective effect on adjusted mortality rate but no
significant impact on atrial arrhythmias in patients <50 years of age.
Across all studies, there was significant heterogeneity between studies
for nearly all clinical outcomes. The overall body of evidence was limited
to observational cohort studies, the limitations of which make for
low-strength evidence. Even within the parameters of the included studies,
quality of evidence was further diminished by the lack of well-defined
clinical outcomes. In conclusion, pooled data analysis on the impact of
secundum ASD closure in adults was notably limited because of the lack of
randomized controlled trials in patients with only secundum ASD. The few
cohort studies in this population demonstrated improvement in functional
status and right ventricular size and function as shown by echocardiogram.
However, our findings suggest that at the time of this publication,
insufficient data are available to determine the impact of ASD repair on
mortality rate in adults. Copyright © 2018 American Heart
Association, Inc.

<49>
Accession Number
629675183
Title
Randomized Trial Evaluating Percutaneous Coronary Intervention for the
Treatment of Chronic Total Occlusion: The DECISION-CTO Trial.
Source
Circulation. 139 (14) (pp 1674-1683), 2019. Date of Publication: 02 Apr
2019.
Author
Lee S.-W.; Lee P.H.; Ahn J.-M.; Park D.-W.; Yun S.-C.; Han S.; Kang H.;
Kang S.-J.; Kim Y.-H.; Lee C.W.; Park S.-W.; Hur S.H.; Rha S.-W.; Her
S.-H.; Choi S.W.; Lee B.-K.; Lee N.-H.; Lee J.-Y.; Cheong S.-S.; Kim M.H.;
Ahn Y.-K.; Lim S.W.; Lee S.-G.; Hiremath S.; Santoso T.; Udayachalerm W.;
Cheng J.J.; Cohen D.J.; Muramatsu T.; Tsuchikane E.; Asakura Y.; Park
S.-J.
Institution
(Lee, Lee, Ahn, Park, Kang, Kang, Kim, Lee, Park, Park) Department of
Cardiology, Center for Medical Research and Information, University of
Ulsan College of Medicine, Asan Medical Center, 88 Olympic-ro 43-gil,
Songpa-gu, Seoul 05505, South Korea
(Yun) Biostatistics, Center for Medical Research and Information,
University of Ulsan College of Medicine, Asan Medical Center, Seoul, South
Korea
(Han) Department of Applied Statistics, Gachon University, Seongnam, South
Korea
(Hur) Department of Cardiology, Keimyung University Dongsan Medical
Center, Daegu, South Korea
(Rha) Department of Cardiology, Korea University Guro Hospital, South
Korea
(Her) Department of Cardiology, Catholic University of Korea, Daejeon St.
Mary's Hospital, South Korea
(Choi) Department of Cardiology, Chungnam National University Hospital,
Daejeon, South Korea
(Lee) Department of Cardiology, Kangwon National University Hospital,
Chuncheon, South Korea
(Lee) Department of Cardiology, Soon Chun Hyang University Hospital,
Bucheon, South Korea
(Lee) Department of Cardiology, Kangbuk Samsung Medical Center, Seoul,
Korea (J.-Y.L.)., South Korea
(Cheong) Department of Cardiology, Gangneung Asan Hospital, South Korea
(Kim) Department of Cardiology, Dong-A University Hospital, Busan, South
Korea
(Ahn) Department of Cardiology, Chonnam National University Hospital,
Gwangju, South Korea
(Lim) Department of Cardiology, CHA Bundang Medical Center, Seongnam,
South Korea
(Lee) Department of Cardiology, Ulsan University Hospital, South Korea
(Hiremath) Department of Cardiology, Ruby Hall Clinic, Pune, India
(Santoso) Department of Cardiology, Medistra Hospital, Jakarta, Indonesia
(Udayachalerm) Department of Cardiology, King Chulalongkorn Memorial
Hospital, Bangkok, Thailand
(Cheng) Department of Cardiology, Shin Kong Hospital, Taipei, Taiwan
(Republic of China)
(Cohen) Saint Luke's Mid America Heart Institute, Kansas City, MO, United
States
(Muramatsu) Department of Cardiology, Tokyo General Hospital, Japan
(Tsuchikane) Toyohashi Heart Center, Aichi, Japan
(Asakura) Department of Cardiology, Hakujikai Memorial Hospital, Tokyo,
Japan
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
Background: Procedural results for percutaneous coronary intervention
(PCI) in coronary vessels with chronic total occlusion (CTO) have improved
in recent years, and PCI strategies have moved toward more complete
revascularization with more liberal use of CTO-PCI. However, evidence
evaluating CTO-PCI is limited to observational studies and small clinical
trials. Method(s): In this open-label, multicenter, randomized,
noninferiority trial, PCI-eligible patients were assigned to receive
either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO
lesion with the option for PCI of obstructive non-CTO lesions at the
discretion of the operator. The primary end point was a composite of
death, myocardial infarction, stroke, or any revascularization.
Health-related quality of life was assessed at baseline and at 1, 6, 12,
24, and 36 months. Because of slow recruitment, the trial was stopped
before completion of the 1284 planned enrollments. Result(s): Between
March 2010 and September 2016, 834 patients were randomly assigned to the
CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients
assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive
staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success
rate was 90.6%. Serious nonfatal complications associated with CTO-PCI
occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with
recurrent episodes of ventricular tachyarrhythmia induced by intracoronary
thrombus). Approximately half of the patients in each group underwent PCI
for an average of 1.3 non-CTO lesions, resulting in a comparable residual
SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery;
3.7+/-5.4 versus 4.0+/-5.9, P=0.42) confined to non-CTO vessels. During a
median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years),
there was no significant difference between the CTO-PCI and the no CTO-PCI
strategies in the incidence of the primary end point (22.3% versus 22.4%,
hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no
CTO-PCI strategy were associated with significant improvements but without
between-group differences in disease-specific health status that was
sustained through 36 months. Conclusion(s): CTO-PCI was feasible with
high success rates. There was no difference in the incidence of major
adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the
study was limited by low power for clinical end points and high crossover
rates between groups. Clinical Trial Registration: URL:
https://www.clinicaltrials.gov. Unique identifier:
NCT01078051. Copyright © 2018 American Heart Association, Inc.

<50>
Accession Number
629662895
Title
Blood pressure in de novo heart transplant recipients treated with
everolimus compared with a cyclosporine-based regimen: Results from the
randomized schedule trial.
Source
Transplantation. 103 (4) (pp 781-788), 2019. Date of Publication: 01 Apr
2019.
Author
Andreassen A.K.; Broch K.; Eiskjaer H.; Karason K.; Gude E.; Molbak D.;
Stueflotten W.; Gullestad L.
Institution
(Andreassen, Broch, Gude, Stueflotten, Gullestad) Department of
Cardiology, Oslo University Hospital Rikshospitalet, PO Box 4950, Nydalen
,Oslo 0424, Norway
(Andreassen, Gullestad) Faculty of Medicine, University of Oslo, Oslo,
Norway
(Eiskjaer, Molbak) Department of Cardiology, Aarhus University Hospital,
Skejby, Denmark
(Karason) Department of Cardiology, Sahlgrenska University Hospital,
Gothenburg, Sweden
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
Background. Systemic hypertension is prevalent in heart transplant
recipients and has been partially attributed to treatment with calcineurin
inhibitors (CNIs). SCandinavian HEart transplant De-novo stUdy with earLy
calcineurin inhibitors avoidancE trial was the first randomized trial to
study early withdrawal of CNIs in de novo heart transplant recipients,
comparing an everolimus-based immunosuppressive regimen with conventional
CNI-based treatment. As a prespecified secondary endpoint, blood pressure
was repeatedly compared across treatment arms. Methods. The The
SCandinavian HEart transplant De-novo stUdy with earLy calcineurin
inhibitors avoidancE trial was a prospective, multicenter, randomized,
controlled, parallel-group, open-label trial in de novo adult heart
transplant recipients, undertaken at transplant centers in Scandinavia.
Blood pressure was assessed with 24-hour ambulatory blood pressure
monitoring up to 3 years after heart transplantation (HTx) in 83 patients.
Results. Overall, systolic blood pressure fell with time, from 138 +/- 15
mm Hg 2 weeks after HTx to 134 +/- 11 mm Hg after 12 months and 132 +/- 14
mm Hg after 36 months (P = 0.003). Diastolic blood pressure did not change
over time. After 12 months, there was a numerically larger fall in
systolic blood pressure in the everolimus arm (between-group difference 8
mm Hg; P = 0.053), and after 36 months, there was a significant between
group difference of 13 mm Hg (P = 0.02) in favor of everolimus.
Conclusions. In this first, randomized trial with early CNI avoidance in
de novo HTx recipients, we observed a modest fall in systolic blood
pressure over the first 1 to 3 years after transplantation. The fall in
systolic blood pressure was more pronounced in patients allocated to
everolimus. Copyright © 2018 Wolters Kluwer Health, Inc. All
rights reserved.

<51>
Accession Number
627827955
Title
Exclusion criteria and adverse events in perioperative trials of
tranexamic acid in cardiac surgery: a systematic review and meta-analysis.
Source
Canadian Journal of Anesthesia. 66 (10) (pp 1240-1250), 2019. Date of
Publication: 15 Oct 2019.
Author
Khair S.; Perelman I.; Yates J.; Taylor J.; Lampron J.; Tinmouth A.;
Saidenberg E.
Institution
(Khair, Perelman, Yates, Taylor, Lampron, Tinmouth, Saidenberg) Faculty of
Medicine, University of Ottawa, Ottawa, Canada
(Perelman, Lampron, Tinmouth, Saidenberg) Clinical Epidemiology, Ottawa
Hospital Research Institute, Ottawa, Canada
(Lampron, Tinmouth, Saidenberg) Ottawa Hospital, 501 Smyth Rd, Ottawa, ON
K1H 8L6, Canada
Publisher
Springer New York LLC (E-mail: barbara.b.bertram@gsk.com)
Abstract
Purpose: Tranexamic acid (TXA) reduces perioperative blood loss and
transfusion requirement following cardiac surgery. Nevertheless, TXA
remains underutilized because of concerns regarding development of adverse
events. We conducted a systematic review to determine which patients are
commonly excluded from TXA cardiac surgery clinical trials to determine if
there are patient groups lacking safety data on TXA. Method(s): The
databases Medline, EMBASE, and the Cochrane Central Register of Controlled
Trials were searched until September 2017. Eligible studies were
randomized-controlled trials (RCTs) administering systemic TXA
perioperatively to patients undergoing any cardiac surgery. Our primary
outcome was the exclusion criteria for each RCT, and the secondary
endpoint was TXA safety. A descriptive synthesis was performed to analyze
the exclusion criteria. TXA safety was assessed with meta-analysis.
Principal findings: Seventy eligible RCTs were included. The most common
reasons for excluding patients from TXA cardiac surgery trials were major
hepatic, renal, or cardiac comorbidities (76% of studies). Meta-analysis
showed that TXA did not increase the risk of adverse events compared with
placebo or no intervention (risk ratio, 0.97; 95% confidence interval,
0.88 to 1.07), including thrombosis and seizure. Conclusion(s): We
found that systemic TXA is safe to use in cardiac surgery. Certain patient
groups are frequently excluded from TXA cardiac surgery trials, and may
consequently have limited efficacy and safety data on TXA. Further
research in these patient groups may be needed; nevertheless, for many
patient populations there are sufficient data to inform evidence-based
guidelines for TXA use in cardiac surgery. Trial registration: PROSPERO
(CRD42017060971); registered 4 April, 2017. Copyright © 2019,
Canadian Anesthesiologists' Society.

<52>
Accession Number
628563068
Title
Subgroup analysis comparing ultrathin, bioresorbable polymer
sirolimus-eluting stents versus thin, durable polymer everolimus-eluting
stents in acute coronary syndrome patients: Bioflow v acute coronary
syndromes subgroup.
Source
Circulation: Cardiovascular Interventions. 11 (10) (no pagination), 2018.
Article Number: e007331. Date of Publication: 2018.
Author
Roguin A.; Kandzari D.E.; Marcusohn E.; Koolen J.J.; Doros G.; Massaro
J.M.; Garcia-Garcia H.M.; Bennett J.; Gharib E.G.; Cutlip D.E.; Waksman R.
Institution
(Roguin, Marcusohn) Division of Invasive Cardiology, Rambam Medical
Center, Bat-Galim, Haifa 31096, Israel
(Kandzari) Piedmont Heart Institute, Atlanta, GA, United States
(Koolen) Catharina Hospital, Eindhoven, Netherlands
(Doros) Baim Institute for Clinical Research, Boston, MA, United States
(Massaro) Department of Biostatistics and Epidemiology, Boston University,
School of Public Health, MA, United States
(Garcia-Garcia, Waksman) Division of Interventional Cardiology, MedStar
Cardiovascular Research Network, MedStar Washington Hospital Center, DC,
United States
(Bennett) Department of Cardiovascular Medicine, University Hospitals
Leuven, Belgium
(Gharib) Charleston Area Medical Center, WV, United States
(Cutlip) Beth Israel Deaconess Medical Center, Baim Institute for Clinical
Research, Boston, MA, United States
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
BACKGROUND: Presentation with acute coronary syndromes (ACS) constitutes a
high-risk subset of patients with worse outcome after percutaneous
coronary intervention. We report clinical outcomes in subjects with ACS
from the BIOFLOW V trial (BIOTRONIK - A Prospective Randomized Multicenter
Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus
Eluting Coronary Stent System in the Treatment of Subjects With up to
Three De Novo or Restenotic Coronary Artery Lesions) comparing an
ultrathin strut (60 mum) bioresorbable polymer sirolimus-eluting stent
(BP-SES) with a thin strut (81 mum) durable polymer everolimus-eluting
stent (DP-EES). METHODS AND RESULTS: Among 1334 patients randomized to 2:1
treatment with either BP-SES or DP-EES, 677 (50.7%) ACS patients without
ST-segment-elevation myocardial infarction (MI; 454 BP-SES and 223 DP-EES)
were identified in the retrospective post hoc analysis. The primary end
point of 12-month target lesion failure, individual component end points,
and stent thrombosis were evaluated. Recurrent MI was defined as a >=50%
increase of creatine kinase-myocardial band or in the absence of creatine
kinase-myocardial band, troponin >50% increase over previous level and >3x
the upper limit of normal). All events were adjudicated by a blinded
independent clinical events committee. Overall, baseline clinical,
angiographic, and procedural characteristics of the ACS population were
similar between the 2 treatment groups. At 12 months, target lesion
failure occurred in 5.6% (24/426) of BP-SES patients versus 11.0% (23/209)
in DP-EES patients (P=0.02); target lesion failure composite components
were cardiac death, 0% versus 1.0% (P=0.11); target vessel-related MI,
3.5% versus 9.7% (P=0.003); and clinically driven target lesion
revascularization, 2.8% versus 3.4% (P=0.80). Spontaneous target vessel MI
was 0.5% (2/425) for BP-SES versus 2.4% (5/206) for DP-EES (P=0.041).
Stent thrombosis rates at 1 year were similar (0.5% versus 1.0%; P=0.601).
 CONCLUSION(S): In the ACS subgroup population of the BIOFLOW V study,
treatment with BP-SES compared with DP-EES was associated with a
significantly lower rate of 12-month target lesion failure, a difference
driven by significantly lower periprocedural MI and spontaneous MI. These
findings support treatment with an ultrathin strut BP-SES in ACS patients
undergoing percutaneous coronary intervention. CLINICAL TRIAL
REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier:
NCT02389946. Copyright © 2018 American Heart Association, Inc.

<53>
Accession Number
628520793
Title
Periprocedural myocardial injury predicts short- And long-term mortality
in patients undergoing transcatheter aortic valve replacement.
Source
Circulation: Cardiovascular Interventions. 11 (11) (no pagination), 2018.
Article Number: e007106. Date of Publication: 2018.
Author
Michail M.; Cameron J.N.; Nerlekar N.; Ihdayhid A.R.; McCormick L.M.;
Gooley R.; Niccoli G.; Crea F.; Montone R.A.; Brown A.J.
Institution
(Michail, Nerlekar, Ihdayhid, McCormick, Gooley, Brown) Monash
Cardiovascular Research Centre, Monash University, MonashHeart, Monash
Health, 246 Clayton Rd, Clayton, Melbourne, VIC 3168, Australia
(Michail) Institute of Cardiovascular Science, University College London,
United Kingdom
(Cameron) St George's University of London, United Kingdom
(Niccoli, Crea, Montone) Department of Cardiovascular and Thoracic
Sciences, Fondazione Policlinico A. Gemelli IRCCS, Catholic University of
the Sacred Heart, Rome, Italy
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
BACKGROUND: The aim was to assess whether periprocedural myocardial injury
(PPMI) predicts outcomes in patients undergoing transcatheter aortic valve
replacement (TAVR). PPMI is a strong predictor of outcomes following
coronary intervention, but its impact in the context of TAVR remains
unclear. We performed a systematic review and meta-analysis to ascertain
the association between PPMI and short- or long-term outcomes. METHODS AND
RESULTS: Electronic searches identified studies reporting PPMI following
TAVR. Primary end point was 30-day all-cause mortality, with secondary end
points, including 1-year all-cause mortality, neurological events,
post-TAVR pacemaker implantation, and aortic regurgitation. Analyses were
performed using random effects modeling and reported as summary odds ratio
(OR) with 95% CI. Nine studies comprising 3442 patients (mean age
81.0+/-6.6 years, 51.2% female) were included. PPMI occurred in 25.5% of
patients following TAVR. The pooled all-cause mortality at 30-days and
1-year was 5.2% and 18.6%, respectively. The occurrence of PPMI following
TAVR was associated with significantly increased risk of both 30-day (OR,
4.23; CI, 1.95-9.19; P<0.001) and 1-year all-cause mortality (OR, 1.77;
CI, 1.05-2.99; P<0.001). Similarly, PPMI was associated with post-TAVR
neurological events (OR, 2.72; CI, 1.69-4.37; P<0.001) and post-TAVR
permanent pacing (OR, 1.43; CI, 1.02-2.00; P=0.04) but not with a
statistically significant increase in aortic regurgitation post-TAVR (OR,
1.39; CI, 0.93-2.08; P=0.11). CONCLUSION(S): PPMI is common following
TAVR and is strongly associated with 30-day and 1-year mortality.
Detection of PPMI has potential to identify TAVR patients at highest risk
of subsequent adverse events. Copyright © 2018 American Heart
Association, Inc.

<54>
Accession Number
2002549390
Title
Regional analgesia for minimally invasive cardiac surgery.
Source
Journal of Cardiac Surgery. 34 (11) (pp 1289-1296), 2019. Date of
Publication: 01 Nov 2019.
Author
Yu S.; Valencia M.B.; Roques V.; Aljure O.D.
Institution
(Yu, Aljure) Department of Anesthesiology, Jackson Memorial
Hospital/University of Miami, Miami, FL, United States
(Valencia) Department of Cardiac and Transplant Anesthesiology, London
Health Sciences Centre, London, ON, Canada
(Roques) Department of Intensive Care and Chronic Pain Treatment,
University Hospital Virgen de la Arrixaca, Murcia, Spain
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Background: Minimally invasive cardiac surgery (MICS) has expanded during
the recent years due to interest in improved patient satisfaction and
decreased stay in the hospital. To assist in these interests,
postoperative pain control is aimed at decreasing opioid usage but
maintaining adequate pain control. Regional anesthesia has the ability to
provide these goals. This review article will describe different regional
anesthesia techniques and discuss the evidence of their use in MICS.
 Method(s): A literature search was conducted in MEDLINE (PubMed) and
EMBASE with keywords and narrowed to publications between 1998 and 2018.
The results are reviewed, analyzed, and discussed in this paper.
 Result(s): Thoracic epidurals provide improved pain control and
decreased stay in the intensive care unit. Thoracic paravertebral blocks
are as effective as thoracic epidurals for postoperative pain control.
Serratus anterior plane block provides adequate pain control but does not
control pain as well as paravertebral blocks. Intrapleural blocks provide
sufficient pain control and can be placed by the surgeon. Pectoral fascial
blocks, intercostal blocks, and erector spinae plane blocks described in
case reports seem to be viable options for postoperative pain control.
 Conclusion(s): As cardiac surgery moves toward smaller incisions and
MICS with the goal of enhanced recovery, multimodal analgesic techniques
should be explored for postoperative pain control. The regional techniques
discussed in this article show a trend toward improved pain control and
decreased stay in the intensive care unit. Copyright © 2019 Wiley
Periodicals, Inc.

<55>
Accession Number
627090924
Title
Comparing everolimus-based immunosuppression with reduction or withdrawal
of calcineurin inhibitor reduction from 6 months after heart
transplantation: The randomized MANDELA study.
Source
American Journal of Transplantation. 19 (11) (pp 3006-3017), 2019. Date of
Publication: 01 Nov 2019.
Author
Barten M.J.; Hirt S.W.; Garbade J.; Bara C.; Doesch A.O.; Knosalla C.;
Grinninger C.; Stypmann J.; Sieder C.; Lehmkuhl H.B.; Porstner M.; Schulz
U.
Institution
(Barten) Department of Cardiovascular Surgery, University Heart Center
Hamburg, Hamburg, Germany
(Hirt) Department of Cardiothoracic Surgery, University Hospital
Regensburg, Regensburg, Germany
(Garbade) University Department of Cardiac Surgery, Leipzig Heart Center,
Leipzig, Germany
(Bara) Division of Cardiovascular, Thoracic and Transplantation Surgery,
Hannover Medical School, Hannover, Germany
(Doesch) Department of Cardiology, University Hospital Heidelberg,
Heidelberg, Germany
(Knosalla, Lehmkuhl) Department of Cardiothoracic and Vascular Surgery,
German Heart Institute Berlin, DZHK (German Centre for Cardiovascular
Research), partner site Berlin, Berlin, Germany
(Grinninger) Department of Cardiac Surgery, Munich Transplantation Center,
Klinikum Groshadern LMU, Munich, Germany
(Stypmann) Department of Cardiovascular Medicine, Division of Cardiology,
University Hospital Munster, Munster, Germany
(Sieder, Porstner) Novartis Pharma GmbH, Nuremberg, Germany
(Schulz) Department of Thoracic and Cardiovascular Surgery, Heart and
Diabetes Center NRW, Ruhr University Bochum, Bad Oeynhausen, Germany
Publisher
Blackwell Publishing Ltd
Abstract
In the 12-month, open-label MANDELA study, patients were randomized at
month 6 after heart transplantation to (1) convert to calcineurin
inhibitor (CNI)-free immunosuppression with everolimus (EVR), mycophenolic
acid and steroids (CNI-free, n = 71), or to (2) continue reduced-exposure
CNI, with EVR and steroids (EVR/redCNI, n = 74). Tacrolimus was
administered in 48.8% of EVR/redCNI patients and 52.6% of CNI-free
patients at randomization. Both strategies improved and stabilized renal
function based on the primary endpoint (estimated GFR at month 18
posttransplant postrandomization) with superiority of the CNI-free group
vs EVR/redCNI: mean 64.1 mL/min/1.73 m2 vs 52.9 mL/min/1.73
m2; difference + 11.3 mL/min/1.73 m2 (P <.001). By
month 18, estimated GFR had increased by >= 10 mL/min/1.73 m2
in 31.8% and 55.2% of EVR/redCNI and CNI-free patients, respectively, and
by >= 25 mL/min/1.73 m2 in 4.5% and 20.9%. Rates of
biopsy-proven acute rejection (BPAR) were 6.8% and 21.1%; all cases were
without hemodynamic compromise. BPAR was less frequent with EVR/redCNI vs
the CNI-free regimen (P =.015); 6 of 15 episodes in CNI-free patients
occurred with EVR concentration < 5 ng/mL. Rates of adverse events and
associated discontinuations were comparable. EVR/redCNI from month 6
achieved stable renal function with infrequent BPAR. One-year renal
function can be improved by early conversion to EVR-based CNI-free therapy
but requires close EVR monitoring. Clinical trials registry:
ClinicalTrials.gov NCT00862979. Copyright © 2019 The American
Society of Transplantation and the American Society of Transplant Surgeons

<56>
Accession Number
2002212409
Title
Perioperative dexmedetomidine reduces delirium in elderly patients after
non-cardiac surgery: a systematic review and meta-analysis of
randomized-controlled trials.
Source
Canadian Journal of Anesthesia. 66 (12) (pp 1489-1500), 2019. Date of
Publication: 01 Dec 2019.
Author
Pan H.; Liu C.; Ma X.; Xu Y.; Zhang M.; Wang Y.
Institution
(Pan, Liu, Ma, Xu, Zhang, Wang) Department of Anesthesiology, Shandong
Provincial Hospital Affiliated to Shandong University, No. 324 Jingwu
Road, Jinan 250021, China
Publisher
Springer New York LLC (E-mail: barbara.b.bertram@gsk.com)
Abstract
Background: Delirium is a frequent postoperative complication in elderly
patients after non-cardiac surgery. We performed this updated
meta-analysis to ascertain more precisely the efficacy of dexmedetomidine
(DEX) on the incidence of postoperative delirium (POD) in elderly patients
after non-cardiac surgery. Method(s): We searched PubMed, EMBASE, the
Cochrane Library, Web of Science, and the Cumulative Index of Nursing and
Allied Health Literature (CINAHL) from inception until February 24, 2019.
In this meta-analysis, we included randomized-controlled trials comparing
the effect of DEX vs normal saline (NS) or other anesthetic drugs on POD
incidence in elderly (either >= 60 or >= 65 yr old) patients undergoing
non-cardiac surgery. We performed subgroup analyses of the DEX dosing
strategy (starting time, dose, and duration of administration, with or
without loading dose) and the strategy of various control drugs. A
random-effects model was used for all analyses. Result(s): We
included 11 studies involving 2,890 patients in our meta-analysis. The
pooled results of these studies revealed that DEX significantly reduced
the incidence of POD (relative risk [RR], 0.47; 95% confidence interval
[CI], 0.38 to 0.58; P < 0.001) compared with the control group. Meanwhile,
the incidences of hypotension (RR, 1.20; 95% CI, 1.04 to 1.39; P = 0.01)
and bradycardia (RR, 1.33; 95% CI, 1.08 to 1.63; P = 0.007) were increased
in the DEX group. Subgroup analyses revealed a decrease in POD incidence
when DEX was administered intraoperatively (RR, 0.43; 95% CI, 0.33 to
0.57; P < 0.001) and postoperatively (RR, 0.38; 95% CI, 0.27 to 0.54; P <
0.001) with a loading dose (RR, 0.49; 95% CI, 0.36 to 0.69; P < 0.001)
compared with NS (RR, 0.49; 95% CI, 0.37 to 0.64; P < 0.001) and other
anesthetic drugs (RR, 0.40; 95% CI, 0.26 to 0.60; P < 0.001). There were
significant differences in the time to extubation (standardized mean
difference, -0.60; 95% CI, -1.17 to -0.03; P = 0.04) and the length of
hospital stay (mean difference, -0.50 days; 95% CI, -0.97 to -0.03; P =
0.04). The amount of data for the duration of mechanical ventilation and
length of intensive care unit stay were insufficient to perform a
meta-analysis. Conclusion(s): Perioperative dexmedetomidine reduces
the incidence of POD in elderly patients after non-cardiac surgery, but
this comes at the cost of an increased incidence of hypotension and
bradycardia. Copyright © 2019, Canadian Anesthesiologists'
Society.

<57>
Accession Number
2003442211
Title
What are the options for cardiac standstill during aneurysm surgery? A
systematic review.
Source
Neurosurgical Review. 42 (4) (pp 843-852), 2019. Date of Publication: 01
Dec 2019.
Author
Meling T.R.; Lave A.
Institution
(Meling, Lave) Department of Clinical Neurosciences, Division of
Neurosurgery, Geneva University Hospitals, Geneva, Switzerland
(Meling) Faculty of Medicine, University of Geneva, Geneva, Switzerland
(Meling) Service de Neurochirurgie, Hopitaux Universitaires de Geneve, Rue
Gabriel-Perret-Gentil 5, Geneva 1205, Switzerland
Publisher
Springer Verlag (E-mail: service@springer.de)
Abstract
To perform a systematic review of the techniques for transient circulatory
arrest during intracerebral aneurysm surgery according to the PRISMA
guidelines. Search of PubMed and Google Scholar using the following:
("heart arrest" OR "cardiac standstill"[All Fields]) AND ("intracranial
aneurysm" OR "intracranial"[All Fields] AND "aneurysm"[All Fields]). A
total of 41 original articles were retrieved, of which 17 were excluded
(review articles, editorials and single-case reports). A total of 24
separate articles published between 1984 and 2018 were included in the
final analysis, where the majority of patients harbored anterior
circulation giant or large aneurysms. Adenosine-induced cardiac arrest
gave a short, temporary asystole. The method had benefits in aneurysm with
a broad neck, a thin wall, in specific localizations with narrow surgical
corridors or in case of intraoperative rupture. Rapid ventricular pacing
(RVP) allows a longer and more easily controlled hypotension. Its use is
largely limited to elective cases. Deep hypothermic circulatory arrest
required a complex infrastructure, and fatal procedure complications lead
to a 11.5-30% 30-day mortality rate, limiting its application to giant or
complex aneurysm of the basilar artery or to residual posterior
circulation aneurysm after endovascular treatment. Adenosine and RVP are
both effective options to facilitate clipping of complex aneurysms.
However, their use in patient with ischemic heart disease and cardiac
arrhythmias should be avoided, and their safety in the context of
subarachnoid hemorrhage is yet to be determined. Today, deep hypothermic
circulatory arrest is almost obsolete due to endovascular
alternatives. Copyright © 2019, Springer-Verlag GmbH Germany,
part of Springer Nature.

<58>
Accession Number
2002656690
Title
A meta-analysis of impact of mitral stenosis on outcomes after
transcatheter aortic valve implantation.
Source
Journal of Cardiac Surgery. 34 (11) (pp 1256-1263), 2019. Date of
Publication: 01 Nov 2019.
Author
Takagi H.; Hari Y.; Nakashima K.; Kuno T.; Ando T.
Institution
(Takagi, Hari, Nakashima) Department of Cardiovascular Surgery, Shizuoka
Medical Center, Shizuoka, Japan
(Takagi, Hari, Nakashima) Department of Cardiovascular Surgery, Kitasato
University School of Medicine, Sagamihara, Japan
(Kuno) Department of Medicine, Mount Sinai Beth Israel Medical Center, New
York, NY, United States
(Ando) Department of Cardiology, Detroit Medical Center, Detroit, MI,
United States
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Objectives: To determine whether concomitant mitral stenosis (MS) impairs
outcomes after transcatheter aortic valve implantation (TAVI) in patients
with severe aortic stenosis (AS), we performed a meta-analysis of
currently available evidence. Method(s): To identify all
observational comparative studies of outcomes after TAVI for AS in
patients with MS vs patients with no-MS, we searched databases (MEDLINE
and EMBASE) using web-based search engines (PubMed and OVID). Studies
meeting the following criteria were included; the design was an
observational study; the study population was patients undergoing TAVI for
AS; outcomes in patients with MS were compared with those in patients with
no-MS. Study-specific estimates were then pooled using inverse
variance-weighted averages of logarithmic odds and hazard ratios in the
random-effects model. Result(s): We identified six eligible studies
including 111 621 patients undergoing TAVI. In pooled analyses,
postprocedural incidence of >= moderate paravalvular aortic regurgitation
(PAR) (P =.02), early all-cause mortality (P =.008), early incidence of
myocardial infarction (MI) (P =.01), and midterm all-cause mortality (P
=.03) after TAVI were significantly higher in patients with MS than in
patients with no-MS. There were no significant differences in early
incidence of stroke, major bleeding, acute kidney injury, and new
permanent pacemaker implantation after TAVI between patients with MS and
patients with no-MS. When the study for mitral annular calcification was
excluded in the pooled analyses, no results except for MI were
substantially altered but the significance for early incidence of MI
disappeared (P =.10). Conclusion(s): Postprocedural incidence of >=
moderate PAR, early all-cause mortality, early incidence of MI, and
midterm all-cause mortality after TAVI are higher in patients with MS than
in patients with no-MS. Copyright © 2019 Wiley Periodicals, Inc.

<59>
Accession Number
2002641242
Title
Clinical outcomes of automated anastomotic devices: A metanalysis.
Source
Journal of Cardiac Surgery. 34 (11) (pp 1297-1304), 2019. Date of
Publication: 01 Nov 2019.
Author
Micali L.R.; Matteucci F.; Parise O.; Tetta C.; Moula A.I.; de Jong M.;
Londero F.; Gelsomino S.
Institution
(Micali, Matteucci, Parise, Tetta, Moula, de Jong, Londero, Gelsomino)
Cardiothoracic Department, Maastricht University Hospital, Maastricht,
Netherlands
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Background and Aims: We investigated neurological events, graft patency,
major adverse cardiovascular events (MACEs), and mortality at 1 year
following coronary artery bypass grafting (CABG) surgery using automated
proximal anastomotic devices (APADs) and compared the overall rates with
the current literature. Method(s): A systematic review of all
available reports of APADs use in the literature was conducted. Cumulative
incidence and 95% confidence interval (CI) were the main statistical
indexes. Nine observational studies encompassing a total of 718 patients
were included at the end of the selection process. Result(s): The
cumulative event rate of neurological complications was 4.8% (lower-upper
limits: 2.8-8.0, P <.001; I2 = 72.907%, P =.002; Egger's test:
intercept = -2.47, P = 0.16; Begg and Mazumdar test: tau = -0.20, p =
0.57). Graft patency was 90.5% (80.4 to 95.7, P <.001; I2 =
76.823%, P =.005; Egger's test: intercept = -3.04, P =.10; Begg and
Mazumdar test: tau = -0.67, P =.17). Furthermore, the overall incidence of
MACEs was 3.7% (1.3-10.4, P <.001; I2 = 51.556%, P =.103;
Egger's test: intercept = -1.98, P = <.11; Begg and Mazumdar test: tau =
-0.67, P =.17). Finally, mortality within 1 year was 5% (3.5-7, P <.001;
I2 = 29.675%, P =.202; Egger's test: intercept = -0.91, P =.62;
Begg and Mazumdar test: tau = -0.04, P =.88). Conclusion(s): APADs do
not seem to be correlated with a reduction of either neurological events
or mortality. By contrast, these tools showed satisfactory one-year graft
patency and a low incidence of MACEs. Further research on this topic is
warranted. Copyright © 2019 The Authors. Journal of Cardiac
Surgery published by Wiley Periodicals, Inc.

<60>
Accession Number
2002636130
Title
Comprehensive literature review of anomalies of the coronary arteries.
Source
Journal of Cardiac Surgery. 34 (11) (pp 1328-1343), 2019. Date of
Publication: 01 Nov 2019.
Author
Harky A.; Noshirwani A.; Karadakhy O.; Ang J.
Institution
(Harky, Noshirwani) Department of Cardiothoracic Surgery, Liverpool Heart
and Chest Hospital, Liverpool, United Kingdom
(Karadakhy) School of Medicine, Manchester University, United Kingdom
(Ang) School of Medicine, University of Liverpool, Liverpool, United
Kingdom
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Coronary artery anomalies (CAA) are vanishingly rare, affecting less than
1% of the general population. While the majority of anomalies do not cause
significant symptoms; those that do, have devastating outcomes on the
patient. Seventeen percent of deaths from exercise is attributed to CAA,
and over half of these present as sudden death making CAA the second most
common cause of sudden cardiac death in individuals. Computed tomography
is generally regarded as the first-line investigation due to its superior
ability to delineate the course of the coronary vessels and the
surrounding structures, while intravascular coronary angiography can be
helpful in assessing the vessels if there is evidence of stenosis. A
multidisciplinary approach is adopted with patient expectations at the
core of the management. Once the decision to operate has been made, there
are multiple techniques available to the surgeon for the management of
anomalous vessels. Surgical repair forms the key management step in such
patients. Currently, surgery in elective cases is associated with
extremely low morbidity and mortality and it is considered a safe option
with a fantastic long-term prognosis. The ideal approach for assessment
and risk stratification remains uncertain, and the inherent variability of
coronary anomalies and patient factors demands a multidisciplinary team
with an individualized approach. Copyright © 2019 Wiley
Periodicals, Inc.

<61>
Accession Number
2003272732
Title
BARI 2D: A Reanalysis Focusing on Cardiovascular Events.
Source
Mayo Clinic Proceedings. 94 (11) (pp 2249-2262), 2019. Date of
Publication: November 2019.
Author
Genuth S.M.; Vlachos H.; Brooks M.M.; Bantle J.P.; Chaitman B.R.; Green
J.; Kelsey S.F.; King S.B.; McBane R.; Sako E.Y.; Schneider D.J.; Steffes
M.; Frye R.L.
Institution
(Genuth) Division of Clinical and Molecular Endocrinology, Department of
Medicine, Case Western Reserve University, Cleveland, OH, United States
(Vlachos, Brooks, Kelsey) Epidemiology Data Center, University of
Pittsburgh, PA, United States
(Bantle, Steffes) Department of Medicine, University of Minnesota,
Minneapolis, United States
(Bantle, Steffes) Department of Laboratory Medicine and Pathology,
University of Minnesota, Minneapolis, United States
(Chaitman) Division of Cardiology, Department of Medicine, St. Louis
University, MO, United States
(Green) Division of Endocrinology, Department of Medicine, Duke University
Medical Center, Durham, NC, United States
(King) Emory University School of Medicine, Atlanta, GA, United States
(McBane, Frye) Mayo Clinic, Rochester, MN, United States
(Sako) Department of Cardiothoracic Surgery, University of Texas Health
Science Center at San Antonio, United States
(Schneider) Department of Medicine, University of Vermont Medical Center,
Burlington, United States
Publisher
Elsevier Ltd
Abstract
Objective: To reanalyze the Bypass Angioplasty Revascularization
Investigation 2 Diabetes trial using a new composite cardiovascular
disease (CVD) outcome to determine how best to treat patients with type 2
diabetes mellitus and stable coronary artery disease. Patients and
Methods: From January 1, 2001, to November 30, 2008, 2368 patients with
type 2 diabetes mellitus and angiographically proven coronary artery
disease were randomly assigned to insulin-sensitizing (IS) or
insulin-providing (IP) therapy and simultaneously to coronary
revascularization (REV) or no or delayed REV (intensive medical therapy
[MED]), with all patients receiving intensive medical treatment. The
outcome of this analysis was a composite of 8 CVD events. Result(s):
Four-year Kaplan-Meier rates for the composite CVD outcome were 35.8% (95%
CI, 33.1%-38.5%) with IS therapy and 41.6% (95% CI, 38.7%-44.5%) with IP
therapy (P=.004). Much of this difference was associated with lower
in-trial levels of fibrinogen, C-reactive protein, and hemoglobin
A<inf>1c</inf> with IS therapy. Four-year composite CVD rates were 32.7%
(95% CI, 30.0%-35.4%) with REV and 44.7% (95% CI, 41.8%-47.6%) with MED
(P<.001). A beneficial effect of IS vs IP therapy was present with REV
(27.7%; 95% CI, 24.0%-31.4% vs 37.5%; 95% CI, 33.6%-41.4%; P<.001), but
not with MED (43.6%; 95% CI, 39.5%-47.7% vs 45.7%; 95% CI, 41.6%-49.8%;
P=.37) (homogeneity, P=.05). This interaction between IS therapy and REV
was limited to participants preselected for coronary artery bypass
grafting (CABG). The lowest composite CVD rates occurred in patients
preselected for CABG and assigned to IS therapy and REV (17.3%; 95% CI,
11.8%-22.8%). Conclusion(s): In the Bypass Angioplasty
Revascularization Investigation 2 Diabetes trial, the IS treatment
strategy and the REV treatment strategy each reduces cardiovascular
events. The combination of IS drugs and CABG results in the lowest risk of
subsequent CVD events. Trial Registration: clinicaltrials.gov Identifier:
NCT00006305 Copyright © 2019 Mayo Foundation for Medical
Education and Research

<62>
[Use Link to view the full text]
Accession Number
626484353
Title
Cost-Effectiveness of Mitral Valve Repair Versus Replacement for Severe
Ischemic Mitral Regurgitation: A Randomized Clinical Trial From the
Cardiothoracic Surgical Trials Network.
Source
Circulation. Cardiovascular quality and outcomes. 11 (11) (pp e004466),
2018. Date of Publication: 14 Nov 2018.
Author
Ferket B.S.; Ailawadi G.; Gelijns A.C.; Acker M.; Hohmann S.F.; Chang
H.L.; Bouchard, D.; Meltzer D.O.; Michler R.E.; Moquete E.G.; Voisine P.;
Mullen J.C.; Lala A.; Mack M.J.; Gillinov A.M.; Thourani V.H.; Miller
M.A.; Gammie J.S.; Parides M.K.; Bagiella E.; Smith R.L.; Smith P.K.; Hung
J.W.; Gupta L.N.; Rose E.A.; O'Gara P.T.; Moskowitz A.J.; Cardiothoracic
Surgical Trials Network (CTSN) Investigators
Publisher
NLM (Medline)
Abstract
BACKGROUND: The CTSN (Cardiothoracic Surgical Trials Network) recently
reported no difference in left ventricular end-systolic volume index or in
survival at 2 years between patients with severe ischemic mitral
regurgitation (MR) randomized to mitral valve repair or replacement.
However, replacement provided more durable correction of MR and fewer
cardiovascular readmissions. Yet, costeffectiveness outcomes have not been
addressed. METHODS AND RESULTS: We conducted a cost-effectiveness analysis
of the surgical treatment of ischemic MR based on the CTSN trial (n=126
for repair; n=125 for replacement). Patient-level data on readmissions,
survival, qualityof- life, and US hospital costs were used to estimate
costs and quality-adjusted life years per patient over the trial duration
and a 10-year time horizon. We performed microsimulation for extrapolation
of outcomes beyond the 2 years of trial data. Bootstrap and deterministic
sensitivity analyses were done to address parameter uncertainty.
In-hospital cost estimates were $78 216 for replacement versus $72 761 for
repair (difference: $5455; 95% uncertainty interval [UI]: -7784-21 193)
while 2-year costs were $97 427 versus $96 261 (difference: $1166; 95% UI:
-16 253-17 172), respectively. Quality-adjusted life years at 2 years were
1.18 for replacement versus 1.23 for repair (difference: -0.05; 95% UI:
-0.17 to 0.07). Over 5 and 10 years, the benefits of reduction in
cardiovascular readmission rates with replacement increased, and survival
minimally improved compared with repair. At 5 years, cumulative costs and
quality-adjusted life years showed no difference on average, but by 10
years, there was a small, uncertain benefit for replacement: $118 023
versus $119 837 (difference: -$1814; 95% UI: -27 144 to 22 602) and
qualityadjusted life years: 4.06 versus 3.97 (difference: 0.09; 95% UI:
-0.87 to 1.08). After 10 years, the incremental cost-effectiveness of
replacement continued to improve. CONCLUSION(S): Our
cost-effectiveness analysis predicts potential savings in cost and gains
in quality-adjusted survival at 10 years when mitral valve replacement is
compared with repair for severe ischemic MR. These projected benefits,
however, were small and subject to variability. Efforts to further
delineate predictors of long-term outcomes in patients with severe
ischemic MR are needed to optimize surgical decisions for individual
patients, which should yield more cost-effective care. CLINICAL TRIAL
REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier:
NCT00807040. Copyright 2018 American Heart Association, Inc.

<63>
[Use Link to view the full text]
Accession Number
625595266
Title
The Ross Procedure: A Systematic Review, Meta-Analysis, and
Microsimulation.
Source
Circulation. Cardiovascular quality and outcomes. 11 (12) (pp e004748),
2018. Date of Publication: 01 Dec 2018.
Author
Etnel J.R.G.; Grashuis P.; Huygens S.A.; Pekbay B.; Papageorgiou G.;
Helbing W.A.; Roos-Hesselink J.W.; Bogers A.J.J.C.; Mokhles M.M.;
Takkenberg J.J.M.
Institution
(Etnel, Grashuis, Huygens, Pekbay, Papageorgiou, Bogers, Mokhles,
Takkenberg) Department of Cardiothoracic Surgery, Erasmus University
Medical Center, Rotterdam, The Netherlands (J.R.G.E., P.G., S.A.H., B.P.,
G.P., A.J.J.C.B., M.M.M., J.J.M.T.)
(Huygens) Erasmus School of Health Policy & Management
(Papageorgiou) Department of Biostatistics, Erasmus University Medical
Center, Rotterdam, Netherlands
(Helbing) Division of Cardiology, Department of Pediatrics, Erasmus
University Medical Center, Sophia Children's Hospital, Rotterdam,
Netherlands
(Roos-Hesselink) Department of Cardiology, Erasmus University Medical
Center, Rotterdam, Netherlands
Publisher
NLM (Medline)
Abstract
BACKGROUND: To support decision-making in aortic valve replacement in
children and adults, we provide a comprehensive overview of outcome after
the Ross procedure. METHODS AND RESULTS: A systematic search was conducted
for publications reporting clinical outcome after the Ross procedure,
published between January 1, 2000, and November 22, 2017. Reported event
rates and time-to-event data were pooled and entered into a
microsimulation model to calculate life expectancy and lifetime event
risk. Ninety-nine publications were included (13 129 patients; total
follow-up: 93 408 patient-years, pooled mean follow-up: 7.9+/-5.3 years).
Pooled mean age at surgery was 9.4+/-5.5 years for children and
41.9+/-11.4 for adults. For children and adults, respectively, pooled
early mortality risk was 4.19% (95% CI, 3.21-5.46) and 2.01% (95% CI,
1.44-2.82), late mortality rate was 0.54%/y (95% CI, 0.42-0.70) and
0.59%/y (95% CI, 0.46-0.76), autograft reintervention 1.28%/y (95% CI,
0.99-1.66) and 0.83%/y (95% CI, 0.68-1.01), and right ventricular outflow
tract reintervention 1.97%/y (95% CI, 1.64-2.36) and 0.47%/y (95% CI,
0.37-0.59). Pooled thromboembolism and bleeding rates were low and
comparable to the general population. Lifetime risks of autograft and
right ventricular outflow tract reintervention were, respectively, 94% and
100% for children and 49% and 19% for a 45-year-old. Estimated life
expectancy after surgery was 59 years for children (general population: 64
years) and 30 years for a 45 years old (general population: 31 years).
 CONCLUSION(S): Through excellent survival and avoidance of the burden
of anticoagulation, the Ross procedure provides a unique opportunity for
patients whose preferences do not align with the outcome provided by
mechanical valve replacement and for growing children who also benefit
from autograft diameter increase along with somatic growth. On the
downside, almost all pediatric and many adult Ross patients will require a
reintervention in their lifetime.

<64>
Accession Number
629716439
Title
Fresh Frozen Plasma versus Crystalloid Priming of Cardiopulmonary Bypass
Circuit in Pediatric Surgery: A Randomized Clinical Trial.
Source
Anesthesiology. (no pagination), 2019. Date of Publication: 23 Oct 2019.
Author
Dieu A.; Rosal Martins M.; Eeckhoudt S.; Matta A.; Kahn D.; Khalifa C.;
Rubay J.; Poncelet A.; Haenecour A.; Derycke E.; Thiry D.; Gregoire A.;
Momeni M.
Institution
(Dieu) From the Department of Anesthesiology (A.D., M.R.M., C.K., M.M.)
Department of Hematology (S.E.) Department of Cardiac Surgery (J.R., A.P.)
Departments of Perfusion Services (D.T., A.G.) the Pediatric Intensive
Care Unit (A.H., University Hospital Saint Luc, Catholic University of
Louvain (Cliniques Universitaires Saint Luc, Universite Catholique de
Louvain), A.M., Brussels, Belgium
Publisher
NLM (Medline)
Abstract
WHAT WE ALREADY KNOW ABOUT THIS TOPIC: Fresh frozen plasma is often used
to prime the cardiopulmonary bypass circuit for pediatric cardiac surgical
patients to help offset dilutional coagulopathy that might result in
increased perioperative bleeding and allogeneic blood transfusionPrior
randomized trials of crystalloid versus fresh frozen plasma prime have
reported conflicting results, but the vast majority of these studies were
not blinded WHAT THIS ARTICLE TELLS US THAT IS NEW: In this double-blind
randomized controlled trial of patients undergoing pediatric cardiac
surgery with cardiopulomonary bypass, postoperative bleeding and the need
for allogeneic blood products does not differ significantly between
patients for whom the cardiopulmonary bypass circuit was primed with
crystalloid versus fresh frozen plasma BACKGROUND:: In congenital cardiac
surgery, priming cardiopulmonary bypass (CPB) with fresh frozen plasma
(FFP) is performed to prevent coagulation abnormalities. The hypothesis
was that CPB priming with crystalloids would be different compared with
FFP in terms of bleeding and/or need for blood product transfusion.
 METHOD(S): In this parallel-arm double-blinded study, patients
weighing between 7 and 15kg were randomly assigned to a CPB priming with
15ml . kg PlasmaLyte or 15ml . kg FFP in addition to a predefined amount
of packed red blood cells used in all patients. The decision to transfuse
was clinical and guided by point-of-care tests. The primary endpoints
included postoperative bleeding tracked by chest tubes, number of patients
transfused with any additional blood products, and the total number of
additional blood products administered intra- and postoperatively. The
postoperative period included the first 6h after intensive care unit
arrival. RESULT(S): Respectively, 30 and 29 patients in the FFP and
in the crystalloid group were analyzed in an intention-to-treat basis.
Median postoperative blood loss was 7.1ml . kg (5.1, 9.4) in the FFP group
and 5.7ml . kg (3.8, 8.5) in the crystalloid group (P = 0.219); difference
(95% CI): 1.2 (-0.7 to 3.2). The proportion of patients additionally
transfused was 26.7% (8 of 30) and 37.9% (11 of 29) in the FFP and the
crystalloid groups, respectively (P = 0.355; odds ratio [95% CI], 1.7 [0.6
to 5.1]). The median number of any blood products transfused in addition
to priming was 0 (0, 1) and 0 (0, 2) in the FFP and crystalloid groups,
respectively (P = 0.254; difference [95% CI], 0 [0 to 0]). There were no
study-related adverse events. CONCLUSION(S): The results demonstrate
that in infants and children, priming CPB with crystalloids does not
result in a different risk of postoperative bleeding and need for
transfusion of allogeneic blood products.

<65>
Accession Number
629714630
Title
Protocol for a systematic review and network meta-analysis of the
management of new onset atrial fibrillation in critically unwell adult
patients.
Source
Systematic reviews. 8 (1) (pp 242), 2019. Date of Publication: 28 Oct
2019.
Author
Johnston B.W.; Hill R.; Duarte R.; Chean C.S.; McAuley D.F.; Blackwood B.;
Pace N.; Welters I.D.
Institution
(Johnston, Hill, Duarte, Chean, Welters) University of Liverpool and The
Royal Liverpool and Broadgreen University Hospitals, Liverpool Health
Partners, Liverpool, United Kingdom
(McAuley, Blackwood) Wellcome-Wolfson Institute of Experimental Medicine,
Queen's University Belfast, Belfast, United Kingdom
(Pace) University of Utah, Salt Lake City, United States
Publisher
NLM (Medline)
Abstract
BACKGROUND: New onset atrial fibrillation is the most commonly encountered
arrhythmia in critically unwell patients with a reported incidence of 4%
to 29%. The occurrence of new onset atrial fibrillation may precipitate
acute heart failure and lead to thromboembolic complications as well as
being associated with increased in-hospital and in intensive care unit
(ICU) mortality. Despite being common, much of our current knowledge
regarding the treatment of new onset atrial fibrillation comes from
patients with chronic atrial fibrillation or post cardiac surgery. It is
unclear if management strategies in these patient cohorts can be applied
to new onset atrial fibrillation in the general ICU. This protocol for a
systematic review and network meta-analysis aims to address this
uncertainty and define what is the most effective management strategy for
the treatment of new onset atrial fibrillation (NOAF) in acutely unwell
adult patients. METHOD(S): In this systematic review and network
meta-analysis, we plan to search electronic databases (Cochrane Central
Register of Controlled Trials [CENTRAL], MEDLINE, EMBASE, Science Citation
Index Expanded on Web of Science and relevant trial registries) for
relevant randomised and non-randomised trials. Citations will be reviewed
by title, abstract and full text by two independent reviewers and
disagreement resolved by discussion and a third independent reviewer, if
necessary. The Cochrane Risk of Bias tool will be used to assess risk of
bias in randomised trials and the Risk of Bias in Nonrandomised Studies of
Interventions (ROBINS-I) tool will be used for non-randomised studies.
Statistical analysis will be carried out using R package meta and netmeta.
We will first conduct a pairwise meta-analysis. If conditions for indirect
comparison are satisfied and suitable data are available, we will conduct
network meta-analysis using frequentist methodology. Treatments will be
ranked according to efficacy with associated P-scores. We will assess the
quality of the evidence in the pairwise using GRADE methodology and
network meta-analysis comparisons in the CINeMA module in R package meta.
DISCUSSION: Our review will be the first to assess direct and indirect
evidence to assess the efficacy and rank the treatments available for new
onset atrial fibrillation in critically unwell patients. Our review
findings will be applicable to the care of people in a range of acute
settings including, ICU, the emergency department and acute medical units.
SYSTEMATIC REVIEW REGISTRATION: PROSPERO registry number: CRD42019121739.

<66>
Accession Number
629714479
Title
Coronary artery bypass surgery plus medical therapy versus medical therapy
alone for ischaemic heart disease: a protocol for a systematic review with
meta-analysis and trial sequential analysis.
Source
Systematic reviews. 8 (1) (pp 246), 2019. Date of Publication: 28 Oct
2019.
Author
Lorenzen U.S.; Buggeskov K.B.; Nielsen E.E.; Sethi N.J.; Carranza C.L.;
Gluud C.; Jakobsen J.C.
Institution
(Lorenzen) Department of Vascular Surgery, Rigshospitalet, Copenhagen
University Hospital, Copenhagen, Denmark
(Buggeskov) Department of Thoracic Anaesthesiology, Rigshospitalet,
Copenhagen University Hospital, Copenhagen, Denmark
(Nielsen, Sethi, Gluud, Jakobsen) Copenhagen Trial Unit, Centre for
Clinical Intervention Research, Department 7812, Rigshospitalet,
Copenhagen University Hospital, Copenhagen, Denmark
(Carranza) Department of Cardiothoracic Surgery, Rigshospitalet,
Copenhagen University Hospital, Copenhagen, Denmark
(Jakobsen) Department of Cardiology, Holbaek Hospital, Denmark
(Jakobsen) Department of Regional Health Research, Faculty of Health
Sciences, University of Southern Denmark, Odense, Denmark
Publisher
NLM (Medline)
Abstract
BACKGROUND: Despite increasing survival, cardiovascular disease remains
the primary cause of death worldwide with an estimated 7.4 million annual
deaths. The main symptom of ischaemic heart disease is chest pain (angina
pectoris) most often caused by blockage of a coronary artery. The aim of
coronary artery bypass surgery is revascularisation achieved by surgically
grafting harvested arteries or veins distal to the coronary lesion
restoring blood flow to the heart muscle. Older evidence suggested a clear
survival benefit of coronary artery bypass graft surgery, but more recent
trials yield less clear evidence. We want to assess the benefits and harms
of coronary artery bypass surgery combined with different medical
therapies versus medical therapy alone in patients with ischaemic heart
disease. METHOD(S): This protocol for a systematic review follows the
recommendations of Cochrane and the eight-step assessment procedure
suggested by Jakobsen and colleagues. We plan to include all randomised
clinical trials assessing coronary artery bypass surgery combined with
different medical therapies versus medical therapy alone in patients with
ischaemic heart disease. We plan to search the Cochrane Central Register
of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, Science Citation
Index Expanded on Web of Science, and BIOSIS to identify relevant trials.
Any eligible trial will be assessed as high risk or low risk of bias, and
our conclusions will primarily be based on trials at low risk of bias. The
analyses of the extracted data will be performed using Review Manager 5,
STATA 16 and trial sequential analysis. For both our primary and secondary
outcomes, we will create a 'Summary of Findings' table and use GRADE to
assess the certainty of the evidence. DISCUSSION: Coronary artery bypass
surgery is invasive and can cause death, which is why its use must be
thoroughly studied to determine if it yields a large enough long-term
benefit for the thousands of patients receiving it every year. SYSTEMATIC
REVIEW REGISTRATION: PROSPERO ID 131924.

<67>
Accession Number
2003527611
Title
A simple-to-use nomogram to predict long term survival of patients
undergoing coronary artery bypass grafting (CABG) using bilateral internal
thoracic artery grafting technique.
Source
PLoS ONE. 14 (10) (no pagination), 2019. Article Number: e0224310. Date of
Publication: 2019.
Author
Ziv-Baran T.; Mohr R.; Pevni D.; Ben-Gal Y.
Institution
(Ziv-Baran) Department of Epidemiology and Preventive Medicine, School of
Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv,
Israel
(Mohr, Pevni, Ben-Gal) Department of Cardio-Thoracic Surgery, Tel-Aviv
Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University,
Tel Aviv, Israel
Publisher
Public Library of Science (E-mail: plos@plos.org)
Abstract
Background: Several risk scores have been created to predict long term
mortality after coronary artery bypass grafting (CABG). Several studies
demonstrated a reduction in long-term mortality following bilateral
internal thoracic arteries (BITA) compared to single internal thoracic
artery. However, these prediction models usually referred to long term
survival as survival of up to 5 years. Moreover, none of these models were
built specifically for operation incorporating BITA grafting.
 Method(s): A historical cohort study of all patients who underwent
isolated BITA grafting between 1996 and 2011 at Tel-Aviv Sourasky medical
center, a tertiary referral university affiliated medical center with a
24-bed cardio-thoracic surgery department. Study population (N = 2,935)
was randomly divided into 2 groups: learning group which was used to build
the prediction model and validation group. Cox regression was used to
predict death using pre-procedural risk factors (demographic data, patient
comorbidities, cardiac characteristics and patient's status). The accuracy
(discrimination and calibration) of the prediction model was evaluated.
Methods and findings: The learning (1,468 patients) and validation (1,467
patients) groups had similar preoperative characteristics and similar
survival. Older age, diabetes mellitus, chronic obstructive lung disease,
congestive heart failure, chronic renal failure, old MI, ejection fraction
<=30%, preoperative use of intra-aortic balloon, and peripheral vascular
disease, were significant predictors of mortality and were used to build
the prediction model. The area under the ROC curves for 5, 10, and 15-year
survival ranged between 0.742 and 0.762 for the learning group and between
0.766 and 0.770 for the validation group. The prediction model showed good
calibration performance in both groups. A nomogram was built in order to
introduce a simple-to-use tool for prediction of 5, 10, and 15-year
survival. Conclusion(s): A simple-to-use validated model can be used
for a prediction of 5, 10, and 15-year mortality after CABG using the BITA
grafting technique. Copyright © 2019 Ziv-Baran et al.

<68>
Accession Number
2003489238
Title
Association of intra-operative hypotension with acute kidney injury,
myocardial injury and mortality in non-cardiac surgery: A meta-analysis.
Source
International Journal of Clinical Practice. 73 (10) (no pagination), 2019.
Article Number: e13394. Date of Publication: 01 Oct 2019.
Author
An R.; Pang Q.-Y.; Liu H.-L.
Institution
(An, Pang, Liu) Department of Anesthesiology, Chongqing University Cancer
Hospital/Chongqing Cancer Institute/Chongqing Cancer Center, Chongqing
City 400030, China
Publisher
Blackwell Publishing Ltd
Abstract
Background: Intra-operative hypotension might induce poor postoperative
outcomes in non-cardiac surgery, and the relationship between the level or
duration of Intra-operative hypotension (IOH) and postoperative adverse
events is still unclear. In this study, we performed a meta-analysis to
determine how IOH could affect acute kidney injury (AKI), myocardial
injury and mortality in non-cardiac surgery. Method(s): We searched
PubMed (Medline), Embase, Springer, The Cochrane Library, Ovid and Google
Scholar, and retrieved the related clinical trials on intra-operative
hypotension and prognosis in non-cardiac surgery. Result(s): Fifteen
observational studies were included. The meta-analysis showed that in
non-cardiac surgery, intra-operative hypotension (mean arterial pressure
[MAP]) <60 mm Hg for more than 1 minute was associated with an increased
risk of postoperative acute kidney injury(AKI) [1-5 minutes: odds ratio
(OR) = 1.13, 95% CI (1.04, 1.23), I2 = 0, P =.003; 5-10
minutes: OR = 1.18, 95% CI (1.07, 1.31), I2 = 0, P =.001; >10
minutes: OR = 1.35, 95% CI (1.1, 1.67), I2 = 52.6%, P =.004]
and myocardial injury [1-5 minutes: OR = 1.16, 95% CI (1.01, 1.33),
I2 = 30.6%, P =.04; 5-10 minutes: OR = 1.34, 95% CI (1.01,
1.77), I2 = 70.4%, P =.046; >10 minutes: OR = 1.43, 95% CI
(1.18, 1.72), I2 = 39.4%, P <.0001]. Intra-operative
hypotension (MAP < 60 mm Hg) for 1-5 minutes was not associated with
postoperative 30-day mortality [OR = 1.15, 95% CI (0.95, 1.4),
I2 = 0, P =.154], but intra-operative hypotension (MAP < 60 mm
Hg) for more than 5 min was associated with an increased risk of
postoperative 30-day mortality [OR = 1.11, 95% CI (1.06, 1.17),
I2 = 51.9%, P <.0001]. Conclusion(s): Intra-operative
hypotension was associated with an increased risk of postoperative AKI,
myocardial injury and 30-day mortality in non-cardiac surgery.
Intra-operative MAP < 60 mm Hg more than 1 minute should be
avoided. Copyright © 2019 John Wiley & Sons Ltd

<69>
Accession Number
625456211
Title
Prevention of Infections in Cardiac Surgery study (PICS): Study protocol
for a pragmatic cluster-randomized factorial crossover pilot trial.
Source
Trials. 19 (1) (no pagination), 2018. Article Number: 688. Date of
Publication: 17 Dec 2018.
Author
Van Oostveen R.B.; Romero-Palacios A.; Whitlock R.; Lee S.F.; Connolly S.;
Carignan A.; Mazer C.D.; Loeb M.; Mertz D.
Institution
(Van Oostveen, Whitlock, Lee, Connolly, Mertz) Population Health Research
Institute (PHRI), Hamilton Health Sciences, Hamilton, ON, Canada
(Romero-Palacios, Whitlock, Connolly, Loeb, Mertz) McMaster University,
Hamilton, ON, Canada
(Carignan) Department of Microbiology and Infectious Diseases, Universite
de Sherbrooke, Sherbrooke, QC, Canada
(Carignan) Centre de Recherche du Centre Hospitalier Universitaire de
Sherbrooke, Sherbrooke, QC, Canada
(Mazer) Li Ka Shing Knowledge Institute, St. Michael's Hospital,
University of Toronto, Toronto, ON, Canada
(Mertz) Juravinski Hospital and Cancer Center, 711 Concession Street,
Hamilton, ON L8V 1C3, Canada
Publisher
BioMed Central Ltd. (E-mail: info@biomedcentral.com)
Abstract
Background: A wide range of prophylactic antibiotic regimens are used for
patients undergoing open-heart cardiac surgery. This reflects clinical
equipoise in choice and duration of antibiotic agents. Although
individual-level randomized control trials (RCT) are considered the gold
standard when evaluating the efficacy of an intervention, this approach is
highly resource intensive and a cluster RCT can be more appropriate for
testing clinical effectiveness in a real-world setting. Methods/design: We
are conducting a factorial cluster-randomized crossover pilot trial in
cardiac surgery patients to evaluate the feasibility of this design for a
definite trial to evaluate the optimal duration and choice of
perioperative antibiotic prophylaxis. Specifically, we will evaluate: (a)
the non-inferiority of a single preoperative dose compared to prolonged
prophylaxis and (b) the potential superiority of adding vancomycin to
routine cefazolin in terms of preventing deep and organ/space sternal
surgical site infections (s-SSIs). There are four strategies: (i)
short-term cefazolin, (ii) long-term cefazolin, (iii) short-term cefazolin
+ vancomycin, and (iv) long-term cefazolin + vancomycin. These strategies
are delivered in a different order in each health-care center
participating in the trial. The centers are randomized to an order, and
the current strategy becomes the standard operating procedure in that
center during the study. The three feasibility outcomes include: (1) the
proportion of patients receiving preoperative, intra-operative, and
postoperative antibiotics according to the study protocol, (2) the
proportion of completed follow-up assessments, and (3) a full and final
assessment of the incidence of s-SSIs by the outcome adjudication
committee. Discussion(s): We believe that a cluster-randomized
factorial crossover trial is an effective and feasible design for these
research questions, allowing an evaluation of the clinical effectiveness
in a real-world setting. A waiver of individual informed consent was
considered appropriate by the research ethics boards in each participating
site in Canada as long as an information letter with an opt-out option was
provided. However, a waiver of consent was not approved at two sites in
Germany and Switzerland, respectively. Trial registration:
Clinicaltrials.gov, NCT02285140. Registered on 15 October
2015. Copyright © 2018 The Author(s).

<70>
Accession Number
2002703112
Title
Concurrent presentation of a hemorrhagic pericardial effusion and venous
thromboembolism in malignancy: a systematic review of case studies.
Source
Journal of Thrombosis and Thrombolysis. 48 (3) (pp 454-458), 2019. Date of
Publication: 01 Oct 2019.
Author
Pabba K.; Rojas-Hernandez C.M.
Institution
(Pabba) Department of Internal Medicine, McGovern Medical School at The
University of Texas Health Science Center at Houston, Houston, TX, United
States
(Rojas-Hernandez) Section of Benign Hematology, The University of Texas MD
Anderson Cancer Center, 1515 Holcombe Blvd., Suite 1464, Houston, TX
77030, United States
Publisher
Springer New York LLC (E-mail: barbara.b.bertram@gsk.com)
Abstract
The concurrent presentation of symptomatic malignant pericardial
hemorrhage and venous thromboembolism is a rare event that poses a
clinical dilemma. Existing VTE guidelines do not indicate when, or if,
anticoagulation therapy should be started after the treatment of the
pericardial bleed. We performed a systematic review to compile the
published clinical evidence on the occurrence of coexisting pericardial
hemorrhage and VTE in cancer patients and to describe the clinical
presentations and bleeding and thrombosis outcomes before and after
anticoagulation therapy. We studied published case reports on patients
with cancer who presented to the hospital with pericardial hemorrhage and
VTE through April 11, 2019. We found seven published case reports. All
patients had suffered from a pulmonary embolism and had pericardiocentesis
during hospitalization. Five patients (71%) had lung cancer. Four patients
(57%) were started on anticoagulation after pericardial drainage and
survived the index event. Two patients (29%) were not started on
anticoagulation after pericardiocentesis; only one of these patients
survived the hospitalization. Pericardial bleeding risk in cancer may be
inherent to malignancy, and it is unclear if anticoagulation use increases
the risk of recurrent pericardial bleeding. The management of pericardial
bleeding typically requires pericardiocentesis, and clinical registries,
prospective collaboration projects, and case adjudication are needed to
establish the safety of initiation of antithrombotic therapy in such
patients. Copyright © 2019, Springer Science+Business Media, LLC,
part of Springer Nature.

<71>
Accession Number
2003205620
Title
Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular
complications following cardiac surgery: the CARDIOX randomized clinical
trial.
Source
Intensive Care Medicine. 45 (10) (pp 1413-1421), 2019. Date of
Publication: 01 Oct 2019.
Author
Abou-Arab O.; Huette P.; Martineau L.; Beauvalot C.; Beyls C.; Josse E.;
Touati G.; Bouchot O.; Bouhemad B.; Diouf M.; Lorne E.; Guinot P.-G.
Institution
(Abou-Arab, Huette, Martineau, Beyls, Lorne) Department of Anesthesiology
and Critical Care Medicine, Amiens Picardy University Hospital, 1, Rue du
Professeur Christian Cabrol, Amiens 80054, France
(Abou-Arab) MP3CV, EA7517, CURS, Jules Verne University of Picardy, Amiens
80054, France
(Beauvalot, Bouhemad, Guinot) Department of Anesthesiology and Critical
Care Medicine, Dijon University Hospital, Dijon 14033, France
(Josse, Diouf) Department of Clinical Research, Amiens Picardy University
Hospital, Amiens 80054, France
(Touati) Department of Cardiac Surgery, Amiens Picardy University
Hospital, Amiens 80054, France
(Bouchot) Department of Cardiac Surgery, Dijon University Hospital, Dijon
14033, France
Publisher
Springer Verlag (E-mail: service@springer.de)
Abstract
Purpose: Data on the benefit or or harmful effects of oxygen level on
ischemic reperfusion injuries in cardiac surgery are insufficient. We
hypothesized that hyperoxia during cardiopulmonary bypass decreases the
incidence of postoperative atrial fibrillation (POAF) and ventricular
fibrillation, and therefore decreases cardiovascular morbidity (CARDIOX
study). Method(s): An open-label, randomized clinical trial including
adults undergoing elective cardiac surgery, i.e. cardiopulmonary bypass
(CPB) randomized 1:1 to an intervention group or standard group at two
French University Hospitals from June 2016 to October 2018. The
intervention consisted in delivering of an inspired fraction of oxygen of
one to one during CPB. The standard care consisted in delivering oxygen to
achieve a partial arterial blood pressure less than 150 mmHg. The primary
endpoint was the occurrence of POAF and/or ventricular
tachycardia/ventricular fibrillation (VT/VF) within the 15 days following
cardiac surgery. The secondary endpoint was the occurrence of major
adverse cardiovascular events (MACCE: in-hospital mortality, stroke,
cardiac arrest, acute kidney injury, and mesenteric ischemia).
 Result(s): 330 patients were randomly assigned to either the
intervention group (n = 161) or the standard group (n = 163). Mean
PaO<inf>2</inf> was 447 +/- 98 mmHg and 161 +/- 60 mmHg during CPB, for
the intervention and standard group (p < 0.0001) respectively. The
incidence of POAF or VT/VF were similar in the intervention group and the
standard group (30% [49 of 161 patients] and 30% [49 of 163 patients],
absolute risk reduction 0.4%; 95% CI, - 9.6-10.4; p = 0.94). MACCE was
similar between groups with, an occurrence of 24% and 21% for the
intervention group and the standard groups (absolute risk reduction 3.4%;
95% CI, - 5.7-12.5; p = 0.47) respectively. After adjustment, the primary
and secondary endpoints remained similar for both groups.
 Conclusion(s): Hyperoxia did not decrease POAF and cardiovascular
morbidity following cardiac surgery with CPB. Clinicaltrial.gov
identifier: NCT02819739. Copyright © 2019, Springer-Verlag GmbH
Germany, part of Springer Nature.

<72>
Accession Number
629597722
Title
The use of a machine-learning algorithm that predicts hypotension during
surgery in combination with personalized treatment guidance: Study
protocol for a randomized clinical trial.
Source
Trials. 20 (1) (no pagination), 2019. Article Number: 582. Date of
Publication: 11 Oct 2019.
Author
Wijnberge M.; Schenk J.; Terwindt L.E.; Mulder M.P.; Hollmann M.W.; Vlaar
A.P.; Veelo D.P.; Geerts B.F.
Institution
(Wijnberge, Schenk, Terwindt, Mulder, Hollmann, Veelo, Geerts) Department
of Anesthesiology, Amsterdam UMC, Location Academic Medical Center,
University of Amsterdam, Meibergdreef 9, Postbus 22660, Amsterdam,AZ 1105,
Netherlands
(Wijnberge, Vlaar) Department of Intensive Care Medicine, Amsterdam UMC,
Location Academic Medical Center, University of Amsterdam, Meibergdreef 9,
Postbus 22660, Amsterdam AZ 1105, Netherlands
(Mulder) Department of Technical Medicine, University of Twente,
Drienerlolaan 5, Enschede,NB 7522, Netherlands
Publisher
BioMed Central Ltd. (E-mail: info@biomedcentral.com)
Abstract
Background: Intraoperative hypotension is associated with increased
morbidity and mortality. Current treatment is mostly reactive. The
Hypotension Prediction Index (HPI) algorithm is able to predict
hypotension minutes before the blood pressure actually decreases. Internal
and external validation of this algorithm has shown good sensitivity and
specificity. We hypothesize that the use of this algorithm in combination
with a personalized treatment protocol will reduce the time weighted
average (TWA) in hypotension during surgery spent in hypotension
intraoperatively. Methods/design: We aim to include 100 adult patients
undergoing non-cardiac surgery with an anticipated duration of more than 2
h, necessitating the use of an arterial line, and an intraoperatively
targeted mean arterial pressure (MAP) of > 65 mmHg. This study is divided
into two parts; in phase A baseline TWA data from 40 patients will be
collected prospectively. A device (HemoSphere) with HPI software will be
connected but fully covered. Phase B is designed as a single-center,
randomized controlled trial were 60 patients will be randomized with
computer-generated blocks of four, six or eight, with an allocation ratio
of 1:1. In the intervention arm the HemoSphere with HPI will be used to
guide treatment; in the control arm the HemoSphere with HPI software will
be connected but fully covered. The primary outcome is the TWA in
hypotension during surgery. Discussion(s): The aim of this trial is
to explore whether the use of a machine-learning algorithm
intraoperatively can result in less hypotension. To test this, the
treating anesthesiologist will need to change treatment behavior from
reactive to proactive. Trial registration: This trial has been registered
with the NIH, U.S. National Library of Medicine at ClinicalTrials.gov, ID:
NCT03376347. The trial was submitted on 4 November 2017 and accepted for
registration on 18 December 2017. Copyright © 2019 The Author(s).

<73>
Accession Number
2002679107
Title
Randomized placebo controlled open labelled comparison of efficacy of
diclofenac transdermal patch in post operative pain.
Source
Research Journal of Pharmacy and Technology. 12 (3) (pp 1119-1121), 2019.
Date of Publication: March 2019.
Author
Salunke N.; Kumar M.K.; Yogesh; Tabassum M.; Pravallika P.; Sampoorna M.;
Rao P.
Institution
(Salunke, Kumar) Durgabai Deshmukh Hospital, 1-9-27, Osmania University
Rd, Vidya Nagar, Adikmet, Hyderabad, Telangana, India
(Yogesh) Bharath School of Pharmacy, Mangalpally, Ibrahimpatnam,
Telangana, India
(Tabassum, Pravallika, Sampoorna, Rao) Department of Pharmacy, Bharath
School of Pharmacy, Mangalpally, Ibrahimpatnam, Telangana, India
Publisher
Research Journal of Pharmacy and Technology (E-mail: info@rjptonline.org)
Abstract
Postoperative incisional pain is a common form of acute pain. Recent
studies demonstrate that about 50-70% of patients experience moderate to
severe pain after surgery. Reasons for this quandary are distinct
mechanisms of incisional nociception compared to other pain conditions or
lack of an in depth knowledge about the pathophysiology and
neuropharmacology of postoperative pain. Acute postoperative pain is
followed by chronic pain in 10-50% of individuals which can be severe in
about 2-10% of patients undergoing common operations such as groin hernia
repair, breast and thoracic surgery, leg amputation, and coronary artery
bypass surgery. Therefore, persistent postsurgical pain represents a
major, largely unrecognised clinical problem. Iatrogenic neuropathic pain
is probably the most important cause of long-term postsurgical pain.
Consequently, surgical techniques that avoid nerve damage should be
applied whenever possible. Major surgical operations are still followed by
pain, organ dysfunction and prolonged convalescence. It has been assumed
that sufficient pain relief will improve the surgical outcome with reduced
morbidity, need for hospitalization and convalescence. It has been
realized that several other factors in perioperative management are
important in the control of postoperative recovery and rehabilitation, and
that these factors must be considered and revised in order to achieve the
advantageous effects of pain relief on outcome. Among the most commonly
used pain-relieving techniques [patient-controlled analgesia (PCA) with
opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and epidural
analgesic techniques], there is evidence that the epidural local
anaesthetic or local anaesthetic-opioid techniques are the most effective
on providing dynamic pain relief after major surgical procedures. The goal
of postoperative pain management is to relieve the pain while keeping side
effects to a minimum. This can be best accomplished with a multimodal
approach. Minimally invasive surgery and enhanced recovery protocols have
addressed pain management in terms of these goals. Copyright ©
RJPT All right reserved.

<74>
Accession Number
2003583472
Title
Safety and efficacy of a self-expanding versus a balloon-expandable
bioprosthesis for transcatheter aortic valve replacement in patients with
symptomatic severe aortic stenosis: a randomised non-inferiority trial.
Source
The Lancet. 394 (10209) (pp 1619-1628), 2019. Date of Publication: 2 - 8
November 2019.
Author
Lanz J.; Kim W.-K.; Walther T.; Burgdorf C.; Mollmann H.; Linke A.;
Redwood S.; Thilo C.; Hilker M.; Joner M.; Thiele H.; Conzelmann L.;
Conradi L.; Kerber S.; Schymik G.; Prendergast B.; Husser O.; Stortecky
S.; Heg D.; Juni P.; Windecker S.; Pilgrim T.
Institution
(Lanz, Stortecky, Windecker, Pilgrim) Department of Cardiology,
Inselspital, Bern University Hospital, Bern, Switzerland
(Kim) Department of Cardiology, Kerckhoff Heart and Thorax Centre, Bad
Nauheim, Germany
(Walther) Department of Cardiac, Thoracic and Thoracic Vascular Surgery,
University Hospital Frankfurt, Frankfurt, Germany
(Burgdorf) Heart and Vascular Centre, Bad Bevensen, Germany
(Mollmann, Husser) Department of Internal Medicine I,
St-Johannes-Hospital, Dortmund, Germany
(Linke) Department of Internal Medicine and Cardiology, Heart Centre
Dresden, Technische Universitat Dresden, Dresden, Germany
(Redwood, Prendergast) Department of Cardiology, St Thomas' Hospital,
London, United Kingdom
(Thilo) Department of Cardiology, Klinikum Augsburg, Augsburg, Germany
(Hilker) Department of Cardiothoracic Surgery, University Medical Centre,
Regensburg, Germany
(Joner) German Heart Centre, Technical University of Munich, Munich,
Germany
(Thiele) Heart Centre Leipzig, Leipzig, Germany
(Conzelmann) Department of Cardiac Surgery, Helios Klinik, Karlsruhe,
Germany
(Conradi) Department of Cardiovascular Surgery, University Heart Centre
Hamburg, Hamburg, Germany
(Kerber) Department of Cardiology, Cardiovascular Centre Bad Neustadt, Bad
Neustadt, Germany
(Schymik) Department of Cardiology, Stadtisches Klinikum Karlsruhe,
Karslruhe, Germany
(Heg) Clinical Trials Unit, University of Bern, Bern, Switzerland
(Juni) Applied Health Research Centre, Li Ka Shing Knowledge Institute of
St Michael's Hospital, Department of Medicine and Institute of Health
Policy, Management, and Evaluation, University of Toronto, Toronto, ON,
Canada
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background: Transcatheter aortic valve replacement (TAVR) is the preferred
treatment option for older patients with symptomatic severe aortic
stenosis. Differences in the properties of available TAVR systems can
affect clinical outcomes. Among patients undergoing TAVR, we compared the
self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN
3 TAVR system with regard to early safety and efficacy. Method(s): In
this randomised non-inferiority trial, patients (aged >=75 years)
undergoing transfemoral TAVR for treatment of symptomatic severe aortic
stenosis, and who were deemed to be at increased surgical risk, were
recruited at 20 tertiary heart valve centres in Germany, the Netherlands,
Switzerland, and the UK. Participants were randomly assigned (1:1) to
receive treatment with the ACURATE neo or the SAPIEN 3 with a
computer-based randomly permuted block scheme, stratified by study centre
and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM)
category. The primary composite safety and efficacy endpoint comprised
all-cause death, any stroke, life-threatening or disabling bleeding, major
vascular complications, coronary artery obstruction requiring
intervention, acute kidney injury (stage 2 or 3), rehospitalisation for
valve-related symptoms or congestive heart failure, valve-related
dysfunction requiring repeat procedure, moderate or severe prosthetic
valve regurgitation, or prosthetic valve stenosis within 30 days of the
procedure. Endpoint assessors were masked to treatment allocation.
Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the
intention-to-treat population on the basis of a risk-difference margin of
7.7% for the primary composite endpoint, with a one-sided alpha of 0.05.
This trial is registered with ClinicalTrials.gov (number NCT03011346) and
is ongoing but not recruiting. Finding(s): Between Feb 8, 2017, and
Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82.8
years [SD 4.1]; median STS-PROM score 3.5% [IQR 2.6-5.0]) were enrolled.
30-day follow-up was available for 367 (99%) of 372 patients allocated to
the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3
group. Within 30 days, the primary endpoint occurred in 87 (24%) patients
in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus,
non-inferiority of the ACURATE neo was not met (absolute risk difference
7.1% [upper 95% confidence limit 12.0%], p=0.42). Secondary analysis of
the primary endpoint suggested superiority of the SAPIEN 3 device over the
ACURATE neo device (95% CI for risk difference -1.3 to -12.9, p=0.0156).
The ACURATE neo and SAPIEN 3 groups did not differ in incidence of
all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%]
vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and
moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%])
were more common in the ACURATE neo group. Interpretation(s): TAVR
with the self-expanding ACURATE neo did not meet non-inferiority compared
to the balloon-expandable SAPIEN 3 device in terms of early safety and
clinical efficacy outcomes. An early composite safety and efficacy
endpoint was useful in discriminating the performance of different TAVR
systems. Funding(s): Boston Scientific (USA). Copyright ©
2019 Elsevier Ltd

<75>
Accession Number
2003484329
Title
Impact of Perioperative Levosimendan Administration on Risk of Bleeding
After Cardiac Surgery: A Meta-analysis of Randomized Controlled Trials.
Source
American Journal of Cardiovascular Drugs. (no pagination), 2019. Date of
Publication: 2019.
Author
Yan S.-B.; Wang X.-Y.; Shang G.-K.; Wang Z.-H.; Deng Q.-M.; Song J.-W.;
Sai W.-W.; Song M.; Zhong M.; Zhang W.
Institution
(Yan, Shang, Wang, Deng, Song, Sai, Song, Zhong, Zhang) The Key Laboratory
of Cardiovascular Remodeling and Function Research, Chinese Ministry of
Education, Chinese National Health Commission and Chinese Academy of
Medical Sciences, The State and Shandong Province Joint Key Laboratory of
Translational Cardiovascular Medicine, Department of Cardiology, Qilu
Hospital of Shandong University, No.107, Wen Hua Xi Road, Jinan 250012,
China
(Wang) Department of Pharmacy, Qilu Children's Hospital of Shandong
University, Children's Hospital of Jinan, Jinan, Shandong, China
(Wang) Department of Geriatric Medicine, Qilu Hospital of Shandong
University, Key Laboratory of Cardiovascular Proteomics of Shandong
Province, Jinan, Shandong, China
Publisher
Springer International Publishing
Abstract
Background: Levosimendan, a calcium sensitizer and potassium channel
opener, has been demonstrated to improve myocardial function without
increasing oxygen consumption and to show protective effects in other
organs. Recently, a prospective, randomized controlled trial (RCT)
revealed an association between levosimendan use and a possible increased
risk of bleeding postoperatively. Levosimendan's anti-platelet effects
have been shown in in vitro studies. Current studies do not provide
sufficient data to support a relation between perioperative levosimendan
administration and increased bleeding risk. Purpose(s): Our goal was
to investigate the relation between perioperative levosimendan
administration and increased bleeding risk using a meta-analysis study
design. Method(s): The PubMed, Ovid, EMBASE and Cochrane Library
databases were searched for relevant RCTs before July 1, 2019. The outcome
parameters included reoperation secondary to increased bleeding in the
postoperative period, the amount of postoperative recorded blood loss, and
the need for transfusion of packed red blood cells (RBCs) and other blood
products. Result(s): A total of 1160 patients in nine RCTs (576 in
the levosimendan group and 584 in the control group) were included
according to our inclusion criteria. Analysis showed that perioperative
levosimendan administration neither increased the rate of reoperation
secondary to bleeding nor increased the amount of postoperative chest tube
drainage when compared with the control group. In terms of blood product
transfusion, levosimendan did not influence the requirement for RBC
transfusion, platelet transfusion nor fresh frozen plasma (FFP)
transfusion. Levosimendan also did not shorten or prolong the aortic
cross-clamp time or the cardiopulmonary bypass time. Conclusion(s):
The analyzed parameters, including reoperations due to bleeding,
postoperative chest drainage and the requirement for blood products,
revealed that levosimendan did not increase postoperative bleeding risk.
More studies with a larger sample size are needed to address a more
reliable conclusion due to study limitations. Copyright © 2019,
Springer Nature Switzerland AG.

<76>
Accession Number
2003434883
Title
Perioperative Biomarkers Predicting Postoperative Atrial Fibrillation Risk
After Coronary Artery Bypass Grafting: A Narrative Review.
Source
Journal of Cardiothoracic and Vascular Anesthesia. (no pagination), 2019.
Date of Publication: 2019.
Author
Khan M.S.; Yamashita K.; Sharma V.; Ranjan R.; Selzman C.H.; Dosdall D.J.
Institution
(Khan, Yamashita, Ranjan, Selzman, Dosdall) Nora Eccles Harrison
Cardiovascular Research and Training Institute, University of Utah, Salt
Lake City, UT, United States
(Yamashita, Ranjan, Dosdall) Division of Cardiovascular Medicine,
University of Utah, Salt Lake City, UT, United States
(Sharma, Selzman, Dosdall) Division of Cardiothoracic Surgery, University
of Utah, Salt Lake City, UT, United States
(Ranjan, Dosdall) Department of Bioengineering, University of Utah, Salt
Lake City, UT, United States
Publisher
W.B. Saunders
Abstract
Postoperative atrial fibrillation (POAF) after cardiac surgery remains a
highly prevalent and costly condition that negatively impacts patient
quality of life and survival. Numerous retrospective studies,
meta-analysis, and review papers have been reported identifying POAF risk
based on patients' risk factors and clinical biomarkers. In this narrative
review, the authors report significant variations among selected pre- and
perioperative biomarkers used to predict POAF incidence in patients
without a history of atrial fibrillation (AF). POAF prediction based on
B-type natriuretic peptide, N-terminal pro B-type natriuretic peptide,
C-reactive protein, interleukin-6, creatinine, and plasminogen activator
inhibitor-1 differs significantly among different studies, thereby
limiting their clinical utility to predict POAF risk with high accuracy.
Conversely, soluble vascular endothelial cells adhesion molecule-1,
soluble CD40 ligand, Galectin-3, and aldosterone show promise for better
POAF prediction. However, the current datasets for these selected
biomarkers are not of sufficient size to validate the broad clinical
application specifically for patients with no prior history of
AF. Copyright © 2019 Elsevier Inc.

<77>
Accession Number
2003433121
Title
Meta-analysis Evaluating the Safety and Efficacy of Transcarotid
Transcatheter Aortic Valve Implantation.
Source
American Journal of Cardiology. (no pagination), 2019. Date of
Publication: 2019.
Author
Usman M.S.; Rawasia W.F.; Siddiqi T.J.; Mujeeb F.A.; Nadeem S.; Alkhouli
M.
Institution
(Usman, Siddiqi, Mujeeb, Nadeem) Dow University of Health Sciences,
Karachi, Pakistan
(Rawasia) River Region Cardiology Associates, Montgomery, AL, United
States
(Alkhouli) Mayo Clinic School of Medicine - Mayo Clinic, Rochester, MN,
United States
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
We performed a systemic review and meta-analysis of studies evaluating
transcarotid vascular access for transcatheter aortic valve implantation
(TAVI). Published studies evaluating transcarotid vascular access for TAVI
were included in this analysis. Outcomes of interest included 30-day
mortality, stroke/transient ischemic attack (TIA), new pacemaker
implantation, acute kidney injury (AKI), major vascular complication,
major bleeding, and myocardial infarction. Pooled estimate for 30-day
mortality was 5.3% (95% confidence interval [CI] 4.0% to 6.8%;
I2 = 4%), stroke/TIA was 3.4% (95% CI 2.4% to 4.6%;
I2 = 0%), new pacemaker implantation was 15.3% (95% CI 10.8% to
19.7%; I2 = 72%), AKI was 3.4% (95% CI 1.3% to 6.5%;
I2 = 58%), major vascular complication was 2.4% (95% CI 1.1% to
3.7%; I2 = 46%), major bleeding was 4.3% (95% CI 2.8% to 6.1%;
I2 = 11%), and myocardial infarction was 1.1% (95% CI 0.4% to
2.0%; I2 = 0%). Metaregression was carried out to study the
association of effect size with the continuous study-level covariates that
included average age, proportion of males, and mean STS score. In this
regard, mean STS score showed association with major vascular
complications (coefficient: 0.008; p = 0.049). Cumulative meta-analysis
carried out showed that there was temporal trend of decreasing incidence
of stroke/TIA, major vascular complications, and AKI for transcarotid
TAVI. In conclusion, transcarotid access for TAVI is a reasonable choice
in patients requiring alternate access to transfemoral
route. Copyright © 2019 Elsevier Inc.

<78>
Accession Number
2002849890
Title
Predicting Postoperative Lung Function Following Lung Cancer Resection: A
Systematic Review and Meta-analysis.
Source
EClinicalMedicine. 15 (pp 7-13), 2019. Date of Publication: October 2019.
Author
Oswald N.K.; Halle-Smith J.; Mehdi R.; Nightingale P.; Naidu B.; Turner
A.M.
Institution
(Oswald, Naidu) Institute of Inflammation and Ageing, University of
Birmingham, Edgbaston, Birmingham B15 2TT, Ireland
(Halle-Smith) College of Medical and Dental Sciences, University of
Birmingham, Edgbaston, Birmingham B15 2TT, Ireland
(Mehdi) Department of Thoracic Surgery, Heartlands Hospital, Bordesley
Green East, Birmingham B9 5SS, Ireland
(Nightingale) Institute of Translational Medicine, University Hospitals
Birmingham NHS Foundation Trust, Edgbaston, Birmingham B15 2TH, Ireland
(Turner) Institute of Applied Health Research, University of Birmingham,
Edgbaston, Birmingham B15 2TT, Ireland
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background: Lung resection remains the gold standard treatment for early
stage lung cancer; prediction of postoperative lung function is a key
selection criterion for surgery with the aim of determining risk of
postoperative dyspnoea. We aimed to identify the different prediction
techniques used, and compare their accuracy. Method(s): A systematic
review and meta-analysis sought to synthesise studies conducted that
assess prediction of postoperative lung function up to 18/02/2018 (n =
135). PROBAST was used to assess risk of bias in studies, 17 studies were
judged to be at low risk of bias. Finding(s): Meta-analysis revealed
CT volume and density measurement to be the most accurate (mean difference
71 ml) and precise (standard deviation 207 ml) of the reported techniques
used for predicting FEV1; evidence for predicting gas transfer was
lacking. Interpretation(s): The evidence suggests using CT volume and
density is the preferred technique in the prediction of postoperative
FEV1. Further studies are required to ensure that the methods and
thresholds we propose are linked to patient reported outcomes.
 Funding(s): Salary support for NKO, RM, PN, BN, and AMT was provided
by University Hospitals Birmingham NHS Foundation Trust. Copyright
© 2019

<79>
Accession Number
629699600
Title
The utility of 18F-FDG PET/CT in the diagnosis of infectious
endocarditis.
Source
European Journal of Nuclear Medicine and Molecular Imaging. Conference:
32nd Annual Congress of the European Association of Nuclear Medicine, EANM
2019. Spain. 46 (1 Supplement 1) (pp S312), 2019. Date of Publication:
October 2019.
Author
Tamayo-Carabano D.; Acevedo-Banez I.; Fernandez-Lopez R.; Alvarez-Perez
R.; Jimenez-Hoyuela-Garcia J.
Institution
(Tamayo-Carabano, Acevedo-Banez, Fernandez-Lopez, Alvarez-Perez,
Jimenez-Hoyuela-Garcia) Hospital Universitario Virgen Del Rocio, Sevilla,
Spain
Publisher
Springer Berlin Heidelberg
Abstract
Aim/Introduction: Evaluated the utility of 18F -FDG PET/ CT
performed in patients with suspected infectious endocarditis(IE).
 Material(s) and Method(s): Personal history of each patient was
assessed: previous valvular or endovascular surgery or prosthesis, time
elapsed since surgery, results of transthoracic echocardiography and
antibiotic treatment prior to the procedure. All patients were
administered a 18F -FDG dose standardized by weight, and by
size in pediatric cases, one hour before image acquisition. Images were
analyzed measuring the SUVmax of the areas of pathological uptake,
describing the character of the uptake, the Deauville scale, a captation
scale of the uncorrected images, the persistence of the pathological focus
and the modification of the SUVmax in the delayed images. Result(s):
We included 32 studies between June2016 and October2018, conducted in 29
adult and 3 pediatric patients, 25 were men and 7 women with a median age
of 68 years. The reason for requesting the study was feverof-
unknown-origin in 19 cases and bacteremia demonstrated with positive blood
cultures in 13. The 93.75% of the patients had a prosthetic heart valve
and/or an endovascular prosthesis, with a median of 27 months from surgery
to the scan. Prior to the study, only 8 transthoracic echocardiograms were
suspects. A special preparation for cardiac assessment was performed in
87.5% of the cases. The 87.5% of the cases received antibiotic therapy
before the scan. Were considered metabolically positive for IE 19 cases, 9
were negative and 4 were not evaluable due to physiological uptake by the
myocardium. In the positive cases, the average SUVmax was 5.08; the
Deauville scale was 4 in 12 patients and 5 in 7 cases; the scale of
uncorrected images was 2 in 14 patients and 3 in 5. A delayed image of the
thoracic region was performed in 78,9% of the cases, with persistence of
the focus and an average SUVmax of 6.3, increasing the uptake in 73.3% of
the cases. A final diagnosis of suggestive was obtained in 5, definitive
in 14 and rejected in 9. A sensitivity of 82.6%, specificity of 100%,
positive predictive value of 100% and negative predictive value of 55.5%
was demonstrated. Conclusion(s): Although 18F -FDG PET/CT
is included in the diagnostic algorithm of IE, there is no consensus in
the protocol, preparation and interpretation of the images. The model that
we have followed compiled from several research, seems a suitable option
to diagnose this disease that warrants a thorough and early treatment.

<80>
Accession Number
629699316
Title
Effect of intramyocardial injection of erytropetin stimulated autologus
bone marrow cells on myocardial perfusion in patients with chronic
myocardial ischemia-SPECT 99mTc-MIBI study.
Source
European Journal of Nuclear Medicine and Molecular Imaging. Conference:
32nd Annual Congress of the European Association of Nuclear Medicine, EANM
2019. Spain. 46 (1 Supplement 1) (pp S377), 2019. Date of Publication:
October 2019.
Author
Minin S.; Fomichev A.; Nikitin N.; Chernyavskiy A.
Institution
(Minin, Fomichev, Nikitin, Chernyavskiy) Meshalkin National Medical
Research Center, Novosibirsk, Russian Federation
Publisher
Springer Berlin Heidelberg
Abstract
Aim/Introduction: To evaluate the changes of myocardial perfusion using
99mTc-MIBI single-photon emission computed tomography (SPECT)
after the intramyocardial implantation of erythropoietin preconditioned
autologous bone marrow cells (ABMC) in laser channels during coronary
artery disease surgery. Material(s) and Method(s): Randomized study
of 40 patients (mean age 58 +/- 6.9 piet, 9 females) with diffuse and (or)
distal right coronary artery disease (RCA). Patients of the study group (n
= 23) underwent coronary artery bypass grafting (CABG) of the left
coronary artery (LCA) system and intramyocardial implantation of
erythropoietin preconditioned ABMC in the left ventricular inferior wall.
Patients of the control group (n = 17) underwent CABG of the LCA system
only. 99mTc-MIBI SPECT performed 1-2 days before and 12 months
after surgery. Result(s): In study group after 12-month follow-up the
summed stress score in a typical RCA supply area (SSSRCA) improved from
7.0 [5.5; 10.5] to 4.0 [1.0; 5.5] (p <0.01), summed rest score (SRSRCA)
improved from 3.0 [0.0; 7.0] to 1.0 [0.0; 3.5] (p <0.01), and summed
different score (SDSRCA) improved from 3.0 [1.0; 4.0] to 1.0 [0.0; 2.0] (p
= 0.03). Control group patients after 12-month follow-up showed the
significant improvement of SSSRCA only - from 8.0 [6.0; 12.0] to 5.0 [4.0;
7.0] (p <0.01). Conclusion(s): After 12-month follow-up in patients
with diffuse and (or) distal RCA disease, the procedure of intramyocardial
implantation of the erythropoietin preconditioned ABMC in laser channels
is safety and induces the improvement of myocardial perfusion.

<81>
Accession Number
629699117
Title
Prognostic value of coronary flow reserve in patients with suspected or
known coronary artery disease referred to myocardial perfusion imaging by
positron emission tomography: A meta-analysis.
Source
European Journal of Nuclear Medicine and Molecular Imaging. Conference:
32nd Annual Congress of the European Association of Nuclear Medicine, EANM
2019. Spain. 46 (1 Supplement 1) (pp S346), 2019. Date of Publication:
October 2019.
Author
Cantoni V.; Green R.; Mannarino T.; Assante R.; Gaudieri V.; Zampella E.;
Nappi C.; Agliata G.; Petretta M.; Acampa W.; Cuocolo A.
Institution
(Cantoni, Green, Mannarino, Assante, Gaudieri, Zampella, Nappi, Agliata,
Petretta, Acampa, Cuocolo) University Federico II, Naples, Italy
Publisher
Springer Berlin Heidelberg
Abstract
Aim/Introduction: Coronary vascular dysfunction is related to poor
cardiovascular prognosis in patients with suspected or known coronary
artery disease (CAD). We conducted a metaanalysis to evaluate the
prognostic value of coronary flow reserve (CFR) assessed by positron
emission tomography (PET) in predicting adverse cardiovascular events in
patients with suspected or known CAD. Material(s) and Method(s): A
search in electronic databases was conducted including PubMed and Embase
for studies published in English language until April 2019. The studies
were included in the analysis if they evaluated CFR by PET in patients
with suspected or known CAD, providing data on adjusted hazard ratio for
the occurrence of adverse events. Because of the large heterogeneity
experienced and to minimize the effect of confounding, we considered
separately the hazard ratio derived from multivariate regression analyses
for the occurrence of both hard events, defined as cardiac death and
nonfatal myocardial infarction, and all adverse events. Summary risk
estimates for impaired CFR by PET were derived in random effect regression
analysis and causes of heterogeneity were determined in meta-regression
analysis. Result(s): We identified 13 eligible articles including
9,090 patients with suspected or known CAD with a mean followup of
3.17+/-0.55 years. All studies reported the hazard ratio for the
occurrence of all adverse events. The pooled hazard ratio was 1.57 (95%
confidence interval 1.16-2.11). Among the included publications, five
studies reported the hazard ratio for the occurrence of hard events. The
pooled hazard ratio was 2.51 (95% confidence interval 1.73-3.64). At
meta-regression analysis we found an association between the hazard ratio
for all adverse events and clinical variables (family history of CAD and
prior myocardial infarction) and between the hazard ratio for hard events
and demographic (male gender) and clinical variables (diabetes mellitus,
arterial hypertension, and prior coronary revascularization).
 Conclusion(s): The results of this meta-analysis suggest that in
patients with suspected or known CAD an impaired CFR is associated with
adverse cardiovascular events. However, the large heterogeneity in study
population underlines the need for further investigations to maximize the
prognostic role of CFR.

<82>
Accession Number
629703992
Title
The impact of deep sternal wound infections treated by negative pressure
on early, 1 year and late mortality: A longitudinal case-control study.
Source
Journal of cardiac surgery. (no pagination), 2019. Date of Publication: 26
Oct 2019.
Author
Drossos G.; Ampatzidou F.; Baddour A.; Madesis A.; Karaiskos T.
Institution
(Drossos, Baddour, Madesis, Karaiskos) Cardiothoracic Surgery Department,
G. Papanikolaou General Hospital, Thessaloniki, Greece
(Ampatzidou) Cardiothoracic Intensive Care Unit, G. Papanikolaou General
Hospital, Thessaloniki, Greece
Publisher
NLM (Medline)
Abstract
BACKGROUND/AIM: Deep sternal wound infection (DSWI) after cardiac surgery,
is a rare complication that can be fatal. Due to a lack of available data,
we compared early in-hospital, 1-year and long-term mortality in patients
with DSWI. METHOD(S): Patients undergoing any type of cardiac
surgery, in the Cardiothoracic Surgery Department of G. Papanikolaou
Hospital, between May 2012 and December 2016, were investigated. All
patients who developed DWSI postoperatively, treated with negative
pressure wound therapy (NPWT), were included in the group of cases. A
random population from the rest of the patients was selected in a 1:2
ratio, representing controls. RESULT(S): From a total of 2104
patients, 80 patients (3.8%) developed DSWI (cases group), whereas 180
patients were randomly selected as controls. Early (within 30 days)
mortality was significantly higher in the DSWI group compared with
controls (15% vs 3.9%, respectively; P=.002). Similarly, more deaths
occurred in the cases group compared with controls during the follow-up
(ie, 19 vs 12, respectively; P<.001); the majority of deaths (84.2%)
occurred within the first year. Long-term survival did not differ between
the two study groups during follow-up (median duration=1072 vs 1022 days
for cases and controls, respectively). CONCLUSION(S): DSWI
significantly increased early and 1-year mortality in poststernotomy
patients treated with NPWT compared with those not developing this
complication. However, long-term survival was similar between the two
study groups, thus highlighting the beneficial effect of NPWT in terms of
clinical outcomes in patients with DWSI. Copyright © 2019 Wiley
Periodicals, Inc.

<83>
Accession Number
629700820
Title
Does concurrent use of intra-aortic balloon pumps improve survival in
patients with cardiogenic shock requiring venoarterial extracorporeal
membrane oxygenation?.
Source
Interactive cardiovascular and thoracic surgery. (no pagination), 2019.
Date of Publication: 25 Oct 2019.
Author
Wang D.; Chao V.; Yap K.H.; Tan T.E.
Institution
(Wang, Chao, Yap, Tan) Department of Cardiothoracic Surgery, National
Heart Centre Singapore, Singapore
Publisher
NLM (Medline)
Abstract
A best evidence topic in cardiac surgery was written according to a
structured protocol. The question addressed was 'Does concurrent use of
intra-aortic balloon pump (IABP) improve survival in patients with
cardiogenic shock requiring venoarterial extracorporeal membrane
oxygenation (VA-ECMO)?'. Altogether 472 papers were found using the
reported search, of which 3 level 2 systematic reviews represented the
best evidence to answer the clinical question. The authors, journal, date
and country of publication, patient group studied, study type, relevant
outcomes and results of these papers are tabulated. The reported
comparative outcomes were mortality, weaning off extracorporeal membrane
oxygenation (ECMO), vascular complications and non-vascular complications.
One systematic review demonstrated significantly lower in-hospital
mortality with concurrent use of IABP and VA-ECMO, while the other 2
studies showed no difference in mortality. One paper reported on the
weaning success from ECMO and demonstrated significantly higher weaning
success with concurrent IABP usage. Another paper reported on the
complications and showed no differences in vascular and non-vascular
complications. We conclude that there was no significant improvement in
survival with the concurrent use of IABP and VA-ECMO for a cardiogenic
shock as compared to the use of VA-ECMO alone. However, the concurrent use
of IABP with VA-ECMO improved weaning success from VA-ECMO. The incidence
of vascular and non-vascular complications was similar with or without
IABP usage. Copyright © The Author(s) 2019. Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery. All rights reserved.

<84>
[Use Link to view the full text]
Accession Number
629702202
Title
Ultrasound-Guided Femoral Arterial Cannulation in Neonates Undergoing
Cardiac Surgery or Catheterization: Comparison of 0.014-Inch Floppy Versus
0.019-Inch Straight Guidewire.
Source
Pediatric Critical Care Medicine. 20 (7) (pp 608-613), 2019. Date of
Publication: 01 Jul 2019.
Author
Polat T.B.
Institution
(Polat) Department of Pediatric Cardiology, Altinbas University, School of
Medicine, Istanbul, Turkey
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
Objectives: Percutaneous femoral artery cannulation can be technically
challenging in small infants. Design(s): We designed a prospective
randomized trial to compare the use of two different guidewires for
femoral arterial cannulation in neonates undergoing cardiac surgery or
catheterization. Setting(s): Cardiac ICU in a university hospital.
 Patient(s): One-hundred twenty-four children were enrolled in this
prospective study, with 64 being randomized to the 0.019-inch straight
guidewire group and 60 to the 0.014-inch floppy guidewire group.
 Intervention(s): Femoral artery cannulation. Measurements and
Main Results: The study period was limited to 10 minutes at the first site
of arterial puncture. The time to complete cannulation, number of
successful cannulation on first attempt, number of attempts, and number of
successful cannulations were compared. The number of successful
cannulations and successful cannulations on first attempt were higher in
0.014-inch floppy guidewire group (p = 0.001; p = 0.002, respectively).
The time to complete cannulation was significantly shorter, and the number
of attempts was lower in 0.014-inch floppy guidewire group (p = 0.001).
Among the neonates less than 2000g, the number of attempts and time to
complete cannulation were significantly lower (p < 0.001), and number of
successful cannulation on first attempt and number of successful
cannulations were significantly higher (p < 0.028; p < 0.001,
respectively) in the 0.014-inch floppy guidewire Conclusion(s): Using
0.014-inch floppy guidewire for femoral arterial cannulation in
particularly very small neonates provides significant improvement in first
attempt success, number of successful cannulations, number of attempts,
time to complete cannulation. Copyright © 2019 by the Society of
Critical Care Medicine and the World Federation of Pediatric Intensive and
Critical Care Societies.

<85>
Accession Number
2003583431
Title
Meta-analysis of Randomized Controlled Trials Assessing the Impact of
Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies on Mortality and
Cardiovascular Outcomes.
Source
American Journal of Cardiology. (no pagination), 2019. Date of
Publication: 2019.
Author
AlTurki A.; Marafi M.; Dawas A.; Dube M.-P.; Vieira L.; Sherman M.H.;
Gregoire J.; Thanassoulis G.; Tardif J.-C.; Huynh T.
Institution
(AlTurki, Dawas, Thanassoulis, Huynh) Division of Cardiology, McGill
University Health Center, Montreal, Quebec, Canada
(Marafi, Vieira) Department of Neurology, Montreal Neurological Institute,
Montreal, Quebec, Canada
(Dube, Gregoire, Tardif) Montreal Heart Institute, Universite de Montreal,
Montreal, Quebec, Canada
(Sherman) Division of Endocrinology, McGill University Health Center,
Montreal, Quebec, Canada
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition by
monoclonal antibodies has been shown to reduce low density lipoprotein
(LDL-C) but its effects on cardiovascular (CV) outcomes have not been
fully described. The aim of this study is to assess the impact of PCSK9
inhibition on mortality and CV outcomes by pooling data from all available
randomized clinical trials (RCT) of PCSK9 inhibitors. We conducted a
comprehensive search of electronic databases, up to December 1, 2018, for
all RCTs comparing PCSK9 inhibition to placebo or ezetimibe in patients
with hypercholesterolemia or coronary artery disease receiving maximally
tolerated statin for primary or secondary prevention of mortality and
cardiovascular outcomes. We used random-effects meta-analyses to summarize
the studies. We retained 23 RCTs having included 88,041 patients in
primary and secondary prevention. The follow-up ranged from 6 to 36
months. PCSK9 inhibition was not significantly associated with reductions
in total mortality (odds ratio [OR] 0.91, 95% confidence interval [CI] 078
to 1.06; p = 0.22) and CV mortality (OR 0.95, 95% CI 0.84 to 1.07; p =
0.37). In contrast, PCSK9 inhibition was associated with reductions in
myocardial infarction (OR 0.80, 95% CI 0.71 to 0.91; p <0.0001), stroke
(OR 0.75, 95% CI 0.65 to 0.85; p <0.0001), and coronary revascularization
(OR 0.82, 95% CI 0.77 to 0.88; p <0.0001). In conclusion, PCSK9 inhibition
was associated with reductions in myocardial infarction, stroke, and
coronary revascularization. Future analyses may identify high-risk
patients who may benefit more from these agents and longer follow-up of
current or new trials may show a mortality benefit. Copyright ©
2019 Elsevier Inc.

<86>
Accession Number
2003346867
Title
Noninvasive Mapping of Premature Ventricular Contractions by Merging
Magnetocardiography and Computed Tomography.
Source
JACC: Clinical Electrophysiology. 5 (10) (pp 1144-1157), 2019. Date of
Publication: October 2019.
Author
Aita S.; Ogata K.; Yoshida K.; Inaba T.; Kosuge H.; Machino T.; Tsumagari
Y.; Hattori A.; Ito Y.; Komatsu Y.; Sekihara K.; Horigome H.; Aonuma K.;
Nogami A.; Kandori A.; Ieda M.
Institution
(Aita, Yoshida, Inaba, Kosuge, Machino, Tsumagari, Hattori, Ito, Komatsu,
Aonuma, Nogami, Ieda) Department of Cardiology, University of Tsukuba,
Tsukuba, Japan
(Ogata, Kandori) Research and Development Group, Hitachi Ltd., Kokubunji,
Japan
(Yoshida) Department of Cardiology, Ibaraki Prefectural Central Hospital,
Kasama, Japan
(Kosuge) Tsukuba Advanced Imaging Center, Tsukuba, Japan
(Sekihara) Signal Analysis Inc., Hachioji, Japan
(Horigome) Department of Pediatrics, University of Tsukuba, Tsukuba, Japan
Publisher
Elsevier Inc
Abstract
Objectives: This study aimed to develop a novel premature ventricular
contraction (PVC) mapping method to predict PVC origins in whole
ventricles by merging a magnetocardiography (MCG) image with a cardiac
computed tomography (CT) image. Background(s): MCG can noninvasively
discriminate PVCs originating from the aortic sinus cusp from those
originating from the right ventricular outflow tract. Method(s): This
study was composed of 22 candidates referred for catheter ablation of
idiopathic PVCs. MCG and CT were performed the same day before ablation.
Estimated origins by MCG-CT imaging using the recursive null steering
spatial filter algorithm were compared with origins determined by
electroanatomic mapping (CARTO, Biosense Webster, Inc., Diamond Bar,
California) during the ablation procedure. Radiopaque acrylic markers for
the CT scan and coil markers generating a weak magnetic field during MCG
measurements were used as reference markers to merge the 2 images
3-dimensionally. Result(s): PVC origins were determined by
endocardial and epicardial mapping and ablation results in 18 (86%)
patients (right ventricular outflow tract in 10 patients, aortic sinus
cusp in 2 patients, interventricular septum in 1 patient, near His bundle
in 1 patient, right ventricular free wall in 1 patient, and left
ventricular free wall in 3 patients). Estimated origins by MCG-CT imaging
matched the origins determined during the procedure in 94% (17 of 18) of
patients, whereas the electrocardiography algorithms were accurate in only
56% (10 of 18). Discrimination of an epicardium versus an endocardium or
right- versus left-sided septum was successful in 3 of 4 patients (75%).
 Conclusion(s): The diagnostic accuracy of noninvasive MCG-CT mapping
was high enough to allow clinical use to predict the site of PVC origins
in the whole ventricles. Copyright © 2019 The Authors

<87>
Accession Number
2003343071
Title
Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow
Reserve-Guided Revascularization Strategy.
Source
JACC: Cardiovascular Interventions. 12 (20) (pp 2035-2046), 2019. Date of
Publication: 28 October 2019.
Author
Kim C.H.; Koo B.-K.; Dehbi H.-M.; Lee J.M.; Doh J.-H.; Nam C.-W.; Shin
E.-S.; Cook C.M.; Al-Lamee R.; Petraco R.; Sen S.; Malik I.S.; Nijjer
S.S.; Mejia-Renteria H.; Alegria-Barrero E.; Alghamdi A.; Altman J.;
Baptista S.B.; Bhindi R.; Bojara W.; Brugaletta S.; Silva P.C.; Di Mario
C.; Erglis A.; Gerber R.T.; Going O.; Harle T.; Hellig F.; Indolfi C.;
Janssens L.; Jeremias A.; Kharbanda R.K.; Khashaba A.; Kikuta Y.;
Krackhardt F.; Laine M.; Lehman S.J.; Matsuo H.; Meuwissen M.; Niccoli G.;
Piek J.J.; Ribichini F.; Samady H.; Sapontis J.; Seto A.H.; Sezer M.;
Sharp A.S.P.; Singh J.; Takashima H.; Talwar S.; Tanaka N.; Tang K.; Van
Belle E.; van Royen N.; Vinhas H.; Vrints C.J.; Walters D.; Yokoi H.;
Samuels B.; Buller C.; Patel M.R.; Serruys P.W.; Escaned J.; Davies J.E.
Institution
(Kim) Division of Cardiology, Department of Internal Medicine, VHS Medical
Center, Seoul, South Korea
(Koo) Division of Cardiology, Department of Internal Medicine, Seoul
National University Hospital, Seoul National University, Seoul, South
Korea
(Koo) Institute on Aging, Seoul National University, Seoul, South Korea
(Dehbi) Cancer Research UK and University College London Cancer Trials
Centre, University College London, London, United Kingdom
(Lee) Division of Cardiology, Department of Internal Medicine, Heart
Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University
School of Medicine, Seoul, South Korea
(Doh) Department of Medicine, Inje University Ilsan Paik Hospital,
Daehwa-dong, South Korea
(Nam) Department of Medicine, Keimyung University Dongsan Medical Center,
Daegu, South Korea
(Shin) Division of Cardiology, Department of Internal Medicine, Ulsan
Medical Center, Ulsan Hospital, Ulsan, South Korea
(Cook, Al-Lamee, Petraco, Sen, Malik, Nijjer, Serruys, Davies) Hammersmith
Hospital, Imperial College London, London, United Kingdom
(Mejia-Renteria, Escaned) Hospital Clinico San Carlos, Instituto de
Investigacion Sanitaria San Carlos, Universidad Complutense de Madrid,
Madrid, Spain
(Alegria-Barrero) Hospital Universitario de Torrejon, Universidad
Francisco de Vitoria, Madrid, Spain
(Alghamdi) King Abdulaziz Medical City Cardiac Center, Riyadh, Saudi
Arabia
(Altman) Colorado Heart and Vascular, Lakewood, CO, United States
(Baptista) Hospital Prof. Doutor Fernando Fonseca, Amadora, Portugal
(Bhindi) Royal North Shore Hospital, Sydney, Australia
(Bojara) Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz,
Germany
(Brugaletta) Cardiovascular Institute, Hospital Clinic, Institut
d'Investigacions Biomediques August Pi i Sunyer, Barcelona, Spain
(Silva) Hospital Santa Maria, Lisbon, Portugal
(Di Mario) Royal Brompton Hospital, Imperial College London, London,
United Kingdom
(Di Mario) University of Florence, Florence, Italy
(Erglis) Pauls Stradins Clinical University Hospital, Riga, Latvia
(Gerber) Conquest Hospital, St Leonards-on-Sea, United Kingdom
(Going) Sana Klinikum Lichtenberg, Lichtenberg, Germany
(Harle) Klinikum Oldenburg, European Medical School, Carl von Ossietzky
University, Oldenburg, Germany
(Hellig) Sunninghill Hospital, Johannesburg, South Africa
(Indolfi) University Magna Graecia, Catanzaro, Italy
(Janssens) Imelda Hospital, Bonheiden, Belgium
(Jeremias) Stony Brook University Medical Center, New York, NY, United
States
(Kharbanda) John Radcliffe Hospital, Oxford University Hospitals
Foundation Trust, Oxford, United Kingdom
(Khashaba) Ain Shams University, Cairo, Egypt
(Kikuta) Fukuyama Cardiovascular Hospital, Fukuyama, Japan
(Krackhardt) Charite Campus Virchow Klinikum, Universitaetsmedizin,
Berlin, Germany
(Laine) Helsinki University Hospital, Helsinki, Finland
(Lehman) Flinders University, Adelaide, Australia
(Matsuo) Gifu Heart Center, Gifu, Japan
(Meuwissen) Amphia Hospital, Breda, Netherlands
(Niccoli) Catholic University of the Sacred Heart, Rome, Italy
(Piek) AMC Heart Center, Academic Medical Center, Amsterdam, Netherlands
(Ribichini) University Hospital Verona, Verona, Italy
(Samady) Emory University, Atlanta, Georgia
(Sapontis) MonashHeart, Monash University, Melbourne, Australia
(Seto) Veterans Affairs Long Beach Healthcare System, Long Beach, CA,
United States
(Sezer) Istanbul University, Istanbul Faculty of Medicine, Istanbul,
Turkey
(Sharp) Royal Devon and Exeter Hospital, University of Exeter, Exeter,
United Kingdom
(Singh) Washington University School of Medicine in St. Louis, St. Louis,
MO, United States
(Takashima) Aichi Medical University Hospital, Aichi, Japan
(Talwar) Royal Bournemouth General Hospital, Bournemouth, United Kingdom
(Tanaka) Tokyo Medical University, Tokyo, Japan
(Tang) Essex Cardiothoracic Centre, Basildon, United Kingdom
(Tang) Anglia Ruskin University, Chelmsford, United Kingdom
(Van Belle) Institut Coeur Poumon, Lille University Hospital, Lille,
France
(Van Belle) UMR INSERM 1011, Centre Hospitalier Universitaire de Lille et
de Institut Pasteur de Lille, Universite de Lille, Lille, France
(van Royen) VU University Medical Center, Amsterdam, Netherlands
(Vinhas) Hospital Garcia de Horta, Lisbon, Portugal
(Vrints) Antwerp University Hospital, Antwerp, Belgium
(Walters) Prince Charles Hospital, Brisbane, Australia
(Yokoi) Fukuoka Sannou Hospital, Fukuoka, Japan
(Samuels) Cedars-Sinai Heart Institute, Los Angeles, CA, United States
(Buller) St. Michaels Hospital, Toronto, Canada
(Patel) Duke University, Durham, Norh Carolina, United Kingdom
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Objectives: This study sought to evaluate sex differences in procedural
characteristics and clinical outcomes of instantaneous wave-free ratio
(iFR)- and fractional flow reserve (FFR)-guided revascularization
strategies. Background(s): An iFR-guided strategy has shown a lower
revascularization rate than an FFR-guided strategy, without differences in
clinical outcomes. Method(s): This is a post hoc analysis of the
DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to
guide Revascularization) study, in which 601 women and 1,891 men were
randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year
major adverse cardiac events (MACE), a composite of all-cause death,
nonfatal myocardial infarction, or unplanned revascularization.
 Result(s): Among the entire population, women had a lower number of
functionally significant lesions per patient (0.31 +/- 0.51 vs. 0.43 +/-
0.59; p < 0.001) and less frequently underwent revascularization than men
(42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value
according to sex (0.91 +/- 0.09 vs. 0.91 +/- 0.10; p = 0.442). However,
the mean FFR value was lower in men than in women (0.83 +/- 0.09 vs. 0.85
+/- 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a
higher rate of revascularization than an iFR-guided strategy (57.1% vs.
49.3%; p = 0.001), but this difference was not observed in women (41.4%
vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR-
and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard
ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men
(6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66
to 1.46; p = 0.919). Conclusion(s): An FFR-guided strategy was
associated with a higher rate of revascularization than iFR-guided
strategy in men, but not in women. However, iFR- and FFR-guided strategies
showed comparable clinical outcomes, regardless of sex. (Functional Lesion
Assessment of Intermediate Stenosis to guide Revascularization
[DEFINE-FLAIR]; NCT02053038) Copyright © 2019 American College of
Cardiology Foundation

<88>
Accession Number
623126927
Title
Left ventricular aneurysms in hypertrophic cardiomyopathy with
midventricular obstruction: A systematic review of literature.
Source
PACE - Pacing and Clinical Electrophysiology. 41 (7) (pp 854-865), 2018.
Date of Publication: July 2018.
Author
Elsheshtawy M.O.; Mahmoud A.N.; Abdelghany M.; Suen I.H.; Sadiq A.; Shani
J.
Institution
(Elsheshtawy, Sadiq, Shani) Division of Cardiovascular Medicine,
Department of Medicine, Maimonides Medical Center, Brooklyn, NY, United
States
(Elsheshtawy, Suen) Division of Cardiovascular Medicine, Department of
Medicine, Coney Island Hospital, Brooklyn, NY, United States
(Mahmoud) Division of Cardiovascular Medicine, Department of Medicine,
University of Florida, Gainesville, FL, United States
(Abdelghany) Division of Cardiovascular Medicine, Department of Medicine,
State University of New York, Upstate Medical University, Syracuse, NY,
United States
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Background: Hypertrophic cardiomyopathy (HCM) with or without left
ventricular apical aneurysm (LVA) had been studied in the past.
Midventricular obstruction associated with HCM and LVA is a unique entity
that has not been distinguished previously as a separate phenotypic
disease in HCM patients. Method(s): A systematic review of Pubmed and
Google Scholar was conducted from inception until September 2017 for all
observational studies conducted on HCM with midventricular obstruction and
LVA. Result(s): A total of 94 patients from 39 studies were included
in our analysis. The mean age of the patients was 58.05 +/- 11.76 years
with 59.6% being males. The most common electrocardiographic finding was T
wave inversion occurring in 13.8% of the cases followed by ST elevation
(9.5%). Maximal left ventricle (LV) wall thickness was reported 18.89 +/-
5.19 mm on transthoracic echocardiography and paradoxical jet flow was
detected in 29.8% of patients. Beta-blockers (58.5%) were the most common
drug therapy at baseline and amiodarone (10.6%) was the most common
antiarrhythmic used for ventricular tachycardia (VT). The most common
complication, VT, occurred in 39.3% of cases and the incidence of
all-cause mortality was 13.8 % over 16 +/- 20.1 months follow-up.
Implantable cardioverter defibrillator (ICD) was used in 37.2% of
patients; 25.7% of patients with ICD received appropriate shock therapy.
 Conclusion(s): HCM with LVA and midventricular obstruction is a
unique entity that appears to be associated with high incidence of
morbidity and mortality. Thus, early diagnosis and therapeutic
intervention is recommended for management of this
condition. Copyright © 2018 Wiley Periodicals, Inc.

<89>
Accession Number
623779007
Title
Inotropic and lusitropic effects of levosimendan and milrinone assessed by
strain echocardiography-A randomised trial.
Source
Acta Anaesthesiologica Scandinavica. 62 (9) (pp 1246-1254), 2018. Date of
Publication: October 2018.
Author
Fredholm M.; Jorgensen K.; Houltz E.; Ricksten S.-E.
Institution
(Fredholm, Jorgensen, Houltz, Ricksten) Department of Anesthesiology and
Intensive Care Medicine at the Sahlgrenska Academy, University of
Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden
Publisher
Blackwell Munksgaard (E-mail: info@mks.blackwellpublising.com)
Abstract
Background: We compared the direct inotropic and lusitropic effects of two
inodilators, milrinone and levosimendan in patients after aortic valve
replacement for aortic stenosis. Method(s): In this randomised,
blinded study, 31 patients with normal LV function, were randomised to
either levosimendan (0.1 and 0.2 mug/kg/min, n = 15) or milrinone (0.4 and
0.8 mug/kg/min, n = 16) after aortic valve replacement. The effects on LV
performance, LV strain, systolic (SR-S) and early diastolic (SR-E) strain
rate were assessed by a pulmonary artery catheter and transoesophageal
two-dimensional speckle tracking echocardiography of the LV inferior wall.
To circumvent the inodilator-induced hemodynamic changes on LV systolic
and diastolic deformation, central venous pressure (CVP), systolic artery
pressure (SAP), and heart rate were maintained constant by colloid
infusion, phenylephrine-induced vasoconstriction and atrial pacing,
respectively, during drug infusion. Result(s): Both inotropic agents
induced a dose-dependent increase in cardiac index and stroke volume index
by approximately 20% at the highest infusion rates with no differences
between groups (P =.139 and.249, respectively). CVP, pulmonary capillary
wedge pressure, SAP and heart rate were maintained constant in both
groups. LV strain and SR-S increased with both agents, dose-dependently,
by 17%-18% and 25%-30%, respectively, at the highest infusion rates, with
no difference between groups (P =.434 and.284, respectively). Both agents
improved early LV relaxation with no differences between groups (P =.637).
At the higher doses, both agents increased SR-E by 30%.
 Conclusion(s): At clinically relevant infusion rates and a certain
increase in LV performance the direct inotropic and lusitropic of
milrinone and levosimendan were comparable. Copyright © 2018 The
Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley &
Sons Ltd

<90>
Accession Number
2003305329
Title
Percutaneous coronary intervention versus coronary artery bypass grafting
in patients with three-vessel or left main coronary artery disease:
10-year follow-up of the multicentre randomised controlled SYNTAX trial.
Source
The Lancet. 394 (10206) (pp 1325-1334), 2019. Date of Publication: 12 - 18
October 2019.
Author
Thuijs D.J.F.M.; Kappetein A.P.; Serruys P.W.; Mohr F.-W.; Morice M.-C.;
Curzen N.; Davierwala P.; Noack T.; Milojevic M.; Dawkins K.D.; da Costa
B.R.; Juni P.; Head S.J.; Casselman F.; de Bruyne B.; Hoj Christiansen E.;
Ruiz-Nodar J.M.; Vermeersch P.; Schultz W.; Sabate M.; Guagliumi G.;
Grubitzsch H.; Stangl K.; Darremont O.; Bentala M.; den Heijer P.; Preda
I.; Stoler R.; Mack M.J.; Szerafin T.; Buckner J.K.; Guber M.S.;
Verberkmoes N.; Akca F.; Feldman T.; Beyersdorf F.; Drieghe B.; Oldroyd
K.; Berg G.; Jeppsson A.; Barber K.; Wolschleger K.; Heiser J.; van der
Harst P.; Mariani M.A.; Reichenspurner H.; Stark C.; Laine M.; Ho P.C.;
Chen J.C.; Zelman R.; Horwitz P.A.; Bochenek A.; Krauze A.; Grothusen C.;
Dudek D.; Heyrich G.; Kolh P.; LeGrand V.; Coelho P.; Ensminger S.;
Nasseri B.; Ingemansson R.; Olivecrona G.; Escaned J.; Guera R.; Berti S.;
Chieffo A.; Burke N.; Mooney M.; Spolaor A.; Hagl C.; Nabauer M.; Suttorp
M.J.; Stine R.A.; McGarry T.; Lucas S.; Endresen K.; Taussig A.; Accola
K.; Canosi U.; Horvath I.; Cannon L.; Talbott J.D.; Akins C.W.; Kramer R.;
Aschermann M.; Killinger W.; Narbute I.; Holmes D.R.; Burzotta F.; Bogers
A.; Zijlstra F.; Eltchaninoff H.; Berland J.; Stefanini G.; Cruz Gonzalez
I.; Hoppe U.; Kiesz S.; Gora B.; Ahlsson A.; Corbascio M.; Bilfinger T.;
Carrie D.; Tchetche D.; Hauptman K.-E.; Stahle E.; James S.; Sandner S.;
Laufer G.; Lang I.; Witkowski A.; Thourani V.; Suryapranata H.; Redwood
S.; Knight C.; MacCarthy P.; de Belder A.; Banning A.; Gershlick A.
Institution
(Thuijs, Kappetein, Milojevic, Head) Department of Cardiothoracic Surgery,
Erasmus University Medical Centre, Rotterdam, Netherlands
(Kappetein) Medtronic, Maastricht, Netherlands
(Serruys) Department of Cardiology, Imperial College London, London,
United Kingdom
(Mohr, Davierwala, Noack) University Department of Cardiac Surgery, Heart
Centre Leipzig, Leipzig, Germany
(Morice) Department of Cardiology, Cardiovascular Institute Paris-Sud,
Hopital Prive Jacques Cartier, Ramsay Generale de Sante, Massy, France
(Mack) Department of Cardiothoracic Surgery, Baylor University Medical
Centre, Dallas, TX, United States
(Holmes) Department of Cardiovascular Diseases and Internal Medicine, Mayo
Clinic, Rochester, MN, United States
(Curzen) University Hospital Southampton NHS Foundation Trust and School
of Medicine, University of Southampton, Southampton, United Kingdom
(Dawkins) Shockwave Medical Inc., Santa Clara, CA, United States
(da Costa, Juni) Applied Health Research Centre, Li Ka Shing Knowledge
Institute of St Michael's Hospital, University of Toronto, Toronto, ON,
Canada
(Juni) Department of Medicine, Institute of Health Policy, Management and
Evaluation, University of Toronto, Toronto, ON, Canada
(da Costa) Institute of Primary Health Care, University of Bern, Bern,
Switzerland
(Head) Medtronic, Minneapolis, MN, United States
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background: The Synergy between PCI with Taxus and Cardiac Surgery
(SYNTAX) trial was a non-inferiority trial that compared percutaneous
coronary intervention (PCI) using first-generation paclitaxel-eluting
stents with coronary artery bypass grafting (CABG) in patients with
de-novo three-vessel and left main coronary artery disease, and reported
results up to 5 years. We now report 10-year all-cause death results.
 Method(s): The SYNTAX Extended Survival (SYNTAXES) study is an
investigator-driven extension of follow-up of a multicentre, randomised
controlled trial done in 85 hospitals across 18 North American and
European countries. Patients with de-novo three-vessel and left main
coronary artery disease were randomly assigned (1:1) to the PCI group or
CABG group. Patients with a history of PCI or CABG, acute myocardial
infarction, or an indication for concomitant cardiac surgery were
excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause
death, which was assessed according to the intention-to-treat principle.
Prespecified subgroup analyses were performed according to the presence or
absence of left main coronary artery disease and diabetes, and according
to coronary complexity defined by core laboratory SYNTAX score tertiles.
This study is registered with ClinicalTrials.gov, NCT03417050.
 Finding(s): From March, 2005, to April, 2007, 1800 patients were
randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status
information at 10 years was complete for 841 (93%) patients in the PCI
group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%)
patients had died after PCI and 211 (24%) after CABG (hazard ratio 1.17
[95% CI 0.97-1.41], p=0.092). Among patients with three-vessel disease,
151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG
(hazard ratio 1.41 [95% CI 1.10-1.80]), and among patients with left main
coronary artery disease, 93 (26%) of 357 had died after PCI versus 98
(28%) of 348 after CABG (0.90 [0.68-1.20], p<inf>interaction</inf>=0.019).
There was no treatment-by-subgroup interaction with diabetes
(p<inf>interaction</inf>=0.66) and no linear trend across SYNTAX score
tertiles (p<inf>trend</inf>=0.30). Interpretation(s): At 10 years, no
significant difference existed in all-cause death between PCI using
first-generation paclitaxel-eluting stents and CABG. However, CABG
provided a significant survival benefit in patients with three-vessel
disease, but not in patients with left main coronary artery disease.
 Funding(s): German Foundation of Heart Research (SYNTAXES study,
5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study,
0-5-year follow-up). Copyright © 2019 Elsevier Ltd

<91>
Accession Number
2003305307
Title
Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen
after successful coronary stenting in patients with atrial fibrillation
(ENTRUST-AF PCI): a randomised, open-label, phase 3b trial.
Source
The Lancet. 394 (10206) (pp 1335-1343), 2019. Date of Publication: 12 - 18
October 2019.
Author
Vranckx P.; Valgimigli M.; Eckardt L.; Tijssen J.; Lewalter T.; Gargiulo
G.; Batushkin V.; Campo G.; Lysak Z.; Vakaliuk I.; Milewski K.; Laeis P.;
Reimitz P.-E.; Smolnik R.; Zierhut W.; Goette A.
Institution
(Vranckx) Department of Cardiology and Intensive Care, Jessa Ziekenhuis,
Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt,
Belgium
(Valgimigli, Gargiulo) Department of Cardiology, Inselspital, Bern
University Hospital, University of Bern, Bern, Switzerland
(Eckardt, Lewalter, Goette) Atrial Fibrillation Network, Munster, Germany
(Eckardt) Department of Cardiology and Angiology, Division of
Electrophysiology, University of Munster, Munster, Germany
(Tijssen) Department of Cardiology, Amsterdam University Medical Centers,
University of Amsterdam, Amsterdam, Netherlands
(Tijssen) Cardialysis, Rotterdam, Netherlands
(Lewalter) Department of Cardiology, Hospital Munich South, Munich,
Germany
(Lewalter) University of Bonn, Bonn, Germany
(Gargiulo) Department of Advanced Biomedical Sciences, Federico II
University of Naples, Naples, Italy
(Batushkin) Department of Cardiology, Kyiv City Clinical Hospital #5,
Kiev, Ukraine
(Campo) Cardiovascular Institute, Azienda Ospedaliero-Universitaria di
Ferrara, Cona, Venice, Italy
(Campo) Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy
(Lysak) Department of Cardiac Rehabilitation, Oleksandrivska Kyiv City
Clinical Hospital, Kiev, Ukraine
(Milewski) Center for Cardiovascular Research and Development, American
Heart of Poland Katowice, Poland
(Milewski) The Jerzy Kukuczka Academy of Physical Education, Faculty of
Physiotherapy, Katowice, Katowice, Poland
(Vakaliuk) Department Internal Medicine No2 and Nursing, Ivano-Frankivsk
National Medical University, Ivano-Frankivsk, Ukraine
(Vakaliuk) Department of Anesthesiology with Wards of Intensive Care,
Ivano-Frankivsk Regional Clinical Cardiological Clinic, Ivano-Frankivsk,
Ukraine
(Laeis, Reimitz, Smolnik, Zierhut) Daiichi Sankyo Europe, Munich, Germany
(Goette) Cardiology and Intensive Care Medicine, St Vincenz-Hospital,
Paderborn, Germany
(Goette) Working Group of Molecular Electrophysiology, University Hospital
Magdeburg, Magdeburg, Germany
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background: We aimed to assess the safety of edoxaban in combination with
P2Y12 inhibition in patients with atrial fibrillation who had percutaneous
coronary intervention (PCI). Method(s): ENTRUST-AF PCI was a
randomised, multicentre, open-label, non-inferiority phase 3b trial with
masked outcome evaluation, done at 186 sites in 18 countries. Patients had
atrial fibrillation requiring oral anticoagulation, were aged at least 18
years, and had a successful PCI for stable coronary artery disease or
acute coronary syndrome. Participants were randomly assigned (1:1) from 4
h to 5 days after PCI using concealed, stratified, and blocked web-based
central randomisation to either edoxaban (60 mg once daily) plus a P2Y12
inhibitor for 12 months or a vitamin K antagonist (VKA) in combination
with a P2Y12 inhibitor and aspirin (100 mg once daily, for 1-12 months).
The edoxaban dose was reduced to 30 mg per day if one or more factors
(creatinine clearance 15-50 mL/min, bodyweight <=60 kg, or concomitant use
of specified potent P-glycoprotein inhibitors) were present. The primary
endpoint was a composite of major or clinically relevant non-major (CRNM)
bleeding within 12 months. The primary analysis was done in the
intention-to-treat population and safety was assessed in all patients who
received at least one dose of their assigned study drug. This trial is
registered with ClinicalTrials.gov, NCT02866175, is closed to new
participants, and follow-up is completed. Finding(s): From Feb 24,
2017, through May 7, 2018, 1506 patients were enrolled and randomly
assigned to the edoxaban regimen (n=751) or VKA regimen (n=755). Median
time from PCI to randomisation was 45.1 h (IQR 22.2-76.2). Major or CRNM
bleeding events occurred in 128 (17%) of 751 patients (annualised event
rate 20.7%) with the edoxaban regimen and 152 (20%) of 755 patients
(annualised event rate 25.6%) patients with the VKA regimen; hazard ratio
0.83 (95% CI 0.65-1.05; p=0.0010 for non-inferiority, margin hazard ratio
1.20; p=0.1154 for superiority). Interpretation(s): In patients with
atrial fibrillation who had PCI, the edoxaban-based regimen was
non-inferior for bleeding compared with the VKA-based regimen, without
significant differences in ischaemic events. Funding(s): Daiichi
Sankyo. Copyright © 2019 Elsevier Ltd

<92>
Accession Number
625825944
Title
Hypoglossal Nerve Stimulation and Heart Rate Variability: Analysis of STAR
Trial Responders.
Source
Otolaryngology - Head and Neck Surgery (United States). 160 (1) (pp
165-171), 2019. Date of Publication: 01 Jan 2019.
Author
Dedhia R.C.; Shah A.J.; Bliwise D.L.; Quyyumi A.A.; Strollo P.J.; Li Q.;
Da Poian G.; Clifford G.D.
Institution
(Dedhia) Department of Otolaryngology, School of Medicine, Emory
University, Atlanta, GA, United States
(Dedhia, Bliwise) Emory Sleep Center, Emory Healthcare, Atlanta, GA,
United States
(Shah) Department of Epidemiology, Rollins School of Public Health, Emory
University, Atlanta, GA, United States
(Quyyumi) Division of Cardiology, Department of Medicine, School of
Medicine, Emory University, Atlanta, GA, United States
(Strollo) Division of Pulmonary, Allergy and Critical Care Medicine,
School of Medicine, University of Pittsburgh, Pittsburgh, PA, United
States
(Li, Da Poian, Clifford) Department of Biomedical Informatics, Emory
University, Atlanta, GA, United States
(Li, Da Poian, Clifford) Department of Biomedical Engineering, Georgia
Institute of Technology, Atlanta, GA, United States
Publisher
SAGE Publications Inc. (E-mail: claims@sagepub.com)
Abstract
Objective: Hypoglossal nerve stimulation represents a novel therapy for
the treatment of moderate-severe obstructive sleep apnea; nonetheless, its
cardiovascular effects are not known. We examine the effects of
hypoglossal nerve stimulation on heart rate variability, a measure of
autonomic function. Study Design: Substudy of the STAR trial
(Stimulation Therapy for Apnea Reduction): a multicenter prospective
single-group cohort. Setting(s): Academic and private practice
centers in the United States and Europe. Subjects and Methods: A subset of
responder participants (n = 46) from the STAR trial was randomized to
therapy withdrawal or therapy maintenance 12 months after surgery. Heart
rate variability analysis included standard deviation of the R-R interval
(SDNN), low-frequency power of the R-R interval, and high-frequency power
of the R-R interval. Analysis was performed by sleep with 5-minute sliding
window epochs during baseline, 12 months, and the maintenance/withdrawal
period. Result(s): A significant improvement from baseline to 12
months in heart rate variability was seen for SDNN and low frequency
across all sleep stages. SDNN analysis demonstrated no change in the wake
period (mean +/- SD: 0.042 +/- 0.01 vs 0.077 +/- 0.07, P =.19). Reduction
in SDNN was correlated to improvement in apnea-hypopnea index (r = 0.39, P
=.03). In the therapy withdrawal group, no significant changes in SDNN
were seen for N1/N2, N3, or rapid eye movement sleep. Conclusion(s):
Hypoglossal nerve stimulation therapy appears to reduce heart rate
variability during sleep. This reduction was not affected by a 1-week
withdrawal period. Larger prospective studies are required to better
understand the effect of hypoglossal nerve stimulation on autonomic
dysfunction in obstructive sleep apnea. Copyright © American
Academy of Otolaryngology-Head and Neck Surgery Foundation 2018.

<93>
Accession Number
2002984801
Title
Meta-analysis Comparing Multivessel Versus Culprit Coronary Arterial
Revascularization for Patients With Non-ST-Segment Elevation Acute
Coronary Syndromes.
Source
American Journal of Cardiology. 124 (10) (pp 1501-1511), 2019. Date of
Publication: 15 November 2019.
Author
Siebert V.R.; Borgaonkar S.; Jia X.; Nguyen H.L.; Birnbaum Y.; Lakkis
N.M.; Alam M.
Institution
(Siebert, Nguyen) Department of Medicine, Baylor College of Medicine,
Houston, TX, United States
(Borgaonkar, Jia, Birnbaum, Lakkis, Alam) Department of Medicine, Section
of Cardiology, Baylor College of Medicine, Houston, TX, United States
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
We present a systematic review and meta-analysis comparing efficacy and
safety outcomes between single procedure multivessel revascularization
(MVR) and culprit vessel only revascularization in patients presenting
with non-ST-segment-elevation acute coronary syndrome (NSTE-ACS). NSTE-ACS
is the most common form of acute coronary syndrome (ACS), and multivessel
disease is common. There is no consensus on the most efficacious single
procedure revascularization strategy for patients undergoing percutaneous
coronary intervention not meeting coronary artery bypass grafting
criteria. Studies in PubMed and EMBASE databases were systematically
reviewed, and 15 studies met criteria for inclusion in the meta-analysis.
Baseline characteristics between the groups were similar. A random effects
model was used to calculate odds ratios (OR) with 95% confidence intervals
(CI). Heterogeneity of studies was assessed using Cochrane's Q and Higgins
I2 tests. For short-term outcomes, patients who underwent MVR
had higher rates of major adverse cardiac events (OR 1.14; 95% CI 1.01 to
1.29; p = 0.03); and stroke (OR 1.94; 95% CI 1.01 to 3.72; p = 0.05), but
lower rates of urgent or emergent coronary artery bypass grafting (OR
0.35; 95% CI 0.29 to 0.43; p <0.00001). In the long-term, MVR patients had
less frequent major adverse cardiac events (OR 0.76; 95% CI 0.61-0.93; p =
0.009), all-cause death (OR 0.83; 95% CI 0.71 to 0.97; p = 0.03), and
repeat revascularization, (OR 0.62; 95% CI 0.42 to 0.90; p = 0.01). MVR
following NSTE-ACS was associated with higher short-term risk, but
long-term benefit. In conclusion, these results support the use of single
procedure multivessel revascularization for NSTE-ACS patients who are
suitable candidates at the time of percutaneous coronary
intervention. Copyright © 2019 Elsevier Inc.

<94>
Accession Number
2003479561
Title
Perioperative care of children with sickle cell disease: A systematic
review and clinical recommendations.
Source
American Journal of Hematology. (no pagination), 2019. Date of
Publication: 2019.
Author
Schyrr F.; Dolci M.; Nydegger M.; Canellini G.; Andreu-Ullrich H.; Joseph
J.-M.; Diezi M.; Cachat F.; Rizzi M.; Renella R.
Institution
(Schyrr, Diezi, Rizzi, Renella) Pediatric Hematology-Oncology Unit,
Division of Pediatrics, Department "Woman-Mother-Child", Lausanne
University Hospital and Lausanne University, Lausanne, Switzerland
(Dolci, Nydegger) Division of Anesthesia, Department of Surgery, Lausanne
University Hospital and Lausanne University, Lausanne, Switzerland
(Canellini, Andreu-Ullrich) Transfusion Medicine Unit, Department of
Laboratory Medicine, Lausanne University Hospital and Lausanne University,
Lausanne, Switzerland
(Joseph) Division of Pediatric Surgery, Department "Woman-Mother-Child",
Lausanne University Hospital and Lausanne University, Lausanne,
Switzerland
(Cachat) Pediatric Nephrology Unit, Division of Pediatrics, Department
"Woman-Mother-Child", Lausanne University Hospital and Lausanne
University, Lausanne, Switzerland
Publisher
Wiley-Liss Inc. (E-mail: info@wiley.com)
Abstract
Children with sickle cell disease (SCD) require specific perioperative
care, and clinical practice in this area remains poorly defined. We aimed
to conduct a systematic, PRISMA-based review of the literature, available
clinical guidelines and practice recommendations. We also aimed to extract
any valuable information for the "best of available-evidence"-based
prevention of perioperative adverse events in children with SCD, and
highlight the most urgent priorities in clinical research. As data
sources, US National Library of Medicine, Medline, National Guideline
Clearinghouse, International Guideline Network, TRIP databases were
searched for any content until January 2019. We also included
institutional, consortia and expert group guidelines. Included were
reports/guidelines in English, French, German, and Italian. Excluded were
reports on obstetrical and fetal management. We identified 202
reports/guidelines fulfilling the criteria outlined above. A majority
focused on visceral, cardiovascular and orthopedic surgery procedures, and
only five were multicenter randomized controlled trials and two
prospective randomized studies. After grading of the quality of the
evidence, the extracted data was summarized into clinical recommendations
for daily practice. Additionally, we designed a risk-grading algorithm to
identify contexts likely to be associated with adverse outcomes. In
conclusion, we provide a systematic PRISMA-based review of the existing
literature and ancillary practice and delineate a set of clinical
recommendations and priorities for research. Copyright © 2019
Wiley Periodicals, Inc.

<95>
Accession Number
628688910
Title
Outcomes of left atrial appendage occlusion using the AtriClip device: a
systematic review.
Source
Interactive cardiovascular and thoracic surgery. 29 (5) (pp 655-662),
2019. Date of Publication: 01 Nov 2019.
Author
Toale C.; Fitzmaurice G.J.; Eaton D.; Lyne J.; Redmond K.C.
Institution
(Toale, Fitzmaurice, Eaton, Redmond) Department of Thoracic Surgery, Mater
Misericordiae University Hospital, Dublin, Ireland
(Lyne) Department of Cardiology, Blackrock Clinic, Dublin, Ireland
Publisher
NLM (Medline)
Abstract
Atrial fibrillation increases lifetime stroke risk. The left atrial
appendage (LAA) is thought to be the source of embolic strokes in up to
90% of cases, and occlusion of the LAA may be safer than the alternative
of oral anticoagulation. Occlusion devices, such as the AtriClipTM
(AtriCure, Mason, OH, USA) enable safe and reproducible epicardial
clipping of the LAA. A systematic review was performed in May 2018, based
on the Preferred Reporting Items for Systematic Reviews and Meta-analyses
guidelines, using the keyword 'AtriClip'. A total of 68 papers were
identified and reviewed; 11 studies were included. Data including
demographics, medical history intervention(s) performed, periprocedural
outcomes and follow-up were assessed and analysed. A total of 922 patients
were identified. LAA occlusion was achieved in 902 out of 922 patients
(97.8%). No device-related adverse events were reported across the
studies. The reported incidence of stroke or transient ischaemic attack
post-clip placement ranged from 0.2 to 1.5/100 patient-years. Four hundred
and seventy-seven of 798 patients (59.7%) had ceased anticoagulation on
follow-up. The AtriClip device is safe and effective in the management of
patients with atrial fibrillation, either as an adjunct in patients
undergoing cardiac surgery or as a stand-alone thoracoscopic
procedure. Copyright © The Author(s) 2019. Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery. All rights reserved.

<96>
Accession Number
624751005
Title
Effect of physical exercise on weight loss and physical function following
bariatric surgery: A meta-analysis of randomised controlled trials.
Source
BMJ Open. 8 (10) (no pagination), 2018. Article Number: e023208. Date of
Publication: 2018.
Author
Ren Z.-Q.; Lu G.-D.; Zhang T.-Z.; Xu Q.
Institution
(Ren, Zhang, Xu) School of Nursing, Nanjing Medical University, Nanjing,
China
(Lu) Department of Interventional Radiology, First Affiliated Hospital of
Nanjing Medical University, Nanjing, China
Publisher
BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com)
Abstract
Objectives We performed a meta-analysis of all of the available randomised
controlled trials (RCTs) to investigate whether physical exercise
contributes to weight loss or physical function improvement in adults
receiving bariatric surgery. Methods We searched PubMed, Embase, the
Cochrane Library, OVID and the CINAHL up through May 2018. RCTs that
assigned adults with obesity to either an exercise training group or a
no-exercise group after bariatric surgery were included. The primary
outcomes were weight loss and physical function. Study bias was assessed
using the Cochrane risk of bias tool, and the quality of evidence was
assessed using GRADEpro. Results A total of eight studies met the
inclusion criteria (n=347 participants). Most of the studies carried a low
risk of bias due to randomisation and blinding. Compared with those
without exercise intervention after surgery, patients engaging in physical
exercise were associated with greater weight loss (weighted mean
difference (WMD) -1.94 kg; 95% CI -3.18 to -0.69; n=8) and longer 6 min
walk distance (6MWD; WMD29.67 m; 95% CI 25.97 to 33.37; n=2) during
follow-up. By subgroup analyses, the additional weight loss in exercise
group was related to the starting time and type of exercise: patients
engaging in exercise 1 year or more after surgery and patients received
aerobic-resistance exercise experienced more weight loss. Besides,
patients in exercise training group also had lower systolic blood pressure
and resting heart rate after surgery. The quality of evidence for these
outcomes was moderate to very low. Conclusions Physical exercise after
bariatric surgery provides 1.94 kg additional weight loss and 29.67 m
longer 6MWD compared with surgery alone. Moreover, engaging in exercise 1
year or more after surgery, and a combined aerobic and resistance training
programme may result in greater weight loss. Copyright © 2018
Author(s) (or their employer(s)).

<97>
Accession Number
629698186
Title
Mini-extracorporeal circulation surgery produces less inflammation than
off-pump coronary surgery.
Source
European journal of cardio-thoracic surgery : official journal of the
European Association for Cardio-thoracic Surgery. (no pagination), 2019.
Date of Publication: 25 Oct 2019.
Author
Permanyer E.; Munoz-Guijosa C.; Padro J.-M.; Ginel A.; Montiel J.;
Sanchez-Quesada J.L.; Vila L.; Camacho M.
Institution
(Permanyer) Department of Cardiac Surgery, Barcelona, Spain
(Permanyer, Padro, Ginel, Montiel) Department of Cardiac Surgery, Hospital
de la Santa Creu i Sant Pau, Research Institute Hospital Sant Pau, IIB
Sant Pau, Barcelona, Spain
(Munoz-Guijosa) Department of Cardiac Surgery, University Hospital Germans
Trias i Pujol, Badalona, Spain
(Sanchez-Quesada) Cardiovascular Research Group, CIBERDEM, Research
Institute Hospital Sant Pau, IIB Sant Pau, Barcelona, Spain
(Vila, Camacho) Laboratory of Angiology, Vascular Biology and
Inflammation, Research Institute Hospital Sant Pau, IIB Sant Pau,
Barcelona, Spain
(Camacho) Genomics of Complex Diseases, Research Institute Hospital Sant
Pau, IIB Sant Pau, Barcelona, Spain
Publisher
NLM (Medline)
Abstract
OBJECTIVES: Both off-pump coronary artery bypass grafting surgery (OPCABG)
and mini-extracorporeal circulation (MECC) have been associated with lower
morbidity and mortality and less inflammation than conventional
cardiopulmonary bypass. However, studies comparing the 2 techniques are
scarce and the results are controversial. We compared the clinical
outcomes and inflammatory response of low-risk patients undergoing
coronary bypass grafting with MECC versus OPCABG. METHOD(S): We
conducted a prospective, randomized study in patients undergoing coronary
heart surgery. Two hundred and thirty consecutive low-risk patients were
randomly assigned to either receive OPCABG (n=117) or MECC (n=113).
Clinical outcomes and postoperative biochemical results were analysed in
both groups. We also analysed 19 circulating inflammatory markers in a
subgroup of 40 patients at 4 perioperative time points. The area under the
curve for each marker was calculated to monitor differences in the
inflammatory response. RESULT(S): No significant differences were
found between groups regarding perioperative clinical complications and no
deaths occurred during the trial. Plasma levels in 9 of the 19
inflammatory markers were undetectable or showed no temporal variation, 3
were higher in the MECC group [interleukin (IL)-10, macrophage
inflammatory protein-1beta and epidermal growth factor] and 7 were higher
in the OPCABG group (growth regulator oncogene, IL-6, IL-8, soluble CD40
ligand, monocyte chemoattractant protein-1, monocyte chemoattractant
protein-3 and tumour necrosis factor-alpha). Differences in 2
proinflammatory cytokines, IL-6 and monocyte chemoattractant protein 1,
between the 2 surgical procedures were statistically significant.
 CONCLUSION(S): No clinical differences were observed between in
low-risk patients undergoing MECC or OPCABG surgery, but OPCABG was
associated with an increased release of proinflammatory cytokines compared
with MECC. Studies in larger cohorts and in patients at higher risk are
needed to confirm these findings. CLINICAL TRIAL REGISTRATION NUMBER:
NCT02118025. Copyright © The Author(s) 2019. Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery. All rights reserved.

<98>
Accession Number
629697730
Title
Protocol for a multi-centered, stepped wedge, cluster randomized
controlled trial of the de-adoption of oral chlorhexidine prophylaxis and
implementation of an oral care bundle for mechanically ventilated
critically ill patients: the CHORAL study.
Source
Trials. 20 (1) (pp 603), 2019. Date of Publication: 24 Oct 2019.
Author
Dale C.M.; Rose L.; Carbone S.; Smith O.M.; Burry L.; Fan E.; Amaral
A.C.K.-B.; McCredie V.A.; Pinto R.; Quinonez C.R.; Sutherland S.; Scales
D.C.; Cuthbertson B.H.
Institution
(Dale, Rose, Carbone, Smith) Lawrence S. Bloomberg Faculty of Nursing,
University of Toronto, Toronto, Canada
(Dale) Trauma, Emergency and Critical Care, Sunnybrook Health Sciences
Centre, Toronto, Canada
(Dale, Rose, Amaral, Scales, Cuthbertson) Sunnybrook Research Institute,
Toronto, Canada
(Rose, Amaral, Pinto, Scales, Cuthbertson) Department of Critical Care
Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada
(Rose) Florence Nightingale Faculty of Nursing, King's College, London,
United Kingdom
(Smith) Department of Critical Care, St. Michael's Hospital, Toronto,
Canada
(Smith) Li Ka Shing Knowledge Institute, Toronto, Canada
(Burry) Department of Pharmacy, Mount Sinai Hospital, Toronto, Canada
(Burry) Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto,
Canada
(Burry, Fan, Amaral, McCredie, Scales, Cuthbertson) Interdepartmental
Division of Critical Care Medicine, University of Toronto, Toronto, Canada
(Fan, McCredie) Department of Medicine, University Health Network,
Toronto, Canada
(Quinonez) Faculty of Dentistry, University of Toronto, Toronto, Canada
(Sutherland) Department of Dentistry, Sunnybrook Health Sciences Centre,
Toronto, Canada
Publisher
NLM (Medline)
Abstract
BACKGROUND: Routine application of chlorhexidine oral rinse is recommended
to reduce risk of ventilator-associated pneumonia (VAP) in mechanically
ventilated patients. Recent reappraisal of the evidence from two
meta-analyses suggests chlorhexidine may cause excess mortality in
non-cardiac surgery patients and does not reduce VAP. Mechanisms for
possible excess mortality are unclear. The CHORAL study will evaluate the
impact of de-adopting chlorhexidine and implementing an oral care bundle
(excluding chlorhexidine) on mortality, infection-related
ventilator-associated complications (IVACs), and oral health status.
 METHOD(S): The CHORAL study is a stepped wedge, cluster randomized
controlled trial in six academic intensive care units (ICUs) in Toronto,
Canada. Clusters (ICU) will be randomly allocated to six sequential steps
over a 14-month period to de-adopt oral chlorhexidine and implement a
standardized oral care bundle (oral assessment, tooth brushing,
moisturization, and secretion removal). On study commencement, all
clusters begin with a control period in which the standard of care is oral
chlorhexidine. Clusters then begin crossover from control to intervention
every 2 months according to the randomization schedule. Participants
include all mechanically ventilated adults eligible to receive the
standardized oral care bundle. The primary outcome is ICU mortality;
secondary outcomes are IVACs and oral health status. We will determine
demographics, antibiotic usage, mortality, and IVAC rates from a validated
local ICU clinical registry. With six clusters and 50 ventilated patients
on average each month per cluster, we estimate that 4200 patients provide
80% power after accounting for intracluster correlation to detect an
absolute reduction in mortality of 5.5%. We will analyze our primary
outcome of mortality using a generalized linear mixed model adjusting for
time to account for secular trends. We will conduct a process evaluation
to determine intervention fidelity and to inform interpretation of the
trial results. DISCUSSION: The CHORAL study will inform understanding of
the effectiveness of de-adoption of oral chlorhexidine and implementation
of a standardized oral care bundle for decreasing ICU mortality and IVAC
rates while improving oral health status. Our process evaluation will
inform clinicians and decision makers about intervention delivery to
support future de-adoption if justified by trial results. TRIAL
REGISTRATION: ClinicalTrials.gov, NCT03382730 . Registered on December 26,
2017.

<99>
Accession Number
629696135
Title
Evaluation de l'hypercapnie induite par hyperoxie chez des patients obeses
apres une chirurgie cardiaque: comparaison avec devis croise d'une
administration d'oxygene conservatrice vs liberale, Evaluation of
hyperoxia-induced hypercapnia in obese patients after cardiac surgery: a
randomized crossover comparison of conservative and liberal oxygen
administration.
Source
Canadian journal of anaesthesia = Journal canadien d'anesthesie. (no
pagination), 2019. Date of Publication: 24 Oct 2019.
Author
Denault M.-H.; Ruel C.; Simon M.; Bouchard P.-A.; Simard S.; Lellouche F.
Institution
(Denault, Ruel, Simon, Bouchard, Simard, Lellouche) Institut universitaire
de cardiologie et de pneumologie de Quebec - Universite Laval Research
Center, QC, 2725 Chemin Ste-Foy, QC G1V 4G5, Canada
Publisher
NLM (Medline)

<100>
Accession Number
629690599
Title
Prevalence and patterns of cognitive impairment in acute coronary syndrome
patients: A systematic review.
Source
European journal of preventive cardiology. (pp 2047487319878945), 2019.
Date of Publication: 24 Oct 2019.
Author
Zhao E.; Lowres N.; Woolaston A.; Naismith S.L.; Gallagher R.
Institution
(Zhao, Lowres, Naismith, Gallagher) Charles Perkins Centre, University of
Sydney, Australia
(Zhao, Woolaston) Sydney Nursing School, University of Sydney, Australia
(Lowres, Gallagher) Stroke Prevention, Heart Research Institute, Sydney,
Australia
(Naismith) Healthy Brain Ageing Program, Brain and Mind Centre, University
of Sydney, Australia
Publisher
NLM (Medline)
Abstract
BACKGROUND: Minimising risk factors through secondary prevention behaviour
is challenging for patients following an acute coronary syndrome.
Cognitive impairment can potentially make these changes more difficult.
However, cognitive impairment prevalence in acute coronary syndrome
patients is poorly understood. DESIGN: This study was based on a
systematic review. METHOD(S): A systematic review was conducted of
PubMed, Medline, PsycINFO and Cochrane databases up to March 2019, to
identify studies reporting the prevalence of cognitive impairment in acute
coronary syndrome patients. Predefined inclusion criteria were specified,
including use of a validated cognitive impairment screening tool. Studies
were excluded if patients had diagnosed dementia or coronary artery bypass
graft surgery. Strengthening The Reporting of Observational Studies in
Epidemiology and Cochrane Risk of Bias tools were used to assess quality.
 RESULT(S): From 747 potential studies, nine were included. The total
sample size was 6457 (range 53-2174), mean age range was 51.3-77.4 years,
and range of proportions of males was 57-100%. Reported cognitive
impairment prevalence rates varied substantially (9-85%) with no clear
pattern over time. From the two studies which examined domains, verbal
fluency, memory and language were affected the most. Meta-analysis could
not be undertaken due to diverse screening tools (n=9), cut-off scores and
screening timepoints. CONCLUSION(S): Cognitive impairment in acute
coronary syndrome patients is currently poorly described, and likely
affects a substantial number of acute coronary syndrome patients who
remain undetected and have the potential to develop to dementia in the
future. As domains are most affected, this could impact understanding and
retention of health education. Research is needed to accurately determine
the prevalence of cognitive impairment in acute coronary syndrome patients
and create suitable standardised measures and thresholds.

<101>
Accession Number
629692356
Title
Full sternotomy and minimal access approaches for surgical aortic valve
replacement: a multicentre propensity-matched study.
Source
European journal of cardio-thoracic surgery : official journal of the
European Association for Cardio-thoracic Surgery. (no pagination), 2019.
Date of Publication: 24 Oct 2019.
Author
Paparella D.; Malvindi P.G.; Santarpino G.; Moscarelli M.; Guida P.;
Fattouch K.; Margari V.; Martinelli L.; Albertini A.; Speziale G.
Institution
(Paparella, Malvindi, Margari) Department of Cardiac Surgery, Santa Maria
Hospital, GVM Care & Research, Bari, Italy
(Paparella) Department of Emergency and Organ Transplant, University of
Bari Aldo Moro, Bari, Italy
(Santarpino) Department of Cardiac Surgery, Citta di Lecce Hospital, GVM
Care & Research, Lecce, Italy
(Santarpino) Department of Cardiac Surgery, Klinikum Nurnberg, Paracelsus
Medical University, Nuremberg, Germany
(Moscarelli, Speziale) Department of Cardiac Surgery, Anthea Hospital, GVM
Care & Research, Bari, Italy
(Moscarelli, Albertini, Speziale) Department of Cardiac Surgery, Maria
Cecilia Hospital, GVM Care & Research, Cotignola, Italy
(Guida) Maugeri Foundation, Cassano delle Murge, Bari, Italy
(Fattouch) Department of Cardiac Surgery, Maria Eleonora Hospital, GVM
Care & Research, Palermo, Italy
(Martinelli) Department of Cardiac Surgery, ICLAS, GVM Care & Research,
Rapallo, Italy
Publisher
NLM (Medline)
Abstract
OBJECTIVES: Surgical aortic valve replacement (AVR) can be performed via a
full sternotomy or a minimal access approach (mini-AVR). Despite long-term
experience with the procedure, mini-AVR is not routinely adopted. Our goal
was to compare contemporary outcomes of mini-AVR and conventional AVR in a
large multi-institutional national cohort. METHOD(S): A total of 5801
patients from 10 different centres who had a mini-AVR (2851) or AVR (2950)
from 2011 to 2017 were evaluated retrospectively. Standard aortic
prostheses were used in all cases. The use of the minimally invasive
approach has increased over the years. The primary outcome is the
incidence of 30-day deaths following mini-AVR and AVR. Secondary outcomes
are the occurrence of major complications following both procedures.
Propensity-matched comparisons were performed based on the multivariable
logistic regression model. RESULT(S): In the overall population
patients who had AVR had an increased surgical risk based on the
EuroSCORE, and the 30-day mortality rate was higher (1.5% and 2.3% in
mini-AVR and AVR, respectively; P=0.048). Propensity scores identified
2257 patients per group with similar baseline profiles. In the matched
groups, patients who had mini-AVR, despite longer cardiopulmonary bypass
(81+/-32 vs 76+/-28min; P=0.004) and cross-clamp (64+/-24 vs 59+/-21min;
P<=0.001) times, had lower 30-day mortality rates (1.2% vs 2.0%; P=0.036),
reduced low cardiac output (0.8% vs 1.4%; P=0.046) and reduced
postoperative length of stay (9+/-8 vs 10+/-7days; P=0.004). Blood
transfusions (36.4% vs 30.8%; P<=0.001) and atrial fibrillation (26.0% vs
21.5%, P<=0.001) were higher in patients who had the mini-AVR.
 CONCLUSION(S): In a large multi-institutional recent cohort, minimal
access approach aortic valve replacement is associated with reduced 30-day
mortality rates and shorter postoperative lengths of stay compared to
standard sternotomy. A prospective randomized trial is needed to overcome
the possible biases of a retrospective study. Copyright © The
Author(s) 2019. Published by Oxford University Press on behalf of the
European Association for Cardio-Thoracic Surgery. All rights reserved.

<102>
[Use Link to view the full text]
Accession Number
629689102
Title
Prolonged Perioperative Use of Pregabalin and Ketamine to Prevent
Persistent Pain after Cardiac Surgery.
Source
Anesthesiology. 131 (1) (pp 119-131), 2019. Date of Publication: 01 Jul
2019.
Author
Anwar S.; Cooper J.; Rahman J.; Sharma C.; Langford R.
Institution
(Anwar) Department of Perioperative Medicine, Barts Heart Centre, London,
United Kingdom
(Anwar, Cooper) National Institutes of Health Research Biomedical Research
Centre at Barts, London, United Kingdom
(Rahman, Sharma, Langford) Pain and Anaesthesia Research Centre, St.
Bartholomew's Hospital, London, United Kingdom
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
Editor's Perspective What We Already Know about This Topic Cardiac surgery
is associated with a significant rate of chronic postoperative pain Few
proven strategies exist to reduce chronic postoperative pain What This
Article Tells Us That Is New The administration of pregabalin (14 days)
with or without ketamine (2 days) postoperatively reduced the prevalence
of pain at 3 and 6 months Side effects from pregabalin and ketamine
administration were generally mild Background: Persistent postsurgical
pain is common and affects quality of life. The hypothesis was that use of
pregabalin and ketamine would prevent persistent pain after cardiac
surgery. Method(s): This randomized, double-blind, placebo-controlled
trial was undertaken at two cardiac surgery centers in the United Kingdom.
Adults without chronic pain and undergoing any elective cardiac surgery
patients via sternotomy were randomly assigned to receive either usual
care, pregabalin (150 mg preoperatively and twice daily for 14
postoperative days) alone, or pregabalin in combination with a 48-h
postoperative infusion of intravenous ketamine at 0.1 mg . kg-1
. h-1. The primary endpoints were prevalence of clinically
significant pain at 3 and 6 months after surgery, defined as a pain score
on the numeric rating scale of 4 or higher (out of 10) after a functional
assessment of three maximal coughs. The secondary outcomes included acute
pain, opioid use, and safety measures, as well as long-term neuropathic
pain, analgesic requirement, and quality of life. Result(s): In
total, 150 patients were randomized, with 17 withdrawals from treatment
and 2 losses to follow-up but with data analyzed for all participants on
an intention-to-treat basis. The prevalence of pain was lower at 3
postoperative months for pregabalin alone (6% [3 of 50]) and in
combination with ketamine (2% [1 of 50]) compared to the control group
(34% [17 of 50]; odds ratio = 0.126 [0.022 to 0.5], P = 0.0008; and 0.041
[0.0009 to 0.28], P < 0.0001, respectively) and at 6 months for pregabalin
alone (6% [3 of 50]) and in combination with ketamine 0% (0 of 5) compared
to the control group (28% [14 of 50]; odds ratio = 0.167 [0.029 to 0.7], P
= 0.006; and 0.000 [0 to 0.24], P < 0.0001). Diplopia was more common in
both active arms. Conclusion(s): Preoperative administration of 150
mg of pregabalin and postoperative continuation twice daily for 14 days
significantly lowered the prevalence of persistent pain after cardiac
surgery. Copyright © 2019, the American Society of
Anesthesiologists, Inc. Wolters Kluwer Health, Inc.

<103>
Accession Number
629151186
Title
Meta-Analysis for the value of colchicine for the therapy of pericarditis
and of postpericardiotomy syndrome.
Source
BMC Cardiovascular Disorders. 19 (1) (no pagination), 2019. Article
Number: 207. Date of Publication: 02 Sep 2019.
Author
Lutschinger L.L.; Rigopoulos A.G.; Schlattmann P.; Matiakis M.; Sedding
D.; Schulze C.; Noutsias M.
Institution
(Lutschinger, Schulze, Noutsias) Department of Internal Medicine i,
Division of Cardiology, University Hospital Jena, Jena, Germany
(Rigopoulos, Matiakis, Sedding, Noutsias) Mid-German Heart Center,
Department of Internal Medicine III (KIM III), Martin-Luther-University
Halle-Wittenberg, Ernst-Grube-Strasse 40, Halle Saale D-06120, Germany
(Schlattmann) Institute of Medical Statistics, Informatics and Data
Science (IMSID), University Hospital Jena, Jena, Germany
Publisher
BioMed Central Ltd. (E-mail: info@biomedcentral.com)
Abstract
Background: Colchicine has been used as anti-inflammatory agent in
pericardial effusion (PE). We sought to perform a meta-Analysis of
randomized trials assessing the efficacy and safety of colchicine in
patients with pericarditis or postpericardiotomy syndrome (PPS).
 Method(s): In the systematic literature search following the PRISMA
statement, 10 prospective randomized controlled studies with 1981 patients
with an average follow-up duration of 13.6 months were identified.
 Result(s): Colchicine reduced the recurrence rate of pericarditis in
patients with acute and recurrent pericarditis and reduced the incidence
of PPS (RR: 0.57, 95% CI: 0.44-0.74). Additionally, the rate of
rehospitalizations as well as the symptom duration after 72 h was
significantly decreased in pericarditis (RR 0.33; 95% CI 0.18-0.60; and RR
0.43; 95% CI 0.34-0.54; respectively), but not in PPS. Treatment with
colchicine was associated with significantly higher adverse event (AE)
rates (RR 1.42; 95% CI 1.05-1.92), with gastrointestinal intolerance being
the leading AE. The reported number needed to treat (NNT) for the
prevention of recurrent pericarditis ranged between 3 and 5. The reported
NNT for PPS prevention was 10, and the number needed to harm (NNH) was 12,
respectively. Late colchicine administration > 7 days after heart surgery
did not reduce postoperative PE. Conclusion(s): Our meta-Analysis
confirms that colchicine is efficacious and safe for prevention of
recurrent pericarditis and PPS, while it reduces rehospitalizations and
symptom duration in pericarditis. The clinical use of colchicine for the
setting of PPS and postoperative PE after heart surgery should be
investigated in further multicenter RCT. Copyright © 2019 The
Author(s).

<104>
[Use Link to view the full text]
Accession Number
628315378
Title
Meta-analysis of impact of liver disease on mortality after transcatheter
aortic valve implantation.
Source
Journal of Cardiovascular Medicine. 20 (4) (pp 237-244), 2019. Date of
Publication: April 2019.
Author
Takagi H.; Hari Y.; Kawai N.; Kuno T.; Ando T.
Institution
(Takagi, Hari, Kawai) Department of Cardiovascular Surgery, Shizuoka
Medical Center, Shizuoka, Japan
(Takagi, Hari) Department of Cardiovascular Surgery, Kitasato University
School of Medicine, Sagamihara, Japan
(Kuno) Department of Medicine, Mount Sinai Beth Israel Medical Center, New
York, NY, United States
(Ando) Department of Cardiology, Detroit Medical Center, Detroit, MI,
United States
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
Aims To evaluate whether liver disease is associated with increased
mortality after transcatheter aortic valve implantation (TAVI) and whether
TAVI is associated with decreased mortality compared to surgical aortic
valve replacement (SAVR) in patients with liver disease, we performed
meta-analyses of currently available studies. Methods Studies reporting
mortality in TAVI patients with liver disease versus those without liver
disease and mortality after TAVI versus SAVR in patients with liver
disease were eligible to be included. A relative risk (RR) or hazard ratio
of mortality for TAVI patients with versus without liver disease and
mortality for TAVI versus SAVR in patients with liver disease was
extracted from each individual study. Study-specific estimates were
combined in the random-effects model. Results We identified nine studies
of TAVI patients with versus without liver disease and four studies of
TAVI versus SAVR in patients with liver cirrhosis. Pooled analyses
demonstrated no association of liver disease with early
(in-hospital/30-day) mortality (P = 0.28), but a statistically significant
association of liver disease with increases midterm (1 - 2-year) mortality
(hazard ratio 1.87, P < 0.00001) in TAVI patients, and no statistically
significant difference in in-hospital mortality between TAVI and SAVR in
patients with cirrhosis (RR 0.60, P = 0.12). Conclusion There may be no
impact of liver disease on early mortality in TAVI patients, negative
impact of liver disease on mid-term mortality in TAVI patients, and no
difference in in-hospital mortality between TAVI and SAVR in patients with
liver cirrhosis. Copyright © 2019 Italian Federation of
Cardiology - I.F.C. All rights reserved.

<105>
Accession Number
620231205
Title
Health-related quality of life in older patients with acute coronary
syndrome randomised to an invasive or conservative strategy. The After
Eighty randomised controlled trial.
Source
Age and Ageing. 47 (1) (pp 42-47), 2018. Date of Publication: 01 Jan 2018.
Author
Tegn N.; Abdelnoor M.; Aaberge L.; Ranhoff A.H.; Endresen K.; Gjertsen E.;
Skardal R.; Gullestad L.; Bendz B.
Institution
(Tegn, Aaberge, Endresen, Skardal, Gullestad, Bendz) Department of
Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway
(Tegn, Gullestad, Bendz) Faculty of Medicine, University of Oslo, Norway
(Abdelnoor) Centre for Biostatistics and Epidemiology, Oslo University
Hospital, Ulleval, Oslo, Norway
(Ranhoff) Diakonhjemmet Hospital and Department of Clinical Science,
University of Bergen, Bergen, Norway
(Gjertsen) Department of Cardiology, Drammen Hospital, Drammen, Norway
Publisher
Oxford University Press
Abstract
Objective: in the After Eighty study (ClinicalTrials.gov.number,
NCT01255540), patients aged 80 years or more, with non-ST-elevation
myocardial infarction (NSTEMI), and unstable angina pectoris (UAP), were
randomised to either an invasive or conservative management approach. We
sought to compare the effects of these management strategies on health
related quality of life (HRQOL) after 1 year. Method(s): the After
Eighty study was a prospective randomised controlled multicenter trial. In
total, 457 patients aged 80 or over, with NSTEMI or UAP, were randomised
to either an invasive strategy (n = 229, mean age: 84.7 years), involving
early coronary angiography, with immediate evaluation for percutaneous
coronary intervention, coronary artery bypass graft, optimal medical
therapy, or to a conservative strategy (n = 228, mean age: 84.9 years).
The Short Form 36 health survey (SF-36) was used to assess HRQOL at
baseline, and at the 1-year follow-up. Result(s): baseline SF-36
completion was achieved for 208 and 216 patients in the invasive and
conservative groups, respectively. A total of 137 in the invasive group
and 136 patients in the conservative group completed the SF-36 form at
follow-up. When comparing the changes from follow-up to baseline (delta)
no significant changes in quality-of-life scores were observed between the
two strategies in any of the domains, expect for a small but statistically
significant difference in bodily pain. This difference in only one of the
SF-36 subscales may not necessarily be clinically significant.
 Conclusion(s): from baseline to the 1 year follow-up, only minor
differences in change of HRQOL as measured by SF-36 were seen by comparing
an invasive and conservative strategy. Copyright © The Author
2017.

<106>
[Use Link to view the full text]
Accession Number
628563131
Title
Benefit and risk of prolonged DAPT after coronary stenting in women:
Results from the DAPT study.
Source
Circulation: Cardiovascular Interventions. 11 (8) (no pagination), 2018.
Article Number: e005308. Date of Publication: 2018.
Author
Berry N.C.; Kereiakes D.J.; Yeh R.W.; Gabriel Steg P.; Cutlip D.E.; Jacobs
A.K.; Dawn Abbott J.; Hsieh W.-H.; Massaro J.M.; Mauri L.
Institution
(Berry, Mauri) Division of Cardiovascular Medicine, Department of
Cardiovascular Medicine, Brigham and Women's Hospital, 75 Francis St,
Boston, MA 02115, United States
(Berry, Yeh, Cutlip, Mauri) Harvard Medical School, Boston, MA, United
States
(Berry, Yeh, Cutlip, Hsieh, Massaro, Mauri) Baim Institute for Clinical
Research, Boston, MA, United States
(Kereiakes) Christ Hospital Heart and Vascular Center, Lindner Center for
Research and Education, Cincinnati, OH, United States
(Cutlip) Division of Cardiology, Department of Medicine, United States
(Yeh) Smith Center for Outcomes Research in Cardiology, Beth Israel
Deaconess Medical Center, Boston, MA, United States
(Gabriel Steg) Universite Paris-Diderot, Sorbonne Paris Cite, INSERM
Unite-1148, Departement Hospitalo-Universitaire Fibrosis Inflammation
Remodeling, Hopital Bichat, Assistance Publique-Hopitaux de Paris, France
(Gabriel Steg) National Heart and Lung Institute, Institute of
Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial
College, London, United Kingdom
(Massaro) Boston University School of Public Health, MA, United States
(Jacobs) Boston University School of Medicine, Boston, MA, United States
(Dawn Abbott) Rhode Island Hospital, Brown University School of Medicine,
United States
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
BACKGROUND: Women may derive differential benefit from prolonged DAPT
(dual antiplatelet therapy) after coronary stenting than men. We assessed
whether the risks/benefits of prolonged DAPT differ between women and men.
METHODS AND RESULTS: The DAPT study was a randomized double-blind,
placebo-controlled trial comparing continued thienopyridine versus placebo
beyond 12 months after coronary stenting. We compared rates of myocardial
infarction, stent thrombosis, major adverse cardiovascular and
cerebrovascular events, and bleeding by sex and randomized treatment. Of
11648 patients, women (N=2925) were older, with higher prevalence of
diabetes mellitus and lower rates of acute coronary syndrome than men. At
12 to 30 months, women had similar adjusted ischemic and bleeding events
as men. The effects of continued thienopyridine therapy did not differ
significantly by sex for stent thrombosis (women: hazard ratio [HR], 0.54;
95% confidence interval [CI], 0.22-1.36; men: HR, 0.26; 95% CI, 0.15-0.44;
interaction P=0.17), myocardial infarction (women: HR, 0.75; 95% CI,
0.50-1.14; men: HR, 0.46; 95% CI, 0.36-0.60; interaction P=0.052), major
adverse cardiovascular and cerebrovascular events (women: HR, 0.87; 95%
CI, 0.62-1.22; men: HR, 0.70; 95% CI, 0.58-0.85; interaction P=0.26), and
bleeding (women: HR, 1.45; 95% CI, 0.88-2.40; men: HR, 1.78; 95% CI,
1.28-2.49; interaction P=0.50). CONCLUSION(S): Women had similar late
risks of ischemia and bleeding as men after coronary stent
procedures. Copyright © 2018 American Heart Association, Inc.

<107>
Accession Number
620548208
Title
Preoperative factors associated with worsening in health-related quality
of life following coronary artery bypass grafting in the Randomized On/Off
Bypass (ROOBY) trial.
Source
American Heart Journal. 198 (pp 33-38), 2018. Date of Publication: April
2018.
Author
Bishawi M.; Hattler B.; Almassi G.H.; Spertus J.A.; Quin J.A.; Collins
J.F.; Grover F.L.; Shroyer A.L.
Institution
(Bishawi, Shroyer) Northport VA Medical Center, Northport, NY, United
States
(Bishawi) Duke University Medical Center, Durham, NC, United States
(Hattler, Grover, Shroyer) Eastern Colorado Health Care System, Denver VA
Medical Center, Denver, CO, United States
(Hattler, Grover) University of Colorado School of Medicine, Anschutz
Medical Campus, Aurora, CO, United States
(Almassi) Clement J. Zablocki Veterans Affairs (VA) Medical Center,
Milwaukee, WI, United States
(Almassi) Medical College of Wisconsin, Milwaukee, WI, United States
(Spertus) Saint Luke's Mid America Heart Institute and University of
Missouri, Kansas City, MO, United States
(Collins) Cooperative Studies Program Coordinating Center, Veterans
Affairs Medical Center, Point, Perry, MD, United States
(Quin) VA Boston Healthcare System, West Roxbury, MA and Harvard Medical
School, Boston, MA, United States
Publisher
Mosby Inc. (E-mail: customerservice@mosby.com)
Abstract
For advanced coronary disease, coronary artery bypass graft (CABG) surgery
generally improves patients' symptoms and long-term survival.
Unfortunately, some patients experience worse health-related quality of
life (HRQL) after CABG. The objective of this study is to report the
frequency and risk factors associated with 1-year post-CABG HRQL
deterioration. Method(s): From 2002 to 2007, 2203 "Randomized On/Off
Bypass" (ROOBY) trial patients randomly received either off-pump or
on-pump CABG at 18 VA medical centers. Subjects completed both baseline
and 1-year Seattle Angina Questionnaire (SAQ) and the Veterans Rand 36
(VR-36) questionnaires to assess HRQL. Using previously published
criteria, the rates of clinically significant changes were determined for
the SAQ [angina frequency (AF), physical limitation (PL), and quality of
life (QoL)] and VR36 [mental component score (MCS) and physical component
score (PCS)] subscales. Multivariate regression models were then used to
identify pre-CABG patient characteristics associated with worsened 1-year
HRQL status for each subscale. Result(s): Over 80% of patients had an
improvement or no change in SAQ and VR-36 subscale scores 1 year after
CABG. The HRQL scale-specific deterioration rates were 4.5% SAQ-AF, 16.8%
SAQ-PL, 4.9% SAQ-QoL, 19.4% VR36-MCS, and 13.5% VR36-PCS. Predictors of
1-year HRQL deterioration were diabetes and smoking for the SAQ-AF;
diabetes, chronic obstructive pulmonary disease (COPD), and peripheral
vascular disease (PVD) for SAQ-PL; COPD and depression for the SAQ-QoL;
diabetes for VR36-PCS, and history of stroke and depression for VR36-MCS.
The baseline score was an independent predictor for worsening in all the
subscales studied. Conclusion(s): Among VA patients, less than 20%
experienced worse HRQL 1 year after CABG. For patients with low symptom
burden at baseline, diabetes, smoking, depression, PVD, COPD, and a prior
stroke, clinicians should be more cautious in pre-CABG counseling as to
their anticipated HRQL improvements. Copyright © 2018

<108>
Accession Number
620401046
Title
Systematic detection of polyvascular disease combined with aggressive
secondary prevention in patients presenting with severe coronary artery
disease: The randomized AMERICA Study.
Source
International Journal of Cardiology. 254 (pp 36-42), 2018. Date of
Publication: 01 Mar 2018.
Author
Collet J.-P.; Cayla G.; Ennezat P.-V.; Leclercq F.; Cuisset T.; Elhadad
S.; Henry P.; Belle L.; Cohen A.; Silvain J.; Barthelemy O.; Beygui F.;
Diallo A.; Vicaut E.; Montalescot G.
Institution
(Collet, Silvain, Barthelemy, Montalescot) Sorbonne Universite Paris 6,
ACTION Study Group, Institut de Cardiologie Hopital Pitie-Salpetriere
(APHP), INSERM UMRS, Paris 1166, France
(Cayla) ACTION Study Group, Cardiologie, CHU Caremeau, Universite de
Montpellier, Nimes, France
(Ennezat) Cardiologie, Pole Thorax et Vaisseaux, CHU La Tronche, Grenoble,
France
(Leclercq) Cardiologie, Hopital Arnaud de Villeneuve-CHU Montpellier,
France
(Cuisset) Department of Cardiology, CHU Timone and Aix-Marseille Univ,
INSERM UMR1062, INRA UMR1260, Nutrition, Obesity and Risk of Thrombosis,
Faculty of Medicine, Marseille F-13385, France
(Elhadad) Cardiologie, CH de Lagny-Marne la Vallee, Jossigny, France
(Henry) Cardiologie, CHU Lariboisiere (APHP), Paris, France
(Belle) Cardiologie, Centre Hospitalier d'Annecy, France
(Cohen) Cardiologie, CHU Saint-Antoine (APHP), Paris, France
(Beygui) Cardiologie, Hopital de la Cote de Nacre, Caen, France
(Diallo, Vicaut) ACTION Study Group, Unite de Recherche Clinique-Hopital
Lariboisiere (APHP), France and Universite Denis Diderot, Paris, France
Publisher
Elsevier Ireland Ltd
Abstract
Background: The prevalence and associated-risk of asymptomatic multisite
artery disease (MSAD) in high risk coronary patients are unknown. Whether
systematic identification and aggressive management of asymptomatic MSAD
is clinically relevant in high risk coronary patients has not been
evaluated. Method(s): We randomly assigned 521 high risk coronary
patients defined by the presence of three-vessel coronary disease (n =
304) or recent acute coronary syndrome beyond the age of 75 years (n =
215) to either a strategy of systematic detection of asymptomatic MSAD
combined with an aggressive secondary prevention (n = 263) or to a more
conventional strategy based on treatment of coronary artery disease only
with standard of care (n = 258). The primary end point was the time to
first occurrence of death, any organ failure or ischemic event leading to
re-hospitalization through two years of follow-up. Result(s): The
pro-active strategy identified asymptomatic MSAD in 21.7% of patients with
few revascularizations (3.6%); the pro-active pharmacological secondary
prevention was obtained in > 85% of patients and life-style changes in <
60% of patients. At 2-year follow-up, the primary end point occurred in
44.9% of patients in the pro-active group and 43.0% of patients in the
conventional group (HR 1.03; 95% confidence interval [CI], 0.80 to 1.34].
The rate of major bleeding did not differ significantly between groups
(4.6% vs 5.0%; HR, 0.97; 95% CI, 0.40 to 1.91). Conclusion(s): In
high risk coronary patients, there is no apparent benefit of a systematic
detection of asymptomatic extra-coronary atherothrombotic disease and
intensified treatment over a 2-year follow-up period. (Funded by the
Academic Allies in Cardiovascular Trials Initiatives and Organized
Networks and Institut de l'Atherothrombose; AMERICA ClinicalTrials.gov
number, NCT00445835). Copyright © 2017 Elsevier Ireland Ltd

<109>
Accession Number
621200759
Title
Comparative performance of transcatheter aortic valve-in-valve
implantation versus conventional surgical redo aortic valve replacement in
patients with degenerated aortic valve bioprostheses: Systematic review
and meta-analysis.
Source
European Journal of Cardio-thoracic Surgery. 53 (3) (pp 495-504), 2018.
Date of Publication: 01 Mar 2018.
Author
Gozdek M.; Raffa G.M.; Suwalski P.; Kolodziejczak M.; Anisimowicz L.;
Kubica J.; Navarese E.P.; Kowalewski M.
Institution
(Gozdek, Anisimowicz, Kowalewski) Department of Cardiac Surgery,
Cardiovascular Institute, Dr Antoni Jurasz Memorial University Hospital,
Bydgoszcz, Poland
(Raffa) Department for the Treatment and Study of Cardiothoracic Diseases
and Cardiothoracic Transplantation, IRCCS-ISMETT (Istituto Mediterraneo
per I Trapianti e Terapie ad alta specializzazione), Palermo, Italy
(Suwalski) Clinical Department of Cardiac Surgery, Central Clinical
Hospital of the Ministry of Interior, Warsaw, Poland
(Suwalski) Pulaski University of Technology and Humanities, Radom, Poland
(Kolodziejczak) Cardiovascular Institute, Collegium Medicum in Bydgoszcz,
University of Nicolaus Copernicus, Torun, Poland
(Kubica) Department of Cardiology and Internal Medicine, Cardiovascular
Institute, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz,
Poland
(Navarese) Inova Center for Thrombosis Research and Drug Development,
Inova Heart and Vascular Institute, Fairfax, VA, United States
Publisher
European Association for Cardio-Thoracic Surgery (E-mail:
info@eacts.co.uk)
Abstract
The objective of this report was to directly compare, by means of a
systematic review and meta-analysis, redo surgical aortic valve
replacement (re-sAVR) with valve-in-valve transcatheter aortic valve
implantation (ViV TAVI) for patients with failed degenerated aortic
bioprostheses. Multiple databases were screened for all available reports
comparing ViV TAVI with re-sAVR in patients with failing degenerated
aortic bioprostheses. The primary outcome was all-cause mortality
determined from the longest available survival data. Five observational
studies (n = 342) were included in the meta-analysis; patients in the ViV
TAVI group were older and had a higher baseline risk compared to those in
the re-sAVR group. Although there was no statistical difference in
procedural mortality [risk ratio (RR) 0.74, 95% confidence interval (CI)
0.18-2.97; P = 0.67], 30-day mortality (RR 1.29, 95% CI 0.44-3.78; P =
0.64) and cardiovascular mortality (RR 0.91, 95% CI 0.30-2.70; P = 0.86)
at a mean follow-up period of 18 months, cumulative survival analysis
favoured surgery with borderline statistical significance (ViV TAVI versus
re-sAVR: hazard ratio 1.91, 95% CI 1.03-3.57; P = 0.039). ViV TAVI was
associated with a significantly lower rate of permanent pacemaker
implantations (RR 0.37, 95% CI 0.20-0.68; P = 0.002) and shorter intensive
care unit (P < 0.001) and hospital stays (P = 0.020). In contrast, re-sAVR
offered superior echocardiographic outcomes: lower incidence of
patient-prosthesis mismatch (P = 0.008), fewer paravalvular leaks (P =
0.023) and lower mean postoperative aortic valve gradients in the
prespecified analysis (P = 0.017). The ViV TAVI approach is a safe and
feasible alternative to re-sAVR that may offer an effective, less invasive
treatment for patients with failed surgical aortic valve bioprostheses who
are inoperable or at high risk. Re-sAVR should remain the standard of
care, particularly in the low-risk population, because it offers superior
haemodynamic outcomes with low mortality rates. Copyright © The
Author 2017. Published by Oxford University Press on behalf of the
European Association for Cardio-Thoracic Surgery. All rights reserved.

<110>
Accession Number
623664113
Title
Long-term use of carvedilol in patients with ST-segment elevation
myocardial infarction treated with primary percutaneous coronary
intervention.
Source
PLoS ONE. 13 (8) (no pagination), 2018. Article Number: e0199347. Date of
Publication: August 2018.
Author
Watanabe H.; Ozasa N.; Morimoto T.; Shiomi H.; Bingyuan B.; Suwa S.;
Nakagawa Y.; Izumi C.; Kadota K.; Ikeguchi S.; Hibi K.; Furukawa Y.; Kaji
S.; Suzuki T.; Akao M.; Inada T.; Hayashi Y.; Nanasato M.; Okutsu M.;
Kametani R.; Sone T.; Sugimura Y.; Kawai K.; Abe M.; Kaneko H.; Nakamura
S.; Kimura T.
Institution
(Watanabe, Ozasa, Shiomi, Bingyuan, Kimura) Department of Cardiovascular
Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
(Morimoto) Department of Clinical Epidemiology, Hyogo College of Medicine,
Hyogo, Japan
(Suwa) Division of Cardiology, Juntendo University Shizuoka Hospital,
Izunokuni, Japan
(Nakagawa, Izumi) Division of Cardiology, Tenri Hospital, Nara, Japan
(Kadota) Division of Cardiology, Kurashiki Central Hospital, Kurashiki,
Japan
(Ikeguchi) Division of cardiology, Shiga General Hospital, Moriyama, Japan
(Hibi) Division of Cardiology, Yokohama City University Medical Center,
Yokohama, Japan
(Furukawa, Kaji) Division of Cardiology, Kobe City Medical Center General
Hospital, Kobe, Japan
(Suzuki) Division of Cardiology, Toyohashi Heart Center, Toyohashi, Japan
(Akao) Department of Cardiology, National Hospital Organization Kyoto
Medical Center, Kyoto, Japan
(Inada) Cardiovascular Center, Osaka Red Cross Hospital, Osaka, Japan
(Hayashi) Division of Cardiology, Tsuchiya General Hospital, Hiroshima,
Japan
(Nanasato) Cardiovascular Center, Nagoya Daini Red Cross Hospital, Nagoya,
Japan
(Okutsu) Division of Cardiology, Nozaki Tokushukai Hospital, Osaka, Japan
(Kametani) Division of Cardiology, Nagoya Tokushukai General Hospital,
Kasugai, Japan
(Sone) Division of Cardiology, Ogaki Municipal Hospital, Ogaki, Japan
(Sugimura) Division of Cardiology, Kawakita General Hospital, Tokyo, Japan
(Kawai) Division of Cardiology, Chikamori Hospital, Kochi, Japan
(Abe) Division of Cardiology, Yotsuba Circulation Clinic, Matsuyama, Japan
(Kaneko) Division of Cardiology, Hoshi General Hospital, Koriyama, Japan
(Nakamura) Division of Cardiology, New Tokyo Hospital, Chiba, Japan
Publisher
Public Library of Science (E-mail: plos@plos.org)
Abstract
Background Despite its recommendation by the current guidelines, the role
of long-term oral beta-blocker therapy has never been evaluated by
randomized trials in uncomplicated ST-segment elevation myocardial
infarction (STEMI) patients without heart failure, left ventricular
dysfunction or ventricular arrhythmia who underwent primary percutaneous
coronary intervention (PCI). Methods and results In a multi-center,
open-label, randomized controlled trial, STEMI patients with successful
primary PCI within 24 hours from the onset and with left ventricular
ejection fraction (LVEF) 40% were randomly assigned in a 1-to-1 fashion
either to the carvedilol group or to the no beta-blocker group within 7
days after primary PCI. The primary endpoint is a composite of all-cause
death, myocardial infarction, hospitalization for heart failure, and
hospitalization for acute coronary syndrome. Between August 2010 and May
2014, 801 patients were randomly assigned to the carvedilol group (N =
399) or the no beta-blocker group (N = 402) at 67 centers in Japan. The
carvedilol dose was up-titrated from 3.4+/-2.1 mg at baseline to 6.3
+/-4.3 mg at 1-year. During median follow-up of 3.9 years with 96.4%
follow-up, the cumulative 3-year incidences of both the primary endpoint
and any coronary revascularization were not significantly different
between the carvedilol and no beta-blocker groups (6.8% and 7.9%, P =
0.20, and 20.3% and 17.7%, P = 0.65, respectively). There also was no
significant difference in LVEF at 1-year between the 2 groups (60.9+/-8.4%
and 59.6+/-8.8%, P = 0.06) Conclusion Long-term carvedilol therapy added
on the contemporary evidence-based medications did not seem beneficial in
selected STEMI patients treated with primary PCI. Trial registration
CAPITAL-RCT (Carvedilol Post-Intervention Long-Term Administration in
Large-scale Randomized Controlled Trial) ClinicalTrials.gov.number, NCT
01155635. Copyright © 2018 Watanabe et al. This is an open access
article distributed under the terms of the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in
any medium, provided the original author and source are credited.

<111>
Accession Number
619331470
Title
Impact of age, sex, therapeutic intent, race and severity of advanced
heart failure on short-term principal outcomes in the MOMENTUM 3 trial.
Source
Journal of Heart and Lung Transplantation. 37 (1) (pp 7-14), 2018. Date of
Publication: January 2018.
Author
Goldstein D.J.; Mehra M.R.; Naka Y.; Salerno C.; Uriel N.; Dean D.; Itoh
A.; Pagani F.D.; Skipper E.R.; Bhat G.; Raval N.; Bruckner B.A.; Estep
J.D.; Cogswell R.; Milano C.; Fendelander L.; O'Connell J.B.; Cleveland J.
Institution
(Goldstein) Department of Cardiothoracic Surgery, Montefiore Medical
Center, Bronx, New York, United States
(Mehra) Brigham and Women's Hospital Heart and Vascular Center and Harvard
Medical School, Boston, Massachusetts, United States
(Naka) Division of Cardiothoracic Surgery, Columbia University College of
Physicians & Surgeons, New York, New York, United States
(Salerno) Department of Cardiothoracic Surgery, St. Vincent Heart Center,
Indianapolis, Indiana, United States
(Uriel) Section of Cardiology, University of Chicago School of Medicine
and Medical Center, Chicago, Illinois, United States
(Dean) Division of Cardiothoracic Surgery, Piedmont Heart Institute,
Atlanta, Georgia, United States
(Itoh) Division of Cardiothoracic Surgery, Washington University School of
Medicine, St. Louis, Missouri, United States
(Pagani) Department of Cardiac Surgery, University of Michigan Health
System, Ann Arbor, Michigan, United States
(Skipper) Department of Thoracic and Cardiovascular Surgery, Danger Heart
and Vascular Institute, Carolinas Medical Center, Charlotte, North
Carolina, United States
(Bhat) Division of Cardiology, Advocate Christ Medical Center, Oak Lawn,
Illinois, United States
(Raval) Cardiology Department, Florida Hospital, Orlando, Florida, United
States
(Bruckner, Estep) Department of Cardiology, Houston Methodist Hospital,
Houston, Texas, United States
(Cogswell) Division of Cardiology, University of Minnesota, Minneapolis,
Minnesota, United States
(Milano) Department of Surgery, Duke Heart Center, Duke University,
Durham, North Carolina, United States
(Fendelander, O'Connell) Abbott, Chicago, Illinois, United States
(Cleveland) Division of Cardiothoracic Surgery, University of Colorado
School of Medicine, Aurora, Colorado, United States
Publisher
Elsevier USA
Abstract
Background Primary outcomes analysis of the Multicenter Study of MagLev
Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM
3) trial short-term cohort demonstrated a higher survival rate free of
debilitating stroke and reoperation to replace/remove the device (primary
end-point) in patients receiving the HeartMate 3 (HM3) compared with the
HeartMate (HMII). In this study we sought to evaluate the individual and
interactive effects of pre-specified patient subgroups (age, sex, race,
therapeutic intent [bridge to transplant/bridge to candidacy/destination
therapy] and severity of illness) on primary end-point outcomes in
MOMENTUM 3 patients implanted with HM3 and HMII devices. Methods Cox
proportional hazard models were used to analyze patients enrolled in the
"as-treated cohort" (n = 289) of the MOMENTUM 3 trial to: (1) determine
interaction of various subgroups on primary end-point outcomes; and (2)
identify independent variables associated with primary end-point success.
Results Baseline characteristics were well balanced among HM3 (n = 151)
and HMII (n = 138) cohorts. No significant interaction between the
sub-groups on primary end-point outcomes was observed. Cox multivariable
modeling identified age (<=65 years vs >65 years, hazard ratio 0.42 [95%
confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII,
hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be
independent predictors of primary outcomes success. After adjusting for
age, no significant impact of sex, race, therapeutic intent and INTERMACS
profiles on primary outcomes were observed. Conclusions This analysis of
MOMENTUM 3 suggests that younger age (<=65 years) at implant and pump
choice are associated with a greater likelihood of primary end-point
success. These findings further suggest that characterization of
therapeutic intent into discrete bridge-to-transplant and destination
therapy categories offers no clear clinical advantage, and should ideally
be abandoned. Copyright © 2018 The Authors

<112>
Accession Number
621224479
Title
Rationale, design, and baseline characteristics of the CArdiovascular
safety and Renal Microvascular outcomE study with LINAgliptin
(CARMELINA): A randomized, double-blind, placebo-controlled
clinical trial in patients with type 2 diabetes and high cardio-renal
risk.
Source
Cardiovascular Diabetology. 17 (1) (no pagination), 2018. Article Number:
39. Date of Publication: 14 Mar 2018.
Author
Rosenstock J.; Perkovic V.; Alexander J.H.; Cooper M.E.; Marx N.; Pencina
M.J.; Toto R.D.; Wanner C.; Zinman B.; Baanstra D.; Pfarr E.; Mattheus M.;
Broedl U.C.; Woerle H.-J.; George J.T.; von Eynatten M.; McGuire D.K.
Institution
(Rosenstock) Dallas Diabetes Research Center at Medical City, 7777 Forest
Lane, Suite C-685, Dallas, TX 75230, United States
(Perkovic) University of New South Wales, The George Institute for Global
Health, Faculty of Medicine, Sydney, NSW, Australia
(Alexander, Pencina) Duke Clinical Research Institute, Duke Health,
Durham, NC, United States
(Cooper) Monash University, Head of Diabetes, Melbourne, VIC, Australia
(Marx) RWTH Aachen University, Department of Internal Medicine I,
University Hospital Aachen, Aachen, Germany
(Toto) University of Texas Southwestern Medical Center, Dallas, TX, United
States
(Wanner) Wurzburg Univ Clinic, Dept of Medicine, Wurzburg, Germany
(Zinman) Mount Sinai Hospital, Lunenfeld-Tanenbaum Research Institute,
Toronto, Canada
(Zinman) University of Toronto, Toronto, Canada
(Baanstra) Boehringer Ingelheim bv, Alkmaar, Netherlands
(Pfarr, Mattheus, Broedl, George, von Eynatten) Boehringer Ingelheim
Pharma GmbH and Co. KG, Ingelheim, Germany
(Woerle) Ulm University, Ulm, Germany
(McGuire) University of Texas Southwestern Medical Center, Division of
Cardiology, Department of Internal Medicine, Dallas, TX, United States
Publisher
BioMed Central Ltd. (E-mail: info@biomedcentral.com)
Abstract
Background: Cardiovascular (CV) outcome trials in type 2 diabetes (T2D)
have underrepresented patients with chronic kidney disease (CKD), leading
to uncertainty regarding their kidney efficacy and safety. The
CARMELINA trial aims to evaluate the effects of linagliptin, a
DPP-4 inhibitor, on both CV and kidney outcomes in a study population
enriched for cardio-renal risk. Method(s): CARMELINA is a
randomized, double-blind, placebo-controlled clinical trial conducted in
27 countries in T2D patients at high risk of CV and/or kidney events.
Participants with evidence of CKD with or without CV disease and HbA1c
6.5-10.0% (48-86 mmol/mol) were randomized 1:1 to receive linagliptin once
daily or matching placebo, added to standard of care adjusted according to
local guidelines. The primary outcome is time to first occurrence of CV
death, non-fatal myocardial infarction, or non-fatal stroke. The key
secondary outcome is a composite of time to first sustained occurrence of
end-stage kidney disease, >= 40% decrease in estimated glomerular
filtration rate (eGFR) from baseline, or renal death. CV and kidney events
are prospectively adjudicated by independent, blinded clinical event
committees. CARMELINA was designed to continue until at least
611 participants had confirmed primary outcome events. Assuming a hazard
ratio of 1.0, this provides 90% power to demonstrate non-inferiority of
linagliptin versus placebo within the pre-specified non-inferiority margin
of 1.3 at a one-sided alpha-level of 2.5%. If non-inferiority of
linagliptin for the primary outcome is demonstrated, then its superiority
for both the primary outcome and the key secondary outcome will be
investigated with a sequentially rejective multiple test procedure.
 Result(s): Between July 2013 and August 2016, 6980 patients were
randomized and took >= 1 dose of study drug (40.6, 33.1, 16.9, and 9.4%
from Europe, South America, North America, and Asia, respectively). At
baseline, mean +/- SD age was 65.8 +/- 9.1 years, HbA1c 7.9 +/- 1.0%, BMI
31.3 +/- 5.3 kg/m2, and eGFR 55 +/- 25 mL/min/1.73
m2. A total of 5148 patients (73.8%) had prevalent kidney
disease (defined as eGFR < 60 mL/min/1.73 m2 or
macroalbuminuria [albumin-to-creatinine ratio > 300 mg/g]) and 3990
patients (57.2%) had established CV disease with increased albuminuria;
these characteristics were not mutually exclusive. Microalbuminuria (n =
2896 [41.5%]) and macroalbuminuria (n = 2691 [38.6%]) were common.
 Conclusion(s): CARMELINA will add important information
regarding the CV and kidney disease clinical profile of linagliptin by
including an understudied, vulnerable cohort of patients with T2D at
highest cardio-renal risk. Copyright © 2018 The Author(s).

<113>
Accession Number
622801072
Title
Closure, anticoagulation, or antiplatelet therapy for cryptogenic stroke
with patent foramen ovale: Systematic review of randomized trials,
sequential meta-analysis, and new insights from the CLOSE study.
Source
Journal of the American Heart Association. 7 (12) (no pagination), 2018.
Article Number: e008356. Date of Publication: 01 Jun 2018.
Author
Chatellier G.; Mas J.-L.; Turc G.; Domigo V.; Guiraud V.; Touze E.; Calvet
D.; Varenne O.; Menacer S.; Sroussi M.; Nana A.; Cabanes L.; Guillon B.;
Schunck A.; Herisson F.; De Gaalon S.; Sevin M.; Langlard J.-M.; Piriou
N.; Jaafar P.; Massardier E.; d'Here B.; Stepowski D.; Bauer F.; Hosseini
H.; Teiger E.; Duval A.-M.; Lim P.; Mechtouff L.; Nighoghossian N.; Derex
L.; Cho T.; Rossi R.; Rioufol G.; Derumeaux G.; Thibaut H.; Barthelet M.;
Thivolet S.; Arquizan C.; Mourand I.; Sportouch C.; Cade S.; Cransac F.;
Giroud M.; Bejot Y.; Eicher J.-C.; L'Huillier I.; Vuillier F.; Moulin T.;
Meneveau N.; Chopard R.; Descotes-Genon V.; Detante O.; Garambois K.;
Bertrand B.; Saunier C.; Mazighi M.; Juliard E.J.-M.; Brochet E.; Guidoux
C.; Meseguer D.; Cabrejo L.; Lavallee P.; Amarenco P.; Messika-Zeitoun;
Lepage L.; Bugnicourt J.-M.; Canaple S.; Lamy C.; Godefroy O.; Leborgne
L.; Guillaumont M.-P.; Trojette F.; Malaquin D.; Vaduva C.; Couvreur G.;
Golfier V.; Plurien F.; Taldir G.; Lucas C.; Cordonnier C.; Henon H.;
Dumont F.; Dequatre-Ponchelle N.; Leys D.; Godart F.; Richardson M.; Polge
A.-S.; Montaigne D.; Coisne A.; Sibon I.; Rouanet F.; Renou P.; Thambo
J.-B.; Reant P.; Laffite S.; Roudaut R.; Garnier P.; Comtet C.; Delsart
D.; Ferrier A.; Bourgois N.; Clavelou P.; Rouhart F.; Timsit S.; Le Cadet
E.; Tirel A.; Mocquard Y.; Guerin P.; Jobic Y.; Le Ven F.; Pouliquen
M.-C.; Milandre L.; Robinet-Borgomano E.; Laksiri N.; Rey C.; Fraisse A.;
Habib G.; Chalvignac V.; Thuny F.; Sablot D.; Runavot G.; Piot C.; Targosz
F.; Chopat P.; Sultan P.; Lacour C.; Richard S.; Ducrocq X.; Marcon F.;
Selton-Suty M.C.; Huttin O.; Bruandet M.; Zuber M.; Tamazyan R.; Antakly
Y.; Garcon P.; Serfaty J.; Favrole P.; Dubois-Rande J.-L.; Hammoudi N.;
Pinel J.-F.; Schleich J.-M.; Donal E.; Lelong B.; Chabanne C.; Viader F.;
Apoil M.; Cogez J.; Labombarda F.; Saloux E.; Reiner P.; Buffon F.; Baudet
M.; Logeart D.; Lefebvre C.; Bataille M.; Godard F.; Biausque F.; Lefetz
Y.; Clement-Dupont M.; Weimar C.; Zegarac V.; Schmitz T.; Plicht B.;
Eissmann M.; Mahabadi A.; Obadia M.; Aubry P.; Iglesias Benyounes N.;
Macian F.; Lusson J.-R.; Darodes N.; Tanguy B.; Mohty D.; Vuillemet F.;
Onea R.; Greciano S.; Roth O.; Neau J.-P.; Quillet L.; Christiaens L.;
Saudeau D.; Patat F.; Singer O.; Fichtlscherer S.; Pico F.; Juliard J.-M.;
Charbonnel C.
Institution
(Turc, Calvet, Mas) Department of Neurology, Hopital Sainte-Anne, Paris,
France
(Turc, Calvet, Sroussi, Chatellier, Mas) Universite Paris Descartes,
Sorbonne Paris Cite, Paris, France
(Turc, Calvet, Mas) INSERM U894, Paris, France
(Turc, Calvet, Mas) DHU Neurovasc, Paris, France
(Guerin) Department of Cardiology, INSERM UMR 915, Institut du Thorax,
Nantes, France
(Guerin) Institut du Thorax, Centre Hospitalier Universitaire de Nantes,
Nantes, France
(Sroussi) Department of Cardiology, Cochin Hospital, India
(Chatellier) Epidemiology and Clinical Research Unit, Georges Pompidou
European Hospital, France
(Chatellier) APHP, Paris, France
(Chatellier) INSERM CIC 1418, Paris, France
(Mas, Turc, Domigo, Guiraud, Touze, Calvet, Lamy, Teiger, Juliard,
Dubois-Rande, Aubry, Varenne, Menacer, Sroussi, Nana, Cabanes) Hopital
Sainte-Anne, Paris, France
(Guillon, Schunck, Herisson, De Gaalon, Sevin, Guerin, Langlard, Piriou,
Jaafar) Hopital Laennec, Nantes, France
(Massardier, Juliard, Aubry, d'Here, Stepowski, Bauer) CHU Rouen, France
(Hosseini, Dubois-Rande, Teiger, Duval, Lim) Hopital Henri Mondor,
Creteil, France
(Mechtouff, Nighoghossian, Derex, Cho, Rossi, Rioufol, Derumeaux, Thibaut,
Barthelet, Thivolet) CHU Pierre Wertheimer, Lyon, France
(Arquizan, Mourand, Piot, Sportouch, Cade, Cransac) Hopital Gui de
Chauliac, Montpellier, France
(Giroud, Bejot, Eicher, Eicher, L'Huillier) CHU Dijon, France
(Vuillier, Moulin, Meneveau, Chopard, Descotes-Genon) CHU Jean Minjoz,
Besancon, France
(Detante, Garambois, Bertrand, Saunier) CHU Grenoble-Alpes, France
(Mazighi, Guidoux, Juliard, Aubry, Brochet, Guidoux, Meseguer, Cabrejo,
Lavallee, Amarenco, Messika-Zeitoun, Lepage) Hopital Bichat, Paris, France
(Bugnicourt, Canaple, Lamy, Godefroy, Rey, Leborgne, Guillaumont,
Trojette, Malaquin) CHU Nord, Amiens, France
(Vaduva, Couvreur, Golfier, Schleich, Plurien, Taldir) Hopital Yves Le
Foll, St-Brieuc, France
(Lucas, Cordonnier, Henon, Dumont, Dequatre-Ponchelle, Leys, Godart, Rey,
Richardson, Polge, Montaigne, Coisne) CHU Salengro, Lille, France
(Sibon, Rouanet, Renou, Thambo, Reant, Laffite, Roudaut) CHU Bordeaux,
France
(Garnier, Lusson, Comtet, Delsart) Hopital Nord, St-Etienne, France
(Ferrier, Bourgois, Clavelou, Lusson, Lusson) CHU Montpied,
Clermont-Ferrand, France
(Rouhart, Timsit, Le Cadet, Tirel, Mocquard, Guerin, Jobic, Le Ven,
Pouliquen) CHU La Cavale Blanche, Brest, France
(Milandre, Robinet-Borgomano, Laksiri, Rey, Fraisse, Habib, Chalvignac,
Thuny) CHU La Timone, Marseille, France
(Sablot, Runavot, Piot, Targosz, Chopat, Sultan) CH Perpignan, France
(Lacour, Richard, Ducrocq, Marcon, Selton-Suty, Huttin) CHU Nancy, France
(Bruandet, Zuber, Tamazyan, Juliard, Aubry, Antakly, Garcon, Serfaty)
Hopital Saint-Joseph, Paris, France
(Favrole, Dubois-Rande, Hammoudi) Hopital Tenon, Paris, France
(Pinel, Schleich, Donal, Lelong, Chabanne) Hopital Pontchaillou, Rennes,
France
(Viader, Apoil, Cogez, Juliard, Labombarda, Saloux) CHU Caen, France
(Reiner, Buffon, Juliard, Baudet, Logeart) Hopital Lariboisiere, Paris,
France
(Lefebvre, Bataille, Godard, Biausque, Lefetz, Clement-Dupont) CH Lens,
France
(Weimar, Zegarac, Schmitz, Plicht, Eissmann, Mahabadi) Essen University
Hospital, Essen, Germany
(Obadia, Juliard, Aubry, Iglesias Benyounes) Fondation Hopital Rothschild,
Paris, France
(Macian, Lusson, Darodes, Tanguy, Mohty) CHU Limoges, France
(Vuillemet, Onea, Greciano, Roth) Hopitaux Civils de Colmar, France
(Neau, Quillet, Christiaens) CHU Poitiers et CHRU Tours, France
(Saudeau, Patat) CHU Bretonneau, Tours, France
(Singer, Fichtlscherer) Goethe University Hospital, Frankfurt, Germany
(Pico, Juliard, Charbonnel) CH Mignot, Versailles, France
Publisher
American Heart Association Inc.
Abstract
Background--We conducted a systematic review and meta-analysis of
randomized controlled trials (RCTs) comparing patent foramen ovale (PFO)
closure, anticoagulation, and antiplatelet therapy to prevent stroke
recurrence in patients with PFO-associated cryptogenic stroke. Methods and
Results--We searched Medline, Cochrane Library, and EMBASE through March
2018. The primary outcome was stroke recurrence. Pooled incidences, hazard
ratios, and risk ratios (RRs) were calculated in random-effects
meta-analyses. PFO closure was associated with a lower risk of recurrent
stroke compared with antithrombotic therapy (antiplatelet therapy or
anticoagulation: 3560 patients from 6 RCTs; RR=0.36, 95% CI: 0.17-0.79;
I2=59%). The effect of PFO closure on stroke recurrence was
larger in patients with atrial septal aneurysm or large shunt (RR=0.27,
95% CI, 0.11-0.70; I2=42%) compared with patients without these
anatomical features (RR=0.80, 95% CI, 0.43-1.47; I2=12%). Major
complications occurred in 2.40% (95% CI, 1.03-4.25; I2=77%) of
procedures. New-onset atrial fibrillation was more frequent in patients
randomized to PFO closure versus antithrombotic therapy (RR=4.33, 95% CI,
2.37-7.89; I2=14%). One RCT compared PFO closure versus
anticoagulation (353 patients; hazard ratio=0.14, 95% CI, 0.00-1.45) and 2
RCTs compared PFO closure versus antiplatelet therapy (1137 patients;
hazard ratio=0.18, 95% CI, 0.05-0.63; I2=12%). Three RCTs
compared anticoagulation versus antiplatelet therapy, with none showing a
significant difference. Conclusions--PFO closure is superior to
antithrombotic therapy to prevent stroke recurrence after cryptogenic
stroke. The annual absolute risk reduction of stroke was low, but it has
to be tempered by a substantial time at risk (at least 5 years) in young
and middle-aged patients. PFO closure was associated with an increased
risk of atrial fibrillation. Copyright © 2018 The Authors.

<114>
Accession Number
615121613
Title
Fractional flow reserve-guided multivessel angioplasty in myocardial
infarction.
Source
New England Journal of Medicine. 376 (13) (pp 1234-1244), 2017. Date of
Publication: 30 Mar 2017.
Author
Smits P.C.; Abdel-Wahab M.; Neumann F.-J.; Boxma-De Klerk B.M.; Lunde K.;
Schotborgh C.E.; Piroth Z.; Horak D.; Wlodarczak A.; Ong P.J.; Hambrecht
R.; Angeras O.; Richardt G.; Omerovic E.
Institution
(Smits, Boxma-De Klerk) Department of Cardiology, Maasstad Hospital,
Maasstadweg 21, Rotterdam 3079 DZ, Netherlands
(Schotborgh) Department of Cardiology, Haga Ziekenhuis, The Hague,
Netherlands
(Abdel-Wahab, Richardt) Department of Cardiology, Heart Center, Segeberger
Kliniken, Bad Segeberg, Germany
(Neumann) Department of Cardiology, University Heart Center Freiburg-Bad
Krozingen, Bad Krozingen, Germany
(Hambrecht) Department of Cardiology, Klinikum Links der Weser, Bremen,
Germany
(Lunde) Department of Cardiology, Rigshospitalet, University of Oslo,
Oslo, Norway
(Piroth) Department of Cardiology, Gyorgy Hungarian Institute of
Cardiology, Budapest, Hungary
(Horak) Department of Cardiology, Liberec Regional Hospital, Liberec,
Czechia
(Wlodarczak) Department of Cardiology, Miedziowe Centrum Zdrowia, Lubin,
Poland
(Ong) Department of Cardiology, Tan Tock Seng Hospital, Singapore
(Angeras, Omerovic) Department of Cardiology, Gothenburg University
Hospital, Gothenburg, Sweden
Publisher
Massachussetts Medical Society
Abstract
Background: In patients with ST-segment elevation myocardial infarction
(STEMI), the use of percutaneous coronary intervention (PCI) to restore
blood flow in an infarct-related coronary artery improves outcomes. The
use of PCI in non-infarct-related coronary arteries remains controversial.
 Method(s): We randomly assigned 885 patients with STEMI and
multivessel disease who had undergone primary PCI of an infarct-related
coronary artery in a 1:2 ratio to undergo complete revascularization of
non-infarct-related coronary arteries guided by fractional flow reserve
(FFR) (295 patients) or to undergo no revascularization of
non-infarct-related coronary arteries (590 patients). The FFR procedure
was performed in both groups, but in the latter group, both the patients
and their cardiologist were unaware of the findings on FFR. The primary
end point was a composite of death from any cause, nonfatal myocardial
infarction, revascularization, and cerebrovascular events at 12 months.
Clinically indicated elective revascularizations performed within 45 days
after primary PCI were not counted as events in the group receiving PCI
for an infarct-related coronary artery only. Result(s): The primary
outcome occurred in 23 patients in the complete-revascularization group
and in 121 patients in the infarct-artery-only group that did not receive
complete revascularization, a finding that translates to 8 and 21 events
per 100 patients, respectively (hazard ratio, 0.35; 95% confidence
interval [CI], 0.22 to 0.55; P<0.001). Death occurred in 4 patients in the
complete-revascularization group and in 10 patients in the
infarct-artery-only group (1.4% vs. 1.7%) (hazard ratio, 0.80; 95% CI,
0.25 to 2.56), myocardial infarction in 7 and 28 patients, respectively
(2.4% vs. 4.7%) (hazard ratio, 0.50; 95% CI, 0.22 to 1.13),
revascularization in 18 and 103 patients (6.1% vs. 17.5%) (hazard ratio,
0.32; 95% CI, 0.20 to 0.54), and cerebrovascular events in 0 and 4
patients (0 vs. 0.7%). An FFR-related serious adverse event occurred in 2
patients (both in the group receiving infarct-related treatment only).
 Conclusion(s): In patients with STEMI and multivessel disease who
underwent primary PCI of an infarct-related artery, the addition of
FFR-guided complete revascularization of non-infarct-related arteries in
the acute setting resulted in a risk of a composite cardiovascular outcome
that was lower than the risk among those who were treated for the
infarct-related artery only. This finding was mainly supported by a
reduction in subsequent revascularizations. © Copyright 2017
Massachusetts Medical Society.

<115>
Accession Number
616041459
Title
Quality of Life After Surgery or DES in Patients With 3-Vessel or Left
Main Disease.
Source
Journal of the American College of Cardiology. 69 (16 Supplement) (pp
2039-2050), 2017. Date of Publication: 25 Apr 2017.
Author
Abdallah M.S.; Wang K.; Magnuson E.A.; Osnabrugge R.L.; Kappetein A.P.;
Morice M.-C.; Mohr F.A.; Serruys P.W.; Cohen D.J.
Institution
(Abdallah) Robert and Suzanne Tomsich Department of Cardiovascular
Medicine, Cleveland Clinic, Cleveland, Ohio, United States
(Wang, Magnuson, Cohen) Saint Luke's Mid America Heart Institute, Kansas
City, Missouri, United States
(Magnuson, Cohen) University of Missouri-Kansas City School of Medicine,
Kansas City, Missouri, United States
(Osnabrugge, Kappetein, Serruys) Erasmus University Medical Center,
Rotterdam, Netherlands
(Morice) Hopital Prive Jacques Cartier, Massy, France
(Mohr) Herzzentrum Universitat Leipzig, Leipzig, Germany
Publisher
Elsevier USA
Abstract
Background In the SYNTAX (Synergy Between Percutaneous Coronary
Intervention With Taxus and Cardiac Surgery) trial, patients with 3-vessel
or left main coronary artery disease (CAD) had improved long-term outcomes
with coronary artery bypass graft (CABG) surgery compared with
percutaneous coronary intervention (PCI) with drug-eluting stents (DES),
improvements driven mainly by differences in myocardial infarction and
repeat revascularization. Objectives This study compared the long-term
quality-of-life benefits of DES-PCI versus CABG for patients with 3-vessel
or left main CAD. Methods Between 2005 and 2007, the SYNTAX trial
randomized 1,800 patients with 3-vessel or left main CAD to either CABG or
DES-PCI. Health status was assessed at baseline and at 1, 6, 12, 36, and
60 months by using the Seattle Angina Questionnaire (SAQ) and the 36-Item
Short Form Health Survey. Results At 5-year follow-up, CABG was superior
to DES-PCI on several SAQ domains including angina frequency and physical
function, as well as the role physical and role emotional scales of the
36-Item Short Form Health Survey. Subgroup analysis demonstrated a
significant interaction between angiographic complexity (as assessed by
the SYNTAX score) and angina relief (mean difference in the SAQ angina
frequency score for CABG vs. PCI of -0.9, 3.3, and 3.9 points for low,
intermediate, and high SYNTAX score patients, respectively; p = 0.048 for
interaction). Conclusions Among patients with 3-vessel or left main CAD,
both CABG and DES-PCI were associated with substantial and sustained
quality-of-life benefits over 5 years of follow-up. In general, CABG
resulted in greater angina relief, although the absolute treatment benefit
was small. Angina relief at 5 years was enhanced with CABG among patients
with high SYNTAX scores, a finding reinforcing the recommendation that
CABG should be strongly preferred for such patients. (Synergy Between
Percutaneous Coronary Intervention With Taxus and Cardiac Surgery
[SYNTAX]; NCT00114972) Copyright © 2017 American College of
Cardiology Foundation

<116>
Accession Number
614254252
Title
Usefulness of Drug-Eluting Balloons for Bare-Metal and Drug-Eluting
In-Stent Restenosis (from the RIBS IV and V Randomized Trials).
Source
American Journal of Cardiology. 119 (7) (pp 983-990), 2017. Date of
Publication: 01 Apr 2017.
Author
Alfonso F.; Perez-Vizcayno M.J.; Garcia del Blanco B.; Garcia-Touchard A.;
Lopez-Minguez J.-R.; Sabate M.; Zueco J.; Melgares R.; Hernandez R.;
Moreno R.; Dominguez A.; Sanchis J.; Moris C.; Moreu J.; Cequier A.;
Romaguera R.; Rivero F.; Cuesta J.; Gonzalo N.; Jimenez-Quevedo P.;
Cardenas A.; Fernandez C.
Institution
(Alfonso, Rivero, Cuesta) Hospital Universitario de La Princesa, Madrid,
Spain
(Perez-Vizcayno, Gonzalo, Jimenez-Quevedo, Cardenas, Fernandez) Hospital
Universitario Clinico San Carlos, Madrid, Spain
(Perez-Vizcayno) Funacion Interhospitalaria Investigacion Cardiovascular,
Madrid, Spain
(Garcia del Blanco) Hospital Universitario Vall d'Hebron, Barcelona, Spain
(Garcia-Touchard) Hospital Universitario Puerta de Hierro-Majadahonda,
Madrid, Spain
(Lopez-Minguez) Hospital Universitario Infanta Cristina, Badajoz, Spain
(Sabate) Hospital Universitario Clinic de Barcelona, Barcelona, Spain
(Zueco) Hospital Universitario Marques de Valdecilla, Santander, Spain
(Melgares) Hospital Universitario Virgen de las Nieves, Granada, Spain
(Hernandez) Hospital Universitario Ramon y Cajal, Madrid, Spain
(Moreno) Hospital Universitario La Paz, Madrid, Spain
(Dominguez) Hospital Universitario Virgen de la Victoria, Malaga, Spain
(Sanchis) Hospital Universitario Clinico de Valencia, Valencia, Spain
(Moris) Hospital Universitario Central de Asturias, Oviedo, Spain
(Moreu) Hospital Universitario Virgen de la Salud Toledo, Toledo, Spain
(Cequier, Romaguera) Hospital Universitario de Bellvitge, Barcelona, Spain
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Treatment of patients with drug-eluting stent (DES) in-stent restenosis
(ISR) is particularly challenging. We sought to compare results of
drug-eluting balloons in patients with DES-ISR with those in patients with
bare-metal stent (BMS) ISR. A pooled analysis of the Restenosis
Intra-Stent: Drug-Eluting Balloon versus Everolimus-Eluting Stent IV and V
randomized trials was performed. Both trials had identical inclusion and
exclusion criteria. Results of drug-eluting balloons in 95 patients with
BMS-ISR and 154 patients with DES-ISR were compared. Patients with DES-ISR
were more frequently diabetics, presented more often as an acute coronary
syndrome and had more severe lesions and more frequently a focal pattern,
including edge-ISR. Late angiographic findings (92% of eligible patients),
including minimal lumen diameter (1.80 +/- 0.6 vs 2.01 +/- 0.6 mm, p =
0.001; absolute mean difference 0.21 mm; 95% confidence interval 0.04 to
0.38; p = 0.014) and restenosis rate (19% vs 9.5%, p <0.05) were poorer in
DES-ISR. Results were consistent across 10 prespecified subgroups.
Moreover, on multiple linear regression analysis, minimal lumen diameter
at follow-up remained significantly smaller in patients with DES-ISR after
adjusting for potential confounders (adjusted absolute mean difference
0.17 mm; 95% confidence interval 0.04 to 0.41; p = 0.019). Finally, at
1-year clinical follow-up (100% of patients), rates of target vessel
revascularization (16% vs 6%, p = 0.02) and of the main combined clinical
end point (18% vs 8%, p = 0.03) were significantly higher in patients
treated for DES-ISR. In conclusion, this study confirms the efficacy of
DEB for patients with ISR. However, the long-term clinical and
angiographic results of DEB are poorer in patients with DES-ISR than in
those with BMS-ISR. (ClinicalTrials.gov Identifier: NCT01239953 &
NCT01239940). Copyright © 2017 Elsevier Inc.

<117>
Accession Number
615342823
Title
A meta-analysis of effects of transcatheter versus surgical aortic valve
replacement on left ventricular ejection fraction and mass.
Source
International Journal of Cardiology. 238 (pp 31-36), 2017. Date of
Publication: 01 Jul 2017.
Author
Takagi H.; Ando T.; Umemoto T.
Institution
(Takagi, Umemoto) Department of Cardiovascular Surgery, Shizuoka Medical
Center, Shizuoka, Japan
(Ando) Department of Cardiology, Detroit Medical Center, Detroit, MI,
United States
Publisher
Elsevier Ireland Ltd
Abstract
Objectives To determine which procedure, transcatheter aortic valve
implantation (TAVI) or surgical aortic valve replacement (SAVR), for
severe aortic stenosis (AS) improves follow-up left ventricular (LV)
function or hypertrophy more effectively, we performed the first
meta-analysis of comparative studies reporting LV ejection fraction (LVEF)
or mass (LVM) after TAVI versus SAVR. Methods Studies considered for
inclusion met the following criteria: the article was written in English;
the design was a comparative study; the study population was patients with
severe AS; patients were assigned to TAVI versus SAVR; and outcomes
included follow-up (6-12-month) LVEF or LVM. For each study, data
regarding fractional changes in LVEF or LVM in both the TAVI and SAVR
groups were used to generate mean differences (MDs) and 95% confidence
intervals (CIs). Results Our search identified 8 eligible studies. Two
studies with baseline LVEF < 40% demonstrated significantly greater
fractional changes in LVEF after TAVI than after SAVR. A pooled analysis
of 6 studies demonstrated no statistically significant difference in
fractional changes in LVEF between TAVI and SAVR (MD, 3.25%; 95% CI,
-1.30% to 7.80%; p = 0.16). Another pooled analysis of 5 studies
demonstrated significantly greater fractional changes (i.e. less
fractional "reductions") in LVM after TAVI than after SAVR (MD, 4.75%; 95%
CI, 2.18% to 7.32%; p = 0.0003). Conclusions For patients with severe AS,
SAVR may be associated with greater improvement in LVM, probably not in
LVEF, at 6-12 months. For limited patients with reduced LVEF, TAVI might
be associated with greater improvement in LVEF. Copyright © 2017
Elsevier B.V.

<118>
[Use Link to view the full text]
Accession Number
614341167
Title
Sudden cardiac death in patients with ischemic heart failure undergoing
coronary artery bypass grafting: Results from the STICH randomized
clinical trial (Surgical Treatment for Ischemic Heart Failure).
Source
Circulation. 135 (12) (pp 1136-1144), 2017. Date of Publication: 2017.
Author
Rao M.P.; Al-Khatib S.M.; Pokorney S.D.; She L.; Romanov A.; Nicolau J.C.;
Lee K.L.; Carson P.; Selzman C.H.; Stepinska J.; Cleland J.G.F.;
Tungsubutra W.; Desvigne-Nickens P.M.; Sueta C.A.; Siepe M.; Lang I.;
Feldman A.M.; Yii M.; Rouleau J.L.; Velazquez E.J.
Institution
(Rao, Al-Khatib, Pokorney, She, Lee, Velazquez) Duke Clinical Research
Institute, Duke University, School of Medicine, PO Box 17969, Durham, NC
27715, United States
(Lee) Departments of Biostatistics and Bioinformatics, Duke University
School of Medicine, Durham, United States
(Al-Khatib, Velazquez) Departments of Medicine, Duke University School of
Medicine, Durham, United States
(Romanov) State Research Institute of Circulation Pathology, Novosibirsk,
Russian Federation
(Nicolau) Heart Institute, University of Sao Paulo Medical School, Brazil
(Carson) Washington DC Veterans Affairs Medical Center, United States
(Selzman) Division of Cardiothoracic Surgery, University of Utah, Salt
Lake City, United States
(Stepinska) Institute of Cardiology, Warsaw, Poland
(Cleland) National Heart and Lung Institute, Royal Brompton and Harefield
Hospitals, Imperial College, London, United Kingdom
(Tungsubutra) Siriraj Hospital, Mahidol University, Bangkok, Thailand
(Desvigne-Nickens) Division of Cardiovascular Sciences, National Heart,
Lung, and Blood Institute, Bethesda, United States
(Sueta) University of North Carolina, Chapel Hill, United States
(Siepe) University Heart Center Freiburg-Bad Krozingen, Germany
(Lang) Medical University of Vienna, Austria
(Feldman) Department of Medicine, Temple University School of Medicine,
Philadelphia, United States
(Yii) St. Vincent's Hospital, University of Melbourne, Fitzroy, Australia
(Rouleau) Department of Medicine, Montreal Heart Institute, University of
Montreal, QC, Canada
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
BACKGROUND: The risk of sudden cardiac death (SCD) in patients with heart
failure after coronary artery bypass graft surgery (CABG) has not been
examined in a contemporary clinical trial of surgical revascularization.
This analysis describes the incidence, timing, and clinical predictors of
SCD after CABG. METHOD(S): Patients enrolled in the STICH trial
(Surgical Treatment of Ischemic Heart Failure) who underwent CABG with or
without surgical ventricular reconstruction were included. We excluded
patients with prior implantable cardioverter-defibrillator and those
randomized only to medical therapy. The primary outcome was SCD as
adjudicated by a blinded committee. A Cox model was used to examine and
identify predictors of SCD. The Fine and Gray method was used to estimate
the incidence of SCD accounting for the competing risk of other deaths.
 RESULT(S): Over a median follow-up of 46 months, 113 of 1411 patients
who received CABG without (n = 934) or with (n = 477) surgical ventricular
reconstruction had SCD; 311 died of other causes. The mean left
ventricular ejection fraction at enrollment was 28-9%. The 5-year
cumulative incidence of SCD was 8.5%. Patients who had SCD and those who
did not die were younger and had fewer comorbid conditions than did those
who died of causes other than SCD. In the first 30 days after CABG, SCD
(n=5) accounted for 7% of all deaths. The numerically greatest monthly
rate of SCD was in the 31- to 90-day time period. In a multivariable
analysis including baseline demographics, risk factors, coronary anatomy,
and left ventricular function, end-systolic volume index and B-type
natriuretic peptide were most strongly associated with SCD.
 CONCLUSION(S): The monthly risk of SCD shortly after CABG among
patients with a low left ventricular ejection fraction is highest between
the first and third months, suggesting that risk stratification for SCD
should occur early in the postoperative period, particularly in patients
with increased preoperative end-systolic volume index or B-type
natriuretic peptide. CLINICAL TRIAL REGISTRATION: URL:
http://www.clinicaltrials.gov. Unique identifier:
NCT0002359. Copyright © 2017 American Heart Association, Inc.

<119>
Accession Number
614120537
Title
Effect of Erythropoietin in patients with acute myocardial infarction:
Five-year results of the REVIVAL-3 trial.
Source
BMC Cardiovascular Disorders. 17 (1) (no pagination), 2017. Article
Number: 38. Date of Publication: 21 Jan 2017.
Author
Steppich B.; Groha P.; Ibrahim T.; Schunkert H.; Laugwitz K.-L.;
Hadamitzky M.; Kastrati A.; Ott I.
Institution
(Steppich, Groha, Hadamitzky, Kastrati, Ott) Deutsches Herzzentrum der
Technischen Universitat Munchen, Lazarettstr. 36, Munich 80636, Germany
(Ibrahim, Schunkert, Laugwitz) Medizinische Klinik Klinikum rechts der
Isar der Technischen Universitat Munchen, Ismaningerstr. 22, Munich 81675,
Germany
Publisher
BioMed Central Ltd. (E-mail: info@biomedcentral.com)
Abstract
Background: Erythropoietin (EPO) has been suggested to promote cardiac
repair after MI. However, the randomized, double-blind, placebo controlled
REVIVAL-3 trial showed that short term high dose EPO in timely reperfused
myocardium does not improve left ventricular ejection fraction after 6
months. Moreover, the study raised safety concerns due to a trend towards
a higher incidence of adverse clinical events as well as a increase in
neointima formation after treatment with EPO. The present study therefore
aimed to assess the 5-year clinical outcomes. Method(s): After
successful reperfusion 138 patients with STEMI were randomly assigned to
receive epoetin beta (3.33x104 U, n = 68) or placebo (n = 70)
immediately, 24 and 48 h after percutaneous coronary intervention. The
primary outcome of the present study- the combined incidence of MACE 5
years after randomization - occurred in 25% of the patients assigned to
epoetin beta and 17% of the patients assigned to placebo (RR 1.5; 95% CI
0.8-3.5; p = 0.26). Target lesion revascularization was required in 15
patients (22.1%) treated with epoetin-s and 9 patients (12.9%) treated
with placebo (p = 0.15). Analysis of patients in the upper and lower
quartile of baseline hemoglobin as an indirect estimate of endogenous
erythropoietin levels revealed no significant impact of endogenous
erythropoietin on efficiency of exogen administered epoetin-s in terms of
death and MACE. Conclusion(s): These long-term follow-up data show
that epoetin beta does not improve clinical outcomes of patients with
acute myocardial infarction. Trial registration: URL
www.clinicaltrials.gov ; Unique identifier NCT00390832; trial registration
date October 19th 2006 Copyright © 2017 The Author(s).

<120>
Accession Number
615452596
Title
Cardiovascular efficacy and safety of bococizumab in high-risk patients.
Source
New England Journal of Medicine. 376 (16) (pp 1527-1539), 2017. Date of
Publication: 20 Apr 2017.
Author
Ridker P.M.; Revkin J.; Amarenco P.; Brunell R.; Curto M.; Civeira F.;
Flather M.; Glynn R.J.; Jukema J.W.; Karpov Y.; Kastelein J.J.P.; Koenig
W.; Lorenzatti A.; Manga P.; Masiukiewicz U.; Miller M.; Mosterd A.; Murin
J.; Nicolau J.C.; Nissen S.; Ponikowski P.; Santos R.D.; Schwartz P.F.;
Soran H.; White H.; Wright R.S.; Vrablik M.; Yunis C.; Shear C.L.; Tardif
J.-C.; Conde D.; Colquhoun D.; Missault L.; Gregoire J.; Gao R.; Urina M.;
Solar M.; Jensen H.K.; Grobbee D.; Savolainen M.; Schiele F.N.;
Montalescot G.; Edes I.; Blake G.; Lotan C.; Maggioni A.; Savonitto S.;
Lee C.W.; Leiva Pons J.L.; Dan G.A.; Cortada J.B.; Mellbin L.; Kahan T.;
Noble S.; Hwang J.J.; Sritara P.; Tokgozoglu L.; Tarasenko L.; Borer J.S.;
Black H.; Carmena R.; Furie K.L.; McMurray J.; Neaton J.; Zannad F.;
O'Neill B.; Welty F.; McNamara R.; Chun H.; Abbott J.D.; Jacoby D.;
McPherson C.; Jadbabaie F.; Pinto D.; McCullough L.; Silverman I.E.;
Sansing L.H.; Dearborn-Tomazos J.; Foody J.; Schindler J.; Piazza G.;
Chakrabarti A.; Pride Y.; Gelfand E.; Baultrukonis D.; Chaudhuri S.;
Frederich R.; Johnson M.; Mridha K.; Powell C.; Wang E.; Wei C.; Anderson
P.; Buonanno M.; Epsley C.; Evans B.; Frolova M.; Goetsch M.; Hessinger
D.; Ikehara E.; Ivanac K.; Kizko J.; Le K.; McNally-Dufort C.; Morocco T.;
Nadkarni S.; Nye R.; Pak R.; Pence D.; Redifer P.; Sattler C.; Schade R.;
Sullivan B.; Wegner J.; Alvarez C.A.; Budassi N.; Vogel D.R.; Avaca H.;
Conde D.G.; Estol C.C.; Gelersztein E.; Glenny J.A.; Hershson A.R.; Bruno
R.L.; Maffei L.E.; Soler J.M.; Zaidman C.J.; Carnero G.S.; Colombo H.R.;
Jure H.O.; Luquez H.A.; Ramos H.R.; Resk J.H.; Rusculleda M.M.; Ulla M.R.;
Caccavo A.; Farias E.F.; Wenetz L.M.; Cabella P.R.; Cuadrado J.A.; Chahin
M.; Mackinnon I.J.; Zarandon R.B.; Schmidberg J.; Fernandez A.A.; Montana
O.; Codutti O.R.; Gorosito V.M.; Maldonado N.; Sala J.; De La Fuente R.A.;
Casabella T.E.; Di Gennaro J.P.; Guerrero R.A.; Alvarez M.S.; Berli M.;
Botta C.E.; Montenegro E.E.; Vico M.L.; Begg A.; Lehman R.; Gilfillan
C.P.; d'Emden M.; Markovic T.P.; Sullivan D.; Aroney C.; Stranks S.N.;
Crimmins D.S.; Arstall M.; Van Gaal W.; Davis T.; Aylward P.E.; Amerena
J.; William M.; Proietto J.; Purnell P.W.; Singh B.; Arya K.W.; Dart A.M.;
Thompson P.; Davis S.M.; Carroll P.A.; De Looze F.; Jayasinghe R.; Bhindi
R.; Buysschaert I.; Sarens T.; van de Borne P.; Scott B.P.; Roosen J.;
Cools F.; Missault L.H.; Debroye C.; Schoors D.F.; Hollanders G.; Schroe
H.H.; De Sutter J.; Hermans K.; Carlier M.; van Landegem P.; Verwerft J.;
Mulleners T.; Delforge M.D.; Soufflet V.; Elegeert I.; Descamps O.S.;
Janssens S.; Lemmens R.C.; Desfontaines P.; Scheen A.; Heijmans S.; Capiau
L.; Vervoort G.; Carlier S.G.; Faes D.; Alzand B.; Keuleers S.; De Wolf
L.; Thoeng J.; De Bruyne L.; de Santos M.O.; Felicio J.S.; Areas C.A.;
Figueiredo E.L.; Michalaros Y.L.; Neuenschwander F.C.; Reis G.; Saad J.A.;
Kormann A.P.; Nascimento C.V.; Precoma D.B.; Abib E.; dos Santos F.R.;
Mello Y.G.; Saraiva J.F.; Rech R.L.; Cerci R.; Fortes J.A.; Rossi P.R.; de
Lima e Silva F.A.; Hissa M.; Silva R.P.; de Souza W.K.; Guimaraes Filho
F.V.; Mangili O.C.; de Oliveira Paiva M.S.; Tumelero R.; Abrantes J.A.;
Caramori P.R.; Dutra O.P.; Leaes P.E.; Manenti E.R.; Polanczyk C.A.;
Bandeira e Farias F.A.; de Moraes Junior J.B.; Russo L.A.; Alves A.R.;
Dracoulakis M.D.; Ritt L.E.; Saporito W.F.; Herdy A.H.; Maia L.N.;
Sternieri M.V.; Ayoub J.C.; Bianco H.T.; da Costa F.A.; Eliaschewitz F.G.;
Fonseca F.A.; Nakandakare E.R.; Bonansea T.C.; Castro N.M.; de Barros e
Silva P.G.; Smith P.; Botelho R.V.; Resende E.S.; Barbieri D.S.; Hernandes
M.E.; Bajaj H.; Beaudry P.; Berlingieri J.C.; Salter T.J.; Ajala B.;
Anderson T.J.; Nanji A.; Ross S.; Pandey S.; Desrosiers D.; Gaudet D.;
Moran G.; Csanadi M.A.; St-Amour E.; Cusimano S.; Halperin F.A.; Babapulle
M.; Vizel S.; Petrella J.; Spence J.D.; Gupta N.; Tellier G.; Bourgeois
R.; Gregoire J.C.; Wesson T.; Zadra R.; Twum-Barima D.Y.; Cha J.Y.;
Hartleib M.C.; Bergeron J.; Chouinard G.; McPherson T.P.; Searles G.;
Peterson S.R.; Mukherjee A.; Lepage S.; Conway J.R.; Kouz S.M.; Dion D.;
Pesant Y.; Cheung S.S.; Goldenberg R.M.; Aronson R.; Gupta A.K.; O'Mahoney
M.; Pliamm L.; Teitelbaum I.; Hoag G.N.; Nadra I.J.; Yared Z.; Yao L.C.;
Nguyen T.; Saunders K.K.; Potthoff S.; Varleta P.; Assef V.; Godoy J.G.;
Olivares C.; Roman O.; Vejar M.; Montecinos H.; Pincetti C.; Li Y.; Wang
D.; Li J.; Yang X.; Du Y.; Wang G.; Yang P.; Zhang X.; Xu P.; Zhao Y.;
Chen J.; Li S.; Li W.; Zhang L.; Zhu Y.; Zhang Y.; Zhou C.; Wang Y.; Liu
F.; Ma Y.; Ti Z.; Zeng X.; Zhou Y.; Cui G.; Li D.; Xue L.; Jiang J.; Lian
Y.; He Y.; Mendoza J.A.; Bonfanti J.A.; Dada F.A.; Urina-Triana M.A.;
Rodriguez W.R.; Sanchez M.L.; Lozno H.Y.; Triana E.H.; Arambula R.M.;
Rico-Carrillo A.E.; Gallo H.J.; Catano J.S.; Jattin F.G.; Plazas J.A.;
Gomez J.E.; Botero-Lopez R.; Gomez N.I.; Munoz C.F.; Pelaez S.V.; Eraso
A.M.; Goyes A.R.; Elbl L.; Fiserova N.; Vesely J.; Wasserburger B.; Blaha
V.; Vojacek J.; Maskova P.; Hutyra M.; Vrkoc J.; Hala T.; Vodnansky P.;
Bocek P.; Cifkova R.; Bufka V.; Ceska R.; Machkova M.; Zidkova E.; Lukac
M.; Mikusova T.; Kellnerova I.; Kuchar L.; Ferkl R.; Cech V.; Zemek S.;
Monhart Z.; Davidsen F.; Joensen A.; Lihn A.S.; Rasmussen T.K.; Wiggers
H.; Lindgren L.M.; Schmidt U.; Galatius S.; Sillesen H.; Bronnum Schou J.;
Thomsen K.K.; Urhammer S.; Jeppensen J.; Schou M.; May O.; Steffensen R.;
Nielsen W.B.; Nielesen T.; Jepsen J.M.; Rai A.; Sykulski R.; Andersen
L.T.; Rickers H.; Frost L.; Lomholdt J.; Egstrup K.; Wermuth S.; Klausen
L.; Lassus J.; Palomaki A.; Khari J.; Tatlisumak T.; Kekki S.; Vanttinen
E.; Strandberg A.; Valtonen M.; Sia S.M.; Nerg O.; Puhakka M.; Strand J.;
Timonen M.; Levola J.; Arstila L.; Taurio J.; Kantola I.; Suomi J.;
Humaloja K.; Askonen K.; Schiele F.; Sibon I.; Zemour G.; Goube P.; Petit
C.; Chati Z.; Range G.; Rabahi F.; Rihani R.; Bergerot C.; Roubille F.;
Boye A.; Probst V.; Ferrari E.; Cayla G.; Thouvenot E.; Delarche N.;
Couffinhal T.; Coisne D.; Paillard F.; Elbaz M.; Decoulx E.; Angoulvant
D.; Agraou B.; Caudmont S.; Berrouschot J.; Lauer B.; Schoell I.; Trenk
D.; Derwahl K.M.; Khariouzov A.; Proepper F.; Stawowy P.; Da Stephan U.;
Stoessel J.; Voehringer H.F.; Dorsel T.; Stellbrink C.; Rinke A.;
Northroff J.; Bourhaial H.; Stratmann M.; Wetzel T.; Axthelm C.; Guenzel
A.; Weigmann I.; Faghih M.; Hagemann D.; Schaefer A.; Weber D.; Luedemann
J.; Contzen C.; Kornmann M.O.; Winkelmann B.; Simon J.; Felix S.; Brauer
C.; Laufs U.; Schmidt E.; Marten I.; Licka M.; Heisters J.; Appel K.F.;
Kleinecke-Pohl U.; Klein C.; von Hodenberg E.F.; Maus O.; Sigal H.;
Taeschner H.; Schwimmbeck P.; Lemke B.; Perings C.; Illies G.; Pfuetzner
A.; Salbach P.; Hengstenberg C.; Kohler A.; Mudra H.; Behnke T.; Baar M.;
Jeserich M.; Scholz G.; Naudts I.; Voller H.; Herrmann H.J.; von
Engelhardt C.B.; Gerke S.; Pohlmeier L.; Schaufele T.; Woehrle J.;
Al-Zoebi A.; Horacek T.; Peterfai E.; Kemeny V.; Lakatos F.; Bod E.;
Andrassy P.; Andreka P.; Balo T.; Davidovits Z.; Laszlo Z.; Nagy K.; Papp
A.; Somogyi A.; Toldy-Schedel E.; Vertes A.; Voros P.; Paragh G.; Martyin
T.; Hajdu C.; Deak L.; Farago K.; Nagy A.; Kirschner R.; Koszegi Z.;
Zilahi Z.; Toth K.; Wittmann I.; Bajcsi D.; Reiber I.; Toth L.; Benczur
B.; Nagy L.; Sydo T.; Lupkovics G.; Oroszlan T.; Crean P.; Mahon N.G.;
McAdam B.; MacNeill B.; Katz A.; Tsalihin D.; Vazan A.; Eitan A.; Lewis
B.S.; Gavish D.; Wainstein J.; Mosenzon O.; Mosseri M.; Vishlitzky V.;
Atar S.; Nseir W.B.; Brenner H.; Elis A.; Fuchs S.; Shimon I.; Solodky A.;
Goldhaber A.; Tanne D.; Knobler H.; Kracoff O.H.; Hussein O.; Auriel E.;
Chorin E.; Sharir T.; Bitzur R.; Shechter M.; Antonicelli R.; Franceschini
E.; Porcu M.; Sesti G.; Maggiolini S.; Salvioni A.; Filardi P.P.; Trimarco
B.; Averna M.; Pasqualini L.; Pirro M.; Pantaleoni M.; Piovaccari G.; Arca
M.; Fedele F.; Roncon L.; Anselmi M.; Sganzerla P.; Morocutti G.; Bonora
E.; Dimas A.L.; Esperon G.A.; Morales-Villegas E.; Isunza J.M.; Beltran
L.G.; Molina C.A.; Garcia D.K.; Ruiz L.A.; Reyna L.S.; De los Rios Ibarra
M.O.; Soto J.R.; Gonzalez-Ortiz M.; Herrera-Marmolejo M.; Ramos S.A.;
Ramos-Lopez G.A.; Stobschinski C.A.; AguilarSalinas C.A.; Alpizar-Salazar
M.; Jimenez-Sanchez M.; Sanchez Mijangos J.H.; Elizondo Moreno E.R.;
Garcia Castillo A.; Garcia Hernandez P.A.; Gonzalez-Gonzalez J.G.; Riojas
Charles C.M.; Valdez Lopez H.G.; Nuriulu Escobar P.L.; Lechuga Martin del
Campo A.; Castro Montes B.E.; Mendez Bucio A.; Rodriguez-Briones I.; Torre
Amione G.; Violante Ortiz R.; Luna Ceballos R.I.; Lopez Rosas E.; Bax
W.A.; Alhakim M.; van de Wiel A.; Liem S.S.; Groutars R.G.; Herrman J.P.;
Hovingh G.K.; van de Wetering M.L.; van Royen N.; Groenemeijer B.E.;
Hoedemaker G.; Schaap J.; Ronner E.; Angun M.; Mairuhu A.T.; Van Alem
A.P.; Martens F.M.; Heijmeriks J.A.; van Hal J.M.; Schoofs M.W.; den
Hartog F.R.; Kentgens S.; Post J.C.; Louwerenburg J.W.; van Rossum P.;
Viergever E.P.; Donders S.H.; Kamphuisen P.W.; van Beek E.; Nijmeijer R.;
Lenderink T.; Schreuder T.; Kuijper A.F.; The S.H.; Van het Hof-Wiersma
J.J.; Tichelaar P.; Westerndorp I.; Breedveld R.W.; Karalis I.; Romer
T.J.; Bogaard K.; Van Koningsbruggen P.; Kroon A.A.; Hoogslag P.A.;
Rensing B.J.; Cramer E.; Remmen J.J.; Riksen N.P.; Bokern M.J.; Cabezas
M.C.; Mulder H.; Nierop P.R.; van Kempen W.W.; Zoet-Nugteren S.K.; van
Daele M.E.; Swart H.P.; van der Zwaan C.T.; Hermans W.R.; Magro M.; van de
Wal R.M.; Hassink R.J.; Visseren F.; Veenendaal A.; De Nooijer C.; Troquay
R.P.; Imholz B.P.; van der Meer P.; Visser R.P.; van Leendert R.J.;
Gosselink M.A.; Baker J.; Benatar J.R.; Kerr J.; Pryke J.R.; Scott R.S.;
Millar-Corte G.D.; Williams M.; Montgomery B.; Venter D.J.; Ternouth I.F.;
DeCaigney S.C.; Hart H.H.; Corin A.; Garden P.I.; Sheahan D.; Harding
S.A.; Korecki J.; Supronik J.; Styczkiewicz M.; Bijata-Bronisz R.; Rusicka
T.; Walczak M.; Krolikowski Z.; Ostrowski J.; Lukaszewicz M.;
Przekwas-Jaruchowska M.; Zieba B.; Miekus P.; Orkwiszewska-Nalewajko A.;
Piepiorka M.; Kubalski P.; Wychota K.; Blach E.; Ochala A.; Okopien B.;
Wronska D.; Janion M.; Czarnecka D.; Kolodziejczyk J.; Konieczynska M.;
Landa K.; Mirek-Bryniarska E.; Necki M.; Pasternak D.A.; Rozpondek P.;
Trebacz J.; Walczewska J.; Sidor M.; Broncel M.; Drozdz J.; Kosmider M.;
Saryusz-Wolska M.; Kucharska D.; Opalinska E.; Pijanowski Z.; Wozniak I.;
Banaszkiewicz K.; Klecha A.; Horodecki M.; Piskorz-Wapinska J.;
Kobielusz-Gembala I.; Kim M.H.; Kim D.K.; Cho B.R.; Kim K.S.; Her S.H.;
Lee S.Y.; Rhee M.Y.; Kim K.; Kang W.C.; Kim D.H.; Cho Y.S.; Kim S.H.; Rim
S.J.; Tahk S.J.; Jeon H.K.; Yoon J.; Mociran M.; Pop C.F.; Minescu B.;
Andrei L.D.; Radoi M.; Calin A.; Ciomag R.M.; Copaci I.; Fruntelata A.G.;
Popescu M.; Tivadar S.; Roman G.; Avram R.I.; Mistodie C.V.; Morosanu M.;
Popa A.R.; Popescu M.L.; Popoviciu M.S.; Tase A.; Busegeanu M.; Popescu
A.; Szilagyi I.; Sitterli-Natea C.N.; Maximov D.M.; Munteanu M.; Negrisanu
G.D.; Kuzin A.; Popov D.; Shapovalova J.; Vishneva E.; Shutemova E.;
Pasechnik E.; Bogdanov E.; Khasanov N.; Barbarash O.L.; Shangina O.A.;
Tarasov N.; Solonev O.; Kosmacheva E.; Chernyatina M.A.; Ginzburg M.;
Blokhin A.; Bulanova N.; Drapkina O.M.; Gordeev I.G.; Libov I.A.; Lomakin
N.; Panchenko E.; Shogenov Z.S.; Zateyshchikov D.; Klein G.; Motylev I.;
Belenkiy D.I.; Demin A.; Nikolaev K.Y.; Oleynikov V.; Zrazhevskiy K.;
Katelnitskiy I.; Khaisheva L.; Aksentiev S.; Nedoshivin A.; Popova V.B.;
Agafina A.S.; Ballyuzek M.; Baranova E.; Burova N.; Eryshev S.; Filippov
A.; Goloshchekin B.M.; Konstantinov V.; Kostenko V.A.; Simanenkov V.I.;
Volkova A.; Duplyakov D.; Reshetko O.; Shvarts Y.; Kuznetsov V.A.;
Samoylova Y.G.; Tolkacheva V.; Shalaev S.V.; Khokhlov A.L.; Malygin A.;
Shilkina N.P.; Yakusevich V.V.; Margoczy R.; Zubek V.; Dzupina A.; Dubrava
J.; Dulkova K.; Fabryova L.; Gaspar L.; Kamensky G.; Kokles M.; Raslova
K.; Soosova I.; Stevlik J.; Strbova J.; Sumbal J.; Uhliar R.; Micik J.;
Truban J.; Fedacko J.; Pastrnakova E.; Pella D.; Fazekas F.; Ambrovicova
V.; Kycina P.; Martinka E.; Nociar J.; Belicova M.; Banik M.; Kanderkova
D.; Hranai M.; Duris T.; Krahulec B.; Benacka J.; Vinanska D.; Roskova E.;
Skripova D.; Macek V.; Vohnout B.; Buganova I.; Engelbrecht J.M.;
Pretorius M.M.; Ebrahim I.O.; Bayat J.; Ganesh S.; Ranjith N.; Coetzer
T.F.; Jacovides A.; Distiller L.A.; Hellig F.S.; Engelbrecht I.V.; Mahomed
A.A.; Blignault S.C.; Burgess L.J.; Kotze H.J.; van Nieuwenhuizen E.;
Musungaie D.B.; Emanuel S.; van der Walt E.; Pretorius C.E.; Roos J.S.;
Roux S.M.; Badat A.E.; Fouche L.; Vahed Y.A.; Jansen van Resburg D.; van
Zyl L.J.; Soto Gonzalez A.; Diaz J.L.; Segura T.; Botella Serrano M.;
Botas Rodrigues J.; Molto-Jorda J.M.; Dominguez Escribano J.R.; Sogorb
Garri F.; Blanco Coronado J.L.; Gaztambide Saenz M.S.; Brotons Cuixart C.;
Bruguera Cortada J.; Garcia-Moll Marimon X.; Gonzalbez Morgaez J.D.;
Maisterra Santos O.; Roquer Gonzalez J.; Sobrino-Martinez J.; Chueca
Fernandez J.E.; Narejos S.; Suarez Garcia S.; Perez Martinez P.; Figueras
Camos R.; Medrano Martinez V.; Bellido Guerrero D.; Martinez Deben F.;
Vila Belmonte A.; Mediavilla Garcia J.D.; Romero Hinojosa J.A.; Martorell
Mateu E.; Cequier Fillat A.R.; Pinto Sala X.; Adroer Martori R.; Bueno
Diez M.; Lopez Cano C.; Worner Diz F.; Gonzalez Juanatey C.; Alvarez-Sala
Walther L.A.; De Dios Garcia Diaz J.; Garcia Puig J.; Jodar Gimeno E.;
Plaza Perez I.; Suarez-Fernandez C.; Tunon J.; Zamorano Gomez J.L.; Brito
Sanfiel M.A.; Escudier Villa J.M.; de Mora Martin M.; Dominguez Lopez M.;
Hernandez Garcia J.M.; Tinahones Madueno F.J.; Perez Paredes M.; Aracil
Villar J.; Barreda Gonzalez M.J.; Ripoll Vera T.V.; Tofe Povedano S.;
Sanchez Alvarez J.; Martinez Via L.; Robles Iniesta A.; Masana L.;
Vinyoles Bargallo E.; Calvo Gomez C.; Gonzalez Juanatey J.R.; Cruz
Fernandez J.M.; De La Cuesta Mayor C.; Duran Garcia S.; Jimenez Hernandez
M.D.; Morales Portillo C.; Muniz Grijalvo O.; De Castro R.; Taverna
Llaurado E.; Pons Amate J.M.; Terns Riera M.; Linderfalk C.; Curiac D.;
Saldeen-Nilehn K.; Koskinen P.; Khalili P.; Tortensson I.; Lindholm C.J.;
Luts A.; Koskinen P.T.; Gottsater A.; Persson B.E.; Mooe T.; Larnefeldt
H.; Boman K.; Crisby M.; Rasmanis G.; Tengmark B.O.; Witt N.; Hagstrom E.;
Viklund J.; Muller C.; Mach F.; Burnier M.; Nanchen D.; Wuerzner G.;
Banyai M.; Moccetti T.; Miserez A.R.; Bilz S.; Weber K.; Lai W.T.; Chang
K.C.; Ueng K.C.; Tsai W.C.; Chiang C.E.; Hou C.; Pei D.; Krittayaphong R.;
Kiatchoosakun S.; Srimahachota S.; Boonyavarakul A.; Jintapakorn W.; Gullu
H.; Onrat E.; Erkan A.F.; Demirci D.; Sari R.; Ceyhan C.; Ari H.; Araz M.;
Degertekin M.; Goktekin O.; Uresin A.Y.; Yigit Z.; Akdeniz B.; Comlekci
A.; Kayikcioglu M.; Sahin T.; Ozcan T.; Durakoglugil E.; Asamoah-Owusu N.;
Reed R.; Bakhai A.; Dixon L.; Sharma R.; Avornyo A.A.; Jones A.F.; Lip G.;
Clark R.; Banerjee M.; Wakeling J.; Arden C.; Blagden M.D.; Walukiewica
P.; Marshall A.; Maxwell T.G.; Gunstone A.E.; Kadr H.H.; Patle R.; Arif
I.; Jhund P.S.; McKaig G.; Douglas F.; Mierzejewski L.; Turner W.;
Sathyapalan T.; Ivan P.; Manoj A.; Rice S.; Collier D.J.; Nair D.R.; Thom
S.; Fiore G.; De Belder M.; Price D.; Sobolewska J.; Martin S.; Takhar A.;
Moriarty A.; Kondagunta V.; Myhill T.; Gibson J.M.; Cecil J.T.; Halcox J.;
Annamalai N.; Gorog D.A.; McCormack T.; Pegge N.; Field A.; Adams F.;
Klein J.J.; Busch R.S.; Bretton E.M.; Jaffrani N.; Salacata A.;
Assadourian A.; Gogia H.S.; Dyke C.K.; Rubenfire M.; Essandoh L.K.; Welker
J.A.; Ledesma G.; Lupovitch S.; Delgado J.P.; Hendrix E.L.; Quyyumi A.A.;
Riesenberg R.A.; Robertson D.G.; Weinstein D.L.; Weiss R.; Casaubon L.;
Gammon R.S.; Brar H.S.; Bittar G.D.; Guarnieri T.T.; Ince C.S.; Quraishi
A.M.; Saeed S.; Albert M.; Sotolongo R.P.; Bernard J.V.; Karlsbergg R.P.;
Lepor N.E.; Kirby W.E.; McLean B.; Ovalle F.; Townsend J.C.; Beckett P.L.;
Eaves W.B.; West S.H.; Kosinski E.J.; Zarich S.W.; Mahal S.S.; Maw K.;
Maynard K.M.; Chen J.C.; Gelormini J.; Gottlieb D.W.; Gabra N.W.; Narayan
P.; Sparks J.; Field J.C.; Willits V.L.; O'Steen M.B.; Pasquini J.A.;
Sensebrenner J.W.; Yarows S.A.; Hiotis L.; Jagielo T.J.; Levinson D.J.;
Diller P.M.; Kereiakes D.J.; Turner T.A.; Vincent S.; Camp A.D.; Denker
P.S.; Manning M.B.; Rocco M.B.; Stamps H.B.; Strader J.R.; Uusinarkaus
K.T.; Kennett J.D.; Leichter S.B.; McNeil D.L.; Schumacher D.R.; Chang
A.R.; Ellison H.S.; Updegrove J.D.; Hamroff G.S.; Kay J.S.; Marar I.E.;
Flores E.; Saini S.; Abdullah S.; Berk M.R.; Fordan S.; Joshi P.H.;
McCullough P.A.; Reynolds R.D.; Rosenstock J.; Sachson R.A.; Shammas N.;
Fishbein G.J.; Randall W.J.; Henderson D.A.; Nash M.L.; Barker B.A.; Cohen
S.S.; Seidman B.; Odekirk L.L.; Grillo R.S.; Martinez L.M.; Multani P.;
Alwine L.K.; McGarvey J.F.; Mollerus M.E.; Miller A.B.; Kotek L.W.;
Changlani M.; Zavaro S.H.; Munoz F.; Mehta P.M.; Helm R.J.; Farhat N.Z.;
Farsad R.; Raoof T.J.; Shultz J.H.; Geohas J.G.; Allaw M.A.; Dela Llana
A.; Gutmann J.E.; Inzerello A.T.; Alappat P.; George A.R.; Haddad T.M.;
Lillestol M.J.; Grodman R.; Peniston J.H.; Wadud K.; Garcia B.; Hamilton
M.E.; Lerman S.; Perloff D.E.; Graff A.; Saxena S.; Alvarado O.P.; Malik
A.; Reddy R.D.; Kinzfogl G.; Cornett G.M.; Norwood P.C.; Gilbert J.M.;
Willis J.G.; McGrew F.; Sharma S.; Castro M.A.; Cucher F.H.; Altafullah
I.M.; Khurana S.; Knutson T.J.; Kinnaman S.J.; Stuckey T.; Pudi K.K.;
Mayfield R.K.; Funk G.S.; Nixon W.A.; Dor I.; Boyett B.E.; Srivastava S.;
Elosegui A.M.; Isserman S.M.; Cheek H.B.; Promisloff S.D.; Tami L.F.; Zeig
S.; fitz-Patrick D.; Dave K.N.; Ahmad A.; Arain S.; Ballantyne C.M.; Doshi
A.; El Hafi S.E.; Feldman J.; Fragoso V.G.; Gilford T.; Hoffman A.S.;
Pouzar J.E.; Vivekananthan K.; Ansari S.H.; Strzinek R.A.; Crater T.A.;
Robinson J.G.; Fulmer J.J.; Patel A.M.; Pereira E.S.; Stich M.A.; Sultan
S.; Geskin G.; Ruoff G.E.; Gillespie E.; Bybee K.A.; Moriarty P.M.; Savin
V.; Agaiby J.M.; Melucci M.B.; Jantzi C.M.; Davidson E.; Smith W.B.;
Treasure C.B.; Wakefield P.H.; Deck K.; Edris M.A.; Gilmore R.M.; Seep
M.K.; Andersen J.L.; Detweiler R.O.; Rosenfeld J.C.; Strobl D.J.;
Steinhoff J.P.; Adams A.; Estevez R.; Molin C.J.; Kim C.Y.; Dy J.; Fox
K.E.; Farris N.R.; Wayne J.D.; Whitney R.T.; Randhawa P.M.; Mego D.M.;
MacDolnald L.; Caputo R.P.; Rigolosi R.; VanNatta B.; Pacheco T.R.;
El-Shahawy M.; Gonzalez E.J.; Guice M.J.; Cherlin R.S.; Bays H.E.;
Shoukfeh M.; Morris F.H.; Loy J.; Vora S.K.; Staab P.K.; Frisoli A.;
Kimmel M.A.; Cohen A.J.; Green C.B.; Whitlock L.; Butuk D.J.; McCartney
M.J.; Ables L.R.; Acosta R.; Alvarez J.G.; Barrera C.M.; Benitez O.;
Berenguer R.A.; Breton C.F.; Chiong R.; Delgado M.I.; Dufreny A.; Fialkow
J.A.; Franczek S.; Frias J.J.; Iglesias C.; Landron-Garcia L.; Llerena
S.N.; Martinez R.F.; Miranda A.A.; Morytko J.A.; Rodriguez I.J.; Sotolongo
R.; Suarez-Sarmiento A.; Terrelonge A.E.; Vaca C.E.; Venereo J.M.; Verdeza
C.; Zeno M.L.; Chilka S.; Felten W.R.; Hartman A.N.; Shayani S.S.; Duprez
D.; Knickelbine T.; Chambers J.D.; Cone C.L.; Broughton R.; Napoli M.C.;
Seaton B.L.; Smith S.K.; Reedy M.A.; Kesani M.K.; Nicol P.R.; Stringam
S.O.; Talano J.V.; Barnum O.; Desai V.; Montero M.; Jacks R.K.; Kostis
J.B.; Owen J.G.; Makam S.K.; Grosman I.; Underberg J.A.; Masri B.E.;
Peters S.S.; Serje J.; Lenhard M.J.; Glover R.; Paraboschi C.F.; Lim E.H.;
Connery L.; Kipgen W.; Bravo P.; DiGiovanna M.J.; Tayoum H.; Gabriel J.D.;
Ariani M.K.; Robinson M.F.; Clemens P.C.; Corder C.N.; Schifferdecker B.;
Tahirkheli N.K.; Hurling R.T.; Rendell M.S.; Shivaswamy V.; Madu I.J.;
Dahl C.F.; Ayesu K.; Kim C.; Barettella M.B.; Jamidar H.A.; Bloom S.A.;
Vora K.N.; Ong S.T.; Aggarwala G.; Sack G.; Blaze K.; Krichmar P.; Murcia
A.; Teltser M.; Villaman-Bencosme Y.; Fahdi I.E.; Williams D.G.; Lain
E.L.; Garcia H.L.; Karim S.N.; Francyk D.M.; Gordon M.B.; Palchick B.A.;
McKenzie M.E.; Gimness M.P.; Greiff J.; Ruiz-R L.; Vazquez-Tanus J.B.;
Schlager D.; Connelly T.; Soroka E.; Hastings W.L.; O'Dea D.J.; Purdy
D.A.; Jackson B.; Arcanese M.L.; Strain J.E.; Schmedtje J.F.; Davis M.G.;
Prasada S.; Scott D.L.; Vukotic G.; Akhtar N.; Larsen D.C.; Rhudy J.M.;
Zebrack J.S.; Bailey S.R.; Grant D.C.; Mora A.; Perez J.A.; Reyes R.G.;
Sutton J.C.; Brandon D.M.; First B.P.; Risser J.A.; Claudio J.;
Figueroa-Cruz W.L.; Sosa-Padilla M.A.; Tan A.E.; Traboulssi M.A.; Morcos
N.C.; Glaser L.A.; Bredlau C.E.; El Shahawy M.; Ramos M.J.; Kandath D.D.;
Kaluski E.; Akright L.; Rictor K.W.; Pluto T.M.; Hermany P.R.; Bellingar
B.; Clark G.B.; Herrod J.N.; Goisse M.; Hook M.; Barrington P.; Lentz
J.D.; Singal D.K.; Gleason G.P.; Lipetz R.S.; Schuchard T.N.; Bonner J.H.;
Forgosh L.B.; Lefebvre G.C.; Pierpoint B.E.; Radin D.M.; Stoller S.R.;
Segall N.; Shah S.A.; Ramstad D.S.; Nisnisan J.M.; Trippett J.M.; Benjamin
S.A.; Labissiere J.C.; Nashed A.N.; Maaieh M.; Aslam A.A.; Mandviwala M.;
Budoff M.J.; French W.J.; Vlach J.J.; DeStefano P.; Bayron C.J.; Fraser
N.J.; Sandberg J.H.; Fagan T.C.; Peart B.C.; Suryanarayana P.G.; Gupta
D.K.; Lee M.W.; Bertolet B.D.; Hartley P.A.; Kelberman M.; Behmanesh B.;
Buynak R.J.; Chochinov R.H.; Steinberg A.A.; Chandna H.; Bjasker K.R.;
Perlman R.L.; Ball E.M.; Pock J.; Singh S.; Baldari D.; Kaster S.; Lovell
J.P.; Horowitz B.S.; Gorman T.A.; Pham D.N.; Landzberg J.S.; Mootoo K.I.;
Moon E.; Krawczyk J.; Alfieri A.D.; Janik M.J.; Herrington D.M.;
Koilpillai R.N.; Waxler A.R.; Hoffman D.A.; Sahul Z.H.; Gumbiner B.; Cropp
A.; Fujita K.; Garzone P.; Imai K.; Levisetti M.; Plowchalk D.; Sasson S.;
Skaggs J.; Sweeney K.; Vincent J.
Institution
(Ridker, Glynn) Center for Cardiovascular Disease Prevention, Brigham and
Women's Hospital, Harvard Medical School, 900 Commonwealth Ave., Boston,
MA 02215, United States
(Revkin, Brunell, Curto, Masiukiewicz, Schwartz, Yunis, Shear) Pfizer, New
York, United States
(Amarenco) Paris-Diderot Sorbonne Paris Cite University, Paris, France
(Civeira) Universidad de Zaragoza, IIS Aragon, Zaragoza, Spain
(Flather) University of East Anglia, Norwich, United Kingdom
(Soran) Central Manchester University Hospital, Manchester, United Kingdom
(Gregoire, Tardif) Montreal Heart Institute, Universite de Montreal,
Montreal, Canada
(Jukema) Leiden University Medical Center, Leiden, Netherlands
(Kastelein) Academic Medical Center, University of Amsterdam, Amsterdam,
Netherlands
(Mosterd) Meander Medical Center, Amersfoort, Netherlands
(Karpov) Russian Cardiology Research and Production Center, Moscow,
Russian Federation
(Koenig) Deutsches Herzzentrum Munchen, Technische Universitat Munchen,
Munich Heart Alliance, Munich, Germany
(Lorenzatti) Cordoba Hospital, Cordoba, Argentina
(Manga) University of the Witwatersrand, Johannesburg, South Africa
(Miller) University of Maryland, Baltimore, United States
(Murin) University of Comenius, Bratislava, Slovakia
(Nicolau) Heart Institute, University of Sao Paulo Medical School, Sao
Paulo, Brazil
(Santos) Lipid Clinic Heart Institute, University of Sao Paulo Medical
School Hospital, Sao Paulo, Brazil
(Nissen) Cleveland Clinic Foundation, Cleveland, United States
(Ponikowski) Wroclaw Medical University, Wroclaw, Poland
(White) Green Lane Cardiovascular Service, Auckland City Hospital,
Auckland, New Zealand
(Wright) Mayo Clinic, Rochester, MN, United States
(Vrablik) First Faculty of Medicine, Charles University, Prague, Czechia
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND Bococizumab is a humanized monoclonal antibody that inhibits
proprotein convertase subtilisin- kexin type 9 (PCSK9) and reduces levels
of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the
efficacy of bococizumab in patients at high cardiovascular risk. METHODS
In two parallel, multinational trials with different entry criteria for
LDL cholesterol levels, we randomly assigned the 27,438 patients in the
combined trials to receive bococizumab (at a dose of 150 mg)
subcutaneously every 2 weeks or placebo. The primary end point was
nonfatal myocardial infarction, nonfatal stroke, hospitalization for
unstable angina requiring urgent revascularization, or cardiovascular
death; 93% of the patients were receiving statin therapy at baseline. The
trials were stopped early after the sponsor elected to discontinue the
development of bococizumab owing in part to the development of high rates
of antidrug antibodies, as seen in data from other studies in the program.
The median follow-up was 10 months. RESULTS At 14 weeks, patients in the
combined trials had a mean change from baseline in LDL cholesterol levels
of -56.0% in the bococizumab group and +2.9% in the placebo group, for a
between-group difference of -59.0 percentage points (P<0.001) and a median
reduction from baseline of 64.2% (P<0.001). In the lower-risk,
shorter-duration trial (in which the patients had a baseline LDL
cholesterol level of >=70 mg per deciliter [1.8 mmol per liter] and the
median follow-up was 7 months), major cardiovascular events occurred in
173 patients each in the bococizumab group and the placebo group (hazard
ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P = 0.94). In the
higher-risk, longer-duration trial (in which the patients had a baseline
LDL cholesterol level of >=100 mg per deciliter [2.6 mmol per liter] and
the median follow-up was 12 months), major cardiovascular events occurred
in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to
0.97; P = 0.02). The hazard ratio for the primary end point in the
combined trials was 0.88 (95% CI, 0.76 to 1.02; P = 0.08). Injection-site
reactions were more common in the bococizumab group than in the placebo
group (10.4% vs. 1.3%, P<0.001). CONCLUSIONS In two randomized trials
comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no
benefit with respect to major adverse cardiovascular events in the trial
involving lower-risk patients but did have a significant benefit in the
trial involving higher-risk patients. Copyright © 2017
Massachusetts Medical Society. All rights reserved.

<121>
Accession Number
615341291
Title
Clinical significance of chronic obstructive pulmonary disease in patients
undergoing elective total arch replacement: Analysis based on the Japan
adult cardiovascular surgery database.
Source
European Journal of Cardio-thoracic Surgery. 51 (4) (pp 761-766), 2017.
Article Number: ezw371. Date of Publication: 01 Apr 2017.
Author
Miyahara S.; Miyata H.; Motomura N.; Takamoto S.; Okita Y.
Institution
(Miyahara, Okita) Department of Surgery, Division of Cardiovascular
Surgery, Kobe University Graduate School of Medicine, Kobe, Japan
(Miyata) Health Care Quality Assessment, University of Tokyo, Tokyo, Japan
(Motomura) Department of Cardiovascular Surgery, Toho University Medical
Center Sakura Hospital, Chiba, Japan
(Takamoto) Mitsui Memorial Hospital, Tokyo, Japan
Publisher
European Association for Cardio-Thoracic Surgery (E-mail:
info@eacts.co.uk)
Abstract
OBJECTIVE: We investigated the impact of chronic obstructive pulmonary
disease (COPD) on in-hospital outcomes of patients undergoing conventional
total aortic arch replacement (TAR), based on the Japan Adult
Cardiovascular Surgery Database. METHOD(S): A total of 12 590
patients who underwent elective TAR between 2008 and 2013 were
retrospectively reviewed. Patients were divided into 4 categories: normal
respiratory function (control), with ratio of forced expiratory volume of
air in 1 s (FEV<inf>1</inf>) to forced vital capacity (FVC) of 76% or
greater (TAR, n = 10 040); mild COPD, with FEV<inf>1</inf>/FVC ratio
60-75% and/or use of bronchodilator (TAR, n = 1890); moderate COPD,
FEV<inf>1</inf>/FVC ratio 50 to 59% and/or use of steroids (TAR, n = 504);
and severe COPD, FEV<inf>1</inf>/FVC ratio less than 50% and/or presence
of respiratory failure (TAR, n = 156). RESULT(S): In-hospital
mortality was 5.7% (5.2% in controls, 7.0% in mild COPD, 9.3% in moderate
COPD and 9.0% in severe COPD). A significant trend towards the severity of
COPD was noted (P < 0.0001). A higher incidence of postoperative pneumonia
(6.0% in control, 11.0% in mild COPD, 12.3% in moderate COPD and 15.4% in
severe COPD; P < 0.0001) and a greater need for prolonged ventilation
(17.5% in control, 22.0% in mild COPD, 26.6% in moderate COPD and 29.5% in
severe COPD; P < 0.0001) were observed in cases of more severe COPD. The
odds ratio of moderate/severe COPD for in-hospital mortality was 1.44 with
confidence interval of 1.08-1.91 (P = 0.012). CONCLUSION(S): There
was a significant increase in in-hospital mortality and morbidity with
increasing severity of COPD in patients who underwent TAR. Copyright
© The Author 2017. Published by Oxford University Press on behalf of
the European Association for Cardio-Thoracic Surgery. All rights reserved.

<122>
Accession Number
615956392
Title
Evolocumab and clinical outcomes in patients with cardiovascular disease.
Source
New England Journal of Medicine. 376 (18) (pp 1713-1722), 2017. Date of
Publication: 04 May 2017.
Author
Sabatine M.S.; Giugliano R.P.; Keech A.C.; Honarpour N.; Wiviott S.D.;
Murphy S.A.; Kuder J.F.; Wang H.; Liu T.; Wasserman S.M.; Sever P.S.;
Pedersen T.R.; Fish M.P.; Abrahamsen T.E.; Im K.; Kanevsky E.; Bonaca
M.P.; Lira Pineda A.; Hanlon K.; Knusel B.; Somaratne R.; Kurtz C.; Scott
R.; Accini Mendoza J.L.; Amerena J.; Badariene J.; Burgess L.; Ceska R.;
Charng M.J.; Choi D.; Cobos J.L.; Dan G.A.; De Ferrari G.M.; Deedwania
P.C.; Chopra V.K.; Erglis A.; Ezhov M.V.; Ferreira J.; Filipova S.;
Gaciong Z.A.; Pasierski T.; Georgiev B.G.; Gonzalez-Galvez G.;
Gouni-Berthold I.; Schaufele T.; Hirayama A.; Huber K.; Rammer M.;
Kjaerulf Jensen H.; Wermuth S.; Jiang L.; Jukema J.W.; Kraydashenko O.;
Leiter L.A.; Lewis B.S.; Lopez-Miranda J.; Lorenzatti A.J.; Mach F.;
McAdam B.; Nilsson L.; Olsson A.; Rallidis L.; Rogelio G.G.; Kerr Saraiva
J.F.; Scheen A.; Schiele F.; Connolly D.; Siu C.W.; Tay L.; Thorgeirsson
G.; Tikkanen M.J.; Tokgozoglu S.L.; Toth K.; Viigimaa M.; Wan Ahmad W.A.;
Hennekens C.H.; Andreotti F.; Baigent C.; Brown W.V.; Davis B.R.; Newcomer
J.W.; Wood S.K.; LaRosa J.; Ansell B.; Lowe C.; Zahn L.; Awtry E.; Berger
C.; Croce K.; Desai A.; Gelfand E.; Ho C.; Leeman D.; Link M.; Norden A.;
Pande A.; Rost N.; Ruberg F.; Silverman S.; Singhal A.; Vita J.; Mackinnon
I.; Vogel D.R.; Leon de la Fuente R.; Perna E.; Amuchastegui M.; Pacora
F.; Hershson A.; Blumberg E.; Glenny J.A.; Colombo H.; Cuadrado J.A.;
Nicolosi L.; Rojas C.G.; Ulla M.R.; Hasbani E.G.; Cuneo C.; Lopez Santi
R.G.; Sanabria H.D.; Hrabar A.; Lozada A.; Begg A.; Lehman S.; Wittert G.;
Juergens C.; Kostner K.; Beltrame J.; Simpson R.; Sinhal A.; Adams M.;
Kritharides L.; Roberts Thomson P.; Cross D.; Thompson P.; Van Gaal W.;
Cox N.; Farshid A.; Hammett C.; Garrahy P.; Prasan A.; Horrigan M.;
Ebenbichler C.; Hanusch U.; Prager R.; Schernthaner G.; Luger A.;
Siostrzonek P.; Toplak H.; Bergler-Klein J.; Paulweber B.; Sinzinger H.;
Buysschaert I.; Thoeng J.; Vandekerckhove H.; Catez E.; Verheye S.;
Descamps O.; Hoffer E.; Wollaert B.; Chenu P.; van de Borne P.; De
Meulemeester M.; Friart A.; Charlier F.; De Raedt H.; Rietzschel E.;
Roelandt R.; Lalmand J.; Tavares Russo L.A.; Reis G.; Duarte Barbosa E.C.;
Vidotti M.H.; Fernandes Manenti E.R.; Dutra O.; Leaes P.E.; Rech R.L.;
Bertolim Precoma D.; Nicolau J.C.; Amoedo R.; Eliaschewitz F.G.; Pereira
A.; Kurtz Lisboa H.R.; Soares Piegas L.; Cunha Borges J.L.; Ferreira Rossi
P.R.; Pimentel Filho P.; Bodanese L.C.; de Sa Cunha R.; Moura Jorge J.C.;
Ardito W.R.; Barroso de Souza W.K.; Hissa M.; Izar M.C.; Manolova A.;
Kitova L.; Kinova E.; Tzekova M.; Velchev V.; Tarnovska-Kadreva R.;
Gotchev D.; Petrov I.; Raev D.; Trendafilova-Lazarova D.; Yotov Y.; Lazov
P.; Rahimi S.; St Amour E.; Constance C.; Pesant Y.; Hess A.; Anderson T.;
Sussex B.; Henein S.; Tsoukas G.; Pandey A.S.; Bergeron J.; Hart R.;
Gosselin G.; Chehayeb R.; Hamet P.; Hartleib M.; Mukherjee A.; Halperin
F.; Petrella R.; Bhargava R.; Lonn E.; Sabbah E.; Bata I.; Cha J.; Gaudet
D.; Chapman K.; Murthy D.; Nigro F.; Rupka D.; Gossard D.; Gupta M.;
Dowell A.; Mansour S.; Baass A.; Geadah C.; Huynh T.; Peterson S.; Poirier
P.; Sabe-Affaki G.; Vertes G.; Crowley D.; Duchesne L.; Pincetti Jofre
C.P.; Potthoff Cardenas S.; Conejeros Kindel C.; Saavedra Gajardo V.A.;
Lanas Zanetti F.; Sepulveda Varela P.A.; Stockins Fernandez B.A.; Li W.;
Li D.; Zhao S.; Li Z.; Wang J.; Yang Y.; Zhang L.; Yang P.; Zhang X.;
Huang H.; Xue L.; Zheng Z.; Huang W.; Dai H.; Su H.; Zeng X.; Zheng Y.;
Tang Y.; Yao Z.; Sun Y.; Du Y.; Ge Z.; Yan J.; Chen X.; Liu F.; Pei H.;
Yang X.; Cui H.; Gu Y.; Yang Z.; Li J.; Lian Y.; Cui Y.; Wang D.; Jiang
J.; Li X.; Chen J.; Mo Z.; Xu P.; He Y.; Zhou C.; Qu P.; Zhu Y.; Liu Y.;
Shen X.; Gao X.; Terront Lozano M.A.; Moncada Corredor M.A.; Hernandez
Triana E.; Botero Lopez R.; Coronel Arroyo J.A.; Quintero Baiz A.E.;
Sanchez Vallejo G.; Arana Londono C.; Molina de Salazar D.I.; Castellanos
Bueno R.; Manzur Jattin F.; Cure Cure C.A.; Sotomayor Herazo A.; Spinar
J.; Hala T.; Machkova M.; Klimsa Z.; Polasek R.; Jerabek O.; Kazdera P.;
Pozdisek Z.; Vaclavik J.; Frana P.; Elbl L.; Kucera D.; Kryza R.; Malecha
J.; Reichert P.; Sochor K.; Ludka O.; Kellnerova I.; Peterka K.; Zidkova
E.; Cech V.; Brabec T.; Fiserova N.; Kvasnicka J.; Rosolova H.; Nemecek
E.; Adamkova V.; Dunaj M.; Pojsl S.; Cepelak M.; Podpera I.; Kuchar L.;
Rysava D.; Burianova H.; Spinarova L.; Skrobakova J.; Charvat J.; Homza
M.; Zemanek J.; Koleckar P.; Karen I.; Krupicka J.; Blaha V.; Matuska J.;
Brotanek J.; Cifkova R.; Kuchar R.; Vomacka Z.; Kosek Z.; Hulinsky V.;
Krejcova H.; Kuchar J.; Jelinek Z.; Jelinek P.; Markdanner Lindgren L.;
Saetre Lihn A.; Korsgaard Thomsen K.; Bronnum-Schou J.; Nielsen H.;
Nielsen T.; Egstrup K.; Klausen I.C.; Mickley H.; Hove J.; Jeppesen J.;
Melchior T.; Schmidt E.B.; Valter I.; Rosenthal A.; Kaik J.; Kork A.; Alt
I.; Strand J.; Nieminen S.; Kahri J.; Suomi J.; Nyman K.; Strandberg T.E.;
Piippo T.; Savolainen M.; Vikman S.; Pucheu Y.; Cariou B.; Henry P.;
Ferrari E.; Montalescot G.; Ferrieres J.; Roubille F.; Bonnet B.;
Angoulvant D.; Range G.; Bammert A.; Delarche N.; Mariat C.; Cayla G.;
Durlach V.; Coisne D.; Paillard F.; Rouzier R.; Goralski M.; Khanoyan P.;
Cottin Y.; Ziegler O.; Khalife K.; Le Corvoisier P.; Motreff P.; Spaulding
C.; VanBelle E.; Bourhaial H.; Opitz C.; Kahrmann G.; Contzen C.; Appel
K.; Schenkenberger I.; Rinke A.; Trenk D.; Maus O.; Karakas M.; Hanefeld
M.; Darius H.; Hetzel G.; Munzel T.; Wohrle J.; Stawowy P.; Marten I.;
Isermann B.; Kast P.; Vorpahl M.; Bosiljanoff P.; Hengstenberg C.; Kassner
U.; Salbach P.; Fischer M.; Steiner S.; Wagner S.; Kraatz U.; von
Hodenberg E.; Weyland K.; Mantas I.; Tziakas D.; Bousboulas S.;
Patsilinakos S.; Mertzanos G.; Panagoulis C.; Bilianou H.; Skoumas I.;
Elisaf M.; Manolis A.; Moschos N.; Kochiadakis G.; Ntaios G.; Richter D.;
Athyros V.; Kolovou G.; Danias P.; Melidonis A.; Fan K.Y.Y.; Siu S.C.;
Hornyik A.; Lakatos F.; Zilahi Z.; Nagy K.; Laszlo Z.; Peterfai E.;
Lupkovics G.; Andreka P.; Merkely B.; Herczeg B.; Piros G.A.; Salamon C.;
Mark L.; Papp A.; Szakal I.; Edes I.; Mohacsi A.; Tomcsanyi J.; Hajko E.;
Nagy A.; Papp E.; Kiss R.; Karadi I.; Sigurdsson A.; Jain A.; Pai R.;
Kothiwale V.; Kulkarni G.; Mahajan A.; Aggarwal S.; Mehta V.; Rajadhyaksha
G.; Joshi A.; Khandait V.; Parmar M.; Tyagi S.; Airody Govinda R.; Dwivedi
S.K.; Parikh K.; Pothineni R.B.; Solanki B.; O'Donnell M.; Crean P.;
Barton J.; Shechter M.; Shotan A.; Klutstein M.; Chorin E.; Gavish D.;
Kracoff O.; Atar S.; Rigler S.; Hasin Y.; Schiff E.; Merlini P.; Rapezzi
C.; Pirro M.; Gonnelli S.; Floresta A.M.; Mennuni M.; Ardissino D.; Senni
M.; Marenzi G.; Marcucci R.; Sampietro T.; Cosmi F.; Perrone Filardi P.;
De Caterina R.; Fedele F.; Moretti L.; Biasucci L.M.; Ferri C.; Go Y.;
Kiyosue A.; Higashi Y.; Tokunaga T.; Kawasaki T.; Sakagami S.; Namba S.;
Saku K.; Oku K.; Arakawa T.; Iida H.; Nakamura Y.; Yamamoto K.; Hata Y.;
Katsuda Y.; Koga Y.; Shimizu M.; Uehara H.; Kajiyama S.; Okamoto H.;
Shinozaki T.; Fujino Y.; Funazaki T.; Higa N.; Kaigawa K.; Koike A.;
Nakane H.; Sato K.; Satoh Y.; Shirasawa K.; Sugino H.; Tanabe J.; Uemura
O.; Yoshimichi G.; Akai A.; Himeno H.; Inage T.; Inoko M.; Kadokami T.;
Noguchi Y.; Yamashita K.; Yasumura Y.; Yuge M.; Hosokawa S.; Kawamitsu K.;
Kozuma K.; Matsuo H.; Nakashima E.; Okada M.; Wada A.; Yokoya K.; Iwade
K.; Kawabata K.; Tanno H.; Ako J.; Fujita H.; Izumiya Y.; Kanno M.;
Nunohiro T.; Ohmura H.; Ueno T.; Kakurina N.; Jasinkevica I.; Stukena I.;
Veze I.; Eglite R.; Teterovska D.; Sime I.; Strazdiene V.; Venceviciene
L.; Gustiene O.; Radzeviciene-Jurgute R.; Kucinskiene A.; Maskon O.; Lee
C.Y.; Erng T.; Gan H.W.; Mohamed Yusof A.K.; Ramanathan G.L.; Liew H.;
Lopez Alvarado A.; Nevarez Ruiz L.A.; De los Rios Ibarra M.O.; Bazzoni
Ruiz A.E.; Ramos Lopez G.A.; Llamas Esperon G.A.; De la Pena Topete
G.D.J.; Violante Ortiz R.M.; Illescas Diaz J.J.; Leon Gonzalez S.; Sanchez
Diaz C.J.; Mendez Machado G.F.; Venegas Carrillo L.A.; Aldrete Velasco
J.A.; Cardona Munoz E.G.; Leiva Pons J.L.; Perez Alva J.C.; van der Zwaan
C.; Oomen A.; van de Wal R.; Magro M.; Boswijk D.; Janus C.; Groutars R.;
Tonino W.; Cornel J.H.; Oude Ophuis A.; Troquay R.; Liem A.; Westendorp
I.; Van Hessen M.; Lok D.; De Nooijer C.; Den Hartog F.; Van Beek E.;
Bendermacher P.; Jansen R.; Romer T.; Rensing B.; Hersbach F.; Herrman J.;
Ladyjanskaia G.; Karalis I.; Linssen G.; Bokern M.; Visman A.; Kooij A.;
Monajemi H.; Lieverse A.; Baker J.; Tie S.; Risberg K.; Hysing J.; Hoivik
H.O.; Norheim P.; Solnor L.; Hovland A.; Kjaernli T.; Jocson G.; Coching
R.M.; Batalla E.; Go A.; Habaluyas R.; Barcinas R.; Sy R.A.; Estepar R.A.;
Germar A.; Trebacz J.; Szymkowiak K.; Wnetrzak-Michalska R.; Kopaczewski
J.; Przekwas-Jaruchowska M.; Kania G.; Zabowka M.; Mirek-Bryniarska E.;
Dabrowska M.; Napora P.; Konieczny M.; Spyra J.; Lysek R.; Pijanowski Z.;
Grzegorzewski B.; Bednarkiewicz Z.; Kinasz L.; Antkowiak-Piatyszek K.;
Stania K.; Szpajer M.; Staneta P.; Skonieczny G.; Ksiezycka-Majczynska E.;
Blicharski T.; Piepiorka M.; Wozakowska-Kaplon B.; Zechowicz T.; Ilkowski
J.; Lubiszewska B.; Hiczkiewicz J.; Wierzbicka K.; Kosior D.; Garbocz P.;
Kubica J.; Raczak G.; Wozniak I.; Cygler J.; Kramarczuk E.; Bystryk L.;
Pentela-Nowicka J.; Dabrowski M.; Podolec P.; Zieba B.; Mosiewicz J.;
Dubaniewicz W.; Banach M.; Tyszecka G.; Lepich T.; Rychlewska-Hanczewska
A.; Guzik T.; Monteiro P.; Pereira H.; Oliveira L.; Matos P.; Soares
Goncalves S.; Leitao A.; Vasco Salgado A.; Timoteo A.T.; Pintilei E.;
Badila E.; Militaru C.; Tudoran M.; Arsenescu-Georgescu C.; Mitu F.;
Zdrenghea D.; Lighezan D.; Teodorescu I.; Popescu M.I.; Coman I.; Vintila
M.M.; Vishnevsky A.; Lukyanov Y.; Blokhin A.; Kostenko V.; Shvarts Y.;
Markov V.; Motylev I.; Dronov D.; Sherenkov A.; Barbarash O.; Shutemova
E.; Bolshakova O.; Kobalava Z.; Voevoda M.; Treshkur T.; Zrazhevskiy K.;
Pimenov L.; Solovev O.; Tarasov N.; Arkhipov M.; Freidlin M.; Shalaev S.;
Yakhontova P.; Shustov S.; Goloshchekin B.; Panov A.; Bart B.; Bubnova M.;
Gordeev I.; Osipova I.; Tereshenko S.; Solovieva E.; Meshkov A.;
Zateyshchikov D.; Tan J.L.; Subramaniam T.; Pella D.; Fulop P.; Antalik
L.; Dzupina A.; Banikova A.; Sosovec D.; Urgeova L.; Mazur J.; Hranai M.;
Banik M.; Vinanska D.; Lennerova J.; Kovar F.; Pastrnakova E.; Uhliar R.;
Blasko P.; Gonsorcik J.; Lukacova J.; Oriesek R.; Hatalova K.; du Toit M.;
Ebrahim I.; Vawda G.; Lipschitz S.; Blignaut S.; Engelbrecht J.; Coetzer
T.F.; Pretorius M.; Urbach D.; Badat A.; Pillay S.; Van Zyl L.; Abelson
M.; van der Walt E.; Moodley R.; Jacovides A.; Oosthuysen W.M.; Klug E.;
Lottering H.; Kok J.; Saaiman J.; Dawood S.; De Jong D.M.; Kapp C.;
Makotoko E.; Bayat J.; Sarvan M.; Vally T.; Stapelberg A.; Kim M.; Bae J.;
Cho Y.; Kim S.; Han K.H.; Her S.; Kim B.; Lee S.; Hong B.; Kim W.; Rha S.;
Jeong M.; Shin G.J.; Vida Gutierrez M.; Valdes Chavarri M.; Pinto Sala X.;
Gonzalez Juanatey J.R.; Civeira Murillo F.; Zamorano Gomez J.L.; Lekuona
Goya I.; Iniguez Romo A.; Cordero Fort A.; Ascaso Gimilio J.F.; Millan
Nunez-Cortes J.; Lindholm C.; Soderberg S.; Suutari A.; Berglund S.; Mooe
T.; Kusiak D.; Bandh S.; Dahlen G.; Olsson S.; Witt N.; Tyden P.;
Johansson P.; Cizinsky S.; Falck G.; Pettersson S.I.; Rasmanis G.;
Ostergren J.; Moccetti T.; Beer H.J.; Eberli F.; Krahenbuhl S.; Linka A.;
Ackermann D.; Michel P.; Yeh H.; Tsai C.F.; Wu C.; Hsia C.; Juang J.;
Hsieh I.; Lai W.; Huang C.; Hsieh Y.; Sahin T.; Duzenli M.; Yigit Z.;
Demir M.; Yilmaz M.B.; Muderrisoglu I.H.; Kirma C.; Ercan E.; Kayikcioglu
L.; Balbay Y.; Lymar I.; Kulynych O.; Prokhorov O.; Karpenko O.; Kraiz I.;
Vakaliuk I.; Stanislavchuk M.; Korzh O.; Rudyk I.; Zhurba S.; Svishchenko
Y.; Tseluyko V.; Gyrina O.; Reshotko D.; Kopytsya M.; Volkov V.; Myshanych
G.; Rebrov B.; Rishko M.; Rudenko L.; Shatylo V.; Parkhomenko O.; Yena L.;
Golovchenko O.; Sorokina I.; Malynovsky Y.; Ivan P.; Blagden M.; Dear H.;
Mathew A.; Lagocki S.; Kondagunta V.; Ahsan A.; McKinnon C.; Douglas F.;
Thom S.; Fiore G.; Caulfield M.; Lynch M.; Thomas H.; Bain S.; Hall A.;
McNally D.; Fisher M.; Keeling P.; Al-Bahrani A.; Lip G.; Ellery A.;
Purohit J.; Travill C.; Cappuccio F.; Davis G.; Gaunt R.; Adlam D.;
Asamoah N.; Jaafar F.; McCormack T.; Jupp B.; Pye M.; Ainsworth P.;
Chauhan A.; Paul N.; Fairlie H.; Fox C.; Muzulu S.; Trevelyan J.; Aggarwal
R.; Issa B.; Saravanan P.; Cruickshank K.; Gorog D.; Heller S.; Newby D.;
Nicolson A.; Hare P.O.; Donnelly P.; Rutherfurd S.; de Belder M.;
Finlayson J.; Harvey J.; Hoye A.; Kingston D.; Sarkar D.; Negahban A.;
Webster J.; Wyatt N.; Muir S.; Cummings M.; Mackenzie I.; Senior R.; Capps
N.; Fotherby K.; McIntyre H.; Aldegather J.; Dixon L.; Saksena R.; Butler
R.; Ramstad D.; Pierpont B.; Levinson D.; Mohammed A.; Haddad T.; Goel A.;
Dave K.; Haught W.H.; Desire A.; Hershon K.; Napoli M.; Tami L.;
Rothschild R.; Khurana S.; Gupta D.; Cheung D.; Hearne S.; Grubb S.;
Miller A.; Baird I.; Marcus A.; Srivastava S.; Forgosh L.; Fritz R.; Mays
M.; Bertolet B.; Reddy J.; Khan M.; Nakhle S.; Dill S.; Fishbein G.; Khan
B.; Marais H.; Reschak M.; Malone M.; Nadar V.; Whitney R.; Reichman A.;
Reyes H.; El Shahawy M.; Rabinowitz A.; Weinstein D.; Farhat N.; Onyema
D.; Potu R.; Runquist L.; Barnum O.; Crater T.; Fialkow J.; Shah A.;
Thompson C.; Wiseman A.; Doyle T.; Henderson D.; Herzog W.; Schnitzler R.;
Carr K.; Davis M.; Nagajothi N.; Olsen S.; Rogers W.; Rubino J.; Singh I.;
Tarleton G.; Bhagwat R.; Clardy D.; Jardula M.; Robinson J.; Torres M.;
Vijay N.; Farris N.; Lillo J.; Moriarty P.; Recknor C.; Berlacher P.;
Christensen T.; Gabra N.; Issa M.; Janik M.; Lawless A.; Molter D.; Stout
E.; Brezina B.; Claxton E.; Linsky R.; Poock J.; Remler R.; Roseman H.;
Schramm E.; Al-Joundi T.; Amin J.; Hitchcock J.; Isserman S.; Kirstein J.;
Rider J.; Shalek M.; Sherman H.; Bernstein M.; Chandra L.; Hatharasinghe
R.; Ibrahim H.; Iteld B.; Linzmeyer K.; Seaton B.; Zeig S.; Christofides
E.; Dunbar R.; Griffin S.; Kohli N.; Koren M.; Pharr W.; Purdy D.; Spencer
R.; Yeoman G.; Banerjee S.; Cheek H.B.; Engel E.; Hamroff G.; Huling R.;
Kozlowski L.; Levin P.; Makam S.; Meengs M.; Bhushan R.; Erickson B.;
Herman L.; Lo E.; McDowell E.; McGrew F.; Miller M.; Ord J.; Webel R.;
Wilhoit G.; Wise J.; Yang E.; Budoff M.; Collins J.; Dauber I.; Dobkin L.;
Focil A.; Gandy W.; Pasquini J.; Ramos M.; Rodriguez D.; Rosenson R.;
Sanford K.; Schlau A.; Snyder B.; Stonesifer L.; Tang A.; De Souza J.;
Elam M.; French J.; Guyton J.; Hage Korban E.; Kereiakes D.; King M.; Loh
I.; Navarro J.; Simons R.; Tobin T.; Younis L.; Aboufakher R.; Baldari D.;
Ballantyne C.; Broughton R.; Eaton C.; Johnston J.; Simon W.; Thomson S.;
Vora K.; Youngman D.; Alzohaili O.; Auerbach E.; Brown C.; Burrough B.;
Chen Y.; Gilpatrick M.; Landzberg J.; Mitchell C.; Rice L.; Rubenfire M.;
Sofley C.W.; Strobl D.; Atassi K.; Davila W.; Diogo J.; Fagan T.; Joffe
I.; Krishna J.; Osea E.; Penny W.; Rowe W.; Shapiro M.; Welker J.; Benton
R.; Dobratz D.; Fortuin F.; Graham J.; Henry B.; Kusnick B.; Lutskiy M.;
McRae A.; Saway W.; Scott J.; Shah M.; Weinberg B.; Zarich S.; Acheatel
R.; Case C.; Earl J.; Fernandez S.; Giugliano G.; Handelsman Y.; Hermany
P.; Holder S.; Kashyap M.; Khan A.; Lader E.; Peniston J.; Raoof T.; Sacco
J.; Shore K.; Spriggs D.; Stringam S.; Tahirkheli N.; Delgado E.; Derian
W.; Greenwald J.; Harris M.; Jackson R.; Marhefka G.; McElveen W.; Mooss
A.; Morris P.; Murray J.; Pearlstein P.; Raisinghani A.; Rezkalla S.;
Sakhrani L.; Schreibman D.; Shaoulian E.; Steinsapir J.; Yataco A.; De La
Cruz A.; Fredrick M.; Goldenberg E.; Lee D.; McCullum K.; McLellan B.;
Stephens L.; Wilson S.; Alfieri A.; Mandviwala M.; ORourke D.; Samal A.;
Schmedtje J.; Waxman F.; Carhart R.; Clements B.; Dyke C.; Ghali J.;
Gruberg L.; Hack T.; Jehle A.; Pogue B.; Schooley C.; Shifrin G.
Institution
(Sabatine, Giugliano, Wiviott, Murphy, Kuder) Division of Cardiovascular
Medicine, Brigham and Women's Hospital, 60 Fenwood Rd, Boston, MA 02115,
United States
(Keech) Sydney Medical School, National Health and Medical Research
Council Clinical Trials Centre, University of Sydney, Sydney, Australia
(Honarpour, Wang, Liu, Wasserman) Amgen, Thousand OaksCAUnited States
(Sever) International Centre for Circulatory Health, National Heart and
Lung Institute, Imperial College London, London, United Kingdom
(Pedersen) Oslo University Hospital, Ulleval and Medical Faculty,
University of Oslo, Oslo, Norway
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND Evolocumab is a monoclonal antibody that inhibits proprotein
convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density
lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it
prevents cardiovascular events is uncertain. METHODS We conducted a
randomized, double-blind, placebo-controlled trial involving 27,564
patients with atherosclerotic cardiovascular disease and LDL cholesterol
levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were
receiving statin therapy. Patients were randomly assigned to receive
evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching
placebo as subcutaneous injections. The primary efficacy end point was the
composite of cardiovascular death, myocardial infarction, stroke,
hospitalization for unstable angina, or coronary revascularization. The
key secondary efficacy end point was the composite of cardiovascular
death, myocardial infarction, or stroke. The median duration of follow-up
was 2.2 years. RESULTS At 48 weeks, the least-squares mean percentage
reduction in LDL cholesterol levels with evolocumab, as compared with
placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4
mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001).
Relative to placebo, evolocumab treatment significantly reduced the risk
of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%];
hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P<0.001)
and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio,
0.80; 95% CI, 0.73 to 0.88; P<0.001). The results were consistent across
key subgroups, including the subgroup of patients in the lowest quartile
for baseline LDL cholesterol levels (median, 74 mg per deciliter [1.9 mmol
per liter]). There was no significant difference between the study groups
with regard to adverse events (including new-onset diabetes and
neurocognitive events), with the exception of injection-site reactions,
which were more common with evolocumab (2.1% vs. 1.6%). CONCLUSIONS In our
trial, inhibition of PCSK9 with evolocumab on a background of statin
therapy lowered LDL cholesterol levels to a median of 30 mg per deciliter
(0.78 mmol per liter) and reduced the risk of cardiovascular events. These
findings show that patients with atherosclerotic cardiovascular disease
benefit from lowering of LDL cholesterol levels below current
targets. Copyright © 2017 Massachusetts Medical Society.

<123>
Accession Number
618057916
Title
Female sex is not a risk factor for post procedural mortality in coronary
bypass surgery in the elderly: A secondary analysis of the GOPCABE trial.
Source
PLoS ONE. 12 (8) (no pagination), 2017. Article Number: e0184038. Date of
Publication: August 2017.
Author
Faerber G.; Zacher M.; Reents W.; Boergermann J.; Kappert U.; Boening A.;
Diegeler A.; Doenst T.
Institution
(Faerber, Doenst) Department of Cardiothoracic Surgery, Jena University
Hospital, Friedrich-Schiller-University of Jena, Jena, Germany
(Zacher, Reents, Diegeler) Cardiovascular Clinic Bad Neustadt, Bad
Neustadt, Germany
(Boergermann) Clinic for Heart, Thoracic and Cardiovascular Surgery, Heart
and Diabetes Center NRW, Ruhr University Bochum, Bad Oeynhausen, Germany
(Kappert) Department of Cardiac Surgery, Cardiovascular Institute,
University of Dresden, Dresden, Germany
(Boening) Department of Cardiovascular Surgery, University of Giesen,
Giesen, Germany
Publisher
Public Library of Science (E-mail: plos@plos.org)
Abstract
Objective: Female sex is considered a significant risk in cardiac surgery
and is included in the majority of scores for risk assessment. However,
the evidence is controversial and older women undergoing cardiac surgery
have not specifically been investigated. We assessed the influence of
female sex on surgical risk (30-day mortality) in a secondary analysis of
the GOPCABE trial (German Off-Pump Coronary Artery Bypass grafting in the
Elderly (GOPCABE) trial, comparing on- to off-pump) and also evaluated its
impact on risk prediction from commonly used risk scores. Method(s):
We performed logistic regression analyses on the GOPCABE trial population,
where patients were randomized to either on- or off-pump CABG. The study
was performed in 12 cardiac surgery centers in Germany and analyzed 2394
patients having undergone CABG at age >=75 years (1187 on-pump, 1207
off-pump). Of the 2394 patients, 755 (32%) were women. The logistic
EuroSCORE and the German KCH score were calculated as expected (E)
mortality and values were compared to observed (O) 30-day mortality (O/E
ratio). Result(s): There was no difference in mortality or major
cardiovascular adverse events after 30 days between men and women for both
on- and off-pump CABG (men: on- vs. off-pump OR = 0.90, 95%-CI:
[0.63;1.27]; women: on- vs. off-pump OR = 1.07, 95%-CI: [0.62;1.87]).
Therefore, groups were combined for further analyses. Both men and women
had considerable and similar comorbidities. Expected mortality was
significantly higher for women than for men (logistic EuroSCORE:
8.88+/-6.71% vs. 7.99+/-6.69%, p = 0.003; KCH score: 4.42 +/-3.97% vs.
3.57+/-3.65%, p = 0.001). However, observed mortality rates (O) tended to
be even lower in women (2.1% vs. 3.0%). The O/E ratio was closer to 1 in
men than in women (0.84 vs. 0.47). Excluding female sex from the risk
models increased O/E ratio to 0.69. Conclusion(s): Female sex is not
a risk factor in coronary bypass surgery in the GOPCABE population. The
result is the same for on- and off-pump surgery. Since female sex is a
component of most risk scores, the findings may identify a potential
inaccuracy in current surgical risk assessment, specifically for elderly
women. Trial registration: Clinicaltrials.gov GOPCABE trial No.
NCT00719667. Copyright © 2017 Faerber et al. This is an open
access article distributed under the terms of the Creative Commons
Attribution License, which permits unrestricted use, distribution, and
reproduction in any medium, provided the original author and source are
credited.

<124>
Accession Number
617958898
Title
Effect of cerebral embolic protection devices on CNS infarction in
surgical aortic valve replacement: A randomized clinical trial.
Source
JAMA - Journal of the American Medical Association. 318 (6) (pp 536-547),
2017. Date of Publication: 08 Aug 2017.
Author
Mack M.J.; Acker M.A.; Gelijns A.C.; Overbey J.R.; Parides M.K.; Browndyke
J.N.; Groh M.A.; Moskowitz A.J.; Jeffries N.O.; Ailawadi G.; Thourani
V.H.; Moquete E.G.; Iribarne A.; Voisine P.; Perrault L.P.; Bowdish M.E.;
Bilello M.; Davatzikos C.; Mangusan R.F.; Winkle R.A.; Smith P.K.; Michler
R.E.; Miller M.A.; O'Sullivan K.L.; Taddei-Peters W.C.; Rose E.A.; Weisel
R.D.; Furie K.L.; Bagiella E.; Moy C.S.; O'Gara P.T.; Messe S.R.
Institution
(Mack, Winkle) Department of Cardiothoracic Surgery, Baylor Research
Institute, Baylor Scott and White Health, Plano, TX, United States
(Acker) Division of Cardiovascular Surgery, Department of Surgery,
University of Pennsylvania School of Medicine, Philadelphia, United States
(Gelijns, Overbey, Parides, Moskowitz, Moquete, O'Sullivan, Bagiella)
International Center for Health Outcomes and Innovation Research,
Department of Population Health Science and Policy, Icahn School of
Medicine at Mount Sinai, New York, NY, United States
(Browndyke) Division of Geriatric Behavioral Health, Department of
Psychiatry and Behavioral Sciences, Duke University Medical Center,
Durham, NC, United States
(Groh, Mangusan) Cardiovascular and Thoracic Surgery, Mission Health and
Hospitals, Asheville, NC, United States
(Jeffries) Office of Biostatistics Research, National Heart, Lung, and
Blood Institute, Bethesda, MD, United States
(Ailawadi) Division of Thoracic and Cardiovascular Surgery, University of
Virginia School of Medicine, Charlottesville, United States
(Thourani) Clinical Research Unit, Division of Cardiothoracic Surgery,
Emory University School of Medicine, Atlanta, GA, United States
(Iribarne) Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon,
NH, United States
(Voisine) Institut Universitaire de Cardiologie de Quebec, Hopital Laval,
Quebec, QC, Canada
(Perrault) Montreal Heart Institute, University of Montreal, Montreal, QC,
Canada
(Bowdish) Department of Surgery, Keck School of Medicine, University of
Southern California, Los Angeles, United States
(Bilello, Davatzikos) Department of Radiology, University of Pennsylvania,
Philadelphia, United States
(Smith) Division of Cardiovascular and Thoracic Surgery, Department of
Surgery, Duke University Medical Center, Durham, NC, United States
(Michler) Department of Cardiothoracic Surgery, Montefiore Medical Center,
Albert Einstein College of Medicine, New York, NY, United States
(Miller, Taddei-Peters) Division of Cardiovascular Sciences, National
Heart, Lung, and Blood Institute, Bethesda, MD, United States
(Rose) Department of Cardiac Surgery, Mount Sinai Health System, New York,
NY, United States
(Weisel) Peter Munk Cardiac Centre, Division of Cardiovascular Surgery,
Toronto General Hospital, University Health Network, Toronto, ON, Canada
(Weisel) Division of Cardiac Surgery, University of Toronto, Toronto, ON,
Canada
(Furie) Department of Neurology, Rhode Island Hospital, Miriam Hospital
and Bradley Hospital, Warren Alpert Medical School, Brown University,
Providence, RI, United States
(Moy) Division of Clinical Research, National Institute of Neurological
Disorders and Stroke, Bethesda, MD, United States
(O'Gara) Cardiovascular Division, Brigham and Women's Hospital, Boston,
MA, United States
(Messe) Department of Neurology, University of Pennsylvania School of
Medicine, Philadelphia, United States
Publisher
American Medical Association (E-mail: smcleod@itsa.ucsf.edu)
Abstract
IMPORTANCE: Stroke is a major complication of surgical aortic valve
replacement (SAVR). OBJECTIVE(S): To determine the efficacy and
adverse effects of cerebral embolic protection devices in reducing
ischemic central nervous system (CNS) injury during SAVR. DESIGN, SETTING,
AND PARTICIPANTS: A randomized clinical trial of patients with calcific
aortic stenosis undergoing SAVR at 18 North American centers between March
2015 and July 2016. The end of follow-up was December 2016. INTERVENTIONS:
Use of 1 of 2 cerebral embolic protection devices (n = 118 for
suction-based extraction and n = 133 for intra-aortic filtration device)
vs a standard aortic cannula (control; n = 132) at the time of SAVR. MAIN
OUTCOMES AND MEASURES: The primary end point was freedom from clinical or
radiographic CNS infarction at 7 days (+/- 3 days) after the procedure.
Secondary end points included a composite of mortality, clinical ischemic
stroke, and acute kidney injury within 30 days after surgery; delirium;
mortality; serious adverse events; and neurocognition. RESULT(S):
Among 383 randomized patients (mean age, 73.9 years; 38.4% women; 368
[96.1%] completed the trial), the rate of freedom from CNS infarction at 7
days was 32.0% with suction-based extraction vs 33.3% with control
(between-group difference, -1.3%; 95% CI, -13.8% to 11.2%) and 25.6% with
intra-aortic filtration vs 32.4% with control (between-group difference,
-6.9%; 95% CI, -17.9% to 4.2%). The 30-day composite end point was not
significantly different between suction-based extraction and control
(21.4% vs 24.2%, respectively; between-group difference, -2.8% [95% CI,
-13.5% to 7.9%]) nor between intra-aortic filtration and control (33.3% vs
23.7%; between-group difference, 9.7% [95% CI, -1.2% to 20.5%]). There
were no significant differences in mortality (3.4% for suction-based
extraction vs 1.7% for control; and 2.3% for intra-aortic filtration vs
1.5% for control) or clinical stroke (5.1% for suction-based extraction vs
5.8% for control; and 8.3% for intra-aortic filtration vs 6.1% for
control). Delirium at postoperative day 7 was 6.3% for suction-based
extraction vs 15.3% for control (between-group difference, -9.1%; 95% CI,
-17.1% to -1.0%) and 8.1% for intra-aortic filtration vs 15.6% for control
(between-group difference, -7.4%; 95% CI, -15.5% to 0.6%). Mortality and
overall serious adverse events at 90 days were not significantly different
across groups. Patients in the intra-aortic filtration group vs patients
in the control group experienced significantly more acute kidney injury
events (14 vs 4, respectively; P = .02) and cardiac arrhythmias (57 vs 30;
P = .004). CONCLUSIONS AND RELEVANCE: Among patients undergoing SAVR,
cerebral embolic protection devices compared with a standard aortic
cannula did not significantly reduce the risk of CNS infarction at 7 days.
Potential benefits for reduction in delirium, cognition, and symptomatic
stroke merit larger trials with longer follow-up. TRIAL REGISTRATION:
clinicaltrials.gov Identifier: NCT02389894. Copyright © 2017
American Medical Association. All rights reserved.

<125>
Accession Number
614518952
Title
Effects of low-dose atrial natriuretic peptide infusion on cardiac
surgery-associated acute kidney injury: A multicenter randomized
controlled trial.
Source
Journal of Critical Care. 38 (pp 253-258), 2017. Date of Publication: 01
Apr 2017.
Author
Mitaka C.; Ohnuma T.; Murayama T.; Kunimoto F.; Nagashima M.; Takei T.;
Iguchi N.; Tomita M.
Institution
(Mitaka) Department of Anesthesiology, Tokyo Medical and Dental University
Hospital of Medicine, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
(Mitaka) Department of Anesthesiology and Pain Medicine, Juntendo
University, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
(Ohnuma, Murayama) Intensive Care Unit, Department of Anesthesiology,
Saitama Medical Center, Jichi Medical University, 1-847 Amanuma,
Ohmiya-ku, Saitama 330-8503, Japan
(Kunimoto) Intensive Care Unit, Gunma University Hospital, 3-39-15 Shouwa,
Maebashi, Gunma 371-8511, Japan
(Nagashima, Takei) Intensive Care Unit, Yokohama City Minato Red Cross
Hospital, 3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa 231-8682,
Japan
(Iguchi) Intensive Care Unit, Osaka University Hospital, 2-15 Yamadaoka,
Suita, Osaka 565-0871, Japan
(Tomita) Clinical Research Center, Tokyo Medical and Dental University
Hospital of Medicine 1-5-45 Yushima, Tokyo 113-8519, Japan
Publisher
W.B. Saunders
Abstract
Purpose To evaluate the effects of atrial natriuretic peptide (ANP) on
renal function and medical costs in patients with acute kidney injury
(AKI) associated with cardiac surgery. Materials and methods The Japanese
trial for AKI in Post-cardiovascular surgery patients by ANP (JAPAN) was a
prospective, multicenter, randomized, double-blind, placebo-controlled
study conducted in 11 hospitals in Japan. Acute kidney injury was defined
as an increase in serum creatinine of at least 0.3 mg/dL within 48 hours.
The patients were randomly assigned to receive ANP (0.02 mug
kg-1 min-1) or placebo. The primary end point was a
change in renal function. The secondary end points were a need for renal
replacement therapy, the lengths of intensive care unit and hospital
stays, and medical costs incurred over the 90-day follow-up. Results Of
the 77 randomized patients, 37 were in the ANP group and 40 were in the
placebo group. Although ANP significantly (P =.018) increased urine
output, it did not significantly improve renal function compared with
placebo. There were no significant differences between the groups in the
renal replacement therapy rate, the lengths of the intensive care unit and
hospital stays, or medical costs. Conclusion Atrial natriuretic peptide
infusion did not show a renoprotective effect or cost-saving effect in the
treatment of cardiac surgery-associated AKI. Copyright © 2016 The
Authors

<126>
Accession Number
615509473
Title
Fractional Flow Reserve-Guided Complete Revascularization Improves the
Prognosis in Patients with ST-Segment-Elevation Myocardial Infarction and
Severe Nonculprit Disease.
Source
Circulation: Cardiovascular Interventions. 10 (4) (no pagination), 2017.
Article Number: e004460. Date of Publication: 01 Apr 2017.
Author
Lonborg J.; Engstrom T.; Kelbaek H.; Helqvist S.; Klovgaard L.; Holmvang
L.; Pedersen F.; Jorgensen E.; Saunamaki K.; Clemmensen P.; De Backer O.;
Ravkilde J.; Tilsted H.-H.; Villadsen A.B.; Aaroe J.; Jensen S.E.;
Raungaard B.; Kober L.; Hofsten D.E.
Institution
(Lonborg, Engstrom, Helqvist, Klovgaard, Holmvang, Jorgensen, Saunamaki,
De Backer, Tilsted, Kober, Hofsten) Department of Cardiology,
Rigshospitalet, University of Copenhagen, Blegdamsvej 9, Copenhagen 2100,
Denmark
(Kelbaek, Clemmensen) Department of Cardiology, Roskilde Hospital, Denmark
(Pedersen) Department of Cardiology, Nykoebing Falster Hospital, Denmark
(Ravkilde, Villadsen, Aaroe, Jensen, Raungaard) Department of Cardiology,
Aalborg University Hospital, Denmark
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
Background - The impact of disease severity on the outcome after complete
revascularization in patients with ST-segment-elevation myocardial
infarction and multivessel disease is uncertain. The objective of this
post hoc study was to evaluate the impact of number of diseased vessel,
lesion location, and severity of the noninfarct-related stenosis on the
effect of fractional flow reserve-guided complete revascularization.
Methods and Results - In the DANAMI-3-PRIMULTI study (Primary PCI in
Patients With ST-Elevation Myocardial Infarction and Multivessel Disease:
Treatment of Culprit Lesion Only or Complete Revascularization), we
randomized 627 ST-segment-elevation myocardial infarction patients to
fractional flow reserve-guided complete revascularization or
infarct-related percutaneous coronary intervention only. In patients with
3-vessel disease, fractional flow reserve-guided complete
revascularization reduced the primary end point (all-cause mortality,
reinfarction, and ischemia-driven revascularization; hazard ratio [HR],
0.33; 95% confidence interval [CI], 0.17-0.64; P=0.001), with no
significant effect in patients with 2-vessel disease (HR, 0.77; 95% CI,
0.47-1.26; P=0.29; P for interaction =0.046). A similar effect was
observed in patients with diameter stenosis >=90% of noninfarct-related
arteries (HR, 0.32; 95% CI, 0.18-0.62; P=0.001), but not in patients with
less severe lesions (HR, 0.72; 95% CI, 0.44-1.19; P=0.21; P for
interaction =0.06). The effect was most pronounced in patients with
3-vessel disease and noninfarct-related stenoses >=90%, and in this
subgroup, there was a nonsignificant reduction in the end point of
mortality and reinfarction (HR, 0.32; 95% CI, 0.08-1.32; P=0.09). Proximal
versus distal location did not influence the benefit from complete
revascularization. Conclusions - The benefit from fractional flow
reserve-guided complete revascularization in ST-segment-elevation
myocardial infarction patients with multivessel disease was dependent on
the presence of 3-vessel disease and noninfarct diameter stenosis >=90%
and was particularly pronounced in patients with both of these
angiographic characteristics. Clinical Trial Registration - URL:
http://www.clinicaltrials.gov. Unique identifier:
NCT01960933. Copyright © 2017 American Heart Association, Inc.

<127>
Accession Number
618030176
Title
Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin,
durable polymer everolimus-eluting stents in patients undergoing coronary
revascularisation (BIOFLOW V): a randomised trial.
Source
The Lancet. 390 (10105) (pp 1843-1852), 2017. Date of Publication: 21 - 27
October 2017.
Author
Kandzari D.E.; Mauri L.; Koolen J.J.; Massaro J.M.; Doros G.;
Garcia-Garcia H.M.; Bennett J.; Roguin A.; Gharib E.G.; Cutlip D.E.;
Waksman R.
Institution
(Kandzari) Piedmont Heart Institute, Atlanta, GA, United States
(Mauri) Divison of Cardiovascular Medicine, Brigham and Women's Hospital,
Boston, MA, United States
(Koolen) Catharina Hospital, Eindhoven, Netherlands
(Massaro, Doros) Department of Biostatistics and Epidemiology, Boston
University School of Public Health, Boston, MA, United States
(Doros) Baim Institute for Clinical Research, Boston, MA, United States
(Garcia-Garcia, Waksman) Division of Interventional Cardiology, MedStar
Cardiovascular Research Network, MedStar Washington Hospital Center,
Washington, DC, United States
(Bennett) Department of Cardiovascular Medicine, University Hospitals
Leuven, Leuven, Belgium
(Roguin) Department of Cardiology, Rambam Medical Center, Haifa, Israel
(Gharib) Charleston Area Medical Center, Charleston, WV, United States
(Cutlip) Beth Israel Deaconess Medical Center, Baim Institute for Clinical
Research, Boston, MA, United States
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background The development of coronary drug-eluting stents has included
use of new metal alloys, changes in stent architecture, and use of
bioresorbable polymers. Whether these advancements improve clinical safety
and efficacy has not been shown in previous randomised trials. We aimed to
examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting
stent compared with a durable polymer everolimus-eluting stent in a broad
patient population undergoing percutaneous coronary intervention. Methods
BIOFLOW V was an international, randomised trial done in patients
undergoing elective and urgent percutaneous coronary intervention in 90
hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany,
Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain,
Switzerland, and the USA). Eligible patients were those aged 18 years or
older with ischaemic heart disease undergoing planned stent implantation
in de-novo, native coronary lesions. Patients were randomly assigned (2:1)
to either an ultrathin strut (60 mum) bioresorbable polymer
sirolimus-eluting stent or to a durable polymer everolimus-eluting stent.
Randomisation was via a central web-based data capture system (mixed
blocks of 3 and 6), and stratified by study site. The primary endpoint was
12-month target lesion failure. The primary non-inferiority comparison
combined these data from two additional randomised trials of bioresorbable
polymer sirolimus-eluting stent and durable polymer everolimus-eluting
stent with Bayesian methods. Analysis was by intention to treat. The trial
is registered with ClinicalTrials.gov, number NCT02389946. Findings
Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into
the study. 1334 patients met inclusion criteria and were randomly assigned
to treatment with bioresorbable polymer sirolimus-eluting stents (n=884)
or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883
patients in the bioresorbable polymer sirolimus-eluting stent group and 41
(10%) of 427 patients in the durable polymer everolimus-eluting stent
group met the 12-month primary endpoint of target lesion failure (95% CI
-6.84 to -0.29, p=0.0399), with differences in target vessel myocardial
infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0.0155).
The posterior probability that the bioresorbable polymer sirolimus-eluting
stent is non-inferior to the durable polymer everolimus-eluting stent was
100% (Bayesian analysis, difference in target lesion failure frequency
-2.6% [95% credible interval -5.5 to 0.1], non-inferiority margin 3.85%,
n=2208). Interpretation The outperformance of the ultrathin, bioresorbable
polymer sirolimus-eluting stent over the durable polymer
everolimus-eluting stent in a complex patient population undergoing
percutaneous coronary intervention suggests a new direction in improving
next generation drug-eluting stent technology. Funding
BIOTRONIK. Copyright © 2017 Elsevier Ltd

<128>
Accession Number
616541696
Title
Intraoperative ketamine for prevention of postoperative delirium or pain
after major surgery in older adults: an international, multicentre,
double-blind, randomised clinical trial.
Source
The Lancet. 390 (10091) (pp 267-275), 2017. Date of Publication: 15 Jul
2017.
Author
Avidan M.S.; Maybrier H.R.; Abdallah A.B.; Jacobsohn E.; Vlisides P.E.;
Pryor K.O.; Veselis R.A.; Grocott H.P.; Emmert D.A.; Rogers E.M.; Downey
R.J.; Yulico H.; Noh G.-J.; Lee Y.H.; Waszynski C.M.; Arya V.K.; Pagel
P.S.; Hudetz J.A.; Muench M.R.; Fritz B.A.; Waberski W.; Inouye S.K.;
Mashour G.A.; Apakama G.P.; Aquino K.G.; Dicks R.S.; Escallier K.E.;
Fardous H.; Funk D.J.; Gipson K.E.; Girardi L.N.; Gruber A.T.; Ivascu
N.S.; Jayant A.; Kashani H.H.; Kavosh M.S.; Kunkler B.S.; Lenze E.J.;
McKinney A.S.; McKinnon S.L.; Mickle A.M.; Monterola M.; Murphy M.R.;
Redko M.; Schmitt E.M.; Sivanesan L.; Steinkamp M.L.; Tellor B.; Thomas
S.; Upadhyayula R.T.
Institution
(Avidan, Maybrier, Abdallah, Emmert, Muench, Fritz) Department of
Anesthesiology, Washington University School of Medicine, Saint Louis, MO,
United States
(Jacobsohn) Department of Anesthesiology and Department of Internal
Medicine, University of Manitoba, Winnipeg, MB, Canada
(Grocott) Department of Anesthesia and Perioperative Medicine, University
of Manitoba, Winnipeg, MB, Canada
(Vlisides, Mashour) Department of Anesthesiology, University of Michigan,
Ann Arbor, MI, United States
(Pryor, Rogers) Department of Anesthesiology, Weill Cornell Medicine, New
York City, NY, United States
(Veselis) Department of Neuroanesthesiology, Memorial Sloan Kettering
Cancer Center, New York City, NY, United States
(Downey) Department of Surgery, Memorial Sloan Kettering Cancer Center,
New York City, NY, United States
(Yulico) Department of Anesthesiology, Memorial Sloan Kettering Cancer
Center, New York City, NY, United States
(Noh, Lee) Department of Anesthesiology, Asan Medical Center, Seoul, South
Korea
(Waszynski) Department of Medicine, Hartford Hospital, Hartford, CT,
United States
(Arya) Department of Anaesthesiology and Intensive Care, Postgraduate
Institute of Medical Education and Research, Chandigarh, India
(Pagel, Hudetz) Department of Anesthesiology, Medical College of
Wisconsin, Milwaukee, WI, United States
(Waberski) Department of Anesthesiology, Hartford Hospital, Hartford,
Connecticut, United States
(Inouye) Department of Medicine, Beth Israel Deaconess Medical Center,
Harvard Medical School, Institute for Aging Research, Hebrew SeniorLife,
Boston, MA, United States
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background Delirium is a common and serious postoperative complication.
Subanaesthetic ketamine is often administered intraoperatively for
postoperative analgesia, and some evidence suggests that ketamine prevents
delirium. The primary purpose of this trial was to assess the
effectiveness of ketamine for prevention of postoperative delirium in
older adults. Methods The Prevention of Delirium and Complications
Associated with Surgical Treatments [PODCAST] study is a multicentre,
international randomised trial that enrolled adults older than 60 years
undergoing major cardiac and non-cardiac surgery under general
anaesthesia. Using a computer-generated randomisation sequence we randomly
assigned patients to one of three groups in blocks of 15 to receive
placebo (normal saline), low-dose ketamine (0.5 mg/kg), or high dose
ketamine (1.0 mg/kg) after induction of anaesthesia, before surgical
incision. Participants, clinicians, and investigators were blinded to
group assignment. Delirium was assessed twice daily in the first 3
postoperative days using the Confusion Assessment Method. We did analyses
by intention-to-treat and assessed adverse events. This trial is
registered with clinicaltrials.gov, number NCT01690988. Findings Between
Feb 6, 2014, and June 26, 2016, 1360 patients were assessed, and 672 were
randomly assigned, with 222 in the placebo group, 227 in the 0.5 mg/kg
ketamine group, and 223 in the 1.0 mg/kg ketamine group. There was no
difference in delirium incidence between patients in the combined ketamine
groups and the placebo group (19.45% vs 19.82%, respectively; absolute
difference 0.36%, 95% CI -6.07 to 7.38, p=0.92). There were more
postoperative hallucinations (p=0.01) and nightmares (p=0.03) with
increasing ketamine doses compared with placebo. Adverse events
(cardiovascular, renal, infectious, gastrointestinal, and bleeding),
whether viewed individually (p value for each >0.40) or collectively
(36.9% in placebo, 39.6% in 0.5 mg/kg ketamine, and 40.8% in 1.0 mg/kg
ketamine groups, p=0.69), did not differ significantly across groups.
Interpretation A single subanaesthetic dose of ketamine did not decrease
delirium in older adults after major surgery, and might cause harm by
inducing negative experiences. Funding National Institutes of Health and
Cancer Center Support. Copyright © 2017 Elsevier Ltd

<129>
Accession Number
616708673
Title
The effect of statins on cardiovascular outcomes by smoking status: A
systematic review and meta-analysis of randomized controlled trials.
Source
Pharmacological Research. 122 (pp 105-117), 2017. Date of Publication:
August 2017.
Author
Ursoniu S.; Mikhailidis D.P.; Serban M.-C.; Penson P.; Toth P.P.; Ridker
P.M.; Ray K.K.; Kees Hovingh G.; Kastelein J.J.; Hernandez A.V.; Manson
J.E.; Rysz J.; Banach M.
Institution
(Ursoniu) Department of Functional Sciences, Discipline of Public
HealthDiscipline of Public Health, "Victor Babes" University of Medicine
and Pharmacy, Timisoara, Romania
(Mikhailidis) Department of Clinical Biochemistry, Royal Free Campus,
University College London Medical School, University College London (UCL),
London, United Kingdom
(Serban) Department of Epidemiology, University of Alabama at Birmingham,
Birmingham, AL, United States
(Serban) Department of Functional Sciences, Discipline of
PathophysiologyDiscipline of Pathophysiology, "Victor Babes" University of
Medicine and Pharmacy, Timisoara, Romania
(Penson) School of Pharmacy and Biomolecular Sciences, Liverpool John
Moores University, Liverpool, United Kingdom
(Toth) Preventive Cardiology, CGH Medical Center, Sterling, Illinois,
United States
(Toth) The Johns Hopkins Ciccarone Center for the Prevention of Heart
Disease, Baltimore, MD, United States
(Ridker) Center for Cardiovascular Disease Prevention, Brigham and Women's
Hospital, Harvard Medical School, Boston, MA, United States
(Ray) Department of Primary Care and Public Health, School of Public
Health, Imperial College London, United Kingdom
(Kees Hovingh, Kastelein) Department of Vascular Medicine, Academic
Medical Center, Amsterdam, Netherlands
(Hernandez) Health Outcomes and Clinical Epidemiology Section, Department
of Quantitative Health Sciences, Lerner Research Institute, Cleveland
Clinic, Cleveland, OH, United States
(Hernandez) School of Medicine, Universidad Peruana de Ciencias Aplicadas
(UPC), Lima, Peru
(Manson) Division of Preventive Medicine, Brigham and Women's Hospital,
Harvard Medical School, Boston, MA, United States
(Manson) Department of Epidemiology, Harvard T.H. Chan School of Public
Health, Boston, MA, United States
(Rysz, Banach) Department of Hypertension, Chair of Nephrology and
Hypertension, Medical University of Lodz, Poland
(Banach) Cardiovascular Research Centre, University of Zielona Gora,
Zielona Gora, Poland
(Banach) Polish Mother's Memorial Hospital Research Institute, Lodz,
Poland
Publisher
Academic Press
Abstract
Smoking is an important risk factor for cardiovascular disease (CVD)
morbidity and mortality. The impact of statin therapy on CVD risk by
smoking status has not been fully investigated. Therefore we assessed the
impact of statin therapy on CVD outcomes by smoking status through a
systematic review of the literature and meta-analysis of available
randomized controlled trials (RCTs). The literature search included
EMBASE, ProQuest, CINAHL and PUBMED databases to 30 January 2016 to
identify RCTs that investigated the effect of statin therapy on cumulative
incidence of major CVD endpoints (e.g. non-fatal myocardial infarction,
revascularization, unstable angina, and stroke). Relative risks (RR)
ratios were calculated from the number of events in different treatment
groups for both smokers and non-smokers. Finally 11 trials with 89,604
individuals were included. The number of smokers and non-smokers in the
statin groups of the analyzed studies was 8826 and 36,090, respectively.
The RR for major CV events was 0.73 (95% confidence interval [CI]:
0.67-0.81; p < 0.001) in nonsmokers and 0.72 (95%CI: 0.64-0.81; p < 0.001)
in smokers. Moderate to high heterogeneity was observed both in
non-smokers (I2 = 77.1%, p < 0.001) and in smokers
(I2 = 51.6%, p = 0.024) groups. Smokers seemed to benefit
slightly more from statins than non-smokers according to the number needed
to treat (NNT) analysis (23.5 vs 26.8) based on RRs applied to the control
event rates. The number of avoided events per 1000 individuals was 42.5
(95%CI: 28.9-54.6) in smokers and 37.3 (95%CI: 27.2-46.4) in non-smokers.
In conclusion, this meta-analysis suggests that the effect of statins on
CVD is similar for smokers and non-smokers, but in terms of NNTs and
number of avoided events, smokers seem to benefit more although
non-significantly. Copyright © 2017

<130>
Accession Number
616899098
Title
Prognostic value of combined CT angiography and myocardial perfusion
imaging versus invasive coronary angiography and nuclear stress perfusion
imaging in the prediction of major adverse cardiovascular events: The
CORE320 multicenter study.
Source
Radiology. 284 (1) (pp 55-65), 2017. Date of Publication: July 2017.
Author
Chen M.Y.; Rochitte C.E.; Arbab-Zadeh A.; Dewey M.; George R.T.; Miller
J.M.; Niinuma H.; Yoshioka K.; Kitagawa K.; Sakuma H.; Laham R.; Vavere
A.L.; Cerci R.J.; Mehra V.C.; Nomura C.; Kofoed K.F.; Jinzaki M.;
Kuribayashi S.; Scholte A.J.; Laule M.; Tan S.Y.; Hoe J.; Paul N.; Rybicki
F.J.; Brinker J.A.; Arai A.E.; Matheson M.B.; Cox C.; Clouse M.E.; Di
Carli M.F.; Lima J.A.C.
Institution
(Chen, Arai) Laboratory of Cardiac Energetics, National Heart Lung and
Blood Institute, National Institutes of Health, Bethesda, MD, United
States
(Rochitte) InCor Heart In stitute, University of Sao Paulo Medical School,
Sao Paulo, Brazil
(Arbab-Zadeh, George, Miller, Vavere, Cerci, Mehra, Brinker, Lima) Johns
Hopkins Hospital and School of Medicine, 600 N Wolfe St, Blalock 524,
Baltimore, MD 21287, United States
(Dewey, Laule) Department of Radiology, Charite Medical School-Humboldt,
Berlin, Germany
(Niinuma, Yoshioka) Memorial Heart Center, Iwate Medical University,
Morioka, Japan
(Niinuma) Department of Radiology, St. Luke's International Hospital,
Tokyo, Japan
(Kitagawa, Sakuma) Department of Radiology, Mie University Hospital, Tsu,
Japan
(Laham, Clouse) Department of Radiology, Beth Israel Deaconess Medical
Center, Harvard University, Boston, MA, United States
(Nomura) Radiology Sector, Hospital Israelita Albert Einstein, Sao Paulo,
Brazil
(Kofoed) Department of Cardiology, Rigshospitalet, University of
Copenhagen, Denmark
(Jinzaki, Kuribayashi) Keio University School of Medicine, Tokyo, Japan
(Scholte) Department of Cardiology, Leiden University Medical Center,
Leiden, Netherlands
(Tan) Department of Cardiology, National Heart Centre, Singapore
(Hoe) Medi-Rad Associates, CT Centre, Mount Elizabeth Hospital, Singapore
(Paul) Department of Medical Imaging, Toronto General Hospital, Toronto,
ON, Canada
(Rybicki) Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada
(Matheson, Cox) Department of Epidemiology, Johns Hopkins Bloomberg School
of Public Health, Baltimore, MD, United States
(Di Carli) Department of Nuclear Medicine and Cardiovascular Imaging,
Brigham and Women's Hospital, Boston, MA, United States
Publisher
Radiological Society of North America Inc. (820 Jorie Boulevard, Oak Brook
IL 60523-2251, United States)
Abstract
Purpose: To compare the prognostic importance (time to major adverse
cardiovascular event [MACE]) of combined computed tomography (CT)
angiography and CT myocardial stress perfusion imaging with that of
combined invasive coronary angiography (ICA) and stress single photon
emission CT myocardial perfusion imaging. Material(s) and Method(s):
This study was approved by all institutional review boards, and written
informed consent was obtained. Between November 2009 and July 2011, 381
participants clinically referred for ICA and aged 45-85 years were
enrolled in the Combined Noninvasive Coronary Angiography and Myocardial
Perfusion Imaging Using 320-Detector Row Computed Tomography (CORE320)
prospective multicenter diagnostic study. All images were analyzed in
blinded independent core laboratories, and a panel of physicians
adjudicated all adverse events. MACE was defined as revascularization (>30
days after index ICA), myocardial infarction, or cardiac death;
hospitalization for chest pain or congestive heart failure; or arrhythmia.
Late MACE was defined similarly, except for patients who underwent
revascularization within the first 182 days after ICA, who were excluded.
Comparisons of 2-year survival (time to MACE) used standard Kaplan-Meier
curves and restricted mean survival times bootstrapped with 2000
replicates. Result(s): An MACE (49 revascularizations, five
myocardial infarctions, one cardiac death, nine hospitalizations for chest
pain or congestive heart failure, and one arrhythmia) occurred in 51 of
379 patients (13.5%). The 2-year MACE-free rates for combined CT
angiography and CT perfusion findings were 94% negative for coronary
artery disease (CAD) versus 82% positive for CAD and were similar to
combined ICA and single photon emission CT findings (93% negative for CAD
vs 77% positive for CAD, P < .001 for both). Event-free rates for CT
angiography and CT perfusion versus ICA and single photon emission CT for
either positive or negative results were not significantly different for
MACE or late MACE (P > .05 for all). The area under the receiver operating
characteristic curve (AUC) for combined CT angiography and CT perfusion
(AUC = 68; 95% confidence interval [CI]: 62, 75) was similar (P = .36) to
that for combined ICA and single photon emission CT (AUC = 71; 95% CI: 65,
79) in the identification of MACE at 2-year follow-up. Conclusion(s):
Combined CT angiography and CT perfusion enables similar prediction of
2-year MACE, late MACE, and event-free survival similar to that enabled by
ICA and single photon emission CT. Copyright © 2017 RSNA.

<131>
Accession Number
619592387
Title
Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for
Left-Main Disease: Results From the EXCEL Trial.
Source
Journal of the American College of Cardiology. 70 (25) (pp 3113-3122),
2017. Date of Publication: 26 December 2017.
Author
Baron S.J.; Chinnakondepalli K.; Magnuson E.A.; Kandzari D.E.; Puskas
J.D.; Ben-Yehuda O.; van Es G.-A.; Taggart D.P.; Morice M.-C.; Lembo N.J.;
Brown W.M.; Banning A.; Simonton C.A.; Kappetein A.P.; Sabik J.F.; Serruys
P.W.; Stone G.W.; Cohen D.J.
Institution
(Baron, Chinnakondepalli, Magnuson, Cohen) Saint Luke's Mid America Heart
Institute, University of Missouri-Kansas City School of Medicine, Kansas
City, Missouri, United States
(Kandzari) Piedmont Heart Institute, Atlanta, Georgia
(Puskas, Lembo, Brown) Mount Sinai Medical Center, New York, New York,
United States
(Ben-Yehuda, Stone) Cardiovascular Research Foundation, New York, New
York, United States
(van Es) Cardialysis, Rotterdam, Netherlands
(Taggart, Banning) Oxford University Hospitals, Oxford, United Kingdom
(Morice) Ramsay Generale de Sante, Hospital Prive Jacques Cartier, Massy,
France
(Simonton) Abbott Vascular Inc., Abbott Park, Illinois, United States
(Kappetein) Erasmus Medical Center, Rotterdam, Netherlands
(Sabik) Cleveland Clinic Foundation, Cleveland, Ohio, United States
(Serruys) International Centre for Circulatory Health, National Heart and
Lung Institute, Imperial College London, London, United Kingdom
(Stone) New York-Presbyterian Hospital, Columbia University Medical
Center, New York, New York, United States
Publisher
Elsevier USA
Abstract
Background The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass
Surgery for Effectiveness of Left Main Revascularization) trial compared
outcomes in patients with unprotected left main coronary artery disease
(LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous
coronary intervention (PCI) using everolimus-eluting stents. Whereas rates
of death, stroke, and myocardial infarction were similar at 36 months,
event timing and repeat revascularization rates differed by treatment
group. Objectives To understand the effects of revascularization strategy
from the patient's perspective, a prospective quality of life (QoL)
substudy was performed alongside the EXCEL trial. Methods Between
September 2010 and March 2014, 1,905 patients with LMCAD were randomized
to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy.
QoL was assessed at baseline and 1, 12, and 36 months using the Seattle
Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose
Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D.
Differences between PCI and CABG were assessed using longitudinal
random-effect growth curve models. Results Over 36 months, both PCI and
CABG were associated with significant improvements in QoL compared with
baseline. At 1 month, PCI was associated with better QoL than CABG. By 12
months though, these differences were largely attenuated, and by 36
months, there were no significant QoL differences between PCI and CABG.
Conclusions Among selected patients with LMCAD, both PCI and CABG result
in similar QoL improvement through 36 months, although a greater early
benefit is seen with PCI. Taken together with the 3-year clinical results
of EXCEL, these findings suggest that PCI and CABG provide similar
intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience
Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main
Revascularization [EXCEL]; NCT01205776) Copyright © 2017 American
College of Cardiology Foundation

<132>
Accession Number
620053316
Title
A multicenter randomized controlled trial of zephyr endobronchial valve
treatment in heterogeneous emphysema (Transform).
Source
American Journal of Respiratory and Critical Care Medicine. 196 (12) (pp
1535-1543), 2017. Date of Publication: 15 Dec 2017.
Author
Kemp S.V.; Slebos D.-J.; Kirk A.; Kornaszewska M.; Carron K.; Ek L.;
Broman G.; Hillerdal G.; Mal H.; Pison C.; Briault A.; Downer N.; Darwiche
K.; Rao J.; Hubner R.-H.; Ruwwe-Glosenkamp C.; Trosini-Desert V.;
Eberhardt R.; Herth F.J.; Derom E.; Malfait T.; Shah P.L.; Garner J.L.;
Ten Hacken N.H.; Fallouh H.; Leroy S.; Marquette C.H.
Institution
(Kemp, Shah, Garner) Royal Brompton Hospital, Imperial College London,
London, United Kingdom
(Kemp, Downer) Sherwood Forest Hospitals, NHS Foundation Trust,
Nottinghamshire, United Kingdom
(Slebos, Ten Hacken) Department of Pulmonary Diseases, University of
Groningen, University Medical Center Groningen, Groningen, Netherlands
(Kirk) Department of Thoracic Surgery, West of Scotland Regional Heart and
Lung Centre, Golden Jubilee National Hospital, West Dunbartonshire,
Scotland, United Kingdom
(Kornaszewska, Fallouh) Department of Cardiothoracic Surgery, University
Hospital of Wales, Cardiff, United Kingdom
(Carron) Department of Pulmonology, AZ Delta, Menen, Belgium
(Ek) Department of Pulmonary Diseases, Skane University Hospital, Lund,
Sweden
(Broman, Hillerdal) Department of Pulmonary Diseases, Uppsala University
Hospital, Uppsala, Sweden
(Mal) Service de Pneumologie A, Hopital Bichat, Paris, France
(Pison, Briault) Clinique Universitaire de Pneumologie, Pole Thorax et
Vaisseaux, CHU Grenoble Alpes, Grenoble, France
(Darwiche) Department of Interventional Pneumology, Ruhrlandklinik, West
German Lung Center, University Clinic Essen, Essen, Germany
(Rao) Sheffield Teaching Hospitals, NHS Foundation Trust, Sheffield,
United Kingdom
(Hubner, Ruwwe-Glosenkamp) Charite Universitatsmedizin Berlin,
Medizinische Klinik m. Schw. Infektiologie und Pneumologie, Campus
Virchow, Berlin, Germany
(Trosini-Desert) Service de Pneumologie et Reanimation, Unite d'Endoscopie
Bronchique, Groupe Hospitalier Pitie Salpetriere, Paris, France
(Eberhardt, Herth) Department of Pneumology and Critical Care Medicine,
Thoraxklinik, University of Heidelberg and, Translational Lung Research
Center Heidelberg, Heidelberg, Germany
(Derom, Malfait) Department of Pulmonary Diseases, Ghent University
Hospital, Ghent, Belgium
(Leroy, Marquette) Universite Cote d'Azur, Centre Hospitalier
Universitaire de Nice, FHU OncoAge, Service de Pneumologie, Nice, France
Publisher
American Thoracic Society (E-mail: malexander@thoracic.org)
Abstract
Rationale: Single-center randomized controlled trials of the Zephyr
endobronchial valve (EBV) treatment have demonstrated benefit in severe
heterogeneous emphysema. This is the first multicenter study evaluating
this treatment approach. Objective(s): To evaluate the efficacy and
safety of Zephyr EBVs in patients with heterogeneous emphysema and absence
of collateral ventilation. Method(s): This was a prospective,
multicenter 2:1 randomized controlled trial of EBVs plus standard of care
or standard of care alone (SoC). Primary outcome at 3 months
post-procedure was the percentage of subjects with FEV<inf>1</inf>
improvement from baseline of 12% or greater. Changes in FEV<inf>1</inf>,
residual volume, 6-minute-walk distance, St. George's Respiratory
Questionnaire score, and modified Medical Research Council score were
assessed at 3 and 6 months, and target lobe volume reduction on chest
computed tomography at 3 months. Measurements and Main Results:
Ninety seven subjects were randomized to EBV (n = 65) or SoC (n = 32). At
3 months, 55.4% of EBV and 6.5% of SoC subjects had an FEV<inf>1</inf>
improvement of 12% or more (P, 0.001). Improvements were maintained at 6
months: EBV 56.3% versus SoC 3.2% (P, 0.001), with a mean 6 SD change in
FEV<inf>1</inf> at 6 months of 20.7 6 29.6% and 28.6 6 13.0%,
respectively. A total of 89.8% of EBV subjects had target lobe volume
reduction greater than or equal to 350 ml, mean 1.09 6 0.62 L (P, 0.001).
Between-group differences for changes at 6 months were statistically and
clinically significant: DEBV-SoC for residual volume, 2700 ml;
6-minute-walk distance, 178.7 m; St. George's Respiratory Questionnaire
score, 26.5 points; modified Medical Research Council dyspnea score, 20.6
points; and BODE (body mass index, airflow obstruction, dyspnea, and
exercise capacity) index, 21.8 points (all P, 0.05). Pneumothorax was the
most common adverse event, occurring in 19 of 65 (29.2%) of EBV subjects.
 Conclusion(s): EBV treatment in hyperinflated patients with
heterogeneous emphysema without collateral ventilation resulted in
clinically meaningful benefits in lung function, dyspnea, exercise
tolerance, and quality of life, with an acceptable safety
profile. Copyright © 2017 by the American Thoracic Society

<133>
Accession Number
618418792
Title
Meta-Analysis Comparing >=10-Year Mortality of Off-Pump Versus On-Pump
Coronary Artery Bypass Grafting.
Source
American Journal of Cardiology. 120 (11) (pp 1933-1938), 2017. Date of
Publication: 01 Dec 2017.
Author
Takagi H.; Ando T.; Mitta S.
Institution
(Takagi, Mitta) Department of Cardiovascular Surgery, Shizuoka Medical
Center, Shizuoka, Japan
(Ando) Department of Cardiology, Detroit Medical Center, Detroit,
Michigan, United States
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Off-pump coronary artery bypass grafting (CABG) is suggested to be
associated with an increase in long-term (>=5-year) all-cause mortality.
To determine whether off-pump CABG is associated with an increase in very
long-term (>=10-year) all-cause mortality, we performed a meta-analysis of
propensity-score matched observational comparative studies of off-pump
versus on-pump CABG. MEDLINE and EMBASE were searched through May 2017. A
hazard ratio of follow-up (including early) all-cause mortality for
off-pump versus on-pump CABG was extracted from each individual study.
Study-specific estimates were combined using inverse variance-weighted
averages of logarithmic hazard ratios in the random-effects model. Of 164
potentially relevant studies, our search identified 16 propensity-score
matched observational comparative studies of off-pump versus on-pump CABG
with >=10-year follow-up enrolling a total of 82,316 patients. A pooled
analysis of all the 16 studies demonstrated that off-pump CABG was
significantly associated with an increase in all-cause mortality (hazard
ratio 1.07, 95% confidence interval 1.03 to 1.12, p for effect = 0.0008; p
for heterogeneity = 0.30, I2 = 12%). In a sensitivity analysis,
exclusion of any single hazard ratio from the analysis (leave-one-out
meta-analysis) did not substantively alter the overall result. There was
no evidence of a significant publication bias. In conclusion, off-pump
CABG is associated with an increase in very long-term (>=10 years)
all-cause mortality compared with on-pump CABG. Copyright © 2017
Elsevier Inc.

<134>
Accession Number
616310257
Title
Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease.
Source
New England Journal of Medicine. 376 (20) (pp 1933-1942), 2017. Date of
Publication: 18 May 2017.
Author
Lincoff A.M.; Nicholls S.J.; Riesmeyer J.S.; Barter P.J.; Brewer H.B.; Fox
K.A.A.; Gibson C.M.; Granger C.; Menon V.; Montalescot G.; Rader D.; Tall
A.R.; McErlean E.; Wolski K.; Ruotolo G.; Vangerow B.; Weerakkody G.;
Goodman S.G.; Conde D.; McGuire D.K.; Nicolau J.C.; Leiva-Pons J.L.;
Pesant Y.; Li W.; Kandath D.; Kouz S.; Tahirkheli N.; Mason D.; Nissen
S.E.
Institution
(Lincoff, Menon, McErlean, Wolski, Mason, Nissen) Cleveland Clinic
Coordinating Center for Clinical Research (C5Research), Department of
Cardiovascular Medicine, Cleveland Clinic, Cleveland, QLD, Australia
(Nicholls) South Australian Heart and Medical Research Institute,
University of Adelaide, Adelaide, SA, Australia
(Barter) School of Medical Sciences, University of New South Wales,
Sydney, NSW, Australia
(Riesmeyer, Ruotolo, Vangerow, Weerakkody) Eli Lilly, Indianapolis, IN,
United States
(Brewer) Washington Cardiovascular Associates, Medstar Research Institute,
Washington, DC, United States
(Fox) Centre for Cardiovascular Science, University of Edinburgh,
Edinburgh, United Kingdom
(Gibson) Beth Israel Deaconess Medical Center, Boston, United States
(Granger) Duke University Medical Center, Durham, NC, United States
(Montalescot) Universite Sorbonne Paris 6, ACTION Study Group, Hopital
Pitie-Salpetriere, Assistance Publique-Hopitaux de Paris, Institut de
Cardiologie, Paris, France
(Rader) Penn Heart and Vascular Center, Philadelphia, United States
(Tall) Columbia University, New York, NY, United States
(Kandath) Saratoga Cardiology Associates, Saratoga Springs, NY, United
States
(Goodman) St. Michael's Hospital, Toronto, ON, Canada
(Pesant) Recherche Medicale Saint-Jerome, Saint-Jerome, QC, Canada
(Kouz) Centre de Sante et de Services Sociaux du Nord de Lanaudiere-Centre
Hospitalier Regional de Lanaud, Saint-Charles-Borromee, QC, Canada
(Conde) Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina
(McGuire) University of Texas Southwestern Medical Center, Dallas, TX,
United States
(Nicolau) Heart Institute (InCor)-University of Sao Paulo Medical School,
Sao Paulo, Brazil
(Leiva-Pons) Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosi,
Mexico
(Li) Harbin Medical University, Harbin, China
(Tahirkheli) South Oklahoma Heart Research, Oklahoma City, OK, United
States
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND: The cholesteryl ester transfer protein inhibitor evacetrapib
substantially raises the high-density lipoprotein (HDL) cholesterol level,
reduces the low-density lipoprotein (LDL) cholesterol level, and enhances
cellular cholesterol efflux capacity. We sought to determine the effect of
evacetrapib on major adverse cardiovascular outcomes in patients with
high-risk vascular disease. METHOD(S): In a multicenter, randomized,
double-blind, placebo-controlled phase 3 trial, we enrolled 12,092
patients who had at least one of the following conditions: an acute
coronary syndrome within the previous 30 to 365 days, cerebrovascular
atherosclerotic disease, peripheral vascular arterial disease, or diabetes
mellitus with coronary artery disease. Patients were randomly assigned to
receive either evacetrapib at a dose of 130 mg or matching placebo,
administered daily, in addition to standard medical therapy. The primary
efficacy end point was the first occurrence of any component of the
composite of death from cardiovascular causes, myocardial infarction,
stroke, coronary revascularization, or hospitalization for unstable
angina. RESULT(S): At 3 months, a 31.1% decrease in the mean LDL
cholesterol level was observed with evacetrapib versus a 6.0% increase
with placebo, and a 133.2% increase in the mean HDL cholesterol level was
seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of
the planned 1670 primary end-point events had occurred, the data and
safety monitoring board recommended that the trial be terminated early
because of a lack of efficacy. After a median of 26 months of evacetrapib
or placebo, a primary end-point event occurred in 12.9% of the patients in
the evacetrapib group and in 12.8% of those in the placebo group (hazard
ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P = 0.91).
 CONCLUSION(S): Although the cholesteryl ester transfer protein
inhibitor evacetrapib had favorable effects on established lipid
biomarkers, treatment with evacetrapib did not result in a lower rate of
cardiovascular events than placebo among patients with high-risk vascular
disease. Copyright © 2017 Massachusetts Medical Society.

<135>
Accession Number
613696421
Title
A review of comparative studies of MitraClip versus surgical repair for
mitral regurgitation.
Source
International Journal of Cardiology. 228 (pp 289-294), 2017. Date of
Publication: 01 Feb 2017.
Author
Takagi H.; Ando T.; Umemoto T.
Institution
(Takagi, Umemoto) Department of Cardiovascular Surgery, Shizuoka Medical
Center, Shizuoka, Japan
(Ando) Department of Cardiology, Detroit Medical Center, Detroit, MI,
United States
Publisher
Elsevier Ireland Ltd
Abstract
Objectives We summarized comparative studies of MitraClip versus surgical
repair for mitral regurgitation (MR) with a systematic literature search
and meta-analytic estimates. Methods MEDLINE, EMBASE, and the Cochrane
Central Register of Controlled Trials were searched through June 2016.
Eligible studies were randomized controlled or observational comparative
studies of MitraClip versus surgical repair enrolling patients with MR and
reporting early (30-day or in-hospital) or late (>= 6-month including
early) all-cause mortality. For each study, data regarding all-cause
mortality and incidence of recurrent > 2 + MR in both groups were used to
generate odds ratios (ORs). Alternatively, ORs or hazard ratios (HRs) for
mortality and recurrent MR themselves were directly abstracted from each
study. Results Eight reports of 7 studies comparing MitraClip with
surgical repair enrolling a total of 1015 patients with MR were identified
and included. Pooled analyses demonstrated significantly higher age and
logistic European System of Cardiac Operative Risk Evaluation and
significantly lower ejection fraction in the MitraClip than surgical
repair group, no significant difference in rate of women and patients with
New York Heart Association functional class of > II, no statistically
significant difference in early- (OR, 0.54; p = 0.08) and late-mortality
(HR/OR, 1.17; p = 0.46), and significantly higher incidence of recurrent
MR in the MitraClip than surgical repair group (HR/OR, 4.80; p < 0.00001).
Conclusions In patients with MR, the MitraClip procedure achieves similar
survival to surgical MV repair despite higher risk profiles. Recurrent MR,
however, occurs more frequently (4.8-fold) after the MitraClip than
surgical repair. Copyright © 2016 Elsevier Ireland Ltd

<136>
Accession Number
616545369
Title
Conversion after off-pump coronary artery bypass grafting: The CORONARY
trial experience.
Source
European Journal of Cardio-thoracic Surgery. 51 (3) (pp 539-546), 2017.
Date of Publication: 01 Mar 2017.
Author
Stevens L.-M.; Noiseux N.; Avezum A.; Ayapati D.R.; Chen X.; Lucchesee
F.A.; Cacheda H.; Parvathaneni S.; Ou Y.; Lamy A.
Institution
(Stevens, Noiseux) Department of Surgery, Division of Cardiac Surgery,
Centre Hospitalier de l'Universite de Montreal and Research Center,
Montreal, QC, Canada
(Avezum) Research Division, Dante Pazzanese Institute of Cardiology, Sao
Paulo, Brazil
(Ayapati) Department of Cardiothoracic Surgery, India Global Hospitals,
Hyderabad, India
(Chen) Department of Cardiothoracic Surgery, Nanjing First Hospital,
Nanjing, China
(Lucchesee) Department of Cardiovascular Surgery, Sao Francisco Hospital,
Porto Alegre, Brazil
(Cacheda) Department of Cardiothoracic Surgery, Institute of Cardiology of
Corrientes, Corrientes, Argentina
(Parvathaneni) Department of Cardiothoracic Surgery, Mercy Medical
Research Institute, St-Louis, MO, United States
(Ou, Lamy) Department of Surgery, Division of Cardiac Surgery, McMaster
University and Population Health Research Institute, Hamilton, ON, Canada
Publisher
European Association for Cardio-Thoracic Surgery (E-mail:
info@eacts.co.uk)
Abstract
OBJECTIVES: Emergent and late conversions form OFF-to-ON pump coronary
artery bypass grafting (CABG) have been associated with worse outcomes,
however, it remains unclear as to which risk factors are associated with
conversion and how to prevent them. METHOD(S): Among 4718 patients
who randomly underwent off- or on-pump CABG, the incidence of off-pump to
on-pump cross-over, or 'OFF-to-ON conversion', was 7.9% (186/2356). The
primary outcome was a composite of death, stroke, myocardial infarction,
or new renal failure requiring dialysis. We assessed the risk factors and
outcomes of converted patients. RESULT(S): Emergent OFF-to-ON
conversions, defined as conversions for hypotension or ischaemia, were
required for 3.2% of patients (n = 75), while most elective conversions
were due to small or intramuscular coronaries (n = 83). OFF-to-ON
converted patients required increased surgery time, blood transfusions,
intensive care unit stay, and presented a higher incidence at 1 year of
the composite outcome compared with non-converted off-pump patients (all P
< 0.01), especially if the conversion was emergent. Conversely, elective
conversions outcomes were no different compared with non-converted
off-pump patients (P = 0.35). Independent predictors of emergent
conversions included higher heart rate or chronic atrial fibrillation,
urgent surgery, more grafts planned and surgeon experience with off-pump
CABG. CONCLUSION(S): Emergent OFF-to-ON conversion is associated with
worse outcomes compared with elective conversion or no conversion. In the
presence of risk factors for emergent conversion, an early and elective
conversion approach is a judicious strategy. Copyright © The
Author 2016. Published by Oxford University Press on behalf of the
European Association for Cardio-Thoracic Surgery. All rights reserved.

<137>
Accession Number
618525524
Title
Effects of anacetrapib in patients with atherosclerotic vascular disease.
Source
New England Journal of Medicine. 377 (13) (pp 1217-1227), 2017. Date of
Publication: 28 Sep 2017.
Author
Bowman L.; Hopewell J.C.; Chen F.; Wallendszus K.; Stevens W.; Collins R.;
Wiviott S.D.; Cannon C.P.; Braunwald E.; Sammons E.; Landray M.J.; Jiang
L.; Armitage J.; Haynes R.; Maggioni A.P.; Angermann C.E.; Ertl G.; Wanner
C.; Pedersen T.; Goto S.; Teramoto T.; Baigent C.; Barter P.; Chen Y.;
Chen Z.; Gray A.; Mihaylova B.; Sleight P.; Tobert J.; Blaustein R.;
DeLucca P.; Mitchel Y.; van Leijenhorst G.; Sandercock P.; DeMets D.;
Kjekshus J.; Neuberger J.; Tonkin A.; Emberson J.; Granger C.; Colhoun H.;
Barton J.; Bray C.; Dayanandan R.; Knott C.; Lay M.; Murphy K.; Wincott
E.; Achiri P.; Barry S.; Bateman S.; Brewster A.; Briggs S.; Brown R.;
Burke A.; Butler E.; Cobb L.; Collet A.; Crowther J.; Cureton L.;
Danesh-Pour S.; Fathers S.; Fletcher L.; Frederick K.; Gordon T.; Gray M.;
Heineman J.; Howard S.; Jackson D.; Lam N.; Lee R.; Machin O.; Madgwick
Z.; Matthewson M.; Nolan J.; Nunn M.; Panicker A.; Pank L.; Pearson-Burton
E.; Pickworth S.; Qiao Y.; Radley A.; Roby K.; Sayer J.; Shah S.; Taylor
K.; Thorne H.; Timadjer A.; Vandenberg K.; Wickman M.; Willett M.; Woods
J.; Yu H.; Aung T.; Bulbulia R.; Clarke R.; Herrington W.; Judge P.; Lewis
D.; Llewellyn-Bennett R.; Mafham M.; Preiss D.; Reith C.; Storey B.;
Tomson J.; Waters E.; Baxter A.; Goodenough R.; Ait-Sadi R.; Arnold M.;
Barton I.; Berry C.; Blower G.; Booth J.; Brown E.; Bu Y.; Cleverley P.;
Coates G.; Cox J.; Craig M.; Cui G.; Dalton P.; Danel L.; Daniels C.; Dawe
C.; Field A.; Gilbert S.; Harding P.; Jayne K.; Kurien R.; Lancaster G.;
Maskill A.; McDougall A.; Mostefai Y.; Mulay S.; Munday A.; Murawska A.;
Prajapati N.; Ramesh S.; Reid R.; Syed S.; Todd H.; Young A.; Zhu W.;
Parish S.; Valdes-Marquez E.; Hill M.; Clark S.; Emmens K.; McClean G.;
Radley M.; Wintour J.; Allworth M.; Beneat A.M.; Bird C.; Boggs L.; Casey
A.; Chavagnon T.; Chung K.; Chung R.; Cockram L.; Cox R.; Douglas J.;
Finnegan L.; French H.; Goodwin N.; Gordon A.; Gordon J.; Guest C.; Hazim
S.; Hill J.; Hrusecka R.; Lacey M.; Luker N.; Mulligan S.; Obrero M.E.;
Plunkett N.; Sansom L.; Shellard R.; Taylor J.; Taylor P.; Tyler J.;
Weaving L.; Wheeler J.; Williams T.; Yeung M.; Beebe S.; Bowsher-Brown K.;
Dabrowski J.; Henderson J.; James J.; Lochhead H.; Toghill V.; Wright L.;
Young L.; Hundei W.; Liu J.; Qu J.; Zhang H.; Dai H.; Feng F.; Hou L.; Li
J.; Ma L.; Niu S.; Tang R.; Wang S.; Wei X.; Xie M.; Yan X.; Yang M.;
Zhang Y.; Zhang L.; Zhang A.; Zhang S.; Zhao L.; Zhong H.; Chen L.; Gao
Y.; Li L.; Yang H.; Zhang J.; Brenner S.; Heldmann M.; Kraus B.; Meyer B.;
Fajardo-Moser M.; Hartner C.; Knoppe A.; Pop-Marschall D.; Renner J.;
Saemann U.; Fabbri G.; Lorimer A.; Lucci D.; Bartolomei Mecatti B.; Ceseri
M.; Baldini E.; Benoni S.; Bianchini F.; Ferruzzi P.; Miccoli M.; Musio
S.; Ramani F.; Gorini M.; Orsini G.; Kato E.; Tawara K.; Tomita A.;
Kitamura S.; Saitoh Y.; Shimizu M.; Shiozaki S.; Soeda K.; Tanaka A.;
Eisen A.; Steen D.; Fish P.; MacDonnell S.; Kent J.; McCagg A.; Greene E.;
Klements D.; Washington K.; Davis A.; Goeres M.; Joyce J.; Koen J.;
Colicchia J.; Domercant J.; Foster V.; Fox C.; Gennusa C.; Hollis R.;
Kassa Y.; Kelley A.; Magloire V.; Owens C.; Yeh N.; Arnesson K.; Mosegaard
S.; Andersen K.; Haywood S.; Osmanagic A.; Pilgaard Madsen C.; Rebnord E.;
Serup-Hansen K.; Tarras Wahlberg M.; Hannibal K.; Johansen T.; Rasmussen
L.; Sloth A.; Kiuru P.; Lauronen M.; Leinonen A.S.; Mononen T.; Vuola M.;
Wiik S.; Hovdal H.; Lien C.; Svingen S.; Singh P.; Thorsby I.; Westerheim
E.; Bergsten P.; Bergvall L.; Castedal H.; Cederholm A.C.; Froberg L.;
Johansson A.; Jonsson L.; Martin P.; Rasmusson T.; Wiik-Karu S.; Diget H.;
Moll O.; Snejbjerg S.; Sorensen G.; Eronen S.; Roine S.; Vaine T.;
Bjorhovde V.; Edvardsen L.; Saether S.; Blechert A.; Ek I.; Hedlof L.;
Levin J.; Vlaheli D.; Genest J.; Gupta M.; Burgess A.; Dela Cruz C.;
Harnden S.; Hirjikaka S.; Mallari E.; Thevakumaran Y.; Pandey A.; Lake J.;
Pandey M.; Wang C.; Sabbah E.; Chausse I.; Deslongchamp F.; Lavoie J.;
Sabe-Affaki G.; Fontaine S.; Gosselin G.; David M.; Drouin K.; Lachance
N.; Masson C.; Pashko M.; Tremblay C.; Constance C.; Gauthier M.; Kouz S.;
Fleury C.; Lemay-Chretien V.; Roberge N.; Roy M.; Hoag G.; Standring R.;
Warke L.; Pearce S.; Breakwell L.; Cleveland T.; Kastanis D.; Bhargava R.;
Stafford C.; Stata C.; Anderson T.; Brown D.; Madden B.; Pajevic M.;
Ramadan D.; Smith B.; Cha J.; Otis J.; Zadra R.; Harwood A.; McPherson C.;
Rackham C.; Bakbak A.; Baghiana S.; Gibney K.; Swailes L.; Nault P.; Audet
K.; Roy C.; St-Amour E.; Tremblay I.; Chehayeb R.; Lepage C.; Vizel S.;
Fox B.; Yu Q.; Chi L.; Liu F.; Zhao R.; Li X.; Qian Y.; Wang J.; Yang X.;
Chen M.; Lin X.; Zhang F.; Fang X.; Su W.; Zhu X.; Huang L.; Ye G.; Zhao
Y.; Yang P.; He M.; Li B.; Zhi Y.; Sun L.; Xiao L.; Yuan Y.; Guo R.; Wang
Q.; Wang Y.; Guo Y.; Zhai M.; Yang Y.; Song J.; Zheng Z.; Wang X.; Zhao
C.; Wang Z.; Li C.; Cui Z.; Zhang X.; Su H.; Huang X.; Zhang R.; Ge Z.;
Liu D.; Liu Q.; Han Y.; He W.; Qian D.; Liu L.; Yao X.; Du Y.; Song L.;
Che H.; Li D.; Sun C.; Bai H.; Chen W.; Liu Z.; Yang J.; Li Z.; Bai J.;
Wang F.; Xing C.; Yao Y.; Jiang X.; Dong Y.; Wu G.; Zhang B.; Wu Z.; Chu
Y.; Gu X.; Chai X.; Sun S.; Tong L.; Ma S.; Li H.; Liu X.; Shi J.; Xiao
R.; Wu R.; Meng X.; Shao B.; Zhang T.; Chen X.; Feng T.; Huo L.; Shang X.;
Zhou C.; Guo M.; Li P.; Pei H.; Han D.; Cheng C.; Huang M.; Wu W.; Xu T.;
Xia J.; Zhao S.; Ding S.; Guo L.; Li N.; Diao Q.; Wang H.; Qi G.; Jia Z.;
Meng Y.; Wu C.; Liu B.; Bian X.; Li W.; Jing J.; Sun Y.; Wu S.; Xu Y.; Lv
F.; Guo C.; Long J.; Huang Z.; Fu X.; Yao H.; Zheng Y.; Liu C.; Tong Q.;
Wang G.; Cheng Y.; Gang X.; Guo W.; He G.; Han Q.; Bian H.; Duan L.; Jin
C.; Xing W.; Xu J.; Jin Y.; Lin Y.; Zhou X.; Li Y.; Guan X.; Liu H.; Pan
H.; Fan P.; Ma R.; Wang P.; Cui R.; Sun G.; Xie R.; Qu P.; Li G.; Mei J.;
Wang L.; Yang Q.; Zhang C.; Yu B.; Cao W.; Du W.; Luan Y.; Wang W.; Zhu
Y.; Jiao H.; Qu Y.; Yang Z.; Du N.; Liang B.; Wang D.; Zhao P.; Xu B.;
Zong D.; Tang X.; Zong C.; Mo Z.; Jin P.; Xiong J.; Cong H.; Guo X.; Liang
R.; Zhou J.; Liu Y.; Sun Z.; Wan Z.; Bian B.; Zhang W.; Yao Z.; Wang R.;
Chen G.; Ma C.; Jiang J.; Ni L.; Yan H.; Su X.; Cai J.; Ma J.; Zhong R.;
Gu Y.; Hu L.; Wu X.; Feng J.; Huang H.; Ouyang F.; Zhou Y.; Yang T.; Deng
X.; Peng L.; Su S.; Fu Q.; Zong X.; Shang Y.; Sun H.; Guo S.; He Y.; Cha
L.; Lu Y.; Egstrup K.; Berg Schmidt E.; Dinesen P.; Gammelmark A.; Nielsen
M.; Rix T.; Vadmann H.; Christensen B.; Hessing Kobbelgaard L.; Mikkelsen
B.; Storgaard M.; Nyvad O.; Rohold A.; Thomsen K.; Hummelshoj J.;
Svenningsen A.; Tanggaard L.; Gislason G.; Torp Pedersen C.; von Jessen
G.; Larsen J.; Sandberg Madsen J.; Iversen H.; Nielsen C.; Obionu J.;
Simonsen S.; Kjaergaard Dano M.; Hornslet P.; Veng-Olsen T.; May O.;
Madsen L.; Engbjerg Andersen M.; Jensen L.; Lynggaard V.; Sondergaard S.;
Vester S.; Roseva-Nielsen N.; Sorensen V.; Skjodeberg Christensen K.; Bang
Hansen M.; Mollerup H.; Voigt S.; Jepsen J.; Gesla J.; Johansen L.;
Zeuthen E.; Bjerge Kaspersen B.; Felthaus B.; Lokke M.; Holm Pedersen L.;
Schrader A.; Schmidt Thomsen L.; Stender S.; Brink-Kjaer T.; Jonsson H.;
Sykulski R.; Thorsen J.; Osterby Elin P.; Stage Jensen B.; Ralfkier N.;
Gottschalck H.; Bloksgaard Nilesen S.; Lytken Larsen M.; Mickley H.;
Hosbond S.; Saaby L.; Ronn M.; Rosenlund I.; Clemmensen P.; Grande P.;
Kober L.; Andersson H.; Wiberg S.; Graversen K.; Hedgaard L.; Melchior T.;
Larsen C.; Heinsvig S.; Larsen I.; Perret-Gentil V.; Frost L.; Christensen
A.; Arp H.; Mortensen M.; Odgaard A.; Wiggers H.; Poulsen S.; Udsen G.;
Lomholt J.; Niemann K.; Ridderstrale M.; Tarnow L.; Boesgaard T.; Hansen
T.; Safai N.; Andersen M.; Hansen S.; Pedersen M.; Auscher S.; Sheta H.;
Vinter K.; Hindsgaul L.; Lundgaard M.; Moltrup L.; Klausen I.; Haastrup
B.; Hedegaard B.; Gudmundsdottir S.; Kesaniemi A.; Hussi E.; Valpas S.;
Taurio J.; Airaksinen A.; Luukkonen S.; Uusitalo S.; Strandberg T.;
Ronkainen E.; Sarti C.; Tilvis R.; Aaltonen M.; Landstrom E.; Punkka A.;
Lakka T.; Savonen K.; Kastarinen H.; Koskinen N.; Tuominen M.L.; Haaraoja
A.; Laukkanen J.; Hadjikov A.; Hellsten S.; Hiltunen P.; Perhonen M.;
Valtonen M.; Moilanen M.; Varakas M.; Eloranta E.; Ukkola O.; Ojala P.;
Ukkola L.; Pihlman S.; Mononen M.; Hyttinen K.; Lipponen S.; Kotila M.;
Pollanen A.; Rajala A.; Kantola I.; Kiviniemi T.; Strandberg M.; Raali J.;
Roine E.; Appel K.F.; Appel S.; Utech A.; Becker P.; Chmilewski S.;
Kuehnert J.; Pietsch I.; Reinemann A.; Werner S.; Mentz G.; Drexler M.;
Muller-Wittlich I.; Drexler A.; Hobrack S.; Tajouaout K.; Dungen H.D.;
Bekfani T.; Cherian G.; Fritschka M.; Musial-Bright L.; Trippel T.;
Tscholl V.; Baltic A.; Inkrot S.; Maiwald A.; Pinta A.; Sacirovic M.;
Saewe Y.; Stolz R.; Boelmans K.; Breunig M.; Hammer F.; Hofmann U.; Judex
J.; Richter C.; Voehringer H.; Lianopoulos E.; Opitz C.; Buchholz M.;
Gebhardt S.; Helms S.; Horacek T.; Kahrmann G.; Stobbe O.; Fink P.;
Gunesli A.; Richtstein J.; Wilke K.; Weiss N.; Jabs N.; Mahlmann A.; Werth
S.; Brilloff S.; Dechert M.; Festerling E.; Leistner M.; Sehr B.; Weise
I.; Jeserich M.; Haggenmiller S.; Kimmel S.; Schoengart H.O.; Cakir M.;
Eichinger G.; Rupprecht M.; Graf K.; Thieme R.; Tummos E.; Ausner J.;
Fischer L.; Braun-Dullaeus R.; Bonigk H.; Meissler S.; Schmeisser A.;
Schulz H.; Uslar S.; Weigt D.; Gebauer R.; Roeder S.; Schafer K.; Silber
S.; Basler M.; Matt C.; Styllou P.; Bosnjak B.; Huth M.; Schmid A.; Senger
C.; Camerer M.; Drosch H.; Stromer H.; Heid J.; Wilsch R.; Voller H.;
Jawari A.; Stiehl S.; Salzwedel A.; Stolze K.; Mitrovic V.; Gaede L.; Peil
A.; Shaker M.; Stellbrink C.; Drephal C.; Elberg B.; Junge J.; Stellbrink
E.; Weber T.; Brettschneider B.; Gruhne C.; Iselt M.; Kube J.; Lehmann U.;
Potthast C.; Watson S.; Brachmann J.; Held M.; Mahnkopf C.; Saleh A.;
Sallam A.; Schertel-Gruenler B.; Schnupp S.; Goebel U.; Rube S.; Truthan
K.; Kadel C.; Lahiri K.; Moellinger H.; Pagitz M.; Reusch J.; Stadler A.;
Zulauf N.; Anuschek V.; Beissner S.; Buerger M.; Hagmanns M.; Hickmann E.;
Klinger C.; Rahn G.; Schemann J.; Tu E.; Wolfl C.; Schaechinger V.;
Pluecker T.; Strupp G.; Trepels T.; Wahl W.; Roemmelt C.; Fritsch S.;
Schwimmbeck P.; Fahrig A.; Hautmann M.; Oner A.; Weidmann B.; Wenzel I.;
Czihal M.; Hausleiter K.; Kress K.; Kreuzpointner R.; Kuhlencordt P.;
Rieber S.; Nuerbchen J.; Roth-Zetzsche S.; Kaab S.; Franz W.; Feldmann C.;
Grabmaier U.; Sinner M.; Bongartz A.; Gross C.; Halter B.; Sakic J.;
Bauersachs J.; Bavendiek U.; Pirr J.; Sonnenschein K.;
Hohenleitner-Luhrssen K.; Juergens A.; Schaefer N.; Bosiljanoff P.; Betzl
G.; Bosiljanoff E.; Feger J.; Kinateder A.; Sechtem U.; Egenrieder S.;
Karagianni A.; Schaufele T.; Voehringer M.; Gruensfelder S.; Hoffmann L.;
Wenzelburger I.; Dengler T.; Loges C.; Neatu C.; Lindner C.; Pfau C.;
Heuer H.; Bourhaial H.; Dulea I.; Guerocak O.; Halberstadt S.; Kemala E.;
Peterek J.; Philips H.; Dieckheuer U.; Euler K.; Laschewski B.; Maas M.;
Peda J.; Schaper F.; Henkel E.; Teige M.; Schrapel C.; Waetzold K.;
Isermann B.; Westphal S.; Borucki K.; Schulze M.; West K.; Trenk D.;
Hochholzer W.; Leggewie S.; Stratz C.; Schiebeling-Romer A.; Siefer M.;
Werner N.; Schueler R.; Sedaghat A.; Sinning J.M.; Twelker K.; Jones U.;
Lauterborn M.; Lennarz M.; Lubnau S.; Meier A.; Streuber-Bouhksas T.;
Blankenberg S.; Adam M.; Alternburg C.; Huemmelgen M.; Jagodzinski A.;
Karaks M.; Koopmann K.; Schafer S.; Schuler H.; Sydow K.; Thomas C.;
Tigges E.; De Boer I.; Hermes M.; Nebel J.; Schlesner C.; Schluter J.;
Sprechert D.; Zbik S.; Waltenberger J.; Fisscher D.; Schulz C.; Otte B.;
Centofante L.; Kremerskothen R.; Beilker J.; Muller S.; Schlosser E.;
Birner C.; Luchner A.; Egresits J.; Jungbauer C.; Resch M.; Schmid P.;
Buesing M.; Liebl C.; Sulflow S.; Weil J.; Brueggemann B.; Graf T.;
Moeller C.; Miodek M.; Ince H.; Andresen D.; Seidel A.; Sprenger C.;
Stoeckicht Y.; Ziefle S.; Forster S.; Ort J.; Szczesnak S.; Midi P.;
Felici A.; Caranzetti F.; Tomassini L.; Sicuro M.; Aillon C.; Gianonatti
C.; Bare C.; Dona P.; Caldarola P.; Resta M.; Ruggiero M.; Galietti M.; Di
Pasquale G.; Filippini E.; Riva L.; Zagnoni S.; Piccinni G.; Perrone C.;
Aloisi A.; Cosmi F.; Mariottoni B.; Tarquini B.; Frattini S.; Pirelli S.;
Paradiso G.; Signore S.; Baggiore C.; Crescenti C.; Leopardi A.; Pini P.;
Di Biase M.; D'Antuono C.; Ieva R.; Monaco I.; Montrone D.; Mandorla S.;
Buccolieri M.; Capponi E.; Martinelli S.; Piccioni N.; Regni O.;
Iaquaniello A.; Malvestiti A.; Pieroni Minciaroli S.; Olivieri C.; Chiodi
R.; Masciotra A.; Poletti F.; De Servi S.; Affinito S.; Di Donato A.;
Messina S.; Stefanin C.; Casolo G.; Robiglio L.; Vivaldi F.; Buono A.;
Urbani C.; Alberti A.; Giagnoni E.; Pupilella T.; Biondi A.; Lazzari A.;
Montagna L.; Chirio C.; Salvetti I.; Perrelli M.; Baldin M.G.; Cesanelli
R.; Boccati S.; Duri G.; Priori S.; Ceresa M.; Zambelli M.; Savino G.;
Piovaccari G.; Grosseto D.; Testa P.; Gaviani P.; Girardi A.; Manzo I.;
Serroni G.; De Matteis C.; Campidonico U.; Crisci C.; Falco M.; Di Matteo
C.; Fattore L.; Morello G.; Nave C.; Petacchi R.; Bertoli D.; Filorizzo
G.; De Donno O.; De Lorenzi E.; Urso L.; Lecci A.; Cucchi G.; Gianatti E.;
Proietti G.; Bernardinangeli M.; Serani S.; Morocutti G.; Bisceglia T.;
Fresco C.; Andrioli V.; Biundo V.; Giannuzzi P.; Gattone M.; Bolzani V.;
Di Ruocco M.; Temporelli B.; Mihara B.; Okada Y.; Vingsnes T.; Sirnes H.;
Solheim K.; Tilseth R.; Vestre M.; Bjorkas A.; Vassbotten I.; Rod R.;
Stodle R.; Nygard O.; Berge C.; Schartum Hansen H.; Kask A.; Loland K.;
Svingen G.; Tuseth N.; Vavik V.; Wilberg Rebnord E.; Gjellefall B.;
Hovland S.; Nordgaard Thorsen S.; Kjaernli T.; Erstad O.; Grodal K.; Nybo
S.; Royset C.; Stadsnes S.; Hovland A.; Lappegard K.; Sandvik J.; Carlsen
H.; Enebakk T.; Thunhaug H.; Solnor L.; Holmstrom P.; Risberg K.; Hansen
H.; Kulseng B.; Lauglo K.; Tevik Bjoru H.; Langeng T.; Salater S.; Scott
Munk P.; Singsaas E.; Larsen A.G.; Moen S.; Nilsen J.; Larsen T.; Turkerud
Soby E.; Sparby J.; Werenskjold E.; Grundtvig M.; German M.; Szacinski G.;
Hysing J.; Thalamus J.; Flagstad E.; Rosland H.; Klemsdal T.; Bergengen
L.; Kleve R.; Skogsholm A.; Larsby K.; Holde I.; Jonassen R.; Nilsen M.;
Berg-Johansen J.; Tisthammer Antonsen H.; Jonasson L.; Ohlsson A.; Bastani
L.; Delgado T.; Gunvarsdotter S.; Lof P.; Persson L.; Larsdotter-Damm T.;
Skoglund K.; Lindholm C.; Thulin J.; Assarsson E.; Broberg M.; Torstensson
I.; Lager I.; Harsmar K.; Knutsson A.; Hjelmaeus L.; Zlatewa R.; Lindemann
E.; McLain I.; Larnefeldt H.; Eld M.; Bjorkman-Larnefeldt M.; Hardhammar
P.; Johansson P.A.; Karlsson A.C.; Lingman M.; Lofgren M.; Tabandeh A.;
Andersson L.; Palm C.; Timberg I.; Stjernberg M.; Wikstrom P.; Bergmark
C.; Thott O.; Hedin U.; Montan C.; Nilsson O.; Lenquist M.; Nilsson L.;
Wodlin P.; Borjesson M.; Raschberger A.; Ekholm L.; Svensson K.A.; Agardh
A.; Algotsson L.; Bergstrom M.L.; Randers F.; Klintberg L.; Axelsson U.;
Mostrom P.A.; Mourtzinis G.; Paren P.; Persson B.; Risenfors M.; Moodh J.;
Mossmark M.; Ohrtgren L.; Ahlstrom P.; Tornqvist A.; Rosenqvist U.;
Grandas M.; Karlsson G.; Ottander P.; Eriksson A.; Backlund M.; Johansson
M.; Sundholm C.; Kempe A.; Salomonsson S.; Larsson J.; Forsberg K.; Sjodin
A.; Mathiesen U.; Carlsson M.; Keppel E.; Fehling K.; Robertsson U.;
Jansson J.H.; Boman K.; Lundmark L.M.; Norrfors B.; Weiderman A.; Jasinska
E.; Lundvall M.; Eriksson K.; Kjellberg-Eriksson J.; Larsson U.; Vasko P.;
Anderson G.; Bergstrom O.; Johansson S.; Nystrom T.; Uggeldahl I.; Webster
J.; Herd V.; Wilson E.; Mir F.; Blackwood S.; Watts M.; Khan W.; Tahir N.;
Elliot K.; Lichfield J.; Marsh H.; Reid M.; Cooper I.; de Silva R.;
Gallivan A.; Jones A.; Andrews L.; Jewkes C.; Lindsay S.; Rees K.; Wilson
A.; Bayly G.; Chambers J.; George S.; Halestrap M.; Bellamy C.; Evans S.;
Pritchard E.; Stockport J.; Wynne S.; Fulton J.; Simmonds J.; Stewart C.;
West C.; Chidambara H.; Msimanga T.; Moore B.; Roberts G.; Edwards T.;
Breakspear S.; Fleming N.; Newby D.; Fraser E.; Marshall L.; Nailon H.;
Parkin D.; Edwards M.; Mitchell C.; Mahabir N.; Griffiths H.; Mitchell K.;
Appleyard D.; Farr S.; Lloyd-Mostyn R.; Hardingham S.; Sewell T.; Lynch
M.; Burog W.; Dhaliwal M.; Mfuko C.; Travill C.; Gent S.; Norris B.;
Edgell R.; Lake T.; Taylor Bennett A.; Hartland A.; Walton E.; Murphy J.;
Brennan G.; Cawley P.; Dixon L.; Rees E.; Andrews R.; Brownlow T.; Crouch
S.; Mills H.; Nixon M.; Salter N.; Pringle S.; Hutcheon S.; Waldie H.;
Swan J.; McSorland D.; Curless R.; Armstrong M.; Ashbrook-Raby C.; Bunn
D.; Gour R.; Herriott C.; Robson C.; Tanney C.; Davey P.; Campey L.; Smith
K.; Tanqueray E.; Munir A.; Pereira O.; Khalifa M.; Capps N.; Donaldson
D.; Miller C.; Tonks L.; Reynolds T.; Basvi P.; Reynolds J.; Wilcox L.;
Mansell P.; Babington G.; Barnes E.; Beck S.; Craig S.; Patterson L.;
Selby A.; Woodford C.; Watkins H.; Bowsher Brown K.; Robertson J.;
Muthusamy R.; Lawan M.; Weston C.; Orr W.; Foxton J.; Hallett S.; Hilltout
P.; Jones L.; King J.; Ramtoola S.; Grimes Y.; Hutchesson A.; Cummings J.;
Morris K.; Fleming S.; Ludlow K.; Parrett M.; Pellow S.; Quinn L.; James
M.; Green E.; Keenan S.; Reckless J.; Robinson A.; Andrews G.; McLenaghan
A.; ul Haq I.; Albers C.; Labib M.; Higginson E.; Fitchet A.;
Darrel-Asherel E.; Green J.; Healey M.; Sexton D.; Hughes E.; Chackathayil
J.; Willetts S.; Shearman C.; Pal N.; Lewis A.; Pasinabo M.; Trevithick
C.; Tyler D.; Watkins B.; Papouchado M.; Bertram W.; Binley E.; Hierons
S.; Kandola S.; Mann C.; Whitney K.; Wilcox H.; Bibi A.; Fuller J.;
Jackson S.; Kalra P.; Howe S.; Hudson K.; Suttling A.; Turner C.; Wong Y.;
Clayton-Evans L.; Moore S.; Stearn S.; Lewis P.; Cochrane H.; Curtis J.;
Holland M.; Junejo S.; Dungca E.; Robson T.; Smith A.; Carey C.; Felmeden
L.; Summerhayes A.; Sutton J.; Butler R.; Creamer J.; Bellaby J.;
Castro-Foskett K.; Griffiths M.; Machin J.; Massey I.; Sellars E.; Wain
J.; McDowell I.; Davies L.; Davies M.; Dyer H.; Odam M.; Waters A.; Been
M.; Ansell V.; Campbell A.; Davies D.; De Burca B.; Jones J.; Musa A.;
Roberts D.; Brady R.; Dickinson C.; Lane L.; Pickervance S.; Francis M.;
Bryson V.; Clements M.; Ashton L.; George A.; Markwell K.; Walker E.;
Orugun O.; Poultney U.; Lie F.; Taneja A.; Badal B.; Conteh V.; Jones M.;
Montemayor M.; Trevelyan J.; Byng-Hollander E.; Doughty A.; Signy M.;
Dunne A.; Fox H.; Wheatley K.; Price S.; Ray S.; Golledge S.; Murmu M.;
Nicholas A.; Brigden G.; Board J.; Buckley C.; Vickers C.; Albert M.;
Baillargeon G.; Harman D.; Mahal S.; Kaur J.; Padkowsky S.; Walker M.;
Yandamuri S.; Dietrich D.; Armstrong L.; Casey M.; Schaefer V.; Bretton
E.; Hsi D.; Kovach J.; Troy J.; Asbill B.; Brown L.; Cauthren T.; Hull A.;
Lim O.; Tompkins J.; Vaughn J.; Perlman R.; Connors D.; Hoopes D.; Palazzo
D.; Prosser A.; Serrano-Rawls M.; Tedder B.; Johnson E.; Pearson T.;
Rubino K.; Williams P.; Singh N.; Brown M.; Dubal S.; Hall E.; Logwood D.;
Mazahir U.; Raynes K.; Gammon R.; Bauman A.; Hatch J.; Mock P.; Tilton N.;
Abide W.; Gudeman D.; Minor S.; Shipwash T.; Korn D.; Korn A.; Awasty V.;
Baldwin E.; Hunt G.; Kaiser V.; McMurray C.; Khan T.; Al-Jumaily J.;
Foster T.; Holbrook V.; Nambi V.; Ballantyne C.; Jackson M.; Jones P.;
Morris B.; Techmanski M.; Tran A.; Eshaghian S.; Mirshkarlo H.; Zineldine
A.; Bies J.; Hockett D.; Kimball L.; Thakkar M.; Varma S.;
Barkley-Daughtry S.; Collins S.; Evans-Gay S.; Martin L.; McKinley A.;
Murray L.; Noel L.; Prasada S.; Robinson R.; Wheeler S.; Andreo J.;
Bansilal S.; Bergmark B.; Bohula May E.; Cavender M.; Cyr J.; Desai N.;
Fanola C.; Fantony N.; Giugliano R.; Gutierrez J.; Kazanjian P.;
Marti-Bernier J.; Mega J.; Mesa R.; O'Donoghue M.; Scirica B.; Silverman
M.; Williams L.; Meckel C.; Orosco C.; Saalfeld R.; Thompson N.; Wiechert
C.; Kozlowski L.; Cooke B.; Corbelli J.; Galla A.; Stock R.; Benton R.;
Carroll A.; Leeper C.; Orvis E.; Shah P.; Kasson A.; Lieberman J.;
O'Malley A.; Rider J.; Loomis B.; Schantz M.; Heiman M.; Sadowski K.;
Scierka L.; Sclafani J.; Strubberg K.; Mania D.; Del Mastro E.; Jumper R.;
Bukoski K.; Eiben P.; Keegan R.; Kelley E.; Sekerak E.; Weisberger J.;
Serra A.; Augenbraun C.; Jumper S.; Stuart A.; Archer A.; Malak T.; Velky
J.; Spencer R.; Lane B.; Lehmann J.; Henderson D.; Crandall L.; Easterling
A.; Lizama A.; Millard D.; Gelernt M.; Billings C.; Cockrell D.; Anderson
E.; Pavlides A.; Davis M.; Viswanath D.; Kinder M.; Jeffers H.; Manga S.;
Shaw P.; Jones S.; Stover T.; Reeves R.; Frew S.; Menuet R I.I.; Veerina
K.; Domingue N.; Huffman L.; Leach Y.; Rideaux T.; Smith J.; Soileau L.;
Karlsberg R.; Bhatia; Gomez A.; Levi L.; Lopez D.; Treasure C.; Michaelis
L I.I.; Parker M.; Robertson C.; Treasure L.; Erickson B.; Amundson A.;
Humbert J.; Madden H.; Desai V.; Lemmertz K.; Zoghbi J.; Malone M.;
Mullinax K.; Schenks R.; Goldscher D.; Fisher M.; Latteri J.; Goldstein
M.; Lutz H.; Peichert D.; Haskel E.; Powell J.; Yashinski C.; Amin J.;
Bashton D.; Burns S.; Davidson A.; DeSousa C.; Humberger C.; McGee R.;
Zelenka J.; Ferguson D.; Manuel C.; Quinn J.; Zelik J.; Nukta E.; Bittel
B.; Dettmer M.; Palmer C.; Boulware W.; Cooper L.; Freeman R.; Banks K.;
Hall L.; Hall C.; Riser K.; Vaz S.; Winstead J.; Womack L.; Dy J.; Fox L.;
Landers E.; Raby B.; Whisnant T.; Isserman S.; Annas T.; Kirby K.; Lail
J.; Moore C.; Cohen R.; Bossaers J.; Heaney L.; Hislop A.; Moreiras L.;
Ocampo M.; Jetty P.; Allen T.; Custer C.; Key A.; Lipps S.; Banerjee S.;
Carlos S.; Garza A.; Sutton R.; Tobiansky J.; Gluck J.; Tofstad C.; Kmetzo
J.; Brown J.; Carter L.; Riley R.; Scott D.; Seger P.; Taylor D.; Wood D.;
Ahmad A.; Ahmed M.; Ayub H.; Contreras S.; Iqbal S.; Martinez S.; Martinez
M.; Donahoe S.; Dalal P.; Defraia C.; DeStefano R.; Lederman S.; Lorme D.;
Ruhani M.; Acheatel R.; Biggers J.; Emery P.; Kim C.; Barnes D.; Behm K.;
Dziekonski A.; Karunaratne H.; Stastny C.; Bittar N.; Lehmann S.; Spatola
M.; Wilson P.; Staniloae C.; Homberg-Pinassi E.; Hermany P.; Batchlett K.;
Gibson A.; Meissner-Dengler S.; Rosenfeld J.; Seidner M.; Sosonkin K.;
Pollock S.; Johnson S.; Salazar J.; Hovland R.; Jordan J.; Karas S.;
Peacock T.; Schechtmann N.; Tischner G.; Vicari R.; Warren K.; Ghitis A.;
Cusner H.; Klaus Clark M.; Zebrack J.; Christensen S.; Evenson C.;
Fullerton D.; Hartley J.; Broadway K.; Eskridge L.; Raymond D.;
Kizhakekuttu T.; Hillis S.; Klundt R.; McElroy D.; House K.; Begg R.; Acon
J.; Flores A.; Hobbs-Williams J.; Schidemantle E.; Cooper M.; Campbell E.;
Corcoran B.; Hughes S.; Miller N.; Steingard S.; Einhorn D.; Berry M.;
Dawkins Hughes S.; Gilbert L.; Lasala E.; Loeck A.; Mills N.; Oppenheim
J.; O'Dea D.; Brian S.; Gerber G.; Landi T.; Ling J.; Rimmey S.; Gilmore
R.; Bruney C.; Gabbert E.; Hays R.; Stawecki L.; Trahan J.; Winey-Ward D.;
Baker S.; Gervasio B.; Labodin J.; Taheri H.; Brooks J.; Delozier A.;
Jayashekaramurthy J.; Khachab S.; Machineni P.; Morgan K.; Cathcart C.;
Ciampanelli E.; Ervin W.; Soule K.; Stinson J.; Bhargava A.; Borg L.;
Carver A.; Koren M.; West A.; Jenkins R.; Barnett S.; Caro H.; Mooney J.;
Janout M.; Bjergo J.; Passey L.; Sather K.; Hage-Korban E.; Carrington M.;
Childs A.; Harrington A.; Manns D.; Phelan T.; Stuckey T.; Lord S.; Milks
S.; Bays H.; Bushong D.; Keiran S.; Moore M.; Weiter K.; Morris F.; Dignon
C.; Downing J.; Lowry D.; Metcalf A.; Claxton E.; Weiss R.; Dumais S.;
Bernstein R.; Singh C.; Colfer H.; Teklinski A.; Antonishen D.; Antonishen
M.; Ronquist M.; Shaw C.; Hall J.; Hanzich C.; Gessler A.; Skatrud L.;
Collins J.; Bitzer V.; Fruge A.; Gauthier T.; Hernandez M.; Kayner K.;
Michon C.; Naessens L.; Felten W.; Cryderman A.; Lagalo M.; Mostek K.;
Cluley C.; Prior J.; Lader E.; Meyer M.; Alford C.; Bryan S.; Gilley J.;
Levin P.; Bromberger L.; Guerra D.; Brandon P.; Burton C.; Ebert J.;
Garrison K.; Goetz C.; Harris S.; Lumsden C.; Quinn D.; Graf R.; Scott J.;
Ayers S.; Beasley T.; Finney; Gordon R.; Hoekstra J.; Jeter W.; Young C.;
Dionisopoulos P.; Godfrey C.; Holcomb R.; Krenk S.; Randhawa P.; Agarwal
S.; Almond E.; Capstraw E.; Geraldo-Abache A.; Kuchipudi S.; Pasupuleti
L.; Sangiovanni C.; Sheena H.; Vargas B.; Hendrix E.; Crews C.; McNeese
J.; Traboulssi M.; Bohn A.; Humphrey K.; Walton A.; Lupovitch S.; Bellini
S.; Clemens L.; Galindo M.; Piszkiewicz V.; Soni A.; Lash J.; Abell T.;
Flanery V.; Hanrahan J.; Mudd D.; Pasquini J.; Morton V.; Nikitin J.;
Richards P.; Sander C.; Voelkers M.; Hamroff G.; Bentivenga L.;
Fuerst-Carter K.; Hametz C.; Hollenweger L.; Pankovic C.; Solomon A.;
Prashad R.; Colacone T.; Green M.; Lightcap P.; McDonough C.; Metivier E.;
Miller D.; Alton M.; Grimwood-Fidler D.; Heins G.; Looney A.; Orr L.;
Clark W.; Dolan M.; Dugan B.; Feest K.; Foley J.; Perlmutter N.; Aviles
R.; Doucette W.; Fortney T.; Garceau J.; Heywood J.; Kanegae K.; Kozlowski
C.; LeDoux D.; Leggett J.; Mahan A.; McKinney E.; Ostergard S.; Wagoner
S.; Yedinak S.; Zilz N.; Kahn B.; Coombs V.; Phelps J.; Sheridan E.;
Steinberg M.; Littlefield R.; Baty J.; Clark A.; Cooper J.; Hames E.;
Collis W.; Needham J.; Srivastava S.; Bilazarian S.; Ketis C.; Roach K.;
Boccalandro F.; Bryan A.; Krantzler J.; McClelland N.; Muhlenberg T.;
Pickett S.; Rink L.; Brooks-Wolfe A.; Litz B.; Mobley D.; Knutson T.;
Belanger B.; Hermans P.; Quinnell C.; Hack T.; Fisher E.; Morelli L.;
Sullivan S.; Landau C.; Hilts T.; Eisenberg D.; Babar G.; Fam M.; Fernando
D.; Gallegos D.; Kenegos G.; Reed K.; Danish Rizvi M.; Erie G.; Eubanks
C.; Foster B.; Kline J.; Nelson W.; Tami L.; Abdur Rahman M.; Viera Moreno
J.; Krichmar P.; Ferreira J.; Marquez D.; Sanchez-Lacayo H.; Yunes R.;
Hunter J.; Battistelli E.; Cook T.; Iverson R.; Suarez M.; Kandath D.;
Frank S.; Kostedt G.; Nelson J.; Hamburg C.; Diaz L.; Hernandez E.;
Roberts J.; Shatsky K.; Torres E.; Tahirkheli N.; Adams T.; Springer K.;
Springer W.; Talano J.; Ficarra R.; Leo L.; Nolen J.; Perez M.; Rappley
G.; Szalanski N.; Peart B.; Ford-Tarlton M.; Peart K.; Stephens J.;
Schlager D.; Schramm E.; Rabalais M.; Williamson C.; DeSantis J.;
Benedetto K.; Bursey E.; Harting T.; Muller R.; Phang R.; Roccario E.;
Schaummann-Boyle P.; Zuchelkowski A.; Katopodis J.; Gearld K.; Knap P.;
Liebrich S.; Lieber I.; Ferree L.; Stowe F.; Sutton M.; Wiseman D.; Vogel
C.; Aggarwal R.; Baroni C.; Beck P.; Blake J.; Dagher E.; Gryl A.; Johnson
M.; Smith M.; Kereiakes D.; DeFosse C.; Schwartz J.; Ervin J.; Edwards S.;
Gorman C.; Gorsuch A.; Pomeroy S.; Huehnergarth K.; Davis K.; Harder M.;
Lim M.; Schrenker M.; Robinson J.; Cayler J.; Cherrico M.; Chun-Furlong
D.; De La Garza J.; Pothula A.; Antonio-Drabek C.; Bradley A.; Buresh R.;
Hass T.; Lopez C.; Strader J.; Donlin A.; Ensminger E.; Garcia H.;
Gneiting A.; Graf E.; Greenberg D.; Rogers W.; Arora P.; Morgan T.; Saag
L.; Thorington S.; Jerome S.; Black L.; Gupta A.; Aggarwal K.; Belew K.;
Burkhardt V.; Holland Clasby S.; Lau-Sieckman A.; Cebe J.; Calhoun E.;
Kissam C.; Major L.; Butman S.; Bescak K.; Bescak D.; Bigelow A.; Brown
T.; Davidson S.; Haddad T.; Alexander T.; Jain J.; McClain S.; Myhera T.;
Overbeck D.; Torre B.; Wotorson L.; Canto J.; Corneal C.; Donley B.;
McGowan N.; Prisoc K.; Sharrett M.; Kaster S.; Akers J.; Darlington H.;
Gault J.; Horner J.; Roozen C.; Loh I.; Anderson R.; Call T.; Esaki J.;
Patel P.; Plocky J.; Raymond J.; Rideaux C.; Sprafka L.; Stich M.; Andres
C.; Brown C.; Buda M.; Ciuica S.; Minker B.; Perry S.; McCullum K.; Doty
B.; Gates S.; Hutcheson K.
Institution
(Bowman, Hopewell, Chen, Wallendszus, Stevens, Collins) Clinical Trial
Service Unit, University of Oxford, Oxford, United Kingdom
(Wiviott, Cannon, Braunwald) Thrombolysis in Myocardial Infarction Study
Group, Brigham and Women's Hospital, Harvard Medical School, Boston,
United States
(Sammons, Landray) Clinical Trial Service Unit, Medical Research Council
Population Health Research Unit, University of Oxford, Oxford, United
Kingdom
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND: Patients with atherosclerotic vascular disease remain at high
risk for cardiovascular events despite effective statin-based treatment of
low-density lipoprotein (LDL) cholesterol levels. The inhibition of
cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL
cholesterol levels and increases high-density lipoprotein (HDL)
cholesterol levels. However, trials of other CETP inhibitors have shown
neutral or adverse effects on cardiovascular outcomes. METHOD(S): We
conducted a randomized, double-blind, placebo-controlled trial involving
30,449 adults with atherosclerotic vascular disease who were receiving
intensive atorvastatin therapy and who had a mean LDL cholesterol level of
61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol
level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL
cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The
patients were assigned to receive either 100 mg of anacetrapib once daily
(15,225 patients) or matching placebo (15,224 patients). The primary
outcome was the first major coronary event, a composite of coronary death,
myocardial infarction, or coronary revascularization. RESULT(S):
During the median follow-up period of 4.1 years, the primary outcome
occurred in significantly fewer patients in the anacetrapib group than in
the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224
patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97;
P=0.004). The relative difference in risk was similar across multiple
prespecified subgroups. At the trial midpoint, the mean level of HDL
cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the
anacetrapib group than in the placebo group (a relative difference of
104%), and the mean level of non-HDL cholesterol was lower by 17 mg per
deciliter (0.44 mmol per liter), a relative difference of -18%. There were
no significant between-group differences in the risk of death, cancer, or
other serious adverse events. CONCLUSION(S): Among patients with
atherosclerotic vascular disease who were receiving intensive statin
therapy, the use of anacetrapib resulted in a lower incidence of major
coronary events than the use of placebo. Copyright © 2017
Massachusetts Medical Society.

<138>
Accession Number
617760216
Title
Cangrelor Versus Clopidogrel on a Background of Unfractionated Heparin
(from CHAMPION PHOENIX).
Source
American Journal of Cardiology. 120 (7) (pp 1043-1048), 2017. Date of
Publication: 01 Oct 2017.
Author
Vaduganathan M.; Harrington R.A.; Stone G.W.; Steg P.G.; Gibson C.M.; Hamm
C.W.; Price M.J.; Deliargyris E.N.; Prats J.; Mahaffey K.W.; White H.D.;
Bhatt D.L.
Institution
(Vaduganathan, Bhatt) Brigham and Women's Hospital Heart & Vascular Center
and Harvard Medical School, Boston, Massachusetts, United States
(Harrington, Mahaffey) Stanford University Medical School, Stanford,
California, United States
(Stone) Columbia University Medical Center and the Cardiovascular Research
Foundation, New York City, New York, United States
(Steg) FACT (French Alliance for Cardiovascular clinical Trials), DHU
FIRE, INSERM Unite 1148, Universite Paris-Diderot, Paris, France
(Steg) Hopital Bichat, Assistance-Publique-Hopitaux de Paris, Paris,
France
(Steg) NHLI, Imperial College, Royal Brompton Hospital, London, United
Kingdom
(Gibson) Beth Israel Deaconess Medical Center, Division of Cardiology,
Boston, Massachusetts, United States
(Hamm) Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany
(Price) Scripps Clinic and Scripps Translational Science Institute, La
Jolla, California, United States
(Deliargyris) Science and Strategy Consulting Group, Basking Ridge, New
Jersey, United States
(Prats) The Medicines Company, Parsippany, New Jersey, United States
(White) Green Lane Cardiovascular Service, Auckland, New Zealand
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Cangrelor is approved for use during percutaneous coronary intervention
(PCI) and is administered with different parenteral anticoagulants. We
examined the efficacy and safety of cangrelor in the subgroup of patients
who received unfractionated heparin (UFH) during PCI in the modified
intention-to-treat population of the randomized CHAMPION PHOENIX trial
(cangrelor vs clopidogrel; n = 10,939). The primary efficacy end point was
the composite of death, myocardial infarction, ischemia-driven
revascularization, or stent thrombosis (ST) at 48 hours. The key secondary
efficacy end point was ST. UFH was used in 69.2% (7,569/10,939) of
patients. In the UFH subgroup, cangrelor reduced the primary composite
efficacy end point at 48 hours compared with clopidogrel (4.8% vs 5.9%;
odds ratio [OR] 0.80 [0.65 to 0.98]; p = 0.03). Cangrelor consistently
reduced ST at 2 hours (0.7% vs 1.3%; OR 0.56 [0.35 to 0.90]; p = 0.01) and
48 hours (0.9% vs 1.4%; OR 0.70 [0.45 to 1.07]; p = 0.10). There was no
difference in GUSTO (Global Use of Strategies to Open Occluded Coronary
Arteries)-defined severe or life-threatening bleeding (0.1% vs 0.1%; OR
1.24 [0.33 to 4.61]; p = 0.75) or blood transfusion requirement at 48
hours (0.4% vs 0.2%; OR 1.87 [0.83 to 4.21]; p = 0.12). In conclusion,
cangrelor reduces early ischemic periprocedural complications without
increasing severe bleeding compared with clopidogrel in patients
undergoing PCI with UFH. Copyright © 2017 Elsevier Inc.

<139>
Accession Number
614145828
Title
The Society of Thoracic Surgeons Expert Consensus for the Resuscitation of
Patients Who Arrest After Cardiac Surgery.
Source
Annals of Thoracic Surgery. 103 (3) (pp 1005-1020), 2017. Date of
Publication: 01 Mar 2017.
Author
Dunning J.; Levine A.; Ley J.; Strang T.; Lizotte D.E.; Lamarche Y.;
Bartley T.; Zellinger M.; Katz N.; Arora R.C.; Dembitsky W.; Cheng A.M.;
Lonchyna V.A.; Haft J.; Deakin C.D.; Mitchell J.D.; Firestone S.; Bakaeen
F.G.
Institution
(Dunning) Department of Cardiothoracic Surgery, James Cook University
Hospital, Middlesbrough, United Kingdom
(Levine) Department of Cardiothoracic Surgery, North Staffordshire
Hospital, Stoke-on-Trent, United Kingdom
(Ley) Department of Cardiac Surgery, California Pacific Medical Center,
San Francisco, California, United States
(Strang) Department of Cardiothoracic Anaesthesia, Wythenshawe Hospital,
United Kingdom
(Lizotte) Department of Cardiovascular and Thoracic Surgery, University of
Louisville, Louisville, Kentucky, United States
(Lamarche) Department of Surgery, Montreal Heart Institute and Critical
Care Program, Hopital du Sacre Coeur de Montreal, Universite de Montreal,
Montreal, Canada
(Bartley) Department of Cardiothoracic Surgery, Birmingham, United Kingdom
(Zellinger) Cardiac Surgery, Emory University Hospital, Atlanta, Georgia
(Katz) Division of Cardiac Surgery, Johns Hopkins University, Baltimore,
Maryland, United States
(Arora) Department of Surgery, Cardiac Sciences Program, St. Boniface
Hospital, Winnipeg, Manitoba, Canada
(Dembitsky) Department of Cardiac Surgery, Sharp Medical Centre, San
Diego, California, United States
(Cheng) University of Washington Medical Center, Seattle, Washington,
United States
(Lonchyna) Section of Cardiac and Thoracic Surgery, University of Chicago
School of Medicine, Chicago, Illinois, United States
(Haft) Department of Cardiac Surgery, University of Michigan, Ann Arbor,
Michigan, United States
(Deakin) Department of Cardiac Surgery and NIHR Southampton Respiratory
Biomedical Research Unit, University Hospital Southampton, Hampshire,
United Kingdom
(Mitchell) Department of Thoracic Surgery, University of Colorado
Hospital, Aurora, Colorado, United States
(Firestone) The Society of Thoracic Surgeons, Chicago, Illinois, United
States
(Bakaeen) Department of Thoracic and Cardiovascular Surgery, The Cleveland
Clinic, Cleveland, Ohio, United States
Publisher
Elsevier USA
Abstract
Executive Summary The Society of Thoracic Surgeons Task Force on
Resuscitation After Cardiac Surgery provides this professional society
perspective on resuscitation in patients who arrest after cardiac surgery.
This document was created using a multimodal methodology for evidence
generation and includes information from existing guidelines, from the
International Liaison Committee on Resuscitation, from our own structured
literature reviews on issues particular to cardiac surgery, and from an
international survey on resuscitation hosted by CTSNet. In gathering
evidence for this consensus paper, searches were conducted using the
MEDLINE keywords "cardiac surgery," "resuscitation," "guideline,"
"thoracic surgery," "cardiac arrest," and "cardiac massage." Weight was
given to clinical studies in humans, although some case studies, mannequin
simulations of potential protocols, and animal models were also
considered. Consensus was reached using a modified Delphi method
consisting of two rounds of voting until 75% agreement on appropriate
wording and strength of the opinions was reached. The Society of Thoracic
Surgeons Workforce on Critical Care was enlisted in this process to
provide a wider variety of experiences and backgrounds in an effort to
reinforce the opinions provided. We start with the premise that external
massage is ineffective for an arrest due to tamponade or hypovolemia
(bleeding), and therefore these subsets of patients will receive
inadequate cerebral perfusion during cardiac arrest in the absence of
resternotomy. Because these two situations are common causes for an arrest
after cardiac surgery, the inability to provide effective external
cardiopulmonary resuscitation highlights the importance of early emergency
resternotomy within 5 minutes. In addition, because internal massage is
more effective than external massage, it should be used preferentially if
other quickly reversible causes are not found. We present a protocol for
the cardiac arrest situation that includes the following recommendations:
(1) successful treatment of a patient who arrests after cardiac surgery is
a multidisciplinary activity with at least six key roles that should be
allocated and rehearsed as a team on a regular basis; (2) patients who
arrest with ventricular fibrillation should immediately receive three
sequential attempts at defibrillation before external cardiac massage, and
if this fails, emergency resternotomy should be performed; (3) patients
with asystole or extreme bradycardia should undergo an attempt to pace if
wires are available before external cardiac massage, then optionally
external pacing followed by emergency resternotomy; and (4) pulseless
electrical activity should receive prompt resternotomy after quickly
reversible causes are excluded. Finally, we recommend that full doses of
epinephrine should not be routinely given owing to the danger of extreme
hypertension if a reversible cause is rapidly resolved. Protocols are
given for excluding reversible airway and breathing complications, for
left ventricular assist device emergencies, for the nonsternotomy patient,
and for safe emergency resternotomy. We believe that all cardiac units
should have accredited policies and protocols in place to specifically
address the resuscitation of patients who arrest after cardiac
surgery. Copyright © 2017 The Society of Thoracic Surgeons

<140>
Accession Number
611884744
Title
First post-operative urinary kidney injury biomarkers and association with
the duration of AKI in the TRIBE-AKI cohort.
Source
PLoS ONE. 11 (8) (no pagination), 2016. Article Number: e0161098. Date of
Publication: August 2016.
Author
Coca S.G.; Nadkarni G.N.; Garg A.X.; Koyner J.; Thiessen-Philbrook H.;
McArthur E.; Shlipak M.G.; Parikh C.R.; Raman J.; Jeevanandam V.; Akhter
S.; Edelstein C.; Passik C.; Nagy J.; Swaminathan M.; Chu M.; Goldbach M.;
Guo L.R.; McKenzie N.; Myers M.L.; Novick R.; Quantz M.; Zappitelli M.;
Palijan A.; Dewar M.; Darr U.; Hashim S.; Elefteriades J.; Geirsson A.;
Garwood S.; Butrymowicz I.; Krumholz H.
Institution
(Coca, Nadkarni) Division of Nephrology, Department of Medicine, Icahn
School of Medicine at Mount Sinai, New York, NY, United States
(Garg, Thiessen-Philbrook, McArthur, Chu, Goldbach, Guo, McKenzie, Myers,
Novick, Quantz) Division of Nephrology, Department of Medicine, Western
University, London, ON, Canada
(Koyner, Raman, Jeevanandam, Akhter) Section of Nephrology, Department of
Medicine, University of Chicago, Pritzker School of Medicine, Chicago, IL,
United States
(Shlipak) Division of General Internal Medicine, San Francisco VA Medical
Center, University of California, San Francisco, CA, United States
(Parikh) Program of Applied Translational Research, Department of Internal
Medicine, Yale University School of Medicine, New Haven, CT, United States
(Parikh) Section of Nephrology, Department of Medicine, Yale University
School of Medicine, VA CT Healthcare System, Program of Applied
Translational Research, New Haven, CT, United States
(Edelstein) U of Colorado, United States
(Passik, Nagy) Danbury Hospital, United States
(Swaminathan) Duke University, United States
(Zappitelli, Palijan) Montreal Children's, United States
(Dewar, Darr, Hashim, Elefteriades, Geirsson, Garwood, Butrymowicz,
Krumholz) Yale-New Haven, United States
Publisher
Public Library of Science (E-mail: plos@plos.org)
Abstract
Background: We previously demonstrated that assessment of the duration of
AKI, in addition to magnitude of rise in creatinine alone, adds prognostic
information for long-term survival. We evaluated whether post-operative
kidney injury biomarkers in urine collected immediately after cardiac
surgery associate with duration of serum creatinine elevation.
 Method(s): We studied 1199 adults undergoing cardiac surgery in a
prospective cohort study (TRIBEAKI) and examined the association between
the levels of five urinary biomarkers individually at 0-6 hours after
surgery: interleukin-18 (IL-18), neutrophil gelatinase-associated
lipocalin (NGAL), kidney injury molecule-1 (KIM-1), liver fatty acid
binding protein (L-FABP) and albumin with duration of serum
creatinine-based AKIN criteria for AKI (0 (no AKI), 1-2, 3-6, >7 days).
 Result(s): Overall, 407 (34%) patients had at least stage 1 AKI, of
whom 251 (61.7%) had duration of 1-2 days, 118 (28.9%) had duration 3-6
days, and 38 (9.3%) had duration of >7 days. Higher concentrations of all
biomarkers (per log increase) were independently associated with a greater
odds of a longer duration of AKI; odds ratios and 95%confidence intervals
using ordinal logistic regression were the following: IL-18: 1.22,
1.13-1.32; KIM-1: 1.36, 1.21-1.52; albumin 1.20, 1.09-1.32; L-FABP 1.11,
1.04-1.19; NGAL 1.06, 1.00-1.14). AKI duration of 7 days or longer was
associated with a 5-fold adjusted risk of mortality at 3 years.
 Conclusion(s): There was an independent dose-response association
between urinary levels of injury biomarkers immediately after cardiac
surgery and longer duration of AKI. Duration of AKI was also associated
with long term mortality. Future studies should explore the potential
utility of these urinary kidney injury biomarkers to enrich enrollment of
patients at risk for longer duration of AKI into trials of interventions
to prevent or treat post-operative AKI. Copyright © 2016 Coca et
al. This is an open access article distributed under the terms of the
Creative Commons Attribution License, which permits unrestricted use,
distribution, and reproduction in any medium, provided the original author
and source are credited.

<141>
Accession Number
611908892
Title
A multicentre randomised controlled trial of transfusion indication
threshold reduction on transfusion rates, morbidity and health-care
resource use following cardiac surgery (TITRe2).
Source
Health Technology Assessment. 20 (60) (pp 1-259), 2016. Date of
Publication: August 2016.
Author
Reeves B.C.; Pike K.; Rogers C.A.; Brierley R.C.M.; Stokes E.A.;
Wordsworth S.; Nash R.L.; Miles A.; Mumford A.D.; Cohen A.; Angelini G.D.;
Murphy G.J.
Institution
(Reeves, Pike, Rogers, Brierley, Nash, Miles) Clinical Trials and
Evaluation Unit, School of Clinical Sciences, University of Bristol,
Bristol, United Kingdom
(Stokes, Wordsworth) Health Economics Research Centre, Nuffield Department
of Population Health, University of Oxford, Oxford, United Kingdom
(Mumford) School of Cellular and Molecular Medicine, University of
Bristol, Bristol, United Kingdom
(Cohen) Division of Specialised Services, University Hospitals Bristol NHS
Foundation Trust, Bristol, United Kingdom
(Angelini) Bristol Heart Institute, School of Clinical Sciences,
University of Bristol, Bristol, United Kingdom
(Murphy) Department of Cardiovascular Sciences, National Institute for
Health Research Leicester Biomedical Research Unit in Cardiovascular
Medicine, University of Leicester, Leicester, United Kingdom
Publisher
NIHR Journals Library (NETSCCAlpha HouseUniversity of Southampton, Science
Park, Southampton SO167NS, United Kingdom)
Abstract
Background: Uncertainty about optimal red blood cell transfusion
thresholds in cardiac surgery is reflected in widely varying transfusion
rates between surgeons and cardiac centres. Objective(s): To test the
hypothesis that a restrictive compared with a liberal threshold for red
blood cell transfusion after cardiac surgery reduces post-operative
morbidity and health-care costs. Design(s): Multicentre, parallel
randomised controlled trial and within-trial cost-utility analysis from a
UK NHS and Personal Social Services perspective. We could not blind
health-care staff but tried to blind participants. Random allocations were
generated by computer and minimised by centre and operation.
 Setting(s): Seventeen specialist cardiac surgery centres in UK NHS
hospitals. Participant(s): Patients aged > 16 years undergoing
non-emergency cardiac surgery with post-operative haemoglobin < 9 g/dl.
Exclusion criteria were: unwilling to have transfusion owing to beliefs;
platelet, red blood cell or clotting disorder; ongoing or recurrent
sepsis; and critical limb ischaemia. Intervention(s): Participants in
the liberal group were eligible for transfusion immediately after
randomisation (post-operative haemoglobin < 9 g/dl); participants in the
restrictive group were eligible for transfusion if their post-operative
haemoglobin fell to < 7.5 g/dl during the index hospital stay. Main
Outcome Measure(s): The primary outcome was a composite outcome of any
serious infectious (sepsis or wound infection) or ischaemic event
(permanent stroke, myocardial infarction, gut infarction or acute kidney
injury) during the 3 months after randomisation. Events were verified or
adjudicated by blinded personnel. Secondary outcomes included blood
products transfused; infectious events; ischaemic events; quality of life
(European Quality of Life-5 Dimensions); duration of intensive care or
high-dependency unit stay; duration of hospital stay; significant
pulmonary morbidity; all-cause mortality; resource use, costs and
cost-effectiveness. Result(s): We randomised 2007 participants
between 15 July 2009 and 18 February 2013; four withdrew, leaving 1000 and
1003 in the restrictive and liberal groups, respectively. Transfusion
rates after randomization were 53.4% (534/1000) and 92.2% (925/1003). The
primary outcome occurred in 35.1% (331/944) and 33.0% (317/962) of
participants in the restrictive and liberal groups [odds ratio (OR) 1.11,
95% confidence interval (CI) 0.91 to 1.34; p = 0.30], respectively. There
were no subgroup effects for the primary outcome, although some
sensitivity analyses substantially altered the estimated OR. There were no
differences for secondary clinical outcomes except for mortality, with
more deaths in the restrictive group (4.2%, 42/1000 vs. 2.6%, 26/1003;
hazard ratio 1.64, 95% CI 1.00 to 2.67; p = 0.045). Serious post-operative
complications excluding primary outcome events occurred in 35.7% (354/991)
and 34.2% (339/991) of participants in the restrictive and liberal groups,
respectively. The total cost per participant from surgery to 3 months
postoperatively differed little by group, just 182 less (standard error
488) in the restrictive group, largely owing to the difference in red
blood cells cost. In the base-case cost-effectiveness results, the point
estimate suggested that the restrictive threshold was cost-effective;
however, this result was very uncertain partly owing to the negligible
difference in quality-adjusted life-years gained. Conclusion(s): A
restrictive transfusion threshold is not superior to a liberal threshold
after cardiac surgery. This finding supports restrictive transfusion due
to reduced consumption and costs of red blood cells. However, secondary
findings create uncertainty about recommending restrictive transfusion and
prompt a new hypothesis that liberal transfusion may be superior after
cardiac surgery. Reanalyses of existing trial datasets, excluding all
participants who did not breach the liberal threshold, followed by a
meta-analysis of the reanalysed results are the most obvious research
steps to address the new hypothesis about the possible harm of red blood
cell transfusion.. Copyright © Queen's Printer and Controller of
HMSO 2016.

<142>
Accession Number
607143255
Title
Effect of the REG1 anticoagulation system versus bivalirudin on outcomes
after percutaneous coronary intervention (REGULATE-PCI): A randomised
clinical trial.
Source
The Lancet. 387 (10016) (pp 349-356), 2016. Date of Publication: 23 Jan
2016.
Author
Lincoff A.M.; Mehran R.; Povsic T.J.; Zelenkofske S.L.; Huang Z.;
Armstrong P.W.; Steg P.G.; Bode C.; Cohen M.G.; Buller C.; Laanmets P.;
Valgimigli M.; Marandi T.; Fridrich V.; Cantor W.J.; Merkely B.;
Lopez-Sendon J.; Cornel J.H.; Kasprzak J.D.; Aschermann M.; Guetta V.;
Morais J.; Sinnaeve P.R.; Huber K.; Stables R.; Sellers M.A.; Borgman M.;
Glenn L.; Levinson A.I.; Lopes R.D.; Hasselblad V.; Becker R.C.; Alexander
J.H.
Institution
(Lincoff, Borgman) Cleveland Clinic Coordinating Center for Clinical
Research (C5Research), Department of Cardiovascular Medicine, Cleveland
Clinic, Cleveland, OH 44195, United States
(Mehran) Mount Sinai School of Medicine, New York, NY, United States
(Povsic, Huang, Sellers, Lopes, Hasselblad, Alexander) Duke Clinical
Research Institute, Duke Medicine, Durham, NC, United States
(Zelenkofske, Glenn) Regado Biosciences, Basking Ridge, NJ, United States
(Armstrong) Canadian VIGOUR Centre, University of Alberta, Edmonton, AB,
Canada
(Steg) Universite Paris-Diderot, Sorbonne Paris Cite, Paris, France
(Bode) University of Freiburg, Freiburg, Germany
(Cohen) University of Miami, Miller School of Medicine, Miami, FL, United
States
(Buller) St Michael's Hospital, Toronto, ON, Canada
(Laanmets, Marandi) North Estonia Medical Centre, Tallinn, Estonia
(Valgimigli) University Hospital of Ferrara, Institute of Cardiology,
Ferrara, Italy
(Fridrich) National Institute of Cardiovascular Diseases, Bratislava,
Slovakia
(Cantor) Southlake Regional Health Centre, Newmarket, ON, Canada
(Merkely) Semmelweis University Heart, Vascular Center, Budapest, Hungary
(Lopez-Sendon) Hospital Universitario la Paz, IdiPaz, Madrid, Spain
(Cornel) Medical Center Alkmaar, Alkmaar, Netherlands
(Kasprzak) Medical University of Lodz, Bieganski Hospital, Lodz, Poland
(Aschermann) General University Hospital, Prague, Czechia
(Guetta) Heart Institute Sheba Medical Center, Tel Aviv University, Tel
Hashomer, Israel
(Morais) Santo Andre's Hospital, Leiria, Portugal
(Sinnaeve) University Hospitals Leuven, Campus Gasthuisberg, Leuven,
Belgium
(Huber) Wilhelminen Hospital, Vienna, Austria
(Stables) Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
(Levinson) Perelman School of Medicine, University of Pennsylvania,
Philadelphia, PA, United States
(Becker) University of Cincinnati, College of Medicine, Cincinnati, OH,
United States
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Summary Background REG1 is a novel anticoagulation system consisting of
pegnivacogin, an RNA aptamer inhibitor of coagulation factor IXa, and
anivamersen, a complementary sequence reversal oligonucleotide. We tested
the hypothesis that near complete inhibition of factor IXa with
pegnivacogin during percutaneous coronary intervention, followed by
partial reversal with anivamersen, would reduce ischaemic events compared
with bivalirudin, without increasing bleeding. Methods We did a
randomised, open-label, active-controlled, multicentre, superiority trial
to compare REG1 with bivalirudin at 225 hospitals in North America and
Europe. We planned to randomly allocate 13200 patients undergoing
percutaneous coronary intervention in a 1:1 ratio to either REG1
(pegnivacogin 1 mg/kg bolus [>99% factor IXa inhibition] followed by 80%
reversal with anivamersen after percutaneous coronary intervention) or
bivalirudin. Exclusion criteria included ST segment elevation myocardial
infarction within 48 h. The primary efficacy endpoint was the composite of
all-cause death, myocardial infarction, stroke, and unplanned target
lesion revascularisation by day 3 after randomisation. The principal
safety endpoint was major bleeding. Analysis was by intention to treat.
This trial is registered at ClinicalTrials.gov, identifier NCT01848106.
The trial was terminated early after enrolment of 3232 patients due to
severe allergic reactions. Findings 1616 patients were allocated REG1 and
1616 were assigned bivalirudin, of whom 1605 and 1601 patients,
respectively, received the assigned treatment. Severe allergic reactions
were reported in ten (1%) of 1605 patients receiving REG1 versus one (<1%)
of 1601 patients treated with bivalirudin. The composite primary endpoint
did not differ between groups, with 108 (7%) of 1616 patients assigned
REG1 and 103 (6%) of 1616 allocated bivalirudin reporting a primary
endpoint event (odds ratio [OR] 1.05, 95% CI 0.80-1.39; p=0.72). Major
bleeding was similar between treatment groups (seven [<1%] of 1605
receiving REG1 vs two [<1%] of 1601 treated with bivalirudin; OR 3.49, 95%
CI 0.73-16.82; p=0.10), but major or minor bleeding was increased with
REG1 (104 [6%] vs 65 [4%]; 1.64, 1.19-2.25; p=0.002). Interpretation The
reversible factor IXa inhibitor REG1, as currently formulated, is
associated with severe allergic reactions. Although statistical power was
limited because of early termination, there was no evidence that REG1
reduced ischaemic events or bleeding compared with bivalirudin. Funding
Regado Biosciences Inc. Copyright © 2016 Elsevier Ltd.

<143>
Accession Number
611617170
Title
Association between high endocardial unipolar voltage and improved left
ventricular function: In patients with ischemic cardiomyopathy.
Source
Texas Heart Institute Journal. 43 (4) (pp 291-296), 2016. Date of
Publication: August 2016.
Author
Park K.; Lai D.; Handberg E.M.; Moye L.; Perin E.C.; Pepine C.J.; David
Anderson R.
Institution
(Park, Handberg, Pepine, David Anderson) Division of Cardiovascular
Medicine, Houston, TX 77030, United States
(Lai, Moye) Department of Medicine, University of Florida College of
Medicine, Gainesville, FL 32610, United States
(Moye) Coordinating Center for Clinical Trials, Houston, TX 77030, United
States
(Perin) School of Public Health, University of Texas Health Science Center
at Houston, United States
(Perin) Stem Cell Center, Houston, TX 77030, United States
(Lai, Handberg, Moye, Perin, Pepine, David Anderson) Texas Heart
Institute, Houston, TX 77030, United States
Publisher
Texas Heart Institute (E-mail: thijeditor@heart.thi.tmc.edu)
Abstract
We know that endocardial mapping reports left ventricular electrical
activity (voltage) and that these data can predict outcomes in patients
undergoing traditional revascularization. Because the mapping data from
experimental models have also been linked with myocardial viability, we
hypothesized an association between increased unipolar voltage in patients
undergoing intramyocardial injections and their subsequent improvement in
left ventricular performance. For this exploratory analysis, we evaluated
86 patients with left ventricular dysfunction, heart-failure symptoms,
possible angina, and no revascularization options, who were undergoing
endocardial mapping. Fifty-seven patients received bone marrow mononuclear
cell (BMC) injections and 29 patients received cell-free injections of a
placebo. The average mapping site voltage was 9.7 +/- 2 mV, and sites with
voltage of >=6.9 mV were engaged by needle and injected (with BMC or
placebo). For all patients, at 6 months, left ventricular ejection
fraction (LVEF) improved, and after covariate adjustment this improvement
was best predicted by injection-site voltage. For every 2-mV increase in
baseline voltage, we detected a 1.3 increase in absolute LVEF units for
all patients (P=0.038). Multiple linear regression analyses confirmed that
voltage and the CD34+ count present in bone marrow (but not treatment
assignment) were associated with improved LVEF (P=0.03 and P=0.014,
respectively). In an exploratory analysis, higher endocardial voltage and
bone marrow CD34+levels were associated with improved left
ventricular function among ischemic cardiomyopathy patients.
Intramyocardial needle injections, possibly through stimulation of
angiogenesis, might serve as a future therapy in patients with reduced
left ventricular function and warrants investigation. Copyright ©
2016 by the Texas Heart Institute, Houston.

<144>
Accession Number
611124576
Title
Lipoprotein-associated phospholipase A<inf>2</inf> activity is a marker of
risk but not a useful target for treatment in patients with stable
coronary heart disease.
Source
Journal of the American Heart Association. 5 (6) (no pagination), 2016.
Article Number: e003407. Date of Publication: 01 Jun 2016.
Author
Wallentin L.; Held C.; Armstrong P.W.; Cannon C.P.; Davies R.Y.; Granger
C.B.; Hagstrom E.; Harrington R.A.; Hochman J.S.; Koenig W.; Krug-Gourley
S.; Mohler E.R.; Siegbahn A.; Tarka E.; Steg P.G.; Stewart R.A.H.; Weiss
R.; Ostlund O.; White H.D.; Budaj A.; Ardissino D.; Avezum A.; Aylward
P.E.; Bryce A.; Chen H.; Chen M.-F.; Corbalan R.; Dalby A.J.; Danchin N.;
De Winter R.J.; Denchev S.; Diaz R.; Elisaf M.; Flather M.D.; Goudev A.R.;
Grinfeld L.; Husted S.; Kim H.-S.; Linhart A.; Lonn E.; Lopez-Sendon J.;
Manolis A.J.; Nicolau J.C.; Pais P.; Parkhomenko A.; Pedersen T.R.; Pella
D.; Ramos-Corrales M.A.; Ruda M.; Sereg M.; Siddique S.; Sinnaeve P.;
Sritara P.; Swart H.P.; Sy R.G.; Teramoto T.; Tse H.-F.; Douglas Weaver
W.; Viigimaa M.; Vinereanu D.; Zhu J.
Institution
(Wallentin, Held, Hagstrom) Department of Medical Sciences, Cardiology,
Uppsala University, Uppsala, Sweden
(Wallentin, Held, Hagstrom, Siegbahn, Ostlund) Uppsala Clinical Research
Center (UCR), Uppsala University, Uppsala, Sweden
(Siegbahn) Department of Medical Sciences, Clinical Chemistry, Uppsala
University, Uppsala, Sweden
(Armstrong) Canadian VIGOUR Centre, University of Alberta, Edmonton, AB,
Canada
(Cannon) Cardiovascular Division, Brigham and Women's Hospital, Boston,
MA, United States
(Cannon) Harvard Clinical Research Institute, Boston, MA, United States
(Davies, Krug-Gourley) Metabolic Pathways and Cardiovascular Therapeutic
Area, GlaxoSmithKline, King of Prussia, PA, United States
(Tarka) Former Employee of Metabolic Pathways and Cardiovascular
Therapeutic Area, GlaxoSmithKline, King of Prussia, PA, United States
(Granger) Medical Center, Duke University, Durham, NC, United States
(Harrington) Department of Medicine, Stanford University, Stanford, CA,
United States
(Hochman) Department of Medicine, NYU Langone Medical Center, New York,
NY, United States
(Koenig) Department of Internal Medicine II-Cardiology, University of Ulm
Medical Center, Ulm, Germany
(Koenig) Deutsches Herzzentrum Munchen, Technische Universitat Munchen,
Munich, Germany
(Koenig) DZHK (German Centre for Cardiovascular Research), Partner Site
Munich Heart Alliance, Munich, Germany
(Mohler) Perelman School of Medicine, University of Pennsylvania,
Philadelphia, PA, United States
(Steg) FACT (French Alliance for Cardiovascular Trials), Paris, France
(Steg) DHU FIRE, Universite Paris-Diderot, Sorbonne Paris-Cite, Paris,
France
(Steg) Hopital Bichat, INSERUM U-1148, Paris, France
(Steg) NHLI, ICMS, Imperial College, Royal Brompton Hospital, London,
United Kingdom
(Stewart, White) Green Lane Cardiovascular Service, Auckland City
Hospital, Auckland, New Zealand
(Stewart, White) University of Auckland, New Zealand
(Weiss) Maine Research Associates, Auburn, ME, United States
(White) Green Lane Cardiovascular Service, Auckland City Hospital,
Auckland University, Auckland, New Zealand
(Wallentin) Department of Medical Sciences and Uppsala Clinical Research
Center, Uppsala University, Uppsala, Sweden
(Budaj) Grochowski Hospital, Warsaw, Poland
(Cannon) TIMI Study Group, Brigham and Women's Hospital, Boston, MA,
United States
(Harrington) Stanford University, Stanford, CA, United States
(Steg) INSERM-Unite, APHP, Hopital Bichat and Universite Paris-Diderot,
Paris, France
(Davies) GlaxoSmithKline, King of Prussia, PA, United States
(Tarka) GlaxoSmithKline, King of Prussia, PA, United States
(Ardissino) Azienda Ospedaliero-Universitaria di Parma, Parma, Italy
(Armstrong) University of Alberta, Edmonton, CA, Canada
(Avezum) Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil
(Aylward) South Australian Health and Medical Research Institute, Flinders
University and Medical Centre, Adelaide, SA, Australia
(Bryce) Cardiogolf/Clinica El Golf, Lima, Peru
(Chen) Peking University People's Hospital, Beijing, China
(Chen) National Taiwan University Hospital, Taipei, Taiwan (Republic of
China)
(Corbalan) Pontificia Universidad Catolica de Chile, Santiago, Chile
(Dalby) Milpark Hospital, Johannesburg, South Africa
(Danchin) AP-HP and Universite Paris Descartes, Paris, France
(De Winter) University of Amsterdam, Amsterdam, Netherlands
(Denchev) University Hospital Alexandrovska, Sofia, Bangladesh
(Diaz) ECLA Estudios Cardiologicos, Latinoamerica, Rosario, Argentina
(Elisaf) University of Ioannina, Ioannina, Greece
(Flather) University of East Anglia and Norfolk, Norwich University
Hospital, United Kingdom
(Goudev) Queen Giovanna University Hospital, Sofia, Bangladesh
(Granger) Duke University, Medical Center, Durham, NC, United States
(Grinfeld) University of Buenos Aires, School of Medicine, Buenos Aires,
Argentina
(Held) Department of Medical Sciences, Cardiology, Uppsala Clinical
Research Center, Uppsala University, Uppsala, Sweden
(Hochman) NYU Langone Medical Center, New York, NY, United States
(Husted) Hospital Unit West, Herning/Holstebro, Denmark
(Kim) Seoul National University Hospital, Seoul, South Korea
(Koenig) University of Ulm Medical Center, Ulm, Germany
(Linhart) Charles University in Prague, Prague, Czechia
(Lonn) McMaster University, Hamilton, ON, Canada
(Lopez-Sendon) Hospital Universitario La Paz, Madrid, Spain
(Manolis) Asklepeion Hospital, Athens, Greece
(Mohler) University of Pennsylvania, Philadelphia, PA, United States
(Nicolau) University of Sao Paulo Medical School, Sao Paulo, Brazil
(Pais) St. John's Medical Collage, Bangalore, India
(Parkhomenko) Institute of Cardiology, Kiev, Ukraine
(Pedersen) University of Oslo, Oslo University Hospital, Oslo, Norway
(Pella) PJ Safarik University, Kosice, Slovakia
(Ramos-Corrales) San Jose Satelite Hospital, Naucalpan, Mexico
(Ruda) Russian Cardiologic Research and Production Complex of
Rosmedtechnology, Moscow, Russian Federation
(Sereg) St. George Hospital, Szekesfehervar, Hungary
(Siddique) Shaikh Zayed Postgraduate Medical Institute, Lahore, Pakistan
(Sinnaeve) University Hospitals Leuven, Leuven, Belgium
(Sritara) Mahidol University, Bangkok, Thailand
(Stewart) Green Lane Cardiovascular Service, Auckland City Hospital,
Auckland University, Auckland, New Zealand
(Swart) Antonius Hospital Sneek, Netherlands
(Sy) University of the Philippines, Manila, Philippines
(Teramoto) Teikyo Academic Research Center, Itabashi-ku, Tokyo, Japan
(Tse) University of Hong Kong, Hong Kong
(Douglas Weaver) Henry Ford Heart and Vascular Institute, Wayne State
University, Detroit, MI, United States
(Weiss) Maine Research Associates, Auburn, ME, United States
(Viigimaa) Tallinn University of Technology, Tallinn, Estonia
(Vinereanu) University of Medicine and Pharmacy, University and Emergency
Hospital, Bucharest, Romania
(Zhu) Fudan University, Shanghai, China
(Steg) Royal Brompton Hospital, London, United Kingdom
Publisher
American Heart Association Inc.
Abstract
Background--We evaluated lipoprotein-associated phospholipase
A<inf>2</inf> (Lp-PLA<inf>2</inf>) activity in patients with stable
coronary heart disease before and during treatment with darapladib, a
selective Lp-PLA<inf>2</inf> inhibitor, in relation to outcomes and the
effects of darapladib in the STABILITY trial. Methods and Results--Plasma
Lp-PLA<inf>2</inf> activity was determined at baseline (n=14 500); at 1
month (n=13 709); serially (n=100) at 3, 6, and 18 months; and at the end
of treatment. Adjusted Cox regression models evaluated associations
between Lp-PLA<inf>2</inf> activity levels and outcomes. At baseline, the
median Lp-PLA<inf>2</inf> level was 172.4 lmol/min per liter
(interquartile range 143.1-204.2 lmol/min per liter). Comparing the
highest and lowest Lp-PLA<inf>2</inf> quartile groups, the hazard ratios
were 1.50 (95% CI 1.23-1.82) for the primary composite end point
(cardiovascular death, myocardial infarction, or stroke), 1.95 (95% CI
1.29-2.93) for hospitalization for heart failure, 1.42 (1.07-1.89) for
cardiovascular death, and 1.37 (1.03-1.81) for myocardial infarction after
adjustment for baseline characteristics, standard laboratory variables,
and other prognostic biomarkers. Treatment with darapladib led to a =65%
persistent reduction in median Lp-PLA<inf>2</inf> activity. There were no
associations between on-treatment Lp-PLA<inf>2</inf> activity or changes
of Lp-PLA<inf>2</inf> activity and outcomes, and there were no significant
interactions between baseline and on-treatment Lp- PLA<inf>2</inf>
activity or changes in Lp-PLA<inf>2</inf> activity levels and the effects
of darapladib on outcomes. Conclusions--Although high Lp-PLA<inf>2</inf>
activity was associated with increased risk of cardiovascular events,
pharmacological lowering of Lp-PLA<inf>2</inf> activity by =65% did not
significantly reduce cardiovascular events in patients with stable
coronary heart disease, regardless of the baseline level or the magnitude
of change of Lp-PLA<inf>2</inf> activity. Copyright © 2016 The
Authors.

<145>
Accession Number
611170904
Title
3-Year Outcomes in High-Risk Patients Who Underwent Surgical or
Transcatheter Aortic Valve Replacement.
Source
Journal of the American College of Cardiology. 67 (22) (pp 2565-2574),
2016. Date of Publication: 07 Jun 2016.
Author
Deeb G.M.; Reardon M.J.; Chetcuti S.; Patel H.J.; Grossman P.M.; Yakubov
S.J.; Kleiman N.S.; Coselli J.S.; Gleason T.G.; Lee J.S.; Hermiller J.B.;
Heiser J.; Merhi W.; Zorn G.L.; Tadros P.; Robinson N.; Petrossian G.;
Hughes G.C.; Harrison J.K.; Maini B.; Mumtaz M.; Conte J.; Resar J.;
Aharonian V.; Pfeffer T.; Oh J.K.; Qiao H.; Adams D.H.; Popma J.J.
Institution
(Deeb, Chetcuti, Patel, Grossman) University of Michigan Medical Center,
Ann Arbor, Michigan, United States
(Reardon, Kleiman) Houston Methodist DeBakey Heart & Vascular Center,
Houston, Texas, United States
(Yakubov) Riverside Methodist Hospital, Columbus, Ohio, United States
(Coselli) Texas Heart Institute at St. Luke's Medical Center, Houston,
Texas, United States
(Gleason, Lee) University of Pittsburgh Medical Center, Pittsburgh,
Pennsylvania, United States
(Hermiller) St. Vincent Medical Center, Indianapolis, Indiana, United
States
(Heiser, Merhi) Spectrum Health Hospitals, Grand Rapids, Michigan, United
States
(Zorn, Tadros) The University of Kansas Hospital, Kansas City, Kansas,
United States
(Robinson, Petrossian) St. Francis Hospital, Roslyn, New York, United
States
(Hughes, Harrison) Duke University Medical Center, Durham, North Carolina,
United States
(Maini, Mumtaz) Pinnacle Health, Wormleysburg, Pennsylvania, United States
(Conte, Resar) The Johns Hopkins Hospital, Baltimore, Maryland, United
States
(Aharonian, Pfeffer) Kaiser Permanente-Los Angeles Medical Center, Los
Angeles, California, United States
(Oh) Mayo Clinical Foundation, Rochester, Minnesota, United States
(Qiao) Medtronic, Minneapolis, Minnesota, United States
(Adams) Mount Sinai Health System, New York, New York, United States
(Popma) Beth Israel Deaconess Medical Center, Boston, Massachusetts,
United States
Publisher
Elsevier USA
Abstract
Background In patients with severe aortic stenosis at increased risk for
surgery, self-expanding transcatheter aortic valve replacement (TAVR) is
associated with improved 2-year survival compared with surgery. Objectives
This study sought to determine whether this clinical benefit was sustained
over time. Methods Patients with severe aortic stenosis deemed at
increased risk for surgery by a multidisciplinary heart team were
randomized 1:1 to TAVR or open surgical valve replacement (SAVR).
Three-year clinical and echocardiographic outcomes were obtained in those
patients with an attempted procedure. Results A total of 797 patients
underwent randomization at 45 U.S. centers; 750 patients underwent an
attempted procedure. Three-year all-cause mortality or stroke was
significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006).
Adverse clinical outcome components were also reduced in TAVR patients
compared with SAVR patients, including all-cause mortality (32.9% vs.
39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%,
respectively; p = 0.034), and major adverse cardiovascular or
cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3
years aortic valve hemodynamics were better with TAVR patients (mean
aortic valve gradient 7.62 +/- 3.57 mm Hg vs. 11.40 +/- 6.81 mm Hg in
SAVR; p < 0.001), although moderate or severe residual aortic
regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p <
0.001). There was no clinical evidence of valve thrombosis in either
group. Conclusions Patients with severe aortic stenosis at increased risk
for surgery had improved 3-year clinical outcomes after TAVR compared with
surgery. Aortic valve hemodynamics were more favorable in TAVR patients
without differences in structural valve deterioration. (Safety and
Efficacy Study of the Medtronic CoreValve System in the
Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High
Risk Subjects Who Need Aortic Valve Replacement;
NCT01240902) Copyright © 2016 American College of Cardiology
Foundation

<146>
Accession Number
613877784
Title
Randomized trial of bilateral versus single internal-thoracic-artery
grafts.
Source
New England Journal of Medicine. 375 (26) (pp 2540-2549), 2016. Date of
Publication: 29 Dec 2016.
Author
Taggart D.P.; Altman D.G.; Gray A.M.; Lees B.; Gerry S.; Benedetto U.;
Flather M.
Institution
(Taggart, Lees) Nuffield Department of Surgical Sciences, United Kingdom
(Altman, Gerry) Centre for Statistics in Medicine, Nuffield Department of
Orthopaedics, Rheumatology, Musculoskeletal Sciences, Botnar Research
Centre, United Kingdom
(Gray) Health Economics Research Centre, Nuffield Department of Population
Health, United Kingdom
(Benedetto) University of Oxford, Oxford, United Kingdom
(Benedetto) School of Clinical Sciences, University of Bristol and Bristol
Royal Infirmary, Bristol, United Kingdom
(Flather) Norwich Medical School, University of East Anglia and Norfolk
and Norwich University Hospital, Norwich NR4 7TJ, United Kingdom
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND The use of bilateral internal thoracic (mammary) arteries for
coronary-artery bypass grafting (CABG) may improve long-term outcomes as
compared with the use of a single internal-thoracic-artery plus vein
grafts. METHODS We randomly assigned patients scheduled for CABG to
undergo single or bilateral internal-thoracic-artery grafting in 28
cardiac surgical centers in seven countries. The primary outcome was death
from any cause at 10 years. The composite of death from any cause,
myocardial infarction, or stroke was a secondary outcome. Interim analyses
were prespecified at 5 years of follow-up. RESULTS A total of 3102
patients were enrolled; 1554 were randomly assigned to undergo single
internal-thoracic-artery grafting (the single-graft group) and 1548 to
undergo bilateral internal-thoracic-artery grafting (the bilateral-graft
group). At 5 years of follow-up, the rate of death was 8.7% in the
bilateral-graft group and 8.4% in the single-graft group (hazard ratio,
1.04; 95% confidence interval [CI], 0.81 to 1.32; P = 0.77), and the rate
of the composite of death from any cause, myocardial infarction, or stroke
was 12.2% and 12.7%, respectively (hazard ratio, 0.96; 95% CI, 0.79 to
1.17; P = 0.69). The rate of sternal wound complication was 3.5% in the
bilateralgraft group versus 1.9% in the single-graft group (P = 0.005),
and the rate of sternal reconstruction was 1.9% versus 0.6% (P = 0.002).
CONCLUSIONS Among patients undergoing CABG, there was no significant
difference between those receiving single internal-thoracic-artery grafts
and those receiving bilateral internal-thoracic-artery grafts with regard
to mortality or the rates of cardiovascular events at 5 years of
follow-up. There were more sternal wound complications with bilateral
internal-thoracic-artery grafting than with single internal-thoracicartery
grafting. Ten-year follow-up is ongoing. Copyright © 2016
Massachusetts Medical Society. All rights reserved.

<147>
Accession Number
609905531
Title
Use of Coronary Computed Tomographic Angiography to Guide Management of
Patients with Coronary Disease.
Source
Journal of the American College of Cardiology. 67 (15) (pp 1759-1768),
2016. Date of Publication: 19 Apr 2016.
Author
Williams M.C.; Hunter A.; Shah A.S.V.; Assi V.; Lewis S.; Smith J.; Berry
C.; Boon N.A.; Clark E.; Flather M.; Forbes J.; McLean S.; Roditi G.; Van
Beek E.J.R.; Timmis A.D.; Newby D.E.
Institution
(Williams, Hunter, Shah, Boon, Clark, Van Beek, Newby) British Heart
Foundation Centre for Cardiovascular Science, University of Edinburgh,
Chancellor's Building, Room SU314, 49 Little France Crescent, Edinburgh
EH16 4SA, United Kingdom
(Assi, Lewis) Centre for Population Health Sciences, University of
Edinburgh, Edinburgh, United Kingdom
(Smith) Health Economics Research Centre, University of Oxford, Oxford,
United Kingdom
(Berry, Roditi) Institute for Cardiovascular and Medical Sciences,
University of Glasgow, Glasgow, United Kingdom
(Flather) Norwich Medical School, University of East Anglia, Norwich,
United Kingdom
(Forbes) Health Research Institute, University of Limerick, Limerick,
Ireland
(McLean) National Health Service, Fife, United Kingdom
(Timmis) William Harvey Research Institute, Queen Mary University of
London, London, United Kingdom
Publisher
Elsevier USA
Abstract
Background In a prospective, multicenter, randomized controlled trial,
4,146 patients were randomized to receive standard care or standard care
plus coronary computed tomography angiography (CCTA). Objectives The
purpose of this study was to explore the consequences of CCTA-assisted
diagnosis on invasive coronary angiography, preventive treatments, and
clinical outcomes. Methods In post hoc analyses, we assessed changes in
invasive coronary angiography, preventive treatments, and clinical
outcomes using national electronic health records. Results Despite similar
overall rates (409 vs. 401; p = 0.451), invasive angiography was less
likely to demonstrate normal coronary arteries (20 vs. 56; hazard ratios
[HRs]: 0.39 [95% confidence interval (CI): 0.23 to 0.68]; p < 0.001) but
more likely to show obstructive coronary artery disease (283 vs. 230; HR:
1.29 [95% CI: 1.08 to 1.55]; p = 0.005) in those allocated to CCTA. More
preventive therapies (283 vs. 74; HR: 4.03 [95% CI: 3.12 to 5.20]; p <
0.001) were initiated after CCTA, with each drug commencing at a median of
48 to 52 days after clinic attendance. From the median time for preventive
therapy initiation (50 days), fatal and nonfatal myocardial infarction was
halved in patients allocated to CCTA compared with those assigned to
standard care (17 vs. 34; HR: 0.50 [95% CI: 0.28 to 0.88]; p = 0.020).
Cumulative 6-month costs were slightly higher with CCTA: difference $462
(95% CI: $303 to $621). Conclusions In patients with suspected angina due
to coronary heart disease, CCTA leads to more appropriate use of invasive
angiography and alterations in preventive therapies that were associated
with a halving of fatal and non-fatal myocardial infarction. (Scottish
COmputed Tomography of the HEART Trial [SCOT-HEART];
NCT01149590). Copyright © 2016 American College of Cardiology
Foundation.

<148>
[Use Link to view the full text]
Accession Number
612076428
Title
Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study.
Source
Circulation. 134 (14) (pp 989-998), 2016. Date of Publication: 04 Oct
2016.
Author
Resor C.D.; Nathan A.; Kereiakes D.J.; Yeh R.W.; Massaro J.M.; Cutlip
D.E.; Steg P.G.; Hsieh W.-H.; Mauri L.
Institution
(Resor, Mauri) Department of Medicine, Division of Cardiology, Center for
Clinical Biometrics, Harvard Medical School, Cardiovascular Medicine,
Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, United
States
(Yeh, Cutlip, Hsieh, Mauri) Harvard Clinical Research Institute, Boston,
MA, United States
(Yeh, Mauri) Harvard Medical School, Boston, MA, United States
(Nathan) Division of Cardiology, University of Pennsylvania Medical
Center, Philadelphia, United States
(Yeh, Cutlip) Smith Center for Outcomes Research in Cardiology, Beth
Israel Deaconess Medical Center, Boston, MA, United States
(Massaro) Department of Biostatistics, Boston University School of Public
Heath, MA, United States
(Kereiakes) Christ Hospital Heart and Vascular Center, Lindner Center for
Research and Education, Cincinnati, OH, United States
(Steg) Universite Paris-Diderot, INSERM U-1148, Hopital Bichat,
Departement Hospitalo-Universitaire Fibrosis, Inflammation, and
Remodeling, Assistance Publique-Hopitaux de Paris, Paris, France
(Steg) National Heart and Lung Institute, Institute of Cardiovascular
Medicine and Science, Royal Brompton Hospital, Imperial College, London,
United Kingdom
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
Background: Continued dual antiplatelet therapy and optimal medical
therapy (OMT) improve outcomes in selected patient populations with
established coronary heart disease, but whether OMT modifies the treatment
effect of dual antiplatelet therapy is unknown. Method(s): The DAPT
(Dual Antiplatelet Therapy) Study, a double-blind trial, randomly assigned
11 648 patients who had undergone coronary stenting and completed 1 year
of dual antiplatelet therapy without major bleeding or ischemic events to
an additional 18 months of continued thienopyridine or placebo. OMT was
defined as a combination of statin, beta-blocker, and
angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use
in patients with an American College of Cardiology/American Heart
Association class I indication for each medication. Per protocol, all
patients were treated with 75 to 325 mg aspirin daily. End points included
myocardial infarction, major adverse cardiovascular and cerebrovascular
events, and Global Utilization of Streptokinase and Tissue Plasminogen
Activator for Occluded Arteries moderate or severe bleeding events.
 Result(s): Of 11 643 randomly assigned patients with complete
medication data, 63% were on OMT. Between 12 and 30 months, continued
thienopyridine reduced myocardial infarction in comparison with placebo in
both groups (on OMT 2.1% versus 3.3%, hazard ratio [HR], 0.64; 95%
confidence interval [CI], 0.48-0.86; P=0.003; off OMT 2.2% versus 5.2%,
HR, 0.41; CI, 0.29-0.58; P<0.001; interaction P=0.103). Comparing
continued thienopyridine versus placebo, rates of major adverse
cardiovascular and cerebrovascular events were 4.2% versus 5.0% among
patients on OMT (HR, 0.82; CI, 0.66-1.02; P=0.077) and 4.5% versus 7.0%
among those off OMT (HR, 0.63; CI, 0.49-0.82; P<0.001; interaction
P=0.250); rates of bleeding for thienopyridine versus placebo in patients
on OMT were 2.2% versus 1.0% (HR, 2.13; CI, 1.43-3.17; P<0.001), and in
patients off OMT were 2.8% versus 2.2% (HR, 1.30; CI, 0.88-1.92; P=0.189;
interaction P=0.073). Overall, patients on OMT had lower rates of
myocardial infarction (2.7% versus 3.7%, P=0.003), major adverse
cardiovascular and cerebrovascular events (4.6% versus 5.7%, P=0.007), and
bleeding (1.6% versus 2.5%, P<0.001) in comparison with patients off OMT.
Rates of stent thrombosis (0.8% versus 1.0%, P=0.171) and death (1.6%
versus 1.9%, P=0.155) did not differ. Conclusion(s): Continued
thienopyridine therapy reduced the rate of myocardial infarction
regardless of OMT status and had consistent effects on reduction in major
adverse cardiovascular and cerebrovascular events and increased
bleeding. Copyright © 2016 American Heart Association, Inc.

<149>
Accession Number
612393394
Title
Levosimendan in patients with left ventricular systolic dysfunction
undergoing cardiac surgery on cardiopulmonary bypass: Rationale and study
design of the Levosimendan in Patients with Left Ventricular Systolic
Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass
(LEVO-CTS) trial.
Source
American Heart Journal. 182 (pp 62-71), 2016. Date of Publication: 01 Dec
2016.
Author
Mehta R.H.; Van Diepen S.; Meza J.; Bokesch P.; Leimberger J.D.;
Tourt-Uhlig S.; Swartz M.; Parrotta J.; Jankowich R.; Hay D.; Harrison
R.W.; Fremes S.; Goodman S.G.; Luber J.; Toller W.; Heringlake M.; Anstrom
K.J.; Levy J.H.; Harrington R.A.; Alexander J.H.
Institution
(Mehta, Meza, Leimberger, Tourt-Uhlig, Swartz, Harrison, Anstrom, Levy,
Alexander) Duke Clinical Research Institute, Duke University School of
Medicine, Durham, NC, United States
(Van Diepen, Parrotta, Fremes, Goodman) Canadian VIGOUR Centre, University
of Alberta, Edmonton, Canada, Canada
(Bokesch, Jankowich, Hay) Tenax Therapeutics, Morrisville, NC, United
States
(Luber) Franciscan Health System, Tacoma, WA, United States
(Toller) University of Graz, Graz, Austria
(Heringlake) University of Lubeck, Lubeck, Germany
(Harrington) Stanford University School of Medicine, Stanford, CA, United
States
Publisher
Mosby Inc. (E-mail: customerservice@mosby.com)
Abstract
Low cardiac output syndrome is associated with increased mortality and
occurs in 3% to 14% of patients undergoing cardiac surgery on
cardiopulmonary bypass (CPB). Levosimendan, a novel calcium sensitizer and
K<inf>ATP</inf> channel activator with inotropic, vasodilatory, and
cardioprotective properties, has shown significant promise in reducing the
incidence of low cardiac output syndrome and related adverse outcomes in
patients undergoing cardiac surgery on CPB. Methods LEVO-CTS is a phase 3
randomized, controlled, multicenter study evaluating the efficacy, safety,
and cost-effectiveness of levosimendan in reducing morbidity and mortality
in high-risk patients with reduced left ventricular ejection fraction
(<=35%) undergoing cardiac surgery on CPB. Patients will be randomly
assigned to receive either intravenous levosimendan (0.2 mug
kg-1 min-1 for the first hour followed by 0.1 mug/kg
for 23 hours) or matching placebo initiated within 8 hours of surgery. The
co-primary end points are (1) the composite of death or renal replacement
therapy through day 30 or perioperative myocardial infarction, or
mechanical assist device use through day 5 (quad end point tested at alpha
< .01), and (2) the composite of death through postoperative day 30 or
mechanical assist device use through day 5 (dual end point tested at alpha
< .04). Safety end points include new atrial fibrillation and death
through 90 days. In addition, an economic analysis will address the
cost-effectiveness of levosimendan compared with placebo in high-risk
patients undergoing cardiac surgery on CPB. Approximately 880 patients
will be enrolled at approximately 60 sites in the United States and Canada
between July 2014 and September 2016, with results anticipated in January
2017. Conclusion LEVO-CTS, a large randomized multicenter clinical trial,
will evaluate the efficacy, safety, and cost-effectiveness of levosimendan
in reducing adverse outcomes in high-risk patients undergoing cardiac
surgery on CPB. Clinical Trial Registration:ClinicalTrials.gov
(NCT02025621). Copyright © 2016

<150>
Accession Number
612973121
Title
Platelet function monitoring to adjust antiplatelet therapy in elderly
patients stented for an acute coronary syndrome (ANTARCTIC): an
open-label, blinded-endpoint, randomised controlled superiority trial.
Source
The Lancet. 388 (10055) (pp 2015-2022), 2016. Date of Publication: 22 Oct
2016.
Author
Cayla G.; Cuisset T.; Silvain J.; Leclercq F.; Manzo-Silberman S.;
Saint-Etienne C.; Delarche N.; Bellemain-Appaix A.; Range G.; El Mahmoud
R.; Carrie D.; Belle L.; Souteyrand G.; Aubry P.; Sabouret P.; du Fretay
X.H.; Beygui F.; Bonnet J.-L.; Lattuca B.; Pouillot C.; Varenne O.; Boueri
Z.; Van Belle E.; Henry P.; Motreff P.; Elhadad S.; Salem J.-E.; Abtan J.;
Rousseau H.; Collet J.-P.; Vicaut E.; Montalescot G.
Institution
(Cayla, Lattuca) ACTION Study Group, Service de Cardiologie, Centre
Hospitalier Universitaire de Nimes, Universite de Montpellier, Nimes,
France
(Cuisset, Bonnet) Department of Cardiology, Centre Hospitalier
Universitaire Timone, Marseille, France
(Cuisset, Bonnet) INSERM UMR1062, INRA UMR1260, Nutrition, Obesity and
Risk of Thrombosis, Faculty of Medicine, Aix-Marseille University,
Marseille, France
(Silvain, Sabouret, Collet, Montalescot) Sorbonne Universite-Paris 06,
ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hopital
Pitie-Salpetriere (AP-HP), Paris, France
(Leclercq) Departement de Cardiologie, Centre Hospitalier Universitaire
Montpellier, Montpellier, France
(Manzo-Silberman, Henry) Service de Cardiologie, Hopital Lariboisiere,
Paris, France
(Saint-Etienne) Service de Cardiologie, Centre Hospitalier Universitaire
Tours, Tours, France
(Delarche) Hopital Francois Mitterrand, Centre Hospitalier de Pau, Pau,
France
(Bellemain-Appaix) ACTION Study Group, Service de Cardiologie, Centre
Hospitalier d'Antibes-Juans-Les-Pins, Antibes, France
(Range) Service de Cardiologie, Les Hopitaux de Chartres, Le Coudray,
Chartres, France
(El Mahmoud) Hopital Ambroise Pare, Boulogne-Billancourt, France
(Carrie) Service de Cardiologie, Centre Hospitalier Universitaire
Toulouse, Toulouse, France
(Belle) Service de Cardiologie, Centre Hospitalier d'Annecy, Annecy,
France
(Souteyrand, Motreff) Service de Cardiologie, Centre Hospitalier
Universitaire Clermont-Ferrand, Clermont-Ferrand, France
(Aubry, du Fretay, Abtan) Service de Cardiologie, Hopital Bichat Claude
Bernard, Paris, France
(Beygui) ACTION Study Group, Service de Cardiologie, Centre Hospitalier
Universitaire de Caen, Caen, France
(Pouillot) Clinique Sainte Clotilde, Saint Denis de La Reunion, La
Reunion, France
(Varenne) Service de Cardiologie, Hopital Cochin, Paris, France
(Boueri) Service de Cardiologie de Bastia, Centre Hospitalier de Bastia,
Bastia, France
(Van Belle) Service de Cardiologie, Centre Hospitalier Universitaire de
Lille, Lille, France
(Elhadad) Centre Hospitalier de Lagny Marne la Vallee, Jossigny, France
(Salem) Department of Pharmacology, CIC-1421, INSERM U1166-ICAN, Hopital
Pitie-Salpetriere (AP-HP), Paris, France
(Rousseau, Vicaut) ACTION Study Group, Unite de Recherche Clinique,
Lariboisiere, Paris, France
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background Elderly patients are at high risk of ischaemic and bleeding
events. Platelet function monitoring offers the possibility to
individualise antiplatelet therapy to improve the therapeutic risk-benefit
ratio. We aimed to assess the effect of platelet function monitoring with
treatment adjustment in elderly patients stented for an acute coronary
syndrome. Methods We did this multicentre, open-label, blinded-endpoint,
randomised controlled superiority study at 35 centres in France. Patients
aged 75 years or older who had undergone coronary stenting for acute
coronary syndrome were randomly assigned (1:1), via a central interactive
voice-response system based on a computer-generated permuted-block
randomisation schedule with randomly selected block sizes, to receive oral
prasugrel 5 mg daily with dose or drug adjustment in case of inadequate
response (monitoring group) or oral prasugrel 5 mg daily with no
monitoring or treatment adjustment (conventional group). Randomisation was
stratified by centre. Platelet function testing was done 14 days after
randomisation and repeated 14 days after treatment adjustment in patients
in the monitoring group. Study investigators and patients were not masked
to treatment allocation, but allocation was concealed from an independent
clinical events committee responsible for endpoint adjudication. The
primary endpoint was a composite of cardiovascular death, myocardial
infarction, stroke, stent thrombosis, urgent revascularisation, and
Bleeding Academic Research Consortium-defined bleeding complications
(types 2, 3, or 5) at 12 months' follow-up. We did analysis by intention
to treat. This trial is registered with ClinicalTrials.gov, number
NCT01538446. Findings Between March 27, 2012, and May 19, 2015, we
randomly assigned 877 patients to the monitoring group (n=442) or the
conventional group (n=435). The primary endpoint occurred in 120 (28%)
patients in the monitoring group compared with 123 (28%) patients in the
conventional group (hazard ratio [HR], 1.003, 95% CI 0.78-1.29; p=0.98).
Rates of bleeding events did not differ significantly between groups.
Interpretation Platelet function monitoring with treatment adjustment did
not improve the clinical outcome of elderly patients treated with coronary
stenting for an acute coronary syndrome. Platelet function testing is
still being used in many centres and international guidelines still
recommend platelet function testing in high-risk situations. Our study
does not support this practice or these recommendations. Funding Eli Lilly
and Company, Daiichi Sankyo, Stentys, Accriva Diagnostics, Medtronic, and
Fondation Coeur et Recherche. Copyright © 2016 Elsevier Ltd

<151>
Accession Number
610196600
Title
Cardiovascular and other outcomes postintervention with insulin glargine
and omega-3 fatty acids (ORIGINALE).
Source
Diabetes Care. 39 (5) (pp 709-716), 2016. Date of Publication: May 2016.
Author
Gerstein H.C.; Bosch J.; Dagenais G.R.; Jung H.; Maggioni A.P.; Pogue J.;
Probstfield J.; Ramachandran A.; Riddle M.C.; Ryden L.E.; Yusuf S.; Diaz
R.; Johnston P.; Vige R.; Birkeland K.; Budaj A.; Cardona E.; Chazova I.;
Commerford P.; Danilova L.; Davies M.; Fernando R.; Fodor G.; Gilbert R.;
Gomis R.; Hanefeld M.; Hildebrandt P.; Kacerovsky-Bielesz G.; Keltai M.;
Kim J.H.; Krum H.; Lanas F.; Lewis B.S.; Lonn E.; Marin-Neto J.; Marre M.;
McKelvie R.; McQueen M.; Mendoza I.; Morillo C.; Pan C.; Profozic V.;
Ratner R.; Richardson L.; Rosenstock J.; Spinas G.A.; Sreenan S.; Stoel
I.; Syvanne M.; Yale J.F.; Avezum A.; Bahit M.C.; Bogaty P.; Bordeleau L.;
Chacomicronn C.; Corson M.; Harper W.L.; Halon D.; Magloire P.; Mann J.;
Pavlova V.; Punthakee Z.; Silva J.; Tsang B.; Yakubovich N.; Abdallah A.;
Ahmad S.; Chandra J.; Chandra R.; Cukierman-Yaffee T.; Dyal L.; Joldersma
L.; MacRae L.; MacRae S.; Malik S.; Mead A.; Pasha F.; Pazmino-Canizares
J.; Pohl K.; Sakalas A.; Tyrwhitt J.; Ahuad Guerrero R.; Alebuena A.;
Alvarez N.; Alzogaray M.; Amuchastegui M.; Andres M.; Angos M.; Baglivo
H.; Barbieri M.; Bassi F.; Bello F.; Bono J.; Bustamante Labarta M.;
Bustos B.; Caccavo A.; Calveira M.; Camino A.; Cantero M.; Capozzi M.;
Cardone M.; Cartasegna L.; Cassetari A.; Castellanos R.; Chavez Caballero
R.; Cipullo M.; Contreras A.; Coria J.; Corinaldesi F.; Costa G.; Crespo
C.; Cruz M.; Cuello J.; Cuneo C.; Del Corro I.; Diez R.; Dituro C.;
Dominguez A.; Facta A.; Faingold C.; Farah M.; Fares Taie A.; Fernandez
A.; Ferrari A.; Ferrari N.; Garcia Monteverde C.; Garrido M.; Giachello
C.; Gonzalez M.; Gutierrez N.; Guzman L.; Guzman P.; Hasbani E.; Henquin
R.; Hershon A.; Hirschon Alvarez Prado A.; Hominal M.; Hrabar A.; Imposti
H.; La Grutta M.; Lanchiotti P.; Lobo Marquez L.; Lopez Santi R.;
Lowenstein J.; Lugo M.; Luqueci M.; Mainini S.; Majul C.; Manzano R.;
Manzur S.; Marcucci G.; Marino M.; Massari F.; Mendez N.; Molina M.;
Montana O.; Mulazzi M.; Nardone L.; Odetto I.; Orlandini A.; Oviedo A.;
Paez O.; Parnas A.; Patron F.R.; Pedernera C.; Pelagagge M.; Plastino M.;
Polari P.; Pomposiello J.; Porta A.; Prado A.; Quiroz M.; Ramirez A.;
Rodriguez M.; Ronderos R.; Sago L.; Sanchez A.; Sanchez R.; Sandrin A.;
Schygiel P.; Sernia V.; Sinay I.; Smith Casabella T.; Sosa Liprandi A.;
Sosa Liprandi M.; Soso L.; Sposetti G.; Stisman D.; Streitenberger P.;
Suarez G.; Tonin H.; Ulla M.; Valdez J.; Vico M.; Villamil A.; Villarino
A.; Viscaya Castro A.; Visco V.; Vogel D.; Waisman F.; Zaidman C.; Amerena
J.; Applebe A.; Aylward P.; Binnekamp M.; Bruce I.; Burdeniuk C.; Burnet
R.; Colman P.; Colquhoun D.; Davis S.; De Looze F.; De Pasquale C.;
D'Emden M.; Eaton H.; Farshid A.; Foulanos S.; Galanos J.; Gordon G.; Guhu
M.; Ho J.; Jeffery I.; Jerums G.; Kwan M.; Lefkovits J.; Luu S.; MacIsaac
R.; Marjason J.; Mohabbati V.; Nankervis A.; O'Neal D.; Perera N.; Poynten
A.; Rahman A.; Razak S.; Roberts T.; Sebastian M.; Simpson R.; Soldatos
G.; Sullivan D.; Teede H.; Tiong F.; Topliss D.; Torpy D.; Waddell-Smith
K.; Waites J.; Wenman J.; Whelan A.; Williams L.; Yeap B.; Yeow W.; Yong
G.; Aczel S.; Azimy N.; Bertha P.; Blocher J.; Bohnel C.; Brath H.; Breuss
J.; De Campo A.; Drexel H.; Ettmuller Y.; Feder A.; Feinboeck C.; Gulz E.;
Hofmann M.; Hoppichler F.; Jahnel H.; Jankovic V.; Kann T.; Kathrein T.;
Kotter T.; Kratz E.; Kreuzwieser E.; Loreck C.; Ludvik B.; Marte T.;
Mellitzer K.; Nistler S.; Placher-Sorko G.; Prager R.; Rein P.; Riedl M.;
Saly C.; Schernthaner G.; Schichka E.; Seidlhofer C.; Sonnenfeld M.;
Stefan H.; Steiner K.; Thomas B.; Toplak H.; Urstoger K.; Vetter B.;
Vonbank A.; Waldschutz W.; Wallner F.; Winkler F.; Goncharik D.; Lazareva
I.; Lichorad N.; Mrochek A.; Murashko N.; Radyuk D.; Ramanovski A.;
Sudzhaeva S.; Sujayeva V.; Yarashevich N.; Campbell G.; Marshall S.; West
A.; Abreu F.; Alves M.; Ayoub-Aidar J.; Barros M.; Barros-Silveira J.;
Blacher M.; Costa E.; Costa F.; Daltro C.; Delana J.; Eliaschewitz F.;
Facanha C.; Feitosa G.; Figueiredo J.; Forti A.; Franco D.; Franken M.;
Freire F.; Garcia V.; Gouvea-Neto A.; Grofallo S.; Kanedlai N.;
Kerr-Saraiva J.; Ladeira R.; Leaes P.; Lemos M.; Lima F.; Lima Filho M.;
Macedo L.; Manenti E.; Monte O.; Mossman A.; Mothe F.; Mouco O.; Moyses
Golbert M.; Nasser Hissa L.; Nasser-Hissa M.; Nicolau J.; Nigro Maia L.;
Ninno T.; Nunes C.; Oliveira C.; Oliveira O.; Passos da silva R.;
Pericles-Esteves J.; Rabelo L.; Rabelo-Alves Junior A.; Rassi S.; Rech R.;
Roldan F.; Salles J.; Sampaio C.; Seabra A.; Sealissi N.; Seixas A.; Sena
R.; Shehadeh I.; Teixeira M.; Turin H.; Vicente Serrano C.; Vidigal M.;
Vilela M.; Wajchenberg B.; Abbott C.; Abu-Bakare A.; Ardilouze J.;
Auersperg E.; Bailey A.; Bailey G.; Baillargeon J.; Beaurivage C.; Belair
J.; Belanger A.; Bellabarba D.; Berlingieri J.; Bernier F.; Bhargava R.;
Bhesania T.; Booth W.; Bose S.; Boulianne M.; Bourgeois S.; Breton D.;
Brossoit R.; Buithieu J.; Campeau J.; Carlson B.; Carpentier A.;
Cavalcanti R.; Cha J.; Chagnon P.; Chan Y.; Chessex C.; Chiasson J.;
Chouinard S.; Clayton D.; Conway J.; Crepeau J.; Cudmore D.; D'Ignazio G.;
Doig G.; Dominguez M.; Dube F.; Dumas R.; Dupuis R.; Dyrda I.; Eddy D.;
Eiley D.; Fox H.; Fratesi S.; Gallant S.; Garceau C.; Garfield N.; Germain
C.; Glazer S.; Gosselin G.; Gould D.; Grills G.; Halle J.; Hardin P.;
Harper W.; Heath J.; Heath V.; Hivert M.; Ho K.; Houde G.; Hramiak I.;
Hutchinson A.; Huynh T.; Ilie-Haynes R.; Imran S.; Islam A.; Iwanochko M.;
Jones C.; Joyce C.; Kirouac I.; Kumar R.; Lamothe M.; Langlois M.; Lauzon
C.; Lavoie M.; Leader R.; Lecours S.; Lepage S.; Lochnan H.; Ma P.; McLean
A.; Mecci S.; Mehta P.; Mercier M.; Miller D.; Morisset A.; Nawaz S.;
Nisker W.; Nyomba G.; O'Keefe D.; Palardy J.; Parekh P.; Paul T.; Perron
P.; Pesant M.; Phillips R.; Pruneau G.; Quintin I.; Raby K.; Richard C.;
Rosenfeld G.; Saulnier D.; Shaban J.; Shah A.; Shu D.; Sigal R.; Silverman
M.; Singh J.; Sivucha W.; Skamene A.; Sliwowicz D.; Smith R.; St Hilaire
R.; Steinson D.; Sussex B.; Tan K.; Tannous R.; Telner A.; Theroux P.;
Tsoukas C.; Tsoukas G.; van Buuren J.; VanRossum N.; Vexler R.; Vizel S.;
Warnica W.; Weingert M.; Wilson R.; Wong W.; Woo V.; Yale J.; Acevedo M.;
Alwyn C.; Baier E.; Baier S.; Galloso R.; Lahsen R.; Lorenas G.;
Montecinos A.; Montecinos M.; Pineda P.; Pollak F.; Sapunar J.; Serrano
V.; Stockins B.; Varleta P.; Yovanovich J.; Zambra F.; Ba J.; Bao Y.; Bi
Y.; Bu S.; Chen B.; Chen H.; Chen J.; Chen L.; Chen M.; Chen Y.; Cui J.;
Dong M.; Feng P.; Feng Z.; Gao C.; Gao F.; Gao X.; Gao Z.; Gong Y.; Guang
L.; Guo X.; Han F.; Han X.; Hou X.; Hu R.; Ji L.; Jia J.; Jia W.; Jiao X.;
Jin X.; Kuang J.; Li M.; Li Q.; Li X.; Li Y.; Ling Y.; Liu F.; Liu Z.; Lu
B.; Lu J.; Lu Z.; Lv X.; Ning G.; Peng Y.; Ren Y.; Shao Y.; Shi Y.; Shu
X.; Sun H.; Sun L.; Sun X.; Tang K.; Tian H.; Wang C.; Wang F.; Wang L.;
Wang Q.; Wang W.; Wang X.; Wang Y.; Wen J.; Wu C.; Wu H.; Wu J.; Wu M.;
Xing X.; Xue Y.; Yan L.; Yan S.; Yang H.; Yang N.; Yang W.; Yang Z.; Yao
J.; Yao L.; Yu D.; Yu H.; Yu M.; Yu X.; Yuan L.; Yuan M.; Yuan S.; Yuan
W.; Yuan Y.; Yuan Z.; Zeng T.; Zhang J.; Zhang R.; Zhang X.; Zhao L.;
Zheng B.; Zheng J.; Zhou W.; Zhu N.; Zhu Y.; Zou D.; Zou J.;
Lopez-Jaramillo P.; Accini J.L.; Bohorquez R.; Botero R.; Cure C.;
Figueredo M.; Hernandez E.; Kattah W.; Llamas A.; Orozco L.; Pava L.;
Perez M.; Pineda M.; Quintero A.; Quiros R.; Urina M.; Velez S.; Altabas
V.; Baotic I.; Berkovic M.; Goldoni V.; Kerum T.; Mirosevic G.; Tarle D.;
Vidovic I.; Zjacic-Rotkvic V.; Abbas R.; Andersen H.; Auscher S.; Baumbach
L.; Brockstedt H.; Christensen P.; Christiansen M.; Clemmensen K.; Egstrup
K.; Gislason G.; Haar D.; Hansen K.; Heden Andersen P.; Helleberg K.;
Hermansen K.; Holmer J.; Jeppesen J.; Klausen I.; Koustrup-Sonder T.;
Krarup T.; Lerche S.; Lervang H.; Linde B.; Lund P.; Lund S.; Madsbed S.;
Molvig J.; Orskov C.; Ostergaaard O.; Perrild H.; Pietraszek A.; Ralfkjaer
N.; Roenne H.; Rokkedal Nielsen J.; Seibaek M.; Soendergaard H.; Sorensen
L.; Sundahl Mortensen L.; Torp-Pedersen C.; Tuxen C.; Urhammer S.;
Vadstrup E.; Pirags V.; Ambos A.; Janson A.; Rudenko P.; Viitas L.; Aranko
S.; Badeau M.; Eriksson J.; Haapamaki H.; Kajander O.; Kuusisto A.;
Luukkonen S.; Makela J.; Nieminen S.; Niskanen L.; Ripatti J.;
Ruotsalainen S.; Saltevo J.; Savela K.; Strand J.; Valle T.; Virkamaki A.;
Aboud E.; Alavoine L.; Bekherraz A.; Bohme P.; Bourezane H.; Catargi B.;
Charpentier G.; Clergeot A.; Courreges J.; Delmas T.; Duengler F.; Feknous
C.; Gendre D.; Guerci B.; Hadjadj S.; Kerlan V.; Laguerre N.; Le Potier
J.; Lombardo F.; Malville E.; Marechaud R.; Mattei C.; Moreira J.;
Penfornis A.; Petit C.; Pinel J.; Piquel X.; Raccah D.; Reznik Y.; Rod A.;
Roudaut N.; Rousseau E.; Schillo F.; Schmitt B.; Sonnet E.; Torremocha F.;
Travert F.; Vanhoute C.; Vimeux M.; Abdollahnia R.; Adamidou A.; Arslan
S.; Bach-Kliegel B.; Bartusch B.; Bauer N.; Bieler T.; Blankenfeld H.;
Boeckmann U.; Busch K.; Butzer R.; Chenchanna-Merzhaeuser M.; Denger R.;
Deutsch C.; Diessel S.; Donati-Hirsch I.; Dornisch M.; Enghofer K.; Fleig
T.; Forst T.; Frommherz M.; Goeller K.; Habbig J.; Hadziselimovic S.;
Hamann A.; Hampel T.; Heger S.; Helmes C.; Hoffman C.; Hohberg C.; Humpert
P.; Kamke A.; Kamke W.; Kindermann P.; Klein C.; Klein D.; Koehler A.;
Kuehn A.; Langer K.; Limmer S.; Loew A.; Maimer A.; Marck C.; Meier G.;
Methner-Friederich M.; Metzler W.; Meyer K.; Miftari N.; Milde J.; Minnich
J.; Molkewehrum M.; Morcos M.; Mueller-Hoff C.; Nguyen M.; Nishwitz M.;
Oldenburg J.; Ott P.; Pauli K.; Pauly B.; Pfeiffer A.; Pfuetzner A.;
Pischa U.; Radke R.; Reismann P.; Riemer M.; Rochlitz H.; Rudofsky G.;
Ruhla S.; Sammler A.; Schaper F.; Schiemenz K.; Scholz G.; Schumm-Draeger
P.; Segiet T.; Segner A.; Seissler J.; Spahn S.; Stier U.; Tonon G.; von
Amelunxen S.; von Schacky C.; Wilhelm B.; Wilhelm K.; Witt K.;
Wuechner-Hofmann S.; Baranyai M.; Birkus Z.; Foldesi I.; Gaal Z.; Harcsa
E.; Hati K.; Hohmann Z.; Istenes I.; Jozsef I.; Juhasz E.; Kempler P.;
Keresztes B.; Keresztes K.; Kis-Gombos P.; Kovacs I.; Kozma T.; Laszlo Z.;
Noori E.; Nyirati G.; Papp Z.; Patkay J.; Poor F.; Pusztai P.; Putz Z.;
Rigo E.; Sereg M.; Simon K.; Somogyi A.; Sumegi J.; Szabo A.; Szabo J.;
Szigeti S.; Szilveszter D.; Tarko M.; Varga C.; Varga Szabo L.; Voros P.;
Arathi; Aravind S.; Badgandi M.; Balaji M.; Balaji V.; Chamukuttan S.;
Devi Manduva P.; Fatima S.; Ganapathy B.; George O.; George P.; Jaffar M.;
Jain P.; Kamath P.; Karthik V.; Koshy G.; Krishnan L.; Kumar H.; Lal P.;
Mithal A.; Modi S.; Mohan V.; Moses V.; Oomen R.; Pais P.; Pati P.;
Pendsey S.; Rai P.; Rajagopal R.; Ramu M.; Ranjit U.; Rao P.; Senthil V.;
Seshaiah V.; Sethi B.; Shah P.; Sharma R.; Shetty S.; Shobha A.; Siddharth
R.; Sridhar G.; Sudeep K.; Sunil C.; Sunitha S.; Suresh S.; Thomas N.;
Vageesh A.; Anwer Z.; Barton J.; Behan L.; Bell M.; Cullen M.; Dineen S.;
Draman Yusof M.; Dunne F.; Gibney J.; Hussain T.; Khan M.; Kinsley B.;
Kyithar P.; Lavin F.; McGowan A.; McGurk C.; Mirza A.; Mohammadi B.;
O'Brien T.; O'Connell J.; O'Halloran D.; O'Shea D.; Roberts G.; Tomkin G.;
Wan Mahmood W.; Abramod-Ness R.; Adawi F.; Aharon B.; Backer M.;
Beniashvili A.; Berliner A.; Bloch L.; Bugelman D.; Butnaru A.; Cohen O.;
Cohen Y.; Frenkel M.; Glant M.; Gustava B.; Guttman H.; Halabi S.;
Harman-Boehm I.; Ilany J.; Karkabi B.; Khader N.; Khaskia A.; Khudyak Y.;
Klainman E.; Kogan N.; Lender D.; Levin I.; Mardi T.; Marmor A.; Mosseri
M.; Nabriski D.; Omary M.; Orlovsky S.; Peres D.; Quasim M.; Raz I.;
Remesnik M.; Rogowski O.; Rozenfeld I.; Scharr D.; Shnifer I.; Shuster T.;
Solomon R.; Steiner H.; Tzivoni D.; Wolfson N.; Yossef Z.; Zahger D.;
Zeltser D.; Zimlichman R.; Aina F.; Ariatti C.; Bonetti R.; Cacciatore F.;
Calcinaro F.; Corona G.; De Maria P.; Del Prato S.; Derosa G.; Di Pasquale
G.; Falorni A.; Fanelli R.; Fedele D.; Filorizzo G.; Fogari R.; Furgi G.;
Ghio A.; Giorda C.; Gregori G.; Iannuzzi G.; Lapolla A.; Luciano B.;
Lucotti P.; Maggi A.; Marafetti L.; Marchese T.; Martino G.; Marzotti S.;
Miccoli R.; Monti L.D.; Moretti L.; Palvarini M.; Petacchi R.; Piarulli
F.; Piatti P.M.; Rudi S.; Santeusanio F.; Sesti G.; Setola E.; Sforza A.;
Shehaj E.; Veniani M.; Viviani G.; Zigoura E.; Chae S.; Cho D.; Cho E.;
Cho Y.; Choi Y.; Chung M.; Hong E.; Hong Y.; Jeong M.; Kim B.; Kim D.; Kim
H.; Kim I.; Kim J.; Kim P.; Kim S.; Koo B.; Kwok S.; Kwon H.; Lee J.; Lim
J.; Oh S.; Ohn J.; Park C.; Park H.; Park K.; Seung K.; Son H.; Woo J.;
Yoon K.; Ansmite B.; Balcere I.; Bumbure A.; Ducena K.; Lejnieks A.; Rasa
I.; Ritenberga R.; Romanova M.; Salmina I.; Steina S.; Badariene J.;
Gailiuniene S.; Grigonis S.; Juskiene R.; Petrulioniene Z.; Sakalyte G.;
Stasiunas T.; Sulskiene M.; Urbonaite B.; Zarankiene R.; Ziukaite R.;
Arechavaleta R.; Beltran-Jaramillo T.; Calvo-Vargas C.; Campillo-Cardenas
C.; Cardona D.; Carmona-Huerta J.; Cedano-Limon M.; Comellas-De M.;
Dominguez C.; Gomez-Cruz J.; Gonzalez-Perez R.; Illescas J.; Jimenez-Ramos
S.; Lopez-Alvarado A.; Marquez-Rodriguez E.; Martinez G.; Pascoe S.;
Plascencia Vazquez O.; Rodriguez H.; Ruiz-Cornejo M.; Velasco-Sanchez G.;
Vidrio-Velazquez M.; Villeda-Espinosa E.; Badings E.; Bartels G.;
Bruggink-Andre de la Porte P.; Bruijns E.; Cornel J.; De Milliano P.; De
Mulder M.; De Swart J.; Derks A.; Dirkali A.; Droste J.; Galjee M.;
Hautvast R.; Hermans W.; Holwerda N.; Ilmer B.; Kofflard M.;
Kooistra-Huizer J.; Kurvers M.; Langerveld J.; Leenders C.; Liem A.; Lok
D.; Neumann D.; Nierop P.; Plomp K.; Posma J.; Reichert C.; Roeters Van
Lennep H.; Ronner E.; Said S.; Takens L.; Umans V.; Van der Sluis A.A.;
Van der Zwaan C.; Van Dobbenburgh J.; Van Es A.; Van Hessen M.; Van
Mechelen R.; Van Miltenburg-Van Zijl A.; Van Zeijl L.; Veerhoek M.;
Viergever E.; Weijers E.E.; Willems F.; Blix I.; Cooper J.; Debowska A.;
Erichsen K.; Fossum J.; Gjertsen E.; Grill V.; Gudnason S.; Hoye K.; Istad
H.; Winther J.; Joakimsen R.; Jorde R.; Larsen I.; Mella B.; Otterstad J.;
Risberg K.; Skare K.; Skeie S.; Sommervoll L.; Tandberg A.; Whitfield R.;
Wium C.; Cunanan E.; Fernando-Catindig E.; Gomez M.; Jaring C.;
Lantion-Ang F.; Licaros M.; Lim-Abrahan M.; Madronio E.; Panelo A.; Raboca
J.; Ramos G.; Tugna S.; Aksamit-Bialoszewska E.; Bandurska-Stankiewicz E.;
Baranska M.; Bronisz A.; Bronisz M.; Chrustowski W.; Cieslak B.;
Czupryniak L.; Drazkowicz-Gozdzik B.; Galuszka-Bilinska A.; Gmytrasiewicz
M.; Janik K.; Jedynasty K.; Kania G.; Kawka-Urbanek T.; Kinalska I.;
Kincel K.; Kleszczewska U.; Kruszewski J.; Loba J.; Malicka J.;
Mielecka-Kincel M.; Milczarczyk A.; Milosz D.; Mrowczynska A.; Mytnik M.;
Nowakowski A.; Nowakowski P.; Oleskowska L.; Omelanczuk-Wiech E.;
Pawlowski M.; Poplawska A.; Rucinska M.; Rucinski M.; Rutkowska J.;
Saryusz-Wolska M.; Siewko K.; Sikora-Frac M.; Stecka-Wierzbicka J.;
Swiatkowski M.; Swierczynski R.; Szpajer M.; Szymkowiak K.; Tarach J.;
Tarasiewicz U.; Wiatr D.; Wojewoda P.; Woszczak-Marcinkowska H.; Zadrozny
J.; Hancu N.; Albota A.; Bala C.; Barbonta D.; Botnariu G.; Bradescu O.;
Busegeanu M.; Bzduch M.; Catrinoiu D.; Caziuc R.; Cerghizan A.; Cheta D.;
Cif A.; Ciomos D.; Cosma D.; Creteanu G.; Crisan I.; Danciulescu R.;
Dobjanschi C.; Dodan R.; Duma L.; Ferariu I.; Ghenes T.; Ghise G.; Graur
M.; Ilinca M.; Marton R.; Mindrescu N.; Morosanu A.; Morosanu M.; Mota M.;
Nafornita V.; Negrisan G.; Nicodim S.; Nicolau A.; Nita C.; Onaca A.;
Panus C.; Pletea N.; Pop C.; Pop L.; Popa B.; Roman G.; Rosu M.; Sandu N.;
Serban V.; Sima A.; Stamoran L.; Strugariu M.; Suciu G.; Szilagyi I.;
Vacaru G.; Veresiu I.; Vlad A.; Adasheva T.; Ageev F.; Akhmedganov N.;
Akinina A.; Alexandrov A.; Ambatiello L.; Ametov A.; Ausheva A.; Babaeva
L.; Babenko A.; Balyasnikova E.; Bart B.; Belova J.; Berstein L.;
Bondarenko I.; Bondarev E.; Bulkina O.; Chernikova N.; Chumak B.; Deeva
T.; Demicheva O.; Demidova T.; Doskina E.; Duganova A.; Dzhaiani N.;
Egorova I.; Ettinger O.; Feofanova S.; Fofanova T.; Galaktionov P.;
Gavrilova N.; Gilyarevsky S.; Gnidkina N.; Golubev A.; Gornyakova N.;
Grigorova S.; Grineva E.; Gurevich V.; Irtuganov N.; Ivanova L.; Jaiani
N.; Kalashnikova M.; Karpov Y.; Khalimov Y.; Khorocheva G.; Kirillova E.;
Kistner J.; Kobalava Z.; Kochergina I.; Kravchenko T.; Krylov K.; Kulkova
P.; Kuparev I.; Kurbanova E.; Lysenko T.; Markovich A.; Martyanova I.;
Martynyuk T.; Masiinvets M.; Mavlyavieva E.; Maychuk E.; Melnichenko G.;
Mikhailusova M.; Mkrtumyan A.; Mychka V.; Nebieridze D.; Nesterova E.;
Orlov V.; Orlova V.; Orlova Y.; Papov F.; Patroucherva I.; Petunina N.;
Pirozhinskaya S.; Podachina S.; Postnikova S.; Pshikova O.; Rogova L.;
Romashevskiy B.; Runikhina N.; Sadulayeva I.; Safaryan A.; Sakovich E.;
Saprikina T.; Sargsyan V.; Semikozova O.; Shkolnik E.; Shubina A.; Shustov
S.; Sinitsina I.; Solovyeva E.; Storogakov G.; Stovpyuk O.; Sussekov A.;
Telnova M.; Temirov A.; Terekhov V.; Tereschenko S.; Tiourina T.;
Tolkacheva V.; Tsoy U.; Urazgyldeeva S.; Vasyuk Y.; Vinnitskay N.;
Voevodina E.; Volkova A.; Zadionchenko V.; Zalevskaya A.; Zhelninova T.;
Zhukova N.; Zilov A.; Bernatova J.; Duris T.; Markova I.; Martinka E.;
Michalova L.; Minarik P.; Peter L.; Raslova K.; Silvia D.; Subadova M.;
Tisonova J.; Vohnout B.; Adam M.; Badat A.; Bester A.; Bester F.; Blacking
L.; Bouwer D.; Brice B.; Cassimjee S.; Cronje T.; Deftereos J.; Distiller
L.; Ellis G.; Forster O.; Fulat M.; Gani M.; Gibson G.; Hansa S.;
Hendricks N.; Herbst L.; Hitzeroth J.; Joffe B.; Kelbe C.; Kelbe D.; King
J.; Kramer B.; Landau S.; Levitt N.; Meyer-Nell S.; Moore R.; Muller D.;
Nell H.; Omar M.; Randeree H.; Seeber M.; Seedat; Segynu D.; Siebert M.;
Van den Berg E.; Van der Walt P.; Van Dyk C.; Van Niekerk F.; Van Zyl L.;
Wellman H.; Bertomeu V.; Botella M.; Buno M.; Calle A.; Cano Perez J.;
Coves M.; Juanatey J.G.; Garcia-Mayor R.; Gaztambide S.; Gippini A.;
Goikolea I.; Gonzalez J.; Hillman N.; Lopez Garcia Aranda V.; Magueda I.;
Mato J.; Mazon P.; Morillas P.; Novials A.; Pallardo L.; Perez L.;
Rodriguez J.; Romero L.; Sagarra E.; Shamagian L.; Soto A.; Torrealday H.;
Valero R.; Agergaard S.; Agewall S.; Andersson K.; Bergstrom O.;
Bjornstedt Bennermo M.; Blomgren J.; Boman K.; Brohall G.; Cherfan C.;
Dahlen C.; Dotevall A.; Enander P.; Ericsson U.; Hallgren P.; Hansson A.;
Henareh L.; Henriksson P.; Herlitz J.; Holmqvist J.; Jarevi G.; Linderfalk
C.; Jonasson L.; Jovinge S.; Kalen J.; Kilstrup M.; Leosdotir M.; Leppert
J.; Ljungberg J.; Lofdahl B.; Lundman P.; Lysell-Bergstrom C.; Mathiesen
U.; Mellbin L.; Morner S.; Nathanson D.; Nilsson L.; Peterson M.;
Quittenbaum S.; Rosengren A.; Ryttberg B.; Scheel S.; Svensson K.; Tenerz
A.; Vasko P.; Waldenstrom A.; Wieloch M.; Spinas G.; Braendle M.; Felix
B.; Gerber P.; Moccetti T.; Pitteloud N.; Kultursay H.; Aydinalp A.; Balci
M.; Cayli M.; Hatipoglu E.; Ilkova H.; Kayikcioglu M.; Koc M.;
Muderrisoglu H.; Sari R.; Saygili F.; Tekin K.; Tutuncu N.; Yurekli B.;
Adler A.; Ali A.; Balasubramanian; Bandypadhyay P.; Barakat O.; Barnett
A.; Borthwick L.; Brookes; Burton J.; Cecil J.; Chaterjee S.; Clark J.;
Collinson D.; Collinson S.; Crasto W.; Donnelly R.; du Plessis J.; Egan
S.; Ellery A.; Evans R.; Ewing J.; Fox C.; Gibson M.; Hall T.; Higgs E.;
Hollway M.; Hughes E.; Jackson N.; Jalihawi H.; Jones G.; Knights H.;
Korsheed S.; Kumar Singh R.; Laithwaite D.; Lawrence I.; Litchfield J.;
Manning G.; McNally P.; Millar-Craig M.; Mohammed I.; Narayanan R.; Nayani
G.; Norris A.; Purohit J.; Quinn M.; Ramtoola; Randall J.; Rea R.;
Reckless J.; Richardson T.; Robertson D.; Robinson A.; Salem K.; Sampson
M.; Savage M.; Shaker J.; Srinivasan T.; Tracy I.; Tringham J.; Viljoen
A.; Ward A.; Waterhouse H.; Wijenaike N.; Wiles P.; Ahmann A.; Ahmed I.;
Alam A.; Arakaki R.; Asad S.; Banarer S.; Baum H.; Belew K.; Bergenstal
R.; Bethel M.; Boyer C.; Catton S.; Challans P.; Childs B.; Christian R.;
Clement S.; Cuddihy R.; Dailey G.; Damberg G.; De Bold C.; De Lemos J.;
Donovan D.; Dudl J.; Dunbar J.; Ebner S.; Failor R.; Feinglos M.; Flaker
G.; Freiburghaus M.; Furlong K.; Gardner D.; Gillespie E.; Goland R.;
Goldberg R.; Gotham A.; Guthrie R.; Hamaty M.; Hirsch I.; Jabbour S.;
Janci M.; Javorsky B.; Jones S.; Kamana V.; Kashyap M.; Kaufman S.; Kearns
P.; Khera A.; Klopfenstein B.; Kniffen W.; Kringas P.; Licata A.;
Lopez-Jimenez C.; Madden M.; Marx C.; McCall A.; McCallum J.; McFarlane
S.; McGuire D.; Melish J.; Meneghini L.; Miller S.; Miranda-Palma B.;
Mitchell R.; Nasr C.; Nelson J.; Niblack P.; Nylen E.; Osei K.; Pandey A.;
Papademetriou V.; Pilar Solano M.; Sameshima L.; Savarese V.; Schnure J.;
Schuster D.; Shin J.; Taylor A.; Thomson P.; Ting-Ryan M.; Trence D.; Vo
A.; Weiland K.; Wells K.; Wu P.; Zimering M.; Zimmerman R.; Ascanio P.;
Brajkovich I.; Carrillo E.; Coll J.; Gonzalez K.; Gonzalez N.; Jimenez E.;
Lopez R.; Marante D.; Morr I.; Paolillo M.; Perche D.; Portillo M.;
Valbuena H.; Velarde M.; Vergara G.; Augensen N.; Azzalina J.; Fidaly S.;
Bollero G.; Casiello A.I.; Ferraro F.; Guridi M.J.; Ines M.; Martin M.E.;
Pascual A.; Pereyra J.; Toscanelli M.; Appiah M.; Grech S.; Pouras S.;
Watts C.; Denke E.; Feik C.; Litvinenko M.; Platonenko O.; Shadur S.;
Johnson J.; Bonilla E.; Carraway B.; Faith J.; Greer C.; Harding A.;
Heston J.; Lin Y.; Mecca T.; Schuler M.; Rizk C.; Sissoko A.; Strickland
K.; Andrade A.; Lux L.; Machado D.; Mancin E.; Aquino J.; Belanger B.;
Bourque C.; Gagnier K.; Hagerimana A.; McNeil A.; Osachoff J.; Richard B.;
Rogan J.; Styner L.; Maturana X.; Naranjo M.E.; Li E.; Liu Q.; Shuai M.;
Tan Z.; Tang M.; Zhao J.; Ardila M.; Gomez A.M.; Uscategui A.M.;
Marinkovic N.; Miocevic V.V.; Pezo S.; Andersen I.; Bastrup-Larsen B.;
Jeppesen E.; Kofoed-Djursner M.; Joe H.; Hiironen V.; Tarvainen M.; Von
Hedenberg H.; Guillarme C.; Rastelli O.; Roy P.; Igel L.; Lenz T.; Leptich
A.; Peikert S.; Domokos S.; Szotyorine-Polcza G.; Wenczl M.; Chaudhary S.;
Jaiswal G.; Khatri P.; Shah K.; Gibson S.; Bechar Y.; Erdheim D.; Eyal N.;
Frankel M.; Shimoni S.; Tsuri J.; Bianco L.; Cali R.; Sganga P.; Jang M.;
Kim J.M.; Kim Y.; Lim S.; Park J.S.; Song Y.; Kalve E.; Dienyte E.;
Alvarado F.; Rodriguez R.; Bar J.; Lijfering-Lorie K.; Palstra M.; Van der
Kuijl K.; Van de Wetering A.; Eriksen S.; Hejazifar S.; Jendeberg A.;
Johannessen G.; Khammari I.; Meredith E.L.; Dayag A.M.; Figueroa P.;
Hoffmann Korpalska A.; Przemyk M.; Craciunescu A.; Lupu D.; Osanu A.;
Popscu L.; Toader C.; Kirsanova T.; Timoshina E.; Gomez B.; Jankularova
I.; Brett S.; Meyer A.; Pereira V.; Vawda N.; Castano B.; Farre Avella
J.M.; Jimenez I.; Turet N.; Froberg M.; Reppert E.; Wessman S.; Boschung
Y.; Carrozzino F.; Gerstl K.; Cetin Z.; Demirci S.; Ovalioglu S.; Lenehan
A.; McLean H.; Mutsaers K.; Redfern P.; Scoggins A.; Isea Y.; Alvarez M.;
Alvarez D'Amelio A.; Aqueveque S.; Argenta M.; Aviles A.; Barreiro E.;
Battistessa Y.; Bergamo S.; Bertran B.; Bocanera M.; Bowen L.; Brescia H.;
Caceres M.; Cappi A.; Cardelli A.; Carolini E.; Carpintero S.; Carrique
A.; Carrique P.; Casquero M.; Castro M.; Cendali G.; Chatelain M.;
Costanzi A.; Cristofaro C.; Crunger P.; Ehrich S.; Espinosa M.; Esposito
L.; Flenche M.; Fracaro V.; Funosas C.; Garrido I.; Gomez Garrido A.;
Guzman A.; Izzicupo M.; Luca S.; Luciani C.; Majul S.; Moreno Cepeda I.;
Moschin Y.; Niemann G.; Novas V.; Olmi M.; Palma F.; Peralta A.; Puig A.;
Rodera Vigil M.; Ronderos G.; Rosell M.; Samudio M.; Santicchia C.;
Szczygiel V.; Takla M.; Tinnirello C.; Tonin S.; Tristan A.; Troncoso C.;
Vignau S.; Yanez K.; Zarate M.; Appeldorf R.; Batrouney B.; Bonner A.;
Bonner M.; Cahill P.; Carr J.; Caruana M.; Chare J.; Doran A.; Flavel;
Gein J.; Griek S.; Hulley A.; Keays P.; Kent S.; Lai N.; Legg H.; Long A.;
Lynch L.; Maxwell V.; McNamara K.; Nairn J.; Nichols V.; Peeler C.;
Phillips J.; Price-Smith S.; Ryan S.; Stockle P.; Tapp E.; Taverner P.;
Tulloch G.; Viola V.; Wilson L.; Beck A.; Damon S.; Drexel V.; Grabner E.;
Hofurthner A.; Kivioja P.; Kretschmer S.; Lener P.; Maiweg J.; Tscherner
D.; Weichelt H.; Winkler J.; Jones D.; Alves L.; Batista R.; Bernardes A.;
Demore de Souza A.; Ferraz R.; Ferreira A.; Freitas E.; Guanaes D.;
Kuschel K.; Muniz R.; Nasser-Hissa V.; Nhan P.; Osorio R.; Queirantes C.;
Reboucas R.; Souza C.; Tonani M.; Vicente C.; Zilli A.; Andersen K.; Aro
L.; Barber C.; Barnable B.; Berard L.; Bernier A.; Boudreault C.;
Bourbonnais A.; Bourgeois L.; Boutin D.; Boyer D.; Branco N.; Briol L.;
Brousseau M.; Burke M.; Chambers C.; Champoux A.; Chan S.; Colborne C.;
Coles K.; Couture M.; Cryderman C.; DeCurtis D.; Dewar C.; Drown J.; Dunn
P.; Eichmann D.; Eikel L.; Fox B.; Gauthier S.; Gibbons D.; Hicks R.; Ho
V.; Kitagawa H.; Kooistra L.; Landry F.; Lapointe F.; Larrivee L.; Leonard
P.; Louch D.; MacNair D.; Magennis L.; Mallette D.; Marchand C.; McLean
S.; Meilleur M.; Murdock H.; Naud M.; Olson K.; Otis J.; Ouimet F.;
Paquette H.; Peck C.; Pelletier A.; Perkins L.; Petrie F.; Pockett S.;
Poulin F.; Poulin M.; Primbas K.; Renton J.; Rouatt S.; Roy M.; Scarcelli
D.; Schellenberg S.; Schellevis K.; Schmidt N.; Scott L.; Skarpinsky B.;
Smith B.; Smith E.; Stafford C.; Stata C.; Sternberg B.; St-Jean N.;
Stoger S.; Thibodeau C.; Toupin A.; Ullyatt L.; Velonas J.; Vienneau R.;
Wall C.; Zaniol D.; Arau M.; Fuentes J.; Hidalgo J.; Landaeta O.; Padilla
I.; Sanzana S.; Tellos G.; Toro F.; Vergara R.; Che T.; Du Y.; He Y.;
Huang C.; Li H.; Liu S.; Luo X.; Ma Y.; Pan S.; Wan Q.; Wang H.; Wang S.;
Xie Y.; Xu X.; Xu Y.; Zhao F.; Zhou M.; Accini M.; Bello O.; Caceres A.;
Camargo S.; Figueroa J.; Florez M.; Gomez Morales K.; Granados L.;
Martinez M.; Medina Ramos M.; Mejia C.; Montoya L.; Ramos C.; Restrepo P.;
Rodriguez D.; Santamaria A.; Valencia T.; Spanic V.; Borre Hansen A.;
Bulow M.; Ehlers G.; Frederiksen A.; Gottschalck H.; Hejlskov B.; Holm
Fruesnsgaard Pedersen L.; Hornum H.; Jansen S.; Johansen A.; Jorgensen A.;
Kjaeulff Svaneborg T.; Kruse A.; Lund K.; Lundgaard M.; Madsen J.; Meier
A.; Muurholm A.; Nedergaard A.; Nielsen S.; Norgaard D.; Olsen A.; Raae
D.; Reiter P.; Sigsgaard U.; Vestergaar I.; Witt A.; Mitt T.; Timmusk P.;
Heikkila E.; Heiskanen R.; Huotari E.; Keskitalo A.; Kylmala L.; Laitinen
M.; Laukkanen M.; Leskinen S.; Liesivuori J.; Lukkari-Kuronen L.; Merisalo
P.; Muurinen E.; Nikkanen P.; Niskanen T.; Pasanen P.; Pekkonen L.; Retsu
A.; Soppela A.; Andreu N.; Ankotche A.; Bairras C.; Boch C.; Camachon L.;
Cherchouly A.; Coudret S.; Demer C.; Gilg R.; Lemonade L.; Madec O.;
Pinotti D.; Poirier I.; Tenne N.; Vogler C.; Amman M.; Andratschke-Gentsch
B.; Beckmann H.; Bischoff S.; Bleich B.; Bueschges G.; Busch E.;
Deigentasch S.; Dietze S.; Dollinger M.; El-Bahay C.; Flehmig G.; Frenzel
I.; Geissler K.; Guerro J.; Heike B.; Holler D.; Inhoffen C.; Klein K.;
Kraehe I.; Kress P.; Krueger H.; Lenz R.; Linnebach B.; Lueck A.; Markhof
P.; Matthies K.; Meier C.; Metzler E.; Moor E.; Noll I.; Paulsen S.;
Pfeffer B.; Promnitz N.; Saljew B.; Schad S.; Schoner C.; Sellmann R.;
Tanis M.; Vogelbusch J.; Wagner E.; Winkler S.; Zenker K.; Zvork S.;
Balogh E.; Buncsikne Molnar S.; Gulyasne Gaspar E.; Herold M.; Kovacs E.;
Kozmane Paszternak A.; Maarne Nagy S.; Nagyne Zoltan A.; Nemeth Z.; Roth
T.; Rozsa I.; Szalai M.; Anuradha M.; Bawa T.; Bhaskar B.; Chalkhore S.;
Choudhary D.; Dhanalaxmi T.; Dhingra V.; Gayatri R.; Gnanasundram R.;
Gopal U.; Govindaraj S.; Indira P.; James S.; Karkuzhli K.; Koppikar V.;
Malhotra N.; Manmohan B.; Mazher A.; Menon R.; Nalini S.; Panda M.; Patel
K.; Poongothai S.; Ramanathan S.; Ramu I.; Sangeetha K.; Sankar K.;
Savitha; Seeli Abraham C.; Shrinivas K.; Sudha S.; Tripathi S.; Vaseem A.;
Yamuna A.; Banques R.; Chong J.; Courcy M.; Donnelly E.; Fauzi A.; Gately
M.; Hanlon G.; Kelly-Conroy M.; McAteer S.; McGovern G.; Meaney E.; Storey
S.; Todd M.; Aharonof-Segal M.; Aliazarov N.; Arbeli S.; Butbul E.; Chagai
E.; Confino K.; Domb L.; Dvir R.; Erez N.; Foiening O.; Frishberg A.;
Genin I.; Gertman R.; Golan L.; Grosberd A.; Hadad D.; Israeli S.;
Kaplunski Y.; Karpf D.; Katzir A.; Kivity Z.; Li L.; Livshitz L.; Nachmias
A.; Orr I.; Peer E.; Platner N.; Pritulo L.; Rojansky A.; Rosenblat T.;
Saranga H.; Schterchman G.; Shenhar S.; Shkliar T.; Stam T.; Stinmann S.;
Suliman A.; Tsirulnikov E.; Uziel K.; Weinshtock S.; Yedid-Am S.; Yuval
R.; Zuker S.; Brunella L.; Durante A.; Nada E.; Pugolotti M.; Robusto A.;
Testa M.; Toniato R.; Ha I.; Jung S.; Kim C.; Mi Ran K.; Song B.; Wi Y.;
Yang K.; You J.; Gaisute R.; Ozolina L.; Dzagajeva N.; Kasperaviciene V.;
Krikstaponiene Z.; Montviliene R.; Morkunaite K.; Piepoliene L.; Stoniene
E.; Stonkus S.; Ulpaityte I.; Arenas-Vanhorn M.; Espitia-Serrato L.;
Garcia-Munoz E.; Nunez V.; Sainz T.; Bakker H.; Danse I.; De Greef S.; De
Jong C.; De Wit M.; Didden E.; Dommerholt R.; Goddrie M.; Haazer C.;
Havenaar J.; Hendriks-Van Woerden M.; Jongenotter M.; Kort I.; Koster L.;
Kramer H.; Maarssen E.; Posthuma-Visscher M.; Reijnierse-Buitenwerf H.;
Rood P.; Swets E.; Tousain W.A.; Van Buchem-Damming G.; Van
Buijsen-Nutters A.; Van de Loo R.; Van den Hondel M.; Van den Berg A.; Van
der Knaap-van Keulen M.; Van der Zeijst M.; Van Setten-Van der Meer L.;
Von Bannisseht E.E.; Wouda Z.; Aarsland T.; Amlie L.; Andresen B.;
Bakketun A.; Bognaes A.; Botten C.; Coucheron S.; Halsne A.; Hansen H.;
Holthe T.; Husby E.; Iversen E.; Kvalvik A.; Landbakk T.; Lovseth E.; Moen
S.; Orvik E.; Ovrehus G.; Salater S.; Sorgard B.; Sorstrom A.; Tandberg
L.; Veiding B.; Vinje G.; Winge A.; Abquina G.; Patena B.; Reyes R.;
Tamondong A.; Vega A.; Vitug L.; Makuch M.; Torun A.; Adam A.; Basaraba
M.; Chira C.; Darida C.; Haica C.; Nedelcu A.; Patru D.; Patrut L.; Rau
I.; Rotaru N.; Szabo L.; Vrinceanu G.; Sovenko T.; Zatsevskaya O.;
Horynova Z.; Vankova L.; Barkhuizen M.; Barnard L.; Bekker D.; Botha D.;
Commerford A.; de Klerk A.; De Waal A.; Devchand S.; Drummond F.; Du Toit
A.; Du Toit S.; Ellis T.; Engelbrecht M.; Eramus T.; Fonda K.; Goosen A.;
Gopel E.; Govender P.; Hodge E.; Ismael F.; Jonker E.; Jonker L.; Joubert
A.; Kilian M.; Koegenlenberg N.; Lehner L.; Lingham R.; Llyod T.; Mangoeng
P.; Mapele S.; Meiring J.; Methusi P.; Mmethi M.; Mohamed K.; Moore A.;
Ndiweni H.; Parker F.; Schoneman J.; Smit M.; Steyn A.; Van Dongren J.;
Van Schalkwyk S.; Van Staden L.; van Wyngaard G.; Wolf A.; Ashbaugh R.;
Bande C.; Barquero R.; Gaspar R.; Martin E.; Megia B.; Rodriguez C.;
Seoane A.; Viaplana J.; Akesson Jacobsson I.; Andersson C.; Asperen M.;
Backlund M.; Berglund M.; Bjorck L.; Borjesson M.; Brolin G.; Danielsson
Frojd M.; Duckert A.; Eriksson K.; Fehling K.; Glaas A.; Hage C.; Hoglund
K.; Jernhed H.; Johansson K.; Johansson S.; Lidin M.; Lundell L.; Lundgren
C.; Magnusson K.; Matsson E.; Norman J.; Nystrom K.; Ojutkangas M.;
Olofsson M.; Olsson C.; Pettersson U.; Pramberg E.; Raschperger A.; Sjolin
M.; Soderlund M.; Stensgaard Nake E.; Torebo E.; Uggeldahl I.; Walldin C.;
Welin-Berger B.; Dwyer A.; Meyer-Lazzarini V.; Morello R.; Schefer M.;
Oney S.; Seker T.; Tavlayan S.; Appleby M.; Astin J.; Baker M.; Brann H.;
Brennan C.; Bryan L.; Campbell D.; Carey J.; Cox K.; Davis C.; Dyson B.;
Everdell R.; Gammon B.; Godden J.; Gray T.; Griffiths E.; Grimes Y.; Hall
D.; Hall K.; Holme A.; Howe J.; Lambley-Burke R.; Nation M.; Norcott K.;
Mitchell K.; Poxon S.; Quick C.; Shute C.; Thomas J.; Vinnell T.; Bawa S.;
Bogan C.; Fallye O.; Ginsberg J.; Gregory B.; House B.; Isonaga M.;
Keanne-Richmond P.; Kelly C.; Kimpel J.; Leiby A.; Lyons L.; McCoy B.;
Monk A.; Pelayo E.; Perron M.; Posey D.; Rehan M.; Suarez R.; Tilton L.;
Waite K.; White G.; Chacon R.; Meza Y.; Misticchio F.; Torres M.; Urbaneja
H.
Publisher
American Diabetes Association Inc. (E-mail: membership@diabetes.org)
Abstract
OBJECTIVE: The Outcome Reduction With Initial Glargine Intervention
(ORIGIN) trial reported neutral effects of insulin glargine on
cardiovascular outcomes and cancers and reduced incident diabetes in
high-cardiovascular risk adults with dysglycemia after 6.2 years of active
treatment. Omega-3 fatty acids had neutral effects on cardiovascular
outcomes. The ORIGIN and Legacy Effects (ORIGINALE) study measured
posttrial effects of these interventions during an additional 2.7 years.
RESEARCH DESIGN AND METHODS: Surviving ORIGIN participants attended up to
two additional visits. The hazard of clinical outcomes during the entire
follow-up period from randomization was calculated. RESULT(S): Of
12,537 participants randomized, posttrial data were analyzed for 4,718
originally allocated to insulin glargine (2,351) versus standard care
(2,367), and 4,771 originally allocatedto omega-3 fatty acid supplements
(2,368) versus placebo (2,403). Posttrial, small differences in median
HbA1c persisted (glargine 6.6% [49 mmol/mol], standard care 6.7% [50
mmol/mol], P = 0.025). From randomization to the end of posttrial
follow-up, no differences were found between the glargine and standard
care groups in myocardial infarction, stroke, or cardiovascular death
(1,185 vs. 1,165 events; hazard ratio 1.01 [95%CI 0.94-1.10]; P = 0.72);
myocardial infarction, stroke, cardiovascular death, revascularization, or
hospitalization for heart failure (1,958 vs. 1,910 events; 1.03
[0.97-1.10]; P = 0.38); or any cancer (524 vs. 529 events; 0.99
[0.88-1.12]; P = 0.91) or between omega-3 and placebo groups in
cardiovascular death (688 vs. 700; 0.98 [0.88-1.09]; P = 0.68) or other
outcomes. CONCLUSION(S): During >6 years of treatment followed by
>2.5 years of observation, insulin glargine had neutral effects on health
outcomes and salutary effects on metabolic control, whereas omega-3 fatty
acid supplementation had no effect. Copyright © 2016 by the
American Diabetes Association.

<152>
Accession Number
610147444
Title
Stem cell mobilisation by granulocyte-colony stimulating factor in
patients with acute myocardial infarction: Long-term results of the
REVIVAL-2 trial.
Source
Thrombosis and Haemostasis. 115 (4) (pp 864-868), 2016. Date of
Publication: April 2016.
Author
Steppich B.; Hadamitzky M.; Ibrahim T.; Groha P.; Schunkert H.; Laugwitz
K.-L.; Kastrati A.; Ott I.
Institution
(Steppich, Hadamitzky, Groha, Schunkert, Kastrati, Ott) Deutsches
Herzzentrum der Technischen Universitat Munchen, Munchen, Germany
(Ibrahim, Laugwitz) Klinikum rechts der Isar, 1. Medizinische Klinik,
Munchen, Germany
Publisher
Georg Thieme Verlag (E-mail: iaorl@iaorl.org)
Abstract
Treatment with granulocyte-colony stimulating factor (G-CSF) mobilises
cells from the bone marrow to the peripheral blood. Previous preclinical
and early clinical trials may suggest that treatment with G-CSF leads to
improved myocardial perfusion and function in acute or chronic ischaemic
heart disease. In the REVIVAL-2 study we found that stem cell mobilisation
by G-CSF does not influence infarct size, left ventricular function and
coronary restenosis in patients with acute myocardial infarction (MI) that
underwent successful percutaneous coronary intervention. The objective of
the present analysis was to assess the impact of G-CSF treatment on
seven-year clinical outcomes from the REVIVAL-2 trial. In the randomized,
double-blind, placebo-controlled REVIVAL-2 study, 114 patients with the
diagnosis of acute myocardial infarction were enrolled five days after
successful reperfusion by percutaneous coronary intervention. Patients
were assigned to receive 10 micro g/kg G-CSF (n=56) or placebo (n=58)
for five days. The primary endpoint for this long-term outcome analysis
was the composite of death, myocardial infarction or stroke seven years
after randomisation. The endpoint occurred in 14.3 % of patients in the
G-CSF group versus 17.2 % assigned to placebo (p=0.67). The combined
incidence of death or myocardial infarction occurred in 14.3 % of the
patients assigned to G-CSF and 15.5 % of the patients assigned to placebo
(p=0.85). In conclusion, these long-term follow-up data show that G-CSF
does not improve clinical outcomes of patients with acute myocardial
infarction. Copyright © Schattauer 2016.

<153>
Accession Number
613230914
Title
Intraoperative goal directed hemodynamic therapy in noncardiac surgery: a
systematic review and meta-analysis.
Source
Brazilian Journal of Anesthesiology. 66 (5) (pp 513-528), 2016. Date of
Publication: 01 Sep 2016.
Author
Ripolles J.; Espinosa A.; Martinez-Hurtado E.; Abad-Gurumeta A.;
Casans-Frances R.; Fernandez-Perez C.; Lopez-Timoneda F.; Calvo-Vecino
J.M.
Institution
(Ripolles, Martinez-Hurtado, Calvo-Vecino) Departamento de Anestesia,
Hospital Universitario Infanta Leonor, Universidad Complutense de Madrid,
Madrid, Spain
(Espinosa) Department of Anesthesia, Blekinge County Council Hospital,
WamoCenter, Karlskrona, Suecia, Sweden
(Abad-Gurumeta) Departamento de Anestesia, Hospital Universitario la Paz,
Madrid, Spain
(Casans-Frances) Departamento de Anestesia, Hospital Universitario Lozano
Blesa, Zaragoza, Spain
(Fernandez-Perez) Departamento de Medicina Preventiva y Salud Publica,
Hospital Clinico San Carlos, Madrid, Spain
(Lopez-Timoneda) Departamento de Anestesia, Hospital Clinico San Carlos,
Universidad Complutense de Madrid, Madrid, Spain
Publisher
Elsevier Editora Ltda
Abstract
Background The goal directed hemodynamic therapy is an approach focused on
the use of cardiac output and related parameters as end-points for fluids
and drugs to optimize tissue perfusion and oxygen delivery. Primary aim:
To determine the effects of intraoperative goal directed hemodynamic
therapy on postoperative complications rates. Methods A meta-analysis was
carried out of the effects of goal directed hemodynamic therapy in adult
noncardiac surgery on postoperative complications and mortality using
Preferred Reporting Items for Systematic Reviews and Meta-Analyses
methodology. A systematic search was performed in Medline PubMed, Embase,
and the Cochrane Library (last update, October 2014). Inclusion criteria
were randomized clinical trials in which intraoperative goal directed
hemodynamic therapy was compared to conventional fluid management in
noncardiac surgery. Exclusion criteria were trauma and pediatric surgery
studies and that using pulmonary artery catheter. End-points were
postoperative complications (primary) and mortality (secondary). Those
studies that fulfilled the entry criteria were examined in full and
subjected to quantifiable analysis, predefined subgroup analysis
(stratified by type of monitor, therapy, and hemodynamic goal), and
predefined sensitivity analysis. Results 51 RCTs were initially
identified, 24 fulfilling the inclusion criteria. 5 randomized clinical
trials were added by manual search, resulting in 29 randomized clinical
trials in the final analysis, including 2654 patients. A significant
reduction in complications for goal directed hemodynamic therapy was
observed (RR: 0.70, 95% CI: 0.62-0.79, p < 0.001). No significant decrease
in mortality was achieved (RR: 0.76, 95% CI: 0.45-1.28, p = 0.30). Quality
sensitive analyses confirmed the main overall results. Conclusions
Intraoperative goal directed hemodynamic therapy with minimally invasive
monitoring decreases postoperative complications in noncardiac surgery,
although it was not able to show a significant decrease in mortality
rate. Copyright © 2015 Sociedade Brasileira de Anestesiologia

<154>
Accession Number
613466701
Title
Optical coherence tomography compared with intravascular ultrasound and
with angiography to guide coronary stent implantation (ILUMIEN III:
OPTIMIZE PCI): a randomised controlled trial.
Source
The Lancet. 388 (10060) (pp 2618-2628), 2016. Date of Publication: 26 Nov
2016.
Author
Ali Z.A.; Maehara A.; Genereux P.; Shlofmitz R.A.; Fabbiocchi F.; Nazif
T.M.; Guagliumi G.; Meraj P.M.; Alfonso F.; Samady H.; Akasaka T.; Carlson
E.B.; Leesar M.A.; Matsumura M.; Ozan M.O.; Mintz G.S.; Ben-Yehuda O.;
Stone G.W.
Institution
(Ali, Maehara, Nazif, Ben-Yehuda, Stone) New York Presbyterian Hospital
and Columbia University, New York, NY, United States
(Ali, Maehara, Genereux, Nazif, Matsumura, Ozan, Mintz, Ben-Yehuda, Stone)
Cardiovascular Research Foundation, New York, NY, United States
(Shlofmitz) St Francis Hospital, Roslyn, New York, NY, United States
(Fabbiocchi) Centro Cardiologico Monzino Istituto di Ricovero e Cura a
Carattere Scientifico, Milan, Italy
(Guagliumi) Ospedale Papa Giovanni XXIII, Bergamo, Italy
(Meraj) Northwell Health, Manhasset, New York, NY, United States
(Alfonso) Hospital Universitario de La Princesa, Madrid, Spain
(Samady) Emory University Hospital, Atlanta, GA, United States
(Akasaka) Wakayama Medical University, Wakayama, Japan
(Carlson) Eastern Cardiology, Greenville, NC, United States
(Leesar) University of Alabama, Birmingham, AB, United States
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background Percutaneous coronary intervention (PCI) is most commonly
guided by angiography alone. Intravascular ultrasound (IVUS) guidance has
been shown to reduce major adverse cardiovascular events (MACE) after PCI,
principally by resulting in a larger postprocedure lumen than with
angiographic guidance. Optical coherence tomography (OCT) provides higher
resolution imaging than does IVUS, although findings from some studies
suggest that it might lead to smaller luminal diameters after stent
implantation. We sought to establish whether or not a novel OCT-based
stent sizing strategy would result in a minimum stent area similar to or
better than that achieved with IVUS guidance and better than that achieved
with angiography guidance alone. Methods In this randomised controlled
trial, we recruited patients aged 18 years or older undergoing PCI from 29
hospitals in eight countries. Eligible patients had one or more target
lesions located in a native coronary artery with a visually estimated
reference vessel diameter of 2.25-3.50 mm and a length of less than 40 mm.
We excluded patients with left main or ostial right coronary artery
stenoses, bypass graft stenoses, chronic total occlusions, planned
two-stent bifurcations, and in-stent restenosis. Participants were
randomly assigned (1:1:1; with use of an interactive web-based system in
block sizes of three, stratified by site) to OCT guidance, IVUS guidance,
or angiography-guided stent implantation. We did OCT-guided PCI using a
specific protocol to establish stent length, diameter, and expansion
according to reference segment external elastic lamina measurements. All
patients underwent final OCT imaging (operators in the IVUS and
angiography groups were masked to the OCT images). The primary efficacy
endpoint was post-PCI minimum stent area, measured by OCT at a masked
independent core laboratory at completion of enrolment, in all randomly
allocated participants who had primary outcome data. The primary safety
endpoint was procedural MACE. We tested non-inferiority of OCT guidance to
IVUS guidance (with a non-inferiority margin of 1.0 mm2),
superiority of OCT guidance to angiography guidance, and superiority of
OCT guidance to IVUS guidance, in a hierarchical manner. This trial is
registered with ClinicalTrials.gov, number NCT02471586. Findings Between
May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158
[35%] to OCT, 146 [32%] to IVUS, and 146 [32%] to angiography), with 415
final OCT acquisitions analysed for the primary endpoint (140 [34%] in the
OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography
group). The final median minimum stent area was 5.79 mm2 (IQR
4.54-7.34) with OCT guidance, 5.89 mm2 (4.67-7.80) with IVUS
guidance, and 5.49 mm2 (4.39-6.59) with angiography guidance.
OCT guidance was non-inferior to IVUS guidance (one-sided 97.5% lower CI
-0.70 mm2; p=0.001), but not superior (p=0.42). OCT guidance
was also not superior to angiography guidance (p=0.12). We noted
procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of
146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT
vs IVUS p=0.37; OCT vs angiography p=0.37). Interpretation OCT-guided PCI
using a specific reference segment external elastic lamina-based stent
optimisation strategy was safe and resulted in similar minimum stent area
to that of IVUS-guided PCI. These data warrant a large-scale randomised
trial to establish whether or not OCT guidance results in superior
clinical outcomes to angiography guidance. Funding St Jude
Medical. Copyright © 2016 Elsevier Ltd

<155>
Accession Number
610061249
Title
Hypertension Canada's 2016 Canadian Hypertension Education Program
Guidelines for Blood Pressure Measurement, Diagnosis, Assessment of Risk,
Prevention, and Treatment of Hypertension.
Source
Canadian Journal of Cardiology. 32 (5) (pp 569-588), 2016. Date of
Publication: 01 May 2016.
Author
Leung A.A.; Nerenberg K.; Daskalopoulou S.S.; McBrien K.; Zarnke K.B.;
Dasgupta K.; Cloutier L.; Gelfer M.; Lamarre-Cliche M.; Milot A.; Bolli
P.; Tremblay G.; McLean D.; Tobe S.W.; Ruzicka M.; Burns K.D.; Vallee M.;
Prasad G.V.R.; Lebel M.; Feldman R.D.; Selby P.; Pipe A.; Schiffrin E.L.;
McFarlane P.A.; Oh P.; Hegele R.A.; Khara M.; Wilson T.W.; Penner S.B.;
Burgess E.; Herman R.J.; Bacon S.L.; Rabkin S.W.; Gilbert R.E.; Campbell
T.S.; Grover S.; Honos G.; Lindsay P.; Hill M.D.; Coutts S.B.; Gubitz G.;
Campbell N.R.C.; Moe G.W.; Howlett J.G.; Boulanger J.-M.; Prebtani A.;
Larochelle P.; Leiter L.A.; Jones C.; Ogilvie R.I.; Woo V.; Kaczorowski
J.; Trudeau L.; Petrella R.J.; Hiremath S.; Drouin D.; Lavoie K.L.; Hamet
P.; Fodor G.; Gregoire J.C.; Lewanczuk R.; Dresser G.K.; Sharma M.; Reid
D.; Lear S.A.; Moullec G.; Gupta M.; Magee L.A.; Logan A.G.; Harris K.C.;
Dionne J.; Fournier A.; Benoit G.; Feber J.; Poirier L.; Padwal R.S.; Rabi
D.M.
Institution
(Leung) Division of Endocrinology and Metabolism, Department of Medicine,
University of Calgary, Calgary, AB, Canada
(Nerenberg) Department of Medicine and Department of Obstetrics and
Gynecology, University of Calgary, Calgary, AB, Canada
(Daskalopoulou, Dasgupta) Divisions of General Internal Medicine, Clinical
Epidemiology and Endocrinology, Department of Medicine, McGill University,
McGill University Health Centre, Montreal, QC, Canada
(McBrien) Departments of Family Medicine and Community Health Sciences,
Institute for Public Health, Cumming School of Medicine, University of
Calgary, Calgary, AB, Canada
(Zarnke, Herman) Division of General Internal Medicine, University of
Calgary, Calgary, AB, Canada
(Cloutier) Universite du Quebec a Trois-Rivieres, Trois-Rivieres, Quebec,
Canada
(Gelfer) Department of Family Medicine, University of British Columbia,
Copeman Healthcare Centre, Vancouver, BC, Canada
(Lamarre-Cliche, Larochelle) Institut de Recherches Cliniques de Montreal,
Universite de Montreal, Montreal, QC, Canada
(Milot, Lebel) Department of Medicine, Universite Laval, Quebec, QC,
Canada
(Bolli) Ambulatory Internal Medicine Teaching Clinic, St Catharines, ON,
Canada
(Tremblay) CHU-Quebec-Hopital St Sacrement, Quebec, QC, Canada
(McLean, Lewanczuk) University of Alberta, Edmonton, AB, Canada
(Tobe, Prasad, Gupta, Logan) University of Toronto, Toronto, ON, Canada
(Ruzicka, Burns) Division of Nephrology, Department of Medicine, Ottawa
Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada
(Vallee) Hopital Maisonneuve-Rosemont, Universite de Montreal, Montreal,
QC, Canada
(Feldman) Discipline of Medicine, Memorial University of Newfoundland, St
John's, NL, Canada
(Selby) Centre for Addiction and Mental Health, University of Toronto,
Toronto, ON, Canada
(Pipe) University of Ottawa Heart Institute, Ottawa, ON, Canada
(Schiffrin) Department of Medicine and Lady Davis Institute for Medical
Research, Jewish General Hospital, McGill University, Montreal, QC, Canada
(McFarlane) Division of Nephrology, St Michael's Hospital, University of
Toronto, Toronto, ON, Canada
(Oh) University Health Network, University of Toronto, Toronto, ON, Canada
(Hegele) Departments of Medicine (Division of Endocrinology) and
Biochemistry, Western University, London, ON, Canada
(Khara) Vancouver Coastal Health Addiction Services, Faculty of Medicine,
University of British Columbia, Vancouver, BC, Canada
(Wilson) Department of Medicine, University of Saskatchewan, Saskatoon,
SK, Canada
(Penner) Department of Internal Medicine, University of Manitoba,
Winnipeg, MB, Canada
(Burgess) Department of Medicine, University of Calgary, Calgary, AB,
Canada
(Bacon) Department of Exercise Science, Concordia University, and Montreal
Behavioural Medicine Centre, Hopital du Sacre-Coeur de Montreal, Montreal,
QC, Canada
(Rabkin) Vancouver Hospital, University of British Columbia, Vancouver,
BC, Canada
(Gilbert) Division of Endocrinology, St Michael's Hospital, University of
Toronto, Toronto, ON, Canada
(Campbell) Department of Psychology, University of Calgary, Calgary, AB,
Canada
(Grover) Division of Clinical Epidemiology, Montreal General Hospital,
Montreal, QC, Canada
(Honos) University of Montreal, Montreal, QC, Canada
(Lindsay) Best Practices and Performance, Heart and Stroke Foundation,
Toronto, ON, Canada
(Hill) Department of Clinical Neurosciences, Hotchkiss Brain Institute,
University of Calgary, Calgary, AB, Canada
(Coutts) Departments of Clinical Neurosciences and Radiology, Hotchkiss
Brain Institute, University of Calgary, Calgary, AB, Canada
(Gubitz) Division of Neurology, Halifax Infirmary, Dalhousie University,
Halifax, NS, Canada
(Campbell) Medicine, Community Health Sciences, Physiology and
Pharmacology, Libin Cardiovascular Institute of Alberta, University of
Calgary, Calgary, AB, Canada
(Moe) St Michael's Hospital, University of Toronto, Toronto, ON, Canada
(Howlett) Departments of Medicine and Cardiac Sciences, University of
Calgary, Calgary, AB, Canada
(Boulanger) Charles LeMoyne Hospital Research Centre, Sherbrooke
University, Sherbrooke, QC, Canada
(Prebtani, Gupta) McMaster University, Hamilton, ON, Canada
(Leiter) Keenan Research Centre in the Li Ka Shing Knowledge Institute of
St Michael's Hospital, And University of Toronto, Toronto, ON, Canada
(Jones) University of British Columbia, Vancouver, BC, Canada
(Ogilvie) University Health Network, Departments of Medicine and
Pharmacology, University of Toronto, Toronto, ON, Canada
(Woo) University of Manitoba, Winnipeg, MB, Canada
(Kaczorowski) Universite de Montreal and CHUM, Montreal, QC, Canada
(Trudeau) Division of Internal Medicine, McGill University, Montreal, QC,
Canada
(Petrella) Department of Family Medicine, Western University, London, ON,
Canada
(Hiremath) Faculty of Medicine, University of Ottawa, Ottawa Hospital
Research Institute, Ottawa, ON, Canada
(Drouin) Faculty of Medicine, Universite Laval, Quebec, QC, Canada
(Lavoie) Department of Psychology, University of Quebec at Montreal
(UQAM), Montreal, QC, Canada
(Hamet) Faculte de Medicine, Universite de Montreal, Montreal, QC, Canada
(Fodor) University of Ottawa Heart Institute, Ottawa, ON, Canada
(Gregoire) Universite de Montreal, Institut de cardiologie de Montreal,
Montreal, QC, Canada
(Dresser) Schulich School of Medicine and Dentistry, Western University,
London, ON, Canada
(Sharma) The Canadian Stroke Network, Ottawa, ON, Canada
(Reid) Canadian Forces Health Services, Department of National Defence and
Dietitians of Canada, Ottawa, ON, Canada
(Lear) Faculty of Health Sciences, Simon Fraser University, Vancouver, BC,
Canada
(Moullec) Research Center, Hopital du Sacre-Coeur de Montreal, Public
Health School, University of Montreal, Montreal, QC, Canada
(Magee) St George's, University of London, London, United Kingdom
(Harris, Dionne) Department of Pediatrics, University of British Columbia,
Vancouver, BC, Canada
(Fournier) Service de cardiologie, Centre Hospitalier Universitaire
Sainte-Justine, Universite de Montreal, Montreal, QC, Canada
(Benoit) Service de nephrologie, Centre Hospitalier Universitaire
Sainte-Justine, Universite de Montreal, Montreal, QC, Canada
(Feber) Division of Neurology, Department of Pediatrics, Children's
Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada
(Poirier) Centre Hospitalier Universitaire de Quebec et Faculte de
Pharmacie, Universite Laval, Quebec, QC, Canada
(Padwal) Department of Medicine, University of Alberta, Edmonton, AB,
Canada
(Rabi) Departments of Medicine, Community Health and Cardiac Sciences,
University of Calgary, Calgary, AB, Canada
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Hypertension Canada's Canadian Hypertension Education Program Guidelines
Task Force provides annually updated, evidence-based recommendations to
guide the diagnosis, assessment, prevention, and treatment of
hypertension. This year, we present 4 new recommendations, as well as
revisions to 2 previous recommendations. In the diagnosis and assessment
of hypertension, automated office blood pressure, taken without
patient-health provider interaction, is now recommended as the preferred
method of measuring in-office blood pressure. Also, although a serum lipid
panel remains part of the routine laboratory testing for patients with
hypertension, fasting and nonfasting collections are now considered
acceptable. For individuals with secondary hypertension arising from
primary hyperaldosteronism, adrenal vein sampling is recommended for those
who are candidates for potential adrenalectomy. With respect to the
treatment of hypertension, a new recommendation that has been added is for
increasing dietary potassium to reduce blood pressure in those who are not
at high risk for hyperkalemia. Furthermore, in selected high-risk
patients, intensive blood pressure reduction to a target systolic blood
pressure <= 120 mm Hg should be considered to decrease the risk of
cardiovascular events. Finally, in hypertensive individuals with
uncomplicated, stable angina pectoris, either a beta-blocker or calcium
channel blocker may be considered for initial therapy. The specific
evidence and rationale underlying each of these recommendations are
discussed. Hypertension Canada's Canadian Hypertension Education Program
Guidelines Task Force will continue to provide annual
updates. Copyright © 2016 Canadian Cardiovascular Society.

<156>
Accession Number
611440464
Title
Effect of diastolic dysfunction on postoperative outcomes after
cardiovascular surgery: A systematic review and meta-analysis.
Source
Journal of Thoracic and Cardiovascular Surgery. 152 (4) (pp 1142-1153),
2016. Date of Publication: 01 Oct 2016.
Author
Kaw R.; Hernandez A.V.; Pasupuleti V.; Deshpande A.; Nagarajan V.; Bueno
H.; Coleman C.I.; Ioannidis J.P.A.; Bhatt D.L.; Blackstone E.H.
Institution
(Kaw) Department of Hospital Medicine, Medicine Institute, Cleveland
Clinic, Cleveland, Ohio, United States
(Kaw) Department of Outcomes Research, Anesthesiology Institute, Cleveland
Clinic, Cleveland, Ohio, United States
(Hernandez) Health Outcomes and Clinical Epidemiology Section, Department
of Quantitative Health Sciences, Lerner Research Institute, Cleveland
Clinic, Cleveland, Ohio, United States
(Deshpande) Medicine Institute Center for Value Based Care Research,
Cleveland Clinic, Cleveland, Ohio, United States
(Blackstone) Department of Thoracic and Cardiovascular Surgery, Cleveland
Clinic, Cleveland, Ohio, United States
(Hernandez) School of Medicine, Universidad Peruana de Ciencias Aplicadas
(UPC), Lima, Peru
(Pasupuleti) Department of Medicine, Case Western Reserve University,
Cleveland, Ohio, United States
(Nagarajan) Department of Cardiovascular Medicine, University of Virginia,
Charlottesville, Va, United States
(Bueno) Centro Nacional de Investigaciones Cardiovasculares (CNIC),
Madrid, Spain
(Bueno) Department of Cardiology, Hospital Universitario 12 de Octubre,
Madrid, Spain
(Bueno) University of Connecticut School of Pharmacy, Storrs, Conn, United
States
(Coleman) Universidad Complutense de Madrid, Madrid, Spain
(Ioannidis) Department of Medicine, Stanford Prevention Research Center,
Stanford University School of Medicine, Stanford, Calif, United States
(Bhatt) Brigham and Women's Hospital Heart & Vascular Center and Harvard
Medical School, Boston, Mass, United States
Publisher
Mosby Inc. (E-mail: customerservice@mosby.com)
Abstract
Objective The objective of this study was to investigate the effect of
preoperative diastolic dysfunction on postoperative mortality and
morbidity after cardiovascular surgery. Methods We systematically searched
for articles that assessed the prognostic role of diastolic dysfunction on
cardiovascular surgery in PubMed, Cochrane Library, Web of Science,
Embase, and Scopus until February 2016. Twelve studies (n = 8224) met our
inclusion criteria. Because of the scarcity of outcome events,
fixed-effects meta-analysis was performed via the Mantel-Haenszel method.
Results Preoperative diagnosis of diastolic dysfunction was associated
with greater postoperative mortality (odds ratio [OR], 2.41; 95%
confidence interval [CI], 1.54-3.71; P < .0001), major adverse cardiac
events (OR, 2.07; 95% CI, 1.55-2.78; P <= .0001), and prolonged mechanical
ventilation (OR, 2.08; 95% CI, 1.04-4.16; P = .04) compared with patients
without diastolic dysfunction among patients who underwent cardiovascular
surgery. The odds of postoperative myocardial infarction (OR, 1.29; 95%
CI, 0.82-2.05; P = .28) and atrial fibrillation (OR, 2.67; 95% CI,
0.49-14.43; P = .25) did not significantly differ between the 2 groups.
Severity of preoperative diastolic dysfunction was associated with
increased postoperative mortality (OR, 21.22; 95% CI, 3.74-120.33; P =
.0006) for Grade 3 diastolic dysfunction compared with patients with
normal diastolic function. Inclusion of left ventricular ejection fraction
(LVEF) <40% accompanying diastolic dysfunction did not further impact
postoperative mortality (P = .27; I2 = 18%) compared with
patients with normal LVEF and diastolic dysfunction. Conclusions Presence
of preoperative diastolic dysfunction was associated with greater
postoperative mortality and major adverse cardiac events, regardless of
LVEF. Mortality was significantly greater in grade III diastolic
dysfunction. Copyright © 2016 The American Association for
Thoracic Surgery

<157>
Accession Number
611114101
Title
Impact of paravalvular aortic regurgitation after transcatheter aortic
valve implantation on survival.
Source
International Journal of Cardiology. 221 (pp 46-51), 2016. Date of
Publication: 15 Oct 2016.
Author
Takagi H.; Umemoto T.
Institution
(Takagi, Umemoto) Department of Cardiovascular Surgery, Shizuoka Medical
Center, Shizuoka, Japan
Publisher
Elsevier Ireland Ltd
Abstract
Objectives To determine whether >= moderate paravalvular aortic
regurgitation (PAR) after transcatheter aortic valve implantation (TAVI)
independently impairs overall survival and how much the impact on survival
is, we performed an updated meta-analysis pooling not unadjusted but
adjusted hazard ratios (HRs). Methods Databases including MEDLINE and
EMBASE were searched through January 2016 using PubMed and OVID. Search
terms included paravalvular or perivalvular; regurgitation, leak, or
leakage; percutaneous, transcatheter, transluminal, transarterial,
transapical, transaortic, transcarotid, transaxillary, transsubclavian,
transiliac, transfemoral, or transiliofemoral; and aortic valve. Studies
considered for inclusion met the following criteria: the design was an
observational comparative study; the study population was patients
undergoing TAVI; patients were divided into >= moderate and <= mild
post-TAVI PAR; outcomes included >= 1-year all-cause mortality; and the
adjustment method was a multivariate Cox proportional hazards analysis. An
adjusted HR with its 95% confidence interval (CI) for >= moderate
post-TAVI PAR was abstracted from each individual study. Results Our
search identified 17 eligible studies including a total of 15,131
patients. A pooled analysis of all the 17 studies demonstrated a
statistically significant 2.12-fold increase in mortality with >= moderate
PAR (HR, 2.12; 95% CI, 1.79 to 2.51; p < 0.00001). Exclusion of any single
study from the meta-analysis did not substantively alter the overall
result disfavoring >= moderate PAR. Although the statistical tests
suggested funnel plot asymmetry, the corrected effect estimate from the
trim-and-fill method demonstrated still a statistically significant
1.83-fold risk of mortality with >= moderate PAR. Conclusions >= Moderate
post-TAVI PAR is associated with a 2.12-fold increase in overall (>=
1-year) all-cause mortality. Copyright © 2016 Elsevier Ireland
Ltd

<158>
Accession Number
608518396
Title
Genetic basis of familial dilated cardiomyopathy patients undergoing heart
transplantation.
Source
Journal of Heart and Lung Transplantation. 35 (5) (pp 625-635), 2016. Date
of Publication: 01 May 2016.
Author
Cuenca S.; Ruiz-Cano M.J.; Gimeno-Blanes J.R.; Jurado A.; Salas C.;
Gomez-Diaz I.; Padron-Barthe L.; Grillo J.J.; Vilches C.; Segovia J.;
Pascual-Figal D.; Lara-Pezzi E.; Monserrat L.; Alonso-Pulpon L.;
Garcia-Pavia P.
Institution
(Cuenca, Segovia, Alonso-Pulpon, Garcia-Pavia) Heart Failure and Inherited
Cardiac Diseases Unit, Department of Cardiology, Hospital Universitario
Puerta de Hierro, Manuel de Falla 2, Majadahonda, Madrid 28222, Spain
(Ruiz-Cano, Jurado) Heart Failure and Heart Transplantation Unit,
Department of Cardiology, Hospital Universitario 12 de Octubre, Madrid,
Spain
(Gimeno-Blanes, Pascual-Figal) Department of Cardiology, Hospital
Universitario Virgen de la Arrixaca, Murcia, Spain
(Salas) Department of Pathology, Hospital Universitario Puerta de Hierro,
Madrid, Spain
(Gomez-Diaz, Monserrat) Health in Code, A Coruna, Spain
(Padron-Barthe, Lara-Pezzi, Garcia-Pavia) Myocardial Biology Programme,
Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain
(Grillo) Department of Cardiology, Hospital Universitario Nuestra Senora
de Candelaria, Tenerife, Spain
(Vilches) Department of Immunology, Hospital Universitario Puerta de
Hierro, Madrid, Spain
Publisher
Elsevier USA
Abstract
Background Dilated cardiomyopathy (DCM) is the most frequent cause of
heart transplantation (HTx). The genetic basis of DCM among patients
undergoing HTx has been poorly characterized. We sought to determine the
genetic basis of familial DCM HTx and to establish the yield of modern
next generation sequencing (NGS) technologies in this setting. Methods
Fifty-two heart-transplanted patients due to familial DCM underwent NGS
genetic evaluation with a panel of 126 genes related to cardiac conditions
(59 associated with DCM). Genetic variants were initially classified as
pathogenic mutations or as variants of uncertain significance (VUS). Final
pathogenicity status was determined by familial cosegregation studies.
Results Initially, 24 pathogenic mutations were found in 21 patients
(40%); 25 patients (48%) carried 19 VUS and 6 (12%) did not show any
genetic variant. Familial evaluation of 220 relatives from 36 of the 46
families with genetic variants confirmed pathogenicity in 14 patients and
allowed reclassification of VUS as pathogenic in 17 patients, and as
non-pathogenic in 3 cases. At the end of the study, the DCM-causing
mutation was identified in 38 patients (73%) and 5 patients (10%) harbored
only VUS. No genetic variants were identified in 9 cases (17%).
Conclusions The genetic spectrum of familial DCM patients undergoing HTx
is heterogeneous and involves multiple genes. NGS technology plus detailed
familial studies allow identification of causative mutations in the vast
majority of familial DCM cases. Detailed familial studies remain critical
to determine the pathogenicity of underlying genetic defects in a
substantial number of cases. Copyright © 2016 International
Society for Heart and Lung Transplantation.

<159>
Accession Number
609153400
Title
Invasive versus conservative strategy in patients aged 80 years or older
with non-ST-elevation myocardial infarction or unstable angina pectoris
(After Eighty study): An open-label randomised controlled trial.
Source
The Lancet. 387 (10023) (pp 1057-1065), 2016. Date of Publication: 12 Mar
2016.
Author
Tegn N.; Abdelnoor M.; Aaberge L.; Endresen K.; Smith P.; Aakhus S.;
Gjertsen E.; Dahl-Hofseth O.; Ranhoff A.H.; Gullestad L.; Bendz B.
Institution
(Tegn, Aaberge, Endresen, Aakhus, Gullestad, Bendz) Department of
Cardiology, Oslo University Hospital, Rikshospitalet, Oslo 0424, Norway
(Abdelnoor) Centre for Biostatistics and Epidemiology, Oslo University
Hospital, Oslo, Norway
(Abdelnoor) Centre for Clinical Heart Research, Oslo University Hospital,
Oslo, Norway
(Tegn, Smith, Gullestad, Bendz) Faculty of Medicine, University of Oslo,
Oslo, Norway
(Smith) Department of Cardiology, Akershus University Hospital, Lorenskog,
Norway
(Gjertsen) Department of Cardiology, Drammen Hospital, Drammen, Norway
(Dahl-Hofseth) Department of Cardiology, Lillehammer Hospital,
Lillehammer, Norway
(Ranhoff) Diakonhjemmet Hospital, Department of Clinical Science,
University of Bergen, Bergen, Norway
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background Non-ST-elevation myocardial infarction (NSTEMI) and unstable
angina pectoris are frequent causes of hospital admission in the elderly.
However, clinical trials targeting this population are scarce, and these
patients are less likely to receive treatment according to guidelines. We
aimed to investigate whether this population would benefit from an early
invasive strategy versus a conservative strategy. Methods In this
open-label randomised controlled multicentre trial, patients aged 80 years
or older with NSTEMI or unstable angina admitted to 16 hospitals in the
South-East Health Region of Norway were randomly assigned to an invasive
strategy (including early coronary angiography with immediate assessment
for percutaneous coronary intervention, coronary artery bypass graft, and
optimum medical treatment) or to a conservative strategy (optimum medical
treatment alone). A permuted block randomisation was generated by the
Centre for Biostatistics and Epidemiology with stratification on the
inclusion hospitals in opaque concealed envelopes, and sealed envelopes
with consecutive inclusion numbers were made. The primary outcome was a
composite of myocardial infarction, need for urgent revascularisation,
stroke, and death and was assessed between Dec 10, 2010, and Nov 18, 2014.
An intention-to-treat analysis was used. This study is registered with
ClinicalTrials.gov, number NCT01255540. Findings During a median follow-up
of 1.53 years of participants recruited between Dec 10, 2010, and Feb 21,
2014, the primary outcome occurred in 93 (40.6%) of 229 patients assigned
to the invasive group and 140 (61.4%) of 228 patients assigned to the
conservative group (hazard ratio [HR] 0.53 [95% CI 0.41-0.69], p=0.0001).
Five patients dropped out of the invasive group and one from the
conservative group. HRs for the four components of the primary composite
endpoint were 0.52 (0.35-0.76; p=0.0010) for myocardial infarction, 0.19
(0.07-0.52; p=0.0010) for the need for urgent revascularisation, 0.60
(0.25-1.46; p=0.2650) for stroke, and 0.89 (0.62-1.28; p=0.5340) for death
from any cause. The invasive group had four (1.7%) major and 23 (10.0%)
minor bleeding complications whereas the conservative group had four
(1.8%) major and 16 (7.0%) minor bleeding complications. Interpretation In
patients aged 80 years or more with NSTEMI or unstable angina, an invasive
strategy is superior to a conservative strategy in the reduction of
composite events. Efficacy of the invasive strategy was diluted with
increasing age (after adjustment for creatinine and effect modification).
The two strategies did not differ in terms of bleeding complications.
Funding Norwegian Health Association (ExtraStiftelsen) and Inger and John
Fredriksen Heart Foundation. Copyright © 2016 Elsevier Ltd.

<160>
Accession Number
609036692
Title
Measurement of Exercise Tolerance before Surgery (METS) study: A protocol
for an international multicentre prospective cohort study of
cardiopulmonary exercise testing prior to major non-cardiac surgery.
Source
BMJ Open. 6 (3) (no pagination), 2016. Article Number: e010359. Date of
Publication: 2016.
Author
Wijeysundera D.N.; Pearse R.M.; Shulman M.A.; Abbott T.E.F.; Torres E.;
Croal B.L.; Granton J.T.; Thorpe K.E.; Grocott M.P.W.; Farrington C.;
Myles P.S.; Cuthbertson B.H.; Wallace S.; Thompson B.; Ellis M.; Borg B.;
Kerridge R.; Douglas J.; Brannan J.; Pretto J.; Godsall M.G.; Beauchamp
N.; Allen S.; Kennedy A.; Wright E.; Malherbe J.; Ismail H.; Riedel B.;
Melville A.; Sivakumar H.; Murmane A.; Kenchington K.; Gurunathan U.;
Stonell C.; Brunello K.; Steele K.; Tronstand O.; Masel P.; Dent A.; Smith
E.; Bodger A.; Abolfathi M.; Sivalingam P.; Hall A.; Painter T.; Elliott
A.; Carrera A.M.; Terblanche N.C.S.; Pitt S.; Samuels J.; Wilde C.;
MacCormick M.; Leslie K.; Bramley D.; Southcott A.M.; Grant J.; Taylor H.;
Bates S.; Towns M.; Tippett A.; Marshall F.; Mazer C.D.; Kunasingam J.;
Yagnik A.; Crescini C.; McCartney C.J.L.; Choi S.; Somascanthan P.; Flores
K.; Beattie W.S.; Karkouti K.; Clarke H.A.; Jerath A.; McCluskey S.A.;
Wasowicz M.; Day L.; Pazmino-Canizares J.; Oh P.; Belliard R.; Lee L.;
Dobson K.; Chan V.; Brull R.; Ami N.; Stanbrook M.; Kagen K.; Campbell D.;
Short T.; Van Der Westhuizen J.; Higgie K.; Lindsay H.; Jang R.; Wong C.;
McAllister D.; Ali M.; Kumar J.; Waymouth E.; Dimech J.; Lorimer M.; Sara
R.; Collingwood A.; Olliff S.; Gabriel S.; Houston H.; Dalley P.; Hurford
S.; Hunt A.; Andrews L.; Navarra L.; Jason-Smith A.; Lum M.; Martin D.;
James S.; Phull M.; Beilstein C.; Bodger P.; Everingham K.; Hu Y.;
Niebrzegowska E.; Corriea C.; Creary T.; Januszekska M.; Ahmad T.; Whalley
J.; Haslop R.; McNeil J.; Brown A.; MacDonald N.; Jhani S.; Raobaikady R.;
Black E.; Rooms M.; Lawrence H.; Jack S.; Celinski M.; Levett D.; Edwards
M.; Salmon K.; Bolger C.; Loughney L.; Seaward L.; Collins H.; Tyrell B.;
Tantony N.; Golder K.; Ackland G.; Stephens R.C.M.; Gagello-Paredes L.;
Raj A.; Lifford R.; Melo M.; Mamdani M.; Hillis G.; Wijeysundera H.C.
Institution
(Wijeysundera) St. Michael's Hospital, Toronto General Hospital,
University of Toronto, Toronto, ON, Canada
(Pearse, Abbott) Queen Mary University of London, London, United Kingdom
(Shulman, Farrington, Myles) Alfred Hospital, Monash University,
Melbourne, VIC, Australia
(Torres) St. Michael's Hospital, Toronto, ON, Canada
(Croal) NHS Grampian, Aberdeen, United Kingdom
(Granton) University Health Network, Mount Sinai Hospital, University of
Toronto, Toronto, ON, Canada
(Thorpe) University of Toronto, St. Michael's Hospital, Toronto, ON,
Canada
(Grocott) University Hospital Southampton, University of Southampton,
Southampton, United Kingdom
(Cuthbertson) Sunnybrook Health Sciences Centre, University of Toronto,
Toronto, ON, Canada
Publisher
BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com)
Abstract
Introduction: Preoperative functional capacity is considered an important
risk factor for cardiovascular and other complications of major
non-cardiac surgery. Nonetheless, the usual approach for estimating
preoperative functional capacity, namely doctors' subjective assessment,
may not accurately predict postoperative morbidity or mortality. 3
possible alternatives are cardiopulmonary exercise testing; the Duke
Activity Status Index, a standardised questionnaire for estimating
functional capacity; and the serum concentration of N-terminal pro-B-type
natriuretic peptide (NT pro-BNP), a biomarker for heart failure and
cardiac ischaemia. Methods and analysis: The Measurement of Exercise
Tolerance before Surgery (METS) Study is a multicentre prospective cohort
study of patients undergoing major elective non-cardiac surgery at 25
participating study sites in Australia, Canada, New Zealand and the UK. We
aim to recruit 1723 participants. Prior to surgery, participants undergo
symptom-limited cardiopulmonary exercise testing on a cycle ergometer,
complete the Duke Activity Status Index questionnaire, undergo blood
sampling to measure serum NT pro-BNP concentration and have their
functional capacity subjectively assessed by their responsible doctors.
Participants are followed for 1 year after surgery to assess vital status,
postoperative complications and general health utilities. The primary
outcome is all-cause death or non-fatal myocardial infarction within 30
days after surgery, and the secondary outcome is all-cause death within 1
year after surgery. Both receiver-operating-characteristic curve methods
and risk reclassification table methods will be used to compare the
prognostic accuracy of preoperative subjective assessment, peak oxygen
consumption during cardiopulmonary exercise testing, Duke Activity Status
Index scores and serum NT pro- BNP concentration. Ethics and
dissemination: The METS Study has received research ethics board approval
at all sites. Participant recruitment began in March 2013, and 1- year
follow-up is expected to finish in 2016. Publication of the results of the
METS Study is anticipated to occur in 2017.

<161>
Accession Number
607165841
Title
Should Antihypertensive Treatment Recommendations Differ in Patients with
and Without Coronary Heart Disease? (from the Antihypertensive and
Lipid-Lowering Treatment to Prevent Heart Attack Trial [ALLHAT]).
Source
American Journal of Cardiology. 117 (1) (pp 105-115), 2016. Date of
Publication: 01 Jan 2016.
Author
Alderman M.H.; Davis B.R.; Piller L.B.; Ford C.E.; Baraniuk M.S.; Pressel
S.L.; Assadi M.A.; Einhorn P.T.; Haywood L.J.; Ilamathi E.; Oparil S.;
Retta T.M.
Institution
(Alderman) Department of Epidemiology and Population Health, Albert
Einstein College of Medicine, Bronx, NY, United States
(Davis, Piller, Ford, Baraniuk, Pressel) University of Texas School of
Public Health, Coordinating Center for Clinical Trials, Houston, TX,
United States
(Assadi) State University of New York, Health Sciences Center at Brooklyn,
Brooklyn, NY, United States
(Einhorn) Division of Prevention and Population Sciences, National Heart,
Lung, and Blood Institute, Bethesda, MD, United States
(Haywood) LAC + USC Medical Center, Keck School of Medicine, Los Angeles,
CA, United States
(Ilamathi) Suffolk Nephrology Consultants, Stony Brook, NY, United States
(Oparil) Department of Medicine and Physiology and Biophysics, University
of Alabama at Birmingham, Birmingham, AL, United States
(Retta) Department of Medicine, Howard University College of Medicine,
Washington, DC, United States
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Thiazide-type diuretics have been recommended for initial treatment of
hypertension in most patients, but should this recommendation differ for
patients with and without coronary heart disease (CHD)? The
Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack
Trial (ALLHAT) was a randomized, double-blind hypertension treatment trial
in 42,418 participants with high risk of combined cardiovascular disease
(CVD) (25% with preexisting CHD). This post hoc analysis compares
long-term major clinical outcomes in those assigned amlodipine (n = 9048)
or lisinopril (n = 9,054) with those assigned chlorthalidone (n = 15,255),
stratified by CHD status. After 4 to 8 years, randomized treatment was
discontinued. Total follow-up (active treatment + passive surveillance
using national databases for deaths and hospitalizations) was 8 to 13
years. For most CVD outcomes, end-stage renal disease, and total
mortality, there were no differences across randomized treatment arms
regardless of baseline CHD status. In-trial rates of CVD were
significantly higher for lisinopril compared with chlorthalidone, and
rates of heart failure were significantly higher for amlodipine compared
with chlorthalidone in those with and without CHD (overall hazard ratios
[HRs] 1.10, p <0.001, and 1.38, p <0.001, respectively). During extended
follow-up, significant outcomes according to CHD status interactions (p =
0.012) were noted in amlodipine versus chlorthalidone comparison for CVD
and CHD mortality (HR 0.88, p = 0.04, and 0.84, p = 0.04, respectively) in
those with CHD at baseline (HR 1.06, p = 0.15, and 1.08, p = 0.17) and in
those without. The results of the overall increased stroke mortality in
lisinopril compared with chlorthalidone (HR 1.2; p = 0.03) and
hospitalized heart failure in amlodipine compared with chlorthalidone (HR
1.12; p = 0.01) during extended follow-up did not differ by baseline CHD
status. In conclusion, these results provide no reason to alter our
previous recommendation to include a properly dosed diuretic (such as
chlorthalidone 12.5 to 25 mg/day) in the initial antihypertensive regimen
for most hypertensive patients. Copyright © 2016 Elsevier Inc.

<162>
Accession Number
609203018
Title
Predicting reinterventions after open and endovascular aneurysm repair
using the St George's Vascular Institute score.
Source
Journal of Vascular Surgery. 63 (6) (pp 1428-1433.e1), 2016. Date of
Publication: 01 Jun 2016.
Author
Karthikesalingam A.; Holt P.J.; Thompson M.M.; Bak A.A.A.; Pattynama P.M.;
Van Voorthuisen A.E.; Grobbee D.E.; Hunink M.G.; Van Engelshoven J.M.;
Jacobs M.J.H.M.; De Mol B.A.J.M.; Van Bockel J.H.; Reekers J.; Tielbeek
X.; Boekema N.; Heuveling L.M.; Sikking I.; Cuypers P.W.M.; De Bruin J.L.;
Baas A.F.; Prinssen M.; Buth J.; Tielbeek A.V.; Blankensteijn J.D.; Balm
R.; Reekers J.A.; Van Sambeek M.R.H.M.; Pattynama P.; Verhoeven E.L.G.;
Prins T.; Van Der Ham A.C.; Van Der Velden J.J.I.M.; Van Sterkenburg
S.M.M.; Ten Haken G.B.; Bruijninckx C.M.A.; Van Overhagen H.; Tutein
Nolthenius R.P.; Hendriksz T.R.; Teijink J.A.W.; Odink H.F.; De Smet
A.A.E.A.; Vroegindeweij D.; Van Loenhout R.M.M.; Rutten M.J.; Hamming
J.F.; Lampmann L.E.H.; Bender M.H.M.; Pasmans H.; Vahl A.C.; De Vries C.;
MacKaay A.J.C.; Van Dortmont L.M.C.; Van Der Vliet A.J.; Schultze Kool
L.J.; Boomsma J.H.B.; Van H.R.; De Mol Van Otterloo J.C.A.; De Rooij
T.P.W.; Smits T.M.; Yilmaz E.N.; Wisselink W.; Van Den Berg F.G.; Visser
M.J.T.; Van Der Linden E.; Schurink G.W.H.; De Haan M.; Smeets H.J.;
Stabel P.; Van Elst F.; Poniewierski J.; Vermassen F.E.G.
Institution
(De Bruin, Blankensteijn) Division of Vascular Surgery, Department of
Surgery, VU University Medical Center, Amsterdam, Netherlands
(De Bruin, Karthikesalingam, Holt, Thompson) Division of Vascular Surgery,
St George's Vascular Institute, St George's Healthcare NHS Trust, St James
Wing, Blackshaw Rd, London SW17 0QT, United Kingdom
(Prinssen) Julius Center for Health Sciences and Primary Care, University
Medical Center Utrecht, Utrecht, Netherlands
Publisher
Mosby Inc. (E-mail: customerservice@mosby.com)
Abstract
Background Identifying patients at risk for aneurysm rupture and sac
expansion after open and endovascular abdominal aortic aneurysm (AAA)
repair (EVAR) may help to attenuate this risk by intensifying follow-up
and early detection of problems. The goal of this study was to validate
the St George's Vascular Institute (SGVI) score to identify patients at
risk for a secondary intervention after elective aneurysm repair. Methods
A post hoc on-treatment analysis of a randomized trial comparing open AAA
repair and EVAR was performed. In this multicenter trial, 351 patients
were randomly assigned to undergo open AAA repair or EVAR. Information on
survival and reinterventions was available for all patients at 5 years
postoperatively, for 79% at 6 years, and for 53% at 7 years. Open repair
was completed in 173 patients and EVAR in 171, based on an on-treatment
analysis. Because 17 patients had incomplete anatomic data, 327 patients
(157 open repair and 170 EVAR) were available for analysis. During 6 years
of follow-up, 78 patients underwent at least one reintervention. The SGVI
score, which is calculated from preoperative AAA morphology using aneurysm
and iliac diameter, predictively dichotomized patients into groups at
high-risk or low-risk for a secondary intervention. The observed freedom
from reintervention was compared between groups at predicted high-risk and
predicted low-risk. Results The 20 patients in the high-risk group were
indeed at higher risk for a secondary intervention compared with the 307
patients predicted to be at low risk (hazard ratio [HR], 3.82; 95%
confidence interval [CI], 2.05-7.11; P <.001). Discrimination between
high-risk and low-risk groups was valid for EVAR (HR, 4.06; 95% CI,
1.93-8.51; P <.001) and for open repair (HR, 3.41; 95% CI, 1.02-11.4; P
=.033). Conclusions The SGVI score appears to be a useful tool to predict
reintervention risk in patients after open repair and EVAR. Copyright
© 2016 Society for Vascular Surgery.

<163>
Accession Number
608761473
Title
Novel Approaches in Primary Cardiovascular Disease Prevention: The HOPE-3
Trial Rationale, Design, and Participants' Baseline Characteristics.
Source
Canadian Journal of Cardiology. 32 (3) (pp 311-318), 2016. Date of
Publication: 01 Mar 2016.
Author
Lonn E.; Bosch J.; Pogue J.; Avezum A.; Chazova I.; Dans A.; Diaz R.;
Fodor G.J.; Held C.; Jansky P.; Keltai M.; Keltai K.; Kunti K.; Kim J.-H.;
Leiter L.; Lewis B.; Liu L.; Lopez-Jaramillo P.; Pais P.; Parkhomenko A.;
Peters R.J.G.; Piegas L.S.; Reid C.M.; Sliwa K.; Toff W.D.; Varigos J.;
Xavier D.; Yusoff K.; Zhu J.; Dagenais G.; Yusuf S.
Institution
(Lonn, Yusuf) Department of Medicine, McMaster University, Hamilton, ON,
Canada
(Lonn, Bosch, Pogue, Yusuf) Population Health Research Institute, Hamilton
Health Sciences and McMaster University, Hamilton, ON, Canada
(Avezum) Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil
(Chazova) Russian Cardiology Research Complex, Moscow, Russian Federation
(Dans) College of Medicine of the University of the Philippines, Manula,
Philippines
(Diaz) Fundacion ECLA, Rosario, Argentina
(Fodor) University of Ottawa Heart Institute, Ottawa, ON, Canada
(Held) Department of Medical Sciences, Uppsala University, Uppsala, Sweden
(Jansky) University Hospital Motol, Prague, Czechia
(Keltai, Keltai) Hungarian Institute of Cardiology, Semmelweis University,
Budapest, Hungary
(Kunti) Diabetes Research Centre, University of Leicester, Leicester,
United Kingdom
(Kim) St. Paul's Hospital, The Catholic University of Korea, Seoul, South
Korea
(Leiter) Li Ka Shing Knowledge Institute and Keenan Research Centre for
Biomedical Science, St. Michael's Hospital, University of Toronto,
Toronto, ON, Canada
(Lewis) Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport
School of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
(Liu) Fu Wai Hospital, Chinese Academy of Medical Sciences, Beijing, China
(Lopez-Jaramillo) Fundacion Oftalmolgica de Santander (FOSCAL) and
Instituto Masira, Medical School, Universidad de Santander, Bucaramanga,
Colombia
(Pais, Xavier) Division of Clinical Research and Training, St. John's
Research Institute, Bangalore, India
(Parkhomenko) Ukranian Strazhesko Institute of Cardiology, Kiev, Ukraine
(Peters) Department of Cardiology, Academic Medical Center, Amsterdam,
Netherlands
(Piegas) Hospital do Coracao, Sao Paulo, Brazil
(Reid, Varigos) Department of Epidemiology and Preventive Medicine, Monash
University, Melbourne, Australia
(Sliwa) Hatter Institute for Cardiovascular Research in Africa, Department
of Medicine, University of Cape Town and Soweto Cardiovascular Research
Group, Johannesburg, South Africa
(Toff) Department of Cardiovascular Sciences, University of Leicester and
Leicester NIHR Biomedical Research Unit in Cardiovascular Disease,
Glenfield Hospital, Leicester, United Kingdom
(Yusoff) Universiti Teknologi MARA, Selangor, Malaysia
(Zhu) Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union
Medical College, Beijing, China
(Dagenais) Institut Universitaire de Cardiologie et Pneumologie de Quebec,
Universite Laval, QC, Canada
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Background: Cholesterol and blood pressure (BP) can be effectively and
safely lowered with statin drugs and BP-lowering drugs, reducing major
cardiovascular (CV) events by 20%-30% within 5 years in high-risk
individuals. However, there are limited data in lower-risk populations.
The Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial is evaluating
whether cholesterol lowering with a statin drug, BP lowering with low
doses of 2 antihypertensive agents, and their combination safely reduce
major CV events in individuals at intermediate risk who have had no
previous vascular events and have average cholesterol and BP levels.
 Method(s): A total of 12,705 women 65 years or older and men 55 years
or older with at least 1 CV risk factor, no known CV disease, and without
any clear indication or contraindication to the study drugs were
randomized to rosuvastatin 10 mg/d or placebo and to
candesartan/hydrochlorothiazide 16/12.5 mg/d or placebo (2 x 2 factorial
design) and will be followed for a mean of 5.8 years. The coprimary study
outcomes are the composite of CV death, nonfatal myocardial infarction
(MI), and nonfatal stroke and the composite of CV death, nonfatal MI,
nonfatal stroke, resuscitated cardiac arrest, heart failure, and arterial
revascularization. Result(s): Participants were recruited from 21
countries in North America, South America, Europe, Asia, and Australia.
Mean age at randomization was 66 years and 46% were women.
 Conclusion(s): The HOPE-3 trial will provide new information on
cholesterol and BP lowering in intermediate-risk populations with average
cholesterol and BP levels and is expected to inform approaches to primary
prevention worldwide (HOPE-3 ClinicalTrials.gov
NCT00468923). Copyright © 2016 Canadian Cardiovascular Society.

<164>
Accession Number
608714677
Title
Stopping vs. continuing aspirin before coronary artery surgery.
Source
New England Journal of Medicine. 374 (8) (pp 728-737), 2016. Date of
Publication: 25 Feb 2016.
Author
Myles P.S.; Smith J.A.; Forbes A.; Silbert B.; Jayarajah M.; Painter T.;
Cooper D.J.; Marasco S.; McNeil J.; Bussieres J.S.; Wallace S.
Institution
(Myles, Cooper, Marasco, Wallace) Alfred Hospital, Department of
Anaesthesia and Perioperative Medicine, Commercial Rd., Melbourne, VIC
3004, Australia
(Myles, Smith, Forbes, Cooper, Marasco, McNeil) Monash University,
Melbourne, VIC, Australia
(Silbert) St. Vincent's Hospital, Fitzroy, VIC, Australia
(Painter) Royal Adelaide Hospital, Adelaide, SA, Australia
(Jayarajah) Plymouth Medical School Devon, United Kingdom
(Bussieres) Institut Universitaire de Cardiologie et de Pneumologie de
Quebec, Quebec, QC, Canada
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND Most patients with coronary artery disease receive aspirin for
primary or secondary prevention of myocardial infarction, stroke, and
death. Aspirin poses a risk of bleeding in patients undergoing surgery,
but it is unclear whether aspirin should be stopped before coronary artery
surgery. METHODS We used a 2-by-2 factorial trial design to randomly
assign patients who were scheduled to undergo coronary artery surgery and
were at risk for perioperative complications to receive aspirin or placebo
and tranexamic acid or placebo. The results of the aspirin trial are
reported here. Patients were randomly assigned to receive 100 mg of
aspirin or matched placebo preoperatively. The primary outcome was a
composite of death and thrombotic complications (nonfatal myocardial
infarction, stroke, pulmonary embolism, renal failure, or bowel
infarction) within 30 days after surgery. RESULTS Among 5784 eligible
patients, 2100 were enrolled; 1047 were randomly assigned to receive
aspirin and 1053 to receive placebo. A primary outcome event occurred in
202 patients in the aspirin group (19.3%) and in 215 patients in the
placebo group (20.4%) (relative risk, 0.94; 95% confidence interval, 0.80
to 1.12; P = 0.55). Major hemorrhage leading to reoperation occurred in
1.8% of patients in the aspirin group and in 2.1% of patients in the
placebo group (P = 0.75), and cardiac tamponade occurred at rates of 1.1%
and 0.4%, respectively (P = 0.08). CONCLUSIONS Among patients undergoing
coronary artery surgery, the administration of preoperative aspirin
resulted in neither a lower risk of death or thrombotic complications nor
a higher risk of bleeding than that with placebo. (Funded by the
Australian National Health and Medical Research Council and others;
Australia New Zealand Clinical Trials Registry number,
ACTRN12605000557639.). Copyright © 2016 Massachusetts Medical
Society.

<165>
Accession Number
612978344
Title
The Prognostic Impact of New-Onset Persistent Left Bundle Branch Block
Following Transcatheter Aortic Valve Implantation: A Meta-analysis.
Source
Clinical Cardiology. 39 (9) (pp 544-550), 2016. Date of Publication: 01
Sep 2016.
Author
Ando T.; Takagi H.
Institution
(Ando) Department of Internal Medicine, Mount Sinai Beth Israel Medical
Center, Icahn School of Medicine at Mount Sinai, New York, NY, United
States
(Takagi) Department of Cardiovascular Surgery, Shizuoka Medical Center,
Shizuoka, Japan
Publisher
John Wiley and Sons Inc. (E-mail: cs-journals@wiley.com)
Abstract
New-onset persistent left bundle branch block (NOP-LBBB) is one of the
most common conduction disturbances after transcatheter aortic valve
implantation (TAVI). We hypothesized that NOP-LBBB may have a clinically
negative impact after TAVI. To find out, we conducted a systematic
literature search of the MEDLINE/PubMed and Embase databases.
Observational studies that reported clinical outcomes of NOP-LBBB patients
after TAVI were included. The random-effects model was used to combine
odds ratios, risk ratios, or hazard ratios (HRs) with 95% confidence
intervals. Adjusted HRs were utilized over unadjusted HRs or risk ratios
when available. A total of 4049 patients (807 and 3242 patients with and
without NOP-LBBB, respectively) were included. Perioperative (in-hospital
or 30-day) and midterm all-cause mortality and midterm cardiovascular
mortality were comparable between the groups. The NOP-LBBB patients
experienced a higher rate of permanent pacemaker implantation (HR: 2.09,
95% confidence interval: 1.12-3.90, P = 0.021, I2 = 83%) during
midterm follow-up. We found that NOP-LBBB after TAVI resulted in higher
permanent pacemaker implantation but did not negatively affect the midterm
prognosis. Therefore, careful observation during the follow-up is
required. Copyright © 2016 Wiley Periodicals, Inc.

<166>
Accession Number
610068597
Title
Effect of losmapimod on cardiovascular outcomes in patients hospitalized
with acute myocardial infarction: A randomized clinical trial.
Source
JAMA - Journal of the American Medical Association. 315 (15) (pp
1591-1599), 2016. Date of Publication: 19 Apr 2016.
Author
O'Donoghue M.L.; Glaser R.; Cavender M.A.; Aylward P.E.; Bonaca M.P.;
Budaj A.; Davies R.Y.; Dellborg M.; Fox K.A.A.; Gutierrez J.A.T.; Hamm C.;
Kiss R.G.; Kovar F.; Kuder J.F.; Im K.A.; Lepore J.J.; Lopez-Sendon J.L.;
Ophuis T.O.; Parkhomenko A.; Shannon J.B.; Spinar J.; Tanguay J.-F.; Ruda
M.; Steg P.G.; Theroux P.; Wiviott S.D.; Laws I.; Sabatine M.S.; Morrow
D.A.
Institution
(O'Donoghue, Cavender, Bonaca, Gutierrez, Kuder, Im, Wiviott, Sabatine,
Morrow) TIMI Study Group, Cardiovascular Division, Brigham and Women's
Hospital, 350 Longwood Ave, Boston, MA 02115, United States
(Glaser, Davies, Lepore, Laws) Metabolic Pathways and Cardiovascular Unit,
Research and Development, GlaxoSmithKline, Collegeville, PA, United States
(Aylward) South Australian Health and Medical Research Institute, Flinders
University Medical Centre, Adelaide, SA, Australia
(Budaj) Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland
(Dellborg) Sahlgrenska University Hospital, Ostra and Sahlgrenska Academy,
University of Gothenburg, Gothenburg, Sweden
(Fox) Centre for Cardiovascular Science, University of Edinburgh,
Edinburgh, United Kingdom
(Hamm) Kerckhoff Heart Center, Bad Nauheim, University of Giessen,
Giessen, Germany
(Kiss) Department of Cardiology, Military Hospital, Budapest, Hungary
(Kovar) Department of Internal Medicine I, Jessenius Faculty of Medicine
in Martin, Comenius University in Bratislava, Martin, Slovakia
(Lopez-Sendon) Cardiovascular Division, University Hospital La Paz,
Madrid, Spain
(Ophuis) Canisius-Wilhelmina Hospital, Nijmegen, Netherlands
(Parkhomenko) Ukranian Strazhesko Institute of Cardiology, Kiev, Ukraine
(Shannon) PAREXEL International, Durham, NC, United States
(Spinar) University Hospital, Jihlavska, Brno, Czechia
(Tanguay, Theroux) Montreal Heart Institute, University of Montreal,
Montreal, QC, Canada
(Ruda) Cardiology Research Center, Moscow, Russian Federation
(Steg) Departement Hospitalo-Universitaire FIRE, Hopital Bichat,
Assistance Publique-Hopitaux de Paris, Universite Paris-Diderot, Paris,
France
Publisher
American Medical Association (E-mail: smcleod@itsa.ucsf.edu)
Abstract
Importance: p38 Mitogen-activated protein kinase (MAPK)-stimulated
inflammation is implicated in atherogenesis, plaque destabilization, and
maladaptive processes inmyocardial infarction (MI). Pilot data in a phase
2 trial in non-ST elevation MI indicated that the p38 MAPK inhibitor
losmapimod attenuates inflammation and may improve outcomes.
 Objective(s): To evaluate the efficacy and safety of losmapimod on
cardiovascular outcomes in patients hospitalized with an acutemyocardial
infarction. Design, Setting, and Patients: LATITUDE-TIMI 60, a randomized,
placebo-controlled, double-blind, parallel-group trial conducted at 322
sites in 34 countries from June 3, 2014, until December 8, 2015. Part A
consisted of a leading cohort (n = 3503) to provide an initial assessment
of safety and exploratory efficacy before considering progression to part
B (approximately 22 000 patients). Patients were considered potentially
eligible for enrollment if they had been hospitalized with an acute MI and
had at least 1 additional predictor of cardiovascular risk.
 Intervention(s): Patients were randomized to either twice-daily
losmapimod (7.5mg; n = 1738) or matching placebo (n = 1765) on a
background of guideline-recommended therapy. Patients were treated for 12
weeks and followed up for an additional 12 weeks. Main Outcomes and
Measures: The primary end pointwas the composite of cardiovascular death,
MI, or severe recurrent ischemia requiring urgent coronary
revascularization with the principal analysis specified at week 12.
 Result(s): In part A, among the 3503 patients randomized (median age,
66 years; 1036 [29.6%] were women), 99.1%had complete ascertainment for
the primary outcome. The primary end point occurred by 12 weeks in 123
patients treated with placebo (7.0%) and 139 patients treated with
losmapimod (8.1%; hazard ratio, 1.16; 95%CI, 0.91-1.47; P = .24). The
on-treatment rates of serious adverse events were 16.0%with losmapimod and
14.2% with placebo. Conclusions and Relevance: Among patients with
acute MI, use of losmapimod compared with placebo did not reduce the risk
of major ischemic cardiovascular events. The results of this exploratory
efficacy study did not justify proceeding to a larger efficacy trial in
the existing patient population. Copyright © 2016 American
Medical Association. All rights reserved.

<167>
Accession Number
608799841
Title
Ischemic cardiac outcomes and hospitalizations according to prior
macrovascular disease status in patients with type 2 diabetes and recent
acute coronary syndrome from the Examination of Cardiovascular Outcomes
with Alogliptin versus Standard of Care trial.
Source
American Heart Journal. 175 (pp 18-27), 2016. Date of Publication: 01 May
2016.
Author
Shimada Y.J.; Cannon C.P.; Liu Y.; Wilson C.; Kupfer S.; Menon V.; Cushman
W.C.; Mehta C.R.; Bakris G.L.; Zannad F.; White W.B.
Institution
(Shimada, Cannon, Liu) Harvard Clinical Research Institute, 930
Commonwealth Avenue West, Boston, MA 02215, United States
(Shimada) Cardiology Division, Massachusetts General Hospital, Harvard
Medical School, Boston, MA, United States
(Shimada, Cannon) Cardiovascular Division, Department of Medicine, Brigham
and Women's Hospital, Harvard Medical School, Boston, MA, United States
(Liu) Department of Biostatistics, Boston University, Boston, MA, United
States
(Wilson, Kupfer) Takeda Development Center Americas, Deerfield, IL, United
States
(Menon) Department of Cardiovascular Medicine, Cleveland Clinic
Foundation, Cleveland, OH, United States
(Cushman) University of Tennessee College of Medicine, Memphis Veterans
Affairs Medical Center, Memphis, TN, United States
(Mehta) Harvard School of Public Health, Boston, MA, United States
(Bakris) University of Chicago Medicine, Chicago, IL, United States
(Zannad) Institut Lorrain du Coeur et des Vaisseaux, Centre
d'Investigation Clinique Inserm, Universite de Lorraine, CHU,
Vandoeuvre-Les-Nancy, France
(White) Calhoun Cardiology Center, University of Connecticut School of
Medicine, Farmington, CT, United States
Publisher
Mosby Inc. (E-mail: customerservice@mosby.com)
Abstract
Background: Concerns raised regarding adverse cardiovascular (CV) outcomes
with new therapies for type 2 diabetes mellitus (T2DM) have led to several
large-scale CV outcome trials. The EXAMINE trial confirmed noninferiority
of the dipeptidyl dipeptidase 4 inhibitor alogliptin to placebo on major
adverse cardiac event rates in a post-acute coronary syndrome (ACS) T2DM
population. We present data on additional ischemic cardiac events and CV
hospitalizations in EXAMINE. Method(s): Patients with T2DM and an ACS
event in the previous 15 to 90 days were randomly assigned to alogliptin
or placebo on a background of standard treatment for diabetes. The
incident rates of a 5-component composite end point of CV death, stroke,
myocardial infarction, unstable angina, and coronary revascularization as
well as CV hospitalization were calculated in all participants and
according to macrovascular disease at baseline. Result(s): There were
no significant differences between alogliptin (n = 2,701) and placebo (n =
2,679) in the event rate of the 5-component composite endpoint with median
follow-up 533 days (21.0% vs 21.5%, hazard ratio [HR] 0.98 [0.87-1.10], P
=.72). No differences were observed in terms of CV hospitalization (25.0%
vs 25.4%, HR 0.98 [0.88-1.09], P =.70) or coronary revascularization
(10.6% vs 10.2%, HR 1.05 [0.88-1.09], P =.60). No interactions were
observed for treatment and prior macrovascular disease.
 Conclusion(s): EXAMINE demonstrates that there was no increase in the
risk of cardiac ischemic events and CV hospitalizations with alogliptin in
a high-risk post-ACS patient population. Because these are major driver of
overall health care costs, these data suggest that there would be no
adverse impact on health care resource utilization. Copyright ©
2016 Mosby, Inc.

<168>
Accession Number
600879866
Title
Exercise training is safe after coronary stenting: A prospective
multicentre study.
Source
European Journal of Preventive Cardiology. 22 (1) (pp 27-34), 2015. Date
of Publication: 19 Jan 2015.
Author
Iliou M.-C.; Pavy B.; Martinez J.; Corone S.; Meurin P.; Tuppin P.
Institution
(Iliou, Martinez) Cardiac Rehabilitation Department, Hopital Corentin
Celton, 4 parvis Corentin Celton, Issy les Mx Cedex 92130, France
(Pavy) Centre Hospitalier Loire Vendee Ocean, Machecoul, France
(Corone) Centre Hospitalier Bligny, Briis Sous Forges, France
(Meurin) Cardiac Rehabilitation Center, Villeneuve Saint Denis, France
(Tuppin) Caisse Nationale Asuurance Maladie des Travailleurs Salaries,
Paris, France
Publisher
SAGE Publications Inc. (E-mail: claims@sagepub.com)
Abstract
Background: Data on the safety of exercise training after coronary
stenting are scarce. Design(s): This is a prospective cohort study of
3132 patients with coronary stenting within the last 12 months, recruited
by 44 cardiac rehabilitation centres; patients were included in a cardiac
rehabilitation programme with training sessions 3-5 days a week. Cardiac
rehabilitation was defined as early rehabilitation when starting <1 month
after coronary stenting and as late rehabilitation when starting later.
 Method(s): Rate of acute coronary syndrome (ACS) after coronary
stenting was estimated according to time to training session. ACS was
defined as related to exercise when it occurs during or within the hour
after an exercise stress test or a training session. All ACS were
documented by an angiographic control. Result(s): Overall 5016 stents
(41.4% drug-eluting stents) were implanted in 3132 patients aged 56.5 +/-
12.9 years (84.7% men) with a median of 1 stent (range 1-8) per patient.
Indication of coronary senting was ACS (86.4%), angina pectoris (8.6%),
and silent ischaemia (5%). Combined antiplatelet treatment was used in
97.2% of the patients. Overall rate of ACS after coronary stenting was
2.9/1000 patients, corresponding to 1.7 complications out of
106 patient-hours of exercise. There were four stent thromboses
related to exercise (1.2/1000 patients, 0.8/106 patient-hours
of exercise): two in the early rehabilitation group (days 9 and 11), and
two in the late rehabilitation group (days 77 and 228).
 Conclusion(s): Exercise training seems safe and there is no
justification to delay cardiac rehabilitation after coronary
stenting. Copyright © The European Society of Cardiology 2013.

<169>
Accession Number
606363150
Title
A multicenter trial of remote ischemic preconditioning for heart surgery.
Source
New England Journal of Medicine. 373 (15) (pp 1397-1407), 2015. Date of
Publication: 08 Oct 2015.
Author
Meybohm P.; Bein B.; Brosteanu O.; Cremer J.; Gruenewald M.; Stoppe C.;
Coburn M.; Schaelte G.; Boning A.; Niemann B.; Roesner J.; Kletzin F.;
Strouhal U.; Reyher C.; Laufenberg-Feldmann R.; Ferner M.; Brandes I.F.;
Bauer M.; Stehr S.N.; Kortgen A.; Wittmann M.; Baumgarten G.;
Meyer-Treschan T.; Kienbaum P.; Heringlake M.; Schon J.; Sander M.;
Treskatsch S.; Smul T.; Wolwender E.; Schilling T.; Fuernau G.;
Hasenclever D.; Zacharowski K.
Institution
(Meybohm, Strouhal, Reyher, Zacharowski) Department of Anesthesiology,
Intensive Care Medicine, and Pain Therapy, University Hospital Frankfurt,
Theodor-Stern-Kai 7, Frankfurt 60590, Germany
(Meybohm, Bein, Gruenewald) Department of Anesthesiology and Intensive
Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel,
Germany
(Cremer) Department of Cardiovascular Surgery, University Hospital
Schleswig-Holstein, Campus Kiel, Kiel, Germany
(Brosteanu) Clinical Trial Center, Department of Internal
Medicine/Cardiology, University of Leipzig, Leipzig, Germany
(Fuernau) University of Leipzig Heart Center, University of Leipzig,
Leipzig, Germany
(Hasenclever) Institute for Medical Informatics, Statistics, and
Epidemiology, University of Leipzig, Leipzig, Germany
(Stoppe, Coburn, Schaelte) Department of Anesthesiology, University
Hospital Aachen, Aachen, Germany
(Boning, Niemann) Department of Cardiovascular Surgery, University of
Giessen, Giessen, Germany
(Roesner, Kletzin) Clinic of Anesthesiology and Intensive Care Medicine,
University Hospital Rostock, Rostock, Germany
(Laufenberg-Feldmann, Ferner) Department of Anesthesiology, Medical Center
of Johannes Gutenberg University, Mainz, Germany
(Brandes, Bauer) Department of Anesthesiology and Intensive Care Medicine,
University Hospital Gottingen, Gottingen, Germany
(Stehr, Kortgen) Department of Anesthesiology and Intensive Care Medicine,
Center for Sepsis Control and Care, Jena University Hospital, Jena,
Germany
(Wittmann, Baumgarten) Department of Anesthesiology and Intensive Care
Medicine, University Hospital Bonn, Bonn, Germany
(Meyer-Treschan, Kienbaum) Department of Anesthesiology and Intensive Care
Medicine, University Hospital Dusseldorf, Dusseldorf, Germany
(Heringlake, Schon) Department of Anesthesiology and Intensive Care
Medicine, University of Lubeck, Lubeck, Germany
(Sander, Treskatsch) Department of Anesthesiology and Intensive Care
Medicine, Charite-Universitatsmedizin Berlin, Campus Charite Mitte,
Berlin, Germany
(Smul, Wolwender) Department of Anesthesiology, University Hospital
Wurzburg, Wurzburg, Germany
(Schilling) Department of Anesthesiology, University Hospital Magdeburg,
Magdeburg, Germany
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND Remote ischemic preconditioning (RIPC) is reported to reduce
biomarkers of ischemic and reperfusion injury in patients undergoing
cardiac surgery, but uncertainty about clinical outcomes remains. METHODS
We conducted a prospective, double-blind, multicenter, randomized,
controlled trial involving adults who were scheduled for elective cardiac
surgery requiring cardiopulmonary bypass under total anesthesia with
intravenous propofol. The trial compared upper-limb RIPC with a sham
intervention. The primary end point was a composite of death, myocardial
infarction, stroke, or acute renal failure up to the time of hospital
discharge. Secondary end points included the occurrence of any individual
component of the primary end point by day 90. RESULTS A total of 1403
patients underwent randomization. The full analysis set comprised 1385
patients (692 in the RIPC group and 693 in the sham-RIPC group). There was
no significant between-group difference in the rate of the composite
primary end point (99 patients [14.3%] in the RIPC group and 101 [14.6%]
in the sham-RIPC group, P = 0.89) or of any of the individual components:
death (9 patients [1.3%] and 4 [0.6%], respectively; P = 0.21), myocardial
infarction (47 [6.8%] and 63 [9.1%], P = 0.12), stroke (14 [2.0%] and 15
[2.2%], P = 0.79), and acute renal failure (42 [6.1%] and 35 [5.1%], P =
0.45). The results were similar in the per-protocol analysis. No treatment
effect was found in any subgroup analysis. No significant differences
between the RIPC group and the sham-RIPC group were seen in the level of
troponin release, the duration of mechanical ventilation, the length of
stay in the intensive care unit or the hospital, new onset of atrial
fibrillation, and the incidence of postoperative delirium. No RIPC-related
adverse events were observed. CONCLUSIONS Upper-limb RIPC performed while
patients were under propofol-induced anesthesia did not show a relevant
benefit among patients undergoing elective cardiac surgery. Copyright
© 2015 Massachusetts Medical Society.

<170>
Accession Number
606887253
Title
Everolimus-eluting bioresorbable scaffolds for coronary artery disease.
Source
New England Journal of Medicine. 373 (20) (pp 1905-1915), 2015. Date of
Publication: 12 Nov 2015.
Author
Ellis S.G.; Kereiakes D.J.; Metzger D.C.; Caputo R.P.; Rizik D.G.;
Teirstein P.S.; Litt M.R.; Kini A.; Kabour A.; Marx S.O.; Popma J.J.;
McGreevy R.; Zhang Z.; Simonton C.; Stone G.W.
Institution
(Ellis) Cleveland Clinic, Cleveland, OH, United States
(Kereiakes) Christ Hospital, Heart and Vascular Center, Lindner Research
Center, Cincinnati, OH, United States
(Kini) Mercy St. Vincent's Medical Center, Toledo, OH, United States
(Metzger) Wellmont Holston Valley Medical Center, Kingsport, TN, United
States
(Caputo) St. Joseph's Hospital Health Center, Liverpool, NY, United States
(Rizik) Scottsdale Healthcare, Scottsdale, AZ, United States
(Teirstein) Scripps Clinic, San Diego, CA, United States
(McGreevy, Zhang, Simonton) Abbott Vascular, Santa Clara, CA, United
States
(Litt) Baptist Medical Center, Jacksonville, FL, United States
(Kabour) Mount Sinai Medical Center, New York, United States
(Marx, Stone) Columbia University Medical Center, Cardiovascular Research
Foundation, 111 E. 59th St., New York, NY 10022, United States
(Stone) Cardiovascular Research Foundation, New York, United States
(Popma) Beth Israel Deaconess Medical Center, Boston, United States
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND: In patients with coronary artery disease who receive metallic
drug-eluting coronary stents, adverse events such as late target-lesion
failure may be related in part to the persistent presence of the metallic
stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds
have been developed to attempt to improve long-term outcomes.
 METHOD(S): In this large, multicenter, randomized trial, 2008
patients with stable or unstable angina were randomly assigned in a 2:1
ratio to receive an everolimus-eluting bioresorbable vascular (Absorb)
scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience)
stent (686 patients). The primary end point, which was tested for both
noninferiority (margin, 4.5 percentage points for the risk difference) and
superiority, was target-lesion failure (cardiac death, target-vessel
myocardial infarction, or ischemia-driven target-lesion revascularization)
at 1 year. RESULT(S): Target-lesion failure at 1 year occurred in
7.8% of patients in the Absorb group and in 6.1% of patients in the Xience
group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to
3.9; P = 0.007 for noninferiority and P = 0.16 for superiority). There was
no significant difference between the Absorb group and the Xience group in
rates of cardiac death (0.6% and 0.1%, respectively; P = 0.29),
target-vessel myocardial infarction (6.0% and 4.6%, respectively; P =
0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%,
respectively; P = 0.50). Device thrombosis within 1 year occurred in 1.5%
of patients in the Absorb group and in 0.7% of patients in the Xience
group (P = 0.13). CONCLUSION(S): In this large-scale, randomized
trial, treatment of noncomplex obstructive coronary artery disease with an
everolimus-eluting bioresorbable vascular scaffold, as compared with an
everolimus-eluting cobalt-chromium stent, was within the prespecified
margin for noninferiority with respect to target-lesion failure at 1
year. Copyright © 2015 Massachusetts Medical Society. All rights
reserved.

<171>
Accession Number
603697282
Title
Randomized trial of primary PCI with or without routine manual
thrombectomy.
Source
New England Journal of Medicine. 372 (15) (pp 1389-1398), 2015. Date of
Publication: 09 Apr 2015.
Author
Jolly S.S.; Cairns J.A.; Yusuf S.; Meeks B.; Pogue J.; Rokoss M.J.; Kedev
S.; Thabane L.; Stankovic G.; Moreno R.; Gershlick A.; Chowdhary S.; Lavi
S.; Niemela K.; Steg P.G.; Bernat I.; Xu Y.; Cantor W.J.; Overgaard C.B.;
Naber C.K.; Cheema A.N.; Welsh R.C.; Bertrand O.F.; Avezum A.; Bhindi R.;
Pancholy S.; Rao S.V.; Natarajan M.K.; Ten Berg J.M.; Shestakovska O.; Gao
P.; Widimsky P.; Dzavik V.
Institution
(Jolly, Yusuf, Meeks, Pogue, Rokoss, Thabane, Natarajan, Shestakovska,
Gao) Population Health Research Institute and Department of Medicine,
McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada
(Cairns) University of British Columbia, Vancouver, Canada
(Lavi) London Health Sciences Centre, Department of Medicine, London, ON,
Canada
(Cantor) Southlake Regional Health Centre, Newmarket, ON, Canada
(Overgaard, Dzavik) Peter Munk Cardiac Centre, University Health Network,
Canada
(Cheema) St. Michael's Hospital, Toronto, Canada
(Welsh) Mazankowski Alberta Heart Institute, Department of Medicine,
Edmonton, Canada
(Bertrand) Quebec Heart-Lung Institute, Laval University, Quebec, QC,
Canada
(Kedev) University Clinic of Cardiology, Sts. Cyril and Methodius
University, Skopje, North Macedonia
(Stankovic) Clinical Center of Serbia and Department of Cardiology,
Medical Faculty, University of Belgrade, Belgrade, Serbia
(Moreno) University Hospital la Paz, Madrid, Spain
(Gershlick) University Hospitals of Leicester, Department of
Cardiovascular Sciences, Leicester, United Kingdom
(Chowdhary) University Hospitals South Manchester, Manchester Academic
Health Science Centre, Manchester, United Kingdom
(Niemela) Heart Center, Tampere University Hospital, Tampere, Finland
(Steg) Universite Paris-Diderot, Sorbonne Paris-Cite, INSERM Unite 1148,
Paris, France
(Bernat) University Hospital and Faculty of Medicine Pilsen, Pilsen,
Czechia
(Widimsky) Third Faculty of Medicine, Charles University Prague,
University Hospital Kralovske Vinohrady, Prague, Czechia
(Xu) Tenth People's Hospital, Tongji University, Shanghai, China
(Naber) Department of Cardiology and Angiology, Contilla Heart and
Vascular Center, Elisabeth-Krankenhaus, Essen, Germany
(Bhindi) Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil
(Avezum) Royal North Shore Hospital, Sydney, Australia
(Pancholy) Northeast Clinical Trials Group, Scranton, PA, United States
(Rao) Duke Clinical Research Institute, Durham, NC, United States
(Ten Berg) Department of Cardiology, Saint-Antonius Hospital, Nieuwegein,
Netherlands
Publisher
Massachussetts Medical Society
Abstract
Background: During primary percutaneous coronary intervention (PCI),
manual thrombectomy may reduce distal embolization and thus improve
microvascular perfusion. Small trials have suggested that thrombectomy
improves surrogate and clinical outcomes, but a larger trial has reported
conflicting results. Method(s): We randomly assigned 10,732 patients
with ST-segment elevation myocardial infarction (STEMI) undergoing primary
PCI to a strategy of routine upfront manual thrombectomy versus PCI alone.
The primary outcome was a composite of death from cardiovascular causes,
recurrent myocardial infarction, cardiogenic shock, or New York Heart
Association (NYHA) class IV heart failure within 180 days. The key safety
outcome was stroke within 30 days. Result(s): The primary outcome
occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus
351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the
thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P =
0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5%
with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.34) and
the primary outcome plus stent thrombosis or target-vessel
revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to
1.14; P = 0.95) were also similar. Stroke within 30 days occurred in 33
patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the
PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P = 0.02).
 Conclusion(s): In patients with STEMI who were undergoing primary
PCI, routine manual thrombectomy, as compared with PCI alone, did not
reduce the risk of cardiovascular death, recurrent myocardial infarction,
cardiogenic shock, or NYHA class IV heart failure within 180 days but was
associated with an increased rate of stroke within 30 days. Copyright
© 2015 Massachusetts Medical Society.

<172>
Accession Number
603571732
Title
Outcome of patients admitted with acute coronary syndrome on palliative
treatment: Insights from the nationwide AMIS Plus registry 1997-2014.
Source
BMJ Open. 5 (3) (no pagination), 2015. Article Number: e006218. Date of
Publication: 02 Mar 2015.
Author
Erne P.; Radovanovic D.; Seifert B.; Bertel O.; Urban P.
Institution
(Erne, Radovanovic) AMIS Plus Data Center, Epidemiology, Biostatistics and
Prevention Institute, University of Zurich, Zurich, Switzerland
(Erne) Department of Cardiology, Clinic St. Anna, Lucerne, Switzerland
(Erne) University Hospital Zurich, Zurich, Switzerland
(Seifert) Department of Biostatistics, Epidemiology, Biostatistics and
Prevention Institute, University of Zurich, Zurich, Switzerland
(Bertel) Cardiology Centre, Klinik Im Park, Zurich, Switzerland
(Urban) Cardiovascular Department, Hopital de la Tour, Geneva, Switzerland
Publisher
BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com)
Abstract
Objective: Compliance with guidelines is increasingly used to benchmark
the quality of hospital care, however, very little is known on patients
admitted with acute coronary syndromes (ACS) and treated palliatively.
This study aimed to evaluate the baseline characteristics and outcomes of
these patients. Design(s): Prospective cohort study. Setting(s):
Eighty-two Swiss hospitals enrolled patients from 1997 to 2014.
 Participant(s): All patients with ACS enrolled in the AMIS Plus
registry (n=45 091) were analysed according to three treatment groups:
palliative treatment, defined as use of aspirin and analgesics only and no
reperfusion; conservative treatment, defined as any treatment including
antithrombotics or anticoagulants, heparins, P2Y<inf>12</inf> inhibitors,
GPIIb/IIIa but no pharmacological or mechanical reperfusion; and
reperfusion treatment (thrombolysis and/or percutaneous coronary
intervention during initial hospitalisation). The primary outcome measure
was in-hospital mortality and the secondary measure was 1-year mortality.
 Result(s): Of the patients, 1485 (3.3%) were palliatively treated, 11
119 (24.7%) were conservatively treated and 32 487 (72.0%) underwent
reperfusion therapy. In 1997, 6% of all patients were treated palliatively
and this continuously decreased to 2% in 2013. Baseline characteristics of
palliative patients differed in comparison with conservatively treated and
reperfusion patients in age, gender and comorbidities (all p<0.001). These
patients had more in-hospital complications such as postadmission onset of
cardiogenic shock (15.6% vs 5.2%; p<0.001), stroke (1.8% vs 0.8%; p=0.001)
and a higher in-hospital mortality (25.8% vs 5.6%; p<0.001). The subgroup
of patients followed 1 year after discharge (n=8316) had a higher rate of
reinfarction (9.2% vs 3.4%; p=0.003) and mortality (14.0% vs 3.5%;
p<0.001). Conclusion(s): Patients with ACS treated palliatively were
older, sicker, with more heart failure at admission and very high
in-hospital mortality. While refraining from more active therapy may often
constitute the most humane and appropriate approach, we think it is
important to also evaluate these patients and include them in registries
and outcome evaluations. Clinical trial number: ClinicalTrials.gov
Identifier: NCT01 305 785. Copyright © 2015, BMJ. All rights
reserved.

<173>
Accession Number
604762923
Title
Effect of remote ischemic preconditioning on kidney injury among high-risk
patients undergoing cardiac surgery: A randomized clinical trial.
Source
JAMA - Journal of the American Medical Association. 313 (21) (pp
2133-2141), 2015. Date of Publication: 02 Jun 2015.
Author
Zarbock A.; Schmidt C.; Van Aken H.; Wempe C.; Martens S.; Zahn P.K.; Wolf
B.; Goebel U.; Schwer C.I.; Rosenberger P.; Haeberle H.; Gorlich D.;
Kellum J.A.; Meersch M.
Institution
(Zarbock, Schmidt, Van Aken, Wempe, Meersch) Department of
Anaesthesiology, Intensive Care Medicine and Pain Medicine, University
Hospital Munster, Munster, Germany
(Martens) Department of Cardiac Surgery, University of Munster, Munster,
Germany
(Zahn, Wolf) Department of Anaesthesiology, Intensive Care Medicine,
Palliative and Pain Medicine, University Hospital Bochum, Bochum, Germany
(Goebel, Schwer) Department of Anaesthesiology and Intensive Care
Medicine, University Hospital Freiburg, Freiburg, Germany
(Rosenberger, Haeberle) Department of Anaesthesiology and Intensive Care
Medicine, University Hospital Tubingen, Tubingen, Germany
(Gorlich) Institute of Biostatistics and Clinical Research, University of
Munster, Munster, Germany
(Kellum) Center for Critical Care Nephrology, Department of Critical Care
Medicine, University of Pittsburgh, Pittsburgh, PA, United States
(Zarbock) Department of Anesthesiology, Critical Care Medicine and Pain
Therapy, University Hospital Munster, Albert-Schweitzer-Campus 1, Gebaude
A1, Munster 48149, Germany
Publisher
American Medical Association (E-mail: smcleod@itsa.ucsf.edu)
Abstract
IMPORTANCE: No interventions have yet been identified to reduce the risk
of acute kidney injury in the setting of cardiac surgery.
 OBJECTIVE(S): To determine whether remote ischemic preconditioning
reduces the rate and severity of acute kidney injury in patients
undergoing cardiac surgery. DESIGN, SETTING, AND PARTICIPANTS: In this
multicenter trial, we enrolled 240 patients at high risk for acute kidney
injury, as identified by a Cleveland Clinic Foundation score of 6 or
higher, between August 2013 and June 2014 at 4 hospitals in Germany. We
randomized them to receive remote ischemic preconditioning or sham remote
ischemic preconditioning (control). All patients completed follow-up 30
days after surgery and were analyzed according to the intention-to-treat
principle. INTERVENTIONS: Patients received either remote ischemic
preconditioning (3 cycles of 5-minute ischemia and 5-minute reperfusion in
one upper arm after induction of anesthesia) or sham remote ischemic
preconditioning (control), both via blood pressure cuff inflation. MAIN
OUTCOMES AND MEASURES: The primary end point was the rate of acute kidney
injury defined by Kidney Disease: Improving Global Outcomes criteria
within the first 72 hours after cardiac surgery. Secondary end points
included use of renal replacement therapy, duration of intensive care unit
stay, occurrence of myocardial infarction and stroke, in-hospital and
30-day mortality, and change in acute kidney injury biomarkers.
 RESULT(S): Acute kidney injury was significantly reduced with remote
ischemic preconditioning (45 of 120 patients [37.5%]) compared with
control (63 of 120 patients [52.5%]; absolute risk reduction, 15%; 95% CI,
2.56%-27.44%; P = .02). Fewer patients receiving remote ischemic
preconditioning received renal replacement therapy (7 [5.8%] vs 19
[15.8%]; absolute risk reduction, 10%; 95% CI, 2.25%-17.75%; P = .01), and
remote ischemic preconditioning reduced intensive care unit stay (3 days
[interquartile range, 2-5]) vs 4 days (interquartile range, 2-7) (P =
.04). There was no significant effect of remote ischemic preconditioning
on myocardial infarction, stroke, or mortality. Remote ischemic
preconditioning significantly attenuated the release of urinary
insulinlike growth factor-binding protein 7 and tissue inhibitor of
metalloproteinases 2 after surgery (remote ischemic preconditioning, 0.36
vs control, 0.97 ng/mL2/1000; difference, 0.61; 95% CI,
0.27-0.86; P < .001). No adverse events were reported with remote ischemic
preconditioning. CONCLUSIONS AND RELEVANCE: Among high-risk patients
undergoing cardiac surgery, remote ischemic preconditioning compared with
no ischemic preconditioning significantly reduced the rate of acute kidney
injury and use of renal replacement therapy. The observed reduction in the
rate of acute kidney injury and the need for renal replacement warrants
further investigation. TRIAL REGISTRATION: German Clinical Trials Register
Identifier: DRKS00005333. Copyright 2015 American Medical Association.
All rights reserved.

<174>
Accession Number
603917250
Title
Efficacy and safety of evolocumab in reducing lipids and cardiovascular
events.
Source
New England Journal of Medicine. 372 (16) (pp 1500-1509), 2015. Date of
Publication: 16 Apr 2015.
Author
Sabatine M.S.; Giugliano R.P.; Wiviott S.D.; Raal F.J.; Blom D.J.;
Robinson J.; Ballantyne C.M.; Somaratne R.; Legg J.; Wasserman S.M.; Scott
R.; Koren M.J.; Stein E.A.
Institution
(Sabatine, Giugliano, Wiviott) Sabatine at the TIMI Study Group, Division
of Cardiovascular Medicine, Brigham and Women's Hospital, 75 Francis St.,
Boston, MA 02115, United States
(Raal) Carbohydrate and Lipid Metabolism Research Unit, Faculty of Health
Sciences, University of the Witwatersrand, Johannesburg, South Africa
(Blom) Division of Lipidology, Department of Medicine, University of Cape
Town, Cape Town, South Africa
(Robinson) Departments of Epidemiology and Medicine, College of Public
Health, University of Iowa, Iowa City, United States
(Ballantyne) Sections of Cardiovascular Research and Cardiology,
Department of Medicine, Baylor College of Medicine, Houston, United States
(Somaratne, Legg, Wasserman, Scott) Amgen, Thousand OaksCAUnited States
(Koren) Jacksonville Center for Clinical Research, Jacksonville, FL,
United States
(Stein) Metabolic and Atherosclerosis Research Center, 5355 Medpace Way,
Cincinnati, OH 45225, United States
Publisher
Massachussetts Medical Society
Abstract
Background Evolocumab, a monoclonal antibody that inhibits proprotein
convertase subtilisin- kexin type 9 (PCSK9), significantly reduced
low-density lipoprotein (LDL) cholesterol levels in short-term studies. We
conducted two extension studies to obtain longer-term data. Methods In two
open-label, randomized trials, we enrolled 4465 patients who had completed
1 of 12 phase 2 or 3 studies ("parent trials") of evolocumab. Regardless
of studygroup assignments in the parent trials, eligible patients were
randomly assigned in a 2:1 ratio to receive either evolocumab (140 mg
every 2 weeks or 420 mg monthly) plus standard therapy or standard therapy
alone. Patients were followed for a median of 11.1 months with assessment
of lipid levels, safety, and (as a prespecified exploratory analysis)
adjudicated cardiovascular events including death, myocardial infarction,
unstable angina, coronary revascularization, stroke, transient ischemic
attack, and heart failure. Data from the two trials were combined. Results
As compared with standard therapy alone, evolocumab reduced the level of
LDL cholesterol by 61%, from a median of 120 mg per deciliter to 48 mg per
deciliter (P<0.001). Most adverse events occurred with similar frequency
in the two groups, although neurocognitive events were reported more
frequently in the evolocumab group. The risk of adverse events, including
neurocognitive events, did not vary significantly according to the
achieved level of LDL cholesterol. The rate of cardiovascular events at 1
year was reduced from 2.18% in the standard-therapy group to 0.95% in the
evolocumab group (hazard ratio in the evolocumab group, 0.47; 95%
confidence interval, 0.28 to 0.78; P = 0.003). Copyright © 2015
Massachusetts Medical Society.

<175>
Accession Number
605986012
Title
Incidence, predictors, and impact of neurological events in non-ST-segment
elevation acute coronary syndromes: The ACUITY trial.
Source
EuroIntervention. 11 (4) (pp 399-406), 2015. Date of Publication: 01 Aug
2015.
Author
Genereux P.; Bernard S.; Palmerini T.; Caixeta A.; Rosner G.; Reiss G.R.;
Xu K.; Mehran R.; Stone G.W.
Institution
(Genereux, Bernard, Rosner, Reiss, Xu, Stone) Columbia University Medical
Center, Cardiovascular Research Foundation, 111 E 59th St, 11th Floor, New
York, NY 10022, United States
(Genereux) Hopital du Sacre-Coeur de Montreal, Universite de Montreal,
Montreal, QC, Canada
(Palmerini) Istituto di Cardiologia, University of Bologna, Bologna, Italy
(Caixeta) Escola Paulista de Medicina, Universidade Federal de Sao Paulo,
Hospital Israelita Albert Einstein, Sao Paulo, Brazil
(Mehran) Mount Sinai Medical Center, New York, NY, United States
Publisher
EuroPCR
Abstract
Aims: We sought to describe the incidence, predictors, and impact of
adverse neurological events (NE) in a non-ST-segment elevation acute
coronary syndromes (NSTEACS) population undergoing percutaneous coronary
intervention (PCI), coronary artery bypass grafting (CABG), or medical
therapy (MT). Methods and Results: 13,819 patients with moderate and
high-risk NSTEACS were enrolled in the prospective ACUITY trial.
Angiography was performed within 72 hours of presentation, after which
7,789 patients (56.4%) underwent PCI, 1,539 (11.1%) underwent CABG, and
4,491 (32.5%) received MT. The rate of NE (stroke or transient ischaemic
attack) at 30 days and one year and its relationship to adverse ischaemic
events, including death, were assessed. Thirty-day rates of NE were 1.1%
with CABG, 0.3% with PCI, and 0.5% with MT (p<0.001). One-year rates of NE
were 1.1% with CABG, 0.3% with PCI, and 0.6% with MT (p<0.001).
Independent predictors of NE at 30 days and one year included age, renal
insufficiency, baseline troponin elevation, and initial treatment with
CABG. The occurrence of NE was a strong independent predictor of death at
30 days and one year (HR 4.07, 95% CI [1.49, 11.11], p=0.006, and HR 4.25,
95% CI [2.37, 7.62], p<0.001, respectively). Conclusion(s): In the
large-scale ACUITY trial, CABG was associated with a higher risk of NE at
30 days and one year compared to PCI and MT. The occurrence of NE in
patients with NSTEACS was strongly associated with increased early and
late mortality. Clinical Trials.gov Identifier NCT00093158. Copyright
© Europa Digital & Publishing 2015. All rights reserved.

<176>
[Use Link to view the full text]
Accession Number
606242201
Title
Meta-analysis of cell-based CaRdiac stUdiEs (ACCRUE) in patients with
acute myocardial infarction based on individual patient data.
Source
Circulation Research. 116 (8) (pp 1346-1360), 2015. Date of Publication:
10 Apr 2015.
Author
Gyongyosi M.; Wojakowski W.; Lemarchand P.; Lunde K.; Tendera M.; Bartunek
J.; Marban E.; Assmus B.; Henry T.D.; Traverse J.H.; Moye L.A.; Surder D.;
Corti R.; Huikuri H.; Miettinen J.; Wohrle J.; Obradovic S.; Roncalli J.;
Malliaras K.; Pokushalov E.; Romanov A.; Kastrup J.; Bergmann M.W.; Atsma
D.E.; Diederichsen A.; Edes I.; Benedek I.; Benedek T.; Pejkov H.;
Nyolczas N.; Pavo N.; Bergler-Klein J.; Pavo I.J.; Sylven C.; Berti S.;
Navarese E.P.; Maurer G.
Institution
(Gyongyosi, Pavo, Bergler-Klein, Pavo, Maurer) Cardiology Department,
Medical University of Vienna, Wahringer Gurtel 18-20, Vienna A-1090,
Austria
(Wojakowski, Tendera) Third Department of Cardiology, School of Medicine
in Katowice, Medical University of Silesia, Katowice, Poland
(Lemarchand) Inserm, UMR1087, CNRS UMR6291, University of Nantes, Nantes,
France
(Lunde) Cardiology Department, Rikshospitalet University Hospital, Oslo,
Norway
(Bartunek) Cardiovascular Center, OLV Hospital, Aalst, Belgium
(Marban, Henry, Malliaras) Cedars-Sinai Heart Institute, Los Angeles, CA,
United States
(Assmus) Cardiology Division, Department of Medicine III, Goethe
University Frankfurt, Frankfurt, Germany
(Traverse) Minneapolis Heart Institute, Abbott Northwestern Hospital,
Minneapolis, MN, United States
(Moye) Coordinating Center for Clinical Trials, University of Texas School
of Public Health, Houston, United States
(Surder) Cardiology Division, Cardiovascular Center, University Hospital,
Zurich, Switzerland
(Surder, Corti) Fondazione Cardiocentro Ticino, Lugano, Switzerland
(Corti) Heart Clinic Hirslanden, Zurich, Switzerland
(Huikuri, Miettinen) Department of Internal Medicine, Institute of
Clinical Medicine, Medical Research Center, University of Oulu, Finland
(Wohrle) Cardiology Department, University of Ulm, Ulm, Germany
(Obradovic) Clinic of Emergency Medicine, Military Medical Academy,
Belgrade, Serbia
(Roncalli) Cardiology Division, Institute CARDIOMET, CIC Biotherapies,
University Hospital of Toulouse, France
(Pokushalov, Romanov) State Research Institute of Circulation Pathology,
Novosibirsk, Russian Federation
(Kastrup) Cardiology Department, Rigshospitalet, Copenhagen University,
Copenhagen, Denmark
(Bergmann) Asklepios Klinik St. Georg, Hamburg, Germany
(Atsma) Cardiology Department, Leiden University Medical Center, Leiden,
Netherlands
(Diederichsen) Cardiology Department, Odense University Hospital, Denmark
(Edes) Cardiology Department, University of Debrecen, Hungary
(Benedek, Benedek) Cardiology Department, University of Tirgu Mures,
Romania
(Pejkov) University Clinic for Cardiology, Skopje, North Macedonia
(Nyolczas) Medical Centre, Hungarian Defense Forces, Budapest, Hungary
(Sylven) Karolinska Institute, Stockholm, Sweden
(Berti) Invasive Cardiology, National Research Council Institute of
Clinical Physiology (CNR-IFC), Pisa, Italy
(Navarese) Internal Medicine, Division of Cardiology, Pulmonology and
Vascular Medicine, Heinrich-Heine-University, Dusseldorf, Germany
(Navarese) Systematic Investigation and Research on Interventions and
Outcomes MEDICINE Research Network, 10th Military Research Hospital and
Polyclinic, Bydgoszcz, Poland
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
Rationale: The meta-Analysis of Cell-based CaRdiac study is the first
prospectively declared collaborative multinational database, including
individual data of patients with ischemic heart disease treated with cell
therapy. Objective(s): We analyzed the safety and efficacy of
intracoronary cell therapy after acute myocardial infarction (AMI),
including individual patient data from 12 randomized trials (ASTAMI,
Aalst, BOOST, BONAMI, CADUCEUS, FINCELL, REGENT, REPAIR-AMI, SCAMI,
SWISS-AMI, TIME, LATE-TIME; n=1252). Methods and Results: The primary
end point was freedom from combined major adverse cardiac and
cerebrovascular events (including all-cause death, AMI recurrance, stroke,
and target vessel revascularization). The secondary end point was freedom
from hard clinical end points (death, AMI recurrence, or stroke), assessed
with random-effects meta-analyses and Cox regressions for interactions.
Secondary efficacy end points included changes in end-diastolic volume,
end-systolic volume, and ejection fraction, analyzed with random-effects
meta-analyses and ANCOVA. We reported weighted mean differences between
cell therapy and control groups. No effect of cell therapy on major
adverse cardiac and cerebrovascular events (14.0% versus 16.3%; hazard
ratio, 0.86; 95% confidence interval, 0.63-1.18) or death (1.4% versus
2.1%) or death/AMI recurrence/stroke (2.9% versus 4.7%) was identified in
comparison with controls. No changes in ejection fraction (mean
difference: 0.96%; 95% confidence interval, -0.2 to 2.1), end-diastolic
volume, or systolic volume were observed compared with controls. These
results were not influenced by anterior AMI location, reduced baseline
ejection fraction, or the use of MRI for assessing left ventricular
parameters. Conclusion(s): This meta-analysis of individual patient
data from randomized trials in patients with recent AMI revealed that
intracoronary cell therapy provided no benefit, in terms of clinical
events or changes in left ventricular function. Copyright © 2015
American Heart Association, Inc.

<177>
[Use Link to view the full text]
Accession Number
605325662
Title
Temporal Trends in Quality of Life Outcomes after Transapical
Transcatheter Aortic Valve Replacement: A Placement of AoRTic
TraNscathetER Valve (PARTNER) Trial Substudy.
Source
Circulation: Cardiovascular Quality and Outcomes. 8 (4) (pp 338-346),
2015. Date of Publication: 23 Jul 2015.
Author
Gada H.; Kirtane A.J.; Wang K.; Lei Y.; Magnuson E.; Reynolds M.R.;
Williams M.R.; Kodali S.; Vahl T.P.; Arnold S.V.; Leon M.B.; Thourani V.;
Szeto W.Y.; Cohen D.J.
Institution
(Gada) Robert Wood Johnson Medical School, New Brunswick, NJ, United
States
(Kirtane, Kodali, Vahl, Leon) Columbia University Medical Center, New York
Presbyterian Hospital and the Cardiovascular Research Foundation, New
York, NY, United States
(Wang, Lei, Magnuson, Arnold, Cohen) Saint Luke's Mid America Heart
Institute, University of Missouri-Kansas City School of Medicine, 4401
Wornall Rd, Kansas City, MO 64111, United States
(Reynolds) Lahey Hospital and Medical Center, Burlington, MA, United
States
(Reynolds) Harvard Clinical Research Institute, Boston, MA, United States
(Williams) NYU Langone Medical Center, New York, NY, United States
(Thourani) Emory University School of Medicine, Atlanta, GA, United States
(Szeto) University of Pennsylvania School of Medicine, Philadelphia,
United States
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
Background - In the Placement of AoRTic TraNscathetER Valve (PARTNER)
randomized controlled trial (RCT), which represented the first exposure to
transapical transcatheter aortic valve replacement (TA-TAVR) for many
clinical sites, high-risk patients undergoing TA-TAVR derived similar
health-related quality of life (HRQoL) outcomes when compared with
surgical aortic valve replacement (SAVR). With increasing experience, it
is possible that HRQoL outcomes of TA-TAVR may have improved. Methods and
Results - We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups
among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized
continued access (NRCA) registry and compared these outcomes with those of
the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with
the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes
Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary
score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR
and SAVR groups were generally similar. The primary outcome, the KCCQ
summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR
group at any follow-up timepoints, although there were small differences
in favor of the NRCA cohort on several KCCQ subscales at 1 month. There
were no significant differences in follow-up HRQOL between the NRCA-TAVR
and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the
disease-specific or generic subscales. Conclusions - Despite greater
experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained
similar to those of TA-TAVR in the original RCT cohort and no better than
those with SAVR. These findings have important implications for patient
selection for TAVR when transfemoral access is not an
option. Copyright © 2015 American Heart Association, Inc.

<178>
Accession Number
607075138
Title
Effect of intravascular ultrasound-guided vs angiography- guided
everolimus-eluting stent implantation: The IVUS-XPL randomized clinical
trial.
Source
JAMA - Journal of the American Medical Association. 314 (20) (pp
2155-2163), 2015. Date of Publication: 24 Nov 2015.
Author
Hong S.-J.; Kim B.-K.; Shin D.-H.; Nam C.-M.; Kim J.-S.; Ko Y.G.; Choi D.;
Kang T.-S.; Kang W.-C.; Her A.-Y.; Kim Y.; Hur S.-H.; Hong B.-K.; Kwon H.;
Jang Y.; Hong M.-K.; Yang J.-Y.; Cheon D.W.; Lee S.W.; Kim B.-O.; Ahn
C.-M.; Chang H.-J.; Choi S.-H.; Cho D.-K.; Choi E.-Y.; Shim J.-Y.; Yoon
S.-J.; Kim J.-Y.; Hong M.K.; Lee S.-G.; Yoon J.H.; Jeon D.-W.; Cho Y.-H.;
Choi J.-W.; Rhee S.-J.; Choi R.-K.; Lee S.-Y.; Kim W.-H.; Lee N.-H.; Hong
Y.-J.; Choi H.-H.; Park J.-P.; Lim S.-W.
Institution
(Hong) Department of Internal Medicine, Sanggye Paik Hospital, Inje
University, Seoul, South Korea
(Hong, Kim, Shin, Kim, Ko, Choi, Jang, Hong) Division of Cardiology,
Severance Cardiovascular Hospital, Yonsei University College of Medicine,
Seoul, South Korea
(Nam) Department of Preventive Medicine and Biostatistics, Yonsei
University College of Medicine, Seoul, South Korea
(Kang) Dankook University College of Medicine, Cheonan, South Korea
(Kang) Gil Hospital, Gachon University College of Medicine, Incheon, South
Korea
(Her, Kim) School of Medicine, Kangwon National University, Chuncheon,
South Korea
(Hur) Keimyung University College of Medicine, Daegu, South Korea
(Hong, Kwon) Kangnam Severance Hospital, Seoul, South Korea
(Jang, Hong) Severance Biomedical Science Institute, Yonsei University
College of Medicine, Division of Cardiology, Severance Cardiovascular
Hospital, 134 Sinchon-dong, Seodaemun-gu, Seoul 120-752, South Korea
(Jang, Hong) Cardiovascular Research Institute, Yonsei University College
of Medicine, Seoul, South Korea
(Hong) Yonsei University College of Medicine, Seoul, South Korea
(Hong) GSH, Seoul, South Korea
(Lee) Ulsan University Hospital, Ulsan, South Korea
(Yoon) Wonju Christian Hospital, Wonju, South Korea
(Yoon) GGUH, Incheon, South Korea
(Jeon) DUH, Cheonan, South Korea
(Jeon) NHIC Ilsan Hospital, Ilsan, South Korea
(Cho) Myongji Hospital, Goyang, South Korea
(Choi) Seoul Eulji Hospital, Seoul, South Korea
(Rhee) Wonkwang University Hospital, Iksan, South Korea
(Choi) Sejong General Hospital, Bucheon, South Korea
(Lee) Inje University Ilsan Paik Hosital, Ilsan, South Korea
(Kim) KUDH, Daegu, South Korea
(Kim) Daejeon Eulji University Hospital, Dae-jeon, South Korea
(Lee) Hallym University Kangnam Sacred Heart Hospital, Seoul, South Korea
(Lee) KNUH, Chuncheon, South Korea
(Hong) Chunnam National University Hospital, Kwangju, South Korea
(Choi) Hallym University Chunchun Scared Hospital, Chuncheon, South Korea
(Park) Jeonnju Presbyterian Medical Center, Jeonju, South Korea
(Lim) CHA University Medical Center, Seongnam, South Korea
Publisher
American Medical Association (E-mail: smcleod@itsa.ucsf.edu)
Abstract
IMPORTANCE:Use of intravascular ultrasound (IVUS) promotes better clinical
outcomes for coronary intervention in complex coronary lesions. However,
randomized data demonstrating the clinical usefulness of IVUS are limited
for lesions treated with drug-eluting stents. OBJECTIVE(S):To
determine whether the long-term clinical outcomes with IVUS-guided
drug-eluting stent implantation are superior to those with
angiography-guided implantation in patients with long coronary lesions.
DESIGN, SETTING, AND PARTICIPANTS: The Impact of Intravascular Ultrasound
Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL)
randomized, multicenter trial was conducted in 1400 patients with long
coronary lesions (implanted stent>=28 mmin length) between October 2010
and July 2014 at 20 centers in Korea. INTERVENTIONS: Patients were
randomly assigned to receive IVUS-guided (n = 700) or angiography-guided
(n = 700) everolimus-eluting stent implantation. MAIN OUTCOMES AND
MEASURES: Primary outcome measure was the composite of major adverse
cardiac events, including cardiac death, target lesion-related myocardial
infarction, or ischemia-driven target lesion revascularization at 1 year,
analyzed by intention-to-treat. RESULT(S): One-year follow-up was
complete in 1323 patients (94.5%). Major adverse cardiac events at 1 year
occurred in 19 patients (2.9%) undergoing IVUS-guided and in 39 patients
(5.8%) undergoing angiography-guided stent implantation (absolute
difference, -2.97% [95% CI, -5.14%to -0.79%]) (hazard ratio [HR], 0.48
[95% CI, 0.28 to 0.83], P = .007). The difference was driven by a lower
risk of ischemia-driven target lesion revascularization in patients
undergoing IVUS-guided (17 [2.5%]) compared with angiography-guided (33
[5.0%]) stent implantation (HR, 0.51 [95% CI, 0.28 to 0.91], P = .02).
Cardiac death and target lesion-related myocardial infarction were not
significantly different between the 2 groups. For cardiac death, there
were 3 patients (0.4%) in the IVUS-guided group and 5 patients (0.7%) in
the angiography-guided group (HR, 0.60 [95% CI, 0.14 to 2.52], P = .48).
Target lesion-related myocardial infarction occurred in 1 patient (0.1%)
in the angiography-guided stent implantation group (P = .32). CONCLUSIONS
AND RELEVANCE: Among patients requiring long coronary stent implantation,
the use of IVUS-guided everolimus-eluting stent implantation, compared
with angiography-guided stent implantation, resulted in a significantly
lower rate of the composite of major adverse cardiac events at 1 year.
These differences were primarily due to lower risk of target lesion
revascularization. Copyright © 2015 American Medical Association.
All rights reserved.

<179>
Accession Number
605989402
Title
Bivalirudin or unfractionated heparin in acute coronary syndromes.
Source
New England Journal of Medicine. 373 (11) (pp 997-1009), 2015. Date of
Publication: 10 Sep 2015.
Author
Valgimigli M.; Frigoli E.; Leonardi S.; Rothenbuhler M.; Gagnor A.;
Calabro P.; Garducci S.; Rubartelli P.; Briguori C.; Ando G.; Repetto A.;
Limbruno U.; Garbo R.; Sganzerla P.; Russo F.; Lupi A.; Cortese B.;
Ausiello A.; Ierna S.; Esposito G.; Presbitero P.; Santarelli A.; Sardella
G.; Varbella F.; Tresoldi S.; De Cesare N.; Rigattieri S.; Zingarelli A.;
Tosi P.; Van't Hof A.; Boccuzzi G.; Omerovic E.; Sabate M.; Heg D.; Juni
P.; Vranckx P.
Institution
(Valgimigli) Swiss Cardiovascular Center Bern, Bern University Hospital,
University of Bern, Bern CH-3010, Switzerland
(Rothenbuhler, Heg) Clinical Trials Unit, Institute of Social and
Preventive Medicine, University of Bern, Bern, Switzerland
(Juni) Institute of Primary Health Care, University of Bern, Bern,
Switzerland
(Valgimigli) Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
(Van't Hof) Isala Klinieken, Zwolle, Netherlands
(Frigoli) EUSTRATEGY Association, Forli, Italy
(Leonardi, Repetto) Unita Operativa Complessa Cardiologia, Dipartimento
CardioToracoVascolare, Fondazione IRCCS Policlinico San Matteo, Pavia,
Italy
(Gagnor, Varbella) Cardiology Unit, Ospedali Riuniti di Rivoli, Italy
(Garbo, Boccuzzi) San Giovanni Bosco Hospital, Turin, Italy
(Calabro) Division of Cardiology, Department of Cardiothoracic Sciences,
Second University of Naples, Italy
(Esposito) Department of Advanced Biomedical Sciences, Division of
Cardiology, Federico II University of Naples, Italy
(Briguori) Clinica Mediterranea, Naples, Italy
(Garducci) Azienda Ospedaliera Ospedale Civile di Vimercate, Desio, Italy
(Rubartelli) Department of Cardiology, ASL3 Ospedale Villa Scassi, Italy
(Zingarelli) IRCCS Azienda Ospedaliera Universitaria San Martino, Genoa,
Italy
(Ando) Azienda Ospedaliera Universitaria Policlinico Gaetano Martino,
University of Messina, Messina, Italy
(Limbruno) Unita Operativa Cardiologia, ASL 9 Grosseto, Grosseto, Italy
(Sganzerla) Azienda Ospedaliera Ospedale Treviglio-Caravaggio, Treviglio,
Italy
(Russo) Azienda Ospedaliera Sant'Anna, Como, Italy
(Lupi) University Hospital Maggiore della Carita, Novara, Italy
(Cortese) Ospedale Fatebenefratelli, Milan, Italy
(Ausiello) Casa di Cura Villa Verde, Taranto, Italy
(Ierna) Ospedale Sirai-Carbonia, Carbonia, Italy
(Presbitero) IRCCS Humanitas, Rozzano, Italy
(Santarelli) Cardiovascular Department, Infermi Hospital, Rimini, Italy
(Sardella) Policlinico Umberto i, Sapienza University of Rome, Italy
(Rigattieri) Interventional Cardiology Unit, Sandro Pertini Hospital Rome,
Rome, Italy
(Tresoldi) Azienda Ospedaliera Ospedale di Desio, Desio, Italy
(De Cesare) Policlinico San Marco, Zingonia, Italy
(Tosi) Mater Salutis Hospital, Legnago, Italy
(Omerovic) Sahlgrenska University Hospital, Goteborg, Sweden
(Sabate) Hospital Clinic, University of Barcelona, Thorax Institute,
Department of Cardiology, Barcelona, Spain
(Vranckx) Department of Cardiology and Critical Care Medicine, Hartcentrum
Hasselt, Jessa Ziekenhuis, Hasselt, Belgium
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND Conflicting evidence exists on the efficacy and safety of
bivalirudin administered as part of percutaneous coronary intervention
(PCI) in patients with an acute coronary syndrome. METHODS We randomly
assigned 7213 patients with an acute coronary syndrome for whom PCI was
anticipated to receive either bivalirudin or unfractionated heparin.
Patients in the bivalirudin group were subsequently randomly assigned to
receive or not to receive a post-PCI bivalirudin infusion. Primary
outcomes for the comparison between bivalirudin and heparin were the
occurrence of major adverse cardiovascular events (a composite of death,
myocardial infarction, or stroke) and net adverse clinical events (a
composite of major bleeding or a major adverse cardiovascular event). The
primary outcome for the comparison of a post-PCI bivalirudin infusion with
no post-PCI infusion was a composite of urgent target-vessel
revascularization, definite stent thrombosis, or net adverse clinical
events. RESULTS The rate of major adverse cardiovascular events was not
significantly lower with bivalirudin than with heparin (10.3% and 10.9%,
respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to
1.09; P = 0.44), nor was the rate of net adverse clinical events (11.2%
and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P =
0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did
not significantly decrease the rate of urgent target-vessel
revascularization, definite stent thrombosis, or net adverse clinical
events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74
to 1.11; P = 0.34). CONCLUSIONS In patients with an acute coronary
syndrome, the rates of major adverse cardiovascular events and net adverse
clinical events were not significantly lower with bivalirudin than with
unfractionated heparin. The rate of the composite of urgent target-vessel
revascularization, definite stent thrombosis, or net adverse clinical
events was not significantly lower with a post-PCI bivalirudin infusion
than with no post-PCI infusion. (Funded by the Medicines Company and
Terumo Medical; MATRIX ClinicalTrials.gov number,
NCT01433627.) Copyright © 2015 Massachusetts Medical Society. All
rights reserved.

<180>
Accession Number
604492042
Title
Benefits and risks of extended duration dual antiplatelet therapy after
PCI in patients with and without acute myocardial infarction.
Source
Journal of the American College of Cardiology. 65 (20) (pp 2211-2221),
2015. Date of Publication: 26 May 2015.
Author
Yeh R.W.; Kereiakes D.J.; Steg P.G.; Windecker S.; Rinaldi M.J.; Gershlick
A.H.; Cutlip D.E.; Cohen D.J.; Tanguay J.-F.; Jacobs A.; Wiviott S.D.;
Massaro J.M.; Iancu A.C.; Mauri L.
Institution
(Yeh) Massachusetts General Hospital, Boston, MA, United States
(Yeh, Cutlip, Massaro, Mauri) Harvard Clinical Research Institute, Boston,
MA, United States
(Yeh, Cutlip, Wiviott, Mauri) Harvard Medical School, Boston, MA, United
States
(Kereiakes) Christ Hospital Heart and Vascular Center, Lindner Center for
Research and Education, Cincinnati, OH, United States
(Steg) Universite Paris-Diderot, Paris, France, INSERM U-1148, Paris,
France
(Steg) Hopital Bichat, Departement Hospitalo-Universitaire FIRE,
Assistance Publique-Hopitaux de Paris, Paris, France
(Steg) NHLI, Imperial College, Royal Brompton Hospital, London, United
Kingdom
(Windecker) Bern University Hospital, Bern, Switzerland
(Rinaldi) Sanger Heart and Vascular Institute, Carolinas HealthCare
System, Charlotte, NC, United States
(Gershlick) Department of Cardiovascular Sciences, University of
Leicester, University Hospitals of Leicester, Leicester, United Kingdom
(Cutlip) Beth Israel Deaconess Medical Center, Boston, MA, United States
(Cohen) Saint Luke's Mid-America Heart Institute, University of
Missouri-Kansas City School of Medicine, Kansas City, MO, United States
(Tanguay) Montreal Heart Institute, Universite de Montreal, Montreal,
Canada
(Jacobs) Boston Medical Center, Boston University School of Medicine,
Boston, MA, United States
(Wiviott, Mauri) Brigham and Women's Hospital, Boston, MA, United States
(Massaro) Boston University School of Public Health, Boston, MA, United
States
(Iancu) Heart Institute, University of Medicine Iuliu Hatieganu, Cluj
Napoca, Romania
Publisher
Elsevier USA
Abstract
Background The benefits and risks of prolonged dual antiplatelet therapy
may be different for patients with acute myocardial infarction (MI)
compared with more stable presentations. Objectives This study sought to
assess the benefits and risks of 30 versus 12 months of dual antiplatelet
therapy among patients undergoing coronary stent implantation with and
without MI. Methods The Dual Antiplatelet Therapy Study, a randomized
double-blind, placebo-controlled trial, compared 30 versus 12 months of
dual antiplatelet therapy after coronary stenting. The effect of continued
thienopyridine on ischemic and bleeding events among patients initially
presenting with versus without MI was assessed. The coprimary endpoints
were definite or probable stent thrombosis and major adverse
cardiovascular and cerebrovascular events (MACCE). The primary safety
endpoint was GUSTO (Global Utilization of Streptokinase and Tissue
Plasminogen Activator for Occluded Arteries) moderate or severe bleeding.
Results Of 11,648 randomized patients (9,961 treated with drug-eluting
stents, 1,687 with bare-metal stents), 30.7% presented with MI. Between 12
and 30 months, continued thienopyridine reduced stent thrombosis compared
with placebo in patients with and without MI at presentation (MI group,
0.5% vs. 1.9%, p < 0.001; no MI group, 0.4% vs. 1.1%, p < 0.001;
interaction p = 0.69). The reduction in MACCE for continued thienopyridine
was greater for patients with MI (3.9% vs. 6.8%; p < 0.001) compared with
those with no MI (4.4% vs. 5.3%; p = 0.08; interaction p = 0.03). In both
groups, continued thienopyridine reduced MI (2.2% vs. 5.2%, p < 0.001 for
MI; 2.1% vs. 3.5%, p < 0.001 for no MI; interaction p = 0.15) but
increased bleeding (1.9% vs. 0.8%, p = 0.005 for MI; 2.6% vs. 1.7%, p =
0.007 for no MI; interaction p = 0.21). Conclusions Compared with 12
months of therapy, 30 months of dual antiplatelet therapy reduced the risk
of stent thrombosis and MI in patients with and without MI, and increased
bleeding. (The Dual Antiplatelet Therapy Study [The DAPT Study];
NCT00977938) Copyright © 2015 American College of Cardiology
Foundation.

<181>
Accession Number
605794449
Title
Transfemoral vs Non-transfemoral Access for Transcatheter Aortic Valve
Implantation: A Systematic Review and Meta-analysis.
Source
Canadian Journal of Cardiology. 31 (12) (pp 1427-1438), 2015. Date of
Publication: 2015.
Author
Chandrasekhar J.; Hibbert B.; Ruel M.; Lam B.-K.; Labinaz M.; Glover C.
Institution
(Chandrasekhar, Hibbert, Labinaz, Glover) University of Ottawa Heart
Institute, CAPITAL Research Group, Division of Cardiology, Ottawa, ON,
Canada
(Ruel, Lam) Division of Cardiac Surgery, University of Ottawa Heart
Institute, Ottawa, ON, Canada
(Chandrasekhar) Icahn School of Medicine at Mount Sinai, New York, NY,
United States
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Background: Transcatheter aortic valve implantation (TAVI) is the
definitive therapy for high-risk patients with severe aortic stenosis. The
aim of this study was to determine the effect of non-transfemoral access
on clinical outcomes in TAVI. Method(s): We conducted a computerized
literature search on SCOPUS and selected all studies published in the
English language, from 2002 until March 12 2014, that compared
transfemoral access with a non-transfemoral access cohort. Two independent
reviewers evaluated the studies and extracted data for analysis.
 Result(s): A total 17,020 patients (11,079 transfemoral, 5941
non-transfemoral) encompassing 28 studies underwent TAVI between 2007 to
2013. Overall, the 30-day mortality was 4.7% with the transfemoral
approach and 8.1% with a non-transfemoral approach (odds ratio [OR], 0.56;
95% confidence interval [CI], 0.49-0.64; P < 0.01). The 1-year mortality
was 16.4% with transfemoral access and 24.8% with non-transfemoral access
(OR, 0.68; 95% CI, 0.60-0.75; P < 0.01). Transfemoral access was
associated with a greater incidence of vascular complications (OR, 2.1;
95% CI, 1.48-2.99; P < 0.01) but a lower rate of surgical conversion (OR,
0.59; 95% CI, 0.42-0.81; P < 0.01) and similar bleeding (OR, 1.01; 95% CI,
0.81-1.27; P = 0.91) compared with non-transfemoral access. The incidence
of cerebrovascular events was similar in both groups (1.6% vs 2.1%; OR,
0.86; 95% CI, 0.64-1.15; P = 0.31). Conclusion(s): Transfemoral
access was associated with lower rate of 30-day and 1-year mortality
compared with non-transfemoral access for TAVI. Randomized studies are
needed to ascertain the effect of alternative access sites on clinical
outcomes in prohibitive-risk, high-risk, and intermediate-risk
populations, using currently available technologies. Copyright ©
2015 Canadian Cardiovascular Society.

<182>
Accession Number
606357917
Title
Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): A
randomised, double-blind, placebo-controlled trial.
Source
The Lancet. 386 (10000) (pp 1243-1253), 2015. Date of Publication: 26 Sep
2015.
Author
Whitlock R.P.; Devereaux P.J.; Teoh K.H.; Lamy A.; Vincent J.; Pogue J.;
Paparella D.; Sessler D.I.; Karthikeyan G.; Villar J.C.; Zuo Y.; Avezum
A.; Quantz M.; Tagarakis G.I.; Shah P.J.; Abbasi S.H.; Zheng H.; Pettit
S.; Chrolavicius S.; Yusuf S.
Institution
(Whitlock, Devereaux, Lamy, Vincent, Pogue, Pettit, Chrolavicius, Yusuf)
Population Health Research Institute, Hamilton Health Sciences and
McMaster University, Hamilton, ON L8L 2X2, Canada
(Whitlock, Lamy) Department of Surgery, McMaster University, Hamilton, ON,
Canada
(Whitlock, Devereaux, Lamy) Department of Clinical Epidemiology and
Biostatistics, McMaster University, Hamilton, ON, Canada
(Devereaux, Yusuf) Department of Medicine, McMaster University, Hamilton,
ON, Canada
(Teoh) Department of Surgery, Southlake Regional Health Centre, Newmarket,
ON, Canada
(Paparella) University of Bari Aldo Moro, Bari, Italy
(Sessler) Department of Outcomes Research, Cleveland Clinic, Cleveland,
OH, United States
(Karthikeyan) All India Institute of Medical Sciences, New Delhi, India
(Villar) Fundacion Cardio Infantil, Instituto de Cardiologia, Bogota,
Colombia
(Zuo) Department of Anesthesiology, West China Hospital, Sichuan
University, Chengdu, China
(Avezum) Divisao de Pesquisa, Instituto Dante Pazzanese de Cardiologia,
Sao Paulo, Brazil
(Quantz) London Health Sciences Centre, London, ON, Canada
(Tagarakis) Department of Cardiovascular and Thoracic Surgery, University
of Thessaly, Larissa, Greece
(Shah) Princess Alexandra Hospital, Woolloongabba, Brisbane, QLD,
Australia
(Abbasi) Tehran Heart Centre, Tehran University of Medical Sciences,
Tehran, Iran, Islamic Republic of
(Zheng) First Teaching Hospital, Xinjiang Medical University, Urumqi,
China
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background Cardiopulmonary bypass initiates a systemic inflammatory
response syndrome that is associated with postoperative morbidity and
mortality. Steroids suppress inflammatory responses and might improve
outcomes in patients at high risk of morbidity and mortality undergoing
cardiopulmonary bypass. We aimed to assess the effects of steroids in
patients at high risk of morbidity and mortality undergoing
cardiopulmonary bypass. Methods The Steroids In caRdiac Surgery (SIRS)
study is a double-blind, randomised, controlled trial. We used a central
computerised phone or interactive web system to randomly assign (1:1)
patients at high risk of morbidity and mortality from 80 hospital or
cardiac surgery centres in 18 countries undergoing cardiac surgery with
the use of cardiopulmonary bypass to receive either methylprednisolone
(250 mg at anaesthetic induction and 250 mg at initiation of
cardiopulmonary bypass) or placebo. Patients were assigned with block
randomisation with random block sizes of 2, 4, or 6 and stratified by
centre. Patients aged 18 years or older were eligible if they had a
European System for Cardiac Operative Risk Evaluation of at least 6.
Patients were excluded if they were taking or expected to receive systemic
steroids in the immediate postoperative period or had a history of
bacterial or fungal infection in the preceding 30 days. Patients,
caregivers, and those assessing outcomes were masked to allocation. The
primary outcomes were 30-day mortality and a composite of death and major
morbidity (ie, myocardial injury, stroke, renal failure, or respiratory
failure) within 30 days, both analysed by intention to treat. Safety
outcomes were also analysed by intention to treat. This study is
registered with ClinicalTrials.gov, number NCT00427388. Findings Patients
were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day
data was available for all 7507 patients randomly assigned to
methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone,
compared with placebo, did not reduce the risk of death at 30 days (154
[4%] vs 177 [5%] patients; relative risk [RR] 0.87, 95% CI 0.70-1.07,
p=0.19) or the risk of death or major morbidity (909 [24%] vs 885 [24%];
RR 1.03, 95% CI 0.95-1.11, p=0.52). The most common safety outcomes in the
methylprednisolone and placebo group were infection (465 [12%] vs 493
[13%]), surgical site infection (151 [4%] vs 151 [4%]), and delirium (295
[8%] vs 289 [8%]). Interpretation Methylprednisolone did not have a
significant effect on mortality or major morbidity after cardiac surgery
with cardiopulmonary bypass. The SIRS trial does not support the routine
use of methylprednisolone for patients undergoing cardiopulmonary bypass.
Funding Canadian Institutes of Health Research. Copyright © 2015
Elsevier Ltd.

<183>
Accession Number
603700041
Title
Reduced dose tenecteplase and outcomes in elderly ST-segment elevation
myocardial infarction patients: Insights from the STrategic Reperfusion
Early after Myocardial infarction trial.
Source
American Heart Journal. 169 (6) (pp 890-898.e1), 2015. Date of
Publication: 01 Jun 2015.
Author
Armstrong P.W.; Zheng Y.; Westerhout C.M.; Rosell-Ortiz F.; Sinnaeve P.;
Lambert Y.; Lopes R.D.; Bluhmki E.; Danays T.; Van De Werf F.
Institution
(Armstrong, Zheng, Westerhout) Canadian VIGOUR Centre, University of
Alberta, 2-132 Li Ka Shing Centre for Health Research Innovation,
Edmonton, AB T6G 2E1, Canada
(Rosell-Ortiz) Empresa Publica de Emergencias Sanitarias, Almeria, Spain
(Sinnaeve, Van De Werf) Department of Cardiology, University Hospital
Gasthuisberg, Leuven, Belgium
(Lambert) Centre Hospitalier de Versailles, SAMU 78 and Mobile Intensive
Care Unit, Versailles, France
(Lopes) Duke University Medical Centre, Duke Clinical Research Institute,
Durham, NC, United States
(Bluhmki) Boehringer Ingelheim, Berkshire, United Kingdom
(Danays) Boehringer Ingelheim France, Reims, France
Publisher
Mosby Inc. (E-mail: customerservice@mosby.com)
Abstract
Background Elderly patients with ST-segment elevation myocardial
infarction (STEMI) have worse outcomes and a greater risk of intracranial
bleeding than nonelderly patients. Baseline characteristics, clinical
outcomes, and the relationship of the tenecteplase (TNK) dose reduction to
the efficacy, safety, and electrocardiographic indicators of reperfusion
efficacy were evaluated in STEMI patients >=75 years. Methods The STREAM
trial evaluated early presenting STEMI patients who could not undergo
primary percutaneous coronary intervention within 1 hour of first medical
contact. Because of excess intracranial hemorrhage (ICH) in patients >=75
years, the dose of TNK was reduced by 50%. Results Before dose amendment,
there were 3 (7.1%) of 42 elderly patients with ICH; 2 of these were
fatal, whereas no ICH occurred in the 93 elderly patients who received
half-dose TNK postamendment. The median extent of ST-segment elevation
resolution (>=50%) and proportion of patients with >=2 mm in the
electrocardiogram lead with greatest ST-segment elevation was comparable
in elderly patients preamendment and postamendment (63.2% vs 56.0% and
43.6% vs 40.0%, respectively). Patients requiring rescue coronary
intervention after TNK was also similar (42.9% vs 44.1%). The primary
composite end point (30-day all-cause death, cardiogenic shock, congestive
heart failure, and reinfarction) was 31.0% before versus 24.7%
postamendment. onclusions Our data, from a modest-sized population of
elderly STEMI patients, indicate that half-dose TNK reduces the likelihood
of ICH without compromising reperfusion efficacy. These observations are
hypothesis generating and warrant further confirmation in randomized
clinical trials in the elderly. Copyright © 2015 Elsevier Inc.
All rights reserved.

<184>
Accession Number
612650365
Title
Randomized, double-blinded, placebo-controlled trial Of fibrinogen
concentrate supplementation after complex cardiac surgery.
Source
Journal of the American Heart Association. 4 (6) (no pagination), 2015.
Article Number: e002066. Date of Publication: 2015.
Author
Ranucci M.; Baryshnikova E.; Crapelli G.B.; Rahe-Meyer N.; Menicanti L.;
Frigiola A.; Castelvecchio S.; Pistuddi V.; Trimarchi S.; Carlucci C.;
Varrica A.; Satriano A.; Rovere M.T.L.
Institution
(Ranucci, Baryshnikova, Crapelli) Department of Cardiothoracic, Vascular
Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Milan, Italy
(Menicanti, Frigiola) Department of Cardiac Surgery, IRCCS Policlinico San
Donato, Milan, Italy
(Rahe-Meyer) Clinic for Anesthesiology and Intensive Care Medicine,
Hannover Medical School, Hannover, Germany
(Ranucci, Baryshnikova, Menicanti, Frigiola, Castelvecchio, Pistuddi,
Trimarchi, Carlucci, Varrica, Satriano) San Donato Milanese, Milan, Italy
(Rovere) Montescano, Pavia, Italy
Publisher
American Heart Association Inc.
Abstract
Background-Postoperative bleeding after heart operations is still a common
finding, leading to allogeneic blood products transfusion. Fibrinogen and
coagulation factors deficiency are possible determinants of bleeding. The
experimental hypothesis of this study is that a first-line fibrinogen
supplementation avoids the need for fresh frozen plasma (FFP) and reduces
the need for any kind of transfusions. Methods and Results--This was a
single-center, prospective, randomized, placebo-controlled, double-blinded
study. One-hundred sixteen patients undergoing heart surgery with an
expected cardiopulmonary bypass duration >90 minutes were admitted to the
study. Patients in the treatment arm received fibrinogen concentrate after
protamine administration; patients in the control arm received saline
solution. In case of ongoing bleeding, patients in the treatment arm could
receive prothrombin complex concentrates (PCCs) and those in the control
arm saline solution. The primary endpoint was avoidance of any allogeneic
blood product. Patients in the treatment arm had a significantly lower
rate of any allogeneic blood products transfusion (odds ratio, 0.40; 95%
confidence interval, 0.19 to 0.84, P=0.015). The total amount of packed
red cells and FFP units transfused was significantly lower in the
treatment arm. Postoperative bleeding was significantly (P=0.042) less in
the treatment arm (median, 300 mL; interquartile range, 200 to 400 mL)
than in the control arm (median, 355 mL; interquartile range, 250 to 600
mL). Conclusions--Fibrinogen concentrate limits postoperative bleeding
after complex heart surgery, leading to a significant reduction in
allogeneic blood products transfusions. No safety issues were
raised. Copyright © 2015 The Authors.

<185>
Accession Number
602260332
Title
High-dose atorvastatin is superior to moderate-dose simvastatin in
preventing peripheral arterial disease.
Source
Heart. 101 (5) (pp 356-362), 2015. Date of Publication: 01 Mar 2015.
Author
Stoekenbroek R.M.; Boekholdt S.M.; Fayyad R.; Laskey R.; Tikkanen M.J.;
Pedersen T.R.; Hovingh G.K.
Institution
(Stoekenbroek, Hovingh) Department of Vascular Medicine, Academic Medical
Center, Amsterdam, Netherlands
(Boekholdt) Department of Cardiology, Academic Medical Center, Amsterdam,
Netherlands
(Fayyad, Laskey) Pfizer Inc., New York, NY, United States
(Tikkanen) Department of Medicine, Helsinki University Central Hospital,
Helsinki and the Folkhalsan Research Center, Helsinki, Finland
(Pedersen) University of Oslo and Centre of Preventive Medicine, Oslo
University Hospital, Ulleval, Oslo, Norway
(Stoekenbroek) Department of Vascular Medicine, Academic Medical Center,
Meibergdreef 9, 1100 DD, Amsterdam 1105 AZ, Netherlands
Publisher
BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com)
Abstract
Objectives To study whether high-dose versus usualdose statin treatment
reduces the incidence of peripheral artery disease (PAD) and what is the
effect of high-dose statin treatment on cardiovascular disease (CVD)
outcome in patients with PAD. Methods and results In the Incremental
Decrease in End Points Through Aggressive Lipid Lowering trial, 8888
post-myocardial infarction patients were randomised to high-dose or
usual-dose statin therapy (atorvastatin 80 mg/day vs simvastatin 20-40
mg/day). We investigated the effect of high-dose versus usualdose statins
on the pre-specifi ed outcome PAD incidence, and additionally performed a
posthoc analysis of the efficacy of high-dose statins in reducing CVD risk
among patients with PAD. During a median follow-up of 4.8 years, 94
patients (2.2%) receiving atorvastatin and 135 patients (3.2%) receiving
simvastatin developed PAD (HR=0.70, 95% CI 0.53 to 0.91; p=0.007). The
risk of major coronary events was almost twofold higher in patients with
PAD at baseline, but was no longer significant after adjusting for the
adverse cardiovascular risk profile. In PAD patients, major coronary
events occurred in fewer patients in the atorvastatin group (14.4%) than
in the simvastatin group (20.1%), but the difference did not reach
statistical significance. (HR=0.68, 95% CI 0.41 to 1.11; p=0.13).
Atorvastatin treatment significantly reduced overall cardiovascular
(p=0.046) and coronary events ( p=0.004), and coronary revascularisation
(p=0.007) in these patients. Conclusions High-dose statin therapy with
atorvastatin significantly reduced the incidence of PAD compared with
usual-dose statin therapy with simvastatin. Patients with a history of PAD
at baseline were at higher risk of future coronary events and this risk
was reduced by high-dose atorvastatin treatment. Trial registration number
NCT00159835 (URL: http://clinicaltrials.gov/show/NCT00159835).

<186>
Accession Number
611975162
Title
Preoperative estimated glomerular filtration rate and the risk of major
adverse cardiovascular and cerebrovascular events in non-cardiac surgery.
Source
British Journal of Anaesthesia. 113 (4) (pp 644-651), 2014. Date of
Publication: 01 Oct 2014.
Author
Mases A.; Sabate S.; Guilera N.; Sadurni M.; Arroyo R.; Fau M.; Rojo A.;
Castillo J.; Bover J.; Sierra P.; Canet J.; Paniagua P.; Martin B.;
Rivilla M.; Gine M.; Fita G.; Rosa E.P.; Rovira I.; Alcon A.; Sabate A.;
Lacambra M.; Pi A.; Campello D.; Arnal A.; Llorente C.; Mazo V.; Rodryguez
A.; Lopez S.; Calo N.; Laso M.; Subirana M.A.; Andrade J.; Brugal G.;
Ramiro O.; Vilalta T.; Cardenas G.; Parramon F.; Hernandez C.; March X.;
Munoz A.; Ciurana P.; Canadell A.; Jimenez L.; Balev G.; Lomban E.; Martin
C.; Planella T.; Serrat J.; Casbas J.L.; Mahillo L.; Fornaguera J.;
Martinez L.; Villalba M.; Del Pozo D.; Ibanez F.; Garces A.; Alonso A.;
Orrego C.
Institution
(Mases, Sadurni, Arroyo, Fau, Rojo, Castillo) Department of
Anaesthesiology, Parc de Salut Mar, Pg. Maritim 25-29, Barcelona 08003,
Spain
(Sabate, Sierra) Department of Anaesthesiology, Fundacio Puigvert (IUNA),
Barcelona, Spain
(Bover) Department of Nephrology, Fundacio Puigvert (IUNA), Barcelona,
Spain
(Guilera) Department of Anaesthesiology, Hospital de Sabadell, Sabadell,
Spain
(Fau) Department of Anaesthesiology, Vivantes Klinikum Hellersdorf,
Berlin, Germany
(Rojo) Department of Anaesthesiology, Centre Hospitalier Saint Palais,
Sant Palais, France
(Canet) Department of Anaesthesiology, Hospital Germans Trias i Pujol,
Badalona, Spain
(Paniagua, Martin, Rivilla, Gine) Fundacio de Gestio Sanitaria, L Hospital
de la Santa Creu i Sant Pau, Spain
(Fita, Rosa, Rovira, Alcon) Hospital Clinic, Barcelona, Spain
(Sabate, Lacambra, Pi, Campello) Hospital Universitari de Bellvitge, L
Hospitalet de Llobregat, Spain
(Arnal) Fundacio Puigvert (IUNA), Barcelona, Spain
(Llorente, Mazo) Hospital Universitari Germans Trias i Pujol, Badalona,
Spain
(Rodryguez, Lopez, Calo, Laso) Hospital de Sabadell, Spain
(Subirana, Andrade) Hospital Comarcal de L Alt Penedes, Vilafranca Del
Penedes, Spain
(Brugal) Hospital Arnau de Vilanova, Lleida, Spain
(Ramiro) Hospital Universitari de Tarragona Joan XXIII, Spain
(Vilalta, Cardenas) Fundacio Hospital-Asil de Granollers, Spain
(Parramon, Hernandez, March, Munoz) Hospital Universitari Josep Trueta,
Girona, Spain
(Ciurana) Hospital Universitari de la Vall D Hebron, Barcelona, Spain
(Canadell, Jimenez, Balev) Althaia Xarxa Assistencial, Manresa, Spain
(Lomban, Martin) Hospital de Terrassa, Spain
(Planella, Serrat) Hospital General de Vic, Spain
(Casbas, Mahillo) Hospital Sant Rafael, Barcelona, Spain
(Fornaguera, Martinez) Hospital Municipal de Badalona, Spain
(Villalba, Del Pozo) Hospital de la Santa Maria, Lleida, Spain
(Ibanez) Hospital de Sant Jaume, Olot, Spain
(Garces) Hospital Sant Joan de Deu, Barcelona, Spain
(Alonso) Fundacio Sanitaria D Igualada, Spain
(Orrego) Avedis Donabedian Institute, Autonomous University of Barcelona,
CIBER Epidemiology and Public Health (CIBERESP), Barcelona, Spain
Publisher
Elsevier Ltd
Abstract
Background. Chronic kidney disease is an independent predictor of
perioperative cardiovascular morbidity and mortality. We analysed the
preoperative estimated glomerular filtration rate (EGFR) as a risk factor
for perioperative major adverse cardiovascular and cerebrovascular events
(MACCE) in non-cardiac surgery. Methods. In a post hoc analysis of the
ANESCARDIOCATdatabase, patients were classified into six stages of EGFR
calculated with the abbreviated Modification of Diet in Renal Disease
Study and the Chronic Kidney Disease Epidemiology Collaboration equations:
>90 (1), 60 89.9 (2), 45 59.9 (3a), 30 44.9 (3b), 15 29.9 (4), and <15 (5)
ml min-1 1.73 m-2. We analysed differences in MACCE,
length of hospital stay, and all-causemortality between EGFR stages.
Results. The EGFR was available in 2323 patients. Perioperative MACCE
occurred in 4.5% of patients and cardiac-related mortality was 0.5%. Five
hundred and forty-three (23.4%) patients had an EGFR of ,60 ml
min-1 1.73 m-2 and 127 (5.4%) had an EGFR below 45
ml min-1 1.73 m-2. Logistic regression analysis
showed that MACCE increased with EGFR impairment (P<0.001), with a marked
increase from stage 3b onwards (odds ratio 1.8 vs 3.9 in 3a and 3b,
respectively, P=0.047). All-cause mortality was not related to EGFR
(P=0.071), but increased substantially between stages 3b and 4. The length
of stay correlated with EGFR (P,0.001). Conclusions. Perioperative MACCE
increase with declining EGFR, primarily when ,45 ml min-1 1.73
m-2. We recommend the use of preoperative EGFR for
cardiovascular risk assessment. Copyright © The Author 2014.

<187>
Accession Number
600339210
Title
Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis.
Source
New England Journal of Medicine. 371 (12) (pp 1121-1130), 2014. Date of
Publication: 18 Sep 2014.
Author
Mayosi B.M.; Ntsekhe M.; Bosch J.; Pandie S.; Jung H.; Gumedze F.; Pogue
J.; Thabane L.; Smieja M.; Francis V.; Joldersma L.; Thomas K.M.; Thomas
B.; Awotedu A.A.; Magula N.P.; Naidoo D.P.; Damasceno A.; Banda A.C.;
Brown B.; Manga P.; Kirenga B.; Mondo C.; Mntla P.; Tsitsi J.M.; Peters
F.; Essop M.R.; Russell J.B.W.; Hakim J.; Matenga J.; Barasa A.F.; Sani
M.U.; Olunuga T.; Ogah O.; Ansa V.; Aje A.; Danbauchi S.; Ojji D.; Yusuf
S.
Institution
(Mayosi, Ntsekhe, Pandie, Francis) Department of Medicine, University of
Cape Town, Groote Schuur Hospital, J Fl., Groote Schuur Dr., Observatory,
Cape Town 7925, South Africa
(Gumedze) Department of Statistical Sciences, University of Cape Town,
Cape Town, South Africa
(Thomas, Thomas, Awotedu) Department of Internal Medicine, Nelson Mandela
Academic Hospital, Walter Sisulu University, Mthatha, South Africa
(Magula) Division of Medicine, King Edward VIII Hospital, University of
KwaZulu Natal, Durban, South Africa
(Naidoo) Department of Cardiology, Inkosi Albert Luthuli Central Hospital,
University of KwaZulu Natal, Durham, South Africa
(Brown) Department of Cardiology, Provincial and Livingstone Hospitals,
Walter Sisulu University, Port Elizabeth, South Africa
(Manga) Division of Cardiology, Charlotte Maxeke Johannesburg Academic
Hospital, University of the Witwatersrand, Johannesburg, South Africa
(Mntla) Division of Cardiology, Dr. George Mukhari Hospital, University of
Limpopo, Pretoria, South Africa
(Tsitsi, Peters, Essop) Division of Cardiology, Chris Hani Baragwanath
Hospital, University of Witwatersrand, Soweto, South Africa
(Bosch, Jung, Pogue, Thabane, Smieja, Joldersma, Yusuf) McMaster
University and the Population Health Research Institute, Hamilton Health
Sciences, Hamilton, ON, Canada
(Damasceno) Hospital Central de Maputo, Maputo, Mozambique
(Banda) Malawi Military Health Services, Lilongwe, Malawi
(Kirenga, Mondo) New Mulago Hospital, Kampala, Uganda
(Russell) Connaught Hospital, Freetown, Sierra Leone
(Hakim, Matenga) Parirenyatwa Hospital, Harare, Zimbabwe
(Barasa) Moi Hospital, Eldoret, Kenya
(Sani) Aminu Kano Teaching Hospital, Kano, Nigeria
(Olunuga, Ogah) Federal Medical Center, Abeokuta, Ogun State, Nigeria
(Ansa) University of Calabar Teaching Hospital, Calabar, Nigeria
(Aje) University College Hospital, Ibadan, Oyo State, Nigeria
(Danbauchi) Ahmadu Bello Teaching Hospital, Zaria, Kaduna State, Nigeria
(Ojji) Abuja Teaching Hospital, Abuja, Nigeria
Publisher
Massachussetts Medical Society
Abstract
Background Tuberculous pericarditis is associated with high morbidity and
mortality even if antituberculosis therapy is administered. We evaluated
the effects of adjunctive glucocorticoid therapy and Mycobacterium indicus
pranii immunotherapy in patients with tuberculous pericarditis.
Methods Using a 2-by-2 factorial design, we randomly assigned 1400 adults
with definite or probable tuberculous pericarditis to either prednisolone
or placebo for 6 weeks and to either M. indicus pranii or placebo,
administered in five injections over the course of 3 months. Two thirds of
the participants had concomitant human immunodeficiency virus (HIV)
infection. The primary efficacy outcome was a composite of death, cardiac
tamponade requiring pericardiocentesis, or constrictive pericarditis.
Results There was no significant difference in the primary outcome between
patients who received prednisolone and those who received placebo (23.8%
and 24.5%, respectively; hazard ratio, 0.95; 95% confidence interval [CI],
0.77 to 1.18; P = 0.66) or between those who received M. indicus pranii
immunotherapy and those who received placebo (25.0% and 24.3%,
respectively; hazard ratio, 1.03; 95% CI, 0.82 to 1.29; P = 0.81).
Prednisolone therapy, as compared with placebo, was associated with
significant reductions in the incidence of constrictive pericarditis (4.4%
vs. 7.8%; hazard ratio, 0.56; 95% CI, 0.36 to 0.87; P = 0.009) and
hospitalization (20.7% vs. 25.2%; hazard ratio, 0.79; 95% CI, 0.63 to
0.99; P = 0.04). Both prednisolone and M. indicus pranii, each as compared
with placebo, were associated with a significant increase in the incidence
of cancer (1.8% vs. 0.6%; hazard ratio, 3.27; 95% CI, 1.07 to 10.03; P =
0.03, and 1.8% vs. 0.5%; hazard ratio, 3.69; 95% CI, 1.03 to 13.24; P =
0.03, respectively), owing mainly to an increase in HIV-associated cancer.
Conclusions In patients with tuberculous pericarditis, neither
prednisolone nor M. indicus pranii had a significant effect on the
composite of death, cardiac tamponade requiring pericardiocentesis, or
constrictive pericarditis. Copyright © 2014 Massachusetts Medical
Society.

<188>
Accession Number
372153520
Title
Varespladib and cardiovascular events in patients with an acute coronary
syndrome: The VISTA-16 randomized clinical trial.
Source
JAMA - Journal of the American Medical Association. 311 (3) (pp 252-262),
2014. Date of Publication: 2014.
Author
Nicholls S.J.; Kastelein J.J.P.; Schwartz G.G.; Bash D.; Rosenson R.S.;
Cavender M.A.; Brennan D.M.; Koenig W.; Jukema J.W.; Nambi V.; Wright
R.S.; Menon V.; Lincoff A.M.; Nissen S.E.; Hennekens C.; Brown W.V.;
DeMets D.; Pfeffer M.; Roleau J.; Abraham J.; Gebel J.; Huff C.; Katzan
I.; Shishehbor M.; Rassi A.; Uchino K.; Vest A.; Zishiri E.; Heckman M.J.;
Balog C.; Dart A.; Amerena J.; Prasad C.; Farshid A.; Gunalingam B.;
Thompson P.; Collins N.; Arstall M.; van Gaal W.; Aroney C.; Mahar L.;
Youssef G.; Horowitz J.; Anand D.; Rodes-Cabau J.; Polasek P.; Lai C.;
Huynh T.; Hubacek J.; Kokis A.; Paradis J.M.; Mukherjee A.; Senaratne M.;
Constance C.; Gosselin G.; Lavi S.; Parker J.; Zadra R.; Abramson B.;
Della-Siega A.; Spinar J.; Pudil R.; Motovska Z.; Maly M.; Hutyra M.;
Pleva L.; Mayer O.; Semenka J.; Klimovic T.; Horak D.; Cervinka P.; Klimsa
Z.; Hulinsky V.; Reichert P.; Monhart Z.; Rotterova H.; Kobulia B.;
Shaburishvili T.; Mamatsashvili M.; Chapidze G.; Chumburidze V.;
Megreladze I.; Khintibidze I.; Leithauser B.; Voehringer H.F.; Wachter R.;
Nogai K.; Lapp H.; Haltern G.; Gielen S.; Dorsel T.; Mollmann H.;
Stellbrink C.; Hengstenberg C.; Dengler T.; Heuer H.; Kreuzer J.; Leschke
M.; Mudra H.; Werner N.; Braun-Dullaeus R.; Rosenberg M.; Frey N.;
Strasser R.; Genth-Zotz S.; Kiss R.; Nagy A.; Kovacs Z.; Csapo K.; Edes
I.; Sereg M.; Vertes A.; Ronaszeki A.; Kancz S.; Benczur B.; Polgar P.;
Muller G.; Simonyi G.; Dezsi C.; Merkely B.; Dinnyes J.; Lupkovics G.;
Kahali D.; Banker D.; Trivedi S.; Rajput R.; Premchand R.; Dani S.;
Vadaganelli P.; Gupta S.; Chandra S.; Fulwani M.; Chawla K.; Parikh K.;
Prati F.; Speciale G.; Valgimigli M.; Suriano P.; Berni A.; Sangiorgi G.;
Fineschi M.; Merenda R.; Marenzi G.; Berti S.; Corrada E.; Cuccia C.;
Testa R.; Moretti L.; Mennuni M.; Biasucci L.M.; Lioy E.; Auguadro C.;
Magagnini E.; Fedele F.; Piscione F.; Azar R.; Trip M.D.; Liem A.; den
Hartoog M.; Lenderink T.; van de Wetering M.L.; Lok D.; Oei F.; Tans J.G.;
Ilmer B.; Keijzers M.; Monraats P.; Kedhi E.; Breedveld R.W.; Herrman J.;
van Wijk L.; Ronner E.; Nierop P.; Bosschaert M.; Hermans W.; Doevendans
P.; Troquay R.; van der Heijden R.; Veen G.; Bokern M.J.; Bronzwaer P.N.;
Kie S.H.; Den Hartog F.; Elliott J.; Wilkins G.; Hart H.; Devlin G.;
Harding S.; Ponikowski P.; Madej A.; Kochmanski M.; Witkowski A.; Pluta
W.; Bronisz M.; Kornacewicz-Jach Z.; Wysokinski A.; Ujda M.; Drozdz J.;
Derlaga B.; Gessek J.; Dabrowski M.; Miekus P.; Kozlowski A.; Gniot J.;
Musial W.; Dobrzycki S.; Rynkiewicz A.; Psuja P.; Rekosz J.; Drzewiecki
A.; Kuznetsov V.; Gordeev I.; Goloshchekin B.; Markov V.; Barbarich V.;
Belenky D.; Mikhin V.; Volkova E.; Timofeev A.; Ermoshkina L.; Barbarash
O.; Klein G.; Libis R.; Vishnevsky A.; Linev K.; Khaisheva L.; Ruda M.;
Dovgalevskiy Y.; Shvarts Y.; Zateyshchikov D.; Kostenko V.; Shalnev V.;
Simanenkov V.; Arkhipov M.; Ovcharenko E.; Guseva G.; Akhunova S.; Ortiz
A.I.; Navarro M.J.; Romero A.J.; Goya I.L.; Penaranda A.S.; Cendon A.A.;
Rubio A.M.; Zubiri J.J.; Soriano F.R.; Sanz R.R.; Genis A.B.; Lago V.N.;
Fernandez J.D.; Romo A.I.; Franco S.N.; Martin I.H.; Montero J.S.; Martin
Mde M.; Gonzalez M.J.; Antolin J.M.; Areses E.L.; Miranda J.M.;
Alonso-Pulpon L.; Esquivias G.B.; Jarne E.F.; Cortes J.M.; Perez M.B.;
Gormaz C.L.; Alegret J.M.; Nava J.S.; Ingelmo J.M.; Urbano R.H.; Sanmartin
M.; Katerenchuk O.; Vakaliuk I.; Karpenko O.; Prokhorov O.; Koval O.;
Faynyk A.; Kopytsya M.; Karpenko Y.; Kraiz I.; Feskov O.; Rudenko L.;
Kozhukhov S.; Goloborodko B.; Rivera E.; Broadwater S.; Crowley S.; Vijay
N.; Goswami R.; Ferrier L.; Blanchard A.; McCullum K.; Chernick R.;
Bertolet B.; Battaglia J.; Richardson J.; Lochridge S.; Lieberman S.;
Amkieh A.; Cavender J.B.; Denning S.; Treasure C.; Kmetzo J.; Stillabower
M.; Brilakis E.; Acheatel R.; Kukuy E.; Ashchi M.; Skelding K.; Martin L.;
Gillespie E.; French W.; Pollock S.; Polk D.; Black R.; Drenning D.;
Anderson J.; Sanz M.; Korban E.; Wiley M.; Rezkalla S.; Minisi A.; Shah
A.; Silverman P.; Amlani M.; Eaton G.; Brown A.; Jay D.; Loussararian A.;
Lamas G.; Lauer M.; Williams J.; Asfour A.; Runquist L.; Robertson R.;
Blonder R.; Davies C.; Downes T.; Chronos N.; Marso S.; Haldis T.; Eich
D.; Ahmed M.; East C.; MacDonald L.; Seigel P.; White M.; Camp A.; Kleiman
N.; Burtt D.; Strain J.; Go B.; Henry P.; Sultan P.; Delafontaine P.;
Kashou H.; Lambert C.; Movahed M.; Saucedo J.; Thadani U.; Chandrashekhar
Y.; Lu D.; Chandna H.; Mann J.; Ramaswamy G.; Browne K.; Janik M.; Cannon
K.; Tolerico P.
Institution
(Nicholls) South Australian Health and Medical Research Institute,
University of Adelaide, Adelaide, SA, Australia
(Kastelein) Academic Medical Center, Amsterdam, Netherlands
(Schwartz) Veterans Affairs Medical Center, University of Colorado,
Denver, CO, United States
(Bash, Brennan, Menon, Lincoff, Nissen) Cleveland Clinic Coordinating
Center for Clinical Research, Cleveland, OH, United States
(Rosenson) Icahn School of Medicine at Mount Sinai, New York, NY, United
States
(Cavender) Brigham and Women's Hospital, Boston, MA, United States
(Koenig) University of Ulm Medical Center, Ulm, Germany
(Jukema) Leiden University Medical Center, Leiden, Netherlands
(Jukema) Interuniversity Cardiology Institute of the Netherlands, Utrecht,
Netherlands
(Nambi) Michael E. DeBakey Veterans Affairs Hospital, Baylor College of
Medicine, Houston, TX, United States
(Wright) Mayo Clinic, Rochester, MN, United States
Publisher
American Medical Association (E-mail: smcleod@itsa.ucsf.edu)
Abstract
IMPORTANCE: Secretory phospholipase A<inf>2</inf> (sPLA<inf>2</inf>)
generates bioactive phospholipid products implicated in atherosclerosis.
The sPLA<inf>2</inf> inhibitor varespladib has favorable effects on lipid
and inflammatory markers; however, its effect on cardiovascular outcomes
is unknown. OBJECTIVE(S): To determine the effects of
sPLA<inf>2</inf> inhibition with varespladib on cardiovascular outcomes.
DESIGN, SETTING, AND PARTICIPANTS: A double-blind, randomized, multicenter
trial at 362 academic and community hospitals in Europe, Australia, New
Zealand, India, and North America of 5145 patients randomized within 96
hours of presentation of an acute coronary syndrome (ACS) to either
varespladib (n = 2572) or placebo (n = 2573) with enrollment between June
1, 2010, and March 7, 2012 (study termination on March 9, 2012).
INTERVENTIONS: Participants were randomized to receive varespladib (500
mg) or placebo daily for 16 weeks, in addition to atorvastatin and other
established therapies. MAIN OUTCOMES AND MEASURES: The primary efficacy
measurewas a composite of cardiovascular mortality, nonfatal myocardial
infarction (MI), nonfatal stroke, or unstable angina with evidence of
ischemia requiring hospitalization at 16 weeks. Six-month survival status
was also evaluated. RESULT(S): At a prespecified interim analysis,
including 212 primary end point events, the independent data and safety
monitoring board recommended termination of the trial for futility and
possible harm. The primary end point occurred in 136 patients (6.1%)
treated with varespladib compared with 109 patients (5.1%) treated with
placebo (hazard ratio [HR], 1.25; 95%CI, 0.97-1.61; log-rank P = .08).
Varespladib was associated with a greater risk of MI (78 [3.4%] vs 47
[2.2%]; HR, 1.66; 95%CI, 1.16-2.39; log-rank P = .005). The composite
secondary end point of cardiovascular mortality, MI, and stroke was
observed in 107 patients (4.6%) in the varespladib group and 79 patients
(3.8%) in the placebo group (HR, 1.36; 95% CI, 1.02-1.82; P = .04).
CONCLUSIONS AND RELEVANCE: In patients with recent ACS, varespladib did
not reduce the risk of recurrent cardiovascular events and significantly
increased the risk of MI. The sPLA<inf>2</inf> inhibition with varespladib
may be harmful and is not a useful strategy to reduce adverse
cardiovascular outcomes after ACS. TRIAL REGISTRATION: clinicaltrials.gov
Identifier: NCT01130246. Copyright 2014 American Medical Association. All
rights reserved.

<189>
Accession Number
53290601
Title
Adverse effects of perioperative paracetamol, NSAIDs, glucocorticoids,
gabapentinoids and their combinations: A topical review.
Source
Acta Anaesthesiologica Scandinavica. 58 (10) (pp 1182-1198), 2014. Date of
Publication: 01 Nov 2014.
Author
Mathiesen O.; Wetterslev J.; Kontinen V.K.; Pommergaard H.-C.; Nikolajsen
L.; Rosenberg J.; Hansen M.S.; Hamunen K.; Kjer J.J.; Dahl J.B.
Institution
(Mathiesen) Section of Acute Pain Management, Rigshospitalet, Copenhagen
University Hospital, Copenhagen, Denmark
(Wetterslev) Copenhagen Trial Unit, Rigshospitalet, Copenhagen University
Hospital, Copenhagen, Denmark
(Kontinen) Department of Anaesthesia and Intensive Care, Helsinki
University Central Hospital, Helsinki, Finland
(Pommergaard, Rosenberg) Department of Surgery, Herlev Hospital,
University of Copenhagen, Herlev, Denmark
(Nikolajsen) Department of Anaesthesiology, Aarhus University Hospital,
Aarhus, Denmark
(Hansen, Dahl) Department of Anaesthesiology, Rigshospitalet, Copenhagen
University Hospital, Copenhagen, Denmark
(Hamunen) Pain Clinic, Helsinki University Central Hospital, Helsinki,
Finland
(Kjer) Department of Gynecology, Rigshospitalet, Copenhagen University
Hospital, Copenhagen DK-2100, Denmark
Publisher
Blackwell Munksgaard (E-mail: info@mks.blackwellpublising.com)
Abstract
Post-operative pain affects millions of patients worldwide and the
post-operative period has high rates of morbidity and mortality. Some of
this morbidity may be related to analgesics. The aim of this review was to
provide an update of current knowledge of adverse events (AE) associated
with the most common perioperative non-opioid analgesics: paracetamol,
non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids (GCCs),
gabapentinoids and their combinations. The review is based on data from
systematic reviews with meta-analyses of analgesic efficacy and/or adverse
effects of perioperative non-opioid analgesics, and randomised trials and
cohort/retrospective studies. Generally, data on AE are sparse and related
to the immediate post-operative period. For paracetamol, the incidence of
AEs appears trivial. Data are inconclusive regarding an association of
NSAIDs with mortality, cardiovascular events, surgical bleeding and renal
impairment. Anastomotic leakage may be associated with NSAID usage. No
firm evidence exists for an association of NSAIDs with impaired bone
healing. Single-dose GCCs were not significantly related to increased
infection rates or delayed wound healing. Gabapentinoid treatment was
associated with increased sedation, dizziness and visual disturbances, but
the clinical relevance needs clarification. Importantly, data on AEs of
combinations of the above analgesics are sparse and inconclusive. Despite
the potential adverse events associated with the most commonly applied
non-opioid analgesics, including their combinations, reporting of such
events is sparse and confined to the immediate perioperative period.
Knowledge of benefit and harm related to multimodal pain treatment is
deficient and needs clarification in large trials with prolonged
observation. Copyright © 2014 The Acta Anaesthesiologica
Scandinavica Foundation.

<190>
Accession Number
602187797
Title
A randomized comparison of novel biodegradable polymer-and durable
polymer-coated cobalt-chromium sirolimus-eluting stents.
Source
JACC: Cardiovascular Interventions. 7 (12) (pp 1352-1360), 2014. Date of
Publication: 2014.
Author
Han Y.; Xu B.; Jing Q.; Lu S.; Yang L.; Xu K.; Li Y.; Li J.; Guan C.;
Kirtane A.J.; Yang Y.
Institution
(Han, Jing, Xu, Li, Li) Department of Cardiology, General Hospital of
Shenyang Military Region, 83 Wenhua Road, Shenhe District, Shenyang
110016, China
(Xu, Guan, Yang) Fu Wai Hospital, National Center for Cardiovascular
Diseases, Beijing, China
(Lu) Affiliated Anzhen Hospital of Capital Medical University, Beijing,
China
(Yang) Kunming General Hospital of Chengdu Military Region, Kunming, China
(Kirtane) Columbia University Medical Center, New York Presbyterian
Hospital, New York, NY, United States
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Objectives: The aim of this study was to investigate the hypothesis that a
novel biodegradable polymer-coated, cobalt-chromium (CoCr),
sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy
outcomes compared with a durable polymer (DP)-SES. Background(s): No
randomized trials have the compared safety and efficacy of BP-SES versus
DP-SES on similar CoCr platforms, thereby isolating the effect of the
polymer type. Method(s): In this prospective, single-blind,
randomized trial conducted at 32 Chinese sites, 2,737 patients eligible
for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The
primary endpoint was 12-month target lesion failure (TLF), a composite of
cardiac death, target vessel myocardial infarction, or clinically
indicated target lesion revascularization. Secondary endpoints included
TLF components, and definite/probable stent thrombosis. Result(s): At
12 months, the difference in the primary endpoint of TLF between BP-SES
(6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: -1.67%
to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of
BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs.
0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p =
0.39), and clinically indicated target lesion revascularization (2.6% vs.
2.2%, p = 0.50) were similar, as were low definite/probable stent
thrombosis rates (0.4% vs. 0.6%, p = 0.55). Conclusion(s): In this
large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year
TLF. (Evaluate Safety and Effectiveness of the Tivoli DES and the
Firebird DES for Treatment of Coronary Revascularization;.
NCT01681381). Copyright © 2014 by the American College of
Cardiology Foundation.

<191>
Accession Number
600029592
Title
Colchicine for prevention of postpericardiotomy syndrome and postoperative
atrial fibrillation: The COPPS-2 randomized clinical trial.
Source
JAMA - Journal of the American Medical Association. 312 (10) (pp
1016-1023), 2014. Date of Publication: 10 Sep 2014.
Author
Imazio M.; Brucato A.; Ferrazzi P.; Pullara A.; Adler Y.; Barosi A.;
Caforio A.L.; Cemin R.; Chirillo F.; Comoglio C.; Cugola D.; Cumetti D.;
Dyrda O.; Ferrua S.; Finkelstein Y.; Flocco R.; Gandino A.; Hoit B.;
Innocente F.; Maestroni S.; Musumeci F.; Oh J.; Pergolini A.; Polizzi V.;
Ristic A.; Simon C.; Spodick D.H.; Tarzia V.; Trimboli S.; Valenti A.;
Belli R.; Gaita F.
Institution
(Imazio, Belli) Department of Cardiology, Maria Vittoria Hospital,
University of Torino, Via Cibrario 72, Torino, Torino 10141, Italy
(Imazio, Pullara, Gaita) University of Torino, Torino, Italy
(Brucato, Ferrazzi, Cugola, Cumetti, Innocente, Maestroni, Simon, Valenti)
Ospedale Papa Giovanni XXIII, Bergamo, Italy
(Pullara, Gaita) AOU Citta Della Salute e Della Scienza di Torino, Torino,
Italy
(Adler) Chaim Sheba Medical Center, Tel Hashomer and Sacker University,
Tel Aviv, Israel
(Barosi, Gandino) Department of Internal Medicine and Cardiac Surgery,
Ospedale Niguarda, Milano, Italy
(Caforio, Tarzia) Department of Cardiological Thoracic and Vascular
Sciences, University of Padova, Padova, Italy
(Cemin) Cardiology Department, Ospedale Regionale San Maurizio, Bolzano,
Italy
(Chirillo) Department of Cardiology and Cardiac Surgery, Ca Foncello
Hospital, Treviso, Italy
(Comoglio, Dyrda, Trimboli) Department of Cardiac Surgery and
Rehabilitation, Villa Maria Pia Hospital, Torino, Italy
(Ferrua) Department of Cardiology, Ospedale degli Infermi, Rivoli, Italy
(Finkelstein) Department of Pediatrics, Hospital for Sick Children,
University of Toronto, Toronto, ON, Canada
(Flocco) Cardiac Surgery, Ospedale Mauriziano, Torino, Italy
(Hoit) Case Western Reserve University, Cleveland, OH, United States
(Hoit) University Hospitals Case Medical Center, Cleveland, OH, United
States
(Musumeci, Pergolini, Polizzi) Department of Cardiac Surgery, Ospedale San
Camillo, Roma, Italy
(Oh) Division of Cardiovascular Disease, Mayo Clinic, Rochester, MN,
United States
(Ristic) Department of Cardiology, Belgrade University School of Medicine,
Clinical Centre of Serbia, Belgrade, Serbia
(Spodick) St Vincent Hospital, Worcester, MA, United States
Publisher
American Medical Association (E-mail: smcleod@itsa.ucsf.edu)
Abstract
IMPORTANCE: Postpericardiotomy syndrome, postoperative atrial fibrillation
(AF), and postoperative effusions may be responsible for increased
morbidity and health care costs after cardiac surgery. Postoperative use
of colchicine prevented these complications in a single trial.
 OBJECTIVE(S): To determine the efficacy and safety of perioperative
use of oral colchicine in reducing postpericardiotomy syndrome,
postoperative AF, and postoperative pericardial or pleural effusions.
DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, double-blind,
placebo-controlled, randomized clinical trial among 360 consecutive
candidates for cardiac surgery enrolled in 11 Italian centers between
March 2012 and March 2014. At enrollment, mean age of the trial
participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had
planned valvular surgery. Main exclusion criteria were absence of sinus
rhythm at enrollment, cardiac transplantation, and contraindications to
colchicine. INTERVENTIONS: Patients were randomized to receive placebo
(n=180) or colchicine (0.5mg twice daily in patients >=70 kg or 0.5 mg
once daily in patients <70 kg; n=180) starting between 48 and 72 hours
before surgery and continued for 1 month after surgery. MAIN OUTCOMES AND
MEASURES: Occurrence of postpericardiotomy syndrome within 3 months; main
secondary study end points were postoperative AF and pericardial or
pleural effusion. RESULT(S): The primary end point of
postpericardiotomy syndrome occurred in 35 patients (19.4%) assigned to
colchicine and in 53 (29.4%) assigned to placebo (absolute difference,
10.0%; 95% CI, 1.1%-18.7%; number needed to treat = 10). There were no
significant differences between the colchicine and placebo groups for the
secondary end points of postoperative AF (colchicine, 61 patients [33.9%];
placebo, 75 patients [41.7%]; absolute difference, 7.8%; 95% CI, -2.2% to
17.6%) or postoperative pericardial/pleural effusion (colchicine, 103
patients [57.2%]; placebo, 106 patients [58.9%]; absolute difference,
1.7%; 95% CI, -8.5% to 11.7%), although there was a reduction in
postoperative AF in the prespecified on-treatment analysis (placebo,
61/148 patients [41.2%]; colchicine, 38/141 patients [27.0%]; absolute
difference, 14.2%; 95% CI, 3.3%-24.7%). Adverse events occurred in 21
patients (11.7%) in the placebo group vs 36 (20.0%) in the colchicine
group (absolute difference, 8.3%; 95% CI; 0.76%-15.9%; number needed to
harm = 12), but discontinuation rates were similar. No serious adverse
events were observed. CONCLUSIONS AND RELEVANCE: Among patients undergoing
cardiac surgery, perioperative use of colchicine compared with placebo
reduced the incidence of postpericardiotomy syndrome but not of
postoperative AF or postoperative pericardial/pleural effusion. The
increased risk of gastrointestinal adverse effects reduced the potential
benefits of colchicine in this setting. TRIAL REGISTRATION:
clinicaltrials.gov Identifier: NCT01552187 Copyright 2014 American Medical
Association. All rights reserved.

<192>
Accession Number
600029584
Title
Effect of darapladib on major coronary events after an acute coronary
syndrome: The SOLID-TIMI 52 randomized clinical trial.
Source
JAMA - Journal of the American Medical Association. 312 (10) (pp
1006-1015), 2014. Date of Publication: 10 Sep 2014.
Author
O'Donoghue M.L.; Braunwald E.; White H.D.; Lukas M.A.; Tarka E.; Steg
P.G.; Hochman J.S.; Bode C.; Maggioni A.P.; Im K.; Shannon J.B.; Davies
R.Y.; Murphy S.A.; Crugnale S.E.; Wiviott S.D.; Bonaca M.P.; Watson D.F.;
Weaver W.D.; Serruys P.W.; Cannon C.P.; Steen D.P.; Lamp J.M.; McCourt A.;
Barakat D.; Mezzetti J.; Morrison C.; Stevens M.; Ward C.; Ardissino D.;
Aylward P.E.; Babilonia N.; Britto F.; Budaj A.; Chen S.A.; Corbalan R.;
Dalby A.J.; Dellborg M.; deWinter R.J.; Dorobantu M.; Duris T.; Gao R.;
Goudev A.R.; Grande P.; Gratsiansky N.; Guneri S.; Hamm C.; Husted S.;
Isaza D.; Kimura T.; Kiss R.; Lewis B.; Lopez-Sendon J.; Mancini G.B.;
Mathur A.; Mittal S.; Montalescot G.; Nicolau J.C.; Ophuis T.O.; Paolasso
E.; Parkhomenko A.; Ray K.; Reddy K.; Seung K.B.; Somaraju B.; Spinar J.;
Sritara P.; Theroux P.; Wijns W.; Collins R.; DeMets D.; Ganz P.;
Sandercock P.; Weber M.; Fisher M.; Buhr K.; Diegel S.; Schultz M.; Lowe
C.; Mills K.; Ruvido J.; Alkhalil M.; Rehman M.Q.; Stebletsova I.; Shimmer
M.; Forni D.; Awtry E.; Berger C.J.; Croce K.; Desai A.; Gelfand E.; Ho
C.; Leeman D.E.; Link M.S.; Pande A.; Ruberg F.; Vita J.A.; Gignac G.;
Hochberg E.; Lane A.; Rosenberg C.; Wagner A.; Wolpin B.M.; Goessling W.;
Acquilano D.E.; Waltemyer R.; Kunder S.; Syed A.; Aigbogun J.; Taylor M.;
Daga S.; Cicconetti G.; Nandy I.; Deenadayalu N.; Koduru S.; Zhou J.;
Abraham L.; Beloscar J.; Bettinotti M.; Dumont C.; Fernandez R.;
Fuentealba V.J.; Covelli G.; Garcia Duran R.; Hominal M.A.; Jure H.;
Litvak M.; Luciardi H.; Macin S.; MacKinnon I.; Milesi R.; Montana O.;
Olavegogeascoechea P.; Prado A.; Sala J.; Gorosito V.; Sassone S.; Maffei
L.; Schmuck R.; Vico M.; Vita N.; Arstall M.; Ashby D.; Colquhoun D.;
Cross D.; Farshid A.; Freeman M.; New G.; Hammett C.; Kanna R.; Lehman R.;
Roberts-Thomson P.; William M.; Yamen E.; Beauloye C.; Beunk J.; Boland
J.; Charlier F.; Claeys M.; Dujardin K.; Friart A.; Legrand V.; Schoors
D.; Sinnaeve P.; Vandenbossche J.L.; Abrantes J.; Alves da Costa F.;
Ardito W.; Bodanese L.; Braga J.C.; Carvalho A.; Dutra O.; Feitosa G.;
Guimaraes A.E.; Hernandes M.; Leaes P.; Lima F.; Lotufo P.; Maia L.;
Manenti E.; Mattos M.A.; Michalaros Y.; Paiva M.S.; Piegas L.; Pimentel
Filho P.; Precoma D.; Rabelo Alves Junior A.; Rassi S.; Reis G.; Resende
E.; Rossi P.; Saraiva J.F.; Silva Junior D.; Silva F.A.; Souza J.;
Wainstein M.; Ribeiro J.; Benov H.; Chompalova B.; Goshev E.; Raev D.;
Goudev A.; Grigorov M.; Grigorova V.; Mihov A.; Nikolov F.; Petrov I.;
Postadzhiyan A.; Ramshev K.; Tisheva S.; Tzekova M.; Bhargava R.; Cha J.;
Constance C.; Della Siega A.; Klinke P.; Dong R.; Dupuis R.; Gyenes G.;
Huynh T.; Labonte R.; Lai C.; Leader R.; Leiter L.; Lonn E.; Nguyen M.;
Pandey A.; Polasek P.; Ramanathan K.; Rose B.; Rupka D.; Sabbah E.; Syan
G.; Tishler S.; Vizel S.; Zeman P.; Albornoz Alarcon F.J.; Castro Galvez
P.; Florenzano Urzua F.; Pedemonte Villablanca O.A.; Perez Pino L.;
Pincetti C.; Rodriguez Venegas M.; Romero Castro C.; Lamich R.; Sepulveda
Varela P.A.; Stockins B.; Chen Y.; Dong Y.; Fu G.; Hao Y.; Huang D.; Jiao
Y.; Ke Y.; Li C.; Li H.; Li T.; Li X.; Li Z.; Liao D.; Liu L.; Lu Q.; Qu
P.; Shen Z.; Shi H.; Wu S.; Xiang M.; Xu J.; Yang X.; Yu J.; Yuan Z.;
Zhang Y.; Zhou S.; Accini Mendoza J.L.; Bohorquez R.; Botero R.; Cano
Lopez N.; Hernandez H.; Jaramillo C.; Jaramillo M.; Jaramillo N.; Manzur
F.; Mendoza F.; Reynales H.; Sanchez Vallejo G.; Ternera A.; Urina M.;
Cermak O.; Coufal Z.; Dedek V.; Francek L.; Grunfeldova H.; Gregor P.;
Kellnerova I.; Klimsa Z.; Kuchar L.; Linhart A.; Mayer O.; Taborsky M.;
Vitovec J.; Andersen U.; Kristensen K.; Bang L.; Bronnum-Schou J.; Egstrup
K.; Frost L.; Galatius S.; Jeppesen J.; Rokkedal J.; Klarlund K.; Laursen
R.; Nielsen T.; Melchior T.; Mickley H.; Nielsen H.; Nielsen W.; Schmidt
E.; Sjol A.; Skagen K.; Sykulski R.; Zeuthen E.; Nyvad O.; Agraou B.;
Bayet G.; Caussin C.; Coisne D.; Cottin Y.; Decoulx E.; Delahaye F.;
Delarche N.; D'Houdain F.; Dourmap-Collas C.; Dubois-Rande J.L.; Elbaz M.;
Martelet M.; Nallet O.; Cattan S.; Ohlmann P.; Schiele F.; Traisnel G.;
Tricot O.; Berrouschot J.; Duengen H.D.; Elsaesser A.; Erbel R.;
Moehlenkamp S.; Franz N.; Frey N.; Hambrecht R.; Haude M.; Janssens U.;
Joost A.; Schunkert H.; Kadel C.; Katus H.; Koenig W.; Laufs U.; Loew A.;
Klauss V.; Koenig A.; Sohn H.Y.; Mudra H.; Neumann F.J.; Olbrich H.G.;
Plehn A.; Buerke M.; Ebelt H.; Schaefer A.; Fischer D.; Schaeufele T.;
Steiner S.; Kreuzer J.; Tsoy I.; Stellbrink C.; Sydow K.; Baldus S.;
Tiroch K.; Guelker H.; Haltern G.; Voehringer H.F.; Weber D.; Werner G.;
Zeiher A.M.; Zeymer U.; Zirlik A.; Csapo K.; Herczeg B.; Katona A.; Keltai
K.; Kiss R.G.; Laszlo Z.; Lupkovics G.; Medvegy M.; Merkely B.; Muller G.;
Nagy A.; Nagy L.; Palinkas A.; Sziliczei-Nemeth; Sereg M.; Valco J.;
Vertes A.; Zamolyi K.; Arora P.; Bali H.; Banker D.; Chaganti V.R.;
Chandra P.K.; Chopra A.; Christopher J.; Dani S.; Gupta S.; Shah S.;
Hiremath S.; Kaul U.; Koduganti S.; Kumar N.; Kumar S.; Mandala G.; Naik
S.; Oomman A.; Padmanabhan T.N.; Parikh K.; Reddy R.P.; Roy S.; Sankardas
M.; Sapra R.; Chopra V.; Sathe S.; Sawhney J.; Atar S.; Banai S.; Eldar
M.; Elis A.; Gavish D.; Goldhaber A.; Gottlieb S.; Hayek T.; Hussein O.;
Katz A.; Klutstein M.; Kracoff O.; Lishner M.; Lotan C.; Meisel S.;
Mosseri M.; Qarawani D.; Hasin Y.; Rozenman Y.; Schiff E.; Oliven A.;
Weiss A.; Baldin M.G.; Berni A.; Biasucci L.M.; Bongo A.; Campo G.;
Valgimigli M.; Colivicchi F.; De Servi S.; Esposito G.; Gavazzi A.;
Marzilli M.; Merlini P.; Moretti L.; Morocutti G.; Mos L.; Patrizi G.;
Rapezzi C.; Branzi A.; Terrosu P.; Domae H.; Fujii S.; Furukawa Y.; Goto
Y.; Hirokami M.; Ito H.; Kawajiri K.; Kimura K.; Kuramochi T.; Miyauchi
K.; Muroya T.; Hata S.; Yoshida T.; Oku K.; Okutsu M.; Ooie T.; Saito T.;
Shimomura H.; Shinozaki N.; Shishido K.; Sugitatsu K.; Tanaka S.; Suwa S.;
Takenaka T.; Tamada A.; Tanabe K.; Tanaka Y.; Takahashi S.; Yamazaki S.;
Chae S.C.; Hong T.J.; Jeong J.O.; Jeong M.; Kim H.S.; Kim Y.H.; Ko Y.G.;
Lee S.H.; Yoon J.; Bartels L.; Basart D.; De Nooijer C.; Dijkgraaf R.; de
Graaf J.J.; Groutars R.; Visser J.; Hamer B.J.; Hamraoui K.; Heijmeriks
J.; Huizenga A.; Herrman J.P.; Knufman N.M.; Frederiks J.; Kuijper A.F.;
Lenderink T.; van der Meer P.; Milhous G.J.; Nierop P.; Oude Ophuis A.J.;
Peerenboom P.; Peters R.; Plomp J.; Prins P.; Schaap A.; van der Sluis A.;
Smeele F.J.; van Hal J.M.; Swart H.P.; Tjeerdsma G.; Troquay R.; Van Eck
M.; Viergever E.; de Weerd G.J.; van Daele M.; de Winter R.J.;
Zoet-Nugteren S.K.; van der Zwaan C.; Zwart P.; Devlin G.; Elliott J.;
Harrison N.; Hart H.; O'Meeghan T.; Stewart R.; Ternouth I.; Tisch J.; van
Pelt N.; Wilkins G.; Chen V.; Alarco Leon W.; Rodriguez Chavez V.E.; Rojas
Canamero R.; Rotta Rotta A.; Toce L.; Anonuevo J.; Barcinas R.; Coching
R.M.; Matiga G.; Sulit D.J.; Uy N.; Bronisz M.; Buszman P.; Dalkowski M.;
Derlaga B.; Fijalkowski M.; Rynkiewicz A.; Firek B.; Gil R.; Jaworska K.;
Kasprzak J.; Krzeminska-Pakula M.; Kleinrok A.; Kopaczewski J.; Kuc K.;
Kusnierz B.; Lewczuk J.; Lysek R.; Miekus P.; Mirek-Bryniarska E.;
Mlodziankowski A.; Musial W.; Mysiak A.; Napora P.; Piepiorka M.; Pluta
W.; Prochaczek F.; Przewlocki T.; Rekosz J.; Rusicka T.; Galaj A.;
Sciborski R.; Szelemej R.; Szpajer M.; Wojewoda P.; Wrzosek B.; Zurakowski
A.; Arsenescu Georgescu C.M.; Benedek I.; Capalneanu R.; Cinteza M.; Craiu
E.; Cristea M.; Dimulescu D.; Fruntelata A.G.; Ginghina C.; Minescu B.;
Musetescu R.; Ionescu D.; Pop C.; Radoi M.; Sinescu C.; Vinereanu D.;
Arkhipov M.; Barbarash O.; Bessonova N.; Boldueva S.; Boyarkin M.; Demko
A.; Duplyakov D.; Ermoshkina L.; Glezer M.; Goloshchekin B.; Gordeev I.;
Grinshtein Y.; Karpov Y.; Kobalava Z.; Konstantinov V.; Kostenko V.;
Kuimov A.; Kuznetsov V.; Libis R.; Markov V.; Motylev I.; Novikova N.;
Orlikova O.; Panchenko E.; Panov A.; Ruda M.; Sementsov D.; Shalaev S.;
Shvarts Y.; Simanenkov V.; Skorichenko V.; Sukmanova I.; Smolenskaya O.;
Tsyba L.; Vishnevsky A.; Yakhontov D.; Yakusevich V.; Zadionchenko V.;
Zateyshchikov D.; Zateyshchikova A.; Zrazhevskiy K.; Fridrich V.; Gaspar
L.; Hasilla J.; Hranai M.; Kokles M.; Pella D.; Basson M.; Bayat J.;
Blignaut S.; Burgess L.; Corbett C.; Da Silva A.; Dalby A.; De Jong D.;
Mabin T.; Manga P.; Oosthuysen W.; Ranjith N.; Roodt A.; Roux J.; Soma P.;
Swanepoel N.; Theron H.; van Zyl L.; Barrabes Riu J.A.; Figueras Bellot
J.; Bayon Fernandez J.; Simarro Martin-Ambrosio E.; Benedicto Buendia A.;
Castro Conde A.; Iniguez Romo A.; Jimenez Navarro M.; Lopez Garcia-Aranda
V.; Mainar Tello V.; Marco Garde P.; Mayordomo Lopez J.; Molla Jimenez C.;
Anton Pascual J.L.; Plaza Perez I.; Ridocci Soriano F.; Viles Beltran D.;
Bandh S.; Christensen K.; Herlitz J.; Karlsson J.E.; Mooe T.; Persson B.;
Timberg I.; Witt N.; Cheng C.C.; Hung H.H.; Lai W.T.; Tu C.M.; Li A.H.; Wu
C.F.; Wu C.J.; Yin W.H.; Buakhamsri A.; Kaewsuwanna P.; Kiatchoosakun S.;
Kuanprasert S.; Wongpraparut N.; Bayata S.; Yavuzgil O.; Amosova E.;
Batushkin V.; Dyadyk O.; Goloborodko B.; Karpenko O.; Kononenko L.;
Kopytsya M.; Koval O.; Kovalskyy I.; Legkonogov O.; Malynovsky Y.;
Shershnyova O.; Netiazhenko V.; Nikonov V.; Parkhomenko O.; Prokhorov O.;
Rebrov B.; Potapenko P.; Rudenko L.; Shcherbak V.; Stanislavchuk M.;
Tseluyko V.; Yagensky A.; Ahsan A.; Been M.; Bethell H.; Senior R.; Cox
D.; Findlay I.; Gandhi M.; Gorog D.; Jacques A.; Keeling P.; O'Rourke B.;
Pell A.; Spratt J.; Trouton T.; Wong Y.K.; Abadier R.; Abrahams L.; Afonso
L.; Aggarwal A.; Aggarwal K.; Ahmed A.; Ahmed S.; Albirini A.; Anderson
J.; Angiolillo D.; Ansari S.; Applegate R.; Arif I.; Leesar M.; Aronow H.;
Asbill B.; Ashraf R.; Atalay H.; Atassi K.; Atieh M.; Babayan Z.; Harjai
K.; Baker S.; Barr L.; Barringhaus K.; Bayron C.; Benjamin S.; Benton R.;
Berglund R.; Conn E.; Bertolet B.; Bhagwat R.; Biederman R.; Bisher E.;
Blanchard A.; Brown C.; Butman S.; Campbell C.; Canaday D.; Carlson T.;
Casale P.; Cashion W.; Chandler A.; Chandna H.; Chandrasekaran S.; Chang
G.; Chronos N.; Chang M.; Chhabra A.; Chin J.; Cochran D.; Cohen K.;
Cucher F.; Dauber I.; De Gregorio M.; Del Core M.; Dewhurst R.; Rodriguez
R.; Dionisopoulos P.; Donovan D.; Doty W.; Drossner M.; East C.; Eaton G.;
Ebrahimi R.; Effron B.; Elkhadra M.; Elsner G.; Erickson B.; Fehrenbacher
G.; Feldman R.; Fernandes V.; Fishberg R.; Flores A.; Foreman R.; Frankel
R.; French W.; Fuentes F.; Fujise K.; Fulmer J.; Gabry M.; Baig M.; Curran
P.; Garcia Pulido J.; Gatien L.; Gazmuri R.; Gencheff N.; Gilmore R.;
Giugliano G.; Goldberg R.; Goldman S.; Movahed M.R.; Goldstein M.;
Gonzalez D.; Gottlieb D.; Grabarczyk M.; Graham B.; Gruberg L.; Gumm D.;
Lee D.; Hage-Korban E.; Hakas J.; Hamroff G.; Harris B.; Hearne S.; Held
J.; Henderson D.A.; Hermany P.; Herzog W.; Hinchman D.; Fry S.; Hockstad
E.; Hodson R.; Hollenbaugh D.; Horwitz P.; Hurst P.; Ibrahim H.; Imburgia
M.; Izzo M.; Jaffrani N.; Jan M.; Janout M.; Ring M.; Jones S.; Kahn B.;
Kakavas P.; Kates A.; Bach R.; Katopodis J.; Kazimir M.; Kennett J.;
Kereiakes D.; Kersh R.; Kershner D.; Meilman H.; Kerwin P.; Khera A.;
Kieval J.; Kim E.; Kobayashi J.; Nelson R.; Kosinski E.; Kovacich D.;
Kraft P.; Kramer J.; Kruse K.; Kuvin J.; Labib A.; Labroo A.; Langer M.;
Lau T.; Lee K.; Lee T.; Levite H.; Lewis D.; Lieber I.; Loh I.; Lopez M.;
Lui H.; Malkowski M.; Mammen G.; Mascolo R.; Matsumura M.; Matthews G.;
Corbelli J.; Mayer T.; McAlhany C.; McCullum K.; Meholick A.; Mehta V.;
Melhado M.; Menees D.; Miller M.; Minisi A.; Minor S.; Moore C.; Nygaard
T.; Morcos N.; Morris P.; Morrow D.; Mostel E.; Murdock D.; Nadar V.;
Nahhas A.; Navas J.; Nukta E.; Oberoi M.; O'Donnell P.; Ostfeld R.;
Pacheco T.; Panchal V.; Parang P.; Paraschos A.; Pasquini J.; Williams J.;
Patlola R.; Peart B.; Penny W.; Pepine C.; Perlman R.; Pavlides A.; Popeil
L.; Prashad R.; Price D.; Price R.; Puleo P.; Puri S.; Raikhel M.;
Ramachandran A.; Ramos M.; Concha M.; Randhawa P.; Reichek N.; Riba A.;
Ricciardi M.; Rider J.; Fenton S.; Rizvi M.A.; Dahiya R.; Rogers W.; Roth
D.; Rowe W.; Saba F.; Sabri M.; Patel P.; Sandoval J.; Sangrigoli R.;
Schwartzbard A.; Seidner M.; Shah A.; Shanes J.; Sharma M.; Siegel C.;
Singal D.; Singh N.; Smith A.; Panetta C.; Smith S.; Whitaker J.; Snell
J.; Snyder H.; Soffer A.; Sonel A.; Spencer R.; Staniloae C.; Stephenson
C.; Sundaram S.; Sutton L.; Letts D.; Swint R.; Tallet J.; Tami L.; Taylor
R.; Hanovich G.; Tedder B.; Teufel E.; Brett C.; Thomas J.; Thompson P.;
Polk D.; Tilkian A.; Tinkel J.; Pandya U.; Tobiansky J.; Trippi J.; Tuohy
E.; Uretsky B.; Uusinarkaus K.; Varma S.; Velasquez E.; Vogel C.; Voyce
S.; Wainwright W.; Hancock H.; Walder J.; Wali A.; Watkins S.; Weiss R.;
Wickemeyer W.; Wilson D.; Wilson V.; Wiseman A.; Wright W.; Xenakis M.;
Zelenka J.; Zilz N.; Amidon T.
Institution
(O'Donoghue, Braunwald, Steen, Im, Murphy, Crugnale, Wiviott, Bonaca,
Cannon) TIMI Study Group, Cardiovascular Division, Brigham AndWomen's
Hospital, 350 Longwood Ave, Boston, MA 02115, United States
(White) Green Lane Cardiovascular Service, Auckland City Hospital,
Auckland University, Auckland, New Zealand
(Lukas) Metabolic Pathways and Cardiovascular Therapeutic Area,
GlaxoSmithKline, Philadelphia, PA, United States
(Tarka, Davies) Metabolic Pathways and Cardiovascular Therapeutic Area,
GlaxoSmithKline, King of Prussia, PA, United States
(Steg) Departement Hospitalo-Universitaire FIRE, Hopital Bichat,
Universite Paris-Diderot, Paris, France
(Steg) NHLI Imperial College, ICMS Royal Brompton Hospital, United Kingdom
(Hochman) Department of Medicine, NYU Langone Medical Center, New York,
NY, United States
(Bode) Heart Center, Department for Cardiology and Angiology I, University
of Freiburg, Freiburg, Germany
(Maggioni) ANMCO Research Center, Florence, Italy
(Shannon, Watson) Metabolic Pathways and Cardiovascular Therapeutic Area,
GlaxoSmithKline, Research Triangle Park, NC, United States
(Weaver) Henry Ford Heart and Vascular Institute, Detroit, MI, United
States
(Serruys) Erasmus University, Thoraxcentrum, Rotterdam, Netherlands
(Serruys) International Center for Circulatory Health, Imperial College,
London, United Kingdom
Publisher
American Medical Association (E-mail: smcleod@itsa.ucsf.edu)
Abstract
IMPORTANCE: Lipoprotein-associated phospholipase
A<inf>2</inf>(Lp-PLA<inf>2</inf>) has been hypothesized to be involved in
atherogenesis through pathways related to inflammation. Darapladib is an
oral, selective inhibitor of the Lp-PLA<inf>2</inf>enzyme.
 OBJECTIVE(S): To evaluate the efficacy and safety of darapladib in
patients after an acute coronary syndrome (ACS) event. DESIGN, SETTING,
AND PARTICIPANTS: SOLID-TIMI 52was a multinational, double-blind,
placebo-controlled trial that randomized 13 026 participants within 30
days of hospitalization with an ACS (non-ST-elevation or
ST-elevationmyocardial infarction [MI]) at 868 sites in 36 countries.
INTERVENTIONS: Patients were randomized to either once-daily darapladib
(160mg) or placebo on a background of guideline-recommended therapy.
Patients were followed up for a median of 2.5 years between December 7,
2009, and December 6, 2013. MAIN OUTCOMES AND MEASURES: The primary end
point (major coronary events)was the composite of coronary heart disease
(CHD) death, MI, or urgent coronary revascularization formyocardial
ischemia. Kaplan-Meier event rates are reported at 3 years.
 RESULT(S): During a median duration of 2.5 years, the primary end
point occurred in 903 patients in the darapladib group and 910 in the
placebo group (16.3%vs 15.6%at 3 years; hazard ratio [HR], 1.00 [95%CI,
0.91-1.09]; P = .93). The composite of cardiovascular death, MI, or stroke
occurred in 824 in the darapladib group and 838 in the placebo group
(15.0%vs 15.0%at 3 years; HR, 0.99 [95%CI, 0.90-1.09]; P = .78). There
were no differences between the treatment groups for additional secondary
end points, for individual components of the primary end point, or in
all-cause mortality (371 events in the darapladib group and 395 in the
placebo group [7.3%vs 7.1%at 3 years; HR, 0.94 [95%CI, 0.82-1.08]; P =
.40). Patients were more likely to report an odor-related concern in the
darapladib group vs the placebo group (11.5%vs 2.5%) and also more likely
to report diarrhea (10.6%vs 5.6%). CONCLUSIONS AND RELEVANCE: In patients
who experienced an ACS event, direct inhibition of Lp-PLA<inf>2</inf>with
darapladib added to optimal medical therapy and initiated within 30 days
of hospitalization did not reduce the risk of major coronary events. TRIAL
REGISTRATION: clinicaltrials.gov Identifier: NCT01000727 Copyright 2014
American Medical Association. All rights reserved.

<193>
Accession Number
366059433
Title
Fish oil and postoperative atrial fibrillation: The omega-3 fatty acids
for prevention of post-operative atrial fibrillation (OPERA) randomized
trial.
Source
JAMA - Journal of the American Medical Association. 308 (19) (pp
2001-2011), 2012. Date of Publication: 21 Nov 2012.
Author
Mozaffarian D.; Marchioli R.; Macchia A.; Silletta M.G.; Ferrazzi P.;
Gardner T.J.; Latini R.; Libby P.; Lombardi F.; O'Gara P.T.; Page R.L.;
Tavazzi L.; Tognoni G.; Santini M.; Albert C.M.; Maggioni A.P.; Murray
K.T.; Harris B.; Saffitz J.E.; Siscovick D.; Stein P.; Corradi D.; Masson
S.; Brown N.J.; Ely E.W.; Jackson J.C.; Shintani A.; Milne G.L.; Song X.;
Sellke F.W.; Pioggiarella R.; Marfisi L.; King S.L.; Mills K.E.; Ogunleye
A.; Schelling N.H.; Wu J.; Simon C.; Iascone M.; Sinatra R.; Benedetto U.;
Dreas L.; Aleksova A.; Rinaldi M.; Salizzoni S.; Marchetto G.; Lamarra M.;
Pagliaro M.; Jori M.C.; Dozza L.; Calvi S.; Casabona R.; Zingarelli E.;
Flocco R.; Eusebio A.; Raffa G.; Tarelli G.; Parolari A.; Cavallotti L.;
Miyasoedova V.; Laguzzi F.; Gregorini R.; Mangia F.; Gazzoli F.; Raviola
E.; Vigano M.; Livi U.; Pompei E.; Salvador L.; Lamascese N.; Bilotta M.;
Martinelli L.; Cannata A.; Byrne J.; Leacche M.; Petracek M.R.; Ball S.K.;
Jessen M.E.; Weyant M.; Damiano R.J.; Singh A.K.; McDonald M.J.; Bolman
R.M.; Conboy D.A.; Burgess A.; Puskas J.D.; Vander-Woude J.; Bell M.C.;
Sethi G.; Lee D.C.; Favaloro R.R.; Hershson A.R.; Figal J.C.; Domenech A.;
Halac M.; Nicolosi L.N.; Moros C.G.; Del Carmen Rubio M.; Suarez R.F.;
Cacheda H.; Casal J.P.; Medrano J.C.; Cucurell M.C.; Scattini F.; Nojek
C.; Camporrotondo M.; Herrington D.M.; Brooks M.M.; De Caterina R.;
Gillinov M.; Padeletti L.; Pellegrini F.; Rothschild B.B.; Rubinstein F.;
Diep P.Q.; Guzman J.B.; Palmarini L.; Sacchetti S.; Flamminio A.V.;
Marfisi R.; Scarano M.; Afshin A.; Huang H.; Otite F.; Ambrosio M.;
Lincesso A.; Pezzoli L.; Anzini M.; Carriere C.; Belfiore R.; Fortunato
G.; Pellegrini A.; Reale V.; Sorrentino P.; Schiavina G.; Negrosanti M.;
Ravenni G.; Moro F.; Brambilla M.; Nava C.; Giroli M.; Daprati A.; Gennari
M.; Cusihuaman D.E.P.; Spagnolo B.; Francia M.; Stanca M.; Paris M.;
Berwick D.; Lusona B.; Castiglione N.; De Biasio M.; Daffarra C.; Ahmad
R.; Meisch C.A.; Maltais S.; Balaguer J.; Donahue T.; Guyton R.A.;
Thourani V.; Halkos M.; Lattouf O.; Baio K.T.; Levine S.R.; Pitts Z.E.;
Janssen K.; Ruhlman M.; Sharp S.; Pang K.; Mungo M.N.; Servian A.L.;
Battellini R.; Marenchino R.; Kotowicz V.; Cesareo V.; Sanchez R.; Romero
V.; Avila S.; Donnini F.; Biancospino L.; Laurino R.; Portalea R.
Institution
(Mozaffarian, Libby, O'Gara) Division of Cardiovascular Medicine, 665
Huntington Ave, Bldg 2-319, Boston, MA 02115, United States
(Mozaffarian, Libby, O'Gara, Albert, Saffitz, Bolman, Conboy, Burgess)
Channing Division of Network Medicine, Department of Medicine, Brigham and
Women's Hospital, Harvard Medical School, 665 Huntington Ave, Bldg 2-319,
Boston, MA 02115, United States
(Mozaffarian) Department of Epidemiology and Nutrition, Harvard School of
Public Health, 665 Huntington Ave, Bldg 2-319, Boston, MA 02115, United
States
(Marchioli, Silletta, Tognoni, Pellegrini) Department of Clinical
Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Laboratory of
Clinical Epidemiology of Cardiovascular Disease, Via Nazionale 8,
Santa-Maria-Imbaro CH 66030, Italy
(Macchia) GESICA Foundation, Buenos-Aires, Argentina
(Ferrazzi, Simon, Iascone, Ambrosio, Lincesso, Pezzoli) Ospedali Riuniti
di Bergamo, Bergamo, Italy
(Gardner) Center for Heart and Vascular Health, Christiana Care Health
System, Newark, DE, United States
(Latini, Masson) Department of Cardiovascular Research, Istituto di
Ricerche Farmacologiche Mario Negri, Milan, Italy
(Lombardi) Department of Health Sciences, University of Milan, Milan,
Italy
(Page) Department of Medicine, University of Wisconsin, School of Medicine
and Public Health, Madison, United States
(Tavazzi) GVM Hospitals of Care and Research, Villa Maria Cecilia
Hospital, Cotignola, Italy
(Santini) Ospedale San Filippo Neri, Rome, Italy
(Maggioni) Centro Studi Associazione Nazionale Medici Cardiologi
Ospedalieri, Florence, Italy
(Murray, Brown, Ely, Jackson, Shintani, Milne, Byrne, Leacche, Petracek,
Ball, Ahmad, Meisch, Maltais, Balaguer) Vanderbilt University, School of
Medicine, Nashville, TN, United States
(Harris) Sanford School of Medicine, Sioux Falls, SD, United States
(Siscovick) University of Washington, Seattle, United States
(Stein, Damiano, Donahue) Washington University, School of Medicine, St.
Louis, MO, United States
(Corradi) University of Parma, Parma, Italy
(Song, Diep, Guzman) Fred Hutchinson Cancer Research Center, Seattle, WA,
United States
(Sellke, Singh, McDonald) Brown Medical School, Rhode Island Hospital,
Providence, United States
(Silletta, Pioggiarella, Marfisi, Palmarini, Sacchetti, Flamminio,
Marfisi, Scarano) Main Data Coordinating Center, Consorzio Mario Negri
Sud, Santa-Maria-Imbaro, Italy
(King, Mills, Ogunleye, Schelling, Wu, Afshin, Huang, Otite) US Clinical
Coordinating Center, Harvard School of Public Health, Boston, MA, United
States
(Sinatra, Benedetto) Ospedale S. Andrea, Universita la Sapienza, Roma,
Italy
(Dreas, Aleksova, Anzini, Carriere, Belfiore) Ospedali Riuniti, University
of Trieste, Trieste, Italy
(Rinaldi, Salizzoni, Marchetto, Raviola, Fortunato, Pellegrini, Reale,
Sorrentino) Department of Surgical Sciences, Division of Cardiac Surgery,
University of Torino, Torino, Italy
(Lamarra, Pagliaro, Jori, Dozza, Calvi, Schiavina, Negrosanti) GVM Care
and Research, E.S. Health Science Foundation, Cotignola, Italy
(Casabona, Zingarelli, Flocco, Ravenni) Azienda Ospedaliera Ordine
Mauriziano di Torino, Ospedale Mauriziano Umberto I, Torino, Italy
(Eusebio, Raffa, Tarelli) Unit of Cardiac Surgery, Humanitas Clinical and
Research Center, Rozzano, Italy
(Parolari, Cavallotti, Miyasoedova, Laguzzi, Moro, Brambilla, Nava,
Giroli, Daprati, Gennari, Cusihuaman) Centro Cardiologico Monzino,
I.R.C.C.S., Milano, Italy
(Gregorini, Mangia, Spagnolo, Francia, Stanca) GVM Care and Research, E.S.
Health Science Foundation, Lecce, Italy
(Gazzoli, Raviola, Vigano, Paris, Berwick, Lusona, Castiglione) Fondazione
I.R.C.C.S. Policlinico S. Matteo, Pavia, Italy
(Livi, Pompei, De Biasio, Daffarra) Azienda Ospedaliero, Universitaria
Santa Maria della Misericordia, Udine, Italy
(Salvador, Lamascese, Bilotta) Ospedale San Bortolo, Vicenza, Italy
(Martinelli, Cannata) Niguarda Ca' Granda Hospital, Department of Cardiac
Surgery, Milan, Italy
(Jessen, Weyant) University of Texas Southwestern Medical Center, Dallas,
United States
(Puskas, Guyton, Thourani, Halkos, Lattouf, Baio, Levine, Pitts) Emory
Healthcare, Atlanta, GA, United States
(Vander-Woude, Bell, Janssen, Ruhlman) Sanford Health, Sanford University
of South Dakota Medical Center, Sioux Falls, United States
(Sethi, Sharp) University of Arizona, Tucson Medical Center, Tucson,
United States
(Lee, Pang) State University of New York Downstate, Brooklyn, United
States
(Favaloro, Hershson, Figal, Mungo, Servian) Fundacion Favaloro, Buenos
Aires, Argentina
(Domenech, Halac, Battellini, Marenchino, Kotowicz, Cesareo, Sanchez,
Romero, Avila) Hospital Italiano, Buenos Aires, Argentina
(Nicolosi, Moros, Del Carmen Rubio, Suarez, Donnini, Biancospino) Hospital
Espanol, Buenos Aires, Argentina
(Cacheda, Casal, Laurino, Portalea) Instituto de Cardiologia de
Corrientes, Corrientes, Argentina
(Medrano, Cucurell, Scattini) Clinica y Maternidadde Suizo, Buenos Aires,
Argentina
(Nojek, Camporrotondo) Instituto Fundacion de Lucha Contra Las
Enfermedades Neurologicas en la Infancia, Buenos Aires, Argentina
(Herrington) Wake Forest University, School of Medicine, Winston-Salem,
NC, United States
(Brooks) University of Pittsburgh, Pittsburgh, PA, United States
(De Caterina) Universita degli Studi G. d'Annunzio, Chieti, Italy
(Gillinov) Cleveland Clinic Main Campus, Cleveland, OH, United States
(Padeletti) University of Florence, Florence, Italy
(Rothschild) University of North Carolina, Chapel Hill, United States
(Rubinstein) IECS - Instituto de Efectividad Clinica y Sanitaria, Buenos
Aires, Argentina
Publisher
American Medical Association (E-mail: smcleod@itsa.ucsf.edu)
Abstract
Context: Postoperative atrial fibrillation or flutter (AF) is one of the
most common complications of cardiac surgery and significantly increases
morbidity and health care utilization. A few small trials have evaluated
whether long-chain n-3-polyunsaturated fatty acids (PUFAs) reduce
postoperative AF, with mixed results. Objective(s): To determine
whether perioperative n-3-PUFA supplementation reduces postoperative AF.
Design, Setting, and Patients: The Omega-3 Fatty Acids for Prevention of
Postoperative Atrial Fibrillation (OPERA) double-blind,
placebo-controlled, randomized clinical trial. A total of 1516 patients
scheduled for cardiac surgery in 28 centers in the United States, Italy,
and Argentina were enrolled between August 2010 and June 2012. Inclusion
criteria were broad; the main exclusions were regular use of fish oil or
absence of sinus rhythm at enrollment. Intervention(s): Patients were
randomized to receive fish oil (1-g capsules containing >=840 mg n-3-PUFAs
as ethyl esters) or placebo, with preoperative loading of 10 g over 3 to 5
days (or 8 g over 2 days) followed postoperatively by 2 g/d until hospital
discharge or postoperative day 10, whichever came first. Main Outcome
Measure(s): Occurrence of postoperative AF lasting longer than 30 seconds.
Secondary end points were postoperative AF lasting longer than 1 hour,
resulting in symptoms, or treated with cardioversion; postoperative AF
excluding atrial flutter; time to first postoperative AF; number of AF
episodes per patient; hospital utilization; and majoradverse
cardiovascular events, 30-day mortality, bleeding, and other adverse
events. Result(s): At enrollment, mean age was 64 (SD, 13) years;
72.2% of patients were men, and 51.8% had planned valvular surgery. The
primary end point occurred in 233 (30.7%) patients assigned to placebo and
227 (30.0%) assigned to n-3-PUFAs (odds ratio, 0.96 [95% CI, 0.77-1.20];
P=74). None of the secondary end points were significantly different
between the placebo and fish oil groups, including postoperative AF that
was sustained, symptomatic, or treated (231 [30.5%] vs224 [29.6%], P=70)
or number of postoperative AF episodes per patient (1 episode: 156 [20.6%]
vs 157 [20.7%]; 2 episodes: 59 [7.8%] vs 49 [6.5%]; >=3 episodes: 18
[2.4%] vs 21 [2.8%]) (P=.73). Supplementation with n-3-PUFAs was generally
well tolerated, with no evidence for increased risk of bleeding or serious
adverse events. Conclusion(s): In this large multinational trial
among patients undergoing cardiac surgery, perioperative supplementation
with n-3-PUFAs, compared with placebo, did not reduce the risk of
postoperative AF. Copyright © 2012 American Medical Association.
All rights reserved.

<194>
Accession Number
365300092
Title
Basal insulin and cardiovascular and other outcomes in dysglycemia.
Source
New England Journal of Medicine. 367 (4) (pp 319-328), 2012. Date of
Publication: 26 Jul 2012.
Author
Gerstein H.C.; Bosch J.; Dagenais G.R.; Jung H.; Maggioni A.P.; Pogue J.;
Probstfield J.; Ramachandran A.; Riddle M.C.; Ryden L.E.; Yusuf S.; Diaz
R.; Johnston P.; Vige R.; Birkeland K.; Budaj A.; Cardona E.; Chazova I.;
Commerford P.; Danilova L.; Davies M.; Fernando R.; Fodor G.; Gilbert R.;
Gomis R.; Hanefeld M.; Hildebrandt P.; Kacerovsky-Bielesz G.; Keltai M.;
Kim J.H.; Krum H.; Lanas F.; Lewis B.S.; Lonn E.; Marin-Neto J.; Marre M.;
McKelvie R.; McQueen M.; Mendoza I.; Morillo C.; Pan C.; Profozic V.;
Ratner R.; Richardson L.; Rosenstock J.; Spinas G.A.; Sreenan S.; Stoel
I.; Syvanne M.; Yale J.F.; Avezum A.; Bahit M.C.; Bogaty P.; Bordeleau L.;
Chacomicronn C.; Corson M.; Harper W.L.; Halon D.; Magloire P.; Mann J.;
Pavlova V.; Punthakee Z.; Silva J.; Tsang B.; Yakubovich N.; Abdallah A.;
Ahmad S.; Chandra J.; Chandra R.; Cukierman-Yaffee T.; Dyal L.; Joldersma
L.; MacRae L.; MacRae S.; Malik S.; Mead A.; Pasha F.; Pazmino-Canizares
J.; Pohl K.; Sakalas A.; Tyrwhitt J.; Ahuad Guerrero R.; Alebuena A.;
Alvarez N.; Alzogaray M.; Amuchastegui M.; Andres M.; Angos M.; Baglivo
H.; Barbieri M.; Bassi F.; Bello F.; Bono J.; Bustamante Labarta M.;
Bustos B.; Caccavo A.; Calveira M.; Camino A.; Cantero M.; Capozzi M.;
Cardone M.; Cartasegna L.; Cassetari A.; Castellanos R.; Chavez Caballero
R.; Cipullo M.; Contreras A.; Coria J.; Corinaldesi F.; Costa G.; Crespo
C.; Cruz M.; Cuello J.; Cuneo C.; Del Corro I.; Diez R.; Dituro C.;
Dominguez A.; Facta A.; Faingold C.; Farah M.; Fares Taie A.; Fernandez
A.; Ferrari A.; Ferrari N.; Garcia Monteverde C.; Garrido M.; Giachello
C.; Gonzalez M.; Gutierrez N.; Guzman L.; Guzman P.; Hasbani E.; Henquin
R.; Hershon A.; Hirschon Alvarez Prado A.; Hominal M.; Hrabar A.; Imposti
H.; La Grutta M.; Lanchiotti P.; Lobo Marquez L.; Lopez Santi R.;
Lowenstein J.; Lugo M.; Luqueci M.; Mainini S.; Majul C.; Manzano R.;
Manzur S.; Marcucci G.; Marino M.; Massari F.; Mendez N.; Molina M.;
Montana O.; Mulazzi M.; Nardone L.; Odetto I.; Orlandini A.; Oviedo A.;
Paez O.; Parnas A.; Patron F.R.; Pedernera C.; Pelagagge M.; Plastino M.;
Polari P.; Pomposiello J.; Porta A.; Prado A.; Quiroz M.; Ramirez A.;
Rodriguez M.; Ronderos R.; Sago L.; Sanchez A.; Sanchez R.; Sandrin A.;
Schygiel P.; Sernia V.; Sinay I.; Smith Casabella T.; Sosa Liprandi A.;
Sosa Liprandi M.; Soso L.; Sposetti G.; Stisman D.; Streitenberger P.;
Suarez G.; Tonin H.; Ulla M.; Valdez J.; Vico M.; Villamil A.; Villarino
A.; Viscaya Castro A.; Visco V.; Vogel D.; Waisman F.; Zaidman C.; Amerena
J.; Applebe A.; Aylward P.; Binnekamp M.; Bruce I.; Burdeniuk C.; Burnet
R.; Colman P.; Colquhoun D.; Davis S.; De Looze F.; De Pasquale C.;
D'Emden M.; Eaton H.; Farshid A.; Foulanos S.; Galanos J.; Gordon G.; Guhu
M.; Ho J.; Jeffery I.; Jerums G.; Kwan M.; Lefkovits J.; Luu S.; MacIsaac
R.; Marjason J.; Mohabbati V.; Nankervis A.; O'Neal D.; Perera N.; Poynten
A.; Rahman A.; Razak S.; Roberts T.; Sebastian M.; Simpson R.; Soldatos
G.; Sullivan D.; Teede H.; Tiong F.; Topliss D.; Torpy D.; Waddell-Smith
K.; Waites J.; Wenman J.; Whelan A.; Williams L.; Yeap B.; Yeow W.; Yong
G.; Aczel S.; Azimy N.; Bertha P.; Blocher J.; Bohnel C.; Brath H.; Breuss
J.; De Campo A.; Drexel H.; Ettmuller Y.; Feder A.; Feinboeck C.; Gulz E.;
Hofmann M.; Hoppichler F.; Jahnel H.; Jankovic V.; Kann T.; Kathrein T.;
Kotter T.; Kratz E.; Kreuzwieser E.; Loreck C.; Ludvik B.; Marte T.;
Mellitzer K.; Nistler S.; Placher-Sorko G.; Prager R.; Rein P.; Riedl M.;
Saly C.; Schernthaner G.; Schichka E.; Seidlhofer C.; Sonnenfeld M.;
Stefan H.; Steiner K.; Thomas B.; Toplak H.; Urstoger K.; Vetter B.;
Vonbank A.; Waldschutz W.; Wallner F.; Winkler F.; Goncharik D.; Lazareva
I.; Lichorad N.; Mrochek A.; Murashko N.; Radyuk D.; Ramanovski A.;
Sudzhaeva S.; Sujayeva V.; Yarashevich N.; Campbell G.; Marshall S.; West
A.; Abreu F.; Alves M.; Ayoub-Aidar J.; Barros M.; Barros-Silveira J.;
Blacher M.; Costa E.; Costa F.; Daltro C.; Delana J.; Eliaschewitz F.;
Facanha C.; Feitosa G.; Figueiredo J.; Forti A.; Franco D.; Franken M.;
Freire F.; Garcia V.; Gouvea-Neto A.; Grofallo S.; Kanedlai N.;
Kerr-Saraiva J.; Ladeira R.; Leaes P.; Lemos M.; Lima F.; Lima Filho M.;
Macedo L.; Manenti E.; Monte O.; Mossman A.; Mothe F.; Mouco O.; Moyses
Golbert M.; Nasser Hissa L.; Nasser-Hissa M.; Nicolau J.; Nigro Maia L.;
Ninno T.; Nunes C.; Oliveira C.; Oliveira O.; Passos da silva R.;
Pericles-Esteves J.; Rabelo L.; Rabelo-Alves Junior A.; Rassi S.; Rech R.;
Roldan F.; Salles J.; Sampaio C.; Seabra A.; Sealissi N.; Seixas A.; Sena
R.; Shehadeh I.; Teixeira M.; Turin H.; Vicente Serrano C.; Vidigal M.;
Vilela M.; Wajchenberg B.; Abbott C.; Abu-Bakare A.; Ardilouze J.;
Auersperg E.; Bailey A.; Bailey G.; Baillargeon J.; Beaurivage C.; Belair
J.; Belanger A.; Bellabarba D.; Berlingieri J.; Bernier F.; Bhargava R.;
Bhesania T.; Booth W.; Bose S.; Boulianne M.; Bourgeois S.; Breton D.;
Brossoit R.; Buithieu J.; Campeau J.; Carlson B.; Carpentier A.;
Cavalcanti R.; Cha J.; Chagnon P.; Chan Y.; Chessex C.; Chiasson J.;
Chouinard S.; Clayton D.; Conway J.; Crepeau J.; Cudmore D.; D'Ignazio G.;
Doig G.; Dominguez M.; Dube F.; Dumas R.; Dupuis R.; Dyrda I.; Eddy D.;
Eiley D.; Fox H.; Fratesi S.; Gallant S.; Garceau C.; Garfield N.; Germain
C.; Glazer S.; Gosselin G.; Gould D.; Grills G.; Halle J.; Hardin P.;
Harper W.; Heath J.; Heath V.; Hivert M.; Ho K.; Houde G.; Hramiak I.;
Hutchinson A.; Huynh T.; Ilie-Haynes R.; Imran S.; Islam A.; Iwanochko M.;
Jones C.; Joyce C.; Kirouac I.; Kumar R.; Lamothe M.; Langlois M.; Lauzon
C.; Lavoie M.; Leader R.; Lecours S.; Lepage S.; Lochnan H.; Ma P.; McLean
A.; Mecci S.; Mehta P.; Mercier M.; Miller D.; Morisset A.; Nawaz S.;
Nisker W.; Nyomba G.; O'Keefe D.; Palardy J.; Parekh P.; Paul T.; Perron
P.; Pesant M.; Phillips R.; Pruneau G.; Quintin I.; Raby K.; Richard C.;
Rosenfeld G.; Saulnier D.; Shaban J.; Shah A.; Shu D.; Sigal R.; Silverman
M.; Singh J.; Sivucha W.; Skamene A.; Sliwowicz D.; Smith R.; St Hilaire
R.; Steinson D.; Sussex B.; Tan K.; Tannous R.; Telner A.; Theroux P.;
Tsoukas C.; Tsoukas G.; van Buuren J.; VanRossum N.; Vexler R.; Vizel S.;
Warnica W.; Weingert M.; Wilson R.; Wong W.; Woo V.; Yale J.; Acevedo M.;
Alwyn C.; Baier E.; Baier S.; Galloso R.; Lahsen R.; Lorenas G.;
Montecinos A.; Montecinos M.; Pineda P.; Pollak F.; Sapunar J.; Serrano
V.; Stockins B.; Varleta P.; Yovanovich J.; Zambra F.; Ba J.; Bao Y.; Bi
Y.; Bu S.; Chen B.; Chen H.; Chen J.; Chen L.; Chen M.; Chen Y.; Cui J.;
Dong M.; Feng P.; Feng Z.; Gao C.; Gao F.; Gao X.; Gao Z.; Gong Y.; Guang
L.; Guo X.; Han F.; Han X.; Hou X.; Hu R.; Ji L.; Jia J.; Jia W.; Jiao X.;
Jin X.; Kuang J.; Li M.; Li Q.; Li X.; Li Y.; Ling Y.; Liu F.; Liu Z.; Lu
B.; Lu J.; Lu Z.; Lv X.; Ning G.; Peng Y.; Ren Y.; Shao Y.; Shi Y.; Shu
X.; Sun H.; Sun L.; Sun X.; Tang K.; Tian H.; Wang C.; Wang F.; Wang L.;
Wang Q.; Wang W.; Wang X.; Wang Y.; Wen J.; Wu C.; Wu H.; Wu J.; Wu M.;
Xing X.; Xue Y.; Yan L.; Yan S.; Yang H.; Yang N.; Yang W.; Yang Z.; Yao
J.; Yao L.; Yu D.; Yu H.; Yu M.; Yu X.; Yuan L.; Yuan M.; Yuan S.; Yuan
W.; Yuan Y.; Yuan Z.; Zeng T.; Zhang J.; Zhang R.; Zhang X.; Zhao L.;
Zheng B.; Zheng J.; Zhou W.; Zhu N.; Zhu Y.; Zou D.; Zou J.;
Lopez-Jaramillo P.; Accini J.L.; Bohorquez R.; Botero R.; Cure C.;
Figueredo M.; Hernandez E.; Kattah W.; Llamas A.; Orozco L.; Pava L.;
Perez M.; Pineda M.; Quintero A.; Quiros R.; Urina M.; Velez S.; Altabas
V.; Baotic I.; Berkovic M.; Goldoni V.; Kerum T.; Mirosevic G.; Tarle D.;
Vidovic I.; Zjacic-Rotkvic V.; Abbas R.; Andersen H.; Auscher S.; Baumbach
L.; Brockstedt H.; Christensen P.; Christiansen M.; Clemmensen K.; Egstrup
K.; Gislason G.; Haar D.; Hansen K.; Heden Andersen P.; Helleberg K.;
Hermansen K.; Holmer J.; Jeppesen J.; Klausen I.; Koustrup-Sonder T.;
Krarup T.; Lerche S.; Lervang H.; Linde B.; Lund P.; Lund S.; Madsbed S.;
Molvig J.; Orskov C.; Ostergaaard O.; Perrild H.; Pietraszek A.; Ralfkjaer
N.; Roenne H.; Rokkedal Nielsen J.; Seibaek M.; Soendergaard H.; Sorensen
L.; Sundahl Mortensen L.; Torp-Pedersen C.; Tuxen C.; Urhammer S.;
Vadstrup E.; Pirags V.; Ambos A.; Janson A.; Rudenko P.; Viitas L.; Aranko
S.; Badeau M.; Eriksson J.; Haapamaki H.; Kajander O.; Kuusisto A.;
Luukkonen S.; Makela J.; Nieminen S.; Niskanen L.; Ripatti J.;
Ruotsalainen S.; Saltevo J.; Savela K.; Strand J.; Valle T.; Virkamaki A.;
Aboud E.; Alavoine L.; Bekherraz A.; Bohme P.; Bourezane H.; Catargi B.;
Charpentier G.; Clergeot A.; Courreges J.; Delmas T.; Duengler F.; Feknous
C.; Gendre D.; Guerci B.; Hadjadj S.; Kerlan V.; Laguerre N.; Le Potier
J.; Lombardo F.; Malville E.; Marechaud R.; Mattei C.; Moreira J.;
Penfornis A.; Petit C.; Pinel J.; Piquel X.; Raccah D.; Reznik Y.; Rod A.;
Roudaut N.; Rousseau E.; Schillo F.; Schmitt B.; Sonnet E.; Torremocha F.;
Travert F.; Vanhoute C.; Vimeux M.; Abdollahnia R.; Adamidou A.; Arslan
S.; Bach-Kliegel B.; Bartusch B.; Bauer N.; Bieler T.; Blankenfeld H.;
Boeckmann U.; Busch K.; Butzer R.; Chenchanna-Merzhaeuser M.; Denger R.;
Deutsch C.; Diessel S.; Donati-Hirsch I.; Dornisch M.; Enghofer K.; Fleig
T.; Forst T.; Frommherz M.; Goeller K.; Habbig J.; Hadziselimovic S.;
Hamann A.; Hampel T.; Heger S.; Helmes C.; Hoffman C.; Hohberg C.; Humpert
P.; Kamke A.; Kamke W.; Kindermann P.; Klein C.; Klein D.; Koehler A.;
Kuehn A.; Langer K.; Limmer S.; Loew A.; Maimer A.; Marck C.; Meier G.;
Methner-Friederich M.; Metzler W.; Meyer K.; Miftari N.; Milde J.; Minnich
J.; Molkewehrum M.; Morcos M.; Mueller-Hoff C.; Nguyen M.; Nishwitz M.;
Oldenburg J.; Ott P.; Pauli K.; Pauly B.; Pfeiffer A.; Pfuetzner A.;
Pischa U.; Radke R.; Reismann P.; Riemer M.; Rochlitz H.; Rudofsky G.;
Ruhla S.; Sammler A.; Schaper F.; Schiemenz K.; Scholz G.; Schumm-Draeger
P.; Segiet T.; Segner A.; Seissler J.; Spahn S.; Stier U.; Tonon G.; von
Amelunxen S.; von Schacky C.; Wilhelm B.; Wilhelm K.; Witt K.;
Wuechner-Hofmann S.; Baranyai M.; Birkus Z.; Foldesi I.; Gaal Z.; Harcsa
E.; Hati K.; Hohmann Z.; Istenes I.; Jozsef I.; Juhasz E.; Kempler P.;
Keresztes B.; Keresztes K.; Kis-Gombos P.; Kovacs I.; Kozma T.; Laszlo Z.;
Noori E.; Nyirati G.; Papp Z.; Patkay J.; Poor F.; Pusztai P.; Putz Z.;
Rigo E.; Sereg M.; Simon K.; Somogyi A.; Sumegi J.; Szabo A.; Szabo J.;
Szigeti S.; Szilveszter D.; Tarko M.; Varga C.; Varga Szabo L.; Voros P.;
Arathi; Aravind S.; Badgandi M.; Balaji M.; Balaji V.; Chamukuttan S.;
Devi Manduva P.; Fatima S.; Ganapathy B.; George O.; George P.; Jaffar M.;
Jain P.; Kamath P.; Karthik V.; Koshy G.; Krishnan L.; Kumar H.; Lal P.;
Mithal A.; Modi S.; Mohan V.; Moses V.; Oomen R.; Pais P.; Pati P.;
Pendsey S.; Rai P.; Rajagopal R.; Ramu M.; Ranjit U.; Rao P.; Senthil V.;
Seshaiah V.; Sethi B.; Shah P.; Sharma R.; Shetty S.; Shobha A.; Siddharth
R.; Sridhar G.; Sudeep K.; Sunil C.; Sunitha S.; Suresh S.; Thomas N.;
Vageesh A.; Anwer Z.; Barton J.; Behan L.; Bell M.; Cullen M.; Dineen S.;
Draman Yusof M.; Dunne F.; Gibney J.; Hussain T.; Khan M.; Kinsley B.;
Kyithar P.; Lavin F.; McGowan A.; McGurk C.; Mirza A.; Mohammadi B.;
O'Brien T.; O'Connell J.; O'Halloran D.; O'Shea D.; Roberts G.; Tomkin G.;
Wan Mahmood W.; Abramod-Ness R.; Adawi F.; Aharon B.; Backer M.;
Beniashvili A.; Berliner A.; Bloch L.; Bugelman D.; Butnaru A.; Cohen O.;
Cohen Y.; Frenkel M.; Glant M.; Gustava B.; Guttman H.; Halabi S.;
Harman-Boehm I.; Ilany J.; Karkabi B.; Khader N.; Khaskia A.; Khudyak Y.;
Klainman E.; Kogan N.; Lender D.; Levin I.; Mardi T.; Marmor A.; Mosseri
M.; Nabriski D.; Omary M.; Orlovsky S.; Peres D.; Quasim M.; Raz I.;
Remesnik M.; Rogowski O.; Rozenfeld I.; Scharr D.; Shnifer I.; Shuster T.;
Solomon R.; Steiner H.; Tzivoni D.; Wolfson N.; Yossef Z.; Zahger D.;
Zeltser D.; Zimlichman R.; Aina F.; Ariatti C.; Bonetti R.; Cacciatore F.;
Calcinaro F.; Corona G.; De Maria P.; Del Prato S.; Derosa G.; Di Pasquale
G.; Falorni A.; Fanelli R.; Fedele D.; Filorizzo G.; Fogari R.; Furgi G.;
Ghio A.; Giorda C.; Gregori G.; Iannuzzi G.; Lapolla A.; Luciano B.;
Lucotti P.; Maggi A.; Marafetti L.; Marchese T.; Martino G.; Marzotti S.;
Miccoli R.; Monti L.D.; Moretti L.; Palvarini M.; Petacchi R.; Piarulli
F.; Piatti P.M.; Rudi S.; Santeusanio F.; Sesti G.; Setola E.; Sforza A.;
Shehaj E.; Veniani M.; Viviani G.; Zigoura E.; Chae S.; Cho D.; Cho E.;
Cho Y.; Choi Y.; Chung M.; Hong E.; Hong Y.; Jeong M.; Kim B.; Kim D.; Kim
H.; Kim I.; Kim J.; Kim P.; Kim S.; Koo B.; Kwok S.; Kwon H.; Lee J.; Lim
J.; Oh S.; Ohn J.; Park C.; Park H.; Park K.; Seung K.; Son H.; Woo J.;
Yoon K.; Ansmite B.; Balcere I.; Bumbure A.; Ducena K.; Lejnieks A.; Rasa
I.; Ritenberga R.; Romanova M.; Salmina I.; Steina S.; Badariene J.;
Gailiuniene S.; Grigonis S.; Juskiene R.; Petrulioniene Z.; Sakalyte G.;
Stasiunas T.; Sulskiene M.; Urbonaite B.; Zarankiene R.; Ziukaite R.;
Arechavaleta R.; Beltran-Jaramillo T.; Calvo-Vargas C.; Campillo-Cardenas
C.; Cardona D.; Carmona-Huerta J.; Cedano-Limon M.; Comellas-De M.;
Dominguez C.; Gomez-Cruz J.; Gonzalez-Perez R.; Illescas J.; Jimenez-Ramos
S.; Lopez-Alvarado A.; Marquez-Rodriguez E.; Martinez G.; Pascoe S.;
Plascencia Vazquez O.; Rodriguez H.; Ruiz-Cornejo M.; Velasco-Sanchez G.;
Vidrio-Velazquez M.; Villeda-Espinosa E.; Badings E.; Bartels G.;
Bruggink-Andre de la Porte P.; Bruijns E.; Cornel J.; De Milliano P.; De
Mulder M.; De Swart J.; Derks A.; Dirkali A.; Droste J.; Galjee M.;
Hautvast R.; Hermans W.; Holwerda N.; Ilmer B.; Kofflard M.;
Kooistra-Huizer J.; Kurvers M.; Langerveld J.; Leenders C.; Liem A.; Lok
D.; Neumann D.; Nierop P.; Plomp K.; Posma J.; Reichert C.; Roeters Van
Lennep H.; Ronner E.; Said S.; Takens L.; Umans V.; Van der Sluis A.A.;
Van der Zwaan C.; Van Dobbenburgh J.; Van Es A.; Van Hessen M.; Van
Mechelen R.; Van Miltenburg-Van Zijl A.; Van Zeijl L.; Veerhoek M.;
Viergever E.; Weijers E.E.; Willems F.; Blix I.; Cooper J.; Debowska A.;
Erichsen K.; Fossum J.; Gjertsen E.; Grill V.; Gudnason S.; Hoye K.; Istad
H.; Winther J.; Joakimsen R.; Jorde R.; Larsen I.; Mella B.; Otterstad J.;
Risberg K.; Skare K.; Skeie S.; Sommervoll L.; Tandberg A.; Whitfield R.;
Wium C.; Cunanan E.; Fernando-Catindig E.; Gomez M.; Jaring C.;
Lantion-Ang F.; Licaros M.; Lim-Abrahan M.; Madronio E.; Panelo A.; Raboca
J.; Ramos G.; Tugna S.; Aksamit-Bialoszewska E.; Bandurska-Stankiewicz E.;
Baranska M.; Bronisz A.; Bronisz M.; Chrustowski W.; Cieslak B.;
Czupryniak L.; Drazkowicz-Gozdzik B.; Galuszka-Bilinska A.; Gmytrasiewicz
M.; Janik K.; Jedynasty K.; Kania G.; Kawka-Urbanek T.; Kinalska I.;
Kincel K.; Kleszczewska U.; Kruszewski J.; Loba J.; Malicka J.;
Mielecka-Kincel M.; Milczarczyk A.; Milosz D.; Mrowczynska A.; Mytnik M.;
Nowakowski A.; Nowakowski P.; Oleskowska L.; Omelanczuk-Wiech E.;
Pawlowski M.; Poplawska A.; Rucinska M.; Rucinski M.; Rutkowska J.;
Saryusz-Wolska M.; Siewko K.; Sikora-Frac M.; Stecka-Wierzbicka J.;
Swiatkowski M.; Swierczynski R.; Szpajer M.; Szymkowiak K.; Tarach J.;
Tarasiewicz U.; Wiatr D.; Wojewoda P.; Woszczak-Marcinkowska H.; Zadrozny
J.; Hancu N.; Albota A.; Bala C.; Barbonta D.; Botnariu G.; Bradescu O.;
Busegeanu M.; Bzduch M.; Catrinoiu D.; Caziuc R.; Cerghizan A.; Cheta D.;
Cif A.; Ciomos D.; Cosma D.; Creteanu G.; Crisan I.; Danciulescu R.;
Dobjanschi C.; Dodan R.; Duma L.; Ferariu I.; Ghenes T.; Ghise G.; Graur
M.; Ilinca M.; Marton R.; Mindrescu N.; Morosanu A.; Morosanu M.; Mota M.;
Nafornita V.; Negrisan G.; Nicodim S.; Nicolau A.; Nita C.; Onaca A.;
Panus C.; Pletea N.; Pop C.; Pop L.; Popa B.; Roman G.; Rosu M.; Sandu N.;
Serban V.; Sima A.; Stamoran L.; Strugariu M.; Suciu G.; Szilagyi I.;
Vacaru G.; Veresiu I.; Vlad A.; Adasheva T.; Ageev F.; Akhmedganov N.;
Akinina A.; Alexandrov A.; Ambatiello L.; Ametov A.; Ausheva A.; Babaeva
L.; Babenko A.; Balyasnikova E.; Bart B.; Belova J.; Berstein L.;
Bondarenko I.; Bondarev E.; Bulkina O.; Chernikova N.; Chumak B.; Deeva
T.; Demicheva O.; Demidova T.; Doskina E.; Duganova A.; Dzhaiani N.;
Egorova I.; Ettinger O.; Feofanova S.; Fofanova T.; Galaktionov P.;
Gavrilova N.; Gilyarevsky S.; Gnidkina N.; Golubev A.; Gornyakova N.;
Grigorova S.; Grineva E.; Gurevich V.; Irtuganov N.; Ivanova L.; Jaiani
N.; Kalashnikova M.; Karpov Y.; Khalimov Y.; Khorocheva G.; Kirillova E.;
Kistner J.; Kobalava Z.; Kochergina I.; Kravchenko T.; Krylov K.; Kulkova
P.; Kuparev I.; Kurbanova E.; Lysenko T.; Markovich A.; Martyanova I.;
Martynyuk T.; Masiinvets M.; Mavlyavieva E.; Maychuk E.; Melnichenko G.;
Mikhailusova M.; Mkrtumyan A.; Mychka V.; Nebieridze D.; Nesterova E.;
Orlov V.; Orlova V.; Orlova Y.; Papov F.; Patroucherva I.; Petunina N.;
Pirozhinskaya S.; Podachina S.; Postnikova S.; Pshikova O.; Rogova L.;
Romashevskiy B.; Runikhina N.; Sadulayeva I.; Safaryan A.; Sakovich E.;
Saprikina T.; Sargsyan V.; Semikozova O.; Shkolnik E.; Shubina A.; Shustov
S.; Sinitsina I.; Solovyeva E.; Storogakov G.; Stovpyuk O.; Sussekov A.;
Telnova M.; Temirov A.; Terekhov V.; Tereschenko S.; Tiourina T.;
Tolkacheva V.; Tsoy U.; Urazgyldeeva S.; Vasyuk Y.; Vinnitskay N.;
Voevodina E.; Volkova A.; Zadionchenko V.; Zalevskaya A.; Zhelninova T.;
Zhukova N.; Zilov A.; Bernatova J.; Duris T.; Markova I.; Martinka E.;
Michalova L.; Minarik P.; Peter L.; Raslova K.; Silvia D.; Subadova M.;
Tisonova J.; Vohnout B.; Adam M.; Badat A.; Bester A.; Bester F.; Blacking
L.; Bouwer D.; Brice B.; Cassimjee S.; Cronje T.; Deftereos J.; Distiller
L.; Ellis G.; Forster O.; Fulat M.; Gani M.; Gibson G.; Hansa S.;
Hendricks N.; Herbst L.; Hitzeroth J.; Joffe B.; Kelbe C.; Kelbe D.; King
J.; Kramer B.; Landau S.; Levitt N.; Meyer-Nell S.; Moore R.; Muller D.;
Nell H.; Omar M.; Randeree H.; Seeber M.; Seedat; Segynu D.; Siebert M.;
Van den Berg E.; Van der Walt P.; Van Dyk C.; Van Niekerk F.; Van Zyl L.;
Wellman H.; Bertomeu V.; Botella M.; Buno M.; Calle A.; Cano Perez J.;
Coves M.; Juanatey J.G.; Garcia-Mayor R.; Gaztambide S.; Gippini A.;
Goikolea I.; Gonzalez J.; Hillman N.; Lopez Garcia Aranda V.; Magueda I.;
Mato J.; Mazon P.; Morillas P.; Novials A.; Pallardo L.; Perez L.;
Rodriguez J.; Romero L.; Sagarra E.; Shamagian L.; Soto A.; Torrealday H.;
Valero R.; Agergaard S.; Agewall S.; Andersson K.; Bergstrom O.;
Bjornstedt Bennermo M.; Blomgren J.; Boman K.; Brohall G.; Cherfan C.;
Dahlen C.; Dotevall A.; Enander P.; Ericsson U.; Hallgren P.; Hansson A.;
Henareh L.; Henriksson P.; Herlitz J.; Holmqvist J.; Jarevi G.; Linderfalk
C.; Jonasson L.; Jovinge S.; Kalen J.; Kilstrup M.; Leosdotir M.; Leppert
J.; Ljungberg J.; Lofdahl B.; Lundman P.; Lysell-Bergstrom C.; Mathiesen
U.; Mellbin L.; Morner S.; Nathanson D.; Nilsson L.; Peterson M.;
Quittenbaum S.; Rosengren A.; Ryttberg B.; Scheel S.; Svensson K.; Tenerz
A.; Vasko P.; Waldenstrom A.; Wieloch M.; Spinas G.; Braendle M.; Felix
B.; Gerber P.; Moccetti T.; Pitteloud N.; Kultursay H.; Aydinalp A.; Balci
M.; Cayli M.; Hatipoglu E.; Ilkova H.; Kayikcioglu M.; Koc M.;
Muderrisoglu H.; Sari R.; Saygili F.; Tekin K.; Tutuncu N.; Yurekli B.;
Adler A.; Ali A.; Balasubramanian; Bandypadhyay P.; Barakat O.; Barnett
A.; Borthwick L.; Brookes; Burton J.; Cecil J.; Chaterjee S.; Clark J.;
Collinson D.; Collinson S.; Crasto W.; Donnelly R.; du Plessis J.; Egan
S.; Ellery A.; Evans R.; Ewing J.; Fox C.; Gibson M.; Hall T.; Higgs E.;
Hollway M.; Hughes E.; Jackson N.; Jalihawi H.; Jones G.; Knights H.;
Korsheed S.; Kumar Singh R.; Laithwaite D.; Lawrence I.; Litchfield J.;
Manning G.; McNally P.; Millar-Craig M.; Mohammed I.; Narayanan R.; Nayani
G.; Norris A.; Purohit J.; Quinn M.; Ramtoola; Randall J.; Rea R.;
Reckless J.; Richardson T.; Robertson D.; Robinson A.; Salem K.; Sampson
M.; Savage M.; Shaker J.; Srinivasan T.; Tracy I.; Tringham J.; Viljoen
A.; Ward A.; Waterhouse H.; Wijenaike N.; Wiles P.; Ahmann A.; Ahmed I.;
Alam A.; Arakaki R.; Asad S.; Banarer S.; Baum H.; Belew K.; Bergenstal
R.; Bethel M.; Boyer C.; Catton S.; Challans P.; Childs B.; Christian R.;
Clement S.; Cuddihy R.; Dailey G.; Damberg G.; De Bold C.; De Lemos J.;
Donovan D.; Dudl J.; Dunbar J.; Ebner S.; Failor R.; Feinglos M.; Flaker
G.; Freiburghaus M.; Furlong K.; Gardner D.; Gillespie E.; Goland R.;
Goldberg R.; Gotham A.; Guthrie R.; Hamaty M.; Hirsch I.; Jabbour S.;
Janci M.; Javorsky B.; Jones S.; Kamana V.; Kashyap M.; Kaufman S.; Kearns
P.; Khera A.; Klopfenstein B.; Kniffen W.; Kringas P.; Licata A.;
Lopez-Jimenez C.; Madden M.; Marx C.; McCall A.; McCallum J.; McFarlane
S.; McGuire D.; Melish J.; Meneghini L.; Miller S.; Miranda-Palma B.;
Mitchell R.; Nasr C.; Nelson J.; Niblack P.; Nylen E.; Osei K.; Pandey A.;
Papademetriou V.; Pilar Solano M.; Sameshima L.; Savarese V.; Schnure J.;
Schuster D.; Shin J.; Taylor A.; Thomson P.; Ting-Ryan M.; Trence D.; Vo
A.; Weiland K.; Wells K.; Wu P.; Zimering M.; Zimmerman R.; Ascanio P.;
Brajkovich I.; Carrillo E.; Coll J.; Gonzalez K.; Gonzalez N.; Jimenez E.;
Lopez R.; Marante D.; Morr I.; Paolillo M.; Perche D.; Portillo M.;
Valbuena H.; Velarde M.; Vergara G.; Augensen N.; Azzalina J.; Fidaly S.;
Bollero G.; Casiello A.I.; Ferraro F.; Guridi M.J.; Ines M.; Martin M.E.;
Pascual A.; Pereyra J.; Toscanelli M.; Appiah M.; Grech S.; Pouras S.;
Watts C.; Denke E.; Feik C.; Litvinenko M.; Platonenko O.; Shadur S.;
Johnson J.; Bonilla E.; Carraway B.; Faith J.; Greer C.; Harding A.;
Heston J.; Lin Y.; Mecca T.; Schuler M.; Rizk C.; Sissoko A.; Strickland
K.; Andrade A.; Lux L.; Machado D.; Mancin E.; Aquino J.; Belanger B.;
Bourque C.; Gagnier K.; Hagerimana A.; McNeil A.; Osachoff J.; Richard B.;
Rogan J.; Styner L.; Maturana X.; Naranjo M.E.; Li E.; Liu Q.; Shuai M.;
Tan Z.; Tang M.; Zhao J.; Ardila M.; Gomez A.M.; Uscategui A.M.;
Marinkovic N.; Miocevic V.V.; Pezo S.; Andersen I.; Bastrup-Larsen B.;
Jeppesen E.; Kofoed-Djursner M.; Joe H.; Hiironen V.; Tarvainen M.; Von
Hedenberg H.; Guillarme C.; Rastelli O.; Roy P.; Igel L.; Lenz T.; Leptich
A.; Peikert S.; Domokos S.; Szotyorine-Polcza G.; Wenczl M.; Chaudhary S.;
Jaiswal G.; Khatri P.; Shah K.; Gibson S.; Bechar Y.; Erdheim D.; Eyal N.;
Frankel M.; Shimoni S.; Tsuri J.; Bianco L.; Cali R.; Sganga P.; Jang M.;
Kim J.M.; Kim Y.; Lim S.; Park J.S.; Song Y.; Kalve E.; Dienyte E.;
Alvarado F.; Rodriguez R.; Bar J.; Lijfering-Lorie K.; Palstra M.; Van der
Kuijl K.; Van de Wetering A.; Eriksen S.; Hejazifar S.; Jendeberg A.;
Johannessen G.; Khammari I.; Meredith E.L.; Dayag A.M.; Figueroa P.;
Hoffmann Korpalska A.; Przemyk M.; Craciunescu A.; Lupu D.; Osanu A.;
Popscu L.; Toader C.; Kirsanova T.; Timoshina E.; Gomez B.; Jankularova
I.; Brett S.; Meyer A.; Pereira V.; Vawda N.; Castano B.; Farre Avella
J.M.; Jimenez I.; Turet N.; Froberg M.; Reppert E.; Wessman S.; Boschung
Y.; Carrozzino F.; Gerstl K.; Cetin Z.; Demirci S.; Ovalioglu S.; Lenehan
A.; McLean H.; Mutsaers K.; Redfern P.; Scoggins A.; Isea Y.; Alvarez M.;
Alvarez D'Amelio A.; Aqueveque S.; Argenta M.; Aviles A.; Barreiro E.;
Battistessa Y.; Bergamo S.; Bertran B.; Bocanera M.; Bowen L.; Brescia H.;
Caceres M.; Cappi A.; Cardelli A.; Carolini E.; Carpintero S.; Carrique
A.; Carrique P.; Casquero M.; Castro M.; Cendali G.; Chatelain M.;
Costanzi A.; Cristofaro C.; Crunger P.; Ehrich S.; Espinosa M.; Esposito
L.; Flenche M.; Fracaro V.; Funosas C.; Garrido I.; Gomez Garrido A.;
Guzman A.; Izzicupo M.; Luca S.; Luciani C.; Majul S.; Moreno Cepeda I.;
Moschin Y.; Niemann G.; Novas V.; Olmi M.; Palma F.; Peralta A.; Puig A.;
Rodera Vigil M.; Ronderos G.; Rosell M.; Samudio M.; Santicchia C.;
Szczygiel V.; Takla M.; Tinnirello C.; Tonin S.; Tristan A.; Troncoso C.;
Vignau S.; Yanez K.; Zarate M.; Appeldorf R.; Batrouney B.; Bonner A.;
Bonner M.; Cahill P.; Carr J.; Caruana M.; Chare J.; Doran A.; Flavel;
Gein J.; Griek S.; Hulley A.; Keays P.; Kent S.; Lai N.; Legg H.; Long A.;
Lynch L.; Maxwell V.; McNamara K.; Nairn J.; Nichols V.; Peeler C.;
Phillips J.; Price-Smith S.; Ryan S.; Stockle P.; Tapp E.; Taverner P.;
Tulloch G.; Viola V.; Wilson L.; Beck A.; Damon S.; Drexel V.; Grabner E.;
Hofurthner A.; Kivioja P.; Kretschmer S.; Lener P.; Maiweg J.; Tscherner
D.; Weichelt H.; Winkler J.; Jones D.; Alves L.; Batista R.; Bernardes A.;
Demore de Souza A.; Ferraz R.; Ferreira A.; Freitas E.; Guanaes D.;
Kuschel K.; Muniz R.; Nasser-Hissa V.; Nhan P.; Osorio R.; Queirantes C.;
Reboucas R.; Souza C.; Tonani M.; Vicente C.; Zilli A.; Andersen K.; Aro
L.; Barber C.; Barnable B.; Berard L.; Bernier A.; Boudreault C.;
Bourbonnais A.; Bourgeois L.; Boutin D.; Boyer D.; Branco N.; Briol L.;
Brousseau M.; Burke M.; Chambers C.; Champoux A.; Chan S.; Colborne C.;
Coles K.; Couture M.; Cryderman C.; DeCurtis D.; Dewar C.; Drown J.; Dunn
P.; Eichmann D.; Eikel L.; Fox B.; Gauthier S.; Gibbons D.; Hicks R.; Ho
V.; Kitagawa H.; Kooistra L.; Landry F.; Lapointe F.; Larrivee L.; Leonard
P.; Louch D.; MacNair D.; Magennis L.; Mallette D.; Marchand C.; McLean
S.; Meilleur M.; Murdock H.; Naud M.; Olson K.; Otis J.; Ouimet F.;
Paquette H.; Peck C.; Pelletier A.; Perkins L.; Petrie F.; Pockett S.;
Poulin F.; Poulin M.; Primbas K.; Renton J.; Rouatt S.; Roy M.; Scarcelli
D.; Schellenberg S.; Schellevis K.; Schmidt N.; Scott L.; Skarpinsky B.;
Smith B.; Smith E.; Stafford C.; Stata C.; Sternberg B.; St-Jean N.;
Stoger S.; Thibodeau C.; Toupin A.; Ullyatt L.; Velonas J.; Vienneau R.;
Wall C.; Zaniol D.; Arau M.; Fuentes J.; Hidalgo J.; Landaeta O.; Padilla
I.; Sanzana S.; Tellos G.; Toro F.; Vergara R.; Che T.; Du Y.; He Y.;
Huang C.; Li H.; Liu S.; Luo X.; Ma Y.; Pan S.; Wan Q.; Wang H.; Wang S.;
Xie Y.; Xu X.; Xu Y.; Zhao F.; Zhou M.; Accini M.; Bello O.; Caceres A.;
Camargo S.; Figueroa J.; Florez M.; Gomez Morales K.; Granados L.;
Martinez M.; Medina Ramos M.; Mejia C.; Montoya L.; Ramos C.; Restrepo P.;
Rodriguez D.; Santamaria A.; Valencia T.; Spanic V.; Borre Hansen A.;
Bulow M.; Ehlers G.; Frederiksen A.; Gottschalck H.; Hejlskov B.; Holm
Fruesnsgaard Pedersen L.; Hornum H.; Jansen S.; Johansen A.; Jorgensen A.;
Kjaeulff Svaneborg T.; Kruse A.; Lund K.; Lundgaard M.; Madsen J.; Meier
A.; Muurholm A.; Nedergaard A.; Nielsen S.; Norgaard D.; Olsen A.; Raae
D.; Reiter P.; Sigsgaard U.; Vestergaar I.; Witt A.; Mitt T.; Timmusk P.;
Heikkila E.; Heiskanen R.; Huotari E.; Keskitalo A.; Kylmala L.; Laitinen
M.; Laukkanen M.; Leskinen S.; Liesivuori J.; Lukkari-Kuronen L.; Merisalo
P.; Muurinen E.; Nikkanen P.; Niskanen T.; Pasanen P.; Pekkonen L.; Retsu
A.; Soppela A.; Andreu N.; Ankotche A.; Bairras C.; Boch C.; Camachon L.;
Cherchouly A.; Coudret S.; Demer C.; Gilg R.; Lemonade L.; Madec O.;
Pinotti D.; Poirier I.; Tenne N.; Vogler C.; Amman M.; Andratschke-Gentsch
B.; Beckmann H.; Bischoff S.; Bleich B.; Bueschges G.; Busch E.;
Deigentasch S.; Dietze S.; Dollinger M.; El-Bahay C.; Flehmig G.; Frenzel
I.; Geissler K.; Guerro J.; Heike B.; Holler D.; Inhoffen C.; Klein K.;
Kraehe I.; Kress P.; Krueger H.; Lenz R.; Linnebach B.; Lueck A.; Markhof
P.; Matthies K.; Meier C.; Metzler E.; Moor E.; Noll I.; Paulsen S.;
Pfeffer B.; Promnitz N.; Saljew B.; Schad S.; Schoner C.; Sellmann R.;
Tanis M.; Vogelbusch J.; Wagner E.; Winkler S.; Zenker K.; Zvork S.;
Balogh E.; Buncsikne Molnar S.; Gulyasne Gaspar E.; Herold M.; Kovacs E.;
Kozmane Paszternak A.; Maarne Nagy S.; Nagyne Zoltan A.; Nemeth Z.; Roth
T.; Rozsa I.; Szalai M.; Anuradha M.; Bawa T.; Bhaskar B.; Chalkhore S.;
Choudhary D.; Dhanalaxmi T.; Dhingra V.; Gayatri R.; Gnanasundram R.;
Gopal U.; Govindaraj S.; Indira P.; James S.; Karkuzhli K.; Koppikar V.;
Malhotra N.; Manmohan B.; Mazher A.; Menon R.; Nalini S.; Panda M.; Patel
K.; Poongothai S.; Ramanathan S.; Ramu I.; Sangeetha K.; Sankar K.;
Savitha; Seeli Abraham C.; Shrinivas K.; Sudha S.; Tripathi S.; Vaseem A.;
Yamuna A.; Banques R.; Chong J.; Courcy M.; Donnelly E.; Fauzi A.; Gately
M.; Hanlon G.; Kelly-Conroy M.; McAteer S.; McGovern G.; Meaney E.; Storey
S.; Todd M.; Aharonof-Segal M.; Aliazarov N.; Arbeli S.; Butbul E.; Chagai
E.; Confino K.; Domb L.; Dvir R.; Erez N.; Foiening O.; Frishberg A.;
Genin I.; Gertman R.; Golan L.; Grosberd A.; Hadad D.; Israeli S.;
Kaplunski Y.; Karpf D.; Katzir A.; Kivity Z.; Li L.; Livshitz L.; Nachmias
A.; Orr I.; Peer E.; Platner N.; Pritulo L.; Rojansky A.; Rosenblat T.;
Saranga H.; Schterchman G.; Shenhar S.; Shkliar T.; Stam T.; Stinmann S.;
Suliman A.; Tsirulnikov E.; Uziel K.; Weinshtock S.; Yedid-Am S.; Yuval
R.; Zuker S.; Brunella L.; Durante A.; Nada E.; Pugolotti M.; Robusto A.;
Testa M.; Toniato R.; Ha I.; Jung S.; Kim C.; Mi Ran K.; Song B.; Wi Y.;
Yang K.; You J.; Gaisute R.; Ozolina L.; Dzagajeva N.; Kasperaviciene V.;
Krikstaponiene Z.; Montviliene R.; Morkunaite K.; Piepoliene L.; Stoniene
E.; Stonkus S.; Ulpaityte I.; Arenas-Vanhorn M.; Espitia-Serrato L.;
Garcia-Munoz E.; Nunez V.; Sainz T.; Bakker H.; Danse I.; De Greef S.; De
Jong C.; De Wit M.; Didden E.; Dommerholt R.; Goddrie M.; Haazer C.;
Havenaar J.; Hendriks-Van Woerden M.; Jongenotter M.; Kort I.; Koster L.;
Kramer H.; Maarssen E.; Posthuma-Visscher M.; Reijnierse-Buitenwerf H.;
Rood P.; Swets E.; Tousain W.A.; Van Buchem-Damming G.; Van
Buijsen-Nutters A.; Van de Loo R.; Van den Hondel M.; Van den Berg A.; Van
der Knaap-van Keulen M.; Van der Zeijst M.; Van Setten-Van der Meer L.;
Von Bannisseht E.E.; Wouda Z.; Aarsland T.; Amlie L.; Andresen B.;
Bakketun A.; Bognaes A.; Botten C.; Coucheron S.; Halsne A.; Hansen H.;
Holthe T.; Husby E.; Iversen E.; Kvalvik A.; Landbakk T.; Lovseth E.; Moen
S.; Orvik E.; Ovrehus G.; Salater S.; Sorgard B.; Sorstrom A.; Tandberg
L.; Veiding B.; Vinje G.; Winge A.; Abquina G.; Patena B.; Reyes R.;
Tamondong A.; Vega A.; Vitug L.; Makuch M.; Torun A.; Adam A.; Basaraba
M.; Chira C.; Darida C.; Haica C.; Nedelcu A.; Patru D.; Patrut L.; Rau
I.; Rotaru N.; Szabo L.; Vrinceanu G.; Sovenko T.; Zatsevskaya O.;
Horynova Z.; Vankova L.; Barkhuizen M.; Barnard L.; Bekker D.; Botha D.;
Commerford A.; de Klerk A.; De Waal A.; Devchand S.; Drummond F.; Du Toit
A.; Du Toit S.; Ellis T.; Engelbrecht M.; Eramus T.; Fonda K.; Goosen A.;
Gopel E.; Govender P.; Hodge E.; Ismael F.; Jonker E.; Jonker L.; Joubert
A.; Kilian M.; Koegenlenberg N.; Lehner L.; Lingham R.; Llyod T.; Mangoeng
P.; Mapele S.; Meiring J.; Methusi P.; Mmethi M.; Mohamed K.; Moore A.;
Ndiweni H.; Parker F.; Schoneman J.; Smit M.; Steyn A.; Van Dongren J.;
Van Schalkwyk S.; Van Staden L.; van Wyngaard G.; Wolf A.; Ashbaugh R.;
Bande C.; Barquero R.; Gaspar R.; Martin E.; Megia B.; Rodriguez C.;
Seoane A.; Viaplana J.; Akesson Jacobsson I.; Andersson C.; Asperen M.;
Backlund M.; Berglund M.; Bjorck L.; Borjesson M.; Brolin G.; Danielsson
Frojd M.; Duckert A.; Eriksson K.; Fehling K.; Glaas A.; Hage C.; Hoglund
K.; Jernhed H.; Johansson K.; Johansson S.; Lidin M.; Lundell L.; Lundgren
C.; Magnusson K.; Matsson E.; Norman J.; Nystrom K.; Ojutkangas M.;
Olofsson M.; Olsson C.; Pettersson U.; Pramberg E.; Raschperger A.; Sjolin
M.; Soderlund M.; Stensgaard Nake E.; Torebo E.; Uggeldahl I.; Walldin C.;
Welin-Berger B.; Dwyer A.; Meyer-Lazzarini V.; Morello R.; Schefer M.;
Oney S.; Seker T.; Tavlayan S.; Appleby M.; Astin J.; Baker M.; Brann H.;
Brennan C.; Bryan L.; Campbell D.; Carey J.; Cox K.; Davis C.; Dyson B.;
Everdell R.; Gammon B.; Godden J.; Gray T.; Griffiths E.; Grimes Y.; Hall
D.; Hall K.; Holme A.; Howe J.; Lambley-Burke R.; Nation M.; Norcott K.;
Mitchell K.; Poxon S.; Quick C.; Shute C.; Thomas J.; Vinnell T.; Bawa S.;
Bogan C.; Fallye O.; Ginsberg J.; Gregory B.; House B.; Isonaga M.;
Keanne-Richmond P.; Kelly C.; Kimpel J.; Leiby A.; Lyons L.; McCoy B.;
Monk A.; Pelayo E.; Perron M.; Posey D.; Rehan M.; Suarez R.; Tilton L.;
Waite K.; White G.; Chacon R.; Meza Y.; Misticchio F.; Torres M.; Urbaneja
H.
Institution
(Gerstein, Yusuf) Department of Medicine, Population Health Research
Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON,
Canada
(Bosch) Population Health Research Institute and School of Rehabilitation
Science, McMaster University and Hamilton Health Sciences, Hamilton, ON,
Canada
(Dagenais) Institut Universitaire de Cardiologie et de Pneumologie de
Quebec, Quebec, QC, Canada
(Diaz) Estudios Clinicos Latino America, Rosario, Argentina
(Jung) McMaster University and Hamilton Health Sciences, Hamilton, ON,
Canada
(Maggioni) Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO)
Research Center, Florence, Italy
(Pogue) Population Health Research Institute, McMaster University and
Hamilton Health Sciences, Hamilton, ON, Canada
(Probstfield) University of Washington, Seattle, United States
(Ramachandran) India Diabetes Research Foundation, Chennai, India
(Riddle) Oregon Health and Science University, Portland, United States
(Ryden) Department of Medicine, Karolinska Institute, Stockholm, Sweden
Publisher
Massachussetts Medical Society
Abstract
Background: The provision of sufficient basal insulin to normalize fasting
plasma glucose levels may reduce cardiovascular events, but such a
possibility has not been formally tested. Method(s): We randomly
assigned 12,537 people (mean age, 63.5 years) with cardiovascular risk
factors plus impaired fasting glucose, impaired glucose tolerance, or type
2 diabetes to receive insulin glargine (with a target fasting blood
glucose level of <=95 mg per deciliter [5.3 mmol per liter]) or standard
care and to receive n-3 fatty acids or placebo with the use of a 2-by-2
factorial design. The results of the comparison between insulin glargine
and standard care are reported here. The coprimary outcomes were nonfatal
myocardial infarction, nonfatal stroke, or death from cardiovascular
causes and these events plus revascularization or hospitalization for
heart failure. Microvascular outcomes, incident diabetes, hypoglycemia,
weight, and cancers were also compared between groups. Result(s): The
median follow-up was 6.2 years (interquartile range, 5.8 to 6.7). Rates of
incident cardiovascular outcomes were similar in the insulin-glargine and
standard-care groups: 2.94 and 2.85 per 100 person-years, respectively,
for the first coprimary outcome (hazard ratio, 1.02; 95% confidence
interval [CI], 0.94 to 1.11; P = 0.63) and 5.52 and 5.28 per 100
person-years, respectively, for the second coprimary outcome (hazard
ratio, 1.04; 95% CI, 0.97 to 1.11; P = 0.27). New diabetes was diagnosed
approximately 3 months after therapy was stopped among 30% versus 35% of
1456 participants without baseline diabetes (odds ratio, 0.80; 95% CI,
0.64 to 1.00; P = 0.05). Rates of severe hypoglycemia were 1.00 versus
0.31 per 100 person-years. Median weight increased by 1.6 kg in the
insulin-glargine group and fell by 0.5 kg in the standard-care group.
There was no significant difference in cancers (hazard ratio, 1.00; 95%
CI, 0.88 to 1.13; P = 0.97). Conclusion(s): When used to target
normal fasting plasma glucose levels for more than 6 years, insulin
glargine had a neutral effect on cardiovascular outcomes and cancers.
Although it reduced new-onset diabetes, insulin glargine also increased
hypoglycemia and modestly increased weight. Copyright © 2012
Massachusetts Medical Society.

<195>
Accession Number
51141585
Title
Efficacy and safety of more intensive lowering of LDL cholesterol: A
meta-analysis of data from 170 000 participants in 26 randomised trials.
Source
The Lancet. 376 (9753) (pp 1670-1681), 2010. Date of Publication: 13 Nov
2010.
Author
De Lemos J.; Blazing M.; Downs J.R.; Gotto A.; Clearfield M.; Gordon D.;
Davis B.; Koren M.; Dahlof B.; Poulter N.; Sever P.; Knopp R.H.; Fellstrom
B.; Holdaas H.; Jardine A.; Schmieder R.; Zannad F.; Goldbourt U.;
Kaplinsky E.; Colhoun H.M.; Betteridge D.J.; Durrington P.N.; Hitman G.A.;
Fuller J.; Neil A.; Wanner C.; Krane V.; Sacks F.; Moye L.; Pfeffer M.;
Hawkins C.M.; Barter P.; Tavazzi L.; Marchioli R.; Tognoni G.; Franzosi
M.G.; Maggioni A.; Bloomfield H.; Robins S.; Pedersen T.R.; Ridker P.M.;
Holman R.; Meade T.; MacMahon S.; Marschner I.; Tonkin A.; Shaw J.;
Serruys P.W.; Nakamura H.; Knatterud G.; Furberg C.; Byington R.; Murphy
M.; Blauw G.J.; Packard C.; Kjekshus J.; Pedersen T.; Wilhelmsen L.;
Braunwald E.; Cannon C.; Murphy S.; Armitage J.; Bowman L.; Parish S.;
Peto R.; Sleight P.; Landray M.; La Rosa J.; Rossouw J.; Probstfield J.;
Shepherd J.; Cobbe S.; Macfarlane P.; Ford I.; Flather M.; Kastelein J.;
Newman C.; Shear C.; Tobert J.; Varigos J.; White H.; Yusuf S.; Mellies
M.; McGovern M.; Barclay J.; Belder R.; Mitchel Y.; Musliner T.; Ansquer
J.-C.; Llewellyn M.; Bortolini M.; Brandrup-Wognsen G.; Bryzinski B.;
Olsson G.; Pears J.; De Micco D.; Baxter A.; Baigent C.; Barnes E.H.;
Bhala N.; Blackwell L.; Buck G.; Collins R.; Emberson J.; Herrington W.G.;
Holland L.E.; Kearney P.M.; Keech A.; Kirby A.; Lewis D.A.; Pollicino C.;
Reith C.; Simes J.; Sourjina T.
Institution
(De Lemos, Braunwald, Blazing, Murphy) Phase Z, United States
(Downs, Gotto, Clearfield) AFCAPS/TEXCAPS (AirForce/Texas Coronary
Atherosclerosis Prevention Study), United States
(Holdaas) ALERT (Assessment of Lescol in Transplantation), United States
(Gordon, Davis) ALLHAT (Antihypertensive Lipid Lowering Heart Attack
Trial), United States
(Koren) ALLIANCE (Aggressive Lipid-Lowering Initiation Abates New Cardiac
Events), United States
(Dahlof, Poulter, Sever) ASCOT (Anglo-Scandinavian Cardiac Outcomes
Trial), United States
(Knopp) ASPEN, United States
(Fellstrom, Holdaas, Jardine, Schmieder, Zannad) AURORA, United States
(Goldbourt, Kaplinsky) BIP (Bezafibrate Infarction Prevention Study),
United States
(Colhoun, Betteridge, Durrington, Hitman, Fuller, Neil) CARDS
(Collaborative Atorvastatin Diabetes Study), United States
(Wanner, Krane) 4D (Die Deutsche Diabetes Dialyse Study), United States
(Sacks, Moye, Pfeffer) CARE (Cholesterol and Recurrent Events Study),
United States
(Keech, Barter) FIELD (Fenofibrate Intervention and Event Lowering in
Diabetes), United States
(Tavazzi, Maggioni) GISSI (Gruppo Italiano per Lo Studio della
Sopravvivenza nell'Infarto Miocardico)-Heart Failure, Italy
(Marchioli, Tognoni, Franzosi, Maggioni) GISSI-Prevention, Italy
(Bloomfield, Robins) HIT (Veteran Administration Low HDL Intervention
Trial), United States
(Keech, Collins, Armitage, Parish, Peto, Sleight) HPS (Heart Protection
Study), United States
(Pedersen) IDEAL (Incremental Decrease in Endpoints Through Aggressive
Lipid-lowering), United States
(Ridker) JUPITER, United States
(Holman) LDS (Lipids in Diabetes Study), United States
(Meade) LEADER (Lower Extremity Arterial Disease Event Reduction Trial),
United States
(Keech, Simes, MacMahon, Marschner, Tonkin, Shaw) LIPID (Long-term
Intervention with Pravastatin in Ischaemic Disease), United States
(Serruys) LIPS (Lescol Intervention Prevention Study), United States
(Nakamura) MEGA (Management of Elevated Cholesterol in the Primary
Prevention Group of Adult Japanese), United States
(Knatterud) Post-CABG (Post- Coronary Artery Bypass Graft Study), United
States
(Furberg, Byington) PPP (Pravastatin Pooling Project), United States
(Macfarlane, Cobbe, Ford, Murphy, Blauw, Packard, Shepherd) PROSPER
(Prospective Study of Pravastatin in the Elderly at Risk), United States
(Kjekshus, Pedersen, Wilhelmsen) 4S (Scandinavian Simvastatin Survival
Study), United States
(Braunwald, Cannon, Murphy) PROVE-IT (Pravastatin or Atorvastatin
Evaluation and Infection Therapy), United States
(Collins, Armitage, Bowman, Parish, Peto, Sleight) SEARCH (Study of
Effectiveness of Additional Reductions in Cholesterol and Homocysteine),
United States
(Baigent, Baxter, Collins, Landray) SHARP (Study of Heart and Renal
Protection), United States
(La Rosa) TNT (Testing New Targets), United States
(Rossouw, Probstfield) WHI (Women's Health Initiative), United States
(Shepherd, Cobbe, Macfarlane, Ford) WOSCOPS (West of Scotland Coronary
Prevention Study), United Kingdom
(Mellies, McGovern, Barclay, Belder) Bristol-Myers Squibb, United States
(Mitchel, Musliner) Merck, United States
(Ansquer) Laboratoires Fournier, United States
(Llewellyn) Bayer, United States
(Bortolini) Novartis Pharma, United States
(Brandrup-Wognsen, Bryzinski, Olsson, Pears) AstraZeneca, United States
(De Micco) Pfizer, United States
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Lowering of LDL cholesterol with standard statin regimens reduces the risk
of occlusive vascular events in a wide range of individuals. We aimed to
assess the safety and efficacy of more intensive lowering of LDL
cholesterol with statin therapy. We undertook meta-analyses of individual
participant data from randomised trials involving at least 1000
participants and at least 2 years' treatment duration of more versus less
intensive statin regimens (five trials; 39 612 individuals; median
follow-up 5.1 years) and of statin versus control (21 trials; 129 526
individuals; median follow-up 4.8 years). For each type of trial, we
calculated not only the average risk reduction, but also the average risk
reduction per 1.0 mmol/L LDL cholesterol reduction at 1 year after
randomisation. In the trials of more versus less intensive statin therapy,
the weighted mean further reduction in LDL cholesterol at 1 year was 0.51
mmol/L. Compared with less intensive regimens, more intensive regimens
produced a highly significant 15 (95 CI 11-18; p<0.0001) further reduction
in major vascular events, consisting of separately significant reductions
in coronary death or non-fatal myocardial infarction of 13 (95 CI 7-19;
p<0.0001), in coronary revascularisation of 19 (95 CI 15-24; p<0.0001),
and in ischaemic stroke of 16 (95 CI 5-26; p=0.005). Per 1.0 mmol/L
reduction in LDL cholesterol, these further reductions in risk were
similar to the proportional reductions in the trials of statin versus
control. When both types of trial were combined, similar proportional
reductions in major vascular events per 1.0 mmol/L LDL cholesterol
reduction were found in all types of patient studied (rate ratio [RR]
0.78, 95 CI 0.76-0.80; p<0.0001), including those with LDL cholesterol
lower than 2 mmol/L on the less intensive or control regimen. Across all
26 trials, all-cause mortality was reduced by 10 per 1.0 mmol/L LDL
reduction (RR 0.90, 95 CI 0.87-0.93; p<0.0001), largely reflecting
significant reductions in deaths due to coronary heart disease (RR 0.80,
99 CI 0.74-0.87; p<0.0001) and other cardiac causes (RR 0.89, 99 CI
0.81-0.98; p=0.002), with no significant effect on deaths due to stroke
(RR 0.96, 95 CI 0.84-1.09; p=0.5) or other vascular causes (RR 0.98, 99 CI
0.81-1.18; p=0.8). No significant effects were observed on deaths due to
cancer or other non-vascular causes (RR 0.97, 95 CI 0.92-1.03; p=0.3) or
on cancer incidence (RR 1.00, 95 CI 0.96- 1.04; p=0.9), even at low LDL
cholesterol concentrations. Further reductions in LDL cholesterol safely
produce definite further reductions in the incidence of heart attack, of
revascularisation, and of ischaemic stroke, with each 1.0 mmol/L reduction
reducing the annual rate of these major vascular events by just over a
fifth. There was no evidence of any threshold within the cholesterol range
studied, suggesting that reduction of LDL cholesterol by 2-3 mmol/L would
reduce risk by about 40-50. UK Medical Research Council, British Heart
Foundation, European Community Biomed Programme, Australian National
Health and Medical Research Council, and National Heart
Foundation. Copyright © 2010 Elsevier Ltd.

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