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EMBASE Cardiac Update AutoAlert: EPICORE Cardiac Surgery Blogger2

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<1>
Accession Number
2012215757
Authors
Bokesch P.M. Szabo G. Wojdyga R. Grocott H.P. Smith P.K. Mazer C.D.
Vetticaden S. Wheeler A. Levy J.H.
Institution
(Bokesch, Vetticaden, Wheeler) Cubist Pharmaceuticals, Inc., 65 Hayden
Avenue, Lexington, MA 02421, United States
(Bokesch) St. Elizabeth's Hospital, Tufts University School of Medicine,
Boston, MA, United States
(Szabo) University of Heidelberg, Heidelberg, Germany
(Wojdyga) Institute of Cardiology, Warsaw, Poland
(Grocott) University of Manitoba, Winnipeg, MB, Canada
(Smith) Duke University Medical Center, Durham, NC, United States
(Mazer) University of Toronto, St. Michael's Hospital, Toronto, ON, Canada
(Levy) Emory University School of Medicine, Atlanta, GA, United States
Title
A phase 2 prospective, randomized, double-blind trial comparing the
effects of tranexamic acid with ecallantide on blood loss from high-risk
cardiac surgery with cardiopulmonary bypass (CONSERV-2 Trial).
Source
Journal of Thoracic and Cardiovascular Surgery. 143 (5) (pp 1022-1029),
2012. Date of Publication: May 2012.
Publisher
Mosby Inc. (11830 Westline Industrial Drive, St. Louis MO 63146, United
States)
Abstract
Objective: Ecallantide is a recombinant peptide in the same class as
aprotinin that inhibits plasma kallikrein, a major component of the
contact coagulation and inflammatory cascades. Therefore, ecallantide was
expected to reduce blood loss associated with cardiac surgery requiring
cardiopulmonary bypass. Methods: This prospective multinational,
randomized, double-blind trial enrolled patients undergoing cardiac
surgery using cardiopulmonary bypass for procedures associated with a high
risk of bleeding. Patients were randomly assigned to ecallantide (n = 109)
or tranexamic acid (high dose, n = 24; low dose, n = 85). Efficacy was
assessed from the volume of packed red blood cells administered within the
first 12 hours after surgery. Results: The study was terminated early
after the independent data safety and monitoring board observed a
statistically significantly higher 30-day mortality in the ecallantide
group (12%) than in the tranexamic acid groups (4%, P = .041). Patients
receiving ecallantide received more packed red blood cells within 12 hours
of surgery than tranexamic acid-treated patients: median = 900 mL (95%
confidence interval, 600-1070) versus 300 mL (95% confidence interval,
0-523) (P < .001). Similar differences were seen at 24 hours and at
discharge. Patients treated with the higher tranexamic acid dose received
less packed red blood cells, 0 mL (95% confidence interval, 280-600), than
the group treated with the lower dose, 400 mL (95% confidence interval,
0-400) (P = .008). No deaths occurred in the higher dose tranexamic acid
group. Conclusions: Ecallantide was less effective at reducing
perioperative blood loss than tranexamic acid. High-dose tranexamic acid
was more effective than the low dose in reducing blood loss. Copyright
2012 by The American Association for Thoracic Surgery.

<2>
Accession Number
2012210564
Authors
Tietge W.J. de Heer L.M. van Hessen M.W.J. Jansen R. Bots M.L. van Gilst
W. Schalij M. Klautz R.J.M. van den Brink R.B.A. van Herwerden L.A.
Doevendans P.A. Chamuleau S.A.J. Kluin J.
Institution
(Tietge, Jansen, Doevendans, Chamuleau) Department of Cardiology, UMC
Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, Netherlands
(de Heer, van Herwerden, Kluin) Department of Cardiothoracic Surgery, UMC
Utrecht, Utrecht, Netherlands
(van Hessen) WCN, Utrecht, Netherlands
(Bots) Julius Center Utrecht, Utrecht, Netherlands
(van Gilst) ICIN, Utrecht, Netherlands
(Schalij) Department of Cardiology, LUMC, Leiden, Netherlands
(Klautz) Department of Cardiothoracic Surgery, LUMC, Leiden, Netherlands
(van den Brink) Department of Cardiology, AMC Amsterdam, Amsterdam,
Netherlands
Title
Early mitral valve repair versus watchful waiting in patients with severe
asymptomatic organic mitral regurgitation; rationale and design of the
Dutch AMR trial, a multicenter, randomised trial.
Source
Netherlands Heart Journal. 20 (3) (pp 94-101), 2012. Date of Publication:
2012.
Publisher
Bohn Stafleu van Loghum (P.O. Box 246, Houten 3990 GA, Netherlands)
Abstract
Background Asymptomatic severe mitral valve (MV) regurgitation with
preserved left ventricular function is a challenging clinical entity as
data on the recommended treatment strategy for these patients are scarce
and conflicting. For asymptomatic patients, no randomised trial has been
performed for objectivising the best treatment strategy. Methods The Dutch
AMR (Asymptomatic Mitral Regurgitation) trial is a multicenter,
prospective, randomised trial comparing early MV repair versus watchful
waiting in asymptomatic patients with severe organic MV regurgitation. A
total of 250 asymptomatic patients (18-70 years) with preserved left
ventricular function will be included. Intervention will be either
watchful waiting or MV surgery. Follow-up will be 5 years. Primary outcome
measures are all-cause mortality and a composite endpoint of
cardiovascular mortality, congestive heart failure, and hospitalization
for non-fatal cardiovascular and cerebrovascular events. Secondary outcome
measures are total costs, cost-effectiveness, quality of life,
echocardiographic and cardiac magnetic resonance parameters, exercise
tests, asymptomatic atrial fibrillation and brain natriuretic peptide
levels. Additionally, the complication rate in the surgery group and rate
of surgery in the watchful waiting group will be determined. Implications
The DutchAMR trial will be the first multicenter randomised trial on this
topic. We anticipate that the results of this study are highly needed to
elucidate the best treatment strategy and that this may prove to be an
international landmark study. Springer Media / Bohn Stafleu van Loghum
2012.

<3>
Accession Number
2012212254
Authors
Qiu Y. Xu H. Shi D.
Institution
(Qiu) Graduate School, Beijing University of Chinese Medicine, Beijing
100029, China
(Xu, Shi) Center for Cardiovascular Diseases, Xiyuan Hospital, China
Academy of Chinese Medical Sciences, Beijing 100091, China
Title
Traditional chinese herbal products for coronary heart disease: An
overview of cochrane reviews.
Source
Evidence-based Complementary and Alternative Medicine. 2012 , 2012.
Article Number: 417387. Date of Publication: 2012.
Publisher
Hindawi Publishing Corporation (410 Park Avenue, 15th Floor, 287 pmb, New
York NY 10022, United States)
Abstract
Objective. The aim of this overview was to evaluate and summarize Cochrane
reviews of traditional Chinese herbal products (TCHPs) as the treatment
for coronary heart disease (CHD). Methods. We searched the Cochrane
Database that was concerned with the effectiveness of TCHPs for CHD. We
also searched the Cochrane Central Register of Controlled Trials. Reviews
and primary studies of TCHP as the treatment of any type of CHD were
included. Data were extracted according to predefined inclusion criteria
by two independent reviewers. Results. Six Cochrane reviews were included.
They related to a wide range of TCHPs for different types of CHD. Four
reviews were concerned with angina pectoris (unstable or stable), one
review was concerned with heart failure, and for acute myocardial
infarction. No reviews concluded that TCHPs were definitely effective for
CHD because of the weak evidence. Eight primary studies were TCHPs from
CHD. These studies also maybe result in bias, but better than before.
Conclusion. Several Cochrane reviews of TCHPs for the treatment of
different types of CHD have recently been published. None of these reviews
got definite conclusion favoring the effectiveness of TCHPs due to the
weak evidence. With the improved quality of the new registered RCTs. The
potential role of TCHPs in treating CHD is anticipated to be detected.
Copyright 2012 Yu Qiu et al.

<4>
Accession Number
2012210997
Authors
Giugliano G.R. Falcone M.W. Mego D. Ebersole D. Jenkins S. Das T. Barker
E. Ruggio J.M. Maini B. Bailey S.R.
Institution
(Giugliano) Baystate Medical Center, Springfield, MA, United States
(Falcone) Providence Hospital, Waco, TX, United States
(Mego) Arkansas Heart Hospital, Little Rock, AR, United States
(Ebersole) Lakeland Regional Medial Center, Lakeland, FL, United States
(Jenkins) Ochsner Hospital, New Orleans, LA, United States
(Das) Presbyterian Hospital, Dallas, TX, United States
(Barker) Cardiovascular Institute of the South Lafayette, LA, United
States
(Ruggio) Irvine Regional Medical Center, Irvine, CA, United States
(Maini) Harrisburg Hospital, Harrisburg, PA, United States
(Bailey) University of Texas Health Sciences Center at San Antonio, TX,
United States
Title
A prospective multicenter registry of laser therapy for degenerated
saphenous vein graft stenosis: The COronary graft Results following
Atherectomy with Laser (CORAL) trial.
Source
Cardiovascular Revascularization Medicine. 13 (2) (pp 84-89), 2012. Date
of Publication: March 2012.
Publisher
Elsevier Inc. (360 Park Avenue South, New York NY 10010, United States)
Abstract
Purpose: The primary aim of this study was to prospectively evaluate the
safety and efficacy of Excimer laser atherectomy as a primary treatment
strategy in consecutively eligible patients presenting for percutaneous
coronary intervention (PCI) of degenerated saphenous vein graft (SVG)
lesions using a multicenter registry. Prior single-center experience
suggested that laser atherectomy may decrease acute procedural
complications during treatment of degenerated SVGs, including lesions not
amenable to distal protection devices (DPDs). Methods and materials: The
COronary graft Results following Atherectomy with Laser investigators
enrolled 98 patients at 18 centers between June 23, 2003, and October 4,
2004, with greater than 50% stenosis of an SVG who presented for PCI due
to angina pectoris or objective evidence of myocardial ischemia in a
concordant myocardial distribution. Laser atherectomy was planned.
Patients were excluded if the operator planned to utilize a DPD. Inclusion
and exclusion criteria were aligned to those in the Saphenous vein graft
Angioplasty Free of Emboli Randomized (SAFER) trial. Results: The primary
end point [30-day major adverse cardiac events (MACE)] occurred in 18/98
(18.4%) patients driven primarily by non-q-wave myocardial infarction.
Major procedural complications included no reflow (. n=5) and major
dissection (. n=1). No perforations occurred. Univariate predictors of
30-day MACE included lesion length, vessel angulation, plaque burden, SVG
degeneracy score, number of laser pulses used, and larger-sized laser
catheters. Conclusions: This study demonstrated that Excimer laser
atherectomy of diseased SVGs is feasible with results comparable to the
30-day MACE in the control population from the SAFER trial. Whether the
addition of laser to embolic protection devices is of any clinical utility
remains to be tested in future studies. 2012 Elsevier Inc.

<5>
[Use Link to view the full text]
Accession Number
2012214221
Authors
Eljezi V. Duale C. Azarnoush K. Skrzypczak Y. Sautou V. Pereira B.
Tsokanis I. Schoeffler P.
Institution
(Eljezi, Skrzypczak, Tsokanis, Schoeffler) Pole Anesthesie-Reanimation,
Univ. Clermont1, Clermont-Ferrand, France
(Duale) Centre de Pharmacologie Clinique (INSERM CIC 501), CHU de
Clermont-Ferrand, Rue Montalembert, 63003, Clermont-Ferrand Cedex 1,
France
(Azarnoush) Pole Cardiologie (Chirurgie Cardio-Vasculaire), Univ.
Clermont1, Clermont-Ferrand, France
(Sautou) Pharmacie Centrale, Univ. Clermont1, Clermont-Ferrand, France
(Pereira) Direction de la Recherche Clinique et des Innovations CHU, Univ.
Clermont1, Clermont-Ferrand, France
(Sautou) C-Biosenss, Univ. Clermont1, Clermont-Ferrand, France
(Schoeffler) Fac. Medecine, Univ. Clermont1, Clermont-Ferrand, France
Title
The analgesic effects of a bilateral sternal infusion of ropivacaine after
cardiac surgery.
Source
Regional Anesthesia and Pain Medicine. 37 (2) (pp 166-174), 2012. Date of
Publication: March/April 2012.
Publisher
Lippincott Williams and Wilkins (530 Walnut Street,P O Box 327,
Philadelphia PA 19106-3621, United States)
Abstract
Background and Objectives: The aim of this study was to assess the effects
of a continuous postoperative administration of local anesthetic through 2
catheters placed deeply under fascia at the lateral edges of the sternum,
close to the emergence of the intercostal nerves.We focused on pain during
mobilization, as this aspect is likely to interact with postoperative
morbidity. Methods: Forty adult patients scheduled for open heart surgery
with sternotomy were included in this randomized, placebo-controlled,
double-blind study. A continuous fixed-rate infusion of 4 mL/hr of 0.2%
ropivacaine or normal saline was administered during the first 48
postoperative hrs. All patients received acetaminophen and
self-administered morphine. The efficacy outcomes were as follows: pain
score during standardized mobilization and at rest; morphine consumption;
spirometry and arterial blood gases; postoperative rehabilitation
criteria, and patient satisfaction. Total ropivacaine plasma level was
monitored throughout the study. Results: Pain scores were lower in the
ropivacaine group during mobilization (P = 0.0004) and at rest (P =
0.0006), but the analgesic effects were mostly apparent during the second
day after surgery, with a 41% overall reduction in movement-evoked pain
levels. The bilateral sternal block also reduced morphine consumption. It
improved the patients' satisfaction and rehabilitation, but no effects
were noted on respiratory outcomes. No major adverse effect due to the
treatment occurred, but the ropivacaine plasma level was greater than 4
mg/L in 1 patient. Conclusions: This technique may find a role within the
framework of multimodal analgesia after sternotomy, although further
confirmatory studies are needed. Copyright 2012 by American Society of
Regional Anesthesia and Pain Medicine.

<6>
Accession Number
2012211057
Authors
Thim T. Maeng M. Lassen J.F. Kaltoft A. Jensen L.O. Ravkilde J. Thayssen
P. Galatius S. Christiansen E.H. Engstrom T. Madsen M. Thuesen L. Tilsted
H.H.
Institution
(Thim, Maeng, Lassen, Kaltoft, Christiansen, Thuesen) Department of
Cardiology, Aarhus University Hospital, Aarhus, Denmark
(Jensen, Thayssen) Department of Cardiology, Odense University Hospital,
Odense, Denmark
(Ravkilde, Tilsted) Department of Cardiology, Aarhus University Hospital
Aalborg, Aalborg, Denmark
(Galatius) Department of Cardiology, Gentofte University Hospital,
Copenhagen, Denmark
(Engstrom) Department of Cardiology, Rigshospitalet, Copenhagen University
Hospital, Copenhagen, Denmark
(Madsen) Department of Clinical Epidemiology, Aarhus University Hospital,
Aarhus, Denmark
(Thim) Department of Cardiology, Aarhus University Hospital,
Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
Title
Clinical outcomes after treatment of multiple lesions with
zotarolimus-eluting versus sirolimus-eluting coronary stents (a SORT OUT
III substudy).
Source
BMC Cardiovascular Disorders. 12 , 2012. Article Number: 18. Date of
Publication: 19 Mar 2012.
Publisher
BioMed Central Ltd. (Floor 6, 236 Gray's Inn Road, London WC1X 8HB, United
Kingdom)
Abstract
Background: Data on clinical outcomes among patients treated with the
zotarolimus-eluting Endeavor stent versus the sirolimus-eluting Cypher
stent favor the sirolimus-eluting stent. However, a separate comparison of
clinical outcome among patients treated for multiple lesions with these
stents is lacking. We performed this comparison within the SORT OUT III
trial data set.Methods: Among 2332 patients randomized in SORT OUT III,
695 were treated for multiple lesions with zotarolimus-eluting (n = 350)
or sirolimus-eluting (n = 345) stents and followed for 18 months. Major
adverse cardiac events (MACE); composite of cardiac death, myocardial
infarction, or target vessel revascularization (TVR); was the primary
endpoint.Results: Zotarolimus-eluting compared to sirolimus-eluting stent
treatment was associated with increased MACE rate (13.2% vs. 2.6%; hazard
ratio 5.29 with 95% confidence interval: 2.59-10.8). All secondary
endpoints; all cause death, cardiac death, myocardial infarction, TVR,
target lesion revascularization, in-stent restenosis, and definite stent
thrombosis; were observed more frequently among zotarolimus-eluting stent
treated patients. For all endpoints, hazard ratios were 1.6 to 4.6 times
higher than in the overall results of the SORT OUT III trial.Conclusions:
We observed better clinical outcomes among patients treated for multiple
lesions with the sirolimus-eluting stent compared to those treated with
the zotarolimus-eluting stent. 2012 Thim et al; licensee BioMed Central
Ltd.

<7>
Accession Number
2012214783
Authors
Mahfoud F. Bohm M. Baumhakel M.
Institution
(Mahfoud, Bohm) University Hospital of the Saarland, Homburg, Germany
(Baumhakel) Medizinische Klinik fur Interventionelle Kardiologie und
Angiologie, CaritasKlinikum Saarbrucken St. Theresia, Rheinstr. 2, 66113
Saarbrucken, Germany
Title
Inadequate reporting of concomitant drug treatment in cardiovascular
interventional head-to-head trials.
Source
Clinical Cardiology. 35 (4) (pp 255-256), 2012. Date of Publication: April
2012.
Publisher
John Wiley and Sons Inc. (111 River Street, Hoboken NJ 07030-5774, United
States)
Abstract
Background: Optimal revascularization strategy is still under debate in
patients with coronary artery disease, particularly due to the results of
the Synergy Between Percutaneous Coronary Intervention With TAXUS and
Cardiac Surgery (SYNTAX) trial. Although medical prevention has been
clearly shown to be beneficial in coronary artery disease, it has been
suggested that patients were significantly undertreated with
evidence-based medications for cardiovascular protection. Hypothesis: The
purpose of the study was to evaluate concomitant medical treatment in
cardiovascular interventional head-to-head trials comparing coronary
artery bypass grafting (CABG) and percutaneous coronary intervention
(PCI). Methods: A systematic search of the literature regarding
documentation and reports of medical treatment in cardiovascular
interventional head-to-head trials with more than 500 patients comparing
CABG and PCI was performed. Results: Systematic research of the literature
identified 2106 articles of potential interest. After review and
selection, only 3 trials reported on medical treatment. Baseline
medication was reported in the RITA (Randomized Intervention Treatment of
Angina), CABRI (Coronary Angioplasty versus Bypass Revascularisation
Investigation), and SYNTAX trials, and follow-up data were provided by the
CABRI and SYNTAX 3-year trials only. Conclusions: Poor reporting of
medical treatment at discharge might reflect an underestimation of
secondary prevention in patients undergoing cardiac surgery or
interventional procedures in head-to-head interventional trials. Thus,
discussion of optimal revascularization procedure has to remain open, even
in terms of concomitant medical treatment of patients. Additional
Supporting Information may be found in the online version of this article.
The authors have no funding, financial relationships, or conflicts of
interest to disclose. 2012 Wiley Periodicals, Inc.

<8>
Accession Number
2012214712
Authors
Warmuth M. Mad P. Wild C.
Institution
(Warmuth, Mad, Wild) Ludwig Boltzmann Institute for Health Technology
Assessment, Garnisongasse 7/20, 1090 Vienna, Austria
Title
Systematic review of the efficacy and safety of fibrinogen concentrate
substitution in adults.
Source
Acta Anaesthesiologica Scandinavica. 56 (5) (pp 539-548), 2012. Date of
Publication: May 2012.
Publisher
Blackwell Munksgaard (1 Rosenorns Alle, P.O. Box 227, Copenhagen V
DK-1502, Denmark)
Abstract
Background A sufficient plasma level of fibrinogen is critical for the
formation of a fibrin clot and haemostasis in both the perioperative
setting and in massive haemorrhage. We assessed the efficacy and safety of
fibrinogen concentrate substitution in the perioperative setting and in
massive haemorrhage. Methods We conducted a systematic literature search
for studies conducted on humans and published in either English or German
in several databases from 1985 to 2010. In addition, we screened several
web sites for assessments on fibrinogen concentrate substitution and
conducted a hand search using Scopus. In terms of efficacy, we included
all prospective, controlled studies. Concerning safety, we included all
prospective studies. Results We identified two randomised controlled
trials and two non-randomised controlled studies, which included a total
of 74 patients. The studies indicate that the administration of fibrinogen
concentrate is associated with improved clot firmness and reduction in the
substitution of other blood products such as red blood cells, fresh frozen
plasma and platelet concentrates, as well as decreased post-operative
bleeding and drainage volume. In addition, fibrinogen concentrate
administration has been reported to be safe with regard to thrombosis and
thromboembolic complications, as well as mortality. However, the studies
identified were of poor quality. Conclusion In conclusion, the results of
the available controlled trials suggest that the administration of
fibrinogen concentrate was effective and safe. However, because all
studies identified were of inadequate quality, these findings need to be
confirmed by randomised controlled trials of sufficient size and long-term
follow-up. 2011 Ludwig Boltzmann Institute for Health Technology
Assessment Acta Anaesthesiologica Scandinavica.

<9>
Accession Number
2012215770
Authors
Sundareswaran K.S. Haggerty C.M. De Zelicourt D. Dasi L.P. Pekkan K.
Frakes D.H. Powell A.J. Kanter K.R. Fogel M.A. Yoganathan A.P.
Institution
(Sundareswaran, Haggerty, De Zelicourt, Yoganathan) Wallace H. Coulter
Department of Biomedical Engineering, Georgia Institute of Technology,
Emory University, 313 Ferst Dr, Atlanta, GA 30332, United States
(Dasi) Department of Mechanical Engineering, Colorado State University,
Fort Collins, CO, United States
(Pekkan) Department of Biomedical Engineering, Carnegie Mellon University,
Pittsburgh, PA, United States
(Frakes) School of Biological and Health Systems Engineering, Arizona
State University, Tempe, AZ, United States
(Frakes) Department of Cardiology, Children's Hospital Boston, Boston, MA,
United States
(Powell) Department of Pediatrics, Harvard Medical School, Boston, MA,
United States
(Kanter) Division of Pediatric Cardiothoracic Surgery, Emory University
School of Medicine, Atlanta, GA, United States
(Fogel) Division of Pediatric Cardiology, Children's Hospital of
Philadelphia, Philadelphia, PA, United States
Title
Visualization of flow structures in Fontan patients using 3-dimensional
phase contrast magnetic resonance imaging.
Source
Journal of Thoracic and Cardiovascular Surgery. 143 (5) (pp 1108-1116),
2012. Date of Publication: May 2012.
Publisher
Mosby Inc. (11830 Westline Industrial Drive, St. Louis MO 63146, United
States)
Abstract
Objective: Our objective was to analyze 3-dimensional (3D) blood flow
patterns within the total cavopulmonary connection (TCPC) using in vivo
phase contrast magnetic resonance imaging (PC MRI). Methods: Sixteen
single-ventricle patients were prospectively recruited at 2 leading
pediatric institutions for PC MRI evaluation of their Fontan pathway.
Patients were divided into 2 groups. Group 1 comprised 8 patients with an
extracardiac (EC) TCPC, and group 2 comprised 8 patients with a lateral
tunnel (LT) TCPC. A coronal stack of 5 to 10 contiguous PC MRI slices with
3D velocity encoding (5-9 ms resolution) was acquired and a volumetric
flow field was reconstructed. Results: Analysis revealed large vortices in
LT TCPCs and helical flow structures in EC TCPCs. On average, there was no
difference between LT and EC TCPCs in the proportion of inferior vena cava
flow going to the left pulmonary artery (43% +/- 7% vs 46% +/- 5%; P =
.34). However, for EC TCPCs, the presence of a caval offset was a primary
determinant of inferior vena caval flow distribution to the pulmonary
arteries with a significant bias to the offset side. Conclusions: 3D flow
structures within LT and EC TCPCs were reconstructed and analyzed for the
first time using PC MRI. TCPC flow patterns were shown to be different,
not only on the basis of LT or EC considerations, but with significant
influence from the superior vena cava connection as well. This work adds
to the ongoing body of research demonstrating the impact of TCPC geometry
on the overall hemodynamic profile. Copyright 2012 by The American
Association for Thoracic Surgery.

<10>
Accession Number
2012215759
Authors
Mann D.L. Kubo S.H. Sabbah H.N. Starling R.C. Jessup M. Oh J.K. Acker M.A.
Institution
(Mann) Division of Cardiology, Washington University School of Medicine,
660 S. Euclid Ave, St Louis, MO 63110-1093, United States
(Kubo) Acorn Cardiovascular, St Paul, MN, United States
(Sabbah) Henry Ford Hospital, Detroit, MI, United States
(Starling) Cleveland Clinic Foundation, Cleveland, OH, United States
(Jessup, Acker) University of Pennsylvania, Philadelphia, PA, United
States
(Oh) Mayo Clinic, Rochester, MN, United States
Title
Beneficial effects of the CorCap cardiac support device: Five-year results
from the Acorn Trial.
Source
Journal of Thoracic and Cardiovascular Surgery. 143 (5) (pp 1036-1042),
2012. Date of Publication: May 2012.
Publisher
Mosby Inc. (11830 Westline Industrial Drive, St. Louis MO 63146, United
States)
Abstract
Background: The CorCap cardiac support device (Acorn Cardiovascular, Inc,
St Paul, Minn) is the first device that specifically addresses ventricular
remodeling in heart failure by reducing wall stress. We previously
reported outcomes from the Acorn randomized trial to a common closing date
(22.9 months of follow-up). This report summarizes results of extended
followup to 5 years. Methods: A total of 107 patients were enrolled in the
no-mitral valve repair/replacement stratum including 57 in the CorCap
treatment group and 50 in the control (optimal medical therapy alone)
group. Patients were assessed every year, until completing 5 years of
follow-up, for survival, adverse events, major cardiac procedures, New
York Heart Association (NYHA) functional status, and echocardiograms,
which were read at a core laboratory. Results: Overall survivals were
similar between the treatment and control groups, demonstrating no late
adverse effect on mortality. The treatment group had significant
reductions in left ventricular end-diastolic volume (P = .029) as well as
a small increase in sphericity index. More patients in the treatment group
improved by at least 1 NYHA functional class (P = .0005). There was no
difference in rates of adverse events. In a subgroup of patients with an
intermediate left ventricular end-diastolic dimension, there was a
significant reduction in the Kaplan-Meier estimate of the freedom from the
composite end point of death and major cardiac procedures (P = .04).
Conclusions: These cumulative data demonstrate the sustained reverse
remodeling of the left ventricle and the long-term safety and efficacy of
the CorCap cardiac support device as an adjunctive therapy for patients
with heart failure who remain symptomatic despite optimal medical therapy.
Copyright 2012 Published by Elsevier Inc. on behalf of The American
Association for Thoracic Surgery.

<11>
Accession Number
2012201124
Authors
Capranzano P. Dangas G.
Institution
(Capranzano) Cardiovascular Department, Ferrarotto Hospital, University of
Catania, Italy
(Dangas) Cardiovascular Institute, Box 1030, Mount Sinai Medical Center,
New York, NY 10029, United States
Title
Bivalirudin for primary percutaneous coronary intervention in acute
myocardial infarction: The HORIZONS-AMI trial.
Source
Expert Review of Cardiovascular Therapy. 10 (4) (pp 411-422), 2012. Date
of Publication: April 2012.
Publisher
Expert Reviews Ltd. (2 Albert Place, London N3 1QB, United Kingdom)
Abstract
The combination of unfractionated heparin (UFH) plus glycoprotein IIb/IIIa
inhibitors (GPIs) has been a frequently used anti-thrombotic treatment
strategy for acute coronary syndrome patients, including those with
ST-segment elevation myocardial infarction undergoing primary percutaneous
coronary intervention. However, the ischemic benefit of the UFH plus GPI
combination came at the expense of high rates of bleeding complications
and thrombocytopenia, both of which have been independently associated
with increased mortality. By contrast, bivalirudin monotherapy compared
with the combination of UFH plus GPI resulted in improved net clinical
outcomes, based on similar ischemic protection with significant reductions
in bleeding complications in randomized trials including patients with
stable angina, those with unstable angina and those with non-ST-segment
elevation myocardial infarction. More recently, the HORIZONS-AMI
randomized, open-label, multicenter trial has compared the efficacy and
safety of bivalirudin alone versus UFH plus a GPI in 3602 patients with
ST-segment elevation myocardial infarction undergoing primary percutaneous
coronary intervention. Clinical results derived from this large study,
including the final 3-year follow-up data, will be reviewed in the present
clinical trial report. 2012 Expert Reviews Ltd.

<12>
Accession Number
22098690
Authors
Campanella A. Bergamasco L. Macri L. Asioli S. Devotini R. Scipioni S.
Barbaro S. Rispoli P. Rinaldi M.
Institution
(Campanella) Thoracic and Cardiovascular Department, Division of Cardiac
Surgery, San Giovanni Battista of Turin Hospital, University of Turin,
Corso Bramante 84, 10126 Turin, Italy.
Title
Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for
coronary artery bypass grafting surgery: study protocol for a randomized
controlled trial.
Source
Trials. 12 (pp 243), 2011. Date of Publication: 2011.
Abstract
In coronary artery bypass grafting surgery, arterial conduits are
preferred because of more favourable long-term patency and outcome. Anyway
the greater saphenous vein continues to be the most commonly used bypass
conduit. Minimally invasive endoscopic saphenous vein harvesting is
increasingly being investigated in order to reduce the morbidity
associated with conventional open vein harvesting, includes postoperative
leg wound complications, pain and patient satisfaction. However, to date
the short and the long-term benefits of the endoscopic technique remain
controversial. This study provides an interesting opportunity to address
this gap in the literature. Endoscopic Saphenous harvesting with an Open
CO2 System trial includes two parallel vein harvesting arms in coronary
artery bypass grafting surgery. It is an interventional, single centre,
prospective, randomized, safety/efficacy, cost/effectiveness study, in
adult patients with elective planned and first isolated coronary artery
disease. A simple size of 100 patients for each arm will be required to
achieve 80% statistical power, with a significant level of 0.05, for
detecting most of the formulated hypotheses. A six-weeks leg wound
complications rate was assumed to be 20% in the conventional arm and less
of 4% in the endoscopic arm. Previously quoted studies suggest a
first-year vein-graft failure rate of about 20% with an annual occlusion
rate of 1% to 2% in the first six years, with practically no difference
between the endoscopic and conventional approaches. Similarly, the results
on event-free survival rates for the two arms have barely a 2-3% gap.
Assuming a 10% drop-out rate and a 5% cross-over rate, the goal is to
enrol 230 patients from a single Italian cardiac surgery centre. The goal
of this prospective randomized trial is to compare and to test improvement
in wound healing, quality of life, safety/efficacy, cost-effectiveness,
short and long-term outcomes and vein-graft patency after endoscopic open
CO2 harvesting system versus conventional vein harvesting.The expected
results are of high clinical relevance and will show the safety/efficacy
or non-inferiority of one treatment approach in terms of vein harvesting
for coronary artery bypass grafting surgery. www.clinicalTrials.gov
NCT01121341.

<13>
Accession Number
2012204773
Authors
Morrow D.A. Braunwald E. Bonaca M.P. Ameriso S.F. Dalby A.J. Fish M.P. Fox
K.A.A. Lipka L.J. Liu X. Nicolau J.C. Ophuis A.J.O. Paolasso E. Scirica
B.M. Spinar J. Theroux P. Wiviott S.D. Strony J. Murphy S.A.
Institution
(Morrow, Braunwald, Bonaca, Fish, Scirica, Wiviott, Murphy) TIMI Study
Group, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis
St., Boston, MA 02115, United States
(Ameriso) Institute for Neurological Research, FLENI, Buenos Aires,
Argentina
(Dalby) Milpark Hospital, Johannesburg, South Africa
(Fox) Division of Cardiovascular Research, University of Edinburgh,
Edinburgh, United Kingdom
(Lipka, Liu, Strony) Merck Research Laboratories, Rahway, NJ, United
States
(Nicolau) Heart Institute (InCor), University of Sao Paulo Medical School,
Sao Paulo, Brazil
(Ophuis) Canisius-Wilhelmina Hospital, Nijmegen, Netherlands
(Paolasso) Instituto de Investigaciones Clinicas Rosario, Rosario,
Argentina
(Spinar) University Hospital Brno, Masaryk University, Brno, Czech
Republic
(Theroux) Montreal Heart Institute, University of Montreal, Montreal,
Canada
Title
Vorapaxar in the secondary prevention of atherothrombotic events.
Source
New England Journal of Medicine. 366 (15) (pp 1404-1413), 2012. Date of
Publication: 12 Apr 2012.
Publisher
Massachussetts Medical Society (860 Winter Street, Waltham MA 02451-1413,
United States)
Abstract
BACKGROUND: Thrombin potently activates platelets through the
protease-activated receptor PAR-1. Vorapaxar is a novel antiplatelet agent
that selectively inhibits the cellular actions of thrombin through
antagonism of PAR-1. METHODS: We randomly assigned 26,449 patients who had
a history of myocardial infarction, ischemic stroke, or peripheral
arterial disease to receive vorapaxar (2.5 mg daily) or matching placebo
and followed them for a median of 30 months. The primary efficacy end
point was the composite of death from cardiovascular causes, myocardial
infarction, or stroke. After 2 years, the data and safety monitoring board
recommended discontinuation of the study treatment in patients with a
history of stroke owing to the risk of intracranial hemorrhage. RESULTS:At
3 years, the primary end point had occurred in 1028 patients (9.3%) in the
vorapaxar group and in 1176 patients (10.5%) in the placebo group (hazard
ratio for the vorapaxar group, 0.87; 95% confidence interval [CI], 0.80 to
0.94; P<0.001). Cardiovascular death, myocardial infarction, stroke, or
recurrent ischemia leading to revascularization occurred in 1259 patients
(11.2%) in the vorapaxar group and 1417 patients (12.4%) in the placebo
group (hazard ratio, 0.88; 95% CI, 0.82 to 0.95; P = 0.001). Moderate or
severe bleeding occurred in 4.2% of patients who received vorapaxar and
2.5% of those who received placebo (hazard ratio, 1.66; 95% CI, 1.43 to
1.93; P<0.001). There was an increase in the rate of intracranial
hemorrhage in the vorapaxar group (1.0%, vs. 0.5% in the placebo group;
P<0.001). CONCLUSIONS:Inhibition of PAR-1 with vorapaxar reduced the risk
of cardiovascular death or ischemic events in patients with stable
atherosclerosis who were receiving standard therapy. However, it increased
the risk of moderate or severe bleeding, including intracranial
hemorrhage. (Funded by Merck; TRA 2P-TIMI 50 ClinicalTrials.gov number,
NCT00526474.) Copyright 2012 Massachusetts Medical Society.

<14>
Accession Number
2012208215
Authors
Clark A.L.
Institution
(Clark) Department of Clinical Cardiology, Castle Hill Hospital, United
Kingdom
Title
Heart failure.
Source
Archivos de Cardiologia de Mexico. 81 (4) (pp 383-390), 2011. Date of
Publication: 2011.
Publisher
Instituto Nacional de Cardiologia Ignazio Chavez (Juan Badiano 1, Col.
Seccion XVI, Deleg. Tlalpan, Mexico D.F. 14080, Mexico)

<15>
Accession Number
70719556
Authors
Valencia G. Canale G. Barolo R. Gorosito P. Picasso D.G.
Title
Usefulness of stress echocardiography in perioperative evaluation of
patients scheduled for non-cardiac surgery: A review.
Source
British Journal of Anaesthesia. Conference: 15th WFSA World Congress of
Anaesthesiologists Predio Ferial de Buenos Aires Argentina. Conference
Start: 20120325 Conference End: 20120330. Conference Publication:
(var.pagings). 108 (pp ii360), 2012. Date of Publication: March 2012.
Publisher
Oxford University Press
Abstract
Introduction: The need for assessment of the risk for developing
cardiovascular events in patients scheduled for noncardiac surgery
(PSFNCS) is undeniable. In many cases it is not enough to rely on the
patients clinical features, and stress tests must be used in order to
detect ischaemia. Stress Echocardiography (SE) rises as a useful tool,
joining exercise testing (ET) and single-photon emission computed
tomography (SPECT). Objectives: To assess the usefulness of SE in PSFNCS,
compared to that of ET and SPECT. Methods and Materials: We conducted a
throughout search in Medline and Ovid databases. Our keywords were "stress
echocardiography", "perioperative evaluation" and "noncardiac surgery". We
took into account reviews, meta-analysis, and RCTs published between 2000
and 2011. We included in our work 6 selected articles. Results and
Discussion: Exercise is the prototype of ischaemic stress. However, many
patients requiring a stress test can' t exercise, can exercise
submaximally, or have an uninterpretable ECG[1]. Besides, with
pharmacological stress testing factors such as hyperventilation, excessive
chest wall movement and myocardial hypercontraction (which make
echocardiographical assesment difficult and therefore reduce diagnostic
accuracy) are avoided.[2] SE with either dobutamine or dypiridamole shows
similar accuracy and sensibility. The choice of one test over the other
will depend on patient characteristics, availability and physician's
preferences.[3] Nevertheless, SE should be used as a first-line technique
only when ET is uninterpretable (like in left bundle-branch block, or
pacing).[4] The less informative and/or interpretable ET is, the higher is
the level of appropriateness to SE [5]. On the other hand, it must be
aknowledged that SE is recommended for high-risk patients with a previous
history of coronary artery disease (CAD) sheduled for high-risk surgical
procedures. The test is not recommended in low-to-medium-risk patients
[6]. One of the tests with which SE has been compared to, is SPECT.
According to many authors, SE should be chosen instead of SPECT, because
of its lower costs and lack of radiation (SPECT radiation burden equals
that of up to 1300 chest x-rays). [1] Conclusions: SE's diagnostic and
pronostic accuracy is similar to that of SPECT, at a lower cost, with no
enviromental impact and avoiding exposure to radiation. Stress testing
with SE is useful in patients for whom ET is not, and should only be used
in that setting. Finally, we remark that SE is useful for high surgical
risk patients, with known CAD.

<16>
Accession Number
70719048
Authors
Cheng D. Martin J. Bainbridge D.
Institution
(Cheng, Martin, Bainbridge) Department of Anesthesia and Perioperative
Medicine, EPiCOR Program, LHSC-University Hospital, University of Western
Ontario, Canada
Title
Opcab surgery in elderly patients: Evidence of benefits?.
Source
British Journal of Anaesthesia. Conference: 15th WFSA World Congress of
Anaesthesiologists Predio Ferial de Buenos Aires Argentina. Conference
Start: 20120325 Conference End: 20120330. Conference Publication:
(var.pagings). 108 (pp ii59-ii60), 2012. Date of Publication: March 2012.
Publisher
Oxford University Press
Abstract
Introduction: The majority of earlier trials comparing clinical outcomes
after off-pump bypass surgery (OPCAB) and conventional bypass surgery
(CCAB) were non-randomized comparisons of low-risk patients undergoing
single- or double-vessel bypass, with the potential risk of unbalanced
baseline patient characteristics leading to bias in favor of either OPCAB
or CCAB. There remains considerable uncertainty as to the role of OPCAB
for patients across the full spectrum of risk groups. Objectives: This
systematic review and meta-analysis sought to determine whether off-pump
bypass surgery (OPCAB) provides significant clinical advantages compared
to conventional coronary artery bypass surgery (CCAB) in elderly patients
(>60y, >70y, >80y, >90y), and whether the benefits of OPCAB over CCAB are
directly related to increasing age. Methods: Comprehensive searches of
MEDLINE, Cochrane CENTRAL, EMBASE, abstract databases up to January 2011.
Criteria for Included Trials: Randomized or non-randomized controlled
studies - Elderly patients (age>60) undergoing OPCAB compared directly
with elderly patients (age >60) undergoing CCAB, reporting a least one
relevant outcome in any language. Two reviewers independently identified
relevant trials and extracted outcomes data. Bias. Publication bias was
explored through visual inspection of funnel plots. Meta-Analysis: Odds
ratios [OR, 95% CI] were calculated for proportions, and weighted mean
differences [WMD, 95% CI] were calculated for continuous data. Results:
Eligible studies: 27 studies (26 nRCT and 1 RCT - 10,271 patients) were
included in the analysis. Regression did not show publication bias, but
significant heterogeneity was found for neurocognitive dysfunction, low
cardiac output syndrome, transfusions, ventilation time, and length of
stay. Significant clinical benefit of OPCAB over CCAB in elderly patients
was summarized in table 1. (Table presented) Conclusions: In elderly
patients, OPCAB is superior to CCAB for reducing risk of death, stroke,
AF, neurologic complications, low cardiac output syndrome, renal
insufficiency, transfusions, ventilation time, and hospital length of
stay, without increased risk for reoperation for bleeding, myocardial
infarction, angina recurrence, or need for reintervention. However, the
magnitude of benefit of OPCAB over CCAB did not rise further with
increasing age >70.

Saturday, April 21, 2012

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<1>
Accession Number
2012203323
Authors
D'Ascenzo F. Cerrato E. Biondi-Zoccai G. Moretti C. Omede P. Sciuto F.
Bollati M. Modena M.G. Gaita F. Sheiban I.
Institution
(D'Ascenzo, Cerrato, Moretti, Omede, Sciuto, Bollati, Gaita, Sheiban)
Division of Cardiology, University of Turin, S. Giovanni Battista
'Molinette' Hospital, Corso Bramante 88-90, Turin 10126, Italy
(Biondi-Zoccai, Modena) Division of Cardiology, University of Modena and
Reggio Emilia, Modena, Italy
Title
Acute coronary syndromes in human immunodeficiency virus patients: A
meta-analysis investigating adverse event rates and the role of
antiretroviral therapy.
Source
European Heart Journal. 33 (7) (pp 875-880), 2012. Date of Publication:
April 2012.
Publisher
Oxford University Press (Great Clarendon Street, Oxford OX2 6DP, United
Kingdom)
Abstract
Aims: Highly active antiretroviral therapy (HAART) dramatically reduces
human immunodeficiency virus (HIV)-associated morbidity and mortality, but
adverse effects of HAART are becoming an increasing challenge, especially
in the setting of acute coronary syndromes (ACS). We thus performed a
comprehensive review of studies focusing on ACS in HIV patients. Methods
and results: MEDLINE/PubMed was systematically screened for studies
reporting on ACS in HIV patients. Baseline, treatment, and outcome data
were appraised and pooled with random-effect methods computing summary
estimates [95% confidence intervals (CIs)]. A total of 11 studies
including 2442 patients were identified, with a notably low prevalence of
diabetes [10.86 (4.11, 17.60); 95% CI]. Rates of in-hospital death were
8.00% (2.8, 12.5; 95% CI), ascribable to cardiovascular events for 7.90%
(2.43, 13.37; 95% CI), with 2.31% (0.60, 4.01; 95% CI) developing
cardiogenic shock. At a median follow-up of 25.50 months (11.25, 42; 95%
CI), no deaths were recorded, with an incidence of 9.42% of acute
myocardial infarction (2.68, 16.17; 95% CI) and of 20.18% (9.84, 30.51;
95% CI) of percutaneous coronary revascularization. Moreover, pooled
analysis of the studies reporting incidence of acute myocardial infarction
in patients exposed to protease inhibitors showed an overall significant
risk of 2.68 (odds ratio 1.89, 3.89; 95% CI). Conclusion: Human
immunodeficiency virus patients admitted for ACS face a substantial
short-term risk of death and a significant long-term risk of coronary
revascularization and myocardial infarction, especially if receiving
protease inhibitors. Published on behalf of the European Society of
Cardiology. All rights reserved. The Author 2011.

<2>
Accession Number
2012180024
Authors
Ting R.-D. Keech A.C. Drury P.L. Donoghoe M.W. Hedley J. Jenkins A.J.
Davis T.M.E. Lehto S. Celermajer D. Simes R.J. Rajamani K. Stanton K.
Institution
(Ting, Keech, Donoghoe, Jenkins, Simes, Rajamani) National Health and
Medical Research Council Clinical Trials Centre, University of Sydney,
Sydney, NSW, Australia
(Ting, Keech, Celermajer, Rajamani) Department of Cardiology, Royal Prince
Alfred Hospital, Sydney, NSW, Australia
(Drury) Auckland Diabetes Centre, Auckland, New Zealand
(Hedley) Department of Internal Medicine, Wairau Hospital, Blenheim, New
Zealand
(Jenkins) Department of Medicine, University of Melbourne, Melbourne, VIC,
Australia
(Davis) School of Medicine and Pharmacology, University of Western
Australia, Perth, WA, Australia
(Lehto) Department of Medicine, Kuopio University Hospital, Kuopio,
Finland
(Stanton) Department of Endocrinology and Diabetes, Royal Perth Hospital,
Perth, WA, Australia
Title
Benefits and safety of long-term fenofibrate therapy in people with type 2
diabetes and renal impairment: The FIELD study.
Source
Diabetes Care. 35 (2) (pp 218-225), 2012. Date of Publication: February
2012.
Publisher
American Diabetes Association Inc. (1701 North Beauregard St., Alexandria
VA 22311, United States)
Abstract
OBJECTIVE - Diabetic patients with moderate renal impairment (estimated
glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m<sup>2</sup>) are at
particular cardiovascular risk. Fenofibrate's safety in these patients is
an issue because it may elevate plasma creatinine. Furthermore, guidelines
regarding fenofibrate dosing in renal impairment vary internationally. We
investigated fenofibrate's effects on cardiovascular and end-stage renal
disease (ESRD) events, according to eGFR, in the Fenofibrate Intervention
and Event Lowering in Diabetes (FIELD) Study. RESEARCH DESIGN AND METHODS
- Type 2 diabetic patients (aged 50-75 years) with eGFR>30 mL/min/1.73
m<sup>2</sup> were randomly allocated to a fixed dose of fenofibrate (200
mg daily) (n = 4,895) or placebo (n = 4,900) for 5 years. Baseline renal
function (Modification of Diet in Renal Disease equation) was grouped by
eGFR (30-59, 60-89, and >=90 mL/min/1.73 m<sup>2</sup>). The prespecified
outcome was total cardiovascular events (composite of cardiovascular
death, myocardial infarction, stroke, and coronary/carotid
revascularization). Serious adverse events and instances of ESRD (plasma
creatinine >400 mumol/L, dialysis, renal transplant, or renal death) were
recorded. Analysis was by intention to treat. RESULTS - Overall,
fenofibrate reduced total cardiovascular events, compared with placebo
(hazard ratio 0.89 [95% CI 0.80-0.99]; P = 0.035). This benefit was not
statistically different across eGFR groupings (P = 0.2 for interaction)
(eGFR 30-59 mL/min/1.73 m<sup>2</sup>: 0.68 [0.47-0.97], P = 0.035; eGFR
>=90 mL/min/1.73 m<sup>2</sup>: 0.85 [0.70-1.02], P = 0.08). ESRD rates
were similar between treatment arms, without adverse safety signals of
fenofibrate use in renal impairment. CONCLUSIONS - Patients with type 2
diabetes andmoderate renal impairment benefit from long-term fenofibrate,
without excess drug-related safety concerns compared with those with no
ormild renal impairment. Fenofibrate treatment should not be
contraindicated in moderate renal impairment, suggesting that current
guidelines may be too restrictive. 2012 by the American Diabetes
Association.

<3>
Accession Number
2012205462
Authors
Cittadini A. Napoli R. Monti M.G. Rea D. Longobardi S. Netti P.A. Walser
M. Sama M. Aimaretti G. Isgaard J. Sacca L.
Institution
(Cittadini, Napoli, Monti, Rea, Sacca) Department of Clinical Medicine and
Cardiovascular and Immunological Sciences, University Federico II, Naples,
Italy
(Longobardi) Merck Serono Group, Rome, Italy
(Netti) Interdisciplinary Research Centre on Biomaterials, University
Federico II, Naples, Italy
(Netti) Center for Advanced Biomaterial for Health Care, Interdisciplinary
Research Centre on Biomaterials, Italian Institute of Technology, Naples,
Italy
(Walser, Isgaard) Department of Internal Medicine, Sahlgrenska Academy,
University of Gothenburg, Gothenburg, Sweden
(Sama, Aimaretti) Department of Clinical and Experimental Medicine,
University A. Avogadro, Novara, Italy
Title
Metformin prevents the development of chronic heart failure in the SHHF
rat model.
Source
Diabetes. 61 (4) (pp 944-953), 2012. Date of Publication: April 2012.
Publisher
American Diabetes Association Inc. (1701 North Beauregard St., Alexandria
VA 22311, United States)
Abstract
Insulin resistance is a recently identified mechanism involved in the
pathophysiology of chronic heart failure (CHF). We investigated the
effects of two insulin-sensitizing drugs (metformin and rosiglitazone) in
a genetic model of spontaneously hypertensive, insulin-resistant rats
(SHHF). Thirty SHHF rats were randomized into three treatment groups as
follows: 1) metformin (100 mg/kg per day), 2) rosiglitazone (2 mg/kg per
day), and 3) no drug. Ten Sprague-Dawley rats served as normal controls.
At the end of the treatment period (12 months), the cardiac phenotype was
characterized by histology, echocardiography, and isolated perfused heart
studies. Metformin attenuated left ventricular (LV) remodeling, as shown
by reduced LV volumes, wall stress, perivascular fibrosis, and cardiac
lipid accumulation. Metformin improved both systolic and diastolic indices
as well as myocardial mechanical efficiency, as shown by improved ability
to convert metabolic energy into mechanical work. Metformin induced a
marked activation of AMP-activated protein kinase, endothelial nitric
oxide synthase, and vascular endothelial growth factor and reduced tumor
necrosis factor-alpha expression and myocyte apoptosis. Rosiglitazone did
not affect LV remodeling, increased perivascular fibrosis, and promoted
further cardiac lipid accumulation. In conclusion, long-term treatment
with metformin, but not with rosiglitazone, prevents the development of
severe CHF in the SHHF model by a wide-spectrum interaction that involves
molecular, structural, functional, and metabolic-energetic mechanisms.
2012 by the American Diabetes Association.

<4>
Accession Number
2012185841
Authors
Jilaihawi H. Kashif M. Fontana G. Furugen A. Shiota T. Friede G. Makhija
R. Doctor N. Leon M.B. Makkar R.R.
Institution
(Jilaihawi, Kashif, Furugen, Shiota, Friede, Makhija, Doctor, Makkar)
Heart Institute, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los
Angeles, CA 90048, United States
(Fontana) Lenox Hill Hospital, Heart and Vascular Institute of New York,
New York, NY, United States
(Leon) Columbia University Medical Center, New York, NY, United States
Title
Cross-sectional computed tomographic assessment improves accuracy of
aortic annular sizing for transcatheter aortic valve replacement and
reduces the incidence of paravalvular aortic regurgitation.
Source
Journal of the American College of Cardiology. 59 (14) (pp 1275-1286),
2012. Date of Publication: 03 Apr 2012.
Publisher
Elsevier USA (6277 Sea Harbor Drive, Orlando FL 32862 8239, United States)
Abstract
Objectives: In an effort to define the gold standard for annular sizing
for transcatheter aortic valve replacement (TAVR), we sought to critically
analyze and compare the predictive value of multiple measures of the
aortic annulus for post-TAVR paravalvular (PV) regurgitation and then
assess the impact of a novel cross-sectional computed tomographic (CT)
approach to annular sizing. Background: Recent studies have shown clear
discrepancies between conventional 2-dimensional (2D) echocardiographic
and CT measurements. In terms of aortic annular measurement for TAVR, such
findings have lacked the outcome analysis required to inform clinical
practice. Methods: The discriminatory value of multiple CT annular
measures for post-TAVR PV aortic regurgitation was compared with 2D
echocardiographic measures. TAVR outcomes with device selection according
to aortic annular sizing using a traditional 2D transesophageal
echocardiographyguided or a novel CT-guided approach were also studied.
Results: In receiver-operating characteristic models, cross-sectional CT
parameters had the highest discriminatory value for post-TAVR PV
regurgitation: This was with the area under the curve for [maximal
cross-sectional diameter minus prosthesis size] of 0.82 (95% confidence
interval: 0.69 to 0.94; p < 0.001) and that for [circumference-derived
cross-sectional diameter minus prosthesis size] of 0.81 (95% confidence
interval: 0.7 to 0.94; p < 0.001). In contrast, traditional
echocardiographic measures were nondiscriminatory in relation to post-TAVR
PV aortic regurgitation. The prospective application of a CT-guided
annular sizing approach resulted in less PV aortic regurgitation of grade
worse than mild after TAVR (7.5% vs. 21.9%; p = 0.045). Conclusions: Our
data lend strong support to 3-dimensional cross-sectional measures, using
CT as the new gold standard for aortic annular evaluation for TAVR with
the Edwards SAPIEN device. 2012 American College of Cardiology
Foundation.

<5>
Accession Number
2012185843
Authors
Herrmann H.C. Gertz Z.M. Silvestry F.E. Wiegers S.E. Woo Y.J. Hermiller J.
Segar D. Heimansohn D. Gray W. Homma S. Argenziano M. Wang A. Jollis J.
Lampert M.B. Alexander J. Mauri L. Foster E. Glower D. Feldman T.
Institution
(Herrmann, Gertz, Silvestry, Wiegers, Woo) University of Pennsylvania
Medical Center, Philadelphia, PA, United States
(Hermiller, Segar, Heimansohn) Care Group Heart Center, Indianapolis, IN,
United States
(Gray, Homma, Argenziano) Columbia University Medical Center, New York,
NY, United States
(Wang, Jollis, Glower) Duke University Medical Center, Durham, NC, United
States
(Lampert, Alexander, Feldman) Northshore University Health System,
Evanston, IL, United States
(Mauri) Brigham and Women's Hospital, Harvard Medical School, Boston, MA,
United States
(Foster) University of California San Francisco, San Francisco, CA, United
States
Title
Effects of atrial fibrillation on treatment of mitral regurgitation in the
EVEREST II (Endovascular valve edge-to-edge repair study) randomized
trial.
Source
Journal of the American College of Cardiology. 59 (14) (pp 1312-1319),
2012. Date of Publication: 03 Apr 2012.
Publisher
Elsevier USA (6277 Sea Harbor Drive, Orlando FL 32862 8239, United States)
Abstract
Objectives: The purpose of this study was to characterize patients with
mitral regurgitation (MR) and atrial fibrillation (AF) treated
percutaneously using the MitraClip device (Abbott Vascular, Abbott Park,
Illinois) and compare the results with surgery in this population.
Background: The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study)
randomized controlled trial compared a less invasive catheter-based
treatment for MR with surgery, providing an opportunity to assess the
impact of AF on the outcomes of both the MitraClip procedure and surgical
repair. Methods: The study population included 264 patients with
moderately severe or severe MR assessed by an independent
echocardiographic core laboratory. Comparison of safety and effectiveness
study endpoints at 30 days and 1 year were made using both
intention-to-treat and per-protocol (cohort of patients with MR <=2+ at
discharge) analyses. Results: Pre-existing AF was present in 27% of
patients. These patients were older, had more advanced disease, and were
more likely to have a functional etiology. Similar reduction of MR to <=2+
before discharge was achieved in patients with AF (83%) and in patients
without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for
valve dysfunction, and MR >2+ was similar at 12 months for AF patients
(64%) and for no-AF patients (61%, p = 0.3). At 12 months, MR reduction to
<2+ was greater with surgery than with MitraClip, but there was no
interaction between rhythm and MR reduction, and no difference in
all-cause mortality between patients with and patients without AF.
Conclusions: Atrial fibrillation is associated with more advanced valvular
disease and noncardiac comorbidities. However, acute procedural success,
safety, and 1-year efficacy with MitraClip therapy is similar for patients
with AF and without AF. 2012 American College of Cardiology Foundation.

<6>
[Use Link to view the full text]
Accession Number
22057829
Authors
Matamis D. Pampori S. Papathanasiou A. Papakonstantinou P. Tsagourias M.
Galiatsou E. Koulouras V. Nakos G.
Institution
(Matamis) Intensive Care Unit, Papageorgiou General Hospital,
Thessalonica, Greece.
Title
Inhaled NO and sildenafil combination in cardiac surgery patients with
out-of-proportion pulmonary hypertension: acute effects on postoperative
gas exchange and hemodynamics.
Source
Circulation. Heart failure. 5 (1) (pp 47-53), 2012. Date of Publication: 1
Jan 2012.
Abstract
The goal of this study was to examine the effects of coadministration of
sildenafil and inhaled nitric oxide (iNO) in patients with
out-of-proportion pulmonary hypertension who underwent cardiac valve
replacement surgery. Twenty consecutive cardiac surgery patients with
out-of-proportion pulmonary hypertension were randomly assigned
postoperatively into 2 groups: group A received 10 ppm of iNO followed by
sildenafil (100 mg) orally 30 minutes later, and group B initially
received sildenafil (100 mg) orally followed by 10 ppm of iNO 60 minutes
later. Hemodynamic and gas exchange data were obtained at baseline, after
administration of either iNO or sildenafil alone, and at 90 minutes from
baseline. In group A, iNO resulted in a significant reduction in mean
pulmonary artery pressure (MPAP) and pulmonary vascular resistance index
(PVRI) (by 9.6% and 20.8%, respectively). In group B, sildenafil
administration also resulted in a significant decrease in mean arterial
pressure, MPAP, pulmonary artery occlusive pressure, PVRI, and systemic
vascular resistance index but also in the PaO(2)/inspired fraction of
oxygen ratio (by 18.7%, 22.0%, 15.7%, 31.6%, 21.3%, and 14%,
respectively). In both groups, the coadministration of the 2 drugs
resulted in a significant further reduction of mean arterial pressure,
MPAP, pulmonary artery occlusive pressure, systemic vascular resistance
index, and PVRI, whereas cardiac index and mixed venous oxygen saturation
remained unchanged. The hypoxemia after sildenafil administration in group
B improved after the coadministration of iNO, and thus PaO(2)/inspired
fraction of oxygen returned to values near baseline. In this study, the
postoperative coadministration of iNO and oral sildenafil in patients with
out-of-proportion pulmonary hypertension undergoing cardiac surgery is
safe and results in an additive favorable effect on pulmonary arterial
pressure and pulmonary vascular resistance, without systemic hypotension
and ventilation/perfusion mismatch.

<7>
Accession Number
20709514
Authors
Monti L.D. Lucotti P.C.G. Setola E. Rossodivita A. Pala M.G. Galluccio E.
LaCanna G. Castiglioni A. Cannoletta M. Meloni C. Zavaroni I. Bosi E.
Alfieri O. Piatti P.M.
Institution
(Monti, Galluccio, Bosi, Piatti) Cardiodiabetes and Core Laboratory,
Metabolic and Cardiovascular Science Division, San Raffaele Scientific
Institute, Via Olgettina 60, 20132 Milan, Italy
(Lucotti, Setola, Bosi) Internal Medicine Department, Cardio-Metabolic and
Clinical Trials Unit, Metabolic and Cardiovascular Science Division, San
Raffaele Scientific Institute, 20132 Milan, Italy
(Rossodivita, Pala, LaCanna, Castiglioni, Cannoletta, Meloni, Alfieri)
Cardio-thoraco-vascular Department, Metabolic and Cardiovascular Science
Division, San Raffaele Scientific Institute, 20132 Milan, Italy
(Bosi, Alfieri, Piatti) Vita-Salute San Raffaele University, Scientific
Institute San Raffaele, Milan, Italy
(Zavaroni) Internal Medicine and Biomedical Science Department, Parma
University, Parma, Italy
Title
Effects of chronic elevation of atrial natriuretic peptide and free fatty
acid levels in the induction of type 2 diabetes mellitus and insulin
resistance in patients with mitral valve disease.
Source
Nutrition, Metabolism and Cardiovascular Diseases. 22 (1) (pp 58-65),
2012. Date of Publication: January 2012.
Publisher
Elsevier (P.O. Box 211, Amsterdam 1000 AE, Netherlands)
Abstract
Background and aims: The relationship between atrial natriuretic peptide
(ANP), increased free fatty acid (FFA) and insulin resistance in patients
with mitral valve disease (MVD), a group characterised by elevated atrial
pressure and increased ANP levels, is not defined. The present study was
performed to evaluate, in MVD patients, the relationship between increased
ANP and FFA levels and insulin resistance and the role of mitral valve
replacement/repair in ameliorating these metabolic alterations.
Conversely, coronary heart disease (CHD) patients were evaluated before
and after coronary artery bypass grafting (CABG), since they are known to
be insulin resistant in the presence of chronic FFA increase. Methods and
results: Fifty MVD patients and 55 CHD patients were studied before and 2
months after surgery and compared with 166 normal subjects. Before
surgery, 56% of MVD patients had impaired glucose tolerance or newly
diagnosed type 2 diabetes after a standard oral glucose load and this
percentage decreased to 46% after surgery. In CHD, impaired glucose
tolerance (IGT) or newly diagnosed type 2 diabetic patients were 67% of
patients before and after CABG. In MVD, left atrial (LA) volume, ANP, FFA
incremental area and insulin levels were higher and Insulin Sensitivity
(IS) index significantly reduced while after surgery, LA volume, ANP and
FFA significantly decreased and IS index significantly improved. In CHD,
insulin resistance and hyperinsulinaemia were present both before and
after surgery with increased tumour necrosis factor (TNF)-alpha and
interleukin (IL)-6 levels. Conclusion: In MVD, a higher degree of abnormal
glucose tolerance and insulin resistance are associated to increased
levels of ANP and FFA, while these metabolic alterations are improved by
mitral valve replacement/repair surgery.Clinical Trial.gov registration
number NCT 00520962. 2010 Elsevier B.V.

<8>
[Use Link to view the full text]
Accession Number
2012191961
Authors
Ling X. Xiong J. Liang W. Schroder P.M. Wu L. Ju W. Kong Y. Shang Y. Guo
Z. He X.
Institution
(Ling, Liang, Wu, Ju, Kong, Shang, Guo, He) Organ Transplant Center, First
Affiliated Hospital, Sun Yat-sen University, No. 58 Zhongshan Er Road,
Guangzhou 510080, China
(Xiong) Department of Hepatobiliary Surgery, Tongji Medical College,
Huazhong University of Science and Technology, Wuhan, China
(Schroder) Department of Medical Microbiology and Immunology, University
of Toledo College of Medicine, Toledo, OH, United States
Title
Can immune cell function assay identify patients at risk of infection or
rejection? A meta-analysis.
Source
Transplantation. 93 (7) (pp 737-743), 2012. Date of Publication: 15 Apr
2012.
Publisher
Lippincott Williams and Wilkins (351 West Camden Street, Baltimore MD
21201-2436, United States)
Abstract
Background. The Cylex ImmuKnow cell function assay (CICFA) is being
considered as a possible tool for identification of infection and
rejection in transplant recipients. However, the predictive capability of
CICFA is still unclear. Methods. Herein, we performed a meta-analysis to
assess the efficacy of CICFA in identifying risks of infection and
rejection posttransplantation. After a careful review of eligible studies,
sensitivity, specificity, and other measures of the accuracy of CICFA were
pooled. Summary receiver operating characteristic curves were used to
represent the overall test performance. Results. Nine studies met the
inclusion criteria. The pooled estimates for CICFA in identification of
infection risk were poor, with a sensitivity of 0.58 (95% confidence
interval [CI]: 0.52-0.64), a specificity of 0.69 (95% CI: 0.66-0.70), a
positive likelihood ratio of 2.37 (95% CI: 1.90-2.94), a negative
likelihood ratio of 0.39 (95% CI: 0.16-0.70), and a diagnostic odds ratio
of 7.41 (95% CI: 3.36-16.34). The pooled estimates for CICFA in
identifying risk of rejection were also fairly poor with a sensitivity of
0.43 (95% CI: 0.34-0.52), a specificity of 0.75 (95% CI: 0.72-0.78), a
positive likelihood ratio of 1.30 (95% CI: 0.74-2.28), a negative
likelihood ratio of 0.96 (95% CI: 0.85-1.07), and a diagnostic odds ratio
of 1.19 (95% CI: 0.65-2.20). Conclusion. The current evidence suggests
that CICFA is not able to identify individuals at risk of infection or
rejection. Additional studies are still needed to clarify the usefulness
of this test for identifying risks of infection and rejection in
transplant recipients. 2012 by Lippincott Williams & Wilkins.

<9>
Accession Number
2012196800
Authors
De Goede B. Klitsie P.J. Lange J.F. Metselaar H.J. Kazemier G.
Institution
(De Goede, Klitsie, Lange) Erasmus University Medical Center, Department
of Surgery, Medical Center, P.O. Box 2040, 3000 CA Rotterdam, Netherlands
(Metselaar) Erasmus University Medical Center, Department of
Gastroenterology and Hepatology, Netherlands
(Kazemier) VUmc, University Medical Center, Department of Surgery, Medical
Center, P.O. BOX 7057, 1007 MB Amsterdam, Netherlands
Title
Morbidity and mortality related to non-hepatic surgery in patients with
liver cirrhosis; A systematic review.
Source
Best Practice and Research: Clinical Gastroenterology. 26 (1) (pp 47-59),
2012. Date of Publication: February 2012.
Publisher
Bailliere Tindall Ltd (32 Jamestown Road, London NW1 7BY, United Kingdom)
Abstract
Background: The aim of this study is to review systematically morbidity
and mortality after non-hepatic surgery in patients with liver cirrhosis.
Methods: Comprehensive searches were conducted in PubMed, Embase and the
Cochrane Library for articles using the words: liver failure, hepatic
insufficiency, liver cirrhosis, cirrhosis, cirrhotic, surgical procedures,
operative complications, operative mortality, postoperative complications,
surgical complication, surgical risk, hernia. Results: Forty-six articles
were selected from 5247 included after the initial search. Level of
evidence provided in the articles varied greatly. Non-hepatic surgery of
patients with cirrhosis resulted in increased postoperative morbidity and
mortality compared to similar surgery for non-cirrhotic patients.
Cholecystectomy and umbilical and inguinal hernia correction were
associated with the lowest increased morbidity and mortality while
pancreatic surgery, cardiovascular, and trauma surgery correlated with the
highest. The preoperative model for end stage liver disease (MELD) and
Child-Turcotte-Pugh (CTP) scores appeared to be predictive of
postoperative risks. Portal hypertension and surgery in the emergency
setting were associated with extra increased mortality and morbidity
rates. Conclusion: This systematic review of the literature showed that in
patients with liver cirrhosis who undergo non-hepatic surgery,
postoperative morbidity and mortality rates varied greatly depending on
severity of the cirrhosis and the surgical procedure. However, the
majority of procedures can be safely performed in patients with low MELD
scores or CTP A cirrhosis without portal hypertension. 2012 Elsevier Ltd.
All rights reserved.

<10>
Accession Number
2012125905
Authors
Alamri H. Almoghairi A. Almasood A. Alotaibi M. Alonazi S.
Institution
(Alamri, Almoghairi, Almasood, Alotaibi, Alonazi) Adult Cardiology
Department, Prince Sultan Cardiac Center (PSCC), Riyadh, Saudi Arabia
Title
Do we need premedication before coronary angiography? A controlled
clinical trial.
Source
Cardiology Research. 2 (5) (pp 224-228), 2011. Date of Publication:
October 2011.
Publisher
Elmer Press (8230 Boul Taschereau, CP 50577,Brossard, Quebec J4X 2S0,
Canada)
Abstract
Background: Premedication with benzodiazepines has been thought to reduce
patient anxiety, pain perception, and non-catheter-induced coronary spasms
and may increase procedure-related complications. We used to routinely
provide premedication with diazepam and chlorpheniramine before cardiac
catheterization procedures. However the benefi ts of such a treatment are
not well established here. Therefore, we designed this study to test
whether the routine use of premedication during coronary angiography is
needed. Methods: A total of 200 consecutive patients scheduled to undergo
either diagnostic or therapeutic coronary angiographic procedures were
randomized to receive either premedication with diazepam (5 mg) and
chlorpheniramine (4 mg) 60 minutes prior to their procedures (n = 100) or
no premedication (n = 100). The administration of intravenous midazolam
during the procedures was permitted at the operator's discretion. The
primary endpoints were anxiety and pain perception during the procedure.
Results: A total of 200 patients with similar baseline characteristics
were randomized into two groups. The fi rst group received oral
premedication with diazepam (5 mg) and chlorphenamine (4 mg) 60 minutes
prior to their procedures, and the other group did not receive
premedication. We observed no differences in periprocedural pain
perception (31% in the premedicated group versus 29% in the
non-premedicated group; P = 0.75) or anxiety (59% in the premedicated
group versus 50% in the non-premedicated group; P = 0.2). Interestingly,
local pain was more pronounced in the premedicated patients than in the
non-premedicated patients (30% versus 16%, respectively; P = 0.018). There
were no contrast-related reactions reported in either group. Conclusions:
Treatment with oral diazepam and chlorphenamine prior to cardiac
catheterization and percutaneous coronary intervention does not alter
rates of anxiety, periprocedural pain. Articles The authors. Journal
compilation Cardiol Res and Elmer Press.

<11>
Accession Number
2012198636
Authors
Kajimoto K. Miyauchi K. Yamamoto T. Daida H. Amano A.
Institution
(Kajimoto, Yamamoto, Amano) Department of Cardiovascular Surgery, Juntendo
University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
(Miyauchi, Daida) Department of Cardiology, Juntendo University School of
Medicine, Tokyo, Japan
Title
Meta-analysis of randomized controlled trials on the treatment of
unprotected left main coronary artery disease: One-year outcomes with
coronary artery bypass grafting versus percutaneous coronary artery
intervention with drug-eluting stent.
Source
Journal of Cardiac Surgery. 27 (2) (pp 152-157), 2012. Date of
Publication: March 2012.
Publisher
Blackwell Publishing Inc. (350 Main Street, Malden MA 02148, United
States)
Abstract
Background and aim: Coronary artery bypass surgery (CABG) is the standard
treatment for left main coronary artery (LMCA) disease. However,
percutaneous coronary intervention using drug-eluting stents (DES-PCI) is
now widely used and is associated with improved outcomes following
coronary revascularization. The goal of this study was to assess early
outcomes associated with CABG and DES-PCI among patients with LMCA disease
through a meta-analysis of randomized controlled trials. Methods and
Results: After searching of electronic databases, three randomized
controlled trials with 2601 patients were identified. All-cause death
occurred in 3.3% with CABG and 3.6% with DES-PCI (odds ratio [OR], 0.92;
95% confidence interval [CI] = 0.60 to 1.40; p = 0.76). The incidence of
myocardial infarction was 2.6% with CABG and 3.8% with DES-PCI (OR, 0.67;
95% CI = 0.43 to 1.05; p = 0.10). Target vessel revascularization occurred
in 5.1% with CABG and 11.7% with DES-PCI (OR, 0.40; 95% CI = 0.29 to 0.55;
p < 0.0001). Major adverse cardiac and cerebrovascular events (MACCE)
occurred in 10.7% with CABG and 15.7% with DES-PCI (OR, 0.40; 95% CI =
0.29 to 0.55; p 0.0001). Conclusions: DES-PCI is a safe alternative to
CABG for the management of LMCA disease. However, CABG was superior to
DES-PCI in terms of MACCE and need for target vessel revascularization at
one year. Thus, CABG remains the standard of care for the treatment of
LMCA disease. 2012 Wiley Periodicals, Inc.

<12>
Accession Number
70715326
Authors
Banka G. Wu C. Morton J. Garber A.
Institution
(Banka, Wu, Morton, Garber) Stanford School of Medicine, Stanford, CA,
United States
(Banka, Wu, Morton, Garber) University of California Los Angeles, Los
Angeles, CA, United States
Title
Comparative effectiveness analysis of bariatric surgery versus medical
treatment ALONE for patients with BMIS between 30 and 35.
Source
Journal of the American College of Cardiology. Conference: 61th Annual
Scientific Session of the American College of Cardiology and i2 Summit:
Innovation in Intervention, ACC.12 Chicago, IL United States. Conference
Start: 20120324 Conference End: 20120327. Conference Publication:
(var.pagings). 59 (13 SUPPL. 1) (pp E1886), 2012. Date of Publication: 27
Mar 2012.
Publisher
Elsevier USA
Abstract
Background: Bariatric surgery is currently restricted to those with a Body
Mass Index (BMI) >40 kg/m2 or a BMI >35 kg/m2 with obesity related
co-morbidities. However, there is a large population of class 1 obese
individuals (BMIs between 30 to 35 kg/m2) with obesity related
comorbidities. Offering bariatric surgery to these patients may be
cost-effective. Methods: Our goal was to assess the comparative
effectiveness of Laparoscopic Roux-en-Y Gastric Bypass (LARYGB) and
Laparoscopic Gastric Band (LAGB) versus non-surgical treatment for class 1
obese patients with hypertension, diabetes, and hyperlipidemia. We created
a cohort of 46 year-old patients diagnosed with diabetes, hypertension,
hyperlipidemia, and a BMI of 32.5 kg/m2. Quality Adjusted Life Years
(QALYs) were estimated using the United Kingdom Prospective Diabetes Study
(UKPDS) Computer Simulation Model. The inputs for the UKPDS model include
HbA1c, cholesterol, systolic blood pressure, age, and weight. Inputs for
the bariatric surgery treatment group were based on bariatric surgery
metaanalysis in patients with BMI >35. Bariatric surgery trials in
patients with BMI <35 showed that the outcomes were the same or better
than those reported in the meta-analysis in patients with BMI >35. Inputs
for the UKPDS for the medical treatment alone arm were from UKPDS and
Heart Protection studies. Surgery costs were derived from previous
cost-effectiveness studies. Medical treatment costs were assumed to be
driven by diabetes status.Yearly utilities and costs were discounted at a
rate of 3%. A one-way sensitivity analysis was also performed. Results:
The ICER of LAGB compared to the non-surgical cohort was $9092/QALY.
LARYGB was strictly dominated by LAGB in the base-case scenario and in the
one-way sensitivity analysis of LARYGB inputs. The ICER was sensitive to
changes in in BMI, HTN resolution, and cholesterol in the LAGB cohort.
Conclusion: Our study suggests that LAGB is more cost-effective than
LARYGB and medical treatment alone in class 1 obese diabetics with
hypertension and hyperlipidemia. Our results are sensitive to changes in
BMI, hypertension, and cholesterol post surgery.

<13>
Accession Number
70715041
Authors
Savarese G. Paolillo S. Costanzo P. Musella F. Marsico F. Perrone-Filardi
P.
Institution
(Savarese, Paolillo, Costanzo, Musella, Marsico, Perrone-Filardi)
Department of Internal Medicine, Cardiovascular and Immunological
Sciences, Federico II University, Naples, Italy
Title
Does 6-minute walk test predict clinical events in pulmonary arterial
hypertension? A meta-analysis of 22 studies.
Source
Journal of the American College of Cardiology. Conference: 61th Annual
Scientific Session of the American College of Cardiology and i2 Summit:
Innovation in Intervention, ACC.12 Chicago, IL United States. Conference
Start: 20120324 Conference End: 20120327. Conference Publication:
(var.pagings). 59 (13 SUPPL. 1) (pp E1601), 2012. Date of Publication: 27
Mar 2012.
Publisher
Elsevier USA
Abstract
Background: 6-minute walk test (6MWT) is usually used as end-point in
clinical trials to assess the benefit of therapies in patients with
pulmonary arterial hypertension (PAH). The purpose of this study was to
verify whether improvement in 6MWT is associated with reduced incidence of
clinical outcomes in PAH. Methods: the MEDLINE and Cochrane databases, ISI
Web of Science and SCOPUS were searched for articles about PAH treatment
until August 2011. All randomized trials assessing functional capacity by
6MWT at baseline and at end of follow-up and including clinical end-points
(all-cause death, hospitalization for PAH and/or lung or heart-lung
transplantation, initiation of PAH rescue therapy) were included in
meta-analysis. Metaanalysis was performed to assess the influence of
treatments on outcomes. Meta-regression analysis was performed to test the
relationship between 6MWT changes and outcomes. The influence of baseline
patients' characteristics, 6MWT at baseline, Detsky quality score,
follow-up and study publication year were also explored. Macaskill's
modified test was used to assess the presence of publication bias.
Results: 22 trials enrolling 3,112 participants were included. Active
treatments led to significant reduction in the risk of all-cause death
(odds ratio [OR]:0.429; 95% confidence interval [CI]:0.277 to 0.664;
p<0.01), hospitalization for PAH and/or lung or heart-lung transplantation
(OR:0.442; CI:0.309 to 0.632; p<0.01), initiation of PAH rescue therapy
(OR:0.555; CI:0.347 to 0.889; p=0.01) and composite outcome (OR:0.400;
CI:0.313 to 0.510; p<0.01). In meta-regression analysis, no relationship
between 6MWT changes from baseline to end of follow-up and outcomes was
detected. Only baseline 6MWT values influenced the relationship between
changes in 6MWT and hospitalization for PAH and/or lung or heartlung
transplantation that became weakly significant (p=0.042). There was no
heterogeneity among trials included in meta-analysis. No publication bias
was detected. Conclusions: improvement in 6MWT, induced by pharmacological
treatment, does not reflect reduction in clinical outcomes.

<14>
Accession Number
70715036
Authors
Savarese G. Musella F. Carmen D. Cecere M. Losco T. Marciano C. Gargiulo
P. Perrone-Filardi P.
Institution
(Savarese, Musella, Carmen, Cecere, Losco, Marciano, Gargiulo,
Perrone-Filardi) Department of Internal Medicine, Cardiovascular and
Immunological Sciences, Federico II University, Naples, Italy
Title
Do changes in pulmonary hemodynamics predict clinical events in pulmonary
arterial hypertension? A meta-analysis of 17 studies.
Source
Journal of the American College of Cardiology. Conference: 61th Annual
Scientific Session of the American College of Cardiology and i2 Summit:
Innovation in Intervention, ACC.12 Chicago, IL United States. Conference
Start: 20120324 Conference End: 20120327. Conference Publication:
(var.pagings). 59 (13 SUPPL. 1) (pp E1596), 2012. Date of Publication: 27
Mar 2012.
Publisher
Elsevier USA
Abstract
Background: Right heart catheterization remains the gold standard in
diagnosis and evaluation of pulmonary arterial hypertension (PAH). The aim
of this study was to verify whether changes in hemodynamics reflect the
incidence of clinical events in PAH patients. Methods: MEDLINE, Cochrane,
ISI Web of Science and SCOPUS database were searched for articles about
PAH treatment until November 2011. All randomized trials assessing
hemodynamics at baseline and at end of follow-up and including clinical
end-points (all-cause death, hospitalization for PAH and/or lung or
heart-lung transplantation, initiation of PAH rescue therapy) were
included. Meta-analysis was performed to assess the influence of
treatments on outcomes. Meta-regression analysis was performed to test the
relationship between hemodynamics (pulmonary artery pressure, pulmonary
vascular resistance, cardiac index and right atrial pressure) changes and
outcomes. The influence of baseline patients' characteristics,
hemodynamics at baseline, 6-minute walk distance (6MWD), Detsky quality
score, follow-up and study publication year were also explored.
Macaskill's modified test was used to assess the presence of publication
bias. Results: 17 trials enrolling 2,417 participants were included.
Active treatments led to significant reduction in the risk of all-cause
death (odds ratio [OR]: 0.533; 95% confidence interval [CI]: 0.341 to
0.833; p<0.01), hospitalization for PAH and/or lung or heart-lung
transplantation (OR: 0.384; CI: 0.218 to 0.674; p<0.01), initiation of PAH
rescue therapy (OR: 0.341; CI: 0.200 to 0.582; p<0.01) and composite
outcome (OR: 0.368; CI: 0.277 to 0.489; p<0.01). In meta-regression
analysis, no relationship between hemodynamics changes from baseline to
end of follow-up and outcomes was detected. No potential confounding
variable or publication bias was detected. There was no heterogeneity
among trials included in meta-analysis. Changes in pulmonary vascular
resistance correlated with changes in 6MWD (r=-0.63; p<0.01). Conclusions:
in PAH patients, improvement in pulmonary hemodynamics, induced by
pharmacological treatment, does not predict reduction in clinical
outcomes.

<15>
Accession Number
70714890
Authors
Zenati M. Biswas K. Laurie Shroyer A. Quin J. Haime M. Gaziano J.M. Taylor
K. Bhatt D.
Institution
(Zenati, Biswas, Laurie Shroyer, Quin, Haime, Gaziano, Taylor, Bhatt) VA
Boston/Harvard Medical School, Boston, MA, United States
Title
Long-term patency of coronary artery bypass vein grafts harvested
endoscopically: A meta-analysis.
Source
Journal of the American College of Cardiology. Conference: 61th Annual
Scientific Session of the American College of Cardiology and i2 Summit:
Innovation in Intervention, ACC.12 Chicago, IL United States. Conference
Start: 20120324 Conference End: 20120327. Conference Publication:
(var.pagings). 59 (13 SUPPL. 1) (pp E1450), 2012. Date of Publication: 27
Mar 2012.
Publisher
Elsevier USA
Abstract
Background: Failure of saphenous vein grafts (SVG) used in CABG is
associated with increased rates of late major adverse cardiac events:
these include death, myocardial infarction and need for revascularization.
In the last 10 years endoscopic vein harvest (EVH) has become the
preferred method of venous conduit procurement in the United States, due
to the reduced rates of leg wound healing complications. However, sub
analysis from both the PREVENT and ROOBY Trials have identified increased
rates of late (>6 months) SVG failure compared with open vein harvest
(OVH). We report the results of a meta-analysis of the available long-term
SVG patency studies. Methods: A literature search (1996 to 2011)
identified 5 observational studies with angiographically documented
long-term SVG patency (one year in four studies and nine months in one
study) for both EVH and OVH vein grafts used for CABG. SVG failure was
expressed as the combination of angiographic occlusion and severe stenosis
(Fitzgibbon grades B+O). A forest plot was constructed. Results: There
were a total of 6,866 graft assessed by angiography in the five pooled
studies. There was some heterogeneity among the pooled studies (I2 =
63.7%; 95% CI = 0% - 84.1%). Both random (DerSimonian-Laird) and fixed
(Mantel-Haenszel) effects models showed significantly lower graft patency
with EVH. Given the presence of heterogeneity among the studies, the
random effect pooled OR was used to compare EVH with OVH. This showed an
OR of 1.62 (95% CI = 1.22 - 2.15; p = 0.0009). The fixed effect pooled OR
was 1.49 (95% CI = 1.33 - 1.68; p<0.0001). Conclusion: Available evidence
suggests compromised SVG patency when the conduit was harvested with the
EVH technique. A large, multicenter prospective randomized clinical trial
is warranted to more definitively determine the long-term safety and
efficacy of EVH in CABG.

<16>
Accession Number
70714399
Authors
Harrison R. Hasselblad V. Levin R. Mehta R. Harrington R. Alexander J.
Institution
(Harrison, Hasselblad, Levin, Mehta, Harrington, Alexander) Duke Clinical
Research Institute, Durham, NC, United States
Title
Levosimendan reduces mortality in patients with reduced ejection fraction
undergoing cardiac surgery: A meta-analysis of randomized clinical trials.
Source
Journal of the American College of Cardiology. Conference: 61th Annual
Scientific Session of the American College of Cardiology and i2 Summit:
Innovation in Intervention, ACC.12 Chicago, IL United States. Conference
Start: 20120324 Conference End: 20120327. Conference Publication:
(var.pagings). 59 (13 SUPPL. 1) (pp E959), 2012. Date of Publication: 27
Mar 2012.
Publisher
Elsevier USA
Abstract
Background: Left ventricular systolic dysfunction is associated with
increased mortality in patients undergoing cardiac surgery. Levosimendan
has been shown in several small clinical trials to improve outcomes in
cardiac surgery. We performed a meta-analysis of trials investigating
levosimendan in patients with reduced ejection fraction (EF) undergoing
cardiac surgery. Methods: PubMed, Embase, and conference proceedings were
searched for clinical trials of perioperative levosimendan in patients
undergoing cardiac surgery. The company marketing levosimendan (Orion
Pharma) was also contacted regarding unpublished data. Randomized clinical
trials of patients with a mean EF <=40% were included in the analysis. Our
primary endpoint was study reported mortality out to 30 days. Results: 480
abstracts were reviewed. Nine studies, totaling 796 randomized patients,
were included in the analysis. Levosimendan was administered
preoperatively in one study, intraoperatively in five studies, and
postoperatively in three studies. Levosimendan was associated with reduced
morbidity and mortality (see table) as well as a decrease in postoperative
atrial fibrillation (odds ratio 0.35; 95% CI 0.27-0.58). Conclusion:
Levosimendan use was associated with improved morbidity and mortality in
patients with reduced ejection fraction undergoing cardiac surgery. These
data support the need for an adequately powered randomized clinical trial
of levosimendan in this patient population. (Table presented).

<17>
Accession Number
70714179
Authors
Graham E.M. Taylor S.N. Zyblewski S. Wolf B. Bradley S. Hollis B.W.
McGowan F.X. Atz A.
Institution
(Graham, Taylor, Zyblewski, Wolf, Bradley, Hollis, McGowan, Atz) Medical
University of South Carolina, Charleston, SC, United States
Title
Vitamin D status in neonates undergoing cardiac operations: Relationship
to cardiopulmonary bypass and outcomes.
Source
Journal of the American College of Cardiology. Conference: 61th Annual
Scientific Session of the American College of Cardiology and i2 Summit:
Innovation in Intervention, ACC.12 Chicago, IL United States. Conference
Start: 20120324 Conference End: 20120327. Conference Publication:
(var.pagings). 59 (13 SUPPL. 1) (pp E739), 2012. Date of Publication: 27
Mar 2012.
Publisher
Elsevier USA
Abstract
Background: Emerging evidence suggests that altered vitamin D metabolism
has a role in multiple disease processes including ischemiareperfusion and
inflammation. Vitamin D status and its association with outcomes have been
unexplored in children with congenital heart disease or cardiac surgery
and cardiopulmonary bypass (CPB). The objective of this study is to test
two hypotheses: 1) Neonates with congenital heart disease have a high
incidence of vitamin D deficiency that differs by race; 2) Postoperative
outcomes are negatively associated with 25-hydroxyvitamin D [25(OH)D]
levels. Methods: A secondary analysis of a prospective randomized
controlled trial in 70 neonates undergoing cardiac surgery involving CPB
was performed. 25(OH)D levels were collected at 3 time points: in the
operating room prior to skin incision (baseline), at the cessation of CPB
and 24 hours post-operatively. Associations between these levels and
clinical outcomes were explored. Vitamin D deficiency was defined as a
25(OH)D level <20 ng/ml. Results: Mean (standard deviation) levels of
25(OH)D were 14.4 +/- 5.8, 17.0 +/- 4.3 and 14.1 +/- 4.8 ng/ml at the 3
time points respectively. Vitamin D deficiency was present in 84% (59/70)
of these neonates at baseline; concentrations in African-Americans (n =
20) were significantly lower than Caucasian/other (n = 50) (10.2 +/- 4.2
ng/ml vs. 16.0 +/- 5.6 ng/ml, p<0.0001). The 24 hour postoperative 25(OH)D
level correlated with a reduced postoperative inotropic requirement (r =
-0.316, p = 0.008). Conclusion: The unique findings of this study are
3-fold. First, vitamin D deficiency is prevalent in neonates with
congenital cardiac defects, regardless of race. Second, 25(OH)D levels are
not altered by CPB. Third, higher 24 hour postoperative 25(OH)D levels are
associated with a reduction in inotropic requirement in neonates
undergoing cardiac operations with CPB. These findings provide support
that vitamin D may play a role in myocardial injury and postoperative
recovery. The role of vitamin D in postoperative pediatric cardiac
operations warrants further investigation, and supplementation of mothers
and/or newborn infants with congenital heart disease may be in order.

<18>
Accession Number
70714126
Authors
Chatterjee S. Sardar P. Mukherjee D. Lichstein E. Aikat S.
Institution
(Chatterjee, Sardar, Mukherjee, Lichstein, Aikat) Maimonides Medical
Center, Brooklyn, NY, United States
(Chatterjee, Sardar, Mukherjee, Lichstein, Aikat) Gill Heart Institute,
University of Kentucky, Lexington, Lexington, KY, United States
Title
Optimal timing and route of amiodarone for prevention of post operative
atrial fibrillation after cardiac surgery - A network regression
meta-analysis.
Source
Journal of the American College of Cardiology. Conference: 61th Annual
Scientific Session of the American College of Cardiology and i2 Summit:
Innovation in Intervention, ACC.12 Chicago, IL United States. Conference
Start: 20120324 Conference End: 20120327. Conference Publication:
(var.pagings). 59 (13 SUPPL. 1) (pp E686), 2012. Date of Publication: 27
Mar 2012.
Publisher
Elsevier USA
Abstract
Introduction: There is no conclusive agreement on the optimal route or
timing of peri-operative amiodarone administration for prevention of post
operative atrial fibrillation(POAF). We attempted to evaluate if an oral
only regimen was as effective in preventing POAF after cardiac surgery, in
comparison to a regimen that included intravenous (IV) administration also
by a network meta-analysis of available data. We also attempted to assess
if pre-operative administration at least one day prior to surgery was
superior to post-operative prophylaxis (at least one day after
surgery)-and included studies had amiodarone administered from 6 days
before to 1 day after cardiac surgery. Methods: We searched PubMed,
EMBASE,and Cochrane Central Register of Controlled Trials' databases for
randomized controlled trials conducted between 1990 and 2011 that assessed
rates of POAF with amiodarone. The comparator was standard medical
therapy.Event rates were compared using a forest plot of relative risk
using a random effects model (Mantel-Haenszel); and Odd's ratio was
calculated in absence of heterogeneity. Finally an interaction Odd's ratio
was computed to assess efficacy of an oral only regimen compared to one
including intravenous administration. We also looked to assess if
pre-operative amiodarone was superior to post-op prophylaxis. Results:
Twenty three studies (total N = 3,950) met the inclusion-exclusion
criteria. Both regimens of amiodarone improved risk of POAF; oral only RR
0.59 (95% CI 0.49-0.70; p<0.01) and regimen including IV RR 0.57(95% CI
0.43-0.75, p<0.01). The interaction Odd's ratio was 1.17(95% CI 0.72-1.89,
p=0.533).However, pre-operative amiodarone was successful in prevention of
POAF (p<0.01), while post-operative prophylaxis was ineffective (p=0.09).
Univariate regression revealed that benefit of pre-operative amiodarone
was independent of the duration of therapy (p=0.98), beyond initiation 1
day prior to surgery. Conclusions: This systematic review suggests both
regimens are effective in prevention of POAF after cardiac surgery and
that pre-operative amiodarone irrespective of duration was effective in
preventing POAF while post-operative administration was not.

<19>
Accession Number
70713789
Authors
Cerisano G. Buonamici P. Valenti R. Sciagra R. Raspanti S. Carrabba N.
Santini A. Dovellini E.V. Antoniucci D.
Institution
(Cerisano, Buonamici, Valenti, Sciagra, Raspanti, Carrabba, Santini,
Dovellini, Antoniucci) Careggi Hospital, Florence, Italy
Title
Early short-term doxycycline therapy in patients with acute myocardial
infarction and left ventricular dysfunction and the ominous progression to
adverse remodeling (TIPTOP). A randomized controlled trial.
Source
Journal of the American College of Cardiology. Conference: 61th Annual
Scientific Session of the American College of Cardiology and i2 Summit:
Innovation in Intervention, ACC.12 Chicago, IL United States. Conference
Start: 20120324 Conference End: 20120327. Conference Publication:
(var.pagings). 59 (13 SUPPL. 1) (pp E349), 2012. Date of Publication: 27
Mar 2012.
Publisher
Elsevier USA
Abstract
Background: Experimental studies have shown that doxycycline (DOX)
attenuates post-myocardial infarction (MI) remodeling through matrix
metalloproteinase inhibition, and exerts protective effects on myocardial
ischemia/reperfusion injury. We assessed the effect of DOX on left
ventricular (LV) remodeling in patients with acute ST-elevation MI (STEMI)
and moderate LV dysfunction treated with primary coronary intervention
(PCI). Methods: Single-blinded, randomized, phase III trial
(ClinicalTrial.gov Identifier: NCT00469261). Patients with acute STEMI and
LV ejection fraction < 40 % successfully treated with primary PCI and
stenting, were randomly assigned to oral DOX (100 mg at admission and then
100 mg b.i.d. for 7 days) in addition to standard therapy [DOX group] or
to standard care [control group]. Echo LV end-diastolic and end-systolic
volumes index (EDVi and ESVi) were determined at baseline, pre-discharge,
1 and 6 months. 99mTc Sestamibi SPECT infarct size/severity, and coronary
infarct-related artery (IRA) patency were assessed at 6 months. The
primary end-point was echo % LVEDVi (baseline to 6 months). Based on
experimental results, we calculated a sample size of 110 patients (55 per
group), assuming that DOX would reduce % LVEDVi > 50% as compared to
standard therapy, considering an attrition rate of 15%, and a statistical
power of 90% with a type I error <= = .05. The secondary end-point was
scintigraphic infarct size/severity. Results: Out 110 patients enrolled,
97 (88%) completed 6-month echo follow-up (DOX group 51 patients, control
group 46 patients). The 2 groups were well balanced on baseline clinical
and procedural characteristics. IRA patency rate at follow-up was 99% in
the entire patient cohort. At 6 month % LVEDVi was signficantly lower in
DOX group than in control group: - 5 +/- 27% vs + 25 +/- 41%, respectively
(p < .001). Infarct size and severity were inferior in DOX group than in
control group: 10 +/- 12% vs 16 +/- 15%, p = .04, and 0.5 +/- 0.1 vs 0.4
+/- 0.2, p = .01, respectively. Conclusions: In patients with acute STEMI
and LV dysfunction, early short-term DOX therapy was associated with a
lower LV remodeling and smaller infarct size/severity, as compared to
standard therapy.

<20>
Accession Number
70713668
Authors
Genereux P. Head S. Van Mieghem N. Kodali S. Kirtane A. Xu K. Moses J.
Smith C. Serruys P. Kappetein A. Leon M.
Institution
(Genereux, Head, Van Mieghem, Kodali, Kirtane, Xu, Moses, Smith, Serruys,
Kappetein, Leon) Columbia University Medical Center, Cardiovascular
Research Foundation, New York, NY, United States
(Genereux, Head, Van Mieghem, Kodali, Kirtane, Xu, Moses, Smith, Serruys,
Kappetein, Leon) Hopital du Sacre-Coeur de Montreal, Universite de
Montreal, Montreal, Canada
Title
Clinical outcomes after transcatheter aortic valve replacement (TAVR)
using valve academic research consortium (VARC) definitions: A weighted
meta-analysis of 3,519 patients from 17 studies.
Source
Journal of the American College of Cardiology. Conference: 61th Annual
Scientific Session of the American College of Cardiology and i2 Summit:
Innovation in Intervention, ACC.12 Chicago, IL United States. Conference
Start: 20120324 Conference End: 20120327. Conference Publication:
(var.pagings). 59 (13 SUPPL. 1) (pp E228), 2012. Date of Publication: 27
Mar 2012.
Publisher
Elsevier USA
Abstract
Backgrounds: Recently, the published Valve Academic Research Consortium
(VARC) definitions have helped to add uniformity for reporting outcomes
after Transcatheter Aortic Valve Replacement (TAVR). We sought to perform
a weighted meta-analysis to determine rates of major outcomes after TAVR
using VARC definitions and to evaluate their current use in the
literature. Methods: A comprehensive search of multiple electronic
databases from January 1st 2011 through October 12th 2011 was conducted
using predefined criteria. We included studies reporting at least one
outcome using VARC definitions. Results: A total of 17 studies including
3,519 patients met inclusion criteria and were included in the analysis.
The pooled estimate rate of outcomes were determined according to VARC's
definitions: device success: 92.1%, 95%CI [88.7,95.5]; all cause 30-day
mortality: 7.8%, 95%CI [5.5,11.1]; myocardial infarction: 1.1%, 95% CI
[0.2,2.0]; acute kidney injury stage II-III: 7.5%, 95%CI [5.1,11.4]; life
threatening bleeding: 15.6%, 95% CI [11.7,20.7]; major vascular
complication: 11.9%, 95% CI [8.6,16.4]; major stroke 3.2%, 95%CI
[2.1,4.8]; and new permanent pace maker (PPM) implantation: 13.9%, 95% CI
[10.6,18.9]. Medtronic CorevalveTM prosthesis use was associated with a
significant higher rate of PPM implantation compared to the Edwards's
prosthesis (28.9%, 95% CI [23.0,36.0] vs. 4.9%, 95% CI [3.9,6.2], p value
< 0.0001). The 30-day safety composite endpoint rate was 32.7%, 95%CI
[27.5,38.8] and the 1-year total mortality was 22.1%, 95% CI [17.9,26.9].
Conclusion: VARC definitions have already been used by the TAVR clinical
research community, establishing a new standard for reporting clinical
outcomes. Future revisions of the VARC definitions are needed based upon
evolving TAVR clinical experiences.

<21>
Accession Number
70713478
Authors
Shah R. Bhuriya R. Molnar J. Singh M. Shah T. Jawad E. Khosla S.
Institution
(Shah, Bhuriya, Molnar, Singh, Shah, Jawad, Khosla) Rosalind Franklin
University, Chicago Medical Scool, Chicago, IL, United States
Title
Very late stent thrombosis with bare metal stents compared to drug eluting
stents after primary percutaneous coronary intervention for st-segment
elevation myocardial infarction: A meta analysis of prospective clinical
trials.
Source
Journal of the American College of Cardiology. Conference: 61th Annual
Scientific Session of the American College of Cardiology and i2 Summit:
Innovation in Intervention, ACC.12 Chicago, IL United States. Conference
Start: 20120324 Conference End: 20120327. Conference Publication:
(var.pagings). 59 (13 SUPPL. 1) (pp E38), 2012. Date of Publication: 27
Mar 2012.
Publisher
Elsevier USA
Abstract
Background: Controversy persists regarding the incidence of very late
stent thrombosis (VLST) with bare metal stents (BMS) compared to drug
eluting stents (DES) after primary percutaneous coronary intervention
(PCI) for ST-segment elevation myocardial infarction (STEMI). We performed
a meta-analysis of prospective clinical trials comparing this outcome
between BMS and DES. Methods: We performed a systematic literature search
for prospective clinical trials comparing this outcome between BMS and
DES. All prospective clinical trials with a minimum follow up of 2 years
were included. Stent thrombosis was defined as per classification set by
academic research consortium. A two-sided alpha error of less than 0.05
was considered to be statistically significant (p<0.05). Results: We found
9 prospective clinical trials with a follow up of 2-15 years comparing the
effects of DES and BMS in STEMI, enrolling a total of 6854 patients.
Median duration of follow up was 3 years. The studies were homogeneous;
therefore the Mantel-Haenszel fixed-effect model was used to calculate
relative risk (RR). Incidence of very late stent thrombosis was 1.35% in
patients treated with BMS and 2.0% in patients treated with DES with a RR
of 0.50 with 95% CI 0.33-0.76 (P = 0.001). Conclusion: Although the
incidence of very late stent thrombosis after coronary revascularization
is low, drug-eluting stents appear to increase the risk for very late
thrombosis. (Table presented).