EMBASE Cardiac Update AutoAlert: EPICORE Cardiac Surgery Blogger2

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<1>
Accession Number
2015384627
Authors
Liu Y. Petrini M.A.
Institution
(Liu, Petrini) HOPE School of Nursing, Wuhan University, Wuhan, China
Title
Effects of music therapy on pain, anxiety, and vital signs in patients
after thoracic surgery.
Source
Complementary Therapies in Medicine. 23 (5) (pp 714-718), 2015. Date of
Publication: 01 Oct 2015.
Publisher
Churchill Livingstone
Abstract
Objective: To examine the effectiveness of music listening on pain,
anxiety, and vital signs among patients after thoracic surgery in China.
Design and setting: A randomized controlled clinical trial was conducted
in the thoracic surgery department of two tertiary hospitals in Wuhan,
China. 112 patients were recruited and randomly assigned to either
experimental (. n=. 56) or control (. n=. 56) group respectively.
Intervention: The experimental group received standard care and a 30-min
soft music intervention for 3 days, while the control group received only
standard care. Measures include pain, anxiety, vital signs (blood
pressure, heart rate and respiratory rate), patient controlled analgesia,
and diclofenac sodium suppository use. Results: The experimental group
showed statistically significant decrease in pain, anxiety, systolic blood
pressure and heart rate over time compared to the control group, but no
significant difference were identified in diastolic blood pressure,
respiratory rate, patient controlled analgesia and diclofenac sodium
suppository use. Conclusion: The findings provide further evidence to
support the practice of music therapy to reduce postoperative pain and
anxiety, and lower systolic blood pressure and heart rate in patients
after thoracic surgery in China.

<2>
Accession Number
2015380674
Authors
Lee J.M. Jung J.-H. Park K.W. Shin E.-S. Oh S.K. Bae J.-W. Rhew J.Y. Lee
N. Kim D.-B. Kim U. Han J.-K. Lee S.E. Yang H.-M. Kang H.-J. Koo B.-K. Kim
S. Cho Y.K. Shin W.-Y. Lim Y.-H. Rha S.-W. Kim S.-Y. Lee S.Y. Kim Y.-D.
Chae I.-H. Cha K.S. Kim H.-S.
Institution
(Lee, Jung, Park, Han, Lee, Yang, Kang, Koo, Kim) Seoul National
University Hospital, Division of Cardiology, Department of Internal
Medicine, 101 Daehak-ro, Jongro-gu, Seoul 110-744, South Korea
(Shin) University of Ulsan College of Medicine, Division of Cardiology,
Ulsan University Hospital, Ulsan, South Korea
(Oh) Wonkwang University Hospital, Department of Cardiovascular Medicine,
Regional Cardiocerebrovascular Center, Iksan, South Korea
(Bae) Chungbuk National University, Cheongju, South Korea
(Rhew) Presbyterian Medical Center, Department of Internal Medicine and
Cardiovascular Center, Jeonju, South Korea
(Lee) Hallym University Medical Center, Cardiology Division, Kangnam
Sacred Heart Hospital, Seoul, South Korea
(Kim) The Catholic University of Korea, Cardiovascular Center, St. Paul's
Hospital, Seoul, South Korea
(Kim) Yeungnam University Medical Center, Division of Cardiology, Daegu,
South Korea
(Kim) Seoul National University, Cardiovascular Center, Boramae Medical
Center, Seoul, South Korea
(Cho) Keimyung University College of Medicine, Division of Cardiology,
Department of Internal Medicine, Dongsan Medical Center, Daegu, South
Korea
(Shin) Soon Chun Hyang University Hospital Cheonan, Department of
Cardiology, Cheonan, South Korea
(Lim) Hanyang University Medical Center, Division of Cardiology,
Department of Internal Medicine, College of Medicine, Seoul, South Korea
(Rha) Korea University Guro Hospital, Seoul, South Korea
(Kim) Seoul Medical Center, Department of Cardiology, Seoul, South Korea
(Lee) Inje University Ilsan Paik Hospital, Goyang, South Korea
(Kim) Dong-A University Hospital, Department of Cardiology, Busan, South
Korea
(Chae) Seoul National University Bundang Hospital, Seongnam, South Korea
(Cha) Pusan National University Hospital, Department of Cardiology, Busan,
South Korea
Title
Harmonizing Optimal Strategy for Treatment of coronary artery diseases -
comparison of REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS
patients (HOST-REDUCE-POLYTECH-ACS RCT): Study protocol for a randomized
controlled trial.
Source
Trials. 16 (1) , 2015. Article Number: 409. Date of Publication: September
15, 2015.
Publisher
BioMed Central Ltd.
Abstract
Background: Antiplatelet treatment is an important component in optimizing
the clinical outcomes after percutaneous coronary intervention (PCI)
especially in patients with acute coronary syndrome (ACS). Prasugrel,
which is a new P2Y12 inhibitor, has been confirmed as efficacious in a
large trial in Western countries, and a similar trial is also to be
launched in Asian countries. Although a 60-mg loading dose of prasugrel
followed by 10 mg per day should be acceptable, there have been no data
regarding the optimal dose in Asian patients. Furthermore, serum levels of
prasugrel and the rates of platelet inhibition are known to be higher in
Asians than Caucasians with the same dose of the drug. Polymer, a key
component of drug-eluting stents (DES), has been suggested as the cause of
inflammation leading to late complications, and has driven many companies
to develop biodegradable-polymer DES. Currently, there are limited data
regarding the head-to-head comparison between BP-BES and the biostable
polymer CoCr-EES or the newest platinum-chromium everolimus-eluting stent
(PtCr-EES). Furthermore, the polymer issue may be more important in ACS
where there is ruptured thrombotic plaque where polymer-induced
inflammation may affect the local milieu of the stented artery. Therefore,
the present study dedicated only to ACS patients, will offer important
information on the optimal prasugrel dose in the Asian population by
comparing a 10-mg versus a 5-mg maintenance dose beyond 1 month after PCI,
as well as giving important insight into the polymer issue by comparing
BP-BES versus biostable-polymer PtCr-EES. Method/Design: Harmonizing
Optimal Strategy for Treatment of coronary artery diseases - comparison of
REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS patients
(HOST-REDUCE-POLYTECH-ACS) trial is a multicenter, randomized and
open-label clinical study with a 2 x 2 factorial design, according to the
type of stent (PtCr-EES versus BP-BES) and prasugrel maintenance dose (5
mg versus 10 mg), to demonstrate non-inferiority of PtCr-EES relative to
BP-BES or the reduced prasugrel dose relative to conventional dose in an
Asian all-comers PCI population presenting with ACS. Approximately 3400
patients will undergo prospective, random assignment separately to either
stent or prasugrel arm (1:1 ratio, respectively). When the patients have
contraindications to prasugrel, they are categorized into an antiplatelet
observation group after stent-randomization. The primary endpoint is the
patient-oriented composite outcome, which is a composite of all-cause
mortality, any myocardial infarction (MI), any repeat revascularization in
the stent arm at 12 months after index PCI. In the prasugrel arm, primary
endpoint is any major adverse cardiovascular event, which is a composite
of all-cause mortality, any MI, any stent thrombosis (Academic Research
Consortium (ARC)-defined), any repeat revascularization, stroke, or
bleeding (BARC class > 2). Discussion: The HOST-REDUCE-POLYTECH-ACS RCT is
the first study exploring the optimal maintenance dose of prasugrel beyond
1 month after PCI for ACS in Asian all-comers. In addition, this is the
largest study dedicated only to ACS patients to evaluate the polymer issue
in the situation of ACS by directly comparing biostable-polymer PtCr-EES
versus BP-BES.

<3>
Accession Number
2015382334
Authors
Jolly S.S. Cairns J.A. Yusuf S. Meeks B. Gao P. Hart R.G. Kedev S.
Stankovic G. Moreno R. Horak D. Kassam S. Rokoss M.J. Leung R.C.M. El-Omar
M. Romppanen H.O. Alazzoni A. Alak A. Fung A. Alexopoulos D. Schwalm J.D.
Valettas N. Dzavik V.
Institution
(Jolly, Yusuf, Meeks, Gao, Hart, Rokoss, Alazzoni, Alak, Schwalm,
Valettas) Population Health Research Institute, McMaster University,
Hamilton General Hospital, 237 Barton St. East, Hamilton, ON L8L2X2,
Canada
(Cairns) Department of Medicine, University of British Columbia,
Vancouver, BC, Canada
(Kedev) University Clinic of Cardiology, Sts. Cyril and Methodius
University, Skopje, Macedonia
(Stankovic) Clinical Center of Serbia, Department of Cardiology,
University of Belgrade, Belgrade, Serbia
(Moreno) University Hospital la Paz, Madrid, Spain
(Horak) Krajska Nemocnice Liberec, Liberec, Czech Republic
(Kassam) Rouge Valley Health System, Toronto, ON, Canada
(Leung) CK Hui Heart Centre, Edmonton, AB, Canada
(El-Omar) Central Manchester Foundation Trust, Manchester Academic Health
Science Centre, Manchester, United Kingdom
(Romppanen) Heart Centre, Kuopio University Hospital, Kuopio, Finland
(Fung) Division of Cardiology, Vancouver General Hospital, University of
British Columbia, Vancouver, BC, Canada
(Alexopoulos) Patras University Hospital, Patras, Greece
(Dzavik) Peter Munk Cardiac Centre, University Health Network, Toronto,
ON, Canada
Title
Stroke in the TOTAL trial: A randomized trial of routine thrombectomy vs.
percutaneous coronary intervention alone in ST elevation myocardial
infarction.
Source
European Heart Journal. 36 (35) (pp 2364-2372), 2015. Date of Publication:
14 Sep 2015.
Publisher
Oxford University Press
Abstract
Aims TOTAL (N = 10 732), a randomized trial of routine manual thrombectomy
vs. percutaneous coronary intervention alone in ST elevation myocardial
infarction, showed no difference in the primary efficacy outcome but a
significant increase in stroke. We sought to understand these findings.
Methods and results A detailed analysis of stroke timing, stroke severity,
and stroke subtype was performed. Strokes were adjudicated by neurologists
blinded to treatment assignment. Stroke within 30 days, the primary safety
outcome, was increased [33 (0.7%) vs. 16 (0.3%), hazard ratio (HR) 2.06;
95% confidence interval (CI) 1.13-3.75]. The difference in stroke was
apparent within 48 h [15 (0.3%) vs. 5 (0.1%), HR 3.00; 95% CI 1.09-8.25].
There was an increase in strokes within 180 days with minor or no
disability (Rankin 0-2) [18 (0.4%) vs. 13 (0.3%) HR 1.38; 95% CI
0.68-2.82] and in strokes with major disability or fatal (Rankin 3-6) [35
(0.7%) vs. 13 (0.3%), HR 2.69; 95% CI 1.42-5.08]. Most of the absolute
difference was due to an increase in ischaemic strokes within 180 days [37
(0.7%) vs. 21 (0.4%), HR 1.71; 95% CI 1.03-3.00], but there was also an
increase in haemorrhagic strokes [10 (0.2%) vs. 2 (0.04%), HR 4.98; 95% CI
1.09-22.7]. Patients that had a stroke had a mortality of 30.8% within 180
days vs. 3.4% without a stroke (P < 0.001). A meta-analysis of randomized
trials (N = 21 173) showed an increase in risk of stroke (odds ratio 1.59;
95% CI 1.11-2.27) but a trend towards reduction in mortality odds ratio
(odds ratio 0.87; 95% CI 0.76-1.00). Conclusion Thrombectomy was
associated with a significant increase in stroke. Based on these findings,
future trials must carefully collect stroke to determine safety in
addition to efficacy.

<4>
Accession Number
2015379412
Authors
Nombela-Franco L. Eltchaninoff H. Zahn R. Testa L. Leon M.B. Trillo-Nouche
R. Donofrio A. Smith C.R. Webb J. Bleiziffer S. De Chiara B. Gilard M.
Tamburino C. Bedogni F. Barbanti M. Salizzoni S. Del Blanco B.G. Sabate M.
Moreo A. Fernandez C. Ribeiro H.B. Amat-Santos I. Urena M. Allende R.
Garcia E. Macaya C. Dumont E. Pibarot P. Rodes-Cabau J.
Institution
(Nombela-Franco, Ribeiro, Amat-Santos, Urena, Allende, Dumont, Pibarot,
Rodes-Cabau) Quebec Heart and Lung Institute, 2725 cheminSte-Foy, Quebec
City, QC G1V 4G5, Canada
(Nombela-Franco, Fernandez, Garcia, Macaya) Cardiovascular Institute,
Hospital Clinico San Carlos, Madrid, Spain
(Eltchaninoff) Cardiology Department, Charles Nicolle Hospital, University
of Rouen, Rouen, France
(Zahn) Abteilung fur Kardiologie, Herzzentrum Ludwigshafen, Ludwigshafen,
Germany
(Testa, Bedogni) Cardiology Department, Instituto Clinico S. Ambrogio,
Milan, Italy
(Leon, Smith) Columbia University, Medical Center, New York-Presbyterian
Hospital, New York, United States
(Trillo-Nouche) Hospital Universitario de Santiago Compostela, A Coruna,
Spain
(Donofrio) Division of Cardiac Surgery, University of Padova, Padova,
Italy
(Webb) St. Paul's Hospital, University of British Columbia, Vancouver, BC,
Canada
(Bleiziffer) German Heart Center, Munich, Germany
(De Chiara, Moreo) Cardiology Department, Niguarda Ca' Granda Hospital,
Milan, Italy
(Gilard) Department of Cardiology, La Cavale Blanche Hospital, Brest,
France
(Tamburino, Barbanti) Ferrarotto Hospital, Catania, Italy
(Salizzoni) Department of Surgical Sciences Torino, Citta della Salute e
della Scienza Hospital, Molinette, Torino, Italy
(Del Blanco) Department of Cardiology, Vall d'Hebron University Hospital,
Barcelona, Spain
(Sabate) Cardiology Department, Hospital Clinic de Barcelona, IDIBAPS,
Barcelona, Spain
Title
Clinical impact and evolution of mitral regurgitation following
transcatheter aortic valve replacement: A meta-analysis.
Source
Heart. 101 (17) (pp 1395-1405), 2015. Date of Publication: 01 Sep 2015.
Publisher
BMJ Publishing Group
Abstract
Objectives: Mitral regurgitation (MR) is a common entity in patients with
aortic stenosis undergoing transcatheter aortic valve replacement (TAVR),
but its influence on outcomes remains controversial. The purpose of this
metaanalysis was to assess the clinical impact of and changes in
significant (moderate-severe) MR in patients undergoing TAVR, overall and
according to valve design (self-expandable (SEV) vs balloon-expandable
(BEV)). Methods: All national registries and randomised trials were pooled
using meta-analytical guidelines to establish the impact of
moderate-severe MR on mortality after TAVR. Studies reporting changes in
MR after TAVR on an individual level were electronically searched and used
for the analysis. Results: Eight studies including 8015 patients (SEV:
3474 patients; BEV: 4492 patients) were included in the analysis. The
overall 30-day and 1-year mortality was increased in patients with
significant MR (OR 1.49, 95% CI 1.16 to 1.92; HR 1.32, 95% CI 1.12 to
1.55, respectively), but a significant heterogeneity across studies was
observed (p<0.05). The impact of MR on mortality was not different between
SEV and BEV in meta-regression analysis for 30-day (p=0.360) and 1-year
(p=0.388) mortality. Changes in MR over time were evaluated in nine
studies including 1278 patients. Moderate-severe MR (SEV: 326 patients;
BEV: 192 patients) improved in 50.5% of the patients at a median follow-up
of 180 (30-360) days after TAVR, and the degree of improvement was greater
in patients who had received a BEV (66.7% vs 40.8% in the SEV group,
p=0.001). Conclusions: Concomitant moderate-severe MR was associated with
increased early and late mortality following TAVR. A significant
improvement in MR severity was detected in half of the patients following
TAVR, and the degree of improvement was greater in those patients who had
received a BEV.

<5>
Accession Number
2015378912
Authors
Kang D.-H. Jang J.Y. Park S.-J. Kim D.-H. Yun S.-C. Song J.-M. Park S.W.
Chung C.-H. Song J.-K. Lee J.-W.
Institution
(Kang, Jang, Kim, Song, Song) Division of Cardiology, ASAN Medical Center,
College of Medicine, University of Ulsan, Seoul, South Korea
(Park, Park) Division of Cardiology, Samsung Medical Center, Sungkyunkwan
University, School of Medicine, Seoul, South Korea
(Yun) Division of Biostatistics, ASAN Medical Center, College of Medicine,
University of Ulsan, Seoul, South Korea
(Chung, Lee) Division of Cardiac Surgery, ASAN Medical Center, College of
Medicine, University of Ulsan, Seoul, South Korea
Title
Watchful observation versus early aortic valve replacement for symptomatic
patients with normal flow, low-gradient severe aortic stenosis.
Source
Heart. 101 (17) (pp 1375-1381), 2015. Date of Publication: 01 Sep 2015.
Publisher
BMJ Publishing Group
Abstract
Objectives: The timing of aortic valve replacement (AVR) remains
controversial in symptomatic patients with normal flow, low-gradient
severe aortic stenosis (AS) and preserved LVEF. We sought to compare
long-term mortality of early AVR versus a watchful observation strategy.
Methods: From 2000 to 2011, we prospectively evaluated 284 consecutive
symptomatic patients (136 men, age 68+/-10 years) with normal flow,
low-gradient severe AS and preserved LVEF who were potential candidates
for early AVR. Normal flow, low-gradient severe AS was defined as indexed
aortic valve area <0.6 cm²/m² with mean gradient <40
mm Hg and stroke volume index >35 mL/m². Early AVR was
performed on 98 patients (early AVR group), while the watchful observation
strategy was selected for 186 patients (watchful observation group).
Patients in the watchful observation group were referred for AVR if mean
gradient was >40 mm Hg during follow-up. Results: There were no
significant differences between the early AVR and the watchful observation
groups for the risk of overall mortality (HR 0.94 for the early AVR; 95%
CI 0.51 to 1.73) or for the estimated actuarial 8-year mortality rates
(17+/-5% vs 27+/-5%, p=0.84) in the overall cohort. Society of Thoracic
Surgeons score, comorbidity index, age, coronary artery disease, aetiology
of AS and performance of AVR were associated with overall survival. For 83
propensity-score-matched pairs, the risk of overall death was not
significantly different between the two groups (HR 1.13 for the early AVR,
95% CI 0.55 to 2.35, p=0.74). Conclusions: Early AVR and watchful
observation strategy show similar survival in symptomatic patients with
normal flow, low-gradient severe AS and preserved LVEF. Watchful
observation with timely performance of AVR should be considered a
therapeutic option.

<6>
Accession Number
2015378527
Authors
Kowalewski M. Schulze V. Berti S. Waksman R. Kubica J. Kolodziejczak M.
Buffon A. Suryapranata H. Gurbel P.A. Kelm M. Pawliszak W. Anisimowicz L.
Navarese E.P.
Institution
(Kowalewski, Pawliszak, Anisimowicz) Department of Cardiac Surgery, Dr
Antoni Jurasz Memorial University Hospital in Bydgoszcz, Bydgoszcz, Poland
(Kowalewski, Schulze, Berti, Kubica, Kolodziejczak, Kelm, Navarese)
Systematic Investigation and Research on Interventions and Outcomes
(SIRIO), MEDICINE Research Network, Dusseldorf, Germany
(Schulze, Kelm, Navarese) Department of Internal Medicine, Division of
Cardiology, Pulmonology and Vascular Medicine, Heinrich-Heine-University,
Moorenstr. 5, Dusseldorf 40225, Germany
(Berti) Department of Invasive Cardiology, Institute of Clinical
Physiology, National Research Council, Pisa, Italy
(Waksman) MedStar Washington Hospital Center, Washington, DC, United
States
(Kubica, Kolodziejczak) Department of Cardiology and Internal Medicine,
Nicolaus Copernicus University in Torun, Collegium Medicum in Bydgoszcz,
Bydgoszcz, Poland
(Buffon) Department of Cardiovascular Sciences, Catholic University of the
Sacred Heart, Rome, Italy
(Suryapranata) Department of Cardiology, Radboud University, Nijmegen
Medical Center, Nijmegen, Netherlands
(Gurbel) Sinai Center for Thrombosis Research, Sinai Hospital of
Baltimore, Baltimore, MD, United States
Title
Complete revascularisation in ST-elevation myocardial infarction and
multivessel disease: Meta-analysis of randomised controlled trials.
Source
Heart. 101 (16) (pp 1309-1317), 2015. Date of Publication: 01 Aug 2015.
Publisher
BMJ Publishing Group
Abstract
Background: Current guidelines recommend culpritonly revascularisation
(COR) in haemodynamically stable patients with ST-segment elevation
myocardial infarction (STEMI) and multivessel (MV) disease. Contrarily,
growing body of evidence available from recent randomised controlled
trials (RCTs) demonstrates improved outcomes with complete MV-percutaneous
coronary intervention (PCI). Methods and results: We performed a
meta-analysis of RCTs comparing complete MV-PCI with non-complete MV-PCI
in STEMI and MV disease. Complete MV-PCI was defined as revascularisation
to non-infarct-related artery lesions during index procedure, non-complete
MVPCI-encompassed COR and staged approaches. Multiple databases and
congress proceedings from major cardiovascular societies' meetings were
screened for relevant studies. Primary endpoint was the composite of major
adverse cardiac events (MACE) typically defined as death, recurrent
myocardial infarction (MI) and repeat revascularisation. Secondary
endpoints were cardiovascular mortality, recurrent MI and repeat
revascularisation. Outcomes were analysed at longest available follow-up
with differences accounted for with adjusted models by person-years. Seven
RCTs (N=1303) were included. The median follow-up was 12 months. Complete
MV-PCI reduced the odds of MACE compared with non-complete MV-PCI (OR (95%
CIs) 0.59 (0.36 to 0.97), p=0.04) driven by reduction in recurrent MI
(0.48 (0.27 to 0.85), p=0.01) and repeat revascularisation (0.51 (0.31 to
0.84), p=0.008). Complete MV-PCI was associated with a non-significant
trend towards reduced cardiovascular mortality (0.54 (0.26 to 1.10),
p=0.09) as well. In a sensitivity analysis, none of the baseline clinical
variables significantly influenced overall estimates. Conclusions: In
STEMI and MV disease, complete MVPCI as compared with non-complete
strategy reduces MACE by 41%, driven by a 52% reduction in recurrent MI
and 49% reduction in repeat revascularisation.

<7>
Accession Number
2015376762
Authors
Wu J. Xie F. Lof J. Sayyed S. Porter T.R.
Institution
(Wu) Department of Cardiology, Nanfang Hospital, Southern Medical
University, Guangzhou, China
(Xie, Lof, Sayyed, Porter) Division of Cardiology, University of Nebraska,
Medical Center, 982265 Nebraska Medical Center, Omaha, NE 68198-2265,
United States
Title
Utilization of modified diagnostic ultrasound and microbubbles to reduce
myocardial infarct size.
Source
Heart. 101 (18) (pp 1468-1474), 2015. Date of Publication: 01 Sep 2015.
Publisher
BMJ Publishing Group
Abstract
Objective: We sought to determine whether guided high mechanical index
(MI) impulses from a diagnostic ultrasound transducer during an
intravenous microbubble infusion could augment low-dose fibrinolytic
therapy in treating acute myocardial infarction (ST segment elevation
myocardial infarction, STEMI). Methods: Acute thrombotic occlusions of the
left anterior descending were created in 32 atherosclerotic pigs. Fourteen
historical control pigs received half dose of tissue plasminogen activator
alone (half tPA), while the subsequent 18 were randomised to (a) 1.0 mg/kg
tPA (full-dose tPA); (b) low-dose tPA (0.5 mg/kg) and an intravenous
microbubble infusion where guided transthoracic high MI impulses were
applied intermittently to the risk area (guided high MI/half tPA) or (c)
guided high MI impulses and microbubbles alone (guided high MI alone).
Angiographic recanalisation, ST segment resolution and wall thickening
(WT) at 60 min were compared between all pigs, while indexed infarct size
at 48 h was compared in the 18 randomised pigs. Results: Recanalisation
rates improved from 36% for half dose tPA alone to 83% with the addition
of guided high MI impulses, while it was 50% for full-dose tPA and guided
high MI alone. WT recovery within the risk area following treatment was
highest for guided high MI/half tPA (p=0.007 compared with full-dose tPA;
ANOVA), and indexed infarct size was lowest (p<0.05 compared to full-dose
tPA). Conclusions: Guided high MI-induced microbubble cavitation from a
diagnostic transducer added to lowdose tPA can immediately improve
regional function and reduce infarct size in acute STEMI. Trial
registration number: Clinical Trials.gov NCT02170103.

<8>
Accession Number
2015193937
Authors
Gianos E. Schoenthaler A. Mushailov M. Fisher E.A. Berger J.S.
Institution
(Gianos, Mushailov, Fisher, Berger) Department of Medicine, Division of
Cardiology, Center for the Prevention of Cardiovascular Disease, New York
University School of Medicine, 530 First Avenue, Schwartz HCC 4, New York,
NY 10016, United States
(Fisher, Berger) Marc and Ruti Bell Program in Vascular Biology, New York
University School of Medicine, New York, NY, United States
(Schoenthaler) Department of Population Health, Center for Healthful
Behavioral Change, New York University School of Medicine, New York, NY,
United States
Title
Rationale and design of the Investigation of Motivational Interviewing and
Prevention Consults to Achieve Cardiovascular Targets (IMPACT) trial.
Source
American Heart Journal. 170 (3) (pp 430-437.e9), 2015. Date of
Publication: 01 Sep 2015.
Publisher
Mosby Inc.
Abstract
Background Patients undergoing cardiovascular procedures remain at
increased risk for myocardial infarction, stroke, and cardiovascular
death. Risk factor control in this patient population remains suboptimal
and would likely benefit from strategies targeting education, lifestyle,
and healthy behaviors. Design The IMPACT trial is a 400-subject
prospective randomized trial designed to compare different cardiovascular
prevention strategies in subjects following a cardiovascular intervention.
The trial began enrollment in the Spring of 2012 and is randomizing
subjects in a 1:1:1 manner to usual care, a one-time cardiovascular
prevention consult, or a one-time cardiovascular prevention consult plus
behavioral intervention program (telephone-based motivational interviewing
and tailored text messages) over a 6-month period. The primary end point
is non-high-density lipoprotein cholesterol. Secondary end points include
other plasma lipid values, metabolic risk, smoking cessation, physical
activity, dietary intake, medication use and adherence, and quality of
life. Conclusions The IMPACT trial provides data on different management
strategies for risk factor optimization in subjects following
cardiovascular procedures. The results will provide a platform for the
continued development of novel multidisciplinary interventions in this
high-risk population.

<9>
Accession Number
2015117257
Authors
Johansson P.I. Rasmussen A.S. Thomsen L.L.
Institution
(Johansson, Rasmussen) Department of Clinical Immunology, Rigshospitalet,
Copenhagen University Hospital, Copenhagen, Denmark
(Thomsen) Pharmacosmos A/S, Holbaek, Denmark
Title
Intravenous iron isomaltoside 1000 (Monofer) reduces
postoperative anaemia in preoperatively non-anaemic patients undergoing
elective or subacute coronary artery bypass graft, valve replacement or a
combination thereof: A randomized double-blind placebo-controlled clinical
trial (the PROTECT trial).
Source
Vox Sanguinis. 109 (3) (pp 257-266), 2015. Date of Publication: 01 Oct
2015.
Publisher
Blackwell Publishing Ltd
Abstract
Background and Objectives: This trial explores whether intravenous iron
isomaltoside 1000 (Monofer) results in a better regeneration of
haemoglobin levels and prevents anaemia compared to placebo in
preoperative non-anaemic patients undergoing cardiac surgery. Study Design
and Methods: The trial is a prospective, double-blind, comparative,
placebo-controlled trial of 60 non-anaemic patients undergoing cardiac
surgery. The patients were randomized 1:1 to either 1000 mg intravenous
iron isomaltoside 1000 administered perioperatively by infusion or
placebo. Results: Mean preoperative haemoglobin in the active treatment
group was 143 g/dl vs. 140 g/dl in the placebo group. At discharge 5 days
after surgery, haemoglobin levels were reduced to 107 and 105 g/dl,
respectively. One month after surgery, haemoglobin concentration had
increased to an average of 126 g/dl vs. 118 g/dl (p = 0012) and
significantly more patients were non-anaemic in the intravenous iron
isomaltoside 1000-treated group compared to the placebo group (385% vs.
80%; p = 0019). There were no differences in side-effects between the
groups. Conclusion: A single perioperative 1000 mg dose of intravenous
iron isomaltoside 1000 significantly increased the haemoglobin level and
prevented anaemia 4 weeks after surgery, with a short-term safety profile
similar to placebo. Future trials on potential clinical benefits of
preoperative treatment with intravenous iron in non-anaemic patients are
needed.

<10>
Accession Number
2015371539
Authors
Bonvini J.M. Beck-Schimmer B. Kuhn S.J. Graber S.M. Neff T.A. Schlapfer M.
Institution
(Bonvini, Beck-Schimmer, Kuhn, Schlapfer) Institute of Anesthesiology,
University Hospital Zurich, Raemistrasse 100, Zurich 8091, Switzerland
(Beck-Schimmer, Schlapfer) Zurich Center for Integrative Human Physiology,
Institute of Physiology, University of Zurich, Winterthurerstrasse 190,
Zurich 8057, Switzerland
(Beck-Schimmer) Department of Anesthesiology, University of Illinois
College of Medicine at Chicago, 1740 West Taylor Street, Chicago, IL
60612, United States
(Graber) Antropological Institute and Museum, University of Zurich,
Winterthurerstrasse 190, Zurich 8057, Switzerland
(Neff) Department of Anesthesia and Intensive Care Medicine, Cantonal
Hospital of Muensterlingen, Campus 1, Muensterlingen 8596, Switzerland
Title
Late post-conditioning with sevoflurane after cardiac surgery - Are
surrogate markers associated with clinical outcome?.
Source
PLoS ONE. 10 (7) , 2015. Article Number: e0132165. Date of Publication: 21
Jul 2015.
Publisher
Public Library of Science
Abstract
Introduction In a recent randomized controlled trial our group has
demonstrated in 102 patients that late post-conditioning with sevoflurane
performed in the intensive care unit after surgery involving
extracorporeal circulation reduced damage to cardiomyocytes exposed to
ischemia reperfusion injury. On the first post-operative day the
sevoflurane patients presented with lower troponin T values when compared
with those undergoing propofol sedation. In order to assess possible
clinical relevant long-term implications in patients enrolled in this
study, we performed the current retrospective analysis focusing on cardiac
and non-cardiac events during the first 6 months after surgery. Methods
All patients who had successfully completed the late post-conditioning
trial were included into this follow-up. Our primary and secondary
endpoints were the proportion of patients experiencing cardiac and
non-cardiac events, respectively. Additionally, we were interested in
assessing therapeutic interventions such as initiation or change of drug
therapy, interventional treatment or surgery. Results Of 102 patients
analyzed in the primary study 94 could be included in this follow-up. In
the sevoflurane group (with 41 patients) 16 (39%) experienced one or
several cardiac events within 6 months after cardiac surgery, in the
propofol group (with 53 patients) 19 (36%, p=0.75). Four patients (9%)
with sevoflurane vs. 7 (13%) with propofol sedation had non-cardiac events
(p=0.61). While a similar percentage of patients suffered from cardiac
and/or non-cardiac events, only 12 patients in the sevoflurane group
compared to 20 propofol patients needed a therapeutic intervention (OR:
0.24, 95% CI: 0.04-1.43, p=0.12). A similar result was found for hospital
admissions: 2 patients in the sevoflurane group had to be re-admitted to
the hospital compared to 8 in the propofol group (OR 0.23, 95% CI: 0.04-
1.29, p=0.10). Conclusions Sevoflurane does not seem to provide protection
with regard to the occurrence of cardiac and non-cardiac events in the
6-month period following cardiac surgery with the use of extracorporeal
circulation. However, there was a clear trend towards fewer interventions
(less need for treatment, fewer hospital admissions) associated with
sevoflurane post-conditioning in patients experiencing any event. Such
results might encourage launching large multicenter post-conditioning
trials with clinical outcome defined as primary endpoint.

<11>
Accession Number
2015359629
Authors
McNally J.D. O'Hearn K. Lawson M.L. Maharajh G. Geier P. Weiler H. Redpath
S. McIntyre L. Fergusson D. Menon K.
Institution
(McNally, Lawson, Geier, Redpath, Menon) Faculty of Medicine, University
of Ottawa, Children's Hospital of Eastern Ontario, Department of
Pediatrics, Ottawa, Canada
(McNally, O'Hearn, Lawson, Geier, Menon) Children's Hospital of Eastern
Ontario, Research Institute, 401 Smyth Road, Ottawa, ON K1H 8L1, Canada
(Maharajh) Division of Cardiovascular Surgery, University of Ottawa,
Ottawa, Canada
(Weiler) School of Dietetics and Human Nutrition, McGill University,
Montreal, QC, Canada
(McIntyre) University of Ottawa, Department of Medicine (Division of
Critical Care), Ottawa Hospital Research Institute (OHRI), Ottawa, ON,
Canada
(Fergusson) Ottawa Hospital Research Institute (OHRI), University of
Ottawa, Department of Epidemiology and Community Medicine, Ottawa, ON,
Canada
Title
Prevention of vitamin D deficiency in children following cardiac surgery:
study protocol for a randomized controlled trial.
Source
Trials. 16 (1) , 2015. Article Number: 402. Date of Publication: September
09, 2015.
Publisher
BioMed Central Ltd.
Abstract
Background: Vitamin D is a pleiotropic hormone important for the recovery
of organ systems after critical illness. Recent observational studies have
suggested that three out of every four children are vitamin D deficient
following cardiac surgery, with inadequate preoperative intake and
surgical losses playing important contributory roles. Observed
associations between postoperative levels, cardiovascular dysfunction and
clinical course suggest that perioperative optimization of vitamin D
status could improve outcome. With this two-arm, parallel, double blind,
randomized controlled trial (RCT), we aim to compare immediate
postoperative vitamin D status in children requiring cardiopulmonary
bypass for congenital heart disease who receive preoperative daily high
dose vitamin D supplementation (high-dose arm) with those who receive
usual intake (low-dose arm). Methods/Design: Eligibility requirements
include age (>36 weeks, <18 years) and a congenital heart defect requiring
cardiopulmonary bypass surgical correction. Enrollment of 62 participants
will take place at a single Canadian tertiary care center over a period of
2 years. Children randomized to the high-dose group will receive age-based
dosing that was informed by the Institute of Medicine (IOM) daily
tolerable upper intake level (<1 year old = 1,600 IU/day, >1 year old =
2,400 IU/day). Children in the low-dose arm will receive usual care based
on IOM recommendations (<1 year old = 400 IU, >1 year old = 600 IU). The
primary outcome measure is immediate postoperative vitamin D status, using
blood 25(OH)D. Discussion: Maintaining adequate postoperative vitamin D
levels following surgery could represent an effective therapy to speed
recovery following CHD surgery. The proposed research project will
determine whether preoperative supplementation with a dosing regimen based
on the IOM recommended daily upper tolerable intake will prevent
postoperative vitamin-D deficiency in the majority of children. The
results will then be used to inform the design of a large international
RCT exploring whether preoperative optimization of vitamin D status might
improve short and long-term outcomes in this vulnerable population. Trial
Registration: Clinicaltrials.gov Identifier - NCT01838447Date of
registration: 11 April 2013

<12>
Accession Number
2015229737
Authors
Tie H.-T. Shi R. Li Z.-H. Zhang M. Zhang C. Wu Q.-C.
Institution
(Tie, Zhang, Zhang, Wu) Department of Cardiothoracic Surgery, First
Affiliated Hospital of Chongqing Medical University, No. 1, Youyi Road,
Yuanjiagang, Yuzhong District, Chongqing 400016, China
(Shi) Department of Cardiology, First Affiliated Hospital of Chongqing
Medical University, Chongqing 400016, China
(Li) First College of Clinical Medicine, Chongqing Medical University,
Chongqing 400016, China
Title
Risk of major adverse cardiovascular events in patients with metabolic
syndrome after revascularization: A meta-analysis of eighteen cohorts with
18457 patients.
Source
Metabolism: Clinical and Experimental. 64 (10) (pp 1224-1234), 2015. Date
of Publication: 01 Oct 2015.
Publisher
W.B. Saunders
Abstract
Objective To provide a comprehensive evaluation of the association between
metabolic syndrome (MetS) and major adverse cardiovascular events (MACE)
and to clarify the effect of revascularization methods among them in
patients with coronary artery disease (CAD) undergoing successful
revascularization. Methods PubMed and Embase databases were searched.
Cohort studies evaluating the association between MetS and risk of MACE
and providing the hazard ratio (HR) with 95% confidence interval (CI) or
sufficient data to calculate HR and its 95%CI among patients after
revascularization were included. The pooled estimates were performed by
using a random-effects model despite heterogeneity. Subgroup and
sensitivity analyses were also conducted adherence to guidelines. Results
Eighteen trials with 18457 patients were included. Overall, MetS was
associated with significant increased risks of MACE (HR 1.47, 95%CI
1.26-1.72, I² = 46.4%, P<inf>H</inf> = 0.016, P < 0.001) and
all-cause mortality (HR 1.58, 95%CI 1.29-1.92, I² = 45.6%,
P<inf>H</inf> = 0.075, P < 0.001) in CAD patients received
revascularization. The results remained stable and robust in our subgroup
analysis. However, no significant increased risk of MACE or all-cause
mortality was found in patients undergoing coronary artery bypass graft
(CABG) or drug-eluting stent (DES) in the sensitivity analysis. Conclusion
MetS was associated with increased risks of MACE and all-cause mortality
in patients after revascularization, but not in patients receiving CABG or
DES. Therefore, prevention and treatment of MetS are extremely necessary
in patients undergoing revascularization. Moreover, CABG and DES should be
recommended for CAD patients with MetS and future researches are still
warranted.

<13>
Accession Number
2015150480
Authors
Davey C. Zoumot Z. Jordan S. McNulty W.H. Carr D.H. Hind M.D. Hansell D.M.
Rubens M.B. Banya W. Polkey M.I. Shah P.L. Hopkinson N.S.
Institution
(Davey, Zoumot, Jordan, McNulty, Carr, Hind, Hansell, Rubens, Banya,
Polkey, Shah, Hopkinson) NIHR Respiratory Disease, Biomedical Research
Unit, Royal Brompton and Harefield NHS Foundation Trust, Imperial College
London, London, United Kingdom
Title
Bronchoscopic lung volume reduction with endobronchial valves for patients
with heterogeneous emphysema and intact interlobar fissures (the
BeLieVeR-HIFi study): A randomised controlled trial.
Source
The Lancet. 386 (9998) (pp 1066-1073), 2015. Date of Publication: 12 Sep
2015.
Publisher
Lancet Publishing Group
Abstract
Background Lung volume reduction surgery improves survival in selected
patients with emphysema, and has generated interest in bronchoscopic
approaches that might achieve the same effect with less morbidity and
mortality. Previous trials with endobronchial valves have yielded modest
group benefits because when collateral ventilation is present it prevents
lobar atelectasis. Methods We did a single-centre, double-blind
sham-controlled trial in patients with both heterogeneous emphysema and a
target lobe with intact interlobar fissures on CT of the thorax. We
enrolled stable outpatients with chronic obstructive pulmonary disease who
had a forced expiratory volume in 1 s (FEV<inf>1</inf>) of less than 50%
predicted, significant hyperinflation (total lung capacity >100% and
residual volume >150%), a restricted exercise capacity (6 min walking
distance <450 m), and substantial breathlessness (MRC dyspnoea score 3).
Participants were randomised (1:1) by computer-generated sequence to
receive either valves placed to achieve unilateral lobar occlusion
(bronchoscopic lung volume reduction) or a bronchoscopy with sham valve
placement (control). Patients and researchers were masked to treatment
allocation. The study was powered to detect a 15% improvement in the
primary endpoint, the FEV<inf>1</inf> 3 months after the procedure.
Analysis was on an intention-to-treat basis. The trial is registered at
controlled-trials.com, ISRCTN04761234. Findings 50 patients (62% male,
FEV<inf>1</inf> [% predicted] mean 317% [SD 102]) were enrolled to receive
valves (n=25) or sham valve placement (control, n=25) between March 1,
2012, and Sept 30, 2013. In the bronchoscopic lung volume reduction group,
FEV<inf>1</inf> increased by a median 877% (IQR 227-3585) versus 288%
(0-851) in the control group (Mann-Whitney p=00326). There were two deaths
in the bronchoscopic lung volume reduction group and one control patient
was unable to attend for follow-up assessment because of a prolonged
pneumothorax. Interpretation Unilateral lobar occlusion with endobronchial
valves in patients with heterogeneous emphysema and intact interlobar
fissures produces significant improvements in lung function. There is a
risk of significant complications and further trials are needed that
compare valve placement with lung volume reduction surgery. Funding
Efficacy and Mechanism Evaluation Programme, funded by the Medical
Research Council (MRC) and managed by the National Institute for Health
Research (NIHR) on behalf of the MRC-NIHR partnership.

<14>
Accession Number
2015370114
Authors
Cung T.-T. Morel O. Cayla G. Rioufol G. Garcia-Dorado D. Angoulvant D.
Bonnefoy-Cudraz E. Guerin P. Elbaz M. Delarche N. Coste P. Vanzetto G.
Metge M. Aupetit J.-F. Jouve B. Motreff P. Tron C. Labeque J.-N. Steg P.G.
Cottin Y. Range G. Clerc J. Claeys M.J. Coussement P. Prunier F. Moulin F.
Roth O. Belle L. Dubois P. Barragan P. Gilard M. Piot C. Colin P. De Poli
F. Morice M.-C. Ider O. Dubois-Rande J.-L. Unterseeh T. Le Breton H. Beard
T. Blanchard D. Grollier G. Malquarti V. Staat P. Sudre A. Elmer E.
Hansson M.J. Bergerot C. Boussaha I. Jossan C. Derumeaux G. Mewton N.
Ovize M.
Institution
(Cung) Centre Hospitalier Universitaire (CHU) Arnaud de Villeneuve, France
(Piot) Clinique du Millenaire, Montpellier, France
(Morel) Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil,
Strasbourg, France
(Cayla) CHU de Nimes, Nimes, France
(Rioufol, Bonnefoy-Cudraz, Bergerot, Boussaha, Jossan, Derumeaux, Mewton,
Ovize) Hopital Cardiovasculaire Louis Pradel, France
(Rioufol, Bonnefoy-Cudraz, Bergerot, Boussaha, Jossan, Derumeaux, Mewton,
Ovize) Claude Bernard University, France
(Aupetit) Centre Hospitalier Saint-Joseph et Saint-Luc, France
(Malquarti) Clinique de la Sauvegarde, France
(Staat) Clinique du Tonkin, France
(Bergerot, Boussaha, Jossan, Derumeaux, Mewton, Ovize) Clinical
Investigation Center of Lyon, Explorations Fonctionnelles
Cardiovasculaires, 28 Ave. Doyen Lepine, Lyon 69677, France
(Angoulvant) CHU de Tours, Lyon, France
(Blanchard) Clinique Saint-Gatien, Tours, France
(Guerin) Hopital Guillaume et Rene Laennec, Nantes, France
(Elbaz) CHU de Rangueil, Toulouse, France
(Delarche) Centre Hospitalier de Pau, Pau, France
(Coste) Hopital Haut Leveque, Bordeaux, France
(Vanzetto) Hopital A. Michallon- CHU de Grenoble, Grenoble, France
(Metge) Hopital Henri Duffau, Avignon, France
(Jouve) Centre Hospitalier du Pays D'Aix, Aixen- Provence, France
(Motreff) Hopital Gabriel Montpied, Clermont Ferrand, France
(Tron) Hopital Charles Nicolle, Rouen, France
(Labeque) Clinique de la Fourcade, Bayonne, France
(Steg) Assistance Publique-Hopitaux de Paris, Hopital Bichat, Paris,
France
(Cottin) Hopital du Bocage, Dijon, France
(Range) Centre Hospitalier General, Chartres, France
(Clerc) Centre Hospitalier de Compiegne, Compiegne, France
(Prunier) CHU D'Angers, Angers, France
(Moulin) CHU de Nancy-Brabois, Vandoeuvre-les-Nancy, France
(Roth) CHU de Mulhouse, France
(Ider) Clinique du Diaconat, Mulhouse, France
(Belle) Centre Hospitalier D'Annecy, Annecy, France
(Barragan) Polyclinique des Fleurs, Ollioules, France
(Gilard) Hopital de la Cavale Blanche, Brest, France
(Colin, De Poli) Clinique Esquirol, Agen, France
(Morice) Institut Jacques Cartier, Massy, France
(Dubois-Rande) Centre Hospitalier Henri Mondor, Creteil, France
(Unterseeh) Hopital Claude Galien, Quincy sous Senat, France
(Le Breton) Hopital Pontchaillou, Rennes, France
(Beard) Clinique de L'Ormeau, Tarbes, France
(Grollier) Hopital de la Cote de Nacre, Caen, France
(Sudre) Hopital Cardiologique Calmette, Lille, France
(Garcia-Dorado) Hospital Universitari Vall D'Hebron, Barcelona, Spain
(Claeys) University Hospital Antwerp, Edegem, Belgium
(Coussement) Algemeen Ziekenhuis Sint Jan, Brugge, Belgium
(Dubois) CHU de Charleroi, Charleroi, Belgium
(Elmer, Hansson) Department of Clinical Sciences, Lund University, Lund,
Sweden
Title
Cyclosporine before PCI in patients with acute myocardial infarction.
Source
New England Journal of Medicine. 373 (11) (pp 1021-1031), 2015. Date of
Publication: 10 Sep 2015.
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND Experimental and clinical evidence suggests that cyclosporine
may attenuate reperfusion injury and reduce myocardial infarct size. We
aimed to test whether cyclosporine would improve clinical outcomes and
prevent adverse left ventricular remodeling. METHODS In a multicenter,
double-blind, randomized trial, we assigned 970 patients with an acute
anterior ST-segment elevation myocardial infarction (STEMI) who were
undergoing percutaneous coronary intervention (PCI) within 12 hours after
symptom onset and who had complete occlusion of the culprit coronary
artery to receive a bolus injection of cyclosporine (administered
intravenously at a dose of 2.5 mg per kilogram of body weight) or matching
placebo before coronary recanalization. The primary outcome was a
composite of death from any cause, worsening of heart failure during the
initial hospitalization, rehospitalization for heart failure, or adverse
left ventricular remodeling at 1 year. Adverse left ventricular remodeling
was defined as an increase of 15% or more in the left ventricular
end-diastolic volume. RESULTS A total of 395 patients in the cyclosporine
group and 396 in the placebo group received the assigned study drug and
had data that could be evaluated for the primary outcome at 1 year. The
rate of the primary outcome was 59.0% in the cyclosporine group and 58.1%
in the control group (odds ratio, 1.04; 95% confidence interval, 0.78 to
1.39; P = 0.77). Cyclosporine did not reduce the incidence of the separate
clinical components of the primary outcome or other events, including
recurrent infarction, unstable angina, and stroke. No significant
difference in the safety profile was observed between the two treatment
groups. CONCLUSIONS In patients with anterior STEMI who had been referred
for primary PCI, intravenous cyclosporine did not result in better
clinical outcomes than those with placebo and did not prevent adverse left
ventricular remodeling at 1 year. (Funded by the French Ministry of Health
and NeuroVive Pharmaceutical; CIRCUS ClinicalTrials .gov number,
NCT01502774; EudraCT number, 2009-013713-99.)

<15>
Accession Number
2015370112
Authors
Valgimigli M. Frigoli E. Leonardi S. Rothenbuhler M. Gagnor A. Calabro P.
Garducci S. Rubartelli P. Briguori C. Ando G. Repetto A. Limbruno U. Garbo
R. Sganzerla P. Russo F. Lupi A. Cortese B. Ausiello A. Ierna S. Esposito
G. Presbitero P. Santarelli A. Sardella G. Varbella F. Tresoldi S. De
Cesare N. Rigattieri S. Zingarelli A. Tosi P. Van't Hof A. Boccuzzi G.
Omerovic E. Sabate M. Heg D. Juni P. Vranckx P.
Institution
(Valgimigli) Swiss Cardiovascular Center Bern, Bern University Hospital,
University of Bern, Bern CH-3010, Switzerland
(Rothenbuhler, Heg) Clinical Trials Unit, Institute of Social and
Preventive Medicine, University of Bern, Bern, Switzerland
(Juni) Institute of Primary Health Care, University of Bern, Bern,
Switzerland
(Valgimigli) Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
(Van't Hof) Isala Klinieken, Zwolle, Netherlands
(Frigoli) EUSTRATEGY Association, Forli, Italy
(Leonardi, Repetto) Unita Operativa Complessa Cardiologia, Dipartimento
CardioToracoVascolare, Fondazione IRCCS Policlinico San Matteo, Pavia,
Italy
(Gagnor, Varbella) Cardiology Unit, Ospedali Riuniti di Rivoli, Italy
(Garbo, Boccuzzi) San Giovanni Bosco Hospital, Turin, Italy
(Calabro) Division of Cardiology, Department of Cardiothoracic Sciences,
Second University of Naples, Italy
(Esposito) Department of Advanced Biomedical Sciences, Division of
Cardiology, Federico II University of Naples, Italy
(Briguori) Clinica Mediterranea, Naples, Italy
(Garducci) Azienda Ospedaliera Ospedale Civile di Vimercate, Desio, Italy
(Rubartelli) Department of Cardiology, ASL3 Ospedale Villa Scassi, Italy
(Zingarelli) IRCCS Azienda Ospedaliera Universitaria San Martino, Genoa,
Italy
(Ando) Azienda Ospedaliera Universitaria Policlinico Gaetano Martino,
University of Messina, Messina, Italy
(Limbruno) Unita Operativa Cardiologia, ASL 9 Grosseto, Grosseto, Italy
(Sganzerla) Azienda Ospedaliera Ospedale Treviglio-Caravaggio, Treviglio,
Italy
(Russo) Azienda Ospedaliera Sant'Anna, Como, Italy
(Lupi) University Hospital Maggiore della Carita, Novara, Italy
(Cortese) Ospedale Fatebenefratelli, Milan, Italy
(Ausiello) Casa di Cura Villa Verde, Taranto, Italy
(Ierna) Ospedale Sirai-Carbonia, Carbonia, Italy
(Presbitero) IRCCS Humanitas, Rozzano, Italy
(Santarelli) Cardiovascular Department, Infermi Hospital, Rimini, Italy
(Sardella) Policlinico Umberto i, Sapienza University of Rome, Italy
(Rigattieri) Interventional Cardiology Unit, Sandro Pertini Hospital Rome,
Rome, Italy
(Tresoldi) Azienda Ospedaliera Ospedale di Desio, Desio, Italy
(De Cesare) Policlinico San Marco, Zingonia, Italy
(Tosi) Mater Salutis Hospital, Legnago, Italy
(Omerovic) Sahlgrenska University Hospital, Goteborg, Sweden
(Sabate) Hospital Clinic, University of Barcelona, Thorax Institute,
Department of Cardiology, Barcelona, Spain
(Vranckx) Department of Cardiology and Critical Care Medicine, Hartcentrum
Hasselt, Jessa Ziekenhuis, Hasselt, Belgium
Title
Bivalirudin or unfractionated heparin in acute coronary syndromes.
Source
New England Journal of Medicine. 373 (11) (pp 997-1009), 2015. Date of
Publication: 10 Sep 2015.
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND Conflicting evidence exists on the efficacy and safety of
bivalirudin administered as part of percutaneous coronary intervention
(PCI) in patients with an acute coronary syndrome. METHODS We randomly
assigned 7213 patients with an acute coronary syndrome for whom PCI was
anticipated to receive either bivalirudin or unfractionated heparin.
Patients in the bivalirudin group were subsequently randomly assigned to
receive or not to receive a post-PCI bivalirudin infusion. Primary
outcomes for the comparison between bivalirudin and heparin were the
occurrence of major adverse cardiovascular events (a composite of death,
myocardial infarction, or stroke) and net adverse clinical events (a
composite of major bleeding or a major adverse cardiovascular event). The
primary outcome for the comparison of a post-PCI bivalirudin infusion with
no post-PCI infusion was a composite of urgent target-vessel
revascularization, definite stent thrombosis, or net adverse clinical
events. RESULTS The rate of major adverse cardiovascular events was not
significantly lower with bivalirudin than with heparin (10.3% and 10.9%,
respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to
1.09; P = 0.44), nor was the rate of net adverse clinical events (11.2%
and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P =
0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did
not significantly decrease the rate of urgent target-vessel
revascularization, definite stent thrombosis, or net adverse clinical
events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74
to 1.11; P = 0.34). CONCLUSIONS In patients with an acute coronary
syndrome, the rates of major adverse cardiovascular events and net adverse
clinical events were not significantly lower with bivalirudin than with
unfractionated heparin. The rate of the composite of urgent target-vessel
revascularization, definite stent thrombosis, or net adverse clinical
events was not significantly lower with a post-PCI bivalirudin infusion
than with no post-PCI infusion. (Funded by the Medicines Company and
Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.)

<16>
Accession Number
2015376859
Authors
Taylor R.S. Anderson L.J.
Institution
(Taylor) Institute of Health Research, University of Exeter, Medical
School, South Cloisters, St. Lukes Campus, Heavitree Road, Exeter EX1 2LU,
United Kingdom
(Anderson) Evidence Synthesis and Modelling for Health Improvement (ESMI),
Institute of Health Services Research, University of Exeter, Medical
School, Exeter, United Kingdom
Title
Cochrane corner: Cardiac rehabilitation for people with heart disease.
Source
Heart. 101 (16) (pp 1256-1260), 2015. Date of Publication: 01 Aug 2015.
Publisher
BMJ Publishing Group

<17>
Accession Number
2015379116
Authors
Ker K. Roberts I.
Institution
(Ker, Roberts) Clinical Trials Unit, London School of Hygiene and Tropical
Medicine, London, United Kingdom
Title
Exploring redundant research into the effect of tranexamic acid on
surgical bleeding: Further analysis of a systematic review of randomised
controlled trials.
Source
BMJ Open. 5 (8) , 2015. Article Number: e009460. Date of Publication:
2015.
Publisher
BMJ Publishing Group
Abstract
Objectives: We examined whether apparent redundancy in a cumulative
meta-analysis of trials is justified by concern about bias, random error
or generalisability of the results. Design: Cumulative meta-analysis, risk
of bias assessment, trial sequential analysis, description of study
participants over time and a review of rationales for conducting trials.
Data source: 126 randomised trials included in a systematic review
assessing of tranexamic acid on blood transfusion in surgery. Results: The
cumulative meta-analysis including all trials shows that the pooled
estimate first reached statistical significance after the second trial in
1993. When the analysis was limited to the 38 high-quality trials and
adjusted to account for potential systematic and random errors, the
uncertainty was resolved after the 22nd trial in 2008. When the analysis
was restricted to the two high-quality, prospectively registered trials,
the cumulative z-curve crossed p=0.05 but not the monitoring boundary,
suggesting an early potentially spurious statistically significant result.
As precision of the pooled estimate increased, the number of trials
initiated increased, although trial activity appeared to move to other
surgery types. Most (62%) reports cited at least one systematic review. Of
118 reports examined, concern about generalisability was the reason for
initiating the trial in 60%. Other reasons were to address a question
other than the effect on bleeding (26%) and to confirm previously observed
results (4%). Unawareness of previous research was apparent in 4% trials,
while the rationale was unclear in 3%. Conclusions: Our results indicate
that poor quality is a more important cause of redundant research than the
failure to review existing evidence. Concerns about generalisability of
results is the main motivation for new trials. Contrary to previous
claims, our results suggest that systematic reviews showing treatment
effects can stimulate an increase in trial activity rather than reduce it.

<18>
Accession Number
2015373419
Authors
Ye W. Brandle M. Brown M.B. Herman W.H.
Institution
(Ye, Brown) Department of Biostatistics, University of Michigan, 1415
Washington Heights, Ann Arbor, MI 48109-2029, United States
(Brandle) Division of Endocrinology and Diabetes, Kantonsspital St.
Gallen, St. Gallen, Switzerland
(Herman) Department of Internal Medicine, University of Michigan, Ann
Arbor, MI, United States
(Herman) Department of Epidemiology, University of Michigan, Ann Arbor,
MI, United States
Title
The Michigan Model for Coronary Heart Disease in Type 2 Diabetes:
Development and Validation.
Source
Diabetes Technology and Therapeutics. 17 (10) (pp 701-711), 2015. Date of
Publication: 01 Oct 2015.
Publisher
Mary Ann Liebert Inc.
Abstract
Objectives: The aim of this study was to develop and validate a computer
simulation model for coronary heart disease (CHD) in type 2 diabetes
mellitus (T2DM) that reflects current medical and surgical treatments.
Research Design and Methods: We modified the structure of the CHD submodel
in the Michigan Model for Diabetes to allow for revascularization
procedures before and after first myocardial infarction, for repeat
myocardial infarctions and repeat revascularization procedures, and for
congestive heart failure. Transition probabilities that reflect the direct
effects of medical and surgical therapies on outcomes were derived from
the literature and calibrated to recently published population-based
epidemiologic studies and randomized controlled clinical trials. Monte
Carlo techniques were used to implement a discrete-state and discrete-time
multistate microsimulation model. Performance of the model was assessed
using internal and external validation. Simple regression analysis
(simulated outcome=b<inf>0</inf>+b<inf>1</inf>xpublished outcome) was used
to evaluate the validation results. Results: For the 21 outcomes in the
six studies used for internal validation, R² was 0.99, and the
slope of the regression line was 0.98. For the 16 outcomes in the five
studies used for external validation, R² was 0.81, and the
slope was 0.84. Conclusions: Our new computer simulation model predicted
the progression of CHD in patients with T2DM and will be incorporated into
the Michigan Model for Diabetes to assess the cost-effectiveness of
alternative strategies to prevent and treat T2DM.

<19>
Accession Number
2015371194
Authors
Cheungpasitporn W. Thongprayoon C. Kittanamongkolchai W. Srivali N.
O'Corragain O.A. Edmonds P.J. Ratanapo S. Spanuchart I. Erickson S.B.
Institution
(Cheungpasitporn, Thongprayoon, Kittanamongkolchai, Erickson) Division of
Nephrology and Hypertension, Mayo Clinic, Rochester, MN, United States
(Srivali) Division of Pulmonary and Critical Care Medicine, Mayo Clinic,
Rochester, MN, United States
(O'Corragain) Department of Medicine, University College Cork, Cork,
Ireland
(Edmonds) Department of Medicine, SUNY Upstate Medical University,
Syracuse, NY, United States
(Ratanapo) Division of Cardiology, Medical College of Georgia, Augusta,
GA, United States
(Spanuchart) Department of Medicine, University of Hawaii, Honolulu, HI,
United States
Title
Comparison of renal outcomes in off-pump versus on-pump coronary artery
bypass grafting: A systematic review and meta-analysis of randomized
controlled trials.
Source
Nephrology. 20 (10) (pp 727-735), 2015. Date of Publication: 01 Oct 2015.
Publisher
Blackwell Publishing
Abstract
Aim The objective of this meta-analysis was to compare the effects of
off-pump and on-pump coronary artery bypass grafting (CABG) on acute
kidney injury (AKI) and the need of dialysis after surgery. Methods
Comprehensive literature searches for randomized controlled trials (RCTs)
of CABG with on-pump and off-pump was performed using MEDLINE, EMBASE,
Cochrane Database of Systematic Reviews, Cochrane Central Register of
Controlled Trials Systematic Reviews and clinicaltrials.gov from inception
through September 2014. Primary outcomes were the incidence of AKI and the
need of dialysis. Mortality was assessed among the studies that reported
renal outcomes. Pooled risk ratios (RRs) and 95% confidence interval (CI)
were calculated using a random-effect, generic inverse variance method.
Results Thirty-three RCTs with 17 322 patients were enrolled in our study.
Patients in the off-pump CABG group had overall lower incidence of AKI
(19.1%) compared with the on-pump CABG group (22.2%). There was a
protective effect of off-pump CABG on the incidence of AKI compared with
the on-pump CABG group (RR: 0.87; 95% CI: 0.77-0.98). However, there was
no significant difference in the need for dialysis in the off-pump group
compared with the on-pump group (RR: 0.84; 95% CI 0.63-1.13). Within the
selected trials, post hoc analysis assessing the mortality outcome
demonstrated a pooled RR of 0.97 (95% CI, 0.77-1.23) in off-pump versus
on-pump CABGs. Conclusions Our study demonstrates a beneficial effect of
off-pump CABG on the incidence of AKI. However, our meta-analysis does not
show benefits of the need of dialysis or survival among patients
undergoing off-pump CABG.

<20>
Accession Number
2015368683
Authors
Genereux P. Bernard S. Palmerini T. Caixeta A. Rosner G. Reiss G.R. Xu K.
Mehran R. Stone G.W.
Institution
(Genereux, Bernard, Rosner, Reiss, Xu, Stone) Columbia University Medical
Center, Cardiovascular Research Foundation, 111 E 59th St, 11th Floor, New
York, NY 10022, United States
(Genereux) Hopital du Sacre-Coeur de Montreal, Universite de Montreal,
Montreal, QC, Canada
(Palmerini) Istituto di Cardiologia, University of Bologna, Bologna, Italy
(Caixeta) Escola Paulista de Medicina, Universidade Federal de Sao Paulo,
Hospital Israelita Albert Einstein, Sao Paulo, Brazil
(Mehran) Mount Sinai Medical Center, New York, NY, United States
Title
Incidence, predictors, and impact of neurological events in non-ST-segment
elevation acute coronary syndromes: The ACUITY trial.
Source
EuroIntervention. 11 (4) (pp 399-406), 2015. Date of Publication: 01 Aug
2015.
Publisher
EuroPCR
Abstract
Aims: We sought to describe the incidence, predictors, and impact of
adverse neurological events (NE) in a non-ST-segment elevation acute
coronary syndromes (NSTEACS) population undergoing percutaneous coronary
intervention (PCI), coronary artery bypass grafting (CABG), or medical
therapy (MT). Methods and results: 13,819 patients with moderate and
high-risk NSTEACS were enrolled in the prospective ACUITY trial.
Angiography was performed within 72 hours of presentation, after which
7,789 patients (56.4%) underwent PCI, 1,539 (11.1%) underwent CABG, and
4,491 (32.5%) received MT. The rate of NE (stroke or transient ischaemic
attack) at 30 days and one year and its relationship to adverse ischaemic
events, including death, were assessed. Thirty-day rates of NE were 1.1%
with CABG, 0.3% with PCI, and 0.5% with MT (p<0.001). One-year rates of NE
were 1.1% with CABG, 0.3% with PCI, and 0.6% with MT (p<0.001).
Independent predictors of NE at 30 days and one year included age, renal
insufficiency, baseline troponin elevation, and initial treatment with
CABG. The occurrence of NE was a strong independent predictor of death at
30 days and one year (HR 4.07, 95% CI [1.49, 11.11], p=0.006, and HR 4.25,
95% CI [2.37, 7.62], p<0.001, respectively). Conclusions: In the
large-scale ACUITY trial, CABG was associated with a higher risk of NE at
30 days and one year compared to PCI and MT. The occurrence of NE in
patients with NSTEACS was strongly associated with increased early and
late mortality. Clinical Trials.gov Identifier NCT00093158.

<21>
Accession Number
2015373674
Authors
Valsangkar N.P. Zimmers T.A. Kim B.J. Blanton C. Joshi M.M. Bell T.M.
Nakeeb A. Dunnington G.L. Koniaris L.G.
Institution
(Valsangkar, Zimmers, Kim, Blanton, Joshi, Bell, Nakeeb, Dunnington,
Koniaris) Department of Surgery, Indiana University School of Medicine,
Indianapolis, IN 46202, United States
Title
Determining the drivers of academic success in surgery: An analysis of
3,850 faculty.
Source
PLoS ONE. 10 (7) , 2015. Article Number: e0131678. Date of Publication: 15
Jul 2015.
Publisher
Public Library of Science
Abstract
Objective: Determine drivers of academic productivity within U.S.
departments of surgery. Methods: Eighty academic metrics for 3,850 faculty
at the top 50 NIH-funded university- and 5 outstanding hospital-based
surgical departments were collected using websites, Scopus, and NIH
RePORTER. Results: Mean faculty size was 76. Overall, there were
35.3%assistant, 27.8% associate, and 36.9% full professors. Women
comprised 21.8%; 4.9% were MD-PhDs and 6.1% PhDs. By faculty-rank, median
publications/citations were: assistant, 14/175, associate, 39/649 and
full-professor, 97/2250. General surgery divisions contributed the most
publications and citations. Highest performing sub-specialties per faculty
member were: research (58/1683), transplantation (51/1067), oncology
(41/777), and cardiothoracic surgery (48/860). Overall, 23.5% of faculty
were principal investigators for a current or former NIH grant, 9.5% for a
current or former R01/U01/P01. The 10 most cited faculty (MCF) within each
department contributed to 42% of all publications and 55% of all
citations. MCF were most commonly general (25%), oncology (19%), or
transplant surgeons (15%). Fifty-one-percent of MCF had current/former NIH
funding, compared with 20% of the rest (p<0.05); funding rates for
R01/U01/P01 grants was 25.1% vs. 6.8% (p<0.05). Rate of current-NIH MCF
funding correlated with higher total departmental NIH rank (p < 0.05).
Conclusions: Departmental academic productivity as defined by citations
and NIH funding is highly driven by sections or divisions of research,
general and transplantation surgery. MCF, regardless of subspecialty,
contribute disproportionally to major grants and publications. Approaches
that attract, develop, and retain funded MCF may be associated with
dramatic increases in total departmental citations and NIH-funding.
Copyright:

<22>
Accession Number
2015119156
Authors
Davydow D.S. Lease E.D. Reyes J.D.
Institution
(Davydow) Department of Psychiatry and Behavioral Sciences, University of
Washington, Seattle, WA, United States
(Lease) Division of Pulmonary and Critical Care Medicine, Department of
Medicine, University of Washington, Seattle, WA, United States
(Reyes) Division of Transplant Surgery, Department of Surgery, University
of Washington, Seattle, WA, United States
Title
Posttraumatic stress disorder in organ transplant recipients: A systematic
review.
Source
General Hospital Psychiatry. 37 (5) (pp 387-398), 2015. Date of
Publication: 01 Sep 2015.
Publisher
Elsevier Inc.
Abstract
Objective: To summarize and critically review the existing literature on
the prevalence of posttraumatic stress disorder (PTSD) following organ
transplantation, risk factors for posttransplantation PTSD and the
relationship of posttransplant PTSD to other clinical outcomes including
health-related quality of life (HRQOL) and mortality. Methods: We
conducted a systematic literature review using PubMed, CINAHL Plus, the
Cochrane Library and PsycInfo and a search of the online contents of 18
journals. Results: Twenty-three studies were included. Posttransplant, the
point prevalence of clinician-ascertained PTSD ranged from 1% to 16% (n =
738), the point prevalence of questionnaire-assessed substantial PTSD
symptoms ranged from 0% to 46% (n = 1024) and the cumulative incidence of
clinician-ascertained transplant-specific PTSD ranged from 10% to 17% (n =
482). Consistent predictors of posttransplant PTSD included history of
psychiatric illness prior to transplantation and poor social support
posttransplantation. Posttransplant PTSD was consistently associated with
worse mental HRQOL and potentially associated with worse physical HRQOL.
Conclusions: PTSD may impact a substantial proportion of organ transplant
recipients. Future studies should focus on transplant-specific PTSD and
clarify potential risk factors for, and adverse outcomes related to,
posttransplant PTSD.

<23>
[Use Link to view the full text]
Accession Number
25652319
Authors
Gargiulo G. Capodanno D. Sannino A. Perrino C. Capranzano P. Stabile E.
Trimarco B. Tamburino C. Esposito G.
Institution
(Gargiulo) From the Division of Cardiology, Department of Advanced
Biomedical Sciences, Federico II University, Naples, Italy (G.G., A.S.,
C.P., E.S., B.T., G.E.); Division of Cardiology, Ferrarotto Hospital,
University of Catania, Catania, Italy (D.C., P.C., C.T.); and Excellence
Through Newest Advances (ETNA) Foundation, Catania, Italy (C.T.)
(Capodanno) From the Division of Cardiology, Department of Advanced
Biomedical Sciences, Federico II University, Naples, Italy (G.G., A.S.,
C.P., E.S., B.T., G.E.); Division of Cardiology, Ferrarotto Hospital,
University of Catania, Catania, Italy (D.C., P.C., C.T.); and Excellence
Through Newest Advances (ETNA) Foundation, Catania, Italy (C.T.)
(Sannino) From the Division of Cardiology, Department of Advanced
Biomedical Sciences, Federico II University, Naples, Italy (G.G., A.S.,
C.P., E.S., B.T., G.E.); Division of Cardiology, Ferrarotto Hospital,
University of Catania, Catania, Italy (D.C., P.C., C.T.); and Excellence
Through Newest Advances (ETNA) Foundation, Catania, Italy (C.T.)
(Perrino) From the Division of Cardiology, Department of Advanced
Biomedical Sciences, Federico II University, Naples, Italy (G.G., A.S.,
C.P., E.S., B.T., G.E.); Division of Cardiology, Ferrarotto Hospital,
University of Catania, Catania, Italy (D.C., P.C., C.T.); and Excellence
Through Newest Advances (ETNA) Foundation, Catania, Italy (C.T.)
(Capranzano) From the Division of Cardiology, Department of Advanced
Biomedical Sciences, Federico II University, Naples, Italy (G.G., A.S.,
C.P., E.S., B.T., G.E.); Division of Cardiology, Ferrarotto Hospital,
University of Catania, Catania, Italy (D.C., P.C., C.T.); and Excellence
Through Newest Advances (ETNA) Foundation, Catania, Italy (C.T.)
(Stabile) From the Division of Cardiology, Department of Advanced
Biomedical Sciences, Federico II University, Naples, Italy (G.G., A.S.,
C.P., E.S., B.T., G.E.); Division of Cardiology, Ferrarotto Hospital,
University of Catania, Catania, Italy (D.C., P.C., C.T.); and Excellence
Through Newest Advances (ETNA) Foundation, Catania, Italy (C.T.)
(Trimarco) From the Division of Cardiology, Department of Advanced
Biomedical Sciences, Federico II University, Naples, Italy (G.G., A.S.,
C.P., E.S., B.T., G.E.); Division of Cardiology, Ferrarotto Hospital,
University of Catania, Catania, Italy (D.C., P.C., C.T.); and Excellence
Through Newest Advances (ETNA) Foundation, Catania, Italy (C.T.)
(Tamburino) From the Division of Cardiology, Department of Advanced
Biomedical Sciences, Federico II University, Naples, Italy (G.G., A.S.,
C.P., E.S., B.T., G.E.); Division of Cardiology, Ferrarotto Hospital,
University of Catania, Catania, Italy (D.C., P.C., C.T.); and Excellence
Through Newest Advances (ETNA) Foundation, Catania, Italy (C.T.)
(Esposito) From the Division of Cardiology, Department of Advanced
Biomedical Sciences, Federico II University, Naples, Italy (G.G., A.S.,
C.P., E.S., B.T., G.E.); Division of Cardiology, Ferrarotto Hospital,
University of Catania, Catania, Italy (D.C., P.C., C.T.); and Excellence
Through Newest Advances (ETNA) Foundation, Catania, Italy (C.T.).
espogiov@unina.it
Title
Moderate and severe preoperative chronic kidney disease worsen clinical
outcomes after transcatheter aortic valve implantation: meta-analysis of
4992 patients.
Source
Circulation. Cardiovascular interventions. 8 (2) (pp e002220), 2015. Date
of Publication: 01 Feb 2015.
Abstract
BACKGROUND: There is a conflicting evidence on safety and efficacy of
transcatheter aortic valve implantation in patients with preoperative
chronic kidney disease (CKD). Therefore, we conducted a meta-analysis on
the impact of CKD on outcomes after transcatheter aortic valve
implantation.
METHODS AND RESULTS: Nine studies including 4992 patients were analyzed.
Overall preoperative CKD (stages 3-5) significantly increased early (odds
ratio [OR], 1.44; 95% confidence interval [CI], 1.08-1.94 and OR, 1.66;
95% CI, 1.04-2.67) and 1-year (OR, 1.66; 95% CI, 1.23-2.25 and OR, 1.32;
95% CI, 1.06-1.63) all-cause and cardiovascular mortality, respectively.
Moderate CKD (stage 3) alone also increased early and 1-year all-cause
mortality (OR, 1.43; 95% CI, 1.10-1.85 and OR, 1.41; 95% CI, 1.13-1.74).
CKD stages 4 to 5 and 3 compared with stages 1 to 2 increased early stroke
(OR, 2.67; 95% CI, 1.53-4.65 and OR, 1.66; 95% CI, 1.09-2.52), acute
kidney injury (OR, 2.09; 95% CI, 1.17-3.72 and OR, 1.32; 95% CI,
1.09-1.60) and need for dialysis (OR, 5.92; 95% CI, 2.46-14.27 and OR,
1.55; 95% CI, 0.65-3.70), in the absence of significant differences in
contrast medium administration (mean difference, -26.07; 95% CI, -53.00 to
0.85 and mean difference, -0.42; 95% CI, -16.10 to 15.26). Bleeding
(life-threatening or major) was nonsignificantly increased in CKD 3 to 5
compared with CKD 1 to 2, but significantly increased in most severe
patients (CKD 4-5 versus CKD 1-2: OR, 1.66; 95% CI, 1.13-2.44; CKD 4-5
versus CKD 3: OR, 1.68; 95% CI, 1.27-2.24).
CONCLUSIONS: Both moderate and severe preoperative CKD significantly
worsen transcatheter aortic valve implantation prognosis. Future studies
on risk evaluation, prevention, and postoperative management are needed.

<24>
Accession Number
25123092
Authors
Probst S. Cech C. Haentschel D. Scholz M. Ender J.
Title
A specialized post anaesthetic care unit improves fast-track management in
cardiac surgery: a prospective randomized trial.
Source
Critical care (London, England). 18 (4) (pp 468), 2014. Date of
Publication: 2014.
Abstract
INTRODUCTION: Fast-track treatment in cardiac surgery has become the
global standard of care. We compared the efficacy and safety of a
specialised post-anaesthetic care unit (PACU) to a conventional intensive
care unit (ICU) in achieving defined fast-track end-points in adult
patients after elective cardiac surgery.
METHODS: In a prospective, single blinded, randomized study, 200 adult
patients undergoing elective cardiac surgery (coronary artery bypass graft
(CABG), valve surgery or combined CABG and valve surgery), were selected
to receive their postoperative treatment either in the ICU (n=100), or in
the PACU (n=100). Patients who, at the time of surgery, were in
cardiogenic shock, required renal dialysis, or had an additive EuroSCORE
of more than 10 were excluded from the study. The primary end points were:
time to extubation (ET), and length of stay in the PACU or ICU (PACU/ICU
LOS respectively). Secondary end points analysed were the incidences of:
surgical re-exploration, development of haemothorax, new onset cardiac
arrhythmia, low cardiac output syndrome, need for cardio-pulmonary
resuscitation, stroke, acute renal failure, and death.
RESULTS: Median time to extubation was 90 [50; 140] min in the PACU vs.
478 [305; 643] min in the ICU group (P<0.001). Median length of stay in
PACU was 3.3 [2.7; 4.0] hours vs. 17.9 [10.3; 24.9] hours in the ICU
(P<0.001). Of the adverse events examined, only the incidence of new onset
cardiac arrhythmia (25 in PACU vs. 41 in ICU, P=0.02) was statistically
different between groups.
CONCLUSIONS: Treatment in a specialised PACU rather than an ICU, after
elective cardiac surgery leads to earlier extubation and quicker discharge
to a step down unit, without compromising patient safety.
TRIAL REGISTRATION: ISRCTN71768341. Registered 11 March 2014.

<25>
Accession Number
25498035
Authors
Scalone G. Brugaletta S. Martin-Yuste V. Seixo F. Cotes C.
Gomez-Monterrosas O. Alvarez-Contreras L. Camprecios M. Mirabet S. Brossa
V. Sabate M.
Institution
(Scalone) Catholic University of Sacred Heart, Cardiology Department,
Rome, Italy
(Brugaletta) Thorax Institute, Department of Cardiology, Institut
d'Investigacions Biomediques Agust Pi i Sunyer (IDIBAPS), Hospital Clinic,
Barcelona, Spain
(Martin-Yuste) Thorax Institute, Department of Cardiology, Institut
d'Investigacions Biomediques Agust Pi i Sunyer (IDIBAPS), Hospital Clinic,
Barcelona, Spain
(Seixo) Department of Cardiology, Hospital de la Santa Creu i Sant Pau,
Barcelona, Spain
(Cotes) Department of Cardiology, Hospital de la Santa Creu i Sant Pau,
Barcelona, Spain
(Gomez-Monterrosas) Thorax Institute, Department of Cardiology, Institut
d'Investigacions Biomediques Agust Pi i Sunyer (IDIBAPS), Hospital Clinic,
Barcelona, Spain
(Alvarez-Contreras) Thorax Institute, Department of Cardiology, Institut
d'Investigacions Biomediques Agust Pi i Sunyer (IDIBAPS), Hospital Clinic,
Barcelona, Spain
(Camprecios) Department of Cardiology, Hospital de la Santa Creu i Sant
Pau, Barcelona, Spain
(Mirabet) Department of Cardiology, Hospital de la Santa Creu i Sant Pau,
Barcelona, Spain
(Brossa) Department of Cardiology, Hospital de la Santa Creu i Sant Pau,
Barcelona, Spain
(Sabate) Thorax Institute, Department of Cardiology, Institut
d'Investigacions Biomediques Agust Pi i Sunyer (IDIBAPS), Hospital Clinic,
Barcelona, Spain. Electronic address: masabate@clinic.ub.es
Title
RAndomized Comparison of raDIal vs. femorAL Access for Routine
Catheterization of Heart Transplant Patients (RADIAL-heart transplant
study).
Source
Transplantation proceedings. 46 (10) (pp 3262-3267), 2014. Date of
Publication: 01 Dec 2014.
Abstract
Although a transradial approach (TRA) is considered feasible in many
clinical situations, no data are available in patients undergoing
orthotopic heart transplantation (OHT). Our goal was to randomly compare
TRA versus a transfemoral approach (TFA) in this clinical setting. This
single-center, prospective, randomized trial was conducted from January to
November 2006, and all OHT patients scheduled for a control coronary
angiography were randomized to receive TRA or TFA. The primary endpoint
was the amount of contrast used during the procedure. The participating
interventional cardiologists were intermediate-volume radial operators,
and this was their initial experience of TRA in OHT patients. The analysis
was performed according to the intention-to-treat principle. Overall, 49
patients (mean age, 55 +/- 13 years; 74% male) were included in the trial:
26 patients were assigned to TRA, and 23 were assigned to TFA. A higher
amount of contrast (147 mL [range, 113-175 mL] vs 105 mL [range, 86-127
mL]; P = .009), a longer fluoroscopy time (9.2 minutes [range, 6-12
minutes] vs 3.5 minutes [range, 3-5 minutes]; P < .001), a trend toward
increased number of catheters used for left ostium cannulation, and a
higher crossover rate (19% vs 0%; P = .03) were associated with TRA
compared with TFA. Furthermore, patients treated with TRA exhibit a
shorter hospital stay (6 [range 4-8]) compared with the other group (26
[range 24-28]) (P < .001). There were no significant differences between
the 2 groups regarding total procedural time, and no vascular
complications were reported in either group. For these operators with
their first experience of TRA in OHT patients, TFA seemed to be more
efficient.