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<1>
Accession Number
2003558536
Title
Neuroimaging in randomized, multi-center clinical trials of endovascular
treatment for acute ischemic stroke: A systematic review.
Source
Korean Journal of Radiology. 21 (1) (pp 42-57), 2020. Date of Publication:
January 2020.
Author
Suh C.H.; Jung S.C.; Kim B.; Cho S.J.; Woo D.-C.; Oh W.Y.; Lee J.G.; Kim
K.W.
Institution
(Suh, Jung, Cho, Kim) Department of Radiology and Research Institute of
Radiology, University of Ulsan College of Medicine, Asan Medical Center,
Seoul, South Korea
(Kim) Department of Radiology, Korea University Anam Hospital, Korea
University College of Medicine, Seoul, South Korea
(Woo) Bioimaging Center, Biomedical Research Center, Asan Institute for
Life Sciences, Asan Medical Center, Seoul, South Korea
(Oh, Lee) Clinical Research Division, National Institute of Food and Drug
Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea
(Kim) Asan Image Metrics, Clinical Trial Center, Asan Institute for Life
Sciences, Asan Medical Center, Seoul, South Korea
Publisher
Korean Radiological Society (E-mail: office@radiology.or.kr)
Abstract
Appropriate use and analysis of neuroimaging techniques is an inevitable
aspect of clinical trials for patients with acute ischemic stroke.
Neuroimaging examinations were recently used to define the core
eligibility criteria and outcomes in acute ischemic stroke research.
Recent clinical trials for endovascular treatment in acute ischemic stroke
have also demonstrated the efficacy or safety of endovascular treatment
using various imaging modalities as well as clinical indices. Furthermore,
independent imaging reviews and imaging core laboratory assessments are
essential to manage and analyze imaging data in order to enhance the
reliability of the outcomes. Therefore, we systematically reviewed the use
of neuroimaging in recent randomized clinical trials for endovascular
treatment of acute ischemic stroke in order to provide a thorough summary,
which would serve as a resource guiding the use of appropriate imaging
protocols and analyses in future clinical trials for acute ischemic
stroke. This review will help researchers select appropriate imaging
biomarkers among the various imaging protocols available and apply the
selected type of imaging examination for each study in accordance with the
academic purpose.<br/>Copyright &#xa9; 2020 The Korean Society of
Radiology.

<2>
Accession Number
2003557913
Title
Impact of right atrial physiology on heart failure and adverse events
after myocardial infarction.
Source
Journal of Clinical Medicine. 9 (1) (no pagination), 2020. Article Number:
210. Date of Publication: January 2020.
Author
Schuster A.; Backhaus S.J.; Stiermaier T.; Navarra J.-L.; Uhlig J.; Rommel
K.-P.; Koschalka A.; Kowallick J.T.; Bigalke B.; Kutty S.; Gutberlet M.;
Hasenfuss G.; Thiele H.; Eitel I.
Institution
(Schuster, Backhaus, Navarra, Koschalka, Hasenfus) Department of
Cardiology and Pneumology, University Medical Center Gottingen,
Georg-August University, German Center for Cardiovascular Research (DZHK),
Gottingen 37075, Germany
(Schuster) Department of Cardiology, Royal North Shore Hospital, The
Kolling Institute, Northern Clinical School, University of Sydney, Sydney,
NSW 2065, Australia
(Stiermaier, Eitel) University Heart Center Lubeck, Medical Clinic II
(Cardiology/Angiology/Intensive Care Medicine), University Hospital
Schleswig-Holstein, German Center for Cardiovascular Research (DZHK),
Lubeck 23538, Germany
(Uhlig, Kowallick) University Medical Center Gottingen, Institute for
Diagnostic and Interventional Radiology, Georg-August University, German
Center for Cardiovascular Research (DZHK), Gottingen 37075, Germany
(Rommel, Thiele) Department of Internal Medicine/Cardiology, Heart Center
Leipzig at University of Leipzig, Leipzig Heart Institute, Leipzig 04289,
Germany
(Bigalke) Department of Cardiology and Pneumology, Charite Campus Benjamin
Franklin, University Medical Center Berlin, Berlin 12203, Germany
(Kutty) Taussig Heart Center, Johns Hopkins Hospital, Baltimore, MD 21287,
United States
(Gutberlet) Department of Radiology, Heart Center Leipzig, University of
Leipzig, Leipzig 04289, Germany
Publisher
MDPI AG (Postfach, Basel CH-4005, Switzerland. E-mail: rasetti@mdpi.com)
Abstract
Background: Right ventricular (RV) function is a known predictor of
adverse events in heart failure and following acute myocardial infarction
(AMI). While right atrial (RA) involvement is well characterized in
pulmonary arterial hypertension, its relative contributions to adverse
events following AMI especially in patients with heart failure and
congestion need further evaluation. <br/>Method(s): In this cardiovascular
magnetic resonance (CMR)-substudy of AIDA STEMI and TATORT NSTEMI, 1235
AMI patients underwent CMR after primary percutaneous coronary
intervention (PCI) in 15 centers across Germany (n = 795 with ST-elevation
myocardial infarction and 440 with non-ST-elevation MI). Right atrial (RA)
performance was evaluated using CMR myocardial feature tracking (CMR-FT)
for the assessment of RA reservoir (total strain epsilons), conduit
(passive strain epsilone), booster pump function (active strain epsilona),
and associated strain rates (SR) in a blinded core-laboratory. The primary
endpoint was the occurrence of major adverse cardiac events (MACE) 12
months post AMI. <br/>Result(s): RA reservoir (epsilons p = 0.061, SRs p =
0.049) and conduit functions (epsilone p = 0.006, SRe p = 0.030) were
impaired in patients with MACE as opposed to RA booster pump (epsilona p =
0.579, SRa p = 0.118) and RA volume index (p = 0.866). RA conduit function
was associated with the clinical onset of heart failure and MACE
independently of RV systolic function and atrial fibrillation (AF)
(multivariable analysis hazard ratio 0.95, 95% confidence interval 0.92 to
0.99, p = 0.009), while RV systolic function and AF were not independent
prognosticators. Furthermore, RA conduit strain identified low-and
high-risk groups within patients with reduced RV systolic function (p =
0.019 on log rank testing). <br/>Conclusion(s): RA impairment is a
distinct feature and independent risk factor in patients following AMI and
can be easily assessed using CMR-FT-derived quantification of RA
strain.<br/>Copyright &#xa9; 2020 by the authors. Licensee MDPI, Basel,
Switzerland.

<3>
Accession Number
631223902
Title
Female sex impact on culprit plaque at optical coherence tomography
analysis in the setting of acute coronary syndrome in OCT-FORMIDABLE
registry.
Source
Future Cardiology. 16 (2) (pp 123-131), 2020. Date of Publication: March
2020.
Author
Giordana F.; Errigo D.; D'Ascenzo F.; Montefusco A.; Garbo R.; Omede P.;
D'Amico M.; Moretti C.; Tamburino C.; Ferrari G.M.D.
Institution
(Giordana, Errigo, D'Ascenzo, Montefusco, Omede, D'Amico, Moretti,
Ferrari) Department of Cardiology, AOU Citta della Salute e della Scienza,
University of Turin, Turin, Italy
(Garbo) Department of Cardiology, San Giovanni Bosco Hospital, Turin,
Italy
(Tamburino) Department of Cardiology, Ferrarotto Hospital, University of
Catania, Catania, Italy
Publisher
Future Medicine Ltd. (E-mail: info@futuremedicine.com)
Abstract
Aim: To evaluate sex difference in culprit plaque features at optical
coherence tomography (OCT) and major adverse cardiovascular events at
follow-up. <br/>Patients and Methods: We analyse data from the
OCT-FORMIDABLE (OCT-Features Of moRphology, coMposItion anD instABility of
culprit and pLaquE in acute coronary syndrome [ACS] patients) registry. A
total of 285 patients (20%, 58 females) were included. <br/>Result(s):
Females with ST segment elevation myocardial infarction showed a longer
ruptured area of the plaque (8.6 +/- 7.6 vs 4.6 +/- 5.4; p = 0.003) and a
major necrotic core macrophage infiltration (43 vs 17%; p = 0.017).
Females with non-ST segment elevation-ACS had less lipidic plaques (62 vs
80%; p = 0.04). No between-group sex differences in major adverse
cardiovascular events emerged at follow-up (5 vs 9%; p = 0.88 in ST
segment elevation myocardial infarction group and 19 vs 15%; p = 0.6 in
non-ST segment elevation-ACS group). At multivariate analysis, female sex
was not a major risk of plaque rupture (hazard ratio [HR]: 1.59, CI:
0.44-5.67; p = 0.48). <br/>Conclusion(s): Female sex seems to have no
significant impact. ClincalTrial. gov registration number:
NCT02486861.<br/>Copyright &#xa9; 2020 Future Medicine Ltd.

<4>
Accession Number
631223698
Title
Bypassing the blues: Insomnia in the depressed post-CABG population.
Source
Annals of Clinical Psychiatry. 32 (1) (pp 17-26), 2020. Date of
Publication: February 2020.
Author
Waterman L.A.; Belnap B.H.; Gebara M.A.; Huang Y.; Abebe K.Z.; Rollman
B.L.; Karp J.F.
Institution
(Waterman) Department of Medicine, University of Pittsburgh, School of
Medicine, Pittsburgh, PA, United States
(Belnap) Center for Behavioral Health and Smart Technology, University of
Pittsburgh, School of Medicine, Pittsburgh, PA, United States
(Belnap) Department of Psychosomatic Medicine and Psychotherapy,
University of Gottingen Medical Center, Gottingen, Germany
(Gebara, Karp) Department of Psychiatry, University of Pittsburgh, School
of Medicine, Pittsburgh, PA, United States
(Huang) Center for Research on Health Care, University of Pittsburgh,
School of Medicine, Pittsburgh, PA, United States
(Abebe) Center for Clinical Trials and Data Coordination, University of
Pittsburgh, School of Medicine, Pittsburgh, PA, United States
(Rollman) Department of Medicine, Center for Behavioral Health and Smart
Technology, Center for Research on Health Care, University of Pittsburgh
School of Medicine, Pittsburgh, PA, United States
Publisher
Quadrant Healthcom Inc.
Abstract
background: Recovery from coronary artery bypass graft (CABG) surgery
often is complicated by depression and insomnia, resulting in poorer
health-related quality of life and clinical outcomes. We explored the
relationships among depression, insomnia, quality of life, and the impact
of a collaborative care strategy on reducing insomnia in patients after
CABG surgery. methods: Patients with a Patient Health Questionnaire score
>10 were randomized to nurse-delivered collaborative care for depression
(n = 150) or their physician's usual care (n = 152). A convenience sample
of patients without depression (n = 151) served as the control group.
Using the Hamilton Depression Rating Scale sleep questions, we created an
"insomnia index." results: At baseline, 63% of participants who were
depressed vs 12% of those who were not depressed reported insomnia.
Compared with usual care, fewer collaborative care participants reported
insomnia at 8 months, and they tended to have a lower insomnia score
(insomnia index change score-0.95 and-1.47, respectively; P = .05) with no
time-by-randomization interaction, Cohen's d = 0.22 (95% confidence
interval,-0.001 to 0.43). Participants with baseline insomnia reported
greater improvements in mental health-related quality of life (Medical
Outcomes Survey 36-item Short Form Mental Component Summary score;-3.32, P
= .02), but insomnia was not a significant moderator of the effect of
collaborative care.<br/>Copyright &#xa9; 2020 Quadrant Healthcom Inc.. All
rights reserved.

<5>
Accession Number
627259567
Title
A prospective randomized comparison of airway seal using the novel
vision-guided insertion of LMA-Supreme and LMA-Protector.
Source
Journal of Clinical Monitoring and Computing. 34 (2) (pp 285-294), 2020.
Date of Publication: 01 Apr 2020.
Author
van Zundert A.A.J.; Wyssusek K.H.; Pelecanos A.; Roets M.; Kumar C.M.
Institution
(van Zundert, Wyssusek, Roets) Department of Anaesthesia and Perioperative
Medicine, Royal Brisbane and Women's Hospital, The University of
Queensland, Brisbane, QLD, Australia
(Pelecanos) Statistics Unit, QIMR Berghofer Medical Research Institute,
The University of Queensland, Brisbane, QLD, Australia
(Kumar) Department of Anaesthesia, Khoo Teck Puat Hospital, Yishun
Central, Singapore
(Kumar) Newcastle University, Newcastle, United Kingdom
(van Zundert) Queensland University of Technology, Brisbane, QLD,
Australia
Publisher
Springer (E-mail: editorial@springerplus.com)
Abstract
The laryngeal mask airways supreme (LMA-SupremeTM) and protector
(LMA-ProtectorTM) are generally placed blindly, often resulting in a less
than optimal position and vision-guided placement has been recommended.
This prospective, randomized controlled study compared the efficacy of
airway seal by measuring the oropharyngeal leak pressure in 100 surgical
patients who underwent a variety of non-thoracic surgery under general
anaesthesia, suitable with a supraglottic airway device. Patients were
allocated to either the LMA-Supreme (n = 50) or LMA-Protector (n = 50)
group. All insertions were performed under vision of a videolaryngoscope
using an 'insert-detect-correct-as-you-go' technique with standardized
corrective measures. Our primary endpoint, mean oropharyngeal leak
pressure, was significantly higher in the LMA-Protector (31.7 +/- 2.9 cm
H<inf>2</inf>O) compared to the LMA-Supreme (27.7 +/- 3.5 cm
H<inf>2</inf>O) group (mean difference 4.0 cm H<inf>2</inf>O, 95%
confidence interval (CI) 2.7-5.3 cm H<inf>2</inf>O, p < 0.001) after
achieving a near-optimal fibreoptic position in the LMA-Protector (94%)
and LMA-Supreme (96%) groups. No statistically significant differences
were shown for secondary outcomes of alignment, number of insertion
attempts and malpositions, and final anatomical position as scored by
fibreoptic evaluation. Corrective manoeuvres were required in virtually
all patients to obtain a correct anatomically positioned LMA. Position
outcomes of the two devices were similar except for the proportion of
procedures with folds in the proximal cuff (90% LMA-Supreme vs. 2%
LMA-Protector, p < 0.001), the need for intracuff pressure adjustments
(80% LMA-Supreme vs. 48% LMA-Protector, p = 0.001) and size correction
(18% LMA-Supreme vs. 4% LMA-Protector, p = 0.025). In conclusion, a higher
oropharyngeal leak pressure can be achieved with LMA-Protector compared to
LMA-Supreme with optimal anatomical position when insertion is
vision-guided.<br/>Copyright &#xa9; 2019, Springer Nature B.V.

<6>
Accession Number
2004465193
Title
Review of the discard and/or refusal rate of offered donor hearts to
pediatric waitlisted candidates.
Source
Pediatric Transplantation. (no pagination), 2020. Date of Publication:
2020.
Author
Schweiger M.; Everitt M.D.; Chen S.; Nandi D.; Castro J.; Gupta D.; Scheel
J.; Lal A.K.; Ablonczy L.; Kirk R.; Miera O.; Davies R.R.; Dipchand A.I.
Institution
(Schweiger) Division of Cardiac Surgery, Pediatric Heart Center,
University Children's Hospital Zurich, Zurich, Switzerland
(Everitt) Children's Hospital Colorado, Denver, CO, United States
(Chen) Stanford University, Palo Alto, CA, United States
(Nandi) Nationwide Children's Hospital, Columbus, OH, United States
(Castro) Fundacion Cardiovascular de Colombia, Bucaramanga City, Colombia
(Gupta) Congenital Heart Center, University of Florida, Gainesville, FL,
United States
(Scheel) Washington University School of Medicine, St Louis, MO, United
States
(Lal) University of Utah, Salt Lake City, UT, United States
(Ablonczy) Pediatric Cardiac Center, Hungarian Institute of Cardiology,
Budapest, Hungary
(Kirk) Division of Pediatric Cardiology, University of Texas Southwestern
Medical Center, Children's Medical Center, Dallas, TX, United States
(Miera) Department of Congenital Heart Disease/Pediatric Cardiology,
Deutsches Herzzentrum, Berlin, Germany
(Davies) Department of Cardiovascular and Thoracic Surgery, Children's
Medical Center, University of Texas Southwestern Medical Center, Dallas,
TX, United States
(Dipchand) Labatt Family Heart Centre, Hospital for Sick Children,
University of Toronto, Toronto, ON, Canada
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
We aimed to review current literature on the discard rate of donor hearts
offered to pediatric recipients and assess geographical differences.
Consequences and ways to reduce the discard rate are discussed. A systemic
review on published literature on pediatric transplantation published in
English since 2010 was undertaken. Additionally, a survey was sent to
international OPOs with the goal of incorporating responses from around
the world providing a more global picture. Based on the literature review
and survey, there is a remarkably wide range of discard and/or refusal for
pediatric hearts offered for transplant, ranging between 18% and 57% with
great geographic variation. The data suggest that that the overall refusal
rate may have decreased over the last decade. Reasons for organ discard
were difficult to identify from the available data. Although the refusal
rate of pediatric donor hearts seems to be lower compared to that reported
in adults, it is still as high as 57% with geographic
variation.<br/>Copyright &#xa9; 2020 Wiley Periodicals, Inc.

<7>
Accession Number
2004465105
Title
Review of interactions between high-risk pediatric heart transplant
recipients and marginal donors including utilization of risk score models.
Source
Pediatric Transplantation. (no pagination), 2020. Date of Publication:
2020.
Author
Gossett J.G.; Amdani S.; Khulbey S.; Punnoose A.R.; Rosenthal D.N.; Smith
J.; Smits J.; Dipchand A.I.; Kirk R.; Miera O.; Davies R.R.
Institution
(Gossett) University of California Benioff Children's Hospitals, San
Francisco, CA, United States
(Amdani) Cleveland Clinic Children's Hospital, Cleveland, OH, United
States
(Khulbey) Apollo Hospital, Hyderabad, India
(Punnoose) Children's Hospital of Wisconsin, Milwaukee, WI, United States
(Rosenthal) Stanford University, Palo Alto, CA, United States
(Smith) Freeman Hospital, Newcastle upon Tyne, United Kingdom
(Smits) Eurotransplant International Foundation, Leiden, Netherlands
(Dipchand) Labatt Family Heart Centre, Hospital for Sick Children,
University of Toronto, Toronto, ON, Canada
(Kirk) Division of Pediatric Cardiology, Children's Medical Center,
University of Texas Southwestern Medical Center, Dallas, TX, United States
(Miera) Department of Congenital Heart Disease/Pediatric Cardiology,
Deutsches Herzzentrum, Berlin, Germany
(Davies) Department of Cardiovascular and Thoracic Surgery, Children's
Medical Center, University of Texas Southwestern Medical Center, Dallas,
TX, United States
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Background: Donor organ acceptance practices vary among pediatric heart
transplant professionals. We sought to understand what is known about the
interactions between the "high-risk" recipient and the "marginal donor,"
and how donor risk scores can impact this discussion. <br/>Method(s): A
systematic review of published literature on pediatric HTx was undertaken
with the assistance of a medical librarian. Two authors independently
assessed search results, and papers were reviewed for inclusion.
<br/>Result(s): We found that there are a large number of individual
factors, and clusters of factors, that have been used to label individual
recipients "high-risk" and individual donors "marginal." The terms
"high-risk recipient" and "marginal donor" have been used broadly in the
literature making it virtually impossible to make comparisons between
publications. In general, the data support that patients who could be
easily agreed to be "sicker recipients" are at more risk compared to those
who are clearly "healthier," albeit still "sick enough" to need
transplantation. Given this variability in the literature, we were unable
to define how being a "high-risk" recipient interplays with accepting a
"marginal donor." Existing risk scores are described, but none were felt
to adequately predict outcomes from factors available at the time of offer
acceptance. <br/>Conclusion(s): We could not determine what makes a donor
"marginal," a recipient "high-risk," or how these factors interplay within
the specific recipient-donor pair to determine outcomes. Until there are
better risk scores predicting outcomes at the time of organ acceptance,
programs should continue to evaluate each organ and recipient
individually.<br/>Copyright &#xa9; 2020 Wiley Periodicals, Inc.

<8>
Accession Number
2004453523
Title
Permanent pacemaker implantation in pediatric heart transplant recipients:
A systematic review and evidence quality assessment.
Source
Pediatric Transplantation. (no pagination), 2020. Date of Publication:
2020.
Author
Mylonas K.S.; Repanas T.; Athanasiadis D.I.; Voulgaridou A.; Sfyridis
P.G.; Bakoyiannis C.; Kapelouzou A.; Avgerinos D.V.; Tzifa A.; Kalangos A.
Institution
(Mylonas, Sfyridis, Kalangos) Department of Pediatric Cardiac Surgery,
Mitera Children's Hospital, HYGEIA Group, Athens, Greece
(Mylonas, Tzifa) Department of Pediatric Cardiology and Adult Congenital
Heart Disease, Mitera Children's Hospital, HYGEIA Group, Athens, Greece
(Repanas) Department of Cardiology, Augusta Hospital, Dusseldorf, Germany
(Athanasiadis) Department of Surgery, Indiana University School of
Medicine, Indianapolis, IN, United States
(Voulgaridou) Department of Pediatrics, Kavala General Hospital, Kavala,
Greece
(Bakoyiannis) Division of Vascular Surgery, Laikon General Hospital,
National and Kapodistrian University of Athens, Athens, Greece
(Kapelouzou) Clinical, Experimental Surgery & Translational Research,
Biomedical Research Foundation Academy of Athens, Athens, Greece
(Avgerinos) Department of Cardiothoracic Surgery, New York Presbyterian
Hospital, Weill Cornell Medicine, New York City, NY, United States
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Bradyarrhythmias are a common complication following pediatric OHT and may
require permanent pacemaker implantation (PPM). The purpose of this study
was to investigate the incidence, predictors, and outcomes of children
undergoing PPM implantation following OHT. A PRISMA-compliant systematic
literature review was performed using the PubMed database and the Cochrane
Library (end-of-search date: January 27, 2019). The Newcastle-Ottawa scale
and the Joanna Briggs Institute tool were used to assess the quality of
cohort studies and case reports, respectively. We analyzed data from a
total of 11 studies recruiting 7198 pediatric patients who underwent heart
transplant. PPM implantation was performed in 1.9% (n = 137/7,198; 95% CI:
1.6-2.2) of the patients. Most patients underwent dual-chamber pacing
(46%, 95% CI: 32.6-59.7). Male-to-female ratio was 1.3:1. Mean patient age
at the time of OHT was 10.1 +/- 6.3. Overall, biatrial anastomosis was
used in 62.2% (95% CI: 52.8-70.6) of the patients. The bicaval technique
was performed in the remaining 37.8% (95% CI: 29.4-47.1). Sinus node
dysfunction was the most frequent indication for PPM implantation (54.4%;
95% CI: 42.6-65.7) followed by AV block (45.6%; 95% CI: 34.3-57.3). The
median time interval between OHT and PPM implantation ranged from 17 days
to 12.5 years. All-cause mortality was 27.9% (95% CI: 18.6-39.6) during a
median follow-up of 5 years. PPM implantation is rarely required after
pediatric OHT. The most common indication for pacing is sinus node
dysfunction, and patients undergoing biatrial anastomosis may be more
likely to require PPM.<br/>Copyright &#xa9; 2020 Wiley Periodicals, Inc.

<9>
Accession Number
2005258746
Title
Anticoagulation and amiodarone for new atrial fibrillation after coronary
artery bypass grafting: Prescription patterns and 30-day outcomes in the
United States and Canada.
Source
Journal of Thoracic and Cardiovascular Surgery. (no pagination), 2020.
Date of Publication: 2020.
Author
Matos J.D.; McIlvaine S.; Grau-Sepulveda M.; Jawitz O.K.; Brennan J.M.;
Khabbaz K.R.; Sellke F.W.; Yeh R.; Zimetbaum P.
Institution
(Matos, McIlvaine, Yeh, Zimetbaum) Division of Cardiology, Department of
Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School,
Boston, Mass, United States
(Grau-Sepulveda, Jawitz, Brennan) Duke Clinical Research Institute,
Durham, NC, United States
(Khabbaz) Department of Cardiac Surgery, Beth Israel Deaconess Medical
Center and Harvard Medical School, Boston, Mass, United States
(Sellke) Department of Cardiothoracic Surgery, Brown Medical School and
Lifespan Hospitals, Providence, RI, United States
(Yeh, Zimetbaum) Smith Center for Cardiovascular Outcomes Research, Beth
Israel Deaconess Medical Center, Boston, Mass, United States
Publisher
Mosby Inc. (E-mail: customerservice@mosby.com)
Abstract
Objective: We sought to elucidate national practice patterns regarding
anticoagulation and antiarrhythmic medication use at discharge and examine
short-term patient outcomes. <br/>Method(s): In this retrospective cohort
study, we analyzed the data of patients from the Society of Thoracic
Surgeons Adult Cardiac Surgery Database from July 2011 to June 2018 who
underwent first-time isolated coronary artery bypass graft surgery (CABG)
and developed new post-CABG atrial fibrillation (AF) without significant
complications. In total, 166,747 patients met study criteria. We examined
30-day outcomes. <br/>Result(s): In total, 166,747 patients were analyzed
and divided into 4 groups based on discharge medications: amiodarone with
or without anticoagulation, anticoagulation alone, and neither.
Demographic characteristics were similar among the 4 groups. In total,
25.7% of patients were discharged on anticoagulation with an average
CHA<inf>2</inf>DS<inf>2</inf>-VASc score of 3.2 +/- 1.3. Anticoagulation
use at discharge was not associated with lower 30-day stroke readmissions
(adjusted odds ratio [AOR], 0.87; 95% confidence interval [CI], 0.65-1.16;
P =.35). Adjusted 30-day readmissions for major bleeding were
significantly more common in anticoagulated patients (AOR, 4.30; 95% CI,
3.69-5.03; P <.0001). Among those discharged off anticoagulation, there
was no significant difference in adjusted 30-day stroke rates based on
amiodarone use at discharge (AOR, 1.19; 95% CI, 0.85-1.66; P =.31).
<br/>Conclusion(s): Post-CABG anticoagulation for new AF is associated
with increased bleeding and no difference in stroke at 30 days.
Prospective randomized studies are needed to formalize safe and
efficacious short- and long-term management strategies.<br/>Copyright
&#xa9; 2020

<10>
Accession Number
2005039226
Title
RATE VERSUS RHYTHM CONTROL OF ATRIAL FIBRILLATION AFTER CARDIAC SURGERY IN
PATIENTS WITH HEART FAILURE.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 402), 2020. Date of
Publication: 24 Mar 2020.
Author
Yang E.; Spragg D.; Schulman S.P.; Whitman G.; Metkus T.S.
Institution
(Yang, Spragg, Schulman, Whitman, Metkus) Johns Hopkins Hospital,
Baltimore, MD, United States
Publisher
Elsevier USA
Abstract
Background Whether rhythm control for post-operative atrial fibrillation
after cardiac surgery (POAF) is superior to rate control in patients with
heart failure (HF) is not known. Methods We performed a post-hoc analysis
of a trial by the Cardiothoracic Surgical Trials Network, which randomized
patients with POAF to rate control or rhythm control with
amiodarone/cardioversion. We defined HF as heart failure/cardiomyopathy
history or left ventricular ejection fraction (LVEF) < 50%. We conducted a
stratified analysis in patients with and without HF to determine which
strategy was superior for restoration of normal sinus rhythm (NSR) and for
prevention of readmission. Results Of 523 subjects, 131 (33.4%) had HF. Of
these, 49.6% had isolated CABG and the remainder valve surgery. 49% of HF
patients were randomized to rhythm control. Rhythm control was associated
with increased return to NSR within 7 days in HF patients (Panel A: HR
1.66; 95% CI 1.13-2.45; p=0.01) and less so in non-HF patients (Panel B).
There were no differences at 30 and 60 day follow-up, at which time over
90% of subjects were back in NSR. (Panels C and D). Readmission rates
(21.9% for rhythm control vs. 23.9% for rate control; p=0.78) were
comparable between treatment arms. Conclusion Rhythm control for HF
patients with POAF after cardiac surgery increases early restoration of
sinus rhythm, but does not improve outcomes at 60 days following
discharge. Rate and rhythm control are both reasonable for HF patients
with AF after cardiac surgery. [Figure presented]<br/>Copyright &#xa9;
2020 American College of Cardiology Foundation

<11>
Accession Number
2005039173
Title
MORTALITY & PACEMAKER IMPLANTATION IN BICUSPID VERSUS TRICUSPID SEVERE
AORTIC STENOSIS TREATED WITH TAVR: A SYSTEMATIC REVIEW WITH META-ANALYSIS
OF SEVENTEEN STUDIES.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 1424), 2020. Date of
Publication: 24 Mar 2020.
Author
Majmundar M.M.; Doshi R.P.; Shah P.; Kansara T.; Patel K.; Azhar A.Z.;
Patel A.; Visco F.; Mushiyev S.
Institution
(Majmundar, Doshi, Shah, Kansara, Patel, Azhar, Patel, Visco, Mushiyev)
Metropolitan Hospital Center, New York Medical College, New York, NY,
United States
Publisher
Elsevier USA
Abstract
Background The studies have proven the beneficial effect of transcatheter
aortic valve replacement (TAVR) on mortality in patients with severe
tricuspid aortic stenosis (TAS) in high & intermediate-risk population.
However, these studies excluded individuals with severe bicuspid aortic
stenosis (BAS) due to anatomical challenges and anticipated complications.
We conducted a meta-analysis of clinical outcomes comparing BAS to TAS.
Methods The authors performed a comprehensive literature search in PubMed,
Embase, Cochrane library up to August 31^st, 2019, & included
original articles comparing TAVR in BAS vs. TAS which contains unadjusted
data on the outcome. The authors extracted data on the demographic
characteristics, procedure complication, clinical results, & calculated
relative risk (RR) and 95% confidence interval (CI) for 30-day mortality &
pacemaker implantation. The authors used a random effect
(DirSimonian-Laird model) to pool the results & funnel plot to assess
publication bias. Results This meta-analysis included seventeen studies
totaling 87,827 patients including TAS (n= 84,381) & BAS (n=3,446) group.
There was no difference in 30-day mortality (RR = 1.0, 95% CI 0.98 - 1.01,
p = 0.72, I² = 24.68%) & pacemaker implantation after TAVR (RR
= 1.02, 95% CI 0.98 - 1.05, p = 0.42, I² = 27.69%) in BAS group
compared to TAS. There was no publication bias in both outcomes.
Conclusion TAVR in severe BAS is comparable to severe TAS in terms of
30-days all-cause mortality & pacemaker implantation. [Figure
presented]<br/>Copyright &#xa9; 2020 American College of Cardiology
Foundation

<12>
Accession Number
2005039156
Title
CARDIOMYOPATHY IN PREGNANCY - RISK IN THE ERA OF GOAL-DIRECTED MEDICAL
THERAPY: A TERTIARY CARE CENTER EXPERIENCE & SYSTEMATIC REVIEW.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 889), 2020. Date of
Publication: 24 Mar 2020.
Author
Dodeja A.; Urbina F.; Dodd K.; Ma'ayeh M.; Mehta L.; Fuchs M.; Rood K.;
Mah M.L.; Bradley E.
Institution
(Dodeja, Urbina, Dodd, Ma'ayeh, Mehta, Fuchs, Rood, Mah, Bradley)
Nationwide Childrens Hospital, Columbus, OH, USA, Nationwide Childrens
Hospital, Columbus, OH, USA; The Ohio State University, Columbus, OH, USA,
The Ohio State University, Columbus, OH, USA
Publisher
Elsevier USA
Abstract
Background Women with cardiomyopathy (CM) are often advised against
pregnancy due to risk for maternal major adverse cardiovascular events
(MACE). However, the impact of goal directed therapy on maternal MACE is
not understood. We sought to evaluate maternal MACE by subtype of CM and
use of GDMT in a contemporary cohort. Methods We evaluated all pregnant
women in our high-risk maternal cardiovascular program (2009-2019).
Composite maternal MACE included: death, inotrope use, left ventricular
assist device, orthotopic heart transplant (OHT) and/or escalation in OHT
listing status, acute decompensated heart failure and sustained
ventricular arrhythmia. Results Among 875 women (979 pregnancies)
followed, 32 had CM (29 +/- 7 years old, Ejection Fraction (EF) 41+12%):
Ischemic 3, Peripartum (PPCM) 10 and Other CM 19. Women with Other CM were
more likely to have used beta-blockers pre-pregnancy (16 (84%) vs. PPCM: 4
(40%) & ICM: 2 (66%), p<=0.05). MACE events occurred in 6 (18%) women
(PPCM: 2 (33%), Other CM 4 (67%)). There was no difference in EF at
baseline, however, women with MACE had significantly lower heart function
both early (EF: 27 + 5% vs. 41 + 2%, p<0.05) and late postpartum (EF: 28 +
5% vs. 44 + 2%, p<0.01) (Figure). Conclusion In this contemporary cohort
of women with CM, maternal MACE rates were lower than previously reported,
perhaps due to beta-blocker therapy. However, EF in women with MACE was
lower immediately and late post-partum, suggesting pregnancy may have
lasting effects on function. [Figure presented]<br/>Copyright &#xa9; 2020
American College of Cardiology Foundation

<13>
Accession Number
2005039079
Title
MAINTENANCE IMMUNOSUPPRESSION IN HEART TRANSPLANTATION: INSIGHTS FROM
NETWORK META-ANALYSIS OF VARIOUS IMMUNOSUPPRESSION REGIMENS.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 713), 2020. Date of
Publication: 24 Mar 2020.
Author
Ueyama H.; Kuno T.; Takagi H.; Alvarez P.; Briasoulis A.
Institution
(Ueyama, Kuno, Takagi, Alvarez, Briasoulis) University of Iowa, Iowa, IA,
USA, University of Iowa, Iowa, IA, USA; Icahn School of Medicine at Mount
Sinai, Mount Sinai Beth Israel, New York, NY, USA, Icahn School of
Medicine at Mount Sinai, Mount Sinai Beth Israel, New York, NY, USA
Publisher
Elsevier USA
Abstract
Background mTOR antagonists (mTA) may be superior to calcineurin
inhibitors (CNI) in prevention of cardiac allograft vasculopathy (CAV)
after heart transplant (HT). Methods MEDLINE and EMBASE were searched for
studies comparing the effects of maintenance immunosuppression with mTA +
antimetabolites (AM), CNI+mTA or CNI+ AM post HT on all-cause death, CAV,
acute rejection, CMV infections and change in eGFR. A random-effects
network meta-analysis was performed. Results Our search identified
fourteen eligible studies (4 studies comparing mTA+AM vs. CNI+AM and 10
CNI+mTA vs. CNI+ AM). All-cause death was not different among
immunosuppression regimens. CAV rates were significantly lower with CNI+
mTA (OR 0.53, 95% CI 0.3-0.92). Acute rejection rates were significantly
lower with CNI+AM (OR 0.25, 95% CI 0.07-0.96) and CNI+ mTA (OR 0.17, 95%
CI 0.04-0.71) (Figure) compared with mTA+AM. CMV infections were
significantly lower with mTA+AM (OR 0.13, 95% CI 0.03-0.46) and CNI+ mTA
(OR 0.27, 95% CI 0.2-0.38) compared with CNI+AM. mTA+AM led to significant
improvement of eGFR compared with CNI+ mTA. CNI+ mTA ranked better for CAV
(p=0.78), CNI+AM for acute rejection (p=0.96) and mTA+AM for CMV infection
(p=0.94) and improvement in renal function (p=0.86) than other regimens.
Conclusion Different immunosuppression regimens have similar effects on
survival post HT, but CNI+ mTA was associated with lower CAV rates, CNI+AM
with less rejection, and mTA+AM with less CMV infection and improved eGFR
post HT. [Figure presented]<br/>Copyright &#xa9; 2020 American College of
Cardiology Foundation

<14>
Accession Number
2005039061
Title
OUTCOMES AFTER SURGICAL EXCISION OF THE LEFT ATRIAL APPENDAGE WITH OR
WITHOUT ANTICOAGULATION.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 409), 2020. Date of
Publication: 24 Mar 2020.
Author
Anderson J.L.; Horne B.D.; Doty J.R.; Jones K.W.; Bair T.; May H.;
Muhlestein J.B.; Knowlton K.
Institution
(Anderson, Horne, Doty, Jones, Bair, May, Muhlestein, Knowlton)
Intermountain Medical Center, Salt Lake City, UT, USA, Intermountain
Medical Center, Salt Lake City, UT, USA; University of Utah, Salt Lake
City, UT, USA, University of Utah, Salt Lake City, UT, USA
Publisher
Elsevier USA
Abstract
Background 90% of thromboemboli (TE) causing stroke in patients with
atrial fibrillation (AF) arise from the left atrial appendage (LAA).
Surgical excision of the LAA (seLAA) is often performed during cardiac
surgery. A large STS database study reported a reduction in TE events,
hemorrhagic stroke, or death after seLAA. However, the net impact of the
addition of an oral anticoagulant (OAC) after seLAA is uncertain. Methods
We searched the Intermountain Healthcare database from 2008-2019 for
patients (pts) with a diagnosis of AF undergoing cardiac surgery who had
concomitant seLAA. Pts with mechanical valves, who require an OAC (i.e.,
warfarin) were excluded. For pts receiving a bioprosthesis, for whom OAC
may be indicated short-term, analysis also was performed beginning at 6
months. The primary outcome was all-cause death or stroke. Multivariable
Cox proportional hazard ratios were determined, comparing OAC use with
non-use, and adjusting for potentially confounding variables, including
age, sex, type of surgery, standard risk factors, heart failure, and
medications. Results The study comprised 657 patients. Age averaged 71
years (18-90); 64% were men; type of surgery was 56% bypass (CABG), 38%
CABG/valve, 2% valve alone, and 4% unknown. 326 were discharged on an OAC
and 331 were not. During 4.8+/-2.4 y of follow-up, 73 pts suffered a
stroke and 194 died. Overall, no significant difference in outcome by OAC
at discharge was noted: adjusted (adj) HR=0.97 (CI 0.75,1.25), p=0.82.
Adding bioprosthesis patients only after 6 months to CABG pts resulted in
an adj HR=1.20 (0.89, 1.62), p=0.23 (n=564). Restricting analysis to
CABG-only pts yielded an adj HR=1.20 (0.85, 1.22), p=0.30 (n=366). After a
bioprosthesis, OAC was protective during the first 6 months (adj HR 0.50,
CI 0.28, 0.91; p=0.02). Conclusion In this patient cohort with AF
undergoing seLAA, OAC was associated with better outcomes only during the
first 6 months after surgery including a bioprosthetic valve. Otherwise,
OAC did not add net benefit over seLAA alone for long-term
stroke/mortality prevention. These observations are particularly relevant
to pts at increased hemorrhagic risk and deserve validation in a
prospective, randomized trial.<br/>Copyright &#xa9; 2020 American College
of Cardiology Foundation

<15>
Accession Number
2005038922
Title
QUANTITATIVE ASSESSMENT OF ACUTE REGURGITATION FOLLOWING TRANSCATHETER
AORTIC VALVE IMPLANTATION: A MULTICENTER POOLED ANALYSIS OF 2,258 VALVES.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 2114), 2020. Date of
Publication: 24 Mar 2020.
Author
Modolo R.G.P.; Chang C.C.; Kawashima H.; Ono M.; Tateishi H.; Miyazaki Y.;
Pighi M.; Abdelghani M.; Wykrzykowska J.; de Winter R.; Ruck A.; Chieffo
A.; Yamaji K.; Brito F.S.; Lemos P.A.; Al-Kassou B.; Piazza N.; Tchetche
D.; Sinning J.-M.; Abdel-Wahab M.; Soliman O.; Sondergaard L.; Onuma Y.;
Van Mieghem N.; Serruys P.
Institution
(Modolo, Chang, Kawashima, Ono, Tateishi, Miyazaki, Pighi, Abdelghani,
Wykrzykowska, de Winter, Ruck, Chieffo, Yamaji, Brito, Lemos, Al-Kassou,
Piazza, Tchetche, Sinning, Abdel-Wahab, Soliman, Sondergaard, Onuma, Van
Mieghem, Serruys) Imperial College London, London, United Kingdom
Publisher
Elsevier USA
Abstract
Background Regurgitation following transcatheter aortic valve replacement
(TAVR) impacts all-cause mortality. We sought to compare the quantitative
regurgitation after TAVR with different transcatheter aortic valves.
Methods Pooled analysis of 3,976 TAVR in a multicenter cohort. A total of
2,258 (58.3%) were considered analyzable by an independent academic core
lab using videodensitometry. Results of quantitative regurgitation are
shown in percentage. Valves evaluated were: Acurate (n=115), Centera
(n=11), CoreValve (n=532), Direct-Flow-Medical (n=21), Evolut Pro (n=95),
Evolut R (n=295), Inovare (n=4), Lotus (n=546), Lotus Edge (n=3), Sapien
XT (n=239) and Sapien 3 (n=397). For the main analysis only valves with
more than 50 procedures (7 types) were used. Results Lotus valve had the
lowest mean regurgitation (3.5 +/- 4.4%), followed by Evolut Pro (7.4 +/-
6.5%), Sapien 3 (7.6 +/- 7.1%), Evolut R (7.9 +/- 7.4%), Sapien XT (8.8
+/- 7.5%), Acurate (9.6 +/- 9.2%) and CoreValve (13.7 +/- 10.7%, ANOVA
p-value < 0.001). The only valves that statistically differed from all
their counterparts were Lotus (as the lowest regurgitation) and CoreValve
(the highest). Keeping selection bias in mind, the proportion of pts with
moderate / severe regurgitation is shown in the figure. Conclusion The
Lotus valve was associated with the least amount of regurgitation. This
analysis shows the objective evaluation of regurgitation by a core lab in
real-world patients using a reproducible and quantitative technique.
[Figure presented]<br/>Copyright &#xa9; 2020 American College of
Cardiology Foundation

<16>
Accession Number
2005038852
Title
INTER- AND INTRA-USER VARIABILITY OF THE SYNTAX SCORE.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 1353), 2020. Date of
Publication: 24 Mar 2020.
Author
Levine E.; Basman C.; Tejpal A.; Barry R.; Thampi S.; Rashid U.; Coplan
N.; Singh V.P.
Institution
(Levine, Basman, Tejpal, Barry, Thampi, Rashid, Coplan, Singh) Lenox Hill
Hospital, New York, NY, United States
Publisher
Elsevier USA
Abstract
Background The SYNTAX score (SX) is an angiographic grading system to
determine the burden and complexity of coronary artery disease (CAD) and
to guide operators as to the appropriateness of percutaneous coronary
intervention (PCI) vs coronary artery bypass grafting (CABG). However,
variability of the SX may exist since the assessment relies on individual
clinicians to visually interpret lesion severity and characteristics.
Methods Fifty patient angiograms were randomly selected from a registry of
patients with multi-vessel CAD (treated with PCI or CABG) completed at our
institution during the years 2011-2018. Each angiogram was evaluated by 6
cardiologists on 2 separate occasions (minimum 8 weeks between occasions)
for a total of 600 SX. Our goal was to evaluate both inter- and
intra-observer variability of SX. Variation in both raw score as well as
risk classification (low, intermediate or high SX) was observed. Inter-
and intra-observer reliability were assess using the intra-class
correlation coefficient (ICC). Results SYNTAX scores on both assessments
and across all 6 cardiologists had a mean score of 25.3. The
inter-observer reliability among the 6 on the first assessment was 0.61
(95% CI: 0.50, 0.73). Across the 6 observers, only 16% of angiograms were
classified in the same risk classification by all observers. 34% of
angiograms had less than a majority agreement (3 or less observers) on
risk classification. Intra-observer reliability ranged from 0.3 to 0.81.
Across the 6 observers, the proportion of angiograms classified as the
same risk classification between each observer&apos;s 1st and 2nd
assessment ranged from 46% to 84%. Conclusion This study shows a wide
inter- and intra-user variability in calculating SX. Our data indicates a
significant limitation in using the SX to guide revascularization
strategies. Further studies are needed to determine more reliable ways to
assess SX.<br/>Copyright &#xa9; 2020 American College of Cardiology
Foundation

<17>
Accession Number
2005038813
Title
COMPARISON OF LEFT TRANSRADIAL AND TRANSFEMORAL ACCESS FOR CORONARY
ANGIOGRAPHY IN PATIENTS WITH PRIOR CORONARY ARTERY BYPASS GRAFTS: A
SYSTEMIC REVIEW AND META-ANALYSIS.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 1279), 2020. Date of
Publication: 24 Mar 2020.
Author
Riangwiwat T.; Limpruttidham N.; Prasitlumkum N.; Yost G.W.
Institution
(Riangwiwat, Limpruttidham, Prasitlumkum, Yost) Heart Institute, Geisinger
Medical Center, Danville, PA, USA, Heart Institute, Geisinger Medical
Center, Danville, PA, USA; University of Hawaii Internal Medicine
Residency Program, Honolulu, HI, USA, University of Hawaii Internal
Medicine Residency Program, Honolulu, HI, USA
Publisher
Elsevier USA
Abstract
Background Transradial access (TR) has grown in popularity due to less
bleeding and vascular complications with earlier ambulation compared to
transfemoral access (TF). Left radial access is an alternative to TF for
patients with prior coronary artery bypass graft surgery (CABG) when left
internal mammary artery graft (LIMA) used. We compared outcomes between
left TR and TF in these patients undergoing coronary angiography (CAG) in
terms of contrast amount used, procedural time and fluoroscopy time.
Methods We comprehensively searched the databases of PUBMED and MEDLINE
from inception to August 2019. All randomized and observational studies
that compared the amount of contrast use, procedural time, and fluoroscopy
time between left TR and TF for CAG in prior CABG with LIMA patients were
included. Data from each study were combined using the random-effects,
generic inverse variance method of DerSimonian and Laird to calculate
weighted mean differences (WMD) and 95% confidence intervals (CI). All
statistical analysis was performed using Stata 13 statistical software.
Results One randomized control trial and four observational studies were
included in this meta-analysis with a total of 1,138 patients. Left TR had
statistically significantly longer procedural time, compared to TF (WMD
2.49 minutes, 95% CI 0.65 to 4.34). This was predominantly driven by
Michael et al study in which primary operators were cardiology trainees
and had higher crossover rate than other studies. There was no statistical
difference in fluoroscopic time (WMD 0.61 minutes, 95% CI -2.40 to 3.62),
and contrast use (WMD 2.78 milliliters, 95% CI -14.77 to 20.33).
Conclusion Left TR is associated with slightly longer procedural time but
similar fluoroscopic time and amount of contrast use. We propose that left
TR is clinically non-inferior to TF for CAG in patients with prior CABG
with LIMA.<br/>Copyright &#xa9; 2020 American College of Cardiology
Foundation

<18>
Accession Number
2005038771
Title
PRIMARY UNDIFFERENTIATED PLEOMORPHIC SARCOMA OF THE LEFT ATRIUM: A
CASE-BASED REVIEW OF LITERATURE.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 2532), 2020. Date of
Publication: 24 Mar 2020.
Author
Kalamkarian A.; Natarajan B.; Hasaniya N.; Nazzal S.; Alesh I.G.
Institution
(Kalamkarian, Natarajan, Hasaniya, Nazzal, Alesh) University of
California, Riverside, Riverside, CA, USA, University of California,
Riverside, Riverside, CA, USA; Saint Bernadine Medical Center, San
Bernadino, CA, USA, Saint Bernadine Medical Center, San Bernadino, CA, USA
Publisher
Elsevier USA
Abstract
Background Cardiac sarcomas constitute 0.3% of all soft tissue sarcomas,
but account for 75% of all primary cardiac tumors. Undifferentiated
pleomorphic sarcoma (UPS) is a high-grade tumor associated with poor
survival. Here, we describe the clinical course in a young woman with
recurrent UPS of the left atrium (LA). Case 37-year-old woman was seen for
worsening dyspnea over 6 months. Echo showed a large mobile mass filling
the LA and causing severe mitral stenosis. Our first suspicion was for LA
myxoma with a septal attachment. Heart team decided on surgical debulking.
Intra-operatively, a 5x7x4 cm multi-lobulated mass with fibrous
consistency was seen to arise from the posterior LA. After dissecting the
tumor to its base, it was found to invade the right inferior pulmonary
vein and further debulking was not possible. Frozen section confirmed
high-grade undifferentiated pleomorphic sarcoma. Decision-making PET scan
showed lung metastasis. She was started on TNF-linked Doxorubicin and
Entrectinib chemotherapy. Follow-up chest CT showed recurrence in under 2
months after debulking. Conclusion UPS are locally aggressive, have a
predilection for the left heart and can present early as heart failure.
Complete surgical excision prolongs survival compared to chemotherapy
alone, but hard to achieve due to anatomic location and aggressive nature
of the tumor. Anthracycline based regimens are first-line and various
drugs targeting oncogenes are currently on trial. Overall prognosis
continues to be poor. [Figure presented]<br/>Copyright &#xa9; 2020
American College of Cardiology Foundation

<19>
Accession Number
2005038756
Title
EFFECT OF ALIROCUMAB ON FIRST AND TOTAL REVASCULARIZATIONS IN PATIENTS
WITH RECENT ACUTE CORONARY SYNDROME IN THE ODYSSEY OUTCOMES TRIAL.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 157), 2020. Date of
Publication: 24 Mar 2020.
Author
Szarek M.; Valgimigli M.; Zeiher A.; Steg P.G.; Bhatt D.; Bittner V.;
Chiang C.-E.; Diaz R.; Goodman S.; Gotcheva N.; Harrington R.A.; Jukema
J.W.; Kim H.-S.; Kim Y.-U.; Morais J.; Pordy R.; Roe M.; White H.;
Schwartz G.G.
Institution
(Szarek, Valgimigli, Zeiher, Steg, Bhatt, Bittner, Chiang, Diaz, Goodman,
Gotcheva, Harrington, Jukema, Kim, Kim, Morais, Pordy, Roe, White,
Schwartz) SUNY Downstate Health Sciences University, Brooklyn, NY, USA,
SUNY Downstate Health Sciences University, Brooklyn, NY, USA;
Universitaria di Ferrara, Ferrara, Italy, Universitaria di Ferrara,
Ferrara, Italy
Publisher
Elsevier USA
Abstract
Background In the ODYSSEY OUTCOMES trial, alirocumab (ALI) vs (PBO)
reduced first ischemia-driven coronary revascularization in 18,924
patients with acute coronary syndrome (ACS). The current analysis
determines if the ALI treatment effects on first and total
revascularizations depended on whether patients had coronary
revascularization for their index ACS. Methods Patients were categorized
by whether they had coronary revascularization (coronary artery bypass
graft [CABG] or percutaneous coronary intervention [PCI]) for their index
ACS. Treatment effects on first and total (first and subsequent)
ischemia-driven coronary revascularizations are summarized by hazard
ratios (HR) from proportional hazards models, and mean cumulative function
rates 4 years after randomization. Death was treated as a competing event.
Results 72.3% of patients had index revascularization (66.9% PCI only,
4.8% CABG only, 0.6% both). ALI reduced first and total events (Figure),
with relative effect sizes that did not depend on index revascularization
(interaction p=0.85 and 0.31, for first and total events, respectively).
Additionally, the ALI effect on first coronary revascularization was
minimal during the first year after randomization (HR 0.96, 95% CI
0.84-1.11; p=0.61), but greater after the first year (HR 0.80, 95% CI
0.69-0.92; p=0.002). Conclusion ALI significantly reduced first and total
ischemia-driven coronary revascularizations in patients with ACS,
independent of index revascularization. [Figure presented]<br/>Copyright
&#xa9; 2020 American College of Cardiology Foundation

<20>
Accession Number
2005038708
Title
LEAFLET THICKENING OR IMMOBILITY IN TRANSCATHETER OR SURGICAL AORTIC
VALVES: RESULTS FROM THE EVOLUT LOW RISK LTI SUBSTUDY.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 1101), 2020. Date of
Publication: 24 Mar 2020.
Author
Leipsic J.; Blanke P.; Reardon M.; Deeb G.M.; Yakubov S.J.; Popma J.J.
Institution
(Leipsic, Blanke, Reardon, Deeb, Yakubov, Popma) University of British
Columbia, Vancouver, Canada
Publisher
Elsevier USA
Abstract
Background A substudy of the Evolut Low Risk Trial assessed the incidence
and clinical impact of valve leaflet thickening and restricted mobility
after transcatheter aortic valve replacement (TAVR) and surgical AVR
(SAVR). Methods ECG-gated multi-detector computed tomography (CT) scans at
baseline, 30 days, and 1 year were analyzed by a corelab blinded to
patient details or time of CT. Eligible patients were randomized to TAVR
or SAVR. An evaluable 30-day CT scan was required for inclusion.
Hypoattenuated leaflet thickening (HALT) was defined as abnormal focal
hypoattenuation on >=1 leaflet. The extent of HALT and leaflet immobility
was graded according to guideline recommendations. HALT was quantified by
extent of curvilinear leaflet length involved. Results Thirty-day
follow-up of 197 TAVR and 177 SAVR per protocol patients is complete. At
30 days the prevalence of HALT was similar in both treatment arms (17.8%
TAVR; 12.4% SAVR) and was most often graded as <25% of the leaflet length
being involved. Mean AV gradients remained low regardless of the degree of
HALT (Table). Similar results were observed for leaflet mobility; only 1
patient in each group had a leaflet which was largely immobile at 30 days.
Conclusion HALT and leaflet immobility occurred after TAVR and SAVR but
was generally of low severity and had no discernible impact on 30-day
hemodynamic performance. At the time of ACC, complete 1-year details on
the relationship between HALT and both clinical events and valve
hemodynamics will be presented. [Figure presented]<br/>Copyright &#xa9;
2020 American College of Cardiology Foundation

<21>
Accession Number
2005038590
Title
IMPACT OF TRICUSPID REGURGITATION ON OUTCOMES AFTER MITRACLIP TREATMENT OF
SECONDARY MITRAL REGURGITATION: RESULTS FROM THE COAPT TRIAL.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 1099), 2020. Date of
Publication: 24 Mar 2020.
Author
Hahn R.; Asch F.M.; Weissman N.J.; Grayburn P.A.; Kar S.; Kar; Lim S.;
Ben-Yehuda O.; Shahim B.; Chen S.; Liu M.; Redfors B.; Medvedofsky D.;
Puri R.; Kapadia S.; Sannino A.; Lindenfeld J.; Abraham W.; Mack M.; Stone
G.
Institution
(Hahn, Asch, Weissman, Grayburn, Kar, Kar, Lim, Ben-Yehuda, Shahim, Chen,
Liu, Redfors, Medvedofsky, Puri, Kapadia, Sannino, Lindenfeld, Abraham,
Mack, Stone) Columbia University Irving Medical Center, New York, NY, USA,
Columbia University Irving Medical Center, New York, NY, USA;
Cardiovascular Research Foundation, New York, NY, USA, Cardiovascular
Research Foundation, New York, NY, USA
Publisher
Elsevier USA
Abstract
Background The impact of tricuspid regurgitation (TR) on outcomes after
transcatheter mitral valve repair (TMVr) with MitraClip in heart failure
(HF) pts with secondary mitral regurgitation (MR) is poorly understood.
Methods In the COAPT trial, 614 pts with HF and moderate to severe (3+) or
severe (4+) symptomatic secondary MR were randomized to guideline directed
medical therapy (GDMT) alone, or MitraClip + GDMT. Outcomes were analyzed
according to echo core lab assessed baseline TR severity (n=599): None,
Trace or Mild (<=MildTR) and Mod or Severe (>=ModTR). Results Pts with
>=ModTR (98/599; 16.3%) were more likely to be in NYHA Class III/IV
(p<0.0001), have STS score >=8 (p<0.0001), anemia (p=0.02), chronic kidney
disease (p=0.003), higher NT-proBNP (p=0.02), lower KCCQ (p=0.02) and
lower 6MWT (p<0.0001) compared with <=MildTR. Pts with >=ModTR also had
smaller left ventricular volumes (p<0.005), lower cardiac output
(p=0.002), higher right ventricular systolic pressure (p<0.0001) and more
severe MR (EROA p=0.0005). In all pts, the 2-year rates of composite death
or HF hospitalization (HFH) were significantly greater in pts with >=ModTR
vs. <=MildTR (80.9% vs. 64.3%, p=0.004). Compared to GDMT alone, MitraClip
treatment reduced death, HFH and composite death or HFH in pts with
>=ModTR and <=MildTR (Figure). Conclusion Pts in COAPT with >=ModTR had
substantially worse outcomes compared to those with <=MildTR. Compared to
GDMT alone, TMVr with the MitraClip consistently improved outcomes for all
grades of TR. [Figure presented]<br/>Copyright &#xa9; 2020 American
College of Cardiology Foundation

<22>
Accession Number
2005038472
Title
QUANTIFYING THE GENERALIZABILITY OF TRANSCATHETER AORTIC VALVE REPLACEMENT
CLINICAL TRIALS: FINDINGS FROM THE EXTEND-COREVALVE STUDY.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 3670), 2020. Date of
Publication: 24 Mar 2020.
Author
Butala N.; Song Y.; Shen C.; Yeh R.W.
Institution
(Butala, Song, Shen, Yeh) Smith Center for Outcomes Research in
Cardiology, Boston, MA, USA, Smith Center for Outcomes Research in
Cardiology, Boston, MA, USA; Massachusetts General Hospital, Boston, MA,
USA, Massachusetts General Hospital, Boston, MA, USA
Publisher
Elsevier USA
Abstract
Background Randomized controlled trials (RCTs) are often critiqued for
poor external validity. Inverse probability weighting (IPW) can quantify
generalizability of an RCT and re-estimate trial results based on
characteristics of a target population. We evaluate generalizability of
transcatheter aortic valve replacement (TAVR) trials to non-trial Medicare
patients receiving TAVR. Methods We used the MedPAR database to compare
event rates in patients > 65 years undergoing TAVR in the US CoreValve
Extreme Risk and High Risk trials (trial cohort) and in non-trial Medicare
patients undergoing TAVR between 11/2/11-10/1/15 (non-trial cohort). We
created propensity scores to predict likelihood of trial participation
based on an array of characteristics. We employed IPW to estimate the
predicted frequency of events in the trial cohort based on the
distribution of characteristics in the non-trial cohort. Results A total
of 735 patients received TAVR in the trial cohort and 49,713 patients
received TAVR in the non-trial cohort. The c-statistic for the propensity
score model was 0.636 and the standardized mean difference in propensity
scores between trial and non-trial cohorts was 0.469. Trial patients had
significantly less cognitive impairment, obesity, and musculoskeletal
problems, but more chronic lung disease. Observed rates of 1-year death
(21.2%), stroke (5.2%), reintervention (0.88%), and pacemaker (7.7%) in
the trial cohort were similar to death (19.8%), stroke (4.7%),
reintervention (0.94%), and pacemaker (7.5%) in the trial cohort after
reweighting based on non-trial cohort characteristics. Conclusion Although
trial and non-trial populations were different, trial event rates and
re-estimated trial event rates representing potential effects in a
real-world population were similar, supporting the applicability of trial
estimates and overall TAVR treatment effects to the non-trial Medicare
population of patients receiving TAVR. The standardized mean difference
and c-statistic in this study can serve as benchmarks to quantify
generalizability of RCTs. IPW can re-calibrate event rates to be more
representative of real-world populations when trial populations are
different.<br/>Copyright &#xa9; 2020 American College of Cardiology
Foundation

<23>
Accession Number
2005038208
Title
LONG-TERM IMPACT OF INDUCIBLE MYOCARDIAL ISCHEMIA ON OUTCOMES IN ISCHEMIC
CARDIOMYOPATHY: TEN-YEAR FOLLOW-UP OF THE STICH TRIAL.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 193), 2020. Date of
Publication: 24 Mar 2020.
Author
O'Fee K.; Panza J.; Brown D.
Institution
(O'Fee, Panza, Brown) Washington University School of Medicine, St. Louis,
MO, USA, Washington University School of Medicine, St. Louis, MO, USA;
Westchester Medical Center, New York Medical College, Valhalla, NY, USA,
Westchester Medical Center, New York Medical College, Valhalla, NY, USA
Publisher
Elsevier USA
Abstract
Background The Surgical Treatment for Ischemic Heart Failure (STICH) trial
demonstrated that in patients with coronary artery disease (CAD) and
severe left ventricular (LV) dysfunction, inducible ischemia on stress
testing was not associated with a worse prognosis or greater benefit from
coronary artery bypass graft (CABG) surgery at 5-year follow-up, a
timepoint when there was no observed mortality benefit from randomization
to CABG. However, at 10 years, patients randomized to CABG had
significantly reduced mortality. We therefore sought to determine if
inducible ischemia was associated with worse prognosis or greater benefit
from CABG at 10 years. Methods STICH randomized patients with CAD and LV
ejection fraction<=35% to CABG and medical therapy vs. medical therapy
alone. We assessed the 10-year outcomes of patients who underwent a
radionuclide (RN) stress test or a dobutamine stress echocardiogram (DSE).
A stress test was considered positive for ischemia if the summed
difference score on RN was >=4 or if >=2 of 16 segments were ischemic on
DSE. The primary outcome was all-cause mortality assessed by intention to
treat. Results Of 402 patients who underwent stress testing, 255 had
inducible ischemia. Patients with and without ischemia were similar in
regard to age, multivessel CAD, prior myocardial infarction and LV
ejection fraction (P=not significant for all). Inducible ischemia was not
found to significantly impact 10-year all-cause mortality in unadjusted
(hazard ratio (HR): 1.2; 95% confidence interval (CI): 0.9-1.6, P=0.16)
and adjusted (aHR: 1.3; 95% CI: 0.9-1.8, P=0.16) models. CABG was not
associated with a reduction in mortality in patients with inducible
ischemia (aHR: 0.74; 95% CI: 0.54-1.00) and patients without inducible
ischemia (aHR: 0.81 95% CI: 0.52-1.3). The interaction between inducible
ischemia and treatment assignment was not significant (P=0.62). Conclusion
In patients with CAD and severe LV dysfunction, inducible ischemia did not
identify patients with increased mortality at 10 years. There was no
significant interaction between the presence or absence of ischemia and
the beneficial treatment effect of CABG.<br/>Copyright &#xa9; 2020
American College of Cardiology Foundation

<24>
Accession Number
2005038197
Title
SURGICAL AND TRANSCATHETER MITRAL VALVE REPLACEMENT IN MITRAL ANNULAR
CALCIFICATION- A SYSTEMATIC REVIEW.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 1221), 2020. Date of
Publication: 24 Mar 2020.
Author
Alexis S.; Malik A.; George I.; El-Eshmawi A.; Kodali S.K.; Hahn R.T.;
Khalique O.K.; Zaid S.; Guerrero M.; Bapat V.; Leon M.; Adams D.; Tang G.
Institution
(Alexis, Malik, George, El-Eshmawi, Kodali, Hahn, Khalique, Zaid,
Guerrero, Bapat, Leon, Adams, Tang) Mount Sinai Medical Center, New York,
NY, United States
Publisher
Elsevier USA
Abstract
Background Surgical mitral valve replacement (SMVR) in severe mitral
annular calcification (MAC) remains a challenge. Transcatheter mitral
valve replacement (TMVR) is an emerging alternative in higher risk
patients with appropriate valve anatomy. Methods PubMed, Embase, and
Cochrane Register were searched for studies reporting outcomes of
SMVR/TMVR in patients with MAC. Results Out of 27/1352 selected articles,
TMVR was utilized in 15 studies. Relevant data were available on 82
patients who had transatrial TMVR, while 354 patients had percutaneous
TMVR. SMVR data were mainly reported as small case series (447 patients
from 11 studies), with one large recent study on 9,551 patients. TMVR
studies had shorter median follow-up (12 months) vs. SMVR (54 months).
Compared to SMVR, patients undergoing TMVR were older and had higher STS
risk scores. SMVR resulted in a wide range of early 0-27% (median 6.3%)
and long-term median mortality 0-65% (1-year 15.8%, 5-years 38.8%,
10-years 62.4%). With better patient selection and growing experience,
TMVR showed improved 30-day mortality rates from 34.5% to 12.5%
(transapical and transseptal) and 50% to 16.1% (transatrial). Conclusion
MAC is a complex disease. TMVR offers an alternative to surgery in
high-risk patients. Hybrid transatrial TMVR may provide more options than
percutaneous TMVR in patients with high eccentricity and probable outflow
tract obstruction. [Figure presented]<br/>Copyright &#xa9; 2020 American
College of Cardiology Foundation

<25>
Accession Number
2005038186
Title
COMPARING SEDATION VERSUS GENERAL ANESTHESIA IN TRANSESOPHAGEAL
ECHOCARDIOGRAPHY-GUIDED PERCUTANEOUS TRANSCATHETER MITRAL VALVE REPAIR: A
META-ANALYSIS.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 1169), 2020. Date of
Publication: 24 Mar 2020.
Author
Banga S.; Hafiz A.M.; Chami Y.; Gumm D.; Banga P.; Howard C.; Kim M.;
Sengupta P.
Institution
(Banga, Hafiz, Chami, Gumm, Banga, Howard, Kim, Sengupta) West Virginia
University School of Medicine, Morgantown, WV, USA, West Virginia
University School of Medicine, Morgantown, WV, USA; SIU School of
Medicine, Springfield, IL, USA, SIU School of Medicine, Springfield, IL,
USA
Publisher
Elsevier USA
Abstract
Background Transesophageal echocardiography (TEE)-guided percutaneous
transcatheter mitral valve repair (PMVR) is typically performed under
general anesthesia (GA). Increasing evidence supports the efficacy and
safety of PMVR performed under conscious sedation (CS) or deep sedation
(DS). Methods A comprehensive search was performed using PubMed, CINAHL,
Ovid MEDLINE, Embase and the Cochrane Library. Study characteristics and
procedural outcomes with both types of anesthesia were analyzed. Results
Out of 73 articles, 5 met inclusion criteria with 647 patients. Overall,
there was no significant difference in the primary outcome of procedural
success rate (OR, 0.75; 95% CI, 0.30-1.88, I²= 0.0%, P=0.538)
or post-procedure in-hospital mortality (OR, 1.02; 95% CI, 0.38-2.71,
I²= 0.0%, P=0.970) in the patients undergoing PMVR under CS/DS
versus GA. The secondary endpoint of intensive care unit (ICU) length of
stay (LOS) was significantly shorter in patients under CS/DS versus GA
(Standardized Mean Difference, SMD=-0.97; 95% CI, -1.75 to -0.20;
P=0.014), but the hospital LOS (SMD= 0.36; 95% CI,-0.77 to 0.04, P=0.078)
did not show a statistically significant difference. No difference was
observed between CS/DS and GA in fluoroscopy time, procedure time or
complications, including pneumonia, stroke and major bleeding. Conclusion
CS/DS for PMVR has lower ICU LOS, but comparable procedural success rate
and in-hospital mortality, making it a potential alternative to GA for
TEE-guided PMVR. [Figure presented]<br/>Copyright &#xa9; 2020 American
College of Cardiology Foundation

<26>
Accession Number
2005038131
Title
PREDICTORS OF DEATH OR HEART FAILURE HOSPITALIZATION IN PATIENTS WITH
FUNCTIONAL MITRAL REGURGITATION: SUB-ANALYSIS FROM THE COAPT TRIAL.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 1218), 2020. Date of
Publication: 24 Mar 2020.
Author
Shah N.N.; Gray W.A.; Madhavan M.; Brener S.J.; Lindenfeld J.; Abraham W.;
Grayburn P.A.; Kar S.; Kar; Lim S.; Mishell J.M.; Whisenant B.; Zhang Z.;
Mack M.; Stone G.W.
Institution
(Shah, Gray, Madhavan, Brener, Lindenfeld, Abraham, Grayburn, Kar, Kar,
Lim, Mishell, Whisenant, Zhang, Mack, Stone) Lankenau Heart Institute,
Main Line Health, Wynnewood, PA, USA, Lankenau Heart Institute, Main Line
Health, Wynnewood, PA, USA; Cardiovascular Research Foundation, New York,
NY, USA, Cardiovascular Research Foundation, New York, NY, USA
Publisher
Elsevier USA
Abstract
Background There are limited data on the predictors of death or heart
failure (HF) hospitalization in patients with HF and severe functional
mitral regurgitation (FMR). Methods In the COAPT trial, 614 symptomatic
patients with HF, 3+ or 4+ FMR and left ventricular ejection fraction
20-50% were randomized to maximally-tolerated guideline-directed medical
therapy (GDMT) alone or transcatheter mitral valve repair with the
MitraClip plus GDMT. The primary outcome for this analysis was death or HF
hospitalization (HFH) at 2 years. Multivariable analysis was performed
using Cox proportional hazards models. Results During 2-year follow-up,
201 (64.4%) patients in the GDMT alone group and 133 (44.0%) patients in
the MitraClip group experienced the primary outcome (P<0.001). By
multivariable analysis, MitraClip treatment was the strongest predictor of
freedom from death or HFH (adjusted hazard ratio 0.56, 95% CI 0.45-0.71,
p<0.001). Other significant baseline predictors of death or HFH included
NYHA III/IV functional class, chronic kidney disease (CKD), estimated
right ventricular systolic pressure (RVSP) >50 mm Hg and left ventricular
end-systolic dimension (LVESD) >5.3 cm (the median) (Table). Conclusion In
patients with HF and severe FMR, the MitraClip reduces death or HFH at 2
years, whereas CKD, NYHA III/IV functional class, RVSP >50 mm Hg and LVESD
>5.3 cm predict a worse prognosis. These data may be used to create a
simple risk prediction tool that may be of great value in this high-risk
population. [Figure presented]<br/>Copyright &#xa9; 2020 American College
of Cardiology Foundation

<27>
Accession Number
2005038072
Title
PCSK9 INHIBITION AND AORTIC STENOSIS IN THE FOURIER TRIAL.
Source
Journal of the American College of Cardiology. Conference: ACC.20 - World
Congress of Cardiology. United States. 75 (11) (pp 2112), 2020. Date of
Publication: 24 Mar 2020.
Author
Bergmark B.; O'Donoghue M.; Murphy S.; Kuder J.; Ezhov M.V.; Ceska R.;
Gouni-Berthold I.; Jensen H.K.; Tokgozoglu S.L.; Mach F.; Huber K.;
Gaciong Z.; Lewis B.S.; Schiele F.; Jukema J.W.; Pedersen T.; Giugliano
R.; Sabatine M.S.
Institution
(Bergmark, O'Donoghue, Murphy, Kuder, Ezhov, Ceska, Gouni-Berthold,
Jensen, Tokgozoglu, Mach, Huber, Gaciong, Lewis, Schiele, Jukema,
Pedersen, Giugliano, Sabatine) TIMI Study Group, Brigham and Women's
Hospital, Harvard Medical School, Boston, MA, United States
Publisher
Elsevier USA
Abstract
Background Despite recent advances in treatment of severe aortic valve
stenosis (AS), AS remains a common, life-threatening condition with no
proven preventive therapy. Low-density lipoprotein cholesterol (LDL-C)
and, particularly, lipoprotein(a) (Lp[a]) have been implicated in the
pathobiology of AS. The PCSK9 inhibitor evolocumab (EVO) significantly
reduces LDL-C and Lp(a). Methods FOURIER randomized 27,564 patients w/
ASCVD on statin therapy to EVO vs placebo. The safety database was
searched for events related to new or worsening AS or aortic valve
replacement ("AS events"). Adjusted risk (see Fig for variables) for AS
events was calculated based on 12-wk LDL-C and Lp(a) in both treatment
arms. EVO efficacy was tested using a Cox proportional hazards model.
Results AS events occurred in 63 patients over a median of 2.2 yrs.
Elevated LDL-C and Lp(a) levels were each associated with higher rates of
AS events (Q4 vs Q1: LDL-C HR<inf>adj</inf> 2.52 [1.14-5.57]; Lp[a]
HR<inf>adj</inf> 2.42 [1.05-5.57]; Fig). The overall HR for AS events with
EVO was 0.66 (0.40-1.09), with no apparent effect in the 1^st
year (HR 1.09 [0.48-2.47]) but an apparent halving of risk after the
1^st year of treatment (HR 0.48 [0.25-0.93]; Fig). Conclusion
Higher LDL-C and Lp(a) levels were significantly associated with
subsequent AS events. Long-term therapy with EVO may reduce AS events and
raises the possibility that in the future, specific pharmacologic
lipid-lowering therapy could offer a means to prevent or slow the
progression of AS. [Figure presented]<br/>Copyright &#xa9; 2020 American
College of Cardiology Foundation

<28>
Accession Number
631276944
Title
Phase II, open label, randomized, biomarker study of immune-mediated
mechanism of action of neoadjuvant subcutaneous trastuzumab in patients
with operable, locally advanced, or inflammatory HER2-positive breast
cancer. immunHER trial on behalf of the Gruppo Oncologico Italiano Di
Ricerca Clinica (GOIRC).
Source
Cancer Research. Conference: San Antonio Breast Cancer Symposium, SABCS
2019. United States. 80 (4 Supplement 1) (no pagination), 2020. Date of
Publication: February 2020.
Author
Musolino A.; Gori S.; Cretella E.; Marabese A.; Cavanna L.; Frassoldati
A.; Bisagni G.; Casarini C.; Bria E.; Carbognin L.; Fiorio E.; Brandes
A.A.; Zamagni C.; Gianni L.; Zambelli A.; Montemurro F.; Tognetto M.;
Todeschini R.; Maglietta G.; Missale G.; Silini E.M.
Institution
(Musolino, Maglietta, Missale, Silini) University Hospital of Parma,
Parma, Italy
(Gori) Ospedale Sacro Cuore-Don Calabria, Negrar (VR), Italy
(Cretella, Marabese) Ospedale Di Bolzano, Bolzano, Italy
(Cavanna) Hospital of Piacenza, Piacenza, Italy
(Frassoldati) University Hospital of Ferrara, Ferrara, Italy
(Bisagni) Azienda Unita Sanitaria Locale-IRCCS Di Reggio Emilia, Reggio
Emilia, Italy
(Casarini) AUSL Modena Area Sud, Sassuolo (MO), Italy
(Bria, Carbognin) Fondazione Policlinico Universitario A. Gemelli IRCCS,
Universita Cattolica Del Sacro Cuore, Roma, Italy
(Fiorio) Azienda Ospedaliera Universitaria Integrata Di Verona, Verona,
Italy
(Brandes) Azienda USL, IRCCS Institute of Neurological Sciences, Bologna,
Italy
(Zamagni) Policlinico S.Orsola-Malpighi, Bologna, Italy
(Gianni) Infermi Hospital, AUSL della Romagna, Rimini, Italy
(Zambelli) ASST-Papa Giovanni XXIII, Bergamo, Italy
(Montemurro) Istituto Di Candiolo FPO-IRCCS, Candiolo (TO), Italy
(Tognetto, Todeschini) Gruppo Oncologico Di Ricerca Clinica (GOIRC),
Parma, Italy
Publisher
American Association for Cancer Research Inc.
Abstract
Background: Tumor-infiltrating lymphocytes (TILs) have been reported to be
associated with increased therapeutic efficacy of
trastuzumab/pertuzumab-based neoadjuvant therapy (NT) in patients (pts)
with HER2-positive breast cancer (BC). Subcutaneous (SC) trastuzumab has
non-inferior efficacy to intravenous (IV) administration, with a similar
safety profile. Interestingly, SC trastuzumab has been observed to be more
immunogenic than IV trastuzumab and act at different immunologic levels.
Therefore, by modifying the modality of administration of trastuzumab, it
could be possible to interfere with different immune pathways and exert a
favorable immunomodulation in HER2-positive BC. <br/>Method(s): In this
non-comparative, phase II, neoadjuvant, randomized study, pts were
eligible if they had previously untreated, histologically confirmed,
locally advanced, inflammatory, or early-stage HER2-positive BC. Pts were
treated with FEC (fluorouracil 500 mg/m2; epirubicin 75 mg/m2;
cyclophosphamide 500 mg/m2) q21 x 3 cycles. Then, they were randomly
assigned (1:1) to receive: docetaxel (75 mg/m2) plus pertuzumab (840 mg
loading dose (LD), then 420 mg) plus IV trastuzumab (8 mg/kg LD, then 6
mg/kg) q21 x 4 cycles (arm A) or, docetaxel plus pertuzumab plus SC
trastuzumab (fixed dose of 600 mg) q21 x 4 cycles (arm B). After surgery,
pts received trastuzumab q21 x 14 cycles using the same formulation (SC or
IV) of the preoperative phase. The primary endpoint was the rate of
stromal TILs (sTILs) on residual disease after surgery. Tumor biopsy and
posttreatment surgical samples were centrally analyzed for TILs. Blood
samples were also collected during NT for tumor-specific lymphocyte cell
activity analysis. Feasibility, efficacy and safety were also evaluated.
ClinicalTrials.gov: NCT03144947. <br/>Result(s): Between November 2016 and
September 2017, according to an adaptive Simon's two-stage optimal design,
we enrolled 65 pts, of whom two were deemed ineligible for the study.
Thus, 63 pts (31 in arm A and 32 in arm B) were assessed for the primary
and secondary endpoints. The pathologic complete response (pCR; no
invasive tumor in breast and axilla) rates were 64.5% (95% CI, 47-81) in
arm A, and 59.4% (95% CI, 42-76) in arm B. The most common adverse events
of grade 3 or higher were neutropenia (15 [48.4%] pts in arm A, and 11
[34.4%] in arm B), neurotoxicity (1 [3.2%], and 2 [6.2%], respectively),
and diarrhea (1 [3.2%], and 1 [3.1%], respectively). There were no events
of congestive heart failure. At surgery, 11 pts in arm A and 13 pts in arm
B were evaluable for TIL analysis. The median value of sTILs (7.5%) on
pretreatment tumor biopsies was used as the cut-off value, and high sTIL
levels were observed in 27.3% and in 46.1% of residual tumors after
treatment arm A and B, respectively. There was a positive correlation
between pretreatment sTILs and PD-L1 expression on stromal immune cells
(Kendall's tau =0.80). Interestingly, a significant inverse correlation
was observed between PD-L1 expression on pretreatment sTILs and the T cell
co-receptor CD3 expressed on posttreatment sTILs (Pearson's rho =-0.70).
This finding was particularly evident in the arm B group (rho =-0.85).
<br/>Conclusion(s): NT with either SC or IV trastuzumab in combination
with pertuzumab and chemotherapy had a significant effect on sTIL
expression at surgery. In particular, the SC trastuzumab-based arm exerted
the most relevant enrichment of sTILS in posttreatment residual tumors.
These findings suggest a role for the SC administration of trastuzumab in
determining favorable variations of host immune response parameters among
pts with HER2-positive early BC who had residual disease after NT.

<29>
Accession Number
2005367474
Title
Randomized Trials in Cardiac Surgery: JACC Review Topic of the Week.
Source
Journal of the American College of Cardiology. 75 (13) (pp 1593-1604),
2020. Date of Publication: 7 April 2020.
Author
Gaudino M.; Kappetein A.P.; Di Franco A.; Bagiella E.; Bhatt D.L.; Boening
A.; Charlson M.E.; Flather M.; Gelijns A.C.; Grover F.; Head S.J.; Juni
P.; Lamy A.; Miller M.; Moskowitz A.; Reents W.; Shroyer A.L.; Taggart
D.P.; Tam D.Y.; Zenati M.A.; Fremes S.E.
Institution
(Gaudino, Di Franco) Department of Cardiothoracic Surgery, Weill Cornell
Medicine, New York, NY, United States
(Kappetein, Head) Department of Cardiothoracic Surgery, Erasmus University
Medical Centre, Rotterdam, Netherlands
(Bagiella, Gelijns, Moskowitz) Department of Population Health Science and
Policy, Icahn School of Medicine at Mount Sinai, New York, NY, United
States
(Bhatt) Brigham and Women's Hospital, Heart and Vascular Center, Harvard
Medical School, Boston, MA, United States
(Boening) Department of Cardiovascular Surgery, Justus-Liebig University
Giesen, Giesen, Germany
(Charlson) Division of Clinical Epidemiology and Evaluative Science
Research, Department of Medicine, Weill Cornell Medicine, New York, NY,
United States
(Flather) Norwich Medical School, University of East Anglia and Norfolk
and Norwich University Hospital, Norwich, United Kingdom
(Grover) Division of Cardiothoracic Surgery, Department of Surgery,
University of Colorado School of Medicine, Anschutz Medical Campus,
Aurora, CO, United States
(Juni) Applied Health Research Centre (AHRC), Li Ka Shing Knowledge
Institute of St. Michael's Hospital, Department of Medicine and Institute
of Health Policy, Management, and Evaluation, University of Toronto,
Toronto, Ontario, Canada
(Lamy) Population Health Research Institute, Department of Surgery,
McMaster University, Hamilton, Ontario, Canada
(Miller) Division of Cardiovascular Sciences, National Heart, Lung, and
Blood Institute, Bethesda, MD, United States
(Reents) Department Cardiac Surgery, Cardiovascular Center Bad
Neustadt/Saale, Bad Neustadt/Saale, Germany
(Shroyer) Northport Veterans Affairs Medical Center, Northport, NY, United
States
(Taggart) Nuffield Department of Surgical Sciences, University of Oxford,
Oxford, United Kingdom
(Tam, Fremes) Division of Cardiac Surgery, Schulich Heart Centre,
Sunnybrook Health Sciences Centre, University of Toronto, Toronto,
Ontario, Canada
(Zenati) Division of Cardiac Surgery, Veterans Affairs Boston Healthcare
System, Department of Surgery, Brigham and Women's Hospital, Harvard
Medical School, Boston, MA, United States
Publisher
Elsevier USA
Abstract
Compared with randomized controlled trials (RCTs) in medical specialties,
RCTs in cardiac surgery face specific issues. Individual and collective
equipoise, rapid evolution of the surgical techniques, as well as
difficulties in obtaining funding, and limited education in clinical
epidemiology in the surgical community are among the most important
challenges in the design phase of the trial. Use of complex interventions
and learning curve effect, differences in individual operators' expertise,
difficulties in blinding, and slow recruitment make the successful
completion of cardiac surgery RCTs particularly challenging. In fact, over
the course of the last 20 years, the number of cardiac surgery RCTs has
declined significantly. In this review, a team of surgeons, trialists, and
epidemiologists discusses the most important challenges faced by RCTs in
cardiac surgery and provides a list of suggestions for the successful
design and completion of cardiac surgery RCTs.<br/>Copyright &#xa9; 2020
American College of Cardiology Foundation

<30>
Accession Number
631299900
Title
Minute ventilation stabilization during all pressure-control / support
mechanical ventilation modes.
Source
Physiological research. (no pagination), 2020. Date of Publication: 23 Mar
2020.
Author
Candik P.; Depta F.; Imrecze S.; Sabol F.; Kolesar A.; Jankajova M.;
Pauliny M.; Benova J.; Galkova K.; Donic V.; Torok P.
Institution
(Candik) Department of Human Physiology, Faculty of Medicine, Safarik
University, Slovak Republic, Trieda SNP 1, Kosice
Publisher
NLM (Medline)
Abstract
The main goal of our prospective randomized study was comparing compare
the effectiveness of ventilation control method "Automatic proportional
minute ventilation (APMV) "versus manually set pressure control
ventilation modes in relationship to lung mechanics and gas exchange. 80
patients undergoing coronary artery bypass grafting (CABG) were randomized
into 2 groups. 40 patients in the first group No.1 (APMV group) were
ventilated with pressure control (PCV) or pressure support ventilation
(PSV) mode with APMV control. The other 40 patients (control group No.2)
were ventilated with synchronized intermittent mandatory ventilation
(SIMV-p) or pressure control modes (PCV) without APMV. Ventilation control
with APMV was able to maintain minute ventilation more precisely in
comparison with manual control (p<0.01), similarly deviations of ETCO(2)
were significantly lower (p<0.01). The number of manual corrections of
ventilation settings was significantly lower when APMV was used (p<0.01).
The differences in lung mechanics and hemodynamics were not statistically
significant. Ventilation using APMV is more precise in maintaining minute
ventilation and gas exchange compared with manual settings. It required
less staff intervention, while respiratory system mechanics and
hemodynamics are comparable. APMV showed as effective and safe method
applicable on top of all pressure control ventilation modes.

<31>
Accession Number
631289697
Title
Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the
MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR
Procedures.
Source
Journal of endovascular therapy : an official journal of the International
Society of Endovascular Specialists. (pp 1526602820912224), 2020. Date of
Publication: 20 Mar 2020.
Author
Krajcer Z.; Wood D.A.; Strickman N.; Bernardo N.; Metzger C.; Aziz M.;
Bacharach J.M.; Nanjundappa A.; Campbell J.; Lee J.T.; Dake M.D.; Lumsden
A.; Nardone S.
Institution
(Krajcer, Strickman) Texas Heart Institute and Baylor St Luke's Hospital,
TX, Houston, United States
(Wood) Center for Cardiovascular Innovation, University of British
Columbia, Vancouver, BC, Canada
(Bernardo) MedStar Health, DC, WA, United States
(Metzger, Aziz) TN, Kingsport, United States
(Bacharach) Avera Heart Hospital, Sioux Falls, SD, United States
(Nanjundappa, Campbell) Charleston Area Medical Center, Charleston, United
States
(Lee, Dake) Stanford University Medical Center, Palo Alto, CA, USA
(Lumsden) Houston Methodist Hospital, TX, Houston, United States
(Nardone) Teleflex Inc, Exton, United States
Publisher
NLM (Medline)
Abstract
Purpose: To evaluate the safety and effectiveness of the MANTA
percutaneous vascular closure device in patients undergoing percutaneous
endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic
repair (TEVAR). <br/>Material(s) and Method(s): The SAFE MANTA Study
(ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm,
multicenter trial in patients undergoing endovascular interventions using
large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or
TEVAR) at 20 sites in North America. Patient selection intended to test
the MANTA device in populations without morbid obesity, severe
calcification, or a severely scarred femoral access area. Of the 263
patients enrolled in the primary analysis cohort, 53 (20.2%) patients
(mean age 74.9+/-8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2)
procedures and form the cohort for this subgroup analysis. Per protocol a
single MANTA device was deployed in all PEVAR/TEVAR cases. <br/>Result(s):
The mean time to hemostasis in the PEVAR/TEVAR cohort was 35+/-91 seconds,
with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA
population. The MANTA device met the definition for technical success in
52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE
MANTA population. One (1.9%) major complication (access-site stenosis)
occurred in this subgroup compared to 14 (5.3%) events in the SAFE
population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to
discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of
the 3 minor pseudoaneurysms was treated with ultrasound-guided compression
and the other 2 required no treatment. <br/>Conclusion(s): The MANTA
device demonstrated a short time to hemostasis and low complication rates
compared with published literature results of other percutaneous closure
devices. Time to hemostasis and complication rates were comparable between
the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA
device provides reliable closure with a single percutaneous device for
PEVAR/TEVAR procedures.

<32>
Accession Number
631289358
Title
Health Status Changes and Outcomes in Patients with Heart Failure and
Mitral Regurgitation: From COAPT.
Source
Journal of the American College of Cardiology. (no pagination), 2020. Date
of Publication: 04 Mar 2020.
Author
Arnold S.V.; Stone G.W.; Mack M.J.; Chhatriwalla A.K.; Austin B.A.; Zhang
Z.; Ben-Yehuda O.; Kar S.; Lim D.S.; Lindenfeld J.; Abraham W.T.; Cohen
D.J.
Institution
(Arnold, Chhatriwalla, Austin) Saint Luke's Mid America Heart Institute,
Kansas City, Missouri; University of Missouri-Kansas City, Kansas City,
Missouri
(Stone) Clinical Trials Center, Cardiovascular Research Foundation, New
York, New York; The Zena and Michael A. Wiener Cardiovascular Institute,
Icahn School of Medicine at Mount Sinai, New York, New York
(Mack) Baylor Scott & White Health, Plano, TX, United States
(Zhang) Clinical Trials Center, Cardiovascular Research Foundation, NY
(Ben-Yehuda) Clinical Trials Center, Cardiovascular Research Foundation,
New York, New York; NewYork-Presbyterian Hospital/Columbia University
Medical Center, New York, New York
(Kar) Cedars-Sinai Medical Center, Los Angeles, CA, Mexico
(Lim) Division of Cardiology, University of Virginia, Charlottesville, VA,
United States
(Lindenfeld) Vanderbilt Heart and Vascular Institute, Nashville, TN,
United States
(Abraham) Division of Cardiovascular Medicine, Ohio State University,
Columbus, OH, United States
(Cohen) University of Missouri-Kansas City, Kansas City, MO, United States
Publisher
NLM (Medline)
Abstract
BACKGROUND: In the COAPT trial, transcatheter mitral valve repair (TMVr)
with the MitraClip rapidly improved health status and reduced the
long-term risks of death and heart failure (HF) hospitalization in
patients with HF and severe secondary mitral regurgitation (SMR) who
remained symptomatic despite maximally-tolerated guideline directed
medical therapy (GDMT). <br/>OBJECTIVE(S): To examine if early health
status changes were associated with long-term clinical outcomes in the
COAPT population. <br/>METHOD(S): We evaluated the association between
change in health status (KCCQ-OS) from baseline to 1 month and the
composite rate of death or HF hospitalization between 1 month and 2 years
in the COAPT trial and tested whether treatment (TMVr or GDMT alone)
modified this association. <br/>RESULT(S): Among 551 patients with HF and
severe SMR who were alive at 1 month, those randomized to TMVr were more
likely than GDMT alone to achieve a >=10-point improvement in KCCQ-OS from
baseline to 1 month (TMVr 58%, GDMT alone 26%). Early improvement in
KCCQ-OS was inversely associated with the risk of death or HF
hospitalization between 1 month and 2 years (p<0.001). When analyzed as a
continuous variable, a 10-point increase in KCCQ-OS was associated with a
14% lower risk of death or HF hospitalization (HR 0.86, 95% CI 0.81-0.92,
p<0.001), with no significant interaction with treatment group
(pinteraction=0.17). After adjusting for demographic and clinical factors,
the association between change in KCCQ-OS and outcomes was strengthened
(HR 0.79, 95% CI 0.73-0.86, p<0.001). <br/>CONCLUSION(S): In patients with
HF and severe SMR, a short-term change in disease-specific health status
was strongly associated with the subsequent long-term risk of death or HF
hospitalization. These findings reinforce the prognostic utility of serial
KCCQ-OS assessments to identify patients at risk for poor long-term
clinical outcomes in this population.<br/>Copyright &#xa9; 2020 American
College of Cardiology Foundation. Published by Elsevier Inc. All rights
reserved.

<33>
Accession Number
631289198
Title
Transcatheter Aortic Valve Implantation in Patients With Severe,
Symptomatic Aortic Valve Stenosis at Intermediate Surgical Risk: A Health
Technology Assessment.
Source
Ontario health technology assessment series. 20 (2) (pp 1-121), 2020. Date
of Publication: 2020.
Publisher
NLM (Medline)
Abstract
Background: Surgical aortic valve replacement (SAVR) is the conventional
treatment in patients at low or intermediate surgical risk. Transcatheter
aortic valve implantation (TAVI) is a less invasive procedure, originally
developed as an alternative for patients at high or prohibitive surgical
risk. <br/>Method(s): We conducted a health technology assessment of TAVI
versus SAVR in patients with severe, symptomatic aortic valve stenosis at
intermediate surgical risk, which included an evaluation of effectiveness,
safety, cost-effectiveness, budget impact, and patient preferences and
values. We performed a literature search to retrieve systematic reviews
and selected one that was relevant to our research question. We
complemented the systematic review with a literature search to identify
randomized controlled trials published after the review. Applicable,
previously published cost-effectiveness analyses were available, so we did
not conduct a primary economic evaluation. We analyzed the net budget
impact of publicly funding TAVI in people at intermediate surgical risk in
Ontario. To contextualize the potential value of TAVI for people at
intermediate surgical risk, we spoke with people who had aortic valve
stenosis and their families. <br/>Result(s): We identified two randomized
controlled trials; they found that in patients with severe, symptomatic
aortic valve stenosis, TAVI was noninferior to SAVR with respect to the
composite endpoint of all-cause mortality or disabling stroke within 2
years of follow-up (GRADE: High). However, compared with SAVR, TAVI had a
higher risk of some complications and a lower risk of others.
Device-related costs for TAVI (approximately $23,000) are much higher than
for SAVR (approximately $6,000). Based on two published cost-effectiveness
analyses conducted from the perspective of the Ontario Ministry of Health,
TAVI was more expensive and, on average, more effective (i.e., it produced
more quality-adjusted life-years) than SAVR. The incremental
cost-effectiveness ratios showed that TAVI may be cost-effective, but the
probability of TAVI being cost-effective versus SAVR was less than 60% at
a willingness-to-pay value of $100,000 per quality-adjusted life-year. The
net budget impact of publicly funding TAVI in Ontario would be about $2
million to $3 million each year for the next 5 years. This cost may be
reduced if people receiving TAVI have a shorter hospital stay (<= 3 days).
We interviewed 13 people who had lived experience with aortic valve
stenosis. People who had undergone TAVI reported reduced physical and
psychological effects and a shorter recovery time. Patients and caregivers
living in remote or northern regions reported lower out-of-pocket costs
with TAVI because the length of hospital stay was reduced. People said
that TAVI increased their quality of life in the short-term immediately
after the procedure. <br/>Conclusion(s): In people with severe,
symptomatic aortic valve stenosis at intermediate surgical risk, TAVI was
similar to SAVR with respect to the composite endpoint of all-cause
mortality or disabling stroke. However, the two treatments had different
patterns of complications. The study authors also noted that longer
follow-up is needed to assess the durability of the TAVI valve. Compared
with SAVR, TAVI may provide good value for money, but publicly funding
TAVI in Ontario would result in additional costs over the next 5 years.
People with aortic valve stenosis who had undergone TAVI appreciated its
less invasive nature and reported a substantial reduction in physical and
psychological effects after the procedure, improving their quality of
life.<br/>Copyright &#xa9; Queen's Printer for Ontario, 2020.

<34>
Accession Number
631285921
Title
Association of FADS1/2 Locus Variants and Polyunsaturated Fatty Acids With
Aortic Stenosis.
Source
JAMA cardiology. (no pagination), 2020. Date of Publication: 18 Mar 2020.
Author
Chen H.Y.; Cairns B.J.; Small A.M.; Burr H.A.; Ambikkumar A.; Martinsson
A.; Theriault S.; Munter H.M.; Steffen B.; Zhang R.; Levinson R.T.;
Shaffer C.M.; Rong J.; Sonestedt E.; Dufresne L.; Ljungberg J.; Naslund
U.; Johansson B.; Ranatunga D.K.; Whitmer R.A.; Budoff M.J.; Nguyen A.;
Vasan R.S.; Larson M.G.; Harris W.S.; Damrauer S.M.; Stark K.D.; Boekholdt
S.M.; Wareham N.J.; Pibarot P.; Arsenault B.J.; Mathieu P.; Gudnason V.;
O'Donnell C.J.; Rotter J.I.; Tsai M.Y.; Post W.S.; Clarke R.; Soderberg
S.; Bosse Y.; Wells Q.S.; Smith J.G.; Rader D.J.; Lathrop M.; Engert J.C.;
Thanassoulis G.
Institution
(Chen, Burr, Engert, Thanassoulis) Division of Experimental Medicine,
McGill University, Montreal, QC, Canada
(Chen, Burr, Ambikkumar, Zhang, Dufresne, Nguyen, Engert, Thanassoulis)
Preventive and Genomic Cardiology, McGill University Health Centre and
Research Institute, Montreal, QC, Canada
(Cairns, Clarke) MRC (Medical Research Council) Population Health Research
Unit, Nuffield Department of Population Health, University of Oxford,
Oxford, United Kingdom
(Cairns, Clarke) Clinical Trial Service Unit, Nuffield Department of
Population Health, University of Oxford, Oxford, United Kingdom
(Cairns, Clarke) Epidemiological Studies Unit, Nuffield Department of
Population Health, University of Oxford, Oxford, United Kingdom
(Small, Rader) Department of Medicine, Perelman School of Medicine,
University of Pennsylvania, Philadelphia, United States
(Martinsson) Department of Cardiology, Clinical Sciences, Lund University,
Lund, Sweden
(Martinsson, Smith) Department of Cardiology, Skane University Hospital,
Lund, Sweden
(Theriault, Pibarot, Arsenault, Mathieu, Bosse) Quebec Heart and Lung
Institute, Laval University, Quebec City, QC, Canada
(Munter, Lathrop) McGill University and Genome Quebec Innovation Centre,
Montreal, QC, Canada
(Steffen, Tsai) Department of Laboratory Medicine and Pathology,
University of Minnesota, Minneapolis, MN, United States
(Levinson, Shaffer, Wells) Vanderbilt Translational and Clinical
Cardiovascular Research Center, Vanderbilt University Medical Center,
Nashville, TN, United States
(Rong, Vasan, Larson, O'Donnell) National Heart, Lung, Blood Institute,
Bethesda, MD, United States
(Rong, Vasan, Larson, O'Donnell) Boston University's Framingham Heart
Study, Boston, MA
(Sonestedt) Nutritional Epidemiology, Department of Clinical Sciences
Malmo, Lund University, Malmo, Sweden
(Ljungberg, Naslund, Johansson, Soderberg) Department of Public Health and
Clinical Medicine, Umea University, Umea, Sweden
(Ranatunga) Division of Research, Kaiser Permanente of Northern
California, Oakland, United States
(Whitmer) Department of Public Health Sciences, University of California,
Davis, United States
(Budoff, Rotter) Los Angeles Biomedical Research Institute, Torrance, CA
(Budoff, Rotter) Departments of Pediatrics and Medicine at Harbor-UCLA
(University of California, Los Angeles) Medical Center, Torrance
(Harris) Department of Medicine, Sanford School of Medicine, University of
South Dakota, Sioux Falls, SD
(Harris) Sioux Falls, SD
(Damrauer) Department of Surgery, Perelman School of Medicine, University
of Pennsylvania, Philadelphia, United States
(Stark) Department of Kinesiology, University of Waterloo, Waterloo, ON,
Canada
(Boekholdt) Department of Cardiology, Amsterdam University Medical Center,
University of Amsterdam, Amsterdam, Netherlands
(Wareham) MRC Epidemiology Unit, University of Cambridge, Cambridge,
United Kingdom
(Gudnason) Faculty of Medicine, University of Iceland, Reykjavik
(Post) Division of Cardiology, Department of Medicine, Johns Hopkins
University School of Medicine, Baltimore, MD, United States
(Smith) Wallenberg Center for Molecular Medicine, Lund University, Lund,
Sweden
(Smith) Lund University Diabetes Center, Lund University, Lund, Sweden
(Rader) Department of Genetics, Perelman School of Medicine, University of
Pennsylvania, Philadelphia, United States
(Lathrop, Engert) Department of Human Genetics, McGill University,
Montreal, QC, Canada
Publisher
NLM (Medline)
Abstract
Importance: Aortic stenosis (AS) has no approved medical treatment.
Identifying etiological pathways for AS could identify pharmacological
targets. <br/>Objective(s): To identify novel genetic loci and pathways
associated with AS. <br/>Design, Setting, and Participant(s): This
genome-wide association study used a case-control design to evaluate 44703
participants (3469 cases of AS) of self-reported European ancestry from
the Genetic Epidemiology Research on Adult Health and Aging (GERA) cohort
(from January 1, 1996, to December 31, 2015). Replication was performed in
7 other cohorts totaling 256926 participants (5926 cases of AS), with
additional analyses performed in 6942 participants from the Cohorts for
Heart and Aging Research in Genomic Epidemiology (CHARGE) Consortium.
Follow-up biomarker analyses with aortic valve calcium (AVC) were also
performed. Data were analyzed from May 1, 2017, to December 5, 2019.
Exposures: Genetic variants (615643 variants) and polyunsaturated fatty
acids (omega-6 and omega-3) measured in blood samples. <br/>Main Outcomes
and Measures: Aortic stenosis and aortic valve replacement defined by
electronic health records, surgical records, or echocardiography and the
presence of AVC measured by computed tomography. <br/>Result(s): The mean
(SD) age of the 44703 GERA participants was 69.7 (8.4) years, and 22019
(49.3%) were men. The rs174547 variant at the FADS1/2 locus was associated
with AS (odds ratio [OR] per C allele, 0.88; 95% CI, 0.83-0.93;
P=3.0x10-6), with genome-wide significance after meta-analysis with 7
replication cohorts totaling 312118 individuals (9395 cases of AS) (OR,
0.91; 95% CI, 0.88-0.94; P=2.5x10-8). A consistent association with AVC
was also observed (OR, 0.91; 95% CI, 0.83-0.99; P=.03). A higher ratio of
arachidonic acid to linoleic acid was associated with AVC (OR per SD of
the natural logarithm, 1.19; 95% CI, 1.09-1.30; P=6.6x10-5). In mendelian
randomization, increased FADS1 liver expression and arachidonic acid were
associated with AS (OR per unit of normalized expression, 1.31 [95% CI,
1.17-1.48; P=7.4x10-6]; OR per 5-percentage point increase in arachidonic
acid for AVC, 1.23 [95% CI, 1.01-1.49; P=.04]; OR per 5-percentage point
increase in arachidonic acid for AS, 1.08 [95% CI, 1.04-1.13;
P=4.1x10-4]). <br/>Conclusions and Relevance: Variation at the FADS1/2
locus was associated with AS and AVC. Findings from biomarker measurements
and mendelian randomization appear to link omega-6 fatty acid biosynthesis
to AS, which may represent a therapeutic target.

<35>
Accession Number
631287430
Title
Ticagrelor-based antiplatelet regimens in patients treated with coronary
artery bypass grafting: A meta-analysis of randomized controlled trials.
Source
European Journal of Cardio-thoracic Surgery. 57 (3) (pp 520-528), 2020.
Date of Publication: 01 Mar 2020.
Author
Von Scheidt M.; Bongiovanni D.; Tebbe U.; Nowak B.; Stritzke J.; Zhao Q.;
Zhu Y.; Kastrati A.; Cassese S.; Schunkert H.
Institution
(Von Scheidt, Kastrati, Cassese, Schunkert) Klinik fur Herz- und
Kreislauferkrankungen, Deutsches Herzzentrum Munchen, Technische
Universitat Munchen, Lazarettstrasse 36, Munich 80636, Germany
(Von Scheidt, Bongiovanni, Kastrati, Schunkert) DZHK (German Center for
Cardiovascular Research), Partner Site Munich Heart Alliance, Munich,
Germany
(Bongiovanni) Medical Department i, Cardiology, Klinikum Rechts der Isar,
Technical University, Munich, Germany
(Tebbe) Department of Cardiology, Angiology and Intensive Care Medicine,
District Hospital Lippe-Detmold, Detmold, Germany
(Nowak) CCB, Cardiovascular Center Bethanien, Frankfurt, Germany
(Stritzke) Lanserhof Sylt, Marienstein Privatklinik, List, Germany
(Zhao, Zhu) Ruijin Hospital, Shanghai Jiao Tong University School of
Medicine, Shanghai, China
Publisher
European Association for Cardio-Thoracic Surgery (E-mail:
info@eacts.co.uk)
Abstract
OBJECTIVES: The optimal antiplatelet strategy in patients undergoing CABG
remains unclear. This is the first meta-analysis investigating the
clinical outcomes associated with ticagrelor-based antiplatelet regimens
in patients receiving CABG. <br/>METHOD(S): Relevant scientific databases
were searched for studies investigating antiplatelet regimens after CABG
from inception until April 1, 2019. Studies which randomly assigned CABG
patients to either ticagrelor-based or control antiplatelet regimens were
eligible. The primary outcome of this analysis was all-cause death. The
main secondary outcome was MI. Other outcomes of interest were cardiac
death, major adverse cardiac events, stroke and bleeding. This study is
registered with PROSPERO, number CRD42019122192. <br/>RESULT(S): Five
trials comprising 3996 patients (2002 assigned to ticagrelor-based and
1994 to control antiplatelet regimens) were eligible for quantitative
synthesis. The median follow-up was 12 months. Control antiplatelet
regimens consisted of either aspirin or clopidogrel or both. As compared
to control, ticagrelor-based regimens reduced the risk of all-cause death
[0.61 (0.43-0.87); P = 0.007], cardiac death [0.58 (0.39-0.86); P = 0.007]
and major adverse cardiac events [0.79 (0.63-0.98); P = 0.03], without
difference in the risk of MI [0.76 (0.50-1.18); P = 0.22], stroke [0.99
(0.56-1.78); P = 0.98] or bleeding [1.04 (0.95-1.14); P = 0.41]. There was
a treatment effect modification for the primary outcome associated with
trials enrolling predominantly patients with acute coronary syndrome (P
for interaction = 0.038). <br/>CONCLUSION(S): In patients receiving CABG,
ticagrelor-based regimens reduce mortality and major adverse cardiac
events without excess bleeding risk as compared with aspirin monotherapy
or the combination of aspirin and clopidogrel. The benefit of
ticagrelor-based regimens is more relevant in those studies enrolling
predominantly patients with acute coronary syndrome. These findings
require further confirmation in randomized trials focused on this subset
of patients and powered for clinical outcomes.<br/>Copyright &#xa9; 2019
The Author(s) 2019. Published by Oxford University Press on behalf of the
European Association for Cardio-Thoracic Surgery. All rights reserved.

<36>
Accession Number
631287426
Title
Mini-extracorporeal circulation surgery produces less inflammation than
off-pump coronary surgery.
Source
European Journal of Cardio-thoracic Surgery. 57 (3) (pp 496-503), 2020.
Date of Publication: 01 Mar 2020.
Author
Permanyer E.; Munoz-Guijosa C.; Padro J.-M.; Ginel A.; Montiel J.;
Sanchez-Quesada J.L.; Vila L.; Camacho M.
Institution
(Permanyer) Department of Cardiac Surgery, Quironsalud Teknon Heart
Institute, C. Vilana 12, Barcelona 08022, Spain
(Permanyer, Padro, Ginel, Montiel) Department of Cardiac Surgery, Hospital
de la Santa Creu i Sant Pau, Research Institute Hospital Sant Pau, IIB
Sant Pau, Barcelona, Spain
(Munoz-Guijosa) Department of Cardiac Surgery, University Hospital Germans
Trias i Pujol, Badalona, Spain
(Sanchez-Quesada) Cardiovascular Research Group, CIBERDEM, Research
Institute Hospital Sant Pau, IIB Sant Pau, Barcelona, Spain
(Vila, Camacho) Laboratory of Angiology, Vascular Biology and
Inflammation, Research Institute Hospital Sant Pau, IIB Sant Pau,
Barcelona, Spain
(Camacho) Genomics of Complex Diseases, Research Institute Hospital Sant
Pau, IIB Sant Pau, Barcelona, Spain
Publisher
European Association for Cardio-Thoracic Surgery (E-mail:
info@eacts.co.uk)
Abstract
OBJECTIVES: Both off-pump coronary artery bypass grafting surgery (OPCABG)
and mini-extracorporeal circulation (MECC) have been associated with lower
morbidity and mortality and less inflammation than conventional
cardiopulmonary bypass. However, studies comparing the 2 techniques are
scarce and the results are controversial. We compared the clinical
outcomes and inflammatory response of low-risk patients undergoing
coronary bypass grafting with MECC versus OPCABG. <br/>METHOD(S): We
conducted a prospective, randomized study in patients undergoing coronary
heart surgery. Two hundred and thirty consecutive low-risk patients were
randomly assigned to either receive OPCABG (n = 117) or MECC (n = 113).
Clinical outcomes and postoperative biochemical results were analysed in
both groups. We also analysed 19 circulating inflammatory markers in a
subgroup of 40 patients at 4 perioperative time points. The area under the
curve for each marker was calculated to monitor differences in the
inflammatory response. <br/>RESULT(S): No significant differences were
found between groups regarding perioperative clinical complications and no
deaths occurred during the trial. Plasma levels in 9 of the 19
inflammatory markers were undetectable or showed no temporal variation, 3
were higher in the MECC group [interleukin (IL)-10, macrophage
inflammatory protein-1beta and epidermal growth factor] and 7 were higher
in the OPCABG group (growth regulator oncogene, IL-6, IL-8, soluble CD40
ligand, monocyte chemoattractant protein-1, monocyte chemoattractant
protein-3 and tumour necrosis factor-alpha). Differences in 2
proinflammatory cytokines, IL-6 and monocyte chemoattractant protein 1,
between the 2 surgical procedures were statistically significant.
<br/>CONCLUSION(S): No clinical differences were observed between in
low-risk patients undergoing MECC or OPCABG surgery, but OPCABG was
associated with an increased release of proinflammatory cytokines compared
with MECC. Studies in larger cohorts and in patients at higher risk are
needed to confirm these findings. Clinical trial registration number:
NCT02118025.<br/>Copyright &#xa9; 2019 The Author(s) 2019. Published by
Oxford University Press on behalf of the European Association for
Cardio-Thoracic Surgery. All rights reserved.

<37>
Accession Number
631187266
Title
Transcatheter aortic valve replacement in patients with severe aortic
stenosis and active cancer: A systematic review and meta-analysis.
Source
Open Heart. 7 (1) (no pagination), 2020. Article Number: e001131. Date of
Publication: 11 Mar 2020.
Author
Bendary A.; Ramzy A.; Bendary M.; Salem M.
Institution
(Bendary, Ramzy, Salem) Cardiology, Benha University Faculty of Medicine,
Benha, Egypt
(Bendary) Biostatisitcs, National Cancer Institute, Cairo University,
Cairo, Egypt
Publisher
BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com)
Abstract
Background Patients with severe aortic stenosis and concomitant active
cancer (AC) are considered high-risk patients and usually are not allowed
to undergo surgical valve replacement. Transcatheter aortic valve
replacement (TAVR) may be an attractive option for them; however, little
is known about the outcomes of TAVR in this subset of complex patients.
Methods and results In this meta-analysis, Medline, Cochrane Library and
Scopus databases were searched (anytime up to April 2019) for studies
evaluating the outcomes of TAVR in patients with or without AC. We
assessed pooled estimates (with their 95% CIs) of the risk ratio (RR) for
the all-cause mortality at the 30-day and 1-year follow-ups, a 4-point
safety outcome (any bleeding, stroke, need for a pacemaker and acute
kidney injury) and a 2-point efficacy outcome (device success and residual
mean gradient (mean difference)). Three studies (5162 patients) were
included. Of those patients, a total of 368 (7.1%) had AC. Apart from a
significantly higher need for a postprocedural pacemaker (RR 1.29, 95% CI
1.06 to 1.58, p=0.01), TAVR in patients with AC resulted in similar
outcomes for safety and efficacy at the 30-day follow-up compared with
those without AC. Patients with AC experienced similar rates of the
all-cause mortality at the 30-day follow-up compared with those without
(RR 0.92, 95% CI 0.53 to 1.59, p=0.76); however, the all-cause mortality
was significantly higher in patients with AC at the 1-year follow-up (RR
1.71, 95% CI 1.26 to 2.33, p=0.0006). This mortality difference was
independent of cancer stage (advanced or limited) at the 30-day follow-up
but not at the 1-year follow-up; only patients with limited cancer stages
showed similar all-cause mortality rates compared with those without
cancer at the 1-year follow-up (RR 1.22, 95% CI 0.79 to 1.91, p=0.37).
Conclusion TAVR in patients with AC is associated with similar 30-day and
potentially worse 1-year outcomes compared with those in patients without
AC. The 1-year all-cause mortality appears to be dependent on the cancer
stage. Involving a specialised oncologist who usually considers cancer
stage in the decision-making process and applying additional preoperative
scores such as frailty indices might refine the risk assessment process
among these patients. PROSPERO registration number
CRD42019120416.<br/>Copyright &#xa9; Author(s) (or their employer(s))
2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights
and permissions. Published by BMJ.

<38>
Accession Number
2004465444
Title
Preoperative frailty parameters as predictors for outcomes after
transcatheter aortic valve implantation: a systematic review and
meta-analysis.
Source
Netherlands Heart Journal. (no pagination), 2020. Date of Publication:
2020.
Author
van Mourik M.S.; Velu J.F.; Lanting V.R.; Limpens J.; Bouma B.J.; Piek
J.J.; Baan J.; Henriques J.P.S.; Vis M.M.
Institution
(van Mourik, Velu, Lanting, Bouma, Piek, Baan, Henriques, Vis) Department
of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam
Cardiovascular Sciences, Amsterdam, Netherlands
(Limpens) Medical Library, Amsterdam UMC, University of Amsterdam,
Amsterdam, Netherlands
Publisher
Bohn Stafleu van Loghum (E-mail: e.smid@ntvg.nl)
Abstract
Guidelines suggest using frailty characteristics in the work-up for a
transcatheter aortic valve implantation (TAVI). There are many
frailty-screening tools with different components. The prognostic value of
the individual parameters in frailty is as yet unclear. The objective of
this systematic review and meta-analysis was to find and pool predictors
for 1-year mortality after TAVI. We followed a two-step approach. First,
we searched for randomised controlled trials on TAVI to identify frailty
parameters used in these studies. Second, we searched for publications on
these frailty parameters. Articles were included for pooled analysis if
the studied frailty parameters were dichotomised with clear cut-off values
based on common standards or clinical practice and reported adjusted
hazard ratios (HR) of 1-year mortality after TAVI. We calculated pooled
effect estimates of 49 studies based on dichotomised frailty scores (HR:
2.16, 95% CI: 1.57-3.00), chronic lung disease (HR: 1.57, 95% CI:
1.45-1.70), estimated glomerular filtration rate <30ml/min (HR: 1.95, 95%
CI: 1.68-2.29), body mass index <20kg/m² (HR: 1.49, 95% CI:
1.09-2.03), hypoalbuminaemia (HR: 1.77, 95% CI: 1.38-2.25), anaemia (HR:
2.08, 95% CI: 0.93-4.66), low gait speed (HR: 13.33, 95% CI: 1.75-101.49)
and Katz activities of daily living (ADL) score of 1 or more deficits (HR:
5.16, 95% CI: 0.77-34.47). Chronic lung disease, chronic kidney disease,
underweight, hypoalbuminaemia, a low frailty score, anaemia, low gait
speed and an ADL deficiency were associated with worse 1-year outcomes
after TAVI.<br/>Copyright &#xa9; 2020, The Author(s).

<39>
Accession Number
629783613
Title
Five-year outcomes after PCI or CABG for left main coronary disease.
Source
New England Journal of Medicine. 381 (19) (pp 1820-1830), 2019. Date of
Publication: 07 Nov 2019.
Author
Stone G.W.; Pieter Kappetein A.; Sabik J.F.; Pocock S.J.; Morice M.-C.;
Puskas J.; Kandzari D.E.; Karmpaliotis D.; Morris Brown W.; Lembo N.J.;
Banning A.; Merkely B.; Horkay F.; Boonstra P.W.; Van Boven A.J.; Ungi I.;
Bogats G.; Mansour S.; Noiseux N.; Sabate M.; Pomar J.; Hickey M.;
Gershlick A.; Buszman P.E.; Bochenek A.; Schampaert E.; Page P.; Modolo
R.; Gregson J.; Simonton C.A.; Mehran R.; Kosmidou I.; Genereux P.;
Crowley A.; Dressler O.; Serruys P.W.
Institution
(Stone, Karmpaliotis, Morris Brown, Lembo, Modolo, Kosmidou, Genereux,
Crowley, Dressler) Cardiovascular Research Foundation, 1700 Broadway, 8th
Fl., New York, NY 10019, United States
(Stone, Mehran) Zena and Michael A. Wiener Cardiovascular Institute, Icahn
School of Medicine at Mount Sinai, New York, United States
(Puskas) Mount Sinai Heart at Mount Sinai Saint Luke's, New York, United
States
(Karmpaliotis, Lembo, Kosmidou) New York-Presbyterian Hospital, Columbia
University Medical Center, New York, United States
(Pieter Kappetein) Erasmus Medical Center, Rotterdam, Netherlands
(Van Boven, Buszman) Medisch Centrum Leeuwarden, Leeuwarden, Netherlands
(Modolo) Academic Medical Center, University of Amsterdam, Amsterdam,
Netherlands
(Sabik) University Hospitals Cleveland Medical Center, Cleveland, United
Kingdom
(Pocock, Gregson) London School of Hygiene and Tropical Medicine, United
Kingdom
(Serruys) InternationalCentre for Circulatory Health, National Heart and
Lung Institute, Imperial College London, London, United Kingdom
(Banning) John Radcliffe Hospital, Oxford, United Kingdom
(Hickey, Gershlick) University Hospitals of Leicester, NHS Trust,
Leicester, United Kingdom
(Morice) Hopital Prive Jacques Cartier, Ramsay Generale de Sante, Massy,
France
(Kandzari, Morris Brown) Piedmont Heart Institute, Atlanta, United States
(Merkely, Horkay) Semmelweis University, Budapest, Hungary
(Ungi, Bogats) University of Szeged, Szeged, Hungary
(Mansour, Noiseux) Centre Hospitalier, L'Universite de Montreal, Canada
(Schampaert, Page, Genereux) Hopital du Sacre-Coeur de Montreal, Canada
(Sabate, Pomar) Hospital Clinic, Barcelona, Spain
(Buszman, Bochenek) Medical University of Silesia, Katowice, Poland
(Buszman, Bochenek) American Heart of Poland, Ustron, Poland
(Modolo) University of Campinas, Campinas, Brazil
(Simonton) Abbott Vascular, Santa Clara, CA, United States
(Genereux) Gagnon Cardiovascular Institute, Morristown Medical Center,
Morristown, NJ, United States
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND Long-term outcomes after percutaneous coronary intervention
(PCI) with contemporary drug-eluting stents, as compared with
coronary-artery bypass grafting (CABG), in patients with left main
coronary artery disease are not clearly established. METHODS We randomly
assigned 1905 patients with left main coronary artery disease of low or
intermediate anatomical complexity (according to assessment at the
participating centers) to undergo either PCI with fluoropolymer-based
cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or
CABG (CABG group, 957 patients). The primary outcome was a composite of
death, stroke, or myocardial infarction. RESULTS At 5 years, a primary
outcome event had occurred in 22.0% of the patients in the PCI group and
in 19.2% of the patients in the CABG group (difference, 2.8 percentage
points; 95% confidence interval [CI], -0.9 to 6.5; P=0.13). Death from any
cause occurred more frequently in the PCI group than in the CABG group (in
13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In
the PCI and CABG groups, the incidences of definite cardiovascular death
(5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI,
-1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4
percentage points; 95% CI, -1.3 to 4.2) were not significantly different.
All cerebrovascular events were less frequent after PCI than after CABG
(3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0),
although the incidence of stroke was not significantly different between
the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI,
-2.4 to 0.9). Ischemia-driven revascularization was more frequent after
PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points;
95% CI, 3.7 to 10.0). CONCLUSIONS In patients with left main coronary
artery disease of low or intermediate anatomical complexity, there was no
significant difference between PCI and CABG with respect to the rate of
the composite outcome of death, stroke, or myocardial infarction at
5years.(FundedbyAbbottVascular;EXCELClinicalTrials.govnumber,NCT01205776).
<br/>Copyright &#xa9; 2019 Massachusetts Medical Society.

<40>
Accession Number
2005202439
Title
Quantitative flow ratio-guided strategy versus angiography-guided strategy
for percutaneous coronary intervention: Rationale and design of the FAVOR
III China trial.
Source
American Heart Journal. 223 (pp 72-80), 2020. Date of Publication: May
2020.
Author
Song L.; Tu S.; Sun Z.; Wang Y.; Ding D.; Guan C.; Xie L.; Escaned J.;
Fearon W.F.; Kirtane A.J.; Serruys P.W.; Wijns W.; Windecker S.; Leon
M.B.; Stone G.W.; Qiao S.; Xu B.
Institution
(Song, Sun, Guan, Xie, Qiao, Xu) Fu Wai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing,
China
(Song, Qiao, Xu) National Clinical Research Center for Cardiovascular
Diseases, Beijing, China
(Tu, Ding) Biomedical Instrument Institute, School of Biomedical
Engineering, Shanghai Jiao Tong University, Shanghai, China
(Wang) Medical Research and Biometrics Center, National Center for
Cardiovascular Diseases, Beijing, China
(Escaned) Hospital Clinico San Carlos, Madrid, Spain
(Fearon) Division of Cardiovascular Medicine and Stanford Cardiovascular
Institute, Stanford University School of Medicine, Stanford, CA, United
States
(Kirtane, Leon) New York-Presbyterian Hospital/Columbia University Medical
Center, New York, NY, United States
(Kirtane, Leon, Stone) Cardiovascular Research Foundation, New York, NY,
United States
(Serruys) National Heart and Lung Institute, Imperial College London,
London, United Kingdom
(Wijns) The Lambe Institute for Translational Medicine and Curam, National
University of Ireland, Galway, Ireland
(Windecker) Bern University Hospital, Bern, Switzerland
(Stone) The Zena and Michael A. Wiener Cardiovascular Institute, Icahn
School of Medicine at Mount Sinai, New York, NY, United States
Publisher
Mosby Inc. (E-mail: customerservice@mosby.com)
Abstract
Background: Quantitative flow ratio (QFR) is a novel angiography-based
approach enabling fast computation of fractional flow reserve without use
of pressure wire or adenosine. The objective of this
investigator-initiated, multicenter, patient- and clinical
assessor-blinded randomized trial is to evaluate the efficacy and
cost-effectiveness of a QFR-augmented angiography-guided (QFR-guided)
strategy versus an angiography-only guided (angiography-guided) strategy
for percutaneous coronary intervention (PCI) in patients with coronary
artery disease. <br/>Method(s): Approximately 3,830 patients will be
randomized in a 1:1 ratio to a QFR-guided or an angiography-guided
strategy. Included subjects scheduled for coronary angiography have at
least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with
>=2.5 mm reference diameter. Subjects assigned to the QFR-guided strategy
will have QFR measured in each interrogated vessel and undergo PCI when
QFR <=0.80, with deferral for lesions with QFR >0.80. Those assigned to
the angiography-guided strategy will undergo PCI based on angiography.
Optimal medical therapy will be administered to all treated and deferred
patients. The primary end point is the 1-year rate of major adverse
cardiac events (MACE), a composite of all-cause mortality, any myocardial
infarction, or any ischemia-driven revascularization. The major secondary
end point is 1-year MACE excluding periprocedural myocardial infarction.
Other secondary end points include the individual components of MACE and
cost-effectiveness end points. The sample size affords 85% power to
demonstrate superiority of QFR guidance compared with angiography
guidance. <br/>Conclusion(s): The FAVOR III China study will be the first
randomized trial to examine the effectiveness and cost-effectiveness of a
QFR-guided versus an angiography-guided PCI strategy in coronary artery
disease patients.<br/>Copyright &#xa9; 2020 Elsevier Inc.

<41>
Accession Number
2002370320
Title
Inter- and intrasite variability of mortality and stroke for sites
performing both surgical and transcatheter aortic valve replacement for
aortic valve stenosis in intermediate-risk patients.
Source
Journal of Thoracic and Cardiovascular Surgery. 159 (4) (pp 1233-1244.e4),
2020. Date of Publication: April 2020.
Author
Greason K.L.; Blackstone E.H.; Rajeswaran J.; Lowry A.M.; Svensson L.G.;
Webb J.G.; Tuzcu E.M.; Smith C.R.; Makkar R.R.; Mack M.J.; Thourani V.H.;
Kodali S.K.; Leon M.B.; Miller D.C.
Institution
(Greason) Department of Cardiovascular Surgery, Mayo Clinic, Rochester,
Minn, United States
(Blackstone, Rajeswaran, Lowry, Svensson) Department of Thoracic and
Cardiovascular Surgery, Heart and Vascular Institute, Cleveland, OH,
United States
(Blackstone, Rajeswaran, Lowry) Department of Quantitative Health Sciences
Cleveland Clinic, Research Institute, Cleveland, United States
(Svensson) Aorta Center, Heart and Vascular Institute, Cleveland, United
States
(Webb) Department of Cardiology, St. Paul's Hospital, Vancouver, British
Columbia, Canada
(Tuzcu) Department of Thoracic and Cardiovascular Surgery, Cleveland
Clinic Foundation, Cleveland, United States
(Smith) Department of Surgery, Columbia University Medical Center of New
York Presbyterian Hospital, New York, NY, United States
(Makkar) Department of Cardiovascular Diseases, Cedars-Sinai Medical
Center, Los Angeles, Calif, United States
(Mack) Cardiovascular Service Line, Baylor Scott & White Health, Plano,
Tex, United States
(Thourani) Department of Cardiac Surgery, MedStar Heart & Vascular
Institute, Georgetown University School of Medicine, Washington, DC,
United States
(Kodali, Leon) Structural Heart & Valve Center, Division of Cardiology,
NewYork-Presbyterian Hospital/Columbia University Medical Center, New
York, NY, United States
(Kodali, Leon) Center for Interventional Vascular Therapy, Division of
Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical
Center, New York, NY, United States
(Miller) Department of Cardiovascular Surgery, Stanford University School
of Medicine, Stanford, Calif, United States
Publisher
Mosby Inc. (E-mail: customerservice@mosby.com)
Abstract
Objectives: Multisite procedure-based randomized trials may be confounded
by performance variability and variability among sites. Therefore, we
studied variability in mortality and stroke after patients were randomized
to surgical (SAVR) or transcatheter aortic valve replacement (TAVR) in the
Placement of Aortic Transcatheter Valves-2A (PARTNER-2A) randomized trial.
<br/>Method(s): Patients at intermediate risk for SAVR were randomized to
SAVR (n = 1017) or TAVR (n = 1011) with a SAPIEN XT device (Edwards
Lifesciences, Irvine, Calif) at 54 sites. Patients were followed to 2
years. A mixed-effect model quantified variability at intersite and
intrasite levels. <br/>Result(s): There were 336 deaths (SAVR 170, TAVR
166) and 176 strokes (SAVR 85, TAVR 91). Intersite variability for
mortality was similar across sites for SAVR (hazard ratios ranging from
0.52-1.93 among sites) and TAVR (hazard ratios ranging from 0.49-2.03),
but intersite variability for stroke was greater for SAVR (hazard ratios
ranging from 0.44-2.26) than for TAVR (no detectable variability). Case
mix and lower site trial volume accounted for 37% of mortality intersite
variability for SAVR and 73% for TAVR, but only 14% for stroke for SAVR.
Intrasite mortality hazard ratios demonstrated all but 1 site's 95%
confidence interval overlapped 1.0, indicating generally similar SAVR and
TAVR mortalities within sites. <br/>Conclusion(s): Intersite variability
was similar for mortality in SAVR and TAVR, but variability for stroke was
greater for SAVR than for TAVR. Intrasite events were similar for both
SAVR and TAVR. These findings suggest that in performance-based trials,
site variability and its sources should be taken into account in analyzing
and interpreting trial results.<br/>Copyright &#xa9; 2019

<42>
Accession Number
631212423
Title
Improved regional myocardial blood flow and flow reserve after coronary
revascularization as assessed by serial ¹⁵O-water positron
emission tomography/computed tomography.
Source
European Heart Journal Cardiovascular Imaging. 21 (1) (pp 36-46), 2020.
Date of Publication: 01 Jan 2020.
Author
Aikawa T.; Naya M.; Koyanagawa K.; Manabe O.; Obara M.; Magota K.;
Oyama-Manabe N.; Tamaki N.; Anzai T.
Institution
(Aikawa, Naya, Koyanagawa, Obara, Anzai) Department of Cardiovascular
Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido
University, Kita-15, Nishi-7, Kita-ku, Sapporo, Japan
(Aikawa) Department of Minimally Invasive Advanced Heart Failure
Therapeutics, Faculty of Medicine and Graduate School of Medicine,
Hokkaido University, Kita-15, Nishi-7, Kita-ku, Sapporo, Japan
(Manabe) Department of Nuclear Medicine, Faculty of Medicine and Graduate
School of Medicine, Hokkaido University, Kita-15, Nishi-7, Kita-ku,
Sapporo, Japan
(Magota) Division of Medical Imaging and Technology, Hokkaido University
Hospital, Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
(Oyama-Manabe) Department of Diagnostic and Interventional Radiology,
Hokkaido University Hospital, Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
(Tamaki) Department of Radiology, Kyoto Prefectural University of
Medicine, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
Publisher
Oxford University Press
Abstract
Aims: Myocardial perfusion imaging without and with quantitative
myocardial blood flow (MBF) and myocardial flow reserve (MFR) plays an
important role in the diagnosis and risk stratification of patients with
stable coronary artery disease (CAD). We aimed to quantify the effects of
coronary revascularization on regional stress MBF and MFR and to determine
whether the presence of subendocardial infarction was associated with
these changes. <br/>Methods and Results: Forty-seven patients with stable
CAD were prospectively enrolled. They underwent ¹⁵O-water
positron emission tomography at baseline and 6 months after optimal
medical therapy alone (n = 16), percutaneous coronary intervention (PCI)
(n = 18), or coronary artery bypass grafting (CABG) (n = 13). Stenosis of
>=50% diameter was detected in 98/141 vessels (70%). The regional MFR was
significantly increased from baseline to follow-up [1.84 (interquartile
range, IQR 1.28-2.17) vs. 2.12 (IQR 1.69-2.63), P < 0.001] in vessel
territories following PCI or CABG due to an increase in the stress MBF
[1.33 (IQR 0.97-1.67) mL/g/min vs. 1.64 (IQR 1.38-2.17) mL/g/min, P <
0.001], whereas there was no significant change in the regional stress MBF
or MFR in vessel territories without revascularization. A multilevel
mixed-effects models adjusted for baseline characteristics, subendocardial
infarction assessed by cardiovascular magnetic resonance imaging, and
intra-patient correlation showed that the degree of angiographic
improvement after coronary revascularization was significantly associated
with increased regional stress MBF and MFR (P < 0.05 for all).
<br/>Conclusion(s): Coronary revascularization improved the regional
stress MBF and MFR in patients with stable CAD. The magnitude of these
changes was associated with the extent of revascularization independent of
subendocardial infarction.<br/>Copyright &#xa9; 2019 Published on behalf
of the European Society of Cardiology. All rights reserved. &#xa9; The
Author(s) 2019.

<43>
Accession Number
2003657138
Title
Targeting high-sensitivity C-reactive protein levels in acute coronary
syndrome patients undergoing contemporary lipid-lowering therapy: a
sub-analysis of the HIJ-PROPER trial.
Source
Journal of Cardiology. 75 (5) (pp 500-506), 2020. Date of Publication: May
2020.
Author
Kawada-Watanabe E.; Yamaguchi J.; Sekiguchi H.; Arashi H.; Ogawa H.;
Hagiwara N.
Institution
(Kawada-Watanabe, Yamaguchi, Sekiguchi, Arashi, Ogawa, Hagiwara)
Department of Cardiology, The Heart Institute of Japan, Tokyo Women's
Medical University, Tokyo, Japan
Publisher
Japanese College of Cardiology (Nippon-Sinzobyo-Gakkai)
Abstract
Background: The effects of high-sensitivity C-reactive protein (hs-CRP)
levels on clinical outcomes in chronic-phase acute coronary syndrome (ACS)
patients undergoing aggressive lipid-lowering therapy remain unclear. We
examined the effects of hs-CRP levels on the prognosis of ACS patients who
underwent aggressive lipid-lowering therapy and determined treatment
targets for hs-CRP value. <br/>Method(s): This post-hoc sub-analysis of a
prospective randomized control trial (HIJ-PROPER) included 1734 ACS
patients with dyslipidemia, who were divided into hs-CRP quartiles after 3
months of treatment. Primary endpoints were combined all-cause death,
non-fatal myocardial infarction, non-fatal stroke, unstable angina, and
ischemia-driven coronary revascularization. Secondary endpoint was
all-cause death. <br/>Result(s): The median follow-up period was 3.7
years. Overall, 1415 patients were evaluated retrospectively. No
significant among-group differences were noted in low-density lipoprotein
cholesterol (LDL-C) levels over time (p = 0.44). Kaplan-Meier analyses
revealed that the incidence of the primary and secondary endpoints was
significantly higher in the highest hs-CRP group than in the other groups
[hazard ratio (HR) = 1.52, 95% confidence interval (CI) = 1.16-2.00, p <
0.01; HR = 5.30, 95% CI = 2.47-11.32, p < 0.01, respectively]. The cut-off
hs-CRP level to predict all-cause death was 0.74 mg/L (receiver operating
characteristic curve: sensitivity: 68%, specificity: 62%). Multivariate
analyses revealed that hs-CRP >=0.74 mg/L at 3 months was correlated with
an increased risk of all-cause death (adjusted HR = 3.68, 95% CI =
2.22-6.10, p < 0.01). <br/>Conclusion(s): Elevated hs-CRP levels
independently predicted a worse prognosis, regardless of LDL-C levels,
suggesting that interventions against elevated inflammatory responses plus
intensive lipid-lowering therapy and coronary revascularization are
encouraging options for secondary prevention in ACS patients. Trial
registration: This trial is registered with the UMIN Clinical Trials
Registry number UMIN000002742. Trial name: Proper level of lipid lowering
with pitavastatin and ezetimibe in acute coronary syndrome (HIJ-PROPER)
URL:
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr-view.cgi?recptno=R000003334
<br/>Copyright &#xa9; 2019 Japanese College of Cardiology

<44>
Accession Number
630707575
Title
The efficacy and safety of prophylactic corticosteroids for the prevention
of adverse outcomes in patients undergoing heart surgery using
cardiopulmonary bypass: a systematic review and meta-analysis of
randomized controlled trials.
Source
European journal of cardio-thoracic surgery : official journal of the
European Association for Cardio-thoracic Surgery. 57 (4) (pp 620-627),
2020. Date of Publication: 01 Apr 2020.
Author
Ng K.T.; Van Paassen J.; Langan C.; Sarode D.P.; Arbous M.S.; Alston R.P.;
Dekkers O.M.
Institution
(Ng) Department of Anaesthesiology, Faculty of Medicine, University of
Malaya, Kuala Lumpur, Malaysia
(Van Paassen, Arbous) Department of Intensive Care, Leiden University
Medical Center, Leiden, Netherlands
(Langan, Sarode) Department of General Surgery, NHS Greater Glasgow &
Clyde, United Kingdom
(Arbous, Dekkers) Department of Clinical Epidemiology, Leiden University
Medical Center, Leiden, Netherlands
(Alston) Department of Anaesthesia, Critical Care and Pain Medicine, Royal
Infirmary of Edinburgh, Edinburgh, United Kingdom
Publisher
NLM (Medline)
Abstract
Corticosteroids are often administered prophylactically to attenuate the
inflammatory response associated with cardiac surgery using
cardiopulmonary bypass (CPB). However, the efficacy and safety profile of
corticosteroids remain uncertain. The primary aim of this systematic
review and meta-analysis was to investigate the effect of corticosteroids
on mortality in adult cardiac surgery using CPB. Secondary aims were to
examine the effect of corticosteroids on myocardial adverse events,
pulmonary adverse events, atrial fibrillation, surgical site infection,
gastrointestinal bleeding and duration of stay in the intensive care unit
and hospital. Randomized controlled trials (RCTs) were systematically
searched in electronic databases (MEDLINE, EMBASE, CINAHL, CENTRAL and Web
of Science) from their inception until March 2019. Observational studies,
case reports, case series and literature reviews were excluded. Sixty-two
studies (n=16 457 patients) were included in this meta-analysis. There was
no significant difference in mortality between the corticosteroid and
placebo groups [odds ratio (OR) 0.96, 95% confidence interval (CI)
0.81-1.14; P=0.65, participants=14 693, studies=24, evidence of certainty:
moderate]. Compared to those receiving a placebo, patients who were given
corticosteroids had a significantly higher incidence of myocardial adverse
events (OR 1.17, 95% CI 1.03-1.33; P=0.01, participants=14 512,
studies=23) and a lower incidence of pulmonary adverse events (OR 0.86,
95% CI 0.75-0.98; P=0.02, participants=13 426, studies=17). The incidences
of atrial fibrillation (OR 0.87, 95% CI 0.81-0.94; P<0.001,
participants=14 148, studies=24) and surgical site infection (OR 0.81, 95%
CI 0.73-0.90; P<0.001, participants=13 946; studies=22) were all lower in
patients who were given corticosteroids. In the present meta-analysis of
62 RCTs (16 457 patients), including the 2 major RCTs (SIRS and DECS
trials: 12 001 patients), we found that prophylactic corticosteroids in
cardiac surgery did not reduce mortality. The clinical significance of an
increase in myocardial adverse events remains unclear as the definition of
a relevant myocardial end point following cardiac surgery varied greatly
between RCTs.<br/>Copyright &#xa9; The Author(s) 2020. Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery. All rights reserved.

<45>
Accession Number
629692356
Title
Full sternotomy and minimal access approaches for surgical aortic valve
replacement: a multicentre propensity-matched study.
Source
European journal of cardio-thoracic surgery : official journal of the
European Association for Cardio-thoracic Surgery. 57 (4) (pp 709-716),
2020. Date of Publication: 01 Apr 2020.
Author
Paparella D.; Malvindi P.G.; Santarpino G.; Moscarelli M.; Guida P.;
Fattouch K.; Margari V.; Martinelli L.; Albertini A.; Speziale G.
Institution
(Paparella, Malvindi, Margari) Department of Cardiac Surgery, Santa Maria
Hospital, GVM Care & Research, Bari, Italy
(Paparella) Department of Emergency and Organ Transplant, University of
Bari Aldo Moro, Bari, Italy
(Santarpino) Department of Cardiac Surgery, Citta di Lecce Hospital, GVM
Care & Research, Lecce, Italy
(Santarpino) Department of Cardiac Surgery, Klinikum Nurnberg, Paracelsus
Medical University, Nuremberg, Germany
(Moscarelli, Speziale) Department of Cardiac Surgery, Anthea Hospital, GVM
Care & Research, Bari, Italy
(Moscarelli, Albertini, Speziale) Department of Cardiac Surgery, Maria
Cecilia Hospital, GVM Care & Research, Cotignola, Italy
(Guida) Maugeri Foundation, Cassano delle Murge, Bari, Italy
(Fattouch) Department of Cardiac Surgery, Maria Eleonora Hospital, GVM
Care & Research, Palermo, Italy
(Martinelli) Department of Cardiac Surgery, ICLAS, GVM Care & Research,
Rapallo, Italy
Publisher
NLM (Medline)
Abstract
OBJECTIVES: Surgical aortic valve replacement (AVR) can be performed via a
full sternotomy or a minimal access approach (mini-AVR). Despite long-term
experience with the procedure, mini-AVR is not routinely adopted. Our goal
was to compare contemporary outcomes of mini-AVR and conventional AVR in a
large multi-institutional national cohort. <br/>METHOD(S): A total of 5801
patients from 10 different centres who had a mini-AVR (2851) or AVR (2950)
from 2011 to 2017 were evaluated retrospectively. Standard aortic
prostheses were used in all cases. The use of the minimally invasive
approach has increased over the years. The primary outcome is the
incidence of 30-day deaths following mini-AVR and AVR. Secondary outcomes
are the occurrence of major complications following both procedures.
Propensity-matched comparisons were performed based on the multivariable
logistic regression model. <br/>RESULT(S): In the overall population
patients who had AVR had an increased surgical risk based on the
EuroSCORE, and the 30-day mortality rate was higher (1.5% and 2.3% in
mini-AVR and AVR, respectively; P=0.048). Propensity scores identified
2257 patients per group with similar baseline profiles. In the matched
groups, patients who had mini-AVR, despite longer cardiopulmonary bypass
(81+/-32 vs 76+/-28min; P=0.004) and cross-clamp (64+/-24 vs 59+/-21min;
P<=0.001) times, had lower 30-day mortality rates (1.2% vs 2.0%; P=0.036),
reduced low cardiac output (0.8% vs 1.4%; P=0.046) and reduced
postoperative length of stay (9+/-8 vs 10+/-7days; P=0.004). Blood
transfusions (36.4% vs 30.8%; P<=0.001) and atrial fibrillation (26.0% vs
21.5%, P<=0.001) were higher in patients who had the mini-AVR.
<br/>CONCLUSION(S): In a large multi-institutional recent cohort, minimal
access approach aortic valve replacement is associated with reduced 30-day
mortality rates and shorter postoperative lengths of stay compared to
standard sternotomy. A prospective randomized trial is needed to overcome
the possible biases of a retrospective study.<br/>Copyright &#xa9; The
Author(s) 2019. Published by Oxford University Press on behalf of the
European Association for Cardio-Thoracic Surgery. All rights reserved.

<46>
Accession Number
629620776
Title
Impact of non-respect of SYNTAX score II recommendation for surgery in
patients with left main coronary artery disease treated by percutaneous
coronary intervention: an EXCEL substudy.
Source
European journal of cardio-thoracic surgery : official journal of the
European Association for Cardio-thoracic Surgery. 57 (4) (pp 676-683),
2020. Date of Publication: 01 Apr 2020.
Author
Modolo R.; Chichareon P.; van Klaveren D.; Dressler O.; Zhang Y.; Sabik
J.F.; Onuma Y.; Kappetein A.P.; Stone G.W.; Serruys P.W.
Institution
(Modolo, Chichareon) Department of Cardiology, Academic Medical Center,
University of Amsterdam, Amsterdam, Netherlands
(Modolo) Cardiology Division, Department of Internal Medicine, University
of Campinas (UNICAMP), Campinas, Brazil
(Chichareon) Division of Cardiology, Department of Internal Medicine,
Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand
(van Klaveren) Department of Biomedical Data Sciences, Leiden University
Medical Center, Leiden, Netherlands
(Dressler, Zhang, Stone) Clinical Trials Center, Cardiovascular Research
Foundation, NY, NY, United States
(Sabik) Department of Surgery, UH Cleveland Medical Center, Cleveland, OH,
USA
(Onuma) Department of Cardiology, Erasmus Medical Center, Rotterdam,
Netherlands
(Onuma) Cardialysis Clinical Trials Management and Core Laboratories,
Rotterdam, Netherlands
(Kappetein) Medtronic, Maastricht, Netherlands
(Stone) New York-Presbyterian Hospital, Columbia University Medical
Center, NY, NY, United States
(Serruys) Imperial College London, London, United Kingdom
Publisher
NLM (Medline)
Abstract
OBJECTIVES: The SYNTAX score II (SSII) was developed from the SYNTAX trial
to predict the 4-year all-cause mortality after left main or multivessel
disease revascularization and to facilitate the decision-making process.
The SSII provides the following treatment recommendations: (i) coronary
artery bypass grafting (CABG) or percutaneous coronary intervention (PCI)
(equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii)
PCI preferred (excessive risk for CABG). We sought to externally validate
SSII and to investigate the impact of not abiding by the SSII
recommendations in the randomized EXCEL trial of PCI versus CABG for left
main disease. <br/>METHOD(S): The calibration plot of predicted versus
observed 4-year mortality was constructed from individual values of SSII
in EXCEL. To assess overestimation versus underestimation of predicted
mortality risk, an optimal fit regression line with slope and intercept
was determined. Prospective treatment recommendations based on SSII were
compared with actual treatments and all-cause mortality at 4years.
<br/>RESULT(S): SSII variables were available from EXCEL trial in
1807/1905 (95%) patients. For the entire cohort, discrimination was
possibly helpful (C statistic=0.670). SSII-predicted all-cause mortality
at 4years overestimated the observed mortality, particularly in the
highest-risk percentiles, as confirmed by the fit regression line
[intercept 2.37 (1.51-3.24), P=0.003; slope 0.67 (0.61-0.74), P<0.001].
When the SSII-recommended treatment was CABG, randomized EXCEL patients
treated with PCI had a trend towards higher mortality compared with those
treated with CABG (14.1% vs 5.3%, P=0.07) in the as-treat population. In
the intention-to-treat population, patients randomized to PCI had higher
mortality compared with those randomized to CABG (15.1% vs 4.1%, P=0.02),
when SSII recommended CABG. <br/>CONCLUSION(S): In the EXCEL trial of
patients with left main disease, the SSII-predicted 4-year mortality
overestimated the 4-year observed mortality with a possibly helpful
discrimination. Non-compliance with SSII CABG treatment recommendations
(i.e. randomized to PCI) was associated with higher 4-year all-cause
mortality.<br/>Copyright &#xa9; The Author(s) 2019. Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery. All rights reserved.

<47>
Accession Number
631282155
Title
Portable Normothermic Cardiac Perfusion System in Donation After
Cardiocirculatory Death: A Health Technology Assessment.
Source
Ontario health technology assessment series. 20 (3) (pp 1-90), 2020. Date
of Publication: 2020.
Publisher
NLM (Medline)
Abstract
Background: Heart transplantation is the most effective treatment for
people experiencing end-stage heart failure whose quality of life and life
expectancy are unacceptable. However, there is a chronic shortage of donor
hearts to meet the demand, so it is essential to expand the donor pool and
increase supply. Heart donation mainly occurs after brain death
(neurological determination of death [NDD]), but it may also be feasible
after cardiocirculatory death (when the heart has stopped beating and
there is no longer blood flow or a pulse), provided specialized
preservation techniques are used. An investigational device, a portable
normothermic cardiac perfusion system, could make it possible to procure,
preserve, and transport hearts donated after cardiocirculatory death
(DCD). We conducted a health technology assessment of a portable
normothermic cardiac perfusion system for the preservation and
transportation of DCD hearts for adult transplantation. This included an
evaluation of the effectiveness, safety, value for money, and budget
impact of publicly funding this system, as well as an evaluation of
patient preferences and values. <br/>Method(s): We performed a systematic
review of the clinical literature published since 1998 that examined the
clinical safety and effectiveness of a portable normothermic cardiac
perfusion system for DCD heart transplantation. We assessed the risk of
bias of each included study and the quality of the body of evidence
according to the Grading of Recommendations Assessment, Development, and
Evaluation (GRADE) Working Group criteria. We also reviewed the economic
evidence published during the same time period for the cost-effectiveness
of a portable normothermic cardiac perfusion system for DCD hearts
compared with cold storage for NDD hearts. We further estimated the 5-year
net budget impact of publicly funding a normothermic cardiac perfusion
system for DCD heart transplantation for adults on Ontario's waitlist. To
contextualize the potential value of a portable normothermic cardiac
perfusion system, we spoke with people waiting for a heart transplant,
people who had received a heart transplant, and family members of organ
donors. <br/>Result(s): We screened 2,386 clinical citations. One study
and two case reports met the inclusion criteria. The survival of
recipients of DCD hearts procured with a portable normothermic cardiac
perfusion system did not differ significantly from the survival of
recipients of hearts donated after NDD at 30 days or 90 days, nor was
there a significant difference in cumulative survival at 1 year
post-transplant (GRADE: Very Low). The occurrence of rejection and graft
failure also did not significantly differ between the groups (GRADE: Very
Low). Cardiac function in the early post-operative period was better in
DCD hearts than NDD hearts (GRADE: Very Low). There were no differences in
outcomes between DCD procurement techniques.The economic literature search
yielded 62 citations. One report met the inclusion criteria but was not
directly applicable to the Ontario context. Given the lack of clinical and
economic evidence on long-term outcomes, we did not conduct a primary
economic evaluation. In the budget impact analysis, based on the number of
DCD donors under 40 years of age in the last 5 years, we estimated that
the increased availability of donor hearts made possible by the technology
would result in an additional seven transplants in year 1, increasing to
12 in year 5. The annual net budget impact of publicly funding a
normothermic cardiac perfusion system for the transplantation of DCD
hearts in Ontario over the next 5 years is about $2.0 million in the first
year and about $0.9 million in each of years 2 through 5, yielding a total
net budget impact of about $5.6 million. This number increases to about
$10.3 million if the transplant volume increases to 18 hearts in year 1
(meaning a subsequent increase of up to 21 hearts in year 5). If
transplantation were limited to people who do not qualify for a
ventricular assistive device or who qualify but do not wish to receive
one, the total 5-year net budget impact would be about $7.9 million.People
waiting for a heart transplant or who had received a heart transplant and
family members of organ donors expressed no substantial concerns about the
potential use of a portable normothermic cardiac perfusion system. They
hope that it may increase the number of donor hearts available for
transplant. For family members of organ donors, a perfusion system may
provide comfort and value if it can increase the successful procurement of
donor hearts. <br/>Conclusion(s): Based on very low quality of evidence,
the outcomes for recipients of DCD hearts preserved using a portable
normothermic cardiac perfusion system appear to be similar to outcomes for
recipients of NDD hearts. Owing to a lack of evidence relevant to the
Ontario context, we were unable to determine whether a portable
normothermic perfusion system may be cost-effective. We estimate that
publicly funding a portable normothermic cardiac perfusion system for DCD
heart transplantation over the next 5 years will cost about $5.6 million.
The people we spoke with believe that the system may increase the number
of hearts available for transplant and therefore increase the number of
heart transplants that can be done.<br/>Copyright &#xa9; Queen's Printer
for Ontario, 2020.

<48>
Accession Number
631271359
Title
Role of advanced left ventricular imaging in adults with aortic stenosis.
Source
Heart (British Cardiac Society). (no pagination), 2020. Date of
Publication: 16 Mar 2020.
Author
Calin A.; Mateescu A.D.; Popescu A.C.; Bing R.; Dweck M.R.; Popescu B.A.
Institution
(Calin, Mateescu, Popescu, Popescu) Department of Cardiology, Euroecolab,
University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
(Calin, Mateescu, Popescu) Department of Cardiology, Emergency Institute
for Cardiovascular Diseases "Prof Dr C C Iliescu", Bucharest, Romania
(Popescu) Department of Cardiology, Emergency University Hospital Elias,
Bucharest, Romania
(Bing, Dweck) BHF Centre for Cardiovascular Science, University of
Edinburgh, Edinburgh EH16 4SB, United Kingdom
Publisher
NLM (Medline)
Abstract
This review focuses on the available data regarding the utility of
advanced left ventricular (LV) imaging in aortic stenosis (AS) and its
potential impact for optimising the timing of aortic valve replacement.
Ejection fraction is currently the only LV parameter recommended to guide
intervention in AS. The cut-off value of 50%, recommended for
decision-making in asymptomatic patients with AS, is currently under
debate. Several imaging parameters have emerged as predictors of disease
progression and clinical outcomes in this setting. Global longitudinal LV
strain by speckle tracking echocardiography is useful for risk
stratification of asymptomatic patients with severe AS and preserved LV
ejection fraction. Its prognostic value was demonstrated in these
patients, but further work is required to define the best thresholds to
aid the decision-making process. The assessment of myocardial fibrosis is
the most studied application of cardiac magnetic resonance in AS. The
detection of replacement fibrosis by late gadolinium enhancement offers
incremental prognostic information in these patients. Clinical
implementation of this technique to optimise the timing of aortic valve
intervention in asymptomatic patients is currently tested in a randomised
trial. The use of T1 mapping techniques can provide an assessment of
interstitial myocardial fibrosis and represents an expanding field of
interest. However, convincing data in patients with AS is still lacking.
All these imaging parameters have substantial potential to influence the
management decision in patients with AS in the future, but data from
randomised clinical trials are awaited to define their utility in daily
practice.<br/>Copyright &#xa9; Author(s) (or their employer(s)) 2020.
Re-use permitted under CC BY-NC. No commercial re-use. See rights and
permissions. Published by BMJ.

<49>
Accession Number
2005169767
Title
Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate
Cancer: The PRONOUNCE Trial Study Design.
Source
JACC: CardioOncology. 2 (1) (pp 70-81), 2020. Date of Publication: March
2020.
Author
Melloni C.; Slovin S.F.; Blemings A.; Goodman S.G.; Evans C.P.; Nilsson
J.; Bhatt D.L.; Zubovskiy K.; Olesen T.K.; Dugi K.; Clarke N.W.; Higano
C.S.; Roe M.T.
Institution
(Melloni, Roe) Department of Medicine, Division of Cardiology, Duke
Clinical Research Institute, Duke University Medical Center, Durham, NC,
United States
(Slovin) Department of Medicine, Division of Medical Oncology, Memorial
Sloan Kettering Cancer Center, New York, NY, United States
(Blemings) Ferring Pharmaceuticals A/S, Copenhagen, Denmark
(Goodman) Department of Medicine, Division of Cardiology, St. Michael's
Hospital, University of Toronto, Toronto, Ontario, Canada
(Goodman) Canadian VIGOUR Centre, University of Alberta, Edmonton,
Alberta, Canada
(Evans) Department of Urologic Surgery, University of California, Davis,
Sacramento, California, United States
(Nilsson) Department of Clinical Sciences Malmo, Lund University, Lund,
Sweden
(Bhatt) Division of Cardiovascular Medicine, Brigham and Women's Hospital
Heart and Vascular Center, Harvard Medical School, Boston, MA, United
States
(Zubovskiy, Olesen) Ferring Pharmaceuticals A/S, Parsippany, NJ, United
States
(Dugi) Ferring Pharmaceuticals A/S, Saint-Prex, Switzerland
(Clarke) Division of Urology, Institute of Cancer Sciences, University of
Manchester, United Kingdom
(Higano) Division of Medical Oncology, University of Washington and Fred
Hutchinson Cancer Research Center, Seattle, Washington, United States
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Objectives: This study will compare the incidence of major adverse
cardiovascular events (MACEs) with androgen deprivation therapy (ADT)
among men with advanced prostate cancer who are being treated with a
gonadotropin-releasing hormone (GnRH) antagonist versus a GnRH agonist.
<br/>Background(s): Treatment of advanced prostate cancer with ADT might
increase the risk of subsequent cardiovascular events among men with known
atherosclerotic cardiovascular disease (ASCVD), but a recent meta-analysis
suggested that this risk might be lower with ADT using a GnRH antagonist
versus a GnRH agonist. <br/>Method(s): PRONOUNCE is a multicenter,
prospective, randomized, open, blinded endpoint trial that will enroll
approximately 900 patients with advanced prostate cancer and pre-existing
ASCVD who will be treated with ADT. Participants will be randomized to
receive the GnRH antagonist degarelix or the GnRH agonist leuprolide as
ADT for 12 months. The primary endpoint is time from randomization to
first confirmed, adjudicated occurrence of a MACE, which is defined as a
composite of all-cause death, nonfatal myocardial infarction, or nonfatal
stroke through 12 months of ADT treatment. Baseline cardiovascular
biomarkers (high-sensitivity C-reactive protein, high-sensitivity troponin
T, and N-terminal pro-brain natriuretic peptide), as well as serial
inflammatory and immune biomarkers, will be evaluated in exploratory
analyses. <br/>Result(s): As of October 1, 2019, a total of 364 patients
have been enrolled. The mean age is 74 years, 90% are white, 80% have
hypertension or dyslipidemia, 30% diabetes mellitus, 40% have had a
previous myocardial infarction, and 65% have had previous
revascularization. Regarding prostate cancer features at randomization,
48% of the patients had localized disease, 23% had locally advanced
disease, and 18% had metastatic disease. <br/>Conclusion(s): PRONOUNCE is
the first prospective cardiovascular outcomes trial in advanced prostate
cancer that will delineate whether the risk of subsequent cardiovascular
events associated with ADT is lower with a GnRH antagonist versus a GnRH
agonist for men with pre-existing ASCVD. (A Trial Comparing Cardiovascular
Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate
Cancer and Cardiovascular Disease [PRONOUNCE]; NCT02663908)<br/>Copyright
&#xa9; 2020 The Authors

<50>
Accession Number
631187265
Title
Perioperative interventions for prevention of postoperative pulmonary
complications: Systematic review and meta-analysis.
Source
The BMJ. 368 (no pagination), 2020. Article Number: m540. Date of
Publication: 11 Mar 2020.
Author
Odor P.M.; Bampoe S.; Gilhooly D.; Creagh-Brown B.; Ramani Moonesinghe S.
Institution
(Odor, Bampoe, Gilhooly, Ramani Moonesinghe) Department of Anaesthesia and
Perioperative Medicine, University College Hospital, London, United
Kingdom
(Creagh-Brown) Surrey Perioperative Anaesthesia Critical Care
Collaborative Research (SPACeR) Group, Intensive Care Unit, Royal Surrey
County Hospital NHS Foundation Trust, Guildford, United Kingdom
(Creagh-Brown) Department of Clinical and Experimental Medicine, Faculty
of Health and Medical Sciences, University of Surrey, Guildford, United
Kingdom
(Ramani Moonesinghe) UCL/UCLH Surgical Outcomes Research Centre, UCL
Centre for Perioperative Medicine, Research Department for Targeted
Intervention, Division of Surgery and Interventional Science, University
College London, London, United Kingdom
Publisher
BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com)
Abstract
Objective To identify, appraise, and synthesise the best available
evidence on the efficacy of perioperative interventions to reduce
postoperative pulmonary complications (PPCs) in adult patients undergoing
non-cardiac surgery. Design Systematic review and meta-analysis of
randomised controlled trials. Data sources Medline, Embase, CINHAL, and
CENTRAL from January 1990 to December 2017. Eligibility criteria
Randomised controlled trials investigating short term, protocolised
medical interventions conducted before, during, or after non-cardiac
surgery were included. Trials with clinical diagnostic criteria for PPC
outcomes were included. Studies of surgical technique or physiological or
biochemical outcomes were excluded. Data extraction and synthesis
Reviewers independently identified studies, extracted data, and assessed
the quality of evidence. Meta-analyses were conducted to calculate risk
ratios with 95% confidence intervals. Quality of evidence was summarised
in accordance with GRADE methods. The primary outcome was the incidence of
PPCs. Secondary outcomes were respiratory infection, atelectasis, length
of hospital stay, and mortality. Trial sequential analysis was used to
investigate the reliability and conclusiveness of available evidence.
Adverse effects of interventions were not measured or compared. Results
117 trials enrolled 21 940 participants, investigating 11 categories of
intervention. 95 randomised controlled trials enrolling 18 062
participants were included in meta-analysis; 22 trials were excluded from
meta-analysis because the interventions were not sufficiently similar to
be pooled. No high quality evidence was found for interventions to reduce
the primary outcome (incidence of PPCs). Seven interventions had low or
moderate quality evidence with confidence intervals indicating a probable
reduction in PPCs: enhanced recovery pathways (risk ratio 0.35, 95%
confidence interval 0.21 to 0.58), prophylactic mucolytics (0.40, 0.23 to
0.67), postoperative continuous positive airway pressure ventilation
(0.49, 0.24 to 0.99), lung protective intraoperative ventilation (0.52,
0.30 to 0.88), prophylactic respiratory physiotherapy (0.55, 0.32 to
0.93), epidural analgesia (0.77, 0.65 to 0.92), and goal directed
haemodynamic therapy (0.87, 0.77 to 0.98). Moderate quality evidence
showed no benefit for incentive spirometry in preventing PPCs. Trial
sequential analysis adjustment confidently supported a relative risk
reduction of 25% in PPCs for prophylactic respiratory physiotherapy,
epidural analgesia, enhanced recovery pathways, and goal directed
haemodynamic therapies. Insufficient data were available to support or
refute equivalent relative risk reductions for other interventions.
Conclusions Predominantly low quality evidence favours multiple
perioperative PPC reduction strategies. Clinicians may choose to reassess
their perioperative care pathways, but the results indicate that new
trials with a low risk of bias are needed to obtain conclusive evidence of
efficacy for many of these interventions. Study registration Prospero
CRD42016035662.<br/>Copyright &#xa9; 2019 Author(s).

<51>
Accession Number
631083284
Title
Postoperative pain treatment with erector spinae plane block and
pectoralis nerve blocks in patients undergoing mitral/tricuspid valve
repair - A randomized controlled trial.
Source
BMC Anesthesiology. 20 (1) (no pagination), 2020. Article Number: 51. Date
of Publication: 27 Feb 2020.
Author
Gaweda B.; Borys M.; Belina B.; Bak J.; Czuczwar M.; Woloszczuk-Gebicka
B.; Kolowca M.; Widenka K.
Institution
(Gaweda, Bak, Kolowca, Widenka) Division of Cardiovascular Surgery, St.
Jadwiga Provincial Clinical Hospital, ul. Lwowska 60, Rzeszow 35-301,
Poland
(Borys, Czuczwar) Second Department of Anesthesia and Intensive Care,
Medical University of Lublin, ul. Staszica 16, Lublin 20-081, Poland
(Belina, Woloszczuk-Gebicka) Anesthesiology and Intensive Care Department,
Center for Acute Poisoning, St. Jadwiga Provincial Clinical Hospital, ul.
Lwowska 60, Rzeszow 35-301, Poland
Publisher
BioMed Central Ltd. (E-mail: info@biomedcentral.com)
Abstract
Background: Effective postoperative pain control remains a challenge for
patients undergoing cardiac surgery. Novel regional blocks may improve
pain management for such patients and can shorten their length of stay in
the hospital. To compare postoperative pain intensity in patients
undergoing cardiac surgery with either erector spinae plane (ESP) block or
combined ESP and pectoralis nerve (PECS) blocks. <br/>Method(s): This was
a prospective, randomized, controlled, double-blinded study done in a
tertiary hospital. Thirty patients undergoing mitral/tricuspid valve
repair via mini-thoracotomy were included. Patients were randomly
allocated to one of two groups: ESP or PECS + ESP group (1:1
randomization). Patients in both groups received a single-shot,
ultrasound-guided ESP block. Participants in PECS + ESP group received
additional PECS blocks. Each patient had to be extubated within 2 h from
the end of the surgery. Pain was treated via a patient-controlled
analgesia (PCA) pump. The primary outcome was the total oxycodone
consumption via PCA during the first postoperative day. The secondary
outcomes included pain intensity measured on the visual analog scale
(VAS), patient satisfaction, Prince Henry Hospital Pain Score (PHHPS), and
spirometry. <br/>Result(s): Patients in the PECS + ESP group used
significantly less oxycodone than those in the ESP group: median 12
[interquartile range (IQR): 6-16] mg vs. 20 [IQR: 18-29] mg (p = 0.0004).
Moreover, pain intensity was significantly lower in the PECS + ESP group
at each of the five measurements during the first postoperative day.
Patients in the PECS + ESP group were more satisfied with pain management.
No difference was noticed between both groups in PHHPS and spirometry.
<br/>Conclusion(s): The addition of PECS blocks to ESP reduced consumption
of oxycodone via PCA, reduced pain intensity on the VAS, and increased
patient satisfaction with pain management in patients undergoing
mitral/tricuspid valve repair via mini-thoracotomy. Trial registration:
The study was registered on the 19th July 2018 (first posted) on the
ClinicalTrials.gov identifier: NCT03592485.<br/>Copyright &#xa9; 2020 The
Author(s).

<52>
Accession Number
2005246205
Title
Ten-year improved survival in patients with multi-vessel coronary disease
and poor left ventricular function following surgery: A retrospective
cohort study.
Source
International Journal of Surgery. 76 (pp 146-152), 2020. Date of
Publication: April 2020.
Author
Cummings I.G.; Lucchese G.; Garg S.; Soni M.; Majid A.F.; Marczin N.;
Panoulas V.; Raja S.G.
Institution
(Cummings, Garg, Soni, Majid, Marczin, Raja) Department of Cardiac
Surgery, Harefield Hospital, London, United Kingdom
(Lucchese) Department of Cardiac Surgery, St Thomas' Hospital, London,
United Kingdom
(Panoulas) Department of Cardiology, Harefield Hospital, London, United
Kingdom
Publisher
Elsevier Ltd
Abstract
Objective: Patients with multi-vessel coronary artery disease and poor
left ventricular (LV) function (ejection fraction [EF] < 30%) requiring
revascularization are considered 'high-risk'. Limited long-term survival
data exists comparing percutaneous coronary intervention (PCI) with
second-generation drug-eluting stents (DES) versus surgery for this cohort
of patients. <br/>Method(s): We retrospectively reviewed our data for 321
patients with EF < 30% who underwent multi-vessel revascularization from
January 2005 to December 2015 using Cox regression analyses and inverse
probability treatment weighted (IPTW) methods. We stratified patients that
underwent surgical revascularization into on-pump coronary artery bypass
grafting (CABG) and off-pump CABG and analyzed all-cause mortality at 10
years compared to PCI. <br/>Result(s): 214 patients underwent CABG (n
[on-pump CABG] = 94; n [off-pump CABG] = 120) and 107 patients had PCI
with second generation DES. PCI with DES had higher 10-year mortality
compared with on-pump CABG (Hazard ratio [HR] = 1.86, 95% confidence
interval [CI] = 1.46-2.42; p < 0.001) and off-pump CABG (HR = 2.32, 95% CI
= 1.75-3.15; p < 0.001). This was confirmed in IPTW analyses. When
adjusting for both measured and unmeasured factors using instrumental
variable analyses, PCI with DES had higher 10-year mortality compared with
on-pump CABG (DELTA = 13.5, 95% CI = 3.2-24.5; p = 0.012) and off-pump
CABG (DELTA = 16.1, 95% CI = 5.9-25.8; p < 0.001). <br/>Conclusion(s):
Surgical revascularization, preferably off-pump CABG, results in better
long-term survival compared with PCI using second generation DES for
patients with multi-vessel coronary artery disease and poor left
ventricular function. Randomized controlled trials in this patient group
should be undertaken.<br/>Copyright &#xa9; 2020 IJS Publishing Group Ltd

<53>
Accession Number
2005199500
Title
Comparison between erector spinal plane block and epidural block
techniques for postoperative analgesia in open cholecystectomies: a
randomized clinical trial.
Source
Brazilian Journal of Anesthesiology. (no pagination), 2020. Date of
Publication: 2020.
Author
Sakae T.M.; Yamauchi L.H.I.; Takaschima A.K.K.; Brandao J.C.; Benedetti
R.H.
Institution
(Sakae, Yamauchi, Takaschima, Benedetti) Servico de Anestesiologia
SIANEST, Florianopolis, SC, Brazil
(Sakae, Benedetti) Universidade do Sul de Santa Catarina (UNISUL),
Florianopolis, SC, Brazil
(Yamauchi, Takaschima, Benedetti) Hospital Florianopolis, Florianopolis,
SC, Brazil
(Yamauchi, Takaschima, Brandao, Benedetti) TSA Sociedade Brasileira de
Anestesiologia (SBA), Rio de Janeiro, RJ, Brazil
Publisher
Elsevier Editora Ltda
Abstract
Introduction and objectives: Blockade of the Erector Spinal Muscle (ESP
block) is a relatively new block, initially described for chronic thoracic
pain analgesia, but it has already been described for anesthesia and
analgesia in thoracic surgical procedures and, more recently, for high
abdominal surgeries. The aim of the study was to compare two techniques,
ESP Block and Epidural block with morphine and local anesthetic for
postoperative analgesia of open cholecystectomy surgeries. <br/>Method(s):
Controlled single-blind randomized clinical trial with 31 patients (ESP
block, n = 15; Epidural, n = 16), of both genders, ages between 27 and 77
years. The ESP block was performed at the T8 level with injection of 20 mL
of 0.5% ropivacaine bilaterally. The epidural block was performed at the
T8-T9 space with 20 mL of 0.5% ropivacaine and 1 mg of morphine.
<br/>Result(s): The ESP block group presented higher mean Numeric Pain
Scale (NPS) values for pain in the up to 2 hour (p = 0.001) and in the 24
hour (p = 0.001) assessments. The ESP block group had a three-fold
increased risk (43.7% vs. 13.3%) of rescue opioid use in the 24
postoperative hours when compared to the epidural group (RR = 3.72, 95%
CI: 0.91 to 15.31, p = 0.046). <br/>Conclusion(s): ESP block did not prove
to be an effective technique for postoperative analgesia of open
cholecystectomy, at the doses performed in this study, having required
more use of rescue opioid, and without differences in NPS. More
comprehensive studies are required to assess the efficacy of ESP block for
the visceral and abdominal somatic component, considering the specific
blockade level.<br/>Copyright &#xa9; 2020

<54>
Accession Number
2005197866
Title
Impact of ultrasound-guided erector spinae plane block on postoperative
quality of recovery in video-assisted thoracic surgery: A prospective,
randomized, controlled trial.
Source
Journal of Clinical Anesthesia. 63 (no pagination), 2020. Article Number:
109783. Date of Publication: August 2020.
Author
Yao Y.; Fu S.; Dai S.; Yun J.; Zeng M.; Li H.; Zheng X.
Institution
(Yao, Dai, Zeng, Li, Zheng) Department of Anesthesiology, Shengli Clinical
Medical College of Fujian Medical University, Fuzhou, China
(Fu) Department of Pathology, Union Hospital of Fujian Medical University,
Fuzhou, Fujian, China
(Yun) The 95th Clinical Department, The 900th Hospital of Joint Service
Support Force of the PLA, Putian, China
(Zheng) Department of Anesthesiology, Fujian Provincial Hospital, Fuzhou,
China
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Study objective: Regional anesthesia improves postoperative analgesia and
enhances the quality of recovery (QoR) after surgery. We examine the
efficacy of ultrasound-guided erector spinae plane block (ESPB) on QoR
after video-assisted thoracic surgery (VATS). <br/>Design(s): Prospective,
randomized, double-blinded, placebo-controlled trial. <br/>Setting(s):
Single institution, tertiary university hospital. <br/>Patient(s): Adult
patients who scheduled for VATS under general anesthesia were enrolled in
the study. <br/>Intervention(s): We randomly allocated patients to receive
preoperative ultrasound-guided ESPB with 25 ml of either 0.5% ropivacaine
(ESPB group) or normal saline (Control group). Measurements: The primary
outcome was QoR as measured by the 40-item QoR questionnaire (QoR-40)
score at postoperative day 1. Secondary results were post-anesthesia care
unit (PACU) discharge time, acute postoperative pain, cumulative opioid
consumption, the incidence of postoperative nausea or vomiting (PONV), and
patient satisfaction. <br/>Main Result(s): The global QoR-40 score at
postoperative day 1 (median, interquartile range) was significantly higher
in the ESPB group (174, 170 to 177) than the control group (161.5, 160 to
165), estimated median difference 11 (95% CI 9 to 13, P < 0.001). Compared
with the control group, single-injection of ESPB reduced PACU discharge
time, acute postoperative pain, and cumulative opioid consumption.
Correspondingly, the median patient satisfaction scores were higher in the
ESPB group than the control group (9 versus 7, P < 0.001).
<br/>Conclusion(s): Preoperative single-injection thoracic ESPB with
ropivacaine improves QoR, postoperative analgesia, and patient
satisfaction after VATS.<br/>Copyright &#xa9; 2020 Elsevier Inc.

<55>
Accession Number
2004436110
Title
Sodium nitroprusside versus nicardipine for hypertension management after
surgery: A systematic review and meta-analysis.
Source
Journal of Cardiac Surgery. (no pagination), 2020. Date of Publication:
2020.
Author
Villarreal E.G.; Flores S.; Kriz C.; Iranpour N.; Bronicki R.A.; Loomba
R.S.
Institution
(Villarreal, Flores, Bronicki) Cardiac Intensive Care Unit, Division of
Critical Care, Texas Children's Hospital/Baylor College of Medicine,
Houston, TX, United States
(Villarreal) Tecnologico de Monterrey, Escuela de Medicina y Ciencias de
la Salud, Monterrey, Nuevo Leon, Mexico
(Kriz, Loomba) Cardiology, Advocate Children's Hospital/Chicago Medical
School, Chicago, IL, United States
(Iranpour) Baylor College of Medicine, Houston, TX, United States
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Background: Vasoactive medications are commonly administered for afterload
reduction and arterial hypertension treatment in patients after cardiac
surgery. A systematic review and meta-analysis were conducted to determine
the effects of sodium nitroprusside and nicardipine on hemodynamics and
cardiac performance in this population. <br/>Method(s): A systematic
review of published manuscripts was performed to identify studies of
patients who received sodium nitroprusside and nicardipine as part of the
treatment for arterial hypertension or afterload reduction after cardiac
surgery. A meta-analysis was then conducted to determine the effects of
sodium nitroprusside and nicardipine on hemodynamics and cardiac
performance. The following parameters were captured: blood pressure, heart
rate, right atrial pressure, systemic vascular resistance, and stroke
volume. <br/>Result(s): In total, five studies with 571 patients were
pooled for these analyses. Systolic blood pressure, diastolic blood
pressure, and mean arterial blood pressure were similar in both groups.
The cardiac index was greater with nicardipine while mean pulmonary artery
pressure was lower with sodium nitroprusside. <br/>Conclusion(s):
Nicardipine and sodium nitroprusside have similar abilities in reducing
afterload in the postoperative cardiac population. Statistically
significant differences were found in pulmonary artery pressure and
cardiac index. It may be beneficial to consider nicardipine for afterload
reduction in patients with a low cardiac index.<br/>Copyright &#xa9; 2020
Wiley Periodicals, Inc.

<56>
Accession Number
2004435855
Title
The effect of colchicine on the echocardiographic constrictive physiology
after coronary artery bypass graft surgery.
Source
Echocardiography. (no pagination), 2020. Date of Publication: 2020.
Author
Shojaeifard M.; Pakbaz M.; Beheshti R.; Noohi Bezanjani F.; Ahangar H.;
Gohari S.; Dehghani Mohammad Abadi H.; Erami S.
Institution
(Shojaeifard) Echocardiography Research Center, Rajaie Cardiovascular
Medical and Research Center, Iran University of Medical Sciences, Tehran,
Iran, Islamic Republic of
(Pakbaz) Department of Cardiovascular Disease, Hazrat-e Rasool General
Hospital, Iran University of Medical Sciences, Tehran, Iran, Islamic
Republic of
(Beheshti, Noohi Bezanjani) Department of Cardiology, Rajaie
Cardiovascular Medical and Research Center, Iran University of Medical
Sciences, Tehran, Iran, Islamic Republic of
(Ahangar) Department of Cardiology, Mousavi Hospital, School of Medicine,
Zanjan University of Medical Sciences, Zanjan, Iran, Islamic Republic of
(Gohari) School of Medicine, Zanjan University of Medical Sciences,
Zanjan, Iran, Islamic Republic of
(Dehghani Mohammad Abadi) Shahid Sadoughi Hospital, Shahid Sadoughi
University of Medical Sciences, Yazd, Iran, Islamic Republic of
(Erami) School of Medicine, Shahid Sadoughi University of Medical
Sciences, Yazd, Iran, Islamic Republic of
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Background: Constrictive physiology is a transitory condition that could
lead to constrictive pericarditis, which is a rare complication after
open-heart surgery. Anti-inflammatory drugs like colchicine are
recommended for prevention of constrictive pericarditis; however, there is
no evidence about the effect of colchicine on constrictive pericarditis.
Thus, the aim of this study is to evaluate the preventive effect of
colchicine on the incidence of echocardiographic constrictive physiology
after open-heart surgery. <br/>Method(s): This was a parallel randomized,
double-blind trial. Patients were randomly assigned to receive 1 mg
colchicine once-daily from 48 hours before and 0.5 mg twice daily for 5
days after surgery. Primary outcome was the incidence of the constrictive
physiology after primary endpoint (1 week after the surgery). The
secondary outcome was the primary outcome after secondary endpoint (4
weeks after surgery) plus the new cases of constrictive physiology between
the primary and secondary endpoints. <br/>Result(s): Out of 160
participating patients, the primary outcome occurred in 19 patients (23%)
in placebo and 11 (13%) in intervention groups. There was no significant
difference between two groups (P =.106). After 4 weeks of follow-up, 19
patients (23%) in placebo and 9 (11%) in intervention groups had
constrictive physiology whereas 2 out of 11 patients (18.2%) were
recovered. The difference was significant (P =.038). No new case of
constrictive physiology occurred between primary and secondary endpoints.
<br/>Conclusion(s): Short-term use of colchicine has a preventive effect
on reducing constrictive physiology after 1 month of open-heart surgery
but not a week after that.<br/>Copyright &#xa9; 2020 Wiley Periodicals,
Inc.

<57>
[Use Link to view the full text]
Accession Number
630590689
Title
A Multinational Observational Study Exploring Adherence With the Kidney
Disease: Improving Global Outcomes Recommendations for Prevention of Acute
Kidney Injury After Cardiac Surgery.
Source
Anesthesia and analgesia. 130 (4) (pp 910-916), 2020. Date of Publication:
01 Apr 2020.
Author
Kullmar M.; Weiss R.; Ostermann M.; Campos S.; Grau Novellas N.; Thomson
G.; Haffner M.; Arndt C.; Wulf H.; Irqsusi M.; Monaco F.; Di Prima A.L.;
Garcia-Alvarez M.; Italiano S.; Felipe Correoso M.; Kunst G.; Nair S.;
L'Acqua C.; Hoste E.; Vandenberghe W.; Honore P.M.; Kellum J.A.; Forni L.;
Grieshaber P.; Wempe C.; Meersch M.; Zarbock A.
Institution
(Kullmar, Weis, Wempe, Meersch, Zarbock) From the Department of
Anaesthesiology, Intensive Care Medicine and Pain Medicine, University
Hospital Munster, Munster, Germany
(Ostermann, Campos, Grau Novellas, Thomson, Haffner) Department of
Critical Care, Guy's & St Thomas' NHS Foundation Hospital, London, United
Kingdom
(Arndt, Wulf) Department of Anaesthesiology and Intensive Care Medicine,
University Hospital Marburg, Marburg, Germany
(Irqsusi) Department of Cardiac Surgery, University Hospital Marburg,
Marburg, Germany
(Monaco, Di Prima) Department of Anesthesia and Intensive Care, IRCCS San
Raffaele Scientific Institute, Milan, Italy
(Garcia-Alvarez, Italiano, Felipe Correoso) Department of Anesthesiology,
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
(Kunst, Nair) Department of Anaesthetics, King's College Hospital, Denmark
Hill, London, United Kingdom
(L'Acqua) Centro Cardiologico Monzino IRCCS, Milan, Italy
(Hoste, Vandenberghe) Department of Intensive Care Medicine, University
Hospital Gent, Gent, Belgium
(Honore) Department of Intensive Care, CHU Brugmann University Hospital,
Belgium
(Kellum) Center for Critical Care Nephrology, Department of Critical Care
Medicine, University of Pittsburgh, PA
(Forni) Department of Intensive Care Medicine, Royal Surrey County
Hospital, Guildford, United Kingdom
(Grieshaber) Department of Cardiac Surgery, University Hospital Giessen,
Giessen, Germany
Publisher
NLM (Medline)
Abstract
BACKGROUND: The Kidney Disease: Improving Global Outcomes (KDIGO)
guidelines recommend a bundle of different measures for patients at
increased risk of acute kidney injury (AKI). Prospective, single-center,
randomized controlled trials (RCTs) have shown that management in
accordance with the KDIGO recommendations was associated with a
significant reduction in the incidence of postoperative AKI in high-risk
patients. However, compliance with the KDIGO bundle in routine clinical
practice is unknown. <br/>METHOD(S): This observational prevalence study
was performed in conjunction with a prospective RCT investigating the role
of the KDIGO bundle in high-risk patients undergoing cardiac surgery. A
2-day observational prevalence study was performed in all participating
centers before the RCT to explore routine clinical practice. The
participating hospitals provided the following data: demographics and
surgical characteristics, AKI rates, and compliance rates with the
individual components of the bundle. <br/>RESULT(S): Ninety-five patients
were enrolled in 12 participating hospitals. The incidence of AKI within
72 hours after cardiac surgery was 24.2%. In 5.3% of all patients,
clinical management was fully compliant with all 6 components of the
bundle. Nephrotoxic drugs were discontinued in 52.6% of patients, volume
optimization was performed in 70.5%, 52.6% of the patients underwent
functional hemodynamic monitoring, close monitoring of serum creatinine
and urine output was undertaken in 24.2% of patients, hyperglycemia was
avoided in 41.1% of patients, and no patient received radiocontrast
agents. The patients received on average 3.4 (standard deviation [SD]
+/-1.1) of 6 supportive measures as recommended by the KDIGO guidelines.
There was no significant difference in the number of applied measures
between AKI and non-AKI patients (3.2 [SD +/-1.1] vs 3.5 [SD +/-1.1]; P =
.347). <br/>CONCLUSION(S): In patients after cardiac surgery, compliance
with the KDIGO recommendations was low in routine clinical practice.

<58>
Accession Number
2005255832
Title
SUN-055 SUCCESSFUL MANAGEMENT OF ACUTE KIDNEY INJURY SECONDARY TO
ASCENDING CHOLANGITIS AND BILE CAST NEPHROPATHY: CASE REPORT AND REVIEW OF
LITERATURE.
Source
Kidney International Reports. Conference: ISN World Congress of
Nephrology. United Arab Emirates. 5 (3 Supplement) (pp S226-S227), 2020.
Date of Publication: March 2020.
Author
Akl A.I.; Oweil A.; Al-Shawbaki R.; Bazarah S.; Hammad N.; Al-Khatib N.
Institution
(Akl) Mansoura University, Urology and Nephrology Center, Mansoura, Egypt
(Oweil) King Fahad General Hospital, Internal Medicine, Jeddah, Saudi
Arabia
(Al-Shawbaki, Bazarah, Al-Khatib) Dr Soliman Fakeeh Hospital, Internal
Medicine, Jeddah, Saudi Arabia
(Hammad) Dr Soliman Fakeeh Hospital, Intensive Care Unit, Jeddah, Saudi
Arabia
Publisher
Elsevier Inc.
Abstract
Introduction: Cholestatic liver disease has a number of consequences on
renal function. Most of the clinical manifestations are secondary to
hemodynamic changes resulting in a pre-renal state. In patients with
profound hyperbilirubinemia, bile casts result in direct toxicity to the
nephron. It is commonly known as bile cast nephropathy and has been
described under various terms including cholemic nephrosis, biliary
nephrosis and jaundice-related nephropathy. It is characterized by the
presence of bile casts on renal biopsy in the setting of
hyperbilirubinemia and renal insufficiency. Its prevalence is likely
greater than previously recognized. Early recognition and treatment are
essential as they may lead to reversal of symptoms and improved prognosis.
Presently, there is little literature about the disease and its etiology
with only a few case reports in the past decade. <br/>Method(s): A
59-year-old female known to have diabetes mellitus, hypertension, coronary
artery bypass grafting in 2016 had recently complained of chronic calcular
cholecystitis and was scheduled for cholecystectomy. Suddenly thereafter,
she presented to ER with septic shock, fever, acute kidney injury (serum
creatinine 9.6 from 0.8 mg/dl, BUN 81.18 mg/dl), anuria, acute hepatic
failure (Alt 394 u/l, AST 378 u/l, bilirubin total 7.9 mg/dl, direct 6.44
mg/dl), acute pancreatitis (Amylase 1201 u/l, Lipase 4303 u/l), CRP 241.7
mg/l, with possible ascending cholangitis. Urgent abdominal US revealed
dilated biliary system, hepatic abscesses, calcular cholecystitis,
atrophic pyelonephritic right kidney and average size left kidney with
grade II nephropathy. Patient was transferred to ICU, with initiation of
IV vasopressors, and blood pressure was 90/60 on maximum inotropes. ERCP
(endoscopic retrograde cholangiopancreatography) was performed, a large
impacted pigmented stone in ampulla of vater was found and was extracted
followed by stent insertion [Figure 1.A,B]. Continuous veno-venous
hemodiafiltration (CVVHDF) was initiated at dose of 38 ml/kg/min with
start of broad-spectrum antibiotics coverage until revelation of culture
results. Within 48 hours, the patient's hemodynamics improved, blood
pressure was 148/65 mmHg, she regained full conscious level [Figure 1.C].
So, shift to daily sustained low efficient dialysis (SLED) for 1 /week,
then as she had clinically improved the need for dialysis declined to 3
/week, then 2/week, till reaching a requirement of 1/week. <br/>Result(s):
The patient's urine output improved to around 2L/day prior to discharge
and was weaned off dialysis completely [Figure 2]. As well, the patient
received 4 weeks of IV antibiotics. Aspiration of a liver abscess was
done, cultures revealed negative growth. Repeated ultrasound imaging
revealed a constant interval of the liver abscess. She was discharged home
to complete her course of antibiotics until complete resolution of the
abscess, then for cholecystectomy to be done. At last follow up her serum
creatinine was 4 mg/dl without hemodialysis. <br/>Conclusion(s): In
conclusion severe sepsis combined with ascending cholangitis and impaction
of bile stone can be successfully managed with ERCP and CVVHDF and
stepwise hemodialysis. Figure 1: ERCP extraction of large pigmented
biliary stone obstructing Ampula of Vater and insertion of common bile
duct stent draining large amount of pus and biliary mud Figure 2:
Improvement of urine output over time in comparison to fluid intake (was
anuric in ICU)<br/>Copyright &#xa9; 2020

<59>
Accession Number
2005250507
Title
Mortality in Patients with Cardiogenic Shock Supported with Veno-Arterial
Extracorporeal Membrane Oxygenation: A Systematic Review and Meta-Analysis
Evaluating the Impact of Etiology.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S186), 2020. Date of Publication: April 2020.
Author
Alba A.C.; Foroutan F.; Buchan T.A.; Alvarez J.; Kinsella A.; Clark K.;
Lau K.; Zhu A.; McGuinty C.; Aleksova N.; Vishram-Nielsen J.; Malik A.;
Francis T.; Stanimirovic A.; Bielecki J.; Fan E.; Rao V.; Ross H.J.; Rac
V.; Billia F.
Institution
(Alba, Foroutan, Buchan, Alvarez, Kinsella, Clark, Lau, Zhu, McGuinty,
Aleksova, Vishram-Nielsen, Malik, Fan, Rao, Ross, Rac, Billia) Peter Munk
Cardiac Centre - Toronto General Hospital, Toronto, ON, Canada
(Francis) Institute of Health Policy, Management and Evaluation -
University of Toronto, Toronto, ON, Canada
(Stanimirovic, Bielecki) Institute of Health Policy, Management and
Evaluation - University of Toronto, Toronto, ON, Canada
Publisher
Elsevier USA
Abstract
Purpose: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is
associated with improved outcomes in patients with cardiogenic shock (CS).
However, studies evaluating its benefit have reported contradictory
results. One of the main factors impacting outcomes is likely related to
etiology of CS. This meta-analysis aimed to evaluate mortality after
VA-ECMO across multiple etiologies of CS. <br/>Method(s): In June 2019, we
systematically searched for studies in electronic databases and references
of previous meta-analyses. We selected observational studies with >=10
adults patients reporting on short-term mortality (30 days or discharge)
after the initiation of VA-ECMO by CS etiology published after 2009. We
meta-analyzed mortality using random effect models and performed
meta-regression to evaluate the impact of CS etiology and other study
characteristics. We evaluated the quality of the evidence using the GRADE
tool. <br/>Result(s): We included 342 studies (29,515 patients) with CS
due to myocarditis (11 studies, 846 patients), acute myocardial infarction
- AMI (66 studies, 3,849 patients), decompensated heart failure-HF (30
studies, 3,251 patients), post-heart transplant (23 studies, 703
patients), post-cardiotomy (93 studies, 12,076 patients), and post-cardiac
arrest-CA (119 studies, 8,790 patients). Studies on myocarditis included
younger populations (median age 47 years, 25^th -
75^th percentile 43-53), and higher proportion of female
patients (48%). Studies on AMI and post-cardiotomy reported older
population age (61 years, 56-65). Pooled mortality was significantly
different by CS etiology: in post-heart transplant 36% (95%CI 29%-43%),
myocarditis 41% (34%-47%), HF 51% (44%-58%), post-cardiotomy 58%
(55%-62%), post-AMI 60% (56%-64%), post-in-hospital CA 63% (56%-69%), and
post-out-of-hospital CA 76% (69%-82%). Differences in age, sex and
recruitment time across studies did not explain the differences in
mortality in patients with different CS etiology. The quality of the
evidence was deemed moderate. <br/>Conclusion(s): The benefit of VA-ECMO
differs significantly depending on CS etiology. Further studies evaluating
other factors impacting mortality in each patient population may further
refine patient selection and management to improve short-term
outcomes.<br/>Copyright &#xa9; 2020

<60>
Accession Number
2005250480
Title
Effect of Donor Simvastatin Treatment on Gene Expression Profiles in Human
Cardiac Allografts during Ischemia-Reperfusion Injury.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S88), 2020. Date of Publication: April 2020.
Author
Krebs R.; Holmstrom E.; Dhaygude K.; Kankainen M.; Syrjala S.; Lukac J.;
Mattila P.; Nykanen A.; Lemstrom K.
Institution
(Krebs, Holmstrom, Dhaygude, Syrjala, Lukac, Nykanen, Lemstrom)
Transplantation Laboratory, University of Helsinki, Helsinki, Finland
(Kankainen, Mattila) Institute for Molecular Medicine Finland, University
of Helsinki, Helsinki, Finland
Publisher
Elsevier USA
Abstract
Purpose: Numerous studies have shown that statin therapy initiated early
after heart transplantation has beneficial effects on the development of
cardiac allograft vasculopathy. Recently, we were able to show in a
randomized clinical trial that simvastatin treatment of brain-dead donors
conditions the heart transplant to withstand ischemia-reperfusion injury
and to reduce the need for rejection treatments early after
transplantation. In this study, we analyzed myocardial gene expression
profiles in cardiac allografts after donor simvastatin treatment.
<br/>Method(s): 84 heart transplant donors received 80 mg of simvastatin
via nasogastric tube (n=42), or no treatment (n=42) in a prospective,
double-blinded randomized controlled trial. Transmural Tru-Cut biopsies
were taken from the apex of the donor heart's left ventricle immediately
before reperfusion and 1 hour after reperfusion. The transcriptome of the
biopsies will be analyzed with RNA sequencing. <br/>Result(s): The
preliminary analysis of RNA sequencing data from myocardial biopsies of 20
+ 20 patients revealed altogether 137 significantly differentially
expressed genes in all pairwise comparisons. The overall biological
functions of these genes were related to gene ontology terms such as
response to toxic substance, leukocyte migration, neutrophil mediated
immunity, response to lipopolysaccharide, and response to oxidative
stress. Enrichment pathway analysis indicated alterations in Th17,
TGF-beta, and muscle repair signaling pathways. At time of abstract
submission, data of the remaining samples is about to enter the sequencing
data analysis pipeline. <br/>Conclusion(s): We have shown in previous
studies that donor simvastatin treatment induces protective effects
against IRI in heart transplant recipients. In this study, we were able to
detect significantly differentially expressed genes related to effects of
simvastatin treatment. In order to single out genes that show beneficial
effects of simvastatin treatment, further analysis will be conducted by
exploring gene expression changes in specific biological functional
categories, such as interleukin signaling and neutrophil degranulation.
The complete analysis will be presented at the ISHLT 2020
congress.<br/>Copyright &#xa9; 2020

<61>
Accession Number
631258516
Title
A Single Prophylactic Dose of Ondansetron Given at Cessation of
Postoperative Propofol Sedation Decreases Postoperative Nausea and
Vomiting in Cardiac Surgery Patients: A Randomized Controlled Trial.
Source
Anesthesia and analgesia. (no pagination), 2020. Date of Publication: 09
Mar 2020.
Author
Wang E.H.Z.; Sunderland S.; Edwards N.Y.; Chima N.S.; Yarnold C.H.;
Schwarz S.K.W.; Coley M.A.
Institution
(Wang) From the Pharmacy Department, St Paul's Hospital, Providence Health
Care, Vancouver, BC, Canada
(Wang) Faculty of Pharmaceutical Sciences
(Sunderland, Chima, Yarnold, Schwarz, Coley) Department of Anesthesiology,
Pharmacology & Therapeutics, University of British Columbia, Vancouver,
BC, Canada
(Edwards, Yarnold, Schwarz, Coley) Department of Anesthesia, St Paul's
Hospital, Providence Health Care, Vancouver, BC, Canada
Publisher
NLM (Medline)
Abstract
BACKGROUND: Postoperative nausea and vomiting (PONV) is a common
occurrence after cardiac surgery. However, in contrast to other surgical
populations, routine PONV prophylaxis is not a standard of care in cardiac
surgery. We hypothesized that routine administration of a single
prophylactic dose of ondansetron (4 mg) at the time of stopping
postoperative propofol sedation before extubation in the cardiac surgery
intensive care unit would decrease the incidence of PONV. <br/>METHOD(S):
With institutional human ethics board approval and written informed
consent, we conducted a randomized controlled trial in patients >=19 years
of age with no history of PONV undergoing elective or urgent cardiac
surgery procedures requiring cardiopulmonary bypass. The primary outcome
was the incidence of PONV in the first 24 hours postextubation, compared
by the chi test. Secondary outcomes included the incidence and times to
first dose of rescue antiemetic treatment administration, the incidence of
headaches, and the incidence of ventricular arrhythmias. <br/>RESULT(S):
PONV within the first 24 hours postextubation occurred in 33 of 77
patients (43%) in the ondansetron group versus 50 of 82 patients (61%) in
the placebo group (relative risk, 0.70 [95% confidence interval {CI},
0.51-0.95]; absolute risk difference, -18% [95% CI, -33 to -2]; number
needed to treat, 5.5 [95% CI, 3.0-58.4]; chi test, P = .022). Kaplan-Meier
"survival" analysis of the times to first rescue antiemetic treatment
administration over 24 hours indicated that patients in the ondansetron
group fared better than those in the placebo group (log-rank [Mantel-Cox]
test; P = .028). Overall, 32 of 77 patients (42%) in the ondansetron group
received rescue antiemetic treatment over the first 24 hours
postextubation versus 47 of 82 patients (57%) in the placebo group
(relative risk, 0.73 [95% CI, 0.52-1.00]; absolute risk difference, -16%
[95% CI, -31 to 1]); P = .047. There were no significant differences
between the groups in the incidence of postoperative headache (ondansetron
group, 5 of 77 patients [6%] versus placebo group, 4 of 82 patients [5%];
Fisher exact test; P = .740) or ventricular arrhythmias (ondansetron
group, 2 of 77 patients [3%] versus placebo group, 4 of 82 patients [5%];
P = .68). <br/>CONCLUSION(S): These findings support the routine
administration of ondansetron prophylaxis at the time of discontinuation
of postoperative propofol sedation before extubation in patients following
cardiac surgery. Further research is warranted to optimize PONV
prophylaxis in cardiac surgery patients.

<62>
Accession Number
2003991625
Title
NT-Pro BNP Predicts Myocardial Injury Post-vascular Surgery and is Reduced
with CoQ<inf>10</inf>: A Randomized Double-Blind Trial.
Source
Annals of Vascular Surgery. 64 (pp 292-302), 2020. Date of Publication:
April 2020.
Author
Khan A.; Johnson D.K.; Carlson S.; Hocum-Stone L.; Kelly R.F.; Gravely
A.A.; Mbai M.; Green D.L.; Santilli S.; Garcia S.; Adabag S.; McFalls E.O.
Institution
(Khan, Carlson, Mbai, Adabag, McFalls) Division of Cardiology, University
of Minnesota, Minneapolis, MN, United States
(Johnson, Carlson, Hocum-Stone, Mbai, Adabag, McFalls) Division of
Cardiology, Minneapolis VA Medical Center, Minneapolis, MN, United States
(Hocum-Stone, Kelly) Division of Cardiothoracic Surgery, University of
Minnesota, Minneapolis, MN, United States
(Gravely) Department of Research Statistical Center, Minneapolis VA
Medical Center, Minneapolis, MN, United States
(Green, Santilli) Division of Vascular Surgery, Minneapolis VA Medical
Center, Minneapolis, MN, United States
(Garcia) Division of Cardiology, Minneapolis Heart Institute, Minneapolis,
MN, United States
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Background: NT-Pro BNP levels provide incremental value in perioperative
risk assessment prior to major noncardiac surgery. Whether they can be
pharmacologically modified in patients prior to an elective vascular
operation is uncertain. <br/>Method(s): A double-blind, randomized
controlled trial was implemented at a single institution. Patients were
screened during their preoperative vascular clinic appointment and
randomly assigned to CoQ<inf>10</inf> (400 mg per day) versus Placebo for
3 days prior to surgery. Biomarkers, including NT-Pro BNP, troponin I and
C-reactive protein were obtained prior to and following surgery for up to
48 hours. The primary endpoint was postoperative NT-Pro BNP levels, and
secondary endpoint measures included myocardial injury, defined by an
elevated cardiac troponin level and length of stay. <br/>Result(s): One
hundred and twenty-three patients were randomized to receive either
CoQ<inf>10</inf> (N = 62) versus Placebo (N = 61) for 3 days before
vascular surgery. Preoperative cardiac risks included ischemic heart
disease (N = 52), CHF (N = 12), stroke (N = 23), and diabetes mellitus (N
= 48) and the planned vascular procedures were infrainguinal (N = 78),
carotid (N = 36), and intraabdominal (N = 9). There were no intergroup
differences in these clinical variables. NT-Pro BNP levels (median; IQs)
in the CoQ<inf>10</inf> and Placebo groups were 179 (75-347) and 217
(109-585) pg/ml, respectively, (P = 0.08) preoperatively, and 397
(211-686) and 591 (288-1,433) pg/ml respectively, (P = 0.01) at 24 hours
following surgery. Patients with an elevated NT-Pro BNP had a higher
incidence of myocardial injury, (58% vs. 20%; P < 0.01) and a longer
hospital stay (4.4 +/- 3.8 vs. 2.8 +/- 3.2 days; P < 0.02) compared with
individuals without an elevated NT-Pro BNP level. <br/>Conclusion(s):
NT-Pro BNP levels predict adverse events post-vascular surgery and are
lowered in those patients assigned to preoperative administration of
CoQ<inf>10</inf>. Trial Registration: clinicaltrials.gov Identifier:
NCT03956017. Among patients undergoing elective vascular surgery, 123
patients were randomized to either CoQ<inf>10</inf> (400 mg/day) versus
placebo for three days preoperatively. NT-Pro BNP levels (median; IQs) in
the CoQ<inf>10</inf> and Placebo groups were 179 (75-347) and 217
(109-585) pg/ml, respectively, (P = 0.08) preoperatively, and 397
(211-686) and 591 (288-1,433) pg/ml, respectively, (P = 0.01)
post-surgery. Patients with an elevated NT-Pro BNP had a higher incidence
of myocardial injury (58% vs. 20%; P < 0.01) and a longer hospital stay
(4.4 +/- 3.8 vs. 2.8 +/- 3.2 days; P < 0.02) compared with individuals
without an NT-Pro BNP elevation. In conclusion, BNP predicts adverse
outcomes and can be reduced with preoperative
CoQ<inf>10</inf>.<br/>Copyright &#xa9; 2019

<63>
Accession Number
2005253850
Title
Long-term outcomes of unprotected left main coronary artery disease:
Comparison of coronary artery bypass grafting and percutaneous coronary
intervention.
Source
Journal of Invasive Cardiology. 33 (3) (pp 111-116), 2020. Date of
Publication: 2020.
Author
Song K.; Kim M.H.; Li J.X.; Kim S.J.; Lee K.M.; Cho Y.-R.; Park J.S.; Park
T.H.; Kim Y.D.; Lee M.S.
Institution
(Song, Kim, Li, Kim, Lee, Cho, Park, Park, Kim) Department of Cardiology,
Dong-A University Hospital, Busan, South Korea
(Lee) Division of Cardiology, UCLA Medical Center, Los An-geles, CA,
United States
Publisher
HMP Communications
Abstract
Objective. We compared the long-term outcomes of coronary artery bypass
grafting (CABG) and percutaneous coronary intervention (PCI) for
unprotected left main coronary artery (ULMCA) disease in a real-world
population. Background. CABG is the standard of care for ULMCA disease.
Contemporary randomized trials have reported conflicting results with the
two revascularization strategies for the treatment of ULMCA disease at
intermediate-term follow-up. Methods. We evaluated 422 consecutive
patients with ULMCA disease who underwent CABG (n = 273) or PCI (n = 149)
from 1998-2008. The primary outcome measure was major adverse cardiac and
cerebrovascular event (MACCE) rate, defined as the composite of all-cause
death, myocardial infarction (MI), stroke, or target-vessel
revascularization (TVR) at 10 years. Propensity-score matched (PSM)
analysis was used to assess long-term MACCE. Results. The cumulative
10-year incidence of risk for MACCE was not significantly different
between the PCI and CABG groups (24.8% vs 20.5%, respectively; log rank
P=.22; log rank PSM P=.45). The risk for all-cause death was not
significantly different between the two groups (log rank P=.09; PSM log
rank P=.51). The risk for stroke was significantly lower with PCI (log
rank P=.02), but was not significant after matching (PSM log rank P=.27).
The risk for TVR was significantly higher with PCI vs CABG prior to and
after matching (log rank P<.001; log rank PSM P=.01). There were no
significant differences in MACCE between the two groups when stratified by
SYNTAX scores <=22% (log rank P=.61) and >23% (log rank P=.06).
Conclusion. In patients with ULMCA disease, PCI was comparable with CABG
for long-term MACCE and death rates. The TVR rate was higher in the PCI
group.<br/>Copyright &#xa9; 2020 HMP Communications. All rights reserved.

<64>
Accession Number
2005253818
Title
Systematic review and meta-analysis of interventional emergency treatment
of decompensated severe aortic stenosis.
Source
Journal of Invasive Cardiology. 33 (1) (pp 30-36), 2020. Date of
Publication: 2020.
Author
Wernly B.; Jirak P.; Lichtenauer M.; Veulemans V.; Zeus T.; Piayda K.;
Hoppe U.C.; Lauten A.; Frerker C.; Jung C.
Institution
(Wernly, Jirak, Lichtenauer, Hoppe) Clinic of Internal Medicine II,
Department of Cardiology, Paracelsus Medical University of Salzburg,
Salzburg, Austria
(Veulemans, Zeus, Piayda, Jung) Division of Cardiology, Pulmonology, and
Vascular Medicine, Medical Faculty, University Duesseldorf, Duesseldorf,
Germany
(Lauten) Department of Cardiology, Charite - Universitaetsmedizin Berlin,
Berlin, Germany
(Frerker) Department of Cardiology, Asklepios Klinik St. Georg, Hamburg,
Germany
Publisher
HMP Communications
Abstract
Aims. Patients in cardiogenic shock (CS) due to decompensated aortic
stenosis (AS) evidence poor prognosis. Both emergency transcatheter aortic
valve replacement (eTAVR) and emergency balloon aortic valvuloplasty
(eBAV) have been reported in CS patients. We aimed to summarize and
compare available studies on eBAV and eTAVR in patients suffering from CS
due to decompensated AS with regard to safety and efficacy. Methods and
Results. Study-level data were analyzed. Heterogeneity was assessed using
the I² statistic. Pooled proportions, ie, event rates, were
calculated and obtained using a random-effects model (DerSimonian and
Laird). Eight studies were found suitable for the final analysis,
including 311 patients. Primary endpoint was mortality at 30 days. For
eBAV (n = 238), 30-day mortality rate was 46.2% (95% confidence interval
[CI], 30.3%-62.5%; I²=74%), major bleeding rate was 10% (95%
CI, 5.4%-15.7%; I²=13%), and stroke rate was 0.7% (95% CI,
0.0%-2.7%; I²=0%). Aortic regurgitation (AR) >=II was present
in 8.6% (95% CI, 0.4%-23.5%; I²=86%). For eTAVR (n = 73),
30-day mortality rate was 22.6% (95% CI, 12.0%-35.2%; I²=26%),
major bleeding rate was 5.8% (95% CI, 0.5%-14.7%; I²=0%), and
stroke rate was 5.8% (95% CI, 0.5%-14.7%; I²=0%). AR >=II was
present in 4% (95% CI, 0.0%-12.1%; I²=0%). Conclusion.
Mortality in CS patients due to decompensated severe AS is high,
regardless of interventional treatment strategy. Both eBAV and eTAVR seem
feasible. As eTAVR is associated with better initial improvements in
hemodynamics and simultaneously avoids sequential interventions, it might
be favorable to eBAV in select patients. If eTAVR is not available, eBAV
might serve as a "bridge" to elective TAVR.<br/>Copyright &#xa9; 2020 HMP
Communications. All rights reserved.

<65>
Accession Number
2005253816
Title
Transcatheter aortic valve replacement influence on coronary hemodynamics:
A quantitative meta-analysis and proposed decision-making algorithm.
Source
Journal of Invasive Cardiology. 33 (1) (pp 37-40), 2020. Date of
Publication: 2020.
Author
Kotronias R.A.; Scarsini R.; Rajasundaram S.; de Maria G.L.; Ciofani J.L.;
Ribichini F.; Kharbanda R.K.; Banning A.P.
Institution
(Kotronias, Scarsini, Rajasundaram, de Maria, Ciofani, Kharbanda, Banning)
Oxford Heart Centre, Oxford University Hospitals, NHS Trust, Oxford,
United Kingdom
(Kotronias) Department of Cardiovascular Medicine, University of Oxford,
Oxford, United Kingdom
(Scarsini, Ribichini) Department of Medicine, Division of Cardiology,
University of Verona, Verona, Italy
Publisher
HMP Communications
Abstract
Background. As transcatheter aortic valve replacement (TAVR) expands to
younger and lower-risk severe aortic stenosis patients, appropriate
coronary artery disease treatment is key to reducing long-term adverse
cardiovascular outcomes. Recently, studies have been exploring the role of
coronary-physiology guided revascularization strategies. Our aim was to
investigate whether TAVR influences coronary physiology measurements using
quantitative meta-analytic methods. Methods. We performed a Medline and
Embase search for studies evaluating coronary physiology indices before
and after TAVR. Double independent screening and extractions of baseline,
procedural, angiographic, and echocardiographic data were performed. Risk
of bias was assessed using the ACROBAT-NRSI tool. Pooled mean difference
estimates of coronary hemodynamic indices before and after TAVR were
derived using random-effects models with the inverse variance method
(RevMan, Review Manager, version 5.3.5; Nordic Cochrane Centre). Results.
Five studies evaluating 250 coronary vessels in 169 severe aortic stenosis
patients were quantitatively synthesized. Coronary flow reserve did not
change immediately after TAVR in non-diseased vessels (n = 3; mean
difference, 0.11; 95% confidence interval [CI], -0.10-0.32; P=.29;
I²=0%; P=.68). Importantly, fractional flow reserve also did
not vary significantly following TAVR in both non-diseased (n = 3; mean
difference, -0.01; 95% CI, -0.04-0.03; P=.75; I²=41; P=.19) and
diseased coronaries (n = 3; mean difference, -0.01; 95% CI, -0.03-0.01;
P=.49; I²=0%; P=.46). Similarly, instantaneous wave-free ratio
remained stable following TAVR (n = 2; mean difference, 0.00; 95% CI,
-0.02-0.02; P>.99; I²=0; P>.99. Conclusions. Pooled coronary
physiology measurements before and after TAVR are similar, but data on
variation within individual lesions are limited.<br/>Copyright &#xa9; 2020
HMP Communications. All rights reserved.

<66>
Accession Number
2005273695
Title
Effects of remote ischemic preconditioning on prognosis in patients with
lung injury: A meta-analysis.
Source
Journal of Clinical Anesthesia. 63 (no pagination), 2020. Article Number:
109795. Date of Publication: August 2020.
Author
Zheng L.; Han R.; Tao L.; Yu Q.; Li J.; Gao C.; Sun X.
Institution
(Zheng, Han, Tao, Yu, Li, Gao, Sun) Department of Anesthesiology, Tangdu
Hospital, Air Force Military Medical University, Xian, Shanxi Province
710038, China
Publisher
Elsevier Inc. (E-mail: usjcs@elsevier.com)
Abstract
Objective: A number of trials have shown that remote ischemic
preconditioning (RIPC) could reduce lung injury of patients suffering
cardiovascular surgery, pulmonary transplantation surgery and thoracic
surgery with one-lung ventilation. However, there is still a controversy
over the lung protection of RIPC in patients who suffers different types
of surgery. We undertook meta-analysis of the randomized controlled trials
to evaluate the effect of remote ischemic preconditioning on clinical
outcomes of patients with lung injury. <br/>Design(s): Systematic review
and meta-analysis. <br/>Setting(s): Perioperative care areas.
<br/>Patient(s): Adults and infants suffering cardiovascular surgery with
lung injury. <br/>Intervention(s): Remote ischemic preconditioning.
Measurements: The literatures were selected complying with the inclusive
and exclusive criteria from the following databases as PubMed, Embase,
Medline, Chinese Biomedical Literature and Journal Databases, Chinese
Academic and VIP journal full-text Databases. Inclusion criteria includes:
(1) Human clinical randomized and controlled trial; (2) the article we
included is a clinical randomized controlled study; (3) the article
discusses the effect of RIPC on lung injury of patients; (4) the primary
evaluation indicators of the inclusive studies included postoperative
intensive care unit stay time and mechanical ventilation time; (5)
published in the form of full text, any language; (6) the type of
operation is cardiovascular surgery; (7) there is no serious COPD, ARDS,
respiratory failure and other lung diseases. Articles were excluded if
they reported none of the outcomes as follows: postoperative intensive
care unit stay time and mechanical ventilation time, human clinical
controlled trails, pulmonary protection of RIPC, prospective clinical
controlled trials. Two independent reviewers screened abstracts and
titles, and selected records following full-text review. Software
RevMan5.3 and STATA 12.0 were adopted to perform Meta-analysis.
<br/>Result(s): The search finally includes10 studies of 708 patients, 352
patients in RIPC group and 356 patients in control group. The baseline
characteristics of patients are no differences in two groups (P > 0.05).
Compared with control group, RIPC significantly reduced the duration of
ICU (P < 0.05) and mechanical ventilation time (P < 0.05) in RIPC group.
In addition, the serum TNF-alpha and MDA concentration 24 h after
operation in RIPC group are significantly lower than control group (P <
0.05). However, there are no significant differences between RIPC group
and control group in terms of serum IL-6, IL-8 concentrations,
A-aDO<inf>2</inf>, PaO<inf>2</inf>/FiO<inf>2</inf> and respiratory index
24 h after operation. <br/>Conclusion(s): RIPC can decrease pulmonary
inflammatory responses, reduce the duration of ICU and mechanical
ventilation time, and improve the clinical outcomes of patients with lung
injury.<br/>Copyright &#xa9; 2020

<67>
Accession Number
2004443186
Title
Minimally Invasive Surgery vs Device Closure for Atrial Septal Defects: A
Systematic Review and Meta-analysis.
Source
Pediatric Cardiology. (no pagination), 2020. Date of Publication: 2020.
Author
Mylonas K.S.; Ziogas I.A.; Evangeliou A.; Hemmati P.; Schizas D.; Sfyridis
P.G.; Economopoulos K.P.; Bakoyiannis C.; Kapelouzou A.; Tzifa A.;
Avgerinos D.V.
Institution
(Mylonas, Sfyridis) Department of Pediatric Cardiac Surgery, Mitera
Children's Hospital, HYGEIA Group, Athens, Greece
(Mylonas, Schizas) First Department of Surgery, Laiko General Hospital,
National and Kapodistrian University of Athens, Athens 11527, Greece
(Ziogas) Department of Surgery, Vanderbilt Medical Center, Nashville, TN,
United States
(Ziogas, Evangeliou, Economopoulos) Surgery Working Group, Society of
Junior Doctors, Athens, Greece
(Hemmati) Department of Surgery, Mayo Clinic, Rochester, MN, United States
(Economopoulos) Department of Surgery, Duke University Medical Center,
Durham, NC, United States
(Bakoyiannis) Division of Vascular Surgery, Laikon General Hospital,
National and Kapodistrian University of Athens, Athens, Greece
(Kapelouzou) Clinical, Experimental Surgery & Translational Research,
Biomedical Research Foundation Academy of Athens, Athens, Greece
(Tzifa) Department of Pediatric Cardiology and Adult Congenital Heart
Disease, Mitera Children's Hospital, HYGEIA Group, Athens, Greece
(Avgerinos) Department of Cardiothoracic Surgery, New York Presbyterian
Hospital, Weill Cornell Medicine, New York City, NY, United States
Publisher
Springer
Abstract
Device closure is the first-line treatment for most atrial septal defects
(ASDs). Minimally invasive cardiac surgery (MICS) has been found safe and
effective for ASD closure with comparable mortality/morbidity and superior
cosmetic results compared to conventional median sternotomy. Our goal was
to compare percutaneous versus MICS of ASDs. A systematic review was
performed using PubMed and the Cochrane Library (end-of-search date on May
22, 2019). Meta-analyses were conducted using fixed and random effects
models. In the present systematic review, we analyzed six studies
including 1577 patients with ASDs who underwent either MICS (n = 642) or
device closure (n = 935). Treatment efficacy was significantly higher in
the MICS (99.8%; 95% CI 98.9-99.9) compared to the device closure group
(97.3%; 95% CI 95.6-98.2), (OR 0.1; 95% CI 0.02-0.6). Surgical patients
experienced significantly more complications (16.2%; 95% CI 13.0-19.9)
compared to those that were treated with a percutaneous approach (7.1%;
95% CI 5.0-9.8), (OR 2.0; 95% CI 1.2-3.2). Surgery was associated with
significantly longer length of hospital stay (5.6 +/- 1.7 days) compared
to device closure (1.3 +/- 1.4 days), (OR 4.8; 95% CI 1.1-20.5). Residual
shunts were more common with the transcatheter (3.9%; 95% CI 2.7-5.5)
compared to the surgical approach (0.95%; 95% CI 0.3-2.4), (OR 0.1; 95% CI
0.06-0.5). There was no difference between the two techniques in terms of
major bleeding, hematoma formation, transfusion requirements, cardiac
tamponade, new-onset atrial fibrillation, permanent pacemaker placement,
and reoperation rates. MICS for ASD is a safe procedure and compares
favorably to transcatheter closure. Despite longer hospitalization
requirements, the MICS approach is feasible irrespective of ASD anatomy
and may lead to a more effective and durable repair.<br/>Copyright &#xa9;
2020, Springer Science+Business Media, LLC, part of Springer Nature.

<68>
Accession Number
2002643172
Title
Incidence of cardiovascular events among tildrakizumab-treated patients
with moderate to severe plaque psoriasis: Pooled data from 3 large
randomized clinical trials.
Source
Journal of the American Academy of Dermatology. Conference: American
Academy of Dermatology 2019 Annual Meeting. United States. 81 (4
Supplement 1) (pp AB79), 2019. Date of Publication: October 2019.
Author
Bissonnette R.; Fernandez-Penas P.; Puig L.; Mendelsohn A.M.; Rozzo S.J.;
Menter A.
Institution
(Bissonnette) Innovaderm Research, Montreal, QC, Canada
(Fernandez-Penas) Department of Dermatology, Westmead Hospital and Sydney
Medical School, University of Sydney, NSW, Australia
(Puig) Hospital De la Santa Creu i Sant Pau, Universitat Autonoma De
Barcelona, Barcelona, Spain
(Mendelsohn, Rozzo) 5Sun Pharmaceutical Industries, Inc, Princeton, NJ,
United States
(Menter) Division of Dermatology, Baylor Scott and White, and Texas A and
M College of Medicine, Dallas, TX, United States
Publisher
Mosby Inc.
Abstract
Introduction: Observational studies suggest that patients with moderate to
severe plaque psoriasis may have increased risk of major adverse
cardiovascular events (MACE). We assessed the incidence of cardiovascular
(CV) events during phase 2 and 3 trials of tildrakizumab (TIL), a
high-affinity, humanized, immunoglobulin G1k, antieinterleukin-23p19
antibody for moderate to severe chronic plaque psoriasis. <br/>Method(s):
This pooled analysis included data from patients in P05495 (phase 2b;
NCT01225731) and reSURFACE 1 and 2 (phase 3; NCT01722331 and NCT01729754)
who were treated with placebo (PBO), TIL 100 mg, or TIL 200 mg at Week 0,
Week 4, and every 12 weeks thereafter and followed up to Week 52
(P05495/reSURFACE 2) or Week 64 (reSURFACE 1). reSURFACE 2 included an
etanercept (ETN) 50-mg arm administered 2x/wk for 12 weeks, then 1x/wk up
to Week 28. PBO controls were included up to Week 16 (P05495) or Week 12
(reSURFACE 1 and 2).We analyzed safety data from the full-trial periods
and Year 1 of the extensions. For this safety pool, patients with multiple
treatments were counted in each assigned treatment group after starting
different treatment. Extensions to phase 3 studies are ongoing. MACE
comprised nonfatal myocardial infarction (MI), stroke, and CV deaths
confirmed as CVor sudden. Confirmed composite-adjudicated CV (CACV) events
included MACE, unstable angina, coronary revascularization, resuscitated
cardiac arrest, and fatal or nonfatal thrombotic, embolic, or ischemic CV
events. <br/>Result(s): The pooled safety population included 588 patients
treated with PBO, 1083 with TIL 100 mg, 1041 with TIL 200 mg, and 313 with
ETN. The numbers of patients with CACVevents (exposure-adjusted rate,
measured as the number of patients with events/100 patient-years) were
comparable for the TIL 100-mg (4 [0.40]) and 200-mg (8 [0.86]) groups vs
PBO (1 [0.46]) and ETN (1 [0.65]). Three deaths were adjudicated as MACE
unrelated to study treatment, all in patients with preexistent CV risk
factors (eg, hypertension): aneurysm (TIL 200 mg), respiratory arrest and
MI (both TIL 100 mg). In the extension, across TIL-100 and 200-mg groups
(n = 1237), only 7 patients had CACV events (0.60%); no deaths were due to
CV events. <br/>Conclusion(s): In the TIL clinical program, the incidences
of CV events were low and comparable across TIL treatment groups and vs
the PBO and ETN groups. Supported by Sanofi and Regeneron Pharmaceuticals,
Inc. Medical writing/editorial assistance provided by Luke Shelton, PhD,
of Excerpta Medica, funded by Sanofi Genzyme and.

<69>
Accession Number
52015679
Title
The effects of lowering LDL cholesterol with statin therapy in people at
low risk of vascular disease: Meta-analysis of individual data from 27
randomised trials.
Source
The Lancet. 380 (9841) (pp 581-590), 2012. Date of Publication: 01 Aug
2012.
Author
Mihaylova B.; Emberson J.; Blackwell L.; Keech A.; Simes J.; Barnes E.H.;
Voysey M.; Gray A.; Collins R.; Baigent C.; De Lemos J.; Braunwald E.;
Blazing M.; Murphy S.; Downs J.R.; Gotto A.; Clearfield M.; Holdaas H.;
Gordon D.; Davis B.; Koren M.; Dahlof B.; Poulter N.; Sever P.; Knopp
R.H.; Fellstrom B.; Jardine A.; Schmieder R.; Zannad F.; Goldbourt U.;
Kaplinsky E.; Colhoun H.M.; Betteridge D.J.; Durrington P.N.; Hitman G.A.;
Fuller J.; Neil A.; Wanner C.; Krane V.; Sacks F.; Moye L.; Pfeffer M.;
Hawkins C.M.; Kjekshus J.; Wedel H.; Wikstrand J.; Barter P.; Tavazzi L.;
Maggioni A.; Marchioli R.; Tognoni G.; Franzosi M.G.; Bloomfield H.;
Robins S.; Armitage J.; Parish S.; Peto R.; Sleight P.; Pedersen T.R.;
Ridker P.M.; Holman R.; Meade T.; MacMahon S.; Marschner I.; Tonkin A.;
Shaw J.; Serruys P.W.; Nakamura H.; Knatterud G.; Furberg C.; Byington R.;
MacFarlane P.; Cobbe S.; Ford I.; Murphy M.; Blauw G.J.; Packard C.;
Shepherd J.; Wilhelmsen L.; Cannon C.; Bowman L.; Landray M.; La Rosa J.;
Rossouw J.; Probstfi Eld J.; Flather M.; Kastelein J.; Newman C.; Shear
C.; Tobert J.; Varigos J.; White H.; Yusuf S.; Mellies M.; McGovern M.;
Barclay J.; Belder R.; Mitchel M.Y.; Musliner T.; Ansquer J.-C.; Llewellyn
B.M.; Pharma N.; Bortolini M.; Brandrup-Wognsen G.; Bryzinski B.; Olsson
G.; Pears J.; DeMicco D.; Baxter A.; Bhala N.; Buck G.; Herrington W.G.;
Holland L.E.; Kearney P.M.; Kirby A.; Lewis D.A.; Pollicino C.; Reith C.;
Sourjina T.
Institution
(Baigent, Marschner, Baxter, Bhala, Buck, Herrington, Holland, Kearney,
Kirby, Lewis, Pollicino, Reith, Sourjina) National Health and Medical
Research Council (NHMRC), Clinical Trial Centre, University of Sydney,
Mallett Street Campus M02, NSW 2006, Australia
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Background Statins reduce LDL cholesterol and prevent vascular events, but
their net effects in people at low risk of vascular events remain
uncertain. Methods This meta-analysis included individual participant data
from 22 trials of statin versus control (n=134 537; mean LDL cholesterol
difference 1.08 mmol/L; median follow-up 4.8 years) and five trials of
more versus less statin (n=39 612; difference 0.51 mmol/L; 5.1 years).
Major vascular events were major coronary events (ie, non-fatal myocardial
infarction or coronary death), strokes, or coronary revascularisations.
Participants were separated into five categories of baseline 5-year major
vascular event risk on control therapy (no statin or low-intensity statin)
(<5%, >=5% to <10%, >=10% to <20%, >=20% to <30%, >=30%); in each, the
rate ratio (RR) per 1.0 mmol/L LDL cholesterol reduction was estimated.
Findings Reduction of LDL cholesterol with a statin reduced the risk of
major vascular events (RR 0.79, 95% CI 0.77-0.81, per 1.0 mmol/L
reduction), largely irrespective of age, sex, baseline LDL cholesterol or
previous vascular disease, and of vascular and all-cause mortality. The
proportional reduction in major vascular events was at least as big in the
two lowest risk categories as in the higher risk categories (RR per 1.0
mmol/L reduction from lowest to highest risk: 0.62 [99% CI 0.47-0.81],
0.69 [99% CI 0.60-0.79], 0.79 [99% CI 0.74-0.85], 0.81 [99% CI 0.77-0.86],
and 0.79 [99% CI 0.74-0.84]; trend p=0.04), which reflected significant
reductions in these two lowest risk categories in major coronary events
(RR 0.57, 99% CI 0.36-0.89, p=0.0012, and 0.61, 99% CI 0.50-0.74,
p<0.0001) and in coronary revascularisations (RR 0.52, 99% CI 0.35-0.75,
and 0.63, 99% CI 0.51-0.79; both p<0.0001). For stroke, the reduction in
risk in participants with 5-year risk of major vascular events lower than
10% (RR per 1.0 mmol/L LDL cholesterol reduction 0.76, 99% CI 0.61-0.95,
p=0.0012) was also similar to that seen in higher risk categories (trend
p=0.3). In participants without a history of vascular disease, statins
reduced the risks of vascular (RR per 1.0 mmol/L LDL cholesterol reduction
0.85, 95% CI 0.77-0.95) and all-cause mortality (RR 0.91, 95% CI
0.85-0.97), and the proportional reductions were similar by baseline risk.
There was no evidence that reduction of LDL cholesterol with a statin
increased cancer incidence (RR per 1.0 mmol/L LDL cholesterol reduction
1.00, 95% CI 0.96-1.04), cancer mortality (RR 0.99, 95% CI 0.93-1.06), or
other non-vascular mortality. Interpretation In individuals with 5-year
risk of major vascular events lower than 10%, each 1 mmol/L reduction in
LDL cholesterol produced an absolute reduction in major vascular events of
about 11 per 1000 over 5 years. This benefi t greatly exceeds any known
hazards of statin therapy. Under present guidelines, such individuals
would not typically be regarded as suitable for LDL-lowering statin
therapy. The present report suggests, therefore, that these guidelines
might need to be reconsidered.

<70>
Accession Number
51726129
Title
Effects on 11-year mortality and morbidity of lowering LDL cholesterol
with simvastatin for about 5 years in 20 536 high-risk individuals: A
randomised controlled trial.
Source
The Lancet. 378 (9808) (pp 2013-2020), 2011. Date of Publication: 10 Dec
2011.
Author
Bulbulia R.; Bowman L.; Wallendszus K.; Peto R.; Collins R.; Meade T.;
Sleight P.; Armitage J.; Parish S.; Youngman L.; Buxton M.; De Bono D.;
George C.; Fuller J.; Keech A.; Mansfield A.; Pentecost B.; Simpson D.;
Warlow C.; McNamara J.; O'Toole L.; Doll R.; Wilhelmsen L.; Fox K.M.; Hill
C.; Sandercock P.
Institution
(Bulbulia, Bowman, Wallendszus, Parish, Armitage, Peto, Collins, Collins,
Meade, Sleight, Armitage, Parish, Youngman, Buxton, De Bono, George,
Fuller, Keech, Mansfield, Pentecost, Simpson, Warlow, McNamara, O'Toole,
Doll, Wilhelmsen, Fox, Hill, Sandercock) Clinical Trial Service Unit,
Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford OX3 7LF,
United Kingdom
Publisher
Lancet Publishing Group (E-mail: cususerv@lancet.com)
Abstract
Findings of large randomised trials have shown that lowering LDL
cholesterol with statins reduces vascular morbidity and mortality rapidly,
but limited evidence exists about the long-term efficacy and safety of
statin treatment. The aim of the extended follow-up of the Heart
Protection Study (HPS) is to assess long-term efficacy and safety of
lowering LDL cholesterol with statins, and here we report cause-specific
mortality and major morbidity in the in-trial and post-trial periods. 20
536 patients at high risk of vascular and non-vascular outcomes were
allocated either 40 mg simvastatin daily or placebo, using minimised
randomisation. Mean in-trial follow-up was 5.3 years (SD 1.2), and
post-trial follow-up of surviving patients yielded a mean total duration
of 11.0 years (SD 0.6). The primary outcome of the long-term follow-up of
HPS was first post-randomisation major vascular event, and analysis was by
intention to treat. This trial is registered with ISRCTN, number 48489393.
During the in-trial period, allocation to simvastatin yielded an average
reduction in LDL cholesterol of 1.0 mmol/L and a proportional decrease in
major vascular events of 23 (95 CI 19-28; p<0.0001), with significant
divergence each year after the first. During the post-trial period (when
statin use and lipid concentrations were similar in both groups), no
further significant reductions were noted in either major vascular events
(risk ratio [RR] 0.95 [0.89-1.02]) or vascular mortality (0.98
[0.90-1.07]). During the combined in-trial and post-trial periods, no
significant differences were recorded in cancer incidence at all sites
(0.98 [0.92-1.05]) or any particular site, or in mortality attributed to
cancer (1.01 [0.92-1.11]) or to non-vascular causes (0.96 [0.89-1.03]).
More prolonged LDL-lowering statin treatment produces larger absolute
reductions in vascular events. Moreover, even after study treatment
stopped in HPS, benefits persisted for at least 5 years without any
evidence of emerging hazards. These findings provide further support for
the prompt initiation and long-term continuation of statin treatment. UK
Medical Research Council, British Heart Foundation, Merck & Co, Roche
Vitamins. &#xa9; 2011 Elsevier Ltd.

<71>
Accession Number
2003400464
Title
Prognostic implications of microcirculatory perfusion versus
macrocirculatory perfusion in cardiogenic shock: a CULPRIT-SHOCK substudy.
Source
European Heart Journal: Acute Cardiovascular Care. 9 (2) (pp 108-119),
2020. Date of Publication: 01 Mar 2020.
Author
Wijntjens G.W.M.; Fengler K.; Fuernau G.; Jung C.; den Uil C.; Akin S.;
van de Hoef T.P.; Serpytis R.; Diletti R.; Henriques J.P.S.; Serpytis P.;
Thiele H.; Piek J.J.
Institution
(Wijntjens, van de Hoef, Henriques, Piek) Heart Center, Amsterdam
Universitair Medische Centra, Netherlands
(Fengler, Thiele) Department of Internal Medicine/Cardiology, University
Hospital, Germany
(Fuernau) Medical Clinic II (Cardiology/Angiology/Intensive Care
Medicine), University of Luebeck, Germany
(Jung) Medical Faculty, University Hospital Dusseldorf, Germany
(den Uil) Department of Intensive Care Medicine, Erasmus University
Medical Center, Netherlands
(den Uil, Akin, Diletti) Department of Cardiology, Erasmus University
Medical Center, Netherlands
(Akin) Department of Intensive Care, Haga Teaching Hospital, The Hague,
Netherlands
(Serpytis, Serpytis) Clinic of Cardiac and Vascular Diseases, Vilnius
University, Lithuania
Publisher
SAGE Publications Inc. (E-mail: claims@sagepub.com)
Abstract
Background: After early revascularisation, restoration of macrocirculatory
perfusion parameters is the primary objective in the management of
cardiogenic shock complicated acute myocardial infarction. Nevertheless,
vital organ perfusion may be compromised at the systemic microcirculatory
level, even in patients with preserved macrohaemodynamics. Microvascular
perfusion was shown to have independent prognostic value for early
mortality. The present study aims to compare the prognostic value of
microcirculatory versus macrocirculatory perfusion parameters.
<br/>Method(s): This substudy of the culprit lesion-only percutaneous
coronary intervention versus multivessel percutaneous coronary
intervention in cardiogenic shock (CULPRIT-SHOCK) trial examined the
sublingual capillary network using videomicroscopy post-percutaneous
coronary intervention to determine the proportion of perfused capillaries
(<20 micro&#32;m) and perfused capillary density. Thirty-day follow-up was
performed to obtain the occurrence of a combined clinical endpoint of
all-cause death and renal replacement therapy. <br/>Result(s):
Videomicroscopy measurements were performed in 66 patients. There was a
significant adjusted association between microcirculatory perfusion
parameters and the combined clinical endpoint (proportion of perfused
capillaries: P=0.020; perfused capillary density: P=0.035), whereas there
was no significant adjusted association between macrocirculatory perfusion
parameters and the combined clinical endpoint (systolic blood pressure:
P=0.205). Normotensive patients with compromised microcirculatory
perfusion parameters had a higher risk of the combined clinical endpoint
than normotensive patients with preserved microcirculatory perfusion
parameters (proportion of perfused capillaries: Breslow P=0.014; perfused
capillary density: Breslow P=0.076). <br/>Conclusion(s): There is a
significant and independent association between microcirculatory perfusion
parameters perfused capillary density and proportion of perfused
capillaries and the combined clinical endpoint of all-cause death and
renal replacement therapy at 30 days follow-up. In patients with loss of
haemodynamic coherence between microcirculatory and macrocirculatory
perfusion parameters, microcirculatory perfusion parameters confer
dominant prognostic value.<br/>Copyright &#xa9; The European Society of
Cardiology 2019.

<72>
Accession Number
631132940
Title
Impaired Fibrinolysis Predicts Adverse Outcome in Acute Coronary Syndrome
Patients with Diabetes: A PLATO Sub-Study.
Source
Thrombosis and Haemostasis. 120 (3) (pp 412-422), 2020. Date of
Publication: 01 Mar 2020.
Author
Sumaya W.; Wallentin L.; James S.K.; Siegbahn A.; Gabrysch K.; Himmelmann
A.; Ajjan R.A.; Storey R.F.
Institution
(Sumaya, Storey) Department of Infection, Immunity and Cardiovascular
Disease, University of Sheffield, Sheffield, United Kingdom
(Wallentin, James) Department of Medical Sciences, Cardiology, Uppsala
University, Uppsala, Sweden
(Wallentin, James, Siegbahn, Gabrysch) Uppsala Clinical Research Center,
Uppsala University, Uppsala, Sweden
(Siegbahn) Department of Medical Sciences, Clinical Chemistry, Uppsala
University, Uppsala, Sweden
(Himmelmann) AstraZeneca Research and Development, Gothenburg, Sweden
(Ajjan) Leeds Institute of Cardiovascular and Metabolic Medicine,
University of Leeds, Leeds, United Kingdom
(Sumaya) Department of Infection, Immunity and Cardiovascular Disease,
Medical School, University of Sheffield, Beech Hill Road, Sheffield S10
2RX, United Kingdom
Publisher
Georg Thieme Verlag (E-mail: iaorl@iaorl.org)
Abstract
Hypofibrinolysis is a key abnormality in diabetes but the role of impaired
clot lysis in predicting vascular events and mortality in this population
is yet to be determined. We aimed to investigate the relationship between
fibrin clot properties and clinical outcomes in patients with diabetes and
recent acute coronary syndrome (ACS). Plasma samples were collected at
hospital discharge from 974 ACS patients with diabetes randomised to
clopidogrel or ticagrelor in the PLATO trial. A validated turbidimetric
assay was employed to study fibrin clot lysis and maximum turbidity.
One-year rates of cardiovascular (CV) death, spontaneous myocardial
infarction (MI) and PLATO-defined major bleeding events were assessed
after sample collection. Hazard ratios (HRs) were determined using Cox
proportional analysis. After adjusting for CV risk factors, each 50%
increase in lysis time was associated with increased risk of CV death/MI
(HR 1.21; 95% confidence interval [CI] 1.02-1.44; p = 0.026) and CV death
alone (HR 1.38; 1.08-1.76; p = 0.01). Similarly, each 50% increase in
maximum turbidity was associated with increased risk of CV death/MI (HR
1.25; 1.02-1.53; p = 0.031) and CV death alone (HR 1.49; 1.08-2.04; p =
0.014). The relationship between lysis time and the combined outcome of CV
death and MI remained significant after adjusting for multiple prognostic
vascular biomarkers (p = 0.034). Neither lysis time nor maximum turbidity
was associated with major bleeding events. Impaired fibrin clot lysis
predicts 1-year CV death and MI in diabetes patients following ACS.
Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique
identifier NCT00391872.<br/>Copyright &#xa9; 2020 Georg Thieme Verlag. All
rights reserved.

<73>
Accession Number
631124205
Title
Effect of an ICU diary on psychiatric disorders, quality of life, and
sleep quality among adult cardiac surgical ICU survivors: A randomized
controlled trial.
Source
Critical Care. 24 (1) (no pagination), 2020. Article Number: 81. Date of
Publication: 06 Mar 2020.
Author
Wang S.; Xin H.-N.; Chung Lim Vico C.; Liao J.-H.; Li S.-L.; Xie N.-M.; Hu
R.-F.
Institution
(Wang, Liao, Xie, Hu) School of Nursing, Fujian Medical University,
University Town, 1 Xue Yuan Road, Fuzhou 350122, China
(Xin) Fujian Provincial Hospital, Fuzhou, China
(Chung Lim Vico) School of Nursing, Hong Kong Polytechnic University,
Kowloon, Hong Kong
(Li) Fujian Medical University Union Hospital, Fuzhou, China
Publisher
BioMed Central Ltd. (E-mail: info@biomedcentral.com)
Abstract
Background: Although studies on the effectiveness of the use of ICU
diaries on psychiatric disorders and quality of life have been published,
the results still seem to be controversial. The study aimed to determine
the effects of using an ICU diary on psychiatric disorders, sleep quality,
and quality of life (QoL) in adult ICU survivors in China. <br/>Method(s):
One hundred and twenty-six patients who underwent a scheduled cardiac
surgery and were expected to stay >= 24 h in ICU were randomized to two
groups (63 in each group). The patients in the intervention group received
the use of ICU diaries during the period of post-ICU follow-up, while the
patients in the control group received usual care without ICU diaries. The
primary outcome was significant PTSD symptoms (Chinese version of Impact
of Event Scale-Revised, IES-R; total score >= 35 was defined as
significant PTSD symptoms) and its severity in patients 3 months post-ICU.
The secondary outcomes included memories of the ICU at 1 month, QoL
(Medical Outcomes Study 36-item Short-Form, SF-36), sleep quality
(Pittsburgh Sleep Quality Index Questionnaire, PSQI), anxiety, and
depression symptoms (Hospital Anxiety and Depression Scale, HADS) at 3
months. <br/>Result(s): Eighty-five and 83 patients completed the
follow-up interviews at 1 month and 3 months post-ICU, respectively.
Significant PTSD symptoms were reported by 6 of 41 (14.63%) in the
intervention group vs 9 of 42 (21.43%) in the control group (risk
difference, - 9% [95% CI, - 2% to 21%], P = 0.10). There was no
significant differences between groups in IES-R score, symptoms of
intrusion, symptoms of avoidance, numbers of memories of feeling and
delusional memories, SF-36 score and anxiety score (P > 0.05), while
significant differences were found in symptom of hyperarousal score,
numbers of factual memories and PSQI score (P < 0.05). No adverse effect
was reported. <br/>Conclusion(s): Using an ICU diary is not useful for
preventing PTSD symptoms and anxiety symptoms and preserving the quality
of life of the patients at 3 months post-ICU, while it significantly
improves the survivor's factual memory of ICU and sleep quality, and
prevents the hyperarousal symptom. Trial registration: Chinese Clinical
Trial Registry, ChiCTR-IOR-16009109, registered on 28 August
2016<br/>Copyright &#xa9; 2020 The Author(s).

<74>
Accession Number
2005260660
Title
Cardiac tumors prevalence and mortality: A systematic review and
meta-analysis.
Source
International Journal of Surgery. 76 (pp 178-189), 2020. Date of
Publication: April 2020.
Author
Arisha M.J.; Elmously A.; El-Sayed Ahmed M.M.; Spadaccio C.; Mehta K.;
Baudo M.; Kamel M.; Mansor E.; Ruan Y.; Morsi M.; Shmushkevich S.;
Eldessouki I.; Rahouma M.; Mohamed A.; Gambardella I.; Girardi L.; Gaudino
M.
Institution
(Rahouma, Elmously, Mehta, Baudo, Kamel, Ruan, Morsi, Shmushkevich,
Gambardella, Girardi, Gaudino) Cardiothoracic Surgery Department, Weill
Cornell Medicine/New York Presbyterian Hospital, New York, United States
(Rahouma, Kamel, Mohamed) Surgical Oncology Department, National Cancer
Institute, Cairo University, Egypt
(Arisha, Mansor) Internal Medicine Department, West Virginia University
Charleston Division, Charleston Area Medical Center, Charleston, WV,
United States
(El-Sayed Ahmed) Cardiovascular Surgery, Mayo Clinic College of Medicine,
Jacksonville, FL, United States
(Spadaccio) Department of Cardiothoracic Surgery, Golden Jubilee National
Hospital, Clydebank, Glasgow G814DY, United Kingdom
(Spadaccio) Institute of Cardiovascular and Medical Sciences, Veterinary
and Life Sciences, College of Medical, University of Glasgow, Glasgow
G128QQ, United Kingdom
(Eldessouki) Medical Oncology Department, University of Cincinnati Cancer
Institute, Cincinnati, OH, United States
(Rahouma) Information Technology Department, National Cancer Institute,
Cairo University, Egypt
Publisher
Elsevier Ltd
Abstract
Objectives: Cardiac tumors and their associated outcomes are poorly
characterized. This study sought to comprehensively assess the
epidemiology and natural history of primary and secondary malignant
cardiac tumors (PMCT and SMCT), a well as establish predictors of
mortality. <br/>Method(s): A comprehensive literature review was performed
to identify articles reporting on PMCTs and SMCTs. The prevalence of
important cardiac tumor (CT) subtypes was evaluated and further stratified
based on the continental region. Outcomes of interest included short- and
long-term mortality and utilization of heart transplantation (HTX). A
random effect model was adopted, and a meta-regression was performed to
determine predictors of the prevalence of CTs as well as predictors of
operative mortality. <br/>Result(s): Of the 1,226 retrieved articles, 74
were included in our study (n = 8,849 patients). The mean follow-up was
2.27 years, mean age was 42.9 years, and 55% of the patients were females.
There was a total number of 7,484 benign primary cardiac tumors (PCTs)
(5,140 were myxoma), 862 (9.7%) malignant PCTs, and 355 secondary cardiac
tumors. The prevalence of PMCTs among PCTs was 10.83% [95%CI = 09.11;
12.83%] with a trend towards being lower in South America compared to
other continents (Prevalence = 5.80%). The prevalence of HTX among all
patients was 2.45% [1.36; 4.38%]. The pooled short-term mortality was
5.90% [4.70; 7.39%] and the incidence of late mortality in all CTs, benign
CT and PMCTs was 2.55% [1.76; 3.72%], 0.79% [0.46; 1.37%] and 14.77%
[9.32; 23.40%], respectively. On meta-regression, the annual volume of
cardiac tumor cases per center was the only predictor of lower early
mortality (Beta = -0.14 +/- 0.03, P < 0.0001). <br/>Conclusion(s): PMCTs
represent the minority of PCT (~10%) and have a higher prevalence in
Europe and North America. Survival is higher in benign pathology and is
significantly improved by treatment in specialized high-volume centers.
Approximately 2% of patients with CTs undergo heart
transplantation.<br/>Copyright &#xa9; 2020

<75>
Accession Number
2005246215
Title
Beta-blocker exposure for short-term outcomes following non-cardiac
surgery: A meta-analysis of observational studies.
Source
International Journal of Surgery. 76 (pp 153-162), 2020. Date of
Publication: April 2020.
Author
Nan Y.; Jia F.; Du X.; Mei Z.
Institution
(Nan, Du) Department of Cardiology, The Fifth Central Hospital of Tianjin,
Tianjin, China
(Jia) Department of General Surgery, The Fifth Central Hospital of
Tianjin, Tianjin, China
(Mei) Department of Anorectal Surgery, Shuguang Hospital, Shanghai
University of Traditional Chinese Medicine, Shanghai, China
(Mei) Anorectal Disease Institute of Shuguang Hospital, Shanghai, China
Publisher
Elsevier Ltd
Abstract
Background: It remains uncertain whether there is a benefit to
perioperative beta-blocker use on outcomes after non-cardiac surgery. This
meta-analysis aims to update the evidence regarding the associations
between beta-blocker exposure and patient major short-term outcomes
following non-cardiac surgery. <br/>Method(s): Pubmed, Embase, and the
Cochrane Central Register from their inception to May 2019 were searched
by two independent authors. Observational studies reporting associations
between perioperative beta-blocker treatment and short-term outcomes
including 30-day all-cause mortality (ACM), 30-day major adverse
cardiovascular events (MACE) and 30-day stroke risk were selected for
inclusion. Meta-analyses were carried out by using random effects models.
<br/>Result(s): Nineteen studies with a total of 1,711,766 participants
were identified. Beta-blocker exposure was associated with reduced 30-day
all-cause mortality (ACM) (RR 0.83, 95% CI 0.72 to 0.96). No evidence of
publication bias was observed. Subgroup analyses revealed that significant
30-day survival benefits were observed in prospective, population-based
studies, drug exposure period last till 1-2 months after surgery, patients
having abdominal gastrointestinal surgery or having 3-4 cardiac risk
factors. Beta-blocker exposure was associated with increased 30-day ACM
among patients with no cardiac risk factors (RR 1.30, 95% CI 1.19 to
1.43). However, meta-analysis demonstrated a non-significant risk
reduction in 30-day MACE (RR 1.03; 95% CI 0.85 to 1.25) or 30-day stroke
risk (RR 0.86; 95% CI 0.44 to 1.68) with beta-blocker exposure.
<br/>Conclusion(s): The results of the current meta-analysis indicate
beta-blocker exposure may be a significant indicator for 30-day ACM, but
not for 30-day MACE or 30-day stroke risk. The association between
beta-blocker exposure and long-term outcomes deserves further
investigation.<br/>Copyright &#xa9; 2020 IJS Publishing Group Ltd

<76>
Accession Number
2004477022
Title
An In-hospital Mortality Risk Model for Patients Undergoing Coronary
Artery Bypass Grafting in China.
Source
Annals of Thoracic Surgery. 109 (4) (pp 1234-1242), 2020. Date of
Publication: April 2020.
Author
Hu Z.; Chen S.; Du J.; Gu D.; Wang Y.; Hu S.; Zheng Z.
Institution
(Hu, Chen, Du, Gu, Hu, Zheng) Department of Cardiovascular Surgery, Fuwai
Hospital, National Center for Cardiovascular Diseases, Chinese Academy of
Medical Sciences and Peking Union Medical College, Beijing, China
(Wang) Department of Biostatistics, Harvard T.H. Chan School of Public
Health, Boston, MA, United States
(Wang) Center for Outcomes Research and Evaluation, Yale New Haven Health,
New Haven, CT, United States
Publisher
Elsevier USA
Abstract
Background: To meet the demand of increasing surgical volume and changing
of patient's risk profiles of coronary artery bypass grafting in China, we
developed a new risk model that predicts in-hospital mortality.
<br/>Method(s): The analysis included patients who underwent coronary
artery bypass grafting between January 2013 and December 2016 at 87
hospitals in the Chinese Cardiac Surgery Registry. Patients in years 2013
to 2015 were randomly divided into training (n = 31,297 [75%]) and test (n
= 10,432 [25%]) samples; 2016 patients (n = 15047) comprised the
validation sample. Demographic and clinical risk factors were identified.
The Harrell C statistic was used to evaluate model discrimination, and the
Hosmer-Lemeshow goodness-of-fit test was used to assess calibration.
<br/>Result(s): The 56,776 patients were a mean age of 61.8 (SD, 8.8)
years, and 24.6% were women. Overall, in-hospital mortality was 2.1%. The
final model included 21 risk factors represented by 16 unique variables.
The model achieved good discrimination, with a C statistic of 0.79 (95%
confidence interval [CI], 0.77-0.80) in the training sample, 0.79 (95% CI,
0.76-0.82) in the test sample, and 0.78 (95% CI, 0.76-0.81) in the
validation sample. Model calibration was good according to the
Hosmer-Lemeshow test (P >. 05 in the 3 samples). Compared with the
European System for Cardiac Operative Risk Evaluation 2011 revision
(EuroSCORE II) and the Sino(Chinese) System for Coronary artery bypass
grafting Operative Risk Evaluation (SinoSCORE), the model had better
discrimination and calibration. <br/>Conclusion(s): We developed and
evaluated a model with 16 risk factors that predicted in-hospital
mortality risk after coronary artery bypass grafting in China. This
updated model may help surgeons and hospitals better identify high-risk
patient.<br/>Copyright &#xa9; 2020 The Society of Thoracic Surgeons

<77>
Accession Number
2004400997
Title
Prognostic impact of baseline C-reactive protein levels on mortality after
transcatheter aortic valve implantation.
Source
Journal of Cardiac Surgery. (no pagination), 2020. Date of Publication:
2020.
Author
Takagi H.; Kuno T.; Hari Y.; Nakashima K.; Yokoyama Y.; Ueyama H.; Ando T.
Institution
(Takagi, Hari, Nakashima) Department of Cardiovascular Surgery, Shizuoka
Medical Center, Shizuoka, Japan
(Takagi, Hari, Nakashima) Department of Cardiovascular Surgery, Kitasato
University School of Medicine, Sagamihara, Japan
(Kuno, Ueyama) Department of Medicine, Mount Sinai Beth Israel Medical
Center, New York, NY, United States
(Yokoyama) Department of Surgery, Easton Hospital, Easton, PA, United
States
(Ando) Division of Interventional Cardiology, Department of Cardiology,
New York-Presbyterian Hospital, Columbia University Medical Center, New
York, NY, United States
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Objectives: To determine whether baseline C-reactive protein (CRP) levels
can predict mortality after transcatheter aortic valve implantation
(TAVI), we performed a meta-analysis of currently available studies.
<br/>Method(s): All studies investigating the prognostic impact of
baseline (preprocedural) CRP levels on all-cause mortality after TAVI were
identified by means of searching PubMed and Google Scholar through May
2019. For each study, (preferentially, adjusted rather than unadjusted)
odds/hazard ratios (ORs/HRs) with corresponding 95% confidence intervals
of mortality per standard-deviation (SD) (or unit) increase in CRP levels
or those for high vs low CRP levels. <br/>Result(s): Our search identified
14 eligible studies including a total of 3449 patients undergoing TAVI and
reporting early (in-hospital to 3-month) and midterm (1-year to 3-year)
all-cause mortality after TAVI. Pooled analyses demonstrated associations
of high-baseline CRP levels with a marginal, but statistically
nonsignificant increase in early mortality (pooled OR/HR per SD increase
in CRP levels, 2.72; P =.09 and pooled OR/HR for high vs low CRP levels,
3.32; P =.07) and a statistically significant increase in midterm
mortality after TAVI (pooled OR/HR per SD increase in CRP levels, 1.45; P
<.0001 and pooled OR/HR for high vs low CRP levels, 1.78; P <.00001).
Excluding HRs for high-sensitivity CRP, combining ORs/HRs of 1-year
mortality, pooling HRs of >=2-year mortality, and combining adjusted HRs
did not alter the primary results. <br/>Conclusion(s): High-baseline CRP
levels may predict increased midterm, but not early, mortality after
TAVI.<br/>Copyright &#xa9; 2020 Wiley Periodicals, Inc.

<78>
Accession Number
631172562
Title
Development and usability testing of HEARTPAN: Protocol for a mixed
methods strategy to develop an integrated smartphone and web-based
intervention for women with cardiac pain.
Source
BMJ Open. 10 (3) (no pagination), 2020. Article Number: e033092. Date of
Publication: 09 Mar 2020.
Author
Parry M.; Dhukai A.; Clarke H.; Bjornnes A.K.; Cafazzo J.A.; Cooper L.;
Harvey P.; Katz J.; Lalloo C.; Leegaard M.; Legare F.; Lovas M.;
McFetridge-Durdle J.; McGillion M.; Norris C.; Parente L.; Patterson R.;
Pilote L.; Pink L.; Price J.; Stinson J.; Uddin A.; Victor J.C.;
Watt-Watson J.; Auld C.; Faubert C.; Park D.; Park M.; Rickard B.; DeBonis
V.S.
Institution
(Parry, Dhukai) University of Toronto Lawrence S Bloomberg Faculty of
Nursing, Toronto, ON, Canada
(Clarke) Pain Research Unit, University Health Network, Toronto, ON,
Canada
(Clarke, Cafazzo, Harvey, Victor) University of Toronto, Toronto, ON,
Canada
(Bjornnes) Department of Nursing and Health Promotion, Oslo Metropolitan
University, Oslo, Norway
(Cafazzo, Lovas, Parente, Uddin) Healthcare Human Factors, University
Health Network, Toronto, ON, Canada
(Cooper, Auld, Faubert, Park, Park, DeBonis) Patient Advisor, Toronto, ON,
Canada
(Harvey, Price) Women's College Hospital, Toronto, ON, Canada
(Katz) Faculty of Health - Department of Psychology, York University,
Toronto, ON, Canada
(Lalloo, Stinson) Peter Gilgan Centre for Research and Learning, Toronto,
ON, Canada
(Leegaard) Institute of Nursing, Oslo Metropolitan University, Oslo,
Akershus, Norway
(Legare) Medecine Familiale, Universite Laval, Quebec, QC, Canada
(McFetridge-Durdle) College of Nursing, Florida State University,
Tallahassee, FL, United States
(McGillion) Faculty of Health Sciences, McMaster University, Hamilton, ON,
Canada
(Norris) Faculty of Nursing, University of Alberta, Edmonton, AB, Canada
(Patterson) Anishnawbe Health, Toronto, ON, Canada
(Pilote) Medicine, McGill University, Montreal, QC, Canada
(Pink) Wasser Pain Management Centre, Sinai Health System, Toronto, ON,
Canada
(Stinson, Watt-Watson) Lawrence S Bloomberg Faculty of Nursing, University
of Toronto, Toronto, ON, Canada
(Rickard) Moose Factory, ON, Canada
Publisher
BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com)
Abstract
Introduction: More women experience cardiac pain related to coronary
artery disease and cardiac procedures compared with men. The overall goal
of this programme of research is to develop an integrated smartphone and
web-based intervention (HEARTPAN) to help women recognise and self-manage
cardiac pain. Methods and analysis: This protocol outlines the mixed
methods strategy used for the development of the HEARTPAN content/core
feature set (phase 2A), usability testing (phase 2B) and evaluation with a
pilot randomised controlled trial (RCT) (phase 3). We are using the
individual and family self-management theory, mobile device functionality
and pervasive information architecture of mHealth interventions, and
following a sequential phased approach recommended by the Medical Research
Council to develop HEARTPAN. The phase 3 pilot RCT will enable us to
refine the prototype, inform the methodology and calculate the sample size
for a larger multisite RCT (phase 4, future work). Patient partners have
been actively involved in setting the HEARTPAN research agenda, including
defining patient-reported outcome measures for the pilot RCT: pain and
health-related quality of life (HRQoL). As such, the guidelines for
Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols
(SPIRIT-PRO) are used to report the protocol for the pilot RCT (phase 3).
Quantitative data (eg, demographic and clinical information) will be
summarised using descriptive statistics (phases 2AB and 3) and a content
analysis will be used to identify themes (phase 2AB). A process evaluation
will be used to assess the feasibility of the implementation of the
intervention and a preliminary efficacy evaluation will be undertaken
focusing on the outcomes of pain and HRQoL (phase 3). Ethics and
dissemination: Ethics approval was obtained from the University of Toronto
(36415; 26 November 2018). We will disseminate knowledge of HEARTPAN
through publication, conference presentation and national public forums
(Cafe Scientifique), and through fact sheets, tweets and
webinars.<br/>Copyright &#xa9; Author(s) (or their employer(s)) 2020.

<79>
Accession Number
2005255582
Title
SAT-007 FIGHTING AGAINST PROXIMAL AND DISTAL TUBULAR DAMAGE BY REDUCING
INFLAMMATORY BURDEN AFTER CARDIAC SURGERY.
Source
Kidney International Reports. Conference: ISN World Congress of
Nephrology. United Arab Emirates. 5 (3 Supplement) (pp S3-S4), 2020. Date
of Publication: March 2020.
Author
Dalili MD N.; Jamalian S.A.
Institution
(Dalili MD) Labbafinejad Medical Center-CKDRC-Shahid Beheshti University
of Medical Sciences, Nephrology, Tehran, Iran, Islamic Republic of
(Jamalian) Shahid Lavasani Medical Center, Cardiology, Tehran, Iran,
Islamic Republic of
Publisher
Elsevier Inc.
Abstract
Introduction: Going on cardiopulmonary bypass (CPB) during cardiac surgery
causes systemic inflammatory response syndrome. In different studies
Pentoxifylline and Calcitriol have shown inhibitory effects on
pro-inflammatory cytokines such as tumor necrosis factor (TNF) and
interleukin-6 (IL-6) accompanying with production of free oxygen radicals
in the ischemic reperfusion injury. On the other hand, they have positive
effects on reducing oxidative stress. To investigate the effects of these
drugs on reducing tubular injury after CABG surgery, by their
anti-inflammatory properties we compared pre- and postoperative levels of
urinary NGAL (as a proximal tubular damage marker), KIM-1 level (as a
distal tubular damage marker), serum level of Malondialdehyde (MDA) (as an
oxidative stress marker) and serum inflammatory markers such as IL-6,
IL-8, and TNF levels in two groups of patients undergoing CABG, those who
received Pentoxifylline and Calcitriol before surgery and those who
didn't. <br/>Method(s): After signing an informed consent, 150 consecutive
adult patients undergoing elective on-pump CABG were enrolled in a
randomized control trial. Patients with collagen-vascular disease or
having a history of treatment with immunosuppressive agents,
corticosteroids (> 3 days), Methylxantines, Diltiazem or sodium
Nitroprusside and patients with a history of angiography in the past 7
days or hemorrhagic diathesis and coagulopathy, uncontrolled diabetes
mellitus, sepsis, renal failure (sCr > 2 mg/dl), hepatic failure (AST or
ALT > 40 U/L) or urinary tract infection were excluded. All patients
received the same anesthetic regimen and routine CPB management. The
patients were randomly assigned to one of two groups: (A) Control group
(placebo)(B) Intervention group (Pentoxifylline +Calcitriol)PTX was
administered as an oral 400 mg tab every 12hours plus IV Calcitriol(0.01
mcg/kg) daily starting from 3 days before surgery. In the control group
placebo tab and IV injection of normal saline were prescribed in the same
direction. <br/>Result(s): Results demonstrated that after three days
prophylactic use of oral pentoxifylline plus IV Calcitriol there is
improvement in selected checked inflammatory markers in the intervention
group. Moreover Pentoxifylline+ Calcitriol showed beneficial effects by
controlling the oxidative stress burden and reducing the mean serum MDA
level in the patients undergoing CABG who are at risk of developing AKI as
a post surgery complication. Probably by reducing inflammation and
oxidative stress combination of these two drugs before CABG could decrease
proximal and distal tubular damage which presented with significantly
lower levels of uNGAL and KIM-1, as markers of tubular injury, in the
intervention group. [Formula presented] <br/>Conclusion(s): Combination of
Pentoxifylline and Calcitriol showed a promising prophylactic role in
patients undergoing CABG with anti-inflammatory, anti-oxidant properties.
This study provided scope of add-on drug therapy for better prognosis in
post CABG population, involving risk of endothelial dysfunction and renal
tubular damage due to inflammatory milieu and renders support to future
prospective clinical studies to demonstrate net control of inflammation
and oxidative stress after cardiac surgery. [Formula presented] [Formula
presented]<br/>Copyright &#xa9; 2020

<80>
Accession Number
2005252047
Title
Non-Ischemic Heart Preservation versus Static Cold Storage in Human Heart
Transplantation.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S135), 2020. Date of Publication: April 2020.
Author
Nilsson J.; Jernryd V.; Qin G.; Paskevicius A.; Metzsch C.; Medved D.;
Sjoberg T.; Steen S.
Institution
(Nilsson, Qin, Paskevicius, Metzsch, Medved, Sjoberg, Steen) Clinical
Sciences in Lund, Cardiothoracic Surgery, Lund University and Skanes
University Hospital, Lund, Sweden
(Jernryd) Clinical Sciences in Lund, Cardiothoracic Surgery, Lund
University and Skane University Hospital, Lund, Sweden
Publisher
Elsevier USA
Abstract
Purpose: Pre-clinical studies have shown that ex vivo non-ischemic heart
preservation (NIHP) method can be safely used for 24 hours. This
state-of-the-art method has never been applied on humans. The primary
objective of the study was to evaluate the efficacy and safety of the NIHP
method on early and late human heart allograft function compared with
static cold storage (SCS). <br/>Method(s): We performed a prospective,
open-label, non-randomised phase II study. All adult recipients listed for
heart transplantation were included, unless they met any exclusion
criteria. The primary endpoint was a composite of survival free of severe
primary graft dysfunction, free of ECMO use within 7 days, and free of
acute cellular rejection >=2R within 180 days. Secondary endpoints were
I/R-tissue injury, immediate graft function, and adverse event. Of the 37
eligible patients, nine were assigned to the NIHP method and 28 to SCS.
<br/>Result(s): The median age was 51 years (interquartile range (IQR),
37-58) for the donors and 56 years (IQR, 46 - 63) for the recipients. The
median preservation time was significant longer for the NIHP group, 251
min (IQR, 219-269) compared with the SCS group, 199 min (IQR, 164 - 227),
P=0.008. Over the first three months, all of the patients assigned to the
NIHP group achieved event-free survival, compared with 21 (75%) of those
assigned to the SCS group (Kaplan-Meier estimate of event free survival
75% (95% CI 55-87%); P=0.124). CK-MB assessed 6+/-2 h after ending
perfusion was 77 (IQR, 54-101) ng/mL for the NIHP group compared with 137
(IQR, 73-196) ng/mL for the SCS group, P=0.030. Four (16%) death within
six months after transplantation and three (12%) cardiac-related adverse
events were reported in the SCS group compared with no deaths or
cardiac-related adverse events in the NIHP group. <br/>Conclusion(s): This
first-in-human study shows the NIHP method's feasibility and safety for
use in the clinic of heart transplantation.<br/>Copyright &#xa9; 2020

<81>
Accession Number
2005252039
Title
Outcomes of Mechanical Circulatory Support after Giant Cell Myocarditis: A
Systematic Review.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S185), 2020. Date of Publication: April 2020.
Author
Patel P.M.; Wood C.T.; O'Malley T.J.; Maynes E.J.; Pirlamarla P.R.;
Alvarez R.J.; Morris R.J.; Entwistle J.W.; Massey H.T.; Tchantchaleishvili
V.
Institution
(Patel, Wood, O'Malley, Maynes, Morris, Entwistle, Massey,
Tchantchaleishvili) Division of Cardiac Surgery, Thomas Jefferson
University, Philadelphia, United States
(Pirlamarla, Alvarez) Division of Cardiology, Thomas Jefferson University,
Philadelphia, United States
Publisher
Elsevier USA
Abstract
Purpose: Giant cell myocarditis (GCM) is a rare, serious form of
myocarditis that can require bridging to orthotopic heart transplant (OHT)
with mechanical circulatory support (MCS). Given that the roles of MCS and
immunosuppressive therapy have not been well defined in this patient
population, we sought to analyze the outcomes of patients with GCM who
required MCS. <br/>Method(s): A systematic search was performed in June
2019 to identify all studies of biopsy-proven GCM requiring MCS in the
English literature after 2009. 27 studies were identified consisting of 43
patients. Patient-level data were extracted for statistical analysis.
<br/>Result(s): Median patient age was 45 [IQR: 32 - 57] years, and 42.1%
(16/38) of patients were female. 34.9% (15/43) of patients presented with
symptoms of acute heart failure, and 20.9% (9/43) presented in cardiogenic
shock. Biventricular (BiVAD) MCS was required in 76.7% (33/43) of cases.
The final diagnosis of GCM was made using endomyocardial biopsy in 72.1%
(31/43) of cases, left ventricular apical core biopsy in 23.3% (10/43) of
cases, and biopsy of the explanted heart in 2.3% (1/43) of cases. An
immunosuppressive regimen was used in 62.8% (27/43) of cases. Of these
patients, 81.5% (22/27) received steroids in combination with at least one
other immunosuppressant, of which cyclosporine was the most common,
administered to 40.7% (11/27) of patients. Immunosuppression was initiated
before MCS in 59.3% (16/27) of cases, after MCS in 29.6% (8/27) of cases,
and not specified in 11.1% (3/27) of cases. Survival stratified by
immunosuppression (Panel A) and mode of MCS (Panel B) is shown. 58.5%
(24/41) underwent OHT with a median time to transplant of 104 [58 - 255]
days from diagnosis, and 46 [18 - 201] days from the initiation of MCS.
Recurrence of GCM after OHT was reported in 8.3% (2/24) of cases.
<br/>Conclusion(s): Non-dischargeable BiVAD predominates in mechanically
supported patients with GCM. Survival appears to be better in patients on
immunosuppression, especially if initiated before MCS.<br/>Copyright
&#xa9; 2020

<82>
Accession Number
2005252016
Title
Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant
Recipients (IronIC) - A Randomized, Double Blind, Controlled Trial.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S144), 2020. Date of Publication: April 2020.
Author
Brautaset Englund K.V.; Ostby C.M.; Vartdal T.; Rolid K.; Gude E.;
Andreassen A.K.; Gullestad L.L.; Broch K.
Institution
(Brautaset Englund, Ostby, Vartdal, Rolid, Gude, Andreassen, Gullestad,
Broch) Department of Cardiology, Oslo University Hospital, Rikshospitalet,
Oslo, Norway
Publisher
Elsevier USA
Abstract
Summary of Objectives: Heart transplant recipients have reduced exercise
capacity despite preserved graft function. Numerous mechanisms may
contribute to this impaired exercise tolerance, one of which may be iron
deficiency (ID). Among our heart transplant survivors, 48 % have ID. The
IronIC trial (NCT03662789) was designed to test the hypothesis that
intravenous (i.v.) iron therapy will improve exercise capacity assessed by
peak oxygen consumption. <br/>Method(s): 102 stable, cardiac transplant
recipients with ID, defined as serum ferritin <100 micro&#32;g/l, or
ferritin between 100 and 300 micro&#32;g/l in combination with transferrin
saturation <20 %, have been randomized in a 1:1 manner to treatment with
intravenous iron isomaltoside, 20 mg/kg, or NaCl. Care was taken to blind
patients and personnel to the color of the infusate. All participants
provided written, informed consent. Exclusion criteria included hemoglobin
<100 g/l, red blood cell disorders, end-stage kidney failure, intolerance
to iron isomaltoside, and ongoing infections or rejections. Prior to the
intervention, all patients underwent a treadmill test to measure peak
oxygen consumption. Muscle strength by a hand grip test, cognitive
function, and self-reported quality of life were also measured. All tests
are repeated at follow-up 6 months after intervention. The trial is
powered to detect a 1.5 ml/kg/min between-group difference in the change
in peak oxygen consumption. Last patient is scheduled for follow-up
February 2020. Endpoints: The primary objective is to assess
baseline-adjusted peak oxygen consumption, six months after one single
dose of iron isomaltoside. Secondary objectives are to assess the impact
of treatment on iron stores, muscle strength, cognitive function, quality
of life, safety and tolerability. This study will give insight to whether
heart transplant recipients with ID can benefit from intravenous iron
supplement. Results will be ready for presentation at the 2020 ISHLT
conference.<br/>Copyright &#xa9; 2020

<83>
Accession Number
2005251955
Title
Incidence and Impact of Primary Graft Dysfunction in Adult Heart
Transplant Recipients: A Systematic Review and Meta-Analysis.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S144), 2020. Date of Publication: April 2020.
Author
Buchan T.A.; Moayedi Y.; Truby L.K.; Posada J.D.; Ross H.J.; Alba A.C.;
Foroutan F.
Institution
(Buchan, Moayedi, Posada, Ross, Alba, Foroutan) Cardiology, Toronto
General Hospital, University Health Network, Toronto, ON, Canada
(Truby) Cardiology, Duke University Medical Center, Durham, NC, United
States
Publisher
Elsevier USA
Abstract
Purpose: Primary graft dysfunction (PGD) is a life-threatening
complication and a leading cause of early mortality post heart transplant
(HTx). Recent studies evaluating the incidence and prognosis of PGD have
benefited from the ISHLT 2014 Consensus Report which clearly defines this
condition. Our objective was to systematically review all studies that
reported the incidence of PGD in adult HTX recipients since 2014 to more
accurately identify its incidence and impact on mortality. <br/>Method(s):
We conducted a systematic search of the literature in Medline in October
2019. We included studies that reported the incidence of PGD in adult HTx
recipients, based on the 2014 ISHLT Consensus Report. Two independent
reviewers screened citations and performed data abstraction. We used a
random effects meta-analysis to pool the incidence among HTx recipients,
as well as the rate of mortality among those who developed PGD. We applied
the GRADE instrument for incidence and mortality separately to determine
our certainty in the pooled estimates. <br/>Result(s): Of 127 publications
screened, we included 36 observational studies. HTx recipient age ranged
from 24-69 years and 24% were female. Donor age ranged from 23-50 years,
sex mismatch occurred in 21% and ischemic time ranged from 86-273 minutes.
We observed similar incidence for each severity of PGD but increasing risk
of 1-year mortality (Table 1). Estimates of 30-day mortality were only
available for severe PGD: 39% (95% CI 32% - 46%, 9 studies, high
certainty). <br/>Conclusion(s): Based on the 2014 ISHLT criteria, the
published pooled incidence of PGD is low, and its prognosis is poor. The
extensive heterogeneity in incidence and mortality suggests
inconsistencies in the recognition and/or management of PGD. This
represents an opportunity for improved risk stratification, prevention and
management strategies.<br/>Copyright &#xa9; 2020

<84>
Accession Number
2005251799
Title
Extracorporeal Membrane Oxygenation for Early Graft Dysfunction Following
Heart Transplantation: A Systematic Review and Meta-Analysis.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S418-S419), 2020. Date of Publication: April 2020.
Author
Aleksova N.; Billia F.; Foroutan F.; Buchan T.A.; Bielecki J.;
Vishram-Nielsen J.K.; Alvarez J.; Kinsella A.; Clark K.; Zhu A.; Lau K.;
McGuinty C.; Francis T.; Stanimirovic A.; Malik A.; Posada J.G.D.; Fan E.;
Rac V.; Rao V.; Ross H.J.; Alba A.C.
Institution
(Aleksova, Billia, Foroutan, Buchan, Vishram-Nielsen, Alvarez, Kinsella,
Clark, Zhu, Lau, McGuinty, Malik, Posada, Rao, Ross, Alba) Peter Munk
Cardiac Centre, Toronto General Hospital-University Health Network,
Toronto, ON, Canada
(Bielecki, Francis, Stanimirovic, Rac) Ted Rogers Centre of Health
Research - Peter Munk Cardiac Centre, University of Toronto, Toronto, ON,
Canada
(Fan) Toronto General Hospital-University Health Network, Toronto, ON,
Canada
Publisher
Elsevier USA
Abstract
Purpose: Early graft dysfunction (EGD) is a major cause of morbidity and
mortality following heart transplantation (HT). The rate of severe EGD
requiring inotropes and/or mechanical circulatory support such as
veno-arterial extracorporeal membrane oxygenation (VA ECMO) ranges from
8-20%. Our objective was to systematically review studies that reported on
mortality in adult HT recipients who developed severe EGD requiring VA
ECMO and conduct a meta-analysis. <br/>Method(s): A systematic search of
the literature was conducted until June 1, 2019. Eligible studies included
full texts and abstracts published after 2009, >=10 adults post-HT who
developed EGD requiring VA ECMO and reported on mortality. The primary
outcome of short-term mortality was defined as death at 30 days and/or
hospital discharge and was analysed using a random effects model. A
meta-regression analysis to explore heterogeneity based on a priori
defined factors was performed. The quality of the evidence was assessed
using the GRADE framework. <br/>Result(s): Of 17 305 publications
screened, 22 observational studies identified 242 deaths in 670 patients
from 1987-2018 (Figure). 21 studies (95%) were retrospective and most
(86%) were conducted at a single centre. The quality of the evidence was
rated as moderate. 14 studies (64%) included patients requiring VA ECMO
within 24h post-HT; the rest included an extended early post-HT period (up
to 7 days). The median age of patients was 49 yrs (IQR 36-62), 18% (IQR
13-29) were female, 47% (IQR 39-77) had a prior sternotomy, and ischemic
time was 198 (IQR 191-224) min. Pooled short-term mortality was 36.8% (95%
CI 28.7-43.3, I² =70%). In the meta-regression, short-term
mortality was higher in studies with a higher proportion of females.
<br/>Conclusion(s): The use of VA ECMO for EGD post-HT is associated with
significant clinical benefit with acceptable short-term survival. Future
studies are needed to identify factors that may further improve outcomes
for patients who experience EGD.<br/>Copyright &#xa9; 2020

<85>
Accession Number
2005251765
Title
Benefits of High-Intensity Interval Training in a Young and in an Older De
Novo Heart Transplant Recipient- Cases from the HITTS Study.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S491-S492), 2020. Date of Publication: April 2020.
Author
Rolid K.; Andreassen A.K.; Yardley M.; Bjorkelund E.; Authen A.R.; Grov
I.; Gude E.; Karason K.; Broch K.; Gullestad L.; Nytroen K.
Institution
(Rolid, Andreassen, Yardley, Bjorkelund, Authen, Grov, Gude, Broch,
Gullestad, Nytroen) Department of Cardiology, Oslo University Hospital,
Oslo, Norway
(Karason) Sahlgrenska University Hospital, Gothenburg, Sweden
Publisher
Elsevier USA
Abstract
Purpose: High-intensity interval training (HIT) is an effective method to
increase exercise capacity in de novo heart transplant recipients, as
shown in the recently published HITTS study (High-intensity Interval
Training in de novo Heart Transplant recipients in Scandinavia). We were
interested to scrutinize the potential effect of HIT in different age
categories. The main effects of HIT in one young and one older medically
stable de novo heart transplant recipients are reported. <br/>Method(s):
The HITTS study is a randomized controlled study comparing HIT versus
moderate intensity continuous training (MICT) in de novo heart transplant
recipients (mean 11 weeks after heart transplantation). Eighty-one
participants were randomized (1:1) to 9 months of HIT or MICT. The primary
endpoint was the change in VO<inf>2peak</inf>. Secondary endpoints
included: Heart rate response, muscle strength and self-reported physical
function measured by the Short-Form-36. One of the youngest and one of the
oldest participants with the highest changes in VO<inf>2peak</inf> in the
HIT intervention group were selected for this case report. <br/>Result(s):
The youngest male (< 25 years old) increased his VO<inf>2peak</inf> with
15.3 mL/kg/min from baseline to follow-up (from 23.5 to 38.8 mL/kg/min),
while the older male (> 55 years old) increased his VO<inf>2peak</inf>
with 12.6 mL/kg/min (from 15.6 to 28.3 mL/kg/min). Muscle strength, heart
rate response, O<inf>2</inf> pulse and self-reported physical function
also increased substantially (Table). The young heart transplant recipient
completed 51 exercise sessions whereas the older heart transplant
recipient completed 72 sessions. <br/>Conclusion(s): Both the young and
the older de novo heart transplant recipient increased their
VO<inf>2peak</inf> with at least 4 METS (> 12 mL/kg/min) after a 9-month
long HIT intervention. The results show that both young and older
individuals can derive substantial benefit from HIT soon after heart
transplantation.<br/>Copyright &#xa9; 2020

<86>
Accession Number
2005251751
Title
Gender Differences in Adherence to Nonpharmacologic Recommendations after
Heart Transplant: A Secondary Analysis from the International BRIGHT
Study.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S41), 2020. Date of Publication: April 2020.
Author
Trammell J.; Epstein F.R.; Liu C.; Dobbels F.; Russell C.L.; De Geest S.
Institution
(Trammell, Epstein) Advanced Heart Failure Therapies, Santa Clara Kaiser,
San Jose, CA, United States
(Liu) Santa Clara Kaiser, San Jose, CA, United States
(Dobbels) Academic Centre for Nursing and Midwifery (AccentVV), Katholieke
Universiteit Leuven, Leuven, Belgium
(Russell) University of Missouri-Kansas City, Kansas City, MO, United
States
(De Geest) University of Basel, Basel, Switzerland
Publisher
Elsevier USA
Abstract
Purpose: The aim of this study was to describe and compare gender
differences in adherence and nonadherence to nonpharmacologic
recommendations after heart transplant (HTx) globally; in Europe, North
America, South America and Australia. <br/>Method(s): This a sub-analysis
of self-reported data of 1397 adult HTx recipients from the 36-
HTx-center, 11-country, 4-continent, cross- sectional BRIGHT study
(ClinicalTrials. gov ID: NCT01608477). The analysis included descriptive
statistics. Two-sample t-tests were used to compare the mean gender
differences in health behaviors post-HTx, such as sun protection, diet
keeping, physical activity, and appointment keeping; and chi-square tests
were used to evaluate the relationship between female and male adherence
and nonadherence to alcohol use and to smoking. <br/>Result(s): Females
were more adherent to sun protection in Australia (p=0.03), and in the
total of all continents, compared to males (p=0.00). Females were more
adherent to 30-minute moderate physical activity 5 days-a-week, in each
continent, and in the total of all continents (p-values=0.00, 0.02, 0.04,
0.03, and 0.00 respectively). Complying with 20-minutes of vigorous
physical activity 3 days-a-week, females were more adherent in every
continent, except for Australia, and in the total of all continents
(p-values=0.00, 0.00, 0.00, and 0.00 respectively). Finally, females were
more adherent than males in abstaining from smoking in Europe, and in the
total of all continents (p=0.01, 009 respectively). <br/>Conclusion(s):
The findings support the hypothesis that females are, in general, more
adherent than males to post-HTx recommendations. This study bridges a gap
in the literature, by providing evidence about female and male health
behaviors after HTx. This gender-specific information should be used in
designing behavioral health gender-specific interventions to improve
adherence in transplantation.<br/>Copyright &#xa9; 2020

<87>
Accession Number
2005251676
Title
Effect of High-Intensity Interval Training in De Novo Heart Transplant
Recipients - 3-year Results from the HITTS Randomized Controlled Trial.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S224-S225), 2020. Date of Publication: April 2020.
Author
Rolid K.; Andreassen A.K.; Yardley M.; Bjorkelund E.; Authen A.R.; Grov
I.; Gude E.; Broch K.; Gullestad L.; Nytroen K.
Institution
(Rolid, Andreassen, Yardley, Bjorkelund, Authen, Grov, Gude, Broch,
Gullestad, Nytroen) Department of Cardiology, Oslo University Hospital,
Oslo, Norway
Publisher
Elsevier USA
Abstract
Summary of Objectives: The HITTS study (High -intensity Interval Training
in de novo Heart Transplant Recipients in Scandinavia) is a randomized
controlled trial designed to assess the effect of high-intensity interval
training (HIT) versus moderate intensity continuous training (MICT) on
exercise capacity in de novo heart transplant recipients. The primary
endpoint was the change in oxygen consumption (VO<inf>2peak</inf>) at the
end of the intervention period, which began 3 months after heart
transplantation (HTx). After the 9-month long intervention period, we
reported a between-group difference in VO<inf>2peak</inf> of 1.8 ml/kg/min
in favor of HIT (p = 0.04).We found that HIT was safe, well tolerated and
efficient. The HITTS study is the first randomized controlled trial to
assess the effectiveness of HIT in de novo heart transplant recipients.
However, long-term effects of commencing HIT soon after HTx remain
unknown. In this extension of the HITTS trial, our aim was to examine
whether the benefits of 9 months of supervised HIT training persist two
years after the end of the intervention. <br/>Method(s): In the HITTS
study, we randomized 81 adult de novo heart transplant recipients to 9
months of HIT (4 x 4 min intervals at 85-95% of peak heart rate (HR) or 9
months of MICT (60-80% of peak HR). The mean +/- SD age was 49 +/-13 and
73 % were men. Before the start of the intervention and at follow-up
shortly after the intervention, we measured VO<inf>2peak</inf>, isokinetic
muscle strength, body composition, left ventricular function by echo,
biomarkers, and health-related quality of life (HRQoL). For the extension
study, the measurements will be repeated 3 years after enrollment.
VO<inf>2peak</inf> is measured with breath-by-breath gas exchange on a
treadmill or bicycle ergometer. The last patient is scheduled to complete
his/her 3-year follow-up at Nov 14^th, 2019. Data will be
available for presentation at ISHLT 2020. Endpoints: The primary outcome
is the long-term effect of HIT vs MICT on aerobic exercise capacity as
assessed by VO<inf>2peak</inf>. Secondary outcomes are: Isokinetic
muscular strength in the lower limbs by a dynamometer, body composition
(bio-impedance analysis), left ventricular function by echo, heart rate
response during the cardiopulmonary exercise test, relevant circulation
biomarkers (renal function, NT-proBNP and cardiac troponins), HRQoL,
tolerability, safety and adverse events.<br/>Copyright &#xa9; 2020

<88>
Accession Number
2005251665
Title
Protective Effects of Combined Heart Transplantation on Cardiac Allograft
Vasculopathy: A Systematic Review and Meta-Analysis.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S251), 2020. Date of Publication: April 2020.
Author
Maning J.; Blumer V.; Chaparro S.
Institution
(Maning) Department of Internal Medicine, University of Miami Miller
School of Medicine, Miami, FL, United States
(Blumer) Division of Cardiology, Duke University Medical Center, Durham,
NC, United States
(Chaparro) Division of Cardiovascular Medicine, University of Miami Miller
School of Medicine, Miami, FL, United States
Publisher
Elsevier USA
Abstract
Purpose: Despite significant advances in the field of heart
transplantation, cardiac allograft vasculopathy (CAV) continues to be a
major limitation of long-term survival. Previous studies have suggested
that compared with isolated heart transplant (HTx) recipients, those who
receive multiorgan heart transplants (HTxC) have superior clinical
outcomes. We conducted a systematic review and meta-analysis to
investigate the effects of combined organ transplantation on the incidence
of CAV. <br/>Method(s): We searched Medline, Embase, and the Cochrane
Library for studies evaluating outcomes after combined heart
transplantation, in particular the incidence of CAV. We identified 1207
potential eligible publications. Outcomes were compared using the
random-effects model and heterogenicity examined via X² and
I² statistics. <br/>Result(s): Six retrospective studies were
included in our analysis for a total of 1383 heart transplant recipients.
Of these, 190 (16%) underwent HTxC: 50 heart-kidney transplant (HKTx), 103
heart-lung transplant (HLTx), and 37 heart-liver transplant (HLvTx).
Multiorgan heart transplantation was associated with less incidence of CAV
(OR 0.19; 95% CI 0.07-0.51; p = 0.0009) and acute cardiac rejection (OR
0.18; 95% CI 0.07-0.47; p = 0.0005). Survival at 1 year was not
significantly different among HTxC and HTx recipients (OR 0.68, 95% CI
0.42-1.10; p = 0.12). <br/>Conclusion(s): Multiorgan heart transplantation
appears to be associated with a protective effect against CAV and acute
cardiac rejection. Short term survival after combined heart transplant is
comparable to isolated heart transplantation.<br/>Copyright &#xa9; 2020

<89>
Accession Number
2005251226
Title
The TEAMMATE Trial: Study Design and Rationale of the First Pediatric
Heart Transplant Randomized Clinical Trial.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S207-S208), 2020. Date of Publication: April 2020.
Author
Almond C.; Sleeper L.A.; Rossano J.W.; Pahl E.; Lal A.K.; Castleberry
C.D.; Lee J.; Hollander S.; Klein G.; Barkoff L.M.; Bock M.; Fenton M.;
Daly K.P.
Institution
(Almond) Pediatric Cardiology, Stanford University School of Medicine,
Palo Alto, CA, United States
(Sleeper, Klein) Boston Children's Hospital, Boston, MA, United States
(Rossano) Children's Hospital of Philadelphia, Philadelphia, PA, United
States
(Pahl) Ann & Robert H. Lurie Children's Hospital, Chicago, IL, United
States
(Lal) U of Utah Primary Children's Hospital, Salt Lake City, UT, United
States
(Castleberry) Washington University in St. Louis, St. Louis, MO, United
States
(Lee, Barkoff) Lucile Packard Children's Hospital Stanford, Palo Alto, CA,
United States
(Hollander) Stanford University School of Medicine, Palo Alto, CA, United
States
(Bock) Loma Linda University Children's Hospital, Loma Linda, CA, United
States
(Fenton) Great Ormond Street Hospital, London, United Kingdom
(Daly) Children's Hospital Boston, Boston, MA, United States
Publisher
Elsevier USA
Abstract
Purpose: Currently there are no-FDA approved immunosuppressants specific
to pediatric heart transplantation (HT). In recent years, everolimus (EVL)
has emerged as an alternative to tacrolimus (TAC) as a primary
immunosuppressant to prevent rejection that may also prevent kidney and
coronary disease. However, the two regimens have never been evaluated
systematically. <br/>Method(s): The TEAMMATE Trial (IND 127980) is
designed to evaluate the safety and efficacy of EVL and low-dose (LD-TAC)
compared to standard-therapy TAC and mycophenolate mofetil (MMF). The
study design and rationale are reviewed in light of challenges inherent in
rare disease research. <br/>Result(s): The TEAMMATE trial is the first
multicenter randomized clinical trial (RCT) in pediatric HT. The primary
purpose is to evaluate the risk-benefit profile of the two regimens to
prevent major adverse transplant events (MATE), and to support FDA
approval of 1 or both regimens for pediatric HT. Children <21 years at HT
will be randomized (1:1 ratio) at 6 mo. post-HT to either regimen for 30
months (Figure). Children with recurrent rejection or a GFR <60
ml/min/1.73m2 are excluded. The primary efficacy hypothesis is that
compared to TAC/MMF, EVL/LD-TAC is more effective in preventing 3 MATEs:
cellular rejection, CKD and CAV. The primary safety hypothesis is that
EVL/LD-TAC does not have a higher cumulative burden of 6 MATE (AMR,
infection, and PTLD + the 3 above). The primary endpoint is the MATE
Score, a surrogate endpoint reflecting the frequency and severity of MATEs
and validated against graft loss. The study will enroll 210 patients
across 26 sites and is powered to demonstrate superior efficacy of
EVL/LDTAC. The trial is projected to be completed in 2022.
<br/>Conclusion(s): The TEAMMATE trial is the first RCT in pediatric HT.
It is anticipated that the study will provide important information about
the safety and effectiveness of EVL and TAC and provide valuable lessons
into the design and conduct of future trials in pediatric
HT.<br/>Copyright &#xa9; 2020

<90>
Accession Number
2005251223
Title
Follow-Up Phone Calls are Effective in Increasing Compliance with
Screening for De Novo Cancer among Heart Transplant Recipients.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S494), 2020. Date of Publication: April 2020.
Author
Mabasa A.C.; Kleet A.C.; Gaine M.; Lee J.C.; Jackson R.; Fanek T.;
Czarnecki A.; Farr M.J.; Colombo P.C.
Institution
(Mabasa, Kleet, Gaine, Lee, Jackson, Fanek, Czarnecki, Farr, Colombo)
Surgery, Columbia University Medical Center, New York, NY, United States
Publisher
Elsevier USA
Abstract
Purpose: We aimed to examine the effectiveness of serial follow-up phone
calls as an intervention after clinic visits to enhance compliance with
cancer surveillance among heart transplant (HT) patients. <br/>Method(s):
41 HT cancer-free patients were randomized to intervention (n=21) vs.
control (n=20) groups. Time Series Design was used; the intervention group
received 4 calls post clinic visits within 31 days at different point
intervals between 7-10 days, addressing the patient's specific needs for
cancer screening based on immunotherapy and medical issues. The control
group received 1 phone call at the end of the study. Chi-Square Statistics
was used to compare screening rates between intervention and control
groups. <br/>Result(s): Mean age was 60.3 years, 78% male, and 24% had
prior malignancy. 39% of patients were studied 1-5 years post HT, 20% 5-10
years; 26% 10-14 years; and 15% 15-20 years. Main reasons for
non-compliance reported by patients were: "too busy", "family issues", and
"I forgot". At the end of the study, 50% of patients were fully compliant
with cancer screening recommendations in the intervention group vs. 15% in
the control group. This difference was statistically significant:
(X² (1)= 4.062, p= 0.044) (Fig. 1a). Compliance rates after
each phone call are shown in Fig. 1b. <br/>Conclusion(s): A nurse
practitioner-led follow-up phone calls program is a feasible and effective
strategy to increase compliance with de novo cancer screening among adult
heart transplant recipients. Additional studies are needed to validate the
usefulness of this approach in this unique patient
population.<br/>Copyright &#xa9; 2020

<91>
Accession Number
2005250437
Title
Infection-Related Morbidity with Continuous-Flow Left Ventricular Assist
Systems: A Comprehensive Analysis of the Randomized MOMENTUM 3 Trial.
Source
Journal of Heart and Lung Transplantation. Conference: 2020 Anniversary
Meeting and Scientific Sessions - ISHLT. Canada. 39 (4 Supplement) (pp
S45), 2020. Date of Publication: April 2020.
Author
Patel C.B.; Bailey S.H.; Blue L.; Cagliostro B.; Entwistle J.W.; John R.;
Thohan V.; Su X.; Somo S.I.; Sood P.; Mehra M.R.
Institution
(Patel, Blue) Duke University Medical Center, Durham, NC, United States
(Bailey) Allegheny General Hospital, Pittsburg, PA, United States
(Cagliostro) New York-Presbyterian/Columbia University Medical Center, New
York, NY, United States
(Entwistle) Thomas Jefferson University Hospital, Philadelphia, PA, United
States
(John) University of Minnesota Medical Center, Minneapolis, MN, United
States
(Thohan) Mission Health System, Asheville, NC, United States
(Su, Somo, Sood) Abbott, Abbott Park, IL, United States
(Mehra) Brigham and Women's Hospital, Boston, MA, United States
Publisher
Elsevier USA
Abstract
Purpose: The MOMENTUM 3 trial established superiority of a fully
magnetically-levitated HeartMate 3 (HM3) centrifugal pump over the axial
flow HeartMate II (HMII) pump on hemocompatibility-related outcomes.
Infection-related outcomes were no different between the two devices. We
sought to understand the types of infection, temporal trends, clinical
correlates and risk markers over 2-years of support. <br/>Method(s):
MOMENTUM 3 randomized 1020 patients to either the HM 3 (515) or HM II
(505) groups. Morbidity and mortality related outcomes were analyzed
between patients with or without major infection complications. Cox
regression analyses were utilized to identify characteristics associated
with major infectious complications. <br/>Result(s): The cumulative number
of infections was 1213 (634 HM3 and 579 HMII), and major infection
occurred in 58% HM3 and 56% HMII patients (p=0.57). Localized infections
unrelated to pump components were most common (n=681/1213; 56%), followed
by driveline infection (n=329/1213; 27%), sepsis (n=194/1213; 16%), and
other events (n=9/1213; 0.7%). Bacterial pathogens were implicated in
806/1213 events (66%) and significant predictors of infection included
gender (men vs. women; HR:0.73, p=0.003), BUN (HR:1.12, p=0.01),
preimplant history of cardiac surgery (HR:1.28, p=0.01), and BMI>=30
(HR:1.43, p<0.0001). Most deaths in those with infection ultimately
occurred due to non-infectious causes (Figure). <br/>Conclusion(s):
Infection is the commonest adverse effect in patients implanted with
contemporary continuous-flow pumps with most such events presenting as
events unrelated to the pump components. Whether mechanical circulatory
devices confer an immunosuppressive effect leading to propensity for
infection warrants closer scrutiny to understand and ameliorate this
morbidity. (Funded by Abbott; MOMENTUM 3 NCT02224755)<br/>Copyright &#xa9;
2020

<92>
Accession Number
2005227019
Title
Low-Dose Alteplase During Primary Percutaneous Coronary Intervention
According to Ischemic Time.
Source
Journal of the American College of Cardiology. 75 (12) (pp 1406-1421),
2020. Date of Publication: 31 March 2020.
Author
McCartney P.J.; Maznyczka A.M.; Eteiba H.; McEntegart M.; Oldroyd K.G.;
Greenwood J.P.; Maredia N.; Schmitt M.; McCann G.P.; Fairbairn T.;
McAlindon E.; Tait C.; Welsh P.; Sattar N.; Orchard V.; Corcoran D.; Ford
T.J.; Radjenovic A.; Ford I.; McConnachie A.; Berry C.
Institution
(McCartney, Maznyczka, Eteiba, McEntegart, Welsh, Sattar, Corcoran, Ford,
Radjenovic, Berry) British Heart Foundation Glasgow Cardiovascular
Research Center, University of Glasgow, Glasgow, United Kingdom
(McCartney, Maznyczka, Eteiba, McEntegart, Oldroyd, Orchard, Berry) West
of Scotland Heart and Lung Center, Golden Jubilee National Hospital,
Clydebank, United Kingdom
(Greenwood) Leeds University and Leeds Teaching Hospitals National Health
Service (NHS) Trust, Leeds, United Kingdom
(Maredia) South Tees Hospitals NHS Foundation Trust, Middlesbrough, United
Kingdom
(Schmitt) Manchester University NHS Foundation Trust, Manchester, United
Kingdom
(McCann) University of Leicester and the National Institute for Health
Research Leicester Biomedical Research Center, Leicester, United Kingdom
(Fairbairn) Liverpool Heart and Chest Hospital NHS Foundation Trust,
Liverpool, United Kingdom
(McAlindon) New Cross Hospital, Royal Wolverhampton NHS Trust,
Wolverhampton, United Kingdom
(Tait) Department of Hematology, Royal Infirmary, Glasgow, United Kingdom
(Ford) Department of Cardiology, Gosford Hospital, Gosford, New South
Wales, Australia
(Ford, McConnachie) Robertson Centre for Biostatistics, Institute of
Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom
Publisher
Elsevier USA
Abstract
Background: Microvascular obstruction affects one-half of patients with
ST-segment elevation myocardial infarction and confers an adverse
prognosis. <br/>Objective(s): This study aimed to determine whether the
efficacy and safety of a therapeutic strategy involving low-dose
intracoronary alteplase infused early after coronary reperfusion
associates with ischemic time. <br/>Method(s): This study was conducted in
a prospective, multicenter, parallel group, 1:1:1 randomized, dose-ranging
trial in patients undergoing primary percutaneous coronary intervention.
Ischemic time, defined as the time from symptom onset to coronary
reperfusion, was a pre-specified subgroup of interest. Between March 17,
2016, and December 21, 2017, 440 patients, presenting with ST-segment
elevation myocardial infarction within 6 h of symptom onset (<2 h, n =
107; >=2 h but <4 h, n = 235; >=4 h to 6 h, n = 98), were enrolled at 11
U.K. hospitals. Participants were randomly assigned to treatment with
placebo (n = 151), alteplase 10 mg (n = 144), or alteplase 20 mg (n =
145). The primary outcome was the amount of microvascular obstruction
(MVO) (percentage of left ventricular mass) quantified by cardiac magnetic
resonance imaging at 2 to 7 days (available for 396 of 440).
<br/>Result(s): Overall, there was no association between alteplase dose
and the extent of MVO (p for trend = 0.128). However, in patients with an
ischemic time >=4 to 6 h, alteplase increased the mean extent of MVO
compared with placebo: 1.14% (placebo) versus 3.11% (10 mg) versus 5.20%
(20 mg); p = 0.009 for the trend. The interaction between ischemic time
and alteplase dose was statistically significant (p = 0.018).
<br/>Conclusion(s): In patients presenting with ST-segment elevation
myocardial infarction and an ischemic time >=4 to 6 h, adjunctive
treatment with low-dose intracoronary alteplase during primary
percutaneous coronary intervention was associated with increased MVO.
Intracoronary alteplase may be harmful for this subgroup. (A Trial of
Low-Dose Adjunctive Alteplase During Primary PCI [T-TIME];
NCT02257294)<br/>Copyright &#xa9; 2020 The Authors

<93>
Accession Number
2005245269
Title
Preoperative beta-Blockers as a Coronary Surgery Quality Metric: The Lack
of Evidence of Efficacy.
Source
Annals of Thoracic Surgery. 109 (4) (pp 1150-1158), 2020. Date of
Publication: April 2020.
Author
Filardo G.; da Graca B.; Sass D.M.; Hamilton J.; Pollock B.D.; Edgerton
J.R.
Institution
(Filardo, Sass, Pollock, Edgerton) Epidemiology Department, Baylor Scott &
White Health, Dallas, TX, United States
(Filardo, da Graca, Pollock) Robbins Institute for Health Policy and
Leadership, Baylor University, Waco, TX, United States
(Filardo) Department of Cardiothoracic Surgery, Baylor Scott & White The
Heart Hospital-Plano, Plano, TX, United States
(da Graca) Center for Clinical Effectiveness, Baylor Scott & White Health,
Dallas, United States
(Hamilton) University of North Carolina, Chapel Hill, NC, United States
Publisher
Elsevier USA
Abstract
Background: Two quality measures used in public reporting and value-based
payment programs require beta-blockers be administered less than 24 hours
before isolated coronary artery bypass graft surgery to prevent atrial
fibrillation and mortality. Questions have arisen about continued use of
these measures. <br/>Method(s): We conducted a systematic search for
randomized controlled trials (RCTs) examining the impact of preoperative
beta-blockers on atrial fibrillation or mortality after isolated coronary
artery bypass graft surgery to determine what evidence of efficacy
supports the measures. <br/>Result(s): We identified 11 RCTs. All
continued beta-blockers postoperatively, making it unfeasible to separate
the benefits of preoperative vs postoperative administration.
Meta-analysis was precluded by methodologic variation in beta-blocker
utilized, timing and dosage, and supplemental and comparison treatments.
Of the eight comparisons of beta-blockers/beta-blocker plus digoxin versus
placebo (n = 826 patients), six showed significant reductions in atrial
fibrillation/supraventricular arrhythmias. Of the three comparisons (n =
444) of beta-blockers versus amiodarone, two found no significant
difference in atrial fibrillation; the third showed significantly lower
incidence with amiodarone. One RCT compared beta-blocker plus amiodarone
versus each of those drugs separately; the combination reduced atrial
fibrillation significantly better than the beta-blocker alone, but not
amiodarone alone. Seven RCTs reported short-term mortality, but this
outcome was too rare and the sample sizes too small to provide any
meaningful comparisons. <br/>Conclusion(s): Existing RCT evidence does not
support the structure of quality measures that require beta-blocker
administration specifically within 24 hours before coronary artery bypass
graft surgery to prevent postoperative atrial fibrillation or short-term
mortality. Quality measures should be revised to align with the evidence,
and further studies conducted to determine optimal timing and method of
prophylaxis.<br/>Copyright &#xa9; 2020 The Society of Thoracic Surgeons

<94>
Accession Number
2004443747
Title
Effectiveness of comprehensive cardiac rehabilitation in coronary artery
disease patients treated according to contemporary evidence based
medicine: Update of the Cardiac Rehabilitation Outcome Study (CROS-II).
Source
European Journal of Preventive Cardiology. (no pagination), 2020. Date of
Publication: 2020.
Author
Salzwedel A.; Jensen K.; Rauch B.; Doherty P.; Metzendorf M.-I.; Hackbusch
M.; Voller H.; Schmid J.-P.; Davos C.H.
Institution
(Salzwedel, Voller) Department of Rehabilitation Research, University of
Potsdam, Germany
(Jensen, Hackbusch) Institute of Medical Biometry and Informatics (IMBI),
University of Heidelberg, Germany
(Rauch) Institut fur Herzinfarktforschung Ludwigshafen, Germany
(Doherty) Department of Health Sciences, University of York, United
Kingdom
(Metzendorf) Cochrane Metabolic and Endocrine Disorders Group, Heinrich
Heine University Dusseldorf, Germany
(Schmid) Department of Cardiology, Clinic Barmelweid, Switzerland
(Davos) Cardiovascular Research Laboratory, Academy of Athens, Greece
Publisher
SAGE Publications Inc. (E-mail: claims@sagepub.com)
Abstract
Background: Despite numerous studies and meta-analyses the prognostic
effect of cardiac rehabilitation is still under debate. This update of the
Cardiac Rehabilitation Outcome Study (CROS II) provides a contemporary and
practice focused approach including only cardiac rehabilitation
interventions based on published standards and core components to evaluate
cardiac rehabilitation delivery and effectiveness in improving patient
prognosis. <br/>Design(s): A systematic review and meta-analysis.
<br/>Method(s): Randomised controlled trials and retrospective and
prospective controlled cohort studies evaluating patients after acute
coronary syndrome, coronary artery bypass grafting or mixed populations
with coronary artery disease published until September 2018 were included.
<br/>Result(s): Based on CROS inclusion criteria out of 7096 abstracts six
additional studies including 8671 patients were identified (two randomised
controlled trials, two retrospective controlled cohort studies, two
prospective controlled cohort studies). In total, 31 studies including
228,337 patients were available for this meta-analysis (three randomised
controlled trials, nine prospective controlled cohort studies, 19
retrospective controlled cohort studies; 50,653 patients after acute
coronary syndrome 14,583, after coronary artery bypass grafting 163,101,
mixed coronary artery disease populations; follow-up periods ranging from
9 months to 14 years). Heterogeneity in design, cardiac rehabilitation
delivery, biometrical assessment and potential confounders was
considerable. Controlled cohort studies showed a significantly reduced
total mortality (primary endpoint) after cardiac rehabilitation
participation in patients after acute coronary syndrome (prospective
controlled cohort studies: hazard ratio (HR) 0.37, 95% confidence interval
(CI) 0.20-0.69; retrospective controlled cohort studies HR 0.64, 95% CI
0.53-0.76; prospective controlled cohort studies odds ratio 0.20, 95% CI
0.08-0.48), but the single randomised controlled trial fulfilling the CROS
inclusion criteria showed neutral results. Cardiac rehabilitation
participation was also associated with reduced total mortality in patients
after coronary artery bypass grafting (retrospective controlled cohort
studies HR 0.62, 95% CI 0.54-0.70, one single randomised controlled trial
without fatal events), and in mixed coronary artery disease populations
(retrospective controlled cohort studies HR 0.52, 95% CI 0.36-0.77; two
out of 10 controlled cohort studies with neutral results).
<br/>Conclusion(s): CROS II confirms the effectiveness of cardiac
rehabilitation participation after acute coronary syndrome and after
coronary artery bypass grafting in actual clinical practice by reducing
total mortality under the conditions of current evidence-based coronary
artery disease treatment. The data of CROS II, however, underscore the
urgent need to define internationally accepted minimal standards for
cardiac rehabilitation delivery as well as for scientific
evaluation.<br/>Copyright &#xa9; The European Society of Cardiology 2020.

<95>
Accession Number
631241808
Title
Can we reduce conduction disturbances following transcatheter aortic valve
replacement?.
Source
Expert review of medical devices. (no pagination), 2020. Date of
Publication: 12 Mar 2020.
Author
Alperi Garcia A.; Muntane-Carol G.; Junquera L.; Del Val D.; Faroux L.;
Philippon F.; Rodes-Cabau J.
Institution
(Alperi Garcia, Muntane-Carol, Junquera, Del Val, Faroux, Philippon,
Rodes-Cabau) Quebec Heart & Lung Institute, Laval University, QC, Quebec
City, Canada
Publisher
NLM (Medline)
Abstract
Introduction: Transcatheter aortic valve replacement (TAVR) has been
demonstrated to be a good alternative to surgery for treating severe
aortic stenosis (AS) across the whole range of surgical risk patients.
Whereas most periprocedural TAVR complications have significantly
decreased over time, conduction disturbances remain high. Approaches to
decrease this shortcoming are under continuous investigation.Areas
covered: Overview of the actual evidence regarding conduction disturbances
in the TAVR setting, focusing on modifiable factors. PubMed and Embase
databases were used for literature search.Expert opinion: Several factors
have been associated with an increased risk of conduction disturbances
post-TAVR, and some of them may be modifiable. While some transcatheter
valve systems have been associated with higher rates of conduction
disturbances, additional randomized data are needed to draw definite
conclusions about newer generation transcatheter valve systems. Nowadays,
good haemodynamic valve function can be obtained without excessive valve
oversizing, which has been associated with an increased risk of conduction
disturbances in some studies. Also, contemporary data regarding valve
implantation depth and new anatomical landmarks such as membranous septum
length have provided valuable insights for procedural planning. Finally,
homogenization of the management of conduction abnormalities post-TAVR
should be emphasized to allow a better understanding and generalization of
available evidence.

<96>
Accession Number
631241374
Title
Effect of volatile anesthetics on mortality and clinical outcomes in
patients undergoing coronary artery bypass grafting: a meta-analysis of
randomized clinical trials.
Source
Minerva anestesiologica. (no pagination), 2020. Date of Publication: 11
Mar 2020.
Author
Zhang Y.; Yang L.; Zhang W.; Liu J.
Institution
(Zhang, Yang, Zhang) Department of Anesthesiology, West China Hospital,
Sichuan University, Chengdu, China
(Zhang, Zhang, Liu) Laboratory of Anesthesia and Critical Care Medicine,
Translational Neuroscience Center, West China Hospital, Sichuan
University, Chengdu, China
(Zhang) Department of Anesthesiology, Affiliated Hospital of Zunyi Medical
University, Zunyi, China
(Liu) Department of Anesthesiology, West China Hospital, Sichuan
University, Chengdu, China
Publisher
NLM (Medline)
Abstract
INTRODUCTION: It remains unclear whether intraoperative use of volatile
anesthetics has a positive effect on postoperative clinical outcomes in
patients undergoing coronary artery bypass grafting (CABG). Therefore, we
aimed to systematically analyze the long- and short-term mortality rates
and the clinical outcomes of volatile anesthesia compared to those of
total intravenous anesthesia (TIVA) in patients undergoing CABG. EVIDENCE
ACQUISITION: We queried the MEDLINE, Embase, and CENTRAL databases from
inception to October 2019 for relevant randomized clinical trials (RCTs)
on the intraoperative use of volatile anesthetics in patients undergoing
CABG. EVIDENCE SYNTHESIS: We pooled and analyzed 36 eligible RCTs with
10,308 patients and found that there was no significant difference in the
long- and short-term mortality rate between the use of volatile anesthesia
and TIVA during CABG. 30-day mortality, volatile group (39/2,824, 1.4%) vs
TIVA group (35/2,786, 1.3%), RR=1.11, 95% CI [0.70, 1.74], P-value for
effect = 0.66, I2 =0%, moderate-certainty evidence; One-year mortality,
volatile group (77/2,749, 2.8%) vs TIVA group (78/2,731, 2.9%), RR=0.98,
95% CI [0.72, 1.34], P-value for effect = 0.90, I2 =0%, moderate-
certainty evidence. Mechanical ventilation time was reduced in volatile
group (MD -0.65, 95% CI [-1.07, -0.24], P-value for effect = 0.002, I2 =
26%). <br/>CONCLUSION(S): There is no difference in the long- and
short-term mortality and clinical outcomes between intraoperative use of
volatile anesthetics and TIVA during CABG. However, volatile anesthetics
may shorten the mechanical ventilation time. There is a need for
high-quality multicenter RCTs that specifically assess factors that
influence mortality and clinical outcomes.

<97>
Accession Number
631227593
Title
Perioperative dexmedetomidine and postoperative delirium in non-cardiac
surgery: a meta-analysis.
Source
Annals of palliative medicine. (no pagination), 2020. Date of Publication:
06 Mar 2020.
Author
Ming S.; Zhang X.; Gong Z.; Xie Y.
Institution
(Ming) Department of Anesthesiology, First Affiliated Hospital of Guangxi
Medical University, Nanning 530021, China
(Zhang) Department of Anesthesiology, second Affiliated Hospital Of Guilin
Medical University
(Gong) Department of Anesthesiology, People's Hospital of Guangxi Zhuang
Autonomous Region, Nanning 530021, China
(Xie) Department of Anesthesiology, Second Affiliated Hospital of Guangxi
Medical University, Nanning 530021, China
(Xie) Department of Anesthesiology, First Affiliated Hospital of Guangxi
Medical University, Nanning 530021, China
Publisher
NLM (Medline)
Abstract
BACKGROUND: To compare the effects of perioperative dexmedetomidine with
placebo (or other sedation) on the rate of postoperative delirium in adult
patients who underwent non-cardiac surgeries. <br/>METHOD(S): A
meta-analysis was performed on randomized, controlled trials. MEDLINE, the
Cochrane Central Register of Controlled Trials, and Embase (to March 20,
2019) were searched for literature retrieval. The standardized primary
outcome was postoperative delirium. We pooled risk ratios using a
random-effects model. <br/>RESULT(S): From 10 trials with 2,286 total
participants, we recorded 363 postoperative delirium events during the
follow-up periods. Compared with the control group, patients in the
dexmedetomidine group had a postoperative delirium relative risk of 0.53
[95% confidence interval (CI), 0.37-0.76]. When the dexmedetomidine
infusion rate was higher than 0.2 mug/kg/h, the relative risk of
postoperative delirium reduced significantly by 34%, compared with other
sedation methods (relative risk =0.66; 95% CI, 0.47-0.94; P=0.02), with no
heterogeneity (I2=31%, P=0.18). While it reduced by 62% when the
dexmedetomidine infusion rate was lower than 0.2 mug/kg/h (relative risk
=0.38; 95% CI, 0.27-0.54). <br/>CONCLUSION(S): Compared to the placebo (or
other sedation methods), perioperative dexmedetomidine sedation resulted
in lower rates of postoperative delirium in adult patients who underwent
non-cardiac surgery.

<98>
Accession Number
631108939
Title
Long-term survival following transcatheter mitral valve repair: Pooled
analysis of prospective trials with the Carillon device.
Source
Cardiovascular revascularization medicine : including molecular
interventions. (no pagination), 2020. Date of Publication: 21 Feb 2020.
Author
Lipiecki J.; Kaye D.M.; Witte K.K.; Haude M.; Kapadia S.; Sievert H.;
Goldberg S.L.; Levy W.C.; Siminiak T.
Institution
(Lipiecki) Centre de Cardiologie Interventionnelle, Pole Sante Republique,
Clermont-Ferrand, France
(Kaye) Department of Cardiology, Alfred Hospital, Melbourne, Australia
(Witte) Leeds Institute for Cardiovascular and Metabolic Medicine,
University of Leeds, Leeds, United Kingdom
(Haude) Medical Clinic I Stadtische Kliniken Neuss Lukaskrankenhaus,
Neuss, Germany
(Kapadia) Department of Cardiovascular Medicine, Cleveland Clinic,
Cleveland, OH, United States of America
(Sievert) CardioVascular Center Sankt Katharinen, Frankfurt, Germany;
Anglia Ruskin University, Chelmsford, United Kingdom
(Goldberg) Tyler Heart Institute at Community Hospital of the Monterey
Peninsula, Monterey, CA, United States of America; Cardiac Dimensions,
Kirkland, WA, United States of America
(Levy) Advanced Heart Failure, Division of Cardiology, University of
Washington Heart Institute, Seattle, WA, United States of America
(Siminiak) Poznan University of Medical Sciences, HCP Medical Center,
Poznan, Poland
Publisher
NLM (Medline)
Abstract
PURPOSE: To report long-term survival and to identify potential
determinants of survival among patients receiving treatment for functional
mitral regurgitation (FMR) with the Carillon device. <br/>METHOD(S): This
was a post hoc analysis in which we pooled prospectively collected data
from three studies of the Carillon device with available long-term vital
status data. Patient eligibility in these trials specified symptomatic
congestive heart failure despite guideline-directed medical therapy, grade
2 to 4 FMR, left ventricular enlargement, and reduced ejection fraction.
Echocardiographic parameters were available through the 12-month visit and
vital status was available through 5years. The association of patient
characteristics and changes in echocardiographic parameters at 6 and
12months with long-term survival was analyzed using Cox proportional
hazards regression. <br/>RESULT(S): A total of 74 patients (mean age
67years, 72% male, 59% MR grade 3 or 4) were treated with the Carillon
device. Over 1year of follow-up, the New York Heart Association (NYHA)
class decreased in 64% of patients, distance on the 6-minute walk test
increased, and echocardiographic measures indicated significant decreases
in MR grade and favorable left ventricular remodeling. The Kaplan-Meier
survival rate was 83.6% at 1year, 73.1% at 2years, 67.9% at 3years, and
56.2% at 4 and 5years of follow-up. Primary determinants of long-term
survival were a decrease in NYHA class, an increase in 6-minute walk test
distance, and a decrease in regurgitant volume during the first year of
follow-up. <br/>CONCLUSION(S): Among patients with congestive heart
failure and grade 2 to 4 FMR who were symptomatic despite
guideline-directed medical therapy, transcatheter mitral valve repair with
the Carillon device resulted in a favorable 5-year survival rate. The
survival benefit was greatest among patients with improvement in clinical
and hemodynamic parameters during the first year of
follow-up.<br/>Copyright &#xa9; 2020. Published by Elsevier Inc.

<99>
Accession Number
631101622
Title
Efficacy of different doses of omega-3 fatty acids on cardiovascular
outcomes: rationale and design of a network meta-analysis.
Source
Minerva cardioangiologica. 68 (1) (pp 47-50), 2020. Date of Publication:
01 Feb 2020.
Author
Lombardi M.; Chiabrando J.G.; Vescovo G.M.; Bressi E.; Del Buono M.G.;
Carbone S.; Koenig R.; Van Tassell B.W.; Dixon D.L.; Abbate A.; Biondi
Zoccai G.
Institution
(Lombardi, Bressi, Del Buono, Carbone, Van Tassell, Abbate) VCU Pauley
Heart Center, Division of Cardiology, Department of Internal Medicine,
Virginia Commonwealth University, VA, Richmond, United States
(Lombardi, Del Buono) Department of Cardiovascular and Thoracic Sciences,
Sacred Heart Catholic University, Rome, Italy
(Chiabrando) Interventional Cardiology Service, Hospital Italiano de
Buenos Aires, Buenos Aires, Argentina
(Chiabrando) Health Science Statistics Applied Laboratory (LEACS),
Department of Pharmacology and Toxicology, University of Buenos Aires,
Buenos Aires, Argentina
(Vescovo) Department of Cardiac Thoracic, Vascular Sciences and Public
Health, University of Padua, Padua, Italy
(Carbone) Department of Kinesiology and Health Sciences, College of
Humanities and Sciences, Virginia Commonwealth University, VA, Richmond,
United States
(Koenig) Tompkins-McCaw Library for the Health Sciences, VCU Libraries
Virginia Commonwealth University, VA, Richmond, United States
(Van Tassell, Dixon) Department of Pharmacotherapy and Outcomes Science,
Virginia Commonwealth University, VA, Richmond, United States
(Biondi Zoccai) Department of Medical-Surgical Sciences and
Biotechnologies, Sapienza University, Latina, Italy
(Biondi Zoccai) Mediterranea Cardiocentro, Naples Italy
Publisher
NLM (Medline)
Abstract
INTRODUCTION: The impact of omega-3 fatty acids (O3FA) supplementation on
cardiovascular risk is still in debate, largely due to the heterogeneity
of population enrolled and variable dose and composition of the
formulations used in the previous studies. Yet, O3FA may favorably impact
on cardiovascular risk by reducing major cardiovascular events (including
cardiac death and ischemic events). EVIDENCE ACQUISITION: We aim to
perform a comprehensive review of the topic of O3FA for cardiovascular
prevention, stemming from a systematic review, to pairwise meta-analysis
and network meta-analysis, limiting our inclusion only to randomized
clinical trials comparing low dose (LD) (<1 g per day) O3FA and high dose
(HD) (>1 g per day) O3FA versus placebo. The efficacy outcomes of interest
are total death, cardiac death, sudden cardiac death, myocardial
infarction, stroke, coronary revascularization, unstable angina and major
vascular events. Safety outcomes of interest are bleeding,
gastrointestinal disturbances and atrial fibrillation events. EVIDENCE
SYNTHESIS: This meta-analysis is expected to include several important
studies on cardiovascular primary and secondary prevention and detail on
important cardiovascular outcomes. Furthermore, we intend to highlight
safety outcomes related to O3FA supplementation. <br/>CONCLUSION(S): The
present network meta-analysis results will aid physicians in the decision
to prescribe O3FA in patients with or at risk of cardiovascular events. In
particular, it will be able to solve controversies emerged from previous
randomized clinical trials and meta-analyses regarding the benefit of
different doses of O3FA supplementation in the cardiovascular prevention.

<100>
Accession Number
631239284
Title
Pharmacokinetics of an intravenous bolus dose of clonidine in children
undergoing surgery.
Source
Paediatric anaesthesia. (no pagination), 2020. Date of Publication: 13 Mar
2020.
Author
Nielsen B.N.; Anderson B.J.; Falcon L.; Henneberg S.W.; Lauritsen T.;
Lomstein E.; Ydemann M.; Afshari A.
Institution
(Nielsen, Falcon, Henneberg, Lauritsen, Afshari) Department of
Anaesthesia, Juliane Marie Centre, Copenhagen University Hospital
Rigshospitalet, Copenhagen, Denmark
(Anderson) Department of Anaesthesiology, University of Auckland,
Auckland, New Zealand
(Lomstein) Center for Laboratory, Food and Environmental Technology, The
Business Academy AarhusAarhus, Denmark
(Ydemann) Department of Neuroanaethestesiology, Copenhagen University
Hospital, Rigshospitalet, Copenhagen, Denmark
Publisher
NLM (Medline)
Abstract
BACKGROUND: Clonidine is used off-label in children but only limited
pediatric pharmacokinetic data is available for intravenously administered
clonidine. <br/>OBJECTIVE(S): To determine pharmacokinetic parameter
estimates of clonidine in healthy children undergoing surgery and to
investigate age-related differences. Furthermore, to investigate possible
pharmacokinetic differences of clonidine between this group of children
and a cohort with cardiac diseases. <br/>METHOD(S): In a randomized
placebo-controlled trial (The PREVENT AGITATION trial) blood samples for
clonidine pharmacokinetic analysis were collected in a proportion of the
enrolled patients. Healthy children with ASA score 1-2 in the age-groups 1
to <2 years and 2 to 5 years were randomised for blood sampling. Clonidine
was administered as a single intravenous bolus of 3 micro&#32;g.kg-1
intraoperatively. Blood samples were drawn at baseline, 5, 10, 15, 30, 60
min after dosing and additionally every hour until discharge from the
PACU. Clonidine analysis was performed on liquid chromatography-mass
spectrometry. <br/>RESULT(S): Data form eighteen children were available
for pharmacokinetic analysis (ASA I; male/female: 17/1; age: 1 to 5 years;
weight 8.7-24 kg). Population parameter estimates for the 2-compartment
model were similar to previous published data for children who underwent
cardiac surgery. A pooled analysis including data from 59 children
indicated clearance of 14.4 L.h-1 .70kg-1 and volume of distribution of
192.6 L.70 kg-1 . No age-related pharmacokinetic differences and no
difference in time from administration of study medication to awakening
were found. Children 1 to <2 years had a shorter PACU stay than children 2
to 5 years (mean difference 17% 95% CI:3-34%, p=0.02). <br/>CONCLUSION(S):
Pharmacokinetic parameter estimates were similar for children undergoing
general surgery and cardiac surgery given a single dose of intravenous
clonidine. These results indicated that no dose reduction is needed in
children aged 1 to <2 years compared with those 2 to 5 years, which was
supported by pharmacodynamic observations.<br/>Copyright This article is
protected by copyright. All rights reserved.

<101>
Accession Number
631238863
Title
The role of fractional flow reserve in coronary artery bypass graft
surgery: a meta-analysis.
Source
Interactive cardiovascular and thoracic surgery. (no pagination), 2020.
Date of Publication: 13 Mar 2020.
Author
Jayakumar S.; Bilkhu R.; Ayis S.; Nowell J.; Bogle R.; Jahangiri M.
Institution
(Jayakumar, Bilkhu, Nowell, Jahangiri) Department of Cardiothoracic
Surgery, St George's Hospital, London, United Kingdom
(Ayis) Department of Biostatistics, King's College London, London, United
Kingdom
(Bogle) Department of Cardiology, Clinical Academic Group, St George's
Hospital, London, United Kingdom
Publisher
NLM (Medline)
Abstract
OBJECTIVES: Fractional flow reserve (FFR) measures the drop in perfusion
pressure across a stenosis, therefore representing its physiological
effect on myocardial blood flow. Its use is widespread in percutaneous
coronary interventions, though its role in coronary artery bypass graft
(CABG) surgery remains uncertain. This systematic review and meta-analysis
aims to evaluate current evidence on outcomes following FFR-guided CABG
compared to angiography-guided CABG. <br/>METHOD(S): A literature search
was conducted following PRISMA (Preferred Reporting Items for Systematic
Reviews and Meta-Analyses) guidelines to identify all relevant articles.
Patient demographics and characteristics were extracted. The following
outcomes were analysed: repeat revascularization, myocardial infarction
(MI) and all-cause mortality. Pooled relative risks were analysed and
their 95% confidence intervals (CIs) were estimated using random-effects
models; P-value <0.05 was considered statistically significant.
Heterogeneity was assessed with Cochran's Q score and quantified by I2
index. <br/>RESULT(S): Nine studies with 1146 patients (FFR: 574,
angiography: 572) were included. There was no difference in MI or repeat
revascularization between the 2 groups (relative risk 0.76, 95% CI
0.41-1.43; P=0.40, and relative risk 1.28, 95% CI 0.75-2.19; P=0.36,
respectively). There was a significant reduction in all-cause mortality in
the FFR-guided CABG group compared to angiography-guided CABG, which was
not specifically cardiac related (relative risk 0.58, 95% CI 0.38-0.90;
P=0.02). <br/>CONCLUSION(S): There was no reduction in repeat
revascularization or postoperative MI with FFR. In this fairly small
cohort, FFR-guided CABG provided a reduction in mortality, but this was
not reported to be due to cardiac causes. There may be a role for FFR in
CABG, but large-scale randomized trials are required to establish its
value.<br/>Copyright &#xa9; The Author(s) 2020. Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery. All rights reserved.

<102>
Accession Number
631237352
Title
Cost-effectiveness of a technology-supported multimodal prehabilitation
program in moderate-to-high risk patients undergoing lung cancer
resection: randomized controlled trial protocol.
Source
BMC health services research. 20 (1) (pp 207), 2020. Date of Publication:
12 Mar 2020.
Author
Barberan-Garcia A.; Navarro-Ripoll R.; Sanchez-Lorente D.; Moises-Lafuente
J.; Boada M.; Messaggi-Sartor M.; Gonzalez-Vallespi L.; Montane-Muntane
M.; Alsina-Restoy X.; Campero B.; Lopez-Baamonde M.; Romano-Andrioni B.;
Guzman R.; Lopez A.; Arguis M.J.; Roca J.; Martinez-Palli G.
Institution
(Barberan-Garcia) Respiratory Medicine Department, Hospital Clinic de
Barcelona, Villarroel 170, Barcelona, Catalonia 08036, Spain
(Barberan-Garcia) August Pi i Sunyer Biomedical Research Institute -
IDIBAPS, University of Barcelona (UB), Barcelona, Spain
(Barberan-Garcia) Biomedical Networking Research Centre on Respiratory
Diseases (CIBERES), Barcelona, Spain
(Navarro-Ripoll, Montane-Muntane, Lopez-Baamonde, Lopez, Arguis,
Martinez-Palli) Anaesthesia and Intensive Care Department, Hospital Clinic
de Barcelona, Barcelona, Spain
(Sanchez-Lorente, Boada, Guzman) Thoracic Surgery Department, Hospital
Clinic de Barcelona, Barcelona, Spain
(Moises-Lafuente, Messaggi-Sartor, Alsina-Restoy, Roca) Respiratory
Medicine Department, Hospital Clinic de Barcelona, Villarroel 170,
Barcelona, Catalonia 08036, Spain
(Messaggi-Sartor, Roca, Martinez-Palli) August Pi i Sunyer Biomedical
Research Institute - IDIBAPS, University of Barcelona (UB), Barcelona,
Spain
(Gonzalez-Vallespi) Clinical Psychology Department, Hospital Clinic de
Barcelona, Barcelona, Spain
(Campero, Romano-Andrioni) Endocrinology and Nutrition Department,
Hospital Clinic de Barcelona, Barcelona, Spain
(Roca) Biomedical Networking Research Centre on Respiratory Diseases
(CIBERES), Barcelona, Spain
Publisher
NLM (Medline)
Abstract
BACKGROUND: Multimodal prehabilitation is a preoperative intervention with
the objective to enhance cancer patients' functional status which has been
showed to reduce both postoperative morbidity and hospital length of stay
in digestive oncologic surgery. However, in lung cancer surgery patients
further studies with higher methodological quality are needed to clarify
the benefits of prehabilitation. The main aim of the current protocol is
to evaluate the cost-effectiveness of a multimodal prehabilitation program
supported by information and communication technologies in
moderate-to-high risk lung cancer patients undergoing thoracic surgery.
<br/>METHOD(S): A Quadruple Aim approach will be adopted, assessing the
prehabilitation program at the following levels: i) Patients' and
professionals' experience outcomes (by means of standardized
questionnaires, focus groups and structured interviews); ii) Population
health-based outcomes (e.g. hospital length of stay, number and severity
of postoperative complications, peak oxygen uptake and levels of systemic
inflammation); and, iii) Healthcare costs. DISCUSSION: This study protocol
should contribute not only to increase the scientific basis on
prehabilitation but also to detect the main factors modulating service
adoption. TRIAL REGISTRATION: NCT04052100 (August 9, 2019).

<103>
Accession Number
631245207
Title
Persistent left superior vena cava in patient with right atrial myxoma
undergoing open heart surgery. A case report and review of literature.
Source
Saudi Journal of Anaesthesia. 14 (2) (pp 217-220), 2020. Date of
Publication: April-June 2020.
Author
Elhamamsy M.; Aldemerdash A.; Zahran F.; Bakir B.; Alanazi N.; Awadallah
Y.; Haggag S.; Alshiekh M.
Institution
(Elhamamsy, Aldemerdash, Zahran) Department of Cardiac Anesthesia, P.O.
Box 2925, Riyadh 11461, Saudi Arabia
(Bakir, Awadallah, Haggag, Alshiekh) Department of Cardiac Surgery, King
Fahd Cardiac Center, College of Medicine, King Saud University Medical
City, Riyadh, Saudi Arabia
(Alanazi) Department of Interventional Cardiology, King Fahd Cardiac
Center, College of Medicine, King Saud University Medical City, Riyadh,
Saudi Arabia
Publisher
Wolters Kluwer Medknow Publications (B9, Kanara Business Centre, off Link
Road, Ghatkopar (E), Mumbai 400 075, India)
Abstract
Persistent left superior vena cava (PLSVC) is a rare and asymptomatic
congenital cardiovascular anomaly. Being asymptomatic, PLSVC was usually
discovered while performing interventions (such as insertion of central
lines, Swan-Ganz catheters, or placing pacemakers) through the left
internal jugular vein or left subclavian veins. Commonly, PLSVC is
detected not only as an isolated congenital anomaly, but also it can be
associated with many other cardiac anomalies. Also, presence of a dilated
coronary sinus on echocardiography should raise the suspicion of PLSVC.
The diagnosis should be confirmed by contrast venography or computed
tomography angiography. The present case is a female patient, 29 year old,
who was undergoing elective excision of a right atrial mass, with closure
of patent foramen ovale, and she had end-stage renal failure on regular
hemodialysis three times weekly through a permicath inserted in the right
subclavian vein.<br/>Copyright &#xa9; 2020 Saudi Journal of Anesthesia.

<104>
[Use Link to view the full text]
Accession Number
631105779
Title
Impact of postprocedural thrombocytopenia on mortality after transcatheter
aortic valve implantation.
Source
Journal of Cardiovascular Medicine. 21 (4) (pp 318-324), 2020. Date of
Publication: 01 Apr 2020.
Author
Takagi H.; Hari Y.; Nakashima K.; Ueyama H.; Kuno T.; Ando T.
Institution
(Takagi, Hari, Nakashima) Department of Cardiovascular Surgery, Shizuoka
Medical Center, Shizuoka, Japan
(Takagi, Hari) Department of Cardiovascular Surgery, Kitasato University
School of Medicine, Sagamihara, Japan
(Ueyama, Kuno) Department of Medicine, Mount Sinai Beth Israel Medical
Center, United States
(Ando) Division of Interventional Cardiology, Department of Cardiology,
New York Presbyterian Hospital, Columbia University Medical Center, New
York, NY, United States
Publisher
Lippincott Williams and Wilkins (E-mail: kathiest.clai@apta.org)
Abstract
AimsWe performed a meta-analysis of currently available studies
investigating the impact of postprocedural thrombocytopenia on mortality
after transcatheter aortic valve implantation (TAVI).MethodsAll studies
researching the impact of postprocedural thrombocytopenia on mortality
after TAVI were identified after searching PubMed and Web of Science
through July 2019. The outcome of interest was early (in-hospital or
30-day) and overall (1- to 2-year) all-cause mortality after TAVI. From
each study, the number of deaths in both patients with major
(moderate/severe or higher postprocedural drop platelet counts defined in
each study) and nonmajor (no/minor or lower drop platelet counts defined
in each study) postprocedural thrombocytopenia was extracted. Then, odds
ratios (ORs) of mortality for major vs. no/minor thrombocytopenia and
their confidence intervals were generated. Alternatively, ORs and hazard
ratios of mortality for major vs. no/minor thrombocytopenia (if available,
adjusted) were directly extracted. Study-specific estimates were pooled in
both the fixed-effect and random-effects models.ResultsThe principal
pooled analysis demonstrated that postprocedural thrombocytopenia was
associated with statistically significant increases in early (OR, 3.79; P
for effect <0.00001; P for heterogeneity=0.89) and overall mortality
(OR/hazard ratio, 1.22; P for effect=0.009; P for heterogeneity=0.17) in
the fixed-effect model. All sensitivity analyses did not substantively
alter the results of the principal analysis. No funnel plot asymmetry of
the principal analysis was detected (P for early mortality=0.88; P for
overall mortality=0.14), which suggested probably no publication
bias.ConclusionPostprocedural thrombocytopenia is associated with
increased early and overall mortality after TAVI.<br/>Copyright &#xa9;
2020 Italian Federation of Cardiology - I.F.C. All rights reserved.

<105>
Accession Number
631106918
Title
Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The
Randomized PERSIST-AVR Study Design.
Source
Thoracic and Cardiovascular Surgeon. 68 (2) (pp 114-123), 2020. Date of
Publication: 01 Mar 2020.
Author
Lorusso R.; Folliguet T.; Shrestha M.; Meuris B.; Kappetein A.P.; Roselli
E.; Klersy C.; Nozza M.; Verhees L.; Larracas C.; Goisis G.; Fischlein T.
Institution
(Lorusso) Department of Cardio-Thoracic Surgery, Heart and Vascular
Centre, Maastricht University Medical Centre (MUMC +), P. Debyelaan, 25,
Maastricht 6202 AZ, Netherlands
(Folliguet) Chirurgie Cardiaque and Transplantation, Assistance Publique
Hopital, Henri Mondor, Universite Paris 12, UPEC, France
(Shrestha) Department of Thoracic and Cardiovascular Surgery, Hannover
Medical School, Hannover, Germany
(Meuris) Cardiac Surgery Department, Universitaire Ziekenhuizen Leuven,
Leuven, Belgium
(Kappetein) Thoraxcenter, Erasmus Medical Centre, Rotterdam, Netherlands
(Roselli) Thoracic and Cardiovascular Surgery, Cleveland Clinic,
Cleveland, OH, United States
(Klersy) Fondazione IRCCS Policlinico San Matteo, Pavia, Lombardia, Italy
(Nozza, Verhees, Larracas, Goisis) LivaNova Plc, London, United Kingdom
(Fischlein) Department of Cardiac Surgery, Klinikum Nurnberg, Paracelsus
Medical University, Nuremberg, Germany
Publisher
Georg Thieme Verlag (E-mail: iaorl@iaorl.org)
Abstract
Introduction Sutureless biological valves for surgical aortic valve
replacement (SAVR), characterized by the absence of anchoring sutures at
the aortic annulus, are gaining popularity because of ease and
reproducibility of implant, shorter operating times, and enhancement of
minimally invasive approaches. The stentless configuration of the
sutureless valve was designed to achieve optimal hemodynamic performance.
Materials and Methods PERSIST-AVR (PERceval Sutureless Implant versus
STandard Aortic Valve Replacement) is a prospective, randomized, adaptive,
open-label, international, postmarket trial (NCT02673697). The primary
objective of the trial is to assess the safety and efficacy of the
Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients
undergoing SAVR in the presence of severe aortic stenosis to demonstrate
the noninferiority of Perceval as compared with standard sutured stented
bioprosthetic aortic valve as an isolated procedure or combined with
coronary artery bypass grafting. Sample size will be determined adaptively
through interim analyses performed by an Independent Statistical Unit till
a maximum of 1,234 patients, enrolled at ~60 sites in countries where the
device is commercially available. Patients will be followed up for 5 years
after implant. The primary end point is the number of patients free from
major adverse cardiac and cerebrovascular-related events at 1 year.
Additional secondary outcomes will be assessed up to 5 years. Discussion
PERSIST-AVR is the first prospective, randomized study comparing
in-hospital and postdischarge outcomes in a robust population of patients
undergoing SAVR with either the Perceval sutureless bioprosthesis or a
conventional sutured stented bioprosthesis up to 5 years.<br/>Copyright
&#xa9; 2020 American Institute of Physics Inc.. All rights reserved.

<106>
Accession Number
631235516
Title
Meta-analysis of cardiovascular superiority trials published in the N ew
England J ournal of M edicine to elucidate the concept of superiority
margin.
Source
Postgraduate Medical Journal. (no pagination), 2020. Date of Publication:
2020.
Author
Gamad N.; Shafiq N.; Malhotra S.
Institution
(Gamad, Shafiq, Malhotra) Department of Pharmacology, Postgraduate
Institute of Medical Education and Research, Chandigarh, India
Publisher
BMJ Publishing Group (E-mail: subscriptions@bmjgroup.com)
Abstract
Objective: To show that overpowered trials claim statistical significance
detouring clinical relevance and warrant the need of superiority margin to
avoid such misinterpretation. <br/>Design(s): Selective review of articles
published in the New England Journal of Medicine between 1 January 2015
and 31 December 2018 and meta-analysis following Preferred Reporting Items
for Systematic Reviews and Meta-Analyses checklist. Eligibility criteria
for selecting studies and methods: Published superiority trials evaluating
cardiovascular diseases and diabetes mellitus with positive efficacy
outcome were eligible. Fixed effects meta-analysis was performed using
RevMan V.5.3 to calculate overall effect estimate, pooled HR and it was
compared with mean clinically significant difference. <br/>Result(s):
Thirteen eligible trials with 164 721 participants provided the
quantitative data for this review. Largely, the primary efficacy endpoint
in these trials was the composite of cardiovascular death, non-fatal
myocardial infarction, unstable angina requiring rehospitalisation,
coronary revascularisation and fatal or non-fatal stroke. The pooled HR
was 0.86 (95% CI 0.84 to 0.89, I²=45%) which was lower than the
mean clinically significant difference of 0.196 (19.6%, range:
0.09375-0.35) of these studies. There was a wide 95% CI in these studies
from 0.56 to 0.99. The upper margin of CI in most of the studies was close
to the line of no difference. Absolute risk reduction was small (1.19% to
2.3%) translating to a high median number needed to treat of 63 (range: 43
to 84) over a follow-up duration of 2.95 years. <br/>Conclusion(s): The
results of this meta-analysis indicate that overpowered trials give
statistically significant results undermining clinical relevance. To avoid
such misuse of current statistical tools, there is a need to derive
superiority margin. We hope to generate debate on considering clinically
significant difference, used to calculate sample size, as superiority
margin.<br/>Copyright &#xa9; Author(s) (or their employer(s)) 2020. No
commercial re-use. See rights and permissions. Published by BMJ.

<107>
Accession Number
2005118652
Title
Nonculprit Lesion Myocardial Infarction Following Percutaneous Coronary
Intervention in Patients With Acute Coronary Syndrome.
Source
Journal of the American College of Cardiology. 75 (10) (pp 1095-1106),
2020. Date of Publication: 17 March 2020.
Author
Scirica B.M.; Bergmark B.A.; Morrow D.A.; Antman E.M.; Bonaca M.P.; Murphy
S.A.; Sabatine M.S.; Braunwald E.; Wiviott S.D.
Institution
(Scirica, Bergmark, Morrow, Antman, Bonaca, Murphy, Sabatine, Braunwald,
Wiviott) TIMI Study Group, Cardiovascular Division, Department of
Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston,
MA, United States
(Bonaca) CPC Clinical Research, University of Colorado School of Medicine,
Denver, Colorado, United States
Publisher
Elsevier USA
Abstract
Background: Recent emphasis on reduced duration and/or intensity of
antiplatelet therapy following percutaneous coronary intervention (PCI)
irrespective of indication for PCI may fail to account for the substantial
risk of subsequent nontarget lesion events in acute coronary syndrome
(ACS) patients. <br/>Objective(s): The authors sought to examine the
effect of more potent antiplatelet therapy on the basis of the timing and
etiology of recurrent myocardial infarction (MI) or cardiovascular death
following PCI for ACS. <br/>Method(s): In the TRITON-TIMI 38 study (Trial
to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet
Inhibition With Prasugrel-Thrombolysis In Myocardial Infarction 38), which
randomized patients to prasugrel or clopidogrel, 12,844 patients with ACS
received at least 1 stent. MI and cardiovascular death were categorized
as: 1) procedural (related to revascularization); 2) definite or probable
stent thrombosis (ST); or 3) spontaneous (non-ST or
non-procedure-related). Median follow-up was 14.5 months. <br/>Result(s):
Among the first events occurring within 30 days, 584 (69.0%) were
procedural, 126 (14.9%) ST-related, and 136 (16.1%) spontaneous. After 30
days, 22 (4.7%) were procedural, 63 (13.5%) were ST-related, and 383
(81.8%) spontaneous. Prasugrel significantly reduced the incidence of MI
or cardiovascular death for ST-related (1.0% vs. 2.1%; p < 0.001) and
spontaneous events (3.9% vs. 4.8%; p = 0.012), with a directionally
consistent numerical reduction for procedural events (4.4% vs. 5.1%; p =
0.078). Prasugrel increased spontaneous, but not procedural, major
bleeding. <br/>Conclusion(s): Long-term potent antithrombotic therapy
reduces de novo (spontaneous) atherothrombotic events in addition to
preventing complications associated with stenting of the culprit lesion
following ACS. In patients undergoing PCI for ACS, spontaneous events
predominate after 30 days, with the later-phase cardiovascular benefit of
potent dual antiplatelet therapy driven largely by reducing de novo
atherothrombotic ischemic events. (Comparison of Prasugrel [CS-747] and
Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo
Percutaneous Coronary Intervention; NCT00097591)<br/>Copyright &#xa9; 2020
American College of Cardiology Foundation

<108>
Accession Number
2003508562
Title
The challenge of non-adherence to early rehabilitation after coronary
artery bypass surgery: Secondary results from the SheppHeartCABG trial.
Source
European Journal of Cardiovascular Nursing. 19 (3) (pp 238-247), 2020.
Date of Publication: 01 Mar 2020.
Author
Hojskov I.E.; Thygesen L.C.; Moons P.; Egerod I.; Olsen P.S.; Berg S.K.
Institution
(Hojskov, Olsen, Berg) The Heart Centre, University of Copenhagen, Denmark
(Hojskov) Department of Nursing and Nutrition Education, The Faculty of
Health Sciences, University College, Copenhagen, Denmark
(Thygesen) National Institute of Public Health, University of Southern
Denmark, Denmark
(Moons) Department of Public Health and Primary Care, University of
Leuven, Belgium
(Moons) Department of Pediatrics and Child Health, University of Cape
Town, South Africa
(Egerod) Department of Intensive Care Unit, Rigshospitalet, University of
Copenhagen, Denmark
Publisher
SAGE Publications Inc. (E-mail: claims@sagepub.com)
Abstract
Background: Attending and maintaining a cardiac rehabilitation programme
is a challenge. <br/>Aim(s): The purpose of this study was to explore
associations between non-adherence to early coronary artery bypass graft
rehabilitation and sociodemographic and clinical baseline data.
<br/>Method(s): Coronary artery bypass graft patients were randomised 1:1
to either four weeks of comprehensive early rehabilitation or usual care.
Outcomes were assessed at three time-points points: baseline, discharge
and four weeks post-coronary artery bypass graft. Differences in
sociodemographic and clinical baseline data in adherent versus
non-adherent patients were tested using the Pearson chi² test
for categorical variables. To test associations between non-adherence to
exercise training and sociodemographic and clinical baseline data,
multivariate logistic regression was used to estimate the odds ratio for
in-hospital training and post-discharge training adjusted for age, sex and
left ventricular ejection fraction. <br/>Result(s): Non-adherence to
in-hospital versus post-discharge exercise training was 31% (n=48) versus
53% (n=81). Female non-adherence was 20% versus 70%. Non-adherence to
in-hospital versus post-discharge mindfulness was 87% versus 70%. Male
non-adherence to mindfulness was 85% versus 70%. Non-adherence to
psycho-educational consultations was 3%, most of whom were men. Patients
with university level education were more adherent to in-hospital exercise
training than patients with lower educational level (odds ratio=3.14 (95%
confidence interval; 1.16-8.51), p=0.02). Diabetic patients were more
non-adherent to exercise training after discharge (3.74 (1.54-9.08),
p=0.004) as were overweight patients (0.37 (0.17-0.80), p=0.01).
<br/>Conclusion(s): This study demonstrated wide acceptance of
psycho-educational consultations in post-coronary artery bypass graft
patients. Adherence to physical rehabilitation was low especially after
discharge from hospital and the opportunity to attend a mindfulness
programme was not used.<br/>Copyright &#xa9; The European Society of
Cardiology 2019.

<109>
Accession Number
2004400913
Title
Meta-analysis of results of subvalvular repair for severe ischemic mitral
regurgitation.
Source
Journal of Cardiac Surgery. (no pagination), 2020. Date of Publication:
2020.
Author
Meco M.; Lio A.; Montisci A.; Panisi P.; Ferrarini M.; Miceli A.; Glauber
M.
Institution
(Meco, Panisi) Cardiac Centre, Humanitas Gavazzeni Hospital, Bergamo,
Italy
(Lio, Glauber) Department of Cardiac Surgery and Transplantation, S.
Camillo Hospital, Rome, Italy
(Lio, Montisci, Ferrarini, Miceli, Glauber) Cardiothoracic Center,
Istituto Clinico Sant'Ambrogio, Gruppo Ospedaliero San Donato, Milan,
Italy
(Montisci) University of Milan, Milan, Italy
Publisher
Blackwell Publishing Inc. (E-mail: subscrip@blackwellpub.com)
Abstract
Background and Aim of the Study: The aim of this meta-analysis was to
compare short- and long-term outcomes of patients undergoing mitral
annuloplasty (MA) with or without papillary muscle surgery (PMS) for the
treatment of ischemic mitral regurgitation (IMR). <br/>Method(s): A
systematic review and meta-analysis in accordance with the Preferred
Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
statement were performed. <br/>Result(s): Nine studies met the inclusion
criteria. This meta-analysis identified 478 patients: 228 patients
underwent MA alone and 250 patients underwent concomitant PMS. Early
mortality was similar between two groups (odds ratio [OR] 1.14, 95%
confidence interval [CI], 0.51-2.53; P =.75). PMS was associated at
follow-up with a higher freedom from cardiac-related events (P =.050);
moreover, although both surgical techniques had a positive impact on
ventricular remodeling, the PMS group showed a significant higher
reduction of left ventricle end-diastolic diameter (OR, 4.89, 95% CI,
2.77-7.01; P <.001) and left ventricle end-systolic diameter values (OR,
4.11, 95% CI, 1.98-6.24; P <.001). Finally, PMS compared with MA alone was
associated with a significant reduction of recurrent mitral regurgitation
at follow-up (OR, 3.25, 95% CI, 1.60-6.59; P =.001). <br/>Conclusion(s):
This meta-analysis demonstrated superiority in terms of ventricular
remodeling of a combined approach encompassing PMS and MA over MA alone in
IMR. Moreover, the association of subvalvular surgery with restrictive MA
decreases the incidence of mitral regurgitation recurrence and
cardiac-related events at follow-up.<br/>Copyright &#xa9; 2020 Wiley
Periodicals, Inc.

<110>
Accession Number
2003969691
Title
CHA<inf>2</inf>DS<inf>2</inf>-VASc Score for Identifying Patients at High
Risk of Postoperative Atrial Fibrillation After Cardiac Surgery: A
Meta-analysis.
Source
Annals of Thoracic Surgery. 109 (4) (pp 1210-1216), 2020. Date of
Publication: April 2020.
Author
Chen Y.-L.; Zeng M.; Liu Y.; Xu Y.; Bai Y.; Cao L.; Ling Z.; Fan J.; Yin
Y.
Institution
(Chen, Zeng, Xu, Cao, Ling, Fan, Yin) Department of Cardiology, the 2nd
Affiliated Hospital of Chongqing Medical University, Chongqing, China
(Liu) Biostatistics & Bioinformatics Shared Resource at Winship Cancer
Institute, Emory University, Atlanta, Georgia
(Liu) Department of Biostatistics & Bioinformatics, Rollins School of
Public Health, Emory University, Atlanta, Georgia
(Bai) Department of Respiratory and Critical Care Medicine, the 1st
Affiliated Hospital of Chongqing Medical University, Chongqing, China
(Fan) Department of Biomedical Engineering and Pediatrics, Emory
University, Atlanta, Georgia
Publisher
Elsevier USA
Abstract
Background: Postoperative atrial fibrillation (POAF) is a common
complication after cardiac surgery, resulting in an increased risk of
morbidity and longer hospital stay. Pharmacologic prophylaxis has been
recommended to improve the outcome in patients at high risk of developing
POAF after cardiac surgery. Several studies have applied the
CHA<inf>2</inf>DS<inf>2</inf>-VASc (Congestive heart failure, Hypertension
Age [>=65 = 1 point, >=75 = 2 points], Diabetes, and Stroke/transient
ischemic attack (2 points)-vascular disease [peripheral arterial disease,
previous myocardial infarction, aortic atheroma]) score in the risk
stratification of POAF but yielded contradicting results. This study aims
to determine the association between CHA<inf>2</inf>DS<inf>2</inf>-VASc
score and POAF and further to explore its discriminative ability for the
prediction of POAF. <br/>Method(s): We systematically searched the
Medline, Embase, Cochrane library, and other data sources with key terms
"CHA<inf>2</inf>DS<inf>2</inf>-VASc," "atrial fibrillation," and "cardiac
surgery." Studies designed for CHA<inf>2</inf>DS<inf>2</inf>-VASc score in
stratifying the risks of POAF in patients undergoing cardiac surgery were
included. Statistical analyses were performed with R 3.5.1 and STATA 13.0.
<br/>Result(s): Seven hundred twenty-one studies were identified, of which
12 studies with 18,086 patients were finally included in our analysis. The
CHA<inf>2</inf>DS<inf>2</inf>-VASc score was found to be an independent
predictor of POAF after cardiac surgery (odds ratio, 1.46; 95% confidence
interval [CI], 1.25-1.72) and exhibited a relatively strong specificity
(0.70; 95% CI, 0.61-0.78) and sensitivity (0.72; 95% CI, 0.54-0.85) for
predicting POAF. The bivariate model-based pooled area under the receiver
operating curve was estimated to be 0.76 (95% CI, 0.72-0.79).
<br/>Conclusion(s): The CHA<inf>2</inf>DS<inf>2</inf>-VASc score has
relatively good performance in predicting POAF after cardiac surgery and
may help identify the patients at high risk of POAF.<br/>Copyright &#xa9;
2020 The Society of Thoracic Surgeons

<111>
Accession Number
631044487
Title
The clinical utility of remote ischemic preconditioning in protecting
against cardiac surgery-associated acute kidney injury: A pilot randomized
clinical trial.
Source
Advances in clinical and experimental medicine : official organ Wroclaw
Medical University. 29 (2) (pp 189-196), 2020. Date of Publication: 01 Feb
2020.
Author
Stokfisz K.; Ledakowicz-Polak A.; Zagorski M.; Jander S.; Przybylak K.;
Zielinska M.
Institution
(Stokfisz, Ledakowicz-Polak, Przybylak, Zielinska) Intensive Cardiac
Therapy Clinic, Department of Invasive Cardiology and Electrocardiology,
Medical University of Lodz, Poland
(Zagorski, Jander) Department of Cardiology and Cardiosurgery, Medical
University of Lodz, Poland
Publisher
NLM (Medline)
Abstract
BACKGROUND: Cardiac surgery-associated acute kidney injury (CSA-AKI) is a
well-known, serious complication and a well-recognized independent risk
factor for higher morbidity and mortality among patients undergoing
cardiac surgery. <br/>OBJECTIVE(S): The aim of the study was to assess the
efficacy of remote ischemic preconditioning (RIPC) in reducing the
incidence of CSA-AKI, measured with the standard creatinine technique and
using neutrophil gelatinase-associated lipocalin (NGAL) serum
concentrations as a potential new biomarker of kidney damage. The ethics
committee of the Medical University of Lodz prospectively approved the
protocol (approval No. RNN/286/13/KE). The study was retrospectively
registered with the U.S. National Institutes of Health - NIH (29 June
2017; ClinicalTrials.gov identifier: NCT03205410). MATERIAL AND METHODS:
We conducted a prospective single-center double-blind randomized and
controlled tudy. Data was collected from patients admitted to the
Cardiosurgery Clinic at the Medical University of Lodz (Poland) between
January and December 2014, scheduled for elective cardiac surgery (an
off-pump coronary artery bypass). A total of 28 patients were randomized
to receive either RIPC (n = 14) or sham RIPC (n = 14). After the induction
of anesthesia, the patients assigned to the RIPC group underwent 3 cycles
of 5-minute inflation to 200 mm Hg and 5-minute deflation of the upper-arm
cuff. The control group had a deflated cuff placed on the upper arm for 30
min. The authors measured the patients' serum creatinine concentration to
check for the occurrence of a CSA-AKI within 48 h after cardiac surgery,
and NGAL serum concentration to check its level within 3 h after the
operation. <br/>RESULT(S): Fewer patients in RIPC group developed CSA-AKI
within 48 h after cardiac surgery than in the control group (29% vs 93%; p
= 0.003). Fewer patients in the RIPC group presented an increase in NGAL 3
h after surgery (medians: 124 vs 176.7; p = 0.0003). <br/>CONCLUSION(S):
In patients undergoing an off-pump coronary artery bypass, RIPC
significantly reduces the occurrence of CSA-AKI and protects against
increased postoperative NGAL levels.

<112>
Accession Number
628172949
Title
Is local anaesthesia superior to general anaesthesia in endovascular
repair of abdominal aortic aneurysm?.
Source
Interactive cardiovascular and thoracic surgery. 29 (4) (pp 599-603),
2019. Date of Publication: 01 Oct 2019.
Author
Harky A.; Grafton-Clarke C.; Chan J.
Institution
(Harky) Department of Vascular Surgery, Countess of Chester Hospital,
Chester, United Kingdom
(Grafton-Clarke) College of Life Sciences, University of Leicester,
Leicester, United Kingdom
(Chan) Department of Cardiothoracic Surgery, Morriston Hospital, Swansea,
United Kingdom
Publisher
NLM (Medline)
Abstract
A best evidence topic in cardiovascular surgery was written in accordance
to a structured protocol. The question addressed was: in patients
undergoing endovascular repair of abdominal aortic aneurysm (EVAR), is
local anaesthetic (LA) superior to general anaesthetic in terms of
perioperative outcomes? Altogether, 630 publications were found using the
reported search protocol, of which 3 represented the best evidence to
answer the clinical question. The authors, journal, date and country of
publication, patient group studied, study type and primary outcomes were
tabulated. The 3 included studies are systematic reviews with
meta-analyses, with no randomized trials identified. Within the studies,
there is a degree of heterogeneity in terms of surgical case-mix (elective
or emergency EVAR or both) and anaesthetic technique (LA, regional
anaesthetic, local-regional anaesthetic and general anaesthetic). With 1
study not providing pooled estimates, the second study demonstrated
statistical significance in favour of local-regional anaesthetic within
the elective setting in terms of mortality [pooled odds ratio (OR) 0.70,
95% confidence interval (CI) 0.52-0.95; P=0.02], morbidity (pooled OR
0.73, 95% CI 0.55-0.96; P=0.0006) and total length of hospital admission
(pooled mean difference: -1.53, 95% CI -2.53 to -0.53; P=0.00001). The
third study failed to demonstrate a statistically significant mortality
benefit with LA (pooled OR 0.54, 95% CI 0.21-1.41; P=0.211). While the
results of these studies fail to provide a clear answer to a complex
surgical problem, it would be appropriate, in the light of current
evidence, to recommend LA as non-inferior to general anaesthetic in both
emergency and elective settings.<br/>Copyright &#xa9; The Author(s) 2019.
Published by Oxford University Press on behalf of the European Association
for Cardio-Thoracic Surgery. All rights reserved.

<113>
Accession Number
631218279
Title
Modified Glucose-Insulin-Potassium Regimen Provides Cardioprotection With
Improved Tissue Perfusion in Patients Undergoing Cardiopulmonary Bypass
Surgery.
Source
Journal of the American Heart Association. 9 (6) (pp e012376), 2020. Date
of Publication: 17 Mar 2020.
Author
Zhao K.; Zhang Y.; Li J.; Cui Q.; Zhao R.; Chen W.; Liu J.; Zhao B.; Wan
Y.; Ma X.-L.; Yu S.; Yi D.; Gao F.
Institution
(Zhao, Cui, Zhao, Chen, Liu, Zhao, Yu, Yi) Department of Cardiovascular
Surgery Fourth Military Medical University Xi'an, China
(Zhao, Li, Gao) School of Aerospace Medicine Fourth Military Medical
University Xi'an, China
(Zhao) Department of Thoracic Surgery Provincial Cancer Hospital of
Shannxi Xi'an, China
(Zhang) Department of Ultrasonic Diagnosis Xijing Hospital Fourth Military
Medical University Xi'an, China
(Wan) Department of Health Statistics and Fourth Military Medical
University Xi'an, China
(Wan) Department of Health Services Fourth Military Medical University
Xi'an, China
(Ma) Department of Emergency Medicine Thomas Jefferson University
Philadelphia PA
Publisher
NLM (Medline)
Abstract
Background Laboratory studies demonstrate glucose-insulin-potassium (GIK)
as a potent cardioprotective intervention, but clinical trials have
yielded mixed results, likely because of varying formulas and timing of
GIK treatment and different clinical settings. This study sought to
evaluate the effects of modified GIK regimen given perioperatively with an
insulin-glucose ratio of 1:3 in patients undergoing cardiopulmonary bypass
surgery. Methods and Results In this prospective, randomized,
double-blinded trial with 930 patients referred for cardiac surgery with
cardiopulmonary bypass, GIK (200 g/L glucose, 66.7 U/L insulin, and 80
mmol/L KCl) or placebo treatment was administered intravenously at 1 mL/kg
per hour 10 minutes before anesthesia and continuously for 12.5 hours. The
primary outcome was the incidence of in-hospital major adverse cardiac
events including all-cause death, low cardiac output syndrome, acute
myocardial infarction, cardiac arrest with successful resuscitation,
congestive heart failure, and arrhythmia. GIK therapy reduced the
incidence of major adverse cardiac events and enhanced cardiac function
recovery without increasing perioperative blood glucose compared with the
control group. Mechanistically, this treatment resulted in increased
glucose uptake and less lactate excretion calculated by the differences
between arterial and coronary sinus, and increased phosphorylation of
insulin receptor substrate-1 and protein kinase B in the hearts of
GIK-treated patients. Systemic blood lactate was also reduced in
GIK-treated patients during cardiopulmonary bypass surgery. Conclusions A
modified GIK regimen administered perioperatively reduces the incidence of
in-hospital major adverse cardiac events in patients undergoing
cardiopulmonary bypass surgery. These benefits are likely a result of
enhanced systemic tissue perfusion and improved myocardial metabolism via
activation of insulin signaling by GIK. Clinical Trial Registration URL:
clinicaltrials.gov. Identifier: NCT01516138.

<114>
Accession Number
631074200
Title
Five-year outcomes of transcatheter or surgical aortic-valve replacement.
Source
New England Journal of Medicine. 382 (9) (pp 799-809), 2020. Date of
Publication: 27 Feb 2020.
Author
Makkar R.R.; Thourani V.H.; Mack M.J.; Kodali S.K.; Kapadia S.; Webb J.G.;
Yoon S.-H.; Trento A.; Svensson L.G.; Herrmann H.C.; Szeto W.Y.; Miller
D.C.; Satler L.; Cohen D.J.; Dewey T.M.; Babaliaros V.; Williams M.R.;
Kereiakes D.J.; Zajarias A.; Greason K.L.; Whisenant B.K.; Hodson R.W.;
Brown D.L.; Fearon W.F.; Russo M.J.; Pibarot P.; Hahn R.T.; Jaber W.A.;
Rogers E.; Xu K.; Wheeler J.; Alu M.C.; Smith C.R.; Leon M.B.; PARTNER 2
Investigators
Institution
(Makkar, Yoon, Trento) Cedars-Sinai Medical Center, Los Angeles, CA,
United States
(Miller, Fearon) Stanford University, Stanford, CA, United States
(Rogers, Xu, Wheeler) Edwards Lifesciences, Irvine, CA, United States
(Thourani) Department of Cardiovascular Surgery, Piedmont Heart Institute,
Atlanta, GA, United States
(Babaliaros) Emory University, Atlanta, GA, United States
(Mack, Brown) Baylor Scott and White Healthcare, Plano, TX, United States
(Dewey) Medical City Dallas Hospital, Dallas, TX, United States
(Kodali, Hahn, Alu, Smith, Leon) Columbia University Medical Center, New
York-Presbyterian Hospital, New York, NY, United States
(Williams) NYU Langone Medical Center, New York, NY, United States
(Kapadia, Svensson, Jaber) Cleveland Clinic, Cleveland, OH, United States
(Webb) St. Paul's Hospital, Vancouver, BC, Canada
(Pibarot) Institut Universitaire de Cardiologie et de Pneumologie de
Quebec, Universite Laval, Quebec, QC, Canada
(Herrmann, Szeto) University of Pennsylvania, Philadelphia, PA, United
States
(Satler) Medstar Washington Hospital Center, Washington, DC, United States
(Cohen) University of Missouri, Kansas City School of Medicine, Kansas
City, KS, United States
(Kereiakes) Christ Hospital, Cincinnati, OH, United States
(Zajarias) Barnes-Jewish Hospital, Washington University, St. Louis, WA,
United States
(Greason) Mayo Clinic, Rochester, MN, United States
(Whisenant) Intermountain Medical Center, Salt Lake City, UT, United
States
(Hodson) Providence St. Vincent Medical Center, Portland, OR, United
States
(Russo) Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ,
United States
Publisher
Massachussetts Medical Society
Abstract
Background: There are scant data on long-term clinical outcomes and
bioprosthetic-valve function after transcatheter aortic-valve replacement
(TAVR) as compared with surgical aorticvalve replacement in patients with
severe aortic stenosis and intermediate surgical risk. <br/>Method(s): We
enrolled 2032 intermediate-risk patients with severe, symptomatic aortic
stenosis at 57 centers. Patients were stratified according to intended
transfemoral or transthoracic access (76.3% and 23.7%, respectively) and
were randomly assigned to undergo either TAVR or surgical replacement.
Clinical, echocardiographic, and healthstatus outcomes were followed for 5
years. The primary end point was death from any cause or disabling stroke.
<br/>Result(s): At 5 years, there was no significant difference in the
incidence of death from any cause or disabling stroke between the TAVR
group and the surgery group (47.9% and 43.4%, respectively; hazard ratio,
1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were
similar for the transfemoral-access cohort (44.5% and 42.0%, respectively;
hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or
disabling stroke was higher after TAVR than after surgery in the
transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI,
1.02 to 1.71). At 5 years, more patients in the TAVR group than in the
surgery group had at least mild paravalvular aortic regurgitation (33.3%
vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than
after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions
(3.2% vs. 0.8%). Improvement in health status at 5 years was similar for
TAVR and surgery. <br/>Conclusion(s): Among patients with aortic stenosis
who were at intermediate surgical risk, there was no significant
difference in the incidence of death or disabling stroke at 5 years after
TAVR as compared with surgical aortic-valve replacement.<br/>Copyright
&#xa9; 2020 Massachusetts Medical Society.