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<1>
Accession Number
2002135653
Title
Does left atrial appendage closure reduce mortality? A vital status
analysis of the randomized protect AF and PREVAIL clinical trials.
Source
Journal of Atrial Fibrillation. 11 (4) (no pagination), 2018. Date of
Publication: December 2018.
Author
Whang W.; Holmes D.R.; Miller M.A.; Langan M.-N.; Choudry S.; Sofi A.;
Koruth J.S.; Dukkipati S.R.; Reddy V.Y.
Institution
(Whang, Miller, Langan, Choudry, Sofi, Koruth, Dukkipati, Reddy) Icahn
School of Medicine at Mount Sinai, Box 1030, New York, NY, United States
(Holmes) Mayo Clinic, Rochester, MN, United States
Publisher
CardioFront LLC
Abstract
Compared with warfarin, left atrial appendage closure (LAAC) reduced
mortality in an analysis of the PROTECT AF and PREVAIL trials. However,
these data were limited by patient drop-out.We sought to estimate the
mortality benefit with LAAC using updated vital status information.In
PROTECT AF and PREVAIL, 227 of 1114 randomized subjects failed to complete
5-year follow-up. Centers were manually queried for updated vital status
on 76 subjects (33%). During median follow-up 5.0 years (interquartile
range 3.8, 5.1), 112 of 732 LAAC subjects (15.3%) and 79 of 382 controls
(20.7%) died. The hazard ratio for all-cause mortality with LAAC compared
with warfarin was 0.70 (95% CI 0.53-0.94, p=0.017).Subgroup analyses
suggested that subjects <75 years and those with higher CHA2DS2-VASc
score, history of transient ischemic attack or stroke, and permanent AF
derived particular benefit, although interaction terms were not
significant.The number needed to treat(NNT) with LAAC to prevent one death
over 5 years was 16 (95% CI 10-82). Despite competing mortality risks in
this elderly cohort, updated vital status data from PROTECT AF and PREVAIL
revealed that LAAC was associated with 30% improved survival compared with
warfarin, with an NNT of 16. Copyright © 2018 CardioFront LLC.
All rights reserved.

<2>
Accession Number
361278602
Title
Adding colchicine to standard therapy after cardiac surgery reduced risk
for the postpericardiotomy syndrome.
Source
Annals of Internal Medicine. 154 (4) (pp JC2-10), 2011. Date of
Publication: February 15, 2011.
Author
Imazio M.
Institution
(Imazio) Humanitas Gavazzeni, Bergamo, Italy
Publisher
American College of Physicians

<3>
Accession Number
633409343
Title
Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse
Cardiovascular Events in Patients at High Cardiovascular Risk: The
STRENGTH Randomized Clinical Trial.
Source
JAMA - Journal of the American Medical Association. 324 (22) (pp
2268-2280), 2020. Date of Publication: 08 Dec 2020.
Author
Nicholls S.J.; Lincoff A.M.; Garcia M.; Bash D.; Ballantyne C.M.; Barter
P.J.; Davidson M.H.; Kastelein J.J.P.; Koenig W.; McGuire D.K.;
Mozaffarian D.; Ridker P.M.; Ray K.K.; Katona B.G.; Himmelmann A.; Loss
L.E.; Rensfeldt M.; Lundstrom T.; Agrawal R.; Menon V.; Wolski K.; Nissen
S.E.
Institution
(Nicholls) Monash Cardiovascular Research Centre, Victorian Heart
Institute, Monash University, Melbourne, Australia
(Lincoff, Garcia, Bash, Menon, Wolski, Nissen) Cleveland Clinic
Coordinating Center for Clinical Research, Department of Cardiovascular
Medicine, Cleveland Clinic, Cleveland, OH, United States
(Ballantyne) Baylor College of Medicine, Houston, TX, United States
(Barter) University of New South Wales, Sydney, Australia
(Davidson) University of Chicago, Chicago, IL, United States
(Kastelein) Academic Medical Center, Amsterdam, Netherlands
(Koenig) Deutsches Herzzentrum Munchen, Technische Universitat Munchen,
Dzhk (German Centre for Cardiovascular Research), Partner Site Munich
Heart Alliance, Munich, Germany
(McGuire) Division of Cardiology, University of Texas Southwestern Medical
Center, Dallas, United States
(Mozaffarian) Friedman School of Nutrition Science and Policy, Tufts
University, Boston, MA, United States
(Ridker) Center for Cardiovascular Disease Prevention, Harvard Medical
School, Boston, MA, United States
(Ray) Imperial College of London, London, United Kingdom
(Katona, Loss) AstraZeneca BioPharmaceuticals RandD, Late-stage
Development, Cardiovascular, Renal and Metabolic, Gaithersburg, MD, United
States
(Himmelmann, Rensfeldt, Lundstrom, Agrawal) AstraZeneca BioPharmaceuticals
RandD, Late-stage Development, Cardiovascular, Renal and Metabolic,
Gothenburg, Sweden
(Koenig) Institute of Epidemiology and Medical Biometry, University of
Ulm, Ulm, Germany
(Nissen) Cleveland Clinic Heart and Vascular Institute, 9500 Euclid Ave,
Cleveland, OH 44195, United States
Publisher
American Medical Association
Abstract
Importance: It remains uncertain whether the omega-3 fatty acids
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) reduce
cardiovascular risk. Objective(s): To determine the effects on
cardiovascular outcomes of a carboxylic acid formulation of EPA and DHA
(omega-3 CA) with documented favorable effects on lipid and inflammatory
markers in patients with atherogenic dyslipidemia and high cardiovascular
risk. Design, Setting, and Participant(s): A double-blind,
randomized, multicenter trial (enrollment October 30, 2014, to June 14,
2017; study termination January 8, 2020; last patient visit May 14, 2020)
comparing omega-3 CA with corn oil in statin-treated participants with
high cardiovascular risk, hypertriglyceridemia, and low levels of
high-density lipoprotein cholesterol (HDL-C). A total of 13078 patients
were randomized at 675 academic and community hospitals in 22 countries in
North America, Europe, South America, Asia, Australia, New Zealand, and
South Africa. Intervention(s): Participants were randomized to
receive 4 g/d of omega-3 CA (n = 6539) or corn oil, which was intended to
serve as an inert comparator (n = 6539), in addition to usual background
therapies, including statins. Main Outcomes and Measures: The primary
efficacy measure was a composite of cardiovascular death, nonfatal
myocardial infarction, nonfatal stroke, coronary revascularization, or
unstable angina requiring hospitalization. Result(s): When 1384
patients had experienced a primary end point event (of a planned 1600
events), the trial was prematurely halted based on an interim analysis
that indicated a low probability of clinical benefit of omega-3 CA vs the
corn oil comparator. Among the 13078 treated patients (mean [SD] age, 62.5
[9.0] years; 35% women; 70% with diabetes; median low-density lipoprotein
[LDL] cholesterol level, 75.0 mg/dL; median triglycerides level, 240
mg/dL; median HDL-C level, 36 mg/dL; and median high-sensitivity
C-reactive protein level, 2.1 mg/L), 12633 (96.6%) completed the trial
with ascertainment of primary end point status. The primary end point
occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%)
treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P =.84). A
greater rate of gastrointestinal adverse events was observed in the
omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%).
 Conclusions and Relevance: Among statin-treated patients at high
cardiovascular risk, the addition of omega-3 CA, compared with corn oil,
to usual background therapies resulted in no significant difference in a
composite outcome of major adverse cardiovascular events. These findings
do not support use of this omega-3 fatty acid formulation to reduce major
adverse cardiovascular events in high-risk patients. Trial Registration:
ClinicalTrials.gov Identifier: NCT02104817. Copyright © 2020
American Medical Association. All rights reserved.

<4>
Accession Number
2007552392
Title
Effect of music on patients with cardiovascular diseases and during
cardiovascular interventions: A systematic review.
Source
Wiener Klinische Wochenschrift. (no pagination), 2020. Date of
Publication: 2020.
Author
Ho C.-Y.; Wexberg P.; Schneider B.; Stollberger C.
Institution
(Ho, Wexberg, Stollberger) Klinik Landstrase, Juchgasse 25, Vienna 1030,
Austria
(Schneider) Sana Kliniken Lubeck, Kahlhorststr. 17, Lubeck 23562, Germany
(Ho) Liechtensteinstr. 8/12, Vienna 1090, Austria
Publisher
Springer
Abstract
Background: The therapeutic effects of music have been known for thousands
of years. Recently, studies with music interventions in patients with
cardiovascular diseases yielded controversial results. The aim of this
review is to provide an overview of the effects of receptive music
intervention on the cardiovascular system. Method(s): We searched in
PubMed, SCOPUS and CENTRAL for publications between January 1980 and May
2018. Primary endpoints were heart rate, heart rate variability and blood
pressure. Secondary endpoints comprised respiratory rate, anxiety and
pain. The quality of the studies was assessed by using the CONSORT
statement and the Cochrane risk of bias assessment tool. A meta-analysis
and subgroup analyses concerning music style, gender and region were
planned. Result(s): A total of 29 studies comprising 2579 patients
were included and 18 studies with 1758 patients investigated the effect of
music on patients undergoing coronary angiography or open heart surgery.
Other studies applied music to children with congenital heart diseases,
pregnant women with hypertension or patients with unstable angina. Due to
high methodological study heterogeneity, a meta-analysis was not
performed. The study quality was assessed as medium to low. In ten studies
with higher quality comprising 1054 patients, music intervention was not
associated with significant changes in the cardiovascular endpoints
compared to the control group. The subgroup analyses did not demonstrate
any relevant results. Conclusion(s): Currently no definite effect of
receptive music intervention on the cardiovascular system can be verified.
Further research is needed to assess music as an inexpensive and easy
applicable form of therapy. Copyright © 2020, Springer-Verlag
GmbH Austria, part of Springer Nature.

<5>
Accession Number
2007424830
Title
Implantable cardioverter-defibrillators in cardiac transplant recipients:
A systematic review from the Electrophysiology Collaborative Consortium
for Meta-analysis-ELECTRAM investigators.
Source
PACE - Pacing and Clinical Electrophysiology. 43 (12) (pp 1529-1537),
2020. Date of Publication: December 2020.
Author
Garg J.; Shah K.; Turagam M.K.; Tzou W.; Gopinathannair R.; Natale A.;
Lakkireddy D.
Institution
(Garg) Division of Cardiology, Cardiac Arrhythmia Service, Medical College
of Wisconsin, Milwaukee, WI, United States
(Shah) Department of Cardiovascular Medicine, Beaumont Hospital, Oakland
University William Beaumont School of Medicine, Royal Oak, MI, United
States
(Turagam) Cardiac Arrhythmia Service, Helmsley Electrophysiology Center,
Icahn School of Medicine at Mount Sinai, New York, NY, United States
(Tzou) Division of Cardiology, Section of Cardiac Electrophysiology,
University of Colorado School of Medicine, Aurora, CO, United States
(Gopinathannair, Lakkireddy) Division of Electrophysiology, Kansas City
Heart Rhythm Institute and Research Foundation, Kansas City, KS, United
States
(Natale) Division of Electrophysiology, Texas Cardiac Arrhythmia Institute
at St. David's Medical Center, Austin, TX, United States
Publisher
Blackwell Publishing Inc.
Abstract
Introduction: Implantable cardioverter-defibrillator (ICD) in patients
with heart failure with reduced ejection fraction reduces mortality
secondary to malignant arrhythmias. Whether cardiac transplant patients
considered high risk for sudden death (SD) derive similar benefits remains
controversial. Method(s): Systematic search, without language
restriction, using PubMed, EMBASE, SCOPUS, Google Scholar, and
ClinicalTrials.gov was performed from inception to June 4, 2020, for
studies that had reported outcomes in patients who had ICD implanted after
cardiac transplant. The outcomes studied were as follows: (a) SD and (b)
appropriate and inappropriate ICD therapies. Result(s): Seven studies
(from 1983 through 2018) with a total of 338 cardiac transplant patients
who received ICD met study inclusion criteria. The mean age was 48.37 +/-
14.85 years, and 70.4% were men. The pooled incidence of SD was 16.3% (95%
CI 6.2-29.0%; I2= 66%). Appropriate and inappropriate ICD
therapies were observed in 12.1% (95% CI 5.3-20.4; I2= 0%) and
3.5% (95% CI 0.11-9.58%; I2= 0%), respectively during the
follow-up period (27.48 +/- 24.27 months). The most common cause for SD
was heart failure (15.6%), followed by electromechanical disassociation,
malignant ventricular arrhythmias (4.7% each, respectively), and cardiac
allograft vasculopathy (CAV) (3.1%). Furthermore, approximately 60%
(10/17) of patients with appropriate ICD shocks had CAV.
 Conclusion(s): Despite, low incidence of arrhythmic mortality, there
remains an increased burden of ventricular arrhythmias, as evident by a
12% appropriate ICD shock rates, suggesting ICD might be a practical
decision in selected cardiac transplant patients deemed high risk of SD
(i.e., patients with advanced CAV and left ventricular systolic
dysfunction). Copyright © 2020 Wiley Periodicals LLC

<6>
Accession Number
633657036
Title
Prevalence of Gastrointestinal Bleeding in Continuous-Flow Left
Ventricular Assisted Device Recipients: An Updated Systematic Review and
Meta-Analysis.
Source
American Journal of Gastroenterology. Conference: 2020 Annual Scientific
Meeting of the American College of Gastroenterology, ACG 2020. United
States. 115 (SUPPL) (pp S304-S305), 2020. Date of Publication: October
2020.
Author
Kern C.D.; Fischer K.; Mingbunjerdsuk T.; Vutthikraivit W.; Beyer R.
Institution
(Kern, Beyer) University of Kentucky, Lexington, KY, United States
(Fischer, Mingbunjerdsuk) University of Kentucky College of Medcine,
Lexington, KY, United States
(Vutthikraivit) Texas Tech University Health Sciences Center, Lubbock, TX,
United States
Publisher
Wolters Kluwer Health
Abstract
INTRODUCTION: The use of continuous-flow left ventricular assist device
(CF-LVAD) therapy continues to rise as a treatment modality for patients
with advanced heart failure. Patients with CF-LVAD are at increased risk
of gastrointestinal bleeding (GIB) often requiring recurrent
hospitalizations. Approximately one-third of hospital readmissions after
LVAD placement are due to GIB. The aim of this study is to assess the
prevalence of GIB and recurrent GIB in patients with CF-LVAD by a
systematic review and meta-analysis. METHOD(S): We comprehensively
searched the databases of MEDLINE and EMBASE from inception to November
2019. Included studies were cohort (prospective or retrospective),
case-control, or cross-sectional studies reporting the prevalence of GIB
in CF-LVAD patient. Data from each study were combined using the
random-effects model. RESULT(S): Twenty-three studies from 2009 to
2019 were included in this meta-analysis involving 2,980 CF-LVAD patients.
The prevalence of GIB ranged from 15.4% to 39.3% (pooled prevalence 5
23.8%, 95% confidence interval: 21.0-26.5, I2 5 65.9%) (Figure
1). Eleven studies reported prevalence of recurrent GIB. The prevalence of
recurrent GIB ranged from 4.5% to 17.6% (pooled prevalence = 9.5%, 95%
confidence interval: 6.5-12.5, I2 5 63.7%) (Figure 2). There
was no publication bias observed in Funnel plot as well as no small study
effect observed in Egger's test. CONCLUSION(S): This study
demonstrates that CF-LVAD patients are at significant risk of both
isolated and recurrent GIB. The underlying cause of CF-LVAD associated GIB
is multifactorial including abnormal angiogenesis and acquired von
Willebrand syndrome. These patients require antiplatelet and
antithrombotic therapy further increasing their bleeding risk. Currently
the only definitive treatment is heart transplant. Other strategies for
primary and secondary prevention of GIB in patient with CF-LVAD continue
to be investigated. It is important for clinicians to understand the
prevalence of GIB in order to appropriately discuss risks with patients
prior to receiving CF-LVAD.

<7>
Accession Number
2008502577
Title
863 Outcomes of Transcatheter Aortic Valve Replacement in Oncology
Patients With Symptomatic Severe Aortic Stenosis.
Source
Heart Lung and Circulation. Conference: 68th Cardiac Society of Australia
and New Zealand Annual Scientific Meeting, the International Society for
Heart Research Australasian Section Annual Scientific Meeting and the 14th
Annual Australia and New Zealand Endovascular Therapies Meeting. 29
(Supplement 2) (pp S425), 2020. Date of Publication: January 2020.
Author
Murphy A.; Koshy A.; Cameron W.; Horrigan M.; Kearney L.; Yeo B.; Farouque
O.; Yudi M.
Institution
(Murphy, Koshy, Cameron, Horrigan, Kearney, Yeo, Farouque, Yudi) Austin
Health, Heidelberg, Australia
(Murphy, Koshy, Kearney, Farouque, Yudi) University of Melbourne,
Parkville, Australia
(Murphy, Yeo) Olivia Newton John Cancer Centre, Heidelberg, Australia
Publisher
Elsevier Ltd
Abstract
Background: A history of cancer is incorporated into the surgical risk
assessment of patients undergoing surgical aortic valve replacement
through the Society for Thoracic Surgeons (STS) score. However, the
prognostic significance of cancer in patients treated with transcatheter
aortic valve replacement (TAVR) is unknown. As the cancer survivorship
population increases, it is imperative to establish the efficacy and
safety of TAVR in patients with severe symptomatic aortic stenosis (AS)
and a history of malignancy. Method(s): A systematic review was
conducted to identify studies reporting outcomes in patients with a
history of malignancy undergoing TAVR. A meta-analysis was performed using
a random effects model with a primary outcome of all-cause mortality and
cardiac mortality at longest follow-up. Result(s): A total of 13
observational studies with 10,916 patients were identified in the
systematic review. Seven studies including 6,323 patients were included in
the quantitative analysis. Short-term mortality (RR 0.61, 95% CI
0.36-1.01; p=0.06) and long-term all-cause mortality (RR 1.24, 95% CI
0.95-1.63; p=0.11) were not significantly different when comparing
patients with and without a history of cancer. No significant difference
in the rate of peri-procedural complications including stroke, bleeding,
acute kidney injury and pacemaker implantation were noted.
 Conclusion(s): In patients with severe AS undergoing TAVR, a history
of cancer was not associated with adverse short or long-term survival.
Based on these findings, TAVR should be considered in all patients with
severe symptomatic aortic stenosis, and a life expectancy of greater than
12 months, irrespective of their history of malignancy. [Formula
presented] Copyright © 2020

<8>
Accession Number
2008502555
Title
864 Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in
Low-Risk Patients.
Source
Heart Lung and Circulation. Conference: 68th Cardiac Society of Australia
and New Zealand Annual Scientific Meeting, the International Society for
Heart Research Australasian Section Annual Scientific Meeting and the 14th
Annual Australia and New Zealand Endovascular Therapies Meeting. 29
(Supplement 2) (pp S425), 2020. Date of Publication: January 2020.
Author
Koshy A.; Murphy A.; Farouque O.; Horrigan M.; Yudi M.
Institution
(Koshy, Murphy, Farouque, Horrigan, Yudi) Austin Health, Melbourne,
Australia
(Koshy, Murphy, Farouque, Yudi) University of Melbourne, Melbourne,
Australia
Publisher
Elsevier Ltd
Abstract
Background: Transcatheter aortic valve replacement(TAVR) has
revolutionized the treatment of severe aortic stenosis(AS), though its
safety and efficacy in low-risk patients remains to be established.
 Method(s): A systematic review identified four randomised controlled
trials comparing TAVR to surgical aortic valve replacement(SAVR) in
patients at low surgical risk. A meta-analysis was performed with a
primary outcome of a composite of all-cause mortality and stroke.
 Result(s): Overall, 2,836 patients were included (SAVR:1,363
TAVR:1,473). The composite of all-cause mortality and stroke was
significantly lower in patients undergoing TAVR compared with SAVR (OR
0.59, 95% CI 0.37-0.95, p=0.03) with low heterogeneity(I2=31%).
The difference in the primary composite outcome was driven by a difference
in mortality (OR 0.66, 95% CI 0.44-0.98, p=0.04) without significant
differences in stroke(OR 0.75 95% CI 0.45-1.26, p=0.28). Absolute risk
difference of the primary outcome also favoured TAVR(-2.0% 95% CI -3.3 to
-0.7%, p=0.002) with a number needed to treat (NNT) of 50 to prevent one
death or stroke. Patients undergoing TAVR had a higher risk of permanent
pacemaker implantation(OR 3.9, 95% CI 1.8-8.4, p<0.001) and
moderate/severe paravalvular leak(OR 5.0, 95% CI 1.6-15.7, p=0.01).
 Conclusion(s): In patients with severe AS at low surgical risk, the
rate of the composite of death and stroke was significantly lower with
TAVR than with SAVR. Longer-term follow-up with a focus on the impact of
PPM implantation, PVL and structural valve deterioration is essential
before the use of TAVR can be generalized to the broader population of
patients with AS. Copyright © 2020

<9>
Accession Number
629680938
Title
Cost-effectiveness analysis of anemia treatment among\chronic kidney
disease patients at kien giang general hospital.
Source
Eurasian Journal of Analytical Chemistry. 13 (3) (pp 262-270), 2018. Date
of Publication: 2018.
Author
Nguyen T.D.; Luong X.P.T.; Dinh T.T.; Nguyen H.T.; Le N.Q.
Institution
(Nguyen) Department of Pharmaceutics and Biopharmaceutics (PB), Faculty of
Pharmacy, University of Medicine Pham Ngoc Thach, Ho Chi Minh City 70000,
Vietnam
(Luong) Department of Pharmacy Administration, Faculty of Pharmacy,
University of Medicine and Pharmacy, Ho Chi Minh City 70000, Vietnam
(Dinh) Department of Pharmacy, Kien Giang General Hospital, Kien Giang
91000, Vietnam
(Nguyen) Faculty of Pharmacy, Buon Ma Thuot University, Dak Lak 63000,
Vietnam
(Le) Department of Pharmaceutical Industry, Faculty of Pharmacy,
University of Medicine and Pharmacy, 41 Dinh Tien Hoang Street, Ben Nghe
Ward, District 1, Ho Chi Minh City 70000, Vietnam
Publisher
Society for Innovative Research
Abstract
Background: Anemia due to chronic kidney disease (CKD) is a dangerous
complication that causes a burden on the patients and society. However, it
can be treated with erythropoietin (EPO). There is a lack of studies
evaluating the cost-effectiveness of EPO in Vietnam in treating anemic
complications, leading to difficulties in decision-making in terms of
prescriptions. Objective(s): This studied was undertaken to explore
the incremental cost-effectiveness ratio (ICER) of EPO in maintaining
different Hb levels when treating anemia in hemodialysis patients due to
end-stage CKD at Kien Giang General Hospital, Vietnam, in 2017.
 Method(s): Cost-effectiveness analysis (CEA) was performed based on
the decision tree and Markov models. The cost and quality-of-life data was
collected via face-to-face interviews using the KDQOL-SF questionnaire.
The probability coefficients of the model were sought systemically from
the randomised clinical trials. Result(s): The ICERs indicated that
there were no interventions that were cost-effective in relation to gross
domestic product (GDP) of Vietnam. However, patients with the target Hb
level of >10-11 g/dL were inferred to receive the most benefit from the
treatment, as indicated by the corresponding lowest ICER.
 Conclusion(s): The findings of this study should be proposed to
policy decision makers to set up guidelines for appropriate and
cost-effective use of EPO in hospitals in Vietnam. Copyright ©
2018 Society for Innovative Research. All rights reserved.

<10>
Accession Number
627657119
Title
SUPERIOR SVG: no touch saphenous harvesting to improve patency following
coronary bypass grafting (a multi-Centre randomized control trial,
NCT01047449).
Source
Journal of cardiothoracic surgery. 14 (1) (pp 85), 2019. Date of
Publication: 02 May 2019.
Author
Deb S.; Singh S.K.; de Souza D.; Chu M.W.A.; Whitlock R.; Meyer S.R.;
Verma S.; Jeppsson A.; Al-Saleh A.; Brady K.; Rao-Melacini P.; Belley-Cote
E.P.; Tam D.Y.; Devereaux P.J.; Novick R.J.; Fremes S.E.
Institution
(Deb, Tam, Fremes) Sunnybrook Health Sciences Centre, Institute of Health
Policy, Management and Evaluation, University of Toronto, Room H405, 2075
Bayview Ave., Toronto, ON M4N 3M5, Canada
(Singh) Brigham and Women's Hospital, Harvard Medical School, Boston, MA,
United States
(de Souza) Department of Cardiothoracic and Vascular Surgery, Orebro
University, Orebro, Sweden
(Chu) Department of Surgery, Western University, London Health Sciences
Centre, London, Canada
(Whitlock, Brady, Rao-Melacini, Belley-Cote, Devereaux) Population Health
Research Institute, McMaster University and Hamilton Health Sciences,
Hamilton, Canada
(Meyer) Mazankowski Alberta Heart Institute, University of Alberta,
Edmonton, Canada
(Verma) St. Michael's Hospital, Toronto, Canada
(Jeppsson) Department of Molecular and Clinical Medicine, Institute of
Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg,
Sweden
(Al-Saleh) McMaster University, Hamilton, Canada
(Novick) University of Calgary and Foothills Medical Centre, Calgary,
Canada
Publisher
NLM (Medline)
Abstract
BACKGROUND: Single centre studies support No Touch (NT) saphenous vein
graft (SVG) harvesting technique. The primary objective of the SUPERIOR
SVG study was to determine whether NT versus conventional (CON) SVG
harvesting was associated with improved SVG patency 1year after coronary
artery bypass grafting surgery (CABG). METHOD(S): Adults undergoing
isolated CABG with at least 1 SVG were eligible. CT angiography was
performed 1-year post CABG. Leg adverse events were assessed with a
questionnaire. A systematic review was performed for published NT graft
patency studies and results aggregated including the SUPERIOR study
results. RESULT(S): Two hundred and-fifty patients were randomized
across 12-centres (NT 127 versus CON 123 patients). The primary outcome
(study SVG occlusion or cardiovascular (CV) death) was not significantly
different in NT versus CON (NT: 7/127 (5.5%), CON 13/123 (10.6%), p=0.15).
Similarly, the proportion of study SVGs with significant stenosis or total
occlusion was not significantly different between groups (NT: 8/102
(7.8%), CON: 16/107 (15.0%), p=0.11). Vein harvest site infection was more
common in the NT patients 1month postoperatively (23.3% vs 9.5%, p<0.01).
Including this study's results, in a meta-analysis, NT was associated with
a significant reduction in SVG occlusion, Odds Ratio 0.49, 95% Confidence
Interval 0.29-0.82, p=0.007 in 3 randomized and 1 observational study at
1year postoperatively. CONCLUSION(S): The NT technique was not
associated with improved patency of SVGs at 1-year following CABG while
early vein harvest infection was increased. The aggregated data is
supportive of an important reduction of SVG occlusion at 1year with NT
harvesting. TRIAL REGISTRATION: NCT01047449 .

<11>
Accession Number
2005362705
Title
Surgical Management for Complete Atrioventricular Septal Defects: A
Systematic Review and Meta-Analysis.
Source
Pediatric Cardiology. 41 (7) (pp 1445-1457), 2020. Date of Publication: 01
Oct 2020.
Author
Wu Y.; Kuang H.; Wang G.; Dai J.; Li Y.; Wei G.; Wu C.
Institution
(Wu, Wang, Dai, Wu) Department of Cardiothoracic Surgery, Children's
Hospital of Chongqing Medical University, No.136 Zhongshan Second Road,
Yuzhong District, Chongqing 400014, China
(Wu, Wang, Dai, Li, Wei, Wu) Ministry of Education Key Laboratory of Child
Development and Disorders, China International Science and Technology
Cooperation Base of Child Development and Critical Disorders, National
Clinical Research Center for Child Health and Disorders, Chongqing Key
Laboratory of Pediatrics, Chongqing, China
(Kuang) Department of Cardiology, Chongqing Medical University Affiliated
Second Hospital, Chongqing, China
Publisher
Springer
Abstract
A meta-analysis is performed for a comparison of outcomes between the
modified one-patch repair (MPR) and two-patch repair (TPR) for complete
atrioventricular septal defects (CAVSD). Electronic databases, including
PubMed, Scopus, Embase, and Cochrane Library were searched systematically
for the literature which aimed mainly at comparing the therapeutic effects
for CAVSD administrated by MPR and TPR. Corresponding data sets were
extracted and two reviewers independently assessed the risks of bias.
Meta-analysis was performed using Revman 5.3 and Stata 12.0. Fifteen
studies meeting the inclusion criteria were included, involving 2076
subjects in total. It was observed that MPR was associated with shorter
cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC) times, as
compared with TPR. However, no statistical differences were found in terms
of size of ventricular septal defects (VSD), reoperation, mortality,
implantation of permanent pacemakers, and length of ventilation, hospital
and intensive care unit stay. As compared with TPR, MPR is superior in
terms of ACC and CPB. However, with regard to reoperation, mortality,
length of ventilation, ICU and hospital stay and permanent pacemakers
implantation, no significant differences are found between these two
procedures. MPR is likely to apply to younger infants with faster
completion of surgery. Surgery is recommended between 3 and 6 months of
age. Copyright © 2020, Springer Science+Business Media, LLC, part
of Springer Nature.

<12>
Accession Number
632995772
Title
Effects of electroencephalography and regional cerebral oxygen saturation
monitoring on perioperative neurocognitive disorders: A systematic review
and meta-analysis.
Source
BMC Anesthesiology. 20 (1) (no pagination), 2020. Article Number: 254.
Date of Publication: 30 Sep 2020.
Author
Ding L.; Chen D.X.; Li Q.
Institution
(Ding, Chen, Li) National Clinical Research Center for Geriatrics,
Department of Anesthesiology, West China Hospital, Sichuan University,
Research Units of West China (2018RU012), Chinese Academy of Medical
Sciences, Chengdu 610041, China
Publisher
BioMed Central Ltd
Abstract
Background: Perioperative neurocognitive disorders (PND) is a common
postoperative complication including postoperative delirium (POD),
postoperative cognitive decline (POCD) or delayed neurocognitive recovery.
It is still controversial whether the use of intraoperative cerebral
function monitoring can decrease the incidence of PND. The purpose of this
study was to evaluate the effects of different cerebral function
monitoring (electroencephalography (EEG) and regional cerebral oxygen
saturation (rSO2) monitoring) on PND based on the data from randomized
controlled trials (RCTs). Method(s): The electronic databases of Ovid
MEDLINE, PubMed, EMBASE, Cochrane Library database were systematically
searched using the indicated keywords from their inception to April 2020.
The odds ratio (OR) or mean difference (MD) with 95% confidence interval
(CI) were employed to analyze the data. Heterogeneity across analyzed
studies was assessed with chi-square test and I2 test. Result(s):
Twenty two RCTs with 6356 patients were included in the final analysis.
Data from 12 studies including 4976 patients were analyzed to assess the
association between the EEG-guided anesthesia and PND. The results showed
that EEG-guided anesthesia could reduce the incidence of POD in patients
undergoing non-cardiac surgery (OR: 0.73; 95% CI: 0.57-0.95; P = 0.02),
but had no effect on patients undergoing cardiac surgery (OR: 0.44; 95%
CI: 0.05-3.54; P = 0.44). The use of intraoperative EEG monitoring reduced
the incidence of POCD up to 3 months after the surgery (OR: 0.69; 95% CI:
0.49-0.96; P = 0.03), but the incidence of early POCD remained unaffected
(OR: 0.61; 95% CI: 0.35-1.07; P = 0.09). The remaining 10 studies compared
the effect of rSO2 monitoring to routine care in a total of 1380
participants on the incidence of PND. The results indicated that
intraoperative monitoring of rSO2 could reduce the incidence of POCD (OR
0.53, 95% CI 0.39-0.73; P < 0.0001), whereas no significant difference was
found regarding the incidence of POD (OR: 0.74; 95% CI: 0.48-1.14; P =
0.17). Conclusion(s): The findings in the present study indicated
that intraoperative use of EEG or/and rSO2 monitor could decrease the risk
of PND. Trial registration: PROSPREO registration number:
CRD42019130512. Copyright © 2020 The Author(s).

<13>
Accession Number
2010331191
Title
Motor impairment in children with congenital heart defects: A systematic
review.
Source
Pediatrics. 156 (6) (no pagination), 2020. Article Number: e20200083. Date
of Publication: 01 Dec 2020.
Author
Bolduc M.-E.; Dionne E.; Gagnon I.; Rennick J.E.; Majnemer A.;
Brossard-Racine M.
Institution
(Bolduc, Dionne, Gagnon, Majnemer, Brossard-Racine) School of Physical and
Occupational Therapy, McGill University, Montreal, Canada
(Rennick) Ingram School of Nursing, McGill University, Montreal, Canada
(Rennick, Majnemer, Brossard-Racine) Departments of Pediatrics, McGill
University, Montreal, Canada
(Majnemer, Brossard-Racine) Neurology and Neurosurgery, McGill University,
Montreal, Canada
(Bolduc, Dionne, Brossard-Racine) Advances in Brain and Child Development
Research Laboratory, The Research Institute of the McGill University
Health Centre, Montreal, Canada
(Rennick) Department of Nursing, Montreal Children's Hospital, McGill
University Health Centre, Montreal, Canada
Publisher
American Academy of Pediatrics
Abstract
CONTEXT: With improvements in survival rates in newborns with congenital
heart defects (CHDs) focus has now shifted toward enhancing
neurodevelopmental outcomes across their life span. OBJECTIVE(S): To
systematically review the prevalence and extent of motor difficulties in
infants, children, and adolescents with CHD requiring open-heart surgery.
DATA SOURCES: Data sources included Embase, Medline and the Cumulative
Index to Nursing and Allied Health Literature. STUDY SELECTION: Original
studies published between 1997 and 2019 examining gross and/or fine motor
skills in children born with a CHD requiring open-heart surgery were
selected. DATA EXTRACTION: The prevalence of motor impairments and mean
scores on standardized motor assessments were extracted. Findings were
grouped in 5 categories on the basis of the age of the children.
 RESULT(S): Forty-six original studies were included in this
systematic review. The prevalence of mild to severe motor impairments
(scores <-1 SD below normative data or controls) across childhood ranged
from 12.3% to 68.6%, and prevalence ranged from 0% to 60.0% for severe
motor impairments (<-2 SDs). Although our results suggest that the overall
prevalence of motor impairments , <-1 SD remains rather constant across
childhood and adolescence, severe motor impairments (<-2 SDs) appear to be
more prevalent in younger children. LIMITATIONS: Variability in sampling
and methodology between the reviewed studies is the most important
limitation of this review. CONCLUSION(S): The results of this review
highlight that infants with CHD have an increased risk of motor
impairments across infancy, childhood, and adolescence. These findings
stress the importance of systematic screening or evaluation of motor
skills across childhood and adolescence in children with
CHD. Copyright © 2020 by the American Academy of Pediatrics.

<14>
Accession Number
2010165473
Title
Single Anti-platelet Versus Dual Anti-platelet Therapy After Transcatheter
Aortic Valve Implantation: A Meta-Analysis of Randomized Trials.
Source
American Journal of Cardiology. (no pagination), 2020. Date of
Publication: 2020.
Author
Elbadawi A.; Thakker R.; Abuzaid A.A.; Khalife W.; Goel S.S.; Gilani S.;
Alasnag M.; Elgendy I.Y.
Institution
(Elbadawi, Khalife, Gilani) Department of Cardiovascular Medicine,
University of Texas Medical Branch, Galveston, TX, United States
(Thakker) Division of Internal Medicine, University of Texas Medical
Branch, Galveston, TX, United States
(Abuzaid) Division of Cardiology, University of California San Francisco,
San Francisco, CA, United States
(Goel) Department of Cardiology, Houston Methodist DeBakey Heart and
Vascular Center, Houston, TX, United States
(Alasnag) Cardiac Center-King Fahd Armed Forces Hospital, Jeddah, Saudi
Arabia
(Elgendy) Division of Cardiology, Weill Cornell Medicine-Qatar, Doha,
Qatar
Publisher
Elsevier Inc.

<15>
Accession Number
2007588917
Title
Self-expanding transcatheter aortic valve infolding: Current evidence,
diagnosis, and management.
Source
Catheterization and Cardiovascular Interventions. (no pagination), 2020.
Date of Publication: 2020.
Author
Ancona M.B.; Beneduce A.; Romano V.; Buzzatti N.; Russo F.; Bellini B.;
Ferri L.A.; Agricola E.; Landoni G.; Scandroglio A.M.; Chieffo A.;
Montorfano M.
Institution
(Ancona, Beneduce, Romano, Russo, Bellini, Ferri, Chieffo, Montorfano)
Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute,
Milan, Italy
(Buzzatti) Cardiac Surgery Unit, IRCCS San Raffaele Scientific Institute,
Milan, Italy
(Agricola) Echocardiography Unit, IRCCS San Raffaele Scientific Institute,
Milan, Italy
(Landoni, Scandroglio) Anesthesia and Intensive Care Department, IRCCS San
Raffaele Scientific Institute, Milan, Italy
Publisher
John Wiley and Sons Inc
Abstract
Background: Prosthetic valve infolding is a rare but severe complication
of transcatheter aortic valve implantation (TAVI) with self-expanding
valves. However, currently available clinical data are limited and
fragmented. Objective(s): This report aims to provide a comprehensive
overview of this complication focusing on predisposing factors, clinical
presentation, diagnostic findings, treatment and clinical outcomes.
 Method(s): A systematic review of the literature was performed to
identify cases of infolding occurring during TAVI with self-expanding
valves published until August 2020. These data were pooled with all the
retrospectively identified infolding cases occurred at San Raffaele
Scientific Institute between December 2014 and August 2020.
 Result(s): A total of 34 cases were included. Among patients with
available data, 38% received a first-generation CoreValve, and 62% a
second-generation Evolut R (82%) or Evolut PRO (18%). Infolding occurred
mostly with >=29-mm valves (94%). Predisposing factors included
resheathing of a second-generation valve (82%), heavy calcification of the
native valve (65%), lack of predilatation (16%), Sievers type-1 bicuspid
aortic valve (11%), and improper valve loading (5%). Infolding resulted in
severe PVL causing hemodynamic instability (29%) or cardiac arrest (12%).
Postdilatation was the treatment strategy in 68%, while prosthesis
replacement with a new device in 23% of cases. Device success rate was
82%. Death and stroke occurred in 3% and 12% of cases. Conclusion(s):
Prosthetic valve infolding is typically observed after resheathing of a
large-size self-expanding TAVI. When infolding is timely diagnosed,
prosthesis removal and replacement should be pursued. Further studies are
required to precisely define predisposing factors to prevent this
complication. Copyright © 2020 Wiley Periodicals LLC.

<16>
Accession Number
2007586930
Title
Effects of remote ischemic preconditioning on platelet activation and
reactivity in patients undergoing cardiac surgery using cardiopulmonary
bypass: a randomized controlled trial.
Source
Platelets. (no pagination), 2020. Date of Publication: 2020.
Author
Cho Y.J.; Nam K.; Yoo S.J.; Lee S.; Bae J.; Park J.-Y.; Kim H.-R.; Kim
T.K.; Jeon Y.
Institution
(Cho, Nam, Yoo, Lee, Bae, Kim, Jeon) Department of Anesthesiology and Pain
Medicine, Seoul National University Hospital, Seoul National University
College of Medicine, Seoul, South Korea
(Park) FACS Core Facility, Seoul National University College of Medicine,
Seoul, South Korea
(Kim) Department of Biomedical Sciences, BK21 FOUR Biomedical Science
Project, Seoul National University College of Medicine, Seoul, South Korea
(Kim) Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae
Medical Center, Seoul National University College of Medicine, Seoul,
South Korea
Publisher
Taylor and Francis Ltd.
Abstract
During cardiopulmonary bypass (CPB), platelet activation and dysfunction
are associated with adverse outcomes. Remote ischemic preconditioning
(RIPC) has been shown to attenuate platelet activation. We evaluated the
effects of RIPC on platelet activation during CPB in patients undergoing
cardiac surgery. Among 58 randomized patients, 26 in the RIPC group and 28
in the sham-RIPC group were analyzed. RIPC consisted of 4 cycles of 5-min
ischemia induced by inflation of pneumatic cuff pressure to 200 mmHg,
followed by 5-min reperfusion comprising deflation of the cuff on the
upper arm. Platelet activation was assessed using flow cytometry analysis
of platelet activation markers. The primary endpoint was the AUC of CD62P
expression during the first 3 h after initiation of CPB. Secondary
outcomes were the AUC of PAC-1 expression and monocyte-platelet aggregates
(MPA) during 3 h of CPB. The AUCs of CD62P expression during 3 h after
initiation of CPB were 219.4 +/- 43.9 and 211.0 +/- 41.2 MFI in the RIPC
and sham-RIPC groups, respectively (mean difference, 8.42; 95% CI, -14.8
and 31.7 MFI; p =.471). The AUCs of PAC-1 expression and MPA did not
differ between groups. RIPC did not alter platelet activation and
reactivity during CPB in patients undergoing cardiac
surgery. Copyright © 2020 Taylor & Francis Group, LLC.

<17>
Accession Number
633663525
Title
Congenital diaphragmatic hernia repair in patients requiring
extracorporeal membrane oxygenation: are outcomes better with repair on
ECMO or after decannulation?.
Source
Interactive cardiovascular and thoracic surgery. (no pagination), 2020.
Date of Publication: 08 Dec 2020.
Author
Low Z.K.; Tan A.S.M.; Nakao M.; Yap K.H.
Institution
(Low, Tan, Nakao, Yap) Department of Cardio-thoracic Surgery, KK Women's
and Children's Hospital, Singapore
Publisher
NLM (Medline)
Abstract
A best evidence topic in cardiac surgery was written according to a
structured protocol. The question addressed was whether congenital
diaphragmatic hernia repair outcomes are better before or after
decannulation in infants requiring extracorporeal membrane oxygenation
(ECMO). A total of 884 papers were found using the reported search, of
which 9 represented the best evidence to answer the clinical question. The
authors, journal, date and country of publication, patient group studied,
study type, relevant outcomes and results of these papers are tabulated.
We conclude that infants with congenital diaphragmatic hernia requiring
ECMO should undergo a trial of weaning and aim for post-decannulation
repair, as this has been associated with improved survival, shorter ECMO
duration and fewer bleeding complications. However, if weaning of ECMO is
unsuccessful, the patient should ideally undergo early on-ECMO repair
(within 72h of cannulation), which has been associated with improved
survival, less bleeding, shorter ECMO duration and fewer circuit changes
compared to late on-ECMO repair. Anticoagulation protocols including
perioperative administration of aminocaproic acid or tranexamic acid, as
well as close perioperative monitoring of coagulation parameters have been
associated with reduced bleeding risk with on-ECMO repairs. Copyright
© The Author(s) 2020. Published by Oxford University Press on behalf
of the European Association for Cardio-Thoracic Surgery. All rights
reserved.

<18>
Accession Number
633663479
Title
In patients undergoing coronary artery bypass grafting, is endoscopic
harvesting superior to open radial artery harvesting?.
Source
Interactive cardiovascular and thoracic surgery. (no pagination), 2020.
Date of Publication: 08 Dec 2020.
Author
Lei J.J.H.; Ravendren A.; Snosi M.; Harky A.
Institution
(Lei, Ravendren) School of Medicine, Imperial College London, London,
United Kingdom
(Snosi, Harky) Department of Cardiothoracic Surgery, Liverpool Heart and
Chest Hospital, Liverpool, United Kingdom
(Harky) Department of Integrative Biology, Faculty of Health and Life
Science, University of Liverpool, Liverpool, United Kingdom
(Harky) Liverpool Centre for Cardiovascular Science, Liverpool Heart and
Chest Hospital and University of Liverpool, Liverpool, United Kingdom
Publisher
NLM (Medline)
Abstract
A best evidence topic in cardiac surgery was written according to a
structured protocol. The question addressed was 'In patients undergoing
coronary artery bypass grafting, is endoscopic radial artery harvesting
(ERAH) superior to open radial artery harvesting in terms of postoperative
complications, mortality, graft quality and patency rates?'. Altogether
130 papers were found using the reported search, of which 5 represented
the best evidence to answer the clinical question. Two studies were
meta-analyses and 3 were randomized trials. The authors, journal, date and
country of publication, patient group studied, study type, relevant
outcomes and results of these papers are tabulated. In terms of graft
quality, 2 randomized studies showed preserved endothelial integrity and
vasoreactivity with ERAH, whereas 1 randomized study found superior
endothelial function with open radial artery harvesting. Importantly, 3
studies showed graft patency was not compromised with ERAH. One
meta-analysis reported no differences in graft patency between groups at
1year [odds ratio (OR) 1.24] and up to 3-5-years follow-up (OR 1.81), as
well as similar perioperative myocardial infarction rates (OR 0.80). Two
meta-analyses found similar mortality in the perioperative period (OR
0.62-0.78) and up to 5years (OR 0.64-0.67); ERAH reduced the incidence of
perioperative wound complications (P-values 0.001-0.03); however, harvest
times were increased with ERAH (P < 0.0005). We conclude that ERAH is
non-inferior to open radial artery harvesting in terms of mortality, graft
quality and patency rates, but superior in terms of reducing perioperative
wound complications, with good cosmetic effect. However, these benefits
come at the cost of increased harvesting time. Copyright © The
Author(s) 2020. Published by Oxford University Press on behalf of the
European Association for Cardio-Thoracic Surgery. All rights reserved.

<19>
Accession Number
633654983
Title
Retrograde Autologous Priming in Cardiac Surgery: Results from a
Systematic Review and Meta-analysis.
Source
Anesthesia and Analgesia. (pp 100-107), 2020. Date of Publication: 2020.
Author
Hensley N.B.; Gyi R.; Zorrilla-Vaca A.; Choi C.W.; Lawton J.S.; Brown
C.H.; Frank S.M.; Grant M.C.; Cho B.C.
Institution
(Hensley, Frank, Grant) Department of Anesthesiology, Critical Care
Medicine, the Johns Hopkins Medical Institutions, Baltimore, MD, United
States
(Gyi, Brown, Cho) Department of Anesthesiology/Critical Care Medicine,
Johns Hopkins University, School of Medicine, Baltimore, MD, United States
(Zorrilla-Vaca) Universidad Del Valle School of Medicine, Cali, Colombia
(Choi, Lawton) Division of Cardiac Surgery, Johns Hopkins University
School of Medicine, Baltimore, MD, United States
Publisher
Lippincott Williams and Wilkins
Abstract
Background: Retrograde autologous priming (RAP) before cardiopulmonary
bypass (CPB) may minimize allogeneic red cell transfusion. We conducted a
systematic review of the literature to examine the impact of RAP on
perioperative allogeneic red cell transfusions in cardiac surgical
patients. METHOD(S): This study involved a systematic review and
meta-analysis of randomized controlled trials (RCTs) and observational
studies evaluating the use of RAP in cardiac surgery involving CPB. The
primary outcome was intraoperative allogeneic red cell transfusion.
Secondary outcomes included whole hospital allogeneic transfusions and
adverse events such as acute kidney injury (AKI) and stroke.
 RESULT(S): A total of 11 RCTs (n = 1337 patients) were included,
comparing RAP patients (n = 674) to control (n = 663). In addition, 10
observational studies (n = 2327) were included, comparing RAP patients (n
= 1257) to control (n = 1070). Overall, RAP was associated with a
significantly reduced incidence of intraoperative red cell transfusion (n
= 18 studies; odds ratio [OR] = 0.34; 95% confidence interval [CI],
0.22-0.55, P <.001) compared to controls. This effect was seen among RCTs
(n = 10 studies; OR = 0.19; 95% CI, 0.08-0.45, P <.001) and observational
studies (n = 8 studies; OR = 0.66; 95% CI, 0.50-0.87, P =.004) in
isolation. RAP was also associated with a significantly reduced incidence
of whole hospital red cell transfusion (n = 5 studies; OR = 0.28; 95% CI,
0.19-0.41, P <.001). Among the studies that reported AKI and stroke
outcomes, there was no statistically significant increased odds of AKI or
stroke in either RAP or control patients. CONCLUSION(S): Based on the
pooled results of the available literature, RAP is associated with a
significant reduction in intraoperative and whole hospital allogeneic red
cell transfusion. Use of RAP may prevent hemodilution of cardiac surgical
patients and thus, lessen transfusions. Additional high-quality
prospective studies are necessary to determine the ideal priming volume
necessary to confer the greatest benefit without incurring organ
injury. Copyright © 2020 Lippincott Williams and Wilkins. All
rights reserved.

<20>
Accession Number
633063394
Title
Blood pressure and mortality in patients with type 2 diabetes and a recent
coronary event in the ELIXA trial.
Source
Cardiovascular Diabetology. 19 (1) (no pagination), 2020. Article Number:
175. Date of Publication: 12 Oct 2020.
Author
Wijkman M.O.; Claggett B.; Diaz R.; Gerstein H.C.; Kober L.; Lewis E.;
Maggioni A.P.; Wolsk E.; Aguilar D.; Bentley-Lewis R.; McMurray J.J.;
Probstfield J.; Riddle M.; Tardif J.-C.; Solomon S.D.; Pfeffer M.A.
Institution
(Wijkman, Claggett, Solomon, Pfeffer) Cardiovascular Division, Brigham and
Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA
02115, United States
(Wijkman) Department of Internal Medicine and Department of Health,
Medicine and Caring Sciences, Linkoping University, Norrkoping, Sweden
(Diaz) Estudios Clinicos Latinoamerica, Instituto Cardiovascular de
Rosario, Rosario, Argentina
(Gerstein) Population Health Research Institute, Department of Medicine,
McMaster University and Hamilton Health Sciences, Hamilton, Canada
(Kober, Wolsk) Rigshospitalet Copenhagen University Hospital, Copenhagen,
Denmark
(Lewis) Stanford University Medical Center, Stanford, United States
(Maggioni) Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy
(Maggioni) Research Center of the Italian Association of Hospital
Cardiologists, Florence, Italy
(Aguilar) McGovern Medical School, University of Texas, Houston, United
States
(Bentley-Lewis) Massachusetts General Hospital, Harvard Medical School,
Boston, United States
(McMurray) British Heart Foundation Cardiovascular Research Centre,
University of Glasgow, Glasgow, United Kingdom
(Probstfield) University of Washington Medical Center, Seattle, United
States
(Riddle) Oregon Health and Science University, Portland, United States
(Tardif) Montreal Heart Institute, Universite de Montreal, Montreal,
Canada
Publisher
BioMed Central Ltd
Abstract
Background: The relationship between blood pressure and mortality in type
2 diabetes (T2DM) is controversial, with concern for increased risk
associated with excessively lowered blood pressure. Method(s): We
evaluated whether prior cardiovascular disease (CVD) altered the
relationship between baseline blood pressure and all-cause mortality in
5852 patients with T2DM and a recent acute coronary syndrome (ACS) who
participated in the ELIXA (Evaluation of Lixisenatide in Acute Coronary
Syndrome) trial. Risk of death was assessed in Cox models adjusted for
age, sex, race, heart rate, BMI, smoking, diabetes duration, insulin use,
HbA1c, eGFR, brain natriuretic peptide (BNP), urine albumin/creatinine
ratio, treatment allocation and prior coronary revascularization.
 Result(s): Although overall there was no significant association
between systolic blood pressure (SBP) and mortality (hazard ratio per 10
mmHg lower SBP 1.05 (95% CI 0.99-1.12) P = 0.10), lower SBP was
significantly associated with higher risk of death (hazard ratio per 10
mmHg lower SBP 1.13 (95% CI 1.04-1.22) P = 0.002) in 2325 patients with
additional CVD (index ACS+ at least one of the following prior to
randomization: myocardial infarction other than the index ACS, stroke or
heart failure). In 3527 patients with only the index ACS no significant
association was observed (hazard ratio per 10 mmHg lower SBP 0.95
(0.86-1.04) P = 0.26; P for interaction 0.005). Conclusion(s): The
association between blood pressure and mortality was modified by
additional CVD history in patients with type 2 diabetes and a recent
coronary event. When blood pressures measured after an acute coronary
event are used to assess the risk of death in patients with type 2
diabetes, the cardiovascular history needs to be taken into consideration.
Trial registration ClinicalTrials.gov number NCT01147250, first posted
June 22, 2010 Copyright © 2020 The Author(s).

<21>
Accession Number
633044871
Title
Improved haemodynamic stability and cerebral tissue oxygenation after
induction of anaesthesia with sufentanil compared to remifentanil: A
randomised controlled trial.
Source
BMC Anesthesiology. 20 (1) (no pagination), 2020. Article Number: 258.
Date of Publication: 07 Oct 2020.
Author
Poterman M.; Kalmar A.F.; Buisman P.L.; Struys M.M.R.F.; Scheeren T.W.L.
Institution
(Poterman, Kalmar, Buisman, Struys, Scheeren) Department of
Anaesthesiology, University Medical Center Groningen, PO Box 30 001,
Hanzeplein 1, Groningen 9700 RB, Netherlands
(Kalmar) Department of Anaesthesiology, Az Maria Middelares Gent
Buitenring, Sint-Denijs 30, Ghent 9000, Belgium
Publisher
BioMed Central Ltd
Abstract
Background: Balanced anaesthesia with propofol and remifentanil, compared
to sufentanil, often decreases mean arterial pressure (MAP), heart rate
(HR) and cardiac index (CI), raising concerns on tissue-oxygenation. This
distinct haemodynamic suppression might be attenuated by atropine. This
double blinded RCT, investigates if induction with propofol-sufentanil
results in higher CI and tissue-oxygenation than with
propofol-remifentanil and if atropine has more pronounced beneficial
effects on CI and tissue-oxygenation in a remifentanil-based anaesthesia.
 Method(s): In seventy patients scheduled for coronary bypass grafting
(CABG), anaesthesia was induced and maintained with propofol target
controlled infusion (TCI) with a target effect-site concentration (Cet) of
2.0 mug ml-1 and either sufentanil (TCI Cet 0.48 ng ml-1) or remifentanil
(TCI Cet 8 ng ml-1). If HR dropped below 60 bpm, methylatropine (1 mg) was
administered intravenously. Relative changes (DELTA) in MAP, HR, stroke
volume (SV), CI and cerebral (SctO2) and peripheral (SptO2)
tissue-oxygenation during induction of anaesthesia and after atropine
administration were analysed. Result(s): The sufentanil group
compared to the remifentanil group showed significantly less decrease in
MAP (DELTA =-23 +/- 13 vs.-36 +/- 13 mmHg), HR (DELTA =-5 +/- 7 vs.-10 +/-
10 bpm), SV (DELTA =-23 +/- 18 vs.-35 +/- 19 ml) and CI (DELTA =-0.8 (-1.5
to-0.5) vs.-1.5 (-2.0 to-1.1) l min-1 m-2), while SctO2 (DELTA = 9 +/- 5
vs. 6 +/- 4%) showed more increase with no difference in DELTASptO2 (DELTA
= 8 +/- 7 vs. 8 +/- 8%). Atropine caused higher DELTAHR (13 (9 to 19) vs.
10 +/- 6 bpm) and DELTACI (0.4 +/- 0.4 vs. 0.2 +/- 0.3 l min-1 m-2) in
sufentanil vs. remifentanil-based anaesthesia, with no difference in
DELTAMAP, DELTASV and DELTASctO2 and DELTASptO2. Conclusion(s):
Induction of anaesthesia with propofol and sufentanil results in improved
haemodynamic stability and higher SctO2 compared to propofol and
remifentanil in patients having CABG. Administration of atropine might be
useful to counteract or prevent the haemodynamic suppression associated
with these opioids. Trial registration: Clinicaltrials.gov on June 7, 2013
(trial ID: NCT01871935). Copyright © 2020 The Author(s).

<22>
Accession Number
632660765
Title
Postoperative outcomes of kidney transplant recipients undergoing
non-transplant-related elective surgery: A systematic review and
meta-analysis.
Source
BMC Nephrology. 21 (1) (no pagination), 2020. Article Number: 365. Date of
Publication: 25 Aug 2020.
Author
Palamuthusingam D.; Kunarajah K.; Pascoe E.M.; Johnson D.W.; Hawley C.M.;
Fahim M.
Institution
(Palamuthusingam) Metro South Integrated Nephrology and Transplant
Services, Logan Hospital, Armstrong Road and Loganlea Road, Meadowbrook,
QLD 4131, Australia
(Palamuthusingam, Johnson, Hawley, Fahim) Faculty of Medicine, University
of Queensland, St Lucia, QLD 4072, Australia
(Palamuthusingam) School of Medicine, Griffith University, Mount Gravatt,
QLD, Australia
(Kunarajah) Department of Medicine, Sunshine Coast University Hospital,
Doherty St, Birtinya, QLD 4575, Australia
(Pascoe) Centre for Health Services Research, University of Queensland, St
Lucia, QLD 4072, Australia
(Johnson, Hawley, Fahim) Metro South Integrated Nephrology and Transplant
Services, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba,
QLD 4074, Australia
(Johnson) Translational Research Institute, Brisbane, Australia
Publisher
BioMed Central Ltd
Abstract
Background: Reliable estimates of the absolute and relative risks of
postoperative complications in kidney transplant recipients undergoing
elective surgery are needed to inform clinical practice. This systematic
review and meta-analysis aimed to estimate the odds of both fatal and
non-fatal postoperative outcomes in kidney transplant recipients following
elective surgery compared to non-transplanted patients. Method(s):
Systematic searches were performed through Embase and MEDLINE databases to
identify relevant studies from inception to January 2020. Risk of bias was
assessed by the Newcastle Ottawa Scale and quality of evidence was
summarised in accordance with GRADE methodology (grading of
recommendations, assessment, development and evaluation). Random effects
meta-analysis was performed to derive summary risk estimates of outcomes.
Meta-regression and sensitivity analyses were performed to explore
heterogeneity. Result(s): Fourteen studies involving 14,427 kidney
transplant patients were eligible for inclusion. Kidney transplant
recipients had increased odds of postoperative mortality; cardiac surgery
(OR 2.2, 95%CI 1.9-2.5), general surgery (OR 2.2, 95% CI 1.3-4.0) compared
to non-transplanted patients. The magnitude of the mortality odds was
increased in the presence of diabetes mellitus. Acute kidney injury was
the most frequently reported non-fatal complication whereby kidney
transplant recipients had increased odds compared to their
non-transplanted counterparts. The odds for acute kidney injury was
highest following orthopaedic surgery (OR 15.3, 95% CI 3.9-59.4). However,
there was no difference in the odds of stroke and pneumonia.
 Conclusion(s): Kidney transplant recipients are at increased odds for
postoperative mortality and acute kidney injury following elective
surgery. This review also highlights the urgent need for further studies
to better inform perioperative risk assessment to assist in planning
perioperative care. Copyright © 2020 The Author(s).

<23>
Accession Number
2005497629
Title
Activation of pi3k/akt/hif-1alpha signaling is involved in lung protection
of dexmedetomidine in patients undergoing video-assisted thoracoscopic
surgery: A pilot study.
Source
Drug Design, Development and Therapy. 14 (pp 5155-5166), 2020. Date of
Publication: 2020.
Author
Zhu L.; Zhang Y.; Zhang Z.; Ding X.; Gong C.; Qian Y.
Institution
(Zhu, Zhang, Zhang, Ding, Gong, Qian) Department of Anesthesiology and
Perioperative Medicine, First Affiliated Hospital with Nanjing Medical
University, Nanjing 210029, China
Publisher
Dove Medical Press Ltd
Abstract
Background: Lung resection and one lung ventilation (OLV) during
video-assisted thor-acoscopic surgery (VATS) may lead to acute lung
injury. Dexmedetomidine (DEX), a highly selective alpha<inf>2</inf>
adrenergic receptor agonist, improves arterial oxygenation in adult
patients undergoing thoracic surgery. The aim of this pilot study was to
explore possible mechanism related to lung protection of DEX in patients
undergoing VATS. Patients and Methods: Seventy-four patients
scheduled for VATS were enrolled in this study. Three timepoints (before
anesthesia induction (T<inf>0</inf>), 40 min after OLV (T<inf>1</inf>),
and 10 min after two-lung ventilation (T<inf>2</inf>)) of arterial blood
gas were obtained. Meanwhile, lung histopathologic examination,
immunohistochemistry analysis (occludin and ZO-1), levels of tumor
necrosis factor (TNF)-alpha and interleukin (IL)-6 in lung tissue and
plasma, and activation of phosphoinositide-3-kinase
(PI3K)/AKT/hypoxia-inducible factor (HIF)-1alpha signaling were detected.
Postoperative outcomes including duration of withdrawing the pleural
drainage tube, length of hospital stay, hospitalization expenses, and
postoperative pulmonary complications (PPCs) were also recorded.
 Result(s): Sixty-seven patients were randomly divided into DEX group
(group D, n=33) and control group (group N, n=34). DEX improved
oxygenation at T<inf>1</inf> and T<inf>2</inf> (group D vs group N;
T<inf>1</inf>: 191.8 +/- 49.8 mmHg vs 159.6 +/- 48.1 mmHg, P = 0.009;
T<inf>2</inf>: 406.0 mmHg [392.2--423.7] vs 374.5 mmHg [340.2-378.2], P =
0.001). DEX alleviated the alveolar capillary epithelial structure damage,
increased protein expression of ZO-1 and occludin, inhibited elevation of
the expression of TNF-alpha and IL-6 in lung tissue and plasma, and
increased protein expression of p-PI3K, p-AKT and HIF-1alpha. Dex
administered had better postoperative outcomes with less risk of PPCs and
hospitalization expenses as well as shorter duration of withdrawing the
pleural drainage tube and length of hospital stay. Conclusion(s):
Activation of PI3K/Akt/HIF-1alpha signaling might be involved in lung
protection of DEX in patients undergoing VATS. Copyright © 2020
Zhu et al.

<24>
[Use Link to view the full text]
Accession Number
2007540289
Title
Prothrombin complex concentrate vs. fresh frozen plasma in adult patients
undergoing heart surgery - a pilot randomised controlled trial (PROPHESY
trial).
Source
Anaesthesia. (no pagination), 2020. Date of Publication: 2020.
Author
Green L.; Roberts N.; Cooper J.; Agarwal S.; Brunskill S.J.; Chang I.;
Gill R.; Johnston A.; Klein A.A.; Platton S.; Rossi A.; Sepehripour A.;
Stanworth S.; Monk V.; O'Brien B.
Institution
(Green) Blizard Institute, Barts and the London School of Medicine, Queen
Mary University of London, London, United Kingdom
(Cooper, Chang, Johnston, Monk) William Harvey Research Institute, Barts
and the London School of Medicine, Queen Mary University of London,
London, United Kingdom
(Green, Platton) NHS Blood and Transplant, London, United Kingdom
(Green) Department of Haematology, Barts Health NHS Trust, London, United
Kingdom
(Roberts, Brunskill, Rossi, Sepehripour) Department of Cardiac Surgery,
Barts Health NHS Trust, London, United Kingdom
(O'Brien) Department of Anaesthesia, Barts Health NHS Trust, London,
United Kingdom
(Agarwal) Department of Anaesthesia, Manchester Royal Infirmary,
Manchester, United Kingdom
(Agarwal) Systematic Review Initiative, NHS Blood and Transplant, Oxford,
United Kingdom
(Stanworth) NHS Blood and Transplant, Oxford, United Kingdom
(Gill) Department of Anaesthesia, University Hospital Southampton,
Southampton, United Kingdom
(Klein) Department of Anaesthesia and Intensive Care, Royal Papworth
Hospital, Cambridge, United Kingdom
(Stanworth) Department of Haematology, Oxford University Hospitals NHS
Foundation Trust, Oxford, United Kingdom
(O'Brien) Outcomes Research Consortium, Cleveland Clinic, OH, United
States
Publisher
Blackwell Publishing Ltd
Abstract
There is equipoise regarding the use of prothrombin complex concentrate
vs. fresh frozen plasma in bleeding patients undergoing cardiac surgery.
We performed a pilot randomised controlled trial to determine the
recruitment rate for a large trial, comparing the impact of prothrombin
complex concentrate vs. fresh frozen plasma on haemostasis (1 h and 24 h
post-intervention), and assessing safety. Adult patients who developed
bleeding within 24 h of cardiac surgery that required coagulation factor
replacement were randomly allocated to receive prothrombin complex
concentrate (15 IU.kg-1 based on factor IX) or fresh frozen
plasma (15 ml.kg-1). If bleeding continued after the first
administration of prothrombin complex concentrate or fresh frozen plasma
administration, standard care was administered. From February 2019 to
October 2019, 180 patients were screened, of which 134 (74.4% (95%CI
67-81%)) consented, 59 bled excessively and 50 were randomly allocated; 25
in each arm, recruitment rate 35% (95%CI 27-44%). There were 23 trial
protocol deviations, 137 adverse events (75 prothrombin complex
concentrate vs. 62 fresh frozen plasma) and 18 serious adverse events (5
prothrombin complex concentrate vs. 13 fresh frozen plasma). There was no
increase in thromboembolic events with prothrombin complex concentrate. No
patient withdrew from the study, four were lost to follow-up and two died.
At 1 h after administration of the intervention there was a significant
increase in fibrinogen, Factor V, Factor XII, Factor XIII,
alpha<inf>2</inf>-antiplasmin and antithrombin levels in the fresh frozen
plasma arm, while Factor II and Factor X were significantly higher in the
prothrombin complex concentrate group. At 24 h, there were no significant
differences in clotting factor levels. We conclude that recruitment to a
larger study is feasible. Haemostatic tests have provided useful insight
into the haemostatic changes following prothrombin complex concentrate or
fresh frozen plasma administration. A definitive trial is needed to
ascertain the benefits and safety for each. Copyright © 2020 The
Authors. Anaesthesia published by John Wiley & Sons Ltd on behalf of
Association of Anaesthetists

<25>
Accession Number
633647375
Title
Increased incidence of serious late adverse events with drug-eluting
stents when compared with coronary artery bypass surgery: A cause of
concern.
Source
Future Cardiology. 16 (6) (pp 711-723), 2020. Date of Publication:
November 2020.
Author
Mieres J.; Rodriguez A.E.; Fernandez-Pereira C.; Ascarrunz-Cattoretti D.
Institution
(Mieres, Rodriguez, Fernandez-Pereira, Ascarrunz-Cattoretti) Cardiac Unit
Otamendi Hospital Cardiovascular Research Center (CECI), Azcuenaga 870,
Buenos Aires, Argentina
Publisher
Future Medicine Ltd.
Abstract
Percutaneous coronary intervention (PCI) and coronary artery bypass graft
(CABG) in pre-drug-eluting stents (DESs) era, randomized trials and
meta-analysis showed that the extension of coronary artery disease was not
associated with a better survival with CABG, and only diabetic patients
had an inferior survival with PCI. After the introduction of DES, we would
expect a substantial improvement in PCI results compared with CABG,
narrowing the gap between both revascularization strategies, However, on
the contrary, most randomized studies between DES and CABG showed that
rate of recurrences remained and there is an unexpected increased of late
serious adverse events including spontaneous myocardial infarction and
death. In this review, we try to described each of these problems and find
out explanations for these new findings searching for potential
solutions. Copyright © 2020 Future Medicine Ltd.. All rights
reserved.

<26>
Accession Number
2007575433
Title
Vitamin D for prevention of sternotomy healing complications: REINFORCE-D
trial.
Source
Trials. 21 (1) (no pagination), 2020. Article Number: 1018. Date of
Publication: December 2020.
Author
Cecrle M.; Cerny D.; Sedlackova E.; Mikova B.; Dudkova V.; Drncova E.;
Pokusova M.; Skalsky I.; Tamasova J.; Halacova M.
Institution
(Cecrle, Cerny, Halacova) Department of Clinical Pharmacy, Na Homolce
Hospital, Prague, Czechia
(Cecrle, Cerny) Institute of Pharmacology, 1st Faculty of Medicine,
Charles University, Prague, Czechia
(Sedlackova, Skalsky) Department of Cardiac Surgery, Na Homolce Hospital,
Prague, Czechia
(Mikova) Department of Radiology, Na Homolce Hospital, Prague, Czechia
(Dudkova, Drncova) Department of Clinical Biochemistry, Hematology and
Immunology, Na Homolce Hospital, Prague, Czechia
(Pokusova) Hospital Pharmacy, Na Homolce Hospital, Prague, Czechia
(Tamasova) Department of Medical Physics, Na Homolce Hospital, Prague,
Czechia
(Halacova) Department of Pharmacology, 2nd Faculty of Medicine, Charles
University, Prague, Czechia
Publisher
BioMed Central Ltd
Abstract
Background: Most cardiac surgery patients undergo median sternotomy during
open heart surgery. Sternotomy healing is an arduous, very complex, and
multifactorial process dependent on many independent factors affecting the
sternum and the surrounding soft tissues. Complication rates for median
sternotomy range from 0.5 to 5%; however, mortality rates from
complications are very variable at 7-80%. Low calcidiol concentration
below 80 nmol/L results in calcium absorptive impairment and carries a
risk of bone loss, which is considered as a risk factor in the sternotomy
healing process. The primary objective of this clinical trial is to
compare the incidence of all postoperative sternotomy healing
complications in two parallel patient groups administered cholecalciferol
or placebo. The secondary objectives are focused on general patient
recovery process: sternal bone healing grade at the end of the trial,
length of hospitalization, number of days spent in the ICU, number of days
spent on mechanical lung ventilation, and number of hospital readmissions
for sternotomy complications. Method(s): This clinical trial is
conducted as monocentric, randomized, double-blind, placebo-controlled,
with planned enrollment of 600 patients over 4 years, approximately 300 in
the placebo arm and 300 in the treatment arm. Males and females from 18 to
95 years of age who fulfill the indication criteria for undergoing cardiac
surgery with median sternotomy can be included in this clinical trial, if
they meet the eligibility criteria. Discussion(s): REINFORCE-D is the
first monocentric trial dividing patients into groups based on serum
calcidiol levels, and with dosing based on serum calcidiol levels. This
trial may help to open up a wider range of postoperative healing issues.
Trial registration: EU Clinical Trials Register, EUDRA CT No:
2016-002606-39. Registered on September 8, 2016. Copyright ©
2020, The Author(s).

<27>
Accession Number
2007573044
Title
Feasibility and outcome of mitral valve repair in patients with infective
endocarditis.
Source
Cardiothoracic Surgeon. 28 (1) (no pagination), 2020. Article Number: 27.
Date of Publication: December 2020.
Author
Scheggi V.; Olivotto I.; Del Pace S.; Zoppetti N.; Brunetto A.; Marchionni
N.; Cerillo A.; Stefano P.L.
Institution
(Scheggi, Brunetto) Division of Cardiovascular and Perioperative Medicine,
Cardiothoracovascular Department, Azienda Ospedaliero-Universitaria
Careggi and University of Florence, Largo Brambilla 3, Florence 50133,
Italy
(Olivotto, Del Pace, Marchionni) Division of General Cardiology,
Cardiothoracovascular Department, Azienda Ospedaliero-Universitaria
Careggi and University of Florence, Florence, Italy
(Zoppetti) IFAC-CNR Institute of Applied Physics "Nello Carrara" of the
National Research Council, Florence, Sesto Fiorentino, Italy
(Cerillo, Stefano) Division of Cardiac Surgery, Cardiothoracovascular
Department, Azienda Ospedaliero-Universitaria Careggi and University of
Florence, Florence, Italy
Publisher
Springer Science and Business Media Deutschland GmbH
Abstract
Background: Valve repair is the treatment of choice for native mitral
valve regurgitation. The feasibility of repair when the defect is caused
by acute infective endocarditis (IE) is debated. This study aims to
compare the outcome of repair and replacement procedures, to report the
rate of repair in a single surgical center, and to review the literature
on this topic. Result(s): We retrospectively analyzed 108 patients
with native mitral IE, potentially eligible for surgical repair. Of these
108, 90 (83%) underwent surgery, and 18 were treated conservatively. Among
the 90 surgical patients, 57 (63%) underwent valve replacement and 33
valve repair (37%). The mean follow-up duration was 3 years. The two
primary endpoints were mortality and freedom from recurrent endocarditis.
Secondary endpoints were the post-operative incidence of major adverse
events (hospitalization for any cause, pacemaker implantation, new onset
of atrial fibrillation, sternal dehiscence), left ventricular systolic
function (LVSF), and valvular function at 1-year echocardiographic
follow-up. All-cause mortality was lower for valve repair, although not
significantly (p = 0.86), as well as nonfatal adverse events (p = 0.92)
and relapse rate (p = 0.20) at 3 years. We did not find differences
between the two groups at echocardiographic follow-up, neither for left
ventricular systolic function (p = 0.22), nor for valvular continence (p =
0.28). Conclusion(s): In our experience, the mid-term outcome of
repair in IE is comparable to valve replacement and should be considered
whenever possible, as in degenerative valve disease. The review of the
literature supports this strategy. Copyright © 2020, The
Author(s).

<28>
Accession Number
2010311439
Title
Clinical impact of conduction disturbances in transcatheter aortic valve
replacement recipients: A systematic review and meta-analysis.
Source
European Heart Journal. 41 (29) (pp 2771-2781), 2020. Date of Publication:
01 Aug 2020.
Author
Faroux L.; Chen S.; Muntane-Carol G.; Regueiro A.; Philippon F.;
Sondergaard L.; Jrgensen T.H.; Lopez-Aguilera J.; Kodali S.; Leon M.;
Nazif T.; Rodes-Cabau J.
Institution
(Faroux, Muntane-Carol, Philippon, Rodes-Cabau) Quebec Heart and Lung
Institute, Laval University, 2725 chemin Ste-Foy, Quebec City, QC G1V4G5,
Canada
(Chen, Kodali, Leon, Nazif) Columbia University Medical Center, New
York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, NY
10032, United States
(Regueiro) Institut Clinic Cardiovascular, Hospital Clinic, Institut
d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Carrer de
Villaroel, 170, Barcelona 08036, Spain
(Sondergaard, Jrgensen) Rigshospitalet, University of Copenhagen,
Blegdamsvej 9, Copenhagen 2100, Denmark
(Lopez-Aguilera) Hospital Reina Sofia of Cordoba, Avenida Menendez Pidal,
Cordoba 14004, Spain
Publisher
Oxford University Press
Abstract
Aims: The clinical impact of new-onset persistent left bundle branch block
(NOP-LBBB) and permanent pacemaker implantation (PPI) on transcatheter
aortic valve replacement (TAVR) recipients remains controversial. We aimed
to evaluate the impact of (i) periprocedural NOP-LBBB and PPI post-TAVR on
1-year all-cause death, cardiac death, and heart failure hospitalization
and (ii) NOP-LBBB on the need for PPI at 1-year follow-up. Methods
and Results: We performed a systematic search from PubMed and EMBASE
databases for studies reporting raw data on 1-year clinical impact of
NOP-LBBB or periprocedural PPI post-TAVR. Data from 30 studies, including
7792 patients (12 studies) and 42 927 patients (21 studies) for the
evaluation of the impact of NOP-LBBB and PPI after TAVR were sourced,
respectively. NOP-LBBB was associated with an increased risk of all-cause
death [risk ratio (RR) 1.32, 95% confidence interval (CI) 1.17-1.49; P <
0.001], cardiac death (RR 1.46, 95% CI 1.20-1.78; P < 0.001), heart
failure hospitalization (RR 1.35, 95% CI 1.05-1.72; P = 0.02), and PPI (RR
1.89, 95% CI 1.58-2.27; P < 0.001) at 1-year follow-up. Periprocedural PPI
after TAVR was associated with a higher risk of all-cause death (RR 1.17,
95% CI 1.11-1.25; P < 0.001) and heart failure hospitalization (RR 1.18,
95% CI 1.03-1.36; P = 0.02). Permanent pacemaker implantation was not
associated with an increased risk of cardiac death (RR 0.84, 95% CI
0.67-1.05; P = 0.13). Conclusion(s): NOP-LBBB and PPI after TAVR are
associated with an increased risk of all-cause death and heart failure
hospitalization at 1-year follow-up. Periprocedural NOP-LBBB also
increased the risk of cardiac death and PPI within the year following the
procedure. Further studies are urgently warranted to enhance preventive
measures and optimize the management of conduction disturbances
post-TAVR. Copyright © 2020 Published on behalf of the European
Society of Cardiology. All rights reserved.

<29>
[Use Link to view the full text]
Accession Number
2007589081
Title
The anti-adhesive effect of anti-VEGF agents in experimental models: A
systematic review.
Source
Wound Repair and Regeneration. (no pagination), 2020. Date of Publication:
2020.
Author
Giannis D.; Geropoulos G.; Ziogas I.A.; Gitlin J.; Oropallo A.
Institution
(Giannis) Institute of Health Innovations and Outcomes Research, The
Feinstein Institutes for Medical Research, Manhasset, NY, United States
(Giannis, Geropoulos, Ziogas) Surgery Working Group, Society of Junior
Doctors, Athens, Greece
(Geropoulos) Thoracic Surgery Department, University College London
Hospitals, NHS Foundation Trust, London, United Kingdom
(Ziogas) Aristotle University of Thessaloniki School of Medicine,
Thessaloniki, Greece
(Gitlin) The Donald and Barbara Zucker School of Medicine at
Hofstra/Northwell, Northwell Health, Hempstead, NY, United States
(Oropallo) Department of Vascular Surgery, The Donald and Barbara Zucker
School of Medicine at Hofstra/Northwell, Northwell Health, New Hyde Park,
NY, United States
Publisher
Blackwell Publishing Inc.
Abstract
Adhesions constitute a major problem in abdominal-pelvic and thoracic
surgery with significant impact in the postoperative quality of life and
healthcare services utilization. Adhesiogenesis is the result of increased
fibrin formation, impaired fibrinolysis, angiogenesis, and fibrosis.
Despite the recent advancements, the ideal anti-adhesive agent remains to
be determined. To this end, we performed a comprehensive literature search
in PubMed, EMBASE, and Scopus databases to identify studies investigating
the antiadhesive role of anti-VEGF agents in peritoneal, pleural, and
pericardial experimental adhesion models. Fifteen studies were eligible
for inclusion with a total population of 602 animals (334 rats, 180
rabbits, and 88 mice). The majority of included studies (11/15) used
bevacizumab, while three studies used other anti-VEGF antibodies and one
study used an anti-VEGFR-antibody. A rat model was used in nine studies,
while rabbit (n = 3) or mouse (n = 3) models were used less frequently.
Eleven studies used peritoneal models, three studies used pleural models,
and one study used a pericardial model. The scales (n = 12) and interval
(Range: 1-42 days) used for the evaluation of adhesions varied between the
studies. All studies demonstrated a significant decrease in adhesion
scores between the anti-VEGF and control groups up to 42 days
postprocedure. VEGF blockade resulted in decreased fibrosis in four out of
five studies that used peritoneal models, while the effect on pleural
models depended on the pleurodesis agent and was significant between 7 and
28 days. The effect of anti-VEGF agents on anastomosis integrity depends
on the dose and the model that is used (inconclusive results).Current data
support the anti-adhesive role of Anti-VEGF agents in all three serosal
surfaces up to 6 weeks postprocedure. Further studies are needed to
confirm the anti-adhesive role of anti-VEGF agents in pleural and
pericardial adhesion experimental models and investigate any effect on
anastomosis integrity in peritoneal models. Copyright © 2020 by
the Wound Healing Society

<30>
Accession Number
2007586544
Title
Catheter ablation for atrial fibrillation in patients with end-stage heart
failure and eligibility for heart transplantation.
Source
ESC Heart Failure. (no pagination), 2020. Date of Publication: 2020.
Author
Sohns C.; Marrouche N.F.; Costard-Jackle A.; Sossalla S.; Bergau L.;
Schramm R.; Fuchs U.; Omran H.; Rubarth K.; Dumitrescu D.; Konietschke F.;
Rudolph V.; Gummert J.; Sommer P.; Fox H.
Institution
(Sohns, Bergau, Sommer) Clinic for Electrophysiology, Herz- und
Diabeteszentrum NRW, Ruhr-Universitat Bochum, Bad Oeynhausen, Germany
(Marrouche) Tulane Research Innovation for Arrhythmia Discoveries (TRIAD),
Heart and Vascular Institute, Tulane University School of Medicine, New
Orleans, LA, United States
(Costard-Jackle, Schramm, Fuchs, Omran, Gummert, Fox) Clinic for Thoracic
and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW,
Ruhr-Universitat Bochum, Bad Oeynhausen, Germany
(Sossalla) Department of Internal Medicine II, Cardiology, Pneumology,
Intensive Care, University Hospital Regensburg, Regensburg, Germany
(Rubarth, Konietschke) Department of Biometry and Clinical Epidemiology,
University Medical Center Berlin Charite, Berlin, Germany
(Dumitrescu, Rudolph) Clinic for General and Interventional
Cardiology/Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universitat
Bochum, Bad Oeynhausen, Germany
(Costard-Jackle, Dumitrescu, Rudolph, Gummert, Sommer, Fox) Heart Failure
Department, Herz- und Diabeteszentrum NRW, Ruhr-Universitat Bochum, Bad
Oeynhausen, Germany
Publisher
Wiley-Blackwell
Abstract
Aims: Timely referrals for transplantation and left ventricular assist
device (LVAD) play a key role in favourable outcomes in patients with
advanced heart failure (HF). The purpose of the Catheter Ablation for
atrial fibrillation in patientS with end-sTage heart faiLure and
Eligibility for Heart Transplantation (CASTLE-HTx) trial is to test the
hypothesis that atrial fibrillation (AF) ablation has beneficial effects
on mortality and morbidity during 'waiting time' for heart transplantation
(HTx) or to prolong the time span until LVAD implantation. Methods
and Results: CASTLE-HTx is a randomized evaluation of ablative treatment
of AF in patients with severe left ventricular dysfunction who are
candidates and eligible for HTx. The primary endpoint is the composite of
all-cause mortality, worsening of HF requiring a high urgent
transplantation, or LVAD implantation. The secondary study endpoints are
all-cause mortality, cardiovascular mortality, cerebrovascular accidents,
worsening of HF requiring unplanned hospitalization, AF burden reduction,
unplanned hospitalization due to cardiovascular reason, all-cause
hospitalization, quality of life, number of delivered implantable
cardioverter defibrillator therapies, time to first implantable
cardioverter defibrillator therapy, number of device-detected ventricular
tachycardia/ventricular fibrillation episodes, left ventricular function,
exercise tolerance, and percentage of right ventricular pacing.
Ventricular myocardial tissue will be obtained from patients who will
undergo LVAD implantation or HTx to assess the effect of catheter ablation
on human HF myocardium. CASTLE-HTx will randomize 194 patients over a
minimum time period of 2 years. Conclusion(s): CASTLE-HTx will
determine if AF ablation has beneficial effects on mortality in patients
with end-stage HF who are eligible for HTx. Copyright © 2020 The
Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of
European Society of Cardiology

<31>
Accession Number
2007586431
Title
Prevention of pressure injury in the operating room: Heels operating room
pressure injury trial.
Source
International Wound Journal. (no pagination), 2020. Date of Publication:
2020.
Author
Eberhardt T.D.; de Lima S.B.S.; de Avila Soares R.S.; Silveira L.B.T.D.;
Rossarola Pozzebon B.; Reis C.R.; dos Santos K.P.P.; Alves P.J.P.
Institution
(Eberhardt, de Lima, Silveira, Rossarola Pozzebon, Reis, dos Santos)
Departamento de Enfermagem, Universidade Federal de Santa Maria, Santa
Maria, RS, Brazil
(Eberhardt) Instituto de Ciencias Biologicas, Universidade de Passo Fundo,
Passo Fundo, RS, Brazil
(de Avila Soares) Colegio Politecnico, Universidade Federal de Santa
Maria, Santa Maria, RS, Brazil
(Alves) Instituto de Ciencias da Saude, Universidade Catolica Portuguesa,
Porto, Portugal
Publisher
Blackwell Publishing Ltd
Abstract
The objective was to evaluate the efficacy of multi-layered silicone foam
(intervention) compared with transparent polyurethane film (control) in
preventing heel pressure injuries caused by surgical positioning of
individuals undergoing elective surgery. It was designed an intra-patient,
open, parallel, randomised controlled trial was conducted in a university
hospital in southern Brazil, from March 2019 to February 2020, with
patients undergoing elective surgeries of cardiac and gastrointestinal
specialties. The patients who met the selection criteria constituted,
simultaneously, a single group receiving the intervention and active
control, through paired analysis of the cutaneous sites (right heel and
left heel). The outcome was the occurrence of PI, within the follow-up
period was 72 hours. Brazilian Registry of Clinical Trials: RBR-5GKNG5.
There was analysis of 135 patients/270 heels, with an overall incidence of
36.7%. The pressure injury incidence was significantly lower in the
intervention group (26.7%), compared with the control group (P =.001);
relative risk of 0.57. In the intervention group, the estimated pressure
injury-free time (survival) was 57.5 hours and in the control group, 43.9
hours. It was concluded that Multi-layered silicone foam (intervention) is
more efficacious than transparent polyurethane film (control) in the
prevention of pressure injuries caused by surgical positioning of
individuals undergoing elective surgery. Copyright © 2020 The
Authors. International Wound Journal published by Medicalhelplines.com Inc
(3M) and John Wiley & Sons Ltd.

<32>
Accession Number
633652679
Title
"Predictors of pacemaker implantation after TAVI according to kind of
prosthesis and risk profile: a systematic review and contemporary
meta-analysis".
Source
European heart journal. Quality of care & clinical outcomes. (no
pagination), 2020. Date of Publication: 08 Dec 2020.
Author
Bruno F.; D'Ascenzo F.; Vaira M.P.; Elia E.; Omede P.; Kodali S.; Barbanti
M.; Cabau J.R.; Husser O.; Sossalla S.; Van Mieghem N.M.; Bax J.; Smith
D.H.; Garcia A.J.M.; Pollari F.; Fischlein T.; Budano C.; Montefusco A.;
Gallone G.; De Filippo O.; Rinaldi M.; la Torre M.; Salizzoni S.; Atzeni
F.; Pocar M.; Conrotto F.; De Ferrari G.M.
Institution
(Bruno, D'Ascenzo, Vaira, Elia, Omede, Budano, Montefusco, Gallone, De
Filippo, Conrotto, De Ferrari) Division of Cardiology, Cardiovascular and
Thoracic Department, Citta della Salute e della Scienza Hospital and
University of Turin, Italy
(Kodali) Division of Cardiology, New York-Presbyterian Hospital, Columbia
University Medical Center, NY, United States
(Barbanti) Department of Cardiology, C.A.S.T. Policlinic G. Rodolico
Hospital, University of Catania, Catania, Italy
(Cabau) Quebec Heart and Lung Institute, Laval University, Quebec City,
QC, Canada
(Husser) DortmundGermany
(Sossalla) Department for Internal Medicine II, Cardiology, Pneumology,
Intensive Care, University Hospital Regensburg; Regensburg, Germany
(Van Mieghem) Department of Cardiology Erasmus University Medical Center
(Bax) Department of Cardiology, Heart Lung Center, Leiden University
Medical Center, Leiden, Netherlands
(Smith) Sussex Cardiac Centre, Brighton and Sussex University Hospitals
NHS Trust, Brighton, United Kingdom
(Garcia) Hospital Virgen de la Victoria, Malaga, Spain
(Pollari, Fischlein) Department of Cardiac Surgery, Cardiovascular Center,
Klinikum Nurnberg - Paracelsus Medical University, Breslauer Str. 201,
Nuremberg, Germany
(Rinaldi, la Torre, Salizzoni, Atzeni, Pocar) Cardiovascular and Thoracic
Department, Citta della Salute e della Scienza Hospital and University of
Turin, Italy
Publisher
NLM (Medline)
Abstract
BACKGROUND: Permanent pacemaker implantation (PPI) may be required after
transcatheter aortic valve implantation (TAVI). Evidence on PPI prediction
has largely been gathered from high risk patients receiving first
generation valve implants. OBJECTIVE(S): We undertook a meta-analysis
of the existing literature to examine the incidence and predictors of PPI
after TAVI according to generation of valve, valve type and surgical risk.
 METHOD(S): We made a systematic literature search for studies with
>=100 patients reporting the incidence and adjusted predictors of PPI
after TAVI. Subgroup analyses examined these features according to
generation of valve, specific valve type and surgical risk.
 RESULT(S): We obtained data from 43 studies, encompassing 29,113
patients. PPI rates ranged from 6.7% - 39.2% in individual studies with a
pooled incidence of 19% (95% CI 16-21). Independent predictors for PPI
were age (OR 1.05; 95% CI: 1.01-1.09), left bundle branch block (LBBB)
(OR: 1.45; 95% CI: 1.12 to 1.77), right bundle branch block (RBBB) (OR:
4.15; 95% CI: 3.23 to 4.88), implantation depth (OR: 1.18; 95% CI: 1.11 to
1.26) and self-expanding valve prosthesis (OR 2.99; 95% CI: 1.39-4.59).
Among subgroups analyzed according to valve type, valve generation and
surgical risk, independent predictors were RBBB, self-expanding valve
type, first degree atrioventricular block and implantation depth.
 CONCLUSION(S): The principle independent predictors for PPI following
TAVI are age, RBBB, LBBB, self-expanding valve type and valve implantation
depth. These characteristics should be taken into account in
pre-procedural assessment to reduce PPI rates. PROSPERO ID
CRD42020164043. Copyright Published on behalf of the European Society
of Cardiology. All rights reserved. © The Author(s) 2020. For
permissions please email: journals.permissions@oup.com.

<33>
Accession Number
633652486
Title
Current clinical management of acute myocardial infarction complicated by
cardiogenic shock.
Source
Expert review of cardiovascular therapy. (no pagination), 2020. Date of
Publication: 08 Dec 2020.
Author
El Nasasra A.; Zeymer U.
Institution
(El Nasasra, Zeymer) Klinikum Ludwigshafen, Ludwigshafen, Germany
(Zeymer) Institut fur Herzinfarktforschung Ludwigshafen, Germany
Publisher
NLM (Medline)
Abstract
INTRODUCTION: Cardiogenic shock (CS) remains the leading cause of death
among patients admitted with acute myocardial infarction (AMI). Early
restoration of blood flow of the infarct-related artery is of paramount
importance, either with percutaneous coronary intervention (PCI) or with
coronary artery bypass grafting (CABG). In addition early risk
stratification is a critical task and required to guide complex decisions
on management and therapy of CS after AMI. The use of short-term
mechanical circulatory support (MCS) is increasing, although evidence for
their effectiveness is limited. AREAS COVERED: We review the evidence for
early revascularization of the culprit-lesion and risk stratification in
patients with AMI complicated by cardiogenic shock. The current data for
the use of MCS will be discussed and put into clinical perspective. EXPERT
OPINION: The SHOCK trial has introduced an early invasive strategy with
subsequent revascularization as standard of care in patients with AMI
complicated by CS. In clinical practice PCI is the by far the most often
used revascularization therapy in CS. Most important is restoration of
normal flow (so called TIMI 3 patency) of the infarct artery to reduce
mortality. Therefore, all efforts including intense antithrombotic therapy
should be made to achieve TIMI 3 patency. Around three quarters of
patients with CS have multivessel coronary artery disease. According to
the results of the CULPRIT-SHOCK trial PCI of the culprit lesion only is
recommended as the preferred revascularization strategy in these patients,
while additional lesions can be revascularized during a staged procedure.
Immediate multivessel PCI could be performed in some specific angiographic
scenarios, such as subtotal non-culprit lesions with reduced Thrombolysis
In Myocardial Infarction (TIMI)-flow, or multiple possible culprit
lesions. However, this should be considered on an individual basis. CABG
should be performed only in case of failed PCI and coronary anatomies not
suitable for PCI. However, small case series report good outcomes in
selected patients with CS undergoing CABG. Therefore, a randomized trial
comparing PCI and CABG in patients with CS and multivessel disease seems
warranted. Hopefully such a trial will take place to determine the optimal
revascularization therapy in CS. One problem might be to find a sufficient
number of cardiac surgeons who are willing to operate such high-risk
surgical patients. The current evidence for the use of MCS in CS is
limited. The intra-aortic balloon bump (IABP) has been widely used for
many years. The randomized IABP-SHOCK II trial has shown that the use of
the intra-aortic balloon pump does not improve outcome, so its routine use
in CS is not recommended any more. It may be considered in patients with
mechanical complications as bridge to surgery. Patients treated with
active MCS demonstrated improved hemodynamics as shown by higher mean
arterial pressure and lower lactate levels, but had more bleeding and a
trend towards more femoral access complications. Since mortality in CS is
still around 40 % despite an early invasive approach the use of active MCS
is increasing in clinical practice, despite the lack of evidence from
randomized trials. Several randomized trials have been initiated. The
IMPELLA device is currently under investigation in the DanGer Shock trial
(NCT01633502). The trial has enrolled about half of the intended number of
patients and will need another 3-4 years to be completed. Two large trials
(EURO-SHOCK, NCT03813134 and ECLS-SHOCK, NCT03637205) are ongoing
evaluating the use of ECLS in severe cardiogenic shock. In our opinion so
far, the following strategies for MCS might be used: in predominant left
ventricular failure the IMPELLA CP device might be beneficial, while in
ongoing CPR and in respiratory failure the ECLS should be preferred.

<34>
Accession Number
633650043
Title
Meta-Analysis of Direct Oral Anticoagulants in Patients with Atrial
Fibrillation and Bioprosthetic Valves.
Source
The American journal of cardiology. (no pagination), 2020. Date of
Publication: 04 Dec 2020.
Author
Kheiri B.; Przybylowicz R.; Simpson T.F.; Alhamoud H.; Osman M.; Dalouk
K.; Nazer B.; Henrikson C.A.; Stecker E.
Institution
(Kheiri, Przybylowicz, Simpson, Dalouk, Nazer, Henrikson, Stecker) Knight
Cardiovascular Institute, Oregon Health & Science University, OR,
Portland, United States
(Alhamoud, Osman) Division of Cardiology, West Virginia University School
of Medicine, Morgantown, United States
Publisher
NLM (Medline)

<35>
Accession Number
633647372
Title
Transcatheter Mitral Valve Repair in Patients with Heart Failure: A
Meta-Analysis.
Source
Cardiology (Switzerland). (no pagination), 2020. Date of Publication:
2020.
Author
Vallakati A.; Hasan A.K.; Boudoulas K.D.
Institution
(Vallakati, Hasan, Boudoulas) Division of Cardiovascular Diseases, Ohio
State University, Wexner Medical Center, 410 W 10th Avenue, Columbus, OH
43210, United States
Publisher
S. Karger AG
Abstract
Background: Severe secondary mitral regurgitation (MR) is associated with
poor prognosis in heart failure patients with left ventricular systolic
dysfunction. Few observational and randomized controlled studies
demonstrated the efficacy of transcatheter mitral valve repair in heart
failure patients with significant MR. A meta-analysis of published studies
was performed to evaluate the role of transcatheter mitral valve repair
using the MitraClip device in heart failure patients with significant
secondary MR. Method(s): A literature search was performed using
PubMed, Cochran CENTRAL, and Embase databases using the search terms
"percutaneous mitral valve repair"or "transcatheter mitral valve
repair"and "heart failure."Studies that compared medical therapy plus
transcatheter mitral valve repair using MitraClip to medical therapy alone
in heart failure patients with significant secondary MR were included for
pooled analysis. A random-effects model with the Mantel-Haenszel method
was used to analyze the data. Result(s): Four studies, 2 randomized
controlled and 2 nonrandomized studies met the criteria for analysis.
Pooled analysis included a total of 1,421 patients, of which 746 patients
underwent transcatheter mitral valve repair and 675 patients received
medical therapy alone. When compared to medical therapy, transcatheter
mitral valve repair significantly decreased all-cause mortality (OR 0.58,
95% CI 0.37-0.91; p = 0.02). A trend toward significant reduction in
rehospitalizations (OR 0.35, 95% CI 0.12-1.00; p = 0.05) was also
observed. Periprocedural complications ranged from 7.5 to 12.6%.
 Conclusion(s): Evidence from pooled analysis suggests that
transcatheter mitral valve repair using MitraClip on top of medical
therapy, in appropriately selected symptomatic heart failure patients with
significant secondary MR, provides survival benefit and may decrease
hospitalizations when compared with guideline-directed medical therapy
alone. Copyright © 2020

<36>
Accession Number
2007372360
Title
Downstream or upstream administration of P2Y12 receptor blockers in non-ST
elevated acute coronary syndromes: study protocol for a randomized
controlled trial.
Source
Trials. 21 (1) (no pagination), 2020. Article Number: 966. Date of
Publication: December 2020.
Author
Tarantini G.; Mojoli M.; Varbella F.; Caporale R.; Rigattieri S.; Ando G.;
Cirillo P.; Pierini S.; Santarelli A.; Sganzerla P.; De Cesare N.;
Limbruno U.; Lupi A.; Ricci R.; Cernetti C.; Favero L.; Saia F.; Roncon
L.; Gasparetto V.; Ferlini M.; Ronco F.; Ferri L.; Trabattoni D.; Russo
A.; Guiducci V.; Penzo C.; Tarantino F.; Mauro C.; Marchese A.;
Castiglioni B.; La Manna A.; Martinato M.; Gregori D.; Angiolillo D.J.;
Musumeci G.
Institution
(Tarantini, Martinato, Gregori) Department of Cardiac, Thoracic, and
Vascular Sciences and Public Health, Policlinico Universitario, University
of Padova, Via Giustiniani 2, Padova 35128, Italy
(Mojoli) Ospedale Santa Maria degli Angeli, Pordenone, Italy
(Varbella) Ospedali Riuniti, Rivoli, Italy
(Caporale) Ospedale Civile dell'Annunziata, Cosenza, Italy
(Rigattieri) Sandro Pertini Hospital, Rome, Italy
(Ando) Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino",
Messina, Italy
(Cirillo) University of Naples Federico II, Naples, Italy
(Pierini) Ospedale Bassini, Cinisello Balsamo, Italy
(Santarelli) Ospedale Infermi, Rimini, Italy
(Sganzerla) Hospital of Treviglio Caravaggio, Treviglio, Italy
( De Cesare) Policlinico San Marco, Zingonia, Italy
(Limbruno) Azienda Ospedaliera Grosseto, Grosseto, Italy
(Lupi) Ospedale Universitario "Maggiore della Carita", Novara, Italy
(Ricci) Ospedale S. Spirito, Rome, Italy
(Cernetti, Favero) Ospedale di Treviso ULSS 2, Treviso, Italy
(Saia) University Hospital of Bologna Sant'Orsola-Malpighi, Bologna, Italy
(Roncon) Hospital Santa Maria della Misericordia, Rovigo, Italy
(Gasparetto) Casa di Cura Pederzoli, Peschiera, Italy
(Ferlini) IRCCS Policlinico San Matteo, Pavia, Italy
(Ronco) Ospedale dell'Angelo, Mestre, Italy
(Ferri) A.O. Ospedale di Lecco, Lecco, Italy
(Trabattoni) Centro Cardiologico Monzino, Milan, Italy
(Russo) Sant'Antonio Abate Hospital, Gallarate, Italy
(Guiducci) AO-IRCCS Santa Maria Nuova, Reggio Emilia, Italy
(Penzo) Azienda Ospedaliero Universitaria di Ferrara Arcispedale
Sant'Anna, Ferrara, Italy
(Tarantino) Morgagni-Pierantoni Hospital, Forli, Italy
(Mauro) Antonio Cardarelli Hospital, Naples, Italy
(Marchese) Anthea Hospital, Bari, Italy
(Castiglioni) ASST Sette Laghi, Varese, Italy
(La Manna) University Hospital Vittorio Emanuele, Catania, Italy
(Angiolillo) Division of Cardiology, University of Florida College of
Medicine, Jacksonville, FL, United States
(Musumeci) Division of Cardiology, Azienda Sanitaria Ospedaliera Ordine
Mauriziano, Torino, Italy
Publisher
BioMed Central Ltd
Abstract
Background: The optimal timing to administer a P2Y12 inhibitor in patients
presenting with a non-ST elevation acute coronary syndrome remains a topic
of debate. Pretreatment with ticagrelor before coronary anatomy is known
as a widely adopted strategy. However, there is poor evidence on how this
compares with administration of a P2Y12 inhibitor after defining coronary
anatomy (i.e., downstream administration). Moreover, there are limited
head-to-head comparisons of the two P2Y12 inhibitors-ticagrelor and
prasugrel-currently recommended by the guidelines. Study design: DUBIUS is
a phase 4, multicenter, parallel-group, double randomized study conducted
in NSTE-ACS patients designed to compare a pretreatment strategy
(including only ticagrelor) versus a downstream strategy (including
prasugrel or ticagrelor) and to compare downstream prasugrel with
downstream ticagrelor. A total of 2520 patients will be randomly assigned
to pretreatment with ticagrelor or to no pretreatment. The PCI group of
the downstream arm will be further randomized to receive prasugrel or
ticagrelor. The two primary hypotheses are that the downstream strategy is
superior to the upstream strategy and that downstream ticagrelor is
non-inferior to downstream prasugrel, both measured by the incidence of a
composite efficacy and safety endpoint of death from vascular causes,
non-fatal MI, or non-fatal stroke, and Bleeding Academic Research
Consortium (BARC) type 3, 4, and 5 bleedings. Conclusion(s): The
DUBIUS study will provide important evidence related to the benefits and
risks of pretreatment with ticagrelor compared with a strategy of no
pretreatment. Moreover, the clinical impact of using downstream ticagrelor
compared with downstream prasugrel will be assessed. Trial registration:
ClinicalTrials.gov NCT02618837. Registered on 1 December
2015. Copyright © 2020, The Author(s).

<37>
Accession Number
2008451744
Title
Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic
Plaque.
Source
Journal of the American College of Cardiology. 76 (20) (pp 2289-2301),
2020. Date of Publication: 17 Nov 2020.
Author
Stone G.W.; Maehara A.; Ali Z.A.; Held C.; Matsumura M.; Kjoller-Hansen
L.; Botker H.E.; Maeng M.; Engstrom T.; Wiseth R.; Persson J.; Trovik T.;
Jensen U.; James S.K.; Mintz G.S.; Dressler O.; Crowley A.; Ben-Yehuda O.;
Erlinge D.
Institution
(Stone) The Zena and Michael A. Wiener Cardiovascular Institute, Icahn
School of Medicine at Mount Sinai, New York, NY, United States
(Stone, Maehara, Ali, Matsumura, Mintz, Dressler, Crowley, Ben-Yehuda)
Cardiovascular Research Foundation, New York, NY, United States
(Maehara, Ali) NewYork-Presbyterian Hospital/Columbia University Irving
Medical Center, New York, NY, United States
(Held, James) Uppsala University and Uppsala Clinical Research, Uppsala,
Sweden
(Kjoller-Hansen) Zealand University Hospital, Roskilde, Denmark
(Botker, Maeng) Aarhus University Hospital, Aarhus, Denmark
(Engstrom) University of Copenhagen, Copenhagen, Denmark
(Wiseth) St. Olavs Hospital, Trondheim University Hospital, Trondheim,
Norway
(Persson) Danderyd Hospital, Karolinska Institute, Stockholm, Sweden
(Trovik) University Hospital of North Norway, Tromso, Norway
(Jensen) Sodersjukhuset AB, Stockholm, Sweden
(Ben-Yehuda) University of California San Diego, San Diego, CA, United
States
(Erlinge) Clinical Sciences, Lund University, Lund, Sweden
Publisher
Elsevier Inc.
Abstract
Background: Acute coronary syndromes most commonly arise from thrombosis
of lipid-rich coronary atheromas that have large plaque burden despite
angiographically appearing mild. Objective(s): This study sought to
examine the outcomes of percutaneous coronary intervention (PCI) of
non-flow-limiting vulnerable plaques. Method(s): Three-vessel imaging
was performed with a combination intravascular ultrasound (IVUS) and
near-infrared spectroscopy (NIRS) catheter after successful PCI of all
flow-limiting coronary lesions in 898 patients presenting with myocardial
infarction (MI). Patients with an angiographically nonobstructive stenosis
not intended for PCI but with IVUS plaque burden of >=65% were randomized
to treatment of the lesion with a bioresorbable vascular scaffold (BVS)
plus guideline-directed medical therapy (GDMT) versus GDMT alone. The
primary powered effectiveness endpoint was the IVUS-derived minimum lumen
area (MLA) at protocol-driven 25-month follow-up. The primary (nonpowered)
safety endpoint was randomized target lesion failure (cardiac death,
target vessel-related MI, or clinically driven target lesion
revascularization) at 24 months. The secondary (nonpowered) clinical
effectiveness endpoint was randomized lesion-related major adverse cardiac
events (cardiac death, MI, unstable angina, or progressive angina) at
latest follow-up. Result(s): A total of 182 patients were randomized
(93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter
stenosis of the randomized lesions was 41.6%; by near-infrared
spectroscopy-IVUS, the median plaque burden was 73.7%, the median MLA was
2.9 mm2, and the median maximum lipid plaque content was 33.4%.
Angiographic follow-up at 25 months was completed in 167 patients (91.8%),
and the median clinical follow-up was 4.1 years. The follow-up MLA in
BVS-treated lesions was 6.9 +/- 2.6 mm2 compared with 3.0 +/-
1.0 mm2 in GDMT alone-treated lesions (least square means
difference: 3.9 mm2; 95% confidence interval: 3.3 to 4.5; p <
0.0001). Target lesion failure at 24 months occurred in similar rates of
BVS-treated and GDMT alone-treated patients (4.3% vs. 4.5%; p = 0.96).
Randomized lesion-related major adverse cardiac events occurred in 4.3% of
BVS-treated patients versus 10.7% of GDMT alone-treated patients (odds
ratio: 0.38; 95% confidence interval: 0.11 to 1.28; p = 0.12).
 Conclusion(s): PCI of angiographically mild lesions with large plaque
burden was safe, substantially enlarged the follow-up MLA, and was
associated with favorable long-term clinical outcomes, warranting the
performance of an adequately powered randomized trial. (PROSPECT ABSORB
[Providing Regional Observations to Study Predictors of Events in the
Coronary Tree II Combined with a Randomized, Controlled, Intervention
Trial]; NCT02171065) Copyright © 2020 American College of
Cardiology Foundation

<38>
Accession Number
2010203073
Title
Long-term outcomes of patients with stable coronary disease and chronic
kidney dysfunction: 10-year follow-up of the Medicine, Angioplasty, or
Surgery Study II Trial.
Source
Nephrology Dialysis Transplantation. 35 (8) (pp 1369-1376), 2020. Date of
Publication: 01 Aug 2020.
Author
Lima E.G.; Charytan D.M.; Hueb W.; de Azevedo D.F.C.; Garzillo C.L.;
Favarato D.; Linhares Filho J.P.P.; Martins E.B.; Batista D.V.; Rezende
P.C.; Hueb A.C.; Franchini Ramires J.A.; Filho R.K.
Institution
(Lima, Hueb, de Azevedo, Garzillo, Favarato, Linhares Filho, Martins,
Batista, Rezende, Hueb, Franchini Ramires, Filho) Department of Clinical
Cardiology, Heart Institute (InCor), University of Sao Paulo, Sao Paulo,
Brazil
(Charytan) Department of Medicine, Brigham and Women's Hospital, Harvard
Medical School, Boston, MA, United States
Publisher
Oxford University Press
Abstract
Background. Chronic kidney disease (CKD) is associated with a worse
prognosis in patients with stable coronary artery disease (CAD); however,
there is limited randomized data on long-term outcomes of CAD therapies in
these patients. We evaluated long-term outcomes of CKD patients with CAD
who underwent randomized therapy with medical treatment (MT) alone,
percutaneous coronary intervention (PCI) or coronary artery bypass graft
surgery (CABG). Methods. Baseline estimated glomerular filtration rate
(eGFR) was obtained in 611 patients randomized to one of three therapeutic
strategies in the Medicine, Angioplasty, or Surgery Study II trial.
Patients were categorized in preserved renal function and mild or moderate
CKD groups depending on their eGFR (>=90, 89-60 and 59-30 mL/min/1.73
m2, respectively). The primary clinical endpoint, a composite
of overall death and myocardial infarction, and its individual components
were analyzed using proportional hazards regression (Clinical Trial
registration information: http://www.controlled-trials.com. Registration
number: ISRCTN66068876). Results. Of 611 patients, 112 (18%) had preserved
eGFR, 349 (57%) mild dysfunction and 150 (25%) moderate dysfunction. The
primary endpoint occurred in 29.5, 32.4 and 44.7% (P 1/4 0.02) for
preserved eGFR, mild CKD and moderate CKD, respectively. Overall mortality
incidence was 18.7, 23.8 and 39.3% for preserved eGFR, mild CKD and
moderate CKD, respectively (P 1/4 0.001). For preserved eGFR, there was no
significant difference in outcomes between therapies. For mild CKD, the
primary event rate was 29.4% for PCI, 29.1% for CABG and 41.1% for MT (P
1/4 0.006) [adjusted hazard ratio (HR) 1/4 0.26, 95% confidence interval
(CI) 0.07-0.88; P 1/4 0.03 for PCI versus MT; and adjusted HR 1/4 0.48;
95% CI 0.31-0.76; P 1/4 0.002 for CABG versus MT]. We also observed higher
mortality rates in the MT group (28.6%) compared with PCI (24.1%) and CABG
(19.0%) groups (P 1/4 0.015) among mild CKD subjects (adjusted HR 1/4
0.44, 95% CI 0.25-0.76; P 1/4 0.003 for CABG versus MT; adjusted HR 1/4
0.56, 95% CI 0.07-4.28; P 1/4 0.58 for PCI versus MT). Results were
similar with moderate CKD group but did not achieve significance.
Conclusions. Coronary interventional therapy, both PCI and CABG, is
associated with lower rates of events compared with MT in mild CKD
patients >10 years of follow-up. More study is needed to confirm these
benefits in moderate CKD. Copyright © 2020 Oxford University
Press. All rights reserved.

<39>
Accession Number
633332616
Title
Colchicine in patients with chronic coronary disease.
Source
New England Journal of Medicine. 383 (19) (pp 1838-1847), 2020. Date of
Publication: 05 Nov 2020.
Author
Nidorf S.M.; Fiolet A.T.L.; Mosterd A.; Eikelboom J.W.; Schut A.; Opstal
T.S.J.; The S.H.K.; Xu X.-F.; Ireland M.A.; Lenderink T.; Latchem D.;
Hoogslag P.; Jerzewski A.; Nierop P.; Whelan A.; Hendriks R.; Swart H.;
Schaap J.; Kuijper A.F.M.; van Hessen M.W.J.; Saklani P.; Tan I.; Thompson
A.G.; Morton A.; Judkins C.; Bax W.A.; Dirksen M.; Alings M.; Hankey G.J.;
Budgeon C.A.; Tijssen J.G.P.; Cornel J.H.; Thompson P.L.
Institution
(Nidorf, Xu, Ireland, Latchem, Whelan, Hendriks, Saklani, Tan, Thompson,
Morton, Thompson) GenesisCare Western Australia, Sir Charles Gairdner
Hospital, University of Western Australia, Perth, Australia
(Nidorf, Thompson) Heart and Vascular Research Institute, Sir Charles
Gairdner Hospital, University of Western Australia, Perth, Australia
(Hankey) Department of Neurology, Sir Charles Gairdner Hospital,
University of Western Australia, Perth, Australia
(Hankey, Thompson) Faculty of Health and Medical Sciences, University of
Western Australia, Perth, Australia
(Budgeon) School of Population and Global Health, University of Western
Australia, Perth, Australia
(Judkins) Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA,
Australia
(Thompson) Harry Perkins Institute of Medical Research, Nedlands, WA,
Australia
(Fiolet, Mosterd, Schut, The, Lenderink, Hoogslag, Jerzewski, Nierop,
Swart, Schaap, Kuijper, van Hessen, Dirksen, Alings, Cornel) Dutch Network
for Cardiovascular Research, University Medical Center Utrecht, Utrecht,
Netherlands
(Fiolet) Netherlands Heart Institute, University Medical Center Utrecht,
Utrecht, Netherlands
(Fiolet) Department of Cardiology, University Medical Center Utrecht,
Utrecht, Netherlands
(Mosterd, Alings) Julius Center for Health Sciences and Primary Care,
University Medical Center Utrecht, Utrecht, Netherlands
(Mosterd) Department of Cardiology, Meander Medical Center, Amersfoort,
Netherlands
(Opstal, Dirksen, Cornel) Department of Cardiology, Alkmaar, Netherlands
(Bax) Department of Internal Medicine, Alkmaar, Netherlands
(Opstal, Cornel) Department of Northwest Clinics, Alkmaar, Netherlands
(Opstal, Cornel) Department of Cardiology, Radboud University Medical
Center, Nijmegen, Netherlands
(The) Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and
Stadskanaal, Netherlands
(Lenderink) Department of Cardiology, Zuyderland Medical Center, Heerlen
and Sittard, Netherlands
(Hoogslag) Department of Cardiology, Isala Diaconessenhuis, Meppel,
Netherlands
(Jerzewski) Department of Cardiology, Gelre Hospitals, Apeldoorn,
Netherlands
(Nierop) Department of Cardiology, Franciscus Hospital, Rotterdam,
Netherlands
(Tijssen) Cardialysis, Rotterdam, Netherlands
(Swart) Department of Cardiology, D&A Research and Genetics, Sneek,
Netherlands
(Schaap, Alings) Department of Cardiology, Amphia and Breda, Netherlands
(Kuijper) Department of Cardiology, Spaarne Hospital, Haarlem and
Hoofddorp, Netherlands
(van Hessen) Department of Cardiology, Green Heart Hospital, Gouda,
Netherlands
(Tijssen) Department of Cardiology, Amsterdam UMC, Amsterdam, Netherlands
(Eikelboom) Department of Medicine, McMaster University, Hamilton, ON,
Canada
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND Evidence from a recent trial has shown that the
antiinflammatory effects of colchicine reduce the risk of cardiovascular
events in patients with recent myocardial infarction, but evidence of such
a risk reduction in patients with chronic coronary disease is limited.
METHODS In a randomized, controlled, double-blind trial, we assigned
patients with chronic coronary disease to receive 0.5 mg of colchicine
once daily or matching placebo. The primary end point was a composite of
cardiovascular death, spontaneous (nonprocedural) myocardial infarction,
ischemic stroke, or ischemia-driven coronary revascularization. The key
secondary end point was a composite of cardiovascular death, spontaneous
myocardial infarction, or ischemic stroke. RESULTS A total of 5522
patients underwent randomization; 2762 were assigned to the colchicine
group and 2760 to the placebo group. The median duration of follow-up was
28.6 months. A primary end-point event occurred in 187 patients (6.8%) in
the colchicine group and in 264 patients (9.6%) in the placebo group
(incidence, 2.5 vs. 3.6 events per 100 person-years; hazard ratio, 0.69;
95% confidence interval [CI], 0.57 to 0.83; P<0.001). A key secondary
end-point event occurred in 115 patients (4.2%) in the colchicine group
and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1
events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92;
P=0.007). The incidence rates of spontaneous myocardial infarction or
ischemia-driven coronary revascularization (composite end point),
cardiovascular death or spontaneous myocardial infarction (composite end
point), ischemia-driven coronary revascularization, and spontaneous
myocardial infarction were also significantly lower with colchicine than
with placebo. The incidence of death from noncardiovascular causes was
higher in the colchicine group than in the placebo group (incidence, 0.7
vs. 0.5 events per 100 person-years; hazard ratio, 1.51; 95% CI, 0.99 to
2.31). CONCLUSIONS In a randomized trial involving patients with chronic
coronary disease, the risk of cardiovascular events was significantly
lower among those who received 0.5 mg of colchicine once daily than among
those who received placebo. Copyright © 2020 Massachusetts
Medical Society.

<40>
Accession Number
628282706
Title
Treatment practices and lipid profile of patients with acute coronary
syndrome: results from a tertiary care hospital.
Source
Acta Cardiologica. 75 (6) (pp 527-534), 2020. Date of Publication: October
2020.
Author
Farmakis I.; Zafeiropoulos S.; Kartas A.; Boulmpou A.; Nevras V.;
Papadimitriou I.; Tampaki A.; Vlachou A.; Markidis E.; Koutsakis A.;
Ziakas A.; Karvounis H.; Giannakoulas G.
Institution
(Farmakis, Zafeiropoulos, Kartas, Boulmpou, Nevras, Papadimitriou,
Tampaki, Vlachou, Markidis, Koutsakis, Ziakas, Karvounis, Giannakoulas)
Cardiology Department, AHEPA University Hospital, Aristotle University of
Thessaloniki, Thessaloniki, Greece
Publisher
Taylor and Francis Ltd.
Abstract
Background: Considering the increasing burden of cardiovascular risk
factors and recent advances on the management of acute coronary syndromes
(ACS), we studied the epidemiological characteristics and treatment
strategies of patients presenting with ACS. We also evaluated the lipid
profile and attainment of lipid goals in a 'real world' clinical setting.
 Method(s): This was a substudy of IDEAL-LDL (Motivational
interviewing to support low-density lipoprotein cholesterol (LDL-C)
therapeutic goals and lipid-lowering therapy compliance in patients with
acute coronary syndromes), a single-centre, prospective, randomised
controlled trial. Baseline data from a total of 357 ACS patients were
gathered using standardised methods. Result(s): Median age of
patients was 60 years and 81.2% were males. Arterial hypertension and
smoking were the most prevalent risk factors for coronary artery disease
(CAD). Patients with ST-elevation myocardial infarction (STEMI) were
heavier smokers, but were younger and exercised more compared to those
with non-ST-elevation acute coronary syndrome (NSTE-ACS). Conversely, more
NSTE-ACS patients had arterial hypertension, dyslipidaemia and diabetes
mellitus. One-fifth of ACS patients was treated conservatively without a
percutaneous coronary intervention (PCI). A combination of statin, dual
antiplatelet therapy and beta-blockers were prescribed to 79.6% of
patients upon discharge. A renin-angiotensin-aldosterone system inhibitor
and a beta-blocker were prescribed to 67.3 and 91.8% of patients with LVEF
<=40%, respectively. Of patients with prior history of CAD, 63.1%, 71.4%
and 58.3% received regularly statins, antiplatelets and beta-blocker
treatment, respectively. Only 22.3% of these CAD patients had an optimal
LDL-C of <70 mg/dl at admission. Conclusion(s): In hospitalised
patients with ACS, management practices differed by ACS type and discharge
medication was, mostly, in line with the latest guidelines. However,
medication adherence and lipid lowering goals of secondary CAD prevention
were largely unachieved. Copyright © 2019 Belgian Society of
Cardiology.

<41>
Accession Number
2008417187
Title
Meta-Analysis of Bioprosthetic Valve Thrombosis After Transcatheter Aortic
Valve Implantation.
Source
American Journal of Cardiology. 138 (pp 92-99), 2021. Date of Publication:
01 Jan 2021.
Author
Rheude T.; Pellegrini C.; Stortecky S.; Marwan M.; Xhepa E.; Ammon F.;
Pilgrim T.; Mayr N.P.; Husser O.; Achenbach S.; Windecker S.; Cassese S.;
Joner M.
Institution
(Rheude, Pellegrini, Xhepa, Cassese, Joner) Klinik fur Herz- und
Kreislauferkrankungen, Deutsches Herzzentrum Munchen, Technische
Universitat Munchen, Munich, Germany
(Stortecky, Pilgrim, Windecker) Department of Cardiology, Bern University
Hospital, University of Bern, Bern, Switzerland
(Marwan, Ammon, Achenbach) Department of Cardiology,
Friedrich-Alexander-Universitat Erlangen-Nurnberg, Erlangen, Germany
(Husser) Klinik fur Innere Medizin I, Kardiologie, St. Johannes-Hospital
Dortmund, Dortmund, Germany
(Mayr) Institut fur Anasthesiologie, Deutsches Herzzentrum Munchen,
Technische Universitat Munchen, Munich, Germany
(Joner) DZHK (German Centre for Cardiovascular Research), Munich Heart
Alliance, Munich, Germany
Publisher
Elsevier Inc.
Abstract
Bioprosthetic valve thrombosis may complicate transcatheter aortic valve
implantation (TAVI). This meta-analysis sought to evaluate the prevalence
and clinical impact of subclinical leaflet thrombosis (SLT) and clinical
valve thrombosis (CVT) after TAVI. We summarized diagnostic strategies,
prevalence of SLT and/or CVT and estimated their impact on the risk of
all-cause death and stroke. Twenty studies with 12,128 patients were
included. The prevalence of SLT and CVT was 15.1% and 1.2%, respectively.
The risk of all-cause death was not significantly different between
patients with SLT (relative risk [RR] 0.77; p = 0.22) and CVT (RR 1.29; p
= 0.68) compared with patients without. The risk of stroke was higher in
patients with CVT (RR 7.51; p <0.001) as compared with patients without,
while patients with SLT showed no significant increase in the risk of
stroke (RR 1.81; p = 0.17). Reduced left ventricular function was
associated with increased prevalence, while oral anticoagulation was
associated with reduced prevalence of bioprosthetic valve thrombosis.
Bioprosthetic valve thrombosis is frequent after TAVI, but does not
increase the risk of death. Clinical valve thrombosis is associated with a
significantly increased risk of stroke. Future studies should focus on
prevention and treatment of bioprosthetic valve thrombosis. Copyright
© 2020 Elsevier Inc.

<42>
Accession Number
2008362965
Title
Aortic valve sparing surgery. Results to 9 years.
Source
Cirugia Cardiovascular. 27 (6) (pp 236-245), 2020. Date of Publication: 01
Nov 2020.
Author
Alvarez-Cabo R.; Vigil-Escalera C.; Escalera A.E.; Meana B.; Martin M.; de
la Hera J.M.; Salmeron C.; Diaz R.; Hernandez-Vaquero D.; Meca J.; Mencia
P.; Zabala M.; Callejo F.; Llosa J.C.; Morales C.; Silva J.
Institution
(Alvarez-Cabo, Vigil-Escalera, Escalera, Meana, Salmeron, Diaz,
Hernandez-Vaquero, Meca, Mencia, Zabala, Callejo, Llosa, Morales, Silva)
Servicio de Cirugia Cardiaca, Area del Corazon, Hospital Universitario
Central de Asturias (HUCA), Oviedo, Asturias, Spain
(Martin, de la Hera) Servicio de Cardiologia, Area del Corazon, Hospital
Universitario Central de Asturias (HUCA), Oviedo, Asturias, Spain
Publisher
Elsevier Doyma
Abstract
Introduction and objectives: Clinical practice guidelines recommend, in
young patients and experienced centers, aortic valve sparing surgery for
the treatment of aortic regurgitation as an alternative to aortic valve
replacement. It is a complex surgery, but demanded more frequently. We
must consider it as a therapeutic option and explain its results.
 Method(s): Prospective, non randomized, analysis of 138 patients
operated on with aortic valve sparing surgery (2011-2019). Result(s):
They presented: mean-age 58.1+/-14.2 years, 33 (23.9%) women, 9 (6.5%)
emerging; EUROSCORE-II: 3.35+/-2.9, EUROSCORE-LOGISTIC: 9.29+/-7. Valve
morphology was: 83 (60.1%)-tricuspid, 44 (31.9%)-bicuspid, 11
(8%)-unicuspid. Procedures performed: (valve-reimplantation [DAVID] +
aortic-plasty): 78 (56.5%); (aortic-remodeling [YACOUB] + aortic-plasty):
22 (15.9%); aortic-plasty+supracoronary-tube: 15 (10.9%); aortic-plasty:
23 (16.7%). The 69.36% of aortic leafleats required multiple techniques:
(63.5%) central-plication, (10.3%) decalcification and (20.9%)
pericardium-plasty. There was reoperation for bleeding 4 (2.9%). Eight
(5.8%) patients died in the immediate postoperative period (3.9% of
electives). Preoperative aortic regurgitation was: I-II(18.1%), III(17.4%)
and IV(64.5%). Intra-operative regurgitation grade II persisted in 16
(11.6%) patients, converting to aortic prostheses. The mean follow-up was
44.2+/-28.6 (median 42.5) months. At 9 years they are free of aortic
regurgitation >= III: 83.5% (whole-series); 84.6% (aortic-root-treatment
[DAVID+YACOUB]) vs. 81.9% (no-aortic-root-treatment) (p=0.4); 88.8%
(DAVID), 63.2% (YACOUB), 85.7% (aortic-plasty+supracoronary-tube) and
78.3% (aortic-plasty) (p=0.22); 63.5% (pericardium-plasty) vs. 97.7%
(without pericardium-plasty) (p<0.0001). And they are free of
re-operation: 88.4% (whole-series); 89.7% (aortic-root-treatment
[DAVID+YACOUB]) vs. 85.8% (no-aortic-root-treatment) (p=0.27); 89.5%
(DAVID), 93.3% (YACOUB), 92.8% (aortic-plasty+supracoronary-tube) and
78.3% (aortic-plasty) (p=0.24); 71.5% (pericardium-plasty) vs.
100%(without pericardium-plasty) (p<0.0001). At follow-up there were
endocarditis in 2 (1.75%) patients, there were no thromboembolic events.
 Conclusion(s): The durability of aortic valve sparing surgery is
good, without significant differences between different types of
techniques; the use of heterologous pericardium is the main cause of
reduced durability. Copyright © 2020 Sociedad Espanola de Cirugia
Cardiovascular y Endovascular

<43>
Accession Number
2008476014
Title
Predictive value of early cardiac magnetic resonance imaging functional
and geometric indexes for adverse left ventricular remodelling in patients
with anterior ST-segment elevation myocardial infarction: A report from
the CIRCUS study.
Source
Archives of Cardiovascular Diseases. 113 (11) (pp 710-720), 2020. Date of
Publication: November 2020.
Author
Pezel T.; Besseyre des Horts T.; Schaaf M.; Croisille P.; Biere L.;
Garcia-Dorado D.; Jossan C.; Roubille F.; Cung T.-T.; Prunier F.; Meyer
E.; Amaz C.; Derumeaux G.; de Poli F.; Hovasse T.; Gilard M.; Bergerot C.;
Thibault H.; Ovize M.; Mewton N.
Institution
(Pezel) Inserm, UMRS 942, Department of Cardiology, Lariboisiere Hospital,
Paris University, AP-HP, Paris 75010, France
(Pezel) Division of Cardiology, Johns-Hopkins University, Baltimore, MD
21287-0409, United States
(Besseyre des Horts, Schaaf, Jossan, Amaz, Bergerot, Thibault, Ovize,
Mewton) Inserm 1407, Clinical Investigation Centre and Heart Failure
Department, Cardiovascular Hospital Louis-Pradel, hospices civils de Lyon,
universite Claude-Bernard Lyon 1, Bron 69677, France
(Croisille) Radiology Department, University Hospital of Saint-Etienne,
Saint-Priest-en-Jarez 42270, France
(Biere, Prunier) Cardiology Division, University Hospital of Angers,
Angers 49100, France
(Garcia-Dorado) CIBERCV, Hospital Universitari Vall d'Hebron & Research
Institute, Universitat Autonoma de Barcelona, Barcelona 08035, Spain
(Roubille, Cung) UMR5203, UMR661, Cardiology Division, University Hospital
of Montpellier, University of Montpellier 1 and 2, Montpellier 34295,
France
(Meyer) Rangeuil Hospital, University Hospital of Toulouse, Paul-Sabatier
University, Toulouse 31400, France
(Derumeaux) DHU-ATVB, Henri-Mondor Hospital, Paris-Est Creteil University,
AP-HP, Creteil 94010, France
(de Poli) Cardiology Division, Haguenau Hospital, Haguenau 67500, France
(Hovasse) Cardiology Division, Jacques-Cartier Institute, Massy 91300,
France
(Gilard) Department of Cardiology, Brest University Hospital, Brest 29200,
France
Publisher
Elsevier Masson s.r.l.
Abstract
Background: Postinfarction adverse left ventricular (LV) remodelling is
strongly associated with heart failure events. Conicity index, sphericity
index and LV global functional index (LVGFI) are new LV remodelling
indexes assessed by cardiac magnetic resonance (CMR). Aim(s): To
assess the predictive value of the new indexes for 1-year adverse LV
remodelling in patients with anterior ST-segment elevated myocardial
infarction (STEMI). Method(s): CMR studies were performed in 129
patients with anterior STEMI (58 +/- 12 years; 78% men) from the
randomized CIRCUS trial (CMR substudy) treated with primary percutaneous
coronary intervention and followed for the occurrence of major adverse
cardiovascular events (MACE) (death or hospitalization for heart failure).
Conicity index, sphericity index, LVGFI, infarct size and microvascular
obstruction (MVO) were assessed by CMR performed 5 +/- 4 days after
coronary reperfusion. Adverse LV remodelling was defined as an increase in
LV end-diastolic volume of >=15% by transthoracic echocardiography at 1
year. Result(s): Adverse LV remodelling occurred in 27% of patients
at 1 year. Infarct size and MVO were significantly predictive of adverse
LV remodelling: odds ratio [OR] 1.03, 95% confidence interval [CI]
1.01-1.05 (P < 0.001) and OR 1.12, 95% CI 1.05-1.22 (P < 0.001),
respectively. Among the newly tested indexes, only LVGFI was significantly
predictive of adverse LV remodelling (OR 1.10, 95% CI 1.03-1.16; P =
0.001). In multivariable analysis, infarct size remained an independent
predictor of adverse LV remodelling at 1 year (OR 1.05, 95% CI 1.02-1.08;
P < 0.001). LVGFI and infarct size were associated with occurrence of
MACE: OR 1.21, 95% CI 1.08-1.37 (P < 0.001) and OR 1.02, 95% CI 1.00-1.04
(P = 0.018), respectively. Conicity and sphericity indexes were not
associated with MACE. Conclusion(s): LVGFI was associated with
adverse LV remodelling and MACE 1 year after anterior STEMI. Copyright
© 2020

<44>
Accession Number
2010119061
Title
Functional and Echocardiographic Improvement After Transcatheter Repair
for Tricuspid Regurgitation: A Systematic Review and Pooled Analysis.
Source
JACC: Cardiovascular Interventions. 13 (23) (pp 2719-2729), 2020. Date of
Publication: 14 Dec 2020.
Author
Montalto C.; Sticchi A.; Crimi G.; Laricchia A.; Khokhar A.; Giannini F.;
Ferlini M.; Colombo A.; Latib A.; Mangieri A.
Institution
(Montalto, Crimi, Ferlini) Division of Cardiology, Fondazione IRCCS
Policlinico San Matteo, Pavia, Italy
(Sticchi, Crimi) Campus Bio-Medico di Roma, Rome, Italy
(Sticchi, Crimi, Laricchia, Khokhar, Giannini, Colombo, Mangieri) GVM Care
and Research, Maria Cecilia Hospital, Cotignola, Italy
(Crimi) Interventional Cardiology Unit, Thoraco Vascular Department
(DICATOV), IRCCS Policlinico San Martino, Genova, Italy
(Latib) Montefiore Medical Center, New York, NY, United States
Publisher
Elsevier Inc.
Abstract
Objectives: The aim of this study was to assess the feasibility, efficacy,
and clinical outcomes of transcatheter repair of tricuspid regurgitation
(TR) in a pooled analysis of interventional studies. Background(s):
New percutaneous devices are available to treat severe TR, but the
evidence is sparse and limited to smaller cohorts. Method(s): Several
electronic databases were searched for interventional studies involving
percutaneous repair of TR. Devices used were the Cardioband, FORMA,
MitraClip, PASCAL, and Trialign. Outcomes included in the final analysis
were successful implantation, residual severe TR, post-procedural New York
Heart Association (NYHA) functional class III or IV, 6-min walk distance,
and echocardiographic parameters. Subgroup and meta-regression analysis
were performed to further explore residual heterogeneity. Result(s):
Seven studies and 454 patients undergoing transcatheter tricuspid valve
repair were included in the pooled analysis; 95% of patients had at least
severe TR, and 91% were in NYHA functional class III or IV. Successful
implantation was achieved in 86% of patients. At the longest follow-up
available (weighted mean 265 days), 9% had died. Compared with baseline, a
significantly lower proportion of patients had at least severe TR
(relative risk: 0.38; 95% confidence interval: 0.20 to 0.70; p = 0.004)
and were in NYHA functional class III or IV (relative risk: 0.23; 95%
confidence interval: 0.20 to 0.30; p < 0.001). Patients also experienced
increases in 6-min walk distance (mean difference +64.6 m; p < 0.001) and
significant reductions in tricuspid valve annular diameter (mean
difference -3 mm; p < 0.001), while left and right ventricular function
did not change significantly. Conclusion(s): A strategy of
transcatheter repair for severe TR appears to be feasible, effective, and
associated with improved clinical outcomes at mid-term
follow-up. Copyright © 2020 American College of Cardiology
Foundation

<45>
Accession Number
2004207266
Title
Honorary authorship in cardiothoracic surgery.
Source
Journal of Thoracic and Cardiovascular Surgery. 161 (1) (pp 156-162.e1),
2021. Date of Publication: January 2021.
Author
Noruzi A.; Takkenberg J.J.M.; Kayapa B.; Verhemel A.; Gadjradj P.S.
Institution
(Noruzi, Takkenberg) Department of Cardiothoracic Surgery, Erasmus Medical
Centre, Rotterdam, Netherlands
(Kayapa, Verhemel, Gadjradj) Department of Neurosurgery, Leiden University
Medical Centre, Leiden, Netherlands
Publisher
Mosby Inc.
Abstract
Background: Honorary authorship (HA) refers to enlisted authors who did
not make sufficient contributions to a paper according to the guidelines,
as defined by the International Committee of Medical Journal Editors
(ICMJE). This study assessed the proportion of, and factors associated
with, HA in cardiothoracic surgical literature in 2017. Method(s):
Five cardiothoracic surgery journals were selected based on their impact
factors in 2017 for evaluation of HA. Articles were included in the
analysis if there was more than 1 listed author and if there was an
available E-mail address of the corresponding author. All corresponding
authors received an invitation to fill out our survey regarding their
paper in 2017. Result(s): In total, 1511 authors opened the
invitation, resulting in a total of 590 respondents (28.9%); 77.1% of all
authors were aware of the ICMJE guidelines and 47.0% were aware of the
general issue of HA. A total of 367 (62.7%) authors stated that at least
one of the coauthors had performed solely nonauthorship tasks, whereas 148
(25.3%) authors stated that they believed that their article contained at
least one honorary author. Having a senior member who was automatically
included on all submitted manuscripts and not being aware of the general
issue of HA were associated with significantly greater odds of having HA.
 Conclusion(s): Our results show that, despite the high awareness of
the ICMJE guidelines, there is a large discrepancy in perceived HA and
guideline-based HA. The authors plead for a better understanding and
implementation of the guidelines in a more transparent authorship
system. Copyright © 2019 The American Association for Thoracic
Surgery

<46>
Accession Number
2003779290
Title
Long-term survival after xenograft versus homograft aortic root
replacement: Results from a prospective randomized trial.
Source
Journal of Thoracic and Cardiovascular Surgery. 161 (1) (pp 57-65), 2021.
Date of Publication: January 2021.
Author
Melina G.; De Robertis F.; Gaer J.A.; Angeloni E.; El-Hamamsy I.; Bahrami
T.; Pepper J.R.; Takkenberg J.J.M.; Yacoub M.H.
Institution
(Melina, De Robertis, Gaer, Bahrami, Pepper) Royal Brompton and Harefield
NHS Foundation Trust, London, United Kingdom
(Melina, Angeloni) Department of Cardiac Surgery, Ospedale Sant'Andrea,
"Sapienza" Universita di Roma, Rome, Italy
(El-Hamamsy) Division of Cardiac Surgery, Montreal Heart Institute,
Universite de Montreal, Montreal, QC, Canada
(Takkenberg) Department of Cardiothoracic Surgery, Erasmus University
Medical Center, Rotterdam, Netherlands
(Yacoub) Imperial College, London, United Kingdom
Publisher
Mosby Inc.
Abstract
Objective: The study objective was to investigate the long-term survival
of patients undergoing xenograft versus homograft full root aortic valve
replacement. Method(s): A total of 166 patients requiring aortic
valve surgery were randomized to undergo the Freestyle (Medtronic Inc,
Minneapolis, Minn) bioprosthesis (N = 90) or a homograft (N = 76) full
root aortic valve replacement between 1997 and 2005 in a single
institution. Six patients randomly assigned to the homograft crossed over
to the Freestyle bioprosthesis because of the unavailability of suitably
sized homografts. All surgeons were required to adhere to the standard
surgical technique for homograft root implantation previously described.
Follow-up was 98.5% complete. Result(s): The mean age of the study
population was 65 +/- 8 years. Coronary artery bypass grafting was
associated with root aortic valve replacement in 76 of 166 patients (46%,
P = not significant between groups), and overall hospital mortality was
4.8% (8/166, P = not significant between groups). Median follow-up was
13.8 years (range, 0-21.8 years; 2033 patient-years). The Kaplan-Meier
survival analysis showed that there was no significant difference in
overall survival between the 2 arms at 5, 10, and 15 years. Twenty-year
survival was 28.3% +/- 5% for the Freestyle group versus 25.1% +/- 5.7%
for the homograft group (P =.90), which was comparable to the age- and
sex-matched UK general population. The freedom from aortic valve
reoperation at 20 years was comparable for the Freestyle group versus the
homograft group (67.9% +/- 8.8% vs 67.2% +/- 10.3%, respectively; P =.74).
 Conclusion(s): This is the first study to investigate the long-term
survival of xenograft versus homograft full root aortic valve replacement
from a prospective randomized trial. The observed 20-year overall survival
and freedom from aortic valve reoperation serve as a benchmark for future
studies on interventions for aortic valve disease in the
elderly. Copyright © 2019 The American Association for Thoracic
Surgery

<47>
Accession Number
2007593692
Title
Pectointercostal Fascial Block (PIFB) as a Novel Technique for
Postoperative Pain Management in Patients Undergoing Cardiac Surgery.
Source
Journal of Cardiothoracic and Vascular Anesthesia. 35 (1) (pp 116-122),
2021. Date of Publication: January 2021.
Author
Kumar A.K.; Chauhan S.; Bhoi D.; Kaushal B.
Institution
(Kumar, Chauhan, Kaushal) Department of Cardiac Anesthesiology, CN Center,
All India Institute of Medical Sciences, New Delhi, India
(Bhoi) Department of Anesthesiology, Pain Medicine and Critical Care, All
India Institute of Medical Sciences, New Delhi, India
Publisher
W.B. Saunders
Abstract
Objective: To determine the efficacy of pectointercostal fascial block in
relieving postoperative pain in patients undergoing cardiac surgery.
 Design(s): Single-blinded, prospective, randomized controlled trial.
 Setting(s): Single-center tertiary care teaching hospital.
 Participant(s): A total 40 participants undergoing cardiac surgery
aged 18 to 80 years. Intervention(s): Subjects were categorized into
2 groups of 20 each. In group 2 participants (interventional group),
bilateral pectointercostal fascial block was given using ropivacaine
injection 0.25% after completion of surgery, before shifting to the
intensive care unit. Measurements and Main Results: Postoperative
pain was measured after extubation at 0, 3, 6, and 12 hours, using a
numeric rating scale. Pain in group 2 was significantly less and lasted
for a longer duration than in group 1. Fentanyl requirement was
significantly higher in group 1 (1.06 +/- 0.12 micro/kg) than in group 2
(0.82 +/- 0.19 micro/kg). Conclusion(s): Pectointercostal fascial
block is an easy and efficient technique to reduce postoperative pain
after cardiac surgery. Copyright © 2020 Elsevier Inc.

<48>
Accession Number
2007334311
Title
Surgical Closure of Atrial Septal Defects in Young Children-A Review of
Anesthesia Care in Sternotomy and Thoracotomy Approaches.
Source
Journal of Cardiothoracic and Vascular Anesthesia. 35 (1) (pp 123-127),
2021. Date of Publication: January 2021.
Author
Karuppiah N.; Pehora C.; Haller C.; Taylor K.
Institution
(Karuppiah, Pehora, Taylor) Department of Anesthesia and Pain Medicine,
The Hospital for Sick Children, University of Toronto, Toronto, Canada
(Haller) Division of Cardiovascular Surgery, The Labatt Family Heart
Centre, The Hospital for Sick Children, Toronto, Canada
(Taylor) University of Toronto, Toronto, Canada
Publisher
W.B. Saunders
Abstract
Objectives: To review and compare the anesthetic management of atrial
septal defect (ASD) closures via mini lateral thoracotomy and sternotomy
approaches. Design(s): Retrospective analysis. Setting(s):
Single- center pediatric quaternary care hospital. Participant(s):
Patients aged <8 years of age undergoing ASD closure.
 Intervention(s): None. Measurements and Main Results: Outcome
measures included anesthetic technique, total amount and type of
analgesics, pain scores, procedure duration, complications, blood
transfusion requirements, and duration of stay. Each group had 15
patients. All patients in the sternotomy group received 0.25% bupivacaine
subcutaneous infiltration. Eleven of the 15 thoracotomy patients received
a fascial plane block, including serratus anterior and erector spinae
blocks, and 3 received subcutaneous infiltration. There was no difference
in opioid consumption intraoperatively or in the first 24 hours after
surgery (0.28 +/- 0.24 mg/kg morphine equivalents in thoracotomy group and
0.21 +/- 0.12 mg/kg in sternotomy group). Duration of procedure and
cardiopulmonary bypass duration were longer in the thoracotomy group.
There was no difference in cross-clamp duration between groups. There was
no difference in intensive care unit or hospital stay. Conclusion(s):
The authors reviewed perioperative pain management strategies used in
surgical ASD closures. Different fascial plane blocks were used. This
study has paved way to design a randomized control trial to compare
various regional techniques for cardiac surgeries and identified
opportunities for improved pain assessment scoring in children after
cardiac surgery. Copyright © 2020 Elsevier Inc.

<49>
Accession Number
2007244173
Title
Transcatheter Versus Surgical Aortic Valve Replacement: An Updated
Systematic Review and Meta-Analysis With a Focus on Outcomes by Sex.
Source
Heart Lung and Circulation. 30 (1) (pp 86-99), 2021. Date of Publication:
January 2021.
Author
Dagan M.; Yeung T.; Stehli J.; Stub D.; Walton A.S.; Duffy S.J.
Institution
(Dagan, Yeung, Stehli, Stub, Walton, Duffy) Department of Cardiology, The
Alfred Hospital, Melbourne, Vic, Australia
(Stub, Walton, Duffy) Baker IDI Heart and Diabetes Institute, Melbourne,
Vic, Australia
(Stub, Duffy) Centre of Cardiovascular Research and Education in
Therapeutics, Department of Epidemiology and Preventive Medicine, Monash
University, Melbourne, Vic, Australia
Publisher
Elsevier Ltd
Abstract
Background and Aims: Women at increased surgical risk have been shown to
have better outcomes with transcatheter aortic valve implantation (TAVI)
as compared to surgical valve replacement (SAVR). With the scope of TAVI
moving into low-surgical risk patients, we aimed to update the current
literature to include the new low-risk randomised controlled trial (RCT)
data in investigating outcomes by sex. Method(s): We systematically
searched MEDLINE (Ovid), PubMed, Cochrane Central Register of Controlled
Trials (CENTRAL), ClinicalTrials.gov and reference lists for relevant RCTs
comparing TAVI to SAVR published prior to 4 May 2020. Data extraction was
performed by two independent authors and included trial design details,
baseline characteristics and outcome data stratified by sex. Risk of bias
was assessed using the Cochrane Risk of Bias 2 (RoB 2) tool. Quantitative
synthesis of pooled data was performed using Mantel-Haenszel fixed or
random effects model. Q-statistic and the I2 test were used for
assessment of heterogeneity. Result(s): Our search yielded eight RCTs
included in the final quantitative synthesis. The overall pooled cohort
was 8,040, of whom 41.4% were female. Women had significantly lower rates
of one-year all-cause mortality (12.2% vs 17.7%, pooled OR 0.59, 95% CI
0.40-0.86) and one-year composite endpoint (9.7% vs 12.4%, pooled OR 0.73,
95% CI 0.58-0.92) with TAVI as compared to SAVR. The selective mortality
benefit with TAVI over SAVR in women did not persist to 5 years (pooled HR
1.01, 95% CI 0.87-1.17). At 30 days, women demonstrated lower rates of
major bleeding and acute kidney injury following TAVI compared to SAVR.
For men, these outcomes were similar regardless of type of intervention.
Both sexes were at increased risk of major vascular complications with
TAVI as compared to SAVR, however women demonstrated nearly double the
odds of major vascular complication with TAVI compared to men.
 Conclusion(s): Our updated meta-analysis demonstrates that at
one-year women undergoing TAVI have significantly lower mortality and
better safety outcomes compared to those undergoing SAVR. These benefits
are not seen in men. In the new low-risk era, these results are ever more
important for guiding appropriate patient selection. Copyright ©
2020 Australian and New Zealand Society of Cardiac and Thoracic Surgeons
(ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ)

<50>
Accession Number
2007243965
Title
Outcomes of Open Versus Percutaneous Access for Patients Enrolled in the
GREAT Registry.
Source
Annals of Vascular Surgery. 70 (pp 370-377), 2021. Date of Publication:
January 2021.
Author
Baxter R.D.; Hansen S.K.; Gable C.E.; DiMaio J.M.; Shutze W.P.; Gable D.R.
Institution
(Baxter) Department of Graduate Medical Education - General Surgery,
Baylor University Medical Center, Dallas, TX, United States
(Hansen) Department of Graduate Medical Education - Vascular Surgery,
Baylor University Medical Center, Dallas, TX, United States
(Gable) Texas A&M University, College Station, TX, United States
(DiMaio, Shutze, Gable) Division of Vascular Surgery, Baylor Scott and
White Heart Hospital, Texas Vascular Associates, Plano, TX, United States
Publisher
Elsevier Inc.
Abstract
Background: Arterial access and device delivery in endovascular aortic
repair (EVAR) and thoracic endovascular aortic repair (TEVAR) have evolved
from open femoral or iliac artery exposure to selective percutaneous
arterial access. Although regional application of percutaneous access for
these 2 procedures varies widely, the use of this technique continues to
increase. Currently, differences in the use of percutaneous access between
EVAR and TEVAR have not been well explored. The Gore Global Registry for
Endovascular Aortic Treatment (GREAT) registry collected relevant data for
evaluation of these issues and the comparative results between open and
percutaneous approaches in regard to complication rates and length of stay
(LOS). Method(s): This study was performed via a retrospective review
of patients from the GREAT registry (Clinicaltrials.gov no. NCT01658787).
The primary variable of this study was access site complications including
postoperative hematoma, vessel dissection, and pseudoaneurysm. Patients
were categorized by abdominal (EVAR) and thoracic (TEVAR) aortic
procedures using percutaneous-only, cutdown-only, and combined vascular
access techniques for a total of 6 groups. Standard statistical
methodology was used to perform single-variable and multivariable analysis
of a variety of covariates including LOS, geographical location of
procedure, procedural success rate, and access sheath size.
 Result(s): Of 4,781 patients from the GREAT registry, 3,837 (80.3%)
underwent EVAR and 944 (19.7%) underwent TEVAR with percutaneous-only
access techniques being used in 2,017 (42.2%) and cutdown-only in 2,446
(51.2%). There was variable application of percutaneous access by
geographic region with Australia and New Zealand using this technique more
frequently and Brazil using percutaneous access the least. No significant
difference in the rate of access site complications was detected between
the 6 groups of patients in the study; however, significantly lower rates
of access site complications were associated with percutaneous-only
compared with both cutdown-only and combined techniques (P = 0.03). In
addition, associated with significantly higher rates of access site
complications was longer LOS (P < 0.01). Average LOS was 5.2 days and was
higher in the TEVAR group (10.1 days) than that in EVAR (4.0 days, P <
0.05). Increased sheath size does not appear to increase the risk of
access site complication. Conclusion(s): There was no significant
difference found in the complication rate between percutaneous and cutdown
access techniques. This analysis demonstrates that percutaneous-only
access is safe, has low complication rates, and has lower LOS compared
with open access or combined access techniques. Copyright © 2020
Elsevier Inc.

<51>
Accession Number
2007684982
Title
Ultrasound-Guided Out-of-Plane Versus In-Plane Radial Artery Cannulation
in Adult Cardiac Surgical Patients.
Source
Journal of Cardiothoracic and Vascular Anesthesia. 35 (1) (pp 84-88),
2021. Date of Publication: January 2021.
Author
Arora N.R.; Maddali M.M.; Al-Sheheimi R.A.R.; Al-Mughairi H.;
Panchatcharam S.M.
Institution
(Arora, Maddali) Department of Cardiac Anesthesia, National Heart Center,
Royal Hospital, Muscat, Oman
(Al-Sheheimi, Al-Mughairi) Oman Medical Specialty Board, Muscat, Oman
(Panchatcharam) Department of Studies and Research, Oman Medical Specialty
Board, Muscat, Oman
Publisher
W.B. Saunders
Abstract
Objectives: The primary objective was to compare the rate of first-pass
radial arterial cannulation using out-of-plane ultrasound guidance with
in-plane imaging. The secondary endpoints were a comparison of the number
of times the cannula was redirected, the number of attempts, the number of
skin punctures, the incidence of hematoma, the time to completion of the
cannulation procedure, and the number of failed attempts between the 2
ultrasound imaging techniques. Design(s): A prospective, randomized,
observational study. Setting(s): A tertiary cardiac care center.
 Participant(s): Adult patients undergoing elective cardiac surgery.
 Intervention(s): Radial artery cannulation with ultrasound guidance.
 Measurements and Main Results: Eighty-four adult patients scheduled
for elective cardiac surgery were randomly assigned to the out-of-plane
ultrasound group (group I, n = 42) or the in-plane ultrasound group (group
II, n = 42) for left radial artery cannulation. A linear ultrasound probe
was used to identify the radial artery. In each approach, the number of
times first-pass success was achieved, the number of times the cannula was
redirected, the number of skin punctures, the incidence of hematomas, and
the number of failed attempts were recorded. The first-pass success rate
was greater in the in-plane ultrasound group and was statistically
significant (p = 0.007). In the out-of-plane ultrasound group, a larger
number of patients needed redirection of the cannula (p = 0.002). The
number of patients in whom the skin needed to be punctured more than once
was greater in the out-of-plane ultrasound group compared with the
in-plane ultrasound group (p = 0.002). The incidence of hematoma formation
and time to completion of the technique were similar in both groups (p =
0.241 and p = 0.792, respectively). Conclusion(s): In-plane
ultrasound guidance appeared to be superior for achieving a higher
first-pass success rate more often with minimal redirections and skin
punctures compared with out-of-plane ultrasound guidance. Copyright
© 2020 Elsevier Inc.

<52>
Accession Number
2007902495
Title
Safety of Enalapril in Infants: Data from the Pediatric Heart Network
Infant Single Ventricle Trial.
Source
Journal of Pediatrics. 227 (pp 218-223), 2020. Date of Publication:
December 2020.
Author
Mathur K.; Hsu D.T.; Lamour J.M.; Aydin S.I.
Institution
(Mathur, Hsu, Lamour, Aydin) Division of Pediatric Cardiology, Children's
Hospital at Montefiore/Albert Einstein College of Medicine, New York, NY,
United States
(Aydin) Division of Pediatric Critical Care, Children's Hospital at
Montefiore/Albert Einstein College of Medicine, New York, NY, United
States
Publisher
Mosby Inc.
Abstract
Objective: To assess the safety profile of angiotensin-converting enzyme
inhibitor therapy in infants with single ventricle. Study design: The
Pediatric Heart Network conducted a double-blind trial involving infants
with single ventricle physiology randomized to receive enalapril or
placebo and followed to 14 months of age. Data including demographics,
drug administration, hemodynamic monitoring, laboratory measurements,
adverse events, and survival were extracted from the public use data set
and compared between the placebo and enalapril-treated groups.
 Result(s): The Infant Single Ventricle trial randomized 230 patients,
with 115 patients in each group. Initial enalapril dose was 0.10 mg/kg/d
and median maximal dose was 0.38 mg/kg/d. There was no significant
difference in change in blood pressure at study drug initiation or when
resuming study drug after Glenn surgery. The incidence of hyperkalemia and
neutropenia did not differ between groups. Renal dysfunction occurred in
3% of the enalapril group and none of the placebo patients, which was not
statistically significant. There was a high frequency of serious adverse
events in both groups. There was no difference in the frequency of heart
transplant or death between groups. Conclusion(s): Enalapril did not
have sustained hemodynamic effects at initiation or up-titration of drug.
Creatinine and potassium were not different between groups, although renal
dysfunction occurred more often in the patients on enalapril. Although
efficacy of enalapril in neonates with single ventricle has not been
demonstrated, the safety profile of angiotensin-converting enzyme
inhibitors appears to be low risk in infants and children with significant
heart disease. Copyright © 2020 Elsevier Inc.

<53>
Accession Number
2006151338
Title
Percutaneous large-bore axillary access is a safe alternative to surgical
approach: A systematic review.
Source
Catheterization and Cardiovascular Interventions. 96 (7) (pp 1481-1488),
2020. Date of Publication: December 2020.
Author
Southmayd G.; Hoque A.; Kaki A.; Tayal R.; Rab S.T.
Institution
(Southmayd, Hoque, Rab) Division of Cardiology, Emory University School of
Medicine, Atlanta, GA, United States
(Kaki) Division of Cardiology, Ascension St. John Hospital, Detroit, MI,
United States
(Tayal) Division of Cardiology, RWJ Barnabas Health, Newark Beth Israel
Medical Center, Newark, NJ, United States
Publisher
John Wiley and Sons Inc
Abstract
Objectives: To systematically review relevant literature regarding
cardiovascular outcomes of large-bore axillary arterial access via
percutaneous and surgical approaches. Background(s): In patients with
severe peripheral arterial disease (PAD) undergoing cardiac interventions,
large-bore femoral access may be prohibitive. The axillary artery provides
an alternative vascular access for transcatheter aortic valve replacement
(TAVR) or mechanical circulatory support. There have been limited
comparisons of percutaneous transaxillary (pTAX) approach with the more
traditional surgical transaxillary (sTAX) approach. Method(s): Pubmed
and Medline databases were queried through January 2019 for studies
describing pTAX or sTAX approaches with TAVR or Impella insertion. Primary
outcomes were access-related mortality, 30-day mortality, stroke, major
vascular complications, and major bleeding. Result(s): One hundred
and fifty five studies were reviewed, with additional unpublished data
from 1 institution. Twenty-two studies met the inclusion criteria. Patient
data was heterogeneous, with 69% TAVR and 31% Impella use in the pTAX
group, and 96% TAVR and 4% Impella use in the sTAX group. There was more
cardiogenic shock in the pTAX group. When compared to surgical approach,
the percutaneous approach had similar 30-day mortality for TAVR (5.6% vs
4.6%, OR non-significant) and Impella (43.4% vs 38.6%, OR
non-significant), similar stroke rates (4.3% vs 4.2%, OR non-significant),
similar major vascular complications (2.8% vs 2.3%, OR non-significant)
and less major bleeding (2.7% vs 17.9%, OR significant).
 Conclusion(s): Data suggests large-bore pTAX access has similar
30-day mortality, stroke rates, and major vascular complications as sTAX
access, with less major bleeding. Additional studies are needed to
validate results. Copyright © 2020 Wiley Periodicals LLC.

<54>
Accession Number
633194874
Title
Overall and Cause-Specific Mortality in Randomized Clinical Trials
Comparing Percutaneous Interventions with Coronary Bypass Surgery: A
Meta-analysis.
Source
JAMA Internal Medicine. 180 (12) (pp 1638-1646), 2020. Date of
Publication: December 2020.
Author
Gaudino M.; Hameed I.; Farkouh M.E.; Rahouma M.; Naik A.; Robinson N.B.;
Ruan Y.; Demetres M.; Biondi-Zoccai G.; Angiolillo D.J.; Bagiella E.;
Charlson M.E.; Benedetto U.; Ruel M.; Taggart D.P.; Girardi L.N.; Bhatt
D.L.; Fremes S.E.
Institution
(Gaudino, Hameed, Rahouma, Naik, Robinson, Ruan, Girardi) Department of
Cardiothoracic Surgery, Weill Cornell Medicine, 525 E 68th St, New York,
NY 10065, United States
(Hameed) Section of Cardiothoracic Surgery, Yale School of Medicine, New
Haven, CT, United States
(Farkouh) Peter Munk Cardiac Centre, University of Toronto, Toronto, ON,
Canada
(Demetres) Samuel J. Wood Library and C. V. Starr Biomedical Information
Center, Weill Cornell Medicine, New York, NY, United States
(Biondi-Zoccai) Department of Medical-Surgical Sciences and
Biotechnologies, Sapienza University of Rome, Latina, Italy
(Biondi-Zoccai) Mediterranea Cardiocentro, Napoli, Italy
(Angiolillo) Division of Cardiology, Department of Medicine, University of
Florida College of Medicine-Jacksonville, Jacksonville, United States
(Bagiella) Department of Population Health Science and Policy, Icahn
School of Medicine at Mount Sinai, New York, NY, United States
(Charlson) Division of General Internal Medicine, Weill Cornell Medical
College, New York, NY, United States
(Benedetto) Bristol Heart Institute, University of Bristol, Bristol,
United Kingdom
(Ruel) University of Ottawa Heart Institute, Ottawa, ON, Canada
(Taggart) Nuffield Department of Surgical Sciences, John Radcliffe
Hospital, University of Oxford, Oxford, United Kingdom
(Bhatt) Brigham and Women's Hospital Heart and Vascular Center, Harvard
Medical School, Boston, MA, United States
(Fremes) Schulich Heart Centre, Sunnybrook Health Sciences Centre,
University of Toronto, Toronto, ON, Canada
Publisher
American Medical Association
Abstract
Importance: Mortality is a common outcome in trials comparing percutaneous
coronary intervention (PCI) with coronary artery bypass grafting (CABG).
Controversy exists regarding whether all-cause mortality or cardiac
mortality is preferred as a study end point, because noncardiac mortality
should be unrelated to the treatment. Objective(s): To evaluate the
difference in all-cause and cause-specific mortality in randomized
clinical trials (RCTs) comparing PCI with CABG for the treatment of
patients with coronary artery disease. Data Sources: MEDLINE (1946 to
the present), Embase (1974 to the present), and the Cochrane Library (1992
to the present) databases were searched on November 24, 2019. Reference
lists of included articles were also searched, and additional studies were
included if appropriate. Study Selection: Articles were considered for
inclusion if they were in English, were RCTs comparing PCI with
drug-eluting or bare-metal stents and CABG for the treatment of coronary
artery disease, and reported mortality and/or cause-specific mortality.
Trials of PCI involving angioplasty without stenting were excluded. For
each included trial, the publication with the longest follow-up duration
for each outcome was selected. Data Extraction and Synthesis: For data
extraction, all studies were reviewed by 2 independent investigators, and
disagreements were resolved by a third investigator in accordance with the
Preferred Reporting Items for Systematic Reviews and Meta-analyses
guideline. Data were pooled using fixed-and random-effects models.
 Main Outcomes and Measures: The primary outcomes were all-cause and
cause-specific (cardiac vs noncardiac) mortality. Subgroup analyses were
performed for PCI trials using drug-eluting vs bare-metal stents and for
trials involving patients with left main disease. Result(s):
Twenty-three unique trials were included involving 13620 unique patients
(6829 undergoing PCI and 6791 undergoing CABG; men, 39.9%-99.0% of study
populations; mean age range, 60.0-71.0 years). The weighted mean (SD)
follow-up was 5.3 (3.6) years. Compared with CABG, PCI was associated with
a higher rate of all-cause (incidence rate ratio, 1.17; 95% CI, 1.05-1.29)
and cardiac (incidence rate ratio, 1.24; 95% CI, 1.05-1.45) mortality but
also noncardiac mortality (incidence rate ratio, 1.19; 95% CI, 1.00-1.41).
 Conclusions and Relevance: Percutaneous coronary intervention was
associated with higher all-cause, cardiac, and noncardiac mortality
compared with CABG at 5 years. The significantly higher noncardiac
mortality associated with PCI suggests that even noncardiac deaths after
PCI may be procedure related and supports the use of all-cause mortality
as the end point for myocardial revascularization trials. Copyright
© 2020 American Medical Association. All rights reserved.

<55>
Accession Number
2004097924
Title
The importance of the Heart Team evaluation before transcatheter aortic
valve replacement: Results from the BRAVO-3 trial.
Source
Catheterization and Cardiovascular Interventions. 96 (7) (pp E688-E694),
2020. Date of Publication: December 2020.
Author
Camaj A.; Claessen B.E.; Mehran R.; Yudi M.B.; Power D.; Baber U.;
Hengstenberg C.; Lefevre T.; Van Belle E.; Giustino G.; Guedeney P.;
Sorrentino S.; Kupatt C.; Webb J.G.; Hildick-Smith D.; Hink H.U.;
Deliargyris E.N.; Anthopoulos P.; Sharma S.K.; Kini A.; Sartori S.;
Chandrasekhar J.; Dangas G.D.
Institution
(Camaj, Claessen, Mehran, Power, Baber, Giustino, Sharma, Kini, Sartori,
Chandrasekhar, Dangas) The Zena and Michael A. Wiener Cardiovascular
Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United
States
(Yudi) Austin Health, Heidelberg, VIC, Australia
(Hengstenberg) DZHK (German Centre for Cardiovascular Research), partner
site Munich Heart Alliance, Munich, Germany, and Deutsches Herzzentrum
Munchen, Technische Universitat Munchen, Munich, Germany
(Lefevre) Institut Cardio Vasculaire Paris Sud, Hopital Prive Jacques
Cartier, Massy, France
(Van Belle) Department of Cardiology and INSERM UMR 1011, University
Hospital, and CHRU Lille, Lille, France
(Guedeney) Sorbonne Universite, ACTION Study Group, INSERM UMRS_1166
Institut de cardiologie (AP-HP), Paris, France
(Sorrentino) Division of Cardiology, Department of Medical and Surgical
Sciences, Magna Graecia University, Catanzaro, Italy
(Kupatt) LMU Munich, Munich, Germany
(Webb) St. Paul's Hospital, Vancouver, BC, Canada
(Hildick-Smith) Sussex Cardiac Centre-Brighton & Sussex University
Hospitals NHS Trust, Brighton, East Sussex, United Kingdom
(Hink) Universitatsmedizin Mainz, Mainz, Germany
(Deliargyris) Science and Strategy Consulting Group, Basking Ridge, NJ,
United States
(Anthopoulos) Arena Pharmaceuticals, Inc., Zurich, Switzerland
Publisher
John Wiley and Sons Inc
Abstract
Background/Objectives: Clinicians use validated scores to risk-stratify
patients undergoing transcatheter aortic valve replacement (TAVR).
However, evaluation by the Heart Team often deems patients to be at higher
risk than their formal scores suggest. We sought to assess clinical
outcomes of TAVR patients defined as high-risk by the Heart Team's
assessment versus the patient's logistic EuroSCORE (LES). Method(s):
The BRAVO-3 trial randomized patients at high risk (LES >= 18, or deemed
inoperable by the Heart Team) to TAVR with periprocedural anticoagulation
with unfractionated heparin versus bivalirudin. Endpoints included net
adverse cardiac events (NACE: the composite of all-cause mortality, MI,
stroke, or bleeding), major adverse cardiovascular events (MACE: death,
MI, or stroke), the individual components of MACE, major vascular
complications, BARC >= 3b bleeding and VARC life-threatening bleeding at
30 days. We compared patients deemed high-risk based on LES >= 18 versus
high-risk by the Heart Team despite lower LES. Result(s): A total of
467/800 (58.4%) patients were deemed high-risk by the Heart Team despite
LES < 18. After multivariable analysis, there were no differences in the
odds of endpoints between groups (NACE, OR<inf>LES>=18</inf>: 1.32, 95% CI
0.86-2.02, p =.21; MACE, OR<inf>LES>=18</inf>: 1.27, 95% CI 0.72-2.25, p
=.41; major vascular complications, OR<inf>LES>=18</inf>: 0.97, 95% CI
0.65-1.44, p =.88; BARC >=3b, OR<inf>LES>=18</inf>: 1.38, 95% CI
0.82-2.33, p =.23; and VARC life-threatening bleeding,
OR<inf>LES>=18</inf>: 0.99, 95% CI 0.69-1.41, p =.95). Conclusion(s):
Patients undergoing TAVR and labeled high-risk by LES >= 18 or Heart Team
assessment despite LES < 18 have comparable short-term outcomes.
Assignment of high-risk status to over 50% of patients is attributable to
Heart Team's clinical assessment. Copyright © 2020 Wiley
Periodicals, Inc.

<56>
Accession Number
2003929359
Title
Impact of established cardiovascular disease on outcomes in the randomized
global leaders trial.
Source
Catheterization and Cardiovascular Interventions. 96 (7) (pp 1369-1378),
2020. Date of Publication: December 2020.
Author
Garg S.; Chichareon P.; Kogame N.; Takahashi K.; Modolo R.; Chang C.-C.;
Tomaniak M.; Fath-Ordoubadi F.; Anderson R.; Oldroyd K.G.; Stables R.H.;
Kukreja N.; Chowdhary S.; Galasko G.; Hoole S.; Zaman A.; Hamm C.W.; Steg
P.G.; Juni P.; Valgimigli M.; Windecker S.; Onuma Y.; Serruys P.W.
Institution
(Garg) Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust,
Blackburn, United Kingdom
(Chichareon, Kogame, Takahashi, Modolo) Department of Clinical and
Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC,
University of Amsterdam, Heart Center, Amsterdam, Netherlands
(Chichareon) Cardiology Unit, Department of Internal Medicine, Faculty of
Medicine, Prince of Songkla University, Songkhla, Thailand
(Modolo) Department of Internal Medicine, Cardiology Division, University
of Campinas (UNICAMP). Campinas, Brazil
(Chang, Tomaniak) Erasmus Medical Center, Thoraxcenter, Rotterdam,
Netherlands
(Tomaniak) First Department of Cardiology, Medical University of Warsaw,
Warsaw, Poland
(Fath-Ordoubadi) Manchester Heart Centre, Manchester Royal Infirmary,
Manchester University Foundation Trust, Manchester, United Kingdom
(Anderson) Department of Cardiology, University Hospital of Wales,
Cardiff, United Kingdom
(Oldroyd) West of Scotland Heart and Lung Centre, Golden Jubilee National
Hospital, Glasgow, United Kingdom
(Stables) Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
(Kukreja) Department of Cardiology, East and North Hertfordshire NHS
Trust, Hertfordshire, United Kingdom
(Chowdhary) Wythenshawe Hospital, Manchester University Foundation Trust,
Manchester, United Kingdom
(Galasko) Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS
Foundation Trust, Blackpool, United Kingdom
(Hoole) Department of Interventional Cardiology, Royal Papworth Hospital,
Cambridge, United Kingdom
(Zaman) Department of Cardiology, Freeman Hospital and Institute of
Cellular Medicine, Newcastle University, Newcastle-upon-Tyne, United
Kingdom
(Hamm) Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim,
Germany
(Steg) FACT, French Alliance for Cardiovascular Trials; Hopital Bichat,
AP-HP; Universite Paris-Diderot; and INSERM U-1148, Paris, France
(Steg) Royal Brompton Hospital, Imperial College, London, United Kingdom
(Juni) Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto,
Canada
(Valgimigli, Windecker) Department of Cardiology, Bern University
Hospital, Bern, Switzerland
(Onuma, Serruys) Department of Cardiology, National University of Ireland
Galway, Galway, Ireland
(Serruys) NHLI, Imperial College London, London, United Kingdom
Publisher
John Wiley and Sons Inc
Abstract
Objective: To investigate the impact of different anti-platelet strategies
on outcomes after percutaneous coronary intervention (PCI) in patients
with established cardiovascular disease (CVD). Method(s): GLOBAL
LEADERS was a randomized, superiority, all-comers trial comparing
one-month dual anti-platelet therapy (DAPT) with ticagrelor and aspirin
followed by 23-month ticagrelor monotherapy (experimental treatment) with
standard 12-month DAPT followed by 12-month aspirin monotherapy (reference
treatment) in patients treated with a biolimus A9-eluting stent.
Established CVD was defined as >=1 prior myocardial infarction, PCI,
coronary artery bypass operation, stroke, or established peripheral
vascular disease. The primary endpoint was a composite of all-cause death
or new Q-wave MI at 2-years. The secondary safety endpoint was BARC 3 or 5
bleeding. Exploratory secondary endpoints were the patient-orientated
composite endpoint and net adverse clinical events. Result(s): Among
the 15,761 patients in this cohort were 6,693 patients (42.5%) with
established CVD. Compared to those without established CVD, these patients
had significantly higher rates of the primary (5.1 vs. 3.3%,
HR1.59[1.36-1.86], p <.001) and secondary composite endpoints with no
significant differences in bleeding. There was a nonsignificant reduction
in the primary endpoint in patients with established CVD receiving the
experimental treatment (4.6 vs. 5.6%, HR0.82[0.66-1.02], p =.07). When
comparing patients without CVD to those with one or three territories of
CVD, the hazard ratio for the primary endpoint increased in unadjusted and
adjusted models. Conclusion(s): The poorer outcomes in patients with
established CVD are not mitigated by prolonged monotherapy with a potent
P2Y12 inhibitor suggesting a greater need to focus on modifiable risk
factors. Copyright © 2019 Wiley Periodicals, Inc.

<57>
Accession Number
2003927538
Title
Outcomes of patients who undergo percutaneous coronary intervention with
covered stents for coronary perforation: A systematic review and pooled
analysis of data.
Source
Catheterization and Cardiovascular Interventions. 96 (7) (pp 1360-1366),
2020. Date of Publication: December 2020.
Author
Nagaraja V.; Schwarz K.; Moss S.; Kwok C.S.; Gunning M.
Institution
(Nagaraja) Department of Cardiovascular Medicine, Heart and Vascular
Institute, Cleveland Clinic, Cleveland, OH, United States
(Schwarz) Cardiology Department, Worcestershire Royal Hospital, Worcester,
United Kingdom
(Moss) Orange Base Hospital, Orange, NSW, Australia
(Kwok) School of Primary, Community and Social Care, Keele University,
Stoke-on-Trent, United Kingdom
(Kwok, Gunning) Royal Stoke University Hospital, Stoke-on-Trent, United
Kingdom
Publisher
John Wiley and Sons Inc
Abstract
Objectives: This review aims to evaluate the adverse outcomes for patients
after treatment with covered stents. Background(s): Coronary
perforation is a potentially fatal complication of percutaneous coronary
revascularization which may be treated using covered stents. Studies have
evaluated long-term outcomes among patients who received these devices,
but hitherto no literature review has taken place. Method(s): We
conducted a systematic review of adverse outcomes for patients after
treatment with covered stents. Data from studies were pooled and outcomes
were compared according to stent type. Result(s): A total of 29
studies were analyzed with data from 725 patients who received covered
stents. The proportion of patients with chronic total occlusions, vein
graft percutaneous coronary intervention (PCI), intracoronary imaging and
rotational atherectomy were 16.9, 11.5, 9.2, and 6.6%, respectively. The
stents used were primarily polytetrafluoroethylene (PTFE) (70%) and
Papyrus (20.6%). Mortality, major adverse cardiovascular events,
pericardiocentesis/tamponade and emergency surgery were 17.2, 35.3, 27.1,
and 5.3%, respectively. Stratified analysis by use of PTFE, Papyrus and
pericardial stents, suggested no difference in mortality (p =.323), or
target lesion revascularization (p =.484). Stent thrombosis,
pericardiocentesis/tamponade and emergency coronary artery bypass surgery
(CABG) occurred more frequently in patients with PTFE stent use (p =.011,
p =.005, p =.012, respectively). In-stent restenosis was more common with
pericardial stent use (<.001, pooled analysis for first- and
second-generation pericardial stents). Conclusion(s): Cases of
coronary perforation which require implantation of a covered stent are
associated with a high rate of adverse outcomes. The use of PTFE covered
stents appears to be associated with more stent thrombosis,
pericardiocentesis/tamponade, and emergency CABG when compared to Papyrus
or pericardial stents. Copyright © 2019 Wiley Periodicals, Inc.

<58>
Accession Number
2003783543
Title
Distal transradial access for cardiac catheterization: A systematic
scoping review.
Source
Catheterization and Cardiovascular Interventions. 96 (7) (pp 1381-1389),
2020. Date of Publication: December 2020.
Author
Coomes E.A.; Haghbayan H.; Cheema A.N.
Institution
(Coomes) Department of Medicine, University of Toronto, Toronto, ON,
Canada
(Haghbayan) Division of Cardiology, London Health Sciences Centre, Western
University, London, ON, Canada
(Haghbayan) Department of Social and Preventive Medicine, Universite
Laval, QC, Canada
(Cheema) Terrence Donnelly Heart Centre, St. Michael's Hospital, Toronto,
ON, Canada
Publisher
John Wiley and Sons Inc
Abstract
Objective: Systematically review the literature for cardiac
catheterization and coronary angiography via distal transradial access
(dTRA) and its outcomes. Background(s): dTRA, via anatomical
snuffbox, may have several advantages over conventional transradial access
(cTRA) for percutaneous cardiac procedures, including easier left-sided
access for aorto-coronary grafts, future proximal radial artery
preservation, and patient and operator comfort. However, its procedural
characteristics and safety profile remain unclear. Method(s): Ovid
MEDLINE and EMBASE were searched from inception to September 2018. Two
authors independently performed two-stage selection and data extraction.
Reports assessing the dTRA approach for cardiac intervention in adults
reporting any outcomes were eligible. Descriptive summary statistics were
calculated from pooled data. Result(s): A total of 19 publications
comprising 4,212 participants undergoing dTRA were included. Mean age was
63.8 years, and 23.0% were female. dTRA was primarily undertaken for
assessment of stable coronary artery disease (87.6%), with 41.7% for
diagnostic procedures and 46.9% undergoing percutaneous coronary
intervention. The overall success rate for undertaking the dTRA approach
was 95.4% (69-100%). Complications occurred in 2.4% of cases, of which the
leading complications were bleeding/hematoma (18.2%). Complication rates
did not significantly differ between dTRA and cTRA. The occurrence of
radial artery occlusion in patients undergoing dTRA was low (1.7%).
 Conclusion(s): Observational data demonstrate that dTRA is a safe and
feasible method for percutaneous cardiac procedures, with high rates of
procedural success and low rates of complication. As data comparing dTRA
with cTRA remain limited, future high-quality randomized comparative
studies are required. Copyright © 2019 Wiley Periodicals, Inc.

<59>
Accession Number
628873234
Title
Renin-angiotensin blockade after aortic valve replacement: A review based
on current literature.
Source
European Journal of Preventive Cardiology. 27 (19) (pp 2113-2115), 2020.
Date of Publication: December 2020.
Author
Malik A.H.; Shetty S.S.; Yandrapalli S.; Accaoui R.E.
Institution
(Malik) Department of Medicine, Westchester Medical Center, New York
Medical College, Valhalla, United States
(Shetty, Accaoui) Division of Cardiology, Department of Internal Medicine,
University of Iowa Health Care, Carver College of Medicine, Iowa City,
United States
(Yandrapalli) Division of Cardiology, Westchester Medical Center, New York
Medical College, Valhalla, United States
Publisher
SAGE Publications Inc.

<60>
Accession Number
2010302146
Title
Unique Considerations in Preventing Intraoperative Aspiration in a Patient
with Gastroesophageal Cancer.
Source
Journal of the National Medical Association. Conference: 2020 NMA Annual
Meeting. 112 (5 Supplement) (pp S9-S10), 2020. Date of Publication:
October 2020.
Author
Ta A.; Thompson N.C.P.
Institution
(Ta, Thompson) University of Illinois at Chicago, Chicago, IL, United
States
Publisher
National Medical Association
Abstract
Introduction: Anesthesia-related aspiration and its impact on
perioperative outcomes are of concern for anesthesiologists. We present a
case of intraoperative aspiration despite precautions and subsequent
ethical considerations regarding palliative extubation for a patient with
metastatic gastroesophageal junction adenocarcinoma. Case: A 31-year-old
male with metastatic gastroesophageal junction adenocarcinoma s/p
esophageal stent, gastroesophageal reflux disease, and lower extremity
deep vein thrombosis s/p filter presented for cystoscopic bilateral
urethral stents after recent hematuria. Findings included bilateral DVTs,
worsened metastasis with bilateral renal obstruction, a thickened stomach,
a hiatal hernia, and a fungating, friable, ulcerating distal esophageal
tumor. Preoperative nasogastric tube was not placed with concern for
bleeding from the friable tumor. During intubation, patient vomited and
aspirated gastric fluid that was immediately suctioned. Second intubation
attempt was successful. Fiberoptic exam revealed minimal aspirate in both
main bronchi that was suctioned. The patient was extubated while fully
awake and upright but became tachypneic. He again vomited and aspirated
gastric content which was immediately suctioned. Saturation declined to
the mid-70s despite oxygen and he was reintubated with rapid sequence
induction. A nasal gastric tube (NGT) was placed and the post-intubation
x-ray showed bilateral pulmonary edema. Recruitment maneuvers and
ventilator adjustments unsuccessfully treated the patient's hypoxemia
leading to cardiac arrest. After the return of spontaneous circulation,
the family opted for comfort care. The patient passed after pressor
termination and palliative extubation. Discussion(s): Strategies for
aspiration prevention include preoperative risk assessment, extended
fasting, preemptive NGT placement, rapid sequence induction, pharmacologic
options, and head-up positioning.1-4 This patient's friable
esophageal tumor discouraged an NGT. Extubation precautions involve
prophylactic suctioning, verifying laryngeal reflexes, and noninvasive
ventilation to prevent respiratory failure.1,2,5-7 This patient
likely experienced subclinical aspiration causing respiratory distress,
emesis, and subsequent aspiration. References: 1. Apfel CC, Roewer N. Ways
to prevent and treat pulmonary aspiration of gastric contents. Curr Opin
Anaesthesiol. 2005;18(2):157-162. 2. Blank RS, Collins SR, Huffmyer JL,
Jaeger JM. Anesthesia for esophageal surgery. In: Principles and practice
of anesthesia for thoracic surgery. Springer; 2019:609-649. 3. Nason KS.
Acute Intraoperative Pulmonary Aspiration. Thorac Surg Clin.
2015;25(3):301-307. 4. Rozen D, Grass GW. Perioperative and intraoperative
pain and anesthetic care of the chronic pain and cancer pain patient
receiving chronic opioid therapy. Pain Pract. 2005;5(1):18-32. 5. Glossop
AJ, Shephard N, Bryden DC, Mills GH. Non-invasive ventilation for weaning,
avoiding reintubation after extubation and in the postoperative period: a
meta-analysis. Br J Anaesth. 2012;109(3):305-314. 6. Robinson M, Davidson
A. Aspiration under anaesthesia: risk assessment and decision-making.
Continuing Education in Anaesthesia Critical Care & Pain.
2014;14(4):171-175. 7. Sheta SA, Abdelhalim AA, Nada E. Evaluation of "no
touch" extubation technique on airway-related complications during
emergence from general anesthesia. Saudi J Anaesth. 2011;5(2):125-131. 8.
Poelaert J, Szegedi L, Blot S. Prevention of postoperative pulmonary
problems starts intraoperatively. In: Annual Update in Intensive Care and
Emergency Medicine 2013. Springer; 2013:539-552. 9. Congedo E, Aceto P,
Petrucci R, Mascia A, Gualtieri E, De Cosmo G. Preoperative anesthetic
evaluation and preparation in patients requiring esophageal surgery for
cancer. Rays. 2005;30(4):341-345. 10. Cook TM, Woodall N, Frerk C. Major
complications of airway management in the UK: results of the Fourth
National Audit Project of the Royal College of Anaesthetists and the
Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth.
2011;106(5):617-631. 11. Kluger MT, Short TG. Aspiration during
anaesthesia: a review of 133 cases from the Australian Anaesthetic
Incident Monitoring Study (AIMS). Anaesthesia. 1999;54(1):19-26. 12.
Tanaka A, Isono S, Ishikawa T, Nishino T. Laryngeal reflex before and
after placement of airway interventions: endotracheal tube and laryngeal
mask airway. Anesthesiology. 2005;102(1):20-25. 13. Lanuti M, de Delva PE,
Maher A, et al. Feasibility and outcomes of an early extubation policy
after esophagectomy. Ann Thorac Surg. 2006;82(6):2037-2041. 14. Weledji
EP, Verla V. Failure to rescue patients from early critical complications
of oesophagogastric cancer surgery. Ann Med Surg (Lond). 2016;7:34-41. 15.
Gale M, Kawai F, Pan C, Morris J, Gasperino J. Withdrawal of Mechanical
Ventilation: A Systematic Review and Approach Following Two Unusual Cases.
Chest. 2016;150(4):945A. 16. Huynh TN, Walling AM, Le TX, Kleerup EC, Liu
H, Wenger NS. Factors associated with palliative withdrawal of mechanical
ventilation and time to death after withdrawal. J Palliat Med.
2013;16(11):1368-1374. 17. Truog RD, Brock DW, White DB. Should patients
receive general anesthesia prior to extubation at the end of life? Crit
Care Med. 2012;40(2):631-633. 18. Billings JA. Humane terminal extubation
reconsidered: the role for preemptive analgesia and sedation. Crit Care
Med. 2012;40(2):625-630. 19. Morrison W. Titration of medication and the
management of suffering at the end of life. Virtual Mentor.
2012;14(10):780-783. Copyright © 2020

<61>
Accession Number
2010134599
Title
13632 Long-term safety of tildrakizumab in patients 65 years of age or
older with moderate to severe psoriasis: Pooled analysis through 3 years
(148 weeks) from reSURFACE 1 and reSURFACE 2 phase 3 trials.
Source
Journal of the American Academy of Dermatology. Conference: AAD Annual
Meeting. United States. 83 (6 Supplement) (pp AB120), 2020. Date of
Publication: December 2020.
Author
van de Kerkhof P.C.; Dauden E.; Pau-Charles I.; Lopez A.S.; Langley R.
Institution
(van de Kerkhof) Radboud University Medical Center
(Dauden) Department of Dermatology, Hospital Universitario la Princesa,
Madrid, Spain
(Pau-Charles) Almirall R&D
(Lopez) Almirall, SA
(Langley) Dalhousie University
Publisher
Mosby Inc.
Abstract
Background: Tildrakizumab (TIL) is a high-affinity anti-IL-23p19
monoclonal antibody approved for the treatment of plaque psoriasis.
 Objective(s): To report 148-week pooled safety data in patients >=65
years of age from 2 phase 3 trials: reSURFACE 1/2
(NCT01722331/NCT01729754). Method(s): Post hoc pooled analysis of
patients >=65 years of age with moderate to severe plaque psoriasis from
reSURFACE 1 (64 wk) and reSURFACE 2 (52 wk) trials. This safety analysis
includes pooled data from both trials (all-subjects-as-treated
population). Extended major adverse cardiovascular events (MACEs) included
non-fatal myocardial infarction, non-fatal stroke, unstable angina,
coronary revascularisation, resuscitated cardiac arrest, and
cardiovascular deaths that were confirmed as "cardiovascular" or "sudden."
Exposure-adjusted incidence rates (EAIRs) are reported (ie events per 100
patient-years of exposure). Result(s): A total of 161 patients >=65
years of age were exposed to TIL up to wk 148 (159.5 patient-years of
exposure to TIL 100 mg, 170.8 patient-years of exposure to TIL 200 mg).
The EAIRs of drug-related serious adverse events (SAEs) were
2.51/1.76/6.83 in the TIL100 mg/TIL200 mg/etanercept (ETN) groups
respectively. The EAIRs of severe infections were 3.76/2.34/6.83 events
per 100 patient-years of exposure [TIL100 mg/TIL200 mg/ETN]. The EAIRs of
malignancies (excluding nonmelanoma skin cancer [NMSC]) were
1.88/1.76/6.83 [TIL100 mg/TIL200 mg/ETN]. The EAIRs of NMSC were
3.76/2.93/6.83 [TIL100 mg/TIL200 mg/ETN]. The EAIRs of confirmed extended
MACE were 0.63/1.17/6.83 [TIL100 mg/TIL200 mg/ETN]. The EAIRs of injection
site reactions were 0.63/2.34/20.48 [TIL100 mg/TIL200 mg/ETN].
 Conclusion(s): Up to wk 148, TIL was well tolerated in patients >=65
years of age, with low drug-related SAEs and adverse events of special
interest. No dose-related increase in the rate of adverse events was
observed. Copyright © 2020

<62>
Accession Number
633626745
Title
Feasibility and Acceptability of Acupuncture during Hospitalization
Following Open-Heart Valve Surgery: The Acu-Heart Pilot Trial.
Source
Psychosomatic Medicine. Conference: 78th Annual Scientific Meeting
Achieving Health Equity: Opportunities for Psychosomatic Science. United
States. 82 (6) (pp A47), 2020. Date of Publication: July - August 2020.
Author
Carroll A.J.; Moskowitz J.T.; Whisler C.; Davidson C.J.; McCarthy P.M.;
Ring M.; Feingold K.L.
Institution
(Carroll) Bluhm Cardiovascular Institute, Chicago, IL, United States
(Moskowitz) Northwestern University Feinberg School of Medicine, Chicago,
IL, United States
(Whisler) Bluhm Cardiovascular Institute, Northwestern University,
Chicago, IL, United States
(Davidson, McCarthy) Bluhm Cardiovascular Institute, Northwestern
University Feinberg School of Medicine, Chicago, IL, United States
(Ring, Feingold) Bluhm Cardiovascular Institute, Northwestern University
Feinberg School of Medicine, Chicago, IL, United States
Publisher
Lippincott Williams and Wilkins
Abstract
Background: Cardiac surgery patients suffer high rates of depression,
somatic sequelae (e.g., pain, nausea), and medical complications (e.g.,
atrial fibrillation). Acupuncture is an effective treatment for
depression, pain/nausea, and cardiac arrhythmias. No studies have directly
tested the effects of acupuncture on these factors following cardiac
surgery. The purpose of this study was to assess the feasibility and
acceptability of acupuncture during post-operative hospitalization.
 Method(s): This study was a randomized, controlled, feasibility trial
of daily acupuncture (ACU) or treatment as usual (TAU) following isolated
valve surgery via sternotomy. ACU patients received up to six, 1-hour
sessions of acupuncture starting on post-operative day 1 in the patient's
room in the intensive care unit. TAU patients had no intervention. To
assess the feasibility and acceptability of acupuncture, we recorded rates
of eligibility, exclusion, withdrawal, and study completion; reasons for
refusal; and acupuncture session completion. Result(s): In total, 253
patients were approached and invited to participate in the study. Of
those, 45 patients (18%) declined to participate, citing reasons including
not interested in research, not interested in acupuncture/traditional
Chinese medicine, or feeling stressed about surgery. Sixty-two patients
(25%) were lost to follow-up. Among those who consented (n=146, 58% of
those approached), 42 (29%) were subsequently excluded, including 11
patients prior to randomization, 14 ACU patients, and 17 TAU patients.
Reasons for exclusion included intraoperative factors (e.g., concomitant
procedures; n=25), not completing the baseline measures (n=4), not
scheduling surgery (n=4), or other (n=9). Only 3 patients (ACU arm)
withdrew during the study. In total, 100 patients (51 ACU; 49 TAU)
completed the study. On average, ACU patients completed 3.8 acupuncture
sessions (SD=1.1) out of an average length of stay of 4.7 days (SD=1.5).
 Conclusion(s): Acupuncture was accepted by the large majority of
eligible open-heart valve surgery patients. It was a feasible intervention
during the post-operative hospitalization, including in the intensive care
unit. Few patients withdrew from the acupuncture intervention. Future
analyses will assess the impact of acupuncture on depressive symptoms,
somatic sequelae, and atrial fibrillation in this population.

<63>
Accession Number
633623908
Title
The routine use of post-operative NSAIDs in the pediatric patient is
effective and safe.
Source
Pediatrics. Conference: National Conference and Exhibition Meeting of the
American Academy of Pediatrics, AAP 2019. United States. 146 (1) (pp
165-166), 2020. Date of Publication: July 2020.
Author
Gaid E.; Mehta R.; Waller J.
Institution
(Gaid) Medical College of Georgia at Augusta University, Augusta, GA,
United States
(Mehta) Medical College of Georgia at Augusta University, Augusta, GA,
United States
(Waller) Medical College of Georgia, Department of Population Health
Science: Biostatistics and Data Science, Augusta, GA, United States
Publisher
American Academy of Pediatrics
Abstract
Purpose: Appropriate post-operative pain management in the pediatric
population is necessary for a safe and effective recovery process.
Opioids, non-steroidal anti-inflammatory drugs (NSAIDs), and acetaminophen
remain the current pharmacologic therapy for post-operative pain
management, with an increasing preference for the use of scheduled NSAIDs
to avoid opioid-related side effects. With increasing use of NSAIDs,
concern has grown over their associated renal and hematologic adverse
effects. The objective of this study is to examine the renal and bleeding
complications of scheduled post-operative NSAID use in the pediatric
population (ages 0-18). We hypothesize that pediatric patients started on
a scheduled regimen of NSAIDs immediately post-operatively are at an equal
risk of bleeding and renal complications for the first 5 days post- op
compared to those not receiving the medications. Method(s): A
retrospective chart review was conducted with patients admitted to the
pediatric intensive care unit from July 2015-May 2018 status post
congenital heart defect surgery or other surgery requiring pain control.
Renal adverse effects were measured by comparing serum creatinine levels
to age-adjusted reference values. Bleeding complications were evaluated
through a review of patient notes for documented intracranial hemorrhage,
GI consult or significant upper GI bleed, or bleeding requiring additional
surgical exploration or transfusion. Result(s): Analyses were
conducted using descriptive statistics to evaluate the significance of
abnormal creatinine values by age, surgery, and NSAID status. Percent of
days with an abnormal creatinine level was used to assess for differences
between groups. There was no overall statistically significant difference
among number of days or percent of days with an abnormal creatinine level
in cardiac surgery and NSAID groups (p=0.0621 for number of days, p=0.4347
for percent of days). There was no significant association between
patients receiving scheduled NSAIDs and the presence of a bleeding event
in cardiac or non-cardiac surgeries (p=0.2950). Conclusion(s): There
is no association with increased bleeding or renal complications following
the use of scheduled NSAIDs in the pediatric post-operative setting in
both cardiac and non-cardiac surgeries. A randomized prospective study is
needed to further evaluate the safety and efficacy of NSAIDs in the
post-operative pediatric population.

<64>
Accession Number
633623847
Title
The routine use of post-operative NSAIDS in pediatric patient is effective
and safe.
Source
Pediatrics. Conference: National Conference and Exhibition Meeting of the
American Academy of Pediatrics, AAP 2019. United States. 146 (1) (pp 158),
2020. Date of Publication: July 2020.
Author
Mehta R.
Institution
(Mehta) Medical College of Georgia at Augusta University, Augusta, GA,
United States
Publisher
American Academy of Pediatrics
Abstract
* Introduction: Effective and appropriate post-operative pain management
in the pediatric population is important for a safe and comfortable
recovery process. Opioids, non-steroidal anti-inflammatory drugs (NSAIDs),
and acetaminophen remain the current pharmacologic therapy for
postoperative pain management, with an increasing preference for the use
of scheduled NSAIDs to avoid opioid-related side effects. The objective of
this study is to examine the renal and hematologic complications of
scheduled post-operative NSAID use in the pediatric population (ages
0-18). We hypothesize that pediatric patients started on a scheduled
regimen of NSAIDs immediately post-operatively are at an equal risk of
bleeding and renal complications for the first 5 days post-op in
comparison to those not receiving the medications. Method(s): A
retrospective chart review of 170 patients admitted to pediatric intensive
care unit from July 2015-May 2018 status post congenital heart defect or
other surgery requiring pain control. Renal effects were evaluated by
serum creatinine values, while significant bleeding events were evaluated
by clinically documented intracranial hemorrhage, GI consult or
significant upper GI bleed, bleeding requiring additional surgical
exploration or transfusion. Analyses were conducted using descriptive
statistics to evaluate the significance of abnormal creatinine values by
age. Due to a low frequency of abnormal creatinine levels, the percent of
days with an abnormal creatinine level was used to assess for differences
between groups. Results; There was no overall statistically significant
difference between cardiac surgery and NSAID groups in creatinine levels
over time p = 0.2950. There was also not a significant association between
patients with scheduled NSAIDs and the presence of an increased number of
days of abnormal creatinine levels or bleeding events p = 0.0621. There
was a significant difference among groups for age (p< 0.0001), height
(p<0.0001), and weight (p<0.0001). Conclusion(s): There is a no
association with increased bleeding or adverse renal effects use of NSAIDs
in the pediatric postoperative setting in both cardiac and non-cardiac
surgeries. Post-operative cardiac patients undergoing scheduled NSAID
therapies are older as there is hesitancy to use NSAIDs in infants less
than less six months. A randomized prospective study may analyze the
dose-dependent nature of any reported adverse side effects and the
reduction in opioid medications as a result of NSAID.

<65>
Accession Number
2010269414
Title
Mitral valve bioprosthesis is safer han mechanical mitral prosthesis in
young women.
Source
Heart Surgery Forum. 23 (5) (pp E677-E684), 2020. Date of Publication: 23
Sep 2020.
Author
Singab H.; Sami G.
Institution
(Singab, Sami) Department of Cardiovascular and Thoracic Surgery, Faculty
of Medicine, Ain Shams University, Cairo, Egypt
(Sami) Nasser Institute for Research and Treatment, Cardiothoracic Surgery
Cairo, Egypt
Publisher
Forum Multimedia Publishing LLC
Abstract
Background: The ultimate goal of mitral valve surgery in young women is to
extend life expectancy and improve quality of life. Mitral valve
replacement (MVR) prosthesis in middle-aged women is a difficult choice
between the lifelong anticoagulation by mechanical prosthesis versus the
limited long-term durability of bioprosthesis. The current trend towards
reducing women's age for selecting bioprosthesis over mechanical
prosthesis leads to a dilemma for younger women decision making. The aim
of this study was to compare the safety and freedom from complications in
pregnancy and survival rate after mitral valve bioprosthesis versus
mechanical prosthesis in young women for whom mitral valve repair is not
feasible, or unsuitable. Method(s): This single-center non randomized
prospective study included all female patients undergoing MVR at our
center from January 2010 to February 2020. Result(s): In total, 355
young women patients underwent MVR at our center, of whom 174 received a
bioprosthesis and 181 received a mechanical prosthesis. The use of
anticoagulation among young women with mechanical prosthesis was
associated with a remarkable risk of postoperative bleeding, abortion, and
increased frequency of pregnancy-related complications (P < .0001). In
contrast, there was a considerable survival benefit for those who received
bioprosthesis (P = .0001). Conclusion(s): Our data confirm that the
use of mitral bioprosthesis in young women who desire to become pregnant
is safe, reduces complications, and increases survival. Copyright
© 2020 Forum Multimedia Publishing LLC. All rights reserved.

<66>
Accession Number
2010298191
Title
Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at
intermediate operative risk: A post hoc analysis of the randomised SURTAVI
trial.
Source
EuroIntervention. 16 (10) (pp 833-841), 2020. Date of Publication:
November 2020.
Author
Van Mieghem N.M.; Reardon M.J.; Yakubov S.J.; Heiser J.; Merhi W.;
Windecker S.; Makkar R.; Cheng W.; Robbins M.; Fail P.; Feinberg II E.;
Stoler R.C.; Hebeler R.; Serruys P.W.; Popma J.J.
Institution
(Van Mieghem) Department of Interventional Cardiology, Erasmus University
Medical Center, Rotterdam, Netherlands
(Reardon) Department of Cardiothoracic Surgery and Interventional
Cardiology, Houston- Methodist-Debakey Heart and Vascular Center, Houston,
TX, United States
(Yakubov) Department of Cardiology, Riverside Methodist - Ohio Health,
Columbus, OH, United States
(Heiser, Merhi) Departments of Cardiothoracic Surgery and Interventional
Cardiology, Spectrum Health Hospitals, Grand Rapids, MI, United States
(Windecker) Department of Interventional Cardiology, University Hospital
Bern, Bern, Switzerland
(Makkar) Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA,
United States
(Cheng) Cardiac Surgery, Cedars-Sinai Medical Center, Los Angeles, CA,
United States
(Robbins) Interventional Cardiology, Saint Thomas Heart, Ascension Medical
Group, Nashville, TN, United States
(Fail, Feinberg II) Interventional Cardiology, Cardiovascular Institute of
the South, Houma, LA, United States
(Stoler) Interventional Cardiology, Baylor Scott and White Heart and
Vascular Hospital, Dallas, TX, United States
(Hebeler) Cardiothoracic Surgery, Baylor Scott and White Heart and
Vascular Hospital, Dallas, TX, United States
(Serruys) Department of Cardiology, National University of Ireland,
Galway, Ireland
(Popma) Department of Interventional Cardiology, Beth Israel Deaconess
Medical Center, Boston, MA, United States
Publisher
Europa Group
Abstract
Aims: In patients with aortic stenosis randomised to transcatheter aortic
valve implantation (TAVI) or surgical aortic valve replacement (SAVR),
sex-specific differences in complication rates are unclear in
intermediate-risk patients. The purpose of this analysis was to identify
sex-specific differences in outcome for patients at intermediate surgical
risk randomised to TAVI or SAVR in the international Surgical Replacement
and Transcatheter Aortic Valve Implantation (SURTAVI) trial. Methods
and Results: A total of 1,660 intermediate-risk patients underwent TAVI
with a supra-annular, self-expanding bioprosthesis or SAVR. The population
was stratified by sex and treatment modality (female TAVI=366, male
TAVI=498, female SAVR=358, male SAVR=438). The primary endpoint was a
composite of all-cause mortality or disabling stroke at two years.
Compared to males, females had a smaller body surface area, a higher
Society of Thoracic Surgeons score (4.7+/-1.6% vs 4.3+/-1.6%, p<0.01) and
were more frail. Men required more concomitant revascularisation (23% vs
16%). All-cause mortality or disabling stroke at two years was similar
between TAVI and SAVR for females (10.2% vs 10.5%, p=0.90) and males
(14.5% vs 14.4%, p=0.99); the difference between females and males was
10.2% vs 14.5%, for TAVI (p=0.08) and 10.5% vs 14.4%, SAVR (p=0.13).
Functional status improvement was more pronounced after TAVI in females
than in males. Conclusion(s): Aortic valve replacement, either by
surgical or transcatheter approach, appears similarly effective and safe
for males and females at intermediate surgical risk. Functional status
appears to improve most in females after TAVI. Copyright ©
Europa Digital & Publishing 2020.

<67>
Accession Number
2007577717
Title
PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of
tricuspid regurgitation: a propensity-matched analysis.
Source
Clinical Research in Cardiology. (no pagination), 2020. Date of
Publication: 2020.
Author
Sugiura A.; Vogelhuber J.; Ozturk C.; Schwaibold Z.; Reckers D.; Goto T.;
Kavsur R.; Becher M.U.; Zimmer S.; Nickenig G.; Weber M.
Institution
(Sugiura, Vogelhuber, Ozturk, Schwaibold, Reckers, Kavsur, Becher, Zimmer,
Nickenig, Weber) Herzzentrum Bonn, Medizinische Klinik und Poliklinik II,
Universitatsklinikum Bonn, Venusberg-Campus 1, Bonn 53127, Germany
(Goto) Department of Clinical Epidemiology and Health Economics, School of
Public Health, University of Tokyo, TXP Medical Co. Ltd., Tokyo, Japan
Publisher
Springer Science and Business Media Deutschland GmbH
Abstract
Background: Transcatheter tricuspid valve repair (TTVR) is a promising
technique for the treatment of tricuspid regurgitation (TR). Data
comparing the performance of novel edge-to-edge devices (PASCAL and
MitraClip-XTR) are scarce. Method(s): We identified 80 consecutive
patients who underwent TTVR using either the PASCAL or MitraClip-XTR
system to treat symptomatic TR from July 2018 to June 2020. To adjust for
baseline imbalances, we performed a propensity score (PS) 1:1 matching.
The primary endpoint was a reduction in TR severity by at least one grade
at 30 days. Result(s): The PS-matched cohort (n = 44) was at
high-surgical risk (EuroSCORE II: 7.5% [interquartile range (IQR)
4.8-12.1%]) with a mean TR grade of 4.3 +/- 0.8 and median coaptation gap
of 6.2 mm [IQR 3.2-9.1 mm]. The primary endpoint was similarly observed in
both groups (PASCAL: 91% vs. MitraClip-XTR: 96%). Multiple device
implantation was the most common form (59% vs. 82%, p = 0.19), and the
occurrence of SLDA was comparable between the PASCAL and MitraClip-XTR
system (5.7% [2 of 35 implanted devices] vs. 4.4% [2 of 45 implanted
devices], p = 0.99). No periprocedural death or conversions to surgery
occurred, and 30-day mortality (5.0% vs. 5.0%, log-rank p = 0.99) and
3-month mortality (10.0% vs. 5.0%, log-rank p = 0.56) were similar between
both groups. During follow-up, functional NYHA class, 6-min walking
distance, and health status improved in both groups. Conclusion(s):
Both TTVR devices, PASCAL and MitraClip-XTR, appeared feasible and
comparable for an effective TR reduction. Randomized head-to-head
comparisons will help to further define the appropriate scope of
application of each system. Copyright © 2020, The Author(s).

<68>
Accession Number
2007577501
Title
The benefit of fibrosa layer stripping technique during minimally invasive
aortic valve replacement for calcified aortic valve stenosis-A randomized
controlled trial.
Source
Journal of Cardiac Surgery. (no pagination), 2020. Date of Publication:
2020.
Author
Zhou Y.; Zhang L.; Hua K.; Zhang J.; Yang X.
Institution
(Zhou, Zhang, Hua, Zhang, Yang) Department of Cardiac Surgery, Beijing
Anzhen Hospital, Capital Medical University, Beijing, China
Publisher
Blackwell Publishing Inc.
Abstract
Background: Fibrosa layer stripping (FLS) technique is a new approach to
remove the calcified aortic valve. In this study, we aimed to assess the
effectiveness of the FLS technique by comparing it with the conventional
technique in minimally invasive aortic valve replacement (MIAVR).
 Method(s): A prospective, single-center, randomized controlled trial
was conducted at Beijing Anzhen Hospital. Seventy patients diagnosed with
severe calcific aortic stenosis were randomly assigned to undergo FLS (n =
35) or conventional (n = 35) technique to debride calcified aortic valve.
Preoperative profile, procedural parameters, and postoperative outcomes
were analyzed. Result(s): No significant difference was observed in
the preoperative profile between the two groups. Compared with the
conventional technique, the FLS technique had a significantly higher
indexed effective orifice area and lower mean gradient. Moreover, the FLS
technique was associated with significantly reduced aortic cross-clamp
time (41 [38-44] vs. 56 [51-60] min, p <.001), cardiopulmonary bypass
(CPB) time (63 [56-69] vs. 81 [75-84] min, p <.001), and operative time
(148 [141-156] vs. 173 [169-180] min, p <.001). Lastly, the length of
intensive care unit stay (1.2 +/- 0.4 vs. 1.5 +/- 0.8 days, p =.041) and
hospital stay (5.3 +/- 0.6 vs. 6.0 +/- 1.4 days, p =.020) was
significantly reduced in the FLS group compared with those in the
conventional group. Conclusion(s): FLS technique is effective in
removing calcified tissue during MIAVR and is associated with shorter
cross-clamp time and CPB time, and better hemodynamic performance than the
conventional technique. Copyright © 2020 Wiley Periodicals LLC

<69>
Accession Number
2007577416
Title
Development and validation of a model for predicting acute kidney injury
after cardiac surgery in patients of advanced age.
Source
Journal of Cardiac Surgery. (no pagination), 2020. Date of Publication:
2020.
Author
Hu P.; Chen Y.; Wu Y.; Song L.; Zhang L.; Li Z.; Fu L.; Liu S.; Ye Z.; Shi
W.; Liang X.
Institution
(Hu, Liang) The Second School of Clinical Medicine, Southern Medical
University, Guangzhou, China
(Hu, Chen, Wu, Song, Zhang, Li, Fu, Liu, Ye, Shi, Liang) Division of
Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of
Medical Sciences, Guangzhou, China
Publisher
Blackwell Publishing Inc.
Abstract
Objective: To develop a clinical model for predicting postoperative acute
kidney injury (AKI) in patients of advanced age undergoing cardiac
surgery. Method(s): A total of 848 patients (aged >= 60 years)
undergoing cardiac surgery were consecutively enrolled. Among them, 597
were randomly selected for the development set and the remaining 251 for
the validation set. AKI was the primary outcome. To develop a model for
predicting AKI, visualized as a nomogram, we performed logistic regression
with variables selected by Lasso regression analysis. The discrimination,
calibration, and clinical usefulness of the new model were assessed and
compared with those of Cleveland Clinic score and Simplified Renal Index
(SRI) score in the validation set. Result(s): The incidence of AKI
was 61.8% in the development set. The new model included seven variables
including preoperative serum creatinine, hypertension, preoperative uric
acid, New York Heart Association classification >= 3, cardiopulmonary
bypass time > 120 min, intraoperative red blood cell transfusion, and
postoperative prolonged mechanical ventilation. In the validation set, the
areas under the receiver operating characteristic curves for assessing
discrimination of the new model, Cleveland Clinic score, and SRI score
were 0.801, 0.670, and 0.627, respectively. Compared with the other two
scores, the new model presented excellent calibration according to the
calibration curves. Decision curve analysis presented the new model was
more clinically useful than the other two scores. Conclusion(s): We
developed and validated a new model for predicting AKI after cardiac
surgery in patients of advanced age, which may help clinicians assess
patients' risk for AKI. Copyright © 2020 The Authors. Journal of
Cardiac Surgery published by Wiley Periodicals LLC

<70>
Accession Number
2007563566
Title
A systematic review on durability and structural valve deterioration in
TAVR and surgical AVR.
Source
Acta Cardiologica. (no pagination), 2020. Date of Publication: 2020.
Author
Okutucu S.; Niazi A.K.; Oliveira D.; Fatihoglu S.G.; Oto A.
Institution
(Okutucu, Oto) Department of Cardiology, Memorial Ankara Hospital, Ankara,
Turkey
(Niazi) Department of Cardiovascular Surgery, Shalamar Medical & Dental
College, Lahore, Pakistan
(Oliveira) Department of Cardiology, Federal University of Pernambuco,
Recife, Brazil
(Fatihoglu) Department of Cardiology, Iskenderun State Hospital, Hatay,
Turkey
Publisher
Taylor and Francis Ltd.
Abstract
Mechanical valves and bioprosthetic heart valves are widely used for
aortic valve replacement (AVR). Mechanical valves are associated with risk
of bleeding because of oral anticoagulation, while the durability and
structural valve deterioration (SVD) represent the main limitation of the
bioprosthetic heart valves. The implantation of bioprosthetic heart valves
is increasing precipitously due aging population, and the widespread use
of transcatheter aortic valve replacement (TAVR). TAVR has become the
standard treatment for intermediate or high surgical risk patients and a
reasonable alternative to surgery for low risk patients with symptomatic
severe aortic stenosis. Moreover, TAVR is increasingly being used for
younger and lower-risk patients with longer life expectancy; therefore it
is important to ensure the valve durability for long-term transcatheter
aortic valves. Although the results of mid-term durability of the
transcatheter heart valves are encouraging, their long-term durability
remains largely unknown. This review summarises the definitions,
mechanisms, risk factors and assessment of SVD; overviews available data
on surgical bioprosthetic and transcatheter heart valves
durability. Copyright © 2020 Belgian Society of Cardiology.

<71>
Accession Number
2005841156
Title
Use of smart technology for the early diagnosis of complications after
cardiac surgery: The BOX 2.0 study protocol.
Source
JMIR Research Protocols. 9 (4) (no pagination), 2020. Article Number:
e16326. Date of Publication: April 2020.
Author
Biersteker T.E.; Boogers M.J.; de Lind van Wijngaarden R.A.F.; Groenwold
R.H.H.; Trines S.A.; van Alem A.P.; Kirchhof C.J.H.J.; van Hof N.; Klautz
R.J.M.; Schalij M.J.; Treskes R.W.
Institution
(Biersteker, Boogers, Trines, van Hof, Schalij, Treskes) Department of
Cardiology, Leiden University Medical Center, Leiden, Netherlands
(de Lind van Wijngaarden, Klautz) Department of Cardiothoracic Surgery,
Leiden University Medical Center, Leiden, Netherlands
(Groenwold) Department of Clinical Epidemiology, Leiden University Medical
Center, Leiden, Netherlands
(van Alem) Department of Cardiology, Haaglanden Medisch Centrum, Den Haag,
Netherlands
(Kirchhof) Department of Cardiology, Alrijne Ziekenhuis, Leiderdorp,
Netherlands
Publisher
JMIR Publications Inc.
Abstract
Background: Atrial fibrillation (AF), sternal wound infection, and cardiac
decompensation are complications that can occur after cardiac surgery.
Early detection of these complications is clinically relevant, as early
treatment is associated with better clinical outcomes. Remote monitoring
with the use of a smartphone (mobile health [mHealth]) might improve the
early detection of complications after cardiac surgery. Objective(s):
The primary aim of this study is to compare the detection rate of AF
diagnosed with an mHealth solution to the detection rate of AF diagnosed
with standard care. Secondary objectives include detection of sternal
wound infection and cardiac decompensation, as well as assessment of
quality of life, patient satisfaction, and cost-effectiveness.
 Method(s): The Box 2.0 is a study with a prospective intervention
group and a historical control group for comparison. Patients undergoing
cardiac surgery at Leiden University Medical Center are eligible for
enrollment. In this study, 365 historical patients will be used as
controls and 365 other participants will be asked to receive either The
Box 2.0 intervention consisting of seven home measurement devices along
with a video consultation 2 weeks after discharge or standard cardiac care
for 3 months. Patient information will be analyzed according to the
intention-to-treat principle. The Box 2.0 devices include a blood pressure
monitor, thermometer, weight scale, step count watch, single-lead
electrocardiogram (ECG) device, 12-lead ECG device, and pulse oximeter.
 Result(s): The study started in November 2018. The primary outcome of
this study is the detection rate of AF in both groups. Quality of life is
measured with the five-level EuroQol five-dimension (EQ-5D-5L)
questionnaire. Cost-effectiveness is calculated from a society perspective
using prices from Dutch costing guidelines and quality of life data from
the study. In the historical cohort, 93.9% (336/358) completed the
EQ-5D-5L and patient satisfaction questionnaires 3 months after cardiac
surgery. Conclusion(s): The rationale and design of a study to
investigate mHealth devices in postoperative cardiac surgery patients are
presented. The first results are expected in September 2020. Copyright
© Tom E Biersteker, Mark J Boogers, Robert AF de Lind van
Wijngaarden, Rolf HH Groenwold, Serge A Trines, Anouk P van Alem, Charles
JHJ Kirchhof, Nicolette van Hof, Robert JM Klautz, Martin J Schalij,
Roderick W Treskes.

<72>
Accession Number
2004555956
Title
Understanding and addressing variation in health care-associated
infections after durable ventricular assist device therapy: Protocol for a
mixed methods study.
Source
JMIR Research Protocols. 9 (1) (no pagination), 2020. Article Number:
e14701. Date of Publication: 2020.
Author
Chandanabhumma P.P.; Fetters M.D.; Pagani F.D.; Malani P.N.; Hollingsworth
J.M.; Funk R.J.; Aaronson K.D.; Zhang M.; Kormos R.L.; Chenoweth C.E.;
Shore S.; Watt T.M.F.; Cabrera L.; Likosky D.
Institution
(Chandanabhumma, Fetters) Mixed Methods Program, Department of Family
Medicine, University of Michigan, Ann Arbor, MI, United States
(Pagani, Watt, Cabrera, Likosky) Department of Cardiac Surgery, University
of Michigan, 1500 E Medical Center Dr, Ann Arbor, MI 48109, United States
(Malani, Chenoweth) Division of Infectious Diseases, Department of
Internal Medicine, University of Michigan, Ann Arbor, MI, United States
(Hollingsworth) Department of Urology, University of Michigan, Ann Arbor,
MI, United States
(Funk) Department of Strategic Management and Entrepreneurship, Carlson
School of Management, University of Minnesota, Minneapolis, MN, United
States
(Aaronson, Shore) Division of Cardiovascular Medicine, Department of
Internal Medicine, University of Michigan, Ann Arbor, MI, United States
(Zhang) Department of Biostatistics, School of Public Health, University
of Michigan, Ann Arbor, MI, United States
(Kormos) Department of Cardiothoracic Surgery, University of Pittsburgh
Medical Center, Pittsburgh, PA, United States
Publisher
JMIR Publications Inc.
Abstract
Background: Durable ventricular assist device (VAD) therapy is reserved
for patients with advanced heart failure who have a poor estimated 1-year
survival. However, despite highly protocolized management processes,
patients are at a unique risk for developing a health care-associated
infection (HAI). Few studies have examined optimal strategies for HAI
prevention after durable VAD implantation, despite variability in rates
across centers and their impact on short- and long-term outcomes.
 Objective(s): The objective of this study is to develop
recommendations for preventing the most significant HAIs after durable VAD
implantation. The study has 3 specific aims: (1) identify determinants of
center-level variability in HAI rates, (2) develop comprehensive
understanding of barriers and facilitators for achieving low center-level
HAI rates, and (3) develop and disseminate a best practices toolkit for
preventing HAIs that accommodates various center contexts. Method(s):
This is a sequential mixed methods study starting with a cross-sectional
assessment of current practices. To address aim 1, we will conduct (1) a
systematic review of HAI prevention studies and (2) in-depth quantitative
analyses using administrative claims, in-depth clinical data, and
organizational surveys of VAD centers. For aim 2, we will apply a mixed
methods patient tracer assessment framework to conduct semistructured
interviews, field observations, and document analysis informed by findings
from aim 1 at 5 high-performing (ie, low HAIs) and 5 low-performing (ie,
high HAI) centers, which will be examined using a mixed methods case
series analysis. For aim 3, we will build upon the findings from the
previous aims to develop and field test an HAI preventive toolkit, acquire
stakeholder input at an annual cardiac surgical conference, disseminate
the final version to VAD centers nationwide, and conduct follow-up surveys
to assess the toolkit's adoption. Result(s): The project was funded
by the Agency for Healthcare Research and Quality in 2018 and enrollment
for the overall project is ongoing. Data analysis is currently under way
and the first results are expected to be submitted for publication in
2019. Conclusion(s): This mixed methods study seeks to quantitatively
assess the determinants of HAIs across clinical centers and qualitatively
identify the context-specific facilitators and barriers for attaining low
HAI rates. The mixed data findings will be used to develop and disseminate
a stakeholder-acceptable toolkit of evidence-based HAI prevention
recommendations that will accommodate the specific contexts and needs of
VAD centers. Copyright © 2020 Journal of Medical Internet
Research. All rights reserved.

<73>
Accession Number
361525772
Title
Computer based haemodynamic guidance system is effective and safe in
management of postoperative cardiac surgery patients.
Source
Anaesthesia and Intensive Care. 39 (2) (pp 191-201), 2011. Date of
Publication: March 2011.
Author
Pellegrino V.A.; Mudaliar Y.; Gopalakrishnan M.; Horton M.D.; Killick
C.J.; Parkin W.G.; Playford H.R.; Raper R.F.
Institution
(Pellegrino) Intensive Care Unit, Alfred Hospital, Commercial Rd,
Melbourne, VIC 3004, Australia
(Mudaliar, Playford) Intensive Care Unit, Westmead Hospital, Sydney, NSW,
Australia
(Gopalakrishnan) Intensive Care Unit, St. Vincent's Hospital, Sydney, NSW,
Australia
(Horton) Cardiothoracic Unit, St. George Hospital, Sydney, NSW, Australia
(Killick, Parkin) Intensive Care Unit, Monash Medical Centre, Melbourne,
VIC, Australia
(Raper) Intensive Care Unit, Royal North Shore Hospital, Sydney, NSW,
Australia
Publisher
Australian Society of Anaesthetists
Abstract
A circulatory guidance system, NavigatorTM, was evaluated in a
prospective, randomised control trial at six Australian university
teaching hospitals involving 112 scheduled postoperative cardiac surgical
patients with pulmonary artery catheters placed and receiving 1:1 nursing
care. The guidance system was used to achieve and maintain
physician-designated cardiac output and mean arterial pressure targets and
compared these with standard post open-heart surgery care. The primary
efficacy endpoint was the standardised unsigned error between the targeted
and the actual values for cardiac output and mean arterial pressure, time
averaged over the duration of cardiac output monitoring - the average
standardised distance. This was 1.71 (SD=0.65) for the guidance group and
1.92 (SD=0.65) in the control group (P=0.202). Rates of postoperative
atrial fibrillation, adverse events, intensive care unit and hospital
length-of-stay were similar in both groups. There were no device-related
adverse events. Guided haemodynamic therapy with the NavigatorTM device
was non-inferior to standard intensive care unit therapy. The study was
registered with ClinicalTrials.gov Identifier NCT00468247.

<74>
Accession Number
2006892966
Title
Diagnostic accuracy of viscoelastic point-of-care identification of
hypofibrinogenaemia in cardiac surgical patients: A systematic review.
Source
Anaesthesia and Intensive Care. 48 (5) (pp 339-353), 2020. Date of
Publication: 01 Sep 2020.
Author
Gibbs N.M.; Weightman W.M.
Institution
(Gibbs, Weightman) Department of Anaesthesia, Sir Charles Gairdner
Hospital, Nedlands, Australia
(Gibbs) The University of Western Australia, Nedlands, Australia
Publisher
SAGE Publications Inc.
Abstract
Hypofibrinogenaemia during cardiac surgery may increase blood loss and
bleeding complications. Viscoelastic point-of-care tests provide more
rapid diagnosis than laboratory measurement, allowing earlier treatment.
However, their diagnostic test accuracy for hypofibrinogenaemia has never
been reviewed systematically. We aimed to systematically review their
diagnostic test accuracy for the identification of hypofibrinogenaemia
during cardiac surgery. Two reviewers assessed relevant articles from
seven electronic databases, extracted data from eligible articles and
assessed quality. The primary outcomes were sensitivity, specificity and
positive and negative predictive values. A total of 576 articles were
screened and 81 full texts were assessed, most of which were clinical
agreement or outcome studies. Only 10 diagnostic test accuracy studies
were identified and only nine were eligible (ROTEMdelta 7; TEG5000 1;
TEG6S 1, n = 1820 patients) (ROTEM, TEM International GmbH, Munich,
Germany; TEG, Haemonetics, Braintree, MA, USA). None had a low risk of
bias. Four ROTEM studies with a fibrinogen threshold less than 1.5-1.6 g/l
and FIBTEM threshold A10 less than 7.5-8 mm had point estimates for
sensitivity of 0.61-0.88; specificity 0.54-0.94; positive predictive value
0.42-0.70; and negative predictive value 0.74-0.98 (i.e. false positive
rate 30%-58%; false negative rate 2%-26%). Two ROTEM studies with higher
thresholds for both fibrinogen (<2 g/l) and FIBTEM A10 (<9.5 mm) had
similar false positive rates (25%-46%), as did the two TEG studies
(15%-48%). This review demonstrates that there have been few diagnostic
test accuracy studies of viscoelastic point-of-care identification of
hypofibrinogenaemia in cardiac surgical patients. The studies performed so
far report false positive rates of up to 58%, but low false negative
rates. Further diagnostic test accuracy studies of viscoelastic
point-of-care identification of hypofibrinogenaemia are required to guide
their better use during cardiac surgery. Copyright © The
Author(s) 2020.

<75>
Accession Number
2010039062
Title
High-dimensional propensity scores improved the control of indication bias
in surgical comparative effectiveness studies.
Source
Journal of Clinical Epidemiology. 130 (pp 78-86), 2021. Date of
Publication: February 2021.
Author
Payet C.; Polazzi S.; Obadia J.-F.; Armoiry X.; Labarere J.; Rabilloud M.;
Duclos A.
Institution
(Payet, Polazzi, Duclos) Health Data Department, Hospices Civils de Lyon,
lyon F-69003, France
(Payet, Polazzi, Duclos) Universite Claude Bernard Lyon 1, Health Services
and Performance Research Lab (HESPER EA7425), Lyon F-69008, France
(Obadia) Department of Cardio-Thoracic Surgery and Transplantation,
Hospices Civils de Lyon, Bron F-69500, France
(Armoiry) Division of Health Sciences, University of Warwick, Warwick
medical school, Gibbet Hill Road, Coventry CV47AL, United Kingdom
(Armoiry) Pharmacy Department, Hospices Civils de Lyon, lyon F-69003,
France
(Armoiry) MATEIS lab, UMR-CNRS 5510, Lyon F-69008, France
(Labarere) TIMC lab, UMR 5525 CNRS, Univ. Grenoble Alpes, Grenoble
F-38706, France
(Labarere) Quality of Care Unit, Grenoble Alpes University Hospital, CIC
1406, Grenoble F-38043, France
(Rabilloud) Department of Biostatistics, Hospices Civils de Lyon, Lyon
F-69003, France
(Rabilloud) LBBE lab, Biostatistics Health Group, CNRS, UMR5558,
universite de Lyon, Villeurbanne F-69100, France
Publisher
Elsevier Inc.
Abstract
Objectives: The objective of the study is to evaluate the performance of
high-dimensional propensity scores (hdPSs) for controlling indication bias
as compared with propensity scores (PSs) in surgical comparative
effectiveness studies. Study Design and Setting: Patients who underwent
interventional transcatheter aortic valve implantation (TAVI) or surgical
aortic valve replacement (SAVR) between 2013 and 2017 were included from
the French nationwide hospitals. At each hospital level, matched pairs of
patients who underwent TAVI and SAVR were formed using PSs, considering 20
patient baseline characteristics, and hdPSs, considering the same patient
characteristics and 300 additional variables from procedure and diagnosis
codes the year before surgery. We compared death, reoperation, and stroke
up to 3 years between TAVI and SAVR using Cox or Fine and Gray models.
 Result(s): Before matching, 12 of 20 patient characteristics were
imbalanced between the included patients who underwent TAVI and SAVR. No
significant imbalance persisted after matching with both methods. Hazard
ratio of 1-year death, reoperation, and stroke was 1.3 [1.1; 1.4], 1.6
[1.1; 2.4], and 1.4 [1.2; 1.7] for TAVI relative to SAVR with PSs (n =
9,498 pairs) and 1.1 [1.0; 1.3], 1.3 [0.8; 2.0], and 1.3 [1.0; 1.6] with
hdPSs (n = 7,157). Conclusion(s): HdPS estimations were more
consistent with results seen in randomized controlled trials. The HdPS is
a promising alternative for the PS to control indication bias in
comparative studies of surgical procedures. Copyright © 2020
Elsevier Inc.

<76>
Accession Number
2010172651
Title
Impact of COPD on Outcomes After MitraClip for Secondary Mitral
Regurgitation: The COAPT Trial.
Source
JACC: Cardiovascular Interventions. 13 (23) (pp 2795-2803), 2020. Date of
Publication: 14 Dec 2020.
Author
Saxon J.T.; Cohen D.J.; Chhatriwalla A.K.; Kotinkaduwa L.N.; Kar S.; Lim
D.S.; Abraham W.T.; Lindenfeld J.; Mack M.J.; Arnold S.V.; Stone G.W.
Institution
(Saxon, Chhatriwalla, Arnold) Saint Luke's Mid America Heart Institute,
Kansas City, MO, United States
(Saxon, Cohen, Chhatriwalla, Arnold) University of Missouri-Kansas City,
Kansas City, MO, United States
(Kotinkaduwa, Stone) Clinical Trials Center, Cardiovascular Research
Foundation, New York, NY, United States
(Kar) Los Robles Regional Medical Center, Thousand Oaks, CA, United States
(Kar) Bakersfield Heart Hospital, Bakersfield, CA, United States
(Lim) Division of Cardiology, University of Virginia, Charlottesville, VA,
United States
(Abraham) Division of Cardiovascular Medicine, The Ohio State University,
Columbus, OH, United States
(Lindenfeld) Advanced Heart Failure and Cardiac Transplantation Section,
Vanderbilt Heart and Vascular Institute, Nashville, TN, United States
(Mack) Baylor Scott & White Health, Plano, TX, United States
(Stone) The Zena and Michael A. Wiener Cardiovascular Institute, Icahn
School of Medicine at Mount Sinai, New York, NY, United States
Publisher
Elsevier Inc.
Abstract
Objectives: The aim of this study was to examine the relationship between
chronic obstructive pulmonary disease (COPD) and outcomes after
transcatheter mitral valve repair (TMVr) for severe secondary mitral
regurgitation. Background(s): TMVr with the MitraClip improves
clinical and health-status outcomes in patients with heart failure and
severe (3+ to 4+) secondary mitral regurgitation. Whether these benefits
are modified by COPD is unknown. Method(s): COAPT (Cardiovascular
Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart
Failure Patients With Functional Mitral Regurgitation) was an open-label,
multicenter, randomized trial of TMVr plus guideline-directed medical
therapy (GDMT) versus GDMT alone. Patients on corticosteroids or
continuous oxygen were excluded. Multivariable models were used to examine
the associations of COPD with mortality, heart failure hospitalization
(HFH), and health status and to test whether COPD modified the benefit of
TMVr compared with GDMT. Result(s): Among 614 patients, 143 (23.2%)
had COPD. Among patients treated with TMVr, unadjusted analyses
demonstrated increased 2-year mortality in those with COPD (hazard ratio
[HR]: 2.08; 95% confidence interval [CI]: 1.33 to 3.26), but this
association was attenuated after risk adjustment (adjusted HR: 1.48; 95%
CI: 0.87 to 2.52). Although TMVr led to reduced 2-year mortality among
patients without COPD (adjusted HR: 0.47; 95% CI: 0.33 to 0.67), for
patients with COPD, 2-year all-cause mortality was similar after TMVr
versus GDMT alone (adjusted HR: 0.94; 95% CI: 0.54 to 1.65;
p<inf>int</inf> = 0.04), findings that reflect offsetting effects on
cardiovascular and noncardiovascular mortality. In contrast, TMVr reduced
HFH (adjusted HR: 0.48 [95% CI: 0.28 to 0.83] vs. 0.46 [95% CI: 0.34 to
0.63]; p<inf>int</inf> = 0.89) and improved both generic and
disease-specific health status to a similar extent compared with GDMT
alone in patients with and without COPD (p<inf>int</inf> >0.30 for all
scales). Conclusion(s): In the COAPT trial, COPD was associated with
attenuation of the survival benefit of TMVr versus GDMT compared with
patients without COPD. However, the benefits of TMVr on both HFH and
health status were similar regardless of COPD. (Cardiovascular Outcomes
Assessment of the MitraClip Percutaneous Therapy for Heart Failure
Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT];
NCT01626079) Copyright © 2020 American College of Cardiology
Foundation

<77>
Accession Number
633578967
Title
Multicentre randomised phase II study of the perioperative administration
of flurbiprofen axetil in patients with non-small cell lung cancer: Study
protocol of the FLAX Study.
Source
BMJ Open. 10 (11) (no pagination), 2020. Article Number: e040969. Date of
Publication: 30 Nov 2020.
Author
Sakamaki K.; Watanabe K.; Woo T.; Masuda M.
Institution
(Sakamaki) Center for Data Science, Yokohama City University, Yokohama,
Japan
(Watanabe) General Thoracic Surgery, National Hospital Organisation
Yokohama Medical Center, Yokohama, Japan
(Woo) Respiratory Center, Yokohama City University Medical Center,
Yokohama, Japan
(Masuda) Surgery, Yokohama City University, Yokohama, Japan
Publisher
BMJ Publishing Group
Abstract
Introduction In patients with non-small cell lung cancer, surgical
treatment with postoperative adjuvant chemotherapy is performed. However,
the improvement of overall survival achieved by postoperative adjuvant
chemotherapy may be insufficient in consideration of the deterioration of
quality of life (QOL). Considering the relationships among surgical
treatments, inflammation and carcinogenesis, non-steroidal
anti-inflammatory drugs (NSAIDs) are a candidate postoperative treatment
for preventing recurrence and maintaining QOL. In this study, we
investigate the effects of the perioperative administration of
flurbiprofen axetil on postoperative recurrence in patients with non-small
cell lung cancer. Methods and analysis This study is a multicentre,
parallel group, open label, randomised controlled trial. Patients
clinically suspected of non-small cell lung cancer are randomly assigned
to the flurbiprofen axetil group or the no-NSAIDs group. A total of 420
patients (210 per group) will be registered. The primary analysis will
evaluate the treatment effect of flurbiprofen axetil on postoperative
recurrence. Ethics and dissemination The study protocol was approved by
the Clinical Research Review Board of Saitama Medical University in
September 2019 (No. 192002) and will be approved by each institutional
review board of all participating institutions before patient enrolment.
This study complies with the latest version of the Declaration of
Helsinki, Clinical Trial Act and related notifications. Results will be
published in a peer-reviewed journal. Trial registration number Japan
Registry of Clinical Trials (jRCTs031190167; Pre-results)
(https://jrct.niph.go.jp/). Copyright ©

<78>
Accession Number
2010297934
Title
Remote ischemic preconditioning in patients undergoing coronary bypass
grafting following acute coronary syndrome without ST elevation.
Source
Vojnosanitetski Pregled. 77 (10) (pp 1017-1023), 2020. Date of
Publication: 2020.
Author
Milicic M.; Soldatovic I.; Nezic D.; Jovic M.; Stojkovic V.M.; Vukovic P.;
Milojevic P.
Institution
(Milicic, Nezic, Stojkovic, Vukovic, Milojevic) University of Belgrade,
Faculty of Medicine, Dedinje Cardiovascular Institute, Department of
Cardiac Surgery, Serbia
(Jovic) Department of Anesthesia, Belgrade, Serbia
(Soldatovic) University of Belgrade, Faculty of Medicine, Department of
Medical Statistics and Informatics, Belgrade, Serbia
Publisher
Inst. Sci. inf., Univ. Defence in Belgrade
Abstract
Background/Aim. A protection of heart and other organs from
ischemic-reperfusion injuries can be provided by remote ischemic
preconditioning (RIPC) by brief episodes of ischemia and reperfusion in
distant tissues. The aim of this study was to assess effects of RIPC on
early outcomes in patients underwent coronary bypass surgery (CABG)
following acute coronary syndrome without persistent ST segment elevation
(NSTEMI ACS). Methods. This trial included 42 patients randomized into two
groups: the group 1 received RIPC and the group 2 was without RIPC
(control group). Pre-, intra- and postoperative parameters were compared
but primary endpoint was myocardial injury reflected as value of troponin
I measured preoperatively and 1, 6, 12, 24, 48 and 72 h postoperatively.
The secondary endpoints were hemodynamic parameters, blood loss, intensive
care unit stay, mortality etc. Results. The groups 1 and 2 were similar in
preoperative characteristics including age, New York Heart Association
(NYHA) class, EuroSCORE II, left ventricular ejection fraction. The only
significant difference between groups was for triple vessel coronary
disease with dominance in the RIPC group [20 (100%) vs. 17 (77.3%), p =
0.049]. Cardiopulmonary bypass time [mean (+/- standard deviation): 83.0
(22.9) vs. 67.0 (17.4) minutes, p = 0.015], cross clamp time [57.9 (15.4)
vs. 44.3 (14.3) minutes, p = 0.005] and number of conduits [median
(25-75th percentile): 23.5(3-4) vs. 3(2-3), p = 0.002] were different.
Other intra- and postoperative variables did not differ between groups.
There were no differences in C reactive protein levels and postoperative
hemodynamic parameters. Average troponin values in all time points
revealed no significant differences between groups (p0h = 0.740, p1h =
0.212, p6h = 0.504, p12h = 0.597, p24h = 0.562, p48h = 0.465 and p72h =
0.715, respectively). Furthermore, there were no significant differences
in adverse events, hospital stay and mortality between groups. Conclusion.
Treatment with RIPC during CABG following NSTEMI ACS did not provide
better myocardial protection and hemodynamics characteristics but further
larger randomized studies are needed t. prove its real
value. Copyright © 2020 Inst. Sci. inf., Univ. Defence in
Belgrade. All rights reserved.

<79>
Accession Number
2010055064
Title
Volatile compared with total intravenous anaesthesia in patients
undergoing high-risk cardiac surgery: a randomized multicentre study.
Source
British Journal of Anaesthesia. 113 (6) (pp 955-963), 2014. Date of
Publication: December 2014.
Author
Landoni G.; Guarracino F.; Cariello C.; Franco A.; Baldassarri R.; Borghi
G.; Covello R.D.; Gerli C.; Crivellari M.; Zangrillo A.
Institution
(Landoni, Franco, Borghi, Covello, Gerli, Crivellari, Zangrillo)
Department of Anaesthesia and Intensive Care, IRCCS San Raffaele
Scientific Institute, Milan 20132, Italy
(Guarracino, Cariello, Baldassarri) Department of Anaesthesia and Critical
Care Medicine, Azienda Ospedaliero Universitaria Pisana, Pisa 56124, Italy
Publisher
Elsevier Ltd
Abstract
Background: The effect of anaesthesia on postoperative outcome is unclear.
Cardioprotective properties of volatile anaesthetics have been
demonstrated experimentally and in haemodynamically stable patients
undergoing coronary artery bypass grafting. Their effects in patients
undergoing high-risk cardiac surgery have not been reported.
 Method(s): We performed a multicentre, randomized, parallel group,
controlled study among patients undergoing high-risk cardiac surgery
(combined valvular and coronary surgery) in 2008-2011. One hundred
subjects assigned to the treatment group received sevoflurane for
anaesthesia maintenance, while 100 subjects assigned to the control group
received propofol-based total i.v. anaesthesia. The primary outcome was a
composite of death, prolonged intensive care unit (ICU) stay, or both.
Thirty day and 1 yr follow-up, focused on mortality, was performed.
 Result(s): All 200 subjects completed the follow-up and were included
in efficacy analyses, conducted according to the intention-to-treat
principle. Death, prolonged ICU stay, or both occurred in 36 out of 100
subjects (36%) in the propofol group and in 41 out of 100 subjects (41%)
in the sevoflurane group; relative risk 1.14, 95% confidence interval
0.8-1.62; P=0.5. No difference was identified in postoperative cardiac
troponin release [1.1 (0.7-2) compared with 1.2 (0.6-2.4) ng
ml-1, P=0.6], 1 yr all-cause mortality [11/100 (11%) compared
with 11/100 (11%), P=0.9], re-hospitalizations [20/89 (22.5%) compared
with 11/89 (12.4%), P=0.075], and adverse cardiac events [10/89 (11.2%)
compared with 9/89 (10.1%), P=0.8]. Conclusion(s): There was no
observed beneficial effect of sevoflurane on the composite endpoint of
prolonged ICU stay, mortality, or both in patients undergoing high-risk
cardiac surgery. Clinical trial registration: ClinicalTrials.gov:
identifier NCT00821262. Eudra CT (2008-001752-43). Copyright ©
2014 The Author(s)

<80>
Accession Number
2010084764
Title
Fused Whole-Heart Coronary and Myocardial Scar Imaging Using 3-T CMR:
Implications for Planning of Cardiac Resynchronization Therapy and
Coronary Revascularization.
Source
JACC: Cardiovascular Imaging. 3 (9) (pp 921-930), 2010. Date of
Publication: September 2010.
Author
White J.A.; Fine N.; Gula L.J.; Yee R.; Al-Admawi M.; Zhang Q.; Krahn A.;
Skanes A.; MacDonald A.; Peters T.; Drangova M.
Institution
(White, Fine, Gula, Yee, Al-Admawi, Krahn, Skanes, MacDonald) Division of
Cardiology, Department of Medicine, Schulich School of Medicine and
Dentistry, University of Western Ontario, London, ON, Canada
(White, Zhang, Peters, Drangova) Imaging Research Laboratories, Robarts
Research Institute, University of Western Ontario, London, ON, Canada
(White) Lawson Health Research Institute, University of Western Ontario,
London, ON, Canada
(Peters, Drangova) Departments of Medical Biophysics and Medical Imaging,
University of Western Ontario, London, ON, Canada
Publisher
Elsevier Inc.
Abstract
Objectives: The aim of this study was to demonstrate the feasibility of
providing spatially matched, 3-dimensional (3D) myocardial scar and
coronary imaging for the purpose of fused volumetric image display in
patients undergoing cardiac resynchronization therapy (CRT) or coronary
artery revascularization (CAR). Background(s): Clinical success in
coronary vascular-based interventions is mitigated by the presence of scar
in related myocardium. Pre-procedural fused volumetric imaging of both
myocardial scar and coronary vasculature may benefit pre-procedural
planning and patient selection in populations referred for CRT or CAR.
 Method(s): A total of 55 studies were performed in patients referred
for either CRT (n = 42) or CAR (n = 13). Coronary-enhanced and
scar-enhanced imaging was performed on a 3-T cardiac magnetic resonance
scanner using the same cardiac-gated, 3D, free-breathing cardiac magnetic
resonance technique during and 20 minutes following slow gadolinium
infusion. Matched image datasets were fused and volume-rendered to
simultaneously display coronary anatomy and myocardial scar. Visual
scoring of coronary artery, coronary vein, and myocardial scar image
quality (score 0 to 4) was performed. The clinical impact of imaging was
also scored using a physician survey. Result(s): Mean age was 57 +/-
14 years. Combined 3D coronary and scar imaging was successful in 49
studies (89%). A quality score >=2 was obtained for 97% of proximal- and
mid-coronary artery and vein segments. The mean quality score of 3D scar
imaging was 2.8 +/- 1.0 and was scored as >=2 in 86% of patients with
myocardial scar. All patients with a scar quality score >=2 achieved
successful image fusion. Transmural scar was present below >=1 planned
target vessel in 9 patients (39%) planned for CRT and 8 patients (62%)
planned for CAR. Physician surveys demonstrated incremental clinical
impact in 67% of patients. Conclusion(s): Three-dimensional
myocardial scar and coronary imaging with fused volumetric display is
clinically feasible and may be valuable for the planning of vascular-based
interventions when regional myocardial scar is pertinent to therapeutic
success. Copyright © 2010 American College of Cardiology
Foundation

<81>
Accession Number
2010304876
Title
Guidelines for enhanced recovery after cardiac surgery. Consensus document
of Spanish Societies of Anesthesia (SEDAR), Cardiovascular Surgery (SECCE)
and Perfusionists (AEP).
Source
Cirugia Cardiovascular. (no pagination), 2020. Date of Publication: 2020.
Author
Margarit J.A.; Pajares M.A.; Garcia-Camacho C.; Castano-Ruiz M.; Gomez M.;
Garcia-Suarez J.; Soto-Viudez M.J.; Lopez-Menendez J.; Martin-Gutierrez
E.; Blanco-Morillo J.; Mateo E.; Hernandez-Acuna C.; Vives M.; Llorens R.;
Fernandez-Cruz J.; Acosta J.; Pradas-Irun C.; Garcia M.; Aguilar-Blanco
E.M.; Castano B.; Lopez S.; Bel A.; Gabaldon T.; Fernandez-Lopez A.R.;
Gutierrez-Carretero E.; Lopez-Forte C.; Moreno J.; Galan J.; Osseyran F.;
Bustamante J.; Veiras S.; Vicente R.
Institution
(Margarit, Soto-Viudez, Hernandez-Acuna) Servicio de Cirugia Cardiaca,
Hospital Universitari de la Ribera, Valencia, Spain
(Pajares, Lopez-Forte, Osseyran, Vicente) Servicio de Anestesiologia,
Reanimacion y Terapeutica del Dolor, Hospital Universitari i Politecnic La
Fe, Valencia, Spain
(Garcia-Camacho) Unidad de Perfusion del Servicio de Cirugia Cardiaca,
Hospital Universitario Puerta del Mar, Cadiz, Spain
(Castano-Ruiz, Martin-Gutierrez) Servicio de Cirugia Cardiaca, Complejo
Asistencial Universitario de Leon, Leon, Spain
(Gomez, Fernandez-Cruz) Servicio de Anestesiologia, Reanimacion y
Terapeutica del Dolor, Hospital Universitari de la Ribera, Valencia, Spain
(Garcia-Suarez) Servicio de Anestesiologia, Reanimacion y Terapeutica del
Dolor, Hospital Universitario Puerta de Hierro, Madrid, Spain
(Lopez-Menendez) Servicio de Cirugia Cardiaca, Hospital Ramon y Cajal,
Madrid, Spain
(Blanco-Morillo) Unidad de Perfusion del Servicio de Cirugia
Cardiovascular, Hospital Clinico Universitario Virgen de la Arrixaca,
Murcia, Spain
(Mateo, Lopez, Gabaldon, Moreno) Servicio Anestesiologia, Reanimacion y
Terapeutica del Dolor, Hospital General Universitario de Valencia,
Valencia, Spain
(Vives) Servicio Anestesiologia, Reanimacion y Terapeutica del Dolor,
Hospital Universitari Dr. Josep Trueta, Girona, Spain
(Llorens) Servicio de Cirugia Cardiovascular, Hospiten Rambla, Santa Cruz
de Tenerife, Spain
(Acosta) Servicio Anestesiologia, Reanimacion y Terapeutica del Dolor,
Hospital Universitario Virgen del Rocio, Sevilla, Spain
(Pradas-Irun) Servicio de Cirugia Cardiaca, Hospital Universitari Dr.
Josep Trueta, Girona, Spain
(Garcia, Galan) Servicio de Anestesiologia, Reanimacion y Terapeutica del
Dolor, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
(Aguilar-Blanco) Servicio de Cirugia Cardiaca, Hospital Universitario 12
de Octubre, Madrid, Spain
(Castano) Servicio de Anestesiologia, Reanimacion y Terapeutica del Dolor,
Complejo Hospitalario de Toledo, Toledo, Spain
(Bel) Servicio de Cirugia Cardiaca, Hospital Universitari i Politecnic La
Fe, Valencia, Spain
(Fernandez-Lopez) Servicio Anestesiologia, Reanimacion y Terapeutica del
Dolor, Hospital Universitario Virgen Macarena, Sevilla, Spain
(Gutierrez-Carretero) Servicio de Cirugia Cardiaca, Hospital Universitario
Virgen del Rocio, Sevilla, Spain
(Bustamante) Servicio de Cirugia Cardiaca, Hospital Clinico Universitario
de Valladolid, Valladolid, Spain
(Veiras) Servicio Anestesiologia, Reanimacion y Terapeutica del Dolor,
Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain
Publisher
Elsevier Doyma
Abstract
The ERAS guidelines are intended to identify, disseminate and promote the
implementation of the best, scientific evidence-based actions to decrease
variability in clinical practice. The implementation of these practices in
the global clinical process will promote better outcomes and the
shortening of hospital and critical care unit stays, thereby resulting in
a reduction in costs and in greater efficiency. After completing a
systematic review at each of the points of the perioperative process in
cardiac surgery, recommendations have been developed based on the best
scientific evidence currently available with the consensus of the
scientific societies involved. Copyright © 2020 Sociedad Espanola
de Cirugia Cardiovascular y Endovascular

<82>
Accession Number
633622922
Title
Nurse-Implemented Goal-Directed Strategy to Improve Pain and Sedation
Management in a Pediatric Cardiac ICU.
Source
Pediatric Critical Care Medicine. (pp 1064-1070), 2020. Date of
Publication: 2020.
Author
Lincoln P.A.; Whelan K.; Hartwell L.P.; Gauvreau K.; Dodsen B.L.; Larovere
J.M.; Thiagarajan R.R.; Hickey P.A.; Curley M.A.Q.
Institution
(Lincoln, Whelan, Hickey) Department of Cardiovascular and Critical Care
Nursing Services, Boston Children's Hospital, Boston, MA, United States
(Hartwell, Gauvreau, Larovere, Thiagarajan) Department of Cardiology,
Boston Children's Hospital, Boston, MA, United States
(Dodsen) Information Services Department, Clinical Integration Architect,
Boston Children's Hospital, Boston, MA, United States
(Dodsen) Department of Pediatrics, Harvard School of Medicine, Boston, MA,
United States
(Thiagarajan) Department of Cardiovascular Services, Boston Children's
Hospital, Boston, MA, United States
(Curley) Department of Family and Community Health, School of Nursing,
University of Pennsylvania, Philadelphia, PA, United States
(Curley) Department of Anesthesia and Critical Care, Perelman School of
Medicine, University of Pennsylvania, Philadelphia, PA, United States
(Curley) Research Institute, Children's Hospital of Philadelphia,
Philadelphia, PA, United States
Publisher
Lippincott Williams and Wilkins
Abstract
Objectives: To assess the impact of a nurse-implemented goal-directed
sedation strategy on patient care and nursing practice in a pediatric
cardiac ICU. Design(s): Quality improvement project with a pre-post
interval measurement plan. Setting(s): Thirty-one bed pediatric
cardiac ICU in a freestanding tertiary care children's hospital.
 Patient(s): Postoperative pediatric cardiac surgery patients.
 Intervention(s): The implementation of cardiac-Randomized Evaluation
of Sedation Titration for Respiratory Failure (RESTORE), a
nurse-implemented goal directed strategy to improve pain and sedation
management in a pediatric cardiac ICU which included daily team discussion
of the patient's trajectory of illness (acute, titration, or weaning
phase), prescription of a sedation target score based on the patient's
trajectory of illness, arousal assessments, and opioid and/or sedative
titration. Withdrawal Assessment Scores were used to assess and manage
iatrogenic withdrawal symptoms. Measurements and Main Results: Data
related to opioid and sedation use, pain and sedation scores, and the
occurrence and management of iatrogenic withdrawal symptoms were reviewed
on 1,243 patients during four separate time periods: one
pre-implementation and three discontinuous post-implementation time
intervals. Patient age and complexity were consistent across the data
collection periods. Post-implementation opioids and benzodiazepines use
was reduced about 50% without a concomitant increase in the use of other
sedative classes. Few post-intervention patients were discharged from the
pediatric cardiac ICU or to home on methadone (pediatric cardiac ICU: pre
19% to post 3%; hospital: pre 12% to post 1.3%). Documentation of pain,
sedation, and withdrawal scores became more consistent and nurses reported
satisfaction with their patient's comfort management. Conclusion(s):
The implementation of a nurse-driven goal-directed plan such as
cardiac-RESTORE to manage pediatric cardiac ICU patient pain and sedation
is possible, sustainable, and associated with reduced sedative and
methadone use. Copyright © 2020 Lippincott Williams and Wilkins.
All rights reserved.

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