EPICORE Embase Updates: EMBASE Cardiac Update AutoAlert: EPICORE Cardiac Surgery Blogger2

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<1>
Accession Number
633467482
Title
Effect of Soft Silicone Foam Dressings on Intraoperatively Acquired
Pressure Injuries: A Randomized Study in Patients Undergoing Spinal
Surgery.
Source
Wound management & prevention. 66 (11) (pp 22-29), 2020. Date of
Publication: 01 Nov 2020.
Author
Yang T.-Y.; Shin S.H.
Institution
(Yang) College of Nursing Science, Kyung Hee University, Seoul, South
Korea
(Shin) College of Nursing Science, East-West Nursing Research Institute,
Kyung Hee University, Seoul, South Korea
Publisher
NLM (Medline)
Abstract
The use of prophylactic dressings to help prevent intraoperatively
acquired pressure injuries (IAPIs) merits further study. PURPOSE: To
examine how the use of a soft silicone foam dressing affects the
development of IAPIs in patients undergoing spinal surgery to obtain
baseline data supporting evidence-based nursing care. METHOD(S):
Using a self-controlled study design, 64 patients requiring thoracic or
lumbar surgery on a Wilson frame at a hospital in Seoul, South Korea, were
recruited between February 12 and September 1, 2018; 50 patients were
eligible. Basic demographic, health, and surgical data were obtained.
Before surgery, the left or right side chest and iliac crest areas were
randomly assigned to be covered with a soft silicone foam dressing. The
areas were assessed at 2 time points: immediately after and 30 minutes
after surgery. If an IAPI was present at 30 minutes after surgery, all
sites were reevaluated after 7 days. RESULT(S): The majority of
participants were male (26 participants, 52%). Average patient age was
62.54 (+/- 13.83) years, with a body mass index of 24.32 (+/- 4.23) kg/m2.
Average length of surgery was 218.4 (+/- 137) minutes. Immediately after
surgery, 26 IAPIs were observed and there was a significant difference
between dressed and non-dressed chest areas for the number of IAPIs (4%
vs. 28%; P = .002). After 30 minutes, the total number of IAPIs was 20 and
the difference between IAPIs in the iliac crest area was significant
between dressed and non-dressed areas (0% vs. 14%; P = .012). After 1
week, there were no chest or iliac crest IAPIs in the areas that had been
covered by a dressing; however, 8 chest (61.5%) and 4 iliac crest (30.8%)
area IAPIs remained when no dressing had been applied. The majority of
IAPIs were stage 1 at all assessment times. After 1 week, 1 IAPI had
evolved into a stage 3 injury. CONCLUSION(S): The results of this
study show that many stage 1 IAPIs do resolve over time and that use of
soft silicone foam dressings during spinal surgery can significantly
reduce IAPI rates. Additional longitudinal studies are needed to help
guide postoperative skin assessment intervals and increase the
understanding about the evolution of stage 1 IAPIs.

<2>
Accession Number
633463243
Title
Is preoperative anxiety associated with postoperative delirium in older
persons undergoing cardiac surgery? Secondary data analysis of a
randomized controlled trial.
Source
BMC geriatrics. 20 (1) (pp 478), 2020. Date of Publication: 18 Nov 2020.
Author
Milisen K.; Van Grootven B.; Hermans W.; Mouton K.; Al Tmimi L.; Rex S.;
Detroyer E.
Institution
(Milisen, Van Grootven, Hermans, Mouton, Detroyer) Department of Public
Health and Primary Care, Academic Centre for Nursing and Midwifery, KU
Leuven - University of Leuven, Kapucijnenvoer 35/4, Leuven B-3000, Belgium
(Milisen, Detroyer) Department of Geriatric Medicine, KU Leuven -
University Hospitals Leuven, Herestraat 49, Leuven B-3000, Belgium
(Van Grootven) Research Foundation Flanders, Brussels, Belgium
(Al Tmimi, Rex) Department of Anesthesiology, KU Leuven - University of
Leuven, University Hospitals of Leuven, Herestraat 49, Leuven B-3000,
Belgium
(Al Tmimi, Rex) Department of Cardiovascular Sciences, KU Leuven -
University of Leuven, Leuven B-3000, Belgium
Publisher
NLM (Medline)
Abstract
BACKGROUND: Although many studies have reported numerous risk factors for
postoperative delirium, data are scarce about preoperative anxiety as a
risk factor. The study aimed to investigate the association between
preoperative anxiety and postoperative delirium in older patients
undergoing cardiac surgery. METHOD(S): Secondary data analysis of a
randomized, observer-blind, controlled trial. A total of 190 patients
65years or older and admitted to the intensive care unit and cardiac
surgery unit of a university hospital scheduled for elective on-pump
cardiac surgery were included. State anxiety was measured preoperatively
using the Amsterdam Preoperative Anxiety and Information Scale and the
Visual Analogue Scale for anxiety. Incidence of delirium was measured
during the first 5 postoperative days using the Confusion Assessment
Method for Intensive Care Unit (when ventilated), or the 3Minute
Diagnostic Interview for Confusion Assessment Method (when extubated) and
by daily chart review. RESULT(S): Preoperative state anxiety was
reported by 31% of the patients and 41% had postoperative delirium. A
multiple step logistic regression analyses revealed no association between
preoperative anxiety and postoperative delirium. Significant risk factors
for postoperative delirium were age (OR=1.10, 95% CI (1.03-1.18)),
activities of daily living (0.69, 95% CI (0.50-0.96)), diabetes mellitus
(OR=3.15, 95% CI (1.42-7.00)) and time on cardiopulmonary bypass (OR=1.01,
95% CI (1.00 to 1.02)). CONCLUSION(S): No relationship could be found
between preoperative anxiety and postoperative delirium.

<3>
Accession Number
2007355107
Title
Intralipid postconditioning in patients of cardiac surgery undergoing
cardiopulmonary bypass (iCPB): study protocol for a randomized controlled
trial.
Source
Trials. 21 (1) (no pagination), 2020. Article Number: 953. Date of
Publication: December 2020.
Author
Yuan Y.; Xiong H.; Zhang Y.; Yu H.; Zhou R.-H.
Institution
(Yuan, Xiong, Zhang, Yu, Zhou) Department of Anesthesiology, West China
Hospital of Sichuan University, No.37, Guoxue Xiang, Wu Hou District,
Chengdu, Sichuan 610041, China
Publisher
BioMed Central Ltd
Abstract
Background: Intralipid is a necessary fatty acid carrier that has been
safely used as an energy supplier in the clinic. It has played an
important role in rescuing the cardiac arrest caused by local anesthetic
toxicity. In recent years, experimental studies have shown that intralipid
postconditioning (ILPC) could reduce myocardial ischemic/reperfusion (I/R)
injuries. Our research group has innovatively conducted a pilot randomized
controlled trial (RCT), and the results showed that ILPC could reduce the
release of cTnT and CK-MB, biomarkers of myocardial I/R injury, in valve
replacement surgery. However, the potential effects of ILPC on the
clinical outcome of adult cardiac surgery patients are unclear. Intralipid
postconditioning in patients of cardiac surgery undergoing cardiopulmonary
bypass (iCPB) trial is aimed to further study whether ILPC could improve
short-term and long-term clinical outcome, as well as cardiac function in
adult cardiac surgery patients. Method(s): The iCPB trial is an
ongoing, single-center, prospective, double-blinded, large sample RCT. In
total, 1000 adults undergoing cardiac surgery will be randomly allocated
to either the ILPC group or the control group. The intervention group
received an intravenous infusion of 2 mL/kg of 20% intralipid
(medium-chain and long-chain fat emulsion injection C6~C24,
Pharmaceutical) within 10 min before aortic cross-unclamping, and the
control group received an equivalent volume of normal saline. The primary
endpoints are complex morbidity of major complications during
hospitalization and all-cause mortality within 30 days after surgery. The
secondary endpoints include (1) all-cause mortality 6 months and 1 year
postoperatively; (2) the quality of life within 1 year after surgery,
using the QoR-15 questionnaire; (3) the postoperative cardiac function
evaluated by LVEF, LVEDS, and LVEDD, and the myocardial injury evaluated
by CK-MB, cTnT, and BNP; and (4) short-term clinical outcomes during
hospitalization and total cost are also detailed evaluated.
 Discussion(s): The iCPB trial is the first to explore ILPC on the
clinical outcome of adult cardiac surgery patients. The results are
expected to provide potential evidences about whether ILPC could reduce
the morbidity and mortality and improve the cardiac function and quality
of life. Therefore, the results will provide a rationale for the
evaluation of the potentially clinically relevant benefit of intralipid
therapy. Trial registration: Chictr.org.cn ChiCTR1900024387. Prospectively
registered on 9 July 2019. Copyright © 2020, The Author(s).

<4>
Accession Number
2005480292
Title
Avoidance of routine endotracheal suction in subjects ventilated for <= 12
hours following elective cardiac surgery.
Source
Respiratory Care. 65 (12) (pp 1838-1846), 2020. Date of Publication: 2020.
Author
Gilder E.; McGuinness S.P.; Cavadino A.; Jull A.; Parke R.L.
Institution
(Gilder, McGuinness, Parke) Cardiothoracic and Vascular Intensive Care
Unit, Auckland City Hospital, Grafton, Auckland, New Zealand
(Gilder, Jull, Parke) School of Nursing, Faculty of Medical and Health
Sciences, University of Auckland, Grafton, Auckland, New Zealand
(McGuinness, Parke) Australian and New Zealand Intensive Care Research
Centre, Monash University, Melbourne, VIC, Australia
(Cavadino) School of Population Health, University of Auckland, Grafton,
Auckland, New Zealand
(McGuinness, Parke) Medical Research Institute of New Zealand, Wellington
Hospital, Newtown, Wellington, New Zealand
Publisher
American Association for Respiratory Care
Abstract
BACKGROUND: Mechanical ventilation requires an endotracheal tube. Airway
management includes endotracheal suctioning, a frequent procedure for
patients in the ICU. Associated risks of endotracheal suctioning include
hypoxia, atelectasis, and infection. There is currently no evidence about
the safety of avoiding endotracheal suction. We aimed to assess the safety
of avoiding endotracheal suction, including at extubation, in cardiac
surgical patients who were mechanically ventilated for <= 12 h.
 METHOD(S): We conducted a single-center, noninferiority, randomized
controlled trial in a cardiac ICU in a metropolitan tertiary teaching
hospital. Subjects were assigned to either avoidance of endotracheal
suction or to usual care including endotracheal suctioning during
mechanical ventilation. In total, we screened 468 patients and randomized
249 subjects (usual care, n = 125; intervention, n = 124). Subjects were
elective cardiac surgical patients anticipated to receive <= 12 h of
mechanical ventilation. The primary outcome was the P<inf>aO2</inf>
/F<inf>IO2</inf> on room air 6 h after extubation, with a noninferiority
margin of 10% (lower bound of one-sided 95% CI to be < 30).
 RESULT(S): There were no differences in group characteristics at
baseline. The primary analysis was a per-protocol analysis performed on
154 subjects. The median P<inf>aO2</inf> /F<inf>IO2</inf> was 323 for the
intervention group and 311 for the stand-ard care group (median difference
= 12, one-sided 95% CI -14.3). The results were consistent when using an
intention-to-treat analysis and a 97.5% CI. There were no differences
between groups in complications or safety measures, including the
escalation of oxygen therapy. CONCLUSION(S): Endotracheal suctioning
can be safely minimized or avoided in low-risk patients who have had
cardiac surgery and are expected to be ventilated for < 12 h after
surgery. Copyright © 2020 Daedalus Enterprises.

<5>
Accession Number
2005480112
Title
Predictors of hospital readmission within 30 days after coronary artery
bypass grafting: Data analysis of 2,272 brazilian patients.
Source
Brazilian Journal of Cardiovascular Surgery. 35 (6) (pp 884-890), 2020.
Date of Publication: 2020.
Author
Chiorino C.D.R.N.; Santos V.B.; Lopes J.L.; Lopes C.T.
Institution
(Chiorino) Educacao Corporativa da Associacao Beneficencia Portuguesa de
Sao Paulo, Sao Paulo, Brazil
(Chiorino, Lopes) Programa de Pos-Graduacao em Enfermagem, Escola Paulista
de Enfermagem, Uni-versidade Federal de Sao Paulo, Sao Paulo, Brazil
(Santos, Lopes, Lopes) Departamento de Enfermagem Clinica e Cirurgica,
Escola Paulista de Enfermagem, Universidade Federal de Sao Paulo, Sao
Paulo, Brazil
Publisher
Sociedade Brasileira de Cirurgia Cardiovascular
Abstract
Introduction: In order to reduce readmission rates after coronary artery
bypass grafting (CABG), its predictors should be known in different
contexts. The objective of this study was to identify predictive factors
of hospital readmission within 30 days after CABG in a Brazilian center.
 Method(s): A secondary analysis of an electronic database of patients
submitted to isolated CABG was performed. The relationship between
readmission within 30 days and demographic, anthropometric, clinical, and
surgery-related characteristics was investigated by univariate analyses.
Predictors were identified by multiple logistic regression.
 Result(s): Data from 2,272 patients were included, with an incidence
of readmission of 8.6%. The predictors of readmission were brown skin
color (Beta=1.613; 95% confidence interval [CI] 1.047-2.458; P=0.030),
African-American ethnicity (Beta=0.136; 95% CI 0.019-0.988; P=0.049),
chronic kidney disease (Beta=2.214; 95% CI 1.269-3.865; P=0.005),
postoperative use of blood products (Beta=1.515; 95% CI 1.101-2.086;
P=0.011), chronic obstructive pulmonary disease (Beta=2.095; 95% CI
1.284-3.419; P=0.003), and use of acetylsalicylic acid (Beta=1.418; 95% CI
1.000-2.011; P=0.05). Preoperative antibiotic prophylaxis (Beta=0.742; 95%
CI 0.547-1.007; P=0.055) was marginally significant. Conclusion(s):
The predictors identified may support a closer postoperative follow-up and
individualized planning for a safe discharge. Copyright © 2020,
Sociedade Brasileira de Cirurgia Cardiovascular. All rights reserved.

<6>
Accession Number
2010034281
Title
Use of an Aortic Valve Replacement Simulation Model to Understand Hospital
Costs and Resource Utilization Associated With Rapid-Deployment Valves.
Source
Clinical Therapeutics. (no pagination), 2020. Date of Publication: 2020.
Author
Cotroneo A.; Novelli E.; Barbieri G.; Freddi R.; Bobbio M.; Stelian E.;
Visetti E.; Martinelli G.L.
Institution
(Cotroneo, Novelli, Bobbio, Stelian, Visetti, Martinelli) Clinica San
Gaudenzio, Gruppo Policlinico di Monza, Novara, Italy
(Barbieri) Edwards Lifesciences, Milan, Italy
(Freddi) Centre for Research on Health and Social Care Management
(CERGAS), SDA Bocconi School of Management, Milan, Italy
Publisher
Excerpta Medica Inc.
Abstract
Purpose: Aortic stenosis (AS) is the most common cause of adult valvular
heart disease. In the past decade, minimally invasive surgery (MIS) to
treat AS has gained popularity, especially if performed in combination
with rapid deployment valves (RDVs), which shorten cross-clamp time (XCT).
This study examines specific outcomes and related costs of aortic valve
replacement (AVR) before and after the introduction of RDVs.
 Method(s): We used the AVR simulator, an economic model developed to
correlate cost and resource utilization associated with the adoption of
RDVs, to compare 2 scenarios: (1) a current scenario based on standard AVR
practices and (2) a proposed scenario based on increasing use of RDVs and
an MIS approach. Both scenarios involved 3 subgroups of patients treated
with (1) conventional AVR, (2) MIS, and (3) AVR combined with a coronary
artery bypass graft. The current scenario (status quo) involved patients
treated with traditional biological valves, and the proposed scenario
involved patients who underwent implantation with an RDV. The AVR
simulator was fed with real-world input data to estimate complication
rates and resource consumption in the proposed scenario. Real-world input
data for this analysis were obtained from patients diagnosed with a
symptomatic heart valve disease between 2015 and 2018, at
Clinica-San-Gaudenzio, Novara, Italy. Lastly, the AVR simulator estimated
hospital savings by comparing the 2 scenarios. Finding(s): A total of
132 patients underwent implantation with a traditional biological valve,
and 107 were treated with a commercial valve system. The RDV was
associated with an increase of 52% of patients undergoing MIS, which
generated a 6.1-h reduction of XCT and a total savings of 6695. RDVs also
reduced intensive care unit (ICU) and hospital ward length of stay (LOS),
leading to savings of 677 and 595 per patient, respectively. Mortality and
blood transfusions also improved. The savings for the hospital (related to
shorter XCT, hospital ward LOS, and ICU LOS) amounted to 144.111. Our
findings were consistent with data gathered from our real-word setting,
and results of a sensitivity analysis indicate that our findings were
robust across different possible situations. Implications: Switching to
RDVs and MIS procedures for AVRs was associated with a reduction of costs
related to XCT, hospital ward LOS, and ICU LOS. Hospitals can upload
literature- and experience-based clinical and cost values to the AVR
simulator to estimate a hospital's performance with the introduction of
RDVs compared with standard biological valves. This study was not
randomized, so more extensive studies could confirm our results in the
future. Copyright © 2020 Elsevier Inc.

<7>
Accession Number
2007357205
Title
Cost-effectiveness analysis of mitral valve repair with the MitraClip
delivery system for patients with mitral regurgitation: a systematic
review.
Source
Heart Failure Reviews. (no pagination), 2020. Date of Publication: 2020.
Author
Rezapour A.; Azari S.; Arabloo J.; Pourasghari H.; Behzadifar M.; Alipour
V.; Omidi N.; Sadeghian S.; Aghajani H.; Bragazzi N.L.
Institution
(Rezapour, Azari, Arabloo, Alipour) Health Management and Economics
Research Center, Iran University of Medical Sciences, Tehran, Iran,
Islamic Republic of
(Azari, Pourasghari) Hospital Management Research Center, Iran University
of Medical Sciences, Tehran, Iran, Islamic Republic of
(Behzadifar) Social Determinants of Health Research Center, Lorestan
University of Medical Sciences, Khorramabad, Iran, Islamic Republic of
(Omidi) Department of Cardiology, Tehran Heart Center, Tehran University
of Medical Sciences, Tehran, Iran, Islamic Republic of
(Sadeghian, Aghajani) Department of Interventional Cardiology, Tehran
Heart Center, Tehran University of Medical Sciences, Tehran, Iran, Islamic
Republic of
(Bragazzi) Laboratory for Industrial and Applied Mathematics (LIAM),
Department of Mathematics and Statistics, York University, Toronto, Canada
Publisher
Springer
Abstract
To assess the cost-effectiveness of mitral valve repair with the MitraClip
delivery system for patients with mitral regurgitation and heart failure,
a systematic literature search was conducted in various electronic
databases to January 3, 2020. Eligibility criteria are the population
(patients with mitral regurgitation (MR)), intervention (transcatheter
mitral valve repair using the MitraClip), comparator (conventional medical
treatment), outcomes, and designs (Model-based or trial-based full
economic evaluations).The quality of included studies was assessed using
the CHEERS checklist. Mortality and survival rate, quality-adjusted life
year (QALY), life years gained (LYG), total cost, and the incremental
cost-effectiveness ratio (ICER) regarding the use of MitraClip System were
considered as the key outcomes. Eight articles were eligible for full-text
assessment. Ultimately, a total of seven studies were considered in the
current systematic review. Results demonstrated that MitraClip reduces
mortality rate and increases survival rate. The mortality rate at 1 year
and 10 years was 16.7% versus 29.77% and 70.9% versus 98.8%, respectively.
Total cost data based on 2019 USD show that the MitraClip has the highest
cost in the USA ($121,390) and the lowest cost in Italy ($33,062). The
results showed that in all selected countries, willingness-to-pay (WTP)
thresholds are upper than the cost per QALY; also, the highest ICER for
the MitraClip is in the USA ($55,600/QALY) and the lowest in Italy
($10,616/QALY). To conclude, evidence from this systematic review suggests
that MitraClip Delivery System improved both life expectancy and QALY
compared with medical treatment in patients at high surgical risk and it
was also a cost-effective treatment option for patients with mitral
regurgitation. Copyright © 2020, Springer Science+Business Media,
LLC, part of Springer Nature.

<8>
Accession Number
633467080
Title
The intraoperative use of recombinant activated factor VII in arterial
switch operations.
Source
Cardiology in the young. (pp 1-5), 2020. Date of Publication: 19 Nov 2020.
Author
Zink J.; Spigel Z.A.; Ibarra C.; Gottlieb E.A.; Adachi I.; Mery C.M.;
Imamura M.; Heinle J.S.; McKenzie E.D.; Fraser C.D.; Binsalamah Z.M.
Institution
(Zink, Spigel, Ibarra, Adachi, Imamura, Heinle, McKenzie, Binsalamah)
Texas Children's Hospital, TX, Houston, United States
(Gottlieb, Mery, Fraser) Dell Children's Medical Center of Central Texas,
TX, Austin, United States
Publisher
NLM (Medline)
Abstract
BACKGROUND: The rate of bleeding complications following arterial switch
operation is too low to independently justify a prospective randomised
study for benefit from recombinant factor VIIa. We aimed to evaluate
factor VIIa in a pilot study. METHOD(S): We performed a retrospective
cohort study of patients undergoing arterial switch operation from 2012 to
2017. Nearest-neighbour propensity score matching on age, gender, weight,
and associated cardiac defects was used to match 27 controls not receiving
recombinant factor VIIa to 30 patients receiving recombinant factor VIIa.
Fisher's exact test was performed to compare categorical variables.
Wilcoxon's rank-sum test was used to compare continuous variables between
cohorts. RESULT(S): Post-operative thrombotic complications were not
associated with factor VIIa administration (Odds Ratio (OR) 0.28, 95% CI
0.005-3.77, p = 0.336), nor was factor VIIa administration associated with
any re-explorations for bleeding. No intraoperative transfusion volumes
were different between the recombinant factor VIIa cohort and controls.
Post-operative prothrombin time (10.8 [10.3-12.3] versus 15.9 [15.1-17.2],
p < 0.001) and international normalised ratio (0.8 [0.73-0.90] versus 1.3
[1.2-1.4], p < 0.001]) were lower in recombinant factor VIIa cohort
relative to controls. CONCLUSION(S): In spite of a higher post-bypass
packed red blood cell transfusion requirement, patients receiving
recombinant factor VIIa had a similar incidence of bleeding
post-operatively. With no difference in thrombotic complications, and with
improved post-operative laboratory haemostasis, a prospective randomised
study is warranted to evaluate recombinant factor VIIa.

<9>
Accession Number
633464834
Title
Motor Impairment in Children With Congenital Heart Defects: A Systematic
Review.
Source
Pediatrics. (no pagination), 2020. Date of Publication: 18 Nov 2020.
Author
Bolduc M.-E.; Dionne E.; Gagnon I.; Rennick J.E.; Majnemer A.;
Brossard-Racine M.
Institution
(Bolduc, Dionne, Gagnon, Majnemer) School of Physical and Occupational
Therapy
(Bolduc, Dionne, Brossard-Racine) Advances in Brain and Child Development
Research Laboratory, The Research Institute of the McGill University
Health Centre, Montreal, Canada; and
(Rennick) Ingram School of Nursing
(Rennick, Majnemer, Brossard-Racine) Departments of Pediatrics and
(Rennick) Department of Nursing, Montreal Children's Hospital, McGill
University Health Centre, Montreal, Canada
(Majnemer, Brossard-Racine) Neurology and Neurosurgery, McGill University,
Montreal, Canada
(Brossard-Racine) School of Physical and Occupational Therapy
Publisher
NLM (Medline)
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.

<10>
Accession Number
633464741
Title
Effects of heparinoid bridging in patients with mechanical heart valves.
Source
Journal of the American Association of Nurse Practitioners. (no
pagination), 2020. Date of Publication: 16 Nov 2020.
Author
Torres M.
Institution
(Torres) University of Pennsylvania, School of Nursing, Philadelphia, PA,
United States
Publisher
NLM (Medline)
Abstract
BACKGROUND: Patients with mechanical heart valves (MHVs) require long-term
oral anticoagulation therapy to protect against thromboembolisms. Invasive
procedures with high bleeding risks require oral anticoagulation therapy
cessation. Currently, guidelines recommend the use of either subcutaneous
low-molecular-weight heparin or intravenous unfractionated heparin in the
perioperative period. It is unclear whether the evidence supports the use
of one heparinoid over the other. OBJECTIVE(S): To compare the
effectiveness of low-molecular-weight heparin and unfractionated heparin
bridging based on the adverse outcomes of thromboembolisms, major
bleeding, and death during the perioperative period. DATE SOURCES: A
literature search was conducted using PubMed, EMBASE, CINAHL, and the
Cochrane Library. Five studies comparing the two bridging therapies in
chronically anticoagulated MHV patients met the inclusion criteria.
 CONCLUSION(S): No statistical significance was found for the
endpoints of thromboembolism and death. One study found a statistically
significant higher occurrence of major bleeding in patients treated with
unfractionated heparin. In all the studies, major bleeding occurred more
often than thromboembolisms. Findings were limited by the study designs
and methodologies. IMPLICATIONS FOR PRACTICE: Based on the available
evidence, neither low-molecular-weight heparin nor intravenous heparin
bridging was found to be more effective in reducing the occurrence of
adverse events. This may be due in part to the study designs and lack of
standardized bridging protocols used in the studies reviewed. Nurse
practitioners should remain informed about bridging protocols and weigh
the risk versus benefit of each bridging agent when caring for patients
with MHVs.

<11>
Accession Number
52757852
Title
Safety and effi cacy of drug-eluting stents in women: A patient-level
pooled analysis of randomised trials.
Source
The Lancet. 382 (9908) (pp 1879-1888), 2013. Date of Publication: 2013.
Author
Stefanini G.G.; Baber U.; Windecker S.; Morice M.-C.; Sartori S.; Leon
M.B.; Stone G.W.; Serruys P.W.; Wijns W.; Weisz G.; Camenzind E.; Steg
P.G.; Smits P.C.; Kandzari D.; Von Birgelen C.; Galatius S.; Jeger R.V.;
Kimura T.; Mikhail G.W.; Itchhaporia D.; Mehta L.; Ortega R.; Kim H.-S.;
Valgimigli M.; Kastrati A.; Chieffo A.; Mehran R.
Institution
(Stefanini, Windecker) Bern University Hospital, Bern, Switzerland
(Baber, Sartori, Mehran) Mount Sinai School of Medicine, New York, NY,
United States
(Leon, Stone, Weisz) Columbia University Medical Center, New York, NY,
United States
(Wijns) Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis
Ziekenhuis, Aalst, Belgium
(Camenzind) University of Geneva, Geneva, Switzerland
(Jeger) University Hospital Basel, Basel, Switzerland
(Steg) Departement Hospitalo- Universitaire Fibrose, Infl Ammation et
REmodelage, Universite Paris- Diderot, Paris, France
(Smits) Maasstad Hospital, Rotterdam, Netherlands
(Von Birgelen) Thoraxcentrum Twente, Enschede, Netherlands
(Kandzari) Piedmont Heart Institute, Atlanta, GA, United States
(Galatius) Gentofte University Hospital, Hellerup, Denmark
(Kimura) Kyoto University Graduate School of Medicine, Kyoto, Japan
(Mikhail) Imperial College Healthcare NHS Trust, London, United Kingdom
(Kim) Seoul National University Main Hospital, Seoul, South Korea
(Valgimigli) University of Ferrara, Ferrara, Italy
(Kastrati) Deutsches Herzzentrum, Munich, Germany
(Serruys) Erasmus MC, Rotterdam, Netherlands
(Itchhaporia) Hoag Memorial Hospital Presbyterian, Newport Beach, CA,
United States
(Ortega) Society of Cardiovascular Angiography and Interventions,
Washington, DC, United States
(Mehta) Ohio State University Medical Center, Columbus, OH, United States
(Chieffo) San Raffaele Hospital, Milan, Italy
(Morice) Institut Cardiovasculaire, Paris-Sud, France
Publisher
Lancet Publishing Group
Abstract
Background The safety and effi cacy of drug-eluting stents (DES) in the
treatment of coronary artery disease have been assessed in several
randomised trials. However, none of these trials were powered to assess
the safety and effi cacy of DES in women because only a small proportion
of recruited participants were women. We therefore investigated the safety
and effi cacy of DES in female patients during long-term follow-up.
Methods We pooled patient-level data for female participants from 26
randomised trials of DES and analysed outcomes according to stent type
(bare-metal stents, early-generation DES, and newer-generation DES). The
primary safety endpoint was a composite of death or myocardial infarction.
The secondary safety endpoint was defi nite or probable stent thrombosis.
The primary effi cacy endpoint was target-lesion revascularisation.
Analysis was by intention to treat. Findings Of 43 904 patients recruited
in 26 trials of DES, 11 557 (26.3%) were women (mean age 67.1 years [SD
10.6]). 1108 (9.6%) women received bare-metal stents, 4171 (36.1%)
early-generation DES, and 6278 (54.3%) newergeneration DES. At 3 years,
estimated cumulative incidence of the composite of death or myocardial
infarction occurred in 132 (12.8%) women in the bare-metal stent group,
421 (10.9%) in the early-generation DES group, and 496 (9.2%) in the
newer-generation DES group (p=0.001). Defi nite or probable stent
thrombosis occurred in 13 (1.3%), 79 (2.1%), and 66 (1.1%) women in the
bare-metal stent, early-generation DES, and newer-generation DES groups,
respectively (p=0.01). The use of DES was associated with a signifi cant
reduction in the 3 year rates of targetlesion revascularisation (197
[18.6%] women in the bare-metal stent group, 294 [7.8%] in the
early-generation DES group, and 330 [6.3%] in the newer-generation DES
group, p<0.0001). Results did not change after adjustment for baseline
characteristics in the multivariable analysis. Interpretation The use of
DES in women is more effective and safe than is use of bare-metal stents
during longterm follow-up. Newer-generation DES are associated with an
improved safety profi le compared with earlygeneration DES, and should
therefore be thought of as the standard of care for percutaneous coronary
revascularisation in women.

<12>
Accession Number
362373706
Title
Novel approaches for the surgical treatment of atrial fibrillation: Time
for a guideline revision?.
Source
Vascular Health and Risk Management. 6 (1) (pp 439-447), 2010. Date of
Publication: 2010.
Author
de Cecco C.N.; Buffa V.; David V.; Fedeli S.
Institution
(de Cecco, Buffa, Fedeli) Department of Cardiovascular Radiology, San
Camillo-Forlanini Hospital, Via Portuense 332, 00149 Rome, Italy
(de Cecco, David) Department of Radiological Sciences, University of Rome,
St Andrea Hospital, Rome, Italy
Publisher
Dove Medical Press Ltd
Abstract
Atrial fibrillation is a major health problem in Western countries, and is
associated with considerable morbidity and resource consumption. Safe and
reliable surgical techniques for the termination of this arrhythmia have
been developed since the time of the original Cox "maze I" procedure.
Novel equipment based on radiofrequency and microwave technologies can be
employed to create transmural atrial lesions, even in the context of
minimally invasive surgery to the atrioventricular valves via right
minithoracotomy. The aim of this paper is to review the recent literature
on this approach, and the clinical results in terms of arrhythmia
termination and postoperative morbidity. With the aim to substantiate the
practice of a simple, yet reliable, surgical ablation during minimally
invasive heart valve surgery, we discuss the results of different patterns
of atrial lesions having different degrees of surgical complexity.
Finally, minimally invasive epicardial ablation for lone atrial
fibrillation represents an emerging surgical indication. The results of
state-of-the-art transcatheter ablation represent now its benchmark of
comparison. © 2010 De Cecco et al, publisher and licensee Dove
Medical Press Ltd.

<13>
Accession Number
2007713531
Title
Systematic review and meta-analysis of the clinical characteristics and
outcomes of spontanous coronary artery dissection.
Source
International Journal of Cardiology. 322 (pp 34-39), 2021. Date of
Publication: 01 Jan 2021.
Author
Franke K.B.; Nerlekar N.; Marshall H.; Psaltis P.J.
Institution
(Franke, Marshall, Psaltis) The University of Adelaide Medical School,
Adelaide, Australia
(Franke, Psaltis) Vascular Research Centre, Lifelong Health Theme, South
Australian Health and Medical Research Institute, Adelaide, Australia
(Franke, Psaltis) Department of Cardiology, Central Adelaide Local Health
Network, Adelaide, Australia
(Nerlekar) Monash Cardiovascular Research Centre, Monash University and
MonashHeart, Monash Health, Clayton, Victoria, Australia
(Nerlekar) Baker Heart and Diabetes Institute, Melbourne, Australia
Publisher
Elsevier Ireland Ltd
Abstract
Background: Spontaneous coronary artery dissection (SCAD) is an uncommon,
non-iatrogenic, non-atherosclerotic cause of acute coronary syndrome. A
lack of large prospective cohort studies and randomised controlled trials
means that important questions about clinical characteristics and outcomes
of patients with SCAD are yet to be fully answered. Method(s): A
literature search of PUBMED, EMBASE and SCOPUS was undertaken up to and
including the 23rd January 2020. Studies reporting any cohort
of 10 or more SCAD patients presenting with acute coronary syndrome, with
appropriate clinical follow-up data were included in the analysis.
Incidences of major adverse cardiovascular events (MACE), myocardial
infarction and SCAD recurrence were meta-analysed using Poisson
regression. Result(s): 19 studies, totalling p=2,172 patients, were
included in the analysis. There was significant heterogeneity across the
studies in all baseline characteristics and clinical outcomes. Prevalence
of traditional cardiovascular risk factors was low; however, hypertension
had a prevalence of 45% (95% CI; [35-54]) and fibromuscular dysplasia
(FMD) was present in 68% (95% CI; [61-74]). Across all cohorts, the
incidence of MACE in patients with SCAD was 7.80 per 100 person years
(n=19, p=2172, 95% CI; [4.50-13.54]) and SCAD recurrence was 5.49 per 100
person years (n=13, p=1408, 95% CI; [3.75-8.02]). Conclusion(s): This
meta-analysis confirms that SCAD is not an inconsequential cause of acute
coronary syndrome and heralds the need for further prospective research to
identify predictors of recurrent events and therapies to prevent
them. Copyright © 2020

<14>
Accession Number
2005213288
Title
Ticagrelor versus clopidogrel in older patients with nste-acs using oral
anticoagulation: A sub-analysis of the popular age trial.
Source
Journal of Clinical Medicine. 9 (10) (pp 1-9), 2020. Article Number: 3249.
Date of Publication: October 2020.
Author
Gimbel M.E.; Tavenier A.H.; Bor W.; Hermanides R.S.; de Vrey E.;
Heestermans T.; Gin M.T.J.; Waalewijn R.; Hofma S.; Den Hartog F.; Jukema
W.; von Birgelen C.; Voskuil M.; Kelder J.; Deneer V.; Ten Berg J.M.
Institution
(Gimbel, Bor, Kelder, Ten Berg) Department of Cardiology, St. Antonius
Hospital, Nieuwegein 3435CM, Netherlands
(Tavenier, Hermanides) Department of Cardiology, Isala, Zwolle 8025AB,
Netherlands
(de Vrey) Department of Cardiology, Meander Medical Centre, Amersfoort
3813TZ, Netherlands
(Heestermans) Department of Cardiology, Noord-west Hospital group, Alkmaar
1815JD, Netherlands
(Gin) Department of Cardiology, Rijnstate, Arnhem 6815AD, Netherlands
(Waalewijn) Department of Cardiology, Gelre Hospitals, Apeldoorn 7334DZ,
Netherlands
(Hofma) Department of Cardiology, Medical Centre Leeuwarden, Leeuwarden
8934AD, Netherlands
(Den Hartog) Department of Cardiology, Gelderse Vallei Hospital, Ede
6716RP, Netherlands
(Jukema) Department of Cardiology, Leids University Medical Centre, Leiden
2333ZA, Netherlands
(von Birgelen) Department of Cardiology, Medisch Spectrum Twente, Enschede
7512KZ, Netherlands
(Voskuil) Department of Cardiology, University Medical Centre Utrecht,
Utrecht 3584CX, Netherlands
(Deneer) Department of Clinical Pharmacy, Division of Laboratories,
Pharmacy, and Biomedical Genetics University, Medical Center Utrecht and
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht
Institute for Pharmaceutical Sciences, Utrecht University, Utrecht 3584CX,
Netherlands
Publisher
MDPI AG
Abstract
There are no randomised data on which antiplatelet agent to use in elderly
patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and an
indication for oral anticoagulation (OAC). The randomised POPular Age
trial, in patients of 70 years or older with NSTE-ACS, showed a reduction
in bleeding without increasing thrombotic events in patients using
clopidogrel as compared to ticagrelor. In this sub-analysis of the POPular
AGE trial, we compare clopidogrel with ticagrelor in patients with a need
for oral anticoagulation. The follow-up duration was one year. The primary
bleeding outcome was Platelet Inhibition and Patient Outcomes (PLATO)
major and minor bleeding. The primary thrombotic outcome consisted of
cardiovascular death, myocardial infarction and stroke. The primary net
clinical benefit outcome was a composite of all-cause death, myocardial
infarction, stroke, and PLATO major and minor bleeding. A total of
184/1011 (18.2%) patients on OAC were included in this subanalysis; 83
were randomized to clopidogrel and 101 to ticagrelor. The primary bleeding
outcome was lower in the clopidogrel group (17/83, 20.9%) compared to the
ticagrelor group (33/101, 33.5%; p = 0.051), as was the thrombotic outcome
(7/83, 8.4% vs. 19/101, 19.2%; p = 0.035) and the primary net clinical
benefit outcome (23/83, 27.7% vs. 49/101, 48.5%; p = 0.003). In this
subgroup of patients using OAC, clopidogrel reduced PLATO major and minor
bleeding compared to ticagrelor without increasing thrombotic risk. This
analysis therefore suggests that, in line with the POPular Age trial,
clopidogrel is a better option than ticagrelor in NSTE-ACS patients >=70
years using OAC. Copyright © 2020 by the authors. Licensee MDPI,
Basel, Switzerland.

<15>
Accession Number
632556758
Title
Intraoperative cell salvage for obstetrics: A prospective randomized
controlled clinical trial.
Source
BMC Pregnancy and Childbirth. 20 (1) (no pagination), 2020. Article
Number: 452. Date of Publication: 07 Aug 2020.
Author
Liu Y.; Li X.; Che X.; Zhao G.; Xu M.
Institution
(Liu, Li, Che, Zhao, Xu) Department of Anaesthesiology, Beijing Obstetrics
and Gynecology Hospital, Capital Medical University, Beijing 100026, China
Publisher
BioMed Central Ltd
Abstract
Background: The latest basic studies and clinical evidence have confirmed
the safety and efficacy of intraoperative autologous blood cell
transfusion in cardiac surgery and orthopaedics. However, in caesarean
section, there are still concerns about the contamination of amniotic
fluid and foetal components, and consequently the application of
intraoperative autologous blood cell transfusion is not universal.
Therefore, this study aimed to evaluate the clinical value of
intraoperative autologous blood cell transfusion in obstetric surgery.
 Method(s): A prospective, randomized, controlled, feasibility study
was performed in women undergoing caesarean section. One hundred sixteen
participants were randomly assigned at a 1:1 ratio into either the
intraoperative cell salvage group or the control group. Allogeneic blood
cells were transfused into patients with haemoglobin concentrations < 80
g/dL in both the intraoperative cell salvage group and the control group.
 Result(s): No significant differences were found between the two
groups in age, weight, maternal parity, history of previous caesarean
section, gestational weeks of delivery, etc. However, compared with the
control group, patients in the intraoperative cell salvage group had a
significantly lower amount of allogeneic blood cell transfusion, lower
incidence of postoperative incision infection, delayed wound healing,
perioperative allergy, adverse cardiovascular events, hypoproteinaemia and
shorter hospital stay. Conclusion(s): The results of this study
suggest that the use of autologous blood cell transfusion is safe and
effective for patients with obstetric haemorrhage. Trial registration: All
procedures performed in studies involving human participants were in
accordance with the ethical standards of the Institutional and/or National
Research Committee of Beijing Obstetrics and Gynecology Hospital, Capital
Medical University (2016-XJS-003-01) as well as the 1964 Helsinki
Declaration and its later amendments or other comparable ethical
standards. The clinical trials were registered (ChiCTR-ICC-15,007,096) on
September 28, 2015. Copyright © 2020 The Author(s).

<16>
Accession Number
2008037684
Title
Atrial Fibrillation and Transcatheter Repair of Functional Mitral
Regurgitation: Evidence From a Meta-Regression.
Source
JACC: Cardiovascular Interventions. 13 (20) (pp 2374-2384), 2020. Date of
Publication: 26 Oct 2020.
Author
Kaur S.; Sadana D.; Patel J.; Gad M.; Sankaramangalam K.; Krishnaswamy A.;
Miyasaka R.; Harb S.C.; Kapadia S.R.
Institution
(Kaur, Patel, Gad) Department of Internal Medicine, Cleveland Clinic,
Cleveland, OH, United States
(Sadana) Department of Pulmonary and Critical Care, Cleveland Clinic,
Cleveland, OH, United States
(Sankaramangalam) Department of Internal Medicine, Saint Peter's
University Hospital/Rutgers Robert Wood Johnson Medical School, New
Brunswick, NJ, United States
(Krishnaswamy, Kapadia) Department of Interventional Cardiology, Cleveland
Clinic, Cleveland, OH, United States
(Miyasaka, Harb) Department of Cardiovascular Imaging, Cleveland Clinic,
Cleveland, OH, United States
Publisher
Elsevier Inc.
Abstract
Objectives: The aim of this study was to assess the impact of atrial
fibrillation (AF) on mortality and efficacy in patients with functional
mitral regurgitation (FMR) undergoing MitraClip implantation.
 Background(s): AF is a common arrhythmia in patients with severe FMR
undergoing transcatheter mitral valve repair with the MitraClip device.
Although AF has been consistently shown to be associated with poor
outcomes after mitral valve surgery, the impact of AF on outcomes of
MitraClip placement in patients with FMR has not been well studied.
 Method(s): Prospective, retrospective registries, observational
studies, and randomized controlled trials on MitraClip reporting AF and
FMR as one of the variables from inception until January 2019 were
included. Result(s): Of the initial 1,694 studies, 15 studies met the
inclusion criteria. From a total of 5,184 patients, 2,105 patients were
identified to have FMR and AF. All-cause 30-day mortality in patients with
FMR was 3.7% (95% confidence interval: 2.87 to 4.66) and 1-year mortality
was 17.9% (95% confidence interval: 16.01 to 19.71). The meta-regression
analysis studying the impact of AF among patients with FMR treated with
the MitraClip demonstrated no difference in mortality at 30 days but
demonstrated significantly increased mortality at 1 year (95% confidence
interval: 0.0006 to 0.0027) (p = 0.004). AF did not influence procedural
success. Conclusion(s): This meta-regression identifies AF as an
independent negative predictor of long-term mortality after MitraClip
implantation in patients with FMR. The mechanism of worse outcomes in
patients with AF requires further study. Copyright © 2020
American College of Cardiology Foundation

<17>
Accession Number
633405527
Title
Transcatheter Mitral Valve Repair in Patients With and Without Cardiac
Resynchronization Therapy: The COAPT Trial.
Source
Circulation. Heart failure. 13 (11) (pp e007293), 2020. Date of
Publication: 01 Nov 2020.
Author
Kosmidou I.; Lindenfeld J.; Abraham W.T.; Kar S.; Lim D.S.; Mishell J.M.;
Whisenant B.K.; Kipperman R.M.; Boudoulas K.D.; Redfors B.; Shahim B.;
Zhang Z.; Mack M.J.; Stone G.W.
Institution
(Kosmidou, Redfors, Shahim, Zhang, Stone) Clinical Trials Center,
Cardiovascular Research Foundation, B.R., B.S., NY
(Kosmidou, Redfors) NewYork-Presbyterian Hospital/Columbia University
Irving Medical Center (I.K.
(Lindenfeld) Vanderbilt Heart and Vascular Institute, Nashville, United
States
(Abraham, Boudoulas) Division of Cardiovascular Medicine, Ohio State
University
(Kar) Los Robles Regional Medical Center, Thousand Oaks
(Kar) Bakersfield Heart Hospital
(Lim) Division of Cardiology, University of Virginia
(Mishell) Kaiser Permanente-San Francisco Hospital
(Whisenant) Intermountain Heart Center, Salt Lake City, United States
(Kipperman) Gagnon Cardiovascular Institute, Morristown Medical Center
(Redfors) Department of Cardiology, Sahlgrenska University Hospital,
Gothenburg, United States
(Mack) Baylor Scott and White Health, Plano, United States
(Stone) Zena and Michael A. Wiener Cardiovascular Institute, Icahn School
of Medicine at Mount Sinai, NY
Publisher
NLM (Medline)
Abstract
BACKGROUND: In the COAPT trial (Cardiovascular Outcomes Assessment of the
MitraClip Percutaneous Therapy for Heart Failure Patients With Functional
Mitral Regurgitation), treatment of heart failure (HF) patients with
moderate-severe or severe secondary mitral regurgitation with
transcatheter mitral valve repair (TMVr) using the MitraClip plus
guideline-directed medical therapy (GDMT) reduced 2-year rates of HF
hospitalization and all-cause mortality compared with GDMT alone. Whether
the benefits of the MitraClip extend to patients with previously implanted
cardiac resynchronization therapy (CRT) is unknown. We sought to examine
the effect of prior CRT in patients enrolled in COAPT. METHOD(S):
Patients (N=614) with moderate-severe or severe secondary mitral
regurgitation who remained symptomatic despite maximally tolerated doses
of GDMT were randomized 1:1 to the MitraClip (TMVr arm) versus GDMT only
(control arm). Outcomes were assessed according to prior CRT use.
 RESULT(S): Among 614 patients, 224 (36.5%) had prior CRT (115 and 109
randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT
(187 and 203 randomized to TMVr and control, respectively). Patients with
CRT had similar 2-year rates of the composite of death or HF
hospitalization compared with those without CRT (57.6% versus 55%,
P=0.32). Death or HF hospitalization at 2 years was lower with TMVr versus
control treatment in patients with prior CRT (48.6% versus 67.2%, hazard
ratio, 0.60 [95% CI, 0.42-0.86]) and without CRT (42.5% versus 66.9%,
hazard ratio, 0.52 [95% CI, 0.39-0.69]; adjusted Pinteraction=0.23). The
effects of TMVr with the MitraClip on reducing the 2-year rates of
all-cause death (adjusted Pinteraction=0.14) and HF hospitalization
(adjusted Pinteraction=0.82) were also consistent in patients with and
without CRT as were improvements in quality-of-life and exercise capacity.
 CONCLUSION(S): In the COAPT trial, TMVr with the MitraClip improved
the 2-year prognosis of patients with HF and moderate-severe or severe
secondary mitral regurgitation who remained symptomatic despite maximally
tolerated GDMT, regardless of prior CRT implantation. Registration: URL:
https://www.clinicaltrials.gov. Unique identifier: NCT01626079.

<18>
Accession Number
632587339
Title
The a wait for symptoms' strategy in asymptomatic severe aortic stenosis.
Source
Heart. 106 (23) (pp 1792-1797), 2020. Date of Publication: 01 Dec 2020.
Author
San Roman J.A.; Vilacosta I.; Antunes M.J.; Iung B.; Lopez J.; Schafers
H.-J.
Institution
(San Roman, Lopez) Cardiology Hospital Clinico Universitario de Valladolid
Servicio de Cardiologia, Valladolid, Spain
(Vilacosta) Cardiology Hospital Clinico, Universitario San Carlos, Madrid,
Spain
(Antunes) Cardiothoracic Surgery, Centro Hospitalar de Coimbra, Coimbra,
Portugal
(Iung) Cardiology Hopital Bichat-Claude-Bernard, Paris, France
(Schafers) Klinik fur Thorax- und Herz- Gefaschirurgie, Universitat des
Saarlandes, Saarbrucken, Germany
Publisher
BMJ Publishing Group
Abstract
Calcific aortic stenosis is a prevalent and worrisome healthcare problem.
The therapeutic approach in asymptomatic aortic stenosis is not well
established. We argue that the natural history of this disease is based on
old incomplete studies with many limitations. Likewise, studies suggesting
that replacement, either surgical or percutaneous, improves prognosis in
asymptomatic patients with severe aortic stenosis have important drawbacks
and do not support this strategy as the treatment of choice. Despite the
lack of evidence, some groups recommend early valve replacement in
patients with severe asymptomatic aortic stenosis. There are five ongoing
randomised trials which will shed light on this topic. Our conclusion is
that unless a randomised study changes the evidence, valve replacement
cannot be recommended in asymptomatic patients with severe aortic
stenosis. Copyright © 2020 BMJ Publishing Group. All rights
reserved.

<19>
[Use Link to view the full text]
Accession Number
631823672
Title
Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve
Replacement in Low-Risk Patients: The PARTNER 3 Trial.
Source
Circulation. 141 (19) (pp 1527-1537), 2020. Date of Publication: 12 May
2020.
Author
Pibarot P.; Salaun E.; Dahou A.; Avenatti E.; Guzzetti E.; Annabi M.-S.;
Toubal O.; Bernier M.; Beaudoin J.; Ong G.; Ternacle J.; Krapf L.;
Thourani V.H.; Makkar R.; Kodali S.K.; Russo M.; Kapadia S.R.; Malaisrie
S.C.; Cohen D.J.; Leipsic J.; Blanke P.; Williams M.R.; McCabe J.M.; Brown
D.L.; Babaliaros V.; Goldman S.; Szeto W.Y.; Genereux P.; Pershad A.; Alu
M.C.; Xu K.; Rogers E.; Webb J.G.; Smith C.R.; Mack M.J.; Leon M.B.; Hahn
R.T.
Institution
(Pibarot, Salaun, Guzzetti, Annabi, Toubal, Bernier, Beaudoin, Ternacle,
Krapf) Institut Universitaire de Cardiologie et de Pneumologie de Quebec,
2725 Chemin Sainte-Foy, Quebec, Canada
(Dahou, Avenatti, Alu, Leon, Hahn) Cardiovascular Research Foundation, New
York, NY, United States
(Ong) St Michael's Hospital, University of Toronto, Canada
(Thourani) Department of Cardiovascular Surgery, Piedmont Heart Institute,
Atlanta, GA, United States
(Makkar) Cedars-Sinai Medical Center, Los Angeles, CA, United States
(Kodali, Alu, Smith, Leon, Hahn) Columbia University Irving Medical
Center, New York-Presbyterian Hospital, New York, United States
(Russo) Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ,
United States
(Kapadia) Cleveland Clinic, OH, United States
(Malaisrie) Feinberg School of Medicine, Northwestern University, Chicago,
IL, United States
(Cohen) University of Missouri-Kansas City, United States
(Leipsic, Blanke, Webb) St Paul's Hospital, Vancouver, Canada
(Williams) NYU-Langone Medical Center, New York, NY, United States
(McCabe) University of Washington, Seattle, United States
(Brown, Mack) Baylor Scott and White Healthcare, Plano, TX, United States
(Babaliaros) Emory University School of Medicine, Atlanta, GA, United
States
(Goldman) Lankenau Medical Center, Wynnewood, PA, United States
(Szeto) University of Pennsylvania, Philadelphia, United States
(Genereux) Gagnon Cardiovascular Institute, Morristown Medical Center, NJ,
United States
(Pershad) Banner University Medical Center, Phoenix, AZ, United States
(Xu, Rogers) Edwards Lifesciences, Irvine, CA, United States
Publisher
Lippincott Williams and Wilkins
Abstract
Background: This study aimed to compare echocardiographic findings in
low-risk patients with severe aortic stenosis after surgical aortic valve
replacement (SAVR) or transcatheter aortic valve replacement (TAVR).
 Method(s): The PARTNER 3 trial (Placement of Aortic Transcatheter
Valves) randomized 1000 patients with severe aortic stenosis and low
surgical risk to undergo either transfemoral TAVR with the
balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms
obtained at baseline and at 30 days and 1 year after the procedure were
analyzed by a consortium of 2 echocardiography core laboratories.
 Result(s): The percentage of moderate or severe aortic regurgitation
(AR) was low and not statistically different between the TAVR and SAVR
groups at 30 days (0.8% versus 0.2%; P=0.38). Mild AR was more frequent
after TAVR than SAVR at 30 days (28.8% versus 4.2%; P<0.001). At 1 year,
mean transvalvular gradient (13.7+/-5.6 versus 11.6+/-5.0 mm Hg; P=0.12)
and aortic valve area (1.72+/-0.37 versus 1.76+/-0.42 cm2;
P=0.12) were similar in TAVR and SAVR. The percentage of severe
prosthesis-patient mismatch at 30 days was low and similar between TAVR
and SAVR (4.6 versus 6.3%; P=0.30). Valvulo-arterial impedance (Z
va), which reflects total left ventricular hemodynamic burden,
was lower with TAVR than SAVR at 1 year (3.7+/-0.8 versus 3.9+/-0.9 mm
Hg/mL/m2; P<0.001). Tricuspid annulus plane systolic excursion
decreased and the percentage of moderate or severe tricuspid regurgitation
increased from baseline to 1 year in SAVR but remained unchanged in TAVR.
Irrespective of treatment arm, high Z vaand low tricuspid
annulus plane systolic excursion, but not moderate to severe AR or severe
prosthesis-patient mismatch, were associated with increased risk of the
composite end point of mortality, stroke, and rehospitalization at 1 year.
 Conclusion(s): In patients with severe aortic stenosis and low
surgical risk, TAVR with the SAPIEN 3 valve was associated with similar
percentage of moderate or severe AR compared with SAVR but higher
percentage of mild AR. Transprosthetic gradients, valve areas, percentage
of severe prosthesis-patient mismatch, and left ventricular mass
regression were similar in TAVR and SAVR. SAVR was associated with
significant deterioration of right ventricular systolic function and
greater tricuspid regurgitation, which persisted at 1 year. High Z
vaand low tricuspid annulus plane systolic excursion were
associated with worse outcome at 1 year whereas AR and severe
prosthesis-patient mismatch were not. Registration: URL:
Https://www.clinicaltrials.gov; Unique identifier:
NCT02675114. Copyright © 2020 Lippincott Williams and Wilkins.
All rights reserved.

<20>
Accession Number
2007324785
Title
Clinical outcomes of transcatheter aortic valve implantation in failed
bioprosthetic surgical valves vs. native aortic stenosis: insights from a
meta-analysis.
Source
Cardiovascular Intervention and Therapeutics. (no pagination), 2020. Date
of Publication: 2020.
Author
Yashima F.; Yokoyama Y.; Takagi H.; Briasoulis A.; Kuno T.
Institution
(Yashima) Department of Cardiology, Saiseikai Utsunomiya Hospital,
Utsunomiya, Japan
(Yokoyama) Department of Surgery, St. Luke's University Health Network,
Bethlehem, PA, United States
(Takagi) Department of Cardiovascular Surgery, Shizuoka Medical Center,
Shizuoka, Japan
(Briasoulis) Division of Cardiovascular Medicine, Section of Heart Failure
and Transplantation, University of Iowa, IA, United States
(Kuno) Department of Medicine, Icahn School of Medicine at Mount Sinai,
Mount Sinai Beth Israel, First Avenue, 16th street, New York, NY 10003,
United States
Publisher
Springer Japan
Abstract
There is no meta-analysis comparing clinical outcomes between
valve-in-valve transcatheter aortic valve implantation for failed surgical
bioprosthetic valves (ViV-TAVI) and native valve TAVI for aortic stenosis
(NV-TAVI). We aimed to investigate clinical outcomes between ViV-TAVI and
NV-TAVI using a meta-analysis. EMBASE and MEDLINE were searched through
April 2020 to investigate the comparative outcomes between ViV-TAVI and
NV-TAVI. The main outcomes were short-term (30-day/in-hospital) mortality,
pacemaker implantation (PMI), life threatening and/or major bleeding,
stroke, and coronary obstruction, and long-term (1-year) mortality and
stroke. Our search identified 5 observational studies enrolling a total of
8428 patients (1442 patients with ViV-TAVI and 6986 with NV-TAVI).
ViV-TAVI was associated with significantly lower rates of short-term
mortality, PMI, and life threatening and/or major bleeding, compared with
NV-TAVI (relative risk [RR] [95% CI] 0.54 [0.34-0.84], P = 0.007; 0.25
[0.19-0.35], P < 0.0001; 0.64 [0.46-0.89], P = 0.008, respectively). There
were no significant differences in rates of short-term stroke and coronary
obstruction between ViV-TAVI and NV-TAVI (RR [95% CI] 0.59 [0.35-1.01], P
= 0.06; 1.86 [0.78-4.41], P = 0.16, respectively). ViV-TAVI was also
associated with a significantly lower rate of 1-year mortality compared
with NV-TAVI (RR [95% CI] 0.64 [0.51-0.81], P = 0.0002), whereas there was
no significant difference in long-term stroke (RR [95% CI] 0.71
[0.45-1.12], P = 0.51). ViV-TAVI was associated with significantly lower
rates of short-term mortality, PMI, and life threatening and/or major
bleeding, and long-term mortality, without increased risks of stroke and
coronary obstruction, compared with NV-TAVI. Copyright © 2020,
Japanese Association of Cardiovascular Intervention and Therapeutics.

<21>
Accession Number
2005455794
Title
Quality of life after coronary artery bypass surgery: A systematic review
and meta-analysis.
Source
International Journal of Environmental Research and Public Health. 17 (22)
(pp 1-12), 2020. Article Number: 8439. Date of Publication: 02 Nov 2020.
Author
Schmidt-Riovalle J.; Ejheisheh M.A.; Membrive-Jimenez M.J.;
Suleiman-Martos N.; Albendin-Garcia L.; Correa-Rodriguez M.; Gomez-Urquiza
J.L.
Institution
(Schmidt-Riovalle, Ejheisheh, Suleiman-Martos, Albendin-Garcia,
Correa-Rodriguez, Gomez-Urquiza) Faculty of Health Sciences, University of
Granada, Avenida de la Ilustracion N. 60, Granada 18016, Spain
(Membrive-Jimenez) Institute of Health Management, University Hospital of
Ceuta, C/Colmenar, s/n, Ceuta 51003, Spain
Publisher
MDPI AG
Abstract
Coronary heart disease is a public health problem and is one of the
leading causes of loss of quality of life, disability, and death
worldwide. The main procedure these patients undergo is cardiac
catheterisation, which helps improve their quality of life, symptoms of
myocardial ischemia, and ventricular function, thus helping increase the
survival rate of sufferers. It can also, however, lead to physical
consequences, including kidney failure, acute myocardial infarction, and
stroke. The objective of this study was to analyse how coronary artery
bypass grafting (CABG) influences quality of life. A systematic review and
meta-analysis were conducted using the CINAHL, PubMed, Scopus, and Cuiden
databases in June 2020. A total of 7537 subjects were included, 16 in the
systematic review and 3 in the meta-analysis. The studies analysing
quality of life using the SF questionnaire showed improvements in the
quality of physical and mental appearance, and those using the NHP
questionnaire showed score improvements and, in some cases, differences in
quality of life between women and men. This operation seems to be a good
choice for improving the quality of life of people with coronary
pathologies, once the possible existing risks have been
assessed. Copyright © 2020, MDPI AG. All rights reserved.

<22>
Accession Number
2004814345
Title
Coagulation ability when separating from cardiopulmonary bypass with and
without fresh frozen plasma: a pilot study.
Source
General Thoracic and Cardiovascular Surgery. 68 (12) (pp 1361-1368), 2020.
Date of Publication: December 2020.
Author
Tamura T.; Yokota S.; Ito T.; Ando M.; Kubo Y.; Waters J.H.; Nishiwaki K.
Institution
(Tamura, Nishiwaki) Department of Anesthesiology, Nagoya University
Graduate School of Medicine, 65 Tsurumai-cho, Showa-Ku, Nagoya 466-8550,
Japan
(Tamura, Waters) Department of Anesthesiology, University of Pittsburgh
Medical Center, Pittsburgh, PA, United States
(Yokota) Division of Anesthesiology, Japanese Red Cross Nagoya Daiichi
Hospital, Nagoya, Japan
(Ito) Division of Cardiovascular Surgery, Japanese Red Cross Nagoya
Daiichi Hospital, Nagoya, Japan
(Ando) Center for Advanced Medicine and Clinical Research, Nagoya
University Hospital, Nagoya, Japan
(Kubo) Department of Preventive Medicine, Nagoya University Hospital,
Nagoya, Japan
Publisher
Springer Japan
Abstract
Objective: Several strategies are employed for administering fresh frozen
plasma (FFP) during weaning from cardiopulmonary bypass (CPB). This study
evaluated by coagulation function aimed to compare two strategies of
administering FFP in cardiovascular surgery: administering 4 units of FFP
before separating from CPB or administering it after weaning from CPB.
 Method(s): Thirty patients who underwent CPB and were expected to
receive 8 units of FFP and 20 units of platelet concentrate were randomly
allocated into group A (8 units of FFP and 20 units of platelet
concentrate administered after separating from CPB) and group B (4 units
of FFP administered before separation, and 4 units of FFP and 20 units of
platelet concentrate administered after separating from CPB).
Thromboelastography (TEG6s, HAEMONETICS Japan GK, Tokyo, Japan)
was conducted at four time points before and after separation. Blood test
results, blood loss, and required amounts of blood transfusion were
compared. The primary outcome was the difference in coagulation function
evaluated by TEG6s 90 min after protamine administration. Result(s):
Twenty-eight patients were enrolled in the study. Coagulation function
after separating from CPB was not significantly different between the
groups. Additionally, no significant differences were found in intensive
care unit outcomes, such as 24-h transfusion requirements.
 Conclusion(s): Coagulation function 90 min after separating from CPB
was not significantly different between the groups. Prior FFP
administration before separation did not provide significant improvement
in coagulation function. Copyright © 2020, The Japanese
Association for Thoracic Surgery.

<23>
Accession Number
2008506272
Title
The efficacy of early postoperative enteral immunonutrition on
T-lymphocytes count in cardiac surgery patients.
Source
Clinical Nutrition ESPEN. Conference: 42nd ESPEN Virtual Congress. 40 (pp
414-415), 2020. Date of Publication: December 2020.
Author
Svetikiene M.; Ringaitiene D.; Trybe D.; Vicka V.; Vezeliene J.; Isajevas
V.; Malickaite R.; Jurgauskiene L.; Norkuniene J.; Serpytis M.; Sipylaite
J.
Institution
(Svetikiene, Ringaitiene, Serpytis, Sipylaite) Department of
Anaesthesiology and Intensive Care, Institute of Clinical Medicine,
Faculty of Medicine, Vilnius University, Vilnius University Hospital
Santaros Klinikos, Lithuania
(Trybe, Vicka) Vilnius University, Lithuania
(Vezeliene, Isajevas) Vilnius University Hospital Santaros Klinikos,
Vilnius, Lithuania
(Malickaite, Jurgauskiene) Clinic of Cardiac and Vascular Diseases,
Institute of Clinical Medicine, Faculty of Medicine, Vilnius University,
Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
(Norkuniene) Vilnius Gediminas Technical University, Vilnius, Lithuania
Publisher
Elsevier Ltd
Abstract
Rationale: Patients undergoing cardiac surgery have a pronounced immune
response that leads to a reduction in cellular immunity. It is considered
that specific immuno nutritional therapy could improve immunological
status of patients who underwent surgery. The aim of the study was to
research the efficacy of early postoperative enteral immunonutrition on
T-lymphocyte count in the cardiac surgery population. Method(s): A
low operative risk adult patients, who underwent elective cardiac surgery,
were included to the study. The patients were randomised into
immunonutrition (IN) and control groups. The IN group was supplemented
with immune nutrients for five postoperative days. The counts of
T-lymphocytes (CD4+ and CD8+ cell subpopulations) were determined on the
day of surgery and on the sixth postoperative day. Student t-test and
Mann-Whitney U test was used to compare differences between the groups.
The univariate and multivariate linear regression models were used.
 Result(s): Fifty-five patients were enrolled in the study, the mean
age was 69.7+/-6.3 years, 28(50.9%) males, the median operative risk was
1.75%. Twenty-seven (49.1%) were in the immunonutrition group. The counts
of the CD3+ T cells and CD4+ T cells on the sixth postoperative day were
significantly higher in the immunonutrition group compared to the control
group with 1.42+/-0.49 vs. 1.12+/-0.56 (*109/l), p = 0.035 and
1.02+/-0.36 vs. 0.80+/-0.43 (*109/l), p=0.048, respectively.
Regression analysis was performed to determine the efficacy of the
immunonutrition on the counts of the CD3+ and CD4+ T cells; CD3+ T and
CD4+ T cell counts were increased to 0.264 (*109/l), p = 0.039
and 0.232 (*109/l), p = 0.021, respectively.
 Conclusion(s): Early postoperative immunonutrition has a positive
effect on T-lymphocytes and their subpopulations in low-risk cardiac
surgical patients. Disclosure of Interest: None declared Copyright
© 2020

<24>
Accession Number
2008505925
Title
Quantitative protein intake and loss of muscle mass in critically ill
patients: results of a randomized controlled trial.
Source
Clinical Nutrition ESPEN. Conference: 42nd ESPEN Virtual Congress. 40 (pp
422), 2020. Date of Publication: December 2020.
Author
Dresen E.; Weissbrich C.; Fimmers R.; Putensen C.; Stehle P.
Institution
(Dresen, Stehle) Institute of Nutrition and Food Sciences, Nutritional
Physiology, University of Bonn, Germany
(Weisbrich, Putensen) Department of Anesthesiology and Intensive Care
Medicine, Germany
(Fimmers) Institute of Medical Biometry, Informatics and Epidemiology,
University Hospital Bonn, Bonn, Germany
Publisher
Elsevier Ltd
Abstract
Rationale: Trauma-related degradation of muscle mass is accompanied by a
loss of metabolic functions and is associated with adverse outcome of
critically ill patients. We hypothesized that an increased quantity of
protein/amino acids within a balanced nutrition therapy minimize muscle
mass deprivation. Method(s): A randomized controlled trial (DRKS-ID:
DRKS00013594) was conducted in critically ill patients (post-surgery,
cardiac surgery, pulmonary diseases) in a routine clinical setting
(SOP-guided therapy: combination of enteral and parenteral nutrition).
Eligible subjects were randomly assigned to either an intervention group
(IG: 1.8 g protein/kg body weight [bw]/d) or a standard group (SG: 1.2 g
protein/kg bw/d). Energy intake was based on actual REE measurements
(indirect calorimetry). Non-protein energy was provided by carbohydrates
and fat (60:40%); commercial products used provided sufficient
micronutrients. Individual energy and nutrient intake was monitored daily.
Primary outcome was quadriceps muscle layer thickness (QMLT; sonography)
measured at inclusion (d0), d16+/-2 (intermediate) and d28+/-2 (final) and
presented as mean+/-SD. Power calculation was based on a pilot study in
hospitalized patients (detection limit: 5% muscle mass changes; n=42 with
80% of power). Group comparisons were made using unpaired two-samples
t-tests. Linear mixed models were applied to evaluate the effect of target
protein intake (group), intervention day (time) and their interaction on
QMLT (DELTAQMLT). Result(s): Fourty-two per-protocol patients
(65+/-15 y; 12 female; SAPS 45+/-11; TISS 20+/-7; SOFA 7+/-3) were
included. In both IG and SG, daily protein intake was lower than target
but significantly different between groups (IG: 1.5+/-0.5 g/kg bw/d; SG:
1.0+/-0.4 g/kg bw/d; P<0.001); mean total energy intake was slightly lower
than planned at comparable levels (IG: 1989+/-655; SG: 1950+/-828 kcal/d;
P=0.403). At d0, QMLT was not different between groups (IG: 13.5+/-7.4 mm;
SG: 13.4+/-7.1 mm; n=21 each; P=0.967). DELTAQMLT at intermediate (IG:
-0.49+/-3.2 mm; SG: -0.002+/-3.3 mm; P=0.645) and final (IG: -2.00+/-3.0
mm; SG: -3.47+/-3.0 mm; P=0.219) measurement did not differ between
groups. Muscle mass decreased generally in both groups over time with no
treatment effect (time, P<0.001; intervention, P=0.368; time x
intervention, P=0.242). Conclusion(s): In contrast to our hypothesis,
an increase of daily protein supply above 1 g/kg bw within proven routine
nutrition concepts did not further affect critical illness-specific loss
of muscle mass. Whether this observation is probably attributed to a still
too low quantity or an inadequate quality of protein sources given remains
questionable. Disclosure of Interest: None declared Copyright ©
2020

<25>
Accession Number
633422886
Title
Fighting against proximal and distal tubular damage by reducing
inflammatory burden after cardiac surgery.
Source
Nephrology Dialysis Transplantation. Conference: 57th Annual Congress of
the European Renal Association-European Dialysis and Transplant
Association, ERA-EDTA 2020. Italy. 35 (SUPPL 3) (pp iii942), 2020. Date of
Publication: June 2020.
Author
Dalili N.
Institution
(Dalili) Chronic Kidney Disease Research Center, Shahid Labbafinejad
Medical Center, Shahid Beheshti University of Medical Sciences, Tehran,
Iran, Islamic Republic of
Publisher
Oxford University Press
Abstract
Background and Aims: Going on cardiopulmonary bypass (CPB) during cardiac
surgery causes systemic inflammatory response syndrome. In different
studies Pentoxifylline and Calcitriol have shown inhibitory effects on
proinflammatory cytokines such as tumor necrosis factor (TNF) and
interleukin-6 (IL-6) accompanying with production of free oxygen radicals
in the ischemic reperfusion injury. On the other hand, they have positive
effects on reducing oxidative stress. To investigate the effects of these
drugs on reducing tubular injury after CABG surgery, by their
anti-inflammatory properties we compared pre-and postoperative levels of
urinary NGAL (as a proximal tubular damage marker), KIM-1 level (as a
distal tubular damage marker), serum level of Malondialdehyde (MDA) (as an
oxidative stress marker) and serum inflammatory markers such as IL-6,
IL-8, and TNF levels in two groups of patients undergoing CABG, those who
received Pentoxifylline and Calcitriol before surgery and those who didn't
Method: After signing an informed consent, 150 consecutive adult patients
undergoing elective on-pump CABG were enrolled in a randomized control
trial. Patients with collagen-vascular disease or having a history of
treatment with immunosuppressive agents, corticosteroids (> 3 days),
Methylxantines, Diltiazem or sodium Nitroprusside and patients with a
history of angiography in the past 7 days or hemorrhagic diathesis and
coagulopathy, uncontrolled diabetes mellitus, sepsis, renal failure (sCr >
2 mg/dl), hepatic failure (AST or ALT > 40 U/L) or urinary tract infection
were excluded. All patients received the same anesthetic regimen and
routine CPB management. The patients were randomly assigned to one of two
groups: Control group (placebo) Intervention group (Pentoxifylline
+Calcitriol) PTX was administered as an oral 400 mg tab every 12hours plus
IV Calcitriol (0.01 mcg/kg) daily starting from 3 days before surgery. In
the control group placebo tab and IV injection of normal saline were
prescribed in the same direction. Result(s): Results demonstrated
that after three days prophylactic use of oral pentoxifylline plus IV
Calcitriol there is improvement in selected checked inflammatory markers
in the intervention group. Moreover Pentoxifylline+ Calcitriol showed
beneficial effects by controlling the oxidative stress burden and reducing
the mean serum MDA level in the patients undergoing CABG who are at risk
of developing AKI as a post surgery complication. Probably by reducing
inflammation and oxidative stress combination of these two drugs before
CABG could decrease proximal and distal tubular damage which presented
with significantly lower levels of uNGAL and KIM-1, as markers of tubular
injury, in the intervention group. Conclusion(s): Combination of
Pentoxifylline and Calcitriol showed a promising prophylactic role in
patients undergoing CABG with anti-inflammatory, anti-oxidant properties.
This study provided scope of add-on drug therapy for better prognosis in
post CABG population, involving risk of endothelial dysfunction and renal
tubular damage due to inflammatory milieu and renders support to future
prospective clinical studies to demonstrate net control of inflammation
and oxidative stress after cardiac surgery.

<26>
Accession Number
633422017
Title
Nephrology intervention in patients awaiting cardiac surgery: A randomised
controlled trial.
Source
Nephrology Dialysis Transplantation. Conference: 57th Annual Congress of
the European Renal Association-European Dialysis and Transplant
Association, ERA-EDTA 2020. Italy. 35 (SUPPL 3) (pp iii25), 2020. Date of
Publication: June 2020.
Author
Codina S.; Coloma A.; Sbraga F.; Boza E.; Vazquez-Reveron J.M.; Ferreiro
E.; Cruzado J.; Montero N.
Institution
(Codina, Coloma, Sbraga, Boza, Vazquez-Reveron, Ferreiro, Cruzado,
Montero) Bellvitge University Hospital, Nephrology, L'Hospitalet De
Llobregat, Spain
Publisher
Oxford University Press
Abstract
Background and Aims: Acute kidney injury (AKI) is a frequent complication
after cardiac surgery. Its incidence ranges from 19 to 44% depending on
the study and which definition is used. There are some well-known risk
factors associated with AKI, including baseline patient characteristics
(age and comorbidities), need of perioperative blood transfusion or
presence of previous chronic kidney disease. We wanted to evaluate if a
nephrologist management and control of potential risk factors of renal
disease can be used to prevent AKI, thereby minimizing the risk of need
RRT, reducing costs and improving survival in these patients. It will be
the first study focused on this intervention. The aim of this study is to
assess if a nephrology intervention before cardiac surgery can reduce the
postoperative incidence of AKI. Method(s): Unicentric prospective
randomized controlled trial of 298 participants from 2015 to 2019. The
inclusion criteria was patients undergoing scheduled cardiac surgery of
>18 years old. The exclusion criteria was a requirement for renal
replacement therapy before surgery. Clinical Research Ethics Committee of
Bellvitge has approved the study before initiation. All patients have
given written informed consent. We have done an intention-to-treat
analysis, continuous variables have been compared between groups using
Student's t test and categorical variables using X2. Result(s):
Nephrology intervention before surgery, included a preoperative study done
minimum 1 month before the surgery to optimize the patient' s overall
condition by optimization of hydration state, remove or minimize dose of
drugs that potentially deteriorate kidney function and correct metabolic
disorders.No differences in the characteristics of the patients between
groups was found (Table 1). The number of patients with AKI were 49
without differences between groups (0.112), with most of them presenting a
stage 1 AKI, only 3 patients present a stage 3 AKI, but none of them
required renal replacement therapy (Table 2). We found 1.3% of mortality
(1 participant in the intervention group and 3 in control group). Data at
1 year follow-up (n= 144) showed low incidence of kidney disease
(creatinine in intervention arm 91.87+/-30.79lmol/L and in control arm
87.08+/-23.58, p=0.292) without differences in albuminuria.
 Conclusion(s): In summary, we did not find any difference in acute
kidney injury and death when a nephrology intervention is done to cardiac
surgery patients, probably it would be necessary to increase the sample
size to make conclusions. The results at 1 year follow-up showed no kidney
disease in these patients.

<27>
Accession Number
633421130
Title
Baseline characteristics in the "ipack-HD" study (inhibit progression of
coronary artery calcification with vitamin k in hemodialysis patients): A
phase 2, multi-centre, double-blind, randomized, placebo-controlled pilot
trial.
Source
Nephrology Dialysis Transplantation. Conference: 57th Annual Congress of
the European Renal Association-European Dialysis and Transplant
Association, ERA-EDTA 2020. Italy. 35 (SUPPL 3) (pp iii1606), 2020. Date
of Publication: June 2020.
Author
Babiolakis C.; Zimmerman D.; Moist L.; Day A.; Norman P.; Turner M.;
Garland J.; Adams M.; Booth S.; Heyland D.; Holden R.
Institution
(Babiolakis, Holden) Queen's University, Medicine, Kingston, Canada
(Zimmerman) University of Ottawa, Canada
(Moist) University of Western Ontario, Medicine, Canada
(Day, Heyland) Queen's University, Critical Care Medicine, Canada
(Norman) Kingston Health Sciences Centre, Canada
(Turner, Adams) Queen's University, Biomedical and Molecular Sciences,
Canada
(Garland) Queen's University, Medicine, Canada
(Booth) Tufts University, Canada
Publisher
Oxford University Press
Abstract
Background and Aims: The leading cause of mortality for patients with
end-stage kidney disease (ESKD) is cardiovascular disease (CVD). This is
due, in part, to vascular calcification (VC) where calcium becomes
deposited within arterial walls causing narrowing of the arteries and
altering their flexibility. Matrix Gla protein (MGP), a vitamin
k-dependent protein, is a key local inhibitor of VC and becomes
up-regulated adjacent to sites of calcification. There is a very high
prevalence of vitamin K deficiency in patients across the chronic kidney
disease (CKD) spectrum and vitamin K has been shown to prevent VC in
experimental models. To date, no trial has examined whether vitamin K
supplementation prevents the progression of coronary artery calcification
in patients with ESKD, a group in which high risk has been established.
The aim of the iPACK-HD pilot study is to determine whether a trial to
determine whether vitamin K has a favourable effect on coronary artery
calcium (CAC) scores in patients with ESKD is feasible. Method(s):
The iPACK-HD pilot trial is a phase 2 multi-centre, double-blind,
randomized, placebo-controlled clinical trial conducted in three sites
(Kingston, Ottawa and London) in Ontario, Canada. Adult patients with ESKD
on chronic dialysis with a baseline CAC score of>=30 Agatston units (AUs)
are randomized to receive 10 mg of vitamin K1 or matching placebo
administered post-hemodialysis 3x/week for a total of 12 months.
Exclusions include medical conditions that require anticoagulation and a
history of either coronary artery bypass, grafting or stenting.
Randomization is stratified based on diabetes and study centre. Baseline
CAC scores are determined by computed tomography (CT) and demographic and
laboratory data at study entry are obtained by participant interview and
medical chart review. Result(s): A total of 85 participants are
randomized into this trial. Baseline characteristics of trial participants
are reported as mean+/-SD, median [IQR], or %. The mean age is 63+/-13
years. There are a higher proportion of males (57%) than females and
whites (85%) compared to all other ethnicities. Forty-four percent of
participants have diabetes and 77% have hypertension. Dialysis vintage is
0.9 [0.4,2.7] years. Most participants take calcium-based phosphate
binders (89%) and over half of participants take an HMG-CoA reductase
inhibitor (53%) or vitamin D (61%). Clinical laboratory values are
presented in Table 1. Total median CAC and volume calcium scores are 587
[252,1416] AUs and 482 [206,1170]mm3, respectively. Sixty-five
(76%) participants had a study exit CT scan performed upon completion of
the study. Of 156 doses, a median of 150 [123,155] were received and 2
[1,6] were missed. Conclusion(s): Participants in the iPACK-HD study
have a high burden of calcification but are similar in baseline
characteristics to the Canadian hemodialysis population. Loss to trial
completion is 24%, but the most frequent reason is kidney transplantation.
Adherence to study drug is very high with few reported side effects.
(Table Presented).

<28>
Accession Number
633421032
Title
Comparison of non-steroidal anti-inflammatory drugs(NSAIDS) and/or
painkillers use by kidney (KTRS) and heart transplant recipients (HTRS).
Source
Nephrology Dialysis Transplantation. Conference: 57th Annual Congress of
the European Renal Association-European Dialysis and Transplant
Association, ERA-EDTA 2020. Italy. 35 (SUPPL 3) (pp iii2006), 2020. Date
of Publication: June 2020.
Author
Jerdrzejczak A.; Szczurek W.; Zakliczynski M.; Foroncewicz B.; Staros R.;
Paczek L.; Mucha K.
Institution
(Jerdrzejczak, Foroncewicz, Staros, Paczek, Mucha) Medical University of
Warsaw, Department of Immunology,Transplantology and Internal Medicine,
Warsaw, Poland
(Szczurek) Medical University of Silesia, 3rd Department of Cardiology,
School of Medicine with the Division of Dentistry in Zabrze, Katowice,
Poland
(Zakliczynski) Medical University of Silesia, Department of
Cardiosurgery,Transplantation,Vascular and Endovascular Surgery, Zabrze,
Poland
Publisher
Oxford University Press
Abstract
Background and Aims: Solid organ transplantation (SOT) has become the
therapy of choice for the treatment of end-stage organ failure. The
non-steroidal anti-inflammatory drugs (NSAIDs) and over-the-counter (OTC)
painkillers are ofenly used. In a group of SOT recipients, co-morbidities
and immunosuppression interactions significantly increase the risk of side
effects. The aim of the study was to analyze the frequency and reasons of
the NSAIDs and/or painkillers use by renal (RTRs) and heart transplant
recipients (HTRs). Method(s): This cross-sectional study was perfomed
in randomly selected 388 RTRs and 286 HTRs aged from 18 to 82 years. The
original annonymus questionnaire consisting of 32 questions related to
health status and NSAIDs and/or analgesics use was applied. Questionnaire
was distributed in paper-form and completed with the participation of
medical worker either in transplant cardiosurgical or renal
transplantation center. 'R' v. 3.6.1. was used for statistical analysis
and p-value<0.05 was considered significant. Result(s): 674 patients
were surveyed. All patients: 34,3% (n=231) women and 65,7% (n=443) men in
the mean age of 62.27 years completed the questionnaire. 70% (n=451) of
respondents declared using NSAIDs and/or analgesics. Furthermore, 87% of
participants declared using OTC painkillers. The most frequent causes for
using analgesics are listed in Table 1. 68,5% of our SOT recipients
declared that they were informed by their doctor about consequences of
other drugs used with immunosuppression. 69,9% of HTRs comparing to 54,3%
of RTRs ask their doctor before taking analgesics. Nevertheless, the
survey also showed that every third patient (31,5%) was not sufficiently
informed. Acetaminophen was the first-choice drug taken by 67,6% of
patients (Fig. 1). Only 20% of patients declared not using NSAIDs and/or
analgesics at all. Conclusion(s): The result of our study indicates
high frequency of NSAID and painkillers usage by RTRs and HTRs.
Considering potentially harmful influence on transplanted organs, the
costs of transplantation and post-trasplant care, the awareness of
drugrelated side effects or interactions and patients compliance need to
be highlighted.

<29>
Accession Number
2001580984
Title
Comparison of del Nido and histidine-tryptophan-ketoglutarate cardioplegia
solutions in pediatric patients undergoing open heart surgery: A
prospective randomized clinical trial.
Source
Journal of Thoracic and Cardiovascular Surgery. 157 (3) (pp 1182-1192.e1),
2019. Date of Publication: March 2019.
Author
Talwar S.; Chatterjee S.; Sreenivas V.; Makhija N.; Kapoor P.M.; Choudhary
S.K.; Airan B.
Institution
(Talwar, Chatterjee, Choudhary, Airan) Department of Cardiothoracic and
Vascular Surgery, All India Institute of Medical Sciences, New Delhi,
India
(Sreenivas) Department of Biostatistics, All India Institute of Medical
Sciences, New Delhi, India
(Makhija, Kapoor) Department of Cardiac Anesthesiology, All India
Institute of Medical Sciences, New Delhi, India
Publisher
Mosby Inc.
Abstract
Objectives: We conducted a prospective randomized controlled trial to
compare del Nido (DN) and histidine-tryptophan-ketoglutarate (HTK)
cardioplegia solution in pediatric patients undergoing intracardiac
tetralogy of Fallot repair. Method(s): One hundred consecutive
patients 12 years of age or younger, undergoing intracardiac repair of
tetralogy of Fallot were randomized into DN (n = 50) and HTK (n = 50)
groups. Cardioplegia strategy consisted of a single dose of DN (20 mL/kg)
or HTK (6 mL/kg/min for 6 minutes). Primary outcome was cardiac index
(CI). Secondary outcomes were ventricular arrhythmias post cross-clamp
release, time to peripheral rewarming, duration of mechanical ventilation,
inotropic score, intensive care unit and hospital stay, and serum levels
of troponin-I, interleukin-6, and tumor necrosis factor-alpha.
Ultrastructural changes in the myocardium were assessed. Result(s):
CI was significantly higher in the DN group compared with the HTK group at
6 (P =.005) and 24 hours (P <.001) after surgery. It was on an average
0.44 L/min/m2 higher in the DN group at any time point (P
=.004). Time for complete cessation of electrical activity was longer in
the HTK group (P =.01) and more patients in the HTK group had ventricular
arrhythmias post cross-clamp release (P =.03). Duration of mechanical
ventilation (P =.006), intensive care unit stay (P =.05), and hospital
stay (P <.001) were lower in the DN group. Patients in the DN group had
lower troponin I levels 24 hours after cardiopulmonary bypass (P <.001).
Electron microscopic studies showed more myocardial edema (P =.02) and
myofibrillar disarray (P =.04) in the HTK group along with lower glycogen
stores (P =.04). DN cardioplegia was more cost-effective than HTK
cardioplegia (P <.001). Conclusion(s): DN cardioplegia was associated
with better preservation of CI, less duration of mechanical ventilation,
shorter intensive care unit and hospital stays, lower inotropic scores,
and less release of troponin-I. Electron microscopy showed less myocardial
edema and better preservation of the myofibrillar architecture and
glycogen stores in the DN group. Copyright © 2018

<30>
Accession Number
2008020457
Title
Effect of permanent right internal mammary artery occlusion on right
coronary artery supply: A randomized placebo-controlled clinical trial.
Source
American Heart Journal. 230 (pp 1-12), 2020. Date of Publication: December
2020.
Author
Bigler M.R.; Stoller M.; Tschannen C.; Grossenbacher R.; Seiler C.
Institution
(Bigler, Stoller, Tschannen, Grossenbacher, Seiler) Department of
Cardiology, Inselspital, Bern University Hospital, University of Bern,
Bern 3010, Switzerland
Publisher
Mosby Inc.
Abstract
Natural, nonsurgical internal mammary artery (IMA) bypasses to the
coronary circulation have been shown to function as extracardiac sources
of myocardial blood supply. The goal of this randomized,
placebo-controlled, double-blind trial was to test the efficacy of
permanent right IMA (RIMA) device occlusion on right coronary artery (RCA)
occlusive blood supply and on clinical and electrocardiographic (ECG)
signs of myocardial ischemia. Method(s): This was a prospective
superiority trial in 100 patients with chronic coronary artery disease
randomly allocated (1:1) to RIMA vascular device occlusion (verum group)
or to RIMA sham procedure (placebo group). The primary study end point was
RCA collateral flow index (CFI) as obtained during a 1-minute ostial RCA
balloon occlusion at baseline before and at follow-up examination 6 weeks
after the trial intervention. CFI is the ratio between simultaneous mean
coronary occlusive divided by mean aortic pressure both subtracted by
central venous pressure. Simultaneously obtained secondary study end
points were the registration of angina pectoris and quantitative
intracoronary ECG ST-segment shift. Result(s): CFI change during the
follow-up period was +0.036 +/- 0.068 in the verum group and -0.021 +/-
0.097 in the placebo group (P =.0011). Angina pectoris during the same RCA
balloon occlusions had disappeared at follow-up in 14/49 patients of the
verum group and in 4/49 patients of the placebo group (P =.0091).
Simultaneous intracoronary ECG ST-segment shift change revealed diminished
myocardial ischemia at follow-up in the verum group and more severe
ischemia in the placebo group. Conclusion(s): Permanent RIMA device
occlusion augments RCA supply to the effect of diminishing clinical and
electrocardiographic signs of myocardial ischemia during a brief
controlled coronary occlusion. Copyright © 2020 The Authors

<31>
Accession Number
2008503398
Title
Parachute mitral valve: Anatomy and operation.
Source
Journal of the College of Physicians and Surgeons Pakistan. 30 (10) (pp
1069-1073), 2020. Date of Publication: October 2020.
Author
Yuan S.-M.
Institution
(Yuan) Department of Cardiothoracic Surgery, First Hospital of Putian,
Teaching Hospital, Fujian Medical University, Putian, Fujian Province,
China
Publisher
College of Physicians and Surgeons Pakistan
Abstract
Parachute mitral valve is a rare congenital heart defect characterised by
a distorted mitral geometry with a single papillary muscle for all mitral
chords to attach. It may develop in isolation or as a constillation of
Shone syndrome. By comprehensive retrieval of the pertinent articles
published since 2000, 22 articles with 149 cases of parachute mitral valve
were recruited into this study. The present article revealed that most
patients with a parachute mitral valve had a stenotic or regurgitant
mitral valve, which is often associated with left heart obstructions,
thereby leading to haemodynamic compromise. Therefore, multiple surgical
maneuvers are warranted for such patients. Mitral valve repair is
preferred over mitral valve replacement for the mitral valve abnormalities
so as to avoid the associated complications of valve replacement
procedure. The patients' outcomes are satisfactory with a total event-free
survival of surgical patients of 84.8%. Copyright © 2020 College
of Physicians and Surgeons Pakistan. All rights reserved.

<32>
Accession Number
2008503370
Title
Coronary artery bypass grafting in patients with systemic lupus
erythematosus.
Source
Journal of the College of Physicians and Surgeons Pakistan. 30 (9) (pp
961-965), 2020. Date of Publication: September 2020.
Author
Yuan S.-M.
Institution
(Yuan) Department of Cardiothoracic Surgery, First Hospital of Putian,
Teaching Hospital, Fujian Medical University, Putian, Fujian Province,
China
Publisher
College of Physicians and Surgeons Pakistan
Abstract
Surgical treatment of coronary artery disease in the systemic lupus
erythematosus (SLE) patients has not been comprehensively addressed. The
present review aimed to give an overview of coronary artery disease in the
SLE patients receiving coronary artery bypass grafting (CABG). The study
materials were based on comprehensive literature retrieval, which
recruited 17 pertinent articles with 30 patients. No differences were
found in the graft patencies between the arterial and venous grafts; and
between the early and late patency rates. Pathological inspections
revealed that all graft vessels were normal with no signs of SLE-related
atherosclerosis or vasculitis, one coronary artery was pathologically
normal, and another coronary artery showed vasculitis. The coexisting
disorders, including diabetes mellitus, hyperlipidemia, and nephropathy in
the SLE patients cause early deterioration of the saphenous vein grafts.
Early occlusion of the saphenous vein grafts was also observed in SLE
patients. The left anterior descending coronary artery was most commonly
affected by SLE and was the most common coronary artery requiring a CABG
procedure. The graft vessels, both arterial and venous, rarely
degenerated; whereas, early and late graft failure was usually caused by
technical failures. The lack of vasculitis and atherosclerosis in the
arterial grafts encourage surgeons to prefer to use the arterial grafts in
SLE patients. Less invasive surgical technique would favour the patients
in terms of long-term outcomes. Copyright © 2020 College of
Physicians and Surgeons Pakistan. All rights reserved.

<33>
Accession Number
2008503358
Title
Percutaneous coronary intervention for left main coronary artery
bifurcation lesions: Two-stent versus one-stent strategy for comparison of
6-month mace.
Source
Journal of the College of Physicians and Surgeons Pakistan. 30 (9) (pp
894-899), 2020. Date of Publication: September 2020.
Author
Nasir M.; Shafique H.M.; Hussain S.; Tuyyab F.; Aziz S.; Khadim R.
Institution
(Nasir, Shafique, Hussain, Tuyyab, Aziz) Armed Forces Institute of
Cardiology, Rawalpindi, Pakistan
(Khadim) Army Medical College, Rawalpindi, Pakistan
Publisher
College of Physicians and Surgeons Pakistan
Abstract
Objective: To assess the short term clinical outcomes for a single-stent
(SS) strategy versus a double-stent (DS) strategy in percutaneous coronary
intervention (PCI) of distal unprotected left main coronary artery (ULMCA)
lesions. Study Design: Descriptive comparative study. Place and
Duration of Study: Armed Forces Institute of Cardiology, Rawalpindi,
Pakistan from January 2017 to April 2018. Methodology: SS treatment was
defined as stenting of the main branch alone and DS treatment as stenting
of both the main and side branches. Patients who underwent LMCA PCI were
recruited in the study using consecutive sampling. Crossover technique,
with or without kissing balloon (KB) dilatation, was employed in those
getting PCI with a SS strategy; whereas, DK crush, mini-crush, culotte and
T-stenting techniques were used in patients undergoing PCI with a DS
strategy. The primary endpoints were a composite of major adverse
cardiovascular event (MACE) i.e. myocardial infarction, stroke or death
and target lesion revascularisation (TLR). Result(s): A total of 103
patients were recruited in the study; out of which, 73 underwent LMCA PCI
employing a SS technique; whereas, 30 of them were treated with a DS
strategy. Mean age of the study participants was 63.2 +/-10.6 years. The
procedural success rate was 100% in both groups. There was a lower
frequency of MACE with single-stent strategy (4.1%) versus the
double-stent strategy (16.7%, p=0.031) during the 6-month follow-up
period. Conclusion(s): In comparison to the two-stent strategy of
ULMCA bifurcation intervention, a single-stent approach seems to show
favourable clinical outcomes and 6-month MACE-free survival. The choice of
optimal revascularisation technique proves to be important for the
prognosis; therefore, it requires pragmatic decision-making. Copyright
© 2020 College of Physicians and Surgeons Pakistan. All rights
reserved.

<34>
[Use Link to view the full text]
Accession Number
633088275
Title
A single-dose of stellate ganglion block for the prevention of
postoperative dysrhythmias in patients undergoing thoracoscopic surgery
for cancer: A randomised controlled double-blind trial.
Source
European Journal of Anaesthesiology. 37 (4) (pp 323-331), 2020. Date of
Publication: 01 Apr 2020.
Author
Wu C.-N.; Wu X.-H.; Yu D.-N.; Ma W.-H.; Shen C.-H.; Cao Y.
Institution
(Wu, Wu, Ma) Department of Anaesthesiology, First Affiliated Hospital of
Guangzhou University of Chinese Medicine, Guangzhou, China
(Wu) Department of Anesthesiology, Peking University Shenzhen Hospital,
Shenzhen, China
(Yu) Department of Anesthesiology, Guangdong Provincial People's Hospital,
Guangzhou, China
(Shen) Department of Thoracic Surgery, First Affiliated Hospital of
Guangzhou University of Chinese Medicine, Guangzhou, China
(Cao) Department of Cardiovascular Pharmacology, School of Pharmacological
Science, Southern Medical University, Guangzhou, China
Publisher
Lippincott Williams and Wilkins
Abstract
BACKGROUNDNew-onset arrhythmias and sleep disturbances are frequently
observed during the postoperative period in patients undergoing thoracic
surgery.OBJECTIVEWe evaluated the effectiveness of a single-dose stellate
ganglion block (SGB) to prevent the occurrence of arrhythmias in patients
undergoing thoracic surgery for cancer.DESIGNRandomised controlled
double-blind study.SETTINGSingle university hospital.PATIENTSNinety
patients with lung cancer or oesophagal cancer scheduled for elective
video-assisted thoracoscopic surgery were randomly randomised into one of
two equal groups (the SGB group and control group, n = 40
each).INTERVENTIONSPatients received a single dose of 5 ml of 0.5%
ropivacaine during ultrasound-guided SGB before induction of general
anaesthesia in the SGB group.MAIN OUTCOME MEASURESHolter ECG was
continuously monitored during the first 48 postoperative hours, and sleep
state was monitored during the first two postoperative nights.RESULTSThe
incidences of postoperative supraventricular tachycardias were lower in
the SGB group compared with the control group during the first 48
postoperative hours; 11.6 (5/43) vs. 31.8% (14/44), respectively, P =
0.023 (odds ratio 0.28, 95% confidence interval 0.09 to 0.87). The SGB
also prolonged the total sleep time and increased the sleep efficiency
during the first two postoperative nights. The duration of stage N2 sleep
was longer in the SGB group compared with the control group [28
(interquartile range, 14 to 58) to 94 (interquartile range, 69 to 113)
min, P = 0.016] on the first postoperative night. There were no
differences in the duration of stage N1 and N3 sleep (P = 0.180, 0.086,
respectively) on the first postoperative night, and the duration of stage
N1, N2 and N3 sleep (P = 0.194, 0.057, 0.405, respectively) on the second
postoperative night between the groups.CONCLUSIONA pre-operative SGB
effectively prevented the occurrence of postoperative supraventricular
tachycardias and improves the objective sleep quality in patients
undergoing thoracic surgery for cancer.TRIAL REGISTRATION
NUMBERChiCTR-1900023064. Copyright © 2020 Lippincott Williams and
Wilkins. All rights reserved.

<35>
[Use Link to view the full text]
Accession Number
632765005
Title
Association of factor v leiden with subsequent atherothrombotic events: A
GENIUS-CHD study of individual participant data.
Source
Circulation. 142 (6) (pp 546-555), 2020. Date of Publication: 11 Aug 2020.
Author
Mahmoodi B.K.; Tragante V.; Kleber M.E.; Holmes M.V.; Schmidt A.F.;
McCubrey R.O.; Howe L.J.; Direk K.; Allayee H.; Baranova E.V.; Braund
P.S.; Delgado G.E.; Eriksson N.; Gijsberts C.M.; Gong Y.; Hartiala J.;
Heydarpour M.; Pasterkamp G.; Kotti S.; Kuukasjarvi P.; Lenzini P.A.;
Levin D.; Lyytikainen L.-P.; Muehlschlegel J.D.; Nelson C.P.; Nikus K.;
Pilbrow A.P.; Wilson Tang W.H.; Van Der Laan S.W.; Van Setten J.;
Vilmundarson R.O.; Deanfield J.; Deloukas P.; Dudbridge F.; James S.;
Mordi I.R.; Teren A.; Bergmeijer T.O.; Body S.C.; Bots M.; Burkhardt R.;
Cooper-Dehoff R.M.; Cresci S.; Danchin N.; Doughty R.N.; Grobbee D.E.;
Hagstrom E.; Hazen S.L.; Held C.; Hoefer I.E.; Hovingh G.K.; Johnson J.A.;
Kaczor M.P.; Kahonen M.; Klungel O.H.; Laurikka J.O.; Lehtimaki T.;
Maitland-Van Der Zee A.H.; McPherson R.; Palmer C.N.; Kraaijeveld A.O.;
Pepine C.J.; Sanak M.; Sattar N.; Scholz M.; Simon T.; Spertus J.A.;
Stewart A.F.R.; Szczeklik W.; Thiery J.; Visseren F.L.J.; Waltenberger J.;
Richards A.M.; Lang C.C.; Cameron V.A.; Akerblom A.; Pare G.; Marz W.;
Samani N.J.; Hingorani A.D.; Ten Berg J.M.; Wallentin L.; Asselbergs F.W.;
Patel R.S.
Institution
(Mahmoodi, Bergmeijer, Ten Berg) St. Antonius Hospital, Department of
Cardiology Nieuwegein, Netherlands
(Mahmoodi) Division of Hemostasis and Thrombosis, Department of
Hematology, UMC Groningen, University of Groningen, Netherlands
(Tragante, Schmidt, Van Setten, Kraaijeveld, Asselbergs) Department of
Cardiology, Division Heart and Lungs, UMC Utrecht, Utrecht University,
Netherlands
(Baranova, Klungel, Maitland-Van Der Zee) Division of Pharmacoepidemiology
and Clinical Pharmacology, UMC Utrecht, Utrecht University, Netherlands
(Pasterkamp) Department of Clinical Chemistry, UMC Utrecht, Utrecht
University, Netherlands
(Van Der Laan) Central Diagnostics Laboratory, Division Laboratories,
Pharmacy, and Biomedical Genetics, UMC Utrecht, Utrecht University,
Netherlands
(Bots, Grobbee) Julius Center for Health Sciences and Primary Care, UMC
Utrecht, Utrecht University, Netherlands
(Hoefer) Department of Clinical Chemistry and Hematology, UMC Utrecht,
Utrecht University, Netherlands
(Visseren) Department of Vascular Medicine, UMC Utrecht, Utrecht
University, Netherlands
(Gijsberts) Laboratory of Experimental Cardiology, UMC Utrecht, Utrecht
University, Netherlands
(Kleber, Delgado, Marz) Vth Department of Medicine, Medical Faculty
Mannheim, Heidelberg University, Germany
(Holmes) Clinical Trial Service Unit and Epidemiological Studies Unit,
Nuffield Department of Population Health, Medical Research Council
Population Health Research Unit, University of Oxford, United Kingdom
(Holmes) National Institute for Health Research Oxford Biomedical Research
Centre, Oxford University Hospital, United Kingdom
(Howe, Direk, Deanfield, Hingorani, Patel) Institute of Cardiovascular
Science, UCL BHF Research Accelerator, Faculty of Population Health
Science, University College London, United Kingdom
(McCubrey) Intermountain Heart Institute, Intermountain Medical Center,
Salt Lake City, UT, United States
(Allayee, Hartiala) Departments of Preventive Medicine and Biochemistry
and Molecular Medicine, Keck School of Medicine of University of Southern
California, Los Angeles, United States
(Hartiala) Institute for Genetic Medicine, Keck School of Medicine of
University of Southern California, Los Angeles, United States
(Braund, Nelson, Samani) Department of Cardiovascular Sciences, University
of Leicester, BHF Cardiovascular Research Centre, Glenfield Hospital,
United Kingdom
(Braund) NIHR Leicester Biomedical Research Centre, Glenfield Hospital,
United Kingdom
(Eriksson, James, Held, Akerblom, Wallentin) Uppsala Clinical Research
Center, Sweden
(Gong, Cooper-Dehoff, Johnson) Department of Pharmacotherapy and
Translational Research, Center for Pharmacogenomics, University of
Florida, Gainesville, United States
(Pepine) College of Medicine, Division of Cardiovascular Medicine,
University of Florida, Gainesville, United States
(Heydarpour, Muehlschlegel) Department of Anesthesiology, Perioperative
and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States
(Heydarpour) Harvard Medical School, Harvard University, Boston, MA,
United States
(Kotti) Assistance Publique-Hopitaux de Paris (APHP), Department of
Clinical Pharmacology, Platform of Clinical Research of East Paris
(URCEST-CRCEST-CRB HUEP-UPMC), France
(Kuukasjarvi, Laurikka) Departments of Cardio-Thoracic Surgery, Finnish
Cardiovascular Research Center - Tampere, Faculty of Medicine and Health
Techonology, Tampere University, Finland
(Lyytikainen, Lehtimaki) Clinical Chemistry, Finnish Cardiovascular
Research Center - Tampere, Faculty of Medicine and Health Techonology,
Tampere University, Finland
(Nikus) Cardiology, Finnish Cardiovascular Research Center - Tampere,
Faculty of Medicine and Health Techonology, Tampere University, Finland
(Kahonen) Clinical Physiology, Finnish Cardiovascular Research Center -
Tampere, Faculty of Medicine and Health Techonology, Tampere University,
Finland
(Kahonen) Department of Clinical Physiology, Tampere University Hospital,
Finland
(Lenzini, Cresci) Department of Genetics, Statistical Genomics Division,
Washington University School of Medicine, Saint Louis, MO, United States
(Lenzini) Department of Medicine, Cardiovascular Division, Washington
University School of Medicine, Saint Louis, MO, United States
(Levin, Mordi, Lang) Division of Molecular and Clinical Medicine, School
of Medicine, University of Dundee, United Kingdom
(Levin) Department of Clinical Chemistry, Fimlab Laboratories, Tampere,
Finland
(Mordi) Department of Cardiology, Heart Center, Tampere University
Hospital, Finland
(Lang) Department of Cardio-Thoracic Surgery, Heart Center, Tampere
University Hospital, Finland
(Pilbrow, Richards, Cameron) Christchurch Heart Institute, University of
Otago Christchurch, New Zealand
(Wilson Tang, Hazen) Department of Cardiovascular and Metabolic Sciences,
Lerner Research Institute, Cleveland Clinic, OH, United States
(Wilson Tang) Department of Cardiovascular Medicine, Heart and Vascular
Institute, Cleveland Clinic, OH, United States
(Wilson Tang) Center for Microbiome and Human Health, Cleveland Clinic,
OH, United States
(Vilmundarson, Stewart) Ruddy Canadian Cardiovascular Genetics Centre,
University of Ottawa Heart Institute, ON, Canada
(McPherson) Departments of Medicine and Biochemistry, Microbiology, and
Immunology, University of Ottawa, ON, Canada
(Deloukas) William Harvey Research Institute, Barts and the London Medical
School, Centre for Genomic Health, Queen Mary University of London, United
Kingdom
(Dudbridge) Department of Health Sciences, University of Leicester, United
Kingdom
(Hagstrom) Department of Medical Sciences, Cardiology, Uppsala University,
Sweden
(Dudbridge, Hagstrom) Department of Cardiology, Uppsala University,
Uppsala Clinical Research Center, Sweden
(Teren) Heart Center Leipzig, Germany
(Burkhardt, Scholz, Thiery) LIFE Research Center for Civilization
Diseases, University of Leipzig, Germany
(Burkhardt) Institute for Medical Informatics, Statistics, and
Epidemiology, University of Leipzig, Germany
(Body) Department of Anesthesiology, Boston University School of Medicine,
MA, United States
(Body) Institute of Clinical Chemistry, Laboratory Medicine, University
Hospital Regensburg, Germany
(Danchin) Assistance Publique-Hopitaux de Paris (APHP), Department of
Cardiology, Hopital Europeen Georges Pompidou, FACT (French Alliance for
Cardiovascular Trials), Universite Paris Descartes, France
(Doughty) Heart Health Research Group, University of Auckland, New Zealand
(Hovingh) Department of Vascular Medicine, Academic Medical Center,
University of Amsterdam, Netherlands
(Hovingh) Department of Respiratory Medicine, Academic Medical Center,
University of Amsterdam, Netherlands
(Kaczor, Sanak, Szczeklik) Department of Internal Medicine, Jagiellonian
University Medical College, Krakow, Poland
(Palmer) Pat Macpherson Centre for Pharmacogenetics and Pharmacogenomics,
Division of Molecular and Clinical Medicine, Ninewells Hospital and
Medical School, Dundee, United Kingdom
(Sattar) Institute of Cardiovascular and Medical Sciences, University of
Glasgow, United Kingdom
(Simon) Assistance Publique-Hopitaux de Paris (APHP), Department of
Clinical Pharmacology, Platform of Clinical Research of East Paris
(URCEST-CRCEST-CRB HUEP-UPMC), FACT (French Alliance for Cardiovascular
Trials), Sorbonne Universite, Paris-06, France
(Simon) Paris-Sorbonne University, UPMC-Site St Antoine, France
(Spertus) University of Missouri-Kansas City, Kansas City, MO, United
States
(Spertus) Saint Luke's Mid America Heart Institute, Kansas City, MO,
United States
(Spertus) Institute of Laboratory Medicine, Clinical Chemistry and
Molecular Diagnostics, University Hospital, Leipzig, Germany
(Waltenberger) Department of Cardiovascular Medicine, University of
Munster, Germany
(Waltenberger) Cardiovascular Research Institute, National University of
Singapore, Singapore
(Pare) Department of Pathology and Molecular Medicine, McMaster
University, Hamilton, ON, Canada
(Pare) Population Health Research Institute, Hamilton, ON, Canada
(Marz) Synlab Academy, Synlab Holding Deutschland GmbH, Mannheim, Germany
(Marz) Clinical Institute of Medical and Chemical Laboratory Diagnostics,
Medical University of Graz, Austria
(Asselbergs) Health Data Research UK, Institute of Health Informatics,
University College London, United Kingdom
(Patel) Bart's Heart Centre, St Bartholomew's Hospital, London, United
Kingdom
Publisher
Lippincott Williams and Wilkins
Abstract
Background: Studies examining the role of factor V Leiden among patients
at higher risk of atherothrombotic events, such as those with established
coronary heart disease (CHD), are lacking. Given that coagulation is
involved in the thrombus formation stage on atherosclerotic plaque
rupture, we hypothesized that factor V Leiden may be a stronger risk
factor for atherothrombotic events in patients with established CHD.
 Method(s): We performed an individual-level meta-analysis including
25 prospective studies (18 cohorts, 3 case-cohorts, 4 randomized trials)
from the GENIUS-CHD (Genetics of Subsequent Coronary Heart Disease)
consortium involving patients with established CHD at baseline.
Participating studies genotyped factor V Leiden status and shared risk
estimates for the outcomes of interest using a centrally developed
statistical code with harmonized definitions across studies. Cox
proportional hazards regression models were used to obtain age- and
sex-adjusted estimates. The obtained estimates were pooled using
fixed-effect meta-analysis. The primary outcome was composite of
myocardial infarction and CHD death. Secondary outcomes included any
stroke, ischemic stroke, coronary revascularization, cardiovascular
mortality, and all-cause mortality. Result(s): The studies included
69 681 individuals of whom 3190 (4.6%) were either heterozygous or
homozygous (n=47) carriers of factor V Leiden. Median follow-up per study
ranged from 1.0 to 10.6 years. A total of 20 studies with 61 147
participants and 6849 events contributed to analyses of the primary
outcome. Factor V Leiden was not associated with the combined outcome of
myocardial infarction and CHD death (hazard ratio, 1.03 [95% CI,
0.92-1.16]; I2=28%; P-heterogeneity=0.12). Subgroup analysis
according to baseline characteristics or strata of traditional
cardiovascular risk factors did not show relevant differences. Similarly,
risk estimates for the secondary outcomes including stroke, coronary
revascularization, cardiovascular mortality, and all-cause mortality were
also close to identity. Conclusion(s): Factor V Leiden was not
associated with increased risk of subsequent atherothrombotic events and
mortality in high-risk participants with established and treated CHD.
Routine assessment of factor V Leiden status is unlikely to improve
atherothrombotic events risk stratification in this
population. Copyright © 2020 Lippincott Williams and Wilkins. All
rights reserved.

<36>
Accession Number
2005711044
Title
Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized
Controlled Trial.
Source
Canadian Journal of Kidney Health and Disease. 7 (no pagination), 2020.
Date of Publication: 2020.
Author
Nagpal A.D.; Cowan A.; Li L.; Nusca G.; Guo L.; Novick R.J.; Harle C.C.;
House A.A.; Fox S.; Jones P.M.
Institution
(Nagpal, Li, Nusca, Guo, Novick, Fox) Department of Surgery, Division of
Cardiac Surgery, Western University, London Health Sciences Centre,
London, ON, Canada
(Nagpal, Novick) Critical Care Western, Western University, London, ON,
Canada
(Cowan, House) Department of Medicine, Division of Nephrology, Western
University, London, ON, Canada
(Harle, Jones) Department of Anesthesia & Perioperative Medicine, Western
University, London, ON, Canada
(Jones) Department of Epidemiology & Biostatistics, Western University,
London, ON, Canada
Publisher
SAGE Publications Ltd
Abstract
Background: Despite decades of investigation, the balance of clinical
risks and benefits of fluid supplementation with starch remain unresolved.
Patient-centered outcomes have not been well explored in a "real-world"
trial in cardiac surgery. Objective(s): We sought to compare a
starch-based fluid strategy with a saline-based fluid strategy in the
cardiac surgery patient. Design(s): A pragmatic blinded randomized
controlled trial comparing starch-based with saline-based fluid strategy.
 Setting(s): A large tertiary academic center in London Ontario
between September 2009 and February 2011. Participant(s): Patients
undergoing planned, isolated coronary revascularization. Measurements:
Serum creatinine and patient weight were measured daily postoperatively.
 Method(s): Patients were randomized to receive 6% hydroxyethyl starch
(Voluven) or saline for perioperative fluid requirements. Fluid
administration was not protocolized. Co-primary outcomes were incidence of
acute kidney injury (AKI) and maximum postoperative weight gain. Secondary
outcomes included bleeding, transfusion, inotropic and ventilator support,
and fluid utilization. Result(s): The study was prematurely
terminated due to resource limitations. A total of 69 patients (19%
female, mean age = 65) were randomized. Using RIFLE criteria for AKI,
"risk" occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95%
confidence interval [CI] = 0.5-1.9; P = 1.00), whereas "injury" occurred
in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline
groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P =.31). Maximum weight
gain, bleeding and blood product usage, and overall fluid requirement were
similar between groups. Limitation(s): The study had to be
prematurely terminated due to resource limitations which led to a small
sample size which was not sufficiently powered to detect a difference in
the primary outcomes. Conclusion(s): This pragmatic double-blinded
randomized controlled trial revealed a number of interesting
hypothesis-generating trends and confirmed the feasibility of undertaking
a logistically complex trial in a pragmatic fashion. Copyright ©
The Author(s) 2020.

<37>
Accession Number
2005445034
Title
The effect of different posture on normal saline injection in optic nerve
sheath diameter in thoracic epidural anesthesia.
Source
Pain Physician. 23 (6) (pp 573-579), 2020. Date of Publication: 2020.
Author
Park J.; Hong J.; Kim J.; Yi S.
Institution
(Park, Hong, Kim, Yi) Keimyung University DongSan Hospital, Keimyung
University School of Medicine, Daegu, South Korea
Publisher
American Society of Interventional Pain Physicians
Abstract
Background: Thoracolumbar or caudal epidural anesthesia affects
intracranial pressure (ICP) in both animals and humans. Epidural injection
increases ICP at least transiently. Measurement of the optic nerve sheath
diameter (ONSD) using ultrasonography is one of the noninvasive methods
for ICP assessment. Objective(s): The purpose of this study was to
investigate the effect of the different posture during epidural saline
injection to the ONSD under awake conditions. Study Design:
Prospective, randomized trial. Setting(s): An interventional pain
management practice in South Korea. Method(s): This study included 44
patients receiving thoracic epidural catheterization for pain management
after upper abdominal or thoracic surgery. Following successful epidural
space confirmation, patients were randomized to receive epidural saline
while supine (A group) or in sitting position (B group), respectively.
Transorbital sonography was performed for the measurement of the ONSD, and
the ONSD was measured at 3 mm posterior to the optic nerve head.
 Result(s): Both A and B groups showed significant increases of ONSD
according to time. Mean ONSD values measured at T10, T20, and T40
significantly increased from the baseline value (T0) (*P < 0.05
vs. T0,+P < 0.001 vs. T0,++P < 0.005 vs. T0). The
mean ONSD values measured at any of the time points and degrees of changes
(T10-T0, T20-T0, and T40-T0) between groups A and B did not show any
significant changes. Limitation(s): Epidural pressure and ONSD
measurement can make this study more reliable. Further study showing
changes of epidural pressure with ONSD measurement is required.
 Conclusion(s): Thoracic epidural injection of 10 mL of normal saline
resulted in a significant increase of ONSD compared with the baseline.
However, the different posture did not affect the increase of
ONSD. Copyright © 2020, American Society of Interventional Pain
Physicians. All rights reserved.

<38>
Accession Number
2005380404
Title
New technology for the use of inhaled nitric oxide to protect the heart
and lungs during operations with cardiopulmonary bypass.
Source
Sovremennye Tehnologii v Medicine. 12 (5) (pp 28-34), 2020. Date of
Publication: 2020.
Author
Pichugin V.V.; Seyfetdinov I.R.; Ryazanov M.V.; Domnin S.E.; Gamzaev A.B.;
Chiginev V.A.; Bober V.V.; Medvedev A.P.
Institution
(Pichugin, Seyfetdinov, Domnin, Bober) Department of Anesthesiology,
Resuscitation, Emergency Medical Aid, Privolzhsky Research Medical
University, 10/1 Minin and Pozharsky Square, Nizhny Novgorod 603005,
Russian Federation
(Ryazanov, Chiginev, Medvedev) Department of Hospital Surgery named after
B.A. Korolyov, Privolzhsky Research Medical University, 10/1 Minin and
Pozharsky Square, Nizhny Novgorod 603005, Russian Federation
(Gamzaev) Department of X-ray Endovascular Diagnostics, Treatment,
Privolzhsky Research Medical University, 10/1 Minin and Pozharsky Square,
Nizhny Novgorod 603005, Russian Federation
Publisher
Privolzhsky Research Medical University
Abstract
The aim of the study was to evaluate the effectiveness of a new technology
for the use of inhaled nitric oxide (NO) for the heart and lung protection
during operations with cardiopulmonary bypass (SPB). Materials and
Methods. The study included 90 patients who underwent heart valve surgery
and combined procedures under CPB and pharmacological cardioplegia. Three
groups were created: group 1 (control, n=30); group 2 (n=30) - NO
inhalation (20 ppm) was conducted traditionally, that is, before and after
CPB; group 3 (n=30) - NO inhalation was performed using a new technology -
during the entire operation, with pulmonary artery perfusion and lung
ventilation performed during CPB. Troponin I (cTn I) level, changes in the
pulmonary function parameters, and clinical indicators were studied.
Results. Statistically significant lower levels of postoperative cTn I
were registered in the patients of groups 2 and 3, at the same time, the
levels were significantly lower in group 3 compared to group 2. The
patients in group 1 (standardized anesthesia protocol) demonstrated an
increase in the alveolar-arterial oxygen difference, an increase in
intrapulmonary shunting, a decrease in blood oxygenation, and static lung
compliance after SPB. In both cases, NO inhalation retained the values of
lung compliance and pulmonary oxygenating function after CPB, and in the
patients of group 3, it also significantly reduced intrapulmonary shunting
and alveolar-arterial difference after CPB. NO inhalation allowed a
statistically significant decrease in the incidence of pulmonary
dysfunction, acute respiratory failure, as well as the time of respiratory
support in the ICU. Conclusion. The developed technology for the use of
inhaled NO in surgery with CPB provides a clinically marked protective
effect on the heart and lungs. The effectiveness of the protective action
of NO depends on the duration of its administration and is most pronounced
when used during the entire operation, including CPB time. Copyright
© 2020, Privolzhsky Research Medical University. All rights reserved.

<39>
Accession Number
2005207320
Title
The effect of preoperative carbohydrate loading on clinical and
biochemical outcomes after cardiac surgery: A systematic review and
meta-analysis of randomized trials.
Source
Nutrients. 12 (10) (pp 1-21), 2020. Article Number: 3105. Date of
Publication: October 2020.
Author
Kotfis K.; Jamiol-Milc D.; Skonieczna-zydecka K.; Folwarski M.; Stachowska
E.
Institution
(Kotfis) Department of Anesthesiology, Intensive Therapy and Acute
Intoxications, Pomeranian Medical University, Szczecin 70-111, Poland
(Jamiol-Milc, Skonieczna-zydecka, Stachowska) Department of Human
Nutrition and Metabolomics, Pomeranian Medical University in Szczecin,
Szczecin 71-460, Poland
(Folwarski) Department of Clinical Nutrition and Dietetics, Medical
University of Gdansk, Gdansk 80-210, Poland
(Folwarski) Home Enteral and Parenteral Nutrition Unit, General Surgery,
Nicolaus Copernicus Hospital, Gdansk 80-210, Poland
Publisher
MDPI AG
Abstract
Background and aim: Preoperative fasting leads to metabolic stress and
causes insulin resistance in patients undergoing cardiac surgery. The aim
of this study was to assess the effect of preoperative oral carbohydrate
loading (OCH) on outcome in patients undergoing planned cardiac surgery by
systematically reviewing the literature and synthesizing evidence from
randomized controlled trials (RCTs). Method(s): Systematic search of
PubMed/MEDLINE/Embase/Cinahl/Web of Science/ClinicalTrials databases was
performed to identify relevant RCTs from databased inception until
05/03/2020. We included studies that compared outcome measures between OCH
with control (placebo or standard starvation). We conducted a
random-effect meta-analysis of clinical and biochemical parameters.
 Result(s): Nine studies (N = 9) were included with a total of 507
patients. OCH significantly decreased aortic clamping duration (n = 151,
standardized mean difference (SMD) = -0.28, 95% confidence interval (CI) =
-0.521 to -0.038, p = 0.023 and differences in means (DM) = -6.388, 95%CI
= -11.246 to -1.529, p = 0.010). Patients from treatment groups had
shorter intensive care unit (ICU) stay (n = 202, SMD = -0.542, 95%CI =
-0.789 to -0.295, p < 0.001 and DM = -25.925, 95%CI = -44.568 to -7.283, p
= 0.006) and required fewer units of insulin postoperatively (n = 85, SMD
= -0.349, 95%CI = -0.653 to -0.044, p = 0.025 and DM = -4.523, 95%CI =
-8.417 to -0.630, p = 0.023). The necessity to use inotropic drugs was
significantly lower in the OCH group (risk ratio (RR) = 0.795, 95%CI =
0.689 to 0.919, p = 0.002). All other primary outcomes did not reveal a
significant effect. Conclusion(s): Preoperative OCH in patients
undergoing cardiac surgery demonstrated a 20% reduction in the use of
inotropic drugs, a 50% reduction of the length of ICU stay, a 28% decrease
in aortic clamping duration and a 35% decrease of postoperative insulin
requirement. Copyright © 2020 by the authors. Licensee MDPI,
Basel, Switzerland.

<40>
Accession Number
2004958829
Title
Cost-effectiveness of drug-eluting stents in percutaneous coronary
intervention in Brazil's unified public health system (SUS).
Source
Arquivos Brasileiros de Cardiologia. 115 (1) (pp 80-89), 2020. Date of
Publication: July 2020.
Author
Pessoa J.A.; Ferreira E.; Araujo D.V.; Maia E.; da Silva F.S.M.; de
Oliveira M.S.; de Albuquerque D.C.
Institution
(Pessoa, Ferreira, Araujo, da Silva, de Oliveira, de Albuquerque)
Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil
(Pessoa, Maia) Hospital Sao Lucas, Nova Friburgo, RJ, Brazil
Publisher
Arquivos Brasileiros de Cardiologia
Abstract
Background: The use of drug-eluting stents (DESs), compared with
bare-metal stents (BMSs), in percutaneous coronary intervention (PCI) has
reduced the rate of restenosis, without an impact on mortality but with an
increase in costs. Medical literature lacks randomized studies that
economically compare these 2 stent types within the reality of the
Brazilian Unified Public Health System (SUS). Objective(s): To
estimate the incremental cost-effectiveness ratio (ICER) between DES and
BMS in SUS patients with singlevessel coronary artery disease.
 Method(s): Over a 3-year period, patients with symptomatic
single-vessel coronary artery disease were randomized in a 1:2 ratio to
receive a DES or BMS during PCI, with a 1-year clinical follow-up. The
evaluation included instent restenosis (ISR), target lesion
revascularization (TLR), major adverse events, and cost-effectiveness for
each group. P-values <0.05 were considered significant. Result(s): In
the DES group, of 74 patients (96.1%) who completed the follow-up, 1
developed ISR (1.4%), 1 had TLR (1.4%), and 1 died (1.4%), with no cases
of thrombosis. In the BMS group, of 141 patients (91.5%), ISR occurred in
14 (10.1%), TLR in 10 (7.3%), death in 3 (2.1%), and thrombosis in 1
(0.74%). In the economic analysis, the cost of the procedure was R$
5,722.21 in the DES group and R$ 4,085.21 in the BMS group. The
effectiveness by ISR and TLR was 8.7% for DES and 5.9% for BMS, with an
ICER of R$ 18,816.09 and R$ 27,745.76, respectively. Conclusion(s):
In the SUS, DESs were cost-effective in accordance with the
cost-effectiveness threshold recommended by the World Health
Organization. Copyright © 2020, Arquivos Brasileiros de
Cardiologia. All rights reserved.

<41>
Accession Number
2004841037
Title
Which is the optimal frozen elephant trunk? A systematic review and
meta-analysis of outcomes in 2161 patients undergoing thoracic aortic
aneurysm surgery using e-vita open plus hybrid stent graft versus
thoraflexTM hybrid prosthesis.
Source
Brazilian Journal of Cardiovascular Surgery. 35 (4) (pp 427-436), 2020.
Date of Publication: 2020.
Author
Harky A.; Fok M.; Bashir M.
Institution
(Harky) Department of Cardiothoracic Surgery, Liverpool Heart and Chest
Hospital, Liverpool, United Kingdom
(Fok) Department of Vascular Surgery, Royal Liverpool Hospital, Liverpool,
United Kingdom
(Bashir) Vascular Surgery Department, Royal Blackburn Teaching Hospital,
Haslingden Rd, Blackburn, United Kingdom
Publisher
Sociedade Brasileira de Cirurgia Cardiovascular
Abstract
Objective: To systematically review the rate of morbidity and mortality
associated with the use of E-vita hybrid stent graft and ThoraflexTM in
patients undergoing complex aortic surgery. Method(s): A
comprehensive search was undertaken among the four major databases to
identify published data about E-vita or ThoraflexTM in patients undergoing
repair of thoracic aortic aneurysms. Result(s): In total, 28 papers
were included in the study, encompassing a total of 2,161 patients (1,919
E-vita and 242 ThoraflexTM). Patients undergoing surgery with E-vita or
ThoraflexTM were of similar age and sex. The number of patients undergoing
non-elective repair with ThoraflexTM was higher than with E-vita (35.2%
vs. 28.7%, respectively). Cardiopulmonary bypass time was associated with
increasing mortality in E-vita patients, however a meta-analysis of
proportions showed higher 30-day mortality, permanent neurological
deficit, and one-year mortality for ThoraflexTM patients. Direct
statistical comparisons between E-vita and ThoraflexTM was not possible
due to heterogeneity of studies. Conclusion(s): Although there are
limited studies available, the available data suggests that mortality and
morbidity are lower for the E-vita device in thoracic aortic aneurysm
surgery than for ThoraflexTM. Long-term data of comparative studies do not
yet exist to assess viability of these procedures. Copyright ©
2020, Sociedade Brasileira de Cirurgia Cardiovascular. All rights
reserved.

<42>
Accession Number
630059366
Title
In patients undergoing video-assisted thoracic surgery for lung resection,
does three-dimensional endoscopic vision provide superior clinical
outcomes?.
Source
Interactive cardiovascular and thoracic surgery. 30 (4) (pp 588-592),
2020. Date of Publication: 01 Apr 2020.
Author
Chandarana K.; Caruana E.J.
Institution
(Chandarana, Caruana) Department of Thoracic Surgery, Glenfield Hospital,
Leicester, United Kingdom
(Caruana) NIHR Biomedical Research Centre, University of Nottingham,
Nottingham, United Kingdom
Publisher
NLM (Medline)
Abstract
A best evidence topic in thoracic surgery was written according to a
structured protocol. The question addressed was whether the use of
3-dimensional endoscopic vision provides superior clinical outcomes to
patients undergoing video-assisted thoracic surgery for lung resection.
Altogether 231 unique papers were found using the reported search, of
which 6 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.
Four of the 6 papers demonstrated a statistically significant reduction in
operative time, although this difference may not be of sufficient
magnitude to be relevant clinically. There was no difference in any other
outcomes assessed. We therefore conclude that, in patients undergoing
video-assisted thoracic surgery for lung resection, 3-dimensional
endoscopic vision has no demonstrable impact on perioperative or
oncological outcomes, or cost, although it may reduce operative
time. Copyright © The Author(s) 2019. Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery. All rights reserved.

<43>
Accession Number
2008574731
Title
Meta-analysis Comparing Early Outcomes Following Transcatheter Aortic
Valve Implantation With the Evolut Versus Sapien 3 Valves.
Source
American Journal of Cardiology. (no pagination), 2020. Date of
Publication: 2020.
Author
Alperi A.; Faroux L.; Muntane-Carol G.; Rodes-Cabau J.
Institution
(Alperi, Faroux, Muntane-Carol, Rodes-Cabau) Quebec Heart & Lung
Institute, Laval University, Quebec City, QC, Canada
Publisher
Elsevier Inc.
Abstract
We aimed to compare the early (in-hospital/30-day) outcomes (major
periprocedural complications, device success/valve performance, and
mortality) following transcatheter aortic valve implantation with the
Sapien 3 versus Evolut transcatheter valve systems. This was a systematic
review from PubMed and EMBASE databases for studies reporting raw data or
estimates. The outcomes analyzed were (1) in-hospital/30-day major
periprocedural complications, (2) device success and valve performance,
and (3) mortality. The outcomes were defined according to VARC-2 criteria.
A total of 24,628 transcatheter aortic valve implantation patients from 9
studies (1 randomized, 8 observational [5 case- or propensity-matched
analyses]) were included: 12,411 and 12,217 patients had Sapien 3 and
Evolut valve implantation, respectively. There were no differences between
devices regarding in-hospital/30-day stroke (risk ratio [RR] 0.95, 95%
confidence interval [CI] 0.34 to 2.66), major vascular complications (RR
1.03, 95% CI 0.63 to 1.68), acute kidney injury (RR 1.17, 95% CI 0.78 to
1.77), device success (RR 1.00, 95% CI 0.97 to 1.04) and moderate-severe
residual aortic regurgitation (RR 0.49, 95% CI 0.20 to 1.17). Sapien 3
recipients exhibited lower risk of permanent pacemaker implantation (RR
0.66, 95% CI 0.55 to 0.80), a higher risk of life-threatening bleeding (RR
1.82, 95% CI 1.18 to 2.80), and higher residual transvalvular gradients
(mean difference 3.95 mmHg, 95% CI 3.37 to 4.56). A lower risk of
in-hospital/30-day mortality was observed for Sapien 3 (RR 0.79, 95% CI
0.69 to 0.90). In conclusion, the similarities in device success rate and
major periprocedural complications (except for a higher and lower risk of
permanent pacemaker implantation and life-threatening bleeding,
respectively, with the Evolut system) support the lack of a valve type
effect accounting for the increased mortality risk observed with the
Evolut valve. Copyright © 2020 Elsevier Inc.

<44>
Accession Number
2008594026
Title
A Comparison of Volatile Anesthesia and Total Intravenous Anesthesia
(TIVA) Effects on Outcome From Cardiac Surgery: A Systematic Review and
Meta-Analysis.
Source
Journal of Cardiothoracic and Vascular Anesthesia. (no pagination), 2020.
Date of Publication: 2020.
Author
Beverstock J.; Park T.; Alston R.P.; Song C.C.A.; Claxton A.; Sharkey T.;
Hutton S.; Fathers J.; Cawley W.
Institution
(Beverstock, Park, Alston, Song, Claxton, Sharkey, Hutton, Fathers,
Cawley) College of Medicine and Veterinary Medicine, University of
Edinburgh, Edinburgh, United Kingdom
(Alston) Department of Anaesthesia, Critical Care and Pain Medicine, Royal
Infirmary of Edinburgh, Edinburgh, United Kingdom
Publisher
W.B. Saunders
Abstract
Objective: The primary objective of this study was to compare one-year
mortality in patients undergoing cardiac surgery with volatile anesthesia
or total intravenous anesthesia (TIVA). Secondary objectives were to
compare in-hospital and 30-day mortality, postoperative levels of creatine
kinase (CK-MB) and cardiac troponin, and durations of tracheal intubation,
intensive care unit (ICU) and hospital stays. Design(s): Systematic
review and meta-analysis of randomized controlled trials (RCTs).
 Setting(s): International, multi-institution centers.
 Participant(s): Adults patients undergoing heart surgery.
 Intervention(s): Volatile anesthesia and TIVA. Measurements and
Main Results: Meta-analysis found no statistically significant difference
between patients receiving TIVA and volatile anesthesia in one-year
mortality (n = 6440, OR = 1.22, 95% CI 0.97 to 1.54, p = 0.09, Z = 1.67,
I2 = 0%), troponin (n = 3127, SMD = 0.26, 95% CI -0.01 to 0.52,
p = 0.05, Z = 1.92, I2 = 90%) and CK-MB concentration 24h
postoperatively (n = 1214, SMD = 0.10, 95% CI -0.17 to 0.36, unadjusted p
= 0.48, Z = 0.71, I2 = 79%), or time to tracheal extubation (n
= 1059, SMD = 0.10, 95% CI -0.28 to 0.49, p = 0.60, Z = 0.53, I2 = 88%).
The durations of ICU stay (n = 2003, SMD = 0.29, 95% CI 0.01 to 0.57, p =
0.04, Z = 2.05, I2 = 88%) and hospital stay (n = 1214, SMD =
0.42, 95% CI 0.10 to 0.75, p = 0.01, Z = 2.53, I2 = 91%) were
shorter in the volatile anesthetic compared to TIVA group.
 Conclusion(s): No significant differences in mortality (in-hospital,
30-day, 1-year), troponin and CK-MB concentrations 24 h postoperatively,
or time to tracheal extubation were found between patients who had
volatile anesthesia or TIVA. Compared to TIVA, volatile anesthesia was
associated with shorter durations of hospital and ICU stays. Copyright
© 2020 Elsevier Inc.

<45>
Accession Number
2004107413
Title
Effect of red blood cell storage duration on major postoperative
complications in cardiac surgery: A randomized trial.
Source
Journal of Thoracic and Cardiovascular Surgery. 160 (6) (pp 1505-1514.e3),
2020. Date of Publication: December 2020.
Author
Koch C.G.; Sessler D.I.; Duncan A.E.; Mascha E.J.; Li L.; Yang D.;
Figueroa P.; Sabik J.F.; Mihaljevic T.; Svensson L.G.; Blackstone E.H.
Institution
(Koch) Department of Anesthesiology and Critical Care Medicine, Johns
Hopkins Medicine, Baltimore, Md, United States
(Sessler, Mascha, Yang) Department of Outcomes Researc, Cleveland Clinic,
Cleveland, OH, United States
(Duncan) Department of Cardiothoracic Anesthesiology, Cleveland Clinic,
Cleveland, OH, United States
(Mascha, Yang, Blackstone) Department of Quantitative Health Sciences,
Cleveland Clinic, Cleveland, OH, United States
(Li) Division of Science, Department of Biostatistics, MD Anderson Cancer
Center, Houston, Tex, United States
(Figueroa) Department of Clinical Pathology, Cleveland Clinic, Cleveland,
OH, United States
(Sabik) Department of Surgery, University Hospitals Cleveland Medical
Center, Cleveland, OH, United States
(Mihaljevic, Svensson, Blackstone) Department of Thoracic and
Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, United States
Publisher
Mosby Inc.
Abstract
Background: Although observational studies suggest an association between
transfusion of older red blood cell (RBC) units and increased
postoperative risk, randomized trials have not supported this. The
objective of this randomized trial was to test the effect of RBC storage
age on outcomes after cardiac surgery. Method(s): From July 2007 to
May 2016, 3835 adults undergoing coronary artery bypass grafting, cardiac
valve procedures, or ascending aorta repair, either alone or in
combination, were randomized to transfusion of RBCs stored for <=14 days
(younger units) or for >=20 days (older units) intraoperatively and
throughout the postoperative hospitalization. According to protocol, 2448
patients were excluded because they did not receive RBC transfusions.
Among the remaining 1387 modified intent-to-treat patients, 701 were
randomized to receive younger RBC units (median age, 11 days) and the
remaining 686 to receive older units (median age, 25 days). The primary
endpoint was composite morbidity and mortality, analyzed using a
generalized estimating equation (GEE) model. The trial was discontinued
midway owing to enrollment constraints. Result(s): A total of 5470
RBC units were transfused, including 2783 in the younger RBC storage group
and 2687 in the older RBC storage group. The GEE average relative-effect
odds ratio was 0.77 (95% confidence interval [CI], 0.50-1.19; P = .083)
for the composite morbidity and mortality endpoint. In-hospital mortality
was lower for the younger RBC storage group (2.1% [n = 15] vs 3.4% [n =
23]), as was occurrence of other adverse events except for atrial
fibrillation, although all CIs crossed 1.0. Conclusion(s): This
clinical trial, which was stopped at its midpoint owing to enrollment
constraints, supports neither the efficacy nor the futility of transfusing
either younger or older RBC units. The effects of transfusing RBCs after
even more prolonged storage (35-42 days) remains untested. Copyright
© 2019 The American Association for Thoracic Surgery

<46>
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. (no pagination), 2020.
Date of Publication: 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
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.

<47>
Accession Number
633374433
Title
Risk Factors for Delirium and Cognitive Decline Following Coronary Artery
Bypass Grafting Surgery: A Systematic Review and Meta-Analysis.
Source
Journal of the American Heart Association. 9 (22) (pp e017275), 2020. Date
of Publication: 17 Nov 2020.
Author
Greaves D.; Psaltis P.J.; Davis D.H.J.; Ross T.J.; Ghezzi E.S.; Lampit A.;
Smith A.E.; Keage H.A.D.
Institution
(Greaves, Ross, Ghezzi, Smith, Keage) Cognitive Ageing and Impairment
Neurosciences Laboratory, Justice and Society Academic Unit University of
South Australia Adelaide Australia
(Psaltis) Vascular Research Centre Lifelong Health Theme South Australian
Health and Medical Research Institute Adelaide Australia
(Psaltis) Adelaide Medical School University of Adelaide Adelaide
Australia
(Psaltis) Department of Cardiology Royal Adelaide Hospital Central
Adelaide Local Health Network Adelaide Australia
(Davis) Medical Reasearch Council Unit for Lifelong Health and Ageing Unit
at UCL London United Kingdom
(Lampit) Academic Unit for Psychiatry of Old Age Department of Psychiatry
University of Melbourne Melbourne Australia
(Lampit) Department of Neurology Charite-Universitatsmedizin Berlin Berlin
Germany
(Smith) Alliance for Research in Exercise, Nutrition and Activity Allied
Health and Human Performance Academic Unit University of South Australia
Adelaide Australia
Publisher
NLM (Medline)
Abstract
Background Coronary artery bypass grafting (CABG) is known to improve
heart function and quality of life, while rates of surgery-related
mortality are low. However, delirium and cognitive decline are common
complications. We sought to identify preoperative, intraoperative, and
postoperative risk or protective factors associated with delirium and
cognitive decline (across time) in patients undergoing CABG. Methods and
Results We conducted a systematic search of Medline, PsycINFO, EMBASE, and
Cochrane (March 26, 2019) for peer-reviewed, English publications
reporting post-CABG delirium or cognitive decline data, for at least one
risk factor. Random-effects meta-analyses estimated pooled odds ratio for
categorical data and mean difference or standardized mean difference for
continuous data. Ninety-seven studies, comprising data from 60 479
patients who underwent CABG, were included. Moderate to large and
statistically significant risk factors for delirium were as follows: (1)
preoperative cognitive impairment, depression, stroke history, and higher
European System for Cardiac Operative Risk Evaluation (EuroSCORE) score,
(2) intraoperative increase in intubation time, and (3) postoperative
presence of arrythmia and increased days in the intensive care unit;
higher preoperative cognitive performance was protective for delirium.
Moderate to large and statistically significant risk factors for acute
cognitive decline were as follows: (1) preoperative depression and older
age, (2) intraoperative increase in intubation time, and (3) postoperative
presence of delirium and increased days in the intensive care unit.
Presence of depression preoperatively was a moderate risk factor for
midterm (1-6 months) post-CABG cognitive decline. Conclusions This
meta-analysis identified several key risk factors for delirium and
cognitive decline following CABG, most of which are nonmodifiable. Future
research should target preoperative risk factors, such as depression or
cognitive impairment, which are potentially modifiable. Registration URL:
https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42020149276.

<48>
Accession Number
633331882
Title
Institutional Red Blood Cell Transfusion Rates Are Correlated Following
Endovascular and Surgical Cardiovascular Procedures: Evidence That Local
Culture Influences Transfusion Decisions.
Source
Journal of the American Heart Association. 9 (22) (pp e016232), 2020. Date
of Publication: 17 Nov 2020.
Author
Apostolidou E.; Kolte D.; Kennedy K.F.; Beale C.E.; Abbott J.D.; Ehsan A.;
Gurm H.S.; Carson J.L.; Mamdani S.; Aronow H.D.
Institution
(Apostolidou, Abbott, Mamdani, Aronow) Division of Cardiology Alpert
Medical School of Brown University Providence RI
(Kolte) Division of Cardiology Massachusetts General Hospital and Harvard
Medical School Boston MA
(Kennedy) Statistical Consultant to the Cardiovascular Institute Kansas
City MO
(Beale) St. Anne's Hospital Fall River MA
(Ehsan) Division of Cardiothoracic Surgery Alpert Medical School of Brown
University Providence RI
(Gurm) Division of Cardiology University of Michigan Ann Arbor MI
(Carson) Division of Internal Medicine Robert Wood Johnson University
Hospital New Brunswick NJ
Publisher
NLM (Medline)
Abstract
Background The relationship between local hospital culture and transfusion
rates following endovascular and surgical cardiovascular procedures has
not been well studied. Methods and Results Patients undergoing coronary
revascularization, aortic valve replacement, lower extremity peripheral
vascular intervention, or carotid artery revascularization from up to 852
US hospitals in the Nationwide Readmissions Database were identified.
Crude and risk-standardized red blood cell transfusion rates were
determined for each procedure. Pearson correlation coefficients were
calculated between respective procedural transfusion rates. Median odds
ratios were estimated to reflect between-hospital variability in red blood
cell transfusion rates following the same procedure for a given patient.
There was wide variation in red blood cell transfusion rates across
different procedures, from 2% following carotid endarterectomy to 29%
following surgical aortic valve replacement. For surgical and endovascular
modalities, transfusion rates at the same hospital were highly correlated
for aortic valve replacement (r=0.67; P<0.001), moderately correlated for
coronary revascularization (r=0.56; P<0.001) and peripheral vascular
intervention (r=0.51; P<0.001), and weakly correlated for carotid artery
revascularization (r=0.19, P<0.001). Median odds ratios were all >2,
highest for coronary artery bypass graft surgery and surgical aortic valve
replacement, indicating substantial site variation in transfusion rates.
Conclusions After adjustment for patient-related factors, wide variation
in red blood cell transfusion rates remained across surgical and
endovascular procedures employed for the same cardiovascular condition.
Transfusion rates following these procedures are highly correlated at
individual hospitals and vary widely across hospitals. In aggregate, these
findings suggest that local institutional culture significantly influences
the decision to transfuse following invasive cardiovascular procedures and
highlight the need for randomized data to inform such decisions.

<49>
Accession Number
631237352
Title
Cost-effectiveness of a technology-supported multimodal prehabilitation
program in moderate-to-high risk patients undergoing lung cancer
resection: randomized controlled trial protocol.
Source
BMC health services research. 20 (1) (pp 207), 2020. Date of Publication:
12 Mar 2020.
Author
Barberan-Garcia A.; Navarro-Ripoll R.; Sanchez-Lorente D.; Moises-Lafuente
J.; Boada M.; Messaggi-Sartor M.; Gonzalez-Vallespi L.; Montane-Muntane
M.; Alsina-Restoy X.; Campero B.; Lopez-Baamonde M.; Romano-Andrioni B.;
Guzman R.; Lopez A.; Arguis M.J.; Roca J.; Martinez-Palli G.
Institution
(Barberan-Garcia) Respiratory Medicine Department, Hospital Clinic de
Barcelona, Villarroel 170, Barcelona, Catalonia 08036, Spain
(Barberan-Garcia) August Pi i Sunyer Biomedical Research Institute -
IDIBAPS, University of Barcelona (UB), Barcelona, Spain
(Barberan-Garcia) Biomedical Networking Research Centre on Respiratory
Diseases (CIBERES), Barcelona, Spain
(Navarro-Ripoll, Montane-Muntane, Lopez-Baamonde, Lopez, Arguis,
Martinez-Palli) Anaesthesia and Intensive Care Department, Hospital Clinic
de Barcelona, Barcelona, Spain
(Sanchez-Lorente, Boada, Guzman) Thoracic Surgery Department, Hospital
Clinic de Barcelona, Barcelona, Spain
(Moises-Lafuente, Messaggi-Sartor, Alsina-Restoy, Roca) Respiratory
Medicine Department, Hospital Clinic de Barcelona, Villarroel 170,
Barcelona, Catalonia 08036, Spain
(Messaggi-Sartor, Roca, Martinez-Palli) August Pi i Sunyer Biomedical
Research Institute - IDIBAPS, University of Barcelona (UB), Barcelona,
Spain
(Gonzalez-Vallespi) Clinical Psychology Department, Hospital Clinic de
Barcelona, Barcelona, Spain
(Campero, Romano-Andrioni) Endocrinology and Nutrition Department,
Hospital Clinic de Barcelona, Barcelona, Spain
(Roca) Biomedical Networking Research Centre on Respiratory Diseases
(CIBERES), Barcelona, Spain
Publisher
NLM (Medline)
Abstract
BACKGROUND: Multimodal prehabilitation is a preoperative intervention with
the objective to enhance cancer patients' functional status which has been
showed to reduce both postoperative morbidity and hospital length of stay
in digestive oncologic surgery. However, in lung cancer surgery patients
further studies with higher methodological quality are needed to clarify
the benefits of prehabilitation. The main aim of the current protocol is
to evaluate the cost-effectiveness of a multimodal prehabilitation program
supported by information and communication technologies in
moderate-to-high risk lung cancer patients undergoing thoracic surgery.
 METHOD(S): A Quadruple Aim approach will be adopted, assessing the
prehabilitation program at the following levels: i) Patients' and
professionals' experience outcomes (by means of standardized
questionnaires, focus groups and structured interviews); ii) Population
health-based outcomes (e.g. hospital length of stay, number and severity
of postoperative complications, peak oxygen uptake and levels of systemic
inflammation); and, iii) Healthcare costs. DISCUSSION: This study protocol
should contribute not only to increase the scientific basis on
prehabilitation but also to detect the main factors modulating service
adoption. TRIAL REGISTRATION: NCT04052100 (August 9, 2019).

<50>
Accession Number
2008499689
Title
Direct Oral Anticoagulants Versus Vitamin K Antagonists in Patients With
Atrial Fibrillation After TAVR.
Source
JACC: Cardiovascular Interventions. 13 (22) (pp 2587-2597), 2020. Date of
Publication: 23 Nov 2020.
Author
Kawashima H.; Watanabe Y.; Hioki H.; Kozuma K.; Kataoka A.; Nakashima M.;
Nagura F.; Nara Y.; Yashima F.; Tada N.; Naganuma T.; Yamawaki M.;
Yamanaka F.; Shirai S.; Mizutani K.; Tabata M.; Ueno H.; Takagi K.;
Yamamoto M.; Hayashida K.
Institution
(Kawashima, Watanabe, Hioki, Kozuma, Kataoka, Nakashima, Nagura, Nara)
Department of Cardiology, Teikyo University School of Medicine, Tokyo,
Japan
(Kawashima) Amsterdam UMC, University of Amsterdam, Heart Center;
Department of Clinical and Experimental Cardiology, Amsterdam
Cardiovascular Sciences, Amsterdam, Netherlands
(Kawashima) Department of Cardiology, National University of Ireland,
Galway (NUIG), Galway, Ireland
(Yashima) Department of Cardiology, Saiseikai Utsunomiya Hospital,
Tochigi, Japan
(Yashima, Hayashida) Department of Cardiology, Keio University School of
Medicine, Tokyo, Japan
(Tada) Department of Cardiology, Sendai Kosei Hospital, Sendai, Japan
(Naganuma) Department of Cardiology, New Tokyo Hospital, Chiba, Japan
(Yamawaki) Department of Cardiology, Saiseikai Yokohama City Eastern
Hospital, Yokohama, Japan
(Yamanaka) Department of Cardiology, Shonan Kamakura General Hospital,
Kanagawa, Japan
(Shirai) Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan
(Mizutani) Department of Cardiovascular Medicine, Osaka City University
Graduate School of Medicine, Osaka, Japan
(Tabata) Department of Cardiovascular Surgery, Tokyo Bay Urayasu-Ichikawa
Medical Center, Chiba, Japan
(Ueno) Department of Cardiology, Toyama University Hospital, Toyama, Japan
(Takagi) Department of Cardiology, Ogaki Municipal Hospital, Gifu, Japan
(Yamamoto) Department of Cardiology, Toyohashi Heart Center, Toyohashi,
Japan
(Yamamoto) Department of Cardiology, Nagoya Heart Center, Nagoya, Japan
Publisher
Elsevier Inc.
Abstract
Objectives: The aim of this study was to compare long-term all-cause
mortality between direct oral anticoagulants (DOACs) and vitamin K
antagonists (VKAs) in patients with atrial fibrillation (AF) after
transcatheter aortic valve replacement (TAVR). Background(s): The
optimal anticoagulant agent for patients with AF after TAVR has not been
clarified. Method(s): OCEAN (Optimized Transcatheter Valvular
Intervention) is a prospective, multicenter, observational cohort registry
comprising 2,588 patients who underwent TAVR between October 2013 and May
2017. Of these, 403 patients (15.6%) with AF on anticoagulant therapy were
identified, of whom 227 (56.3%) were prescribed DOACs and 176 (43.7%) were
prescribed VKAs. Patients who successfully discharged after TAVR were
stratified into DOAC and VKA groups on the basis of the prescription of
anticoagulant agents, and the analyses started from discharge.
 Result(s): In total, 33.3% of patients were men. The mean age was
84.4 +/- 4.7 years, and the average CHA<inf>2</inf>DS<inf>2</inf>-VASc
score was 5.1 +/- 1.1. The median follow-up duration was 568 days. A
multivariate Cox regression model and inverse probability of treatment
weighting based on the propensity score demonstrated that the DOAC group
was significantly associated with a lower incidence of all-cause mortality
compared with the VKA group (10.3% vs. 23.3%; Cox-adjusted hazard ratio:
0.391; 95% confidence interval: 0.204 to 0.749; p = 0.005; and 10.2% vs.
20.6%; inverse probability of treatment weighting-adjusted hazard ratio:
0.531; 95% confidence interval: 0.294 to 0.961; p = 0.036, respectively).
 Conclusion(s): Compared with VKAs, DOACs might be associated with
lower long-term all-cause mortality in patients with concomitant AF who
are successfully discharged after TAVR. This finding warrants
investigation in ongoing prospective randomized trials. Copyright
© 2020 American College of Cardiology Foundation

<51>
Accession Number
2008499688
Title
Comparisons of Nonhyperemic Pressure Ratios: Predicting Functional Results
of Coronary Revascularization Using Longitudinal Vessel Interrogation.
Source
JACC: Cardiovascular Interventions. 13 (22) (pp 2688-2698), 2020. Date of
Publication: 23 Nov 2020.
Author
Omori H.; Kawase Y.; Mizukami T.; Tanigaki T.; Hirata T.; Kikuchi J.; Ota
H.; Sobue Y.; Miyake T.; Kawamura I.; Okubo M.; Kamiya H.; Hirakawa A.;
Kawasaki M.; Nakagawa M.; Tsuchiya K.; Suzuki Y.; Ito T.; Terashima M.;
Kondo T.; Suzuki T.; Escaned J.; Matsuo H.
Institution
(Omori, Kawase, Mizukami, Tanigaki, Hirata, Kikuchi, Ota, Sobue, Miyake,
Kawamura, Okubo, Kamiya, Kawasaki, Nakagawa, Tsuchiya, Kondo, Matsuo)
Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan
(Mizukami) Clinical Research Institute for Clinical Pharmacology and
Therapeutics, Showa University, Tokyo, Japan
(Hirakawa) Department of Biostatistics and Bioinformatics, Graduate School
of Medicine, University of Tokyo, Tokyo, Japan
(Suzuki, Ito) Department of Cardiovascular Medicine, Nagoya Heart Center,
Nagoya, Japan
(Terashima, Suzuki) Department of Cardiovascular Medicine, Toyohashi Heart
Center, Toyohashi, Japan
(Escaned) Hospital Clinico San Carlos IDISSC and Universidad Complutense
de Madrid, Madrid, Spain
Publisher
Elsevier Inc.
Abstract
Objectives: The aim of this study was to investigate the accuracy of
pre-percutaneous coronary intervention (PCI) predicted nonhyperemic
pressure ratios (NHPRs) with actual post-PCI NHPRs and to assess the
efficacy of PCI strategy using pre-PCI NHPR pullback. Background(s):
Predicting the functional results of PCI is feasible using pre-PCI
longitudinal vessel interrogation with the instantaneous wave-free ratio
(iFR), a pressure-based, adenosine-free NHPR. However, the reliability of
novel NHPRs (resting full-cycle ratio [RFR] and diastolic pressure ratio
[dPR]) for this purpose remains uncertain. Method(s): In this
prospective, multicenter, randomized controlled trial, vessels were
randomly assigned to receive pre-PCI iFR, RFR, or dPR pullback (50 vessels
each). The pre-PCI predicted NHPRs were compared with actual NHPRs after
contemporary PCI using intravascular imaging. The number and the total
length of treated lesions were compared between NHPR pullback-guided and
angiography-guided strategies. Result(s): The predicted NHPRs were
strongly correlated with actual NHPRs: iFR, r = 0.83 (95% confidence
interval: 0.72 to 0.90; p < 0.001); RFR, r = 0.84 (95% confidence
interval: 0.73 to 0.91; p < 0.001), and dPR, r = 0.84 (95% confidence
interval: 0.73 to 0.91; p < 0.001). The number and the total length of
treated lesions were lower with the NHPR pullback strategy than with the
angiography-guided strategy, leading to physiological improvement.
 Conclusion(s): Predicting functional PCI results on the basis of
pre-procedural RFR and dPR pullbacks yields similar results to iFR.
Compared with an angiography-guided strategy, a pullback-guided PCI
strategy with any of the 3 NHPRs reduced the number and the total length
of treated lesions. (Study to Examine Correlation Between Predictive Value
and Post PCI Value of iFR, RFR and dPR; UMIN000033534) Copyright
© 2020

<52>
Accession Number
2010047771
Title
Global longitudinal strain in chronic asymptomatic aortic regurgitation:
Systematic review.
Source
Echo Research and Practice. 7 (3) (pp 39-48), 2020. Date of Publication:
2020.
Author
deCampos D.; Teixeira R.; Saleiro C.; Botelho A.; Goncalves L.
Institution
(deCampos, Teixeira, Saleiro, Botelho, Goncalves) Servico de Cardiologia,
Centro Hospitalar e Universitario de Coimbra, Coimbra, Portugal
(Teixeira, Goncalves) Faculdade de Medicina, Universidade de Coimbra,
Coimbra, Portugal
Publisher
BioScientifica Ltd.
Abstract
Chronic aortic regurgitation (AR) patients typically remain asymptomatic
for a long time. Left ventricular mechanics, namely global longitudinal
strain (GLS), has been associated with outcomes in AR patients. The
authors conducted a systematic review to summarize and appraise GLS impact
on mortality, the need for aortic valve replacement (AVR) and disease
progression in AR patients. A literature search was performed using these
key terms 'aortic regurgitation' and 'longitudinal strain' looking at all
randomized and nonrandomized studies conducted on chronic aortic
regurgitation. The search yielded six observational studies published from
2011 and 2018 with a total of 1571 patients with moderate to severe
chronic AR. Only two studies included all-cause mortality as their
endpoint. The other studies looked at the association between GLS with AVR
and disease progression. The mean follow-up period was 4.2 years. We noted
a great variability of clinical, methodological and/or statistical origin.
Thus, meta-analytic portion of our study was limited. Despite a relevant
heterogeneity, an impaired GLS was associated with adverse cardiac
outcomes. Left ventricular GLS may offer incremental value in risk
stratification and decision-making. Copyright © 2020 The authors
Published by Bioscientifica Ltd.

<53>
Accession Number
2008596968
Title
The experiences of adult heart, lung, and heart-lung transplantation
recipients: A systematic review of qualitative research evidence.
Source
PLoS ONE. 15 (11 November) (no pagination), 2020. Article Number:
e0241570. Date of Publication: November 2020.
Author
Stubber C.; Kirkman M.
Institution
(Stubber, Kirkman) Global and Women's Health, Public Health and Preventive
Medicine, Monash University, Melbourne, VIC, Australia
Publisher
Public Library of Science
Abstract
Aim To review evidence about the experience of being the recipient of a
donated heart, lungs, or heart and lungs. Design A systematic review
(registered with PROSPERO: CRD42017067218), in accordance with PRISMA
guidelines. Data sources Seven databases and Google Scholar were searched
in May 2017 and July 2019 for papers reporting English-language research
that had used qualitative methods to investigate experiences of adult
recipients. Review methods Quality was assessed and results were analysed
thematically. Results 24 papers (reporting 20 studies) were eligible and
included. Their results were organised into three chronological periods:
pre-transplant (encompassing the themes of 'dynamic psychosocial impact',
'resources and support'), transplant ('The Call', 'intensive care unit'),
and post-transplant ('dynamic psychosocial impact', 'management',
'rejection'). Sub-themes were also identified. It was evident that
contemplating and accepting listing for transplantation entailed or
amplified realisation of the precipitating illness's existential threat.
The period surrounding transplantation surgery was marked by profound,
often surreal, experiences. Thereafter, although life usually improved, it
incorporated unforeseen challenges. The transplantation clinic remained
important to the recipient. The meaning of the clinic and its staff could
be both reassuring (providing care and support) and threatening
(representing onerous medical requirements and potential organ rejection).
Conclusion This review has implications for the psychosocial care of
transplant recipients and indicates the need for further research to gain
insight into the experience of receiving a donated heart and/or lung.
Impact Medical consequences of heart and lung transplantation are well
documented; this is the first systematic review of research using
qualitative methods to investigate the experience of heart, lung, and
heart-and-lung transplantation. The psychosocial impact of transplantation
was found to be dynamic and complex, with notable features evident before,
during, and after transplantation. Clinic staff remained significant to
recipients. It is clear that recipients need continuing psychosocial as
well as medical support. Copyright © 2020 Stubber, Kirkman. This
is an open access article distributed under the terms of the Creative
Commons Attribution License, which permits unrestricted use, distribution,
and reproduction in any medium, provided the original author and source
are credited.

<54>
Accession Number
633446002
Title
Response to the Comment on "Long-term and Temporal Outcomes of
Transcatheter Versus Surgical Aortic-valve Replacement in Severe Aortic
Stenosis: A Meta-analysis".
Source
Annals of surgery. (no pagination), 2020. Date of Publication: 12 Nov
2020.
Author
Zhang X.-L.; Zhang X.-W.; Xu W.; Xu B.
Institution
(Zhang) Department of Cardiology, China Department of Endocrinology, China
Department of Cardiology, Affiliated Drum Tower Hospital, Nanjing
University School of Medicine, Nanjing 210008, China
Publisher
NLM (Medline)

<55>
Accession Number
633442429
Title
Effect of Evolocumab on Complex Coronary Disease Requiring
Revascularization.
Source
Journal of the American College of Cardiology. (no pagination), 2020. Date
of Publication: 11 Nov 2020.
Author
Oyama K.; Furtado R.H.M.; Fagundes A.; Zelniker T.A.; Tang M.; Kuder J.;
Murphy S.A.; Hamer A.; Wang H.; Keech A.C.; Giugliano R.P.; Sabatine M.S.;
Bergmark B.A.
Institution
(Oyama) TIMI Study Group, Division of Cardiovascular Medicine, Brigham and
Women's Hospital, Harvard Medical School, Boston, MA, USA; Department of
Cardiovascular Medicine, Tohoku University Graduate School of Medicine,
Sendai, Japan
(Furtado) TIMI Study Group, Division of Cardiovascular Medicine, Brigham
and Women's Hospital, Harvard Medical School, Boston, MA, USA; Hospital
Israelita Albert Einsteinand Instituto do Coracao da Faculdade de Medicina
da USP, Sao Paulo, Brazil
(Fagundes, Tang, Kuder, Murphy, Giugliano, Sabatine, Bergmark) TIMI Study
Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital,
Harvard Medical School, MA, Boston, United States
(Zelniker) TIMI Study Group, Division of Cardiovascular Medicine, Brigham
and Women's Hospital, Harvard Medical School, Boston, MA, USA; Division of
Cardiology, Vienna General Hospital and Medical University of Vienna,
Austria
(Hamer, Wang) Amgen, Thousand Oaks, CA, United States
(Keech) National Health and Medical Research Council Clinical Trials
Centre, Sydney Medical School, University of Sydney, Sydney, Australia
Publisher
NLM (Medline)
Abstract
BACKGROUND: Proprotein convertase subtilisin/kexin type 9 (PCSK9)
inhibitors induce plaque regression and reduce the risk of coronary
revascularization overall. OBJECTIVE(S): To evaluate the ability of
PCSK9 inhibitors to reduce the risk of complex coronary atherosclerosis
requiring revascularization. METHOD(S): FOURIER was a randomized
trial of the PCSK9 inhibitor evolocumab vs. placebo in 27,564 patients
with stable atherosclerosis on statin therapy followed for a median of 2.2
years. Clinical documentation of revascularization events was blindly
reviewed to assess coronary anatomy and procedural characteristics.
Complex revascularization was the composite of complex percutaneous
coronary intervention (PCI) (as per previous analyses, >1 of: multivessel
PCI, >=3 stents, >=3 lesions treated, bifurcation PCI, or total stent
length >60 mm) or coronary artery bypass grafting surgery (CABG).
 RESULT(S): 1,724 patients underwent coronary revascularization,
including 1482 who underwent PCI, 296 who underwent CABG, and 54 both.
Complex revascularization was performed in 632 (37%) patients. Evolocumab
reduced the risk of any coronary revascularization by 22% (HR 0.78
[0.71-0.86]; P<0.001), simple PCI by 22% (HR 0.78, [0.70-0.88]; P<0.001),
complex PCI by 33% (HR 0.67 [0.54-0.84]; P<0.001), CABG by 24% (HR 0.76
[0.60-0.96]; P=0.019), and complex revascularization by 29% (HR 0.71
[0.61-0.84]; P<0.001). The magnitude of the risk reduction with evolocumab
in complex revascularization tended to increase over time (20%, 36%, and
41% risk reductions in 1st, 2nd and beyond 2nd year). CONCLUSION(S):
Adding evolocumab to statin therapy significantly reduced the risk of
developing complex coronary disease requiring revascularization, including
complex PCI and CABG individually. Copyright © 2020. Published by
Elsevier Inc.

<56>
Accession Number
633441358
Title
Efficacy of Fractional Flow Reserve-Guided Percutaneous Cornary
Intervention for Patients with Angina Pectoris.
Source
International heart journal. (no pagination), 2020. Date of Publication:
13 Nov 2020.
Author
Shinohara H.; Kodera S.; Kiyosue A.; Ando J.; Morita H.; Komuro I.
Institution
(Shinohara, Kodera, Kiyosue, Ando, Morita, Komuro) Department of
Cardiovascular Medicine, University of Tokyo Hospital
Publisher
NLM (Medline)
Abstract
Evaluation of hemodynamic parameters, such as fractional flow reserve
(FFR), is recommended before percutaneous coronary intervention (PCI) for
patients with angina pectoris (AP). However, the advantage of FFR-guided
PCI has not been fully established. This study was performed to confirm
whether FFR-guided PCI improves the prognosis compared with other
treatments. Multiple databases were searched for studies published from
2000 to 2018, and a network meta-analysis (NMA) was performed to compare
outcomes of FFR-guided PCI, non-FFR-guided PCI, coronary artery bypass
grafting (CABG), and medical treatment (MT) for AP based on estimated odds
ratios (ORs). The study included 18,093 patients from 15 randomized
controlled trials (RCTs). No evidence of inconsistency was observed among
the studies. The NMA showed that the all-cause mortality of FFR-guided PCI
was not significantly different from that of the other treatment groups
(CABG: OR, 1.1; 95% confidence interval [CI], 0.67-1.7; non-FFR-guided
PCI: OR, 0.85; 95% CI, 0.53-1.4; and MT: OR, 0.83; 95% CI, 0.52-1.3). The
NMA for the composite of all-cause mortality and myocardial infarction,
which included 15,454 patients from 12 RCTs, showed that FFR-guided PCI
significantly reduced the composite outcome compared with non-FFR-guided
PCI and MT (non-FFR-guided PCI: OR, 0.66; 95% CI, 0.46-0.95 and MT: OR,
0.66; 95% CI, 0.46-0.95). Although FFR-guided PCI for AP did not show
significant prognostic improvement compared with non-FFR-guided PCI, CABG,
and MT, FFR-guided PCI may significantly reduce the composite of all-cause
mortality and myocardial infarction compared with non-FFR-guided PCI and
MT.

<57>
Accession Number
633433205
Title
Functional and Echocardiographic Improvement After Transcatheter Repair
for Tricuspid Regurgitation: A Systematic Review and Pooled Analysis.
Source
JACC. Cardiovascular interventions. (no pagination), 2020. Date of
Publication: 04 Nov 2020.
Author
Montalto C.; Sticchi A.; Crimi G.; Laricchia A.; Khokhar A.; Giannini F.;
Ferlini M.; Colombo A.; Latib A.; Mangieri A.
Institution
(Montalto) Division of Cardiology, Fondazione IRCCS Policlinico San
Matteo, Pavia, Philippines
(Sticchi) Campus Bio-Medico di Roma, Rome, Italy; GVM Care and Research,
Maria Cecilia Hospital, Cotignola, Italy
(Crimi) Division of Cardiology, Fondazione IRCCS Policlinico San Matteo,
Pavia, Italy; Campus Bio-Medico di Roma, Rome, Italy; GVM Care and
Research, Maria Cecilia Hospital, Cotignola, Italy; Interventional
Cardiology Unit, Thoraco Vascular Department (DICATOV), IRCCS Policlinico
San Martino, Genova, Italy
(Laricchia, Khokhar, Giannini, Colombo, Mangieri) GVM Care and Research,
Maria Cecilia Hospital, Cotignola, Italy
(Ferlini) Division of Cardiology, Fondazione IRCCS Policlinico San Matteo,
Pavia, Italy
(Latib) Montefiore Medical Center, NY
Publisher
NLM (Medline)
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: 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. Published by Elsevier Inc. All rights reserved.

<58>
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
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.

<59>
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
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.

<60>
Accession Number
2007444738
Title
The effect of different types of mechanical circulatory support on
mortality of patients after adult cardiac surgery: A systematic review and
meta-analysis.
Source
Heart Surgery Forum. 23 (4) (pp E537-E545), 2020. Date of Publication: 12
Jun 2020.
Author
Guan Z.; Guan X.; Gu K.; Li Y.; Lin J.; Zhou W.; Xu M.; Song C.; Zhang Z.;
Wan F.
Institution
(Guan, Gu, Lin, Zhou, Zhang) Peking University Third Hospital, Haidian
District, Beijing, China
(Guan) Peking University, Beijing, China
(Li) Beijing University of Technology, Beijing, China
(Xu) Department of Cardiology, Peking University Third Hospital, NHC Key
Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides,
Beijing, China
(Song) Department of Orthopedics, Peking University Third Hospital,
Beijing, China
(Wan) Shanghai East Hospital, Tongji University, Pudong District,
Shanghai, China
Publisher
Forum Multimedia Publishing LLC
Abstract
Objectives: Sample size may limit the ability of individual studies to
detect differences in clinical outcomes between extracorporeal membrane
oxygenation (ECMO) alone and ECMO plus intra-aortic balloon pump (IABP)
after adult cardiac surgery. Therefore, we undertook a meta-analysis of
the best evidence available on the comparison of clinical outcomes of ECMO
alone and ECMO plus IABP after adult cardiac surgery. Method(s):
PubMed, EMBASE, Web of Science, and Cochrane Center Registry of Controlled
Trials were searched for studies comparing the use of ECMO alone and ECMO
plus IABP after adult cardiac surgery. A meta-analysis and a sensitivity
analysis were conducted. Result(s): Among the 472 screened articles,
24 studies (1302 cases of ECMO plus IABP and 1603 cases of ECMO) were
included. A significant relationship between patient risk profile and
benefits from IABP plus ECMO was found in terms of the 30-day mortality
(odds ratio [OR] 0.75; 95% confidence interval [CI] 0.62 to 0.91; P =
.004) with postcardiotomy shock (PCS). However, ECMO alone was associated
with lower in-hospital mortality (OR 1.75; 95% CI 1.06 to 3.01; Z = 2.19;
P = .03) compared with ECMO plus IABP without PCS. Conclusion(s):
Pooled data show that patients receiving IABP plus ECMO with PCS have
lower 30-day mortality than those receiving ECMO also, which in turn show
higher 30-day mortality in patients with IABP plus ECMO without PCS.
Further randomized studies are warranted to corroborate these
observational data. Copyright © 2020 Forum Multimedia Publishing
LLC. All rights reserved.

<61>
Accession Number
2005112379
Title
Quality of life changes in acute coronary syndromes patients: A systematic
review and meta-analysis.
Source
International Journal of Environmental Research and Public Health. 17 (18)
(pp 1-28), 2020. Article Number: 6889. Date of Publication: 02 Sep 2020.
Author
Kaambwa B.; Gesesew H.A.; Horsfall M.; Chew D.
Institution
(Kaambwa, Gesesew, Horsfall, Chew) College of Medicine and Public Health,
Flinders University, Adelaide 5042, Australia
(Gesesew) Epidemiology, College of Health Sciences, Mekelle University,
Mekelle 231, Ethiopia
Publisher
MDPI AG
Abstract
There is little up-to-date evidence about changes in quality of life
following treatment for acute coronary syndrome (ACS) patients. The main
aim of this review was to assess the changes in QoL in ACS patients after
treatment. We undertook a systematic review and meta-analysis of
quantitative studies. The search included studies that described the
change of QoL of ACS patients after receiving treatment options such as
percutaneous coronary intervention (PCI), coronary artery bypass grafting
(CABG) and medical therapy (MT). We synthesized findings using content
analysis and pooled the estimates using meta-analysis. We used the PRISMA
guidelines to select and appraise the studies and report the findings.
Twenty-nine (29) articles were included in the review. We found a
significant improvement of QoL in ACS patients after receiving treatment.
Particularly, the meta-analytic association found that the mean QoL of
patients diagnosed with ACS was higher after receiving treatment compared
to baseline (overall pooled mean difference = 31.88; 95% CI = 31.64-52.11,
I2 = 98) with patients on PCI having slightly lower QoL gains
(pooled mean difference = 30.22; 95% CI = 29.9-30.53, I2 = 0%)
compared to those on CABG (pooled mean difference = 34.01; 95% CI =
33.66-34.37, I2 = 0%). The review confirmed that QoL of ACS
patients improved after receiving treatment therapies although varied by
the treatment options and patients' preferences. This suggests the need to
perform further study on the QoL, patient preferences and physicians'
decision to prescription of treatment options. Copyright © 2020
by the authors. Licensee MDPI, Basel, Switzerland.

<62>
[Use Link to view the full text]
Accession Number
2004292338
Title
Peripheral versus central extracorporeal membrane oxygenation for
postcardiotomy shock: Multicenter registry, systematic review, and
meta-analysis.
Source
Journal of Thoracic and Cardiovascular Surgery. 160 (5) (pp
1207-1216.e44), 2020. Date of Publication: November 2020.
Author
Mariscalco G.; Salsano A.; Fiore A.; Dalen M.; Ruggieri V.G.; Saeed D.;
Jonsson K.; Gatti G.; Zipfel S.; Dell'Aquila A.M.; Perrotti A.; Loforte
A.; Livi U.; Pol M.; Spadaccio C.; Pettinari M.; Ragnarsson S.; Alkhamees
K.; El-Dean Z.; Bounader K.; Biancari F.; Dashey S.; Yusuff H.; Porter R.;
Sampson C.; Harvey C.; Settembre N.; Fux T.; Amr G.; Lichtenberg A.;
Jeppsson A.; Gabrielli M.; Reichart D.; Welp H.; Chocron S.; Fiorentino
M.; Lechiancole A.; Netuka I.; De Keyzer D.; Strauven M.; Palve K.
Institution
(Mariscalco, El-Dean) Department of Cardiac Surgery, Glenfield Hospital,
University Hospitals of Leicester, Leicester, United Kingdom
(Salsano) Division of Cardiac Surgery, Department of Integrated Surgical
and Diagnostic Sciences (DISC), University of Genoa, Genoa, Italy
(Fiore) Department of Cardiothoracic Surgery, Henri Mondor University
Hospital, AP-HP, Paris-Est University, Creteil, France
(Dalen) Department of Molecular Medicine and Surgery, Department of
Cardiac Surgery, Karolinska Institutet, Karolinska University Hospital,
Stockholm, Sweden
(Ruggieri) Division of Cardiothoracic and Vascular Surgery, Robert Debre
University Hospital, Reims, France
(Saeed) Cardiovascular Surgery, University Hospital of Dusseldorf,
Dusseldorf, Germany
(Jonsson) Department of Cardiac Surgery, Sahlgrenska University Hospital,
Gothenburg, Sweden
(Gatti) Division of Cardiac Surgery, Ospedali Riuniti, Trieste, Italy
(Zipfel) Hamburg University Heart Center, Hamburg, Germany
(Dell'Aquila) Department of Cardiothoracic Surgery, Munster University
Hospital, Munster, Germany
(Perrotti) Department of Thoracic and Cardio-Vascular Surgery, University
Hospital Jean Minjoz, Besancon, France
(Loforte) Department of Cardiothoracic, Transplantation and Vascular
Surgery, S. Orsola Hospital, University of Bologna, Bologna, Italy
(Livi) Cardiothoracic Department, University Hospital of Udine, Udine,
Italy
(Pol) Institute of Clinical and Experimental Medicine, Prague, Czechia
(Spadaccio) Department of Cardiothoracic Surgery, Golden Jubilee National
Hospital, Glasgow, United Kingdom
(Pettinari) Department of Cardiovascular Surgery, Ziekenhuis
Oost-Limburgl, Genk, Belgium
(Ragnarsson) Department of Cardiothoracic Surgery, University of Lund,
Lund, Sweden
(Alkhamees) Prince Sultan Cardiac Center, Al Hassa, Saudi Arabia
(Bounader) Division of Cardiothoracic and Vascular Surgery, Pontchaillou
University Hospital, Rennes, France
(Biancari) Heart Center, Turku University Hospital and University of
Turku, Turku, Finland
(Biancari) Department of Surgery, University of Oulu, Oulu, Finland
Publisher
Mosby Inc.
Abstract
Background: We hypothesized that cannulation strategy in venoarterial
extracorporeal membrane oxygenation (VA-ECMO) could play a crucial role in
the perioperative survival of patients affected by postcardiotomy shock.
 Method(s): Between January 2010 and March 2018, 781 adult patients
receiving VA-ECMO for postcardiotomy shock at 19 cardiac surgical centers
were retrieved from the Postcardiotomy Veno-arterial Extracorporeal
Membrane Oxygenation study registry. A parallel systematic review and
meta-analysis (PubMed/MEDLINE, Embase, and Cochrane Library) through
December 2018 was also accomplished. Result(s): Central and
peripheral VA-ECMO cannulation were performed in 245 (31.4%) and 536
(68.6%) patients, respectively. Main indications for the institution
VA-ECMO were failure to wean from cardiopulmonary bypass (38%) and heart
failure following cardiopulmonary bypass weaning (48%). The doubly robust
analysis after inverse probability treatment weighting by propensity score
demonstrated that central VA-ECMO was associated with greater hospital
mortality (odds ratio 1.54; 95% confidence interval, 1.09-2.18),
reoperation for bleeding/tamponade (odds ratio, 1.96; 95% confidence
interval, 1.37-2.81), and transfusion of more than 9 RBC units (odds
ratio, 2.42; 95% confidence interval, 1.59-3.67). The systematic review
provided a total of 2491 individuals with postcardiotomy shock treated
with VA-ECMO. Pooled prevalence of in-hospital/30-day mortality in overall
patient population was 66.6% (95% confidence interval, 64.7-68.4%), and
pooled unadjusted risk ratio analysis confirmed that patients undergoing
peripheral VA-ECMO had a lower in-hospital/30-day mortality than patients
undergoing central cannulation (risk ratio, 0.92; 95% confidence interval,
0.87-0.98). Adjustments for important confounders did not alter our
results. Conclusion(s): In patients with postcardiotomy shock treated
with VA-ECMO, central cannulation was associated with greater in-hospital
mortality than peripheral cannulation. Copyright © 2019 The
American Association for Thoracic Surgery

<63>
Accession Number
2003273825
Title
Single- versus multidose cardioplegia in adult cardiac surgery patients: A
meta-analysis.
Source
Journal of Thoracic and Cardiovascular Surgery. 160 (5) (pp
1195-1202.e12), 2020. Date of Publication: November 2020.
Author
Gambardella I.; Gaudino M.F.L.; Antoniou G.A.; Rahouma M.; Worku B.;
Tranbaugh R.F.; Nappi F.; Girardi L.N.
Institution
(Gambardella, Gaudino, Rahouma, Worku, Tranbaugh, Girardi) Department of
Cardiothoracic Surgery, Weill Cornell Medicine-NewYork Presbyterian
Medical Center, New York, NY, United States
(Gambardella, Antoniou, Worku, Tranbaugh) Department of Cardiothoracic
Surgery, Weill Cornell Medicine-NewYork Presbyterian Brooklyn Methodist
Hospital, Brooklyn, NY, United States
(Antoniou) Department of Vascular & Endovascular Surgery, The Royal Oldham
Hospital, Pennine Acute Hospitals NHS Trust, Manchester, United Kingdom
(Antoniou) Division of Cardiovascular Sciences, School of Medical
Sciences, University of Manchester, Manchester, United Kingdom
(Nappi) Cardiac Surgery Center, Cardiologique du Nord de Saint-Denis,
Paris, France
Publisher
Mosby Inc.
Abstract
Objective: To compare outcomes of single (intervention group: del Nido
[DN], and histamine-tryptophan-ketoglutarate) versus multidose (control
group) cardioplegia in the adult cardiac surgery patients. Method(s):
Medical search engines were interrogated to identify relevant randomized
controlled trials and propensity-score matched cohorts. Meta-analysis was
conducted for primary (in-hospital/30-day mortality) and secondary
(ischemic and cardiopulmonary bypass [CPB] times, reperfusion
fibrillation, peak of cardiac enzymes, myocardial infarction) endpoints.
Subgroup analyses were conducted for study design and type of
intervention, and meta-regression for primary outcome included type of
surgery and left ventricular ejection fraction as moderators.
 Result(s): Ten randomized controlled trials and 13 propensity-score
matched cohorts were included, reporting on 5516 patients. Estimates are
expressed as (parameter value [OR, odds ratio; MD, mean difference; SMD,
standardized mean difference]/unit of measure [95% confidence interval], P
value). DN reduced ischemic time (MD, -7.18 minutes [-12.52 to -1.84], P
<.01), CPB time (MD, -10.44 minutes [-18.99 to -1.88], P.01), reperfusion
fibrillation (OR, 0.16 [0.05-0.54], P <.01), and cardiac enzymes (SMD
-0.17 [-0.29, 0.05], P <.01) compared with multidose cardioplegia. None of
these beneficial effects were reproduced by
histamine-tryptophan-ketoglutarate, which instead increased CPB time (MD,
2.04 minutes [0.73-3.37], P <.01) and reperfusion fibrillation (OR, 1.80
[1.20-2.70], P <.01). There was no difference in mortality and myocardial
infarction between single and multidose, independently of type of surgery
or left ventricular ejection fraction. Conclusion(s): DN decreases
operative times, reperfusion fibrillation, and surge of cardiac enzymes
compared with multidose cardioplegia. Copyright © 2019 The
American Association for Thoracic Surgery

<64>
Accession Number
2008037680
Title
NYHA Functional Classification and Outcomes After Transcatheter Mitral
Valve Repair in Heart Failure: The COAPT Trial.
Source
JACC: Cardiovascular Interventions. 13 (20) (pp 2317-2328), 2020. Date of
Publication: 26 Oct 2020.
Author
Giustino G.; Lindenfeld J.; Abraham W.T.; Kar S.; Lim D.S.; Grayburn P.A.;
Kapadia S.R.; Cohen D.J.; Kotinkaduwa L.N.; Weissman N.J.; Mack M.J.;
Stone G.W.
Institution
(Giustino, Stone) The Zena and Michael A. Wiener Cardiovascular Institute,
Icahn School of Medicine at Mount Sinai, New York, NY, United States
(Lindenfeld) Advanced Heart Failure and Cardiac Transplantation Section,
Vanderbilt Heart and Vascular Institute, Nashville, TN, United States
(Abraham) Division of Cardiovascular Medicine, The Ohio State University
College of Medicine, Columbus, OH, 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
(Grayburn) Baylor University Medical Center, Baylor Heart and Vascular
Institute, Dallas, TX, United States
(Kapadia) Department of Cardiovascular Medicine, Heart and Vascular
Institute, Cleveland Clinic, Cleveland, OH, United States
(Cohen) University of Missouri-Kansas City School of Medicine, Kansas
City, MO, United States
(Kotinkaduwa, Stone) Clinical Trials Center, Cardiovascular Research
Foundation, New York, NY, United States
(Weissman) MedStar Health Research Institute, Washington, DC, United
States
(Weissman) Georgetown University, Washington, DC, United States
(Mack) Baylor Scott and White Heart Hospital Plano, Plano, TX, United
States
Publisher
Elsevier Inc.
Abstract
Objectives: The aim of this study was to evaluate the outcomes of
MitraClip implantation versus guideline-directed medical therapy (GDMT) in
patients with secondary mitral regurgitation (SMR) according to baseline
functional status as assessed by the widely used New York Heart
Association (NYHA) functional classification. Background(s): Patients
with heart failure (HF) and impaired functional status at baseline have
poor prognosis. Whether the effects of transcatheter repair of secondary
SMR in patients with HF are influenced by baseline functional status is
unknown. Method(s): In the COAPT (Cardiovascular Outcomes Assessment
of the MitraClip Percutaneous Therapy for Heart Failure Patients with
Functional Mitral Regurgitation) trial, patients with HF with moderate to
severe or severe SMR who remained symptomatic despite maximally tolerated
GDMT were randomized to MitraClip implantation versus GDMT alone. Outcomes
were evaluated according to baseline functional status as assessed using
the NYHA functional classification. The primary endpoint of interest was
the rate of death or HF-related hospitalization (HFH) at 2 years in
time-to-first-event analyses. Result(s): Among 613 randomized
patients, 240 were in NYHA functional class II (39.2%), 322 were in NYHA
functional class III (52.5%), and 51 were in ambulatory NYHA functional
class IV (8.3%). Rates of death or HFH were progressively higher with
increasing NYHA functional class. Compared with GDMT alone, MitraClip
implantation resulted in lower 2-year rates of death or HFH consistently
in patients in NYHA functional class II (39.7% vs. 63.7%; hazard ratio
[HR]: 0.54; 95% confidence interval [CI]: 0.37 to 0.77), NYHA functional
class III (46.6% vs. 65.5%; HR: 0.60; 95% CI: 0.45 to 0.82), and NYHA
functional class IV (66.7% vs. 85.2%; HR: 0.55; 95% CI: 0.28 to 1.10;
p<inf>interaction</inf> = 0.86). Greater improvements in quality of life
at 2 years were observed in patients treated with the MitraClip compared
with GDMT irrespective of baseline functional status. Conclusion(s):
The NYHA functional classification provides prognostic utility in patients
with HF and moderate to severe or severe SMR. In the COAPT trial, the
benefits of MitraClip implantation were consistent in patients with better
or worse functional status as assessed by NYHA functional class.
(Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy
for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT
Trial] [COAPT]; NCT01626079) Copyright © 2020

<65>
Accession Number
2008574687
Title
Systematic Review and Meta-Analysis of Diagnostic Test Accuracy Studies
Evaluating Point-of-Care Tests of Coagulopathy in Cardiac Surgery.
Source
Transfusion Medicine Reviews. (no pagination), 2020. Date of Publication:
2020.
Author
Wozniak M.J.; Abbasciano R.; Monaghan A.; Lai F.Y.; Corazzari C.; Tutino
C.; Kumar T.; Whiting P.; Murphy G.J.
Institution
(Wozniak, Abbasciano, Monaghan, Lai, Corazzari, Kumar, Murphy) Department
of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre
in Cardiovascular Medicine, University of Leicester, Clinical Sciences
Wing, Glenfield General Hospital, Leicester, United Kingdom
(Corazzari, Tutino) Cardiac Surgery Unit, Insubria University, Varese,
Italy
(Whiting) Centre for Research Synthesis and Decision Analysis (CReSyDA),
Bristol Medical School, University of Bristol, Bristol, United Kingdom
Publisher
W.B. Saunders
Abstract
Treatment guidelines recommend the routine use of point-of-care diagnostic
tests for coagulopathy in the management of cardiac surgery patients at
risk of severe bleeding despite uncertainty as to their diagnostic
accuracy. We performed a systematic review and meta-analysis of studies
that evaluated the diagnostic accuracy of viscoelastometry, platelet
function tests, and modified thromboelastography (TEG) tests, for
coagulopathy in cardiac surgery patients. The reference standard included
resternotomy for bleeding, transfusion of non-red cell components, or
massive transfusion. We searched MEDLINE, EMBASE, CINAHL, and Clinical
Trials.gov, from inception to June 2019. Study quality was assessed using
QUADAS-2. Bivariate models were used to estimate summary sensitivity and
specificity with (95% confidence intervals). All 29 studies (7440
participants) included in the data synthesis evaluated the tests as
predictors of bleeding. No study evaluated their role in the management of
bleeding. None was at low risk of bias. Four were judged as low concern
regarding applicability. Pooled estimates of diagnostic accuracy were;
Viscoelastic tests, 12 studies, sensitivity 0.61 (0.44, 0.76), specificity
0.83 (0.70, 0.91) with significant heterogeneity. Platelet function tests,
12 studies, sensitivity 0.63 (0.53, 0.72), specificity 0.75 (0.64, 0.84)
with significant heterogeneity. TEG modification tests, 3 studies,
sensitivity 0.80 (0.67, 0.89), specificity 0.76 (0.69, 0.82) with no
evidence of heterogeneity. Studies reporting the highest values for
sensitivity and specificity had important methodological limitations. In
conclusion, we did not demonstrate predictive accuracy for commonly used
point-of-care devices for coagulopathic bleeding in cardiac surgery.
However, the certainty of the evidence was low. Copyright © 2020

<66>
Accession Number
2007982244
Title
Randomized Controlled Trial of Working Memory Intervention in Congenital
Heart Disease.
Source
Journal of Pediatrics. 227 (pp 191-198.e3), 2020. Date of Publication:
December 2020.
Author
Calderon J.; Wypij D.; Rofeberg V.; Stopp C.; Roseman A.; Albers D.;
Newburger J.W.; Bellinger D.C.
Institution
(Calderon, Bellinger) Department of Psychiatry, Boston Children's
Hospital, Boston, MA, United States
(Calderon, Bellinger) Department of Psychiatry, Harvard Medical School,
Boston, MA, United States
(Wypij, Rofeberg, Stopp, Roseman, Albers, Newburger) Department of
Cardiology, Boston Children's Hospital, Boston, MA, United States
(Wypij) Department of Biostatistics, Harvard T.H. Chan School of Public
Health, Boston, MA, United States
(Wypij, Newburger) Department of Pediatrics, Harvard Medical School,
Boston, MA, United States
(Bellinger) Department of Neurology, Boston Children's Hospital, Boston,
MA, United States
(Bellinger) Department of Neurology, Harvard Medical School, Boston, MA,
United States
Publisher
Mosby Inc.
Abstract
Objectives: To evaluate the efficacy of Cogmed Working Memory Training
compared with the standard of care to improve executive function and
social outcomes in adolescents with congenital heart disease (CHD) who
underwent open-heart surgery in infancy and to identify factors associated
with changes in outcomes following the intervention. Study design: In a
single-center, randomized controlled trial, adolescents (13-16 years) with
CHD were randomly assigned to either Cogmed (home-based 45-minutes
sessions for 5-8 weeks) or to a control group. The primary outcome was
working memory. Secondary outcomes included inhibitory control and
cognitive flexibility as well as parent-reported executive function,
symptoms of attention deficit hyperactivity disorder, and social outcomes.
All measures were assessed at baseline, post-treatment (1-3 weeks
post-training) and at 3-month follow-up. Data were analyzed using an
intention-to-treat approach. Result(s): Sixty adolescents with CHD
participated (28 assigned to Cogmed). No improvement at the post-treatment
or 3-month follow-up assessments was found for the primary outcome measure
of working memory. Compared with the control group, participants assigned
to the intervention demonstrated benefits in inhibitory control and
attention at the 3-month follow-up (P = .02) and in parent-reported
cognitive regulatory skills at post-treatment and 3-month follow-up (P =
.02 and P = .04, respectively). Preterm birth, biventricular CHD, and
history of attention deficit hyperactivity disorder diagnosis were
associated with improved response to the intervention. Conclusion(s):
Cogmed intervention produced improvements in the self-regulatory control
abilities of adolescents with CHD. The training did not enhance other
areas of executive function or behavioral outcomes. Further studies are
needed to evaluate the longer-term potential benefits to other domains.
Trial registration: Clinicaltrials.gov: NCT02759263. Copyright ©
2020 Elsevier Inc.

<67>
Accession Number
2006000680
Title
Rheumatic heart disease anno 2020: Impacts of gender and migration on
epidemiology and management.
Source
European Journal of Clinical Investigation. 50 (12) (no pagination), 2020.
Article Number: e13374. Date of Publication: December 2020.
Author
Mutagaywa R.K.; Wind A.-M.; Kamuhabwa A.; Cramer M.J.; Chillo P.;
Chamuleau S.
Institution
(Mutagaywa, Chillo) School of Medicine, Muhimbili University of Health and
Allied Sciences, Dar Es Salaam, Tanzania
(Mutagaywa, Wind, Cramer, Chamuleau) Division of Heart and Lung,
Department of Cardiology, Faculty of Medicine, University Medical Centre
Utrecht, Utrecht, Netherlands
(Kamuhabwa) School of Pharmacy, Muhimbili University of Health and Allied
Sciences, Dar Es Salaam, Tanzania
(Chamuleau) Division of Heart and Lung, Department of Cardiology, Faculty
of Medicine, Amsterdam University Medical Centre, Amsterdam, Netherlands
Publisher
Blackwell Publishing Ltd
Abstract
Background: The epidemiology and management of diseases can be influenced
by social demographic factors. Gender and migration are among these
factors. Method(s): We aimed at reviewing the impacts of gender and
migration on rheumatic heart disease (RHD) epidemiology and management by
a nonsystematic literature review of published studies on RHD worldwide.
Our PubMed search terms included RHD pathophysiology, diagnosis,
complications, management or prevention, combined with words 'rheumatic
mitral stenosis (MS)', 'outcomes after percutaneous balloon mitral
valvuloplasty (PBMV)', 'gender or sex difference' and 'migration'. The
reporting of this study conforms to SANRA (the Scale for Assessment of
Narrative Review Articles) guidelines. Result(s): We retrieved eight
studies about the impact of sex on outcomes after PBMV. All of these
studies showed a female predominance for RHD. Two studies showed that
there is no impact, three studies showed female sex as a predictor of poor
outcomes, and the other three showed male sex a predictor of poor
outcomes. Although RHD is reported to be eradicated in the developed
countries, 2.1% of refugees recently screened for RHD in Italy were found
to have subclinical RHD. This prevalence is similar to those found in
India (2.0%), Cambodia (2.2%) and Mozambique (3%). Conclusion(s):
There are contradicting results for outcomes after PBMV between males and
females. It is not clear whether sex difference plays a role in
pathophysiology, diagnosis, management and prognosis of MS. Migration has
impacts on epidemiology and management of RHD. Further studies are
required in these two fields to explore their relationship to
RHD. Copyright © 2020 Stichting European Society for Clinical
Investigation Journal Foundation. Published by John Wiley & Sons Ltd

<68>
Accession Number
2005973364
Title
Desflurane and sevoflurane concentrations in blood passing through the
oxygenator during cardiopulmonary bypass: a randomized prospective pilot
study.
Source
Journal of Anesthesia. 34 (6) (pp 904-911), 2020. Date of Publication:
December 2020.
Author
Tamura T.; Mori A.; Ishii A.; Ando M.; Kubo Y.; Nishiwaki K.
Institution
(Tamura, Nishiwaki) Department of Anesthesiology, Nagoya University
Graduate School of Medicine, 65 Tsurumai-cho, Showa-Ku, Nagoya 466-8550,
Japan
(Mori) Department of Perioperative Management System, Nagoya University
Graduate School of Medicine, Nagoya, Japan
(Ishii) Department of Legal Medicine and Bioethics, Nagoya University
Graduate School of Medicine, Nagoya, Japan
(Ando) Center for Advanced Medicine and Clinical Research, Nagoya
University Hospital, Nagoya, Japan
(Kubo) Department of Preventive Medicine, Nagoya University Graduate
School of Medicine, Nagoya, Japan
Publisher
Springer Japan
Abstract
Purpose: Volatile anesthetics (VAs) protect myocardial cells in
cardiovascular surgery. A recent clinical trial of cardiopulmonary bypass
(CPB) surgery reported no significant difference in mortality rates
between the use of VAs and total intravenous anesthetics at 1 year
postoperatively. However, oxygenator function may affect the VA
pharmacokinetics. Thus, we measured the VA blood concentrations during CPB
in patients managed with four different microporous polypropylene hollow
fiber membrane oxygenators. Method(s): Twenty-four patients scheduled
for elective CPB were randomly allocated to one of the two VA groups
(desflurane and sevoflurane groups) and, then, randomly divided into one
of four oxygenator groups: Terumo, LivaNova, Medtronic, and Senko (n = 3).
Additionally, in each VA group, three patients were randomly selected and
redundantly allocated to the human lung group (for control blood VA
concentration without oxygenator). Blood samples collected 20 min after
starting 6.0 vol% desflurane or 1.7 vol% sevoflurane were analyzed using
gas chromatography. Oxygenator-related complications and structural
changes in the membrane surface of each oxygenator after surgery were
evaluated. Result(s): The mean (standard deviation) concentrations of
desflurane and sevoflurane in the human lung were 182.4 (23.2) and 54.0
(9.6) mug/ml, respectively; not significantly different from those in the
four oxygenator groups. No oxygenator-related complications occurred.
Structural changes in membrane fibers did not occur after clinical use,
except for difficulty in image acquisition with Senko products.
 Conclusion(s): Our results demonstrated that the blood concentrations
of desflurane and sevoflurane passing through oxygenators used during CPB
were similar to those in the human lung control. Copyright ©
2020, Japanese Society of Anesthesiologists.

<69>
Accession Number
2005686839
Title
Comparison of colloid and crystalloid using goal-directed fluid therapy
protocol in non-cardiac surgery: a meta-analysis of randomized controlled
trials.
Source
Journal of Anesthesia. 34 (6) (pp 865-875), 2020. Date of Publication:
December 2020.
Author
Tyagi A.; Maitra S.; Bhattacharjee S.
Institution
(Tyagi, Maitra, Bhattacharjee) Department of Anaesthesiology, Pain
Medicine and Critical Care, All India Institute of Medical Sciences, Room
No: 5013, 5th Floor Teaching Block, New Delhi 110029, India
Publisher
Springer Japan
Abstract
Purpose: A few randomized controlled trials (RCTs) have compared
crystalloid-based goal-directed fluid therapy (GDFT) with starch-based
GDFT in patients undergoing major surgical procedures with conflicting
results. In this meta-analysis, colloid-based GDFT was compared with
crystalloid-based GDFT. Method(s): In this meta-analysis, RCTs
comparing colloid- and crystalloid-based GDFT in patients undergoing
non-cardiac surgery were included. Binary outcomes were reported as risk
ratio (RR) and continuous outcomes were reported as mean difference (MD)
with 95% confidence interval (95% CI). PubMed, PubMed central, The
Cochrane Library database and EMBASE were searched for potentially
eligible trials from inception to 28 February 2020. Result(s): Data
of 2392 patients from nine RCTs were included in this meta-analysis.
Mortality at the longest available follow-up [RR (95% CI) 1.44 (0.88,
2.34); p = 0.15], postoperative kidney dysfunction [RR (95% CI) 1.07
(0.72, 1.60); p = 0.73], postoperative length of hospital stay [MD (95%
CI) - 0.29 (- 1.25, 0.66) d; p = 0.55], cardiovascular complications [RR
(95% CI) 1.20 (0.50, 2.88); p = 0.68], wound complications [RR (95% CI)
1.08 (0.76, 1.54); p = 0.66], pulmonary complications [RR (95% CI) 0.90
(0.71, 1.140); p = 0.40] and bleeding [RR (95% CI) 1.24 (0.77, 1.99); p =
0.37] were similar in both the groups. Postoperative major complications
were also similar between patients who received colloid and crystalloid
[RR (95% CI) 0.79 (0.48, 1.29); p = 0.34]. Conclusion(s): Colloids in
goal-directed fluid therapy protocol does not offer any benefit over
crystalloid-based goal-directed fluid therapy protocol in patients
undergoing major non-cardiac surgical procedure. Copyright ©
2020, Japanese Society of Anesthesiologists.

<70>
Accession Number
2004641098
Title
The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and
methods for a randomized trial of moderate alcohol consumption and
cardiometabolic risk.
Source
European Journal of Preventive Cardiology. 27 (18) (pp 1967-1982), 2020.
Date of Publication: December 2020.
Author
Spiegelman D.; Lovato L.C.; Khudyakov P.; Wilkens T.L.; Adebamowo C.A.;
Adebamowo S.N.; Appel L.J.; Beulens J.W.J.; Coughlin J.W.; Dragsted L.O.;
Edenberg H.J.; Eriksen J.N.; Estruch R.; Grobbee D.E.; Gulayin P.E.;
Irazola V.; Krystal J.H.; Lazo M.; Murray M.M.; Rimm E.B.; Schrieks I.C.;
Williamson J.D.; Mukamal K.J.
Institution
(Spiegelman, Khudyakov, Rimm) Harvard TH Chan School of Public Health,
United States
(Lovato, Williamson) Wake Forest School of Medicine, United States
(Wilkens, Dragsted, Eriksen) University of Copenhagen, Denmark
(Adebamowo, Adebamowo) Department of Epidemiology and Public Health,
Greenebaum Comprehensive Cancer Center, University of Maryland, School of
Medicine, United States
(Appel, Coughlin, Lazo) Welch Center for Prevention, Epidemiology, and
Clinical Research, Johns Hopkins ProHealth Clinical Research Center,
United States
(Beulens) Amsterdam UMC - location VUmc, Amsterdam Cardiovascular Sciences
Research Institute, Netherlands
(Beulens) Julius Center for Health Sciences and Primary Care, University
Medical Center Utrecht, Netherlands
(Edenberg) Indiana University School of Medicine, United States
(Estruch) CIBER de Fisiopatologia de la Obesidad y la Nutricion
(CIBEROBN), Instituto de Salud Carlos III, Spain
(Lovato, Khudyakov, Estruch, Schrieks) Department of Internal Medicine,
Hospital Clinic, IDIBAPS August Pi i Sunyer Biomedical Research Institute,
University of Barcelona, Spain
(Grobbee, Gulayin, Irazola) Julius Clinical, Netherlands
(Krystal, Murray) Yale University School of Medicine, United States
(Rimm) National Institute on Alcohol Abuse and Alcoholism, U.S. National
Institutes of Health, United States
(Mukamal) Channing Laboratory, Brigham and Women's Hospital, Harvard
Medical School, United States
Publisher
SAGE Publications Inc.
Abstract
Background: Observational studies have documented lower risks of coronary
heart disease and diabetes among moderate alcohol consumers relative to
abstainers, but only a randomized clinical trial can provide conclusive
evidence for or against these associations. Aim(s): The purpose of
this study was to describe the rationale and design of the Moderate
Alcohol and Cardiovascular Health Trial, aimed to assess the
cardiometabolic effects of one alcoholic drink daily over an average of
six years among adults 50 years or older. Method(s): This
multicenter, parallel-arm randomized trial was designed to compare the
effects of one standard serving (~11-15 g) daily of a preferred alcoholic
beverage to abstention. The trial aimed to enroll 7800 people at high risk
of cardiovascular disease. The primary composite endpoint comprised time
to the first occurrence of non-fatal myocardial infarction, non-fatal
ischemic stroke, hospitalized angina, coronary/carotid revascularization,
or total mortality. The trial was designed to provide >80% power to detect
a 15% reduction in the risk of the primary outcome. Secondary outcomes
included diabetes. Adverse effects of special interest included injuries,
congestive heart failure, alcohol use disorders, and cancer.
 Result(s): We describe the design, governance, masking issues, and
data handling. In three months of field center activity until termination
by the funder, the trial randomized 32 participants, successfully screened
another 70, and identified ~400 additional interested individuals.
 Conclusion(s): We describe a feasible design for a long-term
randomized trial of moderate alcohol consumption. Such a study will
provide the highest level of evidence for the effects of moderate alcohol
consumption on cardiovascular disease and diabetes, and will directly
inform clinical and public health guidelines. Copyright © The
European Society of Cardiology 2020.

<71>
Accession Number
633159585
Title
Prophylactic corticosteroids for paediatric heart surgery with
cardiopulmonary bypass.
Source
The Cochrane database of systematic reviews. 10 (pp CD013101), 2020. Date
of Publication: 12 Oct 2020.
Author
Gibbison B.; Villalobos Lizardi J.C.; Aviles Martinez K.I.; Fudulu D.P.;
Medina Andrade M.A.; Perez-Gaxiola G.; Schadenberg A.W.; Stoica S.C.;
Lightman S.L.; Angelini G.D.; Reeves B.C.
Institution
(Gibbison) Department of Cardiac Anaesthesia and Intensive Care, Bristol
Heart Institute/University Hospitals Bristol NHS FT, Bristol, United
Kingdom
(Villalobos Lizardi, Aviles Martinez) Emergency Pediatric Department,
Hospital Civil de Guadalajara "Fray Antonio Alcalde", Guadalajara, Mexico
(Fudulu, Angelini) Department of Cardiac Surgery, University Hospital
Bristol NHS Trust, Bristol, United Kingdom
(Medina Andrade) Thoracic and Cardiovascular Department, Hospital Civil
Fray Antonio Alcalde de Guadalajara, Guadalajara, Mexico
(Perez-Gaxiola) Evidence-Based Medicine Department, Hospital Pediatrico de
Sinaloa, Culiacan, Mexico
(Schadenberg) Department of Paediatric Intensive Care, University Hospital
Bristol NHS Trust, Bristol, United Kingdom
(Stoica) Department of Paediatric Cardiac Surgery, University Hospital
Bristol NHS Trust, Bristol, United Kingdom
(Lightman) Henry Wellcome Laboratories for Integrative Metabolism and
Neuroscience, University of Bristol, Bristol, United Kingdom
(Reeves) School of Clinical Sciences, University of Bristol, Bristol,
United Kingdom
Publisher
NLM (Medline)
Abstract
BACKGROUND: Corticosteroids are routinely given to children undergoing
cardiac surgery with cardiopulmonary bypass (CPB) in an attempt to
ameliorate the inflammatory response. Their use is still controversial and
the decision to administer the intervention can vary by centre and/or by
individual doctors within that centre. OBJECTIVE(S): This review is
designed to assess the benefits and harms of prophylactic corticosteroids
in children between birth and 18 years of age undergoing cardiac surgery
with CPB. SEARCH METHOD(S): We searched CENTRAL, MEDLINE, Embase and
Conference Proceedings Citation Index-Science in June 2020. We also
searched four clinical trials registers and conducted backward and forward
citation searching of relevant articles. SELECTION CRITERIA: We included
studies of prophylactic administration of corticosteroids, including
single and multiple doses, and all types of corticosteroids administered
via any route and at any time-point in the perioperative period. We
excluded studies if steroids were administered therapeutically. We
included individually randomised controlled trials (RCTs), with two or
more groups (e.g. multi-drug or dose comparisons with a control group) but
not 'head-to-head' trials without a placebo or a group that did not
receive corticosteroids. We included studies in children, from birth up to
18 years of age, including preterm infants, undergoing cardiac surgery
with the use of CPB. We also excluded studies in patients undergoing heart
or lung transplantation, or both; studies in patients already receiving
corticosteroids; in patients with abnormalities of the
hypothalamic-pituitary-adrenal axis; and in patients given steroids at the
time of cardiac surgery for indications other than cardiac surgery. DATA
COLLECTION AND ANALYSIS: We used the Covidence systematic review manager
to extract and manage data for the review. Two review authors
independently assessed studies for inclusion, extracted data, and assessed
risks of bias. We resolved disagreements by consensus or by consultation
with a third review author. We assessed the certainty of evidence with
GRADE. MAIN RESULTS: We found 3748 studies, of which 888 were duplicate
records. Two studies had the same clinical trial registration number, but
reported different populations and interventions. We therefore included
them as separate studies. We screened titles and abstracts of 2868 records
and reviewed full text reports for 84 studies to determine eligibility. We
extracted data for 13 studies. Pooled analyses are based on eight studies.
We reported the remaining five studies narratively due to zero events for
both intervention and placebo in the outcomes of interest. Therefore, the
final meta-analysis included eight studies with a combined population of
478 participants. There was a low or unclear risk of bias across the
domains. There was moderate certainty of evidence that corticosteroids do
not change the risk of in-hospital mortality (five RCTs; 313 participants;
risk ratio (RR) 0.83, 95% confidence interval (CI) 0.33 to 2.07) for
children undergoing cardiac surgery with CPB. There was high certainty of
evidence that corticosteroids reduce the duration of mechanical
ventilation (six RCTs; 421 participants; mean difference (MD) 11.37 hours
lower, 95% CI -20.29 to -2.45) after the surgery. There was high-certainty
evidence that the intervention probably made little to no difference to
the length of postoperative intensive care unit (ICU) stay (six RCTs; 421
participants; MD 0.28 days lower, 95% CI -0.79 to 0.24) and
moderate-certainty evidence that the intervention probably made little to
no difference to the length of the postoperative hospital stay (one RCT;
176 participants; mean length of stay 22 days; MD -0.70 days, 95% CI -2.62
to 1.22). There was moderate certainty of evidence for no effect of the
intervention on all-cause mortality at the longest follow-up (five RCTs;
313 participants; RR 0.83, 95% CI 0.33 to 2.07) or cardiovascular
mortality at the longest follow-up (three RCTs; 109 participants; RR 0.40,
95% CI 0.07 to 2.46). There was low certainty of evidence that
corticosteroids probably make little to no difference to children
separating from CPB (one RCT; 40 participants; RR 0.20, 95% CI 0.01 to
3.92). We were unable to report information regarding adverse events of
the intervention due to the heterogeneity of reporting of outcomes. We
downgraded the certainty of evidence for several reasons, including
imprecision due to small sample sizes, a single study providing data for
an individual outcome, the inclusion of both appreciable benefit and harm
in the confidence interval, and publication bias. AUTHORS'
 CONCLUSION(S): Corticosteroids probably do not change the risk of
mortality for children having heart surgery using CPB at any time point.
They probably reduce the duration of postoperative ventilation in this
context, but have little or no effect on the total length of postoperative
ICU stay or total postoperative hospital stay. There was inconsistency in
the adverse event outcomes reported which, consequently, could not be
pooled. It is therefore impossible to provide any implications and
policy-makers will be unable to make any recommendations for practice
without evidence about adverse effects. The review highlighted the need
for well-conducted RCTs powered for clinical outcomes to confirm or refute
the effect of corticosteroids versus placebo in children having cardiac
surgery with CPB. A core outcome set for adverse event reporting in the
paediatric major surgery and intensive care setting is
required. Copyright © 2020 The Cochrane Collaboration. Published
by John Wiley & Sons, Ltd.

<72>
Accession Number
2008606338
Title
Effects of empagliflozin on first and recurrent clinical events in
patients with type 2 diabetes and atherosclerotic cardiovascular disease:
a secondary analysis of the EMPA-REG OUTCOME trial.
Source
The Lancet Diabetes and Endocrinology. 8 (12) (pp 949-959), 2020. Date of
Publication: December 2020.
Author
McGuire D.K.; Zinman B.; Inzucchi S.E.; Wanner C.; Fitchett D.; Anker
S.D.; Pocock S.; Kaspers S.; George J.T.; von Eynatten M.; Johansen O.E.;
Jamal W.; Mattheus M.; Elsasser U.; Hantel S.; Lund S.S.
Institution
(McGuire) Division of Cardiology, Department of Internal Medicine,
University of Texas Southwestern Medical Center, Parkland Health and
Hospital System, Dallas, TX, United States
(Zinman) Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital,
Toronto, ON, Canada
(Fitchett) St Michael's Hospital, Division of Cardiology, University of
Toronto, Toronto, ON, Canada
(Inzucchi) Section of Endocrinology, Yale University School of Medicine,
New Haven, CT, United States
(Wanner) Wurzburg University Clinic, Wurzburg, Germany
(Anker) Department of Cardiology (CVK), Berlin Institute of Health Center
for Regenerative Therapies, German Centre for Cardiovascular Research
(DZHK) partner site Berlin, Charite - Universitatsmedizin Berlin, Berlin,
Germany
(Pocock) Department of Medical Statistics, London School of Hygiene &
Tropical Medicine, London, United Kingdom
(Kaspers, George, von Eynatten, Jamal, Lund) Boehringer Ingelheim
International, Ingelheim, Germany
(Johansen) Boehringer Ingelheim Norway KS, Asker, Norway
(Mattheus) Boehringer Ingelheim Pharma, Ingelheim, Germany
(Elsasser, Hantel) Boehringer Ingelheim Pharma, Biberach, Germany
Publisher
Lancet Publishing Group
Abstract
Background: Patients with type 2 diabetes and atherosclerotic
cardiovascular disease are at high clinical risk. We assessed the effect
of the sodium-glucose co-transporter-2 inhibitor, empagliflozin, on total
cardiovascular events and admissions to hospital in the EMPA-REG OUTCOME
trial. Method(s): The EMPA-REG OUTCOME trial was a randomised,
double-blind, non-inferiority trial of patients (aged >=18 years) with
type 2 diabetes and atherosclerotic cardiovascular disease done between
August, 2010, and April, 2015. Participants were randomly assigned (1:1:1)
to empagliflozin 10 mg or 25 mg, or placebo. The primary outcome was major
adverse cardiovascular events: a composite of cardiovascular death,
non-fatal stroke, or non-fatal myocardial infarction. As prespecified, the
effects of pooled empagliflozin versus placebo were assessed on total
(first plus recurrent) events of major adverse cardiovascular events,
fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, and
admission to hospital for heart failure. We also did post-hoc analyses on
additional cardiovascular and admission to hospital outcomes. We used
statistical models that preserve randomisation and account for correlation
of recurrent events, including negative binomial regression, as
prespecified for the primary analyses. The EMPA-REG OUTCOME trial is
registered with ClinicalTrials.gov, NCT01131676, and is closed to accrual.
 Finding(s): In the EMPA-REG OUTCOME trial, 7020 patients were
randomly assigned and treated with empagliflozin 10 mg (n=2345),
empagliflozin 25 mg (n=2342), or placebo (n=2333) and followed up for a
median of 3.2 years (IQR 2.2 to 3.6) in the pooled empagliflozin group and
3.1 years (2.2 to 3.5) in the placebo group. Analysing total (first plus
recurrent) events, empagliflozin versus placebo reduced the risk of major
adverse cardiovascular events (rate ratio [RR] 0.78 [95% CI 0.67 to 0.91];
p=0.0020; 12.88 [95% CI 3.74 to 22.02] events prevented per 1000
patient-years); fatal or non-fatal myocardial infarction (0.79 [0.62 to
0.998]; p=0.049; 4.97 [-0.68 to 10.61] events prevented per 1000
patient-years); the composite of fatal or non-fatal myocardial infarction,
or coronary revascularisation (0.80 [0.67 to 0.95]; p=0.012; 11.65 [1.25
to 22.05] events prevented per 1000 patient-years); admission to hospital
for heart failure (0.58 [0.42 to 0.81]; p=0.0012; 9.67 [3.07 to 16.28]
events prevented per 1000 patient-years); and all-cause admission to
hospital (0.83 [0.76 to 0.91]; p<0.0001; 50.41 [26.20 to 74.63] events
prevented per 1000 patient-years). For outcomes significantly reduced with
empagliflozin, risk reductions were numerically larger for total events
than for first events. Total fatal or non-fatal stroke was not
significantly different between treatment groups (RR 1.10 [95% CI 0.82 to
1.49]; p=0.52). Interpretation(s): Empagliflozin reduced the total
burden of cardiovascular complications and all-cause admission to hospital
in patients with type 2 diabetes and atherosclerotic cardiovascular
disease. Funding(s): The Boehringer Ingelheim and Lilly
Alliance. Copyright © 2020 Elsevier Ltd

<73>
Accession Number
633423510
Title
The effect of immediate postoperative Boussignac CPAP on adverse pulmonary
events after thoracic surgery: A multicentre, randomised controlled trial.
Source
European journal of anaesthesiology. (no pagination), 2020. Date of
Publication: 11 Nov 2020.
Author
Puente-Maestu L.; Lopez E.; Sayas J.; Alday E.; Planas A.; Parise D.J.;
Martinez-Borja M.; Garutti I.
Institution
(Puente-Maestu) From the Servicio de Neumologia Hospital General
Universitario Gregorio Maranon (LP-M), Instituto de Investigacion
Sanitaria Gregorio Maranon (IiSGM) (LP-M, Facultad de Medicina Universidad
Complutense de Madrid (UCM) (LP-M, Servicio de Anestesia Hospital General
Universitario Gregorio Maranon (IG), Servicio de Anestesia Hospital
General Universitario 12 de Octubre (EL), Instituto de Investigacion
Sanitaria 12 de Octubre (I+12) (EL, Servicio de Neumologia Hospital
General Universitario 12 de Octubre (JS), Servicio de Anestesia Hospital
General Universitario La Princesa (EA, Instituto de Investigacion
Sanitaria del Hospital de la Princesa (IIS La Princea) (EA, Facultad de
Medicina Universidad Autonoma de Madrid (UAM) (EA, Servicio de Anestesia
Hospital General Universitario Ramon y Cajal (DJP, Instituto de
Investigacion Sanitaria Hospital Ramon y Cajal (IRICYS) (DJP, Facultad de
Medicina Universidad de Alcala de Henares (UAH), Madrid, Spain
Publisher
NLM (Medline)
Abstract
BACKGROUND: The effectiveness of prophylactic continuous positive pressure
ventilation (CPAP) after thoracic surgery is not clearly established.
 OBJECTIVE(S): The aim of this study was to assess the effectiveness
of CPAP immediately after lung resection either by thoracotomy or
thoracoscopy in preventing atelectasis and pneumonia. DESIGN: A
multicentre, randomised, controlled, open-label trial. SETTINGS: Four
large University hospitals at Madrid (Spain) from March 2014 to December
2016. PATIENTS: Immunocompetent patients scheduled for lung resection,
without previous diagnosis of sleep-apnoea syndrome or severe bullous
emphysema. Four hundred and sixty-four patients were assessed, 426 were
randomised and 422 were finally analysed. INTERVENTION: Six hours of
continuous CPAP through a Boussignac system versus standard care. MAIN
OUTCOME MEASURES: Primary outcome: incidence of the composite endpoint
'atelectasis + pneumonia'. Secondary outcome: incidence of the composite
endpoint 'persistent air leak + pneumothorax'. RESULT(S): The primary
outcome occurred in 35 patients (17%) of the CPAP group and in 58 (27%) of
the control group [adjusted relative risk (ARR) 0.53, 95% CI 0.30 to
0.93]. The secondary outcome occurred in 33 patients (16%) of the CPAP
group and in 29 (14%) of the control group [ARR 0.92, 95% CI 0.51 to
1.65]. CONCLUSION(S): Prophylactic CPAP decreased the incidence of
the composite endpoint 'postoperative atelectasis + pneumonia' without
increasing the incidence of the endpoint 'postoperative persistent air
leaks + pneumothorax'.

<74>
Accession Number
633423360
Title
Efficacy and safety of lowering LDL cholesterol in older patients: a
systematic review and meta-analysis of randomised controlled trials.
Source
Lancet (London, England). (no pagination), 2020. Date of Publication: 09
Nov 2020.
Author
Gencer B.; Marston N.A.; Im K.; Cannon C.P.; Sever P.; Keech A.; Braunwald
E.; Giugliano R.P.; Sabatine M.S.
Institution
(Gencer, Marston, Im, Braunwald, Giugliano, Sabatine) TIMI Study Group,
Division of Cardiovascular Medicine, Harvard Medical School, MA, Boston,
United States
(Cannon) Brigham and Women's Hospital, Harvard Medical School, MA, Boston,
United States
(Sever) National Heart and Lung Institute, Imperial College London,
London, United Kingdom
(Keech) National Health and Medical Research Council Clinical Trials
Centre, Sydney Medical School, University of Sydney, NSW, Sydney,
Australia
Publisher
NLM (Medline)
Abstract
BACKGROUND: The clinical benefit of LDL cholesterol lowering treatment in
older patients remains debated. We aimed to summarise the evidence of LDL
cholesterol lowering therapies in older patients. METHOD(S): In this
systematic review and meta-analysis, we searched MEDLINE and Embase for
articles published between March 1, 2015, and Aug 14, 2020, without any
language restrictions. We included randomised controlled trials of
cardiovascular outcomes of an LDL cholesterol-lowering drug recommended by
the 2018 American College of Cardiology and American Heart Association
guidelines, with a median follow-up of at least 2 years and data on older
patients (aged >=75 years). We excluded trials that exclusively enrolled
participants with heart failure or on dialysis because guidelines do not
recommend lipid-lowering therapy in such patients who do not have another
indication. We extracted data for older patients using a standardised data
form for aggregated study-level data. We meta-analysed the risk ratio (RR)
for major vascular events (a composite of cardiovascular death, myocardial
infarction or other acute coronary syndrome, stroke, or coronary
revascularisation) per 1 mmol/L reduction in LDL cholesterol. FINDINGS:
Data from six articles were included in the systematic review and
meta-analysis, which included 24 trials from the Cholesterol Treatment
Trialists' Collaboration meta-analysis plus five individual trials. Among
244 090 patients from 29 trials, 21 492 (8.8%) were aged at least 75
years, of whom 11 750 (54.7%) were from statin trials, 6209 (28.9%) from
ezetimibe trials, and 3533 (16.4%) from PCSK9 inhibitor trials. Median
follow-up ranged from 2.2 years to 6.0 years. LDL cholesterol lowering
significantly reduced the risk of major vascular events (n=3519) in older
patients by 26% per 1 mmol/L reduction in LDL cholesterol (RR 0.74 [95% CI
0.61-0.89]; p=0.0019), with no statistically significant difference with
the risk reduction in patients younger than 75 years (0.85 [0.78-0.92];
pinteraction=0.37). Among older patients, RRs were not statistically
different for statin (0.82 [0.73-0.91]) and non-statin treatment (0.67
[0.47-0.95]; pinteraction=0.64). The benefit of LDL cholesterol lowering
in older patients was observed for each component of the composite,
including cardiovascular death (0.85 [0.74-0.98]), myocardial infarction
(0.80 [0.71-0.90]), stroke (0.73 [0.61-0.87]), and coronary
revascularisation (0.80 [0.66-0.96]). INTERPRETATION: In patients aged 75
years and older, lipid lowering was as effective in reducing
cardiovascular events as it was in patients younger than 75 years. These
results should strengthen guideline recommendations for the use of
lipid-lowering therapies, including non-statin treatment, in older
patients.None. Copyright © 2020 Elsevier Ltd. All rights
reserved.

<75>
Accession Number
633423075
Title
Personalized Blood Pressure Management During Cardiac Surgery With
Cerebral Autoregulation Monitoring: A Randomized Trial.
Source
Seminars in thoracic and cardiovascular surgery. (no pagination), 2020.
Date of Publication: 10 Nov 2020.
Author
Hogue C.W.; Brown C.H.; Hori D.; Ono M.; Nomura Y.; Balmert L.C.;
Srdanovic N.; Grafman J.; Brady K.
Institution
(Hogue) Department of Anesthesiology, Bluhm Cardiovascular Institute,
Northwestern University Feinberg School of Medicine, Chicago, Mexico
(Brown) Department of Anesthesiology & Critical Care Medicine, Division of
Cardiac Anesthesia, Johns Hopkins University School of Medicine, MD,
Baltimore, United States
(Hori, Nomura) Department of Cardiovascular Surgery, Saitama Medical
Center, Jichi Medical University, Saitama, Japan
(Ono) Department of Cardiac Surgery, Methodist Hospital, TX, San Antonio,
Mexico
(Balmert, Srdanovic) Department of Preventative Medicine, Biostatistics,
Northwestern University Feinberg School of Medicine, Chicago, Mexico
(Grafman) Department of Physical Medicine & Rehabilitation, Neurology,
Cognitive Neurology and Alzheimer's Center, Department of Psychiatry,
Weinberg College of Arts and Sciences, Northwestern University, Feinberg
School of Medicine & Department of Psychology, Chicago, Mexico
(Brady) Department of Anesthesiology, Northwestern University Feinberg
School of Medicine, Chicago, Mexico
Publisher
NLM (Medline)
Abstract
The purpose of this study was to determine if setting mean arterial
pressure (MAP) targets during cardiopulmonary bypass (CPB) based on
individualized cerebral autoregulation data reduces the frequency of
neurological complications compared with usual care. Patients (n=460) >=
55 years old at risk for neurological complications were randomized to
have MAP targets during CPB to be above the lower limit of transcranial
Doppler determined cerebral autoregulation versus usual institutional
practices. The primary outcome was the frequency of the composite endpoint
of clinical stroke, or new brain MRI detected ischemic injury, or
cognitive decline 4 to 6 weeks after surgery from baseline. Secondary
outcomes were components of the primary composite outcome and clinically
detected delirium. Complete outcome data were available from 194 patients
(stroke assessments, n=460; MRI data, n=164; cognitive data n=336). There
was no difference between groups in the frequency of the composite
neurological end-point or its components (p=0.752). Compared with the
usual care there was a 45% reduction in the frequency of clinically
detected delirium in the autoregulation group (8.2% versus 14.9%, risk
ratio=0.55, 95% CI=0.32, 0.93, p=0.035) and improved performance on test
of memory 4 to 6 weeks after surgery from baseline (p=0.019). Basing MAP
during CPB on cerebral autoregulation monitoring did not reduce the
frequency of the primary neurological outcome in high-risk patients
compared with usual care but it was associated with a reduction in the
frequency of delirium and better performance on tests of memory 4 to 6
weeks after surgery. Copyright © 2020. Published by Elsevier Inc.

<76>
Accession Number
633420508
Title
Opioid-sparing effect of modified intercostal nerve block during
single-port thoracoscopic lobectomy: A randomised controlled trial.
Source
European journal of anaesthesiology. (no pagination), 2020. Date of
Publication: 11 Nov 2020.
Author
Cheng X.-Q.; Zhang M.-Y.; Fang Q.; Shi D.-W.; Huang X.-C.; Liu X.-S.; Gu
E.-W.; Xu G.-H.
Institution
(Cheng, Zhang, Fang, Shi, Huang, Liu, Gu, Xu) From the Department of
Anaesthesiology, First Affiliated Hospital, Anhui Medical University and
Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui
Higher Education Institutes, Anhui Medical University, Hefei, Anhui, China
(Cheng, Zhang) Xin-qi Cheng and Mao-yun Zhang contributed equally to this
work
Publisher
NLM (Medline)
Abstract
BACKGROUND: Peripheral local anaesthetic blockade has an important role in
multimodal postoperative analgesia after video-assisted thoracic surgery.
Intercostal nerve block has an opioid-sparing effect after thoracoscopic
surgery, but there is little information about an intra-operative
opioid-sparing effect. OBJECTIVE(S): This prospective randomised
trial was designed to evaluate the feasibility of a modified intercostal
nerve block and its potential opioid-sparing effect during single-port
thoracoscopic lobectomy. DESIGN: This was a randomised controlled study.
SETTING: The First Affiliated Hospital of Anhui Medical University, Hefei,
China, from January 2020 to April 2020. PATIENTS: Fifty patients scheduled
for single-port thoracoscopic lobectomy were enrolled. INTERVENTION:
Patients were randomised to receive the intercostal nerve block using 10
ml 0.35% ropivacaine (group MINB) or conventional general anaesthesia
(group CGA). Following a bolus of 0.5 to 1.0 mug kg remifentanil, it was
then infused at 0.2 to 0.5 mug kg min during surgery to keep mean arterial
pressure or heart rate values around 20% below baseline values. MAIN
OUTCOME MEASURES: The primary outcome was intra-operative remifentanil
consumption. RESULT(S): Median [IQR] remifentanil consumption was
reduced in the MINB group [0 mug (0 to 0 mug)] compared with the CGA group
[1650.0 mug (870.0 to 1892.5 mug)]. The median difference was 1650.0 mug
(95%CI 1200.0 to 1770.0 mug; P = 0.00). The total number of analgesic
demands during the first 24 and 48 h in the MINB group was significantly
less than in the CGA group (difference = 1; 95% CI 1 to 3; P = 0.00 and
difference = 4; 95% CI 3 to 5; P = 0.00; respectively). The difference in
time to first demand for analgesia was significant [difference = 728 min
(95% CI 344 to 1381 min), P = 0.00] and also in the number of patients
requiring additional tramadol (P = 0.03). CONCLUSION(S): We have
shown intra-operative opioid-sparing with a modified intercostal nerve
block during single-port thoracoscopic lobectomy, with opioid-sparing
extending 48 h after surgery. However, the opioid-sparing effect was not
associated with a reduction in opioid side effects. TRIAL REGISTRATION:
http://www.chictr.org.cn, ChiCTR2000029337.

<77>
Accession Number
633420484
Title
Clinical outcomes of complete versus incomplete revascularization in
patients treated with coronary artery bypass grafting: insights from the
TiCAB trial.
Source
European journal of cardio-thoracic surgery : official journal of the
European Association for Cardio-thoracic Surgery. (no pagination), 2020.
Date of Publication: 14 Nov 2020.
Author
Schaefer A.; Conradi L.; Schneeberger Y.; Reichenspurner H.; Sandner S.;
Tebbe U.; Nowak B.; Stritzke J.; Kastrati A.; Schunkert H.; von Scheidt M.
Institution
(Schaefer, Conradi, Schneeberger, Reichenspurner) Department of
Cardiovascular Surgery, University Heart and Vascular Center Hamburg,
Hamburg, Germany
(Sandner) Division of Cardiac Surgery, Medical University of Vienna,
Vienna, Austria
(Tebbe) Department of Cardiology, Angiology, Intensive Care Medicine,
District Hospital Lippe-Detmold, Detmold, Germany
(Nowak) CCB, Cardiovascular Center Bethanien, Frankfurt am Main, Germany
(Stritzke) ListGermany
(Kastrati, Schunkert, von Scheidt) Department of Cardiology, Deutsches
Herzzentrum Munchen, Technische Universitat Munchen, Munich, Germany
(Kastrati, Schunkert, von Scheidt) DZHK (German Center for Cardiovascular
Research), Partner Site Munich Heart Alliance, Munich, Germany
Publisher
NLM (Medline)
Abstract
OBJECTIVES: In this post hoc analysis of the Ticagrelor in coronary artery
bypass grafting (CABG) trial, we aimed to analyse patients treated with
CABG receiving either complete revascularization (CR) or incomplete
revascularization (ICR) independent from random allocation to either
ticagrelor or aspirin. METHOD(S): Of 1859 patients enrolled in the
Ticagrelor in CABG trial, 1550 patients (83.4%) received CR and 309
patients (16.6%) ICR. Outcomes were evaluated regarding all-cause
mortality, cardiovascular death, myocardial infarction (MI), repeat
revascularization, stroke and bleeding within 12months after CABG.
 RESULT(S): Baseline parameters revealed significant differences
regarding clinical presentation (stable angina pectoris: CR 68.9% vs ICR
71.2%, instable angina pectoris: 14.1% vs 7.8%, non-ST elevation MI: 17.0%
vs 21.0%, P < 0.01), lesion characteristics (chronic total occlusion: CR
91.3% vs ICR 96.8%, P < 0.01), operative technique [off-pump coronary
artery bypass surgery (OPCAB): CR 3.0% vs ICR 6.1%, P < 0.01] and number
of utilized grafts (total number of grafts: 2.69/patient vs 2.49/patient,
P < 0.001). ICR patients displayed a significantly increased risk of
repeat revascularization [hazard ratio (HR) 1.91, 95% confidence interval
(CI) 1.16-3.16; P<0.01] and percutaneous coronary intervention (HR 1.95,
95% CI 1.13-3.35; P<0.05) within 12months after CABG. Higher risk for
repeat revascularization in ICR patients was independent from random
allocation to either ticagrelor or aspirin and persisted after adjustment
for baseline imbalances. CONCLUSION(S): Patients with ICR presented
more stable at the time of admission, but received less grafts, highly
likely due to a higher rate of chronic total occlusion lesions and
performed OPCAB. Although mortality presented no difference between
groups, our results suggest that patients benefit from CR with regard to
prevention of repeat revascularization. Copyright © The Author(s)
2020. Published by Oxford University Press on behalf of the European
Association for Cardio-Thoracic Surgery. All rights reserved.

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