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<1>
Accession Number
2018513564
Title
The Relation of Grit and Surgical Specialty Interest Among Medical
Students.
Source
Journal of Surgical Education. 79(5) (pp 1159-1165), 2022. Date of
Publication: 01 Sep 2022.
Author
Huo B.; Dow T.; Helyer L.
Institution
(Huo) Faculty of Medicine, Dalhousie University, Halifax, NS, Canada
(Dow) Division of Plastic Surgery, Department of Surgery, Dalhousie
University, Halifax, NS, Canada
(Helyer) Division of General Surgery, Department of Surgery, Dalhousie
University, Halifax, NS, Canada
Publisher
Elsevier Inc.
Abstract
Objective: The assessment of Grit among medical students applying to
surgical residency programs may be useful, but the relationship between
student Grit and surgical specialty interest is not clear. This study
investigated whether medical student Grit differs based on interest in
direct-entry surgical specialties. Design(s): A literature search
informed the development of a cross-sectional study assessing medical
student ratings of the validated 6-item Short-Grit scale. Medical students
also indicated their career preferences. Setting(s): Faculty of
Medicine, Dalhousie University, Halifax, NS, Canada; a tertiary medical
center. Participant(s): Surgical specialty interest and Grittiness
were assessed among 297 (50.4%) pre-clerkship medical students in their
first or second year of training. Data was collected from program
applicants over 4 years. Result(s): Medical students had high levels
of Grit (M = 4.029, SD = 0.517). There was a significant difference in
Grit level between medical students interested in cardiac surgery ([M =
4.197, SD = 0.471 vs M = 3.919, 0.518]; t(295) = 4.674, p < 0.001; Cohen's
D = 0.556), general surgery ([M = 4.178, SD = 0.466 vs M = 3.916, 0.527];
t(295) = 4.434, p < 0.001; Cohen's D = 0.520), neurosurgery ([M = 4.238,
SD = 0.457 vs M = 3.950, 0.518]; t(295) = 4.412, p < 0.001; Cohen's D =
0.575), plastic surgery ([M = 4.138, SD = 0.497 vs M = 3.967, 0.520];
t(295) = 2.747, p = 0.006; Cohen's D = 0.333), and vascular surgery (M =
4.248, SD = 0.368 vs M = 3.948, 0.541); t(295) = 4.570, p < 0.001; Cohen's
D = 0.501). Conclusion(s): Medical students with a career interest in
"poor lifestyle" surgical specialties have higher Grit than their peers.
These findings may be noteworthy for surgical residency programs with high
rates of attrition and burnout. Copyright © 2022

<2>
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Accession Number
638839954
Title
Normothermic Ex Situ Heart Perfusion With the Organ Care System for
Cardiac Transplantation: A Meta-analysis.
Source
Transplantation. 106(9) (pp 1745-1753), 2022. Date of Publication: 01 Sep
2022.
Author
Langmuur S.J.J.; Amesz J.H.; Veen K.M.; Bogers A.J.J.C.; Manintveld O.C.;
Taverne Y.J.H.J.
Institution
(Langmuur, Amesz, Veen, Bogers, Taverne) Department of Cardiothoracic
Surgery, Erasmus Medical Center, Rotterdam, Netherlands
(Langmuur, Amesz, Taverne) Translational Cardiothoracic Surgery Research
Lab, Erasmus Medical Center, Rotterdam, Netherlands
(Manintveld) Department of Cardiology, Erasmus Medical Center, Rotterdam,
Netherlands
(Manintveld, Taverne) Erasmus MC Transplant Institute, Erasmus Medical
Center, University Medical Center, Rotterdam, Netherlands
Publisher
NLM (Medline)
Abstract
BACKGROUND: Heart transplantation (HTx) is, at present, the most effective
therapy for end-stage heart failure patients; however, the number of
patients on the waiting list is rising globally, further increasing the
gap between demand and supply of donors for HTx. First studies using the
Organ Care System (OCS) for normothermic machine perfusion show promising
results yet are limited in sample size. This article presents a
meta-analysis of heart donation either after brain death (OCS-DBD) or
circulatory death (OCS-DCD) on using OCS versus static cold storage used
for HTx. METHOD(S): A systematic literature search was performed for
articles discussing the use of normothermic ex situ heart perfusion in
adult patients. Thirty-day survival outcomes were pooled, and odds ratios
were calculated using random-effects models. Long-term survival was
visualized with Kaplan-Meier curves, hazard ratios were calculated and
pooled using fixed-effects models, and secondary outcomes were analyzed.
 RESULT(S): A total of 12 studies were included, with 741 patients
undergoing HTx, of which 260 with the OCS (173 DBD and 87 DCD). No
differences were found between the 3 groups for early and late survival
outcomes or for secondary outcomes. CONCLUSION(S): OCS outcomes, for
both DBD and DCD hearts, appeared similar as for static cold storage.
Therefore, OCS is a safe and effective technique to enlarge the cardiac
donor pool in both DBD and DCD, with additional benefits for long-distance
transport and surgically complex procedures. Copyright © 2022 The
Author(s). Published by Wolters Kluwer Health, Inc.

<3>
Accession Number
638838140
Title
Can Chest Ultrasound Replace Chest X-ray in Thoracic Surgery?.
Source
Tomography (Ann Arbor, Mich.). 8(4) (pp 2083-2092), 2022. Date of
Publication: 20 Aug 2022.
Author
Grapatsas K.; Leivaditis V.; Ehle B.; Papaporfyriou A.
Institution
(Grapatsas) Department of Thoracic Surgery, Klinikum Bielefeld, Bielefeld
33647, Germany
(Leivaditis) Department of Cardiothoracic and Vascular Surgery,
Westpfalz-Klinikum, Kaiserslautern 67655, Germany
(Ehle) Department of Thoracic Surgery, Medical Center-University of
Freiburg, Faculty of Medicine, Freiburg 79098, Germany
(Papaporfyriou) Division of Pulmonology, Department of Internal Medicine
II, Medical University of Vienna, Vienna 1090, Austria
Publisher
NLM (Medline)
Abstract
Background: There is growing evidence that supports the use of chest
ultrasound (CUS) versus conventional chest X-ray (CXR) in order to
diagnose postoperative complications. However, data regarding its use
after thoracic surgery are scarce and contradictory. The aim of this study
was to conduct a systematic review to evaluate the accuracy of CUS after
thoracic surgery. Method(s): An electronic search in MEDLINE (via
PubMed), complemented by manual searches in article references, was
conducted to identify eligible studies. Result(s): Six studies with a
total of 789 patients were included in this meta-analysis. Performing CXR
decreased in up to 61.6% of cases, with the main reasons for performing
CXR being massive subcutaneous emphysema or complex hydrothorax. Agreement
between CUS and routine-based therapeutic options was, in some studies, up
to 97%. Conclusion(s): The selectively postoperative use of CUS may
reduce the number of routinely performed CXR. However, if CUS findings are
inconclusive, further radiological examinations are obligatory.

<4>
Accession Number
638849209
Title
A Systematic Review and Meta-Analysis of Serologic Response following
Coronavirus Disease 2019 (COVID-19) Vaccination in Solid Organ Transplant
Recipients.
Source
Viruses. 14(8) (no pagination), 2022. Date of Publication: 19 Aug 2022.
Author
Sakuraba A.; Luna A.; Micic D.
Institution
(Sakuraba, Luna, Micic) Division of Gastroenterology, Hepatology and
Nutrition, Department of Internal Medicine, University of Chicago
Medicine, 5841 S. Maryland Ave. MC 4076, Chicago IL 60637, United States
Publisher
NLM (Medline)
Abstract
Solid organ transplant (SOT) recipients are at greater risk of coronavirus
disease 2019 (COVID-19) and have attenuated response to vaccinations. In
the present meta-analysis, we aimed to evaluate the serologic response to
the COVID-19 vaccine in SOT recipients. A search of electronic databases
was conducted to identify SOT studies that reported the serologic response
to COVID-19 vaccination. We analyzed 44 observational studies including
6158 SOT recipients. Most studies were on mRNA vaccination (mRNA-1273 or
BNT162b2). After a single and two doses of vaccine, serologic response
rates were 8.6% (95% CI 6.8-11.0) and 34.2% (95% CI 30.1-38.7),
respectively. Compared to controls, response rates were lower after a
single and two doses of vaccine (OR 0.0049 [95% CI 0.0021-0.012] and
0.0057 [95% CI 0.0030-0.011], respectively). A third dose improved the
rate to 65.6% (95% CI 60.4-70.2), but in a subset of patients who had not
achieved a response after two doses, it remained low at 35.7% (95% CI
21.2-53.3). In summary, only a small proportion of SOT recipients achieved
serologic response to the COVID-19 mRNA vaccine, and that even the third
dose had an insufficient response. Alternative strategies for prophylaxis
in SOT patients need to be developed. Key Contribution: In this
meta-analysis that included 6158 solid organ transplant recipients, the
serologic response to the COVID-19 vaccine was extremely low after one
(8.6%) and two doses (34.2%). The third dose of the vaccine improved the
rate only to 66%, and in the subset of patients who had not achieved a
response after two doses, it remained low at 36%. The results of our study
suggest that a significant proportion of solid organ transplant recipients
are unable to achieve a sufficient serologic response after completing not
only the two series of vaccination but also the third booster dose. There
is an urgent need to develop strategies for prophylaxis including modified
vaccine schedules or the use of monoclonal antibodies in this vulnerable
patient population.

<5>
Accession Number
2019913607
Title
Left ventricular volume change and long-term outcomes in ischaemic
cardiomyopathy with or without surgical revascularisation: A post-hoc
analysis of a randomised controlled trial.
Source
eClinicalMedicine. 53 (no pagination), 2022. Article Number: 101626. Date
of Publication: November 2022.
Author
Zhou Z.; Zhuang X.; Liu M.; Jian B.; Fu G.; Liao X.; Wu Z.; Liang M.
Institution
(Zhou, Jian, Fu, Wu, Liang) Department of Cardiac Surgery, First
Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China
(Zhuang, Liu, Liao) Departement of Cardiology, First Affiliated Hospital
of Sun Yat-Sen University, Guangzhou, China
Publisher
Elsevier Ltd
Abstract
Background: Whether the association between post-therapeutic left
ventricular volume change and long-term outcomes in ischaemic
cardiomyopathy is influenced by the performance of coronary artery bypass
grafting (CABG) remains unclear. We sought to perform a post-hoc analysis
of the Surgical Treatment of Ischaemic Heart Failure (STICH) trial to
investigate this association in patients treated with medical therapy
(MED) with or without CABG. Method(s): From July 24, 2002, to May 5,
2007, 1212 patients with ischaemic cardiomyopathy were enrolled in the
STICH trial (NCT00023595) from 99 sites in 22 countries, and were randomly
assigned to undergo CABG plus MED or MED alone. We completed a post-hoc
analysis of this trial. Patients with paired left ventricular end-systolic
volume index (ESVI) measured at baseline and 4-months were included in our
analysis. The association between change in ESVI from baseline to 4-months
and cardiovascular mortality or all-cause mortality was assessed in MED
arm and CABG plus MED arm. Finding(s): 523 patients were included,
with 291 (55.6%) assigned to MED arm and 232 (44.4%) to CABG plus MED arm.
At a 4-month follow-up, ESVI reduction was more likely to occur among
patients undergoing CABG plus MED. After a median follow-up of 10.3 years,
for each 26% (1- standard deviation) decrement in ESVI, it was associated
with a 22% lower risk of cardiovascular mortality (HR 0.78; 95% CI,
0.65-0.94) and 19% lower risk of all-cause mortality (HR 0.81; 95% CI,
0.69-0.95) in MED arm, whereas this association was not shown in CABG plus
MED arm (cardiovascular mortality: HR 0.90; 95%CI, 0.74-1.10; all-cause
mortality: HR 0.93; 95%CI, 0.79-1.09). A 16% reduction in ESVI was
determined to be the most appropriate threshold of change in ESVI in the
MED arm. Interpretation(s): In patients with ischaemic
cardiomyopathy, left ventricular volume change was associated with
long-term prognosis after medical therapy alone, whereas was likely not an
optimal benchmark for evaluating the survival benefits associated with
CABG. A more than 16% reduction in ESVI might assist in therapeutic
efficacy assessment and prognostic evaluation in medically treated
patients. Funding(s): National Natural Science Foundation of China;
Natural Science Funds of Guangdong Province. Copyright © 2022 The
Author(s)

<6>
Accession Number
638846703
Title
Effects of Video-Based Patient Education and Consultation on Unplanned
Health Care Utilization and Early Recovery After Coronary Artery Bypass
Surgery (IMPROV-ED): Randomized Controlled Trial.
Source
Journal of medical Internet research. 24(8) (pp e37728), 2022. Date of
Publication: 26 Aug 2022.
Author
van Steenbergen G.; van Veghel D.; van Lieshout D.; Sperwer M.; Ter Woorst
J.; Dekker L.
Institution
(van Steenbergen, van Veghel, Ter Woorst, Dekker) Cardiothoracic Surgery
Department, Catharina Heart Centre, Catharina Hospital, Eindhoven,
Netherlands
(van Lieshout, Sperwer) Dutch Heart Foundation, The Hague, Netherlands
(Dekker) Department of Biomedical Technology, Eindhoven University of
Technology, Eindhoven, Netherlands
Publisher
NLM (Medline)
Abstract
BACKGROUND: Health care utilization after coronary artery bypass graft
(CABG) surgery is high and is partly of an unplanned nature. eHealth
applications have been proposed to reduce care consumption, which involve
and assist patients in their recovery. In this way, health care expenses
could be reduced and quality of care could be improved. OBJECTIVE(S):
The aim of this study was to evaluate if an eHealth program can reduce
unplanned health care utilization and improve mental and physical health
in the first 6 weeks after CABG surgery. METHOD(S): A single-blind
randomized controlled trial was performed, in which patients scheduled for
nonacute CABG surgery were included from a single center in the
Netherlands between February 2020 and October 2021. Participants in the
intervention group had, alongside standard care, access to an eHealth
program consisting of online education videos and video consultations
developed in conjunction with the Dutch Heart Foundation. The control
group received standard care. The primary outcome was the volume and costs
of a composite of unplanned health care utilization, including emergency
department visits, outpatient clinic visits, rehospitalization,
patient-initiated telephone consultations, and visits to a general
practitioner, measured using the Medical Technology Assessment Medical
Consumption Questionnaire. Patient-reported anxiety and recovery were also
assessed. Intention-to-treat and "users-only" analyses were used.
 RESULT(S): During the study period, 280 patients were enrolled and
randomly allocated at a 1:1 ratio to the intervention or control group.
The intention-to-treat analysis consisted of 136 and 135 patients in the
intervention and control group, respectively. At 6 weeks, the primary
endpoint had occurred in 43 of 136 (31.6%) patients in the intervention
group and in 61 of 135 (45.2%) patients in the control group (hazard ratio
0.56, 95% CI 0.34-0.92). Recovery was faster in the intervention group,
whereas anxiety was similar between study groups. "Users-only" analysis
yielded similar results. CONCLUSION(S): An eHealth strategy
comprising educational videos and video consultations can reduce unplanned
health care utilization and can aid in faster patient-reported recovery in
patients following CABG surgery. TRIAL REGISTRATION: Netherlands Trial
Registry NL8510; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8510.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):
RR2-10.1007/s12471-020-01508-9. Copyright ©Gijs van Steenbergen,
Dennis van Veghel, Dideke van Lieshout, Merel Sperwer, Joost ter Woorst,
Lukas Dekker. Originally published in the Journal of Medical Internet
Research (https://www.jmir.org), 26.08.2022.

<7>
Accession Number
2019632451
Title
Direct oral anticoagulants or vitamin K antagonists after TAVR: A
systematic review and meta-analysis.
Source
International Journal of Cardiology. 365 (pp 123-130), 2022. Date of
Publication: 15 Oct 2022.
Author
Oliveri F.; Montalto C.; Tua L.; Lanzillo G.; Compagnoni S.; Fasolino A.;
Gentile F.R.; Ferlini M.; Pepe A.; Oltrona Visconti L.; Bongiorno A.;
Leonardi S.
Institution
(Oliveri, Tua, Lanzillo, Compagnoni, Fasolino, Gentile, Ferlini, Pepe,
Bongiorno, Leonardi) Department of Molecular Medicine, University of
Pavia, Pavia, Italy
(Montalto) Interventional Cardiology, De Gasperis Cardio Center, Niguarda
Hospital, Milan, Italy
(Oltrona Visconti, Leonardi) Division of Cardiology, Fondazione IRCCS
Policlinico San Matteo, Pavia, Italy
Publisher
Elsevier Ireland Ltd
Abstract
Background: Several patients undergoing transcatheter aortic valve
replacement (TAVR) also require oral anticoagulation (OAC) for atrial
fibrillation (AF) or deep vein thromboembolism. However, the optimal type
of OAC strategy (direct oral anticoagulants, DOACs, or vitamin K
antagonists, VKA) is still unclear in this setting. Method(s): We
performed systematic literature research and meta-analysis in PubMed,
Medline, and EMBASE databases for studies reporting either all-cause
mortality, major/life-threatening bleeding or stroke events.
 Result(s): Ten observational studies and two randomized controlled
trials (RCTs) including a total of 29,485 patients were eligible for
inclusion. Compared to VKA, DOACs use after TAVR was associated with a
modest but significantly lower rates of all-cause mortality (RR 0.90; 95%
CI: 0.81-0.99, p-value 0.04) with results mainly driven by observational
studies. Cardiovascular mortality (RR 1.03; 95% CI: 0.81-1.30; p-value
0.84), total stroke events (RR 0.97; 95% CI: 0.76-1.23, p-value 0.79),
major/life-threatening bleeding (RR 0.93; 95% CI: 0.72-1.21, p-value 0.61)
and minor bleeding (RR 0.96; 95% CI: 0.74-1.23; p-value 0.72) were similar
between VKA and DOACs. Conclusion(s): Considering the totality of
available evidence, in patients who underwent TAVR with a concomitant
indication for OAC, DOACs-based strategy is an effective and safe
anticoagulation strategy compared to VKA. Copyright © 2022
Elsevier B.V.

<8>
Accession Number
2019914414
Title
A systematic review and meta-analysis of periprocedural bridging for
patients with mechanical heart valves undergoing non-cardiac
interventions.
Source
Thrombosis Research. 218 (pp 130-137), 2022. Date of Publication: October
2022.
Author
Bontinis V.; Theodosiadis E.; Bontinis A.; Koutsoumpelis A.; Donikidis I.;
Giannakopoulos N.-N.; Ktenidis K.
Institution
(Bontinis, Bontinis, Koutsoumpelis, Ktenidis) Department of Vascular
Surgery, Aristotle University of Thessaloniki, AHEPA University General
Hospital, Thessaloniki, Greece
(Theodosiadis) Department of Anesthesiology and Intensive Care, Aristotle
University of Thessaloniki, AHEPA University General Hospital,
Thessaloniki, Greece
(Donikidis) Department of Orthopedic Surgery, General Hospital of Edessa,
Edessa, Greece
(Giannakopoulos) 3rd Department of General Surgery, Tzaneio General
Hospital, Piraeus, Greece
Publisher
Elsevier Ltd
Abstract
Objective: To evaluate the safety and efficacy of perioperative bridging
in patients with mechanical heart valves undergoing non-cardiac
interventions. Material(s) and Method(s): A systematic research using
Medline, EMBASE, and Google Scholar was implemented corresponding to the
Preferred Reporting Items for Systematic reviews and Meta-analysis
(PRISMA) statement. Data from the eligible studies were obtained and
meta-analyzed. Primary endpoints included major bleeding and
thromboembolism. Secondary endpoints included minor bleeding, overall
mortality, and overall bleeding (major and minor bleeding). We conducted a
comparative analysis between bridging and non-bridging along with a
sensitivity analysis for patients undergoing major and minor operations.
 Result(s): Fifteen studies comprised of 2305 patients (2453 bridging
episodes) were included. Pooled major bleeding and thromboembolism rates
were 3.85 % (95 % CI: 2.12-5.98) (I2 = 69 %, p < 0.01) and 0.39
% (95 % CI: 0.00-1.41) (I2 = 64 %, p < 0.01). Bridging versus
non-bridging major bleeding, thromboembolism, and overall bleeding risk
ratios (RR) were RR 2.05 (95 % CI: 0.98-4.28) (I2 = 10 %, p =
0.34), RR 1.63 (95 % CI: 0.41-6.50) (I2 = 0 %, p = 0.63) and RR
1.79 (95 % CI: 1.17-2.72) (I2 = 55 %, p = 0.09) respectively.
Subgroup analysis displayed major and minor operation thromboembolism and
overall bleeding rates of 3.09 % (95 % CI: 0.78-6.43) (I2 = 0
%, p = 0.89) versus 0.14 % (95 % CI: 0.00-1.40) (I2 = 0 %, p =
0.93), test for subgroup differences (p < 0.01) and 17.37 % (95 % CI:
11.73-23.77) (I2 = 0 %, p = 0.61) versus 28.18 % (95 % CI:
22.80-33.88) (I2 = 0 %, p = 0.47), test for subgroup
differences (p = 0.01) respectively. Conclusion(s): Our analysis
suggests that bridging may potentially put patients at an increased
bleeding risk regarding overall bleeding rates, while failing to provide
statistically significant benefits concerning thromboembolism and overall
mortality compared to non-bridging. Limitations such as the mixed patient
population don't allow for definite conclusions to be drawn warrantying
further research through randomized controlled trials. Copyright
© 2022 Elsevier Ltd

<9>
Accession Number
2018731703
Title
Commissural alignment in transcatheter aortic valve replacement: A
literature review.
Source
Frontiers in Cardiovascular Medicine. 9 (no pagination), 2022. Article
Number: 938653. Date of Publication: 09 Aug 2022.
Author
Khalid A.M.; O'Sullivan C.J.
Institution
(Khalid, O'Sullivan) College of Medicine and Health, University College
Cork, Cork, Ireland
Publisher
Frontiers Media S.A.
Abstract
Introduction: Transcatheter aortic valve replacement (TAVR) is a minimally
invasive procedure to replace a diseased and faulty aortic valve in
patients with severe aortic stenosis. As TAVR gains popularity among
lower-risk younger patients with a longer life expectancy; there is a need
to investigate the long-term shortcomings and limitations of the procedure
for this patient group. One such shortcoming is that commissural alignment
of transcatheter heart valves (THV) appears to be random; meaning that the
THV neo-commissures can misalign with the native commissures of the aortic
valve during deployment or self-expansion. Objective(s): Identify
techniques and procedures used to obtain commissural alignment in TAVR.
Evaluate the effectiveness of these procedures in terms of the degree of
commissural alignment. Analyse the impact of commissural alignment on
coronary filling and re-access. Method(s): Two electronic online
databases were searched to identify existing literature relevant to the
aim and objectives of this review: EBSCOhost and PubMed. After search
filters were applied and duplicates removed; a total of 64 articles from
both databases were screened against the inclusion/exclusion criteria.
This resulted in a total of thirteen articles which met the objectives of
this review and thus; were included. Result(s): All studies focused
on a patient centered approach involving pre-TAVR computed tomography to
obtain commissural alignment. Other studies modified this approach and
combined techniques. All studies that implemented a technique to reduce
commissural misalignment were significantly successful in obtaining
commissural alignment when compared to a study in which alignment was
random when no technique was implemented. Severe coronary overlapping in
commissural aligned heart valves was relatively low compared to severe
coronary overlapping when no technique was implemented.
 Conclusion(s): An increase in optimal commissural alignment via
introduction of an alignment technique may seem attractive; however; the
categorization of commissural alignment is arbitrary and does not
accurately reflect real life clinical implications. Further research is
needed to determine whether a routine procedure to achieve commissural
alignment is necessary in low-risk younger patients undergoing
TAVR. Copyright © 2022 Khalid and O'Sullivan.

<10>
Accession Number
2018715569
Title
Effect of high-flow nasal therapy on patient-centred outcomes in patients
at high risk of postoperative pulmonary complications after cardiac
surgery: a statistical analysis plan for NOTACS, a multicentre adaptive
randomised controlled trial.
Source
Trials. 23(1) (no pagination), 2022. Article Number: 699. Date of
Publication: December 2022.
Author
Dawson S.N.; Chiu Y.-D.; Klein A.A.; Earwaker M.; Villar S.S.
Institution
(Dawson, Chiu, Villar) MRC Biostatistics Unit, School of Clinical
Medicine, University of Cambridge, Cambridge, United Kingdom
(Dawson, Earwaker) Papworth Trials Unit Collaboration, Royal Papworth
Hospital NHS Foundation Trust, Cambridge, United Kingdom
(Klein) Department of Anaesthesia and Intensive Care, Royal Papworth
Hospital, Cambridge, United Kingdom
Publisher
BioMed Central Ltd
Abstract
Background: The NOTACS trial will assess the efficacy, safety and
cost-effectiveness of high-flow nasal therapy (HFNT) compared to standard
oxygen therapy (SOT) on the outcomes of patients after cardiac surgery.
Methods/design: NOTACS is an adaptive, international, multicentre,
parallel-group, randomised controlled trial, with a pre-planned interim
sample size re-estimation (SSR). A minimum of 850 patients will be
randomised 1:1 to receive either HFNT or SOT. The primary outcome is days
alive and at home in the first 90 days after the planned surgery (DAH90),
with a number of secondary analyses and cost-effectiveness analyses also
planned. The interim SSR will take place after a minimum of 300 patients
have been followed up for 90 days and will allow for the sample size to
increase up to a maximum of 1152 patients. Result(s): This manuscript
provides detailed descriptions of the design of the NOTACS trial, and the
analyses to be undertaken at the interim and final analyses. The main
purpose of the interim analysis is to assess safety and to perform a
sample size re-estimation. The main purpose of the final analysis is to
examine the safety, efficacy and cost-effectiveness of HFNT compared to
SOT on the outcomes of patients after cardiac surgery. Discussion(s):
This manuscript outlines the key features of the NOTACS statistical
analysis plan and was submitted to the journal before the interim analysis
in order to preserve scientific integrity under an adaptive design
framework. The NOTACS SAP closely follows published guidelines for the
content of SAPs in clinical trials. Trial registration: ISRCTN14092678.
Registered on 13 May 2020. Copyright © 2022, The Author(s).

<11>
Accession Number
2019941132
Title
The effects of hydroxyethyl starch 130/0.4 on perioperative renal function
in patients undergoing cardiac surgery: A randomised controlled trial.
Source
Annals of Medicine and Surgery. 81 (no pagination), 2022. Article Number:
104475. Date of Publication: September 2022.
Author
Nagaya K.; Yoshida A.; Ito Y.; Watanabe S.; Minagawa T.; Saijo Y.
Institution
(Nagaya, Yoshida, Ito) Department of Anesthesia, Tohoku Medical and
Pharmaceutical University Hospital, Sendai, Japan
(Watanabe) Department of Cardiovascular Surgery, Sendai Medical Center,
Sendai, Japan
(Minagawa) Department of Cardiovascular Surgery, Tohoku Medical and
Pharmaceutical University Hospital, Sendai, Japan
(Saijo) Biomedical Imaging Laboratory, Graduate School of Biomedical
Engineering, Tohoku University, Sendai, Japan
Publisher
Elsevier Ltd
Abstract
Background: Acute kidney injury (AKI) after cardiac surgery increases the
risk of morbidity and mortality. Hydroxyethyl starch (HES) is often used
during surgery due to its plasma-volume expanding effect, but the impact
of HES 130/0.4 on renal function in patients undergoing cardiac surgery
remains unclear. The aim of our study is to investigate the impact of HES
130/0.4 on postoperative renal function in patients undergoing cardiac
surgery using cardiopulmonary bypass. Method(s): Our study was a
randomised, single-center, single-blind study conducted on 60 adult
patients who underwent cardiac surgery using cardiopulmonary bypass: 30
patients were intraoperatively administered with HES 130/0.4; the other 30
with Ringer's bicarbonate. The primary endpoints were occurrence of AKI
within 30 days of surgery and the disease stages. Result(s): The mean
dose of 6% HES 130/0.4 was 28 ml/kg. AKI occurred within 30 days of the
operation in 8 cases (28.6%) in the HES group and 6 cases (21.4%) in the
crystalloid group (no significance: p = 0.5371). Disease stages were as
follows: "no AKI", "stage 1", "stage 2 and "stage 3, accounting for 20
cases (71.5%), 6 cases (21,4%), 2 cases (7.1%), and 0 cases, respectively,
in the HES group, and 22 cases (78.6%), 6 cases (21.4%), 0 cases, and 0
cases, respectively, in the crystalloid group (no significance: p =
0.3508). Conclusion(s): There was no significant difference in the
occurrences or stages of AKI during the 30 days following cardiac surgery
with cardiopulmonary bypass between patients administered with HES 130/0.4
or Ringer's bicarbonate. Copyright © 2022 The Authors

<12>
Accession Number
2018722028
Title
Neurologic complications after cardiopulmonary bypass - A narrative
review.
Source
Perfusion (United Kingdom). (no pagination), 2022. Date of Publication:
2022.
Author
Gilbey T.; Milne B.; de Somer F.; Kunst G.
Institution
(Gilbey, Milne, Kunst) Department of Anaesthesia Pain Medicine, King's
College Hospital NHS Foundation Trust, London, United Kingdom
(de Somer) Department of Human Structure and Repair, Faculty of Medicine
and Health Sciences, Ghent University Hospital, Ghent, Belgium
(Kunst) School of Cardiovascular Medicine and Sciences, Faculty of Life
Sciences and Medicine, King's College London British Heart Foundation
Centre of Excellence, London, United Kingdom
Publisher
SAGE Publications Ltd
Abstract
Neurologic complications, associated with cardiac surgery and
cardiopulmonary bypass (CPB) in adults, are common and can be devastating
in some cases. This comprehensive review will not only consider the broad
categories of stroke and neurocognitive dysfunction, but it also
summarises other neurological complications associated with CPB, and it
provides an update about risks, prevention and treatment. Where
appropriate, we consider the impact of off-pump techniques upon our
understanding of the contribution of CPB to adverse
outcomes. Copyright © The Author(s) 2022.

<13>
Accession Number
638840819
Title
Impact of residual angina on long-term clinical outcomes after
percutaneous coronary intervention or coronary artery bypass graft for
complex coronary artery disease.
Source
European heart journal. Quality of care & clinical outcomes. (no
pagination), 2022. Date of Publication: 24 Aug 2022.
Author
Ono M.; Serruys P.W.; Kawashima H.; Lunardi M.; Wang R.; Hara H.; Gao C.;
Garg S.; O'Leary N.; Wykrzykowska J.J.; Piek J.J.; Holmes D.R.; Morice
M.-C.; Kappetein A.P.; Noack T.; Davierwala P.M.; Spertus J.A.; Cohen
D.J.; Onuma Y.
Institution
(Ono, Kawashima, Hara, Wykrzykowska, Piek) Department of Cardiology,
Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands
(Ono, Serruys, Kawashima, Lunardi, Wang, Hara, Gao, O'Leary, Onuma)
Department of Cardiology, National University of Ireland, Galway (NUIG),
Galway, Ireland
(Serruys, Onuma) CURAM-SFI Centre for Research in Medical Devices, Galway,
Ireland
(Serruys) NHLI, Imperial College London, London, United Kingdom
(Wang, Gao) Department of Cardiology, Radboud University, Nijmegen,
Netherlands
(Garg) Department of Cardiology, Royal Blackburn Hospital, Blackburn,
United Kingdom
(Wykrzykowska) University Medical Center Groningen, Groningen, Netherlands
(Holmes) Department of Cardiovascular Diseases and Internal Medicine, Mayo
Clinic, Rochester, MN, United States
(Morice) Hopital prive Jacques Cartier, Ramsay Generale de Sante Massy,
France
(Kappetein) Department of Cardiothoracic Surgery, Erasmus University
Medical Centre, Rotterdam, Netherlands
(Noack, Davierwala) University Department of Cardiac Surgery, Heart Centre
Leipzig, Leipzig, Germany
(Spertus) Department of Cardiology, Saint Luke's Mid America Heart
Institute/UMKC, Kansas City, MO 22, United States
(Cohen) Cardiovascular Research Foundation, New York NY and St. Francis
Hospital, United States
Publisher
NLM (Medline)
Abstract
AIMS: The aim of this study was to investigate the impact on 10-year
survival of patient-reported anginal status at 1-year following
percutaneous coronary intervention (PCI) or coronary artery bypass graft
(CABG) in patients with left main coronary artery disease (LMCAD) and/or
3-vessel CAD (3VD). METHODS AND RESULTS: In this post-hoc analysis of the
randomized SYNTAX Extended Survival study, patients were classified as
having residual angina (RA) if their self-reported Seattle Angina
Questionnaire angina frequency scale (SAQ-AF) was <= 90 at 1-year
follow-up post revascularization with PCI or CABG. The primary endpoint of
all-cause death at 10 years was compared between the RA and no-RA groups.
A sensitivity analysis was performed using 6-month SAQ-AF.At 1-year, 373
(26.1%) out of 1428 patients reported RA. Whilst RA at 1-year was an
independent correlate of repeat revascularization at 5 years (18.3% vs.
11.5%; adjusted hazard ratio [HR]: 1.54; 95% confidence interval [CI]:
1.10-2.15), it was not associated with all-cause death at 10 years (22.1%
vs. 21.6%; adjusted HR: 1.11; 95%CI: 0.83-1.47). These results were
consistent when stratified by modality of revascularization (PCI or CABG)
or by anginal frequency. The sensitivity analysis replicating the analyses
based on 6-month angina status resulted in similar findings.
 CONCLUSION(S): Among patients with LMCAD and/or 3VD, patient-reported
RA at 1-year post revascularization was independently associated with
repeat revascularization at 5 years, however it did not significantly
increase 10-year mortality, irrespective of the primary modality of
revascularization. Copyright © The Author(s) 2022. Published by
Oxford University Press on behalf of the European Society of Cardiology.

<14>
Accession Number
638837033
Title
Machine learning to predict adverse outcomes after cardiac surgery: A
systematic review and meta-analysis.
Source
Journal of cardiac surgery. (no pagination), 2022. Date of Publication:
24 Aug 2022.
Author
Penny-Dimri J.C.; Bergmeir C.; Perry L.; Hayes L.; Bellomo R.; Smith J.A.
Institution
(Penny-Dimri, Smith) Department of Surgery, School of Clinical Sciences at
Monash Health, Monash University, Clayton, VIC, Australia
(Bergmeir) Department of Data Science and Artificial Intelligence, Faculty
of Information Technology, Monash University, Clayton, VIC, United States
(Perry) Department of Anaesthesia and Pain Management, Royal Melbourne
Hospital, Melbourne, VIC, Australia
(Perry, Bellomo) Department of Critical Care, University of Melbourne,
Melbourne, VIC, Australia
(Hayes) Department of Anaesthesia, Barwon Health, Geelong, VIC, Australia
(Bellomo) Australian New Zealand Intensive Care Research Centre, Monash
University, Melbourne, VIC, Australia
(Bellomo) Department of Intensive Care, Royal Melbourne Hospital,
Melbourne, VIC, Australia
(Bellomo) Department of Intensive Care Research, Austin Hospital,
Melbourne, VIC, Australia
Publisher
NLM (Medline)
Abstract
BACKGROUND: Machine learning (ML) models are promising tools for
predicting adverse postoperative outcomes in cardiac surgery, yet have not
translated to routine clinical use. We conducted a systematic review and
meta-analysis to assess the predictive performance of ML approaches.
 METHOD(S): We conducted an electronic search to find studies
assessing ML and traditional statistical models to predict postoperative
outcomes. Our primary outcome was the concordance (C-) index of
discriminative performance. Using a Bayesian meta-analytic approach we
pooled the C-indices with the 95% credible interval (CrI) across multiple
outcomes comparing ML methods to logistic regression (LR) and clinical
scoring tools. Additionally, we performed critical difference and
sensitivity analysis. RESULT(S): We identified 2792 references from
the search of which 51 met inclusion criteria. Two postoperative outcomes
were amenable for meta-analysis: 30-day mortality and in-hospital
mortality. For 30-day mortality, the pooled C-index and 95% CrI were 0.82
(0.79-0.85), 0.80 (0.77-0.84), 0.78 (0.74-0.82) for ML models, LR, and
scoring tools respectively. For in-hospital mortality, the pooled C-index
was 0.81 (0.78-0.84) and 0.79 (0.73-0.84) for ML models and LR,
respectively. There were no statistically significant results indicating
ML superiority over LR. CONCLUSION(S): In cardiac surgery patients,
for the prediction of mortality, current ML methods do not have greater
discriminative power over LR as measured by the C-index. Copyright
© 2022 The Authors. Journal of Cardiac Surgery published by Wiley
Periodicals LLC.

<15>
Accession Number
638836738
Title
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
- Design and Rationale of the CAPITAL MINOS Trial.
Source
American heart journal. (no pagination), 2022. Date of Publication: 21
Aug 2022.
Author
Parlow S.; Di Santo P.; Jung R.G.; Fam N.; Czarnecki A.; Horlick E.;
Abdel-Razek O.; Chan V.; Hynes M.; Nicholson D.; Dryden A.; Fernando S.M.;
Wells G.A.; Bernick J.; Labinaz M.; Mathew R.; Simard T.; Hibbert B.
Institution
(Parlow, Abdel-Razek, Labinaz, Mathew) Division of Cardiology, University
of Ottawa Heart Institute, Ottawa, Ontario, Canada; CAPITAL Research
Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
(Di Santo) Division of Cardiology, University of Ottawa Heart Institute,
Ottawa, Ontario, Canada; CAPITAL Research Group, University of Ottawa
Heart Institute, Ottawa, Ontario, Canada; School of Epidemiology and
Public Health, University of Ottawa, Ottawa, Ontario, Canada
(Jung) CAPITAL Research Group, University of Ottawa Heart Institute,
Ottawa, Ontario, Canada; Vascular Biology and Experimental Medicine
Laboratory, University of Ottawa Heart Institute, Ottawa, Ontario, Canada;
Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
(Fam) Division of Cardiology, St. Michael's Hospital, University of
Toronto, Toronto, ON, Canada
(Czarnecki) Division of Cardiology, Sunnybrook Hospital, University of
Toronto, Toronto, ON, Canada
(Horlick) Division of Cardiology, Toronto General Hospital, University of
Toronto, Toronto, ON, Canada
(Chan) Division of Cardiac Surgery, University of Ottawa Heart Institute,
Ottawa, ON, Canada
(Hynes, Nicholson, Dryden) Division of Cardiac Anesthesiology, University
of Ottawa Heart Institute, Ottawa, ON, Canada
(Fernando) Division of Critical Care Medicine, Department of Medicine,
University of Ottawa, Ottawa, Ontario, Canada; Clinical Epidemiology
Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa,
Ontario, Canada
(Wells) School of Epidemiology and Public Health, University of Ottawa,
Ottawa, Ontario, Canada; Cardiovascular Research Methods Center,
University of Ottawa Heart Institute, Ottawa, Ontario, Canada
(Bernick) Cardiovascular Research Methods Center, University of Ottawa
Heart Institute, Ottawa, ON, Canada
(Simard) Department of Cardiovascular Diseases, Mayo Clinic School of
Medicine, Rochester, MN, United States
(Hibbert) Division of Cardiology, University of Ottawa Heart Institute,
Ottawa, Ontario, Canada; CAPITAL Research Group, University of Ottawa
Heart Institute, Ottawa, Ontario, Canada; Vascular Biology and
Experimental Medicine Laboratory, University of Ottawa Heart Institute,
Ottawa, Ontario, Canada
Publisher
NLM (Medline)
Abstract
BACKGROUND: Functional mitral regurgitation (MR) is an important clinical
consideration in patients with heart failure. Transcatheter edge-to-edge
repair (TEER) has emerged as a useful therapeutic tool for patients with
chronic heart failure, however the role of TEER in patients with
cardiogenic shock (CS) and MR has not yet been studied in a randomized
trial. The Transcatheter Mitral Valve Repair for Inotrope Dependent
Cardiogenic Shock (CAPITAL MINOS) trial was therefore designed to
determine if TEER improves clinical outcomes in the CS population. METHODS
AND DESIGN: The CAPITAL MINOS trial is an open-label, multi-center
randomized clinical trial comparing TEER to medical therapy in patients
with CS and MR. A total of 144 patients with Society for Cardiovascular
Angiography and Interventions (SCAI) class C or D CS and at least 3+ MR
will be randomized in a 1:1 ratio to TEER or medical therapy alone. The
primary outcome will be a composite of in-hospital all-cause mortality,
cardiac transplantation, implantation of durable left ventricular assist
device, or discharge on palliative inotropic therapy. Patients will be
followed for the duration of their index hospitalization for the primary
outcome. Secondary outcomes include 6-month mortality. IMPLICATIONS: The
CAPITAL MINOS trial will determine whether TEER improves outcomes in
patients with CS and MR and will be an important step in optimizing
treatment for this high-risk patient population. Copyright ©
2022. Published by Elsevier Inc.

<16>
Accession Number
638831806
Title
Effect of a Decision Aid on Agreement between Patient Preferences and
Repair Type for Abdominal Aortic Aneurysm: A Randomized Clinical Trial.
Source
JAMA Surgery. (pp E222935), 2022. Date of Publication: 2022.
Author
Eid M.A.; Barry M.J.; Tang G.L.; Henke P.K.; Johanning J.M.; Tzeng E.;
Scali S.T.; Stone D.H.; Suckow B.D.; Lee E.S.; Arya S.; Brooke B.S.;
Nelson P.R.; Spangler E.L.; Murebee L.; Dosluoglu H.H.; Raffetto J.D.;
Kougais P.; Brewster L.P.; Alabi O.; Dardik A.; Halpern V.J.; O'Connell
J.B.; Ihnat D.M.; Zhou W.; Sirovich B.E.; Metha K.; Moore K.O.; Voorhees
A.; Goodney P.P.
Institution
(Eid, Stone, Suckow, Sirovich, Metha, Moore, Voorhees, Goodney) Department
of Surgery and VA Outcomes Group, White River Junction VA Medical Center,
163 Veterans Drive, White River Junction, VT 05009, United States
(Eid, Stone, Suckow, Sirovich, Metha, Goodney) Geisel School of Medicine
at Dartmouth, Hanover, NH, United States
(Barry) Massachusetts General Hospital Center for Shared Decision Making,
Boston, United States
(Tang) Seattle VA Medical Center, Seattle, WA, United States
(Henke) Ann Arbor VA Medical Center, Ann Arbor, MI, United States
(Johanning) Omaha VA Medical Center, Omaha, NE, United States
(Tzeng) Pittsburgh VA Medical Center, Pittsburgh, PA, United States
(Scali) Gainesville VA Medical Center, Gainesville, FL, United States
(Lee) Sacramento VA Medical Center, Mather, CA, United States
(Arya) Palo Alto VA Medical Center, Palo Alto, CA, United States
(Brooke) Salt Lake City VA, Salt Lake City, UT, United States
(Nelson) Muskogee VA Medical Center, Muskogee, OK, United States
(Spangler) Birmingham VA, Birmingham, AL, United States
(Murebee) Durham VA Medical Center, Durham, NC, United States
(Dosluoglu) Buffalo VA Medical Center, Buffalo, NY, United States
(Raffetto) West Roxbury VA, Boston, MA, United States
(Kougais) Houston VA Medical Center, Houston, TX, United States
(Brewster, Alabi) Atlanta VA Medical Center, Atlanta, GA, United States
(Dardik) West Haven VA Medical Center, West Haven, CT, United States
(Halpern) Phoenix VA Medical Center, Phoenix, AZ, United States
(O'Connell) Los Angeles VA Medical Center, Los Angeles, CA, United States
(Ihnat) Minneapolis VA Medical Center, Minneapolis, MN, United States
(Zhou) Tucson VA Medical Center, Tucson, AZ, United States
Publisher
American Medical Association
Abstract
Importance: Patients with abdominal aortic aneurysm (AAA) can choose open
repair or endovascular repair (EVAR). While EVAR is less invasive, it
requires lifelong surveillance and more frequent aneurysm-related
reinterventions than open repair. A decision aid may help patients receive
their preferred type of AAA repair. Objective(s): To determine the
effect of a decision aid on agreement between patient preference for AAA
repair type and the repair type they receive. Design, Setting, and
Participant(s): In this cluster randomized trial, 235 patients were
randomized at 22 VA vascular surgery clinics. All patients had AAAs
greater than 5.0 cm in diameter and were candidates for both open repair
and EVAR. Data were collected from August 2017 to December 2020, and data
were analyzed from December 2020 to June 2021. Intervention(s):
Presurgical consultation using a decision aid vs usual care. Main
Outcomes and Measures: The primary outcome was the proportion of patients
who had agreement between their preference and their repair type, measured
using chi2analyses, kappa statistics, and adjusted odds ratios.
 Result(s): Of 235 included patients, 234 (99.6%) were male, and the
mean (SD) age was 73 (5.9) years. A total of 126 patients were enrolled in
the decision aid group, and 109 were enrolled in the control group. Within
2 years after enrollment, 192 (81.7%) underwent repair. Patients were
similar between the decision aid and control groups by age, sex, aneurysm
size, iliac artery involvement, and Charlson Comorbidity Index score.
Patients preferred EVAR over open repair in both groups (96 of 122 [79%]
in the decision aid group; 81 of 106 [76%] in the control group; P =.60).
Patients in the decision aid group were more likely to receive their
preferred repair type than patients in the control group (95% agreement
[93 of 98] vs 86% agreement [81 of 94]; P =.03), and kappa statistics were
higher in the decision aid group (kappa = 0.78; 95% CI, 0.60-0.95)
compared with the control group (kappa = 0.53; 95% CI, 0.32-0.74).
Adjusted models confirmed this association (odds ratio of agreement in the
decision aid group relative to control group, 2.93; 95% CI, 1.10-7.70).
 Conclusions and Relevance: Patients exposed to a decision aid were
more likely to receive their preferred AAA repair type, suggesting that
decision aids can help better align patient preferences and treatments in
major cardiovascular procedures. Trial Registration: ClinicalTrials.gov
Identifier: NCT03115346. Copyright © 2022 American Medical
Association. All rights reserved.

<17>
Accession Number
373224384
Title
Kidney Function after off-pump or on-pump Coronary Artery Bypass Graft
Surgery: A randomized clinical trial.
Source
JAMA. 311(21) (pp 2191-2198), 2014. Date of Publication: 04 Jun 2014.
Author
Garg A.X.; Devereaux P.J.; Yusuf S.; Cuerden M.S.; Parikh C.R.; Coca S.G.;
Walsh M.; Novick R.; Cook R.J.; Jain A.R.; Pan X.; Noiseux N.; Vik K.;
Stolf N.A.; Ritchie A.; Favaloro R.R.; Parvathaneni S.; Whitlock R.P.; Ou
Y.; Lawrence M.; Lamy A.
Institution
(Garg, Cuerden) Division of Nephrology, Department of Medicine, Western
University, London, ON, Canada
(Garg) Department of Epidemiology and Biostatistics, Western University,
London, ON, Canada
(Garg, Devereaux, Yusuf, Walsh) Department of Clinical Epidemiology and
Biostatistics, McMaster University, Hamilton, ON, Canada
(Devereaux, Yusuf, Walsh, Whitlock, Ou, Lawrence, Lamy) Population Health
Research Institute, Hamilton, ON, Canada
(Cuerden, Cook) Department of Statistics and Actuarial Science, University
of Waterloo, Waterloo, ON, Canada
(Parikh, Coca) Section of Nephrology, Yale University School of Medicine,
New Haven, CT, United States
(Novick) Division of Cardiac Surgery, Western University, London, ON,
Canada
(Jain) SAL Hospital and Medical Institute, Ahmadabad, India
(Pan) Department of Cardiovascular Surgery, Fuiwai Hospital, Chinese
Academy of Medical Sciences, Peking Union Medical College, Beijing, China
(Noiseux) Department of Cardiac Surgery, Centre Hospitalier de
l'Universite de Montreal CHUM, Montreal, QC, Canada
(Vik) University Hospital Motol, Praha, Czechia
(Stolf) Instituto do Coracao do Hospital Das Clinicas da, Sao Paulo,
Brazil
(Ritchie) Essex Cardiothoracic Centre and Anglia Ruskin University, Essex,
United Kingdom
(Favaloro) Department of Cardiovascular Surgery, Hospital Universitario
Fundacion Favaloro, Buenos Aires, Argentina
(Parvathaneni) Mercy Hospital, Springfield, MO, United States
(Whitlock, Lamy) Division of Cardiac Surgery, McMaster University,
Hamilton, ON, Canada
Publisher
American Medical Association
Abstract
IMPORTANCE: Most acute kidney injury observed in the hospital is defined
by sudden mild or moderate increases in the serum creatinine
concentration, which may persist for several days. Such acute kidney
injury is associated with lower long-term kidney function. However, it has
not been demonstrated that an intervention that reduces the risk of such
acute kidney injury better preserves long-term kidney function.
 OBJECTIVE(S): To characterize the risk of acute kidney injury with an
intervention in a randomized clinical trial and to determine if there is a
difference between the 2 treatment groups in kidney function 1 year later.
DESIGN, SETTING, AND PARTICIPANTS: The Coronary Artery Bypass Grafting
Surgery Off- or On-pump Revascularisation Study (CORONARY) enrolled 4752
patients undergoing first isolated coronary artery bypass graft (CABG)
surgery at 79 sites in 19 countries. Patients were randomized to receive
CABG surgery either with a beating-heart technique (off-pump) or with
cardiopulmonary bypass (on-pump). From January 2010 to November 2011, 2932
patients (from 63 sites in 16 countries) from CORONARY were enrolled into
a kidney function substudy to record serum creatinine concentrations
during the postoperative period and at 1 year. The last 1-year serum
creatinine concentration was recorded on January 18, 2013. MAIN OUTCOMES
AND MEASURES: Acute kidney injury within 30 days of surgery (>=50%
increase in serum creatinine concentration from prerandomization
concentration) and loss of kidney function at 1 year (>=20% loss in
estimated glomerular filtration rate from prerandomization level). RESULTS
Off-pump (n = 1472) vs on-pump (n = 1460) CABG surgery reduced the risk of
acute kidney injury (17.5%vs 20.8%, respectively; relative risk, 0.83
[95%CI, 0.72-0.97], P = .01); however, there was no significant difference
between the 2 groups in the loss of kidney function at 1 year (17.1%vs
15.3%, respectively; relative risk, 1.10 [95%CI, 0.95-1.29], P = .23).
Results were consistent with multiple alternate continuous and categorical
definitions of acute kidney injury or kidney function loss, and in the
subgroup with baseline chronic kidney disease. CONCLUSIONS AND RELEVANCE:
Use of off-pump compared with on-pump CABG surgery reduced the risk of
postoperative acute kidney injury, without evidence of better preserved
kidney function with off-pump CABG surgery at 1 year. In this setting, an
intervention that reduced the risk of mild to moderate acute kidney injury
did not alter longer-term kidney function. TRIAL REGISTRATION:
clinicaltrials.gov Identifier: NCT00463294 Copyright 2014 American Medical
Association. All rights reserved.

<18>
Accession Number
372831414
Title
Comparison of balloon-expandable vs self-expandable valves in patients
undergoing transcatheter aortic valve replacement: The CHOICE randomized
clinical trial.
Source
JAMA. 311(15) (pp 1503-1514), 2014. Date of Publication: 16 Apr 2014.
Author
Abdel-Wahab M.; Mehilli J.; Frerker C.; Neumann F.-J.; Kurz T.; Tolg R.;
Zachow D.; Guerra E.; Massberg S.; Schafer U.; El-Mawardy M.; Richardt G.
Institution
(Abdel-Wahab, Tolg, El-Mawardy, Richardt) Heart Center, Segeberger
Kliniken GmbH, Academic Teaching Hospital of the Universities of Kiel and
Hamburg, Am Kurpark 1, 23795 Bad Segeberg, Germany
(Mehilli, Massberg) Munich University Clinic, Munich, Germany
(Frerker, Schafer) Cardiology Department, Asklepios Clinic St. Georg,
Hamburg, Germany
(Neumann) University Heart Center Freiburg-Bad Krozingen, Bad Krozingen,
Germany
(Kurz) Cardiology Department, Lubeck University Hospital, Lubeck, Germany
(Zachow) Radiology Department, Segeberger Kliniken, Bad Segeberg, Germany
(Guerra) Intracoronary Stenting and Antithrombosis Research Center,
Munich, Germany
(Schafer) Cardiology Department, University Hospital Hamburg-Eppendorf,
Hamburg, Germany
Publisher
American Medical Association
Abstract
IMPORTANCE: Transcatheter aortic valve replacement (TAVR) is an effective
treatment option for high-risk patients with severe aortic stenosis.
Different from surgery, transcatheter deployment of valves requires either
a balloon-expandable or self-expandable system. A randomized comparison of
these 2 systems has not been performed. OBJECTIVE(S): To determine
whether the balloon-expandable device is associated with a better success
rate than the self-expandable device. DESIGN, SETTING, AND PATIENTS: The
CHOICE studywas an investigator-initiated trial in high-risk patients with
severe aortic stenosis and an anatomy suitable for the transfemoral TAVR
procedure. One hundred twenty-one patients were randomly assigned to
receive a balloon-expandable valve (Edwards Sapien XT) and 120 were
assigned to receive a self-expandable valve (Medtronic CoreValve).
Patients were enrolled between March 2012 and December 2013 at 5 centers
in Germany. INTERVENTIONS: Transfemoral TAVR with a balloon-expandable or
self-expandable device. MAIN OUTCOMES AND MEASURES: The primary end
pointwas device success, which is a composite end point including
successful vascular access and deployment of the device and retrieval of
the delivery system, correct position of the device, intended performance
of the heart valve without moderate or severe regurgitation, and only 1
valve implanted in the proper anatomical location. Secondary end points
included cardiovascular mortality, bleeding and vascular complications,
postprocedural pacemaker placement, and a combined safety end point at 30
days, including all-cause mortality, major stroke, and other serious
complications. RESULT(S): Device success occurred in 116 of 121
patients (95.9%) in the balloon-expandable valve group and 93 of 120
patients (77.5%) in the self-expandable valve group (relative risk [RR],
1.24, 95%CI, 1.12-1.37, P < .001). This was attributed to a significantly
lower frequency of residual more-than-mild aortic regurgitation (4.1%vs
18.3%; RR, 0.23; 95%CI, 0.09-0.58; P < .001) and the less frequent need
for implanting more than 1 valve (0.8%vs 5.8%, P = .03) in the
balloon-expandable valve group. Cardiovascular mortality at 30 days was
4.1% in the balloon-expandable valve group and 4.3%in the self-expandable
valve group (RR, 0.97; 95% CI, 0.29-3.25; P = .99). Bleeding and vascular
complications were not significantly different, and the combined safety
end point occurred in 18.2%of those in the balloon-expandable valve group
and 23.1%of the self-expandable valve group (RR, 0.79; 95%CI, 0.48-1.30; P
= .42). Placement of a new permanent pacemaker was less frequent in the
balloon-expandable valve group (17.3%vs 37.6%, P = .001). CONCLUSIONS AND
RELEVANCE: Among patients with high-risk aortic stenosis undergoing TAVR,
the use of a balloon-expandable valve resulted in a greater rate of device
success than use of a self-expandable valve. TRIAL REGISTRATION:
clinicaltrials.gov Identifier: NCT01645202. Copyright 2014 American
Medical Association. All rights reserved.

<19>
Accession Number
372153520
Title
Varespladib and cardiovascular events in patients with an acute coronary
syndrome: The VISTA-16 randomized clinical trial.
Source
JAMA. 311(3) (pp 252-262), 2014. Date of Publication: 15 Jan 2014.
Author
Nicholls S.J.; Kastelein J.J.P.; Schwartz G.G.; Bash D.; Rosenson R.S.;
Cavender M.A.; Brennan D.M.; Koenig W.; Jukema J.W.; Nambi V.; Wright
R.S.; Menon V.; Lincoff A.M.; Nissen S.E.; Hennekens C.; Brown W.V.;
DeMets D.; Pfeffer M.; Roleau J.; Abraham J.; Gebel J.; Huff C.; Katzan
I.; Shishehbor M.; Rassi A.; Uchino K.; Vest A.; Zishiri E.; Heckman M.J.;
Balog C.; Dart A.; Amerena J.; Prasad C.; Farshid A.; Gunalingam B.;
Thompson P.; Collins N.; Arstall M.; van Gaal W.; Aroney C.; Mahar L.;
Youssef G.; Horowitz J.; Anand D.; Rodes-Cabau J.; Polasek P.; Lai C.;
Huynh T.; Hubacek J.; Kokis A.; Paradis J.M.; Mukherjee A.; Senaratne M.;
Constance C.; Gosselin G.; Lavi S.; Parker J.; Zadra R.; Abramson B.;
Della-Siega A.; Spinar J.; Pudil R.; Motovska Z.; Maly M.; Hutyra M.;
Pleva L.; Mayer O.; Semenka J.; Klimovic T.; Horak D.; Cervinka P.; Klimsa
Z.; Hulinsky V.; Reichert P.; Monhart Z.; Rotterova H.; Kobulia B.;
Shaburishvili T.; Mamatsashvili M.; Chapidze G.; Chumburidze V.;
Megreladze I.; Khintibidze I.; Leithauser B.; Voehringer H.F.; Wachter R.;
Nogai K.; Lapp H.; Haltern G.; Gielen S.; Dorsel T.; Mollmann H.;
Stellbrink C.; Hengstenberg C.; Dengler T.; Heuer H.; Kreuzer J.; Leschke
M.; Mudra H.; Werner N.; Braun-Dullaeus R.; Rosenberg M.; Frey N.;
Strasser R.; Genth-Zotz S.; Kiss R.; Nagy A.; Kovacs Z.; Csapo K.; Edes
I.; Sereg M.; Vertes A.; Ronaszeki A.; Kancz S.; Benczur B.; Polgar P.;
Muller G.; Simonyi G.; Dezsi C.; Merkely B.; Dinnyes J.; Lupkovics G.;
Kahali D.; Banker D.; Trivedi S.; Rajput R.; Premchand R.; Dani S.;
Vadaganelli P.; Gupta S.; Chandra S.; Fulwani M.; Chawla K.; Parikh K.;
Prati F.; Speciale G.; Valgimigli M.; Suriano P.; Berni A.; Sangiorgi G.;
Fineschi M.; Merenda R.; Marenzi G.; Berti S.; Corrada E.; Cuccia C.;
Testa R.; Moretti L.; Mennuni M.; Biasucci L.M.; Lioy E.; Auguadro C.;
Magagnini E.; Fedele F.; Piscione F.; Azar R.; Trip M.D.; Liem A.; den
Hartoog M.; Lenderink T.; van de Wetering M.L.; Lok D.; Oei F.; Tans J.G.;
Ilmer B.; Keijzers M.; Monraats P.; Kedhi E.; Breedveld R.W.; Herrman J.;
van Wijk L.; Ronner E.; Nierop P.; Bosschaert M.; Hermans W.; Doevendans
P.; Troquay R.; van der Heijden R.; Veen G.; Bokern M.J.; Bronzwaer P.N.;
Kie S.H.; Den Hartog F.; Elliott J.; Wilkins G.; Hart H.; Devlin G.;
Harding S.; Ponikowski P.; Madej A.; Kochmanski M.; Witkowski A.; Pluta
W.; Bronisz M.; Kornacewicz-Jach Z.; Wysokinski A.; Ujda M.; Drozdz J.;
Derlaga B.; Gessek J.; Dabrowski M.; Miekus P.; Kozlowski A.; Gniot J.;
Musial W.; Dobrzycki S.; Rynkiewicz A.; Psuja P.; Rekosz J.; Drzewiecki
A.; Kuznetsov V.; Gordeev I.; Goloshchekin B.; Markov V.; Barbarich V.;
Belenky D.; Mikhin V.; Volkova E.; Timofeev A.; Ermoshkina L.; Barbarash
O.; Klein G.; Libis R.; Vishnevsky A.; Linev K.; Khaisheva L.; Ruda M.;
Dovgalevskiy Y.; Shvarts Y.; Zateyshchikov D.; Kostenko V.; Shalnev V.;
Simanenkov V.; Arkhipov M.; Ovcharenko E.; Guseva G.; Akhunova S.; Ortiz
A.I.; Navarro M.J.; Romero A.J.; Goya I.L.; Penaranda A.S.; Cendon A.A.;
Rubio A.M.; Zubiri J.J.; Soriano F.R.; Sanz R.R.; Genis A.B.; Lago V.N.;
Fernandez J.D.; Romo A.I.; Franco S.N.; Martin I.H.; Montero J.S.; Martin
Mde M.; Gonzalez M.J.; Antolin J.M.; Areses E.L.; Miranda J.M.;
Alonso-Pulpon L.; Esquivias G.B.; Jarne E.F.; Cortes J.M.; Perez M.B.;
Gormaz C.L.; Alegret J.M.; Nava J.S.; Ingelmo J.M.; Urbano R.H.; Sanmartin
M.; Katerenchuk O.; Vakaliuk I.; Karpenko O.; Prokhorov O.; Koval O.;
Faynyk A.; Kopytsya M.; Karpenko Y.; Kraiz I.; Feskov O.; Rudenko L.;
Kozhukhov S.; Goloborodko B.; Rivera E.; Broadwater S.; Crowley S.; Vijay
N.; Goswami R.; Ferrier L.; Blanchard A.; McCullum K.; Chernick R.;
Bertolet B.; Battaglia J.; Richardson J.; Lochridge S.; Lieberman S.;
Amkieh A.; Cavender J.B.; Denning S.; Treasure C.; Kmetzo J.; Stillabower
M.; Brilakis E.; Acheatel R.; Kukuy E.; Ashchi M.; Skelding K.; Martin L.;
Gillespie E.; French W.; Pollock S.; Polk D.; Black R.; Drenning D.;
Anderson J.; Sanz M.; Korban E.; Wiley M.; Rezkalla S.; Minisi A.; Shah
A.; Silverman P.; Amlani M.; Eaton G.; Brown A.; Jay D.; Loussararian A.;
Lamas G.; Lauer M.; Williams J.; Asfour A.; Runquist L.; Robertson R.;
Blonder R.; Davies C.; Downes T.; Chronos N.; Marso S.; Haldis T.; Eich
D.; Ahmed M.; East C.; MacDonald L.; Seigel P.; White M.; Camp A.; Kleiman
N.; Burtt D.; Strain J.; Go B.; Henry P.; Sultan P.; Delafontaine P.;
Kashou H.; Lambert C.; Movahed M.; Saucedo J.; Thadani U.; Chandrashekhar
Y.; Lu D.; Chandna H.; Mann J.; Ramaswamy G.; Browne K.; Janik M.; Cannon
K.; Tolerico P.
Institution
(Nicholls) South Australian Health and Medical Research Institute,
University of Adelaide, Adelaide, SA, Australia
(Kastelein) Academic Medical Center, Amsterdam, Netherlands
(Schwartz) Veterans Affairs Medical Center, University of Colorado,
Denver, CO, United States
(Bash, Brennan, Menon, Lincoff, Nissen) Cleveland Clinic Coordinating
Center for Clinical Research, Cleveland, OH, United States
(Rosenson) Icahn School of Medicine at Mount Sinai, New York, NY, United
States
(Cavender) Brigham and Women's Hospital, Boston, MA, United States
(Koenig) University of Ulm Medical Center, Ulm, Germany
(Jukema) Leiden University Medical Center, Leiden, Netherlands
(Jukema) Interuniversity Cardiology Institute of the Netherlands, Utrecht,
Netherlands
(Nambi) Michael E. DeBakey Veterans Affairs Hospital, Baylor College of
Medicine, Houston, TX, United States
(Wright) Mayo Clinic, Rochester, MN, United States
Publisher
American Medical Association (E-mail: smcleod@itsa.ucsf.edu)
Abstract
IMPORTANCE: Secretory phospholipase A<inf>2</inf> (sPLA<inf>2</inf>)
generates bioactive phospholipid products implicated in atherosclerosis.
The sPLA<inf>2</inf> inhibitor varespladib has favorable effects on lipid
and inflammatory markers; however, its effect on cardiovascular outcomes
is unknown. OBJECTIVE(S): To determine the effects of
sPLA<inf>2</inf> inhibition with varespladib on cardiovascular outcomes.
DESIGN, SETTING, AND PARTICIPANTS: A double-blind, randomized, multicenter
trial at 362 academic and community hospitals in Europe, Australia, New
Zealand, India, and North America of 5145 patients randomized within 96
hours of presentation of an acute coronary syndrome (ACS) to either
varespladib (n = 2572) or placebo (n = 2573) with enrollment between June
1, 2010, and March 7, 2012 (study termination on March 9, 2012).
INTERVENTIONS: Participants were randomized to receive varespladib (500
mg) or placebo daily for 16 weeks, in addition to atorvastatin and other
established therapies. MAIN OUTCOMES AND MEASURES: The primary efficacy
measurewas a composite of cardiovascular mortality, nonfatal myocardial
infarction (MI), nonfatal stroke, or unstable angina with evidence of
ischemia requiring hospitalization at 16 weeks. Six-month survival status
was also evaluated. RESULT(S): At a prespecified interim analysis,
including 212 primary end point events, the independent data and safety
monitoring board recommended termination of the trial for futility and
possible harm. The primary end point occurred in 136 patients (6.1%)
treated with varespladib compared with 109 patients (5.1%) treated with
placebo (hazard ratio [HR], 1.25; 95%CI, 0.97-1.61; log-rank P = .08).
Varespladib was associated with a greater risk of MI (78 [3.4%] vs 47
[2.2%]; HR, 1.66; 95%CI, 1.16-2.39; log-rank P = .005). The composite
secondary end point of cardiovascular mortality, MI, and stroke was
observed in 107 patients (4.6%) in the varespladib group and 79 patients
(3.8%) in the placebo group (HR, 1.36; 95% CI, 1.02-1.82; P = .04).
CONCLUSIONS AND RELEVANCE: In patients with recent ACS, varespladib did
not reduce the risk of recurrent cardiovascular events and significantly
increased the risk of MI. The sPLA<inf>2</inf> inhibition with varespladib
may be harmful and is not a useful strategy to reduce adverse
cardiovascular outcomes after ACS. TRIAL REGISTRATION: clinicaltrials.gov
Identifier: NCT01130246. Copyright 2014 American Medical Association. All
rights reserved.

<20>
Accession Number
370289534
Title
Coronary artery bypass graft surgery vs percutaneous interventions in
coronary revascularization: A systematic review.
Source
JAMA. 310(19) (pp 2086-2095), 2013. Date of Publication: 20 Nov 2013.
Author
Deb S.; Wijeysundera H.C.; Ko D.T.; Tsubota H.; Hill S.; Fremes S.E.
Institution
(Deb, Wijeysundera, Ko, Tsubota, Hill, Fremes) Schulich Heart Centre,
Division of Cardiology and Cardiac Surgery, Sunnybrook Health Sciences
Centre, Toronto, ON, Canada
(Deb, Wijeysundera, Ko, Fremes) Institute of Health Policy Management and
Evaluation, University of Toronto, Toronto, ON, Canada
(Wijeysundera, Ko) Institute for Clinical Evaluative Sciences, Toronto,
ON, Canada
Publisher
American Medical Association
Abstract
IMPORTANCE: Ischemic heart disease is the leading cause of death globally.
Coronary artery bypass graft (CABG) surgery and percutaneous coronary
intervention (PCI) are the revascularization options for ischemic heart
disease. However, the choice of the most appropriate revascularization
modality is controversial in some patient subgroups. OBJECTIVE(S): To
summarize the current evidence comparing the effectiveness of CABG surgery
and PCI in patients with unprotected left main disease (ULMD, in which
there is >50% left main coronary stenosis without protective bypass
grafts), multivessel coronary artery disease (CAD), diabetes, or left
ventricular dysfunction (LVD). EVIDENCE REVIEW: A search of OvidSP
MEDLINE, EMBASE, and Cochrane databases between January 2007 and June
2013, limited to randomized clinical trials (RCTs) and meta-analysis of
trials and/or observational studies comparing CABG surgery with PCI was
performed. Bibliographies of relevant studies were also searched.
Mortality and major adverse cardiac and cerebrovascular events (MACCE,
defined as all-cause mortality, myocardial infarction, stroke, and repeat
revascularization) were reported wherever possible. FINDINGS: Thirteen
RCTs and 5 meta-analyses were included. CABG surgery should be recommended
in patients with ULMD, multivessel CAD, or LVD, if the severity of
coronary disease is deemed to be complex (SYNTAX >22) due to lower cardiac
events associated with CABG surgery. In cases in which coronary disease is
less complex (SYNTAX <=22) and/or the patient is a higher surgical risk,
PCI should be considered. For patients with diabetes and multivessel CAD,
CABG surgery should be recommended as standard therapy irrespective of the
severity of coronary anatomy, given improved long-term survival and lower
cardiac events (5-year MACCE, 18.7% for CABG surgery vs 26.6% for PCI; P =
.005). Overall, the incidence of repeat revascularization is higher after
PCI, whereas stroke is higher after CABG surgery. Current literature
emphasizes the importance of a heart-team approach that should consider
coronary anatomy, patient characteristics, and local expertise in
revascularization options. Literature pertaining to revascularization
options in LVD is scarce predominantly due to LVD being an exclusion
factor in most studies. CONCLUSIONS AND RELEVANCE: Both CABG surgery and
PCI are reasonable options for patients with advanced CAD. Patients with
diabetes generally have better outcomes with CABG surgery than PCI. In
cases of ULMD, multivessel CAD, or LVD, CABG surgery should be favored in
patients with complex coronary lesions and anatomy and PCI in less
complicated coronary disease or deemed a high surgical risk. A heart-team
approach should evaluate coronary disease complexity, patient
comorbidities, patient preferences, and local expertise. Copyright 2013
American Medical Association. All rights reserved.

<21>
Accession Number
370015116
Title
Quality of life after PCI vs CABG among patients with diabetes and
multivessel coronary artery disease: A randomized clinical trial.
Source
JAMA. 310(15) (pp 1581-1590), 2013. Date of Publication: 16 Oct 2013.
Author
Abdallah M.S.; Wang K.; Magnuson E.A.; Spertus J.A.; Farkouh M.E.; Fuster
V.; Cohen D.J.
Institution
(Abdallah, Wang, Magnuson, Spertus, Cohen) Saint Luke's Mid America Heart
Institute, University of Missouri-Kansas City School of Medicine,
4401Wornall Rd, Kansas City, MO 64111, United States
(Abdallah, Magnuson, Spertus, Cohen) University of Missouri-Kansas City
School of Medicine, Kansas City, MO, United States
(Farkouh, Fuster) Mount Sinai School of Medicine, New York, NY, United
States
(Farkouh) Peter Munk Cardiac Centre, Li Ka Shing Knowledge Institute,
University of Toronto, Toronto, ON, Canada
Publisher
American Medical Association
Abstract
IMPORTANCE: The FREEDOM trial demonstrated that among patients with
diabetes mellitus and multivessel coronary artery disease, coronary artery
bypass graft (CABG) surgery resulted in lower rates of death and
myocardial infarction but a higher risk of stroke when compared with
percutaneous coronary intervention (PCI) using drug-eluting stents.
Whether there are treatment differences in health status, as assessed from
the patient's perspective, is unknown. OBJECTIVE(S): To compare the
relative effects of CABG vs PCI using drug-eluting stents on health status
among patients with diabetes mellitus and multivessel coronary artery
disease. DESIGN, SETTING, AND PARTICIPANTS: Between 2005 and 2010, 1900
patients from 18 countries with diabetes mellitus and multivessel coronary
artery disease were randomized to undergo either CABG surgery (n = 947) or
PCI (n = 953) as an initial treatment strategy. Of these, a total of 1880
patients had baseline health status assessed (935 CABG, 945 PCI) and
comprised the primary analytic sample. INTERVENTIONS: Initial
revascularization with CABG surgery or PCI. MAIN OUTCOMES AND MEASURES:
Health statuswas assessed using the angina frequency, physical
limitations, and quality-of-life domains of the Seattle Angina
Questionnaire at baseline, at 1, 6, and 12 months, and annually
thereafter. For each scale, scores range from 0 to 100 with higher scores
representing better health. The effect of CABG surgery vs PCI was
evaluated using longitudinal mixed-effect models. RESULT(S): At
baseline, mean (SD) scores for the angina frequency, physical limitations,
and quality-of-life subscales of the Seattle Angina Questionnaire were
70.9 (25.1), 67.3 (24.4), and 47.8 (25.0) for the CABG group and 71.4
(24.7), 69.9 (23.2), and 49.2 (25.7) for the PCI group, respectively. At
2-year follow-up, mean (SD) scores were 96.0 (11.9), 87.8 (18.7), and 82.2
(18.9) after CABG and 94.7 (14.3), 86.0 (19.3), and 80.4 (19.6) after PCI,
with significantly greater benefit of CABG on each domain (mean treatment
benefit, 1.3 [95%CI, 0.3-2.2], 4.4 [95%CI, 2.7-6.1], and 2.2 [95%CI,
0.7-3.8] points, respectively; P < .01 for each comparison). Beyond 2
years, the 2 revascularization strategies provided generally similar
patient-reported outcomes. CONCLUSIONS AND RELEVANCE: For patients with
diabetes and multivessel CAD, CABG surgery provided slightly better
intermediate-term health status and quality of life than PCI using
drug-eluting stents. Themagnitude of benefit was small, without consistent
differences beyond 2 years, in part due to the higher rate of repeat
revascularization with PCI.

<22>
Accession Number
368629250
Title
Effect of an investigational vaccine for preventing Staphylococcus aureus
infections after cardiothoracic surgery: A randomized trial.
Source
JAMA. 309(13) (pp 1368-1378), 2013. Date of Publication: 03 Apr 2013.
Author
Fowler V.G.; Allen K.B.; Moreira E.D.; Moustafa M.; Isgro F.; Boucher
H.W.; Corey G.R.; Carmeli Y.; Betts R.; Hartzel J.S.; Chan I.S.F.; McNeely
T.B.; Kartsonis N.A.; Guris D.; Onorato M.T.; Smugar S.S.; DiNubile M.J.;
Meulen A.S.-T.
Institution
(Fowler, Corey) Duke University Medical Center, Duke Clinical Research
Institute, Durham, NC, United States
(Allen) St. Luke's Mid-America Heart and Vascular Institute, Kansas City,
MO, United States
(Moreira) Division of Cancer Epidemiology, McGill University, Montreal,
QC, Canada
(Moreira) Associacao Obras Sociais Irma Dulce- Oswaldo Cruz Foundation,
Brazilian Ministry of Health, Salvador, Bahia, Brazil
(Moustafa) South Carolina Nephrology and Hypertension Center, Orangeburg,
SC, United States
(Isgro) Academic City Hospital Ludwigshafen, Ludwigshafen, Germany
(Boucher) Tufts Medical Center, Boston, MA, United States
(Carmeli) Beth Israel Deaconess Medical Center, Boston, MA, United States
(Betts) University of Rochester, School of Medicine, Rochester, NY, United
States
(Hartzel, Chan, McNeely, Kartsonis, Guris, Onorato, Smugar, DiNubile,
Meulen) Merck Sharp and Dohme, Whitehouse Station, NJ, United States
Publisher
American Medical Association
Abstract
Importance: Infections due to Staphylococcus aureus are serious
complications of cardiothoracic surgery. A novel vaccine candidate (V710)
containing the highly conserved S aureus iron surface determinant B is
immunogenic and generally well tolerated in volunteers. Objective(s):
To evaluate the efficacy and safety of preoperative vaccination in
preventing serious postoperative S aureus infection in patients undergoing
cardiothoracic surgery. Design, Setting, and Participant(s):
Double-blind, randomized, event-driven trial conducted between December
2007 and August 2011 among 8031 patients aged 18 years or older who were
scheduled for full median sternotomy within 14 to 60 days of vaccination
at 165 sites in 26 countries. Intervention(s): Participants were
randomly assigned to receive a single 0.5-mL intramuscular injection of
either V710 vaccine, 60 mug (n=4015), or placebo (n=4016). Main
Outcome Measure(s): The primary efficacy end point was prevention of S
aureus bacteremia and/or deep sternal wound infection (including
mediastinitis) through postoperative day 90. Secondary end points included
all S aureus surgical site and invasive infections through postoperative
day 90. Three interim analyses with futility assessments were planned.
 Result(s): The independent data monitoring committee recommended
termination of the study after the second interim analysis because of
safety concerns and low efficacy. At the end of the study, the V710
vaccine was not significantly more efficacious than placebo in preventing
either the primary end points (22/3528 V710 vaccine recipients [2.6 per
100 person-years] vs 27/3517 placebo recipients [3.2 per 100
person-years]; relative risk, 0.81; 95% CI, 0.44-1.48; P = .58) or
secondary end points despite eliciting robust antibody responses. Compared
with placebo, the V710 vaccine was associated with more adverse
experiences during the first 14 days after vaccination (1219/3958 vaccine
recipients [30.8%; 95% CI, 29.4%-32.3%] and 866/3967 placebo recipients
[21.8%; 95% CI, 20.6%-23.1%], including 797 [20.1%; 95% CI, 18.9%-21.4%]
and 378 [9.5%; 95% CI, 8.6%-10.5%] with injection site reactions and 66
[1.7%; 95% CI, 1.3%-2.1%] and 51 [1.3%; 95% CI, 1.0%-1.7%] with serious
adverse events, respectively) and a significantly higher rate of
multiorgan failure during the entire study (31 vs 17 events; 0.9 [95% CI,
0.6-1.2] vs 0.5 [95% CI, 0.3-0.8] events per 100 person-years; P = .04).
Although the overall incidence of vaccine-related serious adverse events
(1 in each group) and the all-cause mortality rate (201/3958 vs 177/3967;
5.7 [95% CI, 4.9-6.5] vs 5.0 [95% CI, 4.3-5.7] deaths per 100
person-years; P = .20) were not statistically different between groups,
the mortality rate in patients with staphylococcal infections was
significantly higher among V710 vaccine than placebo recipients (15/73 vs
4/96; 23.0 [95% CI, 12.9-37.9] vs 4.2 [95% CI, 1.2-10.8] per 100
person-years; difference, 18.8 [95% CI, 8.0-34.1] per 100 person-years).
 Conclusions and Relevance: Among patients undergoing cardiothoracic
surgery with median sternotomy, the use of a vaccine against S aureus
compared with placebo did not reduce the rate of serious postoperative S
aureus infections and was associated with increased mortality among
patients who developed S aureus infections. These findings do not support
the use of the V710 vaccine for patients undergoing surgical
interventions. Trial Registration: clinicaltrials.gov Identifier:
NCT00518687. ©2013 American Medical Association. All rights reserved.

<23>
Accession Number
368607256
Title
Effect of disodium EDTA chelation regimen on cardiovascular events in
patients with previous myocardial infarction: The TACT randomized trial.
Source
JAMA. 309(12) (pp 1241-1250), 2013. Date of Publication: 27 Mar 2013.
Author
Lamas G.A.; Goertz C.; Boineau R.; Mark D.B.; Rozema T.; Nahin R.L.;
Lindblad L.; Lewis E.F.; Drisko J.; Lee K.L.
Institution
(Lamas) Columbia University, Division of Cardiology, Mount Sinai Medical
Center, 4300 Alton Rd, Miami Beach, FL 33140, United States
(Goertz) Palmer Center for Chiropractic Research, Davenport, IA, United
States
(Boineau) National Heart, Lung, and Blood Institute, Bethesda, MD, United
States
(Nahin) National Center for Complementary and Alternative Medicine,
Bethesda, MD, United States
(Mark, Lindblad, Lee) Duke Clinical Research Institute, Durham, NC, United
States
(Rozema) Biogenesis Medical Center, Landrum, SC, United States
(Lewis) Brigham and Women's Hospital, Harvard Medical School, Boston, MA,
United States
(Drisko) Integrative Medicine, University of Kansas Medical Center, Kansas
City, United States
Publisher
American Medical Association
Abstract
Importance: Chelation therapy with disodium EDTA has been used for more
than 50 years to treat atherosclerosis without proof of efficacy.
 Objective(s): To determine if an EDTA-based chelation regimen reduces
cardiovascular events. Design, Setting, and Participant(s):
Double-blind, placebo-controlled, 2 x 2 factorial randomized trial
enrolling 1708 patients aged 50 years or older who had experienced a
myocardial infarction (MI) at least 6 weeks prior and had serum creatinine
levels of 2.0 mg/dL or less. Participants were recruited at 134 US and
Canadian sites. Enrollment began in September 2003 and follow-up took
place until October 2011 (median, 55 months). Two hundred eighty-nine
patients (17% of total; n=115 in the EDTA group and n=174 in the placebo
group) withdrew consent during the trial. Intervention(s): Patients
were randomized to receive 40 infusions of a 500-mL chelation solution (3
g of disodium EDTA, 7 g of ascorbate, B vitamins, electrolytes, procaine,
and heparin) (n=839) vs placebo (n=869) and an oral vitamin-mineral
regimen vs an oral placebo. Infusions were administered weekly for 30
weeks, followed by 10 infusions 2 to 8 weeks apart. Fifteen percent
discontinued infusions (n=38 [16%] in the chelation group and n=41 [15%]
in the placebo group) because of adverse events. Main Outcome
Measure(s): The prespecified primary end point was a composite of total
mortality, recurrent MI, stroke, coronary revascularization, or
hospitalization for angina. This report describes the intention-to-treat
comparison of EDTA chelation vs placebo. To account for multiple interim
analyses, the significance threshold required at the final analysis was
P=.036. Result(s): Qualifying previous MIs occurred a median of 4.6
years before enrollment. Median age was 65 years, 18% were female, 9% were
nonwhite, and 31% were diabetic. The primary end point occurred in 222
(26%) of the chelation group and 261 (30%) of the placebo group (hazard
ratio [HR], 0.82 [95% CI, 0.69-0.99]; P=.035). There was no effect on
total mortality (chelation: 87 deaths [10%]; placebo, 93 deaths [11%]; HR,
0.93 [95% CI, 0.70-1.25]; P=.64), but the study was not powered for this
comparison. The effect of EDTA chelation on the components of the primary
end point other than death was of similar magnitude as its overall effect
(MI: chelation, 6%; placebo, 8%; HR, 0.77 [95% CI, 0.54-1.11]; stroke:
chelation, 1.2%; placebo, 1.5%; HR, 0.77 [95% CI, 0.34-1.76]; coronary
revascularization: chelation, 15%; placebo, 18%; HR, 0.81 [95% CI,
0.64-1.02]; hospitalization for angina: chelation, 1.6%; placebo, 2.1%;
HR, 0.72 [95% CI, 0.35-1.47]). Sensitivity analyses examining the effect
of patient dropout and treatment adherence did not alter the results.
 Conclusions and Relevance: Among stable patients with a history of
MI, use of an intravenous chelation regimen with disodium EDTA, compared
with placebo, modestly reduced the risk of adverse cardiovascular
outcomes, many of which were revascularization procedures. These results
provide evidence to guide further research but are not sufficient to
support the routine use of chelation therapy for treatment of patients who
have had an MI. Trial Registration: clinicaltrials.gov Identifier:
NCT00044213. ©2013 American Medical Association. All rights reserved.

<24>
Accession Number
368071301
Title
Effect of intravenous paracetamol on postoperative morphine requirements
in neonates and infants undergoing major noncardiac surgery: A randomized
controlled trial.
Source
JAMA. 309(2) (pp 149-154), 2013. Date of Publication: 09 Jan 2013.
Author
Ceelie I.; De Wildt S.N.; Van Dijk M.; Van Den Berg M.M.J.; Van Den Bosch
G.E.; Duivenvoorden H.J.; De Leeuw T.G.; Mathot R.; Knibbe C.A.J.; Tibboel
D.
Institution
(Ceelie, De Wildt, Van Dijk, Van Den Berg, Van Den Bosch, Knibbe, Tibboel)
Department of Pediatric Surgery, Erasmus MC, Sophia Children's Hospital,
Rotterdam, Netherlands
(De Leeuw) Department of Anesthesiology, Erasmus MC, Sophia Children's
Hospital, Rotterdam, Netherlands
(Duivenvoorden) Departments of Medical Psychology and Psychotherapy,
Erasmus MC, Rotterdam, Netherlands
(Mathot) Clinical Pharmacology Unit, Department Hospital Pharmacy,
Academic Medical Centre, Amsterdam, Netherlands
(Knibbe) Leiden/Amsterdam Center for Drug Research, Division of
Pharmacology, Leiden University, Leiden, Netherlands
(Knibbe) Department of Clinical Pharmacy, St. Antonius Hospital,
Nieuwegein, Netherlands
Publisher
American Medical Association
Abstract
Importance: Continuous morphine infusion as standard postoperative
analgesic therapy inyounginfants is associated withunwantedadverse effects
such as respiratory depression. Objective(s): To determine whether
intravenous paracetamol (acetaminophen) would significantly (>30%) reduce
morphine requirements in neonates and infants after major surgery. Design,
Setting, and Patients: Single-center, randomized, double-blind study
conducted in a level3 pediatric intensive care unit in Rotterdam, the
Netherlands. Patients were 71 neonates or infants younger than 1 year
undergoing major thoracic (noncardiac) or abdominal surgery between March
2008 and July 2010, with follow-up of 48 hours. Intervention(s): All
patients received a loading dose of morphine 30 minutes before the end of
surgery, followed by continuous morphine or intermittent intravenous
paracetamol up to 48 hours postsurgery. Infants in both study groups
received morphine (boluses and/or continuous infusion) as rescue
medication on the guidance of the validated pain assessment instruments.
 Main Outcome Measure(s): Primary outcome was cumulative morphine dose
(study and rescue dose). Secondary outcomes were pain scores and
morphine-related adverse effects. Result(s): The cumulative median
morphine dose in the first 48 hours postoperatively was 121 (interquartile
range, 99-264) mug/kg in the paracetamol group (n=33) and 357
(interquartile range, 220-605) mug/kgin the morphine group (n=38), P<.001,
with a between group difference that was 66% (95% CI, 34%-109%) lower in
the paracetamol group. Pain scores and adverse effects were not
significantly different between groups. Conclusion and Relevance: Among
infants undergoing major surgery, postoperative use of intermittent
intravenous paracetamol compared with continuous morphine resulted in a
lower cumulative morphine dose over 48 hours. Trial Registration:
trialregister.nl Identifier: NTR1438. ©2013 American Medical
Association. All rights reserved.

<25>
Accession Number
366059433
Title
Fish oil and postoperative atrial fibrillation: The omega-3 fatty acids
for prevention of post-operative atrial fibrillation (OPERA) randomized
trial.
Source
JAMA. 308(19) (pp 2001-2011), 2012. Date of Publication: 21 Nov 2012.
Author
Mozaffarian D.; Marchioli R.; Macchia A.; Silletta M.G.; Ferrazzi P.;
Gardner T.J.; Latini R.; Libby P.; Lombardi F.; O'Gara P.T.; Page R.L.;
Tavazzi L.; Tognoni G.; Santini M.; Albert C.M.; Maggioni A.P.; Murray
K.T.; Harris B.; Saffitz J.E.; Siscovick D.; Stein P.; Corradi D.; Masson
S.; Brown N.J.; Ely E.W.; Jackson J.C.; Shintani A.; Milne G.L.; Song X.;
Sellke F.W.; Pioggiarella R.; Marfisi L.; King S.L.; Mills K.E.; Ogunleye
A.; Schelling N.H.; Wu J.; Simon C.; Iascone M.; Sinatra R.; Benedetto U.;
Dreas L.; Aleksova A.; Rinaldi M.; Salizzoni S.; Marchetto G.; Lamarra M.;
Pagliaro M.; Jori M.C.; Dozza L.; Calvi S.; Casabona R.; Zingarelli E.;
Flocco R.; Eusebio A.; Raffa G.; Tarelli G.; Parolari A.; Cavallotti L.;
Miyasoedova V.; Laguzzi F.; Gregorini R.; Mangia F.; Gazzoli F.; Raviola
E.; Vigano M.; Livi U.; Pompei E.; Salvador L.; Lamascese N.; Bilotta M.;
Martinelli L.; Cannata A.; Byrne J.; Leacche M.; Petracek M.R.; Ball S.K.;
Jessen M.E.; Weyant M.; Damiano R.J.; Singh A.K.; McDonald M.J.; Bolman
R.M.; Conboy D.A.; Burgess A.; Puskas J.D.; Vander-Woude J.; Bell M.C.;
Sethi G.; Lee D.C.; Favaloro R.R.; Hershson A.R.; Figal J.C.; Domenech A.;
Halac M.; Nicolosi L.N.; Moros C.G.; Del Carmen Rubio M.; Suarez R.F.;
Cacheda H.; Casal J.P.; Medrano J.C.; Cucurell M.C.; Scattini F.; Nojek
C.; Camporrotondo M.; Herrington D.M.; Brooks M.M.; De Caterina R.;
Gillinov M.; Padeletti L.; Pellegrini F.; Rothschild B.B.; Rubinstein F.;
Diep P.Q.; Guzman J.B.; Palmarini L.; Sacchetti S.; Flamminio A.V.;
Marfisi R.; Scarano M.; Afshin A.; Huang H.; Otite F.; Ambrosio M.;
Lincesso A.; Pezzoli L.; Anzini M.; Carriere C.; Belfiore R.; Fortunato
G.; Pellegrini A.; Reale V.; Sorrentino P.; Schiavina G.; Negrosanti M.;
Ravenni G.; Moro F.; Brambilla M.; Nava C.; Giroli M.; Daprati A.; Gennari
M.; Cusihuaman D.E.P.; Spagnolo B.; Francia M.; Stanca M.; Paris M.;
Berwick D.; Lusona B.; Castiglione N.; De Biasio M.; Daffarra C.; Ahmad
R.; Meisch C.A.; Maltais S.; Balaguer J.; Donahue T.; Guyton R.A.;
Thourani V.; Halkos M.; Lattouf O.; Baio K.T.; Levine S.R.; Pitts Z.E.;
Janssen K.; Ruhlman M.; Sharp S.; Pang K.; Mungo M.N.; Servian A.L.;
Battellini R.; Marenchino R.; Kotowicz V.; Cesareo V.; Sanchez R.; Romero
V.; Avila S.; Donnini F.; Biancospino L.; Laurino R.; Portalea R.
Institution
(Mozaffarian, Libby, O'Gara) Division of Cardiovascular Medicine, 665
Huntington Ave, Bldg 2-319, Boston, MA 02115, United States
(Mozaffarian, Libby, O'Gara, Albert, Saffitz, Bolman, Conboy, Burgess)
Channing Division of Network Medicine, Department of Medicine, Brigham and
Women's Hospital, Harvard Medical School, 665 Huntington Ave, Bldg 2-319,
Boston, MA 02115, United States
(Mozaffarian) Department of Epidemiology and Nutrition, Harvard School of
Public Health, 665 Huntington Ave, Bldg 2-319, Boston, MA 02115, United
States
(Marchioli, Silletta, Tognoni, Pellegrini) Department of Clinical
Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Laboratory of
Clinical Epidemiology of Cardiovascular Disease, Via Nazionale 8,
Santa-Maria-Imbaro CH 66030, Italy
(Macchia) GESICA Foundation, Buenos-Aires, Argentina
(Ferrazzi, Simon, Iascone, Ambrosio, Lincesso, Pezzoli) Ospedali Riuniti
di Bergamo, Bergamo, Italy
(Gardner) Center for Heart and Vascular Health, Christiana Care Health
System, Newark, DE, United States
(Latini, Masson) Department of Cardiovascular Research, Istituto di
Ricerche Farmacologiche Mario Negri, Milan, Italy
(Lombardi) Department of Health Sciences, University of Milan, Milan,
Italy
(Page) Department of Medicine, University of Wisconsin, School of Medicine
and Public Health, Madison, United States
(Tavazzi) GVM Hospitals of Care and Research, Villa Maria Cecilia
Hospital, Cotignola, Italy
(Santini) Ospedale San Filippo Neri, Rome, Italy
(Maggioni) Centro Studi Associazione Nazionale Medici Cardiologi
Ospedalieri, Florence, Italy
(Murray, Brown, Ely, Jackson, Shintani, Milne, Byrne, Leacche, Petracek,
Ball, Ahmad, Meisch, Maltais, Balaguer) Vanderbilt University, School of
Medicine, Nashville, TN, United States
(Harris) Sanford School of Medicine, Sioux Falls, SD, United States
(Siscovick) University of Washington, Seattle, United States
(Stein, Damiano, Donahue) Washington University, School of Medicine, St.
Louis, MO, United States
(Corradi) University of Parma, Parma, Italy
(Song, Diep, Guzman) Fred Hutchinson Cancer Research Center, Seattle, WA,
United States
(Sellke, Singh, McDonald) Brown Medical School, Rhode Island Hospital,
Providence, United States
(Silletta, Pioggiarella, Marfisi, Palmarini, Sacchetti, Flamminio,
Marfisi, Scarano) Main Data Coordinating Center, Consorzio Mario Negri
Sud, Santa-Maria-Imbaro, Italy
(King, Mills, Ogunleye, Schelling, Wu, Afshin, Huang, Otite) US Clinical
Coordinating Center, Harvard School of Public Health, Boston, MA, United
States
(Sinatra, Benedetto) Ospedale S. Andrea, Universita la Sapienza, Roma,
Italy
(Dreas, Aleksova, Anzini, Carriere, Belfiore) Ospedali Riuniti, University
of Trieste, Trieste, Italy
(Rinaldi, Salizzoni, Marchetto, Raviola, Fortunato, Pellegrini, Reale,
Sorrentino) Department of Surgical Sciences, Division of Cardiac Surgery,
University of Torino, Torino, Italy
(Lamarra, Pagliaro, Jori, Dozza, Calvi, Schiavina, Negrosanti) GVM Care
and Research, E.S. Health Science Foundation, Cotignola, Italy
(Casabona, Zingarelli, Flocco, Ravenni) Azienda Ospedaliera Ordine
Mauriziano di Torino, Ospedale Mauriziano Umberto I, Torino, Italy
(Eusebio, Raffa, Tarelli) Unit of Cardiac Surgery, Humanitas Clinical and
Research Center, Rozzano, Italy
(Parolari, Cavallotti, Miyasoedova, Laguzzi, Moro, Brambilla, Nava,
Giroli, Daprati, Gennari, Cusihuaman) Centro Cardiologico Monzino,
I.R.C.C.S., Milano, Italy
(Gregorini, Mangia, Spagnolo, Francia, Stanca) GVM Care and Research, E.S.
Health Science Foundation, Lecce, Italy
(Gazzoli, Raviola, Vigano, Paris, Berwick, Lusona, Castiglione) Fondazione
I.R.C.C.S. Policlinico S. Matteo, Pavia, Italy
(Livi, Pompei, De Biasio, Daffarra) Azienda Ospedaliero, Universitaria
Santa Maria della Misericordia, Udine, Italy
(Salvador, Lamascese, Bilotta) Ospedale San Bortolo, Vicenza, Italy
(Martinelli, Cannata) Niguarda Ca' Granda Hospital, Department of Cardiac
Surgery, Milan, Italy
(Jessen, Weyant) University of Texas Southwestern Medical Center, Dallas,
United States
(Puskas, Guyton, Thourani, Halkos, Lattouf, Baio, Levine, Pitts) Emory
Healthcare, Atlanta, GA, United States
(Vander-Woude, Bell, Janssen, Ruhlman) Sanford Health, Sanford University
of South Dakota Medical Center, Sioux Falls, United States
(Sethi, Sharp) University of Arizona, Tucson Medical Center, Tucson,
United States
(Lee, Pang) State University of New York Downstate, Brooklyn, United
States
(Favaloro, Hershson, Figal, Mungo, Servian) Fundacion Favaloro, Buenos
Aires, Argentina
(Domenech, Halac, Battellini, Marenchino, Kotowicz, Cesareo, Sanchez,
Romero, Avila) Hospital Italiano, Buenos Aires, Argentina
(Nicolosi, Moros, Del Carmen Rubio, Suarez, Donnini, Biancospino) Hospital
Espanol, Buenos Aires, Argentina
(Cacheda, Casal, Laurino, Portalea) Instituto de Cardiologia de
Corrientes, Corrientes, Argentina
(Medrano, Cucurell, Scattini) Clinica y Maternidadde Suizo, Buenos Aires,
Argentina
(Nojek, Camporrotondo) Instituto Fundacion de Lucha Contra Las
Enfermedades Neurologicas en la Infancia, Buenos Aires, Argentina
(Herrington) Wake Forest University, School of Medicine, Winston-Salem,
NC, United States
(Brooks) University of Pittsburgh, Pittsburgh, PA, United States
(De Caterina) Universita degli Studi G. d'Annunzio, Chieti, Italy
(Gillinov) Cleveland Clinic Main Campus, Cleveland, OH, United States
(Padeletti) University of Florence, Florence, Italy
(Rothschild) University of North Carolina, Chapel Hill, United States
(Rubinstein) IECS - Instituto de Efectividad Clinica y Sanitaria, Buenos
Aires, Argentina
Publisher
American Medical Association (E-mail: smcleod@itsa.ucsf.edu)
Abstract
Context: Postoperative atrial fibrillation or flutter (AF) is one of the
most common complications of cardiac surgery and significantly increases
morbidity and health care utilization. A few small trials have evaluated
whether long-chain n-3-polyunsaturated fatty acids (PUFAs) reduce
postoperative AF, with mixed results. Objective(s): To determine
whether perioperative n-3-PUFA supplementation reduces postoperative AF.
Design, Setting, and Patients: The Omega-3 Fatty Acids for Prevention of
Postoperative Atrial Fibrillation (OPERA) double-blind,
placebo-controlled, randomized clinical trial. A total of 1516 patients
scheduled for cardiac surgery in 28 centers in the United States, Italy,
and Argentina were enrolled between August 2010 and June 2012. Inclusion
criteria were broad; the main exclusions were regular use of fish oil or
absence of sinus rhythm at enrollment. Intervention(s): Patients were
randomized to receive fish oil (1-g capsules containing >=840 mg n-3-PUFAs
as ethyl esters) or placebo, with preoperative loading of 10 g over 3 to 5
days (or 8 g over 2 days) followed postoperatively by 2 g/d until hospital
discharge or postoperative day 10, whichever came first. Main Outcome
Measure(s): Occurrence of postoperative AF lasting longer than 30 seconds.
Secondary end points were postoperative AF lasting longer than 1 hour,
resulting in symptoms, or treated with cardioversion; postoperative AF
excluding atrial flutter; time to first postoperative AF; number of AF
episodes per patient; hospital utilization; and majoradverse
cardiovascular events, 30-day mortality, bleeding, and other adverse
events. Result(s): At enrollment, mean age was 64 (SD, 13) years;
72.2% of patients were men, and 51.8% had planned valvular surgery. The
primary end point occurred in 233 (30.7%) patients assigned to placebo and
227 (30.0%) assigned to n-3-PUFAs (odds ratio, 0.96 [95% CI, 0.77-1.20];
P=74). None of the secondary end points were significantly different
between the placebo and fish oil groups, including postoperative AF that
was sustained, symptomatic, or treated (231 [30.5%] vs224 [29.6%], P=70)
or number of postoperative AF episodes per patient (1 episode: 156 [20.6%]
vs 157 [20.7%]; 2 episodes: 59 [7.8%] vs 49 [6.5%]; >=3 episodes: 18
[2.4%] vs 21 [2.8%]) (P=.73). Supplementation with n-3-PUFAs was generally
well tolerated, with no evidence for increased risk of bleeding or serious
adverse events. Conclusion(s): In this large multinational trial
among patients undergoing cardiac surgery, perioperative supplementation
with n-3-PUFAs, compared with placebo, did not reduce the risk of
postoperative AF. Copyright © 2012 American Medical Association.
All rights reserved.

<26>
Accession Number
365511473
Title
Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal
stents on cardiovascular events among patients with acute myocardial
infarction: The comfortable AMI randomized trial.
Source
JAMA. 308(8) (pp 777-787), 2012. Date of Publication: 22 Aug 2012.
Author
Raber L.; Kelbaek H.; Ostoijc M.; Baumbach A.; Heg D.; Tuller D.; Von
Birgelen C.; Roffi M.; Moschovitis A.; Khattab A.A.; Wenaweser P.; Bonvini
R.; Pedrazzini G.; Kornowski R.; Weber K.; Trelle S.; Luscher T.F.;
Taniwaki M.; Matter C.M.; Meier B.; Juni P.; Windecker S.
Institution
(Raber, Moschovitis, Khattab, Wenaweser, Taniwaki, Meier, Windecker)
Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland
(Kelbaek) Cardiac Catheterization Laboratory, Rigshospitalet, Copenhagen,
Denmark
(Ostoijc) Department of Cardiology, Clinical Center of Serbia, Belgrade,
Serbia
(Baumbach) Bristol Heart Institute, Bristol, United Kingdom
(Heg, Juni) Institute of Social and Preventive Medicine, University of
Bern, Bern, Switzerland
(Trelle, Juni, Windecker) Clinical Trials Unit, Department of Clinical
Research, University of Bern, Bern, Switzerland
(Tuller) Cardiology Department, Triemlispital, Zurich, Switzerland
(Von Birgelen) Thoraxcentrum Twente, Twente University, Enschede,
Netherlands
(Roffi, Bonvini) Division of Cardiology, University Hospital, Geneva,
Switzerland
(Pedrazzini) Cardiocentro, Lugano, Switzerland
(Kornowski) Rabin Medical Center, Petach Tikva, Israel
(Kornowski) Tel Aviv University, Tel Aviv, Israel
(Weber) Herzzentrum Bodensee, Kreuzlingen, Switzerland
(Luscher, Matter) Cardiology Department, University Hospital Zurich,
Zurich, Switzerland
Publisher
American Medical Association
Abstract
Context: The efficacy and safety of drug-eluting stents compared with
bare-metal stents remains controversial in patients with ST-segment
elevation myocardial infarction (STEMI) undergoing primary percutaneous
coronary intervention (PCI). Objective(s): To compare stents eluting
biolimus from a biodegradable polymer with bare-metal stents in primary
PCI. Design, Setting, and Patients: A prospective, randomized,
single-blinded, controlled trial of 1161 patients presenting with STEMI at
11 sites in Europe and Israel between September 19, 2009, and January 25,
2011. Clinical follow-up was performed at 1 and 12 months.
 Intervention(s): Patients were randomized 1:1 to receive the
biolimus-eluting stent (n=575) or the bare-metal stent (n=582). Main
Outcome Measure(s): Primary end point was the rate of major adverse
cardiac events, a composite of cardiac death, target vessel-related
reinfarction, and ischemiadriven target-lesion revascularization at 1
year. Result(s): Major adverse cardiac events at 1 year occurred in
24 patients (4.3%) receiving biolimus-eluting stents with biodegradable
polymer and 49 patients (8.7%) receiving bare-metal stents (hazard ratio
[HR], 0.49; 95% CI, 0.30-0.80; P=.004). The difference was driven by a
lower risk of target vessel-related reinfarction (3 [0.5%] vs 15 [2.7%];
HR, 0.20; 95% CI, 0.06-0.69; P=.01) and ischemia-driven target-lesion
revascularization (9 [1.6%] vs 32 [5.7%]; HR, 0.28; 95% CI, 0.13-0.59;
P<.001) in patients receiving biolimus-eluting stents compared with those
receiving bare-metal stents. Rates of cardiac death were not significantly
different (16 [2.9%] vs 20 [3.5%], P=.53). Definite stent thrombosis
occurred in 5 patients (0.9%) treated with biolimus-eluting stents and 12
patients (2.1%; HR, 0.42; 95% CI, 0.15-1.19; P=.10) treated with
bare-metal stents. Conclusion(s): Compared with a bare-metal stent,
the use of biolimus-eluting stents with a biodegradable polymer resulted
in a lower rate of the composite of major adverse cardiac events at 1 year
among patients with STEMI undergoing primary PCI. Trial Registration:
clinicaltrials.gov Identifier: NCT00962416. ©2012 American Medical
Association. All rights reserved.

<27>
Accession Number
365215845
Title
Effect of adenosine-regulating agent acadesine on morbidity and mortality
associated with coronary artery bypass grafting: The RED-CABG randomized
controlled trial.
Source
JAMA. 308(2) (pp 157-164), 2012. Date of Publication: 11 Jul 2012.
Author
Newman M.F.; Ferguson T.B.; White J.A.; Ambrosio G.; Koglin J.; Nussmeier
N.A.; Pearl R.G.; Pitt B.; Wechsler A.S.; Weisel R.D.; Reece T.L.; Lira
A.; Harrington R.A.
Institution
(Newman, White, Reece, Harrington) Duke Clinical Research Institute, Duke
University Medical Center, Durham, NC, United States
(Ferguson) Department of Cardiovascular Sciences, East Carolina Heart
Institute, Greenville, NC, United States
(Ambrosio) University of Perugia School of Medicine, Perugia, Italy
(Koglin, Lira) Merck Sharp and Dohme Corp., Whitehouse Station, NJ, United
States
(Nussmeier) SUNY Upstate Medical University, Syracuse, NY, United States
(Pearl) Stanford University School of Medicine, Palo Alto, CA, United
States
(Pitt) University of Michigan School of Medicine, Ann Arbor, MI, United
States
(Wechsler) Drexel University College of Medicine, Philadelphia, PA, United
States
(Weisel) University Health Network, Toronto, ON, Canada
Publisher
American Medical Association
Abstract
Context: Ischemia/reperfusion injury remains an important cause of
morbidity and mortality after coronary artery by pass graft (CABG)
surgery. In a meta-analysis of randomized controlled trials, perioperative
and postoperative infusion of acadesine,afirst-in-class adenosine
regulating agent, was associated with a reduction in early cardiac death,
myocardial infarction, and combined adverse cardiac outcomes in
participants undergoing on-pump CABG surgery. Objective(s): To assess
the efficacy and safety of acadesine administered in the perioperative
period in reducing all-cause mortality, nonfatal stroke, and severe left
ventricular dysfunction (SLVD) through 28 days. Design, Setting, and
Participant(s): The Reduction in Cardiovascular Events by Acadesine in
Patients Undergoing CABG (RED-CABG) trial, a randomized, double-blind,
placebo-controlled, parallel-group evaluation of intermediate- to
high-risk patients (median age, 66 years) undergoing nonemergency, on-pump
CABG surgery at 300 sites in 7 countries. Enrollment occurred from May 6,
2009, to July 30, 2010. Intervention(s): Eligible participants were
randomized 1:1 to receive acadesine (0.1 mg/kg per minute for 7 hours) or
placebo (both also added to cardioplegic solutions) beginning just before
anesthesia induction. Main Outcome Measure(s): Composite of all-cause
mortality, nonfatal stroke, or need for mechanical support for SLVD during
and following CABG surgery through postoperative day 28. Result(s):
Because results of a prespecified futility analysis indicated a very low
likelihood of a statistically significant efficacious outcome, the trial
was stopped after 3080 of the originally projected 7500 study participants
were randomized. The primary outcome occurred in 75 of 1493 participants
(5.0%) in the placebo group and 76 of 1493 (5.1%) in the acadesine group
(odds ratio, 1.01 [95% CI, 0.73-1.41]). There were no differences in key
secondary end points measured. Conclusion(s): In this population of
intermediate- to high-risk patients undergoing CABG surgery, acadesine did
not reduce the composite of all-cause mortality, nonfatal stroke, or SLVD.
Trial Registration: clinicaltrials.gov Identifier: NCT00872001. ©2012
American Medical Association. All rights reserved.

<28>
Accession Number
364664660
Title
Effect of transendocardial delivery of autologous bone marrow mononuclear
cells on functional capacity, left ventricular function, and perfusion in
chronic heart failure: The FOCUS-CCTRN trial.
Source
JAMA. 307(16) (pp 1717-1726), 2012. Date of Publication: 25 Apr 2012.
Author
Perin E.C.; Willerson J.T.; Pepine C.J.; Henry T.D.; Ellis S.G.; Zhao
D.X.M.; Silva G.V.; Lai D.; Thomas J.D.; Kronenberg M.W.; Martin A.D.;
Anderson R.D.; Traverse J.H.; Penn M.S.; Anwaruddin S.; Hatzopoulos A.K.;
Gee A.P.; Taylor D.A.; Cogle C.R.; Smith D.; Westbrook L.; Chen J.;
Handberg E.; Olson R.E.; Geither C.; Bowman S.; Francescon J.; Baraniuk
S.; Piller L.B.; Simpson L.M.; Loghin C.; Aguilar D.; Richman S.; Zierold
C.; Bettencourt J.; Sayre S.L.; Vojvodic R.W.; Skarlatos S.I.; Gordon
D.J.; Ebert R.F.; Kwak M.; Moye L.A.; Simari R.D.
Institution
(Perin, Willerson, Silva, Smith, Westbrook, Chen) Texas Heart Institute,
St. Luke's Episcopal Hospital, Houston, TX, United States
(Pepine, Anderson, Cogle, Handberg) School of Medicine, University of
Florida, Gainesville, FL, United States
(Martin) College of Public Health and Health Professions, University of
Florida, Gainesville, FL, United States
(Henry, Traverse, Olson) Minneapolis Heart Institute, Abbott Northwestern
Hospital, Minneapolis, MN, United States
(Henry, Traverse, Taylor, Zierold) School of Medicine, University of
Minnesota, Minneapolis, MN, United States
(Ellis, Thomas, Geither) Cleveland Clinic Foundation, Cleveland, OH,
United States
(Zhao, Kronenberg, Hatzopoulos, Bowman, Francescon) School of Medicine,
Vanderbilt University, Nashville, TN, United States
(Lai, Baraniuk, Piller, Simpson, Bettencourt, Sayre, Vojvodic, Moye)
School of Public Health, University of Texas, Houston, TX, United States
(Loghin) School of Medicine, University of Texas, Houston, TX, United
States
(Penn) Northeast Ohio Medical University, Akron, OH, United States
(Anwaruddin) Penn Heart and Vascular Hospital, University of Pennsylvania,
Philadelphia, PA, United States
(Gee, Aguilar, Richman) College of Medicine, Baylor University, Houston,
TX, United States
(Skarlatos, Gordon, Ebert, Kwak) National Heart, Lung, and Blood
Institute, Bethesda, MD, United States
(Simari) Mayo Clinic, Rochester, MN, United States
Publisher
American Medical Association
Abstract
Context: Previous studies using autologous bone marrow mononuclear cells
(BMCs) in patients with ischemic cardiomyopathy have demonstrated safety
and suggested efficacy. Objective(s): To determine if administration
of BMCs through transendocardial injections improves myocardial perfusion,
reduces left ventricular end-systolic volume (LVESV), or enhances maximal
oxygen consumption in patients with coronary artery disease or LV
dysfunction, and limiting heart failure or angina. Design, Setting, and
Patients: Aphase 2 randomized double-blind, placebo-controlled trial of
symptomatic patients (New York Heart Association classification II-III or
Canadian Cardiovascular Society classification II-IV) with a left
ventricular ejection fraction of 45% or less, a perfusion defect by
single-photon emission tomography (SPECT), and coronary artery
diseasenotam enable to revascularization who were receiving maximal
medical therapy at 5 National Heart, Lung, and Blood Institute-sponsored
Cardiovascular Cell Therapy Research Network (CCTRN) sites between April
29, 2009, and April 18, 2011. Intervention(s): Bone marrow aspiration
(isolation of BMCs using a standardized automated system performed
locally) and transendocardial injection of 100 million BMCs or placebo
(ratio of 2 for BMC group to 1 for placebo group). Main Outcome
Measure(s): Co-primary end points assessed at 6 months: changes in LVESV
assessed by echocardiography, maximal oxygen consumption, and
reversibility on SPECT. Phenotypic and functional analyses of the cell
product were performed by the CCTRN biorepository core laboratory.
 Result(s): Of 153 patients who provided consent, a total of 92 (82
men; average age: 63 years) were randomized (n=61 in BMC group and n=31 in
placebo group). Changes in LVESV index (-0.9 mL/m2 [95% CI, -6.1 to 4.3];
P=.73), maximal oxygen consumption (1.0 [95% CI, -0.42 to 2.34]; P=.17),
and reversible defect (-1.2 [95% CI, -12.50 to 10.12]; P=.84) were not
statistically significant. There were no differences found in any of the
secondary outcomes, including percent myocardial defect, total defect
size, fixed defect size, regional wall motion, and clinical improvement.
 Conclusion(s): Among patients with chronic ischemic heart failure,
transendocardial injection of autologous BMCs compared with placebo did
not improve LVESV, maximal oxygen consumption, or reversibility on SPECT.
Trial Registration: clinicaltrials.gov Identifier: NCT00824005. ©2012
American Medical Association. All rights reserved.

<29>
Accession Number
364111985
Title
Bridging antiplatelet therapy with cangrelor in patients undergoing
cardiac surgery: A randomized controlled trial.
Source
JAMA. 307(3) (pp 265-274), 2012. Date of Publication: 18 Jan 2012.
Author
Angiolillo D.J.; Firstenberg M.S.; Price M.J.; Tummala P.E.; Hutyra M.;
Welsby I.J.; Voeltz M.D.; Chandna H.; Ramaiah C.; Brtko M.; Cannon L.;
Dyke C.; Liu T.; Montalescot G.; Manoukian S.V.; Prats J.; Topol E.J.
Institution
(Angiolillo) Department of Cardiology, University of Florida,
Jacksonville, FL, United States
(Firstenberg) Division of Cardiothoracic Surgery, Ohio State University
Medical Center, Columbus, OH, United States
(Price, Topol) Division of Cardiovascular Diseases, Scripps Clinic and
Scripps Translational Science Institute, San Diego, CA, United States
(Tummala) Department of Cardiology, Northeast Georgia Heart Center,
Gainesville, GA, United States
(Hutyra) First Internal Clinic, Faculty Hospital Olomouc, Olomouc, Czechia
(Welsby) Department of Anesthesiology, Duke University Medical Center,
Durham, NC, United States
(Voeltz) Department of Cardiology, Henry Ford Hospital, Detroit, MI,
United States
(Chandna) Department of Cardiology, Detar Hospital, Victoria, TX, United
States
(Ramaiah) Deptartment of Surgery, University of Kentucky, Lexington, KY,
United States
(Brtko) Deptartment of Cardiac Surgery, University Hospital, Hradec
Kralove, Czechia
(Cannon) Cardiac and Vascular Research Center of Northern Michigan,
Northern Michigan Regional Hospital, Petoskey, MI, United States
(Dyke) SouthEast Texas Cardiovascular Surgery Associates, Humble, TX,
United States
(Liu, Prats) Medicines Company, Parsippany, NJ, United States
(Montalescot) Groupe Hospitalier Pitie-Salpetriere, Universite Paris 6,
INSERM CMR 937, Paris, France
(Manoukian) Sarah Cannon Research Institute, Hospital Corporation of
America, Nashville, TN, United States
Publisher
American Medical Association
Abstract
Context: Thienopyridines are among the most widely prescribed medications,
but their use can be complicated by the unanticipated need for surgery.
Despite increased risk of thrombosis, guidelines recommend discontinuing
thienopyridines 5 to 7 days prior to surgery to minimize bleeding.
 Objective(s): To evaluate the use of cangrelor, an intravenous,
reversible P2Y<inf>12</inf> platelet inhibitor for bridging
thienopyridine-treated patients to coronary artery bypass grafting (CABG)
surgery. Design, Setting, and Patients: Prospective, randomized,
double-blind, placebocontrolled, multicenter trial, involving 210 patients
with an acute coronary syndrome (ACS) or treated with a coronary stent and
receiving a thienopyridine awaiting CABG surgery to receive either
cangrelor or placebo after an initial open-label, dose-finding phase
(n=11) conducted between January 2009 and April 2011. Interventions
Thienopyridines were stopped and patients were administered cangrelor or
placebo for at least 48 hours, which was discontinued 1 to 6 hours before
CABG surgery. Main Outcome Measure(s): The primary efficacy end point
was platelet reactivity (measured in P2Y<inf>12</inf> reaction units
[PRUs]), assessed daily. The main safety end point was excessive CABG
surgery-related bleeding. Results The dose of cangrelor determined in 10
patients in the open-label stage was 0.75 mug/kg per minute. In the
randomized phase, a greater proportion of patients treated with cangrelor
had low levels of platelet reactivity throughout the entire treatment
period compared with placebo (primary end point, PRU <240; 98.8% (83 of
84) vs 19.0% (16 of 84); relative risk [RR], 5.2 [95% CI, 3.3-8.1]
P<.001). Excessive CABG surgery-related bleeding occurred in 11.8% (12 of
102) vs 10.4% (10 of 96) in the cangrelor and placebo groups, respectively
(RR, 1.1 [95% CI, 0.5-2.5] P=.763). There were no significant differences
in major bleeding prior to CABG surgery, although minor bleeding episodes
were numerically higher with cangrelor. Conclusion(s): Among patients
who discontinue thienopyridine therapy prior to cardiac surgery, the use
of cangrelor compared with placebo resulted in a higher rate of
maintenance of platelet inhibition. Trial Registration: clinicaltrials.gov
Identifier: NCT00767507. ©2012 American Medical Association. All
rights reserved.

<30>
Accession Number
363094328
Title
Percutaneous coronary intervention at centers with and without on-site
surgery: A meta-analysis.
Source
JAMA. 306(22) (pp 2487-2494), 2011. Date of Publication: 14 Dec 2011.
Author
Singh M.; Holmes D.R.; Dehmer G.J.; Lennon R.J.; Wharton T.P.; Kutcher
M.A.; Aversano T.; Rihal C.S.
Institution
(Singh, Holmes, Rihal) Division of Cardiovascular Diseases, Mayo Clinic,
200 First St SW, Rochester, MN 55905, United States
(Lennon) Division of Biomedical Statistics and Informatics, Mayo Clinic,
Rochester, MN, United States
(Dehmer) Division of Cardiology, Scott and White Healthcare, Temple, TX,
United States
(Wharton) Cardiovascular Medicine, Exeter Hospital, Exeter, NH, United
States
(Kutcher) Department of Cardiology, Wake Forest University Baptist Medical
Center, Winston-Salem, NC, United States
(Aversano) Department of Cardiology, Johns Hopkins Hospital, Baltimore,
MD, United States
Publisher
American Medical Association
Abstract
Context: Percutaneous coronary interventions are performed at centers
without onsite surgery, despite current guidelines discouraging this.
 Objective(s): To assess literature comparing rates of in-hospital
mortality and emergency coronary artery bypass grafting surgery at centers
with and without on-site surgery. Data Sources: A systematic search
of studies published between January 1990 and May 2010 was conducted using
MEDLINE, EMBASE, and Cochrane Review databases. Study Selection:
English-language studies of percutaneous coronary intervention performed
at centers with and without on-site surgery providing data on in-hospital
mortality and emergency bypass were identified. Two study authors
independently reviewed the 1029 articles originally identified and
selected 40 for analysis. Data Extraction: Study title, time period,
indication for angioplasty, and outcomes were extracted manually from all
selected studies, and quality of each study was assessed using the
strengthening the reporting of observational studies in epidemiology
(STROBE) checklist. Data Synthesis: High-quality studies of
percutaneous coronary interventions performed at centers with and without
on-site surgery were included. Pooled-effect estimates were calculated
with random-effects models. Analyses of primary percutaneous coronary
intervention for ST-segment elevation myocardial infarction of 124 074
patients demonstrated no increase in in-hospital mortality (no on-site
surgery vs on-site surgery: observed risk, 4.6% vs 7.2%; odds ratio [OR],
0.96; 95% CI, 0.88-1.05; I2 = 0%) or emergency bypass (observed
risk, 0.22% vs 1.03%; OR, 0.53; 95% CI, 0.35-0.79; I2 = 20%) at
centers without on-site surgery. For nonprimary percutaneous coronary
interventions (elective and urgent, n = 914 288), the rates of in-hospital
mortality (observed risk, 1.4% vs 2.1%; OR, 1.15; 95% CI, 0.93-1.41;
I2 = 46%) and emergency bypass (observed risk, 0.17% vs 0.29%;
OR, 1.21; 95% CI, 0.52-2.85; I 2 = 5%) were not significantly
different at centers without or with on-site surgery. Conclusion(s):
Percutaneous coronary interventions performed at centers without onsite
surgery, compared with centers with on-site surgery, were not associated
with a higher incidence of in-hospital mortality or emergency bypass
surgery. ©2011 American Medical Association. All rights reserved.

<31>
Accession Number
362364992
Title
Efficacy and tolerability of pegloticase for the treatment of chronic gout
in patients refractory to conventional treatment: Two randomized
controlled trials.
Source
JAMA. 306(7) (pp 711-720), 2011. Date of Publication: 17 Aug 2011.
Author
Sundy J.S.; Baraf H.S.B.; Yood R.A.; Edwards N.L.; Gutierrez-Urena S.R.;
Treadwell E.L.; Vazquez-Mellado J.; White W.B.; Lipsky P.E.; Horowitz Z.;
Huang W.; Maroli A.N.; Waltrip II R.W.; Hamburger S.A.; Becker M.A.
Institution
(Sundy) Duke Clinical Research Unit, Duke University Medical Center,
Durham, NC, United States
(Baraf) Center for Rheumatology and Bone Research, Wheaton, MD, United
States
(Yood) Fallon Clinic, Worcester, MA, United States
(Edwards) Division of Rheumatology, University of Florida, Gainesville,
FL, United States
(Gutierrez-Urena) Medicine/Rheumatology, Hospital Civil de Guadalajara,
Guadalajara, Mexico
(Treadwell) Division of Rheumatology, East Carolina University,
Greenville, NC, United States
(Vazquez-Mellado) Hospital General de Mexico, Mexico City, Mexico
(White) Calhoun Cardiology Center, University of Connecticut School of
Medicine, Farmington, CT, United States
(Horowitz, Huang, Maroli, Waltrip II, Hamburger) Savient Pharmaceuticals,
East Brunswick, NJ, United States
(Becker) Rheumatology Section, University of Chicago, Chicago, IL, United
States
(Horowitz) Celgene Corporation, Warren, NJ, United States
(Waltrip II) Talecris Biotherapeutics, Chapel Hill, NC, United States
Publisher
American Medical Association
Abstract
Context: Patients with chronic disabling gout refractory to conventional
urate-lowering therapy need timely treatment to control Disease
manifestations related to tissue urate crystal deposition. Pegloticase,
monomethoxypoly(ethylene glycol)-conjugated mammalian recombinant uricase,
was developed to fulfill this need. Objective(s): To assess the
efficacy and tolerability of pegloticase in managing refractory chronic
gout. Design, Setting, and Patients: Two replicate, randomized,
double-blind, placebo-controlled trials (C0405 and C0406) were conducted
between June 2006 and October 2007 at 56 rheumatology practices in the
United States, Canada, and Mexico in patients with severe gout,
allopurinol intolerance or refractoriness, and serum uric acid
concentration of 8.0 mg/dL or greater. A total of 225 patients
participated: 109 in trial C0405 and 116 in trial C0406.
 Intervention(s): Twelve biweekly intravenous infusions containing
either pegloticase 8 mg at each infusion (biweekly treatment group),
pegloticase alternating with placebo at successive infusions (monthly
treatment group), or placebo (placebo group). Main Outcome
Measure(s): Primary end point was plasma uric acid levels of less than 6.0
mg/dL in months 3 and 6. Result(s): In trial C0405 the primary end
point was reached in 20 of 43 patients in the biweekly group (47%; 95% CI,
31%-62%), 8 of 41 patients in the monthly group (20%; 95% CI, 9%-35%), and
in 0 patients treated with placebo (0/20; 95% CI, 0%-17%; P < .001 and
<.04 for comparisons between biweekly and monthly groups vs placebo,
respectively). Among patients treated with pegloticase in trial C0406, 16
of 42 in the biweekly group (38%; 95% CI, 24%-54%) and 21 of 43 in the
monthly group (49%; 95% CI, 33%-65%) achieved the primary end point; no
placebotreated patients reached the primary end point (0/23; 95% CI,
0%-15%; P=.001 and < .001, respectively). When data in the 2 trials were
pooled, the primary end point was achieved in 36 of 85 patients in the
biweekly group (42%; 95% CI, 32%-54%), 29 of 84 patients in the monthly
group (35%; 95% CI, 24%-46%), and 0 of 43 patients in the placebo group
(0%; 95% CI, 0%-8%; P < .001 for each comparison). Seven deaths (4 in
patients receiving pegloticase and 3 in the placebo group) occurred
between randomization and closure of the study database (February 15,
2008). Conclusion(s): Among patients with chronic gout, elevated
serum uric acid level, and allopurinol intolerance or refractoriness, the
use of pegloticase 8 mg either every 2 weeks or every 4 weeks for 6 months
resulted in lower uric acid levels compared with placebo. Trial
Registration clinicaltrials.gov Identifier: NCT00325195. ©2011
American Medical Association. All rights reserved.

<32>
Accession Number
361994035
Title
Risk of incident diabetes with intensive-dose compared with moderate-dose
statin therapy: A meta-analysis.
Source
JAMA. 305(24) (pp 2556-2564), 2011. Date of Publication: June 22-29, 2011.
Author
Preiss D.; Seshasai S.R.K.; Welsh P.; Murphy S.A.; Ho J.E.; Waters D.D.;
DeMicco D.A.; Barter P.; Cannon C.P.; Sabatine M.S.; Braunwald E.;
Kastelein J.J.P.; De Lemos J.A.; Blazing M.A.; Pedersen T.R.; Tikkanen
M.J.; Sattar N.; Ray K.K.
Institution
(Preiss, Welsh, Sattar) BHF Glasgow Cardiovascular Research Centre,
University of Glasgow, 126 University Pl, Glasgow G12 8TA, United Kingdom
(Seshasai) Department of Public Health and Primary Care, University of
Cambridge, Cambridge, United Kingdom
(Murphy, Cannon, Sabatine, Braunwald) TIMI Study Group, Cardiovascular
Division, Harvard Medical School, Boston, MA, United States
(Ho) Cardiovascular Division, Department of Medicine, Brigham and Women's
Hospital, Boston, United States
(Waters) Department of Medicine, University of California, San Francisco,
CA, United States
(DeMicco) Global Pharmaceuticals, Pfizer, New York, NY, United States
(Barter) Heart Research Institute, Sydney, NSW, Australia
(Kastelein) Department of Vascular Medicine, Academic Medical Centre,
University of Amsterdam, Amsterdam, Netherlands
(De Lemos) Division of Cardiology, University of Texas Southwestern
Medical Center, Dallas, TX, United States
(Blazing) Duke Clinical Research Institute, Durham, NC, United States
(Pedersen) University of Oslo, Centre for Preventative Medicine, Oslo
University Hospital, Ulleval, Oslo, Norway
(Tikkanen) University of Helsinki, Helsinki University Hospital,
Folkhalsan Research Center, Helsinki, Finland
(Ray) Division of Cardiac and Vascular Sciences, St. George's University
of London, Cranmer Terrace, London SW17 0RE, United Kingdom
Publisher
American Medical Association
Abstract
Context: A recent meta-analysis demonstrated that statin therapy is
associated with excess risk of developing diabetes mellitus.
 Objective(s): To investigate whether intensive-dose statin therapy is
associated with increased risk of new-onset diabetes compared with
moderate-dose statin therapy. Data Sources: We identified relevant
trials in a literature search of MEDLINE, EMBASE, and the Cochrane Central
Register of Controlled Trials (January 1, 1996, through March 31, 2011).
Unpublished data were obtained from investigators. Study Selection: We
included randomized controlled end-point trials that compared
intensive-dose statin therapy with moderate-dose statin therapy and
included more than 1000 participants who were followed up for more than 1
year. Data Extraction: Tabular data provided for each trial described
baseline characteristics and numbers of participants developing diabetes
and experiencing major cardiovascular events (cardiovascular death,
nonfatal myocardial infarction or stroke, coronary revascularization). We
calculated trial-specific odds ratios (ORs) for new-onset diabetes and
major cardiovascular events and combined these using random-effects model
meta-analysis. Between-study heterogeneity was assessed using the
I2 statistic. Result(s): In 5 statin trials with 32 752
participants without diabetes at baseline, 2749 developed diabetes (1449
assigned intensive-dose therapy, 1300 assigned moderate-dose therapy,
representing 2.0 additional cases in the intensive-dose group per 1000
patient-years) and 6684 experienced cardiovascular events (3134 and 3550,
respectively, representing 6.5 fewer cases in the intensive-dose group per
1000 patient-years) over a weighted mean (SD) follow-up of 4.9 (1.9)
years. Odds ratios were 1.12 (95% confidence interval [CI], 1.04-1.22;
I2 = 0%) for new-onset diabetes and 0.84 (95% CI, 0.75-0.94;
I2 = 74%) for cardiovascular events for participants receiving
intensive therapy compared with moderate-dose therapy. As compared with
moderate-dose statin therapy, the number needed to harm per year for
intensive-dose statin therapy was 498 for new-onset diabetes while the
number neededto treat per year for intensive-dose statin therapy was 155
for cardiovascular events. Conclusion(s): In a pooled analysis of
data from 5 statin trials, intensive-dose statin therapy was associated
with an increased risk of new-onset diabetes compared with moderate-dose
statin therapy. ©2011 American Medical Association. All rights
reserved.

<33>
Accession Number
361102735
Title
Radial artery grafts vs saphenous vein grafts in coronary artery bypass
surgery: A randomized trial.
Source
JAMA. 305(2) (pp 167-174), 2011. Date of Publication: 12 Jan 2011.
Author
Goldman S.; Sethi G.K.; Holman W.; Thai H.; McFalls E.; Ward H.B.; Kelly
R.F.; Rhenman B.; Tobler G.H.; Bakaeen F.G.; Huh J.; Soltero E.; Moursi
M.; Haime M.; Crittenden M.; Kasirajan V.; Ratliff M.; Pett S.; Irimpen
A.; Gunnar W.; Thomas D.; Fremes S.; Moritz T.; Reda D.; Harrison L.;
Wagner T.H.; Wang Y.; Planting L.; Miller M.; Rodriguez Y.; Juneman E.;
Morrison D.; Pierce M.K.; Kreamer S.; Shih M.-C.; Lee K.
Institution
(Goldman, Sethi, Thai, Rhenman, Rodriguez, Juneman, Pierce, Kreamer)
Cardiology Section (1-111C), Southern Arizona VA Health Care System, 3601
S Sixth Ave, Tucson, AZ 85723, United States
(Goldman, Sethi, Thai, Rhenman, Juneman) University of Arizona Sarver
Heart Center, Tucson, AZ, United States
(Holman) Veterans Affairs Medical Center, Birmingham, AL, United States
(McFalls, Ward, Kelly) Veterans Affairs Medical Center, Minneapolis, MN,
United States
(Tobler, Moursi) Veterans Affairs Health Care System, Little Rock, AR,
United States
(Bakaeen, Huh, Soltero) Veterans Affairs Medical Center, Houston, TX,
United States
(Huh) Baylor College of Medicine, Texas Heart Institute, Tucson, TX,
United States
(Soltero) Hospital Damas, Ponce, Puerto Rico
(Haime) Veterans Affairs Health Care Center, West Roxbury, MA, United
States
(Crittenden) Veterans Affairs Medical Center, St Louis, MI, United States
(Kasirajan) Veterans Affairs Medical Center, Richmond, VA, United States
(Ratliff, Pett) Veterans Affairs Medical Center, Albuquerque, NM, United
States
(Irimpen) Veterans Affairs Medical Center, New Orleans, LA, United States
(Gunnar, Thomas, Moritz, Reda) Hines VA Hospital, Cooperative Studies
Program Coordinating Center, Hines, IL, United States
(Fremes) Sunnybrooke and Women's College Health Sciences Center,
University of Toronto, Toronto, ON, Canada
(Harrison) Baptist Health South Florida, Florida International University,
Miami, FL, United States
(Wagner) VA Palo Alto Health Economics Resource Center, Menlo Park, CA,
United States
(Wang, Planting, Miller, Shih, Lee) Veterans Affairs Health Care System,
Cooperative Studies Program Coordinating Center, Palo Alto, CA, United
States
(Morrison) Interventional Cardiology, Yakima Heart Center, Yakima, WA,
United States
(Shih) Department of Health Research and Policy, Stanford University,
Stanford, CA, United States
Publisher
American Medical Association
Abstract
Context: Arterial grafts are thought to be better conduits than saphenous
vein grafts for coronary artery bypass grafting (CABG) based on experience
with using the left internal mammary artery to bypass the left anterior
descending coronary artery. The efficacy of the radial artery graft is
less clear. Objective(s): To compare 1-year angiographic patency of
radial artery grafts vs saphenous vein grafts in patients undergoing
elective CABG. Design, Setting, and Participant(s): Multicenter,
randomized controlled trial conducted from February 2003 to February 2009
at 11 Veterans Affairs medical centers among 757 participants (99% men)
undergoing first-time elective CABG. Intervention(s): The left
internal mammary artery was used to preferentially graft the left anterior
descending coronary artery whenever possible; the best remaining recipient
vessel was randomized to radial artery vs saphenous vein graft. Main
Outcome Measure(s): The primary end point was angiographic graft patency
at 1 year after CABG. Secondary end points included angiographic graft
patency at 1 week after CABG, myocardial infarction, stroke, repeat
revascularization, and death. Result(s): Analysis included 733
patients (366 in the radial artery group, 367 in the saphenous vein
group). There was no significant difference in study graft patency at 1
year after CABG (radial artery, 238/266; 89%; 95% confidence interval
[CI], 86%-93%; saphenous vein, 239/269; 89%; 95% CI, 85%-93%; adjusted OR,
0.99; 95% CI, 0.56-1.74; P=.98). There were no significant differences in
the secondary end points. Conclusion(s): Among Veterans Affairs
patients undergoing first-time elective CABG, the use of a radial artery
graft compared with saphenous vein graft did not result in greater 1-year
patency. Trial Registration: clinicaltrials.gov Identifier: NCT00054847
©2011 American Medical Association. All rights reserved.

<34>
Accession Number
359972254
Title
To the editor.
Source
JAMA. 304(19) (pp 2123-2124), 2010. Date of Publication: 17 Nov 2010.
Author
Friberg O.; Svedjeholm R.; Soderquist B.
Institution
(Friberg) Department of Cardiothoracic Surgery and Anesthesiology, Orebro
University Hospital, Orebro, Sweden
(Svedjeholm) Department of Cardiothoracic Surgery, Linkoping University
Hospital, Linkoping, Sweden
(Soderquist) Department of Laboratory Medicine, Clinical Microbiology,
Orebro University Hospital, Sweden
Publisher
American Medical Association

<35>
Accession Number
359801342
Title
Elective intra-aortic balloon counterpulsation during high-risk
percutaneous coronary intervention: A randomized controlled trial.
Source
JAMA. 304(8) (pp 867-874), 2010. Date of Publication: 25 Aug 2010.
Author
Perera D.; Stables R.; Thomas M.; Booth J.; Pitt M.; Blackman D.; De
Belder A.; Redwood S.
Institution
(Perera, Thomas, Redwood) Cardiovascular Division, St Thomas' Hospital
Campus, King's College London BHF Centre of Excellence, London SE1 7EH,
United Kingdom
(Stables) Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
(Booth) Clinical Trials and Evaluation Unit, Royal Brompton Hospital,
London, United Kingdom
(Pitt) Birmingham Heartlands Hospital, Birmingham, United Kingdom
(Blackman) Leeds Teaching Hospitals, Leeds, United Kingdom
(De Belder) Brighton and Sussex University Hospital, Brighton, United
Kingdom
Publisher
American Medical Association
Abstract
Context: Observational studies have previously reported that elective
intra-aortic balloon pump (IABP) insertion may improve outcomes following
high-risk percutaneous coronary intervention (PCI). To date, this
assertion has not been tested in a randomized trial. Objective(s): To
determine whether routine intra-aortic balloon counterpulsation before PCI
reduces major adverse cardiac and cardiovascular events (MACCE) in
patients with severe left ventricular dysfunction and extensive coronary
disease. Design, Setting, and Patients: The Balloon Pump-Assisted Coronary
Intervention Study, a prospective, open, multicenter, randomized
controlled trial conducted in 17 tertiary referral cardiac centers in the
United Kingdom between December 2005 and January 2009. Patients (n=301)
had severe left ventricular dysfunction (ejection fraction <=30%) and
extensive coronary disease (Jeopardy Score >=8/12); those with
contraindications to or class I indications for IABP therapy were
excluded. Intervention(s): Elective insertion of IABP before PCI.
 Main Outcome Measure(s): Primary end point was MACCE, defined as
death, acute myocardial infarction, cerebrovascular event, or further
revascularization at hospital discharge (capped at 28 days). Secondary end
points included all-cause mortality at 6 months, major procedural
complications, bleeding, and access-site complications. Result(s):
MACCE at hospital discharge occurred in 15.2% (23/151) of the elective
IABP and 16.0% (24/150) of the no planned IABP groups (P=.85; odds ratio
[OR], 0.94 [95% confidence interval {CI}, 0.51-1.76]). All-cause mortality
at 6 months was 4.6% and 7.4% in the respective groups (P=.32; OR, 0.61
[95% CI, 0.24-1.62]). Fewer major procedural complications occurred with
elective IABP insertion compared with no planned IABP use (1.3% vs 10.7%,
P<.001; OR, 0.11 [95% CI, 0.01-0.49]). Major or minor bleeding occurred in
19.2% and 11.3% (P=.06; OR, 1.86 [95% CI, 0.93-3.79]) and access-site
complications in 3.3% and 0% (P=.06) of the elective and no planned IABP
groups, respectively. Conclusion(s): Elective IABP insertion did not
reduce the incidence of MACCE following PCI. These results do not support
a strategy of routine IABP placement before PCI in all patients with
severe left ventricular dysfunction and extensive coronary disease. Trial
Registration isrctn.org Identifier: ISRCTN40553718; clinicaltrials.gov
Identifier: NCT00910481 ©2010 American Medical Association. All
rights reserved.

<36>
Accession Number
359760719
Title
Transfusion requirements after cardiac surgery: The TRACS randomized
controlled trial.
Source
JAMA. 304(14) (pp 1559-1567), 2010. Date of Publication: 13 Oct 2010.
Author
Hajjar L.A.; Vincent J.-L.; Galas F.R.B.G.; Nakamura R.E.; Silva C.M.P.;
Santos M.H.; Fukushima J.; Kalil Filho R.; Sierra D.B.; Lopes N.H.; Mauad
T.; Roquim A.C.; Sundin M.R.; Leao W.C.; Almeida J.P.; Pomerantzeff P.M.;
Dallan L.O.; Jatene F.B.; Stolf N.A.G.; Auler J.O.C.
Institution
(Hajjar, Galas, Nakamura, Silva, Santos, Fukushima, Kalil Filho, Sierra,
Lopes, Mauad, Roquim, Sundin, Leao, Almeida, Pomerantzeff, Dallan, Jatene,
Stolf, Auler) Department of Anesthesiology, Hospital Das Clinicas,
Universidade de Sao Paulo, Sao Paulo, Brazil
(Vincent) Department of Intensive Care, Erasme Hospital, Universite Libre
de Bruxelles, Brussels, Belgium
Publisher
American Medical Association
Abstract
Context: Perioperative red blood cell transfusion is commonly used to
address anemia, an independent risk factor for morbidity and mortality
after cardiac operations; however, evidence regarding optimal blood
transfusion practice in patients undergoing cardiac surgery is lacking.
 Objective(s): To define whether a restrictive perioperative red blood
cell transfusion strategy is as safe as a liberal strategy in patients
undergoing elective cardiac surgery. Design, Setting, and Patients: The
Transfusion Requirements After Cardiac Surgery (TRACS) study, a
prospective, randomized, controlled clinical noninferiority trial
conducted between February 2009 and February 2010 in an intensive care
unit at a university hospital cardiac surgery referral center in Brazil.
Consecutive adult patients (n=502) who underwent cardiac surgery with
cardiopulmonary bypass were eligible; analysis was by intention-to-treat.
 Intervention(s): Patients were randomly assigned to a liberal
strategy of blood transfusion (to maintain a hematocrit >=30%) or to a
restrictive strategy (hematocrit >=24%). Main Outcome Measure(s):
Composite end point of 30-day all-cause mortality and severe morbidity
(cardiogenic shock, acute respiratory distress syndrome, or acute renal
injury requiring dialysis or hemofiltration) occurring during the hospital
stay. The noninferiority margin was predefined at -8% (ie, 8% minimal
clinically important increase in occurrence of the composite end point).
 Result(s): Hemoglobin concentrations were maintained at a mean of
10.5 g/dL (95% confidence interval [CI], 10.4-10.6) in the
liberal-strategy group and 9.1 g/dL (95% CI, 9.0-9.2) in the
restrictive-strategy group (P < .001). A total of 198 of 253 patients
(78%) in the liberal-strategy group and 118 of 249 (47%) in the
restrictive-strategy group received a blood transfusion (P < .001).
Occurrence of the primary end point was similar between groups (10%
liberal vs 11 % restrictive; between-group difference, 1% [95% CI,-6% to
4%]; P=.85). Independent of transfusion strategy, the number of transfused
red blood cell units was an independent risk factor for clinical
complications or death at 30 days (hazard ratio for each additional unit
transfused, 1.2 [95% CI, 1.1-1.4]; P=.002). Conclusion(s): Among
patients undergoing cardiac surgery, the use of a restrictive
perioperative transfusion strategy compared with a more liberal strategy
resulted in noninferior rates of the combined outcome of 30-day all-cause
mortality and severe morbidity. ©2010 American Medical Association.
All rights reserved.

<37>
Accession Number
359374177
Title
Effect of an implantable gentamicin-collagen sponge on sternal wound
infections following cardiac surgery: A randomized trial.
Source
JAMA. 304(7) (pp 755-762), 2010. Date of Publication: 18 Aug 2010.
Author
Bennett-Guerrero E.; Ferguson T.B.; Lin M.; Garg J.; Mark D.B.; Scavo
V.A.; Kouchoukos N.; Richardson J.B.; Pridgen R.L.; Corey G.R.
Institution
(Bennett-Guerrero) Division of Perioperative Clinical Research, Duke
Clinical Research Institute, Duke University, Durham, NC, United States
(Lin, Garg) Division of Biostatistics and Bioinformatics, Duke Clinical
Research Institute, Duke University, Durham, NC, United States
(Mark) Division of Outcomes Research, Duke Clinical Research Institute,
Duke University, Durham, NC, United States
(Pridgen) Division of Project Leadership, Duke Clinical Research
Institute, Duke University, Durham, NC, United States
(Corey) Division of Infectious Disease, Duke Clinical Research Institute,
Duke University, Durham, NC, United States
(Ferguson) Department of Cardiovascular Sciences, East Carolina Heart
Institute, Greenville, NC, United States
(Scavo) Indiana Ohio Heart, Fort Wayne, IN, United States
(Kouchoukos) Missouri Baptist Medical Center, St Louis, MO, United States
(Richardson) Saint Vincent's Hospital, Birmingham, AL, United States
Publisher
American Medical Association
Abstract
Context: Despite the routine use of prophylactic systemic antibiotics,
sternal wound infection still occurs in5%or more of cardiac surgical
patients and is associated with significant excess morbidity, mortality,
and cost. The gentamicin-collagen sponge, a surgically implantable topical
antibiotic, is currently approved in 54 countries.Alarge, 2-center,
randomized trial in Sweden reported in 2005 that the sponge reduced
surgical site infection by 50% in cardiac patients. Objective(s): To
test the hypothesis that the sponge prevents infection in cardiac surgical
patients at increased risk for sternal wound infection. Design,
Setting, and Participant(s): Phase 3 single-blind, prospective randomized
controlled trial, 1502 cardiac surgical patients at high risk for sternal
wound infection (diabetes, body mass index >30, or both) were enrolled at
48 US sites between December 21, 2007, and March 11, 2009.
 Intervention(s): Single-blind randomization to insertion of 2
gentamicin-collagen sponges (total gentamicin of 260 mg) between the
sternal halves at surgical closure (n=753) vs no intervention (control
group: n=749). All patients received standardized care including
prophylactic systemic antibiotics and rigid sternal fixation. Main
Outcome Measure(s): The primary end point was sternal wound infection
occurring through 90 days postoperatively as adjudicated by a clinical
events classification committee blinded to study treatment group. The
primary study comparison was done in the intent-to-treat population.
Secondary outcomes included (1) superficial wound infection (involving
subcutaneous tissue but not extending down to sternal fixation wires), (2)
deep wound infection (involving the sternal wires, sternal bone, and/or
mediastinum), and (3) score for additional treatment, presence of serous
discharge, erythema, purulent exudate, separation of the deep tissues,
isolation of bacteria, and duration of inpatient stay (ASEPSIS; minimum
score of 0 with no theoretical maximum). Result(s): Of 1502 patients,
1006 had diabetes (67%) and 1137 were obese (body mass index >30) (76%).
In the primary analysis, there was no significant difference in sternal
wound infection in 63 of 753 patients randomized to the
gentamicin-collagen sponge group (8.4%) compared with 65 of 749 patients
randomized to the control group (8.7%) (P=.83). No significant differences
were observed between the gentamicin-collagen sponge group and the control
group, respectively, in superficial sternal wound infection (49/753 [6.5%]
vs46/749[6.1%];P=.77), deep sternal wound infection
(14/753[1.9%]vs19/749[2.5%]; P=.37), ASEPSIS score (mean [SD], 1.9 [6.4]
vs 2.0 [7.2]; P=.67), or rehospitalization for sternal wound infection
(23/753 [3.1%] vs 24/749 [3.2%]; P=.87). Conclusion(s): Among US
patients with diabetes, high body mass index, or both undergoing cardiac
surgery, the use of 2 gentamicin-collagen sponges compared with no
intervention did not reduce the 90-day sternal wound infection rate. Trial
Registration: clinicaltrials.gov Identifier: NCT00600483. ©2010
American Medical Association. All rights reserved.

<38>
Accession Number
359053784
Title
Effects of homocysteine-lowering with folic acid plus vitamin B
<inf>12</inf> vs placebo on mortality and major morbidity in myocardial
infarction survivors: A randomized trial.
Source
JAMA. 303(24) (pp 2486-2494), 2010. Date of Publication: June 23-30 2010.
Author
Armitage J.M.; Bowman L.; Clarke R.J.; Wallendszus K.; Bulbulia R.; Rahimi
K.; Haynes R.; Parish S.; Sleight P.; Peto R.; Collins R.
Institution
(Armitage, Bowman, Clarke, Wallendszus, Bulbulia, Rahimi, Haynes, Parish)
SEARCH Study, Clinical Trial Service Unit, University of Oxford, Old Road
Campus, Roosevelt Drive, Oxford OX3 7LF, United Kingdom
(Sleight) Department of Cardiovascular Medicine, University of Oxford,
United Kingdom
(Peto, Collins) Clinical Trial Service Unit, University of Oxford, United
Kingdom
Publisher
American Medical Association
Abstract
Context: Blood homocysteine levels are positively associated with
cardiovascular disease, but it is uncertain whether the association is
causal. Objective(s): To assess the effects of reducing homocysteine
levels with folic acid and vitamin B<inf>12</inf> on vascular and
nonvascular outcomes. Design, Setting, and Patients: Double-blind
randomized controlled trial of 12 064 survivors of myocardial infarction
in secondary care hospitals in the United Kingdom between 1998 and 2008.
 Intervention(s): 2 mg folic acid plus 1 mg vitamin B<inf>12</inf>
daily vs matching placebo. Main Outcome Measure(s): First major
vascular event, defined as major coronary event (coronary death,
myocardial infarction, or coronary revascularization), fatal or nonfatal
stroke, or noncoronary revascularization. Result(s): Allocation to
the study vitamins reduced homocysteine by a mean of 3.8 mumol/L (28%).
During 6.7 years of follow-up, major vascular events occurred in 1537 of
6033 participants (25.5%) allocated folic acid plus vitamin B<inf>12</inf>
vs 1493 of 6031 participants (24.8%) allocated placebo (risk ratio [RR],
1.04; 95% confidence interval [CI], 0.97-1.12; P=.28). There were no
apparent effects on major coronary events (vitamins, 1229 [20.4%], vs
placebo, 1185 [19.6%]; RR, 1.05; 95% CI, 0.97-1.13), stroke (vitamins, 269
[4.5%], vs placebo, 265 [4.4%]; RR, 1.02; 95% CI, 0.86-1.21), or
noncoronary revascularizations (vitamins, 178 [3.0%], vs placebo, 152
[2.5%]; RR, 1.18; 95% CI, 0.95-1.46). Nor were there significant
differences in the numbers of deaths attributed to vascular causes
(vitamins, 578 [9.6%], vs placebo, 559 [9.3%]) or nonvascular causes
(vitamins, 405 [6.7%], vs placebo, 392 [6.5%]) or in the incidence of any
cancer (vitamins, 678 [11.2%], vs placebo, 639 [10.6%]).
 Conclusion(s): Substantial long-term reductions in blood homocysteine
levels with folic acid and vitamin B<inf>12</inf> supplementation did not
have beneficial effects on vascular outcomes but were also not associated
with adverse effects on cancer incidence. Trial Registration: isrctn.org
Identifier: ISRCTN74348595 ©2010 American Medical Association. All
rights reserved.

<39>
Accession Number
359019040
Title
Factors associated with decisions to undergo surgery among patients with
newly diagnosed early-stage lung cancer.
Source
JAMA. 303(23) (pp 2368-2376), 2010. Date of Publication: 16 Jun 2010.
Author
Cykert S.; Dilworth-Anderson P.; Monroe M.H.; Walker P.; McGuire F.R.;
Corbie-Smith G.; Edwards L.J.; Bunton A.J.
Institution
(Cykert, Corbie-Smith, Edwards, Bunton) Cecil G. Sheps Center for Health
Services Research, Chapel Hill, NC, United States
(Cykert, Corbie-Smith) Division of General Internal Medicine and Clinical
Epidemiology, School of Medicine, University of North Carolina, Chapel
Hill, NC, United States
(Dilworth-Anderson) Department of Health Policy and Management, UNC
Institute on Aging, University of North Carolina, Chapel Hill, NC, United
States
(Edwards) Department of Biostatistics, University of North Carolina,
Chapel Hill, NC, United States
(Cykert) Internal Medicine Program, Moses Cone Health System, Greensboro
Area Health Education Center, Greensboro, NC, United States
(Monroe) Department of Internal Medicine, Carolinas Medical Center,
Charlotte, NC, United States
(Walker) Leo Jenkins Cancer Center, Brody School of Medicine, East
Carolina University, Greenville, NC, United States
(McGuire) Division of Pulmonary and Critical Care Medicine, School of
Medicine, University of South Carolina, Columbia, SC, United States
Publisher
American Medical Association
Abstract
Context: Lung cancer is the leading cause of cancer death in the United
States. Surgical resection for stage I or II non-small cell cancer remains
the only reliable treatment for cure. Patients who do not undergo surgery
have a median survival of less than 1 year. Despite the survival
disadvantage, many patients with early-stage disease do not receive
surgical care and rates are even lower for black patients.
 Objective(s): To identify potentially modifiable factors regarding
surgery in patients newly diagnosed with early-stage lung cancer and to
explore why blacks undergo surgery less often than whites. Design,
Setting, and Patients: Prospective cohort study with patients identified
by pulmonary, oncology, thoracic surgery, and generalist practices in 5
communities through study referral or computerized tomography review
protocol. A total of 437 patients with biopsy-proven or probable
early-stage lung cancer were enrolled between December 2005 and December
2008. Before establishment of treatment plans, patients were administered
a survey including questions about trust, patient-physician communication,
attitudes toward cancer, and functional status. Information about comorbid
illnesses was obtained through chart audits. Main Outcome Measure(s):
Lung cancer surgery within 4 months of diagnosis. Result(s): A total
of 386 patients met full eligibility criteria for lung resection surgery.
The median age was 66 years (range, 26-90 years) and 29% of patients were
black. The surgical rate was 66% for white patients (n=179/273) compared
with 55% for black patients (n=62/113; P=.05). Negative perceptions of
patient-physician communication manifested by a 5-point decrement on a
25-point communication scale (odds ratio [OR], 0.42; 95% confidence
interval [CI], 0.32-0.74) and negative perception of 1-year prognosis
postsurgery (OR, 0.27; 95% CI, 0.14-0.50; absolute risk, 34%) were
associated with decisions against surgery. Surgical rates for blacks were
particularly low when they had 2 or more comorbid illnesses (13% vs 62%
for <2 comorbidities; OR, 0.04 [95% CI, 0.01-0.25]; absolute risk, 49%)
and when blacks lacked a regular source of care (42% with no regular care
vs 57% with regular care; OR, 0.20 [95% CI, 0.10-0.43]; absolute risk,
15%). Conclusion(s): A decision not to undergo surgery by patients
with newly diagnosed lung cancer was independently associated with
perceptions of communication and prognosis, older age, multiple
comorbidities, and black race. Interventions to optimize surgery should
consider these factors. ©2010 American Medical Association. All
rights reserved.

<40>
Accession Number
355773440
Title
Telephone-delivered collaborative care for treating post-CABG depression:
A randomized controlled trial.
Source
JAMA. 302(19) (pp 2095-2103), 2009. Date of Publication: 2009.
Author
Rollman B.L.; Herbeck Belnap B.; LeMenager M.S.; Mazumdar S.; Houck P.R.;
Counihan P.J.; Kapoor W.N.; Schulberg H.C.; Reynolds III C.F.
Institution
(Rollman, Herbeck Belnap, LeMenager, Kapoor) Division of General Internal
Medicine, Center for Research on Health Care, University of Pittsburgh
School of Medicine, Pittsburgh, PA, United States
(Houck, Reynolds III) Department of Psychiatry, University of Pittsburgh
School of Medicine, Pittsburgh, PA, United States
(Counihan) Cardiovascular Institute, Department of Medicine, University of
Pittsburgh School of Medicine, Pittsburgh, PA, United States
(Mazumdar) Department of Biostatistics, University of Pittsburgh Graduate
School of Public Health, Pittsburgh, PA, United States
(Schulberg) Department of Psychiatry, Weill Cornell Medical College, White
Plains, NY, United States
Publisher
American Medical Association
Abstract
Context: Depressive symptoms commonly follow coronary artery bypass graft
(CABG) surgery and are associated with less positive clinical outcomes.
 Objective(s): To test the effectiveness of telephone-delivered
collaborative care for post-CABG depression vs usual physician care.
 Design, Setting, and Participant(s): Single-blind effectiveness trial
at 7 university-based and community hospitals in or near Pittsburgh,
Pennsylvania. Participants were 302 post-CABG patients with depression
(150, intervention; 152, usual care) and a comparison group of 151
randomly sampled post-CABG patients without depression recruited between
March 2004 and September 2007 and observed as outpatients until June 2008.
 Intervention(s): Eight months of telephone-delivered collaborative
care provided by nurses working with patients' primary care physicians and
supervised by a psychiatrist and primary care physician from this study.
 Main Outcome Measure(s): Mental health-related quality of life (HRQL)
measured by the Short Form-36 Mental Component Summary (SF-36 MCS) at
8-month follow-up; secondary outcome measures included assessment of mood
symptoms (Hamilton Rating Scale for Depression [HRS-D]), physical HRQL
(SF-36 PCS), and functional status (Duke Activity Status Index [DASI]);
and hospital readmissions. Result(s): The intervention patients
reported greater improvements in mental HRQL (all P<=.02) (SF-36 MCS:
DELTA, 3.2 points; 95% confidence interval [CI], 0.5-6.0), physical
functioning (DASI: DELTA, 4.6 points; 95% CI, 1.9-7.3), and mood symptoms
(HRS-D: DELTA, 3.1 points; 95% CI, 1.3-4.9); and were more likely to
report a 50% or greater decline in HRS-D score from baseline (50.0% vs
29.6%; number needed to treat, 4.9 [95% CI, 3.2-10.4]) than usual care
patients (P<.001). Men with depression were particularly likely to benefit
from the intervention (SF-36 MCS: DELTA, 5.7 points; 95% CI, 2.2-9.2;
P=.001). However, the mean HRQL and physical functioning of intervention
patients did not reach that of the nondepressed comparison group.
 Conclusion(s): Compared with usual care, telephone-delivered
collaborative care for treatment of post-CABG depression resulted in
improved HRQL, physical functioning, and mood symptoms at 8-month
follow-up. Trial Registration clinicaltrials.gov Identifier: NCT00091962.
©2009 American Medical Association. All rights reserved.

<41>
Accession Number
355212615
Title
Immediate vs delayed intervention for acute coronary syndromes: A
randomized clinical trial.
Source
JAMA. 302(9) (pp 947-954), 2009. Date of Publication: 02 Sep 2009.
Author
Montalescot G.; Cayla G.; Collet J.-P.; Elhadad S.; Beygui F.; Le Breton
H.; Choussat R.; Leclercq F.; Silvain J.; Duclos F.; Aout M.; Dubois-Rande
J.-L.; Barthelemy O.; Ducrocq G.; Bellemain-Appaix A.; Payot L.; Steg
P.-G.; Henry P.; Spaulding C.; Vicaut E.
Institution
(Montalescot) Institut de Cardiologie, Bureau 2-236, Centre Hospitalier
Universitaire Pitie-Salpetriere, 47 Boulevard de l'Hopital, 75013 Paris,
France
(Montalescot, Collet, Beygui, Choussat, Silvain, Barthelemy,
Bellemain-Appaix) Institut de Cardiologie, Centre Hospitalier
Universitaire Pitie-Salpetriere (AP-HP), Universite Paris 6, Paris, France
(Cayla) Service de Cardiologie, Centre Hospitalier Universitaire Caremeau,
Nimes, France
(Elhadad) Service de Cardiologie, Centre Hospitalier de Lagny-Marne la
Vallee, Lagny-sur-Marne, France
(Le Breton) Service de Cardiologie et Maladies Vasculaires, Universite de
Rennes 1, Centre Hospitalier Universitaire Rennes, Rennes, France
(Leclercq) Service de Cardiologie, Centre Hospitalier Universitaire Arnaud
de Villeneuve, Montpellier, France
(Duclos) Service de Cardiologie, Centre Hospitalier V. Dupouy, Argenteuil,
France
(Aout, Vicaut) Unite de Recherche Clinique, Centre Hospitalier
Universitaire Lariboisiere (AP-HP), Universite Paris, Paris, France
(Henry) Service de Cardiologie, Centre Hospitalier Universitaire
Lariboisiere (AP-HP), Universite Paris, Paris, France
(Aout, Dubois-Rande, Vicaut) Service de Cardiologie, Centre Hospitalier
Universitaire H. Mondor (AP-HP), Creteil, France
(Ducrocq, Steg) INSERM U-698, Service de Cardiologie, Centre Hospitalier
Universitaire Bichat-Claude Bernard (AP-HP), Paris, France
(Payot) Service de Cardiologie, Centre Hospitalier Intercommunal A.
Gregoire, Montreuil-sous-Bois, France
(Spaulding) Service de Cardiologie, Centre Hospitalier Cochin (AP-HP),
Universite Paris-Descartes, Paris, France
Publisher
American Medical Association
Abstract
Context: International guidelines recommend an early invasive strategy for
patients with high-risk acute coronary syndromes without ST-segment
elevation, but the optimal timing of intervention is uncertain.
 Objective(s): To determine whether immediate intervention on
admission can result in a reduction of myocardial infarction compared with
a delayed intervention. Design, Setting, and Patients The Angioplasty to
Blunt the Rise of Troponin in Acute Coronary Syndromes Randomized for an
Immediate or Delayed Intervention (ABOARD) study, a randomized clinical
trial that assigned, from August 2006 through September 2008 at 13 centers
in France, 352 patients with acute coronary syndromes without ST-segment
elevation and a Thrombolysis in Myocardial Infarction (TIMI) score of 3 or
more to receive intervention either immediately or on the next working day
(between 8 and 60 hours after enrollment). Main Outcome Measure(s):
The primary end point was the peak troponin value during hospitalization;
the key secondary end point was the composite of death, myocardial
infarction, or urgent revascularization at 1-month follow-up.
 Result(s): Time from randomization to sheath insertion was 70 minutes
with immediate intervention vs 21 hours with delayed intervention. The
primary end point did not differ between the 2 strategies (median
[interquartile range] troponin I value, 2.1 [0.3-7.1] ng/mL vs 1.7
[0.3-7.2] ng/mL in the immediate and delayed intervention groups,
respectively; P=.70). The key secondary end point was observed in 13.7%
(95% confidence interval, 8.6%-18.8%) of the group assigned to receive
immediate intervention and 10.2% (95% confidence interval, 5.7%-14.6%) of
the group assigned to receive delayed intervention (P=.31). The other end
points, as well as major bleeding, did not differ between the 2
strategies. Conclusion(s): In patients with acute coronary syndromes
without ST-segment elevation, a strategy of immediate intervention
compared with a strategy of intervention deferred to the next working day
(mean, 21 hours) did not result in a difference in myocardial infarction
as defined by peak troponin level. Trial Registration clinicaltrials.gov
Identifier: NCT00442949 ©2009 American Medical Association. All
rights reserved.

<42>
Accession Number
354662838
Title
Intramyocardial bone marrow cell injection for chronic myocardial
ischemia: A randomized controlled trial.
Source
JAMA. 301(19) (pp 1997-2004), 2009. Date of Publication: 20 May 2009.
Author
Van Ramshorst J.; Bax J.J.; Beeres S.L.M.A.; Dibbets-Schneider P.; Roes
S.D.; Stokkel M.P.M.; De Roos A.; Fibbe W.E.; Zwaginga J.J.; Boersma E.;
Schalij M.J.; Atsma D.E.
Institution
(Atsma) Department of Cardiology, Leiden University, Medical Center, PO
Box 9600, 2300 RC Leiden, Netherlands
(Van Ramshorst, Bax, Beeres, Schalij, Atsma) Departments of Cardiology,
Leiden University, Medical Centre, Leiden, Netherlands
(Dibbets-Schneider, Stokkel) Department of Nuclear Medicine, Leiden
University, Medical Centre, Leiden, Netherlands
(Roes, De Roos) Department of Radiology, Leiden University, Medical
Centre, Leiden, Netherlands
(Fibbe, Zwaginga) Department of Hematology, Leiden University, Medical
Centre, Leiden, Netherlands
(Boersma) Department of Cardiology, Erasmus Medical Centre, Rotterdam,
Netherlands
Publisher
American Medical Association
Abstract
Context Previous studies have suggested that bone marrow cell injection
may improve myocardial perfusion and left ventricular (LV) function in
patients with chronic myocardial ischemia. Objective To investigate the
effect of intramyocardial bone marrow cell injection on myocardial
perfusion and LV function in patients with chronic myocardial ischemia.
Design, Setting, and Patients Randomized, double-blind, placebo-controlled
trial at a Netherlands university hospital, May 1, 2005-March 3, 2008
(6-month follow-up ended September 2008) of 50 patients with chronic
myocardial ischemia (mean age [SD], 64 [8] years; 43 men). Inclusion
criteria: severe angina pectoris despite optimal medical therapy and
myocardial ischemia. All patients were ineligible for conventional
revascularization. Interventions Intramyocardial injection of 100X
106 autologous bone marrowderived mononuclear cells or placebo
solution. Main Outcome Measures Primarily, the summed stress score, a
17-segment score for stress myocardial perfusion assessed by Tc-99m
tetrofosmin single-photon emission computed tomography (SPECT), Secondary
included LV ejection fraction (LVEF), Canadian Cardiovascular Society
(CCS) class, and Seattle Angina Questionnaire qualityof-life score (mean
difference >5% considered clinically significant). Results After 3-month
follow-up, the summed stress score (mean [SD]) improved from 23.5 (4.7) to
20,1 (4,6) (P < .001) in the bone marrow cell group, compared with a
decrease from 24.8 (5.5) to 23.7 (5.4) (P=.004) in the placebo group. In
the bone marrow cell-treated patients who underwent magnetic resonance
imaging (MRI), a 3% absolute increase in LVEF was observed at 3 months
(95% CI, 0.5% to 4.7%; n=18), but the placebo group showed no improvement.
CCS angina score improved significantly in the bone marrow cell group
(6-month absolute difference, -0.79; 95% CI, -1.10 to -0.48; P<.001)
compared with no significant improvement in the placebo group.
Qualityof-life score increased from 56% (9%) to 64% (12%) at 3 months and
69% (12%) at 6 months in bone marrow cell-treated patients, compared with
a smaller increase in the placebo group from 57% (11 %) to 61 % (14%) to
64% (17%). The improvements in CCS class and quality of life score were
significantly greater in bone marrow cell-treated patients than in place
bo-treated patients (P=.03 and P=.04, respectively). Conclusions In this
short-term study of patients with chronic myocardial ischemia refractory
to medical treatment, intramyocardial bone marrow cell injection resulted
in a statistically significant but modest improvement in myocardial
perfusion compared with placebo. Further studies are required to assess
long-term results and efficacy for mortality and morbidity. Trial
Registrations trialregister.nl Identifier: NTR400 and isrctn.org
Identifier: ISRCTN58194927 © 2000 American Medical Association. All
rights reserved.

<43>
Accession Number
354523490
Title
Cardiac outcomes after screening for asymptomatic coronary artery disease
in patients with type 2 diabetes the DIAD study: A randomized controlled
trial.
Source
JAMA. 301(15) (pp 1547-1555), 2009. Date of Publication: 15 Apr 2009.
Author
Young L.H.; Wackers F.J.Th.; Chyun D.A.; Davey J.A.; Barrett E.J.;
Taillefer R.; Heller G.V.; Iskandrian A.E.; Wittlin S.D.; Filipchuk N.;
Ratner R.E.; Inzucchi S.E.
Institution
(Young, Wackers, Davey) Department of Internal Medicine, Section of
Cardiovascular Medicine, Yale University, New Haven, CT, United States
(Inzucchi) Section of Endocrinology, Yale University, School of Medicine,
New Haven, CT, United States
(Chyun) College of Nursing, College of Dentistry, New York University, New
York, United States
(Barrett) Department of Endocrinology, University of Virginia,
Charlottesville, United States
(Taillefer) Medecine Nucleaire, University of Montreal, Montreal, QC,
Canada
(Heller) Department of Cardiology, Hartford Hospital, School of Medicine,
Hartford, New Haven, CT, United States
(Iskandrian) Department of Cardiology, University of Alabama, Birmingham,
United States
(Wittlin) Department of Endocrinology, University of Rochester, Rochester,
NY, United States
(Filipchuk) Cardiology Consultants, Calgary, AB, Canada
(Ratner) MedStar Research Institute, Washington, DC, United States
(Wackers) Yale University, School of Medicine, Section of Cardiovascular
Medicine, 333 Cedar St, Fitkin-3, New Haven, CT 06520, United States
Publisher
American Medical Association
Abstract
Context Coronary artery disease (CAD) is the major cause of mortality and
morbidity in patients with type 2 diabetes. But the utility of screening
patients with type 2 diabetes for asymptomatic CAD is controversial.
Objective To assess whether routine screening for CAD identifies patients
with type 2 diabetes as being at high cardiac risk and whether it affects
their cardiac outcomes. Design, Setting, and Patients The Detection of
Ischemia in Asymptomatic Diabetics (DIAD) study is a randomized controlled
trial in which 1123 participants with type 2 diabetes and no symptoms of
CAD were randomly assigned to be screened with adenosine-stress
radionuclide myocardial perfusion imaging (MPI) or not to be screened.
Participants were recruited from diabetes clinics and practices and
prospectively followed up from August 2000 to September 2007. Main Outcome
Measure Cardiac death or nonfatal myocardial infarction (MI). Results The
cumulative cardiac event rate was 2.9% over a mean (SD) follow-up of 4.8
(0.9) years for an average of 0.6% per year. Seven nonfatal MIs and 8
cardiac deaths (2.7%) occurred among the screened group and 10 nonfatal
MIs and 7 cardiac deaths (3.0%) among the not-screened group (hazard ratio
[HR], 0.88; 95% confidence interval [CI], 0.44-1.88; P=.73). Of those in
the screened group, 409 participants with normal results and 50 with small
MPI defects had lower event rates than the 33 with moderate or large MPI
defects; 0.4% per year vs 2.4% per year (HR, 6.3; 95% CI, 1.9-20.1;
P=.001). Nevertheless, the positive predictive value of having moderate or
large MPI defects was only 12%. The overall rate of coronary
revascularization was low in both groups: 31 (5.5%) in the screened group
and 44 (7.8%) in the unscreened group (HR, 0.71; 95% CI, 0.45-1.1; P=.14).
During the course of study there was a significant and equivalent increase
in primary medical prevention in both groups. Conclusion In this
contemporary study population of patients with diabetes, the cardiac event
rates were low and were not significantly reduced by MPI screening for
myocardial ischemia over 4.8 years. Trial Registration clinicaltrials.gov
Identifier: NCT00769275 © 2009 American Medical Association.

<44>
Accession Number
2017528766
Title
A Brazilian randomized study: Robotic-Assisted vs. Video-assisted lung
lobectomy Outcomes (BRAVO trial).
Source
Jornal Brasileiro de Pneumologia. 48(4) (no pagination), 2022. Article
Number: e20210464. Date of Publication: 2022.
Author
Terra R.M.; de Araujo P.H.X.N.; Lauricella L.L.; de Campos J.R.M.;
Trindade J.R.M.; Pego-Fernandes P.M.
Institution
(Terra, de Araujo, Lauricella, de Campos, Trindade, Pego-Fernandes)
Divisao de Cirurgia Toracica, Departamento de Cardiopneumologia, Hospital
das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo, SP, Sao
Paulo, Brazil
Publisher
Sociedade Brasileira de Pneumologia e Tisiologia
Abstract
Objective: To compare 90-day morbidity in patients undergoing lung
lobectomy performed by either robotic-assisted thoracic surgery (RATS) or
video-assisted thoracic surgery (VATS). Intraoperative complications,
drainage time, length of hospital stay, postoperative pain, postoperative
quality of life, and readmissions within 90 days were also compared.
 Method(s): This was a two-arm randomized clinical trial including
patients with lung lesions (primary lung cancer or lung metastasis) who
were candidates for lung lobectomy. Patients with comorbidities that
precluded surgical treatment were excluded. All patients followed the same
postoperative protocol. Result(s): The overall sample comprised 76
patients (39 in the VATS group and 37 in the RATS group). The two groups
were similar regarding gender, age, BMI, FEV<inf>1</inf> in % of
predicted, and comorbidities. Postoperative complications within 90 days
tended to be more common in the VATS group than in the RATS group, but the
difference was not significant (p = 0.12). However, when only major
complications were analyzed, this tendency disappeared (p = 0.58).
Regarding postoperative outcomes, the VATS group had a significantly
higher number of readmissions within 90 days than did the RATS group (p =
0.029). No significant differences were found regarding intraoperative
complications, drainage time, length of hospital stay, postoperative pain,
and postoperative quality of life. Conclusion(s): RATS and VATS
lobectomy had similar 90-day outcomes. However, RATS lobectomy was
associated with a significant reduction in the 90-day hospital readmission
rate. Larger studies are necessary to confirm such a finding.
(ClinicalTrials.gov identifier: NCT02292914
[http://www.clinicaltrials.gov/]). Copyright © 2022 Sociedade
Brasileira de Pneumologia e Tisiologia.

<45>
Accession Number
2017379553
Title
The Effect of Erythrocyte-Containing Donor Blood Components in the Priming
of the Cardiopulmonary Bypass Circuit on the Development of Systemic
Inflammation During Correction of Congenital Heart Defects in Children.
Source
Obshchaya Reanimatologiya. 18(3) (pp 30-37), 2022. Date of Publication:
2022.
Author
Borisenko D.V.; Ivkin A.A.; Shukevich D.L.; Kornelyuk R.A.
Institution
(Borisenko, Ivkin, Shukevich, Kornelyuk) Research Institute of Complex
Problems of Cardiovascular Disease, 6 Sosnovy bulvar, Kemerovo 650002,
Russian Federation
Publisher
V.A. Negovsky Research Institute of General Reanimatology
Abstract
Various pathological factors accompanying any cardiac surgery can cause
intraoperative systemic inflammatory responses (SIR). As the number of
cardiac surgical interventions grows worldwide, the issue of SIR
prevention appears highly relevant. Aim of the study. To determine the
effect of not using donor blood components in the priming of the
cardiopulmonary bypass circuit in children with septal congenital heart
defects, operated under cardiopulmonary bypass, on the severity of SIR.
Material and methods. A prospective, randomized study included 40 children
with a median age of 14 [12-22.5] months and weight of 8.8 [7.25-11] kg.
All patients underwent radical correction of septal defect under
cardiopulmonary bypass. The patients were divided into two groups
depending on the use of donor blood components for priming the CPB. The
severity of SIR was assessed using four specific serum biomarkers such as
interleukin 1b (IL-1b), interleukin 6 (IL-6), interleukin 10 (IL-10), and
tumor necrosis factor alpha (TNF-alpha), measured before the operation,
after the CPB and 16 hours after the surgery. In addition, the intra-and
postoperative periods were evaluated. Results. The safety of the proposed
strategy of skipping the donor blood was confirmed by lack of any organ
dysfunction in all patients, as well as a significant difference in the
balance of oxygen delivery and consumption. In addition, the levels of
systemic inflammation markers after CPB were significantly higher in
patients who had transfusion: IL-1b was 3.3 [3.2-3.48] pg/mL vs 2.86
[2.7-3.11] pg/mL (P=0.003) and TNF-alpha reached 1.81 [1.37-3.3] pg/mL vs
1.33 [1.26-1.76] pg/mL (P=0.034). Meanwhile, 16 hours post surgery, IL-6
and IL-10 levels were significantly higher in the group using donor blood
components with IL-6 being 48.91 [33.89-57.6] pg/mL vs 31.56 [26.83-48.89]
pg/mL (P=0.087) and IL-10 reaching 0.8 [0.76-1.43] pg/mL vs 0.69
[0.6-0.83] pg/mL (P=0.005). Conclusion. The study demonstrates and
confirms the safety and efficacy of cardiopulmonary bypass without using
donor blood components to reduce the severity of the systemic inflammatory
response in children undergoing correction of septal congenital heart
defects. Copyright © 2022, V.A. Negovsky Research Institute of
General Reanimatology. All rights reserved.

<46>
[Use Link to view the full text]
Accession Number
2017207366
Title
Prophylactic Penehyclidine Inhalation for Prevention of Postoperative
Pulmonary Complications in High-risk Patients: A Double-blind Randomized
Trial.
Source
Anesthesiology. 136(4) (pp 551-566), 2022. Date of Publication: 01 Apr
2022.
Author
Yan T.; Liang X.-Q.; Wang G.-J.; Wang T.; Li W.-O.; Liu Y.; Wu L.-Y.; Yu
K.-Y.; Zhu S.-N.; Wang D.-X.; Sessler D.I.
Institution
(Yan, Liang, Wang, Wang, Li, Liu, Wu, Wang) The Departments of
Anesthesiology and Critical Care Medicine, Peking University First
Hospital, Beijing, China
(Yu) Respiratory and Critical Care Medicine, Peking University First
Hospital, Beijing, China
(Zhu) Biostatistics, Peking University First Hospital, Beijing, China
(Wang) The Department of Anesthesiology, Aerospace Central Hospital,
Peking University Aerospace School of Clinical Medicine, Beijing, China
(Li) The Department of Anesthesiology, Plastic Surgery Hospital, Chinese
Academy of Medical Science, Peking Union Medical College, Beijing, China
(Liu) The Department of Anesthesiology, Beijing Fangshan Liangxiang
Hospital, Beijing, China
(Wu) The Department of Anesthesiology, Beijing Ditan Hospital, Capital
Medical University, Beijing, China
(Sessler) The Outcomes Research Consortium, Cleveland, OH, United States
(Sessler) The Department of Outcomes Research, Cleveland Clinic,
Cleveland, OH, United States
Publisher
Lippincott Williams and Wilkins
Abstract
Background: Postoperative pulmonary complications are common. Aging and
respiratory disease provoke airway hyperresponsiveness, high-risk surgery
induces diaphragmatic dysfunction, and general anesthesia contributes to
atelectasis and peripheral airway injury. This study therefore tested the
hypothesis that inhalation of penehyclidine, a long-acting muscarinic
antagonist, reduces the incidence of pulmonary complications in high-risk
patients over the initial 30 postoperative days. Method(s): This
single-center double-blind trial enrolled 864 patients age over 50 yr who
were scheduled for major upper-abdominal or noncardiac thoracic surgery
lasting 2 h or more and who had an Assess Respiratory Risk in Surgical
Patients in Catalonia score of 45 or higher. The patients were randomly
assigned to placebo or prophylactic penehyclidine inhalation from the
night before surgery through postoperative day 2 at 12-h intervals. The
primary outcome was the incidence of a composite of pulmonary
complications within 30 postoperative days, including respiratory
infection, respiratory failure, pleural effusion, atelectasis,
pneumothorax, bronchospasm, and aspiration pneumonitis. Result(s): A
total of 826 patients (mean age, 64 yr; 63% male) were included in the
intention-to-treat analysis. A composite of pulmonary complications was
less common in patients assigned to penehyclidine (18.9% [79 of 417]) than
those receiving the placebo (26.4% [108 of 409]; relative risk, 0.72; 95%
CI, 0.56 to 0.93; P = 0.010; number needed to treat, 13). Bronchospasm was
less common in penehyclidine than placebo patients: 1.4% (6 of 417) versus
4.4% (18 of 409; relative risk, 0.327; 95% CI, 0.131 to 0.82; P = 0.011).
None of the other individual pulmonary complications differed
significantly. Peak airway pressures greater than 40 cm H<inf>2</inf>O
were also less common in patients given penehyclidine: 1.9% (8 of 432)
versus 4.9% (21 of 432; relative risk, 0.381; 95% CI, 0.171 to 0.85; P =
0.014). The incidence of other adverse events, including dry mouth and
delirium, that were potentially related to penehyclidine inhalation did
not differ between the groups. Conclusion(s): In high-risk patients
having major upper-abdominal or noncardiac thoracic surgery, prophylactic
penehyclidine inhalation reduced the incidence of pulmonary complications
without provoking complications. Copyright © 2022 Lippincott
Williams and Wilkins. All rights reserved.

<47>
Accession Number
2014119140
Title
Valve-in-Valve Transcatheter Aortic Valve Implantation for the Failing
Surgical Perceval Bioprosthesis.
Source
Cardiovascular Revascularization Medicine. 40(Supplement) (pp 148-153),
2022. Date of Publication: July 2022.
Author
Suleiman T.; Tanseco K.; Arunothayaraj S.; Michail M.; Cockburn J.;
Hadjivassilev S.; Hildick-Smith D.
Institution
(Suleiman, Tanseco, Arunothayaraj, Michail, Cockburn, Hadjivassilev,
Hildick-Smith) Sussex Cardiac Centre, University Hospitals Sussex,
Brighton, United Kingdom
Publisher
Elsevier Inc.
Abstract
Introduction: The Perceval Valve has been increasingly used in Surgical
Aortic Valve Replacement (SAVR) recently due to ease of implantation.
However, we have seen some cases of relatively early haemodynamic failure
of the Perceval valve and these patients may then present for
valve-in-valve transcatheter aortic valve implantation (ViV-TAVI).
Experience of ViV-TAVI in the Perceval valve is limited. Method(s):
We report our experience of VIV-TAVI in four cases of early-failing
Perceval valves, two with stenosis and two with regurgitation. We also
review the literature with regard to ViV-TAVI for this indication.
 Result(s): Four patients aged between 66 and 78 years presented with
Perceval valve dysfunction an average of 4.6 years following SAVR. All
cases underwent Heart Team discussion and a ViV-TAVI procedure was planned
thereafter. Strategies to ensure crossing through the centre of the valve
and not outside any portion of the frame were found to be essential. Three
patients had self-expanding valves implanted and one had a
balloon-expandable prosthesis. The average aortic valve area (AVA)
improved from 0.8 cm2 pre-procedure to 1.5 cm2
post-procedure*. The mean gradient (MG) improved from 35.5 mmHg (range
19.7-53 mmHg) pre-procedure to 14.8 mmHg (range 7-30 mmHg) post-procedure.
In one patient a MG of 30 mmHg persisted following valve deployment. There
were no significant peri-procedural complications. Conclusion(s):
ViV-TAVI is a useful option for failed Perceval prostheses and appears
safe and effective in this small series. Crossing inside the whole frame
of the Perceval valve is essential. Copyright © 2021 Elsevier
Inc.

<48>
Accession Number
2019638395
Title
Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of
AKI.
Source
JACC: Cardiovascular Interventions. 15(16) (pp 1639-1648), 2022. Date of
Publication: 22 Aug 2022.
Author
Mauler-Wittwer S.; Sievert H.; Ioppolo A.-M.; Mahfoud F.; Carrie D.;
Lipiecki J.; Nickenig G.; Fajadet J.; Eckert S.; Morice M.-C.; Garot P.
Institution
(Mauler-Wittwer, Ioppolo, Morice, Garot) Hopital Prive Jacques Cartier,
Institut Cardiovasculaire Paris-Sud, Massy, Ramsay-Sante, France
(Mauler-Wittwer, Ioppolo, Morice, Garot) Hopital Prive Claude Galien,
Institut Cardiovasculaire Paris-Sud, Quincy, Ramsay-Sante, France
(Sievert) CardioVascular Center, Frankfurt, Germany
(Mahfoud) Klinik fur Innere Medizin III, Kardiologie, Angiologie une
Internistische Intensivmedizin, Universitatsklinikum des Saarlandes,
Saarland University, Homburg/Saar, Germany
(Carrie) Department of Cardiology, Centre Hospitalier Universitaire de
Toulouse, Hopital Rangueil, Toulouse, France
(Lipiecki) Pole Sante-Republique, Clermont-Ferrand, France
(Nickenig) Department of Internal Medicine and Polyclinic II, University
Hospital Bonn, Germany
(Fajadet) Clinique Pasteur, Toulouse, France
(Eckert) Universitatsklinik der Ruhruniversitat Bochum-Klinik fur
Allgemeine und Interventionelle Kardiologie/Angiologie, Bad Oeynhausen,
Germany
(Morice) Cardiovascular European Research Center, Massy, France
Publisher
Elsevier Inc.
Abstract
Background: Contrast-induced nephropathy (CIN) can occur after
cardiovascular procedures using contrast media, which is associated with
increased morbidity and mortality. RenalGuard is a closed-loop system
designed to match intravenous hydration with diuretic-induced diuresis
that has shown mixed results in the prevention of CIN in previous
randomized controlled trials. Objective(s): The STRENGTH (Study
Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI)
study assessed whether RenalGuard (PLC Medical Systems) is superior to
standard intravenous hydration for CIN prevention in patients with chronic
kidney disease undergoing complex cardiovascular procedures.
 Method(s): STRENGTH is a multicenter, international, open-label,
postmarket, prospective, randomized (1:1) study monitored by the
Cardiovascular European Research Center (Massy, France) that included a
total of 259 patients with moderate to severe chronic kidney disease
(estimated glomerular filtration 15-40 mL/min/m2) requiring a
complex coronary, structural, or peripheral procedure with an expected
contrast injection of at least 3 times the estimated glomerular filtration
rate. Patients were randomized to either RenalGuard or intravenous saline
hydration according to current guidelines. Result(s): The primary
endpoint, the incidence of CIN at day 3 after the procedure, was similar
between the 2 groups (17/107 [15.9%] in the RG group vs 15/110 [13.9%] in
the control group; P = 0.62). In addition, none of the secondary endpoints
differed between the 2 groups. Conclusion(s): In high-risk patients
undergoing complex cardiovascular interventions in experienced centers,
furosemide-induced high urine output with matched hydration using the
RenalGuard system did not reduce the risk of CIN and adverse outcomes at
12 months compared with conventional intravenous hydration. Copyright
© 2022 American College of Cardiology Foundation

<49>
[Use Link to view the full text]
Accession Number
2019581173
Title
Cardiovascular events in patients with rheumatic conditions and biologic
therapy interruption due to serious infections.
Source
Coronary Artery Disease. 33(6) (pp 502-504), 2022. Date of Publication: 01
Sep 2022.
Author
Sehly A.; Ek O.; Lyckenblad K.; Marsden H.; Corrales-Medina V.F.; Keen H.;
Dwivedi G.
Institution
(Sehly, Ek, Lyckenblad, Dwivedi) Department of Cardiology, Fiona Stanley
Hospital, Australia
(Sehly, Ek, Lyckenblad, Marsden, Keen) Department of Rheumatology, Fiona
Stanley Hospital, Murdoch, WA, Australia
(Ek, Lyckenblad) Department of Molecular, Clinical Medicine Institute of
Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg,
Sweden
(Ek, Lyckenblad) Department of Advanced Clinical and Translational
Cardiovascular Imaging, Harry Perkins Institute of Medical Research,
Murdoch, WA, Australia
(Corrales-Medina) Department of Medicine, Ottawa Hospital Research
Institute, Ottawa, ON, Canada
(Keen, Dwivedi) Medical School, The University of Western Australia,
Perth, WA, Australia
Publisher
Lippincott Williams and Wilkins

<50>
Accession Number
2019498396
Title
Multi-Center Experience of Coronary Artery Perforation during Percutaneous
Coronary Intervention: Clinical and Angiographic Characteristics,
Management, and Outcomes between 2010 and 2020.
Source
Anatolian Journal of Cardiology. 26(8) (pp 608-618), 2022. Date of
Publication: August 2022.
Author
Gunduz R.; Yildiz B.S.; Cetin N.; Ozgur S.; Cizgici A.Y.; Tuluce K.;
Tuluce S.Y.; Ozen M.B.; Duman S.; Bayturan O.
Institution
(Gunduz, Ozen) Department of Cardiology, Manisa City Hospital, Manisa,
Turkey
(Yildiz, Cetin, Bayturan) Department of Cardiology, Faculty of Medicine,
Celal Bayar University, Manisa, Turkey
(Ozgur, Duman) Department of Biostatistics, Faculty of Medicine, Ege
University, Izmir, Turkey
(Cizgici) Department of Cardiology, Mehmet Akif Ersoy Thoracic and
Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey
(Tuluce) Department of Cardiology, Cigli Training and Research Hospital,
Izmir, Turkey
(Tuluce) Department of Cardiology, Ataturk Training and Research Hospital,
Izmir, Turkey
Publisher
Turkish Society of Cardiology
Abstract
Background: Coronary artery perforations are one of the most feared, rare,
and catastrophic complication of percutaneous coronary intervention.
Despite the remarkable increase in coronary angiography and percutaneous
coronary intervention, there is no large database that collects coronary
artery perforation for the Turkish population. Our study aimed to report
our experience over a 10-year period for clinical and angiographic
characteristics, management strategies, and outcomes of coronary artery
perforation during the percutaneous coronary intervention at different
cardiology departments in Turkey. Method(s): The study data came from
a retrospective analysis of 48 360 percutaneous coronary intervention
procedures between January 2010 and June 2020. A total of 110 cases who
had coronary artery perforation during the percutaneous coronary
intervention were found by angiographic review. Analysis has been
performed for the basic clinical, angiographic, procedural
characteristics, the management of coronary artery perforation, and
outcome of all patients. Result(s): The coronary artery perforation
rate was 0.22%. Out of 110 patients with coronary artery perforation, 66
patients showed indications for percutaneous coronary intervention with
acute coronary syndrome and 44 patients with stable angina pectoris. The
most common lesion type and perforated artery were type C (34.5%) and left
anterior descending (41.8%), respectively. The most observed coronary
artery perforation according to Ellis classification was type III (37.2%).
Almost 52.7% of patients have a covered stent implanted in the perforated
artery. The all-cause mortality rate of coronary artery perforation
patients in the hospital was 18.1%. Conclusion(s): The observed rate
of coronary artery perforation in our study is consistent with the studies
in this literature. However, the mortality rates related to coronary
artery perforation are higher than in other studies in this literature.
Especially, the in-hospital mortality rate was higher in type II and type
III groups due to perforation and its complications. Nevertheless,
percutaneous coronary intervention should be done in selected patients
despite catastrophic complications. Copyright@Author(s) - Available
online at anatoljcardiol.com.

<51>
[Use Link to view the full text]
Accession Number
2019490692
Title
Effects of Empagliflozin on Symptoms, Physical Limitations, and Quality of
Life in Patients Hospitalized for Acute Heart Failure: Results From the
EMPULSE Trial.
Source
Circulation. 146(4) (pp 279-288), 2022. Date of Publication: 26 Jul 2022.
Author
Kosiborod M.N.; Angermann C.E.; Collins S.P.; Teerlink J.R.; Ponikowski
P.; Biegus J.; Comin-Colet J.; Ferreira J.P.; Mentz R.J.; Nassif M.E.;
Psotka M.A.; Tromp J.; Brueckmann M.; Blatchford J.P.; Salsali A.; Voors
A.A.
Institution
(Kosiborod, Nassif) Saint Luke's Mid America Heart Institute, University
of Missouri-Kansas City, 4330 Wornall Road, Suite 2000, Kansas City, MO
64111, United States
(Kosiborod) School of Medicine, University of Missouri-Kansas City, United
States
(Angermann) George Institute for Global Health, University of New South
Wales, Sydney, Australia
(Angermann) Comprehensive Heart Failure Centre, University and University
Hospital, Wurzburg, Germany
(Collins) Department of Emergency Medicine, Vanderbilt University Medical
Center, Nashville, TN, United States
(Teerlink) Geriatric Research and Education Clinical Care, Tennessee
Valley Healthcare Facility VA Medical Center, Nashville, United States
(Teerlink) Section of Cardiology, San Francisco Veterans Affairs Medical
Center, School of Medicine, University of California San Francisco, United
States
(Ponikowski, Biegus) Institute of Heart Diseases, Medical University,
Wroclaw, Poland
(Comin-Colet) Hospital Universitari de Bellvitge, Institute of Biomedical
Research of Bellvitge (IDIBELL), Barcelona, Spain
(Ferreira) Universite de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France
(Mentz) Cardiovascular Research and Development Center, Department of
Surgery and Physiology, Faculty of Medicine, University of Porto, Portugal
(Mentz) Duke Clinical Research Institute, Division of Cardiology, Duke
University Medical Center, Durham, NC, United States
(Psotka) Inova Heart and Vascular Institute, Falls Church, VA, United
States
(Tromp) Saw Swee Hock School of Public Health, National University of
Singapore, Singapore
(Brueckmann, Brueckmann) Boehringer Ingelheim International GmbH, Germany
(Kosiborod, Angermann, Collins, Teerlink, Ponikowski, Biegus, Comin-Colet,
Ferreira, Mentz, Nassif, Psotka, Tromp, Brueckmann, Blatchford, Salsali,
Voors) First Department of Medicine, Faculty of Medicine Mannheim,
University of Heidelberg, Mannheim, Germany
(Blatchford) Elderbrook Solutions GmbH on behalf of Boehringer Ingelheim
Pharma GmbH & Co. KG, Biberach, Germany
(Salsali) Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, United
States
(Salsali) Faculty of Medicine, Rutgers University, New Brunswick, NJ,
United States
(Voors) University of Groningen, Department of Cardiology, University
Medical Center Groningen, Netherlands
Publisher
Lippincott Williams and Wilkins
Abstract
Background: Patients hospitalized for acute heart failure experience poor
health status, including a high burden of symptoms and physical
limitations, and poor quality of life. SGLT2 (sodium-glucose cotransporter
2) inhibitors improve health status in chronic heart failure, but their
effect on these outcomes in acute heart failure is not well characterized.
We investigated the effects of the SGLT2 inhibitor empagliflozin on
symptoms, physical limitations, and quality of life, using the Kansas City
Cardiomyopathy Questionnaire (KCCQ) in the EMPULSE trial (Empagliflozin in
Patients Hospitalized With Acute Heart Failure Who Have Been Stabilized).
 Method(s): Patients hospitalized for acute heart failure were
randomized to empagliflozin 10 mg daily or placebo for 90 days. The KCCQ
was assessed at randomization and 15, 30, and 90 days. The effects of
empagliflozin on the primary end point of clinical benefit (hierarchical
composite of all-cause death, heart failure events, and a 5-point or
greater difference in KCCQ Total Symptom Score [TSS] change from baseline
to 90 days) were examined post hoc across the tertiles of baseline
KCCQ-TSS. In prespecified analyses, changes (randomization to day 90) in
KCCQ domains, including TSS, physical limitations, quality of life,
clinical summary, and overall summary scores were evaluated using a
repeated measures model. Result(s): In total, 530 patients were
randomized (265 each arm). Baseline KCCQ-TSS was low overall (mean [SD],
40.8 [24.0] points). Empagliflozin-treated patients experienced greater
clinical benefit across the range of KCCQ-TSS, with no treatment effect
heterogeneity (win ratio [95% CIs] from lowest to highest tertile: 1.49
[1.01-2.20], 1.37 [0.94-1.99], and 1.48 [1.00-2.20], respectively; P for
interaction=0.94). Beneficial effects of empagliflozin on health status
were observed as early as 15 days and persisted through 90 days, at which
point empagliflozin-treated patients experienced a greater improvement in
KCCQ TSS, physical limitations, quality of life, clinical summary, and
overall summary (placebo-adjusted mean differences [95% CI]: 4.45 [95% CI,
0.32-8.59], P=0.03; 4.80 [95% CI, 0.00-9.61], P=0.05; 4.66 [95% CI,
0.32-9.01], P=0.04; 4.85 [95% CI, 0.77-8.92], P=0.02; and 4.40 points [95%
CI, 0.33-8.48], P=0.03, respectively). Conclusion(s): Initiation of
empagliflozin in patients hospitalized for acute heart failure produced
clinical benefit regardless of the degree of symptomatic impairment at
baseline, and improved symptoms, physical limitations, and quality of
life, with benefits seen as early as 15 days and maintained through 90
days. Registration: URL: Https://www.clinicaltrials.gov; Unique
identifier: NCT0415775. Copyright © 2022 Lippincott Williams and
Wilkins. All rights reserved.

<52>
[Use Link to view the full text]
Accession Number
2019394337
Title
Effects of telecardiac rehabilitation on coronary heart disease: A
PRISMA-compliant systematic review and meta-Analysis.
Source
Medicine (United States). 101(28) (pp E29459), 2022. Date of Publication:
15 Jul 2022.
Author
Jin Choo Y.; Chang M.C.
Institution
(Jin Choo, Chang) Department of Physical Medicine and Rehabilitation,
College of Medicine, Yeungnam University, 317-1, Daemyungdong, Namku,
Taegu 705-717, South Korea
Publisher
Lippincott Williams and Wilkins
Abstract
Background: We performed a meta-Analysis to investigate the effectiveness
of telecardiac rehabilitation compared to center-based rehabilitation on
cardiorespiratory fitness, blood pressure, blood lipids, body composition,
and quality of life in patients with coronary heart disease.
 Method(s): We searched the Medical Literature Analysis and Retrieval
System Online, Cumulative Index to Nursing and Allied Health Literature,
Cochrane, Embase, and Scopus databases and retrieved studies published
until October 8, 2021. Randomized controlled trials were included to
evaluate cardiorespiratory fitness, blood pressure, blood lipids, body
composition, and quality of life after telecardiac rehabilitation and
center-based rehabilitation in patients with coronary heart disease. The
criteria of the Cochrane Handbook for Systematic Reviews of Interventions
were used to evaluate the methodological quality of the studies. Funnel
plot analysis and Egger test were performed to confirm the publication
bias. Result(s): A total of 8 studies, including 750 participants,
reported the effectiveness of the telecardiac rehabilitation and
center-based rehabilitation included in the analysis. Except for total
cholesterol and mental quality of life (P <.05), all parameters were not
significantly different between telecardiac rehabilitation and
center-based rehabilitation (P >.05). Conclusion(s): Telecardiac
rehabilitation was similar to the effects of center-based rehabilitation.
The overall prognosis of patients with coronary heart disease can be
improved by increasing patients' participation in cardiac rehabilitation
through telerehabilitation. Copyright © 2022 Lippincott Williams
and Wilkins. All rights reserved.

<53>
Accession Number
2019010676
Title
An outbreak of Ralstonia insidiosa bloodstream infections caused by
contaminated heparinized syringes.
Source
Journal of Infection and Chemotherapy. 28(10) (pp 1387-1392), 2022. Date
of Publication: October 2022.
Author
Tuzemen N.U.; Onal U.; Kazak E.; Tezgec N.; Eren H.; Simsek H.; Bakkaloglu
Z.; Unaldi O.; Celebi S.; Yilmaz E.; Hacimustafaoglu M.; Akalin E.H.;
Ozakin C.
Institution
(Tuzemen, Ozakin) Department of Medical Microbiology, Bursa Uludag
University, Faculty of Medicine, Bursa, Turkey
(Onal, Kazak, Yilmaz, Akalin) Department of Infectious Diseases and
Clinical Microbiology, Bursa Uludag University, Faculty of Medicine,
Bursa, Turkey
(Tezgec, Eren) Infection Control Team, Bursa Uludag University, Faculty of
Medicine, Bursa, Turkey
(Simsek, Bakkaloglu, Unaldi) Ministry of Health General Directorate of
Public Health, Department of Microbiology Reference Laboratory and
Biological Products, Ankara, Turkey
(Celebi, Hacimustafaoglu) Department of Pediatric Infectious Disease,
Bursa Uludag University, Faculty of Medicine, Bursa, Turkey
Publisher
Elsevier B.V.
Abstract
Introduction: Ralstonia insidiosa, a gram-negative waterborne bacteria
able to survive and grow in any type of water source, can cause nosocomial
infections, and are considered emerging pathogens of infectious diseases
in hospital settings. In this study, we report an outbreak of R. insidiosa
at our center related to contaminated heparinized syringes.
 Material(s) and Method(s): The present study was conducted in a
tertiary care university hospital in Turkey. An outbreak analysis was
performed between September 2021 and December 2021. Microbiological
samples were obtained from environmental sources and from patient blood
cultures. Species identification was performed using matrix-assisted laser
desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS). To
investigate the clonality of strains, all confirmed isolates were sent to
the National Reference Laboratory and pulsed-field gel electrophoresis
(PFGE) was used to perform molecular typing. Result(s): Seventeen R.
insidiosa isolates were identified from the blood cultures of 13 patients
from various wards and intensive care units. Isolates from seven patient
blood cultures and two heparinized blood gas syringes were characterized
by PFGE. All isolates were found to belong to the same clone of R.
insidiosa. Conclusion(s): R. insidiosa was identified as the cause of
a nosocomial infection outbreak in our hospital, which was then rapidly
controlled by the infection-control team. When rare waterborne
microorganisms grow in blood or other body fluid cultures, clinicians and
the infection-control team should be made aware of a possible
outbreak. Copyright © 2022 Japanese Society of Chemotherapy and
The Japanese Association for Infectious Diseases

<54>
Accession Number
2018975238
Title
Significant Valvular Dysfunction and Outcomes in Cardiogenic Shock:
Insights From the Randomized DOREMI Trial.
Source
Canadian Journal of Cardiology. 38(8) (pp 1211-1219), 2022. Date of
Publication: August 2022.
Author
Parlow S.; Weng W.; Di Santo P.; Jung R.G.; Lepage-Ratte M.F.; Motazedian
P.; Prosperi-Porta G.; Abdel-Razek O.; Simard T.; Chan V.; Labinaz M.;
Froeschl M.; Mathew R.; Hibbert B.
Institution
(Parlow, Weng, Di Santo, Jung, Lepage-Ratte, Motazedian, Prosperi-Porta,
Abdel-Razek, Labinaz, Froeschl, Mathew, Hibbert) CAPITAL Research Group,
Division of Cardiology, University of Ottawa Heart Institute, Ottawa, ON,
Canada
(Parlow, Weng, Di Santo, Motazedian, Prosperi-Porta, Abdel-Razek, Labinaz,
Froeschl, Mathew, Hibbert) Division of Cardiology, University of Ottawa
Heart Institute, Ottawa, ON, Canada
(Di Santo) School of Epidemiology and Public Health, University of Ottawa,
Ottawa, ON, Canada
(Jung, Hibbert) Department of Cellular and Molecular Medicine, University
of Ottawa, Ottawa, ON, Canada
(Jung) Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada
(Lepage-Ratte) Department of Medicine, University of Ottawa, Ottawa, ON,
Canada
(Simard) Department of Cardiovascular Diseases, Mayo Clinic School of
Medicine, Rochester, Minnesota, United States
(Chan) Division of Cardiac Surgery, University of Ottawa Heart Institute,
Ottawa, ON, Canada
Publisher
Elsevier Inc.
Abstract
Background: Patients with cardiogenic shock (CS) suffer high rates of
in-hospital mortality, with little evidence guiding management. The impact
of valvular heart disease in patients with CS remains unclear. We
therefore conducted a post hoc analysis of the randomized Dobutamine
Compared to Milrinone (DOREMI) trial to determine the impact of valvular
disease on outcomes in patients with CS. Method(s): We defined
significant valvular disease as moderate to severe or greater valvular
stenosis or regurgitation and divided participants into a group of those
with significant valvular disease and those without. Our primary outcome
was all-cause in-hospital mortality. Secondary endpoints included
resuscitated cardiac arrest; cardiac transplantation or mechanical
circulatory support; nonfatal myocardial infarction; stroke; initiation of
renal replacement therapy; as well as changes in renal function,
perfusion, and hemodynamics over time. Result(s): One hundred
eighty-nine (98.4%) participants from the DOREMI trial were included in
our analysis, and 74 (39.2%) had significant valvular dysfunction.
Thirty-six (48.7%) patients with valvular disease died in hospital,
compared with 37 (32.2%) in the comparator group (relative risk, 1.5; 95%
confidence interval 1.06-2.15; P = 0.02). Patients with aortic stenosis
(2.42, 1.56-3.75; P < 0.01) and patients with mitral regurgitation (1.63,
1.1-2.43; P = 0.02) also had increased incidence of in-hospital mortality.
There was no significant difference in any secondary outcomes among
groups, apart from variances in mean arterial pressure observed in
patients with valvular disease (P < 0.01). Conclusion(s): Significant
valvular dysfunction is associated with increased in-hospital mortality in
patients with CS. Randomized clinical trial data are needed to further
elucidate the role of transcatheter valvular interventions as a
therapeutic target in this population. Copyright © 2022 Canadian
Cardiovascular Society

<55>
Accession Number
2018851546
Title
Effect of bariatric surgery on long-term cardiovascular outcomes: a
systematic review and meta-analysis of population-based cohort studies.
Source
Surgery for Obesity and Related Diseases. 18(8) (pp 1074-1086), 2022. Date
of Publication: August 2022.
Author
Tang B.; Zhang Y.; Wang Y.; Wang X.; An Z.; Yu X.
Institution
(Tang, Zhang, An, Yu) Department of Pharmacy, Beijing Chao-Yang Hospital,
Capital Medical University, Beijing, China
(Wang) Department of Pharmacy, Beijing An-Zhen Hospital, Capital Medical
University, Beijing, China
(Wang) Department of Pharmacy, Beijing Obstetrics and Gynecology Hospital,
Capital Medical University, Beijing, China
Publisher
Elsevier Inc.
Abstract
This meta-analysis aimed to compare the effects of bariatric surgery and
nonsurgery on cardiovascular outcomes in patients with obesity. A
systematic literature search of the Medline (via PubMed), Embase, and
Cochrane Central Register of Controlled Trials databases was performed
until August 18th, 2021. Population-based cohort studies comparing
long-term cardiovascular outcomes for patients with obesity undergoing
bariatric surgery or not were included. A meta-analysis of relative risks
(RRs) was performed for all outcomes. We conducted subgroup analyses and
meta-regression to explore sources of heterogeneity and the stability of
the results. Twenty-one population-based cohort studies involving
2,857,016 participants were identified. The major adverse cardiovascular
event (MACE) RR in the bariatric surgery group was .53 (95% confidence
interval [CI] = .45-.62, P < .001) relative to the nonsurgical group.
Relative to the nonsurgical group, the risk of myocardial infarction (MI)
(RR = .40, 95% CI = .30-.52, P < .001), stroke (RR = .60, 95% CI =
.46-.79, P < .001), cardiovascular death (RR = .43, 95% CI = .35-.54, P <
.001), and all-cause death (RR = .44, 95% CI = .32-.59, P < .001) was
significantly reduced for patients who underwent bariatric surgery. In
subgroup analyses, as the proportion of patients with diabetes mellitus
increased, lower RRs for MACE, MI, and stroke were observed in the surgery
group relative to the nonsurgical group. The decreased risk of MACE was
also observed in the subgroup with median follow-up duration >=5
years.Bariatric surgery improves cardiovascular outcomes in patients with
obesity, especially providing long-term benefits, and this effect is more
pronounced in patients with comorbid diabetes. Copyright © 2022
American Society for Metabolic and Bariatric Surgery

<56>
Accession Number
2018441948
Title
Patency and adverse outcomes of sequential vs. individual saphenous vein
grafts in coronary artery bypass: A meta-analysis.
Source
Frontiers in Cardiovascular Medicine. 9 (no pagination), 2022. Article
Number: 944717. Date of Publication: 22 Jul 2022.
Author
Jiao H.; Li J.; Bai Y.; Guo Z.
Institution
(Jiao) Academy of Medical Engineering and Translational Medicine, Tianjin
University, Tianjin, China
(Jiao, Bai, Guo) Department of Cardiac Surgery, Chest Hospital, Tianjin
University, Tianjin, China
(Li, Bai, Guo) Clinical School of Thoracic, Tianjin Medical University,
Tianjin, China
Publisher
Frontiers Media S.A.
Abstract
Objectives: To undertake a systematic review and meta-analysis of cohort
studies to compare the patency and adverse outcomes of sequential and
individual saphenous vein grafts (SVGs) in coronary artery bypass grafting
(CABG). Method(s): We searched PubMed, Embase, and the Cochrane
Library for cohort studies. Endpoints for vein graft failure,
perioperative and follow-up adverse events were extracted as risk ratio
(RR) with 95% confidence intervals (95% CI). Statistical heterogeneity
across the studies was examined using the I2 statistic.
Potential of publication bias was evaluated quantitatively by the Egger's
test. Sensitivity analysis was also performed to assess the robustness of
our outcomes. Result(s): The 15 studies were analyzed, including
22,004 patients, 4,580 grafts, and seven different adverse events under
individual or sequential CABG. The sequential group had inferior graft
failure (RR = 0.68; 95% CI, 0.60-0.77) and long-term mortality (RR = 0.76;
95%CI, 0.61-0.95), but with an increased risk of perioperative repeat
revascularization (RR = 1.58; 95%CI, 1.16-2.14) than the individual group.
 Conclusion(s): Taken together, our analysis of the aggregated
evidence comparing the sequential and individual saphenous vein grafts for
coronary heart disease patients showed that the use of the sequential
graft was associated with inferior graft failure and long-term mortality
respectively, but with an increased risk of perioperative repeat
revascularization. According to our study, both surgical techniques have
their own advantages in efficacy and safety, and the selection of surgical
techniques should be based on patients and surgeons. Sequential saphenous
vein grafts should be more recommended to experienced surgeons in order to
both reduce perioperative adverse events and improve long-term patency.
Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/,
identifier CRD42022326992. Copyright © 2022 Jiao, Li, Bai and
Guo.

<57>
Accession Number
2018412269
Title
Effectiveness of Active Chest Tube Clearance Versus Conventional Chest
Tube in Reducing Postoperative Complications After Cardiac Surgery: a
Systematic Review and Meta-analysis.
Source
SN Comprehensive Clinical Medicine. 4(1) (no pagination), 2022. Article
Number: 177. Date of Publication: December 2022.
Author
Hasan M.T.; Hagrass A.I.; Elkhrashy M.N.; Hamouda M.; shada N.M.; Hashem
S.M.; Al-kafarna M.; Almadhoon H.W.; Ragab K.M.; Nourelden A.Z.; Elsnhory
A.B.
Institution
(Hasan, Hagrass, Elkhrashy, Hamouda, Nourelden, Elsnhory) Faculty of
Medicine for Boys, Al-Azhar University, Cairo, Egypt
(Hasan, Hagrass, Elkhrashy, Hamouda, shada, Hashem, Al-kafarna, Almadhoon,
Ragab, Nourelden, Elsnhory) International Medical Research Association
(IMedRA), Cairo, Egypt
(Hagrass) Gamal Abdel Nasser Axis, The 3rd Settlement, New Cairo, Egypt
(shada, Hashem) Faculty of Medicine for Girls, Al-Azhar University, Cairo,
Egypt
(Al-kafarna) Faculty of Pharmacy, Al-Azhar University, Gaza, Palestine
(Almadhoon) Faculty of Dentistry, Al-Azhar University, Gaza, Palestine
(Ragab) Faculty of Medicine, Minia University, Minia, Egypt
Publisher
Springer Nature
Abstract
After heart surgery, the chest tube removes lost mediastinal blood.
Clogging of the chest tube may induce inadequate evacuation of fluids
surrounding the lungs and heart, leading to deadly consequences. This
meta-analysis compared the effectiveness of active chest tube clearance
(ATC) with conventional chest tube (CT) in lowering the incidence of
retained blood complications after heart surgery. We conducted a
systematic search of the available databases to identify cohort studies or
clinical trials that met our inclusion criteria. Studies that compared
active tube clearance and conventional tube in cardiac surgery were
included. The fixed or random-effects model was used to determine the
pooled effect estimates upon the heterogeneity of collected data. This
review included 7003 people from five cohort studies and three clinical
trials. As regard to retained blood, there was no significant difference
between chest tube types in matched group (RR = 0.67, 95% CI = [0.44,
1.04], P = 0.08) or unmatched group (RR = 0.64, 95% CI = [0.39, 1.04], P =
0.07). Re-exploration favored ATC in the matched group (RR = 0.64, 95% CI
= [0.43, 0.95], P = 0.03). The incidence of postoperative atrial
fibrillation was significantly lower in ATC in both matched (RR = 0.73,
95% CI = [0.61, 0.87], P = 0.0005) and unmatched groups (RR = 0.72, 95% CI
= [0.61, 0.84], P = 0.0005). This meta-analysis provides evidence on the
positive effect of active maintenance of chest tube patency during the
first hours of cardiac surgery, which resulted in reducing the incidence
of complications. Copyright © 2022, The Author(s), under
exclusive licence to Springer Nature Switzerland AG.

<58>
[Use Link to view the full text]
Accession Number
2019748585
Title
Effects of perioperative interventions for preventing postoperative
delirium: A protocol for systematic review and meta-Analysis of randomized
controlled trials.
Source
Medicine (United States). 100(29) (pp E26662), 2021. Date of Publication:
23 Jul 2021.
Author
Li X.; Wang Y.; Liu J.; Xiong Y.; Chen S.; Han J.; Xie W.; Wu Q.
Institution
(Li, Wang, Liu, Xiong, Chen, Han, Xie, Wu) Department of Anaesthesiology,
Union Hospital, Tongji Medical College, Huazhong University of Science and
Technology, 1277 Jiefang Avenue, Wuhan 430022, China
Publisher
Lippincott Williams and Wilkins
Abstract
Background:Postoperative delirium (POD) not only increases the medical
burden but also adversely affects patient prognosis. Although some cases
of delirium can be avoided by early intervention, there is no clear
evidence indicating whether any of these measures can effectively prevent
POD in specific patient groups. Objective(s):The aim of this
meta-Analysis was to compare the efficacy and safety of the existing
preventive measures for managing POD. Method(s):The PubMed, OVID
(Embase and MEDLINE), Web of Science, and the Cochrane Library databases
were searched for articles published before January 2020. The relevant
randomized controlled trials (RCTs) were selected based on the inclusion
and exclusion criteria. Data extraction and methodological quality
assessment were performed according to a predesigned data extraction form
and scoring system, respectively. The interventions were compared on the
basis of the primary outcome like incidence of POD, and secondary outcomes
like duration of delirium and the length of intensive care unit and
hospital stay. Result(s):Sixty-Three RCTs were included in the study,
covering interventions like surgery, anesthesia, analgesics,
intraoperative blood glucose control, cholinesterase inhibitors,
anticonvulsant drugs, antipsychotic drugs, sleep rhythmic regulation, and
multi-modal nursing. The occurrence of POD was low in 4 trials that
monitored the depth of anesthesia with bispectral index during the
operation (P<.0001). Two studies showed that supplementary analgesia was
useful for delirium prevention (P=.002). Seventeen studies showed that
perioperative sedation with alpha2-Adrenergic receptor agonists
prevented POD (P=.0006). Six studies showed that both typical and atypical
antipsychotic drugs can reduce the incidence of POD (P=.002). Multimodal
nursing during the perioperative period effectively reduced POD in 6
studies (P<.00001). Furthermore, these preventive measures can reduce the
duration of delirium, as well as the total and postoperative length of
hospitalized stay for non-cardiac surgery patients. For patients
undergoing cardiac surgery, effective prevention can only reduce the
length of intensive care unit stay. Conclusion(s):Measures including
intraoperative monitoring of bispectral index, supplemental analgesia,
alpha2-Adrenergic receptor agonists, antipsychotic drugs, and
multimodal care are helpful to prevent POD effectively. However, larger,
high-quality RCTs are needed to verify these findings and develop more
interventions and drugs for preventing postoperative
delirium. Copyright © 2021 Lippincott Williams and Wilkins. All
rights reserved.

<59>
Accession Number
638627847
Title
Early surgical aortic valve replacement in asymptomatic patients with
severe aortic stenosis: a systematic review and meta-analysis.
Source
Journal of cardiovascular medicine (Hagerstown, Md.). 23(9) (pp 632-634),
2022. Date of Publication: 01 Sep 2022.
Author
Ferlini M.; Munafo A.R.; Lanzillo G.; Aiello M.; Gazzoli F.; Mirizzi A.M.;
Magrini G.; Pelenghi S.; Visconti L.O.
Institution
(Ferlini, Mirizzi, Magrini, Visconti) Division of Cardiology, Fondazione
IRCCS Policlinico San Matteo
(Munafo, Lanzillo) Department of Molecular Medicine, Unit of Cardiology,
University of Pavia, Pavia, Italy
(Aiello, Gazzoli, Pelenghi) Division of Cardiac Surgery, Fondazione IRCCS
Policlinico San Matteo
Publisher
NLM (Medline)

<60>
Accession Number
637041955
Title
Determining the Effectiveness of Forced-Air Warming Blankets in
Maintaining Postoperative Body Temperature: A Randomized Controlled Trial.
Source
Journal of perianesthesia nursing : official journal of the American
Society of PeriAnesthesia Nurses. 37(4) (pp 533-539), 2022. Date of
Publication: 01 Aug 2022.
Author
Isikli A.G.; Findik UY.
Institution
(Isikli) Trakya University, Health Research and Practice Centre of Trakya
University, Thoracic Surgery Department, Balkan Campus, Edirne, Turkey
(Findik) Trakya University Faculty of Health Sciences Nursing Department,
Trakya University Balkan Campus, Edirne, Turkey
Publisher
NLM (Medline)
Abstract
PURPOSE: The aim of this study is to determine the effectiveness of
forced-air warming blankets in normalizing body temperature in the
postoperative period. DESIGN: Randomized controlled trial METHODS: The
study sample consisted of patients (N = 67) who underwent lung lobectomy
in the Thoracic Surgery Service of a university hospital. Forced-air
warming blankets were used in the treatment group and 100% cotton blankets
were used in the control group. Patients' body temperatures were monitored
using a tympanic thermometer until it reached 37degreeC. FINDINGS: The
body temperature of the patients in the treatment group reached 37degreeC
in a shorter time than that of the patients in the control group (52.27
+/- 29.79 min and 139.0 +/- 81.93 min, respectively; P < .001), and that
the perception of comfort of the patients in the treatment and control
groups increased (P < .001) after warming. CONCLUSION(S): We
recommend that forced-air warming blankets are used for patients
undergoing lung lobectomy in order to reach normal body temperature in a
shorter time. Copyright © 2021 American Society of PeriAnesthesia
Nurses. Published by Elsevier Inc. All rights reserved.

<61>
Accession Number
636036098
Title
Thoracic Paravertebral Block Ameliorates Postoperative Delirium in
Geriatric Patients.
Source
Thoracic and Cardiovascular Surgeon. 70(5) (pp 439-444), 2022. Date of
Publication: 01 Aug 2022.
Author
Heng L.; Wang M.; Li L.; Zhu S.
Institution
(Heng, Zhu) Department of Anesthesia, Xuzhou Cancer Hospital, Jiangsu
Province, Xuzhou City, China
(Wang) Department of Anesthesia, Xuzhou Maternity and Child Health Care
Hospital, Jiangsu Province, Xuzhou City, China
(Wang) Department of Anesthesia, The People's Hospital of Jiawang District
of Xuzhou, Jiangsu Province, Xuzhou City, China
(Li) Intensive Care Unit, Xuzhou No. 1 People's Hospital, College Road,
Jiangsu Province, Xuzhou City, China
Publisher
Georg Thieme Verlag
Abstract
Objectives ?Thoracic surgery often causes postoperative delirium (POD) in
geriatric patients. This study aimed to explore the effect of
ultrasound-guided continuous thoracic paravertebral block (UG-TPVB) on POD
in geriatric patients undergoing pulmonary resection. Methods ?Total 128
patients who underwent pulmonary resection were randomly allocated to
either the conventional patient-controlled analgesia (PCA) group or the
UG-TPVB group (n = 64 per group). The consumption of opioid agents
(propofol and remifentanil), postoperative hospital stay, postoperative
pulmonary atelectasis, postoperative nausea/vomiting, and postoperative
itchiness were recorded. The diagnosis of delirium was dependent on the
Nursing Delirium Screening Scale. The postoperative pain was assessed by
visual analogue scale (VAS) score. The serum levels of interleukin
(IL)-1beta, IL-6, and tumor necrosis factor-alpha were used to evaluate
the postoperative neuroinflammation. Results ?The consumption of propofol
and remifentanil, postoperative hospital stay, postoperative pulmonary
atelectasis, postoperative nausea/vomiting, and postoperative itchiness in
the UG-TPVB group were lower than that in the PCA group. Compared with the
PCA group, the prevalence of POD was decreased in the UG-TPVB group. In
addition, use of UG-TPVB not only reduced postoperative pain (VAS score)
but also decreased postoperative neuroinflammation compared with PCA in
geriatric patients undergoing pulmonary resection. Conclusions ?This study
determined the benefits of UG-TPVB over PCA, providing an effectiveness
approach to alleviate POD in geriatric patients undergoing pulmonary
resection. Copyright © 2022 Georg Thieme Verlag. All rights
reserved.

<62>
Accession Number
2013979152
Title
SARS-CoV-2 infection in heart transplant recipients: a systematic
literature review of clinical outcomes and immunosuppression strategies.
Source
Heart Failure Reviews. 27(5) (pp 1653-1663), 2022. Date of Publication:
September 2022.
Author
Ilonze O.J.; Ballut K.; Rao R.S.; Jones M.A.; Guglin M.
Institution
(Ilonze, Ballut, Rao, Jones, Guglin) Krannert Institute of Cardiology,
Section of Advanced Heart Failure and Transplant Cardiology, Division of
Cardiology, Indiana University School of Medicine, Indianapolis, United
States
(Ilonze) IndianapolisUnited States
Publisher
Springer
Abstract
The impact of SARS-CoV-2 infection on heart transplant recipients is
unknown. Literature is limited to case reports and series. The purpose of
this study is to identify the clinical features, outcomes, and
immunosuppression strategies of heart transplant recipients with COVID-19
infection. A systematic review was conducted using the search term
"Coronavirus" or COVID," "SARS-CoV-2," "cardiac transplantation," and
"heart transplant." Case reports and retrospective studies were gathered
by searching Medline/PubMed, Google Scholar, CINAHL, Cochrane CENTRAL, and
Web of Science. Thirty-three articles were selected for review. We
identified 74 cases of SARS-CoV-2 infection in heart transplant and
heart-kidney transplant recipients. The mean age was 60.5 +/- 15.8 years,
and 82.4% were males with median time from transplant of 6.5 years.
Commonest symptoms were fever, cough, and dyspnea, but new left
ventricular (LV) dysfunction was rare. Leukocytosis, lymphopenia, elevated
inflammatory markers, and bilateral ground-glass opacities were common.
Mortality was high, with particularly poor survival in patients who
required intensive care unit (ICU) admission and older patients.
Immunosuppression involved discontinuation of antimetabolites and
steroids. COVID-19 infection in heart transplant (HT) recipients presents
similarly to the general population, but new onset of LV dysfunction is
uncommon. Immunosuppression strategies include increase in corticosteroids
and discontinuation of antimetabolites. Copyright © 2021, The
Author(s), under exclusive licence to Springer Science+Business Media,
LLC, part of Springer Nature.

<63>
Accession Number
2013501749
Title
Post-ablation P wave characteristics correlate with recurrent atrial
fibrillation in the ABCD-AF cohort.
Source
Journal of Interventional Cardiac Electrophysiology. 64(2) (pp 437-442),
2022. Date of Publication: August 2022.
Author
Supanekar N.; Gilge J.L.; Ahmed A.; Patel P.J.
Institution
(Supanekar, Gilge, Ahmed, Patel) St Vincent Medical Group, 8333 Naab Road,
#400, Indianapolis, IN 46260, United States
Publisher
Springer
Abstract
Purpose: Atrial fibrillation (AF) ablation is a common procedure to reduce
cardiovascular morbidity but is limited by recurrence. The objective of
this study was to determine if post-ablation acute surface P wave
morphology and other electrocardiographic parameters correlate with AF
recurrence. Method(s): The Avoiding Bladder Catheters During AF
ablation (ABCD-AF) trial was a randomized, prospective trial in 160
subjects undergoing AF ablation. The present study examined correlation
between AF recurrence in follow-up and acute post-ablation
electrocardiographic P wave parameters. Result(s): Median follow-up
was 255 (188, 306) days. The ABCD-AF cohort had a mean age of 62.7 +/-
12.8 with 32.1% being females. Rate of recurrent AF was 35.8%, with a
median time to AF of 135 (109, 182) days. There was no baseline
demographic associated with AF recurrence. There was more AF recurrence in
those with longer follow-up (p = 0.001). Lead 2 PR interval, lead 2 P wave
duration/PR (Pdur/PR), lead V1 PR interval, and lead V1 Pdur/PR were all
significantly associated with recurrent AF (p = 0.03, 0.02, 0.01, 0.01).
Longer PR and shorter Pdur/PR predicted AF recurrence. In a multivariable
model, lead V1 Pdur/PR provided the best predictor of AF recurrence, with
an odds ratio of 0.018 (p = 0.016) per standard deviation change.
 Conclusion(s): Shorter P wave duration combined with longer AV node
delay, as measured by proportion of the PR that the P wave occupies, was
the best predictor of AF recurrence post-ablation. Copyright ©
2021, Springer Science+Business Media, LLC, part of Springer Nature.

<64>
Accession Number
2019844792
Title
Meta-Analysis Comparing Venoarterial Extracorporeal Membrane Oxygenation
With or Without Impella in Patients With Cardiogenic Shock.
Source
American Journal of Cardiology. (no pagination), 2022. Date of
Publication: 2022.
Author
Bhatia K.; Jain V.; Hendrickson M.J.; Aggarwal D.; Aguilar-Gallardo J.S.;
Lopez P.D.; Narasimhan B.; Wu L.; Arora S.; Joshi A.; Tomey M.I.; Mahmood
K.; Qamar A.; Birati E.Y.; Fox A.
Institution
(Bhatia, Aguilar-Gallardo, Lopez, Wu, Joshi) Mount Sinai Heart, Mount
Sinai Morningside Hospital, New York, New York
(Jain) Division of Internal Medicine, Cleveland Clinic Foundation,
Cleveland, Ohio
(Hendrickson) Department of Medicine, Massachusetts General Hospital,
Harvard Medical School, Boston, MA
(Aggarwal) Department of Internal Medicine, Beaumont Hospital, Royal Oak,
MI, United States
(Narasimhan) Department of Cardiology, Debakey Cardiovascular Center,
Houston Methodist, Texas
(Arora) Division of Cardiology, University of North Carolina School of
Medicine, Chapel Hill, NC, United States
(Tomey, Mahmood, Fox) Zena and Michael A. Wiener Cardiovascular Institute,
Icahn School of Medicine at Mount Sinai, New York, New York
(Qamar) Section of Interventional Cardiology, NorthShore Cardiovascular
Institute, University of Chicago, Chicago, Illinois
(Birati) Poriya Medical Center, Bar-Ilan University, Israel
Publisher
Elsevier Inc.
Abstract
Cardiogenic shock is associated with high short-term mortality.
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly
used as a mechanical circulatory support strategy for patients with
refractory cardiogenic shock. A drawback of this hemodynamic support
strategy is increased left ventricular (LV) afterload, which is mitigated
by concomitant use of Impella (extracorporeal membrane oxygenation with
Impella [ECPELLA]). However, data regarding the benefits of this approach
are limited. We conducted a systematic search of Medline, EMBASE, and
Cochrane databases to identify studies including patients with cardiogenic
shock reporting clinical outcomes with Impella plus VA-ECMO compared with
VA-ECMO alone. Primary outcome was short-term all-cause mortality
(in-hospital or 30-day mortality). Secondary outcomes included major
bleeding, hemolysis, continuous renal replacement therapy, weaning from
mechanical circulatory support, limb ischemia, and transition to
destination therapy with LV assist device (LVAD) or cardiac transplant. Of
2,790 citations, 7 observational studies were included. Of 1,054 patients
with cardiogenic shock, 391 were supported with ECPELLA (37%). Compared
with patients on only VA-ECMO support, patients with ECPELLA had a lower
risk of short-term mortality (risk ratio [RR] 0.89 [0.80 to 0.99],
I2 = 0%, p = 0.04) and were significantly more likely to
receive a heart transplant/LVAD (RR 2.03 [1.44 to 2.87], I2 =
0%, p <0.01). However, patients with ECPELLA had a higher risk of
hemolysis (RR 2.03 [1.60 to 2.57], I2 = 0%, p <0.001), renal
failure requiring continuous renal replacement therapy (RR 1.46 [1.23 to
174], I2 = 11%, p <0.0001), and limb ischemia (RR 1.67 [1.15 to
2.43], I2 = 0%, p = 0.01). In conclusion, among patients with
cardiogenic shock requiring VA-ECMO support, concurrent LV unloading with
Impella had a lower likelihood of short-term mortality and a higher
likelihood of progression to durable LVAD or heart transplant. However,
patients supported with ECPELLA had higher rates of hemolysis, limb
ischemia, and renal failure requiring continuous renal replacement
therapy. Future prospective randomized are needed to define the optimal
treatment strategy in this high-risk cohort. Copyright © 2022
Elsevier Inc.

<65>
Accession Number
2018735532
Title
A survey of cardiac surgeons to evaluate the use of sutureless aortic
valve replacement in Canada.
Source
Journal of Cardiac Surgery. (no pagination), 2022. Date of Publication:
2022.
Author
Makhdoum A.; Kim K.; Koziarz A.; Reza S.; Alsagheir A.; Pandey A.; Teoh
K.; Alhazzani W.; Lamy A.; Yanagawa B.; Belley-Cote E.P.; Whitlock R.
Institution
(Makhdoum, Kim, Reza, Alsagheir, Alhazzani, Lamy, Belley-Cote, Whitlock)
Population Research Health Institute, McMaster University, Hamilton,
Canada
(Makhdoum, Yanagawa) Division of Cardiac Surgery, St. Michael's Hospital,
University of Toronto, Toronto, Canada
(Kim) Department of Health Research Methodology, Evidence, and Impact,
McMaster University, Hamilton, ON, Canada
(Koziarz) Faculty of Medicine, University of Toronto, Toronto, ON, Canada
(Pandey) Department of Medicine, McMaster University, Hamilton, ON, Canada
(Teoh) Southlake Regional Health Sciences Centre, Newmarket, ON, Canada
(Alhazzani, Belley-Cote) Division of Critical Care, Department of
Medicine, McMaster University, Hamilton, ON, Canada
(Whitlock) Division of Cardiac Surgery, Department of Surgery, McMaster
University, Hamilton, ON, Canada
Publisher
John Wiley and Sons Inc
Abstract
Background: Sutureless aortic valve replacement (SuAVR) is gaining
popularity for the treatment of aortic stenosis. We aimed to describe
Canadian cardiac surgeons' practice patterns and perceptions regarding
SuAVR. Method(s): Content experts (clinicians and methodologists)
developed the survey. Domains in the questionnaire include: respondent
characteristics, factors influencing the decision to implant a SuAVR,
barriers to SuAVR use, and interest in participating in a trial.
 Result(s): A total of 66 cardiac surgeons (median duration of
practice: 15 years; range 8-20 years) from 18 hospitals across Canada
responded to the survey for a response rate of 84%. Surgeons reported that
the following patient characteristics increased the likelihood they would
choose SuAVR: hostile root (73%), small annular size (55%), high Society
of Thoracic Surgery risk score (42%), older age (40%), to support
minimally invasive surgery (25%) and redo-operation (23%). The following
patient characteristics made surgeons less likely to pursue SuAVR: young
age (73%), low STS score (40%), and large annular size (30%). Reported
barriers to SuAVR use included: cost (33%), permanent pacemaker risk (27%)
and uncertain durability (12%). Of respondents, 73% were interested in
participating in a randomized controlled trial comparing SuAVR with
transcatheter aortic valve replacement. Conclusion(s): The primary
reasons for surgeons selecting SuAVR were high surgical risk and
anatomical challenges. Cost is a primary factor limiting SuAVR
use. Copyright © 2022 Wiley Periodicals LLC.

<66>
Accession Number
2018286547
Title
Current evidence for pharmacologic therapy following stage 1 palliation
for single ventricle congenital heart disease.
Source
Expert Review of Cardiovascular Therapy. 20(8) (pp 627-636), 2022. Date of
Publication: 2022.
Author
Broberg M.C.G.; Cheifetz I.M.; Plummer S.T.
Institution
(Broberg, Cheifetz) Department of Pediatrics, Division of Pediatric
Cardiac Critical Care, University Hospitals Rainbow Babies and Children's
Hospital, Case Western Reserve University School of Medicine, Cleveland,
OH, United States
(Cheifetz, Plummer) Department of Pediatrics, Division of Pediatric
Cardiology, University Hospitals Rainbow Babies and Children's Hospital,
Case Western Reserve University School of Medicine, Cleveland, OH, United
States
Publisher
Taylor and Francis Ltd.
Abstract
Introduction: Infants with single ventricle congenital heart disease are
vulnerable to complications between stage 1 and stage 2 of palliation.
Pharmaceutical treatment during this period is varied and often dependent
on institutional practices as there is little evidence supporting a
particular treatment path. Areas Covered: This review focuses on medical
management of patients following stage I palliation. We performed a
scoping review of the current literature regarding angiotensin converting
enzyme inhibitors and digoxin treatment in the interstage period. In
addition, we discuss other medication classes frequently used in these
patients. Expert Opinion: Due to significant heterogeneity of anatomy,
rarity of disease, and other confounding factors, there is limited
evidence to support most commonly used medications within the interstage
period. Digoxin is associated with improved mortality within the
interstage period and should be considered; however, no large randomized
controlled trial exists supporting its use. Prevention of thrombotic
complication with aspirin is also associated with improved outcomes and
should be considered unless a contraindication exists. The addition of
other prescriptions in this patient population should be considered only
after an evaluation of the risks and benefits of each medication,
recognizing the burden and risk of polypharmacy in this fragile patient
population. Copyright © 2022 Informa UK Limited, trading as
Taylor & Francis Group.

<67>
Accession Number
2017959294
Title
Machine learning and artificial intelligence in cardiac transplantation: A
systematic review.
Source
Artificial Organs. 46(9) (pp 1741-1753), 2022. Date of Publication:
September 2022.
Author
Naruka V.; Arjomandi Rad A.; Subbiah Ponniah H.; Francis J.; Vardanyan R.;
Tasoudis P.; Magouliotis D.E.; Lazopoulos G.L.; Salmasi M.Y.; Athanasiou
T.
Institution
(Naruka, Athanasiou) Department of Cardiothoracic Surgery, Imperial
College NHS Trust, Hammersmith Hospital, London, United Kingdom
(Naruka, Arjomandi Rad, Subbiah Ponniah, Vardanyan, Salmasi, Athanasiou)
Department of Surgery and Cancer, Faculty of Medicine, Imperial College
London, London, United Kingdom
(Francis) Faculty of Medicine, University of Edinburgh, Edinburgh, United
Kingdom
(Tasoudis, Magouliotis, Lazopoulos, Athanasiou) Department of
Cardiothoracic Surgery, University Hospital Thessaly, Larissa, Greece
(Lazopoulos) Department of Cardiac Surgery, University Hospital of
Heraklion, Crete, Greece
Publisher
John Wiley and Sons Inc
Abstract
Background: This review aims to systematically evaluate the currently
available evidence investigating the use of artificial intelligence (AI)
and machine learning (ML) in the field of cardiac transplantation.
Furthermore, based on the challenges identified we aim to provide a series
of recommendations and a knowledge base for future research in the field
of ML and heart transplantation. Method(s): A systematic database
search was conducted of original articles that explored the use of ML
and/or AI in heart transplantation in EMBASE, MEDLINE, Cochrane database,
and Google Scholar, from inception to November 2021. Result(s): Our
search yielded 237 articles, of which 13 studies were included in this
review, featuring 463 850 patients. Three main areas of application were
identified: (1) ML for predictive modeling of heart transplantation
mortality outcomes; (2) ML in graft failure outcomes; (3) ML to aid
imaging in heart transplantation. The results of the included studies
suggest that AI and ML are more accurate in predicting graft failure and
mortality than traditional scoring systems and conventional regression
analysis. Major predictors of graft failure and mortality identified in ML
models were: length of hospital stay, immunosuppressive regimen,
recipient's age, congenital heart disease, and organ ischemia time. Other
potential benefits include analyzing initial lab investigations and
imaging, assisting a patient with medication adherence, and creating
positive behavioral changes to minimize further cardiovascular risk.
 Conclusion(s): ML demonstrated promising applications for improving
heart transplantation outcomes and patient-centered care, nevertheless,
there remain important limitations relating to implementing AI into
everyday surgical practices. Copyright © 2022 The Authors.
Artificial Organs published by International Center for Artificial Organ
and Transplantation (ICAOT) and Wiley Periodicals LLC.

<68>
Accession Number
2017872047
Title
Implantable cardioverter defibrillators in patients with orthotopic heart
transplant: A multicenter case series.
Source
Journal of Cardiovascular Electrophysiology. 33(8) (pp 1813-1822), 2022.
Date of Publication: August 2022.
Author
Maskoun W.; Raad M.; Cha Y.-M.; Houmsse M.; Abualsuod A.; Ezzeddine F.;
Pieper J.; Jamoor K.; Tita C.; Miller J.
Institution
(Maskoun, Raad, Jamoor) Division of Electrophysiology, Department of
Cardiovascular Diseases, Henry Ford Health System, Detroit, MI, United
States
(Cha, Ezzeddine) Division of Electrophysiology, Department of
Cardiovascular Diseases, Mayo Clinic, Rochester, MN, United States
(Houmsse, Pieper) Division of Electrophysiology, Department of
Cardiovascular Diseases, Ohio State University, Columbus, OH, United
States
(Abualsuod, Miller) Division of Cardiology, Department of Medicine,
Indiana University School of Medicine, Indianapolis, IN, United States
(Tita) Division of Advanced Heart Failure and Transplant Cardiology,
Department of Cardiovascular Diseases, Henry Ford Health System, Detroit,
MI, United States
Publisher
John Wiley and Sons Inc
Abstract
Background: Sudden cardiac death (SCD) is common after orthotopic heart
transplant (OHT). No clear guidelines for implantable cardioverter
defibrillator (ICD) implantation in OHT patients at high risk for SCD
currently exist. Objective(s): To assess the safety, efficacy, and
benefit of ICDs and resynchronization therapy post-OHT. We also provide a
systematic review of previous reports. Method(s): A retrospective
multicenter cohort study within the United States. Patients with ICD
post-OHT between 2000 and 2020 were identified. Result(s): We
analyzed 16 patients from 4 centers. The mean standard-deviation (SD) age
was 43 (18) years at OHT and 51 (20) years at ICD implantation. The mean
(SD) duration from OHT to ICD implantation was 9 (5) years. The mean (SD)
left ventricular ejection fraction (LVEF) was 35% (17%). There were 2
(13%) postprocedural complications: 1 hematoma and 1 death. Mean (SD)
follow-up was 24 (23) months. Survival rate was 63% (10/16) at 1 year and
56% (9/16) at 2 years, with 6/7 of those who died having LVEF < 35% at the
time of the ICD implantation. Patients were more likely to receive
appropriate therapy if their ICD was implanted for secondary (5/8) rather
than primary (0/8) prevention (p =.007). Of those who did, 4 patients
survived to 30 days post-ICD therapy. Severe CAV was not associated with
the rate of appropriate therapy. Conclusion(s): Beneficial outcomes
were observed when ICDs were implanted for secondary prevention only, and
in patients with higher baseline LVEF. We also observed benefits with
resynchronization therapy. Copyright © 2022 Wiley Periodicals
LLC.

<69>
Accession Number
2016477240
Title
The hybrid convergent procedure for persistent and long-standing
persistent atrial fibrillation from an electrophysiologist's perspective.
Source
Journal of Cardiovascular Electrophysiology. 33(8) (pp 1954-1960), 2022.
Date of Publication: August 2022.
Author
DeLurgio D.B.
Institution
(DeLurgio) School of Medicine, Emory University, Atlanta, GA, United
States
Publisher
John Wiley and Sons Inc
Abstract
In atrial fibrillation (AF), the pulmonary veins (PVs) are central to
arrhythmogenicity and are targeted by PV isolation (PVI). As AF
progresses, triggers become more prevalent in non-PV areas including the
left atrial posterior wall (LAPW). Reported benefits of LAPW isolation in
Cox-maze IV led to exploration of ablation strategies using endocardial
catheters. However, no single approach to endocardial LAPW isolation
exists. Relative success in comparison to PVI alone has been mixed. The
hybrid convergent procedure was developed to combine minimally invasive
surgical and electrophysiology techniques to accomplish effective PVI and
LAPW isolation. Epicardial LAPW isolation is performed by a cardiothoracic
surgeon followed by endocardial ablation by an electrophysiologist who
ensures PVI completion and targets any remaining gaps. Safety and
effectiveness of hybrid convergent were evaluated in the prospective,
multicenter, randomized controlled trial, Convergence of Epicardial and
Endocardial Ablation for the Treatment of Symptomatic Persistent AF
(CONVERGE). CONVERGE compared the effectiveness of the hybrid convergent
procedure to endocardial catheter ablation for treatment of
drug-refractory persistent and long-standing persistent AF and
demonstrated primary effectiveness of higher freedom from atrial
arrhythmias absent new/increased dose previously failed/intolerant
antiarrhythmic drugs through 12 months compared to endocardial catheter
ablation. Greater freedom from AF and proportion of patients experiencing
>=90% burden reduction with hybrid convergent ablation were seen through
18 months of follow-up. Improved electrophysiology lab efficiency was
demonstrated by the reduction in endocardial ablation time with addition
of epicardial ablation. This multidisciplinary heart team procedure may
improve outcomes in difficult-to-treat patients with advanced
AF. Copyright © 2022 Wiley Periodicals LLC.

<70>
Accession Number
2015266862
Title
Next-Day Discharge vs Early Discharge After Transcatheter Aortic Valve
Replacement: Systematic Review and Meta-Analysis.
Source
Current Problems in Cardiology. 47(10) (no pagination), 2022. Article
Number: 100998. Date of Publication: October 2022.
Author
Gupta R.; Mahajan S.; Mehta A.; Nyaeme M.; Mehta N.A.; Cheema A.; Khanal
L.; Malik A.H.; Aronow W.S.; Vyas A.V.; Mehta S.S.; Patel N.C.
Institution
(Gupta, Vyas, Patel) Lehigh Valley Heart Institute, Lehigh Valley Health
Network, Allentown, PA, United States
(Mahajan, Mehta, Nyaeme, Cheema, Khanal) Department of Internal Medicine,
Carle Foundation Hospital, Urbana, IL
(Mehta) Department of Cardiology, University of Missouri Kansas City,
Kansas City, MO
(Malik, Aronow) Department of Cardiology, Westchester Medical Center and
New York Medical College, Valhalla, NY
(Mehta) Heart and Vascular Institute, Carle Foundation Hospital, Urbana,
IL
Publisher
Elsevier Inc.
Abstract
With the growing utilization of transcatheter aortic valve replacement
(TAVR) as an alternative option to surgical valve replacement (SAVR) in
patients considered to be suboptimal for surgery, there is a need to
explore the possibility of next day discharge (NDD) and its potential
outcomes. The aim of our study is to compare outcomes and complications
following NDD vs the standard early discharge (ED) (less than 3 days). A
comprehensive literature search was performed in PubMed, Embase, and
Cochrane to identify relevant trials. Summary effects were calculated
using a DerSimonian and Laird random effects model as odds ratio with 95%
confidence intervals for all the clinical endpoints. Studies comparing
same-day or next-day discharge vs discharge within the next three days
were included in our analysis. 6 studies with 2,672 patients were
identified. The risk of bleeding and vascular complications was
significantly lower in patients with NDD compared to ED (OR 0.10, P <
0.00001 and OR 0.22, P = 0.002 respectively). The incidence of permanent
pacemaker (PPM) implants was significantly lower in patients who had NDD
compared to ED (OR 0.21, P = 0.0005). The incidence of 30 day mortality,
stroke, AKI and readmission rates was not different between the two
groups. NDD after TAVR allows for reduction in hospital stay and can
mitigate hospital costs without an increased risk of complications. Our
analysis shows that complication rate is comparable to ED, NDD is a
reasonable option for certain patients with severe aortic stenosis who
undergo TAVR. Further studies are needed to elucidate whether higher risk
patients who would benefit from an extended inpatient monitoring post
TAVR. Copyright © 2021 Elsevier Inc.

<71>
Accession Number
2014435538
Title
Coronary artery revascularizations and cognitive decline - A systematic
review.
Source
Current Problems in Cardiology. 47(10) (no pagination), 2022. Article
Number: 100960. Date of Publication: October 2022.
Author
Lappalainen L.; Rajamaki B.; Tolppanen A.-M.; Hartikainen S.
Institution
(Lappalainen, Rajamaki, Tolppanen, Hartikainen) School of Pharmacy,
University of Eastern Finland, FI, Kuopio, Finland
(Rajamaki, Tolppanen, Hartikainen) Kuopio Research Center of Geriatric
Care, University of Eastern Finland, FI, Kuopio, Finland
Publisher
Elsevier Inc.
Abstract
Coronary artery disease (CAD) is a risk factor for cognitive decline. The
aim of this study was to systematically review recent literature on
whether coronary artery revascularizations are associated to cognitive
decline and dementia. Pubmed, Scopus, and CINAHL (EBSCO) were searched
systematically from January 2009 to September 2020. Studies were conducted
on persons with CAD undergoing coronary artery bypass grafting (CABG) or
percutaneous coronary intervention (PCI) procedure compared to other
coronary artery disease treatments, and the outcome was cognitive decline
or dementia. Altogether four of the 680 reviewed articles met inclusion
criteria. Results were inconsistent, and the outcome measurements
heterogeneous between studies. Our findings indicate an evidence gap in
the current understanding of long-term outcomes following coronary artery
revascularization. However, evidence of long-term effects on cognition
would complement our understanding of their benefits. There is a need for
more studies on long-term cognitive outcomes after coronary artery
revascularizations. Copyright © 2021 The Authors

<72>
Accession Number
365975176
Title
Intraoperative high-dose dexamethasone for cardiac surgery: A randomized
controlled trial.
Source
JAMA. 308(17) (pp 1761-1767), 2012. Date of Publication: 07 Nov 2012.
Author
Dieleman J.M.; Nierich A.P.; Rosseel P.M.; Van Der Maaten J.M.; Hofland
J.; Diephuis J.C.; Schepp R.M.; Boer C.; Moons K.G.; Van Herwerden L.A.;
Tijssen J.G.; Numan S.C.; Kalkman C.J.; Van Dijk D.
Institution
(Dieleman, Moons, Van Herwerden, Numan, Kalkman, Van Dijk) Division of
Anesthesiology, Intensive Care, and Emergency Medicine, University Medical
Center Utrecht, PO Box 85500, 3508 GA, Utrecht, Netherlands
(Nierich) Isala Klinieken, Zwolle, Netherlands
(Rosseel) Amphia Ziekenhuis, Breda, Netherlands
(Van Der Maaten) University Medical Center, Groningen, Netherlands
(Hofland) Erasmus Medical Center, Rotterdam, Netherlands
(Diephuis) Medisch Spectrum Twente, Enschede, Netherlands
(Schepp) Medical Center, Leeuwarden, Netherlands
(Boer) Vrije Universiteit Medical Center, Amsterdam, Netherlands
(Tijssen) Academic Medical Center, University of Amsterdam, Amsterdam,
Netherlands
Publisher
American Medical Association
Abstract
Context: Prophylactic corticosteroids are often administered during
cardiac surgery to attenuate the inflammatory response to cardiopulmonary
bypass and surgical trauma; however, evidence that routine corticosteroid
use can prevent major adverse events is lacking. Objective(s): To
quantify the effect of intraoperative high-dose dexamethasone on the
incidence of major adverse events in patients undergoing cardiac surgery.
 Design, Setting, and Participant(s): A multicenter, randomized,
double-blind, placebocontrolled trial of 4494 patients aged 18 years or
older undergoing cardiac surgery with cardiopulmonary bypass at 8 cardiac
surgical centers in the Netherlands enrolled between April 13, 2006, and
November 23, 2011. Intervention(s): Patients were randomly assigned
to receive a single intraoperative dose of 1 mg/kg dexamethasone (n=2239)
or placebo (n=2255). Main Outcome Measure(s): A composite of death,
myocardial infarction, stroke, renal failure, or respiratory failure,
within 30 days of randomization. Result(s): Of the 4494 patients who
underwent randomization, 4482 (99.7%) could be evaluated for the primary
outcome. A total of 157 patients (7.0%) in the dexamethasone group and 191
patients (8.5%) in the placebo group reached the primary study end point
(relative risk, 0.83; 95% CI, 0.67-1.01; absolute risk reduction, -1.5%;
95% CI, -3.0% to 0.1%; P=.07). Dexamethasone was associated with
reductions in postoperative infection, duration of postoperative
mechanical ventilation, and lengths of intensive care unit and hospital
stays. In contrast, dexamethasone was associated with higher postoperative
glucose levels. Conclusion(s): In our trial of adults undergoing
cardiac surgery, the use of intraoperative dexamethasone did not reduce
the 30-day incidence of major adverse events compared with placebo. Trial
Registration: clinicaltrials.gov Identifier: NCT00293592 ©2012
American Medical Association. All rights reserved.

<73>
Accession Number
2019879887
Title
Pre-surgery optimization of patients' expectations to improve outcome in
heart surgery: Study protocol of the randomized controlled multi-center
PSY-HEART-II trial.
Source
American Heart Journal. 254 (pp 1-11), 2022. Date of Publication: December
2022.
Author
Salzmann S.; Laferton J.A.C.; Shedden-Mora M.C.; Horn N.; Gartner L.;
Schroder L.; Rau J.; Schade-Brittinger C.; Murmann K.; Rastan A.; Andrasi
T.B.; Boning A.; Salzmann-Djufri M.; Lowe B.; Brickwedel J.; Albus C.;
Wahlers T.; Hamm A.; Hilker L.; Albert W.; Falk V.; Zimmermann T.; Ismail
I.; Strauss B.; Doenst T.; Schedlowski M.; Moosdorf R.; Rief W.
Institution
(Salzmann, Horn, Gartner, Schroder, Rief) Division of Clinical Psychology
and Psychotherapy, Philipps University of Marburg, Marburg, Germany
(Laferton) Department of Medicine, Health and Medical University, Potsdam,
Germany
(Shedden-Mora) Department of Psychology, Medical School Hamburg, Hamburg,
Germany
(Shedden-Mora, Lowe) Department of Psychosomatic Medicine and
Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg,
Germany
(Rau, Schade-Brittinger, Murmann) Coordination Center for Clinical Trials
(KKS), University of Marburg, Marburg, Germany
(Rastan, Andrasi, Moosdorf) Department for Cardiovascular Surgery, Heart
Center, Philipps University of Marburg, Marburg, Germany
(Boning, Salzmann-Djufri) Department of Cardiovascular Surgery, University
Hospital Giessen, Giessen, Germany
(Brickwedel) Department of Cardiovascular Surgery, University Heart &
Vascular Center Hamburg, Hamburg, Germany
(Albus) Department of Psychosomatics and Psychotherapy, Medical Faculty
and University Hospital, University of Cologne, Cologne, Germany
(Wahlers) Department of Cardiothoracic Surgery, University Hospital of
Cologne, Cologne, Germany
(Hamm) Department of Physiological and Clinical Psychology/ Psychotherapy,
University of Greifswald, Greifswald, Germany
(Hilker) Department of Cardiovascular Surgery, Clinic Karlsburg, Heart and
Diabetes Center Mecklenburg-Western Pommerania, Karlsburg, Germany
(Albert) Psychosomatics, German Heart Center Berlin, Berlin, Germany
(Falk) Department of Cardiothoracic and Vascular Surgery, German Heart
Center Berlin, Berlin, Germany
(Zimmermann) Department of Psychosomatic Medicine and Psychotherapy,
Hannover Medical School, Hannover, Germany
(Ismail) Division of Cardiac, Thoracic, Transplantation and Vascular
Surgery, Hannover Medical School, Hannover, Germany
(Straus) Institute of Psychosocial Medicine, Psychotherapy, and
Psychooncology, University Hospital Jena, Germany
(Doenst) Jena University Hospital, Friedrich-Schiller-University of Jena,
Jena, Germany
(Schedlowski) Institute of Medical Psychology and Behavioral
Immunobiology, University Clinic Essen, Department of Clinical
Neuroscience, Osher Center for Integrative Medicine, Karolinska Institute,
Essen, Germany
Publisher
Elsevier Inc.
Abstract
The PSY-HEART-I trial indicated that a brief expectation-focused
intervention prior to heart surgery improves disability and quality of
life 6 months after coronary artery bypass graft surgery (CABG). However,
to investigate the clinical utility of such an intervention, a large
multi-center trial is needed to generalize the results and their
implications for the health care system. The PSY-HEART-II study aims to
examine whether a preoperative psychological intervention targeting
patients' expectations (EXPECT) can improve outcomes 6 months after CABG
(with or without heart valve replacement). EXPECT will be compared to
Standard of Care (SOC) and an intervention providing emotional support
without targeting expectations (SUPPORT). In a 3-arm multi-center
randomized, controlled, prospective trial (RCT), N = 567 patients
scheduled for CABG surgery will be randomized to either SOC alone or SOC
and EXPECT or SOC and SUPPORT. Patients will be randomized with a fixed
unbalanced ratio of 3:3:1 (EXPECT: SUPPORT: SOC) to compare EXPECT to SOC
and EXPECT to SUPPORT. Both psychological interventions consist of 2
in-person sessions (a 50 minute), 2 phone consultations (a 20 minute)
during the week prior to surgery, and 1 booster phone consultation
post-surgery 6 weeks later. Assessment will occur at baseline approx. 3-10
days before surgery, preoperatively the day before surgery, 4-6 days
later, and 6 months after surgery. The study's primary end point will be
patients' illness-related disability 6 months after surgery. Secondary
outcomes will be patients' expectations, subjective illness beliefs,
quality of life, length of hospital stay and blood sample parameters (eg,
inflammatory parameters such as IL-6, IL-8, CRP). This large multi-center
trial has the potential to corroborate and generalize the promising
results of the PSY-HEART-I trial for routine care of cardiac surgery
patients, and to stimulate revisions of treatment guidelines in heart
surgery. Copyright © 2022 The Authors

<74>
Accession Number
2017846497
Title
Outcomes of cardiac surgery with left atrial appendage occlusion versus no
Occlusion, direct oral Anticoagulants, and vitamin K Antagonists: A
systematic review with Meta-analysis.
Source
IJC Heart and Vasculature. 40 (no pagination), 2022. Article Number:
100998. Date of Publication: June 2022.
Author
Nso N.; Nassar M.; Zirkiyeva M.; Lakhdar S.; Shaukat T.; Guzman L.;
Alshamam M.; Foster A.; Bhangal R.; Badejoko S.; Lyonga Ngonge A.;
Tabot-Tabot M.; Mbome Y.; Rizzo V.; Munira M.S.; Thambidorai S.
Institution
(Nso, Nassar, Zirkiyeva, Lakhdar, Shaukat, Guzman, Alshamam, Foster,
Bhangal, Rizzo) Department of Medicine, Icahn School of Medicine at Mount
Sinai/NYC H+H/Queens, NY, United States
(Badejoko) Department of Medicine, St. Joseph's Medical Center, Stockton,
CA, United States
(Lyonga Ngonge, Tabot-Tabot) Department of Medicine, Howard University
Hospital, Washington, DC, United States
(Mbome) Department of Medicine, Richmond University Medical Center, Staten
Island, NY, United States
(Munira) Division of Cardiovascular Disease, Icahn School of Medicine at
Mount Sinai/NYC H+H/Queens, NY, United States
(Thambidorai) Chief of Cardiovascular Medicine Division, HCA Medical City
of Fort Worth, TX/ Assistant Professor of Medicine -TCU and UNTHSc School
of Medicine, Fort Worth, TX, United States
Publisher
Elsevier Ireland Ltd
Abstract
Surgical left atrial appendage occlusion (LAAO) is being used increasingly
in the setting of atrial fibrillation but has been associated with
procedural complications. This systematic review and meta-analysis
compared the outcomes of surgical LAAO with those of no LAAO and the use
of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs)
using the PRISMA guidelines. A literature search was undertaken for
relevant studies published between January 1, 2003, and August 15, 2021.
Primary clinical outcomes were all-cause mortality, embolic events, and
stroke. Secondary clinical outcomes included major adverse cardiac events
(MACE), postoperative atrial fibrillation, postoperative complications,
reoperation for bleeding, and major bleeding. There was a statistically
significant 34% reduction in incidence of embolic events (odds ratio [OR]
0.66, 95% confidence interval [CI] 0.57-0.77, p < 0.001) and a significant
42% reduction in risk of MACE (OR 0.58, 95% CI 0.38-0.88, p = 0.01) in
patients who underwent LAAO.Surgical LAAO has the potential to reduce
embolic events and MACE in patients undergoing cardiac surgery for atrial
fibrillation. However, complete replacement of DOACs and warfarin therapy
with surgical LAAO is unlikely despite its non-inferiority in terms of
minimizing all-cause mortality, embolic events, MACE, major bleeding, and
stroke in patients on oral anticoagulation therapies. Copyright ©
2022 The Authors

<75>
Accession Number
2019845710
Title
Driving pressure-guided ventilation and postoperative pulmonary
complications in thoracic surgery: a multicentre randomised clinical
trial.
Source
British Journal of Anaesthesia. (no pagination), 2022. Date of
Publication: 2022.
Author
Park M.; Yoon S.; Nam J.-S.; Ahn H.J.; Kim H.; Kim H.J.; Choi H.; Kim
H.K.; Blank R.S.; Yun S.-C.; Lee D.K.; Yang M.; Kim J.A.; Song I.; Kim
B.R.; Bahk J.-H.; Kim J.; Lee S.; Choi I.-C.; Oh Y.J.; Hwang W.; Lim B.G.;
Heo B.Y.
Institution
(Park, Ahn, Yang, Kim, Heo) Department of Anaesthesiology and Pain
Medicine, Samsung Medical Centre, Sungkyunkwan University School of
Medicine, Seoul, South Korea
(Yoon, Song, Kim, Bahk) Department of Anaesthesiology and Pain Medicine,
Seoul National University Hospital, University of Seoul National College
of Medicine, Seoul, South Korea
(Nam, Kim, Lee, Choi) Department of Anaesthesiology and Pain Medicine,
Asan Medical Centre, University of Ulsan College of Medicine, Seoul, South
Korea
(Kim, Lim) Department of Anaesthesiology and Pain Medicine, Korea
University Guro Hospital, Korea University College of Medicine, Seoul,
South Korea
(Kim, Oh) Department of Anaesthesiology and Pain Medicine, Anaesthesia and
Pain Research Institute, Yonsei University College of Medicine, South
Korea
(Choi, Hwang) Department of Anaesthesiology and Pain Medicine, Seoul St.
Mary's Hospital, College of Medicine, The Catholic University of Korea,
Seoul, South Korea
(Kim) Department of Thoracic and Cardiovascular Surgery, Samsung Medical
Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea
(Blank) Department of Anaesthesiology, University of Virginia Health
System, Charlottesville, VA, United States
(Yun) Department of Biostatistics, Asan Medical Centre, University of
Ulsan College of Medicine, Seoul, South Korea
(Lee) Department of Anaesthesiology and Pain Medicine, Dongguk University
Hospital, Goyang-si, South Korea
Publisher
Elsevier Ltd
Abstract
Background: Airway driving pressure, easily measured as plateau pressure
minus PEEP, is a surrogate for alveolar stress and strain. However, the
effect of its targeted reduction remains unclear. Method(s): In this
multicentre trial, patients undergoing lung resection surgery were
randomised to either a driving pressure group (n=650) receiving an
alveolar recruitment/individualised PEEP to deliver the lowest driving
pressure or to a conventional protective ventilation group (n=650) with
fixed PEEP of 5 cm H<inf>2</inf>O. The primary outcome was a composite of
pulmonary complications within 7 days postoperatively. Result(s): The
modified intention-to-treat analysis included 1170 patients (mean
[standard deviation, SD]; age, 63 [10] yr; 47% female). The mean driving
pressure was 7.1 cm H<inf>2</inf>O in the driving pressure group vs 9.2 cm
H<inf>2</inf>O in the protective ventilation group (mean difference [95%
confidence interval, CI]; -2.1 [-2.4 to -1.9] cm H<inf>2</inf>O; P<0.001).
The incidence of pulmonary complications was not different between the two
groups: driving pressure group (233/576, 40.5%) vs protective ventilation
group (254/594, 42.8%) (risk difference -2.3%; 95% CI, -8.0% to 3.3%;
P=0.42). Intraoperatively, lung compliance (mean [SD], 42.7 [12.4] vs 33.5
[11.1] ml cm H<inf>2</inf>O-1; P<0.001) and Pa<inf>o2</inf>
(median [inter-quartile range], 21.5 [14.5 to 30.4] vs 19.5 [13.5 to 29.1]
kPa; P=0.03) were higher and the need for rescue ventilation was less
frequent (6.8% vs 10.8%; P=0.02) in the driving pressure group.
 Conclusion(s): In lung resection surgery, a driving pressure-guided
ventilation improved pulmonary mechanics intraoperatively, but did not
reduce the incidence of postoperative pulmonary complications compared
with a conventional protective ventilation. Clinical trial registration:
NCT04260451. Copyright © 2022 The Author(s)

<76>
Accession Number
2018735405
Title
Leadless pacemaker implantation in dextrocardia with situs viscerum
inversus: A case report and literature review.
Source
PACE - Pacing and Clinical Electrophysiology. (no pagination), 2022. Date
of Publication: 2022.
Author
Bontempi L.; Fundaliotis A.; Moretti M.; Sammartino A.M.; Saino A.T.;
Arabia G.; Piti A.; Curnis A.; Dell'Aquila A.
Institution
(Bontempi, Fundaliotis, Moretti, Sammartino, Saino, Piti, Dell'Aquila)
Unit of Cardiology, Cardiac Electrophysiology and, Electrostimulation
Laboratory, "Bolognini" Hospital of Seriate - ASST Bergamo Est, Bergamo,
Italy
(Bontempi, Sammartino, Arabia, Curnis, Dell'Aquila) Department of Medical
and Surgical Specialties, Radiological Sciences, and Public Health,
Institute of Cardiology, ASST Spedali Civili Hospital of Brescia and
University of Brescia, Brescia, Italy
Publisher
John Wiley and Sons Inc
Abstract
Leadless pacemaker implantation (LPI) has fewer device complications and
reduced chance of infection compared to conventional pacemakers.
Dextrocardia with situs viscerum inversus (DC+SVI) is a rare condition,
which seldom leads to cardiac complications. However, its presence poses a
challenge to operators in cardiac procedures. LPI reports in DC patients
are scarce. We report a case of LPI in a DC+SVI patient, followed by a
brief but comprehensive literature review. Copyright © 2022 Wiley
Periodicals LLC.

<77>
Accession Number
2018727633
Title
Intraoperative respiratory and hemodynamic strategies for reducing nausea,
vomiting, and pain after surgery: Systematic review and meta-analysis.
Source
Acta Anaesthesiologica Scandinavica. (no pagination), 2022. Date of
Publication: 2022.
Author
Holst J.M.; Klitholm M.P.; Henriksen J.; Vallentin M.F.; Jessen M.K.;
Bolther M.; Holmberg M.J.; Hoybye M.; Lind P.C.; Granfeldt A.; Andersen
L.W.
Institution
(Holst, Klitholm, Henriksen, Bolther, Lind, Granfeldt, Andersen)
Department of Anesthesiology and Intensive Care, Aarhus University
Hospital, Aarhus, Denmark
(Vallentin, Jessen, Holmberg, Hoybye, Lind, Granfeldt, Andersen)
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
(Vallentin, Andersen) Prehospital Emergency Medical Services, Central
Denmark Region, Aarhus, Denmark
(Jessen, Holmberg, Hoybye, Andersen) Research Center for Emergency
Medicine, Aarhus University Hospital, Aarhus, Denmark
(Holmberg) Department of Anesthesiology and Intensive Care, Randers
Regional Hospital, Randers, Denmark
Publisher
John Wiley and Sons Inc
Abstract
Background: Despite improved medical treatment strategies, postoperative
pain, nausea, and vomiting remain major challenges. This systematic review
investigated the relationship between perioperative respiratory and
hemodynamic interventions and postoperative pain, nausea, and vomiting.
 Method(s): PubMed and Embase were searched on March 8, 2021 for
randomized clinical trials investigating the effect of perioperative
respiratory or hemodynamic interventions in adults undergoing non-cardiac
surgery. Investigators reviewed trials for relevance, extracted data, and
assessed risk of bias. Meta-analyses were performed when feasible. GRADE
was used to assess the certainty of the evidence. Result(s): This
review included 65 original trials; of these 48% had pain, nausea, and/or
vomiting as the primary focus. No reduction of postoperative pain was
found in meta-analyses when comparing recruitment maneuvers with no
recruitment, high (80%) to low (30%) fraction of oxygen, low (5-7 ml/kg)
to high (9-12 ml/kg) tidal volume, or goal-directed hemodynamic therapy to
standard care. In the meta-analysis comparing recruitment maneuvers with
no recruitment maneuvers, patients undergoing laparoscopic gynecological
surgery had less shoulder pain 24 h postoperatively (mean difference in
the numeric rating scale from 0 to 10: -1.1, 95% CI: -1.7, -0.5). In
meta-analyses, comparing high to low fraction of inspired oxygen and
goal-directed hemodynamic therapy to standard care in patients undergoing
abdominal surgery, the risk of postoperative nausea and vomiting was
reduced (odds ratio: 0.45, 95% CI: 0.24, 0.87 and 0.48, 95% CI: 0.27,
0.85). The certainty in the evidence was mostly very low to low. The
results should be considered exploratory given the lack of prespecified
hypotheses and corresponding risk of Type 1 errors. Conclusion(s):
There is limited evidence regarding the impact of intraoperative
respiratory and hemodynamic interventions on postoperative pain or nausea
and vomiting. More definitive trials are needed to guide clinical care
within this area. Copyright © 2022 The Authors. Acta
Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on
behalf of Acta Anaesthesiologica Scandinavica Foundation.

<78>
Accession Number
2018722852
Title
The evolving treatment of congenital heart disease in patient with Down
syndrome: Current state of knowledge.
Source
Journal of Cardiac Surgery. (no pagination), 2022. Date of Publication:
2022.
Author
Alkattan H.N.; Ardah H.I.; Arifi A.A.; Yelbuz T.M.
Institution
(Alkattan, Arifi, Yelbuz) Department of Cardiac Sciences, Ministry of the
National Guard - Health Affairs, Riyadh, Saudi Arabia
(Alkattan, Ardah, Arifi, Yelbuz) Department of Cardiac Science, King
Abdulaziz Medical City, King Abdullah International Medical Research
Center, Riyadh, Saudi Arabia
(Alkattan, Ardah, Arifi, Yelbuz) Department of Cardiac Science, King
Abdulaziz Medical City, King Saud bin Abdulaziz University for Health
Sciences, Riyadh, Saudi Arabia
Publisher
John Wiley and Sons Inc
Abstract
Objectives: Children with Down syndrome are usually seen as not worthy of
high-risk cardiac surgery. Through this review, we try to show the results
of curative and palliative surgery for functional single ventricle
syndrome in patients with Down syndrome, as there is currently no standard
protocol for the treatment of this category of patients. Method(s):
An exhaustive search of all related published medical literature included
the following domains: Down syndrome and diagnosis, Down syndrome and
taxonomy, Down syndrome, and natural history, Down syndrome and
cardiovascular abnormalities, Down syndrome and pulmonary hypertension,
Down syndrome and institutionalization, Down syndrome and surgical repair,
Down syndrome, and single ventricle palliation, Down syndrome and Glenn,
Down syndrome, and Fontan. Result(s): 12 articles were included from
775 identified. Low-risk cardiac surgery procedure should be provided for
Down syndrome with a balanced ventricular septal defect. There is no
universal agreement about the surgical approach for Down syndrome with
unbalanced ventricular septal defects, but it can be performed at
relatively low risk. Conclusion(s): TCPC in Down syndrome patients
could be a relatively low-risk procedure if patients are prepared well and
their pulmonary vascular resistance is low. Randomized prospective studies
are required to show the long-term impact of TCPC palliation and develop a
better understanding of standardized care of these patients. Copyright
© 2022 Wiley Periodicals LLC.

<79>
Accession Number
638829971
Title
Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in
Intermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized
Clinical Trial.
Source
JAMA cardiology. (no pagination), 2022. Date of Publication: 24 Aug 2022.
Author
Van Mieghem N.M.; Deeb G.M.; Sondergaard L.; Grube E.; Windecker S.; Gada
H.; Mumtaz M.; Olsen P.S.; Heiser J.C.; Merhi W.; Kleiman N.S.; Chetcuti
S.J.; Gleason T.G.; Lee J.S.; Cheng W.; Makkar R.R.; Crestanello J.;
George B.; George I.; Kodali S.; Yakubov S.J.; Serruys P.W.; Lange R.;
Piazza N.; Williams M.R.; Oh J.K.; Adams D.H.; Li S.; Reardon M.J.
Institution
(Van Mieghem, Serruys) Department of Interventional Cardiology, Erasmus
University Medical Center, Rotterdam, Netherlands
(Deeb, Chetcuti) Department of Interventional Cardiology, University of
Michigan, Ann Arbor, United States
(Deeb) Department of Cardiac Surgery, University of Michigan, Ann Arbor,
United States
(Sondergaard, Olsen) Department of Cardiology, Heart Center,
Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
(Grube) Department of Interventional Cardiology, University of Bonn, Bonn,
Germany
(Windecker) Department of Cardiology, Inselspital, University of Bern,
Bern, Switzerland
(Gada, Mumtaz) Department of Interventional Cardiology, University of
Pittsburgh Medical Center Pinnacle Health, Harrisburg, PA, United States
(Gada, Mumtaz) Department of Cardiothoracic Surgery, University of
Pittsburgh Medical Center Pinnacle Health, Harrisburg, PA, United States
(Heiser, Merhi) Department of Interventional Cardiology, Spectrum Health,
Grand Rapids, MI, United States
(Heiser, Merhi) Department of Cardiothoracic Surgery, Spectrum Health,
Grand Rapids, MI, United States
(Kleiman, Reardon) Department of Interventional Cardiology, Houston
Methodist DeBakey Heart and Vascular Center, Houston, TX, United States
(Kleiman, Reardon) Department of Cardiothoracic Surgery, Houston Methodist
DeBakey Heart and Vascular Center, Houston, TX, United States
(Gleason, Lee) Department of Interventional Cardiology, University of
Pittsburgh, Pittsburgh, PA, United States
(Gleason) Now with Division of Cardiac Surgery, Department of Surgery,
University of Maryland School of Medicine, Baltimore, United States
(Gleason, Lee) Department of Cardiothoracic Surgery, University of
Pittsburgh, Pittsburgh, PA, United States
(Cheng, Makkar) Department of Interventional Cardiology, Cedars-Sinai
Medical Center, Los Angeles, CA, United States
(Cheng, Makkar) Department of Cardiothoracic Surgery, Cedars-Sinai Medical
Center, Los Angeles, CA, United States
(Crestanello, George) Department of Interventional Cardiology, Ohio State
University Wexner Medical Center, Columbus, United States
(Crestanello) RochesterMNUnited States
(Crestanello, George) Department of Cardiovascular Surgery, Ohio State
University Wexner Medical Center, Columbus, United States
(George, Kodali) Department of Interventional Cardiology, New York
Presbyterian Hospital-Columbia University Irving Medical Center, NY,
United States
(George, Kodali) Department of Cardiothoracic Surgery, New York
Presbyterian Hospital-Columbia University Irving Medical Center, NY,
United States
(Yakubov) Department of Interventional Cardiology, OhioHealth Riverside
Methodist Hospital, Columbus, United States
(Serruys) Now with National University of Ireland, Galway, Ireland
(Lange) Department of Cardiac Surgery, German Heart Center, Munich,
Germany
(Piazza) Department of Interventional Cardiology, McGill University Health
Centre, Montreal, QC, Canada
(Williams) Department of Interventional Cardiology and Cardiac Surgery,
Langone-New York University, NY, United States
(Oh) Echocardiography Core Laboratory, Mayo Clinic, Rochester, MN, United
States
(Adams) Department of Cardiovascular Surgery, Mount Sinai Health System,
NY, United States
(Li) Clinical Research, Medtronic, Minneapolis, MN, United States
Publisher
NLM (Medline)
Abstract
Importance: In patients with severe aortic valve stenosis at intermediate
surgical risk, transcatheter aortic valve replacement (TAVR) with a
self-expanding supra-annular valve was noninferior to surgery for
all-cause mortality or disabling stroke at 2 years. Comparisons of
longer-term clinical and hemodynamic outcomes in these patients are
limited. Objective(s): To report prespecified secondary 5-year
outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk
Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical
trial. Design, Setting, and Participant(s): SURTAVI is a prospective
randomized, unblinded clinical trial. Randomization was stratified by
investigational site and need for revascularization determined by the
local heart teams. Patients with severe aortic valve stenosis deemed to be
at intermediate risk of 30-day surgical mortality were enrolled at 87
centers from June 19, 2012, to June 30, 2016, in Europe and North America.
Analysis took place between August and October 2021. Intervention(s):
Patients were randomized to TAVR with a self-expanding, supra-annular
transcatheter or a surgical bioprosthesis. Main Outcomes and
Measures: The prespecified secondary end points of death or disabling
stroke and other adverse events and hemodynamic findings at 5 years. An
independent clinical event committee adjudicated all serious adverse
events and an independent echocardiographic core laboratory evaluated all
echocardiograms at 5 years. Result(s): A total of 1660 individuals
underwent an attempted TAVR (n=864) or surgical (n=796) procedure. The
mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean
(SD) Society of Thoracic Surgery Predicted Risk of Mortality score was
4.5% (1.6%). At 5 years, the rates of death or disabling stroke were
similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI,
0.85-1.22]; P=.85). Transprosthetic gradients remained lower (mean [SD],
8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P<.001) and aortic valve areas were
higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P<.001) with TAVR vs
surgery. More patients had moderate/severe paravalvular leak with TAVR
than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI,
0.17%- 4.85%]; P=.05). New pacemaker implantation rates were higher for
TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio,
3.30 [95% CI, 2.61-4.17]; log-rank P<.001), as were valve reintervention
rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45];
log-rank P=.02), although between 2 and 5 years only 6 patients who
underwent TAVR and 7 who underwent surgery required a reintervention.
 Conclusions and Relevance: Among intermediate-risk patients with
symptomatic severe aortic stenosis, major clinical outcomes at 5 years
were similar for TAVR and surgery. TAVR was associated with superior
hemodynamic valve performance but also with more paravalvular leak and
valve reinterventions.

<80>
Accession Number
638829593
Title
Muscle usage and workload assessment of cardiac ablation procedure with
the use of a novel catheter torque tool in a pediatric simulator.
Source
Journal of interventional cardiac electrophysiology : an international
journal of arrhythmias and pacing. (no pagination), 2022. Date of
Publication: 23 Aug 2022.
Author
Mass P.N.; Kumthekar R.N.; Clark B.C.; Opfermann J.D.; Sherwin E.D.;
DiBiase L.; Berul C.I.
Institution
(Mass, Berul) Children's National Hospital, 111 Michigan Ave NW, WA 20010,
United States
(Mass, Sherwin, Berul) Department of Cardiology, Children's National
Hospital, 111 Michigan Ave NW, WA 20010, United States
(Kumthekar) Division of Cardiology, Nationwide Children's Hospital,
Columbus, OH, United States
(Clark) Division of Cardiology, Children's Hospital at Montefiore, New
York, NY, USA
(Opfermann) Department of Mechanical Engineering, Johns Hopkins
University, Baltimore, MD, United States
(DiBiase) Division of Cardiology, Montefiore Medical Center, New York, NY,
USA
Publisher
NLM (Medline)
Abstract
BACKGROUND: Cardiac ablation catheters are small in diameter and pose
ergonomic challenges that can affect catheter stability. Significant
finger dexterity and strength are necessary to maneuver them safely. We
evaluated a novel torque tool to reduce muscle activation when
manipulating catheters and improve perceived workload of ablation tasks.
The objective was to evaluate measurable success, user perception of
workload, and muscle usage when completing a simulated ablation task with
and without the use of a catheter torque tool. METHOD(S): Cardiology
attendings and fellows were fitted with surface electromyographic (EMG)
sensors on 6 key muscle groups in the left hand and forearm. A standard
ablation catheter was inserted into a pediatric cardiac ablation simulator
and subjects navigated the catheter tip to 6 specific electrophysiologic
targets, including a 1-min simulated radiofrequency ablation lesion. Time
to complete the task, number of attempts required to complete the lesion,
and EMG activity normalized to percentage of maximum voluntary contraction
were collected throughout the task. The task was completed 4 times, twice
with and twice without the torque tool, in semi-randomized order. A NASA
Task Load Index survey was completed by the participant at the conclusion
of each task. RESULT(S): Time to complete the task and number of
attempts to create a lesion were not altered by the tool. Subjectively,
participants reported a significant decrease in physical demand, effort,
and frustration, and a significant increase in performance. Muscle
activation was decreased in 4 of 6 muscle groups. CONCLUSION(S): The
catheter torque tool may improve the perceived workload of cardiac
ablation procedures and reduce muscle fatigue caused by manipulating
catheters. This may result in improved catheter stability and increased
procedural safety. Copyright © 2022. The Author(s), under
exclusive licence to Springer Science+Business Media, LLC, part of
Springer Nature.

<81>
Accession Number
638829264
Title
High-dose adenosine versus saline-induced cardioplegic arrest in coronary
artery bypass grafting: A randomized double-blind clinical feasibility
trial.
Source
Scandinavian journal of surgery : SJS : official organ for the Finnish
Surgical Society and the Scandinavian Surgical Society. (pp
14574969221116943), 2022. Date of Publication: 24 Aug 2022.
Author
Mattila M.S.; Jarvela K.M.; Rinne T.T.; Nikus K.C.; Rantanen M.J.;
Siltanen J.A.A.; Helea J.-J.; Laurikka J.O.
Institution
(Mattila) Heart Hospital Tampere University Hospital PL 2000 33521 Tampere
Finland, Finland
(Jarvela, Rantanen) Heart Hospital, Tampere University Hospital, Tampere,
Finland
(Rinne) Tampere University Hospital, Tampere, Finland
(Nikus, Laurikka) Heart Hospital, Tampere University Hospital, Finland
Faculty of Medicine and Health Technology, Tampere University, Tampere,
Finland
(Siltanen, Helea) Faculty of Medicine and Health Technology, Tampere
University, Tampere, Finland
Publisher
NLM (Medline)
Abstract
BACKGROUND AND OBJECTIVE: In this clinical trial, we evaluated if a
short-acting nucleoside, adenosine, as a high-dose bolus injection with
blood cardioplegia induces faster arrest and provides better myocardial
performance in patients after bypass surgery for coronary artery disease.
 METHOD(S): Forty-three patients scheduled for elective or urgent
coronary artery bypass grafting were prospectively recruited in two-arm
1:1 randomized parallel groups to either receive 20 mg of adenosine (in 21
patients) or saline (in 22 patients) into the aortic root during the first
potassium-enriched blood cardioplegia infusion. The main outcomes of the
study were ventricular myocardial performance measured with cardiac index,
right ventricular stroke work index, and left ventricular stroke work
index at predefined time points and time to asystole after a single bolus
injection of adenosine. Conventional myocardial biomarkers were compared
between the two groups at predefined time points as secondary endpoints.
Electrocardiographic data and other ad hoc clinical outcomes were compared
between the groups. RESULT(S): Compared with saline, adenosine
reduced the time to asystole (68 (95% confidence interval (95% CI) =
37-100) versus 150 (95% CI = 100-210) seconds, p = 0.005). With myocardial
performance, the results were inconclusive, since right ventricular stroke
work index recovered better in the adenosine group (p = 0.008), but there
were no significant overall differences in cardiac index and left
ventricular stroke work index between the groups. Only the
post-cardiopulmonary bypass cardiac index was better in the adenosine
group (2.3 (95% CI = 2.2-2.5) versus 2.1 (95% CI = 1.9-2.2) L/min/m2, p =
0.016). There were no significant differences between the groups in
cardiac biomarker values. CONCLUSION(S): A high dose adenosine bolus
at the beginning of the first cardioplegia infusion resulted in
significantly faster asystole in coronary artery bypass grafting patients
but enhanced only partially the ventricular performance.EudraCT number:
2014-001382-26.
https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-001382-26/FI.

<82>
[Use Link to view the full text]
Accession Number
2017207265
Title
Efficacy and Safety of Short-Term Dual Antiplatelet Therapy in East
Asians: A Systematic Review and a Meta-Analysis of Randomized Clinical
Trials.
Source
Journal of Cardiovascular Pharmacology. 79(3) (pp 264-272), 2022. Date of
Publication: 24 Mar 2022.
Author
Ma Y.; Zhong P.-Y.; Shang Y.-S.; Bai N.; Niu Y.; Wang Z.-L.
Institution
(Ma, Zhong, Shang, Bai, Niu) The First Clinical Medical College of Lanzhou
University, Lanzhou, China
(Wang) Department of Cardiology, The First Hospital of Lanzhou University,
Lanzhou, China
Publisher
Lippincott Williams and Wilkins
Abstract
The optimal duration of dual antiplatelet therapy (DAPT) for patients
implanted with new-generation drug-eluting stents in East Asians is
currently still controversial. The purpose of this meta-analysis was to
investigate the efficacy and safety of short-term DAPT in patients with
those. In this study, randomized controlled trials from PubMed, EMBASE,
and Cochrane Library were searched to compare the efficacy and safety of
short-term DAPT (6 months or less) with long-term DAPT (12 months or more)
in patients implanted with new-generation drug-eluting stents in East
Asian from inception to September 2020. The primary efficacy outcome was
all-cause death, the primary safety outcome was major bleeding, and the
secondary outcomes included cardiovascular death, myocardial infarction,
definite or possible stent thrombosis, and stroke. A total of 6 randomized
controlled trials with 15,688 patients met inclusion criteria; there were
no significant differences in the incidence of all-cause death [risk ratio
(RR), 1.03; 0.76-1.39; P = 0.856)], cardiovascular death (RR, 0.83;
0.55-1.24; P = 0.361), myocardial infarction (RR, 0.97; 0.72-1.31; P =
0.853), definite or possible stent thrombosis (RR, 1.52; 0.83-2.78; P =
0.170), and stroke (RR, 0.90; 0.61-1.31; P = 0.574) between short-term and
long-term DAPTs. However, there was a significant difference in the risk
of major bleeding (RR, 0.64; 0.49-0.85; P = 0.002) between the 2 groups.
Compared with long-term DAPT, the short-term DAPT can reduce the risk of
major bleeding without increasing the risk of death or ischemia for East
Asians (Registered by PROSPERO, CRD42020213266). Copyright © 2022
Lippincott Williams and Wilkins. All rights reserved.

<83>
Accession Number
2015375916
Title
Efficacy of an Autologous Blood Patch for Prolonged Air Leak: A Systematic
Review.
Source
Annals of Thoracic Surgery. 114(3) (pp 1064-1071), 2022. Date of
Publication: September 2022.
Author
Hugen N.; Hekma E.J.; Claessens N.J.M.; Smit H.J.M.; Reijnen M.M.P.J.
Institution
(Hugen, Hekma, Reijnen) Department of Thoracic Surgery, Rijnstate
Hospital, Arnhem, Netherlands
(Hugen) Department of Surgery, Radboud University Medical Center,
Netherlands
(Claessens, Smit) Department of Respiratory Medicine, Rijnstate Hospital,
Arnhem, Netherlands
(Reijnen) Multi-Modality Medical Imaging Group, TechMed Center, University
of Twente, Enschede, Netherlands
Publisher
Elsevier Inc.
Abstract
Background: Prolonged air leak after pulmonary surgery remains a clinical
challenge and sometimes needs surgical reintervention. An autologous blood
patch (ABP) may provide a noninvasive method to stop air leak. Its value,
however, is debatable. The aim of this systematic review is to synthesize
evidence regarding the efficacy of ABP in patients with prolonged air
leak. Method(s): A comprehensive search for published studies was
performed in the Medline database, Embase, and the Cochrane library.
Randomized controlled trials, case-control studies, and case series in
which a postoperative ABP was performed were included. Findings from these
studies were tabulated and data were synthesized graphically (PROSPERO
registration number CRD42020157591). Result(s): A total of eight
studies was included in the analysis, comprising 151 patients. Studies
demonstrated heterogeneity in ABP timing and practice, and an intermediate
to high risk of bias was scored. The majority of studies demonstrated a
beneficial effect of the ABP, with a high rate of success of more than
89%. One randomized trial did not find a difference in time to cessation
of air leak after ABP compared with conservative tube thoracostomy. The
overall complication rate was 10%. Conclusion(s): Quality of included
studies is limited owing to lack of comparison groups. Synthesized data in
this review demonstrate a high rate of successful procedures and
acceptable complication rates, and seems encouraging enough to justify a
large randomized clinical trial on the use of ABP for patients who have
prolonged air leak after thoracic surgery. Copyright © 2022 The
Society of Thoracic Surgeons

<84>
Accession Number
2015256094
Title
Sirolimus-Based Immunosuppression Is Associated with Decreased Incidence
of Post-Transplant Lymphoproliferative Disorder after Heart
Transplantation: A Double-Center Study.
Source
Journal of Clinical Medicine. 11(2) (no pagination), 2022. Article Number:
322. Date of Publication: January-2 2022.
Author
Asleh R.; Vucicevic D.; Petterson T.M.; Kremers W.K.; Pereira N.L.; Daly
R.C.; Edwards B.S.; Steidley D.E.; Scott R.L.; Kushwaha S.S.
Institution
(Asleh, Kremers, Pereira, Daly, Edwards, Kushwaha) Department of
Cardiovascular Diseases and Health Sciences Research and the William J von
Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic,
Rochester, MN 55905, United States
(Asleh) Heart Institute, Hadassah University Medical Center, Faculty of
Medicine, Hebrew University of Jerusalem, Jerusalem 9112001, Israel
(Vucicevic) Department of Cardiology, David Geffen School of Medicine at
UCLA, Los Angeles, CA 90095, United States
(Petterson, Kremers) Division of Biomedical Statistics and Informatics,
Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905,
United States
(Steidley, Scott) Department of Cardiovascular Diseases, Mayo Clinic
Arizona, Phoenix, AZ 85054, United States
Publisher
MDPI
Abstract
Mammalian target of rapamycin (mTOR) inhibitors have been shown to reduce
proliferation of lymphoid cells; thus, their use for immunosuppression
after heart transplantation (HT) may reduce post-transplant
lymphoproliferative disorder (PTLD) risk. This study sought to investigate
whether the sirolimus (SRL)-based immunosuppression regimen is associated
with a decreased risk of PTLD compared with the calcineurin inhibitor
(CNI)-based regimen in HT recipients. We retrospectively analyzed 590
patients who received HTs at two large institutions between 1 June 1988
and 31 December 2014. Cox proportional-hazard modeling was used to examine
the association between type of primary immunosuppression and PTLD after
adjustment for potential confounders, including Epstein-Barr virus (EBV)
status, type of induction therapy, and rejection. Conversion from CNI to
SRL as primary immunosuppression occurred in 249 patients (42.2%). During
a median follow-up of 6.3 years, 30 patients developed PTLD (5.1%). In a
univariate analysis, EBV mismatch was strongly associated with increased
risk of PTLD (HR 10.0, 95% CI: 3.8-26.6; p < 0.001), and conversion to SRL
was found to be protective against development of PTLD (HR 0.19, 95% CI:
0.04-0.80; p = 0.02). In a multivariable model and after adjusting for EBV
mismatch, conversion to SRL remained protective against risk of PTLD
compared with continued CNI use (HR 0.12, 95% CI: 0.03-0.55; p = 0.006).
In conclusion, SRL-based immunosuppression is associated with lower
incidence of PTLD after HT. These findings provide evidence of a benefit
from conversion to SRL as maintenance therapy for mitigating the risk of
PTLD, particularly among patients at high PTLD risk. Copyright ©
2022 by the authors. Licensee MDPI, Basel, Switzerland.

<85>
Accession Number
2015197813
Title
CPAP Intervention as an Add-On Treatment to Lipid-Lowering Medication in
Coronary Artery Disease Patients with Obstructive Sleep Apnea in the
RICCADSA Trial.
Source
Journal of Clinical Medicine. 11(1) (no pagination), 2022. Article Number:
273. Date of Publication: January-1 2022.
Author
Celik Y.; Balcan B.; Peker Y.
Institution
(Celik, Peker) Research Center for Translational Medicine (KUTTAM), Koc
University, Istanbul 34010, Turkey
(Balcan, Peker) Department of Pulmonary Medicine, Koc University Hospital,
Istanbul 34010, Turkey
(Peker) Department of Molecular and Clinical Medicine/Cardiology,
Institute of Medicine, Sahlgrenska Academy, University of Gothenburg,
Gothenburg 40530, Sweden
(Peker) Department of Clinical Sciences, Respiratory Medicine and
Allergology, School of Medicine, Lund University, Lund 22185, Sweden
(Peker) Division of Pulmonary, Allergy, and Critical Care Medicine,
University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United
States
Publisher
MDPI
Abstract
Dyslipidaemia is a well-known risk factor for coronary artery disease
(CAD), and reducing lipid levels is essential for secondary prevention in
management of these high-risk individuals. Dyslip-idaemia is common also
in patients with obstructive sleep apnea (OSA). Continuous positive airway
pressure (CPAP) is the first line treatment of OSA. However, evidence of a
possible lipid-lowering effect of CPAP in CAD patients with OSA is scarce.
We addressed the effect of CPAP as an add-on treatment to lipid-lowering
medication in a CAD cohort with concomitant OSA. This study was a
secondary analysis of the RICCADSA trial (Trial Registry:
ClinicalTrials.gov; No: NCT 00519597), that was conducted in Sweden
between 2005 and 2013. In total, 244 revascularized CAD patients with
nonsleepy OSA (apnea-hypopnea index >= 15/h, Epworth Sleepiness Scale
score < 10) were randomly assigned to CPAP or no-CPAP. Circulating
triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL)
and low-density lipoprotein (LDL) levels (all in mg/dL) were measured at
baseline and 12 months after randomization. The desired TG levels were
defined as circulating TG < 150 mg/dL, and LDL levels were targeted as <70
mg/dL according to the recent guidelines of the European Cardiology
Society and the European Atherosclerosis Society. A total of 196 patients
with available blood samples at baseline and 12-month follow-up were
included (94 randomized to CPAP, 102 to no-CPAP). We found no significant
between-group differences in circulating levels of TG, TC, HDL and LDL at
baseline and after 12 months as well as in the amount of change from
baseline. However, there was a significant decline regarding the
proportion of patients with the desired TG levels from 87.2% to 77.2% in
the CPAP group (p = 0.022), whereas there was an increase from 84.3% to
88.2% in the no-CPAP group (n.s.). The desired LDL levels remained low
after 12 months in both groups (15.1% vs. 17.2% in CPAP group, and 20.8%
vs. 18.8% in no-CPAP group; n.s.). In a multiple linear regression model,
the increase in the TG levels was predicted by the increase in
body-mass-index (beta = 4.1; 95% confidence interval (1.0-7.1); p = 0.009)
adjusted for age, sex and CPAP usage (hours/night). CPAP had no
lipid-lowering effect in this revascularized cohort with OSA. An increase
in body-mass-index predicted the increase in TG levels after 12 months,
suggesting that lifestyle modifications should be given priority in adults
with CAD and OSA, regardless of CPAP treatment. Copyright © 2022
by the authors. Licensee MDPI, Basel, Switzerland.

<86>
Accession Number
2019798850
Title
Sequential Interventions for Major Depression and Heart Failure Self-Care:
A Randomized Clinical Trial.
Source
Circulation: Heart Failure. 15(8) (pp 745-754), 2022. Date of Publication:
01 Aug 2022.
Author
Freedland K.E.; Skala J.A.; Carney R.M.; Steinmeyer B.C.; Rubin E.H.; Rich
M.W.
Institution
(Freedland, Skala, Carney, Steinmeyer, Rubin) Department of Psychiatry,
Washington University School of Medicine, St. Louis, MO, United States
(Rich) Cardiovascular Division of the Department of Internal Medicine,
Washington University School of Medicine, St. Louis, MO, United States
Publisher
Lippincott Williams and Wilkins
Abstract
Background: Major depression and inadequate self-care are common in
patients with heart failure (HF). Little is known about how to intervene
when both problems are present. This study examined the efficacy of a
sequential approach to treating these problems. Method(s): Stepped
Care for Depression in HF was a single-site, single-blind, randomized
controlled trial of cognitive behavior therapy (CBT) versus usual care
(UC) for major depression in patients with HF. The intensive phase of the
CBT intervention lasted between 8 and 16 weeks, depending upon the rate of
improvement in depression. All participants received a tailored HF
self-care intervention that began 8 weeks after randomization. The
intensive phase of the self-care intervention ended at 16 weeks
post-randomization. The coprimary outcome measures were the Beck
Depression Inventory (version 2) and the Maintenance scale of the
Self-Care of HF Index (v6.2) at week 16. Result(s): One hundred
thirty-nine patients with HF and major depression were enrolled; 70 were
randomized to UC and 69 to CBT. At week 16, the patients in the CBT arm
scored 4.0 points ([95% CI, -7.3 to -0.8]; P=0.02) lower on the Beck
Depression Inventory, version 2 than those in the usual care arm. Mean
scores on the Self-Care of HF Index Maintenance scale were not
significantly different between the groups ([95% CI, -6.5 to 1.5];
P=0.22). Conclusion(s): CBT is more effective than usual care for
major depression in patients with HF. However, initiating CBT before
starting a tailored HF self-care intervention does not increase the
benefit of the self-care intervention. Registration: URL:
https://www.clinicaltrials.gov; Unique identifier:
NCT02997865. Copyright © 2022 Lippincott Williams and Wilkins.
All rights reserved.

<87>
Accession Number
2019706457
Title
Enhanced rehabilitation intervention improves postoperative recovery and
quality of life of patients after heart valve replacement surgery.
Source
American Journal of Translational Research. 14(7) (pp 5132-5138), 2022.
Date of Publication: 2022.
Author
Hao J.
Institution
(Hao) Department of Cardiothoracic, Cangzhou Central Hospital, Hebei
Province, China
Publisher
E-Century Publishing Corporation
Abstract
Objective: To explore the application value of enhanced recovery after
surgery (ERAS) for heart valve replacement surgery. Method(s): A
total of 86 patients with heart valve diseases admitted to our hospital
from Jan. 2018 to Mar. 2020 were selected, and randomized into the control
group (n=43) with regular nursing care and the observation group (n=43)
with ERAS. The postoperative recovery, rate of adverse events, quality of
life, visual analogue scale (VAS) score and nursing care satisfaction rate
were compared between the two groups. Result(s): After surgery, the
time to first bowel movement and the first flatulence in the observation
group were earlier than those in the control group, and the hospital stay
of patients in the observation group was shorter than that in the control
group. The rate of adverse events in the observation group was 4.65%,
which was lower than that in the control group (18.60%). In addition, the
observation group obtained higher life quality scores but lower VAS,
self-rating anxiety scale (SAS) and self-rating depression scale (SDS)
scores than the control group, and the observation group showed lower
serum levels of corticotropin and cortisol and exhibited a longer 6-minute
walking distance than the control group. Moreover, the nursing care
satisfaction rate of the observation group was 95.35%, which was higher
than that (76.74%) of the control group (all P<0.05). Conclusion(s):
ERAS can reduce adverse events and pain for patients with heart valve
replacement and improve their postoperative recovery, quality of life, and
nursing care satisfaction. Copyright © 2022 E-Century Publishing
Corporation. All rights reserved.

<88>
Accession Number
2019638398
Title
Impact of Moderate Aortic Stenosis on Long-Term Clinical Outcomes: A
Systematic Review and Meta-Analysis.
Source
JACC: Cardiovascular Interventions. 15(16) (pp 1664-1674), 2022. Date of
Publication: 22 Aug 2022.
Author
Coisne A.; Scotti A.; Latib A.; Montaigne D.; Ho E.C.; Ludwig S.; Modine
T.; Genereux P.; Bax J.J.; Leon M.B.; Bauters C.; Granada J.F.
Institution
(Coisne, Scotti, Ludwig, Leon, Granada) Cardiovascular Research
Foundation, New York, New York, United States
(Coisne, Scotti, Latib, Ho) Montefiore-Einstein Center for Heart and
Vascular Care, Montefiore Medical Center, Albert Einstein College of
Medicine, Bronx, NY, United States
(Coisne, Montaigne) INSERM U1011-EGID, Centre Hospitalier Universitaire de
Lille, Institut Pasteur de Lille, Universite de Lille, Lille, France
(Ludwig) Department of Cardiology, University Heart and Vascular Center
Hamburg, Hamburg, Germany
(Modine) Department of Cardiology and Cardio-Vascular Surgery, Hopital
Cardiologique de Haut-Leveque, Bordeaux University Hospital, Bordeaux,
France
(Genereux) Gagnon Cardiovascular Institute, Morristown Medical Center,
Morristown, NJ, United States
(Bax) Leiden University Medical Center, Leiden, Netherlands
(Bauters) INSERM U1167, Centre Hospitalier Universitaire de Lille,
Institut Pasteur de Lille, Universite de Lille, Universite Lille, Lille,
France
Publisher
Elsevier Inc.
Abstract
Background: The clinical course of patients with moderate aortic stenosis
(AS) remains incompletely defined. Objective(s): This study sought to
analyze the clinical course of moderate AS and compare it with other
stages of the disease. Method(s): Multiple electronic databases were
searched to identify studies on adult moderate AS. Random-effects models
were used to derive pooled estimates. The primary endpoint was all-cause
death. The secondary endpoints were cardiac death, heart failure, sudden
death, and aortic valve replacement. Result(s): Among a total of 25
studies (12,143 moderate AS patients, 3.7 years of follow-up), pooled
rates per 100 person-years were 9.0 (95% CI: 6.9 to 11.7) for all-cause
death, 4.9 (95% CI: 3.1 to 7.5) for cardiac death, 3.9 (95% CI: 1.9 to
8.2) for heart failure, 1.1 (95% CI: 0.8 to 1.5) for sudden death, and 7.2
(95% CI: 4.3 to 12.2) for aortic valve replacement. Meta-regression
analyses detected that diabetes (P = 0.019), coronary artery disease (P =
0.017), presence of symptoms (P < 0.001), and left ventricle (LV)
dysfunction (P = 0.009) were associated with a significant impact on the
overall estimate of all-cause death. All-cause mortality was higher in
patients with reduced LV ejection fraction (<50%) than with normal LV
ejection fraction: 16.5 (95% CI: 5.2 to 52.3) and 4.2 (95% CI: 1.4 to
12.8) per 100 person-years, respectively. Compared with moderate AS, the
incidence rate difference of all-cause mortality was -3.9 (95% CI: -6.7 to
-1.1) for no or mild AS and +2.2 (95% CI: +0.8 to +3.5) for severe AS
patients. Conclusion(s): Moderate AS appears to be associated with a
mortality risk higher than no or mild AS but lower than severe AS, which
increases in specific population subsets. The impact of early intervention
in moderate AS patients having high-risk features deserves further
investigation. Copyright © 2022 American College of Cardiology
Foundation

<89>
Accession Number
2018356562
Title
Effect of electrophysiological mapping on non-transmural annulus ablation
and atrial fibrillation recurrence prediction after 6 months of Cox-Maze
IV procedure.
Source
Frontiers in Cardiovascular Medicine. 9 (no pagination), 2022. Article
Number: 931845. Date of Publication: 15 Jul 2022.
Author
Sun Z.; Fan C.; Song L.; Zhang H.; Jiang Z.; Tan H.; Sun Y.; Liu L.
Institution
(Sun, Fan, Song, Zhang, Jiang, Tan, Sun, Liu) Department of Cardiovascular
Surgery, The Second Xiangya Hospital, Central South University, Changsha,
China
Publisher
Frontiers Media S.A.
Abstract
Objective: The objective of this study was to observe the safety and
efficacy of electrophysiological mapping following the Cox-Maze IV
procedure and to investigate whether a correlation exists between
recurrence of atrial fibrillation (AF) with the completeness of
bidirectional electrical isolation and the inducibility of AF immediately
after the Cox-Maze IV procedure. Method(s): Totally, 80 consecutive
patients who suffered from aortic valve or mitral valve disease and
persistent AF were randomly enrolled into the control group and
electrophysiological mapping following the Cox-Maze IV group
(Electrophysio-Maze group). In the Electrophysio-Maze group, patients
underwent concomitant Cox-Maze procedure and following
electrophysiological mapping of ablation lines in mitral isthmus, left
atrial "box," and tricuspid annulus. If the bidirectional electrical
isolation of tricuspid annulus ablation line is incomplete, whether to
implement supplementary ablation will be independently decided by the
operator. Before and after the Cox-Maze IV procedure, AF induction was
performed. All patients in both groups were continuously followed-up and
underwent electrocardiogram Holter monitoring after 6 months.
 Result(s): In total, 42 Electrophysio-Maze patients and 38 controls
were enrolled. Compared with patients in the control group, there were
shorter hospital stay, better cardiac remodeling changes, and higher
relief from AF during the follow-up period of 6 months in the
Electrophysio-Maze group. Within the Electrophysio-Maze group, the rate of
incomplete the bidirectional electrical isolation of "box" ablation lines
was zero, and the rate of incomplete bidirectional electrical isolation of
mitral isthmus ablation line or tricuspid annulus ablation line was 23.8%.
After two cases of successful complementary ablation on the tricuspid
annulus ablation line, the final incomplete bidirectional electrical
isolation of annulus ablation lines was 19.0%. There were correlations
between late AF recurrence after 6 months with incomplete bidirectional
electrical isolation of annulus ablation lines and AF induction
immediately after the Cox-Maze IV procedure. Conclusion(s):
Electrophysiological mapping following the Cox-Maze procedure is safe and
effective. Electrophysiological mapping in the Cox-Maze procedure can find
out the non-transmural annulus ablation lines by assessing the
completeness of bidirectional electrical isolation of ablation lines,
guide supplementary ablation, and predict AF recurrence after 6
months. Copyright © 2022 Sun, Fan, Song, Zhang, Jiang, Tan, Sun
and Liu.

<90>
Accession Number
2018314018
Title
Surgical Strategies for Preservation of Pulmonary Valve Function in a
Radical Operation for Tetralogy of Fallot: A Systematic Review and
Meta-Analysis.
Source
Frontiers in Cardiovascular Medicine. 9 (no pagination), 2022. Article
Number: 888258. Date of Publication: 13 Jul 2022.
Author
Yi K.; Wang D.; Xu J.; Zhang X.; Gao J.; Wang W.; You T.; Tian J.
Institution
(Yi, Xu, Tian) Evidence-Based Medicine Center, School of Basic Medical
Sciences, Lanzhou University, Lanzhou, China
(Yi, You) Department of Cardiovascular Surgery, Gansu Provincial Hospital,
Lanzhou, China
(Yi, Zhang, Wang, Gao, Wang, You, Tian) Gansu International Scientific and
Technological Cooperation Base of Diagnosis and Treatment of Congenital
Heart Disease, Lanzhou, China
(Wang) Department of Geriatric Medicine, Xiangya Hospital, Central South
University, Changsha, China
(Zhang, Wang) The First School of Clinical Medicine, Gansu University of
Chinese Medicine, Lanzhou, China
(Gao, Wang) The First Clinical Medical College, Lanzhou University,
Lanzhou, China
(Tian) Key Laboratory of Evidence Based Medicine and Knowledge Translation
of Gansu Province, Lanzhou University, Lanzhou, China
Publisher
Frontiers Media S.A.
Abstract
Objective: To evaluate the efficacy and safety of different surgical
strategies to preserve pulmonary valve function. Surgical procedures
evaluated include intraoperative balloon pulmonary valvuloplasty (IBPV),
pulmonary valve reconstruction, and commissurotomy and pulmonary cusp
augmentation (PCA) in patients who underwent a radical operation for
Tetralogy of Fallot (ToF). Material(s) and Method(s): The five
databases searched in the current study included the Cochrane Library,
PubMed, China National Knowledge Infrastructure, VIP, and WanFang data. A
systematic search for control trials was performed in each database from
the start date of each database until December 2021. The Newcastle-Ottawa
Scale (NOS) was used to evaluate the quality of included studies.
 Result(s): A total of 15 retrospective studies with a total number of
1,396 participants were included in this study. In subgroup 1 (IBPV vs.
TAP), patients undergoing IBPV had a less degree of regurgitation at 1-2
years after the surgery. The reintervention rate increased in the IBPV
group at 5 years. In subgroup 2 (pulmonary valve reconstruction vs. TAP),
the degree of regurgitation decreased in the pulmonary valve
reconstruction group at 1 month after the surgery. In subgroup 3
(valve-sparing operation vs. TAP), the comparison demonstrated decreased
rates for surgical mortality and reintervention at 5-10 years after the
surgery. Conclusion(s): We proposed that pulmonary valve function in
a radical operation for ToF was preserved. IBPV, pulmonary valve
reconstruction, and commissurotomy and PCA can be performed during the
surgical procedure based on the developmental status and anatomical
characteristics of the right ventricular outflow tract (RVOT), pulmonary
valve, and pulmonary artery. Systematic Review Registration:
[https://www.crd.york.ac.uk/prospero/], identifier
[CRD42022300987]. Copyright © 2022 Yi, Wang, Xu, Zhang, Wang,
Gao, Wang, You and Tian.

<91>
Accession Number
2017954860
Title
Consequences of Social Distancing Measures During the COVID-19 Pandemic
First Wave on the Epidemiology of Children Admitted to Pediatric Emergency
Departments and Pediatric Intensive Care Units: A Systematic Review.
Source
Frontiers in Pediatrics. 10 (no pagination), 2022. Article Number: 874045.
Date of Publication: 03 Jun 2022.
Author
Levy M.; Lestrade V.; Said C.; Jouvet P.; Kawaguchi A.
Institution
(Levy, Lestrade, Jouvet, Kawaguchi) Department of Pediatrics, Centre
Hospitalier Universitaire Sainte-Justine, Pediatric Critical Care,
University of Montreal, Montreal, QC, Canada
(Levy) Pediatric Intensive Care Unit, Centre Hospitalier Universitaire
Robert-Debre, Assistance Publique Hopitaux de Paris, Universite de Paris,
Paris, France
(Said) School of Medicine, University of Paris Saclay, Paris, France
(Kawaguchi) Department of Intensive Care Medicine, Pediatric Critical Care
Medicine, Tokyo Women's Medical University, Tokyo, Japan
Publisher
Frontiers Media S.A.
Abstract
Objectives: To synthesize knowledge describing the impact of social
distancing measures (SDM) during the first wave of the COVID-19 pandemic
on acute illness in children by focusing on the admission to pediatric
emergency departments (PED) and pediatric intensive care units (PICU).
 Method(s): We searched Cochrane Database of Systematic Reviews,
Cochrane Controlled Trials Register, EPOC Register, MEDLINE,
Evidence-Based Medicine Reviews, EMBASE, WHO database on COVID-19,
Cochrane Resources on COVID-19, Oxford COVID-19 Evidence Service, Google
Scholar for literature on COVID-19 including pre-print engines such as
medRxiv, bioRxiv, Litcovid and SSRN for unpublished studies on COVID-19 in
December 2020. We did not apply study design filtering. The primary
outcomes of interest were the global incidence of admission to PICU and
PED, disease etiologies, and elective/emergency surgeries, compared to the
historical cohort in each studied region, country, or hospital.
 Result(s): We identified 6,660 records and eighty-seven articles met
our inclusion criteria. All the studies were with before and after study
design compared with the historical data, with an overall high risk of
bias. The median daily PED admissions decreased to 65% in 39 included
studies and a 54% reduction in PICU admission in eight studies. A
significant decline was reported in acute respiratory illness and LRTI in
five studies with a median decrease of 63%. We did not find a consistent
trend in the incidence of poisoning, but there was an increasing trend in
burns, DKA, and a downward trend in trauma and unplanned surgeries.
 Conclusion(s): SDMs in the first wave of the COVID-19 pandemic
reduced the global incidence of pediatric acute illnesses. However, some
disease groups, such as burns and DKA, showed a tendency to increase and
its severity of illness at hospital presentation. Continual effort and
research into the subject should be essential for us to better understand
the effects of this new phenomenon of SDMs to protect the well-being of
children. Systematic Review Registration: Clinicaltrials.gov, identifier:
CRD42020221215. Copyright © 2022 Levy, Lestrade, Said, Jouvet and
Kawaguchi.

<92>
Accession Number
2017703242
Title
Tools and scores for perioperative pulmonary, renal, hepatobiliary,
hematological, and surgical site infection risk assessment: an update.
Source
Revista do Colegio Brasileiro de Cirurgioes. 49 (no pagination), 2022.
Article Number: e20223125. Date of Publication: 2022.
Author
de Moraes C.M.T.; Correa L.M.; Procopio R.J.; Do Carmo G.A.L.; Navarro
T.P.
Institution
(de Moraes) Universidade Federal de Minas Gerais, MG, Belo Horizonte,
Brazil
(Correa) Faculdade Ciencias Medicas de Minas Gerais, MG, Belo Horizonte,
Brazil
(Procopio) Universidade Federal de Minas Gerais, Hospital das Clinicas,
Unidade Endovascular, MG, Belo Horizonte, Brazil
(Do Carmo) Universidade Federal de Minas Gerais, Departamento de Clinica
Medica, MG, Belo Horizonte, Brazil
(Navarro) Universidade Federal de Minas Gerais, Departamento de Cirurgia,
MG, Belo Horizonte, Brazil
Publisher
Colegio Brasileiro de Cirurgioes
Abstract
Introduction: perioperative risk assessment is essential to mitigate
surgical complications, which suggests individual and collective interest
since the number of surgical procedures in Brazil has been expanding
steadily. The aim of this study was to summarize and detail the main
calculators, indexes and scores regarding perioperative pulmonary, renal,
hepatobiliary, hematological and surgical site infection risks for general
non-cardiac surgeries, which are dispersed in the literature.
 Method(s): a narrative review was performed based on manuscripts in
English and Portuguese found in the electronic databases Pubmed/MEDLINE
and EMBASE. Result(s): the review included 11 tools related to the
systems covered, for which the application method and its limitations are
detailed. Conclusion(s): the non-cardiovascular perioperative risk
estimation tools are beneficial when disturbances are identified in the
preoperative clinical examination that justify a possible increased risk
to the affected system, so the use of these tools provides palpable values
to aid in the judgment of surgical risk and benefit as well as it
identifies factors amenable to intervention to improve
outcomes. Copyright © 2022, Colegio Brasileiro de Cirurgioes. All
rights reserved.

<93>
Accession Number
638799900
Title
Efficacy of early goal-directed therapy using FloTrac/EV1000 to improve
postoperative outcomes in patients undergoing off-pump coronary artery
bypass surgery: a randomized controlled trial.
Source
Journal of cardiothoracic surgery. 17(1) (pp 196), 2022. Date of
Publication: 21 Aug 2022.
Author
Tribuddharat S.; Sathitkarnmanee T.; Ngamsaengsirisup K.; Sornpirom S.
Institution
(Tribuddharat, Sathitkarnmanee, Ngamsaengsirisup) Department of
Anesthesiology, Faculty of Medicine, Khon Kaen University, 123 Mitrapap
Road, Khon Kaen 40002, Thailand
(Sornpirom) Cardiothoracic Intensive Care Unit, Faculty of Medicine, Khon
Kaen University, 123 Mitrapap Road, Khon Kaen 40002, Thailand
Publisher
NLM (Medline)
Abstract
BACKGROUND: Early goal-directed therapy (EGDT) using FloTrac reduced
length of stay (LOS) in intensive care (ICU) and hospital among patients
undergoing coronary artery bypass graft (CABG) with a cardiopulmonary
bypass. However, this platform in off-pump CABG (OPCAB) has received scant
attention, so we evaluated the efficacy of EGDT using FloTrac/EV1000 as a
modality for improving postoperative outcomes in patients undergoing
OPCAB. METHOD(S): Forty patients undergoing OPCAB were randomized to
the EV1000 or Control group. The Control group received fluid, inotropic,
or vasoactive drugs (at the discretion of the attending anesthesiologist)
to maintain a mean arterial pressure 65-90 mmHg; central venous pressure
8-12 mmHg; urine output>=0.5 mL kg-1 h-1; SpO2>95%; and hematocrit>=30%.
The EV1000 group achieved identical targets using information from the
FloTrac/EV1000. The goals included stroke volume variation<13%; cardiac
index (CI) of 2.2-4.0 L min-1 m-2; and systemic vascular resistance index
of 1500-2500 dynes s-1 cm-5 m-2. RESULT(S): The EV1000 group had a
shorter LOS in ICU (mean difference -1.3 d, 95% CI -1.8 to -0.8; P<0.001).
The ventilator time for both groups was comparable (P=0.316), but the
hospital stay for the EV1000 group was shorter (mean difference -1.4 d,
95% CI -2.1 to -0.6; P<0.001). CONCLUSION(S): EGDT using
FloTrac/EV1000 compared to conventional protocol reduces LOS in ICU and
hospital among patients undergoing OPCAB. Trial registration This study
was retrospectively registered at www. CLINICALTRIALS: gov (NCT04292951)
on 3 March 2020. Copyright © 2022. The Author(s).

<94>
Accession Number
638090034
Title
Delayed hospitalisation for heart failure after transcatheter repair or
medical treatment for secondary mitral regurgitation: a landmark analysis
of the MITRA-FR trial.
Source
EuroIntervention : journal of EuroPCR in collaboration with the Working
Group on Interventional Cardiology of the European Society of Cardiology.
18(6) (pp 514-523), 2022. Date of Publication: 19 Aug 2022.
Author
Leurent G.; Auffret V.; Donal E.; Corbineau H.; Grinberg D.; Bonnet G.;
Leroux P.-Y.; Guerin P.; Wautot F.; Lefevre T.; Messika-Zeitoun D.; Iung
B.; Armoiry X.; Trochu J.-N.; Boutitie F.; Obadia J.-F.
Institution
(Leurent, Auffret, Donal) Universite de Rennes, CHU Rennes, INSERM,
Rennes, France
(Leurent, Auffret, Donal) Service de Cardiologie, CHU Rennes, Rennes,
France
(Corbineau) Division of Thoracic and Cardiovascular Surgery, CHU Rennes,
Rennes, France
(Grinberg, Obadia) Hopital Cardiovasculaire Louis Pradel, Chirurgie
Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon
and Claude Bernard University, Lyon, France
(Bonnet) Service de Cardiologie Interventionnelle, CHU Timone, Assistance
Publique-Hopitaux de Marseille, INSERM, Marseille, France
(Leroux) Cardiologie Medicale et Structurelle, France
(Guerin, Trochu) Universite Nantes, CHU Nantes, CNRS, INSERM, L'institut
du Thorax, Nantes, France
(Wautot) Centre Cardio-Thoracique de Monaco, Monaco
(Lefevre) Institut Cardiovasculaire Paris Sud, Hopital Prive Jacques
Cartier, Massy, France
(Messika-Zeitoun) Division of Cardiology, University of Ottawa Heart
Institute, Ottawa, Canada
(Iung) Hopital Bichat - Claude Bernard, DHU FIRE, France and Universite de
Paris and INSERM 1148, Paris, France
(Armoiry) Pharmacy Department, University of Lyon, School of Pharmacy
(ISPB)/UMR CNRS 5510 MATEIS/Edouard Herriot Hospital, Lyon, France
(Armoiry) University of Warwick, Warwick Medical School, Coventry, United
Kingdom
(Boutitie) Service de Biostatistique - Bioinformatique, Pole Sante
Publique, Hospices Civils de Lyon, Lyon; and Universite Lyon 1,
Villeurbanne, France; and CNRS, UMR 5558, Laboratoire de Biometrie et
Biologie Evolutive, Equipe Biostatistique-Sante, Villeurbanne, France
Publisher
NLM (Medline)
Abstract
BACKGROUND: In the MITRA-FR trial, transcatheter mitral valve repair
(TMVR) was not associated with a 2-year clinical benefit in patients with
secondary mitral regurgitation (SMR). AIMS: This landmark analysis aimed
at investigating a potential reduction of the hospitalisation rate for
heart failure (HF) between 12 and 24 months after inclusion in the
MITRA-FR trial in patients randomised to the intervention group (TMVR with
the MitraClip device), as compared with patients randomised to the control
group (guideline-directed medical therapy [GDMT]). METHOD(S): The
MITRA-FR trial randomised 307 patients with SMR for TMVR on top of GDMT
(TMVR group; n=152) or for GDMT alone (control group; n=155). We conducted
a 12-month landmark analysis in surviving patients who were not
hospitalised for HF within the first 12 months of follow-up. The primary
endpoint was the 1-year cumulative number of HF hospitalisations.
 RESULT(S): A total of 140 patients (TMVR group: 67; GDMT group: 73)
were selected for this landmark analysis with similar characteristics at
inclusion in the trial. The primary endpoint was 28 events per 100
patient-years in the TMVR group, as compared with 60 events per 100
patient-years in the GDMT group (hazard ratio [HR] 0.46, 95% confidence
interval [CI]: 0.20-1.02; p=0.057). CONCLUSION(S): In this landmark
analysis of the MITRA-FR trial, the cumulative rate of HF hospitalisation
between 12 and 24 months among patients treated with TMVR on top of GDMT
was approximately half as many as those of patients treated with GDMT
alone, a difference which did not reach statistical significance in the
setting of a low number of events.

<95>
Accession Number
637841567
Title
Bleeding risk differences after TAVR according to the ARC-HBR criteria:
insights from SCOPE 2.
Source
EuroIntervention : journal of EuroPCR in collaboration with the Working
Group on Interventional Cardiology of the European Society of Cardiology.
18(6) (pp 503-513), 2022. Date of Publication: 19 Aug 2022.
Author
Garot P.; Neylon A.; Morice M.-C.; Tamburino C.; Bleiziffer S.; Thiele H.;
Scholtz S.; Schramm R.; Cockburn J.; Cunnington M.; Wolf A.; Barbanti M.;
Tchetche D.; Pagnotta P.; Gilard M.; Bedogni F.; Van Belle E.;
Vasa-Nicotera M.; Chieffo A.; Bogaerts K.; Hengstenberg C.; Capodanno D.
Institution
(Garot, Neylon, Morice) Institut Cardiovasculaire Paris-Sud, Hopital Prive
Jacques Cartier, Massy, France
(Tamburino, Capodanno) Division of Cardiology Azienda Ospedaliero
Universitaria "Policlinico-Vittorio Emanuele" University of Catania,
Catania, Italy
(Bleiziffer, Schramm) Department of Thoracic and Cardiovascular Surgery,
Heart and Diabetes Center Northrhein-Westfalia, University Hospital,
Ruhr-University Bochum, Bad Oeynhausen, Germany
(Thiele) Department of Cardiology, Leipzig Heart Center, University of
Leipzig, Leipzig, Germany
(Scholtz) Department of Interventional Cardiology, Heart and Diabetes
Center North Rhine Westfalia, Bad Oeynhausen, Germany
(Cockburn) Department of Cardiology, Brighton & Sussex University
Hospitals NHS Trust, Brighton, United Kingdom
(Cunnington) Department of Cardiology, Leeds General Infirmary, Leeds
Teaching Hospitals NHS Trust, Leeds, United Kingdom
(Wolf) Department of Interventional Cardiology, Elisabeth Hospital Essen,
Essen, Germany
(Barbanti) Department of Cardio-Thoracic-Vascular diseases and
transplantation, Catania, Italy
(Tchetche) Groupe CardioVasculaire Interventionnel, Clinique Pasteur,
Toulouse, France
(Pagnotta) Department of Cardiovascular Medicine, Humanitas Clinical and
Research Center, Milano, Italy
(Gilard) Department of Cardiology, Brest University Hospital, Brest,
France
(Bedogni) Cardiology Department, IRCCS Policlinico San Donato, Milano,
Italy
(Van Belle) Department of Cardiology, Lille University Hospital, Lille,
France
(Vasa-Nicotera) Department of Cardiology, Goethe University Hospital
Frankfurt, Frankfurt am Main, Germany
(Chieffo) Interventional Cardiology Unit, IRCCS San Raffaele Scientific
Institute, Milan, Italy
(Bogaerts) KU Leuven, Faculty of Medicine, I-BioStat, Leuven, Belgium and
UHasselt, I-BioStat, Hasselt, Belgium
(Hengstenberg) Department of Internal Medicine II, Medical University of
Vienna, Vienna, Austria
Publisher
NLM (Medline)
Abstract
BACKGROUND: The Academic Research Consortium - High Bleeding Risk
(ARC-HBR) initiative defined conditions associated with percutaneous
coronary intervention (PCI)-related bleeding. AIMS: We sought to further
explore these HBR conditions in the setting of transcatheter aortic valve
replacement (TAVR). METHOD(S): Patients from the SCOPE 2 trial were
stratified by their bleeding risk status based on the ARC-HBR definitions.
Baseline and procedural characteristics, as well as key clinical outcomes
including Bleeding Academic Research Consortium (BARC) 3-5 bleeding, were
compared in ARC-HBR positive (HBR+) and ARC-HBR negative (HBR-) patients.
 RESULT(S): Of 787 patients randomised in SCOPE 2 and included in this
study, 633 were HBR+ (80.4%). Compared with HBR- patients, those HBR+ were
older and more frequently presented with diabetes, a history of coronary
artery disease, atrial fibrillation, prior cerebrovascular accident, and a
Society of Thoracic Surgeons predicted risk of 30-day mortality (STS-PROM)
(4.9+/-2.9% vs 3.3%+/-2.1%; p<0.0001). In addition, HBR+ patients were
more frequently on oral anticoagulation therapy. At 1 year, HBR+ patients
had higher rates of all-cause death (12.4% vs 4.3%, respectively, risk
difference 8.09%; 95% confidence interval [CI]: 3.76-12.41; p=0.0002); the
rates of BARC 3-5 type bleeding were relatively high but not statistically
different compared with HBR- patients (7.7% vs 6.1%, risk difference
1.67%; 95% CI: -2.72 to 6.06; p=0.46). Subgroup analyses for bleeding
events showed no significant interaction in terms of STS-PROM score, age,
or medications. CONCLUSION(S): The ARC-HBR criteria failed to isolate
a subgroup of patients at higher bleeding risk in TAVR patients from a
randomised trial. These findings have potential implications, especially
for the selection of post-TAVR antithrombotic regimens based on individual
bleeding-risk profiles. Specific HBR criteria should be defined for TAVR
patients.

<96>
Accession Number
2019845400
Title
Parasternal Intercostal Nerve Blocks in Patients Undergoing Cardiac
Surgery: Evidence Update and Technical Considerations.
Source
Journal of Cardiothoracic and Vascular Anesthesia. (no pagination), 2022.
Date of Publication: 2022.
Author
Schiavoni L.; Nenna A.; Cardetta F.; Pascarella G.; Costa F.; Chello M.;
Agro F.E.; Mattei A.
Institution
(Schiavoni, Pascarella, Costa, Agro, Mattei) Anesthesia, Intensive Care
and Pain Management, Universita Campus Bio-Medico di Roma, Rome, Italy
(Nenna, Cardetta, Chello) Cardiac Surgery, Universita Campus Bio-Medico di
Roma, Rome, Italy
Publisher
W.B. Saunders
Abstract
In the Enhanced Recovery After Surgery era, parasternal intercostal nerve
block has been proposed to improve pain control and reduce opioid use in
patients undergoing cardiac surgery. However current literature has
reported conflicting evidence about the effect of this multimodal pain
management, as procedural variations might pose a significant bias on
outcomes evaluation. In this setting, the infiltration of the parasternal
plane into 2 intercostal spaces, second and fifth, with a local anesthetic
spread under or above the costal plane with ultrasound guidance, seem to
be standardized in theory, but significant differences might be observed
in clinical practice. This narrative review summarizes and defines the
optimal techniques for parasternal plane blocks in patients undergoing
cardiac surgery with full median sternotomy, considering both
pectointercostal fascial block and transversus thoracic plane block. A
total of 10 randomized trials have been published, in adjunct to
observational studies, which are heterogeneous in terms of techniques,
methods, and outcomes. Parasternal block has been shown to reduce
perioperative opioid consumption and provide a more favorable analgesic
profile, with reduced postoperative opioid-related side effects. A trend
toward reduced intensive care unit stay or duration of mechanical
ventilation should be confirmed by adequately powered randomized trials or
registry studies. Differences in operative technique might impact outcomes
and, therefore, standardization of the procedure plays a pivotal role
before reporting specific outcomes. Parasternal plane blocks might
significantly improve outcomes of cardiac surgery with full median
sternotomy, and should be introduced comprehensively in Enhanced Recovery
After Surgery protocols. Copyright © 2022 Elsevier Inc.

<97>
Accession Number
2019804897
Title
Patent foramen ovale and perioperative stroke in noncardiac surgery: a
systematic review and meta-analysis.
Source
British Journal of Anaesthesia. (no pagination), 2022. Date of
Publication: 2022.
Author
Rais G.; Vassallo P.; Schorer R.; Bollen Pinto B.; Putzu A.
Institution
(Rais, Schorer, Bollen Pinto, Putzu) Department of Acute Medicine,
Division of Anaesthesiology, Geneva University Hospitals, Geneva,
Switzerland
(Vassallo) Department of Clinical Neuroscience, Lausanne University
Hospital, Lausanne, Switzerland
Publisher
Elsevier Ltd
Abstract
Background: Patent foramen ovale (PFO) is associated with perioperative
stroke in noncardiac surgery. The magnitude of this association was
assessed in a systematic review and meta-analysis. Method(s):
Electronic databases were searched up to June 2022 for studies assessing
the association between patent foramen ovale and perioperative stroke in
adult patients undergoing noncardiac surgery. The primary analysis was
limited to studies reporting effect estimates adjusted for significant
clinical confounders. We calculated the adjusted odds ratio (aOR) and 95%
confidence interval (CI). Result(s): We included nine retrospective
and two prospective observational studies, including 21 257 082 patients.
The presence of a patent foramen ovale was independently associated with
stroke at 30 days after surgery (aOR=6.68 [95% CI: 3.51-12.73]; P<0.001)
and at longest follow-up available (aOR=7.36 [95% CI: 3.56-15.21];
P<0.001). The odds of stroke at 30 days varied according to surgical
specialty: neurosurgery (aOR=4.52 [95% CI: 3.17-6.43]), vascular surgery
(aOR=7.15 [95% CI: 2.52-20.22]), thoracic surgery (aOR=10.64 [95% CI:
5.97-18.98]), orthopaedic surgery (aOR=11.85 [95% CI: 5.38-26.08]),
general surgery (aOR=14.40 [95% CI: 10.88-19.06]), and genitourinary
surgery (aOR=17.28 [95% CI: 10.36-28.84]). Conclusion(s): The
presence of a patent foramen ovale is associated with a large and
consistent increase in odds of stroke across all explored surgical
settings. Prospective trials should further explore this association by
systematically assessing patent foramen ovale and stroke prevalence and
identifying a specific population at risk. This is crucial for the
elaboration of prevention plans and may improve perioperative
outcomes. Copyright © 2022 British Journal of Anaesthesia

<98>
Accession Number
2019823089
Title
Efficacy and safety of proton pump inhibitors versus histamine-2 receptor
blockers in the cardiac surgical population: Insights from the PEPTIC
trial.
Source
European Journal of Cardio-thoracic Surgery. 62(2) (no pagination), 2022.
Article Number: ezac124. Date of Publication: 01 Aug 2022.
Author
Van Diepen S.; Coulson T.; Wang X.; Opgenorth D.; Zuege D.J.; Harris J.;
Agyemang M.; Niven D.J.; Bellomo R.; Wright S.E.; Young P.J.; Bagshaw S.M.
Institution
(Van Diepen, Opgenorth, Bagshaw) Department of Critical Care Medicine,
University of Alberta, Alberta Health Services, Edmonton, AB, Canada
(Van Diepen) Division of Cardiology, Department of Medicine, University of
Alberta, Edmonton, AB, Canada
(Coulson) Department of Anaesthesiology and Perioperative Medicine, Alfred
Hospital, Melbourne, VIC, Australia
(Coulson, Bellomo, Young) Australian and New Zealand Intensive Care
Research Centre, Department of Epidemiology and Preventive Medicine,
School of Public Health and Preventive Medicine, Monash University,
Melbourne, VIC, Australia
(Coulson, Bellomo, Young) Department of Critical Care, University of
Melbourne, Parkville, VIC, Australia
(Wang) Health Services Statistical and Analytic Methods, Alberta Health
Services, Calgary, AB, Canada
(Zuege, Niven) Department of Critical Care Medicine, University of
Calgary, Alberta Health Services, Calgary, AB, Canada
(Zuege, Bagshaw) Critical Care Strategic Clinical Network, Alberta Health
Services, Calgary, AB, Canada
(Harris) ECritical Alberta, Alberta Health Services, Calgary, AB, Canada
(Agyemang, Niven) Department of Community Health Sciences, University of
Calgary, Calgary, AB, Canada
(Bellomo) Department of Intensive Care, Royal Melbourne Hospital,
Melbourne, VIC, Australia
(Bellomo) Data Analytics Research and Evaluation Centre, University of
Melbourne and Austin Hospital, Melbourne, VIC, Australia
(Wright) Intensive Care Unit, Freeman Hospital, Newcastle upon Tyne,
United Kingdom
(Young) Medical Research Institute of New Zealand, Wellington, New Zealand
(Young) Intensive Care Unit, Wellington Regional Hospital, Wellington, New
Zealand
Publisher
European Association for Cardio-Thoracic Surgery
Abstract
OBJECTIVES: The comparative effectiveness and safety of proton pump
inhibitors (PPIs) versus histamine-2 receptor blockers for stress ulcer
prophylaxis in the cardiac surgical intensive care unit population is
uncertain. Although the Proton Pump Inhibitors versus Histamine-2 Receptor
Blockers for Ulcer Prophylaxis Therapy in the Intensive Care Unit (PEPTIC)
trial reported a higher risk of mortality in the PPI arm with no
difference in gastrointestinal bleeding, detailed information on surgical
variables and clinically relevant surgical subgroups was not available.
 METHOD(S): The analysis included all Canadian cardiac surgery
patients enrolled in the PEPTIC trial. Data were electronically linked
using unique patient identifiers to a clinical information system.
Outcomes of interest included in-hospital mortality, gastrointestinal
bleeding, Clostridium difficile infections, ventilator-associated
conditions and length of stay. RESULT(S): We studied 823 (50.6%)
randomized to PPIs and 805 (49.4%) to histamine-2-receptor blockers. In
the intention-to-treat analysis, there were no differences in hospital
mortality [PPI: 4.3% vs histamine-2 receptor blockers: 4.8%, adjusted odds
ratio (aOR) 0.97, 95% confidence interval (CI) 0.55-1.70],
gastrointestinal bleeding (3.9% vs 4.8%, aOR 1.09, 95% CI 0.66-1.81), C.
difficile infections (0.9% vs 0.1%, aOR 0.18, 95% CI 0.02-1.59),
ventilator-associated conditions (1.6% vs 1.7%, aOR 0.92, 95% CI
0.85-1.00) or median length of stay (9.2 vs 9.8 days, adjusted risk ratio
1.06, 85% CI 0.99-1.13). No significant treatment differences were
observed among subgroups of interest or per-protocol populations.
 CONCLUSION(S): In a secondary analysis of cardiac surgery patients
enrolled in the PEPTIC trial in Canada, no differences in effectiveness or
safety were observed between use of PPIs and histamine-2 receptor blockers
for stress ulcer prophylaxis. Clinical trial registration number:
anzctr.org.au identifier: ACTRN12616000481471. Copyright © 2022
The Author(s). Published by Oxford University Press on behalf of the
European Association for Cardio-Thoracic Surgery. All rights reserved.

<99>
Accession Number
2019823077
Title
Mechanical versus biological valve prostheses for left-sided infective
endocarditis.
Source
European Journal of Cardio-thoracic Surgery. 62(2) (no pagination), 2022.
Article Number: ezac056. Date of Publication: 01 Aug 2022.
Author
Kahrovic A.; Angleitner P.; Herkner H.; Kocher A.; Ehrlich M.; Laufer G.;
Andreas M.
Institution
(Kahrovic, Angleitner, Kocher, Ehrlich, Laufer, Andreas) Department of
Cardiac Surgery, Medical University of Vienna, Vienna, Austria
(Herkner) Department of Emergency Medicine, Medical University of Vienna,
Vienna, Austria
Publisher
European Association for Cardio-Thoracic Surgery
Abstract
OBJECTIVES: Our aim was to analyse outcomes after implantation of
mechanical versus biological valve prostheses in patients presenting with
left-sided infective endocarditis. METHOD(S): We conducted a
retrospective single-centre cohort study, analysing adults requiring valve
surgery for left-sided infective endocarditis between January 2009 and
December 2018 at the Department of Cardiac Surgery, Medical University of
Vienna. The primary outcome variable was all-cause mortality. Secondary
outcome variables included the occurrence of a combined event (death,
stroke, intracerebral bleeding or reoperation) and the risk of
re-endocarditis. RESULT(S): Among 220 patients, 76 (34.5%) underwent
mechanical valve replacement, while 144 (65.5%) underwent biological valve
replacement. Recipients of mechanical valve prostheses were younger at the
time of surgery and presented with lower European System for Cardiac
Operative Risk Evaluation II values. In patients <55 years of age,
implantation of a mechanical valve prosthesis was independently associated
with significantly lower risk of all-cause mortality (adjusted hazard
ratio 0.35, 95% confidence interval 0.15-0.80, P = 0.013). Moreover, this
group was at significantly lower risk of a combined event (adjusted hazard
ratio 0.38, 95% confidence interval 0.19-0.76, P = 0.006). Implantation of
a mechanical valve prosthesis was not associated with increased risk of
re-endocarditis. The presence of an annular abscess significantly
increased the risk of re-endocarditis (adjusted hazard ratio 3.06, 95%
confidence interval 1.40-6.71, P = 0.005). CONCLUSION(S): In patients
presenting with left-sided infective endocarditis <55 years of age,
implantation of a mechanical valve prosthesis is associated with superior
outcomes. A prospective randomized controlled trial is warranted to
confirm these results. Copyright © 2022 The Author(s). Published
by Oxford University Press on behalf of the European Association for
Cardio-Thoracic Surgery. All rights reserved.

<100>
Accession Number
2019822922
Title
Apixaban vs. standard of care after transcatheter aortic valve
implantation: the ATLANTIS trial.
Source
European Heart Journal. 43(29) (pp 2783-2797), 2022. Date of Publication:
01 Aug 2022.
Author
Collet J.P.; Neumann F.J.; Aubry P.; Baronnet F.; Ederhy S.; Kasty M.E.;
Kerneis M.; Barthelemy O.; Leprince P.; Redheuil A.; Henry P.; Portal
J.J.; Vicaut E.; Montalescot G.; Collet J.-P.; Leroux L.; Le Breton H.;
Schiele F.; Beygui F.; Van Belle E.; Lhermusier T.; Cayla G.; Eltchaninoff
H.; Lefevre T.; Gilard M.; Caussin C.; Souteyrand G.; Himbert D.; Manigold
T.; Maureira J.P.; Rioufol G.; Leclercq F.; Cuisset T.; Chassaing S.;
Dumonteil N.; Karam N.; Lorgis L.; Attias D.; Varenne O.; Morel O.; Isaaz
K.; Ghostine S.; Neumann F.-J.; Klingenberg R.; Liebetrau C.; Thiele H.;
Linke A.; Mehilli J.; Kupatt C.; Zeymer U.; Ince H.; Boekstegers P.; Berti
S.; De Carlo M.; De Benedictis M.; Gandolfo C.; Cequier A.; Hernandez
J.M.; Trillo Nouche R.; Martin Moreiras J.; San Roman Calvar A.; Fernandez
Aviles F.; Alfonso F.; Garcia Del Blanco B.; Cuellas Ramon C.; Pan Alvarez
Osorio M.
Institution
(Collet, Kerneis, Barthelemy, Montalescot) Sorbonne Universite, Action
Group, Inserm Umrs 1166, Hopital Pitie-Salpetriere (AP-HP), Institut de
Cardiologie, Paris 75013, France
(Van Belle) Chu Lille, Institut Coeur Poumon, Pole Cardiovasculaire et
Pulmonaire, Action Group, Inserm U1011, Institut Pasteur de Lille, Egid,
Universite de Lille, Lille, France
(Thiele) Department of Internal Medicine/Cardiology, Heart Center Leipzig,
University of Leipzig and Leipzig, Leipzig, Germany
(Berti) Fondazione Toscana G. Monasterio, Ospedale Del Cuore G,
Pasquinucci, Massa, Italy
(Lhermusier) Hopital de Rangueil, Federation de Cardiologie, Pole
Cardio-vasculaire et Metabolique, Toulouse, France
(Manigold) Hopital Guillaume et Rene Laennec, Institut du Thorax-Clinique
Cardiologique, Unite Hemodynamique et Cardiovasculaire Interventionnel,
Nantes, France
(Neumann) University Heart Centre Freiburg Bad Krozingen, Division of
Cardiology and Angiology Ii, Bad Krozingen, Germany
(Gilard) Chu Brest, Departement de Cardiologie, Brest, France
(Attias) Centre Cardiologique du Nord, Saint Denis, France
(Beygui) Chu de la Cote de Nacre, Departement de Cardiologie, Caen, France
(Cequier) Hospital Universitario de Bellvitge, University of Barcelona,
Heart Disease Institute, L'Hospitalet de Llobregat, Barcelona, Spain
(Alfonso) Hospital Universitario de la Princesa, Department of Cardiology,
Madrid, Spain
(Aubry) Centre Hospitalier Bichat, Departement de Cardiologie, Paris,
France
(Baronnet) Hopital la Pitie-Salpetriere (AP-HP), Unite Intensif de
Neurologie Vasculaire, Paris, France
(Ederhy) Hopital Saint-Antoine (AP-HP), Action Group, Service de
Cardiologie, Paris, France
(Kasty) Hopital de Jossigny, Action Group, Service de Cardiologie,
Jossigny, France
(Lefevre) Hopital Prive Jacques Cartier, Institut Cardiovasculaire Paris
Sud, Massy, France
(Leprince) Sorbonne Universite Hopital Pitie-Salpetriere (AP-HP), Institut
de Cardiologie, Chirurgie Cardiaque, Paris, France
(Redheuil) Laboratoire Imagerie Biomedicale (LIB), Ican, Action Group,
Hopital Pitie-Salpetriere (AP-HP), Institut de Cardiologie, Sorbonne
Universite, Paris, France
(Henry) Hopital Lariboisiere (AP-HP), Service de Cardiologie, Universite
de Paris, Paris, France
(Portal, Vicaut) Unite de Recherche Clinique Lariboisiere St Louis, Action
Group, Hopital St-Louis and Fernand Widal, Paris, France
Publisher
Oxford University Press
Abstract
Aims: The respective roles of oral anticoagulation or antiplatelet therapy
following transcatheter aortic valve implantation (TAVI) remain debated.
ATLANTIS is an international, randomized, open-label, superiority trial
comparing apixaban to the standard of care. Methods and Results:
After successful TAVI, 1500 patients were randomized (1:1) to receive
apixaban 5 mg (2.5 mg if impaired renal function or concomitant
antiplatelet therapy) (n = 749) twice daily, or standard of care (n =
751). Randomization was stratified by the need for chronic anticoagulation
therapy. Standard-of-care patients received a vitamin K antagonist (VKA)
(Stratum 1) or antiplatelet therapy (Stratum 2) if there was an indication
for anticoagulation or not, respectively. The primary endpoint was the
composite of death, myocardial infarction, stroke or transient ischaemic
attack, systemic embolism, intracardiac or bioprosthesis thrombosis, deep
vein thrombosis or pulmonary embolism, and life-threatening, disabling, or
major bleeding over 1-year follow-up. The primary safety endpoint was
major, disabling, or life-threatening bleeding. The primary outcome
occurred in 138 (18.4%) and 151 (20.1%) patients receiving apixaban or
standard of care, respectively [hazard ratio (HR) 0.92; 95% confidence
interval (CI) 0.73-1.16] and there was no evidence of interaction between
treatment and stratum (Pinteraction = 0.57). The primary safety endpoint
was similar in both groups (HR 1.02; 95% CI 0.72-1.44). In Stratum 1 (n =
451), an exploratory analysis showed no difference for all endpoints
between apixaban and VKA. In Stratum 2 (n = 1049), the primary outcome and
primary safety endpoint did not differ, but obstructive valve thrombosis
was reduced with apixaban vs. antiplatelet therapy (HR 0.19; 95% CI
0.08-0.46), while a signal of higher non-cardiovascular mortality was
observed with apixaban. Conclusion(s): After TAVI, apixaban was not
superior to the standard of care, irrespective of an indication for oral
anticoagulation. Copyright © 2022 The Author(s). Published by
Oxford University Press on behalf of European Society of Cardiology. All
rights reserved.

<101>
Accession Number
638805303
Title
Prophylactic Use of Antifibrinolytics During Pediatric Cardiac Surgery
With Cardiopulmonary Bypass on Postoperative Bleeding and Transfusion: A
Systematic Review and Meta-Analysis.
Source
Pediatric critical care medicine : a journal of the Society of Critical
Care Medicine and the World Federation of Pediatric Intensive and Critical
Care Societies. (no pagination), 2022. Date of Publication: 23 Aug 2022.
Author
Schertz K.; Karam O.; Demetres M.; Faraoni S.; Faraoni D.; Nellis M.E.
Institution
(Schertz) Department of Pediatrics, New York-Presbyterian/Weill Cornell
Medicine, New York, NY
(Karam) Pediatric Critical Care Medicine, Yale School of Medicine, New
Haven, CT, United States
(Demetres) Samuel J. Wood Library & C.V. Starr Biomedical Information
Center, Weill Cornell Medicine, New York, NY
(Faraoni) Wagner College, New York, NY
(Faraoni) Arthur S. Keats Division of Pediatric Cardiovascular Anesthesia
Department of Anesthesiology, Perioperative and Pain Medicine Texas
Children's Hospital, Baylor College of Medicine, Houston, TX, United
States
(Nellis) Weill Cornell Medicine, Division of Pediatric Critical Care,
Department of Pediatrics, New York, NY
Publisher
NLM (Medline)
Abstract
OBJECTIVES: To determine the effect of intraoperative antifibrinolytics,
including tranexamic acid (TXA), aminocaproic acid (EACA), or aprotinin,
on bleeding in children undergoing cardiac surgery with cardiopulmonary
bypass (CPB). DATA SOURCES: Relevant articles were systematically searched
from Ovid MEDLINE, Ovid EMBASE, CINAHL, Cochrane Library, and Web of
Science to November 15, 2021. STUDY SELECTION: Abstracts were screened,
and full texts were reviewed using predetermined inclusion and exclusion
criteria using the Preferred Reporting Items for Systematic Reviews and
Meta-analyses reporting guideline. DATA EXTRACTION: A standardized data
extraction tool was used. DATA SYNTHESIS: Sixty-eight studies including
28,735 patients were analyzed. TXA compared with placebo resulted in a
mean decrease in chest tube output of 9.1mL/kg (95% CI, 6.0-12.3mL/kg), I2
equals to 65.2%, p value of less than 0.001, platelet requirement of
2.9mL/kg (95% CI, 0.1-5.8mL/kg), I2=72.5%, p value less than 0.001 and
plasma requirement of 4.0mL/kg (95% CI, 0.6-7.2mL/kg), I2 equals to 94.5%,
p value less than0.001. Aprotinin compared with placebo resulted in a mean
decrease in chest tube output of 4.3mL/kg (2.4-6.2mL/kg), I2 equals to
66.3%, p value of less than 0.001, platelet transfusion of 4.6mL/kg (95%
CI, 0.6-8.6mL/kg), I2 equals to 93.6%, p value of less than 0.001, and
plasma transfusion of 7.7mL/kg (95% CI, 2.1-13.2mL/kg), I2 equals to
95.3%, p value of less than 0.001. EACA compared with placebo resulted in
a mean decrease in chest tube output of 9.2mL/kg (2.3-21.0mL/kg), I2
equals to 96.4%, p value of less than 0.001, RBC transfusion of 7.2mL/kg
(95% CI, 2.4-12.1mL/kg), I2 equals to 94.5%, p value equals to 0.002, and
platelet transfusion of 10.7mL/kg (95% CI, 2.9-18.5mL/kg), I2 equals to
0%, p value of less than 0.001. No statistical difference was observed in
chest tube output when TXA was compared with aprotinin. Subgroup analysis
of cyanotic patients showed a significant decrease in chest tube output,
platelet requirement, and plasma requirement for patients receiving
aprotinin. Overall, the quality of evidence was moderate.
 CONCLUSION(S): Antifibrinolytics are effective at decreasing blood
loss and blood product requirement in children undergoing cardiac surgery
with CPB although the quality of evidence is only moderate. Copyright
© 2022 by the Society of Critical Care Medicine and the World
Federation of Pediatric Intensive and Critical Care Societies.

<102>
Accession Number
638801989
Title
Defining the optimal historical control group for a phase 1 trial of
mesenchymal stromal cell delivery through cardiopulmonary bypass in
neonates and infants.
Source
Cardiology in the young. (pp 1-6), 2022. Date of Publication: 22 Aug
2022.
Author
Kobayashi K.; Higgins T.; Liu C.; Ayodeji M.; Wernovsky G.; Jonas R.A.;
Ishibashi N.
Institution
(Kobayashi, Higgins, Liu, Ayodeji, Jonas, Ishibashi) Center for
Neuroscience Research and Sheikh Zayed Institute for Pediatric Surgical
Innovation, Children's National Hospital, WA, United States
(Kobayashi, Wernovsky, Jonas, Ishibashi) Children's National Heart
Institute, Children's National Hospital, WA, United States
(Higgins, Wernovsky, Jonas, Ishibashi) George Washington University School
of Medicine and Health Sciences, WA, United States
(Liu) Virginia Commonwealth University School of Medicine, Richmond, VA,
United States
Publisher
NLM (Medline)
Abstract
OBJECTIVE: The Mesenchymal Stromal Cell Delivery through Cardiopulmonary
Bypass in Pediatric Cardiac Surgery study is a prospective, open-label,
single-centre, dose-escalation phase 1 trial assessing the
safety/feasibility of delivering mesenchymal stromal cells to
neonates/infants during cardiac surgery. Outcomes will be compared with
historical data from a similar population. We aim to define an optimal
control group for use in the Mesenchymal Stromal Cell Delivery through
Cardiopulmonary Bypass in Pediatric Cardiac Surgery trial. METHOD(S):
Consecutive patients who underwent a two-ventricle repair without aortic
arch reconstruction within the first 6 months of life between 2015 and
2020 were studied using the same inclusion/exclusion criteria as the Phase
1 Mesenchymal Stromal Cell Delivery through Cardiopulmonary Bypass in
Pediatric Cardiac Surgery trial (n = 169). Patients were allocated into
one of three diagnostic groups: ventricular septal defect type, Tetralogy
of Fallot type, and transposition of the great arteries type. To determine
era effect, patients were analysed in two groups: Group A (2015-2017) and
B (2018-2020). In addition to biological markers, three post-operative
scoring methods (inotropic and vasoactive-inotropic scores and the
Pediatric Risk of Mortality-III) were assessed. RESULT(S): All values
for three scoring systems were consistent with complexity of cardiac
anomalies. Max inotropic and vasoactive-inotropic scores demonstrated
significant differences between all diagnosis groups, confirming high
sensitivity. Despite no differences in surgical factors between era
groups, we observed lower inotropic and vasoactive-inotropic scores in
group B, consistent with improved post-operative course in recent years at
our centre. CONCLUSION(S): Our studies confirm max inotropic and
vasoactive-inotropic scores as important quantitative measures after
neonatal/infant cardiac surgery. Clinical outcomes should be compared
within diagnostic groupings. The optimal control group should include only
patients from a recent era. This initial study will help to determine the
sample size of future efficacy/effectiveness studies.

<103>
Accession Number
638800934
Title
Preoperative P-wave parameters and risk of atrial fibrillation after
cardiac surgery: a meta-analysis of 20,201 patients.
Source
Interactive cardiovascular and thoracic surgery. (no pagination), 2022.
Date of Publication: 22 Aug 2022.
Author
Kawczynski M.J.; Van De Walle S.; Maesen B.; Isaacs A.; Zeemering S.;
Hermans B.; Vernooy K.; Maessen J.G.; Schotten U.; Bidar E.
Institution
(Kawczynski, Van De Walle, Maesen, Maessen, Bidar) Department of
Cardiothoracic Surgery, Heart and Vascular Centre, Maastricht University
Medical Centre, Maastricht, Netherlands
(Kawczynski, Maesen, Isaacs, Zeemering, Hermans, Maessen, Schotten, Bidar)
Department of Physiology, Maastricht University, Maastricht, Netherlands
(Zeemering, Hermans, Vernooy) Cardiovascular Research Institute Maastricht
(CARIM), Maastricht, Netherlands
(Vernooy) Department of Cardiology, Heart and Vascular Centre, Maastricht
University Medical Centre, Maastricht, Netherlands
Publisher
NLM (Medline)
Abstract
OBJECTIVES: To evaluate the role of P-wave parameters, as defined on
preprocedural electrocardiography (ECG), in predicting atrial fibrillation
(AF) after cardiac surgery (POAF). METHOD(S): Pubmed, Cochrane
library, and Embase were searched for studies reporting on P-wave
parameters and risk of POAF. Meta-analysis of P-wave parameters reported
by at least five different publications was performed. In case of receiver
operator characteristics (ROC-curve) analysis in the original
publications, a ROC meta-analysis was performed to summarize the
sensitivity and specificity. RESULT(S): Thirty-two publications, with
a total of 20,201 patients, contributed to the meta-analysis. Increased
P-wave duration, measured on conventional 12-lead ECG (22 studies, Cohen's
d=0.4, 95% confidence interval: 0.3-0.5, p<0.0001) and signal-averaged ECG
(SAECG) (12 studies, Cohen's d=0.8, 95% confidence interval: 0.5-1.2,
p<0.0001), was a predictor of POAF independently from left atrial size.
ROC meta-analysis for SAECG P-wave duration showed an overall sensitivity
of 72% (95% confidence interval: 65-78%) and specificity of 68% (95%
confidence interval: 58-77%). Summary ROC-curve had a moderate
discriminative power with an area under the curve of 0.76. There was
substantial heterogeneity in the meta-analyses for P-wave dispersion and
PR-interval. CONCLUSION(S): This meta-analysis shows that increased
P-wave duration, measured on conventional 12-lead ECG and SAECG, predicted
POAF in patients undergoing cardiac surgery. Copyright © The
Author(s) 2022. Published by Oxford University Press on behalf of the
European Association for Cardio-Thoracic Surgery.

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