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<1>
Accession Number
2018717958
Title
Antithrombotic strategies after transcatheter aortic valve implantation: A
systematic review and network meta-analysis of randomized controlled
trials.
Source
International Journal of Cardiology. 362 (pp 139-146), 2022. Date of
Publication: 01 Sep 2022.
Author
Ke Y.; Wang J.; Wang W.; Guo S.; Dai M.; Wu L.; Bao Y.; Li B.; Ju J.; Xu
H.; Jin Y.
Institution
(Ke) Discipline of Pharmacy Administration, Anqing Medical Center
affiliated to Anhui Medical University(Anqing Municipal Hospital), Anhui,
Anqing, China
(Ke, Wu, Bao, Jin) School of Pharmacy, Anhui Medical University, Anhui,
Hefei, China
(Wang) Department of Pharmacy, The Friendship Hospital of ILY Kazak
Autonomous Prefecture, Xinjiang, Yili, China
(Wang) Department of Gastroenterology, Anqing Medical Center affiliated to
Anhui Medical University(Anqing Municipal Hospital), Anhui, Anqing, China
(Guo) Department of Pharmacy, The People's Hospital of Guangxi Zhuang
Autonomous Region, Guangxi, Nanning, China
(Dai) School of Pharmacy, China Pharmaceutical University, Jiangsu,
Nanjing 210000, China
(Li) School of Public Health, Anhui Medical University, Anhui, Hefei,
China
(Ju) Department of Equipment, Anqing Medical Center affiliated to Anhui
Medical University(Anqing Municipal Hospital), Anhui, Anqing, China
(Xu) Department of Pharmacy, Nanjing Drum Tower Hospital Affiliated to
Nanjing University Medical School, Jiangsu, Nanjing, China
Publisher
Elsevier Ireland Ltd
Abstract
Aims: Meta-analyses comparing different antithrombotic strategies were
conducted to determine the optimal therapeutic regimen post transcatheter
aortic valve implantation (TAVI). However, there were restricted
high-quality direct comparisons across the different antithrombotic
therapeutic regimens. We sought to explore the safety and efficacy of
different antithrombotic therapy strategies after TAVI using network
meta-analyses of randomized controlled trials (RCTs). Method(s): We
searched CENTRAL, PubMed, Embase and Medline through August 2021 for RCTs
that directly compared different antithrombotic schemes in adults who had
undergone TAVI. We conducted a pairwise and network meta-analysis
measuring all-cause mortality, stroke, myocardial infarction, all bleeding
and life-threatening or major bleeding events. The surface under the
cumulative ranking (SUCRA) curve was estimated to rank the therapies. We
evaluated the risk of bias and graded the quality of the evidence using
established methods. Result(s): Six RCTs of 2824 patients who
underwent TAVI were analysed. The risk of all bleeding [relative risk (RR)
1.88 (1.34-2.64)] and life-threatening or major bleeding [RR 2.03
(1.27-3.24)] was significantly higher for dual antiplatelet therapy (DAPT)
than single antiplatelet therapy (SAPT), whereas there was no significant
difference in the risk of all-cause mortality [RR 1.01 (0.61-1.68)]
between DAPT and SAPT. Oral anticoagulant (OAC) + SAPT (OACSAPT) had
significantly higher rates of all bleeding and life-threatening or major
bleeding events compared with SAPT ([RR 3.46 (2.23-5.36)], [RR 2.86
(1.50-5.45)]). The risk of all-cause mortality [RR 1.72 (1.14-2.59)] and
all bleeding [RR 1.84 (1.38-2.44)] were significantly higher for OACSAPT
than DAPT, whereas there was no significant difference in the risk of
life-threatening or major bleeding events [RR 1.41 (0.89-2.23)] between
DAPT and OACSAPT. There was no significant difference in stroke or
myocardial infarction among the different antithrombotic strategies (SAPT,
DAPT and OACSAPT). Additionally, patients receiving OACSAPT had the
highest risks for all-cause mortality (SUCRA 3.5%) and life-threatening or
major bleeding (SUCRA 2.3%). SAPT seemed to be superior to DAPT in terms
of all-cause mortality (SUCRA SAPT: 76.7%, DAPT: 69.8%) and stroke (SUCRA
69.6%, 59.7%). Conclusion(s): Except for OACSAPT having a higher
all-cause mortality than DAPT, patients who underwent TAVI had similar
all-cause mortality, stroke and myocardial infarction rates among
different antithrombotic regimens. Patients on SAPT had a significantly
lower bleeding risk than those on DAPT and OACSAPT. Our study indicates
that SAPT is the preferred therapeutic strategy when there is no
indication for OAC or DAPT. Furthermore, the application of OACSAPT was
ranked the worst among all antithrombotic regimens and should be averted
due to an increased risk of all-cause mortality and all
bleeding. Copyright © 2022 Elsevier B.V.

<2>
Accession Number
2019145161
Title
Comparison of Rhomboid Intercostal Block, Erector Spinae Plane Block, and
Serratus Plane Block on Analgesia for Video-Assisted Thoracic Surgery: A
Prospective, Randomized, Controlled Trial.
Source
International Journal of Clinical Practice. 2022 (no pagination), 2022.
Article Number: 6924489. Date of Publication: 2022.
Author
Zhang J.-G.; Jiang C.-W.; Deng W.; Liu F.; Wu X.-P.
Institution
(Zhang, Wu) Department of Infectious Disease, The First Affiliated
Hospital of Nanchang University, Jiangxi, Nanchang, China
(Zhang) Departments of Critical Care Medicine, Linyi People's Hospital,
Shandong, Linyi, China
(Zhang, Liu) Department of Critical Care Medicine, The First Affiliated
Hospital of Nanchang University, Jiangxi, Nanchang, China
(Jiang, Deng) Department of Anesthesiology and Pain Medicine, The
Affiliated Hospital of Jiaxing University, Zhejiang, Jiaxing, China
Publisher
Wiley-Hindawi
Abstract
Background. Thoracic surgery is one of the most painful surgical steps. An
important tool for managing postoperative pain is effective postoperative
analgesia. This research aimed at comparing the analgesic roles of three
new fascial block techniques in the postoperative period after
video-helped thoracoscopic operation (VATS). Methods. We randomly
allocated ninety patients into three teams experiencing
ultrasound-directed serratus plane block, erector spinae plane block, and
the rhomboid intercostal block, respectively. 0.4% ropivacaine of 20 mL
was received by all groups. Outcomes. At 0-12 hours, sufentanil
consumption was significantly lower in the RIB (35.2 +/- 3.3 mg) and ESP
(35.4 +/- 2.8 mg) groups than that in the SAB (43.3 +/- 2.7 mg) group
P<0.001, and no obvious diversity in sufentanil consumption was shown
between the RIB and ESP groups P=0.813. At 12-24 hours, sufentanil
consumption was greatly lower in the RIB and ESP groups than that in the
SAB group P<0.001, and no great diversity in sufentanil consumption was
found between the RIB and ESP groups P=0.589. No great diversity in
sufentanil consumption was shown between the RIB (50.4 +/- 1.4 mg), ESP
(50.4 +/- 1.5 mg), and SAB (51.0 +/- 1.7 mg) groups at 24-48 hours
P=0.192. At 6, 12, 18, and 24 hours, the postoperative dynamic NRS scores
were significantly lower in the RIB and ESP groups than in the SAB group
(P<0.05 for all contrasts). Nevertheless, no great diversity was observed
in postoperative pain marks at 0.5, 1, 3, 6, 12, 18, 24, 36, and 48 hours
after the surgery across the three groups. No statistical diversity was
found in the postoperative NRS mark between groups RIB and ESP within 48
hours after surgery in case of active patients (P<0.05 for all contrasts).
At 24 hours after surgery, a significant difference in IL-1beta and IL-6
inflammatory factor concentrations was found between RIB and ESP compared
with SAB block (P<0.05 for all contrasts). However, no great diversities
were observed in IL-1beta, and IL-6 inflammatory factor concentrations
between RIB, ESP, and SAB at 24 hours preoperatively and at 48 hours
postoperatively (P<0.05 for all comparisons). Conclusion. The dosage of
sufentanil can be effectively reduced by ultrasound-directed rhomboid
intercostal block and erector spinae plane block within 24 hours after
VATS surgery, and pain can be relieved effectively within 24 hours by
comparing with serratus plane block. Copyright © 2022 Jian-Guo
Zhang et al.

<3>
Accession Number
2016149290
Title
Concomitant Surgical Left Atrial Appendage Occlusion: a Review.
Source
Current Cardiology Reports. 24(7) (pp 823-828), 2022. Date of Publication:
July 2022.
Author
Whitlock R.P.; Belley-Cote E.P.
Institution
(Whitlock) Division of Cardiac Surgery, Department of Surgery, McMaster
University, Hamilton, ON, Canada
(Whitlock, Belley-Cote) Population Health Research Institute, 237 Barton
Street E, Hamilton, ON L8L 2X2, Canada
(Belley-Cote) Divisions of Cardiology and Critical Care, Department of
Medicine, McMaster University, Hamilton, ON, Canada
Publisher
Springer
Abstract
Purpose of Review: In this review, we discuss some of the observational
studies that examined the impact of left atrial appendage occlusion on
stroke, the Left Atrial Appendage Occlusion Study (LAAOS) III research
program that provided definitive evidence for the benefit of surgical left
atrial appendage occlusion on ischemic stroke, and high priority studies
in the field that should be pursued by the surgical community. Recent
Findings: Atrial fibrillation is common in patients undergoing cardiac
surgery. Oral anticoagulants are effective at preventing strokes related
to atrial fibrillation; they have been the standard of care for stroke
prevention in patients with atrial fibrillation for decades. Most strokes
in patients with atrial fibrillation originate from the left atrial
appendage. LAAOS III, a large randomized controlled trial, has recently
demonstrated that concomitant left atrial appendage occlusion in patients
undergoing cardiac surgery for another indication reduces the risk of
stroke or systemic embolism on top of oral anticoagulation. Summary:
Surgical left atrial appendage occlusion reduces the risk of ischemic
stroke and systemic embolism in patients with atrial fibrillation and a
CHA<inf>2</inf>DS<inf>2</inf>-VASc score >= 2 undergoing cardiac surgery
for another indication. The role of surgical left atrial appendage
occlusion with patients without atrial fibrillation, as a substitute to
anticoagulation and as a standalone procedure, remains
unclear. Copyright © 2022, The Author(s), under exclusive licence
to Springer Science+Business Media, LLC, part of Springer Nature.

<4>
Accession Number
2014647315
Title
The use of a vascular occlusion test combined with near-infrared
spectroscopy in perioperative care: a systematic review.
Source
Journal of Clinical Monitoring and Computing. 36(4) (pp 933-946), 2022.
Date of Publication: August 2022.
Author
Niezen C.K.; Massari D.; Vos J.J.; Scheeren T.W.L.
Institution
(Niezen, Massari, Vos, Scheeren) Department of Anesthesiology, University
Medical Center Groningen, University of Groningen, PO Box 30 001,
Groningen 9700 RB, Netherlands
Publisher
Springer Science and Business Media B.V.
Abstract
In the perioperative phase oxygen delivery and consumption can be
influenced by different factors, i.e. type of surgery, anesthetic and
cardiovascular drugs, or fluids. By combining near-infrared spectroscopy
(NIRS) monitoring of regional tissue oxygen saturation (StO<inf>2</inf>)
with an ischemic provocation test, the vascular occlusion test (VOT),
local tissue oxygen consumption and vascular reactivity at the
microcirculatory level can be assessed. This systematic review aims to
give an overview of the clinical information that VOT-derived NIRS values
can provide in the perioperative period. After performing a systematic
literature search, we included 29 articles. It was not possible to perform
a meta-analysis because of the lack of comparable data and the
observational nature of the majority of the included articles. We have
clustered the found articles in two groups: non-cardiac surgery and
cardiac surgery. We found that VOT-derived NIRS values show a wide
variability and are influenced by the effects of anesthetics,
cardiovascular drugs, fluids, and by the type of surgery. Additionally,
deviations in VOT-derived NIRS values are also associated with adverse
patients' outcomes, such as postoperative complications, prolonged
mechanical ventilation and prolonged hospital length of stay. However,
given the variability in VOT-derived NIRS values, clinical applicability
remains elusive. Future clinical interventional trials might provide
additional insight into the potential of VOT associated with NIRS to
optimize perioperative care by targeting specific interventions to
optimize the function of the microvasculature. Copyright © 2022,
The Author(s), under exclusive licence to Springer Nature B.V.

<5>
Accession Number
636226120
Title
Cardiovascular Mortality after Venous Thromboembolism: A Meta-Analysis of
Prospective Cohort Studies.
Source
Seminars in Thrombosis and Hemostasis. 48(4) (pp 481-489), 2022. Date of
Publication: 01 Jun 2022.
Author
Noumegni S.R.; Grangereau T.; Demir A.; Bressollette L.; Couturaud F.;
Hoffmann C.
Institution
(Noumegni, Grangereau, Bressollette, Hoffmann) Department of Vascular
Medicine, Brest Teaching Hospital, Brest University, EA 3878 GETBO, Brest,
France
(Noumegni, Bressollette, Couturaud, Hoffmann) EA3878 (GETBO), Western
Brittany Thrombosis Study Group, Brest University, Brest, France
(Grangereau) Department of Cardiovascular Medicine, Guingamp Hospital,
Guingamp, France
(Demir) Department of Vascular Medicine, Bordeaux Teaching Hospital,
Bordeaux, France
(Couturaud) Department of Internal Medicine and Pneumology, Brest Teaching
Hospital, Brest, France
Publisher
Thieme Medical Publishers, Inc.
Abstract
Many studies from current literature show that cardiovascular diseases in
patients with venous thromboembolism (VTE) are more frequent than in the
general population without VTE. However, data summarizing the impact of
cardiovascular diseases on mortality of patients with VTE are lacking. In
this systematic review and meta-analysis, we aimed to determine the
frequency and incidence rate of cardiovascular death in patients with VTE.
MEDLINE and EMBASE were searched from January 1, 2000 to February 28,
2021. Eligible studies were observational prospective cohort studies
including patients with VTE and reporting all causes of death.
Cardiovascular death was defined as deaths that result from new or
recurrent pulmonary embolism, death due to acute myocardial infarction,
sudden cardiac death or heart failure, death due to stroke, death due to
cardiovascular procedures or hemorrhage, death due to ruptured aortic
aneurysm or aortic dissection and death due to other cardiovascular
causes. Random-effect models meta-analysis served to determine all pooled
effect size of interest with their 95% confidence interval (CI). Thirteen
observational studies enrolling 22,251 patients were identified and
included. The mean/median age varied between 49 and 75 years. The
proportion of men ranged from 38.3 to 53.2%. The overall pooled frequency
of cardiovascular death in patients with VTE was 3.9% (95% CI: 2.5-5.6%),
while the overall pooled frequency of all-cause mortality was 12.0% (95%
CI: 9.1-15.4%). The pooled proportion of cardiovascular death among all
causes of deaths in patients with VTE was 35.2% (95% CI: 22.2-49.3%). The
pooled incidence rate of cardiovascular death was 1.92 per 100
patient-years (95% CI: 0-4.1). The frequency of cardiovascular death in
patients with VTE was significantly higher than in patients without VTE
(risk ratio: 3.85, 95% CI: 2.75-5.39). Based on this updated meta-analysis
from 13 prospective cohort studies, cardiovascular death in patients with
VTE is more frequent than in the general population without
VTE. Copyright © 2022 Thieme Medical Publishers, Inc.. All rights
reserved.

<6>
Accession Number
2019263993
Title
Coronary Artery Revascularization in Heart Transplant Patients: A
Systematic Review and Meta-Analysis.
Source
Cardiology (Switzerland). 147(3) (pp 348-363), 2022. Date of Publication:
01 Jul 2022.
Author
El-Andari R.; Bozso S.J.; Fialka N.M.; Kang J.J.H.; Macarthur R.G.G.;
Meyer S.R.; Freed D.H.; Nagendran J.
Institution
(El-Andari, Fialka) Faculty of Medicine and Dentistry, University of
Alberta, Edmonton, AB, Canada
(Bozso, Kang, Macarthur, Meyer, Freed, Nagendran) Division of Cardiac
Surgery, Department of Surgery, University of Alberta, Edmonton, AB,
Canada
Publisher
S. Karger AG
Abstract
Background: Cardiac allograft vasculopathy (CAV) is the primary cause of
late mortality after heart transplantation. We look to provide a
comprehensive review of contemporary revascularization strategies in CAV.
 Method(s): PubMed and Web of Science were systematically searched by
3 authors. 1,870 articles were initially screened and 24 were included in
this review. Result(s): PCI is the main revascularization technique
utilized in CAV. The pooled estimates for restenosis significantly favored
DES over BMS (OR 4.26; 95% CI: 2.54-7.13; p < 0.00001; I2 =
4%). There were insufficient data to quantitatively compare mortality
following DES versus BMS. There was no difference in short-term mortality
between CABG and PCI. In-hospital mortality was 0.0% for CABG and ranged
from 0.0 to 8.34% for PCI. One-year mortality was 8.0% for CABG and
5.0-25.0% for PCI. CABG had a potential advantage at 5 years. Five-year
mortality was 17.0% for CABG and ranged from 14 to 40.4% following PCI.
Select measures of postoperative morbidity trended toward superior
outcomes for CABG. Conclusion(s): In CAV, PCI is the primary
revascularization strategy utilized, with DES exhibiting superiority to
BMS regarding postoperative morbidity. Further investigation into outcomes
following CABG in CAV is required to conclusively elucidate the superior
management strategy in CAV. Copyright © 2022 S. Karger AG,
Basel. All rights reserved.

<7>
Accession Number
2019263988
Title
Sex-Related Differences in Transcatheter Mitral Valve Repair: A Systematic
Review and Meta-Analysis.
Source
Cardiology (Switzerland). 147(3) (pp 337-347), 2022. Date of Publication:
01 Jul 2022.
Author
El-Andari R.; Bozso S.J.; Kang J.J.H.; Adams C.; Nagendran J.
Institution
(El-Andari) Faculty of Medicine and Dentistry, University of Alberta,
Edmonton, AB, Canada
(Bozso, Kang, Nagendran) Division of Cardiac Surgery, Department of
Surgery, University of Alberta, Edmonton, AB, Canada
(Adams) Section of Cardiac Surgery, Department of Cardiac Sciences, Libin
Cardiovascular Institute of Alberta, University of Calgary, Calgary, AB,
Canada
Publisher
S. Karger AG
Abstract
Objective: Inequalities in postoperative outcomes between males and
females are well described with females often experiencing inferior
outcomes after heart valve surgery. The recent literature has demonstrated
equivalent or improved outcomes for females after transcatheter aortic
valve replacement. Transcatheter mitral valve repair (TMVr) and
replacement (TMVR) is a relatively newer field with significantly less
literature comparing sex differences. This systematic review and
meta-analysis looks to provide a comprehensive summary of the published
literature comparing outcomes between males and females undergoing
transcatheter MV interventions. Method(s): PubMed, MEDLINE, and
Scopus were systematically searched for all studies comparing outcomes
between males and females undergoing TMVr and TMVR. A total of 2,178
English manuscript titles and abstracts were reviewed. Articles were
excluded if data were not provided regarding sex differences,
transcatheter MV intervention, full-length text was not accessible, or if
insufficient data was provided. A total of 2,170 articles were excluded,
and 8 articles were included in this study. Result(s): Pooled
estimates of outcomes demonstrated rates of acute kidney injury (OR 1.28
[95% CI, 1.14-1.44; p < 0.0001]) favored females, while rates of major
bleeding favored males (OR 0.85 [95% CI 0.76-0.96; p = 0.01]). Rates of
mortality, postoperative MI, and stroke did not differ significantly.
 Conclusion(s): A trend has emerged in heart valve interventions with
males tending to have improved outcomes after surgical intervention and
females experiencing equivalent or improved outcomes after transcatheter
interventions. This meta-analysis identified increased rates of acute
kidney injury for males, increased rates of major bleeding for females,
and otherwise comparable morbidity and mortality in males and females
undergoing TMVr. Copyright © 2022 S. Karger AG, Basel. All
rights reserved.

<8>
Accession Number
2018285367
Title
Effect of preoperative ultrasound mapping of the saphenous vein on leg
wound complications after coronary artery bypass surgery: a systematic
review.
Source
Cardiothoracic Surgeon. 30(1) (no pagination), 2022. Article Number: 21.
Date of Publication: December 2022.
Author
Media A.S.; Rajendran R.; Kimose H.H.; El-Akkawi A.I.
Institution
(Media, Rajendran, Kimose, El-Akkawi) Department of Cardiothoracic and
Vascular Surgery, Aarhus University Hospital, Palle Juul-Jensens Blvd 99,
Aarhus N 8200, Denmark
(Kimose) Department of Clinical Medicine, Aarhus University, Aarhus,
Denmark
Publisher
Springer Science and Business Media Deutschland GmbH
Abstract
Background: The long saphenous vein is one of the most used conduits for
coronary artery bypass graft surgery. The aim of this study was to assess
the existing evidence regarding the effects of preoperative ultrasound
mapping of the long saphenous vein with special attention to leg wound
complications in patients undergoing elective coronary artery bypass graft
surgery. Main text: A systematic literature search was conducted in
PubMed, Cochrane, and Embase databases. Extraction of relevant data was
performed including study characteristics, patient characteristics, and
all reported outcomes. The Cochrane Risk of Bias tool was used to evaluate
the risk of bias of the included studies. The primary outcome measure was
leg wound infections. Of 4514 papers screened in this systematic review,
36 papers underwent full-text assessment with final inclusion of 5
studies; 3 observational studies, and 2 randomized trials. The two
randomized controlled trials showed no effects of preoperative ultrasound.
Data from the three non-randomized studies was pooled in a meta-analysis,
which suggested a significant reduction in the risk of harvest wound
complications by ultrasound mapping prior to surgery (RR 0.32; 95%CI =
[0.19-0.55]). Conclusion(s): The main findings of this systematic
review showed, that (1) the evidence in this field is limited and of low
quality, i.e., low power or methodology and (2) despite limitations of the
included studies, preoperative ultrasound mapping of the saphenous vein
seems to be beneficial in terms of reducing the risk of postoperative leg
wound complications. Copyright © 2022, The Author(s).

<9>
Accession Number
2018277105
Title
Proton pump inhibitor in the prevention of upper gastrointestinal mucosal
injury associated with dual antiplatelet therapy after coronary artery
bypass grafting (DACAB-GI-2): study protocol for a randomized controlled
trial.
Source
Trials. 23(1) (no pagination), 2022. Article Number: 569. Date of
Publication: December 2022.
Author
Zhu Y.; Wang X.; Yang Y.; Liu L.; Zhao Q.; Yu L.
Institution
(Zhu, Yang, Zhao) Department of Cardiovascular Surgery, Ruijin Hospital,
Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
(Wang, Liu, Yu) Department of Gastroenterology, Ruijin Hospital, Shanghai
Jiao Tong University School of Medicine, Shanghai 200025, China
Publisher
BioMed Central Ltd
Abstract
Background: Dual antiplatelet therapy (DAPT) is recommended in secondary
prevention after coronary artery bypass grafting (CABG), but it is
inevitably associated with the risk of bleeding, of which gastrointestinal
bleeding accounts for more than half. Proton pump inhibitors (PPIs) may
increase the risk of major cardiovascular adverse events when reducing the
risk of upper gastrointestinal bleeding. Therefore, the optimal duration
of a PPI in combination with DAPT is unclear. Method(s): The "Proton
Pump Inhibitor Preventing Upper Gastrointestinal Injury in Patients on
Dual Antiplatelet Therapy after CABG" (DACAB-GI-2) study is a prospective,
single-center, open-label, parallel, randomized controlled trial. A total
of 232 eligible subjects who are scheduled or initiated on DAPT
(clopidogrel plus aspirin or ticagrelor plus aspirin) for 12 months
immediately after CABG will be enrolled and be randomized in a 1:1 ratio
to either a 12-month pantoprazole treatment arm or a 1-month treatment
arm. The primary outcome is to assess the rate of gastroduodenal erosions
and ulcers evaluated by esophagogastroduodenoscopy (EGD) within 12 months
after randomization, based on the modified Lanza score. Secondary outcomes
include reflux esophagitis and upper gastrointestinal bleeding. Other
pre-specified outcomes include major adverse cardiovascular events, graft
failure, and all-cause death. Discussion(s): This study aims to
compare the efficacy and safety of 12 months and 1 month of pantoprazole
treatment in preventing DAPT-related upper gastrointestinal mucosal injury
after CABG. Trial registration: ClinicalTrials.gov
NCT03908593. Copyright © 2022, The Author(s).

<10>
Accession Number
2018275307
Title
Stress Management in Pre- and Postoperative Care Amongst Practitioners and
Patients in Cardiac Catheterization Laboratory: A Study Protocol.
Source
Frontiers in Cardiovascular Medicine. 9 (no pagination), 2022. Article
Number: 830256. Date of Publication: 01 Jul 2022.
Author
Block A.; Bonaventura K.; Grahn P.; Bestgen F.; Wippert P.-M.
Institution
(Block, Grahn, Bestgen, Wippert) Medical Sociology and Psychobiology,
Department of Health and Physical Activity, University of Potsdam,
Potsdam, Germany
(Block, Wippert) Faculty of Health Sciences Brandenburg, Joint Faculty of
the University of Potsdam, the Brandenburg Medical School Theodor Fontane,
Brandenburg University of Technology Cottbus - Senftenberg, Potsdam,
Germany
(Bonaventura) Department of Cardiology and Angiology, Ernst von Bergmann
Hospital, Potsdam, Germany
Publisher
Frontiers Media S.A.
Abstract
Background: As the number of cardiac diseases continuously increases
within the last years in modern society, so does cardiac treatment,
especially cardiac catheterization. The procedure of a cardiac
catheterization is challenging for both patients and practitioners.
Several potential stressors of psychological or physical nature can occur
during the procedure. The objective of the study is to develop and
implement a stress management intervention for both practitioners and
patients that aims to reduce the psychological and physical strain of a
cardiac catheterization. Method(s): The clinical study (DRKS00026624)
includes two randomized controlled intervention trials with parallel
groups, for patients with elective cardiac catheterization and
practitioners at the catheterization lab, in two clinic sites of the
Ernst-von-Bergmann clinic network in Brandenburg, Germany. Both groups
received different interventions for stress management. The intervention
for patients comprises a psychoeducational video with different stress
management technics and additional a standardized medical information
about the cardiac catheterization examination. The control condition
includes the in hospitals practiced medical patient education before the
examination (usual care). Primary and secondary outcomes are measured by
physiological parameters and validated questionnaires, the day before (M1)
and after (M2) the cardiac catheterization and at a postal follow-up 6
months later (M3). It is expected that people with standardized
information and psychoeducation show reduced complications during cardiac
catheterization procedures, better pre- and post-operative wellbeing,
regeneration, mood and lower stress levels over time. The intervention for
practitioners includes a Mindfulness-based stress reduction program (MBSR)
over 8 weeks supervised by an experienced MBSR practitioner directly at
the clinic site and an operative guideline. It is expected that
practitioners with intervention show improved perceived and chronic
stress, occupational health, physical and mental function, higher
effort-reward balance, regeneration and quality of life. Primary and
secondary outcomes are measured by physiological parameters (heart rate
variability, saliva cortisol) and validated questionnaires and will be
assessed before (M1) and after (M2) the MBSR intervention and at a postal
follow-up 6 months later (M3). Physiological biomarkers in practitioners
will be assessed before (M1) and after intervention (M2) on two work days
and a two days off. Intervention effects in both groups (practitioners and
patients) will be evaluated separately using multivariate variance
analysis. Discussion(s): This study evaluates the effectiveness of
two stress management intervention programs for patients and practitioners
within cardiac catheter laboratory. Study will disclose strains during a
cardiac catheterization affecting both patients and practitioners. For
practitioners it may contribute to improved working conditions and
occupational safety, preservation of earning capacity, avoidance of
participation restrictions and loss of performance. In both groups less
anxiety, stress and complications before and during the procedures can be
expected. The study may add knowledge how to eliminate stressful exposures
and to contribute to more (psychological) security, less output losses and
exhaustion during work. The evolved stress management guidelines, training
manuals and the standardized patient education should be transferred into
clinical routines. Copyright © 2022 Block, Bonaventura, Grahn,
Bestgen and Wippert.

<11>
Accession Number
2018269977
Title
Pneumonia After Cardiovascular Surgery: Incidence, Risk Factors and
Interventions.
Source
Frontiers in Cardiovascular Medicine. 9 (no pagination), 2022. Article
Number: 911878. Date of Publication: 30 Jun 2022.
Author
Wang D.; Lu Y.; Sun M.; Huang X.; Du X.; Jiao Z.; Sun F.; Xie F.
Institution
(Wang, Sun, Xie) Department of Cardiovascular Surgery, The First
Affiliated Hospital of Zhengzhou University, Zhengzhou, China
(Lu) Department of Cardiology, The First Affiliated Hospital of Zhengzhou
University, Zhengzhou, China
(Sun) China Medical University, The Queen's University of Belfast Joint
College, China Medical University, Shenyang, China
(Huang, Du) Department of Cardiovascular Surgery, Union Hospital, Tongji
Medical College, Huazhong University of Science and Technology, Wuhan,
China
(Jiao) Department of Vascular and Endovascular Surgery, The First
Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Publisher
Frontiers Media S.A.
Abstract
Postoperative pneumonia (POP) is prevalent in patients undergoing
cardiovascular surgery, associated with poor clinical outcomes, prolonged
hospital stay and increased medical costs. This article aims to clarify
the incidence, risk factors, and interventions for POP after
cardiovascular surgery. A comprehensive literature search was performed to
identify previous reports involving POP after cardiovascular surgery.
Current situation, predictors and preventive measures on the development
of POP were collected and summarized. Many studies showed that POP was
prevalent in various cardiovascular surgical types, and predictors varied
in different studies, including advanced age, smoking, chronic lung
disease, chronic kidney disease, cardiac surgery history, cardiac
function, anemia, body mass index, diabetes mellitus, surgical types,
cardiopulmonary bypass time, blood transfusion, duration of mechanical
ventilation, repeated endotracheal intubation, and some other risk
factors. At the same time, several targeted interventions have been widely
reported to be effective to reduce the risk of POP and improve prognosis,
including preoperative respiratory physiotherapy, oral care and subglottic
secretion drainage. Through the review of the current status, risk factors
and intervention measures, this article may play an important role in
clinical prevention and treatment of POP after cardiovascular
surgery. Copyright © 2022 Wang, Lu, Sun, Huang, Du, Jiao, Sun and
Xie.

<12>
Accession Number
2018271131
Title
Tapia's Syndrome After Cardiac Surgery: A Case Report and Review of
Literature.
Source
Ear, Nose and Throat Journal. (no pagination), 2022. Date of Publication:
2022.
Author
Steehler A.J.; Rothman R.; Sadhar B.; Saran M.; Lipman S.P.; Lipman R.I.
Institution
(Steehler, Saran, Lipman, Lipman) Department of Otolaryngology Head and
Neck Surgery, University of Pittsburgh Medical Center Hamot, Erie, PA,
United States
(Rothman) Medicine Institute, Allegheny Health Network, Pittsburgh, PA,
United States
(Sadhar) Lake Erie College of Osteopathic Medicine, Erie, PA, United
States
Publisher
SAGE Publications Ltd
Abstract
Tapia's syndrome is considered a neuropraxic injury of the recurrent
laryngeal nerve and hypoglossal nerve which commonly presents after
postoperative general anesthesia as hoarseness and dysphagia. Clinicians
should consider this diagnosis in those presenting with symptoms of
cranial nerve X and cranial nerve XII injury in the post-extubation
setting for prompt diagnosis and management. Here, we report a rare case
of Tapia's syndrome following cardiac surgery which was then treated with
carboxymethylcellulose gel implant injection. Copyright © The
Author(s) 2022.

<13>
[Use Link to view the full text]
Accession Number
638495679
Title
Surgical Care of Patients Experiencing Homelessness: A Scoping Review
Using a Phases of Care Conceptual Framework.
Source
Journal of the American College of Surgeons. 235(2) (pp 350-360), 2022.
Date of Publication: 01 Aug 2022.
Author
Abel M.K.; Schwartz H.; Lin J.A.; Decker H.C.; Wu C.L.; Grant M.C.; Kushel
M.; Wick E.C.
Institution
(Abel, Schwartz) From the University of California, San Francisco School
of Medicine, University of California, San Francisco, CA, United States
(Abel, Schwartz, Lin, Decker, Wick) Departments of Surgery (Abel,
Schwartz, Lin, Decker, Wick), University of California, San Francisco, San
Francisco, CA
(Wu) Department of Anesthesia, Critical Care, and Pain Management;
Hospital for Special Surgery, New York, NY (Wu)
(Wu) Department of Anesthesiology, Weill Cornell Medicine, New York, NY
(Wu)
(Grant) Department of Anesthesiology and Critical Care Medicine, Johns
Hopkins University School of Medicine, Baltimore, MD (Grant), United
States
(Kushel) Medicine (Kushel), University of California, San Francisco, CA,
United States
Publisher
NLM (Medline)
Abstract
Homelessness is a growing concern across the world, particularly as
individuals experiencing homelessness age and face an increasing burden of
chronic health conditions. Although substantial research has focused on
the medical and psychiatric care of patients experiencing homelessness,
literature about the surgical care of these patients is sparse. Our
objective was to review the literature to identify areas of concern unique
to patients experiencing homelessness with surgical disease. A scoping
review was conducted using a comprehensive database for studies from 1990
to September 1, 2020. Studies that included patients who were unhoused and
discussed surgical care were included. The inclusion criteria were
designed to identify evidence that directly affected surgical care,
systems management, and policy making. Findings were organized within a
Phases of Surgical Care framework: preoperative care, intraoperative care,
postoperative care, and global use. Our search strategy yielded 553 unique
studies, of which 23 met inclusion criteria. Most studies were performed
at public and/or safety-net hospitals or via administrative datasets, and
surgical specialties that were represented included orthopedic, cardiac,
plastic surgery trauma, and vascular surgery. Using the Surgical Phases of
Care framework, we identified studies that described the impact of housing
status in pre- and postoperative phases as well as global use. There was
limited identification of barriers to surgical and anesthetic best
practices in the intraoperative phase. More than half of studies (52.2%)
lacked a clear definition of homelessness. Thus, there is a marked gap in
the surgical literature regarding the impact of housing status on optimal
surgical care, with the largest area for improvement in the intraoperative
phase of surgical and anesthetic decision making. Consistent use of clear
definitions of homelessness is lacking. To promote improved care, a
standardized approach to recording housing status is needed, and studies
must explore vulnerabilities in surgical care unique to this
population. Copyright © 2022 by the American College of Surgeons.
Published by Wolters Kluwer Health, Inc. All rights reserved.

<14>
Accession Number
2017460222
Title
Continuous Unilateral Erector Spinae Plane Block versus Intravenous
Analgesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled
Trial.
Source
Open Access Macedonian Journal of Medical Sciences. Part B. 10 (pp
1340-1346), 2022. Date of Publication: 2022.
Author
Hoan D.T.; Hung D.D.; Dat P.Q.; Tu N.H.
Institution
(Hoan, Hung, Dat) Department of Anesthesia, Vietnam National Heart
Institute, Bach Mai Hospital, 78 Giai Phong Street, Hanoi 10000, Vietnam
(Hoan, Tu) Department of Anesthesiology, Hanoi Medical University, Hanoi,
Vietnam
Publisher
Scientific Foundation SPIROSKI
Abstract
AIM: The study was conducted to assess the safety and efficacy of
anesthesia under the erector spinae plane block (ESPB) in minimally
invasive cardiac surgery (MICS). METHOD(S): A prospective, randomized
controlled trial was carried out in 56 adults' patients who underwent MICS
through a right thoracic incision at Vietnam National Heart Institute,
Bach Mai Hospital, Vietnam. Patients were randomly allocated into two
groups: ESPB and conventional analgesia (intravenous [IV] morphine
patient-controlled analgesia, [PCA]). Patients in the ESPB group received
ultrasound-guided unilateral ESPB at the T4/T5 transverse process level,
and the tip of the catheter was advanced 5 cm beyond the tip of the
needle; injected with 20 ml ropivacaine 0.5%. At the cardiac intensive
care unit, patients received paracetamol (1 g every 6 h), continuous
infusion ropivacaine 0.1% 0.2 ml/kg/h. Patients in the PCA group received
paracetamol (1 g every 6 h) and IV morphine PCA. All patients were
followed for 72 h after being extubated. RESULT(S): The resting
visual analog scale (VAS) score was significantly lower in the ESPB group
at the time H4, H8, H12, H16, H36, H42, H48, H54, H60, and H66 after
extubated compared to that of the PCA group (p < 0.05). The dynamic VAS
score was also significantly lower in the ESPB group at all measured time
points (p < 0.05). Only four patients in the ESPB group required IV
morphine PCA with the mean amount morphine were statistically lower in the
ESPB group compared to the PCA group at 24 h, 48 h, and 72 h
postoperative. No serious adverse events such as neurological
complications, bleeding, or infection were observed in both groups.
 CONCLUSION(S): ESPB is an effective analgesic for MICS through
thoracic incision in reducing the VAS score and the morphine required. It
is also a safe method with no severe ESPB-related
complications. Copyright © 2022 Duong Thi Hoan, Duong Duc Hung,
Pham Quoc Dat, Nguyen Huu Tu.

<15>
Accession Number
2017452376
Title
Midterm Results of Mitral Repair Using Flexible Bands versus Complete
Rings in Patients with Mitral Regurgitation.
Source
Latin American Journal of Pharmacy. 41(Special Issue) (pp 68-73), 2022.
Date of Publication: April 2022.
Author
Elsharawy M.; Rahiem N.A.; Saber O.; Elalfy E.
Institution
(Elsharawy, Rahiem, Saber) Cardiothoracic Surgery, Faculty of Medicine,
Zagazig University, Zagazig, Egypt
(Elalfy) Cardiothoracic Surgery, Assistant Lecturer of Cardiothoracic
Surgery, Faculty of Medicine, Zagazig University, Zagazig, Egypt
Publisher
Colegio de Farmaceuticos de la Provincia de Buenos Aires
Abstract
SUMMARY. Mitral valve annuloplasty is a mainstay of all mitral valve (MV)
repair procedures. Cardiac surgeon can select from a wide variety of
annuloplasty devices: flexible, semi-rigid, or rigid, incomplete or
complete, planar or saddle-shaped. To assess the midterm results of MV
repair using flexible bands versus complete rings in patients with MV
regurgitation and which technique is superior to the other. We
prospectively reviewed 87 patients who underwent mitral valve repair with
either a flexible band n=46, 52.9% or complete ring n=41, 47.1% between
February 2019 to January 2020. We evaluate all patients 1 year
postoperatively to assess the progress of the repair procedure. There was
no significant difference between both groups regarding demographic data,
preoperative data, and failure of repair, morbidity and mortality. There
was significant difference between both groups regarding postoperative EF
(58.2+/-8.4) %, (54.6+/-7.9) % in the flexible band and complete ring
groups, respectively p=0.043. More re-duction of LVEDD (51.4+/-9.1) vs.
(56.3+/-7.7) mm, p = 0.008) was observed in flexible band group.
Im-provement of NYHA classification was significantly higher in flexible
band group than complete ring group (p = 0.025). Regarding mortality, one
case 2.2% died among flexible band group compared with 2 (3.4%) cases
among complete ring group. The early outcomes of mitral valve repair with
flexible band or complete ring show good results in our prospective
randomized study, regardless of the type of annulo-plasty device. Mitral
valve annuloplasty with flexible band is better than annuloplasty with
complete ring as regards NYHA classification, left ventricular function
and dimensions. Copyright © 2022, Colegio de Farmaceuticos de la
Provincia de Buenos Aires. All rights reserved.

<16>
Accession Number
2017012924
Title
A Systematic Review of Adherence to Immunosuppression among Pediatric
Heart Transplant Patients.
Source
Journal of Cardiovascular Development and Disease. 9(5) (no pagination),
2022. Article Number: 165. Date of Publication: May 2022.
Author
Nassetta K.; Hussain T.; Gambetta K.; Le K.; O'dwyer L.C.; Badawy S.M.
Institution
(Nassetta) Department of Pediatrics, Ann and Robert H. Lurie Children's
Hospital of Chicago, 225 E. Chicago Avenue, Chicago, IL 60611, United
States
(Hussain) Department of Internal Medicine, Northwestern University McGaw
Medical Center, 251 E. Huron St., Ste. 16-738, Chicago, IL 60611, United
States
(Gambetta) Division of Cardiology, Ann and Robert H. Lurie Children's
Hospital of Chicago, 225 E. Chicago Avenue, Chicago, IL 60611, United
States
(Le) Department of Pharmacy, Ann and Robert H. Lurie Children's Hospital
of Chicago, 225 E. Chicago Avenue, Chicago, IL 60611, United States
(O'dwyer) Galter Health Sciences Library & Learning Center, Northwestern
University Feinberg School of Medicine, 320 E. Superior Street, Chicago,
IL 60611, United States
(Badawy) Division of Hematology, Oncology, and Stem Cell Transplant, Ann
and Robert H. Lurie Children's Hospital of Chicago, 225 E. Chicago Avenue,
Chicago, IL 60611, United States
(Badawy) Department of Pediatrics, Northwestern University Feinberg School
of Medicine, 225 E. Chicago Avenue, Chicago, IL 60611, United States
Publisher
MDPI
Abstract
After pediatric heart transplant, commitment to lifelong immunosuppression
is crucial to maintaining graft health. However, a review of the current
literature surrounding adherence to immunosuppression in pediatric heart
transplant patients is lacking. This systematic review aims to summarize
the current landscape of adherence to immunosuppression in pediatric heart
transplant patients. We conducted searches in PubMed MEDLINE, Embase,
CENTRAL register of Controlled Trials (Wiley), and Scopus, from inception
to March 2020. Studies were eligible if they outlined an aspect of
adherence to immunosuppression and the measurement of adherence was
performed with an objective or otherwise validated measure of adherence
(e.g., drug levels, adherence questionnaires). The titles/abstracts of 880
articles were reviewed. After initial screening, 106 articles underwent
full text review. As such, 14 articles were included in the final review.
Baseline adherence estimates varied greatly, with most values between 40%
and 70%. Nonadherence to immunosuppression is associated with worse
outcomes (rejection, hospitalization, mortality), impaired quality of
life, and mental health concerns in pediatric heart transplant patients.
As nonadherence to immunosuppression is common and associated with worse
outcomes, there is a need for further development and evaluation of
interventions in this space. Copyright © 2022 by the authors.
Licensee MDPI, Basel, Switzerland.

<17>
Accession Number
2014814900
Title
Assessment of impact of patient recruitment volume on risk profile,
outcomes, and treatment effect in a randomized trial of ticagrelor versus
prasugrel in acute coronary syndromes.
Source
Journal of the American Heart Association. 10(22) (no pagination), 2021.
Article Number: e021418. Date of Publication: 16 Nov 2021.
Author
Ndrepepa G.; Neumann F.-J.; Menichelli M.; Bernlochner I.; Richardt G.;
Wohrle J.; Witzenbichler B.; Mayer K.; Cassese S.; Gewalt S.; Xhepa E.;
Kufner S.; Sager H.B.; Joner M.; Ibrahim T.; Laugwitz K.-L.; Schunkert H.;
Schupke S.; Kastrati A.
Institution
(Ndrepepa, Mayer, Cassese, Gewalt, Xhepa, Kufner, Sager, Joner, Schunkert,
Schupke, Kastrati) Deutsches Herzzentrum Munchen, Cardiology and
Technische, Universitat Munchen, Munich, Germany
(Neumann) Department of Cardiology and Angiology II, University Heart
Center Freiburg Bad Krozingen, Bad Krozingen, Germany
(Menichelli) Department of Cardiology, Ospedale Fabrizio Spaziani,
Frosinone, Italy
(Bernlochner, Ibrahim, Laugwitz) Medizinische Klinik und Poliklinik Innere
Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der
Isar, Munich, Germany
(Bernlochner, Sager, Joner, Laugwitz, Schunkert, Schupke, Kastrati) German
Center for Cardiovascular Research, Partner Site Munich Heart Alliance,
Munich, Germany
(Richardt) Heart Center Bad Segeberg, Bad Segeberg, Germany
(Wohrle) Department of Cardiology, Medical Campus Lake Constance,
Friedrichshafen, Germany
(Witzenbichler) Department of Cardiology and Pneumology, Helios
Amper-Klinikum Dachau, Dachau, Germany
Publisher
American Heart Association Inc.
Abstract
BACKGROUND: Whether there are differences in the risk profile and
treatment effect in patients recruited in a low recruitment center (LRC)
versus patients recruited in a high recruitment center (HRC) in a
randomized multicenter trial remains unknown. METHODS AND RESULTS: This
study included 4018 patients with acute coronary syndrome recruited in the
ISAR-REACT 5 (Intracoronary Stenting and Antithrombotic Regimen: Rapid
Early Action for Coronary Treatment 5) trial. The primary end point was a
composite of all-cause death, myocardial infarction, or stroke. Overall,
3011 patients (75%) were recruited in the HRCs (7 centers recruiting 258
to 628 patients; median, 413 patients) and 1007 patients (25%) were
recruited in the LRCs (16 centers recruiting 5 to 201 patients; median, 52
patients). Patients recruited in the LRCs had more favorable
cardiovascular risk profiles than patients recruited in the HRCs. The
primary end point occurred in 72 patients in the LRCs and 249 patients in
the HRCs (cumulative inci-dence, 7.3% and 8.4%; P=0.267). All-cause
mortality was lower among patients recruited in the LRCs (n=29) than among
patients recruited in the HRCs (n=134; cumulative incidence 2.9% versus
4.5%; P=0.031). There was no significant interaction between the treatment
effect of ticagrelor versus prasugrel and patient recruitment category
(LRC versus HRC) regarding the primary efficacy end point (LRC: hazard
ratio [HR], 1.42 [95% CI, 0.89-2.28]; HRC: HR, 1.33 [95% CI, 1.04-1.72]; P
for interaction=0.800). CONCLUSION(S): Patients with acute coronary
syndrome recruited in a LRC appear to have more favorable cardiovascular
risk profiles and lower 1-year mortality rates compared with patients
recruited in a HRC. The recruitment volume did not interact with the
treatment effect of ticagrelor versus prasugrel. REGISTRATION: URL:
https://www.clinicaltrials.gov; Unique identifier:
NCT01944800. Copyright © 2021 The Authors. Published on behalf of
the American Heart Association, Inc., by Wiley.

<18>
Accession Number
636562886
Title
Edoxaban versus vitamin K antagonist for atrial fibrillation after TAVR.
Source
New England Journal of Medicine. 385(23) (pp 2150-2160), 2021. Date of
Publication: 02 Dec 2021.
Author
Van Mieghem N.M.; Unverdorben M.; Hengstenberg C.; Mollmann H.; Mehran R.;
Lopez-Otero D.; Nombela-Franco L.; Moreno R.; Nordbeck P.; Thiele H.; Lang
I.; Zamorano J.L.; Shawl F.; Yamamoto M.; Watanabe Y.; Hayashida K.;
Hambrecht R.; Meincke F.; Vranckx P.; Jin J.; Boersma E.; Rodes-Cabau J.;
Ohlmann P.; Capranzano P.; Kim H.-S.; Pilgrim T.; Anderson R.; Baber U.;
Duggal A.; Laeis P.; Lanz H.; Chen C.; Valgimigli M.; Veltkamp R.; Saito
S.; Dangas G.D.
Institution
(Van Mieghem, Boersma) The Department of Cardiology, Erasmus University
Medical Center, Thoraxcenter, Rotterdam, Netherlands
(Unverdorben, Jin, Duggal, Chen) Daiichi Sankyo, Basking Ridge, NJ, United
States
(Hengstenberg, Lang) The Department of Internal Medicine II, Division of
Cardiology, Vienna General Hospital, Medical University, Vienna, Austria
(Mollmann) The Department of Internal Medicine, St. Johannes Hospital,
Dortmund, Germany
(Nordbeck) The Department of Internal Medicine, University Hospital
Wurzburg, Wurzburg, Germany
(Thiele) The Department of Internal Medicine-Cardiology, Heart Center
Leipzig at University of Leipzig, Leipzig, Germany
(Hambrecht) Bremer Institute for Heart and Circulation Research, Klinikum
Links der Weser, Bremen, Germany
(Meincke) The Department of Cardiology, Asklepios Klinik St. Georg,
Hamburg, Germany
(Laeis, Lanz) Daiichi Sankyo Europe, Munich, Germany
(Veltkamp) The Department of Neurology, Alfried Krupp Krankenhaus, Essen,
Germany
(Veltkamp) The Department of Neurology, University Hospital Heidelberg,
Heidelberg, Germany
(Mehran, Dangas) Zena and Michael A. Wiener Cardiovascular Institute,
Mount Sinai Hospital, New York, United States
(Lopez-Otero) The Department of Cardiology, Centro de Investigacion
Biomedica en Red Enfermedades Cardiovasculares, Hospital Clinico
Universitario de Santiago de Compostela, Santiago de Compostela, Spain
(Nombela-Franco) The Cardiovascular Institute, Hospital Clinico San
Carlos, Instituto de Investigacion Sanitaria San Carlos, Madrid, Spain
(Moreno) The Department of Cardiology, University Hospital la Paz, Madrid,
Spain
(Zamorano) The Department of Cardiology, University Hospital Ramon y
Cajal, Madrid, Spain
(Shawl) The Department of Cardiology, Washington Adventist Hospital,
Takoma Park, MD, United States
(Yamamoto) The Department of Cardiology, Toyohashi Heart Center,
Toyohashi, Japan
(Watanabe) The Department of Cardiology, Teikyo University School of
Medicine, Tokyo, Japan
(Hayashida) The Department of Cardiology, Keio University School of
Medicine, Tokyo, Japan
(Saito) The Division of Cardiology and Catheterization Laboratories,
Shonan Kamakura General Hospital, Kamakura, Japan
(Vranckx) The Department of Cardiology, Jessa Hospital, Hasselt, Belgium
(Rodes-Cabau) Quebec Heart and Lung Institute, Laval University, Quebec,
QC, Canada
(Ohlmann) The Division of Cardiovascular Medicine, University Hospital of
Strasbourg, Strasbourg, France
(Capranzano) The Division of Cardiology, Policlinico Hospital, University
of Catania, Catania, Italy
(Kim) The Department of Internal Medicine, Cardiovascular Center, Seoul
National University Hospital, Seoul, South Korea
(Pilgrim) The Department of Cardiology, University of Bern, Bern,
Switzerland
(Valgimigli) Cardiocentro Ticino Institute, Department of Biomedical
Sciences, University of Italian Switzerland, Lugano, Switzerland
(Anderson) The Department of Cardiology, University Hospital of Wales,
Cardiff, United Kingdom
(Veltkamp) The Division of Brain Sciences, Imperial College London,
London, United Kingdom
(Baber) The Cardiology Section, University of Oklahoma Health Sciences
Center, Oklahoma City, United States
(Dangas) National and Kapodistrian University of Athens, School of
Medicine, Athens, Greece
Publisher
Massachussetts Medical Society
Abstract
BACKGROUND The role of direct oral anticoagulants as compared with vitamin
K antagonists for atrial fibrillation after successful transcatheter
aortic-valve replacement (TAVR) has not been well studied. METHODS We
conducted a multicenter, prospective, randomized, open-label,
adjudicator-masked trial comparing edoxaban with vitamin K antagonists in
patients with prevalent or incident atrial fibrillation as the indication
for oral anticoagulation after successful TAVR. The primary efficacy
outcome was a composite of adverse events consisting of death from any
cause, myocardial infarction, ischemic stroke, systemic thromboembolism,
valve thrombosis, or major bleeding. The primary safety outcome was major
bleeding. On the basis of a hierarchical testing plan, the primary
efficacy and safety outcomes were tested sequentially for noninferiority,
with noninferiority of edoxaban established if the upper boundary of the
95% confidence interval for the hazard ratio did not exceed 1.38.
Superiority testing of edoxaban for efficacy would follow if
noninferiority and superiority were established for major bleeding.
RESULTS A total of 1426 patients were enrolled (713 in each group). The
mean age of the patients was 82.1 years, and 47.5% of the patients were
women. Almost all the patients had atrial fibrillation before TAVR. The
rate of the composite primary efficacy outcome was 17.3 per 100
person-years in the edoxaban group and 16.5 per 100 person-years in the
vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval
[CI], 0.85 to 1.31; P = 0.01 for noninferiority). Rates of major bleeding
were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively
(hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P = 0.93 for noninferiority);
the difference between groups was mainly due to more gastrointestinal
bleeding with edoxaban. Rates of death from any cause or stroke were 10.0
per 100 person-years in the edoxaban group and 11.7 per 100 person-years
in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to
1.11). CONCLUSIONS In patients with mainly prevalent atrial fibrillation
who underwent successful TAVR, edoxaban was noninferior to vitamin K
antagonists as determined by a hazard ratio margin of 38% for a composite
primary outcome of adverse clinical events. The incidence of major
bleeding was higher with edoxaban than with vitamin K
antagonists. Copyright © 2021 Massachusetts Medical Society.

<19>
Accession Number
2016962065
Title
Age-Dependent Effect of Ticagrelor Monotherapy Versus Ticagrelor With
Aspirin on Major Bleeding and Cardiovascular Events: A Post Hoc Analysis
of the TICO Randomized Trial.
Source
Journal of the American Heart Association. 10(24) (no pagination), 2021.
Article Number: e022700. Date of Publication: 21 Dec 2021.
Author
Kim B.G.; Hong S.-J.; Kim B.-K.; Lee S.-J.; Ahn C.-M.; Shin D.-H.; Kim
J.-S.; Ko Y.-G.; Choi D.; Hong M.-K.; Jang Y.
Institution
(Kim) Division of Cardiology, Department of Internal Medicine, Sanggye
Paik Hospital, Inje University College of Medicine, Seoul, South Korea
(Hong, Kim, Lee, Ahn, Shin, Kim, Ko, Choi, Hong, Jang) Division of
Cardiology, Department of Internal Medicine, Severance Cardiovascular
Hospital, Yonsei University College of Medicine, Seoul, South Korea
Publisher
American Heart Association Inc.
Abstract
BACKGROUND: We aimed to evaluate the age-dependent effect of ticagrelor
monotherapy after 3-month dual-antiplatelet therapy (DAPT) versus
ticagrelor-based 12-month DAPT on major bleeding and cardiovascular events
in patients with acute coronary syndrome. METHODS AND RESULTS: From the
TICO trial (Ticagrelor Monotherapy After 3 Months in the Patients Treated
With New Generation Sirolimus-eluting Stent for Acute Coronary Syndrome),
which randomized 3056 patients (median age, 61 years) to the ticagre-lor
monotherapy after 3-month DAPT group or ticagrelor-based 12-month DAPT
group, this post hoc analysis evaluated the age-dependent effect of the
treatment strategies on the primary end point (a composite of major
bleeding, death, myocardial infarction, stent thrombosis, stroke, or
target-vessel revascularization) using the subpopulation treatment effect
pattern plot. The cutoff age for distinguishing patients with greater
benefit from this strategy was also determined. The risk reduction effect
of ticagrelor monotherapy after 3-month DAPT versus ticagrelor-based
12-month DAPT on the primary end point gradually increased with age and
was more marked from the subpopulation of age 64 years with the change
point. With this cutoff value of 64 years, the occurrence of the primary
end point was significantly lower in the ticagrelor monotherapy after
3-month DAPT group than in the ticagrelor-based 12-month DAPT group (4.4%
versus 9.0%; P=0.002) in patients aged >=64 years (n=1278), but it was not
different in those aged <64 years (n=1778) with a significant interaction
(P-interaction=0.036). CONCLUSION(S): The age-dependent increase in
the benefit of ticagrelor monotherapy after 3-month DAPT versus
ticagrelor-based 12-month DAPT was observed in the patients with acute
coronary syndrome. In elderly patients with acute coronary syndrome,
ticagrelor monotherapy after short-term DAPT might be more optimal than
ticagrelor-based 12-month DAPT. Copyright © 2021 The Authors.

<20>
Accession Number
638479253
Title
Factors affecting adherence to physical training in the outpatient phase
of rehabilitation, in patients after coronary artery bypass grafting.
Source
Kardiologiia. 62(6) (pp 37-44), 2022. Date of Publication: 30 Jun 2022.
Author
Pomeshkina S.A.; Bezzubova V.A.; Zvereva T.N.; Kagan E.S.; Barbarash O.L.
Institution
(Pomeshkina, Zvereva, Barbarash) Research Institute for Complex Issues of
Cardiovascular Diseases, Kemerovo, Russian Federation
(Bezzubova) Barbarash Kemerovo Regional Clinical Cardiological Dispensary,
Kemerovo, Russian Federation
(Kagan) Kemerovo State Medical University, Kemerovo, Russian Federation
Publisher
NLM (Medline)
Abstract
Aim To evaluate the outpatient physical exercise (PE) compliance and the
affecting factors in patients after coronary bypass (CB).Material and
methods The study included 67 men with ischemic heart disease younger than
75 years who had had CB. All patients were randomized to 2 groups: group 1
exercised on a bicycle ergometer at the rehabilitation center, under the
monitoring of medical staff; patients of group 2 performed home-based
exercise (HBE) by dosed walking. In the preoperative period, at one month
after CB, and after 3 months of exercise, the following was evaluated:
clinical condition of patients in different groups, plasma concentrations
of lipids, body weight index, waist circumference, echocardiography and
bicycle ergometry data, and questionnaire data (SF-36, Bek's Depression
Inventory). At 3 months of follow-up, the outpatient exercise compliance
and the affecting factors were also evaluated.Results The study
demonstrated the effectiveness of the proposed alternative 3-month program
of home-based PE. Both the patients exercising on a bicycle and those
performing HBE had increased exercise tolerance (ET) and improved blood
lipid concentrations. The number of obese patients decreased. Also,
depression severity decreased, quality of life (physical and psychological
components) improved, and compliance with drug therapy increased in both
groups. Analysis of the training attendance in the recommended period
showed that patients who had undergone CB were insufficiently adherent to
physical rehabilitation programs, regardless of the program type
(home-based or monitored). The highest PE adherence was observed in men
with the following characteristics: married, working urban residents, with
a previous history of cardiovascular diseases, who had regularly taken
medications in the preoperative period, and who also had higher quality of
life.Conclusion The proposed outpatient 3-month physical rehabilitation
programs increase the effectiveness of CB, which is evident as improved
adherence to modifying cardiovascular risk factors, increased ET,
optimization of the psychological status and quality of life, and improved
compliance with drug therapy. However, despite the proposed alternative,
home-based 3-month physical rehabilitation programs aimed at increasing
the treatment compliance, the level of ET remained low. This requires
further improvement of methods for monitoring and motivation of patients
to physical rehabilitation and psychological support that would start
already at the preoperative stage.

<21>
Accession Number
638467646
Title
A Brazilian randomized study: Robotic-Assisted vs. Video-assisted lung
lobectomy Outcomes (BRAVO trial).
Source
Jornal brasileiro de pneumologia : publicacao oficial da Sociedade
Brasileira de Pneumologia e Tisilogia. 48(4) (pp e20210464), 2022. Date of
Publication: 2022.
Author
Terra R.M.; Araujo P.H.X.N.; Lauricella L.L.; Campos J.R.M.; Trindade
J.R.M.; Pego-Fernandes P.M.
Institution
(Terra, Araujo, Lauricella, Campos, Trindade, Pego-Fernandes) Divisao de
Cirurgia Toracica, Departamento de Cardiopneumologia, Hospital das
Clinicas, Faculdade de Medicina, Universidade de Sao Paulo, Brazil
Publisher
NLM (Medline)
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, FEV1 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/]).

<22>
Accession Number
2018273855
Title
Effect of dexmedetomidine for prevention of acute kidney injury after
cardiac surgery: an updated systematic review and meta-analysis.
Source
Renal Failure. 44(1) (pp 1150-1159), 2022. Date of Publication: 2022.
Author
Liu X.; Hu Q.; Chen Q.; Jia J.; Liao Y.-H.; Feng J.
Institution
(Liu, Chen, Liao, Feng) Department of Anesthesiology, The Affiliated
Hospital of Southwest Medical University, Luzhou, China
(Hu) Department of Critical Care Medicine, The Affiliated Hospital of
Southwest Medical University, Luzhou, China
(Jia, Feng) Laboratory of Anesthesiology, The Affiliated Hospital of
Southwest Medical University, Luzhou, China
Publisher
Taylor and Francis Ltd.
Abstract
Background: Acute kidney injury (AKI) is a serious complication related to
cardiac surgery. Several studies have been conducted to investigate the
effect of dexmedetomidine administration on AKI prevention.
 Objective(s): To assess if dexmedetomidine is associated with a
protective effect of renal function after cardiac surgery. And the aim of
conducting this meta-analysis is to summarize the literature and determine
the clinical utility of dexmedetomidine administration in patients
undergoing cardiac surgery. Method(s): PubMed, Cochrane Library, and
EMBASE databases were comprehensively searched for all randomized
controlled trials (RCTs) published before 1 December, 2021 that
investigated the effect of dexmedetomidine on AKI prevention.
 Result(s): Our analysis included 16 studies involving 2148 patients.
Compared with the control group, dexmedetomidine administration
significantly reduced AKI incidence (OR, 0.47; 95% CI, 0.36-0.61; p <
0.00001; I 2 = 26%) and the length of stay in the intensive
care unit (ICU) but did not alter mortality rate, length of stay in the
hospital, and mechanical ventilation time. Furthermore, the incidence of
delirium among patients treated with dexmedetomidine was significantly
decreased. Conclusion(s): Dexmedetomidine administration has a
positive effect on preventing AKI and postoperative delirium after cardiac
surgery and significantly reduces the length of stay in the
ICU. Copyright © 2022 The Author(s). Published by Informa UK
Limited, trading as Taylor & Francis Group.

<23>
Accession Number
2018278516
Title
Prospective, randomized, controlled, noninferiority clinical trial to
evaluate the safety and efficacy of absorbable macroporous polysaccharide
composites as adjunct to hemostasis during open surgery.
Source
Journal of Cardiac Surgery. (no pagination), 2022. Date of Publication:
2022.
Author
Li H.; Li Z.; He X.; Zhang F.; OuYang Z.; Wu G.; Liu P.; Yang S.; Dong L.;
Zhen M.; Xu L.
Institution
(Li, Xu) State Key Laboratory of Molecular Immunology and Molecular
Diagnostics, School of Public Health, Xiamen University, Xiamen, China
(Li) General Surgery, Peking University Third Hospital, Beijing, China
(He, Dong) General Surgery, Tianjin Medical University General Hospital,
Tianjin, China
(Zhang, OuYang) General Surgery, Breast Surgery, The First Affiliated
Hospital of Xiamen University, Xiamen, China
(Wu, Liu, Yang, Zhen) General Surgery, Hepatopancreatobiliary Surgery,
Breast Surgery, Zhongshan Hospital Affiliated to Xiamen University,
Xiamen, China
Publisher
John Wiley and Sons Inc
Abstract
Background: To address intraoperative bleeding in cardiac surgery,
reducing blood transfusion requirements, is mandatory to achieve effective
hemostasis. Hemostatic agents may limit localized persistent bleeding. The
introduction of carboxymethyl-chitosan component into the hemostatic agent
and the application of the radiation crosslinking technique maintain its
capacity for achieving intraoperative hemostasis, thus increasing the
clinical utility. Method(s): A prospective, noninferiority and
randomized controlled clinical trial to compare the safety and efficacy of
absorbable macroporous polysaccharide composites (AMPC, treatment group)
with compound microporous polysaccharide hemostatic powder (CMPHP, control
group) (2:1 ratio) as adjuncts to hemostasis in open surgery. The main
indication was used for hemostasis in various traumatic hemorrhage areas,
including cardiothoracic, vascular, and general surgery. The primary
endpoint was success rate of hemostasis within 300 s (at a 10%
noninferiority margin). The secondary endpoint was hemostasis time. Both
endpoints were assessed in the modified intention-to-treat (MITT)
population. Safety parameters were assessed. This study is fully compliant
with the CONSORT statement. Result(s): Randomized patients in AMPC
and CMPHP groups were 168 and 84, respectively. In MITT population, the
success rates of hemostasis within 300 s were 98.8% (163 of 165) in AMPC
and 94.0% (78 of 83) in CMPHP (treatment difference 4.8% [95% CI -0.57% to
10.20%]). AMPC was thus noninferior to CMPHP. Hemostasis time (median
[interquartile range]) with AMPC (87 [52.5, 180] s) was better than CMPHP
(110 [54.5, 181] s). Changes in laboratory parameters over time and shifts
to abnormal values were typical of surgeries and similar between two
groups. No noticeable adverse effects associated with AMPC or CMPHP were
observed. Conclusion(s): AMPC is well tolerated as topical hemostatic
agent, noninferior to commercial CMPHP, and exhibits excellent safety.
This study provides a novel hemostatic agent which appears to offer
significant clinical advantage in various hemorrhage areas. Copyright
© 2022 Wiley Periodicals LLC.

<24>
Accession Number
638486265
Title
Early Peritoneal Dialysis and Postoperative Outcomes in Infants After
Pediatric Cardiac Surgery: 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: 15 Jul 2022.
Author
Namachivayam S.P.; Law S.; Millar J.; d'Udekem Y.
Institution
(Namachivayam, Law, Millar) Intensive Care Unit, The Royal Children's
Hospital, Melbourne, VIC, Australia
(Namachivayam, Millar) Clinical Sciences, Murdoch Children's Research
Institute, Melbourne, VIC, Australia
(Namachivayam) Department of Critical Care, University of Melbourne,
Melbourne, VIC, Australia
(Namachivayam, Law) Department of Pediatrics, Faculty of Medicine Siriraj
Hospital, Mahidol University, Bangkok, Thailand
(Namachivayam, Millar, d'Udekem) Department of Paediatrics, University of
Melbourne, Melbourne, VIC, Australia
(Namachivayam, d'Udekem) Cardiac Surgery, Children's National Heart
Institute, Children's National Hospital, Washington DC
Publisher
NLM (Medline)
Abstract
OBJECTIVE: Peritoneal dialysis (PD) is used in several cardiac surgical
units after cardiac surgery, and early initiation of PD after surgery may
have the potential to influence postoperative outcomes. This systematic
review and meta-analysis aims to summarize the evidence for the
association between early PD after cardiac surgery and postoperative
outcomes. DATA SOURCES: MEDLINE, Embase, and PubMed from 1981 to November
1, 2021. STUDY SELECTION: Observational studies and randomized trials
reporting on early PD after pediatric cardiac surgery. DATA EXTRACTION:
Random-effects meta-analysis was used to estimate the pooled odds ratios
(ORs) and their 95% CIs for postoperative mortality and pooled mean
difference (MD) (95% CI) for duration of mechanical ventilation and ICU
length of stay. DATA SYNTHESIS: We identified nine studies from the
systematic review, and five were considered suitable for meta-analysis.
Early initiation of PD after cardiac surgery was associated with a
reduction in postoperative mortality (OR, 0.43 (95% CI, 0.23-0.80); number
of estimates = 4). Early commencement of PD shortened duration of
mechanical ventilation (MD [95% CI], -1.09 d [-1.86 to -0.33 d]; I2 =
56.1%; p = 0.06) and intensive care length of stay (MD [95% CI], -2.46 d
[-3.57 to -1.35 d]; I2 = 18.7%; p = 0.30], respectively. All three
estimates had broad 95% prediction intervals (crossing null) denoting
major heterogeneity between studies and wide range of possible study
estimates in similar future studies. Overall, studies reporting on the
effects of early PD included only a subset of infants undergoing cardiac
surgery (typically high-risk infants), so selection bias may be a major
issue in published studies. CONCLUSION(S): This review suggests that
early initiation of PD may be associated with beneficial postoperative
outcomes in infants after cardiac surgery. However, these results were
based on studies of varying qualities and risk of bias. Early
identification of high-risk infants after cardiac surgery is important so
that prevention or early mitigation strategies can be applied to this
cohort. Future prospective studies in high-risk populations are needed to
study the role of early PD in influencing postoperative
outcomes. Copyright © 2022 by the Society of Critical Care
Medicine and the World Federation of Pediatric Intensive and Critical Care
Societies.

<25>
Accession Number
2017600381
Title
Femoral or Radial Approach in Treatment of Coronary Chronic Total
Occlusion: A Randomized Clinical Trial.
Source
JACC: Cardiovascular Interventions. 15(8) (pp 823-830), 2022. Date of
Publication: 25 Apr 2022.
Author
Gorgulu S.; Kalay N.; Norgaz T.; Kocas C.; Goktekin O.; Brilakis E.S.
Institution
(Gorgulu, Kalay, Norgaz) Cardiology Department, Acibadem University
Medical Faculty, Istanbul, Turkey
(Kocas) Cardiology Department, Biruni University Medical Faculty,
Istanbul, Turkey
(Goktekin) Cardiology Department, Memorial Bahcelievler Hospital,
Istanbul, Turkey
(Brilakis) Minneapolis Heart Institute and Minneapolis Heart Institute
Foundation, Minneapolis, MN, United States
Publisher
Elsevier Inc.
Abstract
Objectives: The aim of this study was to compare transradial access (TRA)
with transfemoral access (TFA) for chronic total occlusion (CTO)
percutaneous coronary intervention (PCI). Background(s): TRA reduces
the risk for vascular access complications but may make complex PCI, such
as CTO PCI, more challenging. Method(s): FORT CTO (Femoral or Radial
Approach in the Treatment of Coronary Chronic Total Occlusion)
(NCT03265769) was a prospective, noninferiority, randomized controlled
study of TRA vs TFA for CTO PCI. The primary study endpoint was procedural
success, defined as technical success without any in-hospital major
adverse cardiovascular events. The secondary study endpoint was major
access-site complications. Result(s): Between 2017 and 2021, 610 of
800 patients referred for CTO PCI at 4 centers were randomized to TRA (n =
305) or TFA (n = 305). Mean J-CTO (Multicenter CTO Registry in Japan) (2.1
+/- 0.1 vs 2.2 +/- 0.1; P = 0.279), PROGRESS CTO (Prospective Global
Registry for the Study of Chronic Total Occlusion Intervention) (1.3 +/-
0.9 vs 1.1 +/- 1.0; P = 0.058) and PROGRESS CTO complication (2.4 +/- 1.8
vs 2.3 +/- 1.8; P = 0.561) scores and use of the retrograde approach (11%
vs 14%; P = 0.342) were similar in the TRA and TFA groups. TRA was
noninferior to TFA for procedural success (84% vs 86%; P = 0.563) but had
fewer access-site complications (2.0% vs 5.6%; P = 0.019). There was no
difference between TFA and TRA in procedural duration, contrast volume, or
radiation dose. COnclusions: TRA was noninferior to TFA for CTO PCI but
had fewer access-site complications. Copyright © 2022 American
College of Cardiology Foundation

<26>
Accession Number
2014241792
Title
Safety and efficacy of cerebral embolic protection devices in patients
undergoing transcatheter aortic valve replacement: a meta-analysis of
in-hospital outcomes.
Source
Cardiovascular Intervention and Therapeutics. 37(3) (pp 549-557), 2022.
Date of Publication: July 2022.
Author
Shimamura J.; Kuno T.; Malik A.; Yokoyama Y.; Gupta R.; Ahmad H.;
Briasoulis A.
Institution
(Shimamura) Division of Cardiac Surgery, Sunnybrook Health Sciences
Centre, Toronto, ON, Canada
(Kuno) Department of Cardiology, Montefiore Medical Center, Albert
Einstein Medical College, Bronx, NY, United States
(Malik) Department of Cardiology, Westchester Medical Center and New York
Medical College, Valhalla, NY, United States
(Yokoyama) Department of Surgery, Easton Hospital, Easton, PA, United
States
(Gupta) Department of Cardiology, Lehigh Valley Heart Institute, Lehigh
Valley Health Network, Allentown, PA, United States
(Ahmad) Division of Cardiology, Westchester Medical Center, Valhalla, NY,
United States
(Briasoulis) Section of Heart Failure and Transplant, Division of
Cardiovascular Diseases, University of Iowa Hospitals and Clinics, 200
Hawkins Dr, Iowa City, IA 52242, United States
Publisher
Springer
Abstract
The evidence regarding the impact of cerebral embolic protection devices
(EPDs) on outcomes following transcatheter aortic valve replacement (TAVR)
is limited. The objective of this study was to evaluate in-hospital
outcomes with the use of cerebral EPDs in TAVR. We performed a
comprehensive EMBASE and PUBMED search to investigate randomized control
studies or propensity score-matched retrospective studies which assessed
patients undergoing TAVR with or without EPD up to April 2021. Endpoints
of interest were in-hospital mortality, stroke, acute kidney injury,
pacemaker implantation, major bleeding, vascular complication, length of
stay. Ten studies involving 173,002 patients with EPD (n = 16,898, 9.8%)
and those without (n = 156,104, 90.2%) fulfilled the inclusion criteria.
The use of EPD was associated with significantly lower risk of in-hospital
stroke (odds ratio [95% confidential interval]: 0.64 [0.46; 0.89]), but
similar rate of in-hospital mortality (odds ratio [95% confidential
interval]: 0.75 [0.54; 1.05]). No differences were observed in acute
kidney injury, pacemaker implantation, major bleeding, vascular
complication, length of stay. EPD during TAVR was associated with lower
in-hospital stroke but did not affect procedural complications and length
of stay. Copyright © 2021, Japanese Association of Cardiovascular
Intervention and Therapeutics.

<27>
Accession Number
2013566182
Title
Basilar Artery Occlusion Chinese Endovascular Trial: Protocol for a
prospective randomized controlled study.
Source
International Journal of Stroke. 17(6) (pp 694-697), 2022. Date of
Publication: July 2022.
Author
Li C.; Wu C.; Wu L.; Zhao W.; Chen J.; Ren M.; Yao C.; Yan X.; Dong C.;
Song H.; Ma Q.; Duan J.; Zhang Y.; Zhang H.; Jiao L.; Wang Y.; Jovin T.G.;
Ji X.
Institution
(Li, Wu, Wu, Zhao, Song, Ma, Zhang, Wang) Department of Neurology, Xuanwu
Hospital of Capital Medical University, Beijing, China
(Chen, Zhang, Jiao, Ji) Department of Neurosurgery, Xuanwu Hospital of
Capital Medical University, Beijing, China
(Ren) Cerebrovascular Diseases Research Institute, Xuanwu Hospital of
Capital Medical University, Beijing, China
(Yao, Yan, Dong) Clinical Research Institute, Peking University, Beijing,
China
(Duan) Department of Emergency, Xuanwu Hospital of Capital Medical
University, Beijing, China
(Jovin) Cooper Neurological Institute, Cooper University Hospital, Camden,
NJ, United States
Publisher
SAGE Publications Inc.
Abstract
Rationale: There are no randomized trials examining the best treatment for
acute basilar artery occlusion in the 6-24-hour time window. Aim(s):
To assess the safety and efficacy of thrombectomy for stroke due to
basilar artery occlusion in patients randomized within 6-24 h from symptom
onset or time last seen well. Sample size: For an estimated difference of
20% in proportions of the primary outcome between the two groups, 318
patients will be included for 5% significance and 90% power with a planned
interim analysis after two-thirds of the sample size (212 patients) have
achieved the 90 days follow-up. Methods and design: A prospective,
multi-center, randomized, controlled, open-label and blinded-endpoint
trial. The randomization employs a 1:1 ratio of mechanical thrombectomy
with the detachable Solitaire thrombectomy device and best medical therapy
(BMT) vs. BMT alone. Study outcomes: The primary outcome will be the
proportion of patients achieving modified Rankin Scale (mRS) 0-3 at 90
days. Key secondary outcomes are: dramatic early favorable response,
dichotomized mRS score (0-2 vs. 3-6 and 0-4 vs. 5-6) at 90 days, ordinal
(shift) mRS analysis at 90 days, infarct volume at 24 h, vessel
recanalization at 24 h in both treatment arms, and successful
recanalization in the thrombectomy arm according to the modified
thrombolysis in cerebral infarction (mTICI) classification defined as
mTICI 2 b or 3. Safety variables are mortality at 90 days, symptomatic
intracranial hemorrhage rates at 24 h, and procedure-related
complications. Discussion(s): Results from this trial will indicate
whether mechanical thrombectomy is superior to medical management alone in
achieving favorable outcomes in subjects with acute stroke caused by
basilar artery occlusion presenting within 6-24 h from symptom onset.
Trial registration: URL: http://www.clinicaltrials.gov. ClinicalTrials.gov
Identifier: NCT02737189. Copyright © 2021 World Stroke
Organization.

<28>
Accession Number
2017791338
Title
Thoracoscopic Versus Open Lobectomy After Induction Therapy for Nonsmall
Cell Lung Cancer: New Study Results and Meta-analysis.
Source
Journal of Surgical Research. 276 (pp 416-432), 2022. Date of Publication:
August 2022.
Author
Hireche K.; Canaud L.; Lounes Y.; Aouinti S.; Molinari N.; Alric P.
Institution
(Hireche, Canaud, Lounes, Alric) Department of Thoracic and Vascular
Surgery, Arnaud de Villeneuve University Hospital, Montpellier, France
(Hireche, Canaud, Lounes, Alric) PhyMedExp, University of Montpellier,
INSERM, CNRS, Montpellier, France
(Aouinti, Molinari) IDESP, INSERM, University of Montpellier, CHU
Montpellier, Montpellier, France
Publisher
Academic Press Inc.
Abstract
Introduction: The use of video-assisted thoracoscopic surgery (VATS)
lobectomy has become a mainstay of modern thoracic surgery practice and
the technique of choice for resection of early-stage lung cancers.
However, the benefits of VATS following induction therapy are yet to be
clarified. This study aims to assess whether VATS lobectomy achieves
similar perioperative and oncologic outcomes compared to thoracotomy for
nonsmall cell lung cancer after induction therapy. Method(s): We
retrospectively reviewed the outcomes of 72 patients who underwent lung
lobectomy after induction therapy in our institution from January 2017 to
January 2020. Subsequently, we carried out a comprehensive literature
search and pooled our results with available data from previously
published studies to perform a meta-analysis. Result(s): VATS was
associated with reduced intraoperative blood loss (P = 0.05) and less
perioperative complications (P = 0.04) in our local institution. The
meta-analysis comprised nine studies. A total of 943 patients underwent
VATS and 2827 patients underwent open lobectomy. VATS was associated with
significant shorter surgery duration (P < 0.0001), shorter chest-tube
drainage duration (P < 0.0001), and shorter hospital stays (P < 0.0001).
Furthermore, there was significantly less perioperative complications (P =
0.006) and less intraoperative blood loss (P = 0.036) in the VATS group.
However, there were no significant differences in 3-y overall survival and
3-y disease-free survival rates. Conclusion(s): In some selected
patients undergoing induction therapy, VATS lobectomy could achieve
equivalent perioperative outcomes to thoracotomy but evidence is lacking
on oncologic outcomes. Further trials with a focus on oncologic outcomes
and longer follow-up are required. Copyright © 2022 Elsevier Inc.

<29>
Accession Number
2017450137
Title
Overview of mitral valve replacement versus mitral valve repair due to
ischemic papillary muscle rupture: A meta-analysis inspired by a case
report.
Source
Cardiology Journal. 29(4) (pp 680-690), 2022. Date of Publication: 04 Jul
2022.
Author
Pala B.; Romaniello A.; Cristiano E.; D'angelo A.; Grimaldi M.C.;
Figliuzzi I.; Tonelli E.; Volpe M.
Institution
(Pala, Cristiano, D'angelo, Grimaldi, Figliuzzi, Volpe) Division of
Cardiology, Department of Clinical and Molecular Medicine, Faculty of
Medicine and Psychology, Sapienza University of Rome, Italy
(Romaniello) Division of Cardiology, Sant' Andrea Hospital, Sapienza
University of Rome, Italy
(Tonelli) Department of Cardiac Surgery, Sant' Andrea Hospital, Sapienza
University of Rome, Italy
Publisher
Via Medica
Abstract
Background: Papillary muscle rupture (PMR) is an infrequent but
catastrophic complication after myocardial infarction (MI). Surgical
procedure is considered the optimal treatment, despite high risk. However,
the gold standard technique is still a major dilemma. Therefore, a
meta-analysis was carried out to assess and provide an overview comparing
mitral valve replacement (MVR) and mitral valve repair (MVr) for PMR
post-MI. Method(s): A systematic literature search was performed.
Data were extracted and verified using a standardized data extraction
form. Meta-analysis was realized mainly using RevMan 5.4 software.
 Result(s): From four observational studies 1640 patients were
identified; 81% underwent MVR and 19% MVr. Operative mortality results
were significantly higher in MVR group than the MVr group. MVR was
performed under emergency conditions and patients admitted in cardiogenic
shock or who required the use of mechanical cardiac support underwent MVR.
MVr had shorter time of hospitalization and similar incidence of
postoperative complications than MVR. No significant differences existed
between the two procedures regarding cardiopulmonary bypass time.
 Conclusion(s): Mitral valve repair appears to be a viable alternative
to MVR for post-MI PMR, given that it has lower operative mortality,
shorter time of hospitalization and similar incidence of short-term
postoperative complications than MVR. However, it needs to be pointed out
that MVR was associated with the most critical clinical condition
following PMR. There is uncertainty regarding the overall survival and
improvement of the quality of life between the procedures. Nevertheless,
further completed investigation is required. (Cardiol J 2022; 29, 4:
680-690). Copyright © 2022 Via Medica.

<30>
Accession Number
2017450119
Title
Comparative effects of fentanyl versus morphine on platelet inhibition
induced by ticagrelor in patients with ST-segment elevation myocardial
infarction: Full results of the PERSEUS randomized trial.
Source
Cardiology Journal. 29(4) (pp 591-600), 2022. Date of Publication: 04 Jul
2022.
Author
Iglesias J.F.; Valgimigli M.; Carbone F.; Lauriers N.; Masci P.-G.;
Degrauwe S.
Institution
(Iglesias, Degrauwe) Department of Cardiology, Geneva University
Hospitals, Geneva, Switzerland
(Valgimigli) Department of Cardiology, Cardiocentro Ticino, Lugano,
Switzerland
(Carbone) First Clinic of Internal Medicine, Department of Internal
Medicine, University of Genoa, Italy
(Carbone) IRCCS Ospedale Policlinico San Martino Genoa, Italian
Cardiovascular Network, Genoa, Italy
(Lauriers, Masci) Department of Cardiology, Lausanne University Hospital,
Lausanne, Switzerland
Publisher
Via Medica
Abstract
Background: Morphine reduces absorption and delays action onset of potent
oral P2Y<inf>12</inf> receptor in-hibitors in patients with ST-segment
elevation myocardial infarction (STEMI). We sought to determine the
differential effects of fentanyl compared to morphine on the
pharmacodynamics and pharmacokinetics of ticagrelor in STEMI patients
undergoing primary percutaneous coronary intervention (PCI).
 Method(s): PERSEUS (NCT02531165) was a prospective, single-center,
open-label, randomized controlled study. Patients with STEMI who required
analgesia were randomly assigned in a 1:1 ratio to treatment with
intravenous fentanyl or morphine after ticagrelor loading dose (LD)
administration. The primary endpoint was platelet reactivity at 2 hours
after ticagrelor LD assessed by P2Y<inf>12</inf> reaction units (PRU).
 Result(s): The study was prematurely stopped in June 2017 after
enrolment of 38 out of 56 planned patients. PRU at 2 hours following
ticagrelor LD was 173.3 +/- 89.7 in the fentanyl group and 210.3 +/- 76.4
in the morphine group (p = 0.179). At 4 hours, PRU was significantly lower
among patients treated with fentanyl as compared to those treated with
morphine (90.1 +/- 97.4 vs. 168.0 +/- 72.2; p = 0.011). Maximal plasma
concentrations of ticagrelor and its active metabolite AR-C124910XX tended
to be delayed and numerically lower among patients treated with morphine
compared to fentanyl. Total exposures to ticagrelor and AR-C124910XX
within 6 hours after ticagrelor LD were numerically greater among patients
treated with fentanyl compared to those treated with morphine.
 Conclusion(s): In patients with STEMI undergoing primary PCI,
fentanyl did not improve platelet inhibition at 2 hours after ticagrelor
pre-treatment compared with morphine. Fentanyl may, however, accelerate
ticagrelor absorption and increase platelet inhibition at 4 hours compared
to morphine. Copyright © 2022 Via Medica.

<31>
Accession Number
2017450110
Title
Efficacy and safety of bioresorbable scaffolds in patients with coronary
bifurcation lesions: A systematic review and meta-analysis.
Source
Cardiology Journal. 29(4) (pp 563-573), 2022. Date of Publication: 04 Jul
2022.
Author
Liang X.-Y.; Li Y.; Zhang W.-J.; Qiao X.; Yang R.-R.; Wang Z.-L.
Institution
(Liang, Li, Zhang, Qiao, Yang) The First Clinical Medical College of
Lanzhou University, Gansu, Lanzhou, China
(Wang) Department of Cardiology, The First Hospital of Lanzhou University,
Gansu, Lanzhou, China
Publisher
Via Medica
Abstract
Background: Bioresorbable scaffolds (BRS) were considered to be beneficial
for coronary bifurcation lesions regarding the avoidance of lateral branch
opening incarceration after complete absorption. How-ever, data is limited
in this setting. The aim of this meta-analysis was to evaluate the short
(6-month) and medium-term (1-year) outcomes of BRS in patients with
coronary bifurcation lesions. Method(s): PubMed, EMBASE, Web of
Science, Cochrane library databases were searched to find the studies of
BRS implantation in patients with coronary bifurcation lesions. The
effective outcome was target lesion revascularization. The safety outcomes
included major adverse cardiovascular events, target vessel
revascularization, myocardial infarction, definite or probable scaffold
thrombosis, and cardiac death. Result(s): A total of 1204 patients
involved in 12 studies were included. The pooled estimate rate of target
lesion revascularization as efficacy outcome was highly consistent between
6-month and 1-year follow-up, which was 4.74% (95% CI 2.36-9.54%,
I2 = 41.5%, p = 0.14) and 4.37% (95% CI 3.05-5.69%,
I2 = 4.6%, p = 0.39). The pooled estimated rate of major
adverse cardiovascular events as safety outcome was 5.50% and 7.31% for
both 6-month and 1-year follow-up. The pooled estimated rate of target
vessel revascularization, myocardial infarction, definite or probable
scaffold thrombosis, and cardiac death at 1-year follow-up was 5.92%,
2.52%, 1.69%, and 0.42%. Conclusion(s): The application of BRS for
coronary bifurcation lesions is acceptable in efficacy outcome, but the
high rate of scaffold thrombosis remains of concern (Registered by
PROSPERO, CRD42019140341). Copyright © 2022 Via Medica.

<32>
Accession Number
2016907949
Title
Non-invasive Imaging in the Evaluation of Cardiac Allograft Vasculopathy
in Heart Transplantation: A Systematic Review.
Source
Current Problems in Cardiology. 47(8) (no pagination), 2022. Article
Number: 101103. Date of Publication: August 2022.
Author
Ajluni S.C.; Mously H.; Chami T.; Hajjari J.; Stout A.; Zacharias M.;
ElAmm C.; Wilson D.; Janus S.E.; Al-Kindi S.G.
Institution
(Ajluni, Hajjari) Department of Medicine, University Hospitals, Cleveland,
OH
(Mously, Zacharias, ElAmm, Wilson, Janus, Al-Kindi) Harrington Heart and
Vascular Institute, University Hospitals and School of Medicine, Case
Western Reserve University, Cleveland, OH
(Chami) Minneapolis Heart Institute, Minneapolis, MN, United States
(Stout) Core Library, University Hospitals Cleveland Medical Center,
Cleveland, OH
Publisher
Elsevier Inc.
Abstract
Cardiac allograft vasculopathy (CAV) is the leading cause of long-term
graft dysfunction in patients with heart transplantation and is linked
with significant morbidity and mortality. Currently, the gold standard for
diagnosing CAV is coronary imaging with intravascular ultrasound during
traditional invasive coronary angiography. Invasive imaging, however,
carries increased procedural risk and expense to patients in addition to
requiring an experienced interventionalist. With the improvements in
non-invasive cardiac imaging modalities such as transthoracic
echocardiography, computed tomography, magnetic resonance imaging and
positron emission tomography, an alternative non-invasive imaging approach
for the early detection of CAV may be feasible. In this systematic review,
we explored the literature to investigate the utility of non-invasive
imaging in diagnosis of CAV in >3000 patients across 49 studies. We also
discuss the strengths and weaknesses for each imaging modality. Overall,
all 4 imaging modalities show good to excellent accuracy for identifying
CAV with significant variations across studies. Majority of the studies
compared non-invasive imaging with invasive coronary angiography without
intravascular imaging. In summary, non-invasive imaging modalities offer
an alternative approach to invasive coronary imaging for CAV. Future
studies should investigate longitudinal non-invasive protocols in low-risk
patients after heart transplantation. Copyright © 2022 Elsevier
Inc.

<33>
Accession Number
2016893558
Title
Accessory left atrial cords: A case report and literature review.
Source
Journal of Cardiac Surgery. 37(8) (pp 2437-2439), 2022. Date of
Publication: August 2022.
Author
Aranda-Domene R.; Minano-Frutos C.; Arribas-Leal J.M.; Perez-Andreu J.;
Taboada-Martin R.; Alfonso-Colomer L.; Moreno-Moreno J.; Canovas S.
Institution
(Aranda-Domene, Arribas-Leal, Perez-Andreu, Taboada-Martin,
Alfonso-Colomer, Moreno-Moreno, Canovas) Cardiovascular Surgery
Department, Arrixaca University Hospital, IMIB Arrixaca, Murcia, Spain
(Minano-Frutos) Anesthesiology and Reanimation Department, Arrixaca
University Hospital, IMIB Arrixaca, Murcia, Spain
Publisher
John Wiley and Sons Inc
Abstract
Introduction: Accessory left atrial cords are fibroelastic structures
found in the left atrium. Left atrial cords may be associated with mitral
valve disease, atrial fibrillation, stroke, and other congenital left-side
anomalies. Method(s): We presented the case of a man with severe
Mitral Regurgitation and two accessories left atrial cords attached to P2
scallop by a single tendon and performed a literature review using
PUBMED/MEDLINE, Web of Science, and EMBASE databases on December 4, 2021.
 Result(s): According to our review, accessory left atrial cords were
found more frequently in women (36 patients, 62%), more frequently
attached to the mitral valve (66% of reports) and mitral regurgitation was
the most frequently reported pattern of mitral valve disease (64.2%). No
other cases of double left atrial cords attached to P2 segment were found.
 Conclusion(s): Accessory left atrial chords may be related to mitral
valve disease and other left-side congenital abnormalities. These
structures were found more frequently in females and A2 insertion was the
most frequently observed pattern in the review. Copyright © 2022
Wiley Periodicals LLC.

<34>
Accession Number
2015893829
Title
Angiographic quantitative flow ratio-guided coronary intervention (FAVOR
III China): a multicentre, randomised, sham-controlled trial.
Source
The Lancet. 398(10317) (pp 2149-2159), 2021. Date of Publication: 11 Dec
2021.
Author
Xu B.; Tu S.; Song L.; Jin Z.; Yu B.; Fu G.; Zhou Y.; Wang J.; Chen Y.; Pu
J.; Chen L.; Qu X.; Yang J.; Liu X.; Guo L.; Shen C.; Zhang Y.; Zhang Q.;
Pan H.; Fu X.; Liu J.; Zhao Y.; Escaned J.; Wang Y.; Fearon W.F.; Dou K.;
Kirtane A.J.; Wu Y.; Serruys P.W.; Yang W.; Wijns W.; Guan C.; Leon M.B.;
Qiao S.; Stone G.W.
Institution
(Xu, Song, Dou, Wu, Yang, Guan, Qiao) Department of Cardiology, Fuwai
Hospital, National Centre for Cardiovascular Diseases, National Clinical
Research Centre for Cardiovascular Diseases, Chinese Academy of Medical
Sciences and Peking Union Medical College, Beijing, China
(Tu) Biomedical Instrument Institute, School of Biomedical Engineering,
Shanghai Jiao Tong University, Shanghai, China
(Jin) Department of Cardiology, Beijing Tiantan Hospital, Capital Medical
University, Beijing, China
(Yu) Department of Cardiology, the Second Affiliated Hospital of Harbin
Medical University, Harbin, China
(Fu) Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang
University School of Medicine, Hangzhou, China
(Wang) Department of Cardiology, Second Affiliated Hospital, Zhejiang
University School of Medicine, Hangzhou, China
(Zhou) Department of Cardiology, Beijing Anzhen Hospital, Capital Medical
University, Beijing, China
(Chen) Department of Cardiology, the Sixth Medical Centre, Chinese PLA
General Hospital, Beijing, China
(Pu) Department of Cardiology, Renji Hospital, School of Medicine,
Shanghai Jiao Tong University, Shanghai, China
(Chen) Department of Cardiology, Fujian Medical University Union Hospital,
Fuzhou, China
(Qu) Department of Cardiology, Huadong Hospital Affiliated to Fudan
University, Shanghai, China
(Yang) Department of Cardiology, Guangdong Provincial People's Hospital,
Guangdong Academy of Medical Sciences, Guangzhou, China
(Liu) Department of Cardiology, Tongji Hospital, Tongji University School
of Medicine, Shanghai, China
(Zhang) Department of Cardiology, Shanghai East Hospital, Tongji
University School of Medicine, Shanghai, China
(Guo) Department of Cardiology, Peking University Third Hospital, Beijing,
China
(Shen) Department of Cardiology, Shanghai Jiao Tong University Affiliated
Sixth People's Hospital, Shanghai, China
(Zhang) Department of Cardiology, Xuzhou Third People's Hospital, Xuzhou
Medical University, Xuzhou, China
(Pan) Department of Cardiology, Hunan Provincial People's Hospital, The
First Affiliated Hospital of Hunan Normal University, Changsha, China
(Fu) Shanghai Jiao Tong University-Pulse Medical Imaging Technology Joint
Laboratory, Shanghai, China
(Liu) Department of Cardiology, Peking University People's Hospital,
Beijing, China
(Zhao, Wang) Medical Research and Biometrics Centre, National Centre for
Cardiovascular Diseases, Beijing, China
(Escaned) Hospital Clinico San Carlos IDISSC, Complutense University of
Madrid, Madrid, Spain
(Fearon) Division of Cardiovascular Medicine and Stanford Cardiovascular
Institute, Stanford University School of Medicine and VA Palo Alto Health
Care System, Palo Alto, CA, United States
(Kirtane, Leon) NewYork-Presbyterian Hospital/Columbia University Medical
Centre, New York, NY, United States
(Kirtane, Leon, Stone) The Cardiovascular Research Foundation, New York,
NY, United States
(Stone) The Zena and Michael A Wiener Cardiovascular Institute, Icahn
School of Medicine at Mount Sinai, New York, NY, United States
(Serruys) Department of Cardiology, National University of Ireland,
Galway, Ireland
(Serruys) NHLI, Imperial College London, London, UK, United Kingdom
(Wijns) The Lambe Institute for Translational Medicine and Curam, National
University of Ireland, Galway, Ireland
Publisher
Elsevier B.V.
Abstract
Background: Compared with visual angiographic assessment, pressure
wire-based physiological measurement more accurately identifies
flow-limiting lesions in patients with coronary artery disease.
Nonetheless, angiography remains the most widely used method to guide
percutaneous coronary intervention (PCI). In FAVOR III China, we aimed to
establish whether clinical outcomes might be improved by lesion selection
for PCI using the quantitative flow ratio (QFR), a novel angiography-based
approach to estimate the fractional flow reserve. Method(s): FAVOR
III China is a multicentre, blinded, randomised, sham-controlled trial
done at 26 hospitals in China. Patients aged 18 years or older, with
stable or unstable angina pectoris or patients who had a myocardial
infarction at least 72 h before screening, who had at least one lesion
with a diameter stenosis of 50-90% in a coronary artery with a reference
vessel of at least 2.5 mm diameter by visual assessment were eligible.
Patients were randomly assigned to a QFR-guided strategy (PCI performed
only if QFR <=0.80) or an angiography-guided strategy (PCI based on
standard visual angiographic assessment). Participants and clinical
assessors were masked to treatment allocation. The primary endpoint was
the 1-year rate of major adverse cardiac events, a composite of death from
any cause, myocardial infarction, or ischaemia-driven revascularisation.
The primary analysis was done in the intention-to-treat population. The
trial was registered with ClinicalTrials.gov (NCT03656848).
 Finding(s): Between Dec 25, 2018, and Jan 19, 2020, 3847 patients
were enrolled. After exclusion of 22 patients who elected not to undergo
PCI or who were withdrawn by their physicians, 3825 participants were
included in the intention-to-treat population (1913 in the QFR-guided
group and 1912 in the angiography-guided group). The mean age was 62.7
years (SD 10.1), 2699 (70.6%) were men and 1126 (29.4%) were women, 1295
(33.9%) had diabetes, and 2428 (63.5%) presented with an acute coronary
syndrome. The 1-year primary endpoint occurred in 110 (Kaplan-Meier
estimated rate 5.8%) participants in the QFR-guided group and in 167
(8.8%) participants in the angiography-guided group (difference, -3.0%
[95% CI -4.7 to -1.4]; hazard ratio 0.65 [95% CI 0.51 to 0.83]; p=0.0004),
driven by fewer myocardial infarctions and ischaemia-driven
revascularisations in the QFR-guided group than in the angiography-guided
group. Interpretation(s): In FAVOR III China, among patients
undergoing PCI, a QFR-guided strategy of lesion selection improved 1-year
clinical outcomes compared with standard angiography guidance.
 Funding(s): Beijing Municipal Science and Technology Commission,
Chinese Academy of Medical Sciences, and the National Clinical Research
Centre for Cardiovascular Diseases, Fuwai Hospital. Copyright ©
2021 Elsevier Ltd

<35>
Accession Number
2018441105
Title
Prognostic value of tissue inhibitor of metalloproteinase-matrix
metalloproteinase biomarkers at 30 days in patients with acute myocardial
infarction without reperfusion therapy.
Source
Chinese Medical Journal. 134(4) (pp 481-483), 2021. Date of Publication:
20 Feb 2021.
Author
Pang H.-F.; Liu J.-M.; Lu J.-P.; Wang Y.-P.; Wang S.-M.; Hou L.-B.; Tian
A.-X.; Gao Y.; Wang N.-N.
Institution
(Pang, Gao, Liu, Lu, Wang, Wang, Hou, Tian, Gao) National Clinical
Research Center for Cardiovascular Diseases, State Key Laboratory of
Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical
Sciences and Peking Union Medical College, National Center for
Cardiovascular Diseases, Beijing 100037, China
Publisher
Lippincott Williams and Wilkins

<36>
Accession Number
2012311807
Title
Coronary artery bypass grafting versus percutaneous coronary intervention
in end-stage kidney disease: A systematic review and meta-analysis of
clinical studies.
Source
Hemodialysis International. 25(3) (pp 288-299), 2021. Date of Publication:
July 2021.
Author
Kanbay M.; Tapoi L.; Ureche C.; Bulbul M.C.; Kapucu I.; Afsar B.; Basile
C.; Covic A.
Institution
(Kanbay) Department of Medicine, Division of Nephrology, Koc University
School of Medicine, Istanbul, Turkey
(Tapoi, Ureche) Cardiovascular Diseases Institute, "Grigore T. Popa"
University of Medicine and Pharmacy, Iasi, Romania
(Bulbul, Kapucu) Department of Medicine, Koc University School of
Medicine, Istanbul, Turkey
(Afsar) Department of Medicine, Division of Nephrology, Suleyman Demirel
University School of Medicine, Isparta, Turkey
(Basile) Division of Nephrology, Miulli General Hospital, Acquaviva delle
Fonti, Italy
(Covic) Department of Nephrology, "Grigore T. Popa" University of Medicine
and Pharmacy, Iasi, Romania
Publisher
John Wiley and Sons Inc
Abstract
The most significant complication of end-stage kidney disease (ESKD) is
cardiovascular disease, mainly coronary artery disease (CAD). Although the
effective treatment of CAD is an important prognostic factor, whether
percutaneous coronary intervention (PCI) or coronary artery bypass
grafting (CABG) is better for treating CAD in this group of patients is
still controversial. We searched Pubmed/Medline, Web of Science, Embase,
the Cochrane Central Register of Controlled Trials articles that compared
the outcomes of CABG versus PCI in patients with ESKD requiring dialysis.
A total of 10 observational studies with 39,666 patients were included.
Our analysis showed that when compared to PCI, CABG had lower risk of need
for repeat revascularization (relative risk [RR] = 2.25, 95% confidence
interval [CI] 2.1-2.42, p < 0.00001) and cardiovascular death (RR = 1.19,
95% CI 1.14-1.23, p < 0.00001) and higher risk for short-term mortality
(RR = 0.43, 95% CI 0.38-0.48, p < 0.00001). There was no statistically
significant difference between the PCI and CABG groups in the risk for
late mortality (RR = 1.05, 95% CI 0.97-1.14, p = 0.25), myocardial
infarction (RR = 1.05, 95% CI 0.46-2.36, p = 0.91) or stroke (RR = 1.02,
95% CI 0.64-1.61, p = 0.95). This meta-analysis showed that in ESKD
patients requiring dialysis, CABG was superior to PCI in regard to
cardiovascular death and need for repeat revascularization and inferior to
PCI in regard to short term mortality. However, this meta-analysis has
limitations and needs confirmation with large randomized controlled
trials. Copyright © 2021 International Society for Hemodialysis.

<37>
Accession Number
2017683597
Title
Mechanical or biologic prostheses for mitral valve replacement: A
systematic review and meta-analysis.
Source
Clinical Cardiology. 45(7) (pp 701-716), 2022. Date of Publication: July
2022.
Author
Yu J.; Qiao E.; Wang W.
Institution
(Yu, Qiao, Wang) Department of Structural Heart Disease, Fu Wai Hospital,
National Center for Cardiovascular Diseases, Chinese Academy of Medical
Sciences, Peking Union Medical College, Beijing, China
Publisher
John Wiley and Sons Inc
Abstract
Either a mechanical or bioprosthetic valve is used in patients undergoing
mitral valve replacement (MVR). However, the optimal mitral prosthesis
remains controversial. The aim of this meta-analysis was thus to compare
outcomes between mechanical mitral valve replacement (MVRm) and
bioprosthetic mitral valve replacement (MVRb) for MVR patients. We
searched Embase, PubMed, Web of Science, and Cochrane Library databases
from January 1, 2000 to October 31, 2021 for studies that directly
compared surgical outcomes of MVRm and MVRb. A total of 22 studies with 35
903 patients were included in the meta-analysis (n = 23 868 MVRm and n =
12 035 MVRb). The MVRm group displayed lower long-term all causes
mortality (HR, 0.84; 95% confidence interval [CI]: 0.77-0.91; p <.0001; I2
= 51%), and fewer mitral reoperation (hazard ratio [HR]: 0.34; 95% CI:
0.23-0.50; p <.00001; I2 = 74%) than MVRb group. However, the MVRm group
was associated with a greater risk of major bleeding events (HR: 1.21; 95%
CI: 1.14-1.29; p <.00001; I2 = 0%), stroke and systemic embolism (HR:
1.20; 95% CI: 1.10-1.32; p <.0001; I2 = 0%) in matched or adjusted data.
No significant difference was observed between MVRm and MVRb on operative
mortality in matched/adjusted group (risk ratios: 0.83; 95% CI: 0.66-1.05;
p =.12; I2 = 0%). The results were consistent with patients aged under 70
years old. Patients who received a MVRm is associated with 16% lower risk
of long-term mortality and 66% lower risk of mitral reoperation, but 20%
greater risk of stroke or systemic embolism, 21% greater risk of major
bleeding compared with MVRb in matched/adjusted studies group, which were
consistent to patients younger than the age of 70 years who underwent
MVR. Copyright © 2022 The Authors. Clinical Cardiology published
by Wiley Periodicals LLC.

<38>
Accession Number
2016415611
Title
Chronic kidney disease and transcatheter aortic valve implantation.
Source
Cardiovascular Intervention and Therapeutics. 37(3) (pp 458-464), 2022.
Date of Publication: July 2022.
Author
Adachi Y.; Yamamoto M.
Institution
(Adachi, Yamamoto) Department of Cardiology, Toyohashi Heart Center, 21-1
Gobutori, Oyamachyo, Aichi, Toyohashi 441-8530, Japan
(Yamamoto) Department of Cardiology, Nagoya Heart Center, Aichi, Nagoya,
Japan
(Yamamoto) Department of Cardiology, Gifu Heart Center, Gifu, Japan
Publisher
Springer
Abstract
Transcatheter aortic valve implantation (TAVI) is an established treatment
option for patients with severe aortic stenosis. Patients with aortic
stenosis have a higher prevalence of chronic kidney disease (CKD). CKD is
generally associated with an increased risk of mortality, cardiovascular
events, and readmission for heart failure; this supports the concept of a
cardio-renal syndrome (CRS). CRS encompasses a spectrum of disorders of
the heart and kidneys, wherein dysfunction in one organ may cause
dysfunction in the other. TAVI treatment is expected to break this
malignant cycle of CRS and improve cardio-renal function after the
procedure. However, several reports demonstrate that patients with CKD
have been associated with poor outcomes after the procedure. In addition,
TAVI treatments for patients with advanced CKD and those with end-stage
renal disease on hemodialysis are considered more challenging. Adequate
management to preserve cardio-renal function in patients undergoing TAVI
may reduce the risk of cardio-renal adverse events and improve the
long-term prognosis. The current comprehensive review article aims to
assess the prognostic impact of CKD after TAVI and seek optimal care in
patients with CKD even after successful TAVI. Copyright © 2022,
The Author(s) under exclusive licence to Japanese Association of
Cardiovascular Intervention and Therapeutics.

<39>
Accession Number
2016161468
Title
Crossed pulmonary arteries: An underestimated cardiovascular variant with
a strong association with genetic syndromes-A report of 74 cases with
systematic review of the literature.
Source
American Journal of Medical Genetics, Part A. 188(8) (pp 2351-2359), 2022.
Date of Publication: August 2022.
Author
Mastromoro G.; Calcagni G.; Vignaroli W.; Anaclerio S.; Pugnaloni F.;
Rinelli G.; Secinaro A.; Bordonaro V.; Putotto C.; Unolt M.; Digilio M.C.;
Marino B.; Versacci P.
Institution
(Mastromoro, Vignaroli, Anaclerio, Pugnaloni, Putotto, Marino, Versacci)
Department of Pediatrics, Obstetrics and Gynecology, "Sapienza" University
of Rome, Rome, Italy
(Calcagni, Rinelli, Unolt) Department of Pediatric Cardiology and Cardiac
Surgery, Bambino Gesu Pediatric Hospital and Research Institute, Rome,
Italy
(Secinaro, Bordonaro) Department of Imaging, Advanced Cardiovascular
Imaging Unit, Bambino Gesu Pediatric Hospital and Research Institute,
Rome, Italy
(Digilio) Rare Diseases and Medical Genetics, Department of Pediatrics,
Bambino Gesu Pediatric Hospital and Research Institute, Rome, Italy
Publisher
John Wiley and Sons Inc
Abstract
Crossed pulmonary arteries (CPAs) represent an uncommon anatomic variant,
usually associated with some specific syndromes and conotruncal defects.
This finding has been described in 22q11.2 Deletion Syndrome (22q11.2DS).
We evaluated the correlation between CPAs and genetic diseases, in order
to better define the characteristics of this variant, considered a rare
anatomic pattern. An in-depth analysis of CPAs genotype-phenotype
correlations was performed via a literature review. We detected 74 CPAs
patients through echocardiography. Of these 74 patients, 35.1% of patients
showed additional intracardiac malformations, while 29.7% showed
extracardiac vascular anomalies, of which 16.2% were associated with
intracardiac defects and 13.5% were not. In all, 62.2% of patients were
diagnosed with genetic diseases and 52.2% of them were 22q11.2DS patients.
In conclusions, CPAs represent a cardiovascular variant, which is
detectable in nonsyndromic individuals, but especially in various genetic
syndromes and in particular in 22q11.2DS patients. Data on the real
prevalence of this morphology is lacking in literature. Knowledge of this
anatomic variant is useful to interpret the unusual course of the
pulmonary branches and is helpful information before cardiovascular
surgical correction. Moreover, due to the strong association of CPAs with
some genetic syndromes, the identification of this anatomic pattern can
indicate the utility of a genetic assessment of these
patients. Copyright © 2022 Wiley Periodicals LLC.

<40>
Accession Number
2015455465
Title
Heart Team risk assessment with angiography-derived fractional flow
reserve determining the optimal revascularization strategy in patients
with multivessel disease: Trial design and rationale for the DECISION QFR
randomized trial.
Source
Clinical Cardiology. 45(6) (pp 605-613), 2022. Date of Publication: June
2022.
Author
Miyata K.; Asano T.; Saito A.; Abe K.; Tanigaki T.; Hoshino M.; Kobayashi
T.; Takaoka Y.; Kanie T.; Yamasaki M.; Yoshino K.; Wakabayashi N.; Ouchi
K.; Kodama H.; Shiina Y.; Tamaki R.; Nishihata Y.; Masuda K.; Suzuki T.;
Nonaka H.; Emori H.; Katagiri Y.; Miyazaki Y.; Sotomi Y.; Yasunaga M.;
Kogame N.; Kuramitsu S.; Reiber J.H.C.; Okamura T.; Higuchi Y.; Kakuta T.;
Misumi H.; Komiyama N.; Matsuo H.; Tanabe K.
Institution
(Miyata, Asano, Saito, Takaoka, Kanie, Kodama, Shiina, Nishihata, Masuda,
Suzuki, Komiyama) Department of Cardiovascular Medicine, St. Luke's
International Hospital, St. Luke's International University, Tokyo, Japan
(Abe, Yamasaki, Yoshino, Tamaki, Misumi) Department of Cardiovascular
Surgery, St. Luke's International Hospital, St. Luke's International
University, Tokyo, Japan
(Tanigaki, Matsuo) Department of Cardiovascular Medicine, Gifu Heart
Center, Gifu, Japan
(Hoshino, Kakuta) Division of Cardiovascular Medicine, Tsuchiura Kyodo
General Hospital, Ibaraki, Japan
(Kobayashi, Yasunaga, Higuchi) Department of Cardiology, Osaka Police
Hospital, Osaka, Japan
(Wakabayashi, Ouchi) Department of Radiology, St. Luke's International
Hospital, St. Luke's International University, Tokyo, Japan
(Nonaka, Tanabe) Division of Cardiology, Mitsui Memorial Hospital, Tokyo,
Japan
(Emori) Department of Cardiovascular Medicine, Wakayama Medical
University, Wakayama, Japan
(Katagiri) Department of Cardiovascular Medicine, Sapporo Higashi
Tokushukai Hospital, Sapporo, Japan
(Miyazaki, Okamura) Division of Cardiology, Department of Medicine and
Clinical Science, Yamaguchi University Graduate School of Medicine,
Yamaguchi, Japan
(Sotomi) Department of Cardiovascular Medicine, Osaka University Graduate
School of Medicine, Osaka, Japan
(Kogame) Division of Cardiovascular Medicine, Toho University Ohashi
Medical Center, Tokyo, Meguro, Japan
(Kuramitsu) Department of Cardiology, Kokura Memorial Hospital,
Kitakyushu, Japan
(Reiber) Department of Radiology, Leiden University Medical Center,
Leiden, Netherlands
Publisher
John Wiley and Sons Inc
Abstract
In patients with multivessel disease (MVD), functional information on
lesions improves the prognostic capability of the SYNTAX score.
Quantitative flow ratio (QFR) is an angiography-derived fractional flow
reserve (FFR) that does not require a pressure wire or pharmacological
hyperemia. We aimed to investigate the feasibility of QFR-based patient
information in Heart Teams' discussions to determine the optimal
revascularization strategy for patients with MVD. We hypothesized that
there is an acceptable agreement between treatment recommendations based
on the QFR approach and recommendation based on the FFR approach. The
DECISION QFR study is a prospective, multicenter, randomized controlled
trial that will include patients with MVD who require revascularization.
Two Heart Teams comprising cardiologists and cardiac surgeons will be
randomized to select a revascularization strategy (percutaneous coronary
intervention or coronary artery bypass graft) according to patient
information either based on QFR or on FFR. All 260 patients will be
assessed by both teams with reference to the anatomical and functional
SYNTAX score/SYNTAX score II 2020 derived from the allocated physiological
index (QFR or FFR). The primary endpoint of the trial is the level of
agreement between the treatment recommendations of both teams, assessed
using Cohen's kappa. As of March 2022, the patient enrollment has been
completed and 230 patients have been discussed in both Heart Teams. The
current trial will indicate the usefulness of QFR, which enables a
wireless multivessel physiological interrogation, in the discussions of
Heart Teams to determine the optimal revascularization strategy for
MVD. Copyright © 2022 The Authors. Clinical Cardiology published
by Wiley Periodicals, LLC.

<41>
Accession Number
2015124694
Title
Intraoperative Methylprednisolone and Neurodevelopmental Outcomes in
Infants After Cardiac Surgery.
Source
Annals of Thoracic Surgery. 113(6) (pp 2079-2084), 2022. Date of
Publication: June 2022.
Author
Zyblewski S.C.; Martin R.H.; Shipes V.B.; Hamlin-Smith K.; Atz A.M.;
Bradley S.M.; Kavarana M.N.; Mahle W.T.; Everett A.D.; Graham E.M.
Institution
(Zyblewski, Hamlin-Smith, Atz, Graham) Department of Pediatrics, Medical
University of South Carolina, South Carolina, Charleston
(Martin, Shipes) Department of Public Health Sciences, Medical University
of South Carolina, South Carolina, Charleston
(Bradley, Kavarana) Section of Pediatric Cardiac Surgery, Medical
University of South Carolina, South Carolina, Charleston
(Mahle) Department of Pediatrics, Children's Healthcare of Atlanta and
Emory University, Georgia, Atlanta, Georgia
(Everett) Department of Pediatrics, The Johns Hopkins University,
Maryland, Baltimore
Publisher
Elsevier Inc.
Abstract
Background: Neurodevelopmental impairment is an important consequence for
survivors of surgery for critical congenital heart disease. This study
sought to determine whether intraoperative methylprednisolone during
neonatal cardiac surgery is associated with neurodevelopmental outcomes at
12 months of age and to identify early prognostic variables associated
with neurodevelopmental outcomes. Method(s): We performed a planned
secondary analysis of a 2-center, double-blind, randomized,
placebo-controlled trial of intraoperative methylprednisolone in neonates
undergoing cardiac surgery. A brain injury biomarker was measured during
surgery. Bayley Scales of Infant and Toddler Development-III (BSID-III)
were performed at 12 months of age. Two-sample t tests and generalized
linear models were used. Result(s): There were 129 participants (n =
61 methylprednisolone; n = 68 placebo). There were no significant
differences in BSID-III scores and brain injury biomarker levels between
treatment groups. Participants who underwent a palliative (versus
corrective) procedure had lower mean BSID-III cognitive (101 +/- 15 versus
106 +/- 14; P = .03) and motor scores (85 +/- 18 versus 94 +/- 16; P <
.01). Longer ventilation time was associated with lower motor scores.
Longer cardiac intensive care unit stay was associated with lower
cognitive, language, and motor scores. Cardiopulmonary bypass time, aortic
cross-clamp time, and deep hypothermic circulatory arrest were not
associated with BSID-III scores. Conclusion(s): Neurodevelopmental
outcomes were not associated with intraoperative methylprednisolone or
intraoperative variables. Participants who underwent a neonatal palliative
(versus corrective) procedure had longer cardiac intensive care unit stays
and worse neurodevelopmental outcomes at 1 year. This work suggests that
interventions focused solely on the operative period may not be associated
with a long-term neurodevelopmental benefit. Copyright © 2022 The
Society of Thoracic Surgeons

<42>
Accession Number
2015117200
Title
Diagnostic accuracy of coronary computed tomography angiography for the
evaluation of obstructive coronary artery disease in patients referred for
transcatheter aortic valve implantation: a systematic review and
meta-analysis.
Source
European Radiology. 32(8) (pp 5189-5200), 2022. Date of Publication:
August 2022.
Author
Gatti M.; Gallone G.; Poggi V.; Bruno F.; Serafini A.; Depaoli A.; De
Filippo O.; Conrotto F.; Darvizeh F.; Faletti R.; De Ferrari G.M.; Fonio
P.; D'Ascenzo F.
Institution
(Gatti, Poggi, Serafini, Depaoli, Faletti, Fonio) Department of Surgical
Sciences, Radiology Unit, University of Turin, Via Genova 3, Turin 10126,
Italy
(Gallone, Bruno, De Filippo, Conrotto, De Ferrari, D'Ascenzo) Division of
Cardiology, Department of Medical Science, University of Turin, Turin,
Italy
(Darvizeh) School of Medicine, Vita-Salute San Raffaele University, Milan
20121, Italy
Publisher
Springer Science and Business Media Deutschland GmbH
Abstract
Objective: To evaluate the diagnostic accuracy of coronary computed
tomography angiography (CCTA) for the evaluation of obstructive coronary
artery disease (CAD) in patients referred for transcatheter aortic valve
implantation (TAVI). Method(s): EMBASE, PubMed/MEDLINE, and CENTRAL
were searched for studies reporting accuracy of CCTA for the evaluation of
obstructive CAD compared with invasive coronary angiography (ICA) as the
reference standard. QUADAS-2 tool was used to assess the risk of bias. A
bivariate random effects model was used to analyze, pool, and plot the
diagnostic performance measurements across studies. Pooled sensitivity,
specificity, positive (+ LR) and negative (-LR) likelihood ratio,
diagnostic odds ratio (DOR), and hierarchical summary ROC curve (HSROC)
were evaluated. Prospero registration number: CRD42021252527.
 Result(s): Fourteen studies (2533 patients) were included. In the
intention-to-diagnose patient-level analysis, sensitivity and specificity
for CCTA were 97% (95% CI: 94-98%) and 68% (95% CI: 56-68%), respectively,
and + LR and -LR were 3.0 (95% CI: 2.1-4.3) and 0.05 (95% CI: 0.03 -
0.09), with DOR equal to 60 (95% CI: 30-121). The area under the HSROC
curve was 0.96 (95% CI: 0.94-0.98). No significant difference in
sensitivity was found between single-heartbeat and other CT scanners (96%
(95% CI: 90 - 99%) vs. 97% (95% CI: 94-98%) respectively; p = 0.37),
whereas the specificity of single-heartbeat scanners was higher (82% (95%
CI: 66-92%) vs. 60% (95% CI: 46 - 72%) respectively; p < 0.0001). Routine
CCTA in the pre-TAVI workup could save 41% (95% CI: 34 - 47%) of ICAs if a
disease prevalence of 40% is assumed. Conclusion(s): CCTA proved an
excellent diagnostic accuracy for assessing obstructive CAD in patients
referred for TAVI; the use of single-heartbeat CT scanners can further
improve these findings. Key Points: * CCTA proved to have an excellent
diagnostic accuracy for assessing obstructive CAD in patients referred for
TAVI. * Routine CCTA in the pre-TAVI workup could save more than 40% of
ICAs. * Single-heartbeat CT scanners had higher specificity than others in
the assessment of obstructive CAD in patients referred for
TAVI. Copyright © 2022, The Author(s).

<43>
Accession Number
2013803367
Title
A pilot randomized clinical trial of cryopreserved versus liquid-stored
platelet transfusion for bleeding in cardiac surgery: The cryopreserved
versus liquid platelet-New Zealand pilot trial.
Source
Vox Sanguinis. 117(3) (pp 337-345), 2022. Date of Publication: March 2022.
Author
McGuinness S.; Charlewood R.; Gilder E.; Parke R.; Hayes K.; Morley S.;
Al-Ibousi A.; Deans R.; Howe B.; Johnson L.; Marks D.C.; Reade M.C.
Institution
(McGuinness, Gilder, Parke) Cardiothoracic and Vascular Intensive Care
Unit, Auckland City Hospital, Auckland, New Zealand
(McGuinness, Parke) Medical Research Institute of New Zealand, Wellington,
New Zealand
(McGuinness, Parke, Howe, Reade) Australian and New Zealand Intensive Care
Research Centre, School of Public Health and Preventive Medicine, Monash
University, Melbourne, VIC, Australia
(Charlewood, Morley, Al-Ibousi) New Zealand Blood Service, Auckland, New
Zealand
(Gilder, Parke) School of Nursing, The University of Auckland, Auckland,
New Zealand
(Hayes) Greenlane Department of Cardiothoracic Anaesthesia, Auckland City
Hospital, Auckland, New Zealand
(Deans, Reade) Faculty of Medicine, University of Queensland, Royal
Brisbane and Women's Hospital, Herston, QLD, Australia
(Johnson, Marks) Australian Red Cross Lifeblood, Alexandria, NSW,
Australia
(Reade) Joint Health Command, Australian Defence Force, Canberra, ACT,
Australia
Publisher
John Wiley and Sons Inc
Abstract
Background and Objectives: Platelets for transfusion have a shelf-life of
7 days, limiting availability and leading to wastage. Cryopreservation at
-80degreeC extends shelf-life to at least 1 year, but safety and
effectiveness are uncertain. Material(s) and Method(s): This single
centre blinded pilot trial enrolled adult cardiac surgery patients who
were at high risk of platelet transfusion. If treating clinicians
determined platelet transfusion was required, up to three units of either
cryopreserved or liquid-stored platelets intraoperatively or during
intensive care unit admission were administered. The primary outcome was
protocol safety and feasibility. Result(s): Over 13 months, 89
patients were randomized, 23 (25.8%) of whom received a platelet
transfusion. There were no differences in median blood loss up to 48 h
between study groups, or in the quantities of study platelets or other
blood components transfused. The median platelet concentration on the day
after surgery was lower in the cryopreserved platelet group (122 x
103/mul vs. 157 x 103/mul, median difference 39.5
x103/mul, p = 0.03). There were no differences in any of the
recorded safety outcomes, and no adverse events were reported on any
patient. Multivariable adjustment for imbalances in baseline patient
characteristics did not find study group to be a predictor of 24-h blood
loss, red cell transfusion or a composite bleeding outcome.
 Conclusion(s): This pilot randomized controlled trial demonstrated
the feasibility of the protocol and adds to accumulating data supporting
the safety of this intervention. Given the clear advantage of prolonged
shelf-life, particularly for regional hospitals in New Zealand, a
definitive non-inferiority phase III trial is warranted. Copyright
© 2021 International Society of Blood Transfusion.

<44>
Accession Number
638464366
Title
Mechanical versus bioprosthetic valves in chronic dialysis: a systematic
review and meta-analysis.
Source
Canadian journal of surgery. Journal canadien de chirurgie. 65(4) (pp
E450-E459), 2022. Date of Publication: 01 Jul 2022.
Author
Kim K.S.; Belley-Cote E.P.; Gupta S.; Pandey A.; Alsagheir A.; Makhdoum
A.; McClure G.; Newsome B.; Gao S.W.; Bossard M.; Isayama T.; Ikuta Y.;
Walsh M.; Garg A.X.; Guyatt G.H.; Whitlock R.P.
Institution
(Kim, Belley-Cote, Gupta, Pandey, Alsagheir, Makhdoum, McClure, Newsome,
Gao, Bossard, Isayama, Ikuta, Walsh, Garg, Guyatt, Whitlock) From the
Michael G. DeGroote School of Medicine (Kim, Pandey); Department of Health
Research Methodology, Evidence, and Impact (Kim, Gupta, Alsagheir,
Makhdoum, Walsh, Garg, Guyatt, Whitlock); the Population Health Research
Institute (Kim, Belley-Cote, Walsh, Whitlock); Department of Medicine
(Belley-Cote, Walsh, Guyatt); Division of Cardiac Surgery (Gupta,
Alsagheir, Gao, Whitlock), McMaster University, Hamilton, Ont.; Division
of Cardiac Surgery (Makhdoum), University of Toronto, Toronto, Ont.; the
Division of Vascular Surgery (McClure), McMaster University, Hamilton,
Ont; Faculty of Health Sciences (Newsome), McMaster University, Hamilton,
Ont.; Division of Cardiology (Bossard), Heart Center Luzerner
Kantonsspital, Luzern, Switzerland; Division of Neonatology (Isayama,
Ikuta), National Center for Child Health and Development, Tokyo, Japan;
Department of Medicine (Garg), Western University, London, Ont
Publisher
NLM (Medline)
Abstract
BACKGROUND: Many patients with end-stage kidney disease (ESKD) have
valvular heart disease requiring surgery. The optimal prosthetic valve is
not established in this population. We performed a systematic review and
meta-analysis to assess outcomes of patients with dialysis-dependent ESKD
who received mechanical or bioprosthetic valves. METHOD(S): We
searched Cochrane Central, Medline and Embase from inception to January
2020. We performed screening, full-text assessment, risk of bias and data
collection, independently and in duplicate. Data were pooled using a
random-effects model. RESULT(S): We identified 28 observational
studies (n = 9857 patients, including 6680 with mechanical valves and 3717
with bioprosthetic valves) with a median follow-up of 3.45 years.
Twenty-two studies were at high risk of bias and 1 was at critical risk of
bias from confounding. Certainty in evidence was very low for all outcomes
except bleeding. Mechanical valves were associated with reduced mortality
at 30 days (relative risk [RR] 0.79, 95% confidence interval [CI]
0.65-0.97, I2 = 0, absolute effect 27 fewer deaths per 1000) and at 6 or
more years (mean 9.7 yr, RR 0.83, 95% CI 0.72-0.96, I2 = 79%, absolute
effect 145 fewer deaths per 1000), but increased bleeding (incidence rate
ratio [IRR] 2.46, 95% CI 1.41-4.27, I2 = 59%, absolute effect 91 more
events per 1000) and stroke (IRR 1.63, 95% CI 1.21-2.20, I2 = 0%, absolute
effect 25 more events per 1000). CONCLUSION(S): Mechanical valves
were associated with reduced mortality, but increased rate of bleeding and
stroke. Given very low certainty for evidence of mortality and stroke
outcomes, patients and clinicians may choose prosthetic valves based on
factors such as bleeding risk and valve longevity. STUDY REGISTRATION:
PROSPERO no. CRD42017081863. Copyright © 2022 CMA Impact Inc. or
its licensors.

<45>
Accession Number
638420097
Title
Levosimendan in paediatric cardiac anaesthesiology: A systematic review
and meta-analysis.
Source
European journal of anaesthesiology. 39(8) (pp 646-655), 2022. Date of
Publication: 01 Aug 2022.
Author
Lapere M.; Rega F.; Rex S.
Institution
(Lapere) From the Department of Anaesthesiology, University Hospitals
Leuven (ML, Department of Cardiovascular Sciences, SR) and Department of
Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium
Publisher
NLM (Medline)
Abstract
BACKGROUND: Low cardiac output syndrome (LCOS) after congenital cardiac
surgery has an incidence of up to 25%. Preventing and treating LCOS is of
pivotal importance as LCOS is associated with excess morbidity and
mortality. OBJECTIVE(S): This systematic review assesses the safety
and efficacy of peri-operative levosimendan administration in the setting
of paediatric cardiac surgery. DESIGN: Systematic review of randomised
controlled trials. Meta-analyses were performed on efficacy and
exploratory outcomes. DATA SOURCES: Literature was searched in the
following databases (MEDLINE, EMBASE, Web of Science and CENTRAL) from
inception to July 2021. ELIGIBILITY CRITERIA: Randomised controlled trials
comparing levosimendan with other inotropes or placebo in children younger
than 18 years of age undergoing cardiac surgery. RESULT(S): Nine
studies enrolling a total of 539 children could be included in the
systematic review. All trials study the prophylactic administration of
levosimendan in comparison with placebo ( n = 2), milrinone ( n = 6)
or dobutamine ( n = 1). Levosimendan dosing varied considerably with
only three studies using a loading dose. Levosimendan reduced the
incidence of LCOS [risk ratio (RR) 0.80] [95% confidence interval (CI),
0.40 to 0.89, P = 0.01] and increased cardiac index (MD 0.17 l min -1 m
-2 ) (95% CI, 0.06 to 0.28, P = 0.003) without affecting other outcomes
(mortality, ICU length of stay, hospital length of stay, duration of
mechanical ventilation, serum lactate, central venous oxygen saturation,
serum creatine or acute kidney injury). CONCLUSION(S): The
prophylactic use of levosimendan in children undergoing cardiac surgery
reduced the incidence of LCOS and increased cardiac index compared with
other inotropes or placebo. This effect did not translate into an
improvement of other clinical endpoints. Copyright © 2022
European Society of Anaesthesiology and Intensive Care. Unauthorized
reproduction of this article is prohibited.

<46>
Accession Number
2010361300
Title
Cardiac veins, an anatomical review.
Source
Translational Research in Anatomy. 23 (no pagination), 2021. Article
Number: 100096. Date of Publication: June 2021.
Author
Kassem M.W.; Lake S.; Roberts W.; Salandy S.; Loukas M.
Institution
(Kassem) Mercy Health Neuroscience Institute, St. Vincent Medical Centre,
Toledo, OH, United States
(Lake, Loukas) Department of Anatomical Sciences, School of Medicine, St.
George's University, West Indies, Grenada
(Roberts) Surgery Department, Grenada General Hospital, West Indies,
Grenada
(Salandy) Pediatrics Department, Bronx-Lebanon Hospital Center, Bronx, NY,
United States
(Loukas) Department of Anatomy, Warmia and Mazury, Olsztyn, Poland
Publisher
Elsevier GmbH
Abstract
Background: The detailed investigations of the coronary arteries
overshadow the anatomy and clinical relevance of the coronary venous tree.
Many recent advances in diagnostic and therapeutic interventional cardiac
procedures now involve manipulations of the coronary veins.
 Purpose(s): The aim of this paper is to provide a review of the
coronary venous tree to assist in enhancing the clinical knowledge on the
anatomy of the coronary veins. Method(s): A literature search was
conducted using google scholar, and pubmed NCBI data basem in search of
peer-reviewed literature with keyword search including history of cardiac
veins, coronary vein anatomy, and cardiac veins. Conclusion(s):
Cardiac procedures such as ablations and retrograde cardioplegia depends
on the ability to of the clinician to accurately identify critical cardiac
venous structures from imaging studies and while during procedures. These
advances demand that clinicians have a deeper understanding of the
coronary venous tree as it relates to their anatomy and
variants. Copyright © 2020

<47>
Accession Number
638475639
Title
Comparison of Airtraq DL TM and Macintosh laryngoscope for double-lumen
tube placement in simulated difficult airway: A randomised study.
Source
Indian Journal of Anaesthesia. 66(6) (pp 442-448), 2022. Date of
Publication: June 2022.
Author
Mounika K.; Kar P.; Padhy S.; Pathy A.; Durga P.
Institution
(Mounika, Kar, Padhy, Pathy, Durga) Department of Anaesthesia and
Intensive Care, Nizams Institute of Medical Sciences, Telangana,
Hyderabad, India
Publisher
Wolters Kluwer Medknow Publications
Abstract
Background and Aims: The Airtraq DL TM is a prototype channeled video
laryngoscope, designed specifically for endobronchial intubation with a
double-lumen tube (DLT). Evidence on its superiority over Macintosh
laryngoscope for DLT placement in the difficult airway is limited. This
study compared the efficacy of both these laryngoscopes in the simulated
difficult airway. Method(s): A prospective randomised controlled
study was conducted on 52 patients undergoing elective thoracic surgery
with lung isolation using a left-sided DLT. The patients were randomised
into Airtraq DL TM group (group A) and Macintosh group (group M). The
primary objective was to compare the time required for intubation, and the
secondary objectives were to evaluate time to best glottic view,
Cormack-Lehane (CL) grading, intubation difficulty score (IDS),
manoeuvres, attempts at intubation, haemodynamic response and
complications. Operating anaesthesiologists were also asked to grade the
ease of laryngoscopy and intubation for both devices on a 4-point Likert
scale. Result(s): The mean time to intubation was found to be lesser
in group A than in group M (18 +/- 6.91 s vs 25.48 +/- 9.47 s, P = 0.003).
Group A showed better CL grading (P <= 0.001), lesser requirement of
manoeuvres (P = 0.02) and lower IDS (P = 0.003). Also, group A had
significantly better Likert scale results as compared to group M.
 Conclusion(s): The Airtraq DL TM is superior to Macintosh
laryngoscope as it requires lesser time for intubation and provides
favourable intubating conditions (better CL grading, lesser manoeuvres,
lower IDS and improved Likert scales) for double-lumen placement in the
simulated difficult airway. Copyright © 2022 Indian Journal of
Anaesthesia.

<48>
Accession Number
638477251
Title
Association between cuffed tracheal tube use and reduced
ventilator-associated pneumonia and conditions after elective cardiac
surgery in infants and young children.
Source
Minerva anestesiologica. (no pagination), 2022. Date of Publication: 14
Jul 2022.
Author
Nacoti M.; Carobbio A.; Finazzi S.; Pellicioli I.; Consonni F.; Ferrari
F.; Favarato M.; Fazzi F.; Bonanomi E.
Institution
(Nacoti) Pediatric Intensive Care Unit, Anesthesia and Critical Care
Department, ASST Papa Giovanni XXIII, Bergamo, Italy
(Carobbio) FROM Research Foundation, ASST Papa Giovanni XXIII, Bergamo,
Italy
(Finazzi) Dipartimento di Epidemiologia Clinica, IRCCS Istituto di
Ricerche Farmacologiche Mario Negri, Ranica, Bergamo, Italy
(Pellicioli, Consonni, Ferrari, Favarato, Fazzi, Bonanomi) Pediatric
Intensive Care Unit, Anesthesia and Critical Care Department, ASST Papa
Giovanni XXIII, Bergamo, Italy
Publisher
NLM (Medline)
Abstract
BACKGROUND: Ventilator-associated pneumonia (VAP) is a serious
complication in children after cardiac surgery that may result from
micro-aspiration. However, the current recommendation to use cuffed
tracheal tubes (TTs) versus uncuffed TTs in children is still uncertain.
Our main aim was to evaluate the incidence of VAP, ventilator-associated
tracheobronchitis (VAT) and ventilator-associated conditions (VAC) in
children up to five years old who underwent elective cardiac surgery.
 METHOD(S): Single-center, prospective before-and-after study at a
tertiary pediatric intensive care unit (PICU) in Italy. 242 patients (121
in each group) through the following periods: Phase I (from Jan 2017 to
20th Feb 2018), during which children were intubated with uncuffed TTs;
Phase II (from 21th Feb 2018 to Feb 2019), during which children were
intubated with cuffed TTs. RESULT(S): Data were collected using an
electronic dedicated database. Median age was five months. The use of
cuffed tubes reduced the risk of VAC and VAP respectively 15.8 times (95%
CI 3.4-73.1, p=0.0008) and 14.8 times (95% CI 3.1-71.5, p=0.002). No major
related airway complications were observed in the cuffed TTs group.
Average treatment effect, calculated after propensity score matching,
confirmed the significant effect of cuffed TTs on VAC and VAP.
 CONCLUSION(S): Our study suggests a marked reduction of VAP and VAC
associated with use of a cuffed versus uncuffed TT in infants and children
<=5 years of age after elective cardiac surgery. A randomized clinical
trial is needed to confirm these results and define the impact of use of a
cuffed versus uncuffed TT across other relevant ICU outcomes and
non-cardiac PICU patients.

<49>
Accession Number
638475851
Title
Immunosuppressive therapy in virus-negative inflammatory cardiomyopathy:
20-year follow-up of the TIMIC trial.
Source
European heart journal. (no pagination), 2022. Date of Publication: 14
Jul 2022.
Author
Chimenti C.; Russo M.A.; Frustaci A.
Institution
(Chimenti, Frustaci) Department of Clinical, Internal, Anesthesiology and
Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy
(Chimenti, Frustaci) Molecular and Cellular Cardiology Lab, IRCCS 'L.
Spallanzani', Rome, Italy
(Russo) MEBIC Consortium, San Raffaele 21 University, Rome, Italy
Publisher
NLM (Medline)
Abstract
AIMS: Long-term results of the Tailored IMmunosuppression in
virus-negative Inflammatory Cardiomyopathy (TIMIC) trial protocol have
been evaluated. METHODS AND RESULTS: Eighty-five patients with
endomyocardial biopsy-proven virus-negative chronic inflammatory
cardiomyopathy were enrolled in the randomized, double-blind,
placebo-controlled TIMIC trial and received prednisone and azathioprine
(n=43) vs. placebo (n=42) for 6 months. Immunosuppressive treatment
promoted an improvement in cardiac function in 88% of the cases compared
with none of the patients in the placebo group, which were switched to a
6-month immunosuppressive therapy at the end of the 6-month study period.
Long-term (up to 20 years) clinical outcomes of the whole cohort of 85
patients originally enrolled in the TIMIC trial (Group A) were compared
with those of a 1:2 propensity score-matched control cohort of patients
untreated with the TIMIC protocol (Group B) and followed for a comparable
period of time. The primary outcome was a composite of cardiovascular
death and heart transplantation. At long-term follow-up, the risk of
cardiovascular death [hazard ratio (HR) 6.77; 95% confidence interval (CI)
2.36-19.45] and heart transplantation (HR 7.92; 95% CI 1.80-34.88) was
significantly higher in Group B patients. Group A showed a persistent
improvement in the left ventricular ejection fraction compared with Group
B (HR 7.24; 95% CI 3.05-17.18). A higher number of Group B patients
underwent implantable cardioverter defibrillator implantation. The
incidence of recurrent myocarditis was similar between groups, and
patients with evidence of a recurrent cardiac inflammatory process
promptly responded to a TIMIC protocol application. CONCLUSION(S):
Virus-negative inflammatory cardiomyopathy benefits from immunosuppressive
therapy even after long-term follow-up. Recurrence appears to respond to a
new TIMIC protocol application. Copyright © The Author(s) 2022.
Published by Oxford University Press on behalf of European Society of
Cardiology.

<50>
Accession Number
637847130
Title
Negative pressure wound therapy for surgical wounds healing by primary
closure.
Source
Cochrane Database of Systematic Reviews. 2022(4) (no pagination), 2022.
Article Number: CD009261. Date of Publication: 26 Apr 2022.
Author
Norman G.; Shi C.; Goh E.L.; Murphy E.M.A.; Reid A.; Chiverton L.;
Stankiewicz M.; Dumville J.C.
Institution
(Norman, Shi, Dumville) Division of Nursing, Midwifery and Social Work,
School of Health Sciences, Faculty of Biology, Medicine and Health,
University of Manchester, Manchester Academic Health Science Centre,
Manchester, United Kingdom
(Goh) Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and
Musculoskeletal Sciences, Oxford, United Kingdom
(Murphy) Ward 64, St. Mary's Hospital, Manchester Foundation NHS Trust,
Manchester, United Kingdom
(Reid) School of Biological Sciences, Faculty of Biology, Medicine &
Health, Manchester, United Kingdom
(Chiverton) NIHR Clinical Research Facility, Great Ormond Street Hospital,
London, United Kingdom
(Stankiewicz) Chermside Community Health Centre, Community and Oral Health
Directorate, Brisbane, Australia
Publisher
John Wiley and Sons Ltd
Abstract
Background: Indications for the use of negative pressure wound therapy
(NPWT) are broad and include prophylaxis for surgical site infections
(SSIs). Existing evidence for the effectiveness of NPWT on postoperative
wounds healing by primary closure remains uncertain. Objective(s): To
assess the effects of NPWT for preventing SSI in wounds healing through
primary closure, and to assess the cost-effectiveness of NPWT in wounds
healing through primary closure. Search Method(s): In January 2021,
we searched the Cochrane Wounds Specialised Register; the Cochrane Central
Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including
In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL
Plus. We also searched clinical trials registries and references of
included studies, systematic reviews and health technology reports. There
were no restrictions on language, publication date or study setting.
 Selection Criteria: We included trials if they allocated participants
to treatment randomly and compared NPWT with any other type of wound
dressing, or compared one type of NPWT with another. Data Collection
and Analysis: At least two review authors independently assessed trials
using predetermined inclusion criteria. We carried out data extraction,
assessment using the Cochrane risk of bias tool, and quality assessment
according to Grading of Recommendations, Assessment, Development and
Evaluations methodology. Our primary outcomes were SSI, mortality, and
wound dehiscence. Main Result(s): In this fourth update, we added 18
new randomised controlled trials (RCTs) and one new economic study,
resulting in a total of 62 RCTs (13,340 included participants) and six
economic studies. Studies evaluated NPWT in a wide range of surgeries,
including orthopaedic, obstetric, vascular and general procedures. All
studies compared NPWT with standard dressings. Most studies had unclear or
high risk of bias for at least one key domain. Primary outcomes. Eleven
studies (6384 participants) which reported mortality were pooled. There is
low-certainty evidence showing there may be a reduced risk of death after
surgery for people treated with NPWT (0.84%) compared with standard
dressings (1.17%) but there is uncertainty around this as confidence
intervals include risk of benefits and harm; risk ratio (RR) 0.78 (95% CI
0.47 to 1.30; I2 = 0%). Fifty-four studies reported SSI; 44
studies (11,403 participants) were pooled. There is moderate-certainty
evidence that NPWT probably results in fewer SSIs (8.7% of participants)
than treatment with standard dressings (11.75%) after surgery; RR 0.73
(95% CI 0.63 to 0.85; I2 = 29%). Thirty studies reported wound
dehiscence; 23 studies (8724 participants) were pooled. There is
moderate-certainty evidence that there is probably little or no difference
in dehiscence between people treated with NPWT (6.62%) and those treated
with standard dressing (6.97%), although there is imprecision around the
estimate that includes risk of benefit and harms; RR 0.97 (95% CI 0.82 to
1.16; I2 = 4%). Evidence was downgraded for imprecision, risk
of bias, or a combination of these. Secondary outcomes. There is
low-certainty evidence for the outcomes of reoperation and seroma; in each
case, confidence intervals included both benefit and harm. There may be a
reduced risk of reoperation favouring the standard dressing arm, but this
was imprecise: RR 1.13 (95% CI 0.91 to 1.41; I2 = 2%; 18
trials; 6272 participants). There may be a reduced risk of seroma for
people treated with NPWT but this is imprecise: the RR was 0.82 (95% CI
0.65 to 1.05; I2 = 0%; 15 trials; 5436 participants). For skin
blisters, there is low-certainty evidence that people treated with NPWT
may be more likely to develop skin blisters compared with those treated
with standard dressing (RR 3.55; 95% CI 1.43 to 8.77; I2 = 74%;
11 trials; 5015 participants). The effect of NPWT on haematoma is
uncertain (RR 0.79; 95 % CI 0.48 to 1.30; I2 = 0%; 17 trials;
5909 participants; very low-certainty evidence). There is low-certainty
evidence of little to no difference in reported pain between groups. Pain
was measured in different ways and most studies could not be pooled; this
GRADE assessment is based on all fourteen trials reporting pain; the
pooled RR for the proportion of participants who experienced pain was 1.52
(95% CI 0.20, 11.31; I2 = 34%; two studies; 632 participants).
Cost-effectiveness. Six economic studies, based wholly or partially on
trials in our review, assessed the cost-effectiveness of NPWT compared
with standard care. They considered NPWT in five indications: caesarean
sections in obese women; surgery for lower limb fracture; knee/hip
arthroplasty; coronary artery bypass grafts; and vascular surgery with
inguinal incisions. They calculated quality-adjusted life-years or an
equivalent, and produced estimates of the treatments' relative
cost-effectiveness. The reporting quality was good but the evidence
certainty varied from moderate to very low. There is moderate-certainty
evidence that NPWT in surgery for lower limb fracture was not
cost-effective at any threshold of willingness-to-pay and that NPWT is
probably cost-effective in obese women undergoing caesarean section. Other
studies found low or very low-certainty evidence indicating that NPWT may
be cost-effective for the indications assessed. Authors' conclusions:
People with primary closure of their surgical wound and treated
prophylactically with NPWT following surgery probably experience fewer
SSIs than people treated with standard dressings but there is probably no
difference in wound dehiscence (moderate-certainty evidence). There may be
a reduced risk of death after surgery for people treated with NPWT
compared with standard dressings but there is uncertainty around this as
confidence intervals include risk of benefit and harm (low-certainty
evidence). People treated with NPWT may experience more instances of skin
blistering compared with standard dressing treatment (low-certainty
evidence). There are no clear differences in other secondary outcomes
where most evidence is low or very low-certainty. Assessments of
cost-effectiveness of NPWT produced differing results in different
indications. There is a large number of ongoing studies, the results of
which may change the findings of this review. Decisions about use of NPWT
should take into account surgical indication and setting and consider
evidence for all outcomes. Copyright © 2022 The Authors. Cochrane
Database of Systematic Reviews published by John Wiley & Sons, Ltd. on
behalf of The Cochrane Collaboration.

<51>
Accession Number
634446309
Title
Antibiotics for secondary prevention of coronary heart disease.
Source
Cochrane Database of Systematic Reviews. 2021(2) (no pagination), 2021.
Article Number: CD003610. Date of Publication: 23 Feb 2021.
Author
Sethi N.J.; Safi S.; Korang S.K.; Hrobjartsson A.; Skoog M.; Gluud C.;
Jakobsen J.C.
Institution
(Sethi, Safi, Korang, Skoog, Gluud, Jakobsen) Copenhagen Trial Unit,
Centre for Clinical Intervention Research, The Capital Region of Denmark,
Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
(Hrobjartsson) Centre for Evidence-Based Medicine Odense (CEBMO) and
Cochrane Denmark, Department of Clinical Research, University of Southern
Denmark, Odense, Denmark
(Skoog) Clinical Study Support, Clinical Studies Sweden - Forum South,
Lund, Sweden
(Gluud) Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for
Clinical Intervention Research, The Capital Region of Denmark,
Rigshospitalet, Copenhagen, Denmark
(Jakobsen) Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre
for Clinical Intervention Research, The Capital Region of Denmark,
Rigshospitalet, Copenhagen, Denmark
(Hrobjartsson) Open Patient data Explorative Network (OPEN), Odense
University Hospital, Odense, Denmark
(Gluud, Jakobsen) Department of Regional Health Research, The Faculty of
Health Sciences, University of Southern Denmark, Odense, Denmark
Publisher
John Wiley and Sons Ltd
Abstract
Background: Coronary heart disease is the leading cause of mortality
worldwide with approximately 7.4 million deaths each year. People with
established coronary heart disease have a high risk of subsequent
cardiovascular events including myocardial infarction, stroke, and
cardiovascular death. Antibiotics might prevent such outcomes due to their
antibacterial, antiinflammatory, and antioxidative effects. However, a
randomised clinical trial and several observational studies have suggested
that antibiotics may increase the risk of cardiovascular events and
mortality. Furthermore, several non-Cochrane Reviews, that are now
outdated, have assessed the effects of antibiotics for coronary heart
disease and have shown conflicting results. No previous systematic review
using Cochrane methodology has assessed the effects of antibiotics for
coronary heart disease. Objective(s): We assessed the benefits and
harms of antibiotics compared with placebo or no intervention for the
secondary prevention of coronary heart disease. Search Method(s): We
searched CENTRAL, MEDLINE, Embase, LILACS, SCI-EXPANDED, and BIOSIS in
December 2019 in order to identify relevant trials. Additionally, we
searched TRIP, Google Scholar, and nine trial registries in December 2019.
We also contacted 11 pharmaceutical companies and searched the reference
lists of included trials, previous systematic reviews, and other types of
reviews. Selection Criteria: Randomised clinical trials assessing the
effects of antibiotics versus placebo or no intervention for secondary
prevention of coronary heart disease in adult participants (>=18 years).
Trials were included irrespective of setting, blinding, publication
status, publication year, language, and reporting of our outcomes.
 Data Collection and Analysis: Three review authors independently
extracted data. Our primary outcomes were all-cause mortality, serious
adverse event according to the International Conference on Harmonization -
Good Clinical Practice (ICH-GCP), and quality of life. Our secondary
outcomes were cardiovascular mortality, myocardial infarction, stroke, and
sudden cardiac death. Our primary time point of interest was at maximum
follow-up. Additionally, we extracted outcome data at 24+/-6 months
follow-up. We assessed the risks of systematic errors using Cochrane 'Rosk
of bias' tool. We calculated risk ratios (RRs) with 95% confidence
intervals (CIs) for dichotomous outcomes. We calculated absolute risk
reduction (ARR) or increase (ARI) and number needed to treat for an
additional beneficial outcome (NNTB) or for an additional harmful outcome
(NNTH) if the outcome result showed a beneficial or harmful effect,
respectively. The certainty of the body of evidence was assessed by GRADE.
 Main Result(s): We included 38 trials randomising a total of 26,638
participants (mean age 61.6 years), with 23/38 trials reporting data on
26,078 participants that could be meta-analysed. Three trials were at low
risk of bias and the 35 remaining trials were at high risk of bias. Trials
assessing the effects of macrolides (28 trials; 22,059 participants) and
quinolones (two trials; 4162 participants) contributed with the vast
majority of the data. Meta-analyses at maximum follow-up showed that
antibiotics versus placebo or no intervention seemed to increase the risk
of all-cause mortality (RR 1.06; 95% CI 0.99 to 1.13; P = 0.07;
I2 = 0%; ARI 0.48%; NNTH 208; 25,774 participants; 20 trials;
high certainty of evidence), stroke (RR 1.14; 95% CI 1.00 to 1.29; P =
0.04; I2 = 0%; ARI 0.73%; NNTH 138; 14,774 participants; 9
trials; high certainty of evidence), and probably also cardiovascular
mortality (RR 1.11; 95% CI 0.98 to 1.25; P = 0.11; I2= 0%; 4674
participants; 2 trials; moderate certainty of evidence). Little to no
difference was observed when assessing the risk of myocardial infarction
(RR 0.95; 95% CI 0.88 to 1.03; P = 0.23; I2 = 0%; 25,523
participants; 17 trials; high certainty of evidence). No evidence of a
difference was observed when assessing sudden cardiac death (RR 1.08; 95%
CI 0.90 to 1.31; P = 0.41; I2 = 0%; 4520 participants; 2
trials; moderate certainty of evidence). Meta-analyses at 24+/-6 months
follow-up showed that antibiotics versus placebo or no intervention
increased the risk of all-cause mortality (RR 1.25; 95% CI 1.06 to 1.48; P
= 0.007; I2 = 0%; ARI 1.26%; NNTH 79 (95% CI 335 to 42); 9517
participants; 6 trials; high certainty of evidence), cardiovascular
mortality (RR 1.50; 95% CI 1.17 to 1.91; P = 0.001; I2 = 0%;
ARI 1.12%; NNTH 89 (95% CI 261 to 49); 9044 participants; 5 trials; high
certainty of evidence), and probably also sudden cardiac death (RR 1.77;
95% CI 1.28 to 2.44; P = 0.0005; I2 = 0%; ARI 1.9%; NNTH 53
(95% CI 145 to 28); 4520 participants; 2 trials; moderate certainty of
evidence). No evidence of a difference was observed when assessing the
risk of myocardial infarction (RR 0.95; 95% CI 0.82 to 1.11; P = 0.53;
I2 = 43%; 9457 participants; 5 trials; moderate certainty of
evidence) and stroke (RR 1.17; 95% CI 0.90 to 1.52; P = 0.24;
I2 = 0%; 9457 participants; 5 trials; high certainty of
evidence). Meta-analyses of trials at low risk of bias differed from the
overall analyses when assessing cardiovascular mortality at maximum
follow-up. For all other outcomes, meta-analyses of trials at low risk of
bias did not differ from the overall analyses. None of the trials
specifically assessed serious adverse event according to ICH-GCP. No data
were found on quality of life. Authors' conclusions: Our present review
indicates that antibiotics (macrolides or quinolones) for secondary
prevention of coronary heart disease seem harmful when assessing the risk
of all-cause mortality, cardiovascular mortality, and stroke at maximum
follow-up and all-cause mortality, cardiovascular mortality, and sudden
cardiac death at 24+/-6 months follow-up. Current evidence does,
therefore, not support the clinical use of macrolides and quinolones for
the secondary prevention of coronary heart disease. Future trials on the
safety of macrolides or quinolones for the secondary prevention in
patients with coronary heart disease do not seem ethical. In general,
randomised clinical trials assessing the effects of antibiotics,
especially macrolides and quinolones, need longer follow-up so that
late-occurring adverse events can also be assessed. Copyright ©
2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

<52>
Accession Number
636718219
Title
Transfusion thresholds for guiding red blood cell transfusion.
Source
Cochrane Database of Systematic Reviews. 2021(12) (no pagination), 2021.
Article Number: CD002042. Date of Publication: 21 Dec 2021.
Author
Carson J.L.; Stanworth S.J.; Dennis J.A.; Trivella M.; Roubinian N.;
Fergusson D.A.; Triulzi D.; Doree C.; Hebert P.C.
Institution
(Carson) Division of General Internal Medicine, Rutgers Robert Wood
Johnson Medical School, New Brunswick, NJ, United States
(Stanworth) John Radcliffe Hospital, Oxford University Hospitals NHS
Foundation Trust, Oxford, United Kingdom
(Stanworth) Radcliffe Department of Medicine, NIHR Oxford Biomedical
Research Centre, University of Oxford, Oxford, United Kingdom
(Stanworth, Doree) Systematic Review Initiative, NHS Blood and Transplant,
Oxford, United Kingdom
(Dennis) Cochrane Injuries Group, London School of Hygiene & Tropical
Medicine, London, United Kingdom
(Trivella) Department of Cardiovascular Medicine, University of Oxford,
Oxford, United Kingdom
(Roubinian) Kaiser Permanente Division of Research Northern California,
Oakland, CA, United States
(Fergusson) Clinical Epidemiology Program, Ottawa Hospital Research
Institute, Ottawa, Canada
(Triulzi) The Institute for Transfusion Medicine, University of
Pittsburgh, Pittsburgh, PA, United States
(Hebert) Centre for Research, University of Montreal Hospital Research
Centre, Montreal, Canada
Publisher
John Wiley and Sons Ltd
Abstract
Background: The optimal haemoglobin threshold for use of red blood cell
(RBC) transfusions in anaemic patients remains an active field of
research. Blood is a scarce resource, and in some countries, transfusions
are less safe than in others because of inadequate testing for viral
pathogens. If a liberal transfusion policy does not improve clinical
outcomes, or if it is equivalent, then adopting a more restrictive
approach could be recognised as the standard of care. Objective(s):
The aim of this review update was to compare 30-day mortality and other
clinical outcomes for participants randomised to restrictive versus
liberal red blood cell (RBC) transfusion thresholds (triggers) for all
clinical conditions. The restrictive transfusion threshold uses a lower
haemoglobin concentration as a threshold for transfusion (most commonly,
7.0 g/dL to 8.0 g/dL), and the liberal transfusion threshold uses a higher
haemoglobin concentration as a threshold for transfusion (most commonly,
9.0 g/dL to 10.0 g/dL). Search Method(s): We identified trials
through updated searches: CENTRAL (2020, Issue 11), MEDLINE (1946 to
November 2020), Embase (1974 to November 2020), Transfusion Evidence
Library (1950 to November 2020), Web of Science Conference Proceedings
Citation Index (1990 to November 2020), and trial registries (November
2020). We checked the reference lists of other published reviews and
relevant papers to identify additional trials. We were aware of one trial
identified in earlier searching that was in the process of being published
(in February 2021), and we were able to include it before this review was
finalised. Selection Criteria: We included randomised trials of
surgical or medical participants that recruited adults or children, or
both. We excluded studies that focused on neonates. Eligible trials
assigned intervention groups on the basis of different transfusion
schedules or thresholds or 'triggers'. These thresholds would be defined
by a haemoglobin (Hb) or haematocrit (Hct) concentration below which an
RBC transfusion would be administered; the haemoglobin concentration
remains the most commonly applied marker of the need for RBC transfusion
in clinical practice. We included trials in which investigators had
allocated participants to higher thresholds or more liberal transfusion
strategies compared to more restrictive ones, which might include no
transfusion. As in previous versions of this review, we did not exclude
unregistered trials published after 2010 (as per the policy of the
Cochrane Injuries Group, 2015), however, we did conduct analyses to
consider the differential impact of results of trials for which
prospective registration could not be confirmed. Data Collection and
Analysis: We identified trials for inclusion and extracted data using
Cochrane methods. We pooled risk ratios of clinical outcomes across trials
using a random-effects model. Two review authors independently extracted
data and assessed risk of bias. We conducted predefined analyses by
clinical subgroups. We defined participants randomly allocated to the
lower transfusion threshold as being in the 'restrictive transfusion'
group and those randomly allocated to the higher transfusion threshold as
being in the 'liberal transfusion' group. Main Result(s): A total of
48 trials, involving data from 21,433 participants (at baseline), across a
range of clinical contexts (e.g. orthopaedic, cardiac, or vascular
surgery; critical care; acute blood loss (including gastrointestinal
bleeding); acute coronary syndrome; cancer; leukaemia; haematological
malignancies), met the eligibility criteria. The haemoglobin concentration
used to define the restrictive transfusion group in most trials (36) was
between 7.0 g/dL and 8.0 g/dL. Most trials included only adults; three
trials focused on children. The included studies were generally at low
risk of bias for key domains including allocation concealment and
incomplete outcome data. Restrictive transfusion strategies reduced the
risk of receiving at least one RBC transfusion by 41% across a broad range
of clinical contexts (risk ratio (RR) 0.59, 95% confidence interval (CI)
0.53 to 0.66; 42 studies, 20,057 participants; high-quality evidence),
with a large amount of heterogeneity between trials (I2 = 96%). Overall,
restrictive transfusion strategies did not increase or decrease the risk
of 30-day mortality compared with liberal transfusion strategies (RR 0.99,
95% CI 0.86 to 1.15; 31 studies, 16,729 participants; I2 = 30%;
moderate-quality evidence) or any of the other outcomes assessed (i.e.
cardiac events (low-quality evidence), myocardial infarction, stroke,
thromboembolism (all high-quality evidence)). High-quality evidence shows
that the liberal transfusion threshold did not affect the risk of
infection (pneumonia, wound infection, or bacteraemia).
Transfusion-specific reactions are uncommon and were inconsistently
reported within trials. We noted less certainty in the strength of
evidence to support the safety of restrictive transfusion thresholds for
the following predefined clinical subgroups: myocardial infarction,
vascular surgery, haematological malignancies, and chronic bone-marrow
disorders. Authors' conclusions: Transfusion at a restrictive haemoglobin
concentration decreased the proportion of people exposed to RBC
transfusion by 41% across a broad range of clinical contexts. Across all
trials, no evidence suggests that a restrictive transfusion strategy
impacted 30-day mortality, mortality at other time points, or morbidity
(i.e. cardiac events, myocardial infarction, stroke, pneumonia,
thromboembolism, infection) compared with a liberal transfusion strategy.
Despite including 17 more randomised trials (and 8846 participants), data
remain insufficient to inform the safety of transfusion policies in
important and selected clinical contexts, such as myocardial infarction,
chronic cardiovascular disease, neurological injury or traumatic brain
injury, stroke, thrombocytopenia, and cancer or haematological
malignancies, including chronic bone marrow failure. Further work is
needed to improve our understanding of outcomes other than mortality. Most
trials compared only two separate thresholds for haemoglobin
concentration, which may not identify the actual optimal threshold for
transfusion in a particular patient. Haemoglobin concentration may not be
the most informative marker of the need for transfusion in individual
patients with different degrees of physiological adaptation to anaemia.
Notwithstanding these issues, overall findings provide good evidence that
transfusions with allogeneic RBCs can be avoided in most patients with
haemoglobin thresholds between the range of 7.0 g/dL and 8.0 g/dL. Some
patient subgroups might benefit from RBCs to maintain higher haemoglobin
concentrations; research efforts should focus on these clinical
contexts. Copyright © 2021 The Cochrane Collaboration. Published
by John Wiley & Sons, Ltd.

<53>
Accession Number
636447137
Title
Transcatheter and surgical intervention for secondary mitral
regurgitation.
Source
Cochrane Database of Systematic Reviews. 2021(11) (no pagination), 2021.
Article Number: CD014812. Date of Publication: 16 Nov 2021.
Author
Sharma H.; Birkhoelzer S.M.; Liu B.; Su Khin K.L.; Liu S.; Tahir Z.;
Pimenta D.; Ahmad M.; Lall K.; Banerjee A.; Shah B.N.; Myerson S.;
Prendergast B.; Steeds R.
Institution
(Sharma) Institute of Cardiovascular Sciences, University of Birmingham,
Birmingham, United Kingdom
(Birkhoelzer) Department of Cardiology, Portsmouth Hospitals University
NHS Trust, Portsmouth, United Kingdom
(Liu, Su Khin) Department of Cardiology, University Hospital Birmingham,
Birmingham, United Kingdom
(Liu) Department of Cardiology, Barts Heart Centre, St Bartholomew's
Hospital, London, United Kingdom
(Tahir) Cardiothoracic Surgery, University Hospitals Plymouth, Plymouth,
United Kingdom
(Pimenta) University College London, London, United Kingdom
(Ahmad) Department of Cardiology, Royal Free Hospital, Royal Free London
NHS Foundation Trust, London, United Kingdom
(Lall) Department of Cardiothoracic Surgery, Barts Health NHS Trust,
London, United Kingdom
(Banerjee) Institute of Health Informatics Research, University College
London, London, United Kingdom
(Shah) British Heart Valve Society, London, United Kingdom
(Myerson) Division of Cardiovascular Medicine, Radcliffe Department of
Medicine, University of Oxford, Oxford, United Kingdom
(Prendergast) Department of Cardiology, St Thomas' Hospital, London,
United Kingdom
(Steeds) Department of Cardiology, University Hospitals Birmingham (Queen
Elizabeth) NHS FT, Birmingham, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Objectives: This is a protocol for a Cochrane Review (intervention). The
objectives are as follows:. To assess the effects in secondary mitral
regurgitation of:. Surgical mitral valve intervention and coronary artery
bypass graft versus coronary artery bypass graft alone; and Transcatheter
mitral valve intervention and medical therapy versus medical therapy
alone. Copyright © 2021 The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd.

<54>
Accession Number
636379554
Title
Coronary artery bypass surgery versus medical therapy alone for ischaemic
heart disease.
Source
Cochrane Database of Systematic Reviews. 2021(11) (no pagination), 2021.
Article Number: CD013645. Date of Publication: 04 Nov 2021.
Author
Zuo L.; Yue X.; Bian T.; Cai Y.; Zeng L.; He H.; Wang L.; Ioannou A.; Li
S.
Institution
(Zuo, Bian, Cai, Wang, Wang) Department of Cardiovascular Surgery,
Zhengzhou Seventh People's Hospital, Zhengzhou, China
(Yue) Department of Hemangioma Surgery, Henan Province People's Hospital,
Zhengzhou, China
(Zeng) Department of Respiratory and Critical Care Medicine, Mindong
Hospital Affiliated to Fujian Medical University, Fu'an City, China
(He) Statistical Medicine and Preventive Medicine, Basic Medical College
of Henan University, Kaifeng, China
(Ioannou) Royal Free London NHS Foundation Trust, London, United Kingdom
(Li) Zhengzhou Seventh People's Hospital, Zhengzhou, China
Publisher
John Wiley and Sons Ltd
Abstract
This protocol for a Cochrane Review has been withdrawn. Copyright
© 2021 The Cochrane Collaboration. Published by John Wiley & Sons,
Ltd.

<55>
Accession Number
636108915
Title
Surgery for deep venous insufficiency.
Source
Cochrane Database of Systematic Reviews. 2021(9) (no pagination), 2021.
Article Number: CD001097. Date of Publication: 30 Sep 2021.
Author
Goel R.R.; Hardy S.C.; Brown T.
Institution
(Goel, Hardy) Department of Vascular Surgery, East Lancashire Hospitals
NHS Trust, Royal Blackburn Hospital (Trust HQ), Blackburn, United Kingdom
(Brown) Cochrane Vascular, University of Edinburgh, Edinburgh, United
Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Chronic deep venous insufficiency is caused by incompetent
vein valves, blockage of large-calibre leg veins, or both; and causes a
range of symptoms including recurrent ulcers, pain and swelling. Most
surgeons accept that well-fitted graduated compression stockings (GCS) and
local care of wounds serve as adequate treatment for most people, but
sometimes symptoms are not controlled and ulcers recur frequently, or they
do not heal despite compliance with conservative measures. In these
situations, in the presence of severe venous dysfunction, surgery has been
advocated by some vascular surgeons. This is an update of the review first
published in 2000. Objective(s): To assess the effects of surgical
management of deep venous insufficiency on ulcer healing and recurrence,
complications of surgery, clinical outcomes, quality of life (QoL) and
pain. Search Method(s): The Cochrane Vascular Information Specialist
searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE,
Embase and CINAHL databases, and the WHO ICTRP and ClinicalTrials.gov
trials registries to 23 June 2020. Selection Criteria: We considered
randomised controlled trials (RCTs) of surgical treatment versus another
surgical procedure, usual care or no treatment, for people with deep
venous insufficiency. Data Collection and Analysis: Two review
authors independently assessed trials for inclusion, extracted data and
assessed the risk of bias with the Cochrane risk of bias tool. We
evaluated the certainty of the evidence using GRADE. We were unable to
pool data due to differences in outcomes reported and how these were
measured. Outcomes of interest were ulcer healing and recurrence,
complications of surgery, clinical changes, QoL and pain. Main
Result(s): We included four RCTs (273 participants) comparing
valvuloplasty plus surgery of the superficial venous system with surgery
of the superficial venous system for primary valvular incompetence.
Follow-up was two to 10 years. All included studies investigated primary
valve incompetence. No studies investigated other surgical procedures for
the treatment of people with deep venous insufficiency or surgery for
secondary valvular incompetence or venous obstruction. The certainty of
the evidence was downgraded for risk of bias concerns and imprecision due
to small numbers of included trials, participants and events. None of the
studies reported ulcer healing or ulcer recurrence. One study included 27
participants with active venous ulceration at the time of surgery; the
other three studies did not include people with ulcers. There were no
major complications of surgery, no incidence of deep vein thrombosis and
no deaths reported (very low-certainty evidence). All four studies
reported clinical changes but the data could not be pooled due to
different outcome measures and reporting of the data. Two studies assessed
clinical changes using subjective and objective measurements, as specified
in the clinical, aetiological, anatomical and pathophysiological (CEAP)
classification score (low-certainty evidence). One study reported mean
CEAP severity scores and one study reported change in clinical class using
CEAP. At baseline, the mean CEAP severity score was 18.1 (standard
deviation (SD) 4.4) for limbs undergoing external valvuloplasty with
surgery to the superficial venous system and 17.8 (SD 3.4) for limbs
undergoing surgery to the superficial venous system only. At three years
post-surgery, the mean CEAP severity score was 5.2 (SD 1.6) for limbs that
had undergone external valvuloplasty with surgery to the superficial
venous system and 9.2 (SD 2.6) for limbs that had undergone surgery to the
superficial venous system only (low-certainty evidence). In another study,
participants with progressive clinical dynamics over the five years
preceding surgery had higher rates of improvement in clinical condition in
the treatment group (valvuloplasty plus ligation) compared with the
control group (ligation only) (80% versus 51%) after seven years of
follow-up. Participants with stable preoperative clinical dynamics
demonstrated similar rates of improvement in both groups (95% with
valvuloplasty plus ligation versus 90% with ligation only) (low-certainty
evidence). One study reported disease-specific QoL using cumulative scores
from a 10-item visual analogue scale (VAS) and reported that in the
limited anterior plication (LAP) plus superficial venous surgery group the
score decreased from 49 to 11 at 10 years, compared to a decrease from 48
to 36 in participants treated with superficial venous surgery only (very
low-certainty evidence). Two studies reported pain. Within the QoL VAS
scale, one item was 'pain/discomfort' and scores decreased from 4 to 1 at
10 years for participants in the LAP plus superficial venous surgery group
and increased from 2 to 3 at 10 years in participants treated with
superficial venous surgery only. A second study reported that 'leg
heaviness and pain' was resolved completely in 36/40 limbs treated with
femoral vein external valvuloplasty plus high ligation and stripping of
the great saphenous vein (GSV) and percutaneous continuous circumsuture
and 22/40 limbs treated with high ligation and stripping of GSV and
percutaneous continuous circumsuture alone, at three years' follow-up
(very low-certainty evidence). Authors' conclusions: We only identified
evidence from four RCTs for valvuloplasty plus surgery of the superficial
venous system for primary valvular incompetence. We found no studies
investigating other surgical procedures for the treatment of people with
deep venous insufficiency, or that included participants with secondary
valvular incompetence or venous obstruction. None of the studies reported
ulcer healing or recurrence, and few studies reported complications of
surgery, clinical outcomes, QoL and pain (very low- to low-certainty
evidence). Conclusions on the effectiveness of valvuloplasty for deep
venous insufficiency cannot be made. Copyright © 2021 The
Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

<56>
Accession Number
635449476
Title
De-escalation of dual antiplatelet therapy for patients with acute
coronary syndrome after percutaneous coronary intervention: a network
meta-analysis of randomised controlled trials.
Source
Cochrane Database of Systematic Reviews. 2021(7) (no pagination), 2021.
Article Number: CD014813. Date of Publication: 08 Jul 2021.
Author
De Filippo O.; Piroli F.; Bruno F.; Bocchino P.P.; Saglietto A.; Franchin
L.; Angelini F.; Gallone G.; Alabed S.; Gasparini M.; Ahmad M.; De Ferrari
G.M.; D'Ascenzo F.
Institution
(De Filippo, Piroli, Bruno, Bocchino, Saglietto, Franchin, Angelini,
Gallone, De Ferrari) Division of Cardiology, Department of Internal
Medicine, University of Turin, Turin, Italy
(Alabed) Department of Infection, Immunity and Cardiovascular Disease,
University of Sheffield, Sheffield, United Kingdom
(Gasparini) Dipartimento di Scienze Matematiche (DISMA), Giuseppe Luigi
Lagrange, Politecnico di Torino, Torino, Italy
(Ahmad) Department of Cardiology, Royal Free Hospital, Royal Free London
NHS Foundation Trust, London, United Kingdom
(D'Ascenzo) Department of Internal Medicine, Division of Cardiology,
University of Turin, Turin, Italy
Publisher
John Wiley and Sons Ltd
Abstract
Objectives: This is a protocol for a Cochrane Review (intervention). The
objectives are as follows:. The objective of this review is to evaluate
the available evidence in order to identify an optimal de-escalation
strategy in terms of duration and type of therapy for patients with ACS
treated with PCI. We will perform a NMA to appraise the safest and most
efficacious combination of type and length of DAPT
de-escalation. Copyright © 2021 The Cochrane Collaboration.
Published by John Wiley & Sons, Ltd.

<57>
Accession Number
635050033
Title
Single-dose intravenous ketorolac for acute postoperative pain in adults.
Source
Cochrane Database of Systematic Reviews. 2021(5) (no pagination), 2021.
Article Number: CD013263. Date of Publication: 17 May 2021.
Author
McNicol E.D.; Ferguson M.C.; Schumann R.
Institution
(McNicol) Department of Anesthesiology and Perioperative Medicine, Tufts
Medical Center, Boston, MA, United States
(Ferguson) Pharmacy Practice, Southern Illinois University Edwardsville,
Edwardsville, IL, United States
(Schumann) Department of Anesthesia, Critical Care and Pain Medicine, VA
Boston Healthcare System, West Roxbury, MA, United States
Publisher
John Wiley and Sons Ltd
Abstract
Background: Postoperative pain is common and may be severe. Postoperative
administration of non-steroidal anti-inflammatory drugs (NSAIDs) reduces
patient opioid requirements and, in turn, may reduce the incidence and
severity of opioid-induced adverse events (AEs). Objective(s): To
assess the analgesic efficacy and adverse effects of single-dose
intravenous ketorolac, compared with placebo or an active comparator, for
moderate to severe postoperative pain in adults. Search Method(s): We
searched the following databases without language restrictions: CENTRAL,
MEDLINE, Embase and LILACS on 20 April 2020. We checked clinical trials
registers and reference lists of retrieved articles for additional
studies. Selection Criteria: Randomized double-blind trials that
compared a single postoperative dose of intravenous ketorolac with placebo
or another active treatment, for treating acute postoperative pain in
adults following any surgery. Data Collection and Analysis: We used
standard methodological procedures expected by Cochrane. Our primary
outcome was the number of participants in each arm achieving at least 50%
pain relief over a four- and six-hour period.Our secondary outcomes were
time to and number of participants using rescue medication; withdrawals
due to lack of efficacy, adverse events (AEs), and for any other cause;
and number of participants experiencing any AE, serious AEs (SAEs), and
NSAID-related or opioid-related AEs.For subgroup analysis, we planned to
analyze different doses of parenteral ketorolac separately and to analyze
results based on the type of surgery performed.We assessed the certainty
of evidence using GRADE. Main Result(s): We included 12 studies,
involving 1905 participants undergoing various surgeries
(pelvic/abdominal, dental, and orthopedic), with 17 to 83 participants
receiving intravenous ketorolac in each study. Mean study population ages
ranged from 22.5 years to 67.4 years. Most studies administered a dose of
ketorolac of 30 mg; one study assessed 15 mg, and another administered 60
mg. Most studies had an unclear risk of bias for some domains,
particularly allocation concealment and blinding, and a high risk of bias
due to small sample size. The overall certainty of evidence for each
outcome ranged from very low to moderate. Reasons for downgrading
certainty included serious study limitations, inconsistency and
imprecision. Ketorolac versus placebo. Very low-certainty evidence from
eight studies (658 participants) suggests that ketorolac results in a
large increase in the number of participants achieving at least 50% pain
relief over four hours compared to placebo, but the evidence is very
uncertain (risk ratio (RR) 2.81, 95% confidence interval (CI) 1.80 to
4.37). The number needed to treat for one additional participant to
benefit (NNTB) was 2.4 (95% CI 1.8 to 3.7). Low-certainty evidence from 10
studies (914 participants) demonstrates that ketorolac may result in a
large increase in the number of participants achieving at least 50% pain
relief over six hours compared to placebo (RR 3.26, 95% CI 1.93 to 5.51).
The NNTB was 2.5 (95% CI 1.9 to 3.7). Among secondary outcomes, for time
to rescue medication, moderate-certainty evidence comparing intravenous
ketorolac versus placebo demonstrated a mean median of 271 minutes for
ketorolac versus 104 minutes for placebo (6 studies, 633 participants).
For the number of participants using rescue medication, very low-certainty
evidence from five studies (417 participants) compared ketorolac with
placebo. The RR was 0.60 (95% CI 0.36 to 1.00), that is, it did not
demonstrate a difference between groups. Ketorolac probably results in a
slight increase in total adverse event rates compared with placebo (74%
versus 65%; 8 studies, 810 participants; RR 1.09, 95% CI 1.00 to 1.19;
number needed to treat for an additional harmful event (NNTH) 16.7, 95% CI
8.3 to infinite, moderate-certainty evidence). Serious AEs were rare.
Low-certainty evidence from eight studies (703 participants) did not
demonstrate a difference in rates between ketorolac and placebo (RR 0.62,
95% CI 0.13 to 3.03). Ketorolac versus NSAIDs Ketorolac was compared to
parecoxib in four studies and diclofenac in two studies. For our primary
outcome, over both four and six hours there was no evidence of a
difference between intravenous ketorolac and another NSAID (low-certainty
and moderate-certainty evidence, respectively). Over four hours, four
studies (337 participants) produced an RR of 1.04 (95% CI 0.89 to 1.21)
and over six hours, six studies (603 participants) produced an RR of 1.06
(95% CI 0.95 to 1.19). For time to rescue medication, low-certainty
evidence from four studies (427 participants) suggested that participants
receiving ketorolac waited an extra 35 minutes (mean median 331 minutes
versus 296 minutes). For the number of participants using rescue
medication, very low-certainty evidence from three studies (260
participants) compared ketorolac with another NSAID. The RR was 0.90 (95%
CI 0.58 to 1.40), that is, there may be little or no difference between
groups. Ketorolac probably results in a slight increase in total adverse
event rates compared with another NSAID (76% versus 68%, 5 studies, 516
participants; RR 1.11, 95% CI 1.00 to 1.23; NNTH 12.5, 95% CI 6.7 to
infinite, moderate-certainty evidence). Serious AEs were rare.
Low-certainty evidence from five studies (530 participants) did not
demonstrate a difference in rates between ketorolac and another NSAID (RR
3.18, 95% CI 0.13 to 76.99). Only one of the five studies reported a
single serious AE. Authors' conclusions: The amount and certainty of
evidence for the use of intravenous ketorolac as a treatment for
postoperative pain varies across efficacy and safety outcomes and amongst
comparators, from very low to moderate. The available evidence indicates
that postoperative intravenous ketorolac administration may offer
substantial pain relief for most patients, but further research may impact
this estimate. Adverse events appear to occur at a slightly higher rate in
comparison to placebo and to other NSAIDs. Insufficient information is
available to assess whether intravenous ketorolac has a different rate of
gastrointestinal or surgical-site bleeding, renal dysfunction, or
cardiovascular events versus other NSAIDs. There was a lack of studies in
cardiovascular surgeries and in elderly populations who may be at
increased risk for adverse events. Copyright © 2021 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<58>
Accession Number
634288753
Title
Melatonin for preoperative and postoperative anxiety in adults.
Source
Cochrane Database of Systematic Reviews. 2020(12) (no pagination), 2020.
Article Number: CD009861. Date of Publication: 08 Dec 2020.
Author
Madsen B.K.; Zetner D.; Moller A.M.; Rosenberg J.
Institution
(Madsen, Zetner, Rosenberg) Center for Perioperative Optimization,
Department of Surgery, Herlev Hospital, Herlev, Denmark
(Moller) Cochrane Anaesthesia, Critical and Emergency Care Group, Herlev
and Gentofte Hospital, University of Copenhagen, Herlev, Denmark
(Rosenberg) Cochrane Colorectal Group, Herlev and Gentofte Hospital,
University of Copenhagen, Herlev, Denmark
Publisher
John Wiley and Sons Ltd
Abstract
Background: Anxiety in relation to surgery is a well-known problem.
Melatonin offers an alternative treatment to benzodiazepines for
ameliorating this condition in the preoperative and postoperative periods.
 Objective(s): To assess the effects of melatonin on preoperative and
postoperative anxiety compared to placebo or benzodiazepines. Search
Method(s): We searched the following databases on 10 July 2020: CENTRAL,
MEDLINE, Embase, CINAHL, and Web of Science. For ongoing trials and
protocols, we searched clinicaltrials.gov and the World Health
Organization (WHO) International Clinical Trials Registry Platform.
 Selection Criteria: We included randomized, placebo-controlled or
standard treatment-controlled (or both) studies that evaluated the effects
of preoperatively administered melatonin on preoperative or postoperative
anxiety. We included adult patients of both sexes (15 to 90 years of age)
undergoing any kind of surgical procedure for which it was necessary to
use general, regional, or topical anaesthesia. Data Collection and
Analysis: One review author conducted data extraction in duplicate. Data
extracted included information about study design, country of origin,
number of participants and demographic details, type of surgery, type of
anaesthesia, intervention and dosing regimens, preoperative anxiety
outcome measures, and postoperative anxiety outcome measures. Main
Result(s): We included 27 randomized controlled trials (RCTs), involving
2319 participants, that assessed melatonin for treating preoperative
anxiety, postoperative anxiety, or both. Twenty-four studies compared
melatonin with placebo. Eleven studies compared melatonin to a
benzodiazepine (seven studies with midazolam, three studies with
alprazolam, and one study with oxazepam). Other comparators in a small
number of studies were gabapentin, clonidine, and pregabalin. No studies
were judged to be at low risk of bias for all domains. Most studies were
judged to be at unclear risk of bias overall. Eight studies were judged to
be at high risk of bias in one or more domain, and thus, to be at high
risk of bias overall. Melatonin versus placebo. Melatonin probably results
in a reduction in preoperative anxiety measured by a visual analogue scale
(VAS, 0 to 100 mm) compared to placebo (mean difference (MD) -11.69, 95%
confidence interval (CI) -13.80 to -9.59; 18 studies, 1264 participants;
moderate-certainty evidence), based on a meta-analysis of 18 studies.
Melatonin may reduce immediate postoperative anxiety measured on a 0 to
100 mm VAS compared to placebo (MD -5.04, 95% CI -9.52 to -0.55; 7
studies, 524 participants; low-certainty evidence), and may reduce delayed
postoperative anxiety measured six hours after surgery using the
State-Trait Anxiety Inventory (STAI) (MD -5.31, 95% CI -8.78 to -1.84; 2
studies; 73 participants; low-certainty evidence). Melatonin versus
benzodiazepines (midazolam and alprazolam). Melatonin probably results in
little or no difference in preoperative anxiety measured on a 0 to 100 mm
VAS (MD 0.78, 95% CI -2.02 to 3.58; 7 studies, 409 participants;
moderate-certainty evidence) and there may be little or no difference in
immediate postoperative anxiety (MD -2.12, 95% CI -4.61 to 0.36; 3
studies, 176 participants; low-certainty evidence). Adverse events.
Fourteen studies did not report on adverse events. Six studies
specifically reported that no side effects were observed, and the
remaining seven studies reported cases of nausea, sleepiness, dizziness,
and headache; however, no serious adverse events were reported. Eleven
studies measured psychomotor and cognitive function, or both, and in
general, these studies found that benzodiazepines impaired psychomotor and
cognitive function more than placebo and melatonin. Fourteen studies
evaluated sedation and generally found that benzodiazepine caused the
highest degree of sedation, but melatonin also showed sedative properties
compared to placebo. Several studies did not report on adverse events;
therefore, it is not possible to conclude with certainty, from the data on
adverse effects collected in this review, that melatonin is better
tolerated than benzodiazepines. Authors' conclusions: When compared with
placebo, melatonin given as premedication (as tablets or sublingually)
probably reduces preoperative anxiety in adults (measured 50 to 120
minutes after administration), which is potentially clinically relevant.
The effect of melatonin on postoperative anxiety compared to placebo
(measured in the recovery room and six hours after surgery) was also
evident but was much smaller, and the clinical relevance of this finding
is uncertain. There was little or no difference in anxiety when melatonin
was compared with benzodiazepines. Thus, melatonin may have a similar
effect to benzodiazepines in reducing preoperative and postoperative
anxiety in adults. Copyright © 2020 The Cochrane Collaboration.
Published by John Wiley & Sons, Ltd.

<59>
Accession Number
632905149
Title
Cuffed versus uncuffed endotracheal tubes for neonates.
Source
Cochrane Database of Systematic Reviews. 2020(9) (no pagination), 2020.
Article Number: CD013736. Date of Publication: 23 Sep 2020.
Author
Dariya V.; Moresco L.; Bruschettini M.; Brion L.P.
Institution
(Dariya) Department of Pediatrics, Division of Neonatal-Perinatal
Medicine, University of Texas Southwestern Medical Center, Dallas, TX,
United States
(Moresco) Pediatric and Neonatology Unit, Ospedale San Paolo, Savona,
Italy
(Bruschettini) Department of Clinical Sciences Lund, Paediatrics, Lund
University, Skane University Hospital, Lund, Sweden
(Brion) Division of Neonatal-Perinatal Medicine, University of Texas
Southwestern at Dallas, Dallas, TX, United States
Publisher
John Wiley and Sons Ltd
Abstract
Objectives: This is a protocol for a Cochrane Review (intervention). The
objectives are as follows:. To assess the benefits and harms of cuffed
endotracheal tubes (ETT) (inflated or non-inflated) compared to uncuffed
endotracheal tubes for respiratory support in neonates. We will compare
the following comparisons. Cuffed ETT (inflated or not) versus uncuffed
ETT: cuffed not inflated versus uncuffed; cuffed inflated versus uncuffed.
Cuffed inflated versus cuffed not inflated. Copyright © 2020 The
Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

<60>
Accession Number
632653345
Title
Intravenous immunoglobulin for presumed viral myocarditis in children and
adults.
Source
Cochrane Database of Systematic Reviews. 2020(8) (no pagination), 2020.
Article Number: CD004370. Date of Publication: 24 Aug 2020.
Author
Robinson J.; Hartling L.; Vandermeer B.; Sebastianski M.; Klassen T.P.
Institution
(Robinson) Department of Pediatrics, University of Alberta, Edmonton,
Canada
(Hartling, Vandermeer) Department of Pediatrics and the Alberta Research
Centre for Health Evidence, University of Alberta, Edmonton, Canada
(Sebastianski) Pediatrics (AB SPOR Knowledge Translation Unit), University
of Alberta, Edmonton, Canada
(Klassen) Manitoba Institute of Child Health, Winnipeg, Canada
Publisher
John Wiley and Sons Ltd
Abstract
Background: This is an update of a previous review. Case reports and case
series have described dramatic responses to intravenous immunoglobulin
(IVIG) in people with presumed viral myocarditis, and its administration
has become commonplace. Objective(s): The primary objective of this
review was to compare event-free (death, requirement for a cardiac
transplant, or placement of a left ventricular assist device) or overall
(death) survival of adults and children with presumed viral myocarditis
treated with IVIG versus those who did not receive IVIG. A secondary
objective was to determine if a group of patients with presumed viral
myocarditis could be identified (on the basis of age, duration of
symptoms, acuity of onset of symptoms, cardiac function at presentation,
virological results, or the presence or absence of histological evidence
of acute myocarditis on cardiac biopsy in patients in whom a biopsy was
performed) who would be the most likely to benefit from IVIG. Search
Method(s): We searched CENTRAL, MEDLINE, Embase, DARE, CINAHL, Web of
Science Core Collection, and LILACS in July 2019, and two trial registries
in November 2019. We contacted authors of trials and checked reference
lists of relevant papers. We applied no language restrictions.
 Selection Criteria: We included studies if (1) participants had a
clinical diagnosis of acute myocarditis with a left ventricular ejection
fraction (LVEF) <= 0.45, left ventricular end-diastolic diameter (LVEDD) >
2 standard deviations (SDs) above the norm, or a left ventricular
shortening fraction (LVSF) > 2 SDs below the mean, with duration of
cardiac symptoms < 6 months; (2) participants had no evidence of
non-infectious or bacterial cardiac disease; and (3) participants were
randomly assigned to receive at least 1 g/kg of IVIG versus no IVIG or
placebo. We excluded studies if (1) participants had received
immunosuppression before outcome assessment; or (2) onset of myocarditis
was reported to have occurred < 6 months postpartum. Data Collection
and Analysis: Two review authors independently screened the search results
and extracted data. We assessed risk of bias with the Cochrane 'Risk of
bias' tool. We conducted meta-analysis for two outcomes (overall survival
and improvement in LVEF) with two adult trials. Other meta-analyses were
not possible because only three relevant trials were included, and
researchers analysed markedly different populations and used different
outcome measures. Main Result(s): In this update we added two trials
to the two previously included trials. A quasi-randomised trial was
previously included due to a paucity of evidence from randomised trials;
however, with the addition of two new randomised trials, it was removed
from this update. For two adult trials, the overall risk of bias was
unclear with very low-certainty evidence for all outcomes. The first trial
studied 62 adults with recent-onset dilated cardiomyopathy randomly
assigned to receive IVIG or an equivalent volume of 0.1% albumin in a
blinded fashion. The effect on event-free survival between groups was
uncertain (risk ratio (RR) of any event 1.76, 95% confidence interval (CI)
0.48 to 6.40). The second trial studied 41 adults with acute myocarditis
randomised to either high-dose IVIG (1 to 2 g/kg over two days) or no
treatment. The IVIG group reported greater survival time after 60 days (no
raw data, P < 0.01), but the evidence is uncertain. We pooled the reported
number of deaths in both trials, with no evidence of a difference between
groups (RR 0.91, 95% CI 0.23 to 3.62, I2 = 31%, very
low-certainty evidence). The evidence on the effect of IVIG treatment on
LVEF (pooled mean difference (MD) -0.01, 95% CI -0.06 to 0.05) after 12
months and an unknown time frame is uncertain. The results for functional
capacity, assessed by peak oxygen consumption at 12 months, were uncertain
(MD -0.80, 95% CI -4.57 to 2.97). The results for infusion-related side
effects were also uncertain due to a very large CI (RR 20.29, 95% CI 1.25
to 329.93). Lastly, there was uncertain evidence addressing failure to
attain complete recovery (RR 0.46, 95% CI 0.19 to 1.14). Evidence for
improvement in LVEDD, left ventricular shortening fraction, and
hospitalisation status in adults was not reported. In the single included
paediatric trial, the overall risk of bias was low with very low-certainty
evidence for all outcomes. The trial included 86 children in Egypt
presenting with acute myocarditis. Children were randomly assigned to 1
g/kg IVIG daily for two consecutive days or placebo followed by
echocardiography one and six months post randomisation for recording of
LVEDD and LVSF. The evidence for overall survival after six months was
uncertain (risk of death RR 0.48, 95% CI 0.20 to 1.15). The evidence was
also uncertain for improvement in LVEDD and LVSF after six months (LVEDD
MD -4.00, 95% CI -9.52 to 1.52; LVSF no raw data). Evidence for
improvement in LVEF, functional capacity, side effects, complete recovery,
and hospitalisation status in children was not reported. Authors'
conclusions: Evidence from two trials of very low certainty and with
unclear risk of bias provides contradictory evidence on the use of IVIG in
the treatment of adults with presumed viral myocarditis. One trial
reported that use of IVIG results in longer survival time after 60 days,
whilst the other trial found that IVIG does not provide an appreciable
benefit. The evidence of a difference in event-free or overall survival,
LVEDD, or LVSF is of very low certainty in a single paediatric trial with
a low risk of bias. Until higher-quality studies with low risk of bias and
larger sample sizes have demonstrated benefit in a particular group of
patients, the evidence for treatment with IVIG for presumed viral
myocarditis is uncertain. Further studies of the pathophysiology of
myocarditis would lead to improved diagnostic criteria, which would
facilitate future research. Copyright © 2020 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<61>
Accession Number
632408566
Title
Chelation therapy for atherosclerotic cardiovascular disease.
Source
Cochrane Database of Systematic Reviews. 2020(5) (no pagination), 2020.
Article Number: CD002785. Date of Publication: 03 Jun 2020.
Author
Villarruz-Sulit M.V.; Forster R.; Dans A.L.; Tan F.N.; Sulit D.V.
Institution
(Villarruz-Sulit) Asia-Pacific Center for Evidence-Based Healthcare,
Ermita, Manila, Philippines
(Forster) Usher Institute, University of Edinburgh, Edinburgh, United
Kingdom
(Dans) Section of Adult Medicine, College of Medicine, University of the
Philippines, Ermita, Philippines
(Tan) Emergency Department, Montefiore Westchester Square Campus, New
York, United States
(Sulit) Department of Internal Medicine, Cardinal Santos Medical Center,
San Juan City, Metro Manila, Philippines
Publisher
John Wiley and Sons Ltd
Abstract
Background: Chelation therapy is promoted and practiced around the world
as a form of alternative medicine in the treatment of atherosclerotic
cardiovascular disease. It has been suggested as a safe, relatively
inexpensive, non-surgical method of restoring blood flow in
atherosclerotic vessels. However, there is currently limited high-quality,
adequately-powered research informing evidence-based medicine on the
topic, specifically regarding clinical outcomes. Due to this limited
evidence, the benefit of chelation therapy remains controversial at
present. This is an update of a review first published in 2002.
 Objective(s): To assess the effects of ethylene diamine tetra-acetic
acid (EDTA) chelation therapy versus placebo or no treatment on clinical
outcomes among people with atherosclerotic cardiovascular disease.
 Search Method(s): For this update, the Cochrane Vascular Information
Specialist searched the Cochrane Vascular Specialised Register, Cochrane
Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and
Cumulative Index to Nursing and Allied Health Literature (CINAHL)
databases, the World Health Organization International Clinical Trials
Registry Platform and ClinicalTrials.gov trials register to 6 August 2019.
We searched the bibliographies of the studies retrieved by the literature
searches for further trials. Selection Criteria: We included studies
if they were randomised controlled trials of EDTA chelation therapy versus
placebo or no treatment in participants with atherosclerotic
cardiovascular disease. The main outcome measures we considered include
all-cause or cause-specific mortality, non-fatal cardiovascular events,
direct or indirect measurement of disease severity, and subjective
measures of improvement or adverse events. Data Collection and
Analysis: Two review authors independently extracted data and assessed
trial quality using standard Cochrane procedures. A third author
considered any unresolved issues, and we discussed any discrepancies until
a consensus was reached. We contacted study authors for additional
information. Main Result(s): We included five studies with a total of
1993 randomised participants. Three studies enrolled participants with
peripheral vascular disease and two studies included participants with
coronary artery disease, one of which specifically recruited people who
had had a myocardial infarction. The number of participants in each study
varied widely (from 10 to 1708 participants), but all studies compared
EDTA chelation to a placebo. Risk of bias for the included studies was
generally moderate to low, but one study had high risk of bias because the
study investigators broke their randomisation code halfway through the
study and rolled the placebo participants over to active treatment.
Certainty of the evidence, as assessed by GRADE, was generally low to very
low, which was mostly due to a paucity of data in each outcome's
meta-analysis. This limited our ability to draw any strong conclusions. We
also had concerns about one study's risk of bias regarding blinding and
outcome assessment that may have biased the results. Two studies with
coronary artery disease participants reported no evidence of a difference
in all-cause mortality between chelation therapy and placebo (risk ratio
(RR) 0.97, 95% CI 0.73 to 1.28; 1792 participants; low-certainty). One
study with coronary artery disease participants reported no evidence of a
difference in coronary heart disease deaths between chelation therapy and
placebo (RR 1.02, 95% CI 0.70 to 1.48; 1708 participants; very
low-certainty). Two studies with coronary artery disease participants
reported no evidence of a difference in myocardial infarction (RR 0.81,
95% CI 0.57 to 1.14; 1792 participants; moderate-certainty), angina (RR
0.95, 95% CI 0.55 to 1.67; 1792 participants; very low-certainty), and
coronary revascularisation (RR 0.46, 95% CI 0.07 to 3.25; 1792
participants). Two studies (one with coronary artery disease participants
and one with peripheral vascular disease participants) reported no
evidence of a difference in stroke (RR 0.88, 95% CI 0.40 to 1.92; 1867
participants; low-certainty). Ankle-brachial pressure index (ABPI; also
known as ankle brachial index) was measured in three studies, all
including participants with peripheral vascular disease; two studies found
no evidence of a difference in the treatment groups after three months
after treatment (mean difference (MD) 0.02, 95% CI -0.03 to 0.06; 181
participants; low-certainty). A third study reported an improvement in
ABPI in the EDTA chelation group, but this study was at high risk of bias.
Meta-analysis of maximum and pain-free walking distances three months
after treatment included participants with peripheral vascular disease and
showed no evidence of a difference between the treatment groups (MD
-31.46, 95% CI -87.63 to 24.71; 165 participants; 2 studies;
low-certainty). Quality of life outcomes were reported by two studies that
included participants with coronary artery disease, but we were unable to
pool the data due to different methods of reporting and varied criteria.
However, there did not appear to be any major differences between the
treatment groups. None of the included studies reported on vascular
deaths. Overall, there was no evidence of major or minor adverse events
associated with EDTA chelation treatment. Authors' conclusions: There is
currently insufficient evidence to determine the effectiveness or
ineffectiveness of chelation therapy in improving clinical outcomes of
people with atherosclerotic cardiovascular disease. More high-quality,
randomised controlled trials are needed that assess the effects of
chelation therapy on longevity and quality of life among people with
atherosclerotic cardiovascular disease. Copyright © 2020 The
Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

<62>
Accession Number
630208302
Title
Perioperative beta-blockers for preventing surgery-related mortality and
morbidity in adults undergoing cardiac surgery.
Source
Cochrane Database of Systematic Reviews. 2019(9) (no pagination), 2019.
Article Number: CD013435. Date of Publication: 23 Sep 2019.
Author
Blessberger H.; Lewis S.R.; Pritchard M.W.; Fawcett L.J.; Domanovits H.;
Schlager O.; Wildner B.; Kammler J.; Steinwender C.
Institution
(Blessberger, Kammler, Steinwender) Kepler University Hospital, Medical
Faculty of the Johannes Kepler University Linz, Department of Cardiology,
Med Campus III, Krankenhausstrase 9, Linz 4020, Austria
(Lewis, Pritchard, Fawcett) Royal Lancaster Infirmary, Lancaster Patient
Safety Research Unit, Pointer Court 1, Ashton Road, Lancaster LA1 4RP,
United Kingdom
(Domanovits) Vienna General Hospital, Medical University of Vienna,
Department of Emergency Medicine, Wahringer Gurtel 18-20, Vienna 1090,
Austria
(Schlager) Vienna General Hospital, Medical University of Vienna,
Department of Internal Medicine II, Division of Angiology, Wahringer
Gurtel 18-20, Vienna 1090, Austria
(Wildner) University Library of the Medical University of Vienna,
Information Retrieval Office, Wahringer Gurtel 18-20, Vienna 1090, Austria
Publisher
John Wiley and Sons Ltd
Abstract
Background: Randomized controlled trials (RCTs) have yielded conflicting
results regarding the ability of beta-blockers to influence perioperative
cardiovascular morbidity and mortality. Thus routine prescription of these
drugs in unselected patients remains a controversial issue. A previous
version of this review assessing the effectiveness of perioperative
beta-blockers in cardiac and non-cardiac surgery was last published in
2018. The previous review has now been split into two reviews according to
type of surgery. This is an update and assesses the evidence in cardiac
surgery only. Objective(s): To assess the effectiveness of
perioperatively administered beta-blockers for the prevention of
surgery-related mortality and morbidity in adults undergoing cardiac
surgery. Search Method(s): We searched CENTRAL, MEDLINE, Embase,
CINAHL, Biosis Previews and Conference Proceedings Citation Index-Science
on 28 June 2019. We searched clinical trials registers and grey
literature, and conducted backward- and forward-citation searching of
relevant articles. Selection Criteria: We included RCTs and
quasi-randomized studies comparing beta-blockers with a control (placebo
or standard care) administered during the perioperative period to adults
undergoing cardiac surgery. We excluded studies in which all participants
in the standard care control group were given a pharmacological agent that
was not given to participants in the intervention group, studies in which
all participants in the control group were given a beta-blocker, and
studies in which beta-blockers were given with an additional agent (e.g.
magnesium). We excluded studies that did not measure or report review
outcomes. Data Collection and Analysis: Two review authors
independently assessed studies for inclusion, extracted data, and assessed
risks of bias. We assessed the certainty of evidence with GRADE. Main
Result(s): We included 63 studies with 7768 participants; six studies were
quasi-randomized and the remaining were RCTs. All participants were
undergoing cardiac surgery, and in most studies, at least some of the
participants were previously taking beta-blockers. Types of beta-blockers
were: propranolol, metoprolol, sotalol, esmolol, landiolol, acebutolol,
timolol, carvedilol, nadolol, and atenolol. In twelve studies,
beta-blockers were titrated according to heart rate or blood pressure.
Duration of administration varied between studies, as did the time at
which drugs were administered; in nine studies this was before surgery, in
20 studies during surgery, and in the remaining studies beta-blockers were
started postoperatively. Overall, we found that most studies did not
report sufficient details for us to adequately assess risk of bias. In
particular, few studies reported methods used to randomize participants to
groups. In some studies, participants in the control group were given
beta-blockers as rescue therapy during the study period, and all studies
in which the control was standard care were at high risk of performance
bias because of the open-label study design. No studies were prospectively
registered with clinical trials registers, which limited the assessment of
reporting bias. We judged 68% studies to be at high risk of bias in at
least one domain. Study authors reported few deaths (7 per 1000 in both
the intervention and control groups), and we found low-certainty evidence
that beta-blockers may make little or no difference to all-cause mortality
at 30 days (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.47 to
1.90; 29 studies, 4099 participants). For myocardial infarctions, we found
no evidence of a difference in events (RR 1.05, 95% CI 0.72 to 1.52; 25
studies, 3946 participants; low-certainty evidence). Few study authors
reported cerebrovascular events, and the evidence was uncertain (RR 1.37,
95% CI 0.51 to 3.67; 5 studies, 1471 participants; very low-certainty
evidence). Based on a control risk of 54 per 1000, we found low-certainty
evidence that beta-blockers may reduce episodes of ventricular arrhythmias
by 32 episodes per 1000 (RR 0.40, 95% CI 0.25 to 0.63; 12 studies, 2296
participants). For atrial fibrillation or flutter, there may be 163 fewer
incidences with beta-blockers, based on a control risk of 327 incidences
per 1000 (RR 0.50, 95% CI 0.42 to 0.59; 40 studies, 5650 participants;
low-certainty evidence). However, the evidence for bradycardia and
hypotension was less certain. We found that beta-blockers may make little
or no difference to bradycardia (RR 1.63, 95% CI 0.92 to 2.91; 12 studies,
1640 participants; low-certainty evidence), or hypotension (RR 1.84, 95%
CI 0.89 to 3.80; 10 studies, 1538 participants; low-certainty evidence).
We used GRADE to downgrade the certainty of evidence. Owing to studies at
high risk of bias in at least one domain, we downgraded each outcome for
study limitations. Based on effect size calculations in the previous
review, we found an insufficient number of participants in all outcomes
(except atrial fibrillation) and, for some outcomes, we noted a wide
confidence interval; therefore, we also downgraded outcomes owing to
imprecision. The evidence for atrial fibrillation and length of hospital
stay had a moderate level of statistical heterogeneity which we could not
explain, and we, therefore, downgraded these outcomes for inconsistency.
Authors' conclusions: We found no evidence of a difference in early
all-cause mortality, myocardial infarction, cerebrovascular events,
hypotension and bradycardia. However, there may be a reduction in atrial
fibrillation and ventricular arrhythmias when beta-blockers are used. A
larger sample size is likely to increase the certainty of this evidence.
Four studies awaiting classification may alter the conclusions of this
review. Copyright © 2019 The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd.

<63>
Accession Number
629697604
Title
Combined proximal descending aortic endografting plus distal bare metal
stenting (Petticoat technique) versus conventional proximal descending
aortic stent graft repair for complicated type b aortic dissections.
Source
Cochrane Database of Systematic Reviews. 2019(10) (no pagination), 2019.
Article Number: CD013149. Date of Publication: 30 Oct 2019.
Author
Rong D.; Ge Y.; Liu J.; Liu X.; Guo W.
Institution
(Rong, Ge, Liu, Liu, Guo) Department of Vascular and Endovascular Surgery,
Chinese PLA General Hospital, Beijing, China
Publisher
John Wiley and Sons Ltd
Abstract
Background Aortic dissection is a separation of the aortic wall, caused by
blood flowing through a tear in the inner layer of the aorta. Aortic
dissection is an infrequent but life-threatening condition. The incidence
of aortic dissection is 3 to 6 per 10,000 per year in the Western
population, and can be up to 43 per 10,000 per year in the Eastern
population. Over 20% of people with an aortic dissection do not reach a
hospital alive. After admission, the mortality rates for people with an
aortic dissection are between 10% and 20% for those who received
endovascular treatment, and between 20% and 30% for those who had open
surgery. Thoracic endovascular aortic repair (TEVAR) is the standard
endovascular method to treat complicated type B aortic dissection (aortic
dissections without involvement of the ascending aorta). Although TEVAR is
less invasive than open surgery and has a better long-term aortic
remodeling effect than conservative medical treatment, favourable aortic
remodelling is usually limited to the thoracic aortic segment. TEVAR
cannot be extended into the abdominal aorta because it could cover the
ostia of the reno-visceral arteries. Thus, the abdominal aorta is still at
risk of progressive aneurysmal degeneration. The PETTICOAT (provisional
extension to induce complete attachment) technique, with proximal
endograft and distal bare metal stent, was proposed in 2006 to address
this issue. The concept of this technique was to implant a distal bare
metal stent into the aortic true lumen, distal to the proximal endograft,
to stabilize the distal collapsed intimal flap, while allowing blood flow
to reno-visceral arteries. Therefore, the PETTICOAT technique was
considered to be related to a more extensive aortic remodelling for people
with type B aortic dissection, especially in the area of the abdominal
aorta. However, it is still unclear whether the PETTICOAT technique is
superior to standard TEVAR. Objectives To assess the effects of combined
proximal descending aortic endografting plus distal bare metal stenting
versus conventional proximal descending aortic stent graft repair for
treating complicated type B aortic dissections. Search methods The
Cochrane Vascular Information Specialist searched the Cochrane Vascular
Specialised Register, Cochrane Central Register of Controlled Trials
(CENTRAL), MEDLINE, Embase and Cumulative Index to Nursing and Allied
Health Literature (CINAHL) databases, and the World Health Organization
International Clinical Trials Registry Platform and ClinicalTrials.gov
trials registers to 5 November 2018. We also undertook reference checking
and citation searching to identify additional studies. Selection criteria
We considered all randomised controlled trials which compared the outcome
of complicated type B aortic dissection, when treated by combined proximal
descending aortic endografting plus distal bare metal stenting (PETTICOAT
technique) versus conventional proximal descending aortic stent graft
repair. Data collection and analysis Two independent review authors
assessed all references identified by the Cochrane Vascular Information
Specialist. We planned to undertake data collection and analysis in
accordance with recommendations described in the Cochrane Handbook for
Systematic Reviews of Interventions. Main results We found no trials that
met the inclusion criteria for this review. Authors' conclusions We
identified no randomised controlled trials and therefore cannot draw any
definite conclusion on this topic. Evidence from non-ran-domised studies
appears to be favourable in the short-term, for combined proximal
descending aortic endografting plus distal bare metal stenting (PETTICOAT
technique) to solve the problem of unfavourable distal aortic remodeling.
Randomised controlled trials are warranted to provide solid evidence on
this topic. Evidence from cohort studies with large sample sizes would
also be helpful in guiding clinical practice. Copyright © 2019
The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

<64>
Accession Number
629684841
Title
Intra-pleural fibrinolytic therapy versus placebo, or a different
fibrinolytic agent, in the treatment of adult parapneumonic effusions and
empyema.
Source
Cochrane Database of Systematic Reviews. 2019(10) (no pagination), 2019.
Article Number: CD002312. Date of Publication: 30 Oct 2019.
Author
Altmann E.S.; Crossingham I.; Wilson S.; Davies H.R.
Institution
(Altmann) Department of General Medicine, John Hunter Hospital, New
Lambton Heights, Australia
(Crossingham, Wilson) East Lancashire Hospitals NHS Trust, Blackburn,
United Kingdom
(Davies) Respiratory and Sleep Services, Southern Adelaide Local Health
Network (SALHN), Bedford Park, Australia
Publisher
John Wiley and Sons Ltd
Abstract
Background Pleural infection, including parapneumonic effusions and
thoracic empyema, may complicate lower respiratory tract infections.
Standard treatment of these collections in adults involves antibiotic
therapy, effective drainage of infected fluid and surgical intervention if
conservative management fails. Intrapleural fibrinolytic agents such as
streptokinase and alteplase have been hypothesised to improve fluid
drainage in complicated parapneumonic effusions and empyema and therefore
improve treatment outcomes and prevent the need for thoracic surgical
intervention. Intrapleural fibrinolytic agents have been used in
combination with DNase, but this is beyond the scope of this review.
Objectives To assess the benefits and harms of adding intrapleural
fibrinolytic therapy to standard conservative therapy (intercostal
catheter drainage and antibiotic therapy) in the treatment of complicated
parapneumonic effusions and empyema. Search methods We searched the
Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and
Embase, ClinicalTrials.gov and the World Health Organization (WHO) trials
portal. We contacted trial authors for further information and requested
details regarding the possibility of unpublished trials. The most recent
search was conducted on 28 August 2019. Selection criteria Parallel-group
randomised controlled trials (RCTs) in adult patients with post-pneumonic
empyema or complicated parapneumonic effusions (excluding tuberculous
effusions) who had not had prior surgical intervention or trauma comparing
an intrapleural fibrinolytic agent (streptokinase, alteplase or urokinase)
versus placebo or a comparison of two fibrinolytic agents. Data collection
and analysis Two review authors independently extracted data. We contacted
study authors for further information. We used odds ratios (OR) for
dichotomous data and reported 95% confidence intervals (CIs). We used
Cochrane's standard methodological procedures of meta-analysis. We applied
the GRADE approach to summarise results and to assess the overall
certainty of evidence. Main results We included in this review a total of
12 RCTs. Ten studies assessed fibrinolytic agents versus placebo (993
participants); one study compared streptokinase with urokinase (50
participants); and one compared alteplase versus urokinase (99
participants). The primary outcomes were death, requirement for surgical
intervention, overall treatment failure and serious adverse effects. All
studies were in the inpatient setting. Outcomes were measured at varying
time points from hospital discharge to three months. Seven trials were at
low or unclear risk of bias and two at high risk of bias due to inadequate
randomisation and inappropriate study design respectively. We found no
evidence of difference in overall mortality with fibrinolytic versus
placebo (OR 1.16, 95% CI 0.71 to 1.91; 8 studies, 867 participants; I2 =
0%; moderate certainty of evidence). We found evidence of a reduction in
surgical intervention with fibrinolysis in the same studies (OR 0.37, 95%
CI 0.21 to 0.68; 8 studies, 897 participants; I2 = 51%; low certainty of
evidence); and overall treatment failure (OR 0.16, 95% CI 0.05 to 0.58; 7
studies, 769 participants; I2 = 88%; very low certainty of evidence, with
evidence of significant heterogeneity). We found no clear evidence of an
increase in adverse effects with intrapleural fibrinolysis, although this
cannot be excluded (OR 1.28, 95% CI 0.36 to 4.57; low certainty of
evidence). In a sensitivity analysis, the reduction in referrals for
surgery and overall treatment failure with fibrinolysis disappeared when
the analysis was confined to studies at low or unclear risk of bias. In a
moderate-risk population (baseline 14% risk of death, 20% risk of surgery,
27% risk of treatment failure), intra-pleural fibrinolysis leads to 19
more deaths (36 fewer to 59 more), 115 fewer surgical interventions (150
fewer to 55 fewer) and 214 fewer overall treatment failures (252 fewer to
93 fewer) per 1000 people. A single study of streptokinase versus
urokinase found no clear difference between the treatments for requirement
for surgery (OR 1.00, 95% CI 0.13 to 7.72; 50 participants; low-certainty
evidence). A single study of alteplase versus urokinase showed no clear
difference in requirement for surgery (OR alteplase versus urokinase 0.46,
95% CI 0.04 to 5.24) but an increased rate of adverse effects, primarily
bleeding, with alteplase (OR 5.61, 95% CI 1.16 to 27.11; 99 participants;
low-certainty evidence). This translated into 154 (6 to 499 more) serious
adverse events with alteplase compared with urokinase per 1000 people
treated. Authors' conclusions In patients with complicated infective
pleural effusion or empyema, intrapleural fibrinolytic therapy was
associated with a reduction in the requirement for surgical intervention
and overall treatment failure but with no evidence of change in mortality.
Discordance between the negative largest trial of this therapy and other
studies is of concern, however, as is an absence of significant effect
when analysing low risk of bias trials only. The reasons for this
difference are uncertain but may include publication bias. Intrapleural
fibrinolytics may increase the rate of serious adverse events, but the
evidence is insufficient to confirm or exclude this
possibility. Copyright © 2019 The Cochrane Collaboration.
Published by John Wiley & Sons, Ltd.

<65>
Accession Number
629408822
Title
Perioperative beta-blockers for preventing surgery-related mortality and
morbidity in adults undergoing non-cardiac surgery.
Source
Cochrane Database of Systematic Reviews. 2019(9) (no pagination), 2019.
Article Number: CD013438. Date of Publication: 26 Sep 2019.
Author
Blessberger H.; Lewis S.R.; Pritchard M.W.; Fawcett L.J.; Domanovits H.;
Schlager O.; Wildner B.; Kammler J.; Steinwender C.
Institution
(Blessberger, Kammler, Steinwender) Department of Cardiology, Med Campus
III, Kepler University Hospital, Medical Faculty of the Johannes Kepler
University Linz, Linz, Austria
(Lewis, Pritchard, Fawcett) Lancaster Patient Safety Research Unit, Royal
Lancaster Infirmary, Lancaster, United Kingdom
(Domanovits) Department of Emergency Medicine, Vienna General Hospital,
Medical University of Vienna, Vienna, Austria
(Schlager) Department of Internal Medicine II, Division of Angiology,
Vienna General Hospital, Medical University of Vienna, Vienna, Austria
(Wildner) University Library of the Medical University of Vienna, Vienna,
Austria
Publisher
John Wiley and Sons Ltd
Abstract
Background Randomized controlled trials (RCTs) have yielded conflicting
results regarding the ability of beta-blockers to influence perioperative
cardiovascular morbidity and mortality. Thus routine prescription of these
drugs in an unselected population remains a controversial issue. A
previous version of this review assessing the effectiveness of
perioperative beta-blockers in cardiac and non-cardiac surgery was last
published in 2018. The previous review has now been split into two reviews
according to type of surgery. This is an update, and assesses the evidence
in non-cardiac surgery only. Objectives To assess the effectiveness of
perioperatively administered beta-blockers for the prevention of
surgery-related mortality and morbidity in adults undergoing non-cardiac
surgery. Search methods We searched CENTRAL, MEDLINE, Embase, CINAHL,
Biosis Previews and Conference Proceedings Citation Index-Science on 28
June 2019. We searched clinical trials registers and grey literature, and
conducted backward-and forward-citation searching of relevant articles.
Selection criteria We included RCTs and quasi-randomized studies comparing
beta-blockers with a control (placebo or standard care) administered
during the perioperative period to adults undergoing non-cardiac surgery.
If studies included surgery with different types of anaesthesia, we
included them if 70% participants, or at least 100 participants, received
general anaesthesia. We excluded studies in which all participants in the
standard care control group were given a pharmacological agent that was
not given to participants in the intervention group, studies in which all
participants in the control group were given a beta-blocker, and studies
in which beta-blockers were given with an additional agent (e.g.
magnesium). We excluded studies that did not measure or report review
outcomes. Data collection and analysis Two review authors independently
assessed studies for inclusion, extracted data, and assessed risks of
bias. We assessed the certainty of evidence with GRADE. Main results We
included 83 RCTs with 14,967 participants; we found no quasi-randomized
studies. All participants were undergoing non-cardiac surgery, and types
of surgery ranged from low to high risk. Types of beta-blockers were:
propranolol, metoprolol, esmolol, landiolol, nadolol, atenolol, labetalol,
oxprenolol, and pindolol. In nine studies, beta-blockers were titrated
according to heart rate or blood pressure. Duration of administration
varied between studies, as did the time at which drugs were administered;
in most studies, it was intraoperatively, but in 18 studies it was before
surgery, in six postoperatively, one multi-arm study included groups of
different timings, and one study did not report timing of drug
administration. Overall, we found that more than half of the studies did
not sufficiently report methods used for randomization. All studies in
which the control was standard care were at high risk of performance bias
because of the open-label study design. Only two studies were
prospectively registered with clinical trials registers, which limited the
assessment of reporting bias. In six studies, participants in the control
group were given beta-blockers as rescue therapy during the study period.
The evidence for all-cause mortality at 30 days was uncertain; based on
the risk of death in the control group of 25 per 1000, the effect with
beta-blockers was between two fewer and 13 more per 1000 (risk ratio (RR)
1.17, 95% confidence interval (CI) 0.89 to 1.54; 16 studies, 11,446
participants; low-certainty evidence). Beta-blockers may reduce the
incidence of myocardial infarction by 13 fewer incidences per 1000 (RR
0.72, 95% CI 0.60 to 0.87; 12 studies, 10,520 participants; low-certainty
evidence). We found no evidence of a difference in cerebrovascular events
(RR 1.65, 95% CI 0.97 to 2.81; 6 studies, 9460 participants; low-certainty
evidence), or in ventricular arrhythmias (RR 0.72, 95% CI 0.35 to 1.47; 5
studies, 476 participants; very low-certainty evidence). Beta-blockers may
reduce atrial fibrillation or flutter by 26 fewer incidences per 1000 (RR
0.41, 95% CI 0.21 to 0.79; 9 studies, 9080 participants; low-certainty
evidence). However, beta-blockers may increase bradycardia by 55 more
incidences per 1000 (RR 2.49, 95% CI 1.74 to 3.56; 49 studies, 12,239
participants; low-certainty evidence), and hypotension by 44 more per 1000
(RR 1.40, 95% CI 1.29 to 1.51; 49 studies, 12,304 participants;
moderate-certainty evidence). We downgraded the certainty of the evidence
owing to study limitations; some studies had high risks of bias, and the
effects were sometimes altered when we excluded studies with a standard
care control group (including only placebo-controlled trials showed an
increase in early mortality and cerebrovascular events with
beta-blockers). We also downgraded for inconsistency; one large,
well-conducted, international study found a reduction in myocardial
infarction, and an increase in cerebrovascular events and all-cause
mortality, when beta-blockers were used, but other studies showed no
evidence of a difference. We could not explain the reason for the
inconsistency in the evidence for ventricular arrhythmias, and we also
downgraded this outcome for imprecision because we found few studies with
few participants. Authors' conclusions The evidence for early all-cause
mortality with perioperative beta-blockers was uncertain. We found no
evidence of a difference in cerebrovascular events or ventricular
arrhythmias, and the certainty of the evidence for these outcomes was low
and very low. We found low-certainty evidence that beta-blockers may
reduce atrial fibrillation and myocardial infarctions. However,
beta-blockers may increase bradycardia (low-certainty evidence) and
probably increase hypotension (moderate-certainty evidence). Further
evidence from large placebo-controlled trials is likely to increase the
certainty of these findings, and we recommend the assessment of impact on
quality of life. We found 18 studies awaiting classification; inclusion of
these studies in future updates may also increase the certainty of the
evidence. Copyright © 2019 The Cochrane Collaboration.

<66>
Accession Number
628452594
Title
Coronary artery bypass grafting surgery versus percutaneous coronary
intervention for coronary artery disease.
Source
Cochrane Database of Systematic Reviews. 2019(7) (no pagination), 2019.
Article Number: CD013374. Date of Publication: 10 Jul 2019.
Author
Ahmed Z.; Bravo C.A.; Mori M.; Herrera S.A.R.; Gluud C.; Kataria R.;
Zarich S.W.; Hirji S.A.; Desai N.R.; Bhatt D.L.
Institution
(Ahmed, Desai) Department of Cardiovascular Medicine, Yale School of
Medicine, New Haven, United States
(Bravo) Montefiore Einstein Center for Heart & Vascular Care, Albert
Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, United
States
(Mori) Department of Cardiac Surgery, Yale School of Medicine, New Haven,
United States
(Herrera) Jacobi Medical Center, Albert Einstein College of Medicine, New
York, United States
(Gluud) Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for
Clinical Intervention Research, Department 7812, Rigshospitalet,
Copenhagen University Hospital, Copenhagen, Denmark
(Kataria) Department of Cardiovascular Disease, Montefiore Medical Center,
Albert Einstein College of Medicine, Bronx, NY, United States
(Zarich) Department of Cardiology, Yale School of Medicine, New Haven,
United States
(Hirji) Department of Surgery, Brigham and Women's Hospital, Harvard
Medical School, Boston, MA, United States
(Bhatt) Heart & Vascular Centre, Brigham and Women's Hospital, Boston, MA,
United States
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: To assess the safety and efficacy of CABG versus PCI for
the management of CAD. Copyright © 2019 The Cochrane
Collaboration.

<67>
Accession Number
628179828
Title
Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or
low birth weight infants.
Source
Cochrane Database of Systematic Reviews. 2019(6) (no pagination), 2019.
Article Number: CD004213. Date of Publication: 21 Jun 2019.
Author
Ohlsson A.; Shah S.S.
Institution
(Ohlsson) Departments of Paediatrics, Obstetrics and Gynaecology,
Institute of Health Policy, Management and Evaluation, University of
Toronto, Toronto, Canada
(Shah) Department of Pediatrics, Surya Hospital for Women and Children,
Pune, India
Publisher
John Wiley and Sons Ltd
Abstract
Background Patent ductus arteriosus (PDA) complicates the clinical course
of preterm infants and increases the risk of adverse outcomes.
Indomethacin has been the standard treatment to close a PDA but is
associated with renal, gastrointestinal, and cerebral side effects.
Ibuprofen has less effect on blood flow velocity to important organs.
Objectives Primary objectives To determine the effectiveness and safety of
ibuprofen compared to placebo/no intervention, or other cyclo-oxygenase
inhibitor drugs in the prevention of PDA in preterm infants. Search
methods We used the standard search strategy of Cochrane Neonatal to
search the Cochrane Central Register of Controlled Trials (CENTRAL; 2018,
Issue 10), MEDLINE via PubMed (1966 to 17 October 2018), Embase (1980 to
17 October 2018), and CINAHL; 1982 to 17 October 2018). We searched
clinical trials databases, conference proceedings, and the reference lists
of retrieved articles for randomised controlled trials and
quasi-randomised trials. Selection criteria Randomised and
quasi-randomised controlled trials comparing ibuprofen with placebo/no
intervention or other cyclo-oxygenase inhibitor drugs to prevent PDA in
preterm or low birth weight infants. Data collection and analysis We
extracted outcomes data including presence of PDA on day three or four of
life (after 72 hours of treatment), need for surgical ligation or rescue
treatment with cyclo-oxygenase inhibitors, mortality, cerebral, renal,
pulmonary, and gastrointestinal complications. We performed meta-analyses
and reported treatment estimates as typical mean difference (MD), risk
ratio (RR), risk difference (RD) and, if statistically significant, number
needed to treat to benefit (NNTB) or to harm (NNTH), along with their 95%
confidence intervals (CI). We assessed between-study heterogeneity by the
I-squared test (I2). We used the GRADE approach to assess the
quality of evidence. Main results In this updated analysis, we included
nine trials (N = 1070 infants) comparing prophylactic ibuprofen (IV or
oral) with placebo/no intervention or indomethacin. Ibuprofen (IV or oral)
probably decreases the risk of PDA on day 3 or 4 (typical RR 0.39, 95% CI
0.31 to 0.48; typical RD -0.26, 95% CI -0.31 to -0.21; NNTB 4, 95% CI 3 to
5; 9 trials; N = 1029) (moderate-quality evidence). In the control group,
the spontaneous closure rate was 58% by day 3 to 4 of age. In addition,
ibuprofen probably decreases the need for rescue treatment with
cyclo-oxygenase inhibitors (typical RR 0.17, 95% CI 0.11 to 0.26; typical
RD -0.27, 95% CI -0.32 to -0.22; NNTB 4; 95% CI 3 to 5),and the need for
surgical ductal ligation (typical RR 0.46, 95% CI 0.22 to 0.96; typical RD
-0.03, 95% CI -0.05 to -0.00; NNTB 33, 95% CI 20 to infinity; 7 trials; N
= 925) (moderate-quality evidence). There was a possible decrease in the
risk of grade 3 or 4 intraventricular haemorrhage (IVH) in infants
receiving prophylactic ibuprofen (typical RR 0.67, 95% CI 0.45 to 1.00;
I2 = 34%; typical RD -0.04, 95% CI -0.08 to- 0.00;
I2 = 60%; 7 trials; N = 925) (moderate-quality evidence). High
quality evidence showed increased risk for oliguria (typical RR 1.45, 95%
CI 1.04 to 2.02; typical RD 0.06, 95% CI 0.01 to 0.11; NNTH 17, 95% CI 9
to 100; 4 trials; N = 747). Low quality results from four studies (N =
202) showed that administering oral ibuprofen may decrease the risk of PDA
(typical RR 0.47, 95% CI 0.30 to 0.74) and may increase risk of
gastrointestinal bleeding (NNTH 7, 95% CI 4 to 25). No evidence of a
difference was identified for mortality, any intraventricular haemorrhage
(IVH), or chronic lung disease. Authors conclusions This review shows that
prophylactic use of ibuprofen, compared to placebo or no intervention,
probably decreases the incidence of patent ductus arteriosus, the need for
rescue treatment with cyclo-oxygenase inhibitors, and for surgical ductal
closure. Adverse effects associated with ibuprofen (IV or oral) included
increased risks for oliguria, increase in serum creatinine levels, and
increased risk of gastrointestinal haemorrhage. There was a reduced risk
for intraventricular haemorrhage (grade III - IV) but no evidence of a
difference in mortality, chronic lung disease, necrotising enterocolitis,
or time to reach full feeds. In the control group, the patent ductus
arteriosus had closed spontaneously by day 3 or 4 in 58% of neonates.
Prophylactic treatment exposes a large proportion of infants unnecessarily
to a drug that has important side effects without conferring any important
short-term benefits. Current evidence does not support the use of
ibuprofen for prevention of patent ductus arteriosus. Until long-term
follow-up results of the trials included in this review have been
published, no further trials of prophylactic ibuprofen are recommended. A
new approach to patent ductus arteriosus management is an early targeted
treatment based on echocardiographic criteria within the first 72 hours of
life, that have a high sensitivity for diagnosing a patent ductus
arteriosus that is unlikely to close spontaneously. Such trials are
currently ongoing in many parts of the world. Results of such trials will
be included in updates of our "Ibuprofen for treatment of PDA"
review. Copyright © 2019 The Cochrane Collaboration. Published by
JohnWiley & Sons, Ltd.

<68>
Accession Number
627653251
Title
Interventions to prevent surgical site infection in adults undergoing
cardiac surgery.
Source
Cochrane Database of Systematic Reviews. 2019(5) (no pagination), 2019.
Article Number: CD013332. Date of Publication: 15 May 2019.
Author
Rogers L.; Vaja R.; Bleetman D.; Ali J.M.; Rochon M.; Sanders J.; Tanner
J.; Lamagni T.L.; Talukder S.; Quijano-Campos J.C.; Lai F.; Loubani M.;
Murphy G.
Institution
(Vaja, Rochon) Department of Cardiothoracic Surgery, Royal Brompton &
Harefield Hospital NHS Foundation Trust, London, United Kingdom
(Bleetman) Department of Cardiothoracic Surgery, St Bartholomew's
Hospital, Barts Health NHS Trust, London, United Kingdom
(Ali, Talukder) Department of Cardiothoracic Surgery, Royal Papworth
Hospital, Papworth Everard, United Kingdom
(Sanders) St Bartholomew's Hospital, Barts Health NHS Trust, London,
United Kingdom
(Tanner) School of Health Sciences, University of Nottingham, Nottingham,
United Kingdom
(Lamagni) Healthcare-As-sociated Infection & Antimicrobial Resistance
Division, National Infection Service, Public Health England, London,
United Kingdom
(Quijano-Campos) Department of Cardiothoracic Surgery, Royal Papworth
Hospital, Cambridge, United Kingdom
(Lai) Leicester Clinical Trials Unit, University of Leicester, Glen-field
Hospital, Leicester, United Kingdom
(Loubani) Department of Cardiothoracic Surgery, Hull and East Yorkshire
Hospitals NHS Trust, Hull, United Kingdom
(Murphy) Department of Cardiovascular Sciences, University of Leicester,
Leicester, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: Primary objective * To assess the clinical effectiveness
of pre-, intra-, and postoperative interventions in the prevention of
cardiac SSI. Secondary objectives * To evaluate the effects of SSI
prevention interventions on morbidity, mortality, and resource use. * To
evaluate the effects of SSI prevention care bundles on morbidity,
mortality, and resource use. Copyright © 2019 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<69>
Accession Number
627373232
Title
Transcatheter versus surgical aortic valve replacement for severe aortic
stenosis in people with low surgical risk.
Source
Cochrane Database of Systematic Reviews. 2019(4) (no pagination), 2019.
Article Number: CD013319. Date of Publication: 27 Apr 2019.
Author
Kolkailah A.A.; Doukky R.; Pelletier M.P.; Kaneko T.; Nabhan A.F.
Institution
(Kolkailah) Department of Medicine, John H. Stroger, Jr. Hospital of Cook
County, Chicago, IL, United States
(Doukky) Division of Cardiology, John H. Stroger, Jr. Hospital of Cook
County, Chicago, IL, United States
(Pelletier, Kaneko) Division of Cardiac Surgery, Brigham and Women's
Hospital, Harvard Medical School, Boston, MA, United States
(Nabhan) Department of Obstetrics and Gynaecology, Faculty of Medicine,
Ain Shams University, Cairo, Egypt
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: To assess the benefits and harms of TAVR compared to SAVR
in people with severe AS and low surgical risk. Copyright © 2019
The Cochrane Collaboration.

<70>
Accession Number
626566803
Title
Epidural analgesia for adults undergoing cardiac surgery with or without
cardiopulmonary bypass.
Source
Cochrane Database of Systematic Reviews. 2019(3) (no pagination), 2019.
Article Number: CD006715. Date of Publication: 01 Mar 2019.
Author
Guay J.; Kopp S.
Institution
(Guay) Department of Anesthesiology, Faculty of Medicine, University of
Sherbrooke, Sherbrooke, Canada
(Guay) Teaching and Research Unit, Health Sciences, University of Quebec
in Abitibi-Temiscamingue, Rouyn-Noranda, Canada
(Guay) Department of Anesthesiology and Critical Care, Faculty of
Medicine, Laval University, Quebec City, Canada
(Kopp) Department of Anesthesiology and Perioperative Medicine, Mayo
Clinic College of Medicine, Rochester, MN, United States
Publisher
John Wiley and Sons Ltd
Abstract
Background General anaesthesia combined with epidural analgesia may have a
beneficial effect on clinical outcomes. However, use of epidural analgesia
for cardiac surgery is controversial due to a theoretical increased risk
of epidural haematoma associated with systemic heparinization. This review
was published in 2013, and it was updated in 2019. Objectives To determine
the impact of perioperative epidural analgesia in adults undergoing
cardiac surgery, with or without cardiopulmonary bypass, on perioperative
mortality and cardiac, pulmonary, or neurological morbidity. Search
methods We searched CENTRAL, MEDLINE, and Embase in November 2018, and two
trial registers up to February 2019, together with references and relevant
conference abstracts. Selection criteria We included all randomized
controlled trials (RCTs) including adults undergoing any type of cardiac
surgery under general anaesthesia and comparing epidural analgesia versus
another modality of postoperative pain treatment. The primary outcome was
mortality. Data collection and analysis We used standard methodological
procedures as expected by Cochrane. Main results We included 69 trials
with 4860 participants: 2404 given epidural analgesia and 2456 receiving
comparators (systemic analgesia, peripheral nerve block, intrapleural
analgesia, or wound infiltration). The mean (or median) age of
participants varied between 43.5 years and 74.6 years. Surgeries performed
were coronary artery bypass grafting or valvular procedures and surgeries
for congenital heart disease. We judged that no trials were at low risk of
bias for all domains, and that all trials were at unclear/high risk of
bias for blinding of participants and personnel taking care of study
participants. Epidural analgesia versus systemic analgesia Trials show
there may be no difference in mortality at 0 to 30 days (risk difference
(RD) 0.00, 95% confidence interval (CI) -0.01 to 0.01; 38 trials with 3418
participants; low-quality evidence), and there may be a reduction in
myocardial infarction at 0 to 30 days (RD -0.01, 95% CI -0.02 to 0.00; 26
trials with 2713 participants; low-quality evidence). Epidural analgesia
may reduce the risk of 0 to 30 days respiratory depression (RD -0.03, 95%
CI -0.05 to -0.01; 21 trials with 1736 participants; low-quality
evidence). There is probably little or no difference in risk of pneumonia
at 0 to 30 days (RD -0.03, 95% CI -0.07 to 0.01; 10 trials with 1107
participants; moderate-quality evidence), and epidural analgesia probably
reduces the risk of atrial fibrillation or atrial flutter at 0 to 2 weeks
(RD -0.06, 95% CI -0.10 to -0.01; 18 trials with 2431 participants;
moderate-quality evidence). There may be no difference in cerebrovascular
accidents at 0 to 30 days (RD -0.00, 95% CI -0.01 to 0.01; 18 trials with
2232 participants; very low-quality evidence), and none of the included
trials reported any epidural haematoma events at 0 to 30 days (53 trials
with 3982 participants; low-quality evidence). Epidural analgesia probably
reduces the duration of tracheal intubation by the equivalent of 2.4 hours
(standardized mean difference (SMD) -0.78, 95% CI -1.01 to -0.55; 40
trials with 3353 participants; moderate-quality evidence). Epidural
analgesia reduces pain at rest and on movement up to 72 hours after
surgery. At six to eight hours, researchers noted a reduction in pain,
equivalent to a reduction of 1 point on a 0 to 10 pain scale (SMD -1.35,
95% CI -1.98 to -0.72; 10 trials with 502 participants; moderate-quality
evidence). Epidural analgesia may increase risk of hypotension (RD 0.21,
95% CI 0.09 to 0.33; 17 trials with 870 participants; low-quality
evidence) but may make little or no difference in the need for infusion of
inotropics or vasopressors (RD 0.00, 95% CI -0.06 to 0.07; 23 trials with
1821 participants; low-quality evidence). Epidural analgesia versus other
comparators Fewer studies compared epidural analgesia versus peripheral
nerve blocks (four studies), intrapleural analgesia (one study), and wound
infiltration (one study). Investigators provided no data for pulmonary
complications, atrial fibrillation or flutter, or for any of the
comparisons. When reported, other outcomes for these comparisons
(mortality, myocardial infarction, neurological complications, duration of
tracheal intubation, pain, and haemodynamic support) were uncertain due to
the small numbers of trials and participants. Authors' conclusions
Compared with systemic analgesia, epidural analgesia may reduce the risk
of myocardial infarction, respiratory depression, and atrial
fibrillation/atrial flutter, as well as the duration of tracheal
intubation and pain, in adults undergoing cardiac surgery. Theremay be
little or no difference in mortality, pneumonia, and epidural haematoma,
and effects on cerebrovascular accident are uncertain. Evidence is
insufficient to show the effects of epidural analgesia compared with
peripheral nerve blocks, intrapleural analgesia, or wound
infiltration. Copyright © 2019 The Cochrane Collaboration.
Published by John Wiley and Sons, Ltd.

<71>
Accession Number
626169042
Title
Interventions to promote patient utilisation of cardiac rehabilitation.
Source
Cochrane Database of Systematic Reviews. 2019(2) (no pagination), 2019.
Article Number: CD007131. Date of Publication: 01 Feb 2019.
Author
Santiago de Araujo Pio C.; Chaves G.S.S.; Davies P.; Taylor R.S.; Grace
S.L.
Institution
(Santiago de Araujo Pio, Grace) York University, School of Kinesiology and
Health Science, 4700 Keele Street, Toronto, ON M4P 2L8, Canada
(Chaves) Federal University of Minas Gerais, Rehabilitation Science
Program, Belo Horizonte, Brazil
(Davies) University of Bristol, Population Health Sciences, Bristol
Medical School, Canynge Hall, Bristol BS8 2PS, United Kingdom
(Taylor) University of Exeter Medical School, Institute of Health
Research, South Cloisters, St Luke's Campus, Heavitree Road, Exeter EX2
4SG, United Kingdom
(Grace) University Health Network, Toronto Rehabilitation Institute,
8e-402 Toronto Western Hospital, 399 Bathurst Street, Toronto, ON, Canada
Publisher
John Wiley and Sons Ltd
Abstract
Background: International clinical practice guidelines routinely recommend
that cardiac patients participate in rehabilitation programmes for
comprehensive secondary prevention. However, data show that only a small
proportion of these patients utilise rehabilitation. Objective(s):
First, to assess interventions provided to increase patient enrolment in,
adherence to, and completion of cardiac rehabilitation. Second, to assess
intervention costs and associated harms, as well as interventions intended
to promote equitable CR utilisation in vulnerable patient subpopulations.
 Search Method(s): Review authors performed a search on 10 July 2018,
to identify studies published since publication of the previous systematic
review. We searched the Cochrane Central Register of Controlled Trials
(CENTRAL); the National Health Service (NHS) Centre for Reviews and
Dissemination (CRD) databases (Health Technology Assessment (HTA) and
Database of Abstracts of Reviews of Effects (DARE)), in the Cochrane
Library (Wiley); MEDLINE (Ovid); Embase (Elsevier); the Cumulative Index
to Nursing and Allied Health Literature (CINAHL) (EBSCOhost); and
Conference Proceedings Citation Index - Science (CPCI-S) on Web of Science
(Clarivate Analytics). We checked the reference lists of relevant
systematic reviews for additional studies and also searched two clinical
trial registers. We applied no language restrictions. Selection
Criteria: We included randomised controlled trials (RCTs) in adults with
myocardial infarction, with angina, undergoing coronary artery bypass
graft surgery or percutaneous coronary intervention, or with heart failure
who were eligible for cardiac rehabilitation. Interventions had to aim to
increase utilisation of comprehensive phase II cardiac rehabilitation. We
included only studies that measured one or more of our primary outcomes.
Secondary outcomes were harms and costs, and we focused on equity.
 Data Collection and Analysis: Two review authors independently
screened the titles and abstracts of all identified references for
eligibility, and we obtained full papers of potentially relevant trials.
Two review authors independently considered these trials for inclusion,
assessed included studies for risk of bias, and extracted trial data
independently. We resolved disagreements through consultation with a third
review author. We performed random-effects meta-regression for each
outcome and explored prespecified study characteristics. Main
Result(s): Overall, we included 26 studies with 5299 participants (29
comparisons). Participants were primarily male (64.2%). Ten (38.5%)
studies included patients with heart failure. We assessed most studies as
having low or unclear risk of bias. Sixteen studies (3164 participants)
reported interventions to improve enrolment in cardiac rehabilitation, 11
studies (2319 participants) reported interventions to improve adherence to
cardiac rehabilitation, and seven studies (1567 participants) reported
interventions to increase programme completion. Researchers tested a
variety of interventions to increase utilisation of cardiac
rehabilitation. In many studies, this consisted of contacts made by a
healthcare provider during or shortly after an acute care hospitalisation.
Low-quality evidence shows an effect of interventions on increasing
programme enrolment (19 comparisons; risk ratio (RR) 1.27, 95% confidence
interval (CI) 1.13 to 1.42). Meta-regression revealed that the
intervention deliverer (nurse or allied healthcare provider; P = 0.02) and
the delivery format (face-to-face; P = 0.01) were influential in
increasing enrolment. Low-quality evidence shows interventions to increase
adherence were effective (nine comparisons; standardised mean difference
(SMD) 0.38, 95% CI 0.20 to 0.55), particularly when they were delivered
remotely, such as in home-based programs (SMD 0.56, 95% CI 0.37 to 0.76).
Moderate-quality evidence shows interventions to increase programme
completion were also effective (eight comparisons; RR 1.13, 95% CI 1.02 to
1.25), but those applied in multi-centre studies were less effective than
those given in single-centre studies, leading to questions regarding
generalisability. A moderate level of statistical heterogeneity across
intervention studies reflects heterogeneity in intervention approaches.
There was no evidence of small-study bias for enrolment (insufficient
studies to test for this in the other outcomes). With regard to secondary
outcomes, no studies reported on harms associated with the interventions.
Only two studies reported costs. In terms of equity, trialists tested
interventions designed to improve utilisation among women and older
patients. Evidence is insufficient for quantitative assessment of whether
women-tailored programmes were associated with increased utilisation, and
studies that assess motivating women are needed. For older participants,
again while quantitative assessment could not be undertaken, peer
navigation may improve enrolment. Authors' conclusions: Interventions may
increase cardiac rehabilitation enrolment, adherence and completion;
however the quality of evidence was low to moderate due to heterogeneity
of the interventions used, among other factors. Effects on enrolment were
larger in studies targeting healthcare providers, training nurses, or
allied healthcare providers to intervene face-to-face; effects on
adherence were larger in studies that tested remote interventions. More
research is needed, particularly to discover the best ways to increase
programme completion. Copyright © 2019 The Cochrane
Collaboration.

<72>
Accession Number
625335972
Title
Omega-3 fatty acids for the primary and secondary prevention of
cardiovascular disease.
Source
Cochrane Database of Systematic Reviews. 2018(11) (no pagination), 2018.
Article Number: CD003177. Date of Publication: 30 Nov 2018.
Author
Abdelhamid A.S.; Brown T.J.; Brainard J.S.; Biswas P.; Thorpe G.C.; Moore
H.J.; Deane K.H.; Alabdulghafoor F.K.; Summerbell C.D.; Worthington H.V.;
Song F.; Hooper L.
Institution
(Abdelhamid, Brown, Brainard, Alabdulghafoor, Song, Hooper) University of
East Anglia, Norwich Medical School, Norwich Research Park, Norwich,
Norfolk NR4 7TJ, United Kingdom
(Biswas) University of East Anglia, MED/HSC, Norwich Research Park,
Norwich NR4 7TJ, United Kingdom
(Thorpe, Deane) University of East Anglia, School of Health Sciences,
Earlham Road, Norwich NR4 7TJ, United Kingdom
(Moore) Durham University, Wolfson Research Institute, Durham DH1 3LE,
United Kingdom
(Summerbell) Durham University, Department of Sport and Exercise Science,
42 Old Elvet, Durham DH13HN, United Kingdom
(Worthington) Division of Dentistry, School of Medical Sciences, Faculty
of Biology, Medicine and Health, The University of Manchester, Cochrane
Oral Health, JR Moore Building, Oxford Road, Manchester M13 9PL, United
Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Researchers have suggested that omega-3 polyunsaturated fatty
acids from oily fish (long-chain omega-3 (LCn3), including
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), as well as
from plants (alpha-linolenic acid (ALA)) benefit cardiovascular health.
Guidelines recommend increasing omega-3-rich foods, and sometimes
supplementation, but recent trials have not confirmed this.
 Objective(s): To assess effects of increased intake of fish- and
plant-based omega-3 for all-cause mortality, cardiovascular (CVD) events,
adiposity and lipids. Search Method(s): We searched CENTRAL, MEDLINE
and Embase to April 2017, plus ClinicalTrials.gov and World Health
Organization International Clinical Trials Registry to September 2016,
with no language restrictions. We handsearched systematic review
references and bibliographies and contacted authors. Selection
Criteria: We included randomised controlled trials (RCTs) that lasted at
least 12 months and compared supplementation and/or advice to increase
LCn3 or ALA intake versus usual or lower intake. Data Collection and
Analysis: Two review authors independently assessed studies for inclusion,
extracted data and assessed validity. We performed separate random-effects
meta-analysis for ALA and LCn3 interventions, and assessed dose-response
relationships through meta-regression. Main Result(s): We included 79
RCTs (112,059 participants) in this review update and found that 25 were
at low summary risk of bias. Trials were of 12 to 72 months' duration and
included adults at varying cardiovascular risk, mainly in high-income
countries. Most studies assessed LCn3 supplementation with capsules, but
some used LCn3- or ALA-rich or enriched foods or dietary advice compared
to placebo or usual diet. LCn3 doses ranged from 0.5g/d LCn3 to > 5 g/d
(16 RCTs gave at least 3g/d LCn3). Meta-analysis and sensitivity analyses
suggested little or no effect of increasing LCn3 on all-cause mortality
(RR 0.98, 95% CI 0.90 to 1.03, 92,653 participants; 8189 deaths in 39
trials, high-quality evidence), cardiovascular mortality (RR 0.95, 95% CI
0.87 to 1.03, 67,772 participants; 4544 CVD deaths in 25 RCTs),
cardiovascular events (RR 0.99, 95% CI 0.94 to 1.04, 90,378 participants;
14,737 people experienced events in 38 trials, high-quality evidence),
coronary heart disease (CHD) mortality (RR 0.93, 95% CI 0.79 to 1.09,
73,491 participants; 1596 CHD deaths in 21 RCTs), stroke (RR 1.06, 95% CI
0.96 to 1.16, 89,358 participants; 1822 strokes in 28 trials) or
arrhythmia (RR 0.97, 95% CI 0.90 to 1.05, 53,796 participants; 3788 people
experienced arrhythmia in 28 RCTs). There was a suggestion that LCn3
reduced CHD events (RR 0.93, 95% CI 0.88 to 0.97, 84,301 participants;
5469 people experienced CHD events in 28 RCTs); however, this was not
maintained in sensitivity analyses - LCn3 probably makes little or no
difference to CHD event risk. All evidence was of moderate GRADE quality,
except as noted. Increasing ALA intake probably makes little or no
difference to all-cause mortality (RR 1.01, 95% CI 0.84 to 1.20, 19,327
participants; 459 deaths, 5 RCTs),cardiovascular mortality (RR 0.96, 95%
CI 0.74 to 1.25, 18,619 participants; 219 cardiovascular deaths, 4 RCTs),
and CHD mortality (1.1% to 1.0%, RR 0.95, 95% CI 0.72 to 1.26, 18,353
participants; 193 CHD deaths, 3 RCTs) and ALA may make little or no
difference to CHD events (RR 1.00, 95% CI 0.80 to 1.22, 19,061
participants, 397 CHD events, 4 RCTs, low-quality evidence). However,
increased ALA may slightly reduce risk of cardiovascular events (from 4.8%
to 4.7%, RR 0.95, 95% CI 0.83 to 1.07, 19,327 participants; 884 CVD
events, 5 RCTs, low-quality evidence with greater effects in trials at low
summary risk of bias), and probably reduces risk of arrhythmia (3.3% to
2.6%, RR 0.79, 95% CI 0.57 to 1.10, 4,837 participants; 141 events, 1
RCT). Effects on stroke are unclear. Sensitivity analysis retaining only
trials at low summary risk of bias moved effect sizes towards the null (RR
1.0) for all LCn3 primary outcomes except arrhythmias, but for most ALA
outcomes, effect sizes moved to suggest protection. LCn3 funnel plots
suggested that adding in missing studies/results would move effect sizes
towards null for most primary outcomes. There were no dose or duration
effects in subgrouping or meta-regression. There was no evidence that
increasing LCn3 or ALA altered serious adverse events, adiposity or
lipids, except LCn3 reduced triglycerides by ~15% in a dose-dependant way
(high-quality evidence). Authors' conclusions: This is the most extensive
systematic assessment of effects of omega-3 fats on cardiovascular health
to date. Moderate- and high-quality evidence suggests that increasing EPA
and DHA has little or no effect on mortality or cardiovascular health
(evidence mainly from supplement trials). Previous suggestions of benefits
from EPA and DHA supplements appear to spring from trials with higher risk
of bias. Low-quality evidence suggests ALA may slightly reduce CVD event
and arrhythmia risk. Copyright © 2018 The Cochrane Collaboration.

<73>
Accession Number
624705902
Title
Internal iliac artery revascularisation versus internal iliac artery
occlusion for endovascular treatment of aorto-iliac aneurysms.
Source
Cochrane Database of Systematic Reviews. 2018(11) (no pagination), 2018.
Article Number: CD013168. Date of Publication: 01 Nov 2018.
Author
Sousa L.H.D.G.; Baptista-Silva J.C.C.; Vasconcelos V.; Flumignan R.L.G.
Institution
(Sousa, Vasconcelos, Flumignan) Universidade Federal de Sao Paulo,
Department of Surgery, Division of Vascular and Endovascular Surgery, Rua
Borges Lagoa, 754, Sao Paulo 04038-001, Brazil
(Baptista-Silva) Universidade Federal de Sao Paulo, Evidence Based
Medicine, Cochrane Brazil, Rua Borges Lagoa, 564, cj 124, Sao Paulo, Sao
Paulo 04038-000, Brazil
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: To assess the effects of internal iliac artery
revascularisation versus internal iliac artery occlusion during
endovascular repair of aorto-iliac aneurysms and isolated iliac aneurysms
involving the iliac bifurcation. Copyright © 2018 The Cochrane
Collaboration.

<74>
Accession Number
623538873
Title
Intravenous versus inhalational maintenance of anaesthesia for
postoperative cognitive outcomes in elderly people undergoing non-cardiac
surgery.
Source
Cochrane Database of Systematic Reviews. 2018(8) (no pagination), 2018.
Article Number: CD012317. Date of Publication: 21 Aug 2018.
Author
Miller D.; Lewis S.R.; Pritchard M.W.; Schofield-Robinson O.J.; Shelton
C.L.; Alderson P.; Smith A.F.
Institution
(Miller) North Cumbria University Hospitals, Academic Unit, Cumberland
Infirmary, Newtown Road, Carlisle CA2 7HY, United Kingdom
(Lewis, Pritchard, Schofield-Robinson) Royal Lancaster Infirmary,
Lancaster Patient Safety Research Unit, Pointer Court 1, Ashton Road,
Lancaster LA1 4RP, United Kingdom
(Shelton) Lancaster University, Lancaster Medical School, Lancaster,
United Kingdom
(Alderson) National Institute for Health and Care Excellence, Level 1A,
City Tower, Piccadilly Plaza, Manchester M1 4BD, United Kingdom
(Smith) Royal Lancaster Infirmary, Department of Anaesthesia, Ashton Road,
Lancaster, Lancashire LA1 4RP, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: The use of anaesthetics in the elderly surgical population
(more than 60 years of age) is increasing. Postoperative delirium, an
acute condition characterized by reduced awareness of the environment and
a disturbance in attention, typically occurs between 24 and 72 hours after
surgery and can affect up to 60% of elderly surgical patients.
Postoperative cognitive dysfunction (POCD) is a new-onset of cognitive
impairment which may persist for weeks or months after surgery.
Traditionally, surgical anaesthesia has been maintained with inhalational
agents. End-tidal concentrations require adjustment to balance the risks
of accidental awareness and excessive dosing in elderly people. As an
alternative, propofol-based total intravenous anaesthesia (TIVA) offers a
more rapid recovery and reduces postoperative nausea and vomiting. Using
TIVA with a target controlled infusion (TCI) allows plasma and effect-site
concentrations to be calculated using an algorithm based on age, gender,
weight and height of the patient. TIVA is a viable alternative to
inhalational maintenance agents for surgical anaesthesia in elderly
people. However, in terms of postoperative cognitive outcomes, the optimal
technique is unknown. Objective(s): To compare maintenance of general
anaesthesia for elderly people undergoing non-cardiac surgery using
propofol-based TIVA or inhalational anaesthesia on postoperative cognitive
function, mortality, risk of hypotension, length of stay in the
postanaesthesia care unit (PACU), and hospital stay. Search
Method(s): We searched the Cochrane Central Register of Controlled Trials
(CENTRAL; 2017, Issue 11), MEDLINE (1946 to November 2017), Embase (1974
to November 2017), PsycINFO (1887 to November 2017). We searched clinical
trials registers for ongoing studies, and conducted backward and forward
citation searching of relevant articles. Selection Criteria: We
included randomized controlled trials (RCTs) with participants over 60
years of age scheduled for non-cardiac surgery under general anaesthesia.
We planned to also include quasi-randomized trials. We compared
maintenance of anaesthesia with propofol-based TIVA versus inhalational
maintenance of anaesthesia. Data Collection and Analysis: Two review
authors independently assessed studies for inclusion, extracted data,
assessed risk of bias, and synthesized findings. Main Result(s): We
included 28 RCTs with 4507 randomized participants undergoing different
types of surgery (predominantly cardiovascular, laparoscopic, abdominal,
orthopaedic and ophthalmic procedures). We found no quasi-randomized
trials. Four studies are awaiting classification because we had
insufficient information to assess eligibility. All studies compared
maintenance with propofol-based TIVA versus inhalational maintenance of
anaesthesia. Six studies were multi-arm and included additional TIVA
groups, additional inhalational maintenance or both. Inhalational
maintenance agents included sevoflurane (19 studies), isoflurane (eight
studies), and desflurane (three studies), and was not specified in one
study (reported as an abstract). Some studies also reported use of
epidural analgesia/anaesthesia, fentanyl and remifentanil. We found
insufficient reporting of randomization methods in many studies and all
studies were at high risk of performance bias because it was not feasible
to blind anaesthetists to study groups. Thirteen studies described
blinding of outcome assessors. Three studies had a high of risk of
attrition bias, and we noted differences in the use of analgesics between
groups in six studies, and differences in baseline characteristics in five
studies. Few studies reported clinical trials registration, which
prevented assessment of risk of selective reporting bias. We found no
evidence of a difference in incidences of postoperative delirium according
to type of anaesthetic maintenance agents (odds ratio (OR) 0.59, 95%
confidence interval (CI) 0.15 to 2.26; 321 participants; five studies;
very low-certainty evidence); we noted during sensitivity analysis that
using different time points in one study may influence direction of this
result. Thirteen studies (3215 participants) reported POCD, and of these,
six studies reported data that could not be pooled; we noted no difference
in scores of POCD in four of these and in one study, data were at a time
point incomparable to other studies. We excluded one large study from
meta-analysis because study investigators had used non-standard
anaesthetic management and this study was not methodologically comparable
to other studies. We combined data for seven studies and found
low-certainty evidence that TIVA may reduce POCD (OR 0.52, 95% CI 0.31 to
0.87; 869 participants). We found no evidence of a difference in mortality
at 30 days (OR 1.21, 95% CI 0.33 to 4.45; 271 participants; three studies;
very low-certainty evidence). Twelve studies reported intraoperative
hypotension. We did not perform meta-analysis for 11 studies for this
outcome. We noted visual inconsistencies in these data, which may be
explained by possible variation in clinical management and medication used
to manage hypotension in each study (downgraded to low-certainty
evidence); one study reported data in a format that could not be combined
and we noted little or no difference between groups in intraoperative
hypotension for this study. Eight studies reported length of stay in the
PACU, and we did not perform meta-analysis for seven studies. We noted
visual inconsistencies in these data, which may be explained by possible
differences in definition of time points for this outcome (downgraded to
very low-certainty evidence); data were unclearly reported in one study.
We found no evidence of a difference in length of hospital stay according
to type of anaesthetic maintenance agent (mean difference (MD) 0 days, 95%
CI -1.32 to 1.32; 175 participants; four studies; very low-certainty
evidence). We used the GRADE approach to downgrade the certainty of the
evidence for each outcome. Reasons for downgrading included: study
limitations, because some included studies insufficiently reported
randomization methods, had high attrition bias, or high risk of selective
reporting bias; imprecision, because we found few studies; inconsistency,
because we noted heterogeneity across studies. Authors' conclusions: We
are uncertain whether maintenance with propofol-based TIVA or with
inhalational agents affect incidences of postoperative delirium,
mortality, or length of hospital stay because certainty of the evidence
was very low. We found low-certainty evidence that maintenance with
propofol-based TIVA may reduce POCD. We were unable to perform
meta-analysis for intraoperative hypotension or length of stay in the PACU
because of heterogeneity between studies. We identified 11 ongoing studies
from clinical trials register searches; inclusion of these studies in
future review updates may provide more certainty for the review
outcomes. Copyright © 2018 The Cochrane Collaboration.

<75>
Accession Number
623059082
Title
Continuation versus discontinuation of antiplatelet therapy for bleeding
and ischaemic events in adults undergoing non-cardiac surgery.
Source
Cochrane Database of Systematic Reviews. 2018(7) (no pagination), 2018.
Article Number: CD012584. Date of Publication: 18 Jul 2018.
Author
Lewis S.R.; Pritchard M.W.; Schofield-Robinson O.J.; Alderson P.; Smith
A.F.
Institution
(Lewis, Pritchard, Schofield-Robinson) Royal Lancaster Infirmary,
Lancaster Patient Safety Research Unit, Pointer Court 1, Ashton Road,
Lancaster LA1 4RP, United Kingdom
(Alderson) National Institute for Health and Care Excellence, Level 1A,
City Tower, Piccadilly Plaza, Manchester M1 4BD, United Kingdom
(Smith) Royal Lancaster Infirmary, Department of Anaesthesia, Ashton Road,
Lancaster, Lancashire LA1 4RP, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Antiplatelet agents are recommended for people with myocardial
infarction and acute coronary syndromes, transient ischaemic attack or
stroke, and for those in whom coronary stents have been inserted. People
who take antiplatelet agents are at increased risk of adverse events when
undergoing non-cardiac surgery because of these indications. However,
taking antiplatelet therapy also introduces risk to the person undergoing
surgery because the likelihood of bleeding is increased. Discontinuing
antiplatelet therapy before surgery might reduce this risk but
subsequently it might make thrombotic problems, such as myocardial
infarction, more likely. Objective(s): To compare the effects of
continuation versus discontinuation for at least five days of antiplatelet
therapy on the occurrence of bleeding and ischaemic events in adults
undergoing non-cardiac surgery under general, spinal or regional
anaesthesia. Search Method(s): We searched the Cochrane Central
Register of Controlled Trials (CENTRAL; 2018, Issue 1), MEDLINE (1946 to
January 2018), and Embase (1974 to January 2018). We searched clinical
trials registers for ongoing studies, and conducted backward and forward
citation searching of relevant articles. Selection Criteria: We
included randomized controlled trials of adults who were taking single or
dual antiplatelet therapy, for at least two weeks, and were scheduled for
elective non-cardiac surgery. Included participants had at least one
cardiac risk factor. We planned to include quasi-randomized studies. We
excluded people scheduled for minor surgeries under local anaesthetic or
sedation in which bleeding that required transfusion or additional surgery
was unlikely. We included studies which compared perioperative
continuation of antiplatelet therapy versus discontinuation of
antiplatelet therapy or versus substitution of antiplatelet therapy with a
placebo for at least five days before surgery. Data Collection and
Analysis: Two review authors independently assessed studies for inclusion,
extracted data, assessed risk of bias and synthesized findings. Our
primary outcomes were: all-cause mortality at longest follow-up (up to six
months); all-cause mortality (up to 30 days). Secondary outcomes included:
blood loss requiring transfusion of blood products; blood loss requiring
further surgical intervention; risk of ischaemic events. We used GRADE to
assess the quality of evidence for each outcome Main results: We included
five RCTs with 666 randomized adults. We identified three ongoing studies.
All study participants were scheduled for elective general surgery
(including abdominal, urological, orthopaedic and gynaecological surgery)
under general, spinal or regional anaesthesia. Studies compared
continuation of single or dual antiplatelet therapy (aspirin or
clopidogrel) with discontinuation of therapy for at least five days before
surgery. Three studies reported adequate methods of randomization, and two
reported methods to conceal allocation. Three studies were
placebo-controlled trials and were at low risk of performance bias, and
three studies reported adequate methods to blind outcome assessors to
group allocation. Attrition was limited in four studies and two studies
had reported prospective registration with clinical trial registers and
were at low risk of selective outcome reporting bias. We reported
mortality at two time points: the longest follow-up reported by study
authors up to six months, and time point reported by study authors up to
30 days. Five studies reported mortality up to six months (of which four
studies had a longest follow-up at 30 days, and one study at 90 days) and
we found that either continuation or discontinuation of antiplatelet
therapy may make little or no difference to mortality up to six months
(risk ratio (RR) 1.21, 95% confidence interval (CI) 0.34 to 4.27; 659
participants; low-certainty evidence); the absolute effect is three more
deaths per 1000 with continuation of antiplatelets (ranging from eight
fewer to 40 more). Combining the four studies with a longest follow-up at
30 days alone showed the same effect estimate, and we found that either
continuation or discontinuation of antiplatelet therapy may make little or
no difference to mortality at 30 days after surgery (RR 1.21, 95% CI 0.34
to 4.27; 616 participants; low-certainty evidence); the absolute effect is
three more deaths per 1000 with continuation of antiplatelets (ranging
from nine fewer to 42 more). We found that either continuation or
discontinuation of antiplatelet therapy probably makes little or no
difference in incidences of blood loss requiring transfusion (RR 1.37, 95%
CI 0.83 to 2.26; 368 participants; absolute effect of 42 more participants
per 1000 requiring transfusion in the continuation group, ranging from 19
fewer to 119 more; four studies; moderate-certainty evidence); and may
make little or no difference in incidences of blood loss requiring
additional surgery (RR 1.54, 95% CI 0.31 to 7.58; 368 participants;
absolute effect of six more participants per 1000 requiring additional
surgery in the continuation group, ranging from seven fewer to 71 more;
four studies; low-certainty evidence). We found that either continuation
or discontinuation of antiplatelet therapy may make little or no
difference to incidences of ischaemic events (to include peripheral
ischaemia, cerebral infarction, and myocardial infarction) within 30 days
of surgery (RR 0.67, 95% CI 0.25 to 1.77; 616 participants; absolute
effect of 17 fewer participants per 1000 with an ischaemic event in the
continuation group, ranging from 39 fewer to 40 more; four studies;
low-certainty evidence). We used the GRADE approach to downgrade evidence
for all outcomes owing to limited evidence from few studies. We noted a
wide confidence in effect estimates for mortality at the end of follow-up
and at 30 days, and for blood loss requiring transfusion which suggested
imprecision. We noted visual differences in study results for ischaemic
events which suggested inconsistency. Authors' conclusions: We found
low-certainty evidence that either continuation or discontinuation of
antiplatelet therapy before non-cardiac surgery may make little or no
difference to mortality, bleeding requiring surgical intervention, or
ischaemic events. We found moderate-certainty evidence that either
continuation or discontinuation of antiplatelet therapy before non-cardiac
surgery probably makes little or no difference to bleeding requiring
transfusion. Evidence was limited to few studies with few participants,
and with few events. The three ongoing studies may alter the conclusions
of the review once published and assessed. Copyright © 2018 The
Cochrane Collaboration.

<76>
Accession Number
621789378
Title
Local anaesthetics and regional anaesthesia versus conventional analgesia
for preventing persistent postoperative pain in adults and children.
Source
Cochrane Database of Systematic Reviews. 2018(4) (no pagination), 2018.
Article Number: CD007105. Date of Publication: 25 Apr 2018.
Author
Weinstein E.J.; Levene J.L.; Cohen M.S.; Andreae D.A.; Chao J.Y.; Johnson
M.; Hall C.B.; Andreae M.H.
Institution
(Weinstein, Levene) Albert Einstein College of Medicine of Yeshiva
University, 1300 Morris Park Ave, Bronx, NY 10461, United States
(Cohen, Chao) Montefiore Medical Center, Albert Einstein College of
Medicine, Department of Anesthesiology, 111 E 210 Street, Bronx, NY
N4-005, United States
(Andreae) Milton S Hershey Medical Center, Department of Allergy/
Immunology, 500 University Dr, Hershey, PA 17033, United States
(Johnson) Teachers College, Columbia University, Human Development, New
York, NY 10027, United States
(Hall) Albert Einstein College of Medicine, Division of Biostatistics,
Department of Epidemiology and Population Health, 1300 Morris Park Avenue,
Bronx, NY 10461, United States
(Andreae) Milton S Hershey Medical Centre, Department of Anesthesiology
and Perioperative Medicine, 500 University Drive, H187, Hershey, PA 17033,
United States
Publisher
John Wiley and Sons Ltd
Abstract
Background: Regional anaesthesia may reduce the rate of persistent
postoperative pain (PPP), a frequent and debilitating condition. This
review was originally published in 2012 and updated in 2017.
 Objective(s): To compare local anaesthetics and regional anaesthesia
versus conventional analgesia for the prevention of PPP beyond three
months in adults and children undergoing elective surgery. Search
Method(s): We searched CENTRAL, MEDLINE, and Embase to December 2016
without any language restriction. We used a combination of free text
search and controlled vocabulary search. We limited results to randomized
controlled trials (RCTs). We updated this search in December 2017, but
these results have not yet been incorporated in the review. We conducted a
handsearch in reference lists of included studies, review articles and
conference abstracts. We searched the PROSPERO systematic review registry
for related systematic reviews. Selection Criteria: We included RCTs
comparing local or regional anaesthesia versus conventional analgesia with
a pain outcome beyond three months after elective, non-orthopaedic
surgery. Data Collection and Analysis: At least two review authors
independently assessed trial quality and extracted data and adverse
events. We contacted study authors for additional information. We
presented outcomes as pooled odds ratios (OR) with 95% confidence
intervals (95% CI), based on random-effects models (inverse variance
method). We analysed studies separately by surgical intervention, but
pooled outcomes reported at different follow-up intervals. We compared our
results to Bayesian and classical (frequentist) models. We investigated
heterogeneity. We assessed the quality of evidence with GRADE. Main
Result(s): In this updated review, we identified 40 new RCTs and seven
ongoing studies. In total, we included 63 RCTs in the review, but we were
only able to synthesize data on regional anaesthesia for the prevention of
PPP beyond three months after surgery from 41 studies, enrolling a total
of 3143 participants in our inclusive analysis. Evidence synthesis of
seven RCTs favoured epidural anaesthesia for thoracotomy, suggesting the
odds of having PPP three to 18 months following an epidural for
thoracotomy were 0.52 compared to not having an epidural (OR 0.52 (95% CI
0.32 to 0.84, 499 participants, moderate-quality evidence). Simlarly,
evidence synthesis of 18 RCTs favoured regional anaesthesia for the
prevention of persistent pain three to 12 months after breast cancer
surgery with an OR of 0.43 (95% CI 0.28 to 0.68, 1297 participants,
low-quality evidence). Pooling data at three to 8 months after surgery
from four RCTs favoured regional anaesthesia after caesarean section with
an OR of 0.46, (95% CI 0.28 to 0.78; 551 participants, moderate-quality
evidence). Evidence synthesis of three RCTs investigating continuous
infusion with local anaesthetic for the prevention of PPP three to 55
months after iliac crest bone graft harvesting (ICBG) was inconclusive (OR
0.20, 95% CI 0.04 to 1.09; 123 participants, low-quality evidence).
However, evidence synthesis of two RCTs also favoured the infusion of
intravenous local anaesthetics for the prevention of PPP three to six
months after breast cancer surgery with an OR of 0.24 (95% CI 0.08 to
0.69, 97 participants, moderate-quality evidence). We did not synthesize
evidence for the surgical subgroups of limb amputation, hernia repair,
cardiac surgery and laparotomy. We could not pool evidence for adverse
effects because the included studies did not examine them systematically,
and reported them sparsely. Clinical heterogeneity, attrition and sparse
outcome data hampered evidence synthesis. High risk of bias from missing
data and lack of blinding across a number of included studies reduced our
confidence in the findings. Thus results must be interpreted with caution.
Authors' conclusions: We conclude that there is moderate-quality evidence
that regional anaesthesia may reduce the risk of developing PPP after
three to 18 months after thoracotomy and three to 12 months after
caesarean section. There is low-quality evidence that regional anaesthesia
may reduce the risk of developing PPP three to 12 months after breast
cancer surgery. There is moderate evidence that intravenous infusion of
local anaesthetics may reduce the risk of developing PPP three to six
months after breast cancer surgery. Our conclusions are considerably
weakened by the small size and number of studies, by performance bias,
null bias, attrition and missing data. Larger, high-quality studies,
including children, are needed. We caution that except for breast surgery,
our evidence synthesis is based on only a few small studies. On a
cautionary note, we cannot extend our conclusions to other surgical
interventions or regional anaesthesia techniques, for example we cannot
conclude that paravertebral block reduces the risk of PPP after
thoracotomy. There are seven ongoing studies and 12 studies awaiting
classification that may change the conclusions of the current review once
they are published and incorporated. Copyright © 2018 The
Cochrane Collaboration.

<77>
Accession Number
620990707
Title
Alpha-2 adrenergic agonists for the prevention of cardiac complications
among adults undergoing surgery.
Source
Cochrane Database of Systematic Reviews. 2018(3) (no pagination), 2018.
Article Number: CD004126. Date of Publication: 06 Mar 2018.
Author
Duncan D.; Sankar A.; Beattie W.S.; Wijeysundera D.N.
Institution
(Duncan, Sankar) University of Toronto, Department of Anesthesia, 123
Edward Street, 12th Floor, Toronto, ON M5G 1E2, Canada
(Beattie) Toronto General Hospital, University Health Network, Department
of Anaesthesia, EN 3-453 Toronto General Hospital, University Health
Network, 200 Elizabeth Street, Toronto, ON M5G 2C4, Canada
(Wijeysundera) St. Michael's Hospital, Li Ka Shing Knowledge Institute, 30
Bond Street, Toronto, ON M5B 1W8, Canada
Publisher
John Wiley and Sons Ltd
Abstract
Background: The surgical stress response plays an important role on the
pathogenesis of perioperative cardiac complications. Alpha-2 adrenergic
agonists attenuate this response and may help prevent postoperative
cardiac complications. Objective(s): To determine the efficacy and
safety of alpha-2 adrenergic agonists for reducing mortality and cardiac
complications in adults undergoing cardiac surgery and non-cardiac
surgery. Search Method(s): We searched CENTRAL (2017, Issue 4),
MEDLINE (1950 to April Week 4, 2017), Embase (1980 to May 2017), the
Science Citation Index, clinical trial registries, and reference lists of
included articles. Selection Criteria: We included randomized
controlled trials that compared alpha-2 adrenergic agonists (i.e.
clonidine, dexmedetomidine or mivazerol) against placebo or non-alpha-2
adrenergic agonists. Included trials had to evaluate the efficacy and
safety of alpha-2 adrenergic agonists for preventing perioperative
mortality or cardiac complications (or both), or measure one or more
relevant outcomes (i.e. death, myocardial infarction, heart failure, acute
stroke, supraventricular tachyarrhythmia and myocardial ischaemia).
 Data Collection and Analysis: Two authors independently assessed
trial quality, extracted data and independently performed computer entry
of abstracted data. We contacted study authors for additional information.
Adverse event data were gathered from the trials. We evaluated included
studies using the Cochrane 'Risk of bias' tool, and the quality of the
evidence underlying pooled treatment effects using GRADE methodology.
Given the clinical heterogeneity between cardiac and non-cardiac surgery,
we analysed these subgroups separately. We expressed treatment effects as
pooled risk ratios (RR) with 95% confidence intervals (CI). Main
Result(s): We included 47 trials with 17,039 participants. Of these
studies, 24 trials only included participants undergoing cardiac surgery,
23 only included participants undergoing non-cardiac surgery and eight
only included participants undergoing vascular surgery. The alpha-2
adrenergic agonist studied was clonidine in 21 trials, dexmedetomidine in
24 trials and mivazerol in two trials. In non-cardiac surgery, there was
high quality evidence that alpha-2 adrenergic agonists led to a similar
risk of all-cause mortality compared with control groups (1.3% with
alpha-2 adrenergic agonists versus 1.7% with control; RR 0.80, 95% CI 0.61
to 1.04; participants = 14,081; studies = 16). Additionally, the risk of
cardiac mortality was similar between treatment groups (0.8% with alpha-2
adrenergic agonists versus 1.0% with control; RR 0.86, 95% CI 0.60 to
1.23; participants = 12,525; studies = 5, high quality evidence). The risk
of myocardial infarction was probably similar between treatment groups (RR
0.94, 95% CI 0.69 to 1.27; participants = 13,907; studies = 12, moderate
quality evidence). There was no associated effect on the risk of stroke
(RR 0.93, 95% CI 0.55 to 1.56; participants = 11,542; studies = 7; high
quality evidence). Conversely, alpha-2 adrenergic agonists probably
increase the risks of clinically significant bradycardia (RR 1.59, 95% CI
1.18 to 2.13; participants = 14,035; studies = 16) and hypotension (RR
1.24, 95% CI 1.03 to 1.48; participants = 13,738; studies = 15), based on
moderate quality evidence. There was insufficient evidence to determine
the effect of alpha-2 adrenergic agonists on all-cause mortality in
cardiac surgery (RR 0.52, 95% CI 0.26 to 1.04; participants = 1947;
studies = 16) and myocardial infarction (RR 1.01, 95% CI 0.43 to 2.40;
participants = 782; studies = 8), based on moderate quality evidence.
There was one cardiac death in the clonidine arm of a study of 22
participants. Based on very limited data, alpha-2 adrenergic agonists may
have reduced the risk of stroke (RR 0.37, 95% CI 0.15 to 0.93;
participants = 1175; studies = 7; outcome events = 18; low quality
evidence). Conversely, alpha-2 adrenergic agonists increased the risk of
bradycardia from 6.4% to 12.0% (RR 1.88, 95% CI 1.35 to 2.62; participants
= 1477; studies = 10; moderate quality evidence), but their effect on
hypotension was uncertain (RR 1.19, 95% CI 0.87 to 1.64; participants =
1413; studies = 9; low quality evidence). These results were qualitatively
unchanged in subgroup analyses and sensitivity analyses. Authors'
conclusions: Our review concludes that prophylactic alpha-2 adrenergic
agonists generally do not prevent perioperative death or major cardiac
complications. For non-cardiac surgery, there is moderate-to-high quality
evidence that these agents do not prevent death, myocardial infarction or
stroke. Conversely, there is moderate quality evidence that these agents
have important adverse effects, namely increased risks of hypotension and
bradycardia. For cardiac surgery, there is moderate quality evidence that
alpha-2 adrenergic agonists have no effect on the risk of mortality or
myocardial infarction, and that they increase the risk of bradycardia. The
quality of evidence was inadequate to draw conclusions regarding the
effects of alpha-2 agonists on stroke or hypotension during cardiac
surgery. Copyright © 2018 The Cochrane Collaboration.

<78>
Accession Number
620433262
Title
Exercise-based cardiac rehabilitation for adults with stable angina.
Source
Cochrane Database of Systematic Reviews. 2018(2) (no pagination), 2018.
Article Number: CD012786. Date of Publication: 02 Feb 2018.
Author
Long L.; Anderson L.; Dewhirst A.M.; He J.; Bridges C.; Gandhi M.; Taylor
R.S.
Institution
(Long, Anderson, Dewhirst, Taylor) University of Exeter Medical School,
Institute of Health Research, Exeter, United Kingdom
(He, Gandhi) Royal Devon and Exeter NHS Foundation Trust Hospital,
Cardiology, Exeter, United Kingdom
(Bridges) University College London, Farr Institute of Health Informatics
Research, 222 Euston Road, London NW1 2DA, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: A previous Cochrane review has shown that exercise-based
cardiac rehabilitation (CR) can benefit myocardial infarction and
post-revascularisation patients. However, the impact on stable angina
remains unclear and guidance is inconsistent. Whilst recommended in the
guidelines of American College of Cardiology/American Heart Association
and the European Society of Cardiology, in the UK the National Institute
for Health and Care Excellence (NICE) states that there is "no evidence to
suggest that CR is clinically or cost-effective for managing stable
angina". Objective(s): To assess the effects of exercise-based CR
compared to usual care for adults with stable angina. Search
Method(s): We updated searches from the previous Cochrane review
'Exercise-based cardiac rehabilitation for patients with coronary heart
disease' by searching the Cochrane Central Register of Controlled Trials
(CENTRAL), MEDLINE, Embase, DARE, CINAHL and Web of Science on 2 October
2017. We searched two trials registers, and performed reference checking
and forward-citation searching of all primary studies and review articles,
to identify additional studies. Selection Criteria: We included
randomised controlled trials (RCTs) with a follow-up period of at least
six months, which compared structured exercise-based CR with usual care
for people with stable angina. Data Collection and Analysis: Two
review authors independently assessed the risk of bias and extracted data
according to the Cochrane Handbook for Systematic Reviews of
Interventions. Two review authors also independently assessed the quality
of the evidence using GRADE principles and we presented this information
in a 'Summary of findings' table. Main Result(s): Seven studies (581
participants) met our inclusion criteria. Trials had an intervention
length of 6 weeks to 12 months and follow-up length of 6 to 12 months. The
comparison group in all trials was usual care (without any form of
structured exercise training or advice) or a no-exercise comparator. The
mean age of participants within the trials ranged from 50 to 66 years, the
majority of participants being male (range: 74% to 100%). In terms of risk
of bias, the majority of studies were unclear about their generation of
the randomisation sequence and concealment processes. One study was at
high risk of detection bias as it did not blind its participants or
outcome assessors, and two studies had a high risk of attrition bias due
to the numbers of participants lost to follow-up. Two trials were at high
risk of outcome reporting bias. Given the high risk of bias, small number
of trials and participants, and concerns about applicability, we
downgraded our assessments of the quality of the evidence using the GRADE
tool. Due to the very low-quality of the evidence base, we are uncertain
about the effect of exercise-based CR on all-cause mortality (risk ratio
(RR) 1.01, 95% confidence interval (CI) 0.18 to 5.67; 195 participants; 3
studies; very low-quality evidence), acute myocardial infarction (RR 0.33,
95% CI 0.07 to 1.63; 254 participants; 3 studies; very low-quality
evidence) and cardiovascular-related hospital admissions (RR 0.14, 95% CI
0.02 to 1.1; 101 participants; 1 study; very low-quality evidence). We
found low-quality evidence that exercise-based CR may result in a small
improvement in exercise capacity compared to control (standardised mean
difference (SMD) 0.45, 95% CI 0.20 to 0.70; 267 participants; 5 studies,
low-quality evidence). We were unable to draw conclusions about the impact
of exercise-based CR on quality of life (angina frequency and emotional
health-related quality-of-life score) and CR-related adverse events (e.g.
skeletomuscular injury, cardiac arrhythmia), due to the very low quality
of evidence. No data were reported on return to work. Authors'
conclusions: Due to the small number of trials and their small size,
potential risk of bias and concerns about imprecision and lack of
applicability, we are uncertain of the effects of exercise-based CR
compared to control on mortality, morbidity, cardiovascular hospital
admissions, adverse events, return to work and health-related quality of
life in people with stable angina. Low-quality evidence indicates that
exercise-based CR may result in a small increase in exercise capacity
compared to usual care. High-quality, well-reported randomised trials are
needed to assess the benefits and harms of exercise-based CR for adults
with stable angina. Such trials need to collect patient-relevant outcomes,
including clinical events and health-related quality of life. They should
also assess cost-effectiveness, and recruit participants that are
reflective of the real-world population of people with
angina. Copyright © 2018 The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd.

<79>
Accession Number
620353172
Title
Inotropic agents and vasodilator strategies for the treatment of
cardiogenic shock or low cardiac output syndrome.
Source
Cochrane Database of Systematic Reviews. 2018(1) (no pagination), 2018.
Article Number: CD009669. Date of Publication: 29 Jan 2018.
Author
Schumann J.; Henrich E.C.; Strobl H.; Prondzinsky R.; Weiche S.; Thiele
H.; Werdan K.; Frantz S.; Unverzagt S.
Institution
(Schumann) Martin-Luther-University Halle-Wittenberg, Department of
Anaesthesiology and Surgical Intensive Care, Halle/Saale, Germany
(Henrich, Strobl, Unverzagt) Martin-Luther-University Halle-Wittenberg,
Institute of Medical Epidemiology, Biostatistics and Informatics,
Halle/Saale 06112, Germany
(Prondzinsky) Carl von Basedow Klinikum Merseburg, Cardiology/Intensive
Care Medicine, Weisse Mauer 42, Merseburg 06217, Germany
(Weiche, Werdan, Frantz) Martin-Luther-University Halle-Wittenberg,
Department of Internal Medicine III, Halle/Saale, Germany
(Thiele) University Clinic Schleswig-Holstein, Campus Lubeck, Medical
Clinic II (Kardiology, Angiology, Intensive Care Medicine), Ratzeburger
Allee 160, Lubeck D-23538, Germany
Publisher
John Wiley and Sons Ltd
Abstract
Background: Cardiogenic shock (CS) and low cardiac output syndrome (LCOS)
as complications of acute myocardial infarction (AMI), heart failure (HF)
or cardiac surgery are life-threatening conditions. While there is a broad
body of evidence for the treatment of people with acute coronary syndrome
under stable haemodynamic conditions, the treatment strategies for people
who become haemodynamically unstable or develop CS remain less clear. We
have therefore summarised here the evidence on the treatment of people
with CS or LCOS with different inotropic agents and vasodilative drugs.
This is the first update of a Cochrane review originally published in
2014. Objective(s): To assess efficacy and safety of cardiac care
with positive inotropic agents and vasodilator strategies in people with
CS or LCOS due to AMI, HF or cardiac surgery. Search Method(s): We
searched CENTRAL, MEDLINE, Embase and CPCI-S Web of Science in June 2017.
We also searched four registers of ongoing trials and scanned reference
lists and contacted experts in the field to obtain further information. No
language restrictions were applied. Selection Criteria: Randomised
controlled trials in people with myocardial infarction, heart failure or
cardiac surgery complicated by cardiogenic shock or LCOS. Data
Collection and Analysis: We used standard methodological procedures
expected by Cochrane. Main Result(s): We identified 13 eligible
studies with 2001 participants (mean or median age range 58 to 73 years)
and two ongoing studies. We categorised studies into eight comparisons,
all against cardiac care and additional other active drugs or placebo.
These comparisons investigated the efficacy of levosimendan versus
dobutamine, enoximone or placebo, epinephrine versus
norepinephrine-dobutamine, amrinone versus dobutamine, dopexamine versus
dopamine, enoximone versus dopamine and nitric oxide versus placebo. All
trials were published in peer-reviewed journals, and analysis was done by
the intention-to-treat (ITT) principle. Twelve of 13 trials were small
with few included participants. Acknowledgement of funding by the
pharmaceutical industry or missing conflict of interest statements emerged
in five of 13 trials. In general, confidence in the results of analysed
studies was reduced due to serious study limitations, very serious
imprecision or indirectness. Domains of concern, which show a high risk of
more than 50%, include performance bias (blinding of participants and
personnel) and bias affecting the quality of evidence on adverse events.
Levosimendan may reduce short-term mortality compared to a therapy with
dobutamine (RR 0.60, 95% CI 0.37 to 0.95; 6 studies; 1776 participants;
low-quality evidence; NNT: 16 (patients with moderate risk), NNT: 5
(patients with CS)). This initial short-term survival benefit with
levosimendan vs. dobutamine is not confirmed on long-term follow up. There
is uncertainty (due to lack of statistical power) as to the effect of
levosimendan compared to therapy with placebo (RR 0.48, 95% CI 0.12 to
1.94; 2 studies; 55 participants, very low-quality evidence) or enoximone
(RR 0.50, 95% CI 0.22 to 1.14; 1 study; 32 participants, very low-quality
evidence). All comparisons comparing other positive inotropic, inodilative
or vasodilative drugs presented uncertainty on their effect on short-term
mortality with very low-quality evidence and based on only one RCT. These
single studies compared epinephrine with norepinephrine-dobutamine (RR
1.25, 95% CI 0.41 to 3.77; 30 participants), amrinone with dobutamine (RR
0.33, 95% CI 0.04 to 2.85; 30 participants), dopexamine with dopamine (no
in-hospital deaths from 70 participants), enoximone with dobutamine (two
deaths from 40 participants) and nitric oxide with placebo (one death from
three participants). Authors' conclusions: Apart from low quality of
evidence data suggesting a short-term mortality benefit of levosimendan
compared with dobutamine, at present there are no robust and convincing
data to support a distinct inotropic or vasodilator drug-based therapy as
a superior solution to reduce mortality in haemodynamically unstable
people with cardiogenic shock or LCOS. Considering the limited evidence
derived from the present data due to a generally high risk of bias and
imprecision, it should be emphasised that there remains a great need for
large, well-designed randomised trials on this topic to close the gap
between daily practice in critical care medicine and the available
evidence. It seems to be useful to apply the concept of 'early
goal-directed therapy' in cardiogenic shock and LCOS with early
haemodynamic stabilisation within predefined timelines. Future clinical
trials should therefore investigate whether such a therapeutic concept
would influence survival rates much more than looking for the 'best' drug
for haemodynamic support. Copyright © 2018 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<80>
Accession Number
620249241
Title
Hybrid repair versus conventional open repair for aortic arch dissection.
Source
Cochrane Database of Systematic Reviews. 2018(1) (no pagination), 2018.
Article Number: CD012920. Date of Publication: 19 Jan 2018.
Author
Kavanagh E.P.; Jordan F.; Hynes N.; Elhelali A.; Devane D.; Veerasingam
D.; Sultan S.
Institution
(Kavanagh, Hynes) The Galway Clinic, Department of Vascular and
Endovascular Surgery, Suite 24, Galway, Doughiska, Ireland
(Jordan, Devane) National University of Ireland Galway, School of Nursing
and Midwifery, Arus Moyola, Newcastle Road, Galway, Ireland
(Elhelali) Galway-Mayo Institute of Technology, Mechanical and Industrial
Engineering, Dublin Road, Galway, Ireland
(Veerasingam) Galway University Hospital, Cardiothoracic Surgery,
Newcastle Road, Galway, Ireland
(Sultan) Galway University Hospital, Vascular Surgery, Newcastle, Galway,
Ireland
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: To assess the effectiveness and safety of a hybrid
technique of treatment over conventional open repair in the management of
aortic arch dissection. Copyright © 2018 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<81>
Accession Number
622923198
Title
Intraoperative use of low volume ventilation to decrease postoperative
mortality, mechanical ventilation, lengths of stay and lung injury in
adults without acute lung injury.
Source
Cochrane Database of Systematic Reviews. 2018(7) (no pagination), 2018.
Article Number: CD011151. Date of Publication: 09 Jul 2018.
Author
Guay J.; Ochroch E.A.; Kopp S.
Institution
(Guay) University of Sherbrooke, Department of Anesthesiology, Faculty of
Medicine, Sherbrooke, Quebec, Canada
(Guay) University of Quebec in Abitibi-Temiscamingue, Teaching and
Research Unit, Health Sciences, Rouyn-Noranda, QC, Canada
(Guay) Faculty of Medicine, Laval University, Department of Anesthesiology
and Critical Care, Quebec City, QC, Canada
(Ochroch) University of Pennsylvania, Department of Anesthesiology, 3400
Spruce Street, Philadelphia, PA 19104, United States
(Kopp) Mayo Clinic College of Medicine, Department of Anesthesiology and
Perioperative Medicine, 200 1st St SW, Rochester, MN 55901, United States
Publisher
John Wiley and Sons Ltd
Abstract
Background: Since the 2000s, there has been a trend towards decreasing
tidal volumes for positive pressure ventilation during surgery. This an
update of a review first published in 2015, trying to determine if lower
tidal volumes are beneficial or harmful for patients. Objective(s):
To assess the benefit of intraoperative use of low tidal volume
ventilation (less than 10 mL/kg of predicted body weight) compared with
high tidal volumes (10 mL/kg or greater) to decrease postoperative
complications in adults without acute lung injury. Search Method(s):
We searched the Cochrane Central Register of Controlled Trials (CENTRAL
2017, Issue 5), MEDLINE (OvidSP) (from 1946 to 19 May 2017), Embase
(OvidSP) (from 1974 to 19 May 2017) and six trial registries. We screened
the reference lists of all studies retained and of recent meta-analysis
related to the topic during data extraction. We also screened conference
proceedings of anaesthesiology societies, published in two major
anaesthesiology journals. The search was rerun 3 January 2018.
 Selection Criteria: We included all parallel randomized controlled
trials (RCTs) that evaluated the effect of low tidal volumes (defined as
less than 10 mL/kg) on any of our selected outcomes in adults undergoing
any type of surgery. We did not retain studies with participants requiring
one-lung ventilation. Data Collection and Analysis: Two authors
independently assessed the quality of the retained studies with the
Cochrane 'Risk of bias' tool. We analysed data with both fixed-effect
(I2 statistic less than 25%) or random-effects (I2
statistic greater than 25%) models based on the degree of heterogeneity.
When there was an effect, we calculated a number needed to treat for an
additional beneficial outcome (NNTB) using the odds ratio. When there was
no effect, we calculated the optimum information size. Main
Result(s): We included seven new RCTs (536 participants) in the update. In
total, we included 19 studies in the review (776 participants in the low
tidal volume group and 772 in the high volume group). There are four
studies awaiting classification and three are ongoing. All included
studies were at some risk of bias. Participants were scheduled for
abdominal surgery, heart surgery, pulmonary thromboendarterectomy, spinal
surgery and knee surgery. Low tidal volumes used in the studies varied
from 6 mL/kg to 8.1 mL/kg while high tidal volumes varied from 10 mL/kg to
12 mL/kg. Based on 12 studies including 1207 participants, the effects of
low volume ventilation on 0- to 30-day mortality were uncertain (risk
ratio (RR) 0.80, 95% confidence interval (CI) 0.42 to 1.53; I2
= 0%; low-quality evidence). Based on seven studies including 778
participants, lower tidal volumes probably reduced postoperative pneumonia
(RR 0.45, 95% CI 0.25 to 0.82; I2 = 0%; moderate-quality
evidence; NNTB 24, 95% CI 16 to 160), and it probably reduced the need for
non-invasive postoperative ventilatory support based on three studies
including 506 participants (RR 0.31, 95% CI 0.15 to 0.64; moderate-quality
evidence; NNTB 13, 95% CI 11 to 24). Based on 11 studies including 957
participants, low tidal volumes during surgery probably decreased the need
for postoperative invasive ventilatory support (RR 0.33, 95% CI 0.14 to
0.77; I2 = 0%; NNTB 39, 95% CI 30 to 166; moderate-quality
evidence). Based on five studies including 898 participants, there may be
little or no difference in the intensive care unit length of stay
(standardized mean difference (SMD) -0.06, 95% CI -0.22 to 0.10;
I2 = 33%; low-quality evidence). Based on 14 studies including
1297 participants, low tidal volumes may have reduced hospital length of
stay by about 0.8 days (SMD -0.15, 95% CI -0.29 to 0.00; I2 =
27%; low-quality evidence). Based on five studies including 708
participants, the effects of low volume ventilation on barotrauma
(pneumothorax) were uncertain (RR 1.77, 95% CI 0.52 to 5.99; I2
= 0%; very low-quality evidence). Authors' conclusions: We found
moderate-quality evidence that low tidal volumes (defined as less than 10
mL/kg) decreases pneumonia and the need for postoperative ventilatory
support (invasive and non-invasive). We found no difference in the risk of
barotrauma (pneumothorax), but the number of participants included does
not allow us to make definitive statement on this. The four studies in
'Studies awaiting classification' may alter the conclusions of the review
once assessed. Copyright © 2018 The Cochrane Collaboration.

<82>
Accession Number
622895703
Title
Ketorolac for postoperative pain in children.
Source
Cochrane Database of Systematic Reviews. 2018(7) (no pagination), 2018.
Article Number: CD012294. Date of Publication: 07 Jul 2018.
Author
Mcnicol E.D.; Rowe E.; Cooper T.E.
Institution
(Mcnicol) Tufts Medical Center, Department of Anesthesiology and
Perioperative Medicine, Boston, MA, United States
(Mcnicol, Rowe) Tufts Medical Center, Department of Pharmacy, Boston, MA,
United States
(Mcnicol) Tufts University School of Medicine, Pain Research, Education
and Policy (PREP) Program, Department of Public Health and Community
Medicine, Boston, MA, United States
(Cooper) Pain Research Unit, Churchill Hospital, Cochrane Pain, Palliative
and Supportive Care Group, Churchill Hospital, Oxford, Oxfordshire OX3
7LE, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Children who undergo surgical procedures in ambulatory and
inpatient settings are at risk of experiencing acute pain. Nonsteroidal
anti-inflammatory drugs (NSAIDs) can reduce moderate to severe pain
without many of the side effects associated with opioids. However, NSAIDs
may cause bleeding, renal and gastrointestinal toxicity, and potentially
delay wound and bone healing. Intravenous administration of ketorolac for
postoperative pain in children has not been approved in many countries,
but is routinely administered in clinical practise. Objective(s): To
assess the efficacy and safety of ketorolac for postoperative pain in
children. Search Method(s): We searched the following databases,
without language restrictions, to November 2017: CENTRAL (The Cochrane
Library 2017, Issue 10); MEDLINE, Embase, and LILACS. We also checked
clinical trials registers and reference lists of reviews, and retrieved
articles for additional studies. Selection Criteria: We included
randomised controlled trials that compared the analgesic efficacy of
ketorolac (in any dose, administered via any route) with placebo or
another active treatment, in treating postoperative pain in participants
zero to 18 years of age following any type of surgery. Data
Collection and Analysis: We used standard methodological procedures
expected by Cochrane. Two review authors independently considered trials
for inclusion in the review, assessed risk of bias, and extracted data. We
analyzed trials in two groups; ketorolac versus placebo, and ketorolac
versus opioid. However, we performed limited pooled analyses. We assessed
the overall quality of the evidence for each outcome using GRADE, and
created a 'Summary of findings' table. Main Result(s): We included 13
studies, involving 920 randomised participants. There was considerable
heterogeneity among study designs, including the comparator arms (placebo,
opioid, another NSAID, or a different regimen of ketorolac), dosing
regimens (routes and timing of administration, single versus multiple
dose), outcome assessment methods, and types of surgery. Mean study
population ages ranged from 356 days to 13.9 years. The majority of
studies chose a dose of either 0.5 mg/kg (as a single or multiple dose
regimen) or 1 mg/kg (single dose with 0.5 mg/kg for any subsequent doses).
One study administered interventions intraoperatively; the remainder
administered interventions postoperatively, often after the participant
reported moderate to severe pain. There were insufficient data to perform
meta-analysis for either of our primary outcomes: participants with at
least 50% pain relief; or mean postoperative pain intensity. Four studies
individually reported statistically significant reductions in pain
intensity when comparing ketorolac with placebo, but the studies were
small and had various risks of bias, primarily due to incomplete outcome
data and small sample sizes. We found limited data available for the
secondary outcomes of participants requiring rescue medication and opioid
consumption. For the former, we saw no clear difference between ketorolac
and placebo; 74 of 135 (55%) participants receiving ketorolac required
rescue analgesia in the post-anaesthesia care unit (PACU) versus 81 of 127
(64%) receiving placebo (relative risk (RR) 0.85, 95% confidence interval
(CI) 0.71 to 1.00, P = 0.05; 4 studies, 262 participants). For opioid
consumption in the PACU, we saw no clear difference between ketorolac and
placebo (P = 0.61). For the time period zero to four hours after
administration of the interventions, participants receiving ketorolac
received 1.58 mg less intravenous morphine equivalents than those
receiving placebo (95% CI -2.58 mg to -0.57 mg, P = 0.002; 2 studies, 129
participants). However, we are uncertain whether ketorolac has an
important effect on opioid consumption, as the data were sparse and the
results were inconsistent. Only one study reported data for opioid
consumption when comparing ketorolac with an opioid. There were no clear
differences between the ketorolac and opioid group at any time point.
There were no data assessing this outcome for the comparison of ketorolac
with another NSAID. There were insufficient data to allow us to analyze
overall adverse event or serious adverse event rates. Although the
majority of serious adverse events reported in those receiving ketorolac
involved bleeding, the number of events was too low to conclude that
bleeding risk was increased in those receiving ketorolac perioperatively.
There was not a statistically significant increase in event rates for any
specific adverse event, either in pooled analysis or in single studies,
when comparing ketorolac and placebo. When comparing ketorolac with
opioids or other NSAIDs, there were too few data to make any conclusions
regarding event rates. Lastly, withdrawals due to adverse events were vary
rare in all groups, reflecting the acute nature of such studies. We
assessed the quality of evidence for all outcomes for each comparison
(placebo or active) as very low, due to issues with risk of bias in
individual studies, imprecision, heterogeneity between studies, and low
overall numbers of participants and events. Authors' conclusions: Due to
the lack of data for our primary outcomes, and the very low-quality
evidence for secondary outcomes, the efficacy and safety of ketorolac in
treating postoperative pain in children were both uncertain. The evidence
was insufficient to support or reject its use. Copyright © 2018
The Cochrane Collaboration.

<83>
Accession Number
618682668
Title
Blood pressure targets for the treatment of people with hypertension and
cardiovascular disease.
Source
Cochrane Database of Systematic Reviews. 2017(10) (no pagination), 2017.
Article Number: CD010315. Date of Publication: 11 Oct 2017.
Author
Saiz L.C.; Gorricho J.; Garjon J.; Celaya M.C.; Muruzabal L.; Malon M.M.;
Montoya R.; Lopez A.
Institution
(Saiz, Gorricho, Garjon, Celaya, Muruzabal, Lopez) Navarre Health Service,
Drug Prescribing Service, Plaza de la Paz, s/n, Pamplona, Navarre 31002,
Spain
(Malon) Navarre Health Service, Centro de Salud de Olite, Alcalde de
Maillata, 9, Olite, Navarra 31390, Spain
(Montoya) Navarre Health Service, Primary Care, C/ Mayor, S/N, Ancin,
Navarra 31281, Spain
Publisher
John Wiley and Sons Ltd
Abstract
Background: Hypertension is a prominent preventable cause of premature
morbidity and mortality. People with hypertension and established
cardiovascular disease are at particularly high risk, so reducing blood
pressure below standard targets may be beneficial. This strategy could
reduce cardiovascular mortality and morbidity but could also increase
adverse events. The optimal blood pressure target in people with
hypertension and established cardiovascular disease remains unknown.
 Objective(s): To determine if 'lower' blood pressure targets (<=
135/85 mmHg) are associated with reduction in mortality and morbidity as
compared with 'standard' blood pressure targets (<= 140 to 160/ 90 to 100
mmHg) in the treatment of people with hypertension and a history of
cardiovascular disease (myocardial infarction, angina, stroke, peripheral
vascular occlusive disease). Search Method(s): The Cochrane
Hypertension Information Specialist searched the following databases for
randomized controlled trials up to February 2017: the Cochrane
Hypertension Specialised Register, the Cochrane Central Register of
Controlled Trials (CENTRAL), MEDLINE (from 1946), Embase (from 1974), the
World Health Organization International Clinical Trials Registry Platform,
and ClinicalTrials.gov. We also searched the Latin American and Caribbean
Health Science Literature Database (from 1982) and contacted authors of
relevant papers regarding further published and unpublished work. There
were no language restrictions. Selection Criteria: We included
randomized controlled trials (RCTs) with more than 50 participants per
group and at least six months follow-up. Trial reports needed to present
data for at least one primary outcome (total mortality, serious adverse
events, total cardiovascular events, cardiovascular mortality). Eligible
interventions were lower target for systolic/diastolic blood pressure (<=
135/85 mmHg) compared with standard target for blood pressure (<= 140 to
160/90 to 100 mmHg). Participants were adults with documented hypertension
or who were receiving treatment for hypertension and cardiovascular
history for myocardial infarction, stroke, chronic peripheral vascular
occlusive disease or angina pectoris. Data Collection and Analysis:
Two review authors independently assessed search results and extracted
data using standard methodological procedures expected by The Cochrane
Collaboration. Main Result(s): We included six RCTs that involved a
total of 9795 participants. Mean follow-up was 3.7 years (range 1.0 to 4.7
years). Five RCTs provided individual patient data for 6775 participants.
We found no change in total mortality (RR 1.05, 95% CI 0.90 to 1.22) or
cardiovascular mortality (RR 0.96, 95% CI 0.77 to 1.21; moderate-quality
evidence). Similarly, no differences were found in serious adverse events
(RR 1.02, 95% CI 0.95 to 1.11; low-quality evidence). There was a
reduction in fatal and non fatal cardiovascular events (including
myocardial infarction, stroke, sudden death, hospitalization or death from
congestive heart failure) with the lower target (RR 0.87, 95% CI 0.78 to
0.98; ARR 1.6% over 3.7 years; low-quality evidence). There were more
participant withdrawals due to adverse effects in the lower target arm (RR
8.16, 95% CI 2.06 to 32.28; very low-quality evidence). Blood pressures
were lower in the lower' target group by 9.5/4.9 mmHg. More drugs were
needed in the lower target group but blood pressure targets were achieved
more frequently in the standard target group. Authors' conclusions: No
evidence of a difference in total mortality and serious adverse events was
found between treating to a lower or to a standard blood pressure target
in people with hypertension and cardiovascular disease. This suggests no
net health benefit from a lower systolic blood pressure target despite the
small absolute reduction in total cardiovascular serious adverse events.
There was very limited evidence on adverse events, which lead to high
uncertainty. At present there is insufficient evidence to justify lower
blood pressure targets (<= 135/85 mmHg) in people with hypertension and
established cardiovascular disease. More trials are needed to answer this
question. Copyright © 2017 The Cochrane Collaboration. Published
by John Wiley & Sons, Ltd.

<84>
Accession Number
618453786
Title
Exercise-based cardiac rehabilitation for patients with stable angina.
Source
Cochrane Database of Systematic Reviews. 2017(9) (no pagination), 2017.
Article Number: CD012786. Date of Publication: 25 Sep 2017.
Author
Anderson L.; Dewhirst A.M.; He J.; Gandhi M.; Taylor R.S.; Long L.
Institution
(Anderson, Dewhirst, Taylor, Long) University of Exeter Medical School,
Institute of Health Research, Veysey Building, Salmon Pool Lane, Exeter
EX2 4SG, United Kingdom
(He, Gandhi) Royal Devon and Exeter NHS Foundation Trust Hospital,
Cardiology, Exeter, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: To assess the effects of exercise-based CR for patients
with stable angina compared to usual care. Copyright © 2017 The
Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

<85>
Accession Number
617850799
Title
Prophylactic plasma transfusion for patients undergoing non-cardiac
surgery.
Source
Cochrane Database of Systematic Reviews. 2017(8) (no pagination), 2017.
Article Number: CD012745. Date of Publication: 17 Aug 2017.
Author
Huber J.; Stanworth S.J.; Doree C.; Trivella M.; Brunskill S.J.; Hopewell
S.; Wilkinson K.L.; Estcourt L.J.
Institution
(Huber) University Hospital Southampton, Shackleton Department of
Anaesthesia, Tremona Road, Southampton, Hampshire So16 6YD, United Kingdom
(Stanworth) Oxford University Hospitals NHS Foundation Trust and
University of Oxford, National Institute for Health Research (NIHR) Oxford
Biomedical Research Centre, John Radcliffe Hospital, Headley Way, Oxford,
Headington OX3 9BQ, United Kingdom
(Doree, Brunskill) NHS Blood and Transplant, Systematic Review Initiative,
John Radcliffe Hospital, Oxford OX3 9BQ, United Kingdom
(Trivella) University of Oxford, Centre for Statistics in Medicine, Botnar
Research Centre, Windmill Road, Oxford OX3 7LD, United Kingdom
(Hopewell) University of Oxford, Oxford Clinical Trials Research Unit,
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal
Sciences, Windmill Road, Oxford, Oxfordshire OX3 7LD, United Kingdom
(Wilkinson) Southampton University NHS Hospital, Paediatric and Adult
Cardiothoracic Anaesthesia, Tremona Road, Southampton SO16 6YD, United
Kingdom
(Estcourt) NHS Blood and Transplant, Haematology/Transfusion Medicine,
Level 2, John Radcliffe Hospital, Headington, Oxford OX3 9BQ, United
Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: To determine the clinical effectiveness and safety of
prophylactic plasma transfusion for people with confirmed or presumed
coagulopathy requiring non-cardiac surgery. Copyright © 2017 The
Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

<86>
Accession Number
617292209
Title
Psychological interventions for acute pain after open heart surgery.
Source
Cochrane Database of Systematic Reviews. 2017(7) (no pagination), 2017.
Article Number: CD009984. Date of Publication: 13 Jul 2017.
Author
Ziehm S.; Rosendahl J.; Barth J.; Strauss B.M.; Mehnert A.; Koranyi S.
Institution
(Ziehm, Mehnert, Koranyi) University Hospital of Leipzig, Institute of
Medical Psychology and Medical Soziology, Philipp-Rosenthal-Strase 55,
Leipzig, Saxony 4103, Germany
(Rosendahl, Strauss) University Hospital of Jena, Institute of
Psychosocial Medicine and Psychotherapy, Stoystrasse 3, Jena, Thuringia
07743, Germany
(Barth) University of Bern, Institute of Social and Preventive Medicine,
Niesenweg 6, Bern CH-3012, Switzerland
Publisher
John Wiley and Sons Ltd
Abstract
Background: This is an update of a Cochrane review previously published in
2014. Acute postoperative pain is one of the most disturbing complaints in
open heart surgery, and is associated with a risk of negative
consequences. Several trials investigated the effects of psychological
interventions to reduce acute postoperative pain and improve the course of
physical and psychological recovery of participants undergoing open heart
surgery. Objective(s): To compare the efficacy of psychological
interventions as an adjunct to standard care versus standard care alone or
standard care plus attention control in adults undergoing open heart
surgery for pain, pain medication, psychological distress, mobility, and
time to extubation. Search Method(s): For this update, we searched
the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE,
Embase, Web of Science, and PsycINFO for eligible studies up to February
2017. We used the 'related articles' and 'cited by' options of eligible
studies to identify additional relevant studies. We checked lists of
references of relevant articles and previous reviews. We searched the
ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and
the WHO International Clinical Trials Registry Platform to identify any
unpublished material or ongoing trials. We also contacted the authors of
primary studies to identify any unpublished material. In addition, we
wrote to all leading heart centres in Germany, Switzerland, and Austria to
check whether they were aware of any ongoing trials. Selection
Criteria: Randomised controlled trials comparing psychological
interventions as an adjunct to standard care versus standard care alone or
standard care plus attention in adults undergoing open heart surgery.
 Data Collection and Analysis: Two review authors (SZ and SK)
independently assessed trials for eligibility, estimated the risk of bias
and extracted all data. We calculated effect sizes for each comparison
(Hedges' g) and meta-analysed data using a random-effects model. We
assessed the evidence using GRADE and created 'Summary of findings'
tables. Main Result(s): We added six studies to this update. Overall,
we included 23 studies (2669 participants). For the majority of outcomes
(two-thirds), we could not perform a meta-analysis since outcomes were not
measured, or data were provided by one trial only. No study reported data
on the number of participants with pain intensity reduction of at least
50% from baseline. Only one study reported data on the number of
participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain
intensity (very low-quality evidence). Psychological interventions did not
reduce pain intensity in the short-term interval (g 0.39, 95% CI -0.18 to
0.96, 2 studies, 104 participants, low-quality evidence), medium-term
interval (g -0.02, 95% CI -0.24 to 0.20, 4 studies, 413 participants,
moderate-quality evidence) or in the long-term interval (g 0.05, 95% CI
-0.20 to 0.30, 2 studies, 200 participants, moderate-quality evidence). No
study reported data on median time to re-medication or on number of
participants re-medicated. Only two studies provided data on postoperative
analgesic use in the short-term interval, showing that psychological
interventions did not reduce the use of analgesic medication (g 1.18, 95%
CI -2.03 to 4.39, 2 studies, 104 participants, low-quality evidence).
Studies revealed that psychological interventions reduced mental distress
in the medium-term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388
participants, moderate-quality evidence) and likewise in the long-term
interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants,
moderate-quality evidence). Psychological interventions did not improve
mobility in the medium-term interval (g 0.23, 95% CI -0.22 to 0.67, 3
studies, 444 participants, low-quality evidence), nor in the long-term
interval (g 0.09, 95% CI -0.10 to 0.28, 4 studies, 458 participants,
moderate-quality evidence). Only two studies reported data on time to
extubation, indicating that psychological interventions reduced the time
to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants,
low-quality evidence). Overall, the very low to moderate quality of the
body of evidence on the efficacy of psychological interventions for acute
pain after open heart surgery cannot be regarded as sufficient to draw
robust conclusions. Most 'Risk of bias' assessments were low or unclear.
We judged selection bias (random sequence generation) and attrition bias
to be mostly low risk for included studies. However, we judged the risk of
selection bias (allocation concealment), performance bias, detection bias
and reporting bias to be mostly unclear. Authors' conclusions: In line
with the conclusions of our previous review, there is a lack of evidence
to support or refute psychological interventions in order to reduce
postoperative pain in participants undergoing open heart surgery. We found
moderate-quality evidence that psychological interventions reduced mental
distress in participants undergoing open heart surgery. Given the small
numbers of studies, it is not possible to draw robust conclusions on the
efficacy of psychological interventions on outcomes such as analgesic use,
mobility, and time to extubation respectively on adverse events or harms
of psychological interventions. Copyright © 2017 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<87>
Accession Number
619223870
Title
Electrical cardioversion for atrial fibrillation and flutter.
Source
Cochrane Database of Systematic Reviews. 2017(11) (no pagination), 2017.
Article Number: CD002903. Date of Publication: 15 Nov 2017.
Author
Mead G.E.; Elder A.; Flapan A.D.; Cordina J.
Institution
(Mead) University of Edinburgh, Centre for Clinical Brain Sciences, Royal
Infirmary, Little France Crescent, Edinburgh EH16 4SA, United Kingdom
(Elder) Royal Victoria Hospital, 13 Craigleth Road, Edinburgh, United
Kingdom
(Flapan) Royal Infirmary of Edinburgh, Department of Cardiology,
Department of Cardiology, New Royal Infirmary, Little France Crescent,
Edinburgh EH16 4SB, United Kingdom
(Cordina) Victoria Hospital, Ward 11, Hayfield Road, Kirkcaldy KY2 5AH,
United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Atrial fibrillation increases stroke risk and adversely
affects cardiovascular haemodynamics. Electrical cardioversion may, by
restoring sinus rhythm, improve cardiovascular haemodynamics, reduce the
risk of stroke, and obviate the need for long-term anticoagulation.
 Objective(s): To assess the effects of electrical cardioversion of
atrial fibrillation or flutter on the risk of thromboembolic events,
strokes and mortality (primary outcomes), the rate of cognitive decline,
quality of life, the use of anticoagulants and the risk of
re-hospitalisation (secondary outcomes) in adults (>18 years). Search
Method(s): We searched the Cochrane CENTRAL Register of Controlled Trials
(1967 to May 2004), MEDLINE (1966 to May 2004), Embase (1980 to May 2004),
CINAHL (1982 to May 2004), proceedings of the American College of
Cardiology (published in Journal of the American College of Cardiology
1983 to 2003), www.trialscentral.org, www.controlled-trials.com and
reference lists of articles. We hand-searched the indexes of the
Proceedings of the British Cardiac Society published in British Heart
Journal (1980 to 1995) and in Heart (1995 to 2002); proceedings of the
European Congress of Cardiology and meetings of the Joint Working Groups
of the European Society of Cardiology (published in European Heart Journal
1983-2003); scientific sessions of the American Heart Association
(published in Circulation 1990-2003). Personal contact was made with
experts. Selection Criteria: Randomised controlled trial or
controlled clinical trials of electrical cardioversion plus 'usual care'
versus 'usual care' only, where 'usual care' included any combination of
anticoagulants, antiplatelet drugs and drugs for 'rate control'. We
excluded trials which used pharmacological cardioversion as the first
intervention, and trials of new onset atrial fibrillation after cardiac
surgery. There were no language restrictions. Data Collection and
Analysis: For dichotomous data, odds ratios were calculated; and for
continuous data, the weighted mean difference was calculated. Main
Result(s): We found three completed trials of electrical cardioversion
(rhythm control) versus rate control, recruiting a total of 927
participants (Hot Cafe; RACE; STAF) and one ongoing trial (J-RHYTHM).
There was no difference in mortality between the two strategies (OR 0.83;
CI 0.48 to 1.43). There was a trend towards more strokes in the rhythm
control group (OR 1.9; 95% CI 0.99 to 3.64). At follow up, three domains
of quality of life (physical functioning, physical role function and
vitality) were significantly better in the rhythm control group (RACE
2002; STAF 2003). Authors' conclusions: Electrical cardioversion (rhythm
control) led to a non-significant increase in stroke risk but improved
three domains of quality of life. Copyright © 2017 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<88>
Accession Number
619089770
Title
Beta-blockers for preventing aortic dissection in Marfan syndrome.
Source
Cochrane Database of Systematic Reviews. 2017(11) (no pagination), 2017.
Article Number: CD011103. Date of Publication: 07 Nov 2017.
Author
Koo H.-K.; Lawrence K.A.; Musini V.M.
Institution
(Koo) University of British Columbia, 217-2176 Health Sciences Mall,
Vancouver, BC V6T 1Z3, Canada
(Lawrence) University of Utah, Population Health Sciences, Salt Lake City,
UT, United States
(Musini) University of British Columbia, Department of Anesthesiology,
Pharmacology and Therapeutics, 2176 Health Science Mall, Vancouver, BC V6T
1Z3, Canada
Publisher
John Wiley and Sons Ltd
Abstract
Background: Marfan syndrome is a hereditary disorder affecting the
connective tissue and is caused by a mutation of the fibrillin-1 (FBN1)
gene. It affects multiple systems of the body, most notably the
cardiovascular, ocular, skeletal, dural and pulmonary systems. Aortic root
dilatation is the most frequent cardiovascular manifestation and its
complications, including aortic regurgitation, dissection and rupture are
the main cause of morbidity and mortality. Objective(s): To assess
the long-term efficacy and safety of beta-blocker therapy as compared to
placebo, no treatment or surveillance only in people with Marfan syndrome.
 Search Method(s): We searched the following databases on 28 June
2017; CENTRAL, MEDLINE, Embase, Science Citation Index Expanded and the
Conference Proceeding Citation Index - Science in the Web of Science Core
Collection. We also searched the Online Metabolic and Molecular Bases of
Inherited Disease (OMMBID), ClinicalTrials.gov and the World Health
Organization (WHO) International Clinical Trials Registry Platform (ICTRP)
on 30 June 2017. We did not impose any restriction on language of
publication. Selection Criteria: All randomised controlled trials
(RCTs) of at least one year in duration assessing the effects of
beta-blocker monotherapy compared with placebo, no treatment or
surveillance only, in people of all ages with a confirmed diagnosis of
Marfan syndrome were eligible for inclusion. Data Collection and
Analysis: Two review authors independently screened titles and abstracts
for inclusion, extracted data and assessed trial quality. Trial authors
were contacted to obtain missing data. Dichotomous outcomes will be
reported as relative risk and continuous outcomes as mean differences with
95% confidence intervals. We assessed the quality of evidence using the
Grading of Recommendations Assessment, Development and Evaluation (GRADE)
approach. Main Result(s): One open-label, randomised, single-centre
trial including 70 participants with Marfan syndrome (aged 12 to 50 years
old) met the inclusion criteria. Participants were randomly assigned to
propranolol (N = 32) or no treatment (N = 38) for an average duration of
9.3 years in the control group and 10.7 years in the treatment group. The
initial dose of propranolol was 10 mg four times daily and the optimal
dose was reached when the heart rate remained below 100 beats per minute
during exercise or the systolic time interval increased by 30%. The mean
(+/- standard error (SE)) optimal dose of propranolol was 212 +/- 68 mg
given in four divided doses daily. Beta-blocker therapy did not reduce the
incidence of all-cause mortality (RR 0.24, 95% CI 0.01 to 4.75;
participants = 70; low-quality evidence). Mortality attributed to Marfan
syndrome was not reported. Non-fatal serious adverse events were also not
reported. However, study authors report on pre-defined, non-fatal clinical
endpoints, which include aortic dissection, aortic regurgitation,
cardiovascular surgery and congestive heart failure. Their analysis showed
no difference between the treatment and control groups in these outcomes
(RR 0.79, 95% CI 0.37 to 1.69; participants = 70; low-quality evidence).
Beta-blocker therapy did not reduce the incidence of aortic dissection (RR
0.59, 95% CI 0.12 to 3.03), aortic regurgitation (RR 1.19, 95% CI 0.18 to
7.96), congestive heart failure (RR 1.19, 95% CI 0.18 to 7.96) or
cardiovascular surgery, (RR 0.59, 95% CI 0.12 to 3.03); participants = 70;
low-quality evidence. The study reports a reduced rate of aortic
dilatation measured by M-mode echocardiography in the treatment group
(aortic ratio mean slope: 0.084 (control) vs 0.023 (treatment), P <
0.001). The change in systolic and diastolic blood pressure, total adverse
events and withdrawal due to adverse events were not reported in the
treatment or control group at study end point. We judged this study to be
at high risk of selection (allocation concealment) bias, performance bias,
detection bias, attrition bias and selective reporting bias. The overall
quality of evidence was low. We do not know whether a statistically
significant reduced rate of aortic dilatation translates into clinical
benefit in terms of aortic dissection or mortality. Authors' conclusions:
Based on only one, low-quality RCT comparing long-term propranolol to no
treatment in people with Marfan syndrome, we could draw no definitive
conclusions for clinical practice. High-quality, randomised trials are
needed to evaluate the long-term efficacy of beta-blocker treatment in
people with Marfan syndrome. Future trials should report on all clinically
relevant end points and adverse events to evaluate benefit versus harm of
therapy. Copyright © 2017 The Cochrane Collaboration. Published
by John Wiley & Sons, Ltd.

<89>
Accession Number
619682277
Title
Clopidogrel plus aspirin versus aspirin alone for preventing
cardiovascular events.
Source
Cochrane Database of Systematic Reviews. 2017(12) (no pagination), 2017.
Article Number: CD005158. Date of Publication: 14 Dec 2017.
Author
Squizzato A.; Bellesini M.; Takeda A.; Middeldorp S.; Donadini M.P.
Institution
(Squizzato) University of Insubria, Research Center on Thromboembolic
Disorders and Antithrombotic Therapies, Department of Medicine and
Surgery, School of Medicine, c/o Medicina 1, ASST Settelaghi Ospedale di
Circolo, 57, Varese 21100, Italy
(Bellesini, Donadini) University of Insubria, Research Center on
Thromboembolic Disorders and Antithrombotic Therapies, Department of
Clinical and Experimental Medicine, School of Medicine, Varese, Italy
(Takeda) University College London, Farr Institute of Health Informatics
Research, London, United Kingdom
(Middeldorp) Academic Medical Center, Department of Vascular Medicine,
Meibergdreef 9, Amsterdam 1105AZ, Netherlands
Publisher
John Wiley and Sons Ltd
Abstract
Background: Aspirin is the prophylactic antiplatelet drug of choice for
people with cardiovascular disease. Adding a second antiplatelet drug to
aspirin may produce additional benefit for people at high risk and people
with established cardiovascular disease. This is an update to a previously
published review from 2011. Objective(s): To review the benefit and
harm of adding clopidogrel to aspirin therapy for preventing
cardiovascular events in people who have coronary disease, ischaemic
cerebrovascular disease, peripheral arterial disease, or were at high risk
of atherothrombotic disease, but did not have a coronary stent.
 Search Method(s): We updated the searches of CENTRAL (2017, Issue 6),
MEDLINE (Ovid, 1946 to 4 July 2017) and Embase (Ovid, 1947 to 3 July 2017)
on 4 July 2017. We also searched ClinicalTrials.gov and the WHO ICTRP
portal, and handsearched reference lists. We applied no language
restrictions. Selection Criteria: We included all randomised
controlled trials comparing over 30 days use of aspirin plus clopidogrel
with aspirin plus placebo or aspirin alone in people with coronary
disease, ischaemic cerebrovascular disease, peripheral arterial disease,
or at high risk of atherothrombotic disease. We excluded studies including
only people with coronary drug-eluting stent (DES) or non-DES, or both.
 Data Collection and Analysis: We collected data on mortality from
cardiovascular causes, all-cause mortality, fatal and non-fatal myocardial
infarction, fatal and non-fatal ischaemic stroke, major and minor
bleeding. The overall treatment effect was estimated by the pooled risk
ratio (RR) with 95% confidence interval (CI), using a fixed-effect model
(Mantel-Haenszel); we used a random-effects model in cases of moderate or
severe heterogeneity (I2 >= 30%). We assessed the quality of
the evidence using the GRADE approach. We used GRADE profiler (GRADE Pro)
to import data from Review Manager to create a 'Summary of findings'
table. Main Result(s): The search identified 13 studies in addition
to the two studies in the previous version of our systematic review.
Overall, we included data from 15 trials with 33,970 people. We completed
a 'Risk of bias' assessment for all studies. The risk of bias was low in
four trials because they were at low risk of bias for all key domains
(random sequence generation, allocation concealment, blinding, selective
outcome reporting and incomplete outcome data), even if some of them were
funded by the pharmaceutical industry. Analysis showed no difference in
the effectiveness of aspirin plus clopidogrel in preventing cardiovascular
mortality (RR 0.98, 95% CI 0.88 to 1.10; participants = 31,903; studies =
7; moderate quality evidence), and no evidence of a difference in
all-cause mortality (RR 1.05, 95% CI 0.87 to 1.25; participants = 32,908;
studies = 9; low quality evidence). There was a lower risk of fatal and
non-fatal myocardial infarction with clopidogrel plus aspirin compared
with aspirin plus placebo or aspirin alone (RR 0.78, 95% CI 0.69 to 0.90;
participants = 16,175; studies = 6; moderate quality evidence). There was
a reduction in the risk of fatal and non-fatal ischaemic stroke (RR 0.73,
95% CI 0.59 to 0.91; participants = 4006; studies = 5; moderate quality
evidence). However, there was a higher risk of major bleeding with
clopidogrel plus aspirin compared with aspirin plus placebo or aspirin
alone (RR 1.44, 95% CI 1.25 to 1.64; participants = 33,300; studies = 10;
moderate quality evidence) and of minor bleeding (RR 2.03, 95% CI 1.75 to
2.36; participants = 14,731; studies = 8; moderate quality evidence).
Overall, we would expect 13 myocardial infarctions and 23 ischaemic
strokes be prevented for every 1000 patients treated with the combination
in a median follow-up period of 12 months, but 9 major bleeds and 33 minor
bleeds would be caused during a median follow-up period of 10.5 and 6
months, respectively. Authors' conclusions: The available evidence
demonstrates that the use of clopidogrel plus aspirin in people at high
risk of cardiovascular disease and people with established cardiovascular
disease without a coronary stent is associated with a reduction in the
risk of myocardial infarction and ischaemic stroke, and an increased risk
of major and minor bleeding compared with aspirin alone. According to
GRADE criteria, the quality of evidence was moderate for all outcomes
except all-cause mortality (low quality evidence) and adverse events (very
low quality evidence). Copyright © 2017 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<90>
Accession Number
619496067
Title
Interventions for improving medication adherence in solid organ transplant
recipients.
Source
Cochrane Database of Systematic Reviews. 2017(12) (no pagination), 2017.
Article Number: CD012854. Date of Publication: 04 Dec 2017.
Author
Mellon L.; Doyle F.; Hickey A.; Ward K.D.; de Freitas D.G.; Mccormick
P.A.; O'Connell O.; Conlon P.
Institution
(Mellon) Royal College of Surgeons in Ireland, Department of Psychology,
123 St Stephens Green, Dublin 2, Ireland
(Doyle, Hickey) Royal College of Surgeons in Ireland, Department of
Psychology, 123 Ste Stephens Green, Dublin, D2, Ireland
(Ward) University of Memphis, School of Public Health, Memphis, TN 38152,
United States
(de Freitas, Conlon) Beaumont Hospital, Department Nephrology and Kidney
Transplantation, Beaumont Road, Dublin, Dublin 9, Ireland
(Mccormick) St Vincent's University Hospital, Irish Liver Transplant Unit,
Elm Park, Merrion Road, Dublin, D4, Ireland
(O'Connell) Mater Misericordiae University, Irish National Lung and Heart
Transplant Program, Eccles Street, Dublin, D7, Ireland
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: This review aims to look at the benefits and harms of
using interventions for improving adherence to immunosuppressant therapies
in solid organ transplant recipients, including paediatric and adult
heart, lung, kidney, liver and pancreas transplant
recipients. Copyright © 2017 The Cochrane Collaboration.
Published by John Wiley & Sons, Ltd.

<91>
Accession Number
616409442
Title
Local wound analgesia in infants undergoing thoracic or abdominal surgery.
Source
Cochrane Database of Systematic Reviews. 2017(5) (no pagination), 2017.
Article Number: CD012672. Date of Publication: 27 May 2017.
Author
Sloukova E.; Popat H.; Jones L.J.; Shun A.; Spence K.
Institution
(Sloukova, Popat, Spence) The Children's Hospital at Westmead, Grace
Centre for Newborn Care, Westmead, Australia
(Jones) University of Sydney, Central Clinical School, Discipline of
Obstetrics, Gynaecology and Neonatology, Sydney, NSW, Australia
(Shun) The Children's Hospital at Westmead, Department of Surgery, Locked
Bag 4001, Westmead, NSW 2145, Australia
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: To assess whether local wound analgesia provides better
pain relief than other analgesic regimens (epidural analgesia, intravenous
opioids, other analgesics and supportive care regimens) and decreases the
need for systemic analgesic agents in term or preterm neonates undergoing
thoracic or abdominal surgery. Copyright © 2017 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<92>
Accession Number
616205461
Title
Nasal decontamination for the prevention of surgical site infection in
Staphylococcus aureus carriers.
Source
Cochrane Database of Systematic Reviews. 2017(5) (no pagination), 2017.
Article Number: CD012462. Date of Publication: 18 May 2017.
Author
Liu Z.; Norman G.; Iheozor-Ejiofor Z.; Wong J.K.F.; Crosbie E.J.; Wilson
P.
Institution
(Liu, Norman, Iheozor-Ejiofor) University of Manchester, Manchester
Academic Health Science Centre, Division of Nursing, Midwifery and Social
Work, School of Health Sciences, Faculty of Biology, Medicine and Health,
Jean McFarlane Building, Oxford Road, Manchester M13 9PL, United Kingdom
(Wong) University Hospital South Manchester, Plastic and Reconstructive
Surgery, Southmoor Road, Wythenshawe, Manchester M23 9LT, United Kingdom
(Crosbie) Faculty of Biology, Medicine and Health, University of
Manchester, Division of Molecular and Clinical Cancer Sciences, 5th Floor
- Research, St Mary's Hospital, Manchester M13 9WL, United Kingdom
(Crosbie) St Mary's Hospital, Department of Obstetrics and Gynaecology,
Manchester Academic Health Sciences Centre, Manchester, United Kingdom
(Wilson) University College London Hospitals NHS Foundation Trust,
Clinical Microbiology and Virology, 60 Whitfield Street, London W1T 4EU,
United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Surgical site infection rates in the month following surgery
vary from 1% to 5%. Due to the large number of surgical procedures
conducted annually, the costs of these surgical site infections (SSIs) can
be considerable in financial and social terms. Nasal decontamination using
antibiotics or antiseptics is performed to reduce the risk of SSIs by
preventing organisms from the nasal cavity being transferred to the skin
where a surgical incision will be made. Staphylococcus aureus (S aureus)
colonises the nasal cavity and skin of carriers and can cause infection in
open or unhealed surgical wounds. S aureus is the leading nosocomial
(hospital-acquired) pathogen in hospitals worldwide. The potential
effectiveness of nasal decontamination of S aureus is thought to be
dependent on both the antibiotic/antiseptic used and the dose of
application; however, it is unclear whether nasal decontamination actually
reduces postoperative wound infection in S aureus carriers.
 Objective(s): To assess the effects of nasal decontamination on
preventing surgical site infections (SSIs) in people who are S aureus
carriers undergoing surgery. Search Method(s): In September 2016 we
searched the Cochrane Wounds Specialised Register, the Cochrane Central
Register of Controlled Trials (CENTRAL) (the Cochrane Library), Ovid
MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid
Embase, and EBSCO CINAHL Plus. We also searched three clinical trial
registries and the references of included studies and relevant systematic
reviews. There were no restrictions based on language, date of publication
or study setting. Selection Criteria: Randomised controlled trials
(RCTs) which enrolled S aureus carriers with any type of surgery and
assessed the use of nasal decontamination with antiseptic/antibiotic
properties were included in the review. Data Collection and Analysis:
Two review authors independently performed study selection, data
extraction, risk of bias assessment and GRADE assessment. Main
Result(s): We located two studies (291 participants) for inclusion in this
review. The trials were clinically heterogeneous with differences in
duration of follow-up, and nasal decontamination regimens. One study
compared mupirocin (2% contained in a base of polyethylene glycol 400 and
polyethylene glycol 3350) with a placebo in elective cardiac surgery
patients; and one study compared Anerdian (iodine 0.45% to 0.57% (W/V),
chlorhexidine acetate 0.09% to 0.11% (W/V)) with no treatment also in
cardiac surgery patients. The trials reported limited outcome data on SSI,
adverse events and secondary outcomes (e.g. S aureus SSI, mortality).
Mupirocin compared with placebo This study found no clear difference in
SSI risk following use of mupirocin compared with placebo (1 trial, 257
participants); risk ratio (RR) 1.60, 95% confidence interval (CI) 0.79 to
3.25 based on 18/130 events in the mupirocin group and 11/127 in the
control group; low-certainty evidence (downgraded twice due to
imprecision). Anerdian compared with no treatment It is uncertain whether
there is a difference in SSI risk following treatment with Anerdian
compared with no treatment (1 trial, 34 participants); RR 0.89, 95% CI
0.06 to 13.08 based on 1/18 events in the Anerdian group and 1/16 in the
control group; very low certainty evidence (downgraded twice due to
imprecision and once due to risk of bias). Authors' conclusions: There is
currently limited rigorous RCT evidence available regarding the clinical
effectiveness of nasal decontamination in the prevention of SSI. This
limitation is specific to the focused question our review addresses,
looking at nasal decontamination as a single intervention in participants
undergoing surgery who are known S aureus carriers. We were only able to
identify two studies that met the inclusion criteria for this review and
one of these was very small and poorly reported. The potential benefits
and harms of using decontamination for the prevention of SSI in this group
of people remain uncertain. Copyright © 2017 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<93>
Accession Number
615038158
Title
Intravenous versus inhalation anaesthesia for patients undergoing on-pump
or off-pump coronary artery bypass grafting.
Source
Cochrane Database of Systematic Reviews. 2017(3) (no pagination), 2017.
Article Number: CD010345. Date of Publication: 29 Mar 2017.
Author
Modolo N.S.P.; Modolo M.P.; Marton M.A.; Braz L.G.; Alves R.L.; El Dib R.
Institution
(Modolo, Braz) Botucatu Medical School, Universidade Estadual Paulista
(UNESP), Department of Anaesthesiology, Distrito de Rubiao Junior, s/n,
Botucatu, Sao Paulo 18603-970, Brazil
(Modolo, Marton) Botucatu Medical School, UNESP - Univ Estadual Paulista,
Distrito de Rubiao Junior, s/n, Botucatu, Sao Paulo 18603-970, Brazil
(Alves) Universidade Federal da Bahia, Hospital Universitario Professor
Edgard Santos, Department of Anaesthesia, Rua Augusto Viana, s/nCanela,
Salvador, Brazil
(El Dib) Institute of Science and Technology, Unesp - Univ Estadual
Paulista, Department of Biosciences and Oral Diagnosis, Botucatu, Brazil
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: To verify the efficacy and safe of intravenous versus
inhalation anaesthesia in decreasing mortality and morbidity for patients
undergoing on-pump or off-pump coronary artery bypass grafting
(CABG). Copyright © 2017 The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd.

<94>
Accession Number
614830258
Title
Surgical versus non-surgical management for pleural empyema.
Source
Cochrane Database of Systematic Reviews. 2017(3) (no pagination), 2017.
Article Number: CD010651. Date of Publication: 17 Mar 2017.
Author
Redden M.D.; Chin T.Y.; van Driel M.L.
Institution
(Redden) Ipswich Hospital, Ipswich, QLD, Australia
(Chin) The Prince Charles Hospital, Rode Road, Chermside, QLD 4032,
Australia
(Chin) The University of Queensland, School of Medicine, 288 Herston Road,
Brisbane, QLD 4006, Australia
(van Driel) The University of Queensland, Primary Care Clinical Unit,
Faculty of Medicine, Brisbane, QLD 4029, Australia
Publisher
John Wiley and Sons Ltd
Abstract
Background: Empyema refers to pus in the pleural space, commonly due to
adjacent pneumonia, chest wall injury, or a complication of thoracic
surgery. A range of therapeutic options are available for its management,
ranging from percutaneous aspiration and intercostal drainage to
video-assisted thoracoscopic surgery (VATS) or thoracotomy drainage.
Intrapleural fibrinolytics may also be administered following intercostal
drain insertion to facilitate pleural drainage. There is currently a lack
of consensus regarding optimal treatment. Objective(s): To assess the
effectiveness and safety of surgical versus non-surgical treatments for
complicated parapneumonic effusion or pleural empyema. Search
Method(s): We searched the Cochrane Central Register of Controlled Trials
(CENTRAL) (2016, Issue 9), MEDLINE (Ebscohost) (1946 to July week 3 2013,
July 2015 to October 2016) and MEDLINE (Ovid) (1 May 2013 to July week 1
2015), Embase (2010 to October 2016), CINAHL (1981 to October 2016) and
LILACS (1982 to October 2016) on 20 October 2016. We searched
ClinicalTrials.gov and WHO International Clinical Trials Registry Platform
for ongoing studies (December 2016). Selection Criteria: Randomised
controlled trials that compared a surgical with a non-surgical method of
management for all age groups with pleural empyema. Data Collection
and Analysis: Two review authors independently assessed trials for
inclusion and risk of bias, extracted data, and checked the data for
accuracy. We contacted trial authors for additional information. We
assessed the quality of the evidence using the GRADE approach. Main
Result(s): We included eight randomised controlled trials with a total of
391 participants. Six trials focused on children and two on adults. Trials
compared tube thoracostomy drainage (non-surgical), with or without
intrapleural fibrinolytics, to either VATS or thoracotomy (surgical) for
the management of pleural empyema. Assessment of risk of bias for the
included studies was generally unclear for selection and blinding but low
for attrition and reporting bias. Data analyses compared thoracotomy
versus tube thoracostomy and VATS versus tube thoracostomy. We pooled data
for meta-analysis where appropriate. We performed a subgroup analysis for
children along with a sensitivity analysis for studies that used
fibrinolysis in non-surgical treatment arms. The comparison of open
thoracotomy versus thoracostomy drainage included only one study in
children, which reported no deaths in either treatment arm. However, the
trial showed a statistically significant reduction in mean hospital stay
of 5.90 days for those treated with primary thoracotomy. It also showed a
statistically significant reduction in procedural complications for those
treated with thoracotomy compared to thoracostomy drainage. We downgraded
the quality of the evidence for length of hospital stay and procedural
complications outcomes to moderate due to the small sample size. The
comparison of VATS versus thoracostomy drainage included seven studies,
which we pooled in a meta-analysis. There was no statistically significant
difference in mortality or procedural complications between groups. This
was true for both adults and children with or without fibrinolysis.
However, mortality data were limited: one study reported one death in each
treatment arm, and seven studies reported no deaths. There was a
statistically significant reduction in mean length of hospital stay for
those treated with VATS. The subgroup analysis showed the same result in
adults, but there was insufficient evidence to estimate an effect for
children. We could not perform a separate analysis for fibrinolysis for
this outcome because all included studies used fibrinolysis in the
non-surgical arms. We downgraded the quality of the evidence to low for
mortality (due to wide confidence intervals and indirectness), and
moderate for other outcomes in this comparison due to either high
heterogeneity or wide confidence intervals. Authors' conclusions: Our
findings suggest there is no statistically significant difference in
mortality between primary surgical and non-surgical management of pleural
empyema for all age groups. Video-assisted thoracoscopic surgery may
reduce length of hospital stay compared to thoracostomy drainage alone.
There was insufficient evidence to assess the impact of fibrinolytic
therapy. A number of common outcomes were reported in the included studies
that were not directly examined in our primary and secondary outcomes.
These included duration of chest tube drainage, duration of fever,
analgesia requirement, and total cost of treatment. Future studies
focusing on patient-centred outcomes, such as patient functional scores,
and other clinically relevant outcomes, such as radiographic improvement,
treatment failure rates, and amount of fluid drainage, are needed to
inform clinical decisions. Copyright © 2017 The Cochrane
Collaboration. Published by John Wiley & Sons, Ltd.

<95>
Accession Number
614668195
Title
Fixed-dose combination therapy for the prevention of atherosclerotic
cardiovascular diseases.
Source
Cochrane Database of Systematic Reviews. 2017(3) (no pagination), 2017.
Article Number: CD009868. Date of Publication: 06 Mar 2017.
Author
Bahiru E.; de Cates A.N.; Farr M.R.B.; Jarvis M.C.; Palla M.; Rees K.;
Ebrahim S.; Huffman M.D.
Institution
(Bahiru) Northwestern University, Internal Medicine; Division of
Cardiology, 201 E. Huron St. Galter 19-100, Chicago, IL 60611, United
States
(de Cates, Farr, Jarvis, Rees) Warwick Medical School, University of
Warwick, Division of Health Sciences, Coventry CV4 7AL, United Kingdom
(Palla) Wayne State University, Department of Medicine, 540 E Canfield St,
Detroit, MI 48201, United States
(Ebrahim) London School of Hygiene and Tropical Medicine, Department of
Non-communicable Disease Epidemiology, Keppel Street, London WC1E 7HT,
United Kingdom
(Huffman) Northwestern University Feinberg School of Medicine, Departments
of Preventive Medicine and Medicine (Cardiology), 680 N. Lake Shore Drive,
Suite 1400, Chicago, IL 60611, United States
Publisher
John Wiley and Sons Ltd
Abstract
Background: Atherosclerotic cardiovascular disease (ASCVD) is the leading
cause of death and disability worldwide, yet ASCVD risk factor control and
secondary prevention rates remain low. A fixed-dose combination of blood
pressure- and cholesterol-lowering and antiplatelet treatments into a
single pill, or polypill, has been proposed as one strategy to reduce the
global burden of ASCVD. Objective(s): To determine the effect of
fixed-dose combination therapy on all-cause mortality, fatal and non-fatal
ASCVD events, and adverse events. We also sought to determine the effect
of fixed-dose combination therapy on blood pressure, lipids, adherence,
discontinuation rates, health-related quality of life, and costs.
 Search Method(s): We updated our previous searches in September 2016
of CENTRAL, MEDLINE, Embase, ISI Web of Science, and DARE, HTA, and HEED.
We also searched two clinical trials registers in September 2016. We used
no language restrictions. Selection Criteria: We included randomised
controlled trials of a fixed-dose combination therapy including at least
one blood pressure-lowering and one lipid-lowering component versus usual
care, placebo, or an active drug comparator for any treatment duration in
adults 18 years old or older, with no restrictions on presence or absence
of pre-existing ASCVD. Data Collection and Analysis: Three review
authors independently selected studies for inclusion and extracted the
data for this update. We evaluated risk of bias using the Cochrane 'Risk
of bias' assessment tool. We calculated risk ratios (RR) for dichotomous
data and mean differences (MD) for continuous data with 95% confidence
intervals (CI) using fixed-effect models when heterogeneity was low
(I2 < 50%) and random-effects models when heterogeneity was
high (I2 >= 50%). We used the GRADE approach to evaluate the
quality of evidence. Main Result(s): In the initial review, we
identified nine randomised controlled trials with a total of 7047
participants and four additional trials (n = 2012 participants; mean age
range 62 to 63 years; 30% to 37% women) were included in this update.
Eight of the 13 trials evaluated the effects of fixed-dose combination
(FDC) therapy in populations without prevalent ASCVD, and the median
follow-up ranged from six weeks to 23 months. More recent trials were
generally larger with longer follow-up and lower risk of bias. The main
risk of bias was related to lack of blinding of participants and
personnel, which was inherent to the intervention. Compared with the
comparator groups (placebo, usual care, or active drug comparator), the
effects of the fixed-dose combination treatment on mortality (FDC = 1.0%
versus control = 1.0%, RR 1.10, 95% CI 0.64 to 1.89, I2 = 0%, 5
studies, N = 5300) and fatal and non-fatal ASCVD events (FDC = 4.7% versus
control = 3.7%, RR 1.26, 95% CI 0.95 to 1.66, I2 = 0%, 6
studies, N = 4517) were uncertain (low-quality evidence). The low event
rates for these outcomes and indirectness of evidence for comparing
fixed-dose combination to usual care versus individual drugs suggest that
these results should be viewed with caution. Adverse events were common in
both the intervention (32%) and comparator (27%) groups, with participants
randomised to fixed-dose combination therapy being 16% (RR 1.16, 95% CI
1.09 to 1.25, 11 studies, 6906 participants, moderate-quality evidence)
more likely to report an adverse event . The mean differences in systolic
blood pressure between the intervention and control arms was -6.34 mmHg
(95% CI -9.03 to -3.64, 13 trials, 7638 participants, moderate-quality
evidence). The mean differences (95% CI) in total and LDL cholesterol
between the intervention and control arms were -0.61 mmol/L (95% CI -0.88
to -0.35, 11 trials, 6565 participants, low-quality evidence) and -0.70
mmol/L (95% CI -0.98 to -0.41, 12 trials, 7153 participants,
moderate-quality evidence), respectively. There was a high degree of
statistical heterogeneity in comparisons of blood pressure and lipids
(I2 >= 80% for all) that could not be explained, so these
results should be viewed with caution. Fixed-dose combination therapy
improved adherence to a multidrug strategy by 44% (26% to 65%) compared
with usual care (4 trials, 3835 participants, moderate-quality evidence).
Authors' conclusions: The effects of fixed-dose combination therapy on
all-cause mortality or ASCVD events are uncertain. A limited number of
trials reported these outcomes, and the included trials were primarily
designed to observe changes in ASCVD risk factor levels rather than
clinical events, which may partially explain the observed differences in
risk factors that were not translated into differences in clinical
outcomes among the included trials. Fixed-dose combination therapy is
associated with modest increases in adverse events compared with placebo,
active comparator, or usual care but may be associated with improved
adherence to a multidrug regimen. Ongoing, longer-term trials of
fixed-dose combination therapy will help demonstrate whether short-term
changes in risk factors might be maintained and lead to expected
differences in clinical events based on these changes. Copyright
© 2017 The Cochrane Collaboration. Published by John Wiley & Sons,
Ltd.

<96>
Accession Number
614226136
Title
Interventions for the prevention of postoperative atrial fibrillation in
adult patients undergoing noncardiac thoracic surgery.
Source
Cochrane Database of Systematic Reviews. 2017(1) (no pagination), 2017.
Article Number: CD010262. Date of Publication: 12 Jan 2017.
Author
Srinathan S.K.; Whitlock R.P.; Forsyth M.D.; Berg E.R.; Burnside T.C.;
Gottschalk T.H.
Institution
(Srinathan, Forsyth, Berg, Burnside) University of Manitoba, Department of
Surgery, GE611, 820 Sherbrook Street, Winnipeg, MB R3A 1R9, Canada
(Whitlock) McMaster University, Department of Surgery, David Braley
Cardiac, Vascular and Stroke Research Institute, 237 Barton Street East,
Hamilton, ON L8L 2X2, Canada
(Gottschalk) University of Manitoba, Neil John Maclean Health Sciences
Library, 770 Bannatyne Avenue, Winnipeg, MB R3E 0W3, Canada
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: To determine if adults undergoing noncardiac thoracic
surgery who receive a prophylactic intervention have a lower incidence of
postoperative atrial fibrillation (AF) than patients who do not receive a
prophylactic intervention. To determine if there are adverse events
associated with the use of these prophylactic interventions. Specifically
we will determine if there are differences in the incidence of strokes,
ventricular arrhythmias and hypotension. For the purpose of this review,
prophylactic interventions are new interventions administered to patients
undergoing noncardiac thoracic surgery for the purpose of reducing the
incidence of AF in those patients who are initially in sinus rhythm. The
interventions are grouped into the following classes of intervention: A)
cardiovascular agents, B) elemental supplementation, C) anti-inflammatory
agents. These interventions are to be administered either in the
preoperative period, during the operation, or immediately at the end of
the operation. We will not consider maintaining anti-arrhythmic medication
in patients who are already receiving the medication as a prophylactic
intervention. Copyright © 2017 The Cochrane Collaboration.

<97>
Accession Number
613624458
Title
Erythropoietin with iron supplementation for preoperative anaemia in
non-cardiac surgery.
Source
Cochrane Database of Systematic Reviews. 2016(12) (no pagination), 2016.
Article Number: CD012451. Date of Publication: 12 Dec 2016.
Author
Kaufner L.; von Heymann C.; Henkelmann A.; Pace N.L.; Weibel S.; Kranke
P.; Meerpohl J.J.; Gill R.
Institution
(Kaufner, Henkelmann) Charite - University Medicine Berlin, Department of
Anaesthesiology and Intensive Care Medicine, Augustenburger Platz 1,
Berlin 13353, Germany
(von Heymann) Vivantes Klinikum im Friedrichshain, Department of
Anaesthesiology, Intensive Care Medicine, Emergency Care Medicine and Pain
Therapy, Landsberger Allee 49, Berlin 10249, Germany
(Pace) University of Utah, Department of Anesthesiology, 3C444 SOM, 30
North 1900 East, Salt Lake City, UT 84132-2304, United States
(Weibel, Kranke) University of Wurzburg, Department of Anaesthesia and
Critical Care, Oberduerrbacher Str. 6, Wurzburg, Germany
(Meerpohl) Medical Center - University of Freiburg, Cochrane Germany,
Breisacher Strase 153, Freiburg 79110, Germany
(Gill) Southampton University Hospital NHS Trust, Department of
Anaesthetics, Tremona Road, Southampton, Hampshire SO16 6YD, United
Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives
are as follows: We aim to evaluate the efficacy and safety of preoperative
erythropoietin (rHuEPO) with supplemental iron (parenteral or oral) in
reducing perioperative allogeneic red blood cell transfusions in
preoperatively anaemic people undergoing non-cardiac
surgery. Copyright © 2016 The Cochrane Collaboration. Published
by John Wiley & Sons, Ltd.

<98>
Accession Number
612958922
Title
Pentasaccharides for the prevention of venous thromboembolism.
Source
Cochrane Database of Systematic Reviews. 2016(10) (no pagination), 2016.
Article Number: CD005134. Date of Publication: 31 Oct 2016.
Author
Dong K.; Song Y.; Li X.; Ding J.; Gao Z.; Lu D.; Zhu Y.
Institution
(Dong, Zhu) The 2nd Jiangsu Province Hospital of TCM, Nanjing University
of Chinese Medicine, Department of Respiration, No.155, Hanzhong Road,
Nanjing, China
(Song, Gao, Lu) Shanghai Daopei Hospital, Fudan University, Shanghai,
China
(Li) BenQ Medical Center, Nanjing Medical University, Department of
Radiotherapy, Nanjing, Jiangsu Province 210019, China
(Ding) National Institute on Aging, NIH, Laboratory of Epidemiology and
Population Science, 7201 Wisconsin Ave, Suite 3C-309, Bethesda, MD 20814,
United States
Publisher
John Wiley and Sons Ltd
Abstract
Background: Venous thromboembolism (VTE) is a common condition with
potentially serious and life-threatening consequences. The standard method
of thromboprophylaxis uses an anticoagulant such as low molecular weight
heparin (LMWH) or warfarin. In recent years, another type of
anticoagulant, pentasaccharide, an indirect factor Xa inhibitor, has shown
good anticoagulative effect in clinical trials. Three types of
pentasaccharides are available: short-acting fondaparinux, long-acting
idraparinux and idrabiotaparinux. Pentasaccharides cause little
heparin-induced thrombocytopenia and are better tolerated than
unfractionated heparin, LMWH and warfarin. However, no consensus has been
reached on whether pentasaccharides are superior or inferior to other
anticoagulative methods. Objective(s): To assess effects of
pentasaccharides versus other methods of thromboembolic prevention
(thromboprophylaxis) in people who require anticoagulant treatment to
prevent venous thromboembolism. Search Method(s): The Cochrane
Vascular Information Specialist (CIS) searched the Specialised Register
(last searched March 2016) and the Cochrane Central Register of Controlled
Trials (CENTRAL; 2016, Issue 2). The CIS searched trial databases for
details of ongoing and unpublished studies. Review authors searched LILACS
(Latin American and Caribbean Health Sciences) and the reference lists of
relevant studies and reviews identified by electronic searches.
 Selection Criteria: We included randomised controlled trials on any
type of pentasaccharide versus other anticoagulation methods
(pharmaceutical or mechanical) for VTE prevention. Data Collection
and Analysis: Two review authors independently selected trials, assessed
methodological quality and extracted data in predesigned tables. Main
Result(s): We included in this review 25 studies with a total of 21,004
participants. All investigated fondaparinux for VTE prevention; none
investigated idraparinux or idrabiotaparinux. Studies included
participants undergoing abdominal surgery, thoracic surgery, bariatric
surgery or coronary bypass surgery; acutely ill hospitalised medical
patients; people requiring rigid or semirigid immobilisation; and those
with superficial venous thrombosis. Most studies focused on orthopaedic
patients. We lowered the quality of the evidence because of heterogeneity
between studies and a small number of events causing imprecision. When
comparing fondaparinux with placebo, we found less total VTE (risk ratio
(RR) 0.24, 95% confidence interval (CI) 0.15 to 0.38; 5717 participants; 8
studies; I2 = 64%; P < 0.00001), less symptomatic VTE (RR 0.15,
95% CI 0.06 to 0.36; 6503 participants; 8 studies; I2 = 0%; P <
0.0001), less total DVT (RR 0.25, 95% CI 0.15 to 0.40; 5715 participants;
8 studies; I2 = 67%; P < 0.00001), less proximal DVT (RR 0.12,
95% CI 0.04 to 0.39; 2746 participants; 7 studies; I2 = 64%; P
= 0.0004) and less total pulmonary embolism (PE) (RR 0.16, 95% CI 0.04 to
0.62; 6412 participants; 8 studies; I2 = 0%; P = 0.008) in the
fondaparinux group. The quality of the evidence was moderate for total
VTE, total DVT and proximal DVT, and high for symptomatic VTE and total
PE. When fondaparinux was compared with LMWH, analyses indicated that
fondaparinux reduced total VTE and DVT (RR 0.55, 95% CI 0.42 to 0.73; 9339
participants; 11 studies; I2 = 64%; P < 0.0001; and RR 0.54,
95% CI 0.40 to 0.71; 9356 participants; 10 studies; I2 = 67%; P
< 0.0001, respectively), and showed a trend toward reduced proximal DVT
(RR 0.58, 95% CI 0.33 to 1.02; 8361 participants; 9 studies; I2
= 53%; P = 0.06). Symptomatic VTE (RR 1.03, 95% CI 0.65 to 1.63; 12240
participants; 9 studies; I2 = 35%; P = 0.90) and total PE (RR
1.24, 95% CI 0.65 to 2.34; 12350 participants; 10 studies; I2 =
0%; P = 0.51) indicated no difference between fondaparinux and LMWH. The
quality of the evidence was moderate for total VTE, symptomatic VTE, total
DVT and total PE, and low for proximal DVT. We showed that fondaparinux
increased major bleeding compared with both placebo and LWMH (RR 2.56, 95%
CI 1.48 to 4.44; 6659 participants; 8 studies; I2 = 0%; P =
0.0008; moderate-quality evidence; and RR 1.38, 95% CI 1.09 to 1.75;
12,501 participants; 11 studies; I2 = 24%; P = 0.008;
high-quality evidence, respectively). All-cause mortality was not
different between fondaparinux and placebo or LMWH (RR 0.76, 95% CI 0.48
to 1.22; 6674 participants; 8 studies; I2 = 14%; P = 0.26;
moderate-quality evidence; and RR 0.88, 95% CI 0.63 to 1.22; 12,400
participants; 11 studies; I2 = 0%; P = 0.44; moderate-quality
evidence, respectively). One study compared fondaparinux with variable and
fixed (1 mg per day) doses of warfarin after elective hip or knee
replacement surgery and showed no difference in primary and secondary
outcomes between fondaparinux and both variable and fixed doses of
warfarin. The quality of the evidence was very low. One small study
compared fondaparinux with edoxaban in patients with severe renal
impairment undergoing lower-limb orthopaedic surgery and reported no
thromboembolic events, major bleeding events or deaths in either group.
The quality of the evidence was very low. One small study compared
fondaparinux with mechanical thromboprophylaxis. Results showed no
difference in total VTE and total DVT between fondaparinux and mechanical
thromboprophylaxis. This study reported no cases pertaining to the other
outcomes of this review. The quality of the evidence was low. There were
insufficient studies to permit meaningful conclusions for subgroups of
clinical conditions other than orthopaedic surgery. Authors' conclusions:
Moderate to high quality evidence shows that fondaparinux is effective for
short-term prevention of VTE when compared with placebo. It can reduce
total VTE, DVT, total PE and symptomatic VTE, and does not demonstrate a
reduction in deaths compared with placebo. Low to moderate quality
evidence shows that fondaparinux is more effective for short-term VTE
prevention when compared with LMWH. It can reduce total VTE and total DVT
and does not demonstrate a reduction in deaths when compared with LMWH.
However, at the same time, moderate to high quality evidence shows that
fondaparinux increases major bleeding when compared with placebo and LMWH.
Therefore, when fondaparinux is chosen for the prevention of VTE,
attention should be paid to the person's bleeding and thrombosis risks.
Most data were derived from patients undergoing orthopaedic surgery.
Therefore, the conclusion predominantly pertains to these patients. Data
on fondaparinux for other clinical conditions are sparse. Copyright
© 2016 The Cochrane Collaboration. Published by John Wiley & Sons,
Ltd.

<99>
Accession Number
612675378
Title
Transfusion thresholds and other strategies for guiding allogeneic red
blood cell transfusion.
Source
Cochrane Database of Systematic Reviews. 2016(10) (no pagination), 2016.
Article Number: CD002042. Date of Publication: 12 Oct 2016.
Author
Carson J.L.; Stanworth S.J.; Roubinian N.; Fergusson D.A.; Triulzi D.;
Doree C.; Hebert P.C.
Institution
(Carson) Rutgers Robert Wood Johnson Medical School, Division of General
Internal Medicine, 125 Paterson Street, New Brunswick, NJ 08903, United
States
(Stanworth) Oxford University Hospitals NHS Foundation Trust and
University of Oxford, National Institute for Health Research (NIHR) Oxford
Biomedical Research Centre, John Radcliffe Hospital, Headley Way,
Headington, Oxford OX3 9BQ, United Kingdom
(Roubinian) Ottawa Hospital Research Institute, 725 Parkdale Ave., Ottawa,
ON K1Y 4E9, Canada
(Fergusson) Ottawa Hospital Research Institute, Clinical Epidemiology
Program, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada
(Triulzi) University of Pittsburgh, The Institute for Transfusion
Medicine, Five Parkway Center, 875 Greentree Road, Pittsburgh, PA 15220,
United States
(Doree) NHS Blood and Transplant, Systematic Review Initiative, John
Radcliffe Hospital, Oxford OX3 9BQ, United Kingdom
(Hebert) University of Montreal Hospital Research Centre, Centre for
Research, 900 rue St-Denis, local R04-402 Tour Viger, Montreal, QC H2X
0A9, Canada
Publisher
John Wiley and Sons Ltd
Abstract
Background: There is considerable uncertainty regarding the optimal
haemoglobin threshold for the use of red blood cell (RBC) transfusions in
anaemic patients. Blood is a scarce resource, and in some countries,
transfusions are less safe than others because of a lack of testing for
viral pathogens. Therefore, reducing the number and volume of transfusions
would benefit patients. Objective(s): The aim of this review was to
compare 30-day mortality and other clinical outcomes in participants
randomized to restrictive versus liberal red blood cell (RBC) transfusion
thresholds (triggers) for all conditions. The restrictive transfusion
threshold uses a lower haemoglobin level to trigger transfusion (most
commonly 7 g/dL or 8 g/dL), and the liberal transfusion threshold uses a
higher haemoglobin level to trigger transfusion (most commonly 9 g/dL to
10 g/dL). Search Method(s): We identified trials by searching CENTRAL
(2016, Issue 4), MEDLINE (1946 to May 2016), Embase (1974 to May 2016),
the Transfusion Evidence Library (1950 to May 2016), the Web of Science
Conference Proceedings Citation Index (1990 to May 2016), and ongoing
trial registries (27 May 2016). We also checked reference lists of other
published reviews and relevant papers to identify any additional trials.
 Selection Criteria: We included randomized trials where intervention
groups were assigned on the basis of a clear transfusion 'trigger',
described as a haemoglobin (Hb) or haematocrit (Hct) level below which a
red blood cell (RBC) transfusion was to be administered. Data
Collection and Analysis: We pooled risk ratios of clinical outcomes across
trials using a random-effects model. Two people extracted the data and
assessed the risk of bias. We conducted predefined analyses by clinical
subgroups. We defined participants randomly allocated to the lower
transfusion threshold as 'restrictive transfusion' and to the higher
transfusion threshold as 'liberal transfusion'. Main Result(s): A
total of 31 trials, involving 12,587 participants, across a range of
clinical specialities (e.g. surgery, critical care) met the eligibility
criteria. The trial interventions were split fairly equally with regard to
the haemoglobin concentration used to define the restrictive transfusion
group. About half of them used a 7 g/dL threshold, and the other half used
a restrictive transfusion threshold of 8 g/dL to 9 g/dL. The trials were
generally at low risk of bias .Some items of methodological quality were
unclear, including definitions and blinding for secondary outcomes.
Restrictive transfusion strategies reduced the risk of receiving a RBC
transfusion by 43% across a broad range of clinical specialties (risk
ratio (RR) 0.57, 95% confidence interval (CI) 0.49 to 0.65; 12,587
participants, 31 trials; high-quality evidence), with a large amount of
heterogeneity between trials (I2 = 97%). Overall, restrictive transfusion
strategies did not increase or decrease the risk of 30-day mortality
compared with liberal transfusion strategies (RR 0.97, 95% CI 0.81 to
1.16, I2 = 37%; N = 10,537; 23 trials; moderate-quality evidence) or any
of the other outcomes assessed (i.e. cardiac events (low-quality
evidence), myocardial infarction, stroke, thromboembolism (high-quality
evidence)). Liberal transfusion did not affect the risk of infection
(pneumonia, wound, or bacteraemia). Authors' conclusions: Transfusing at a
restrictive haemoglobin concentration of between 7 g/dL to 8 g/dL
decreased the proportion of participants exposed to RBC transfusion by 43%
across a broad range of clinical specialities. There was no evidence that
a restrictive transfusion strategy impacts 30-day mortality or morbidity
(i.e. mortality at other points, cardiac events, myocardial infarction,
stroke, pneumonia, thromboembolism, infection) compared with a liberal
transfusion strategy. There were insufficient data to inform the safety of
transfusion policies in certain clinical subgroups, including acute
coronary syndrome, myocardial infarction, neurological injury/traumatic
brain injury, acute neurological disorders, stroke, thrombocytopenia,
cancer, haematological malignancies, and bone marrow failure. The findings
provide good evidence that transfusions with allogeneic RBCs can be
avoided in most patients with haemoglobin thresholds above 7 g/dL to 8
g/dL. Copyright © 2016 The Cochrane Collaboration. Published by
John Wiley & Sons, Ltd.

<100>
Accession Number
612079337
Title
Fast-track cardiac care for adult cardiac surgical patients.
Source
Cochrane Database of Systematic Reviews. 2016(9) (no pagination), 2016.
Article Number: CD003587. Date of Publication: 12 Sep 2016.
Author
Wong W.-T.; Lai V.K.W.; Chee Y.E.; Lee A.
Institution
(Wong, Lai, Lee) The Chinese University of Hong Kong, Department of
Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, New
Territories, Hong Kong
(Chee) Queen Mary Hospital, Department of Anaesthesiology, Pokfulam, Hong
Kong
(Lee) The Chinese University of Hong Kong, Hong Kong Branch of The Chinese
Cochrane Centre, The Jockey Club School of Public Health and Primary Care,
Faculty of Medicine, Shatin, New Territories, Hong Kong
Publisher
John Wiley and Sons Ltd
Abstract
Background: Fast-track cardiac care is a complex intervention involving
several components of care during cardiac anaesthesia and in the
postoperative period, with the ultimate aim of early extubation after
surgery, to reduce length of stay in the intensive care unit and in the
hospital. Safe and effective fast-track cardiac care may reduce hospital
costs. This is an update of a Cochrane review first published in 2003,
updated in 2012 and updated now in 2016. Objective(s): To determine
the safety and effectiveness of fast-track cardiac care compared with
conventional (not fast-track) care in adult patients undergoing cardiac
surgery. Fast-track cardiac care intervention includes administration of
low-dose opioid-based general anaesthesia or use of a time-directed
extubation protocol, or both. Search Method(s): We searched the
Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 5),
MEDLINE (January 2012 to May 2015), Embase (January 2012 to May 2015), the
Cumulative Index to Nursing and Allied Health Literature (CINAHL; January
2012 to May 2015) and the Institute for Scientific Information (ISI) Web
of Science (January 2012 to May 2015), along with reference lists of
articles, to identify additional trials. We applied no language
restrictions. Selection Criteria: We included all randomized
controlled trials of adult cardiac surgical patients (coronary artery
bypass grafts, aortic valve replacement, mitral valve replacement) that
compared fast-track cardiac care and conventional (not fast-track) care
groups. We focused on the following fast-track interventions, which were
designed for early extubation after surgery: administration of low-dose
opioid-based general anaesthesia during cardiac surgery and use of a
time-directed extubation protocol after surgery. The primary outcome was
risk of mortality. Secondary outcomes included postoperative
complications, reintubation within 24 hours of surgery, time to
extubation, length of stay in the intensive care unit and in the hospital,
quality of life after surgery and hospital costs. Data Collection and
Analysis: Two review authors independently assessed trial quality and
extracted study data. We contacted study authors for additional
information. We calculated a Peto odds ratio (OR) for risk of mortality
and used a random-effects model to report risk ratio (RR), mean difference
(MD) and 95% confidence intervals (95% CIs) for all secondary outcomes.
 Main Result(s): We included 28 trials (4438 participants) in the
updated review. We considered most participants to be at low to moderate
risk of death after surgery. We assessed two studies as having low risk of
bias and 11 studies high risk of bias. Investigators reported no
differences in risk of mortality within the first year after surgery
between low-dose versus high-dose opioid-based general anaesthesia groups
(OR 0.53, 95% CI 0.25 to 1.12; eight trials, 1994 participants, low level
of evidence) and between a time-directed extubation protocol versus usual
care (OR 0.80, 95% CI 0.45 to 1.45; 10 trials, 1802 participants, low
level of evidence). Researchers noted no significant differences between
low-dose and high-dose opioid-based anaesthesia groups in the following
postoperative complications: myocardial infarction (RR 0.98, 95% CI 0.48
to 1.99; eight trials, 1683 participants, low level of evidence), stroke
(RR 1.17, 95% CI 0.36 to 3.78; five trials, 562 participants, low level of
evidence) and tracheal reintubation (RR 1.77, 95% CI 0.38 to 8.27; five
trials, 594 participants, low level of evidence). Comparisons with usual
care revealed no significant differences in the risk of postoperative
complications associated with a time-directed extubation protocol:
myocardial infarction (RR 0.59, 95% CI 0.27 to 1.31; eight trials, 1378
participants, low level of evidence), stroke (RR 0.85, 95% CI 0.33 to
2.16; 11 trials, 1646 participants, low level of evidence) and tracheal
reintubation (RR 1.34, 95% CI 0.74 to 2.41; 12 trials, 1261 participants,
low level of evidence). Although levels of heterogeneity were high,
low-dose opioid anaesthesia was associated with reduced time to extubation
(reduction of 4.3 to 10.5 hours, 14 trials, 2486 participants, low level
of evidence) and length of stay in the intensive care unit (reduction of
0.4 to 7.0 hours, 12 trials, 1394 participants, low level of evidence).
Use of a time-directed extubation protocol was associated with reduced
time to extubation (reduction of 3.7 to 8.8 hours, 16 trials, 2024
participants, low level of evidence) and length of stay in the intensive
care unit (reduction of 3.9 to 10.5 hours, 13 trials, 1888 participants,
low level of evidence). However, these two fast-track care interventions
were not associated with reduced total length of stay in the hospital (low
level of evidence). Authors' conclusions: Low-dose opioid-based general
anaesthesia and time-directed extubation protocols for fast-track
interventions have risks of mortality and major postoperative
complications similar to those of conventional (not fast-track) care, and
therefore appear to be safe for use in patients considered to be at low to
moderate risk. These fast-track interventions reduced time to extubation
and shortened length of stay in the intensive care unit but did not reduce
length of stay in the hospital. Copyright © 2016 The Cochrane
Collaboration.

<101>
Accession Number
611442995
Title
Mammalian target of rapamycin inhibitors for heart transplant patients.
Source
Cochrane Database of Systematic Reviews. 2016(8) (no pagination), 2016.
Article Number: CD011206. Date of Publication: 01 Aug 2016.
Author
Moller C.H.; Gustafsson F.; Gluud C.; Penninga L.
Institution
(Moller) Rigshospitalet, Copenhagen University Hospital, Department of
Cardiothoracic Surgery, Blegdamsvej 9, Copenhagen 2100, Denmark
(Gustafsson) Copenhagen University Hospital, Department of Cardiology B,
Blegdamsvej 9, Copenhagen DK-2100, Denmark
(Gluud) Copenhagen Trial Unit, Centre for Clinical Intervention Research,
Department 7812, Rigshospitalet, Copenhagen University Hospital, The
Cochrane Hepato-Biliary Group, Blegdamsvej 9, Copenhagen DK-2100, Denmark
(Penninga) Department 7812, Rigshospitalet, Copenhagen University
Hospital, Copenhagen Trial Unit, Centre for Clinical Intervention
Research, Blegdamsvej 9, Copenhagen DK-2100, Denmark
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: We will assess the benefits and harms of immunosuppressive
treatment with mTOR inhibitors for heart transplant recipients, both as an
add-on to other immunosuppressive agents, as well as a replacement for
other immunosuppressive agents (e.g., calcineurin inhibitors,
mycophenolate mofetil). More specifically, we will assess the short-term
efficacy of mTOR inhibitors compared with standard therapy regarding acute
rejection, the (long-term) effects of mTOR inhibitor treatment compared
with standard therapy regarding renal impairment and malignancy, and the
safety of mTOR inhibitor treatment regarding adverse
effects. Copyright © 2016 The Cochrane Collaboration.

<102>
Accession Number
611279713
Title
Percutaneous coronary intervention versus coronary artery bypass grafting
for adults with diabetes and multivessel coronary disease.
Source
Cochrane Database of Systematic Reviews. 2016(7) (no pagination), 2016.
Article Number: CD011012. Date of Publication: 20 Jul 2016.
Author
Bravo C.A.; Rada G.; Pachon R.E.; Alvarez M.A.; Oliva P.; Rondon Clavo
C.M.; Rivera-Cornejo M.; Torres-Robles R.; Zarich S.W.
Institution
(Bravo) Bridgeport Hospital/Yale New Haven Health System, Department of
Internal Medicine, Section of Internal Medicine, 267 Grant Street,
Bridgeport, CT 06610, United States
(Rada) Pontificia Universidad Catolica de Chile, Faculty of Medicine, Lira
44, Decanato Primer piso, Santiago, Chile
(Pachon) Rutgers University, Cell Biology and Molecular Medicine, 185
South Orange Avenue, Newark, NJ 07101, United States
(Alvarez) Bridgeport Hospital, Department of Internal Medicine, 267 Grant
Street, Bridgeport, CT 06610, United States
(Oliva) Universidad del Desarrollo, Faculty of Dentistry, Barros Arana
1735, Concepcion CP. 4070553, Chile
(Rondon Clavo) University of Medicine and Dentistry of New Jersey,
Department of Cell Biology and Molecular Medicine, Medical Science
Building, UMDNJ, 185 South Orange Avenue, Newark, NJ 07103-2714, United
States
(Rivera-Cornejo, Torres-Robles) Pontificia Universidad Catolica de Chile,
Sistema de Bibliotecas UC, Santiago, Region Metropolitana 8330074, Chile
(Zarich) Yale New Haven Health System, 267 Grant St, Bridgeport, CT 06610,
United States
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: To assess the efficacy of PCI versus CABG for adults with
DM and MVD. Copyright © 2016 The Cochrane Collaboration.

<103>
Accession Number
610936921
Title
Regional versus general anaesthesia for improved cognitive function after
procedures other than cardiac surgery or neurosurgery in adult and
paediatric patients.
Source
Cochrane Database of Systematic Reviews. 2016(6) (no pagination), 2016.
Article Number: CD008737. Date of Publication: 22 Jun 2016.
Author
Andreae M.H.; Atchabahian A.; Mccrillis A.M.; Chao J.Y.; Suzuki S.;
Shinnar S.; Hall C.B.; Lipton R.B.
Institution
(Andreae, Chao) Montefiore Medical Center, Albert Einstein College of
Medicine, Department of Anesthesiology, 111E 210th Street, #N4-005, Bronx,
NY 10467-2401, United States
(Atchabahian) NYU School of Medicine, Department of Anesthesiology,
Perioperative Care, and Pain Medicine, New York, NY, United States
(Mccrillis) NYU Langone Medical Center, Ehrman Medical Library, 577 First
Avenue, 201, New York, NY 10016, United States
(Suzuki) NYU Hospital Center, Department of Anesthesiology, Department of
Anestesiology C2, 301 East 17th, New York, NY 10003, United States
(Shinnar, Hall, Lipton) Albert Einstein College of Medicine, Saul R Korey
Department of Neurology, 111 E. 210th Street, Bronx, NY 10467, United
States
(Hall) Albert Einstein College of Medicine, Division of Biostatistics,
Department of Epidemiology and Population Health, 1300 Morris Park Avenue,
Bronx, NY 10461, United States
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: The objective of this review is to compare the effects of
regional versus general anaesthesia on cognitive function after procedures
other than cardiac surgery or neurosurgery in adult and in paediatric
patients. Copyright © 2016 The Cochrane Collaboration.

<104>
Accession Number
610597850
Title
Thoracic stent graft versus surgery for thoracic aneurysm.
Source
Cochrane Database of Systematic Reviews. 2016(6) (no pagination), 2016.
Article Number: CD006796. Date of Publication: 06 Jun 2016.
Author
Abraha I.; Romagnoli C.; Montedori A.; Cirocchi R.
Institution
(Abraha) Health Planning Service, Regional Health Authority of Umbria,
Perugia, Italy
(Romagnoli) USLUmbria1, Epidemiological Planning, Perugia 06100, Italy
(Montedori) Regional Health Authority of Umbria, Health Planning Service,
Via Mario Angeloni 61, Perugia, Umbria 06124, Italy
(Cirocchi) University of Perugia, Department of General Surgery, Terni
05100, Italy
Publisher
John Wiley and Sons Ltd
Abstract
Background: Thoracic aortic aneurysm (TAA) is an uncommon disease with an
incidence of 10.4 per 100,000 inhabitants. It occurs mainly in older
individuals and is evenly distributed among both sexes. There are no signs
or symptoms indicative of the presence of the disease. Progressive but
unpredictable enlargement of the dilated aorta is the natural course of
the disease and can lead to rupture. Open chest surgical repair using
prosthetic graft interposition has been a conventional treatment for TAAs.
Despite improvements in surgical procedures perioperative complications
remain significant. The alternative option of thoracic endovascular
aneurysm repair (TEVAR) is considered a less invasive and potentially
safer technique, with lower morbidity and mortality compared with
conventional treatment. Evidence is needed to support the use of TEVAR for
these patients, rather than open surgery. This is an update of the review
first published in 2009. Objective(s): This review aimed to assess
the efficacy of TEVAR versus conventional open surgery in patients with
thoracic aortic aneurysms. Search Method(s): For this update the
Cochrane Vascular Information Specialist searched the Specialised Register
(last searched January 2016) and CENTRAL (2015, Issue 12). Selection
Criteria: Randomised controlled trials in which patients with TAAs were
randomly assigned to TEVAR or open surgical repair. Data Collection
and Analysis: Two review authors independently identified and evaluated
potential trials for eligibility. Excluded studies were further checked by
another author. We did not perform any statistical analyses as no
randomised controlled trials were identified. Main Result(s): We did
not find any published or unpublished randomised controlled trials
comparing TEVAR with conventional open surgical repair for the treatment
of thoracic aortic aneurysms. Authors' conclusions: Stent grafting of the
thoracic aorta is technically feasible and non-randomised studies suggest
reduction of early outcomes such as paraplegia, mortality and hospital
stay. High quality randomised controlled trials assessing all clinically
relevant outcomes including open-conversion, aneurysm exclusion,
endoleaks, and late mortality are needed. Copyright © 2016 The
Cochrane Collaboration.

<105>
Accession Number
610473985
Title
Routine invasive strategies versus selective invasive strategies for
unstable angina and non-ST elevation myocardial infarction in the stent
era.
Source
Cochrane Database of Systematic Reviews. 2016(5) (no pagination), 2016.
Article Number: CD004815. Date of Publication: 26 May 2016.
Author
Fanning J.P.; Nyong J.; Scott I.A.; Aroney C.N.; Walters D.L.
Institution
(Fanning) The Prince Charles Hospital, School of Medicine, The University
of Queensland, Rode Road, Chermside, Brisbane 4032, Australia
(Nyong) FARR Institute UCL, Clinical Epidemiology, 222 Euston Road,
London, Greater London NW1 2DA, United Kingdom
(Scott) Princess Alexandra Hospital, Internal Medicine Department and
Clinical Services Evaluation Unit, Brisbane, Australia
(Aroney) The Prince Charles Hospital, Department of Cardiology, Rode Rd,
Chermside, Brisbane, Australia
(Walters) The Prince Charles Hospital, Executive Chair Prince Charles
Heart and Lung Institute, Road Rd, Brisbane, QLD 4032, Australia
Publisher
John Wiley and Sons Ltd
Abstract
Background: People with unstable angina and non-ST elevation myocardial
infarction (UA/NSTEMI) are managed with a combination of medical therapy,
invasive angiography and revascularisation. Specifically, two approaches
have evolved: either a 'routine invasive' strategy whereby all patients
undergo coronary angiography shortly after admission and, if indicated,
coronary revascularisation; or a 'selective invasive' (also referred to as
'conservative') strategy in which medical therapy alone is used initially,
with a selection of patients for angiography based upon evidence of
persistent myocardial ischaemia. Uncertainty exists as to which strategy
provides the best outcomes for these patients. This Cochrane review is an
update of a Cochrane review originally published in 2006, to provide a
robust comparison of these two strategies in the early management of
patients with UA/NSTEMI. Objective(s): To determine the benefits and
harms associated with the following.1. A routine invasive versus a
conservative or 'selective invasive' strategy for the management of
UA/NSTEMI in the stent era.2. A routine invasive strategy with and without
glycoprotein IIb/IIIa receptor antagonists versus a conservative strategy
for the management of UA/NSTEMI in the stent era. Search Method(s):
We searched the following databases and additional resources up to 25
August 2015: the Cochrane Central Register of Controlled Trials (CENTRAL)
on the Cochrane Library, MEDLINE and EMBASE, with no language
restrictions. Selection Criteria: We included prospective randomised
controlled trials (RCTs) that compared invasive with conservative or
'selective invasive' strategies in participants with acute UA/NSTEMI.
 Data Collection and Analysis: Two review authors screened the records
and extracted data in duplicate. Using intention-to-treat analysis with
random-effects models, we calculated summary estimates of the risk ratio
(RR) with 95% confidence intervals (CIs) for the primary endpoints of
all-cause death, fatal and non-fatal myocardial infarction (MI), combined
all-cause death or non-fatal MI, refractory angina and re-hospitalisation.
We performed further analysis of included studies based on whether
glycoprotein IIb/IIIa receptor antagonists were used routinely. We
assessed the heterogeneity of included trials using Pearson chi2 (Chi2
test) and variance (I2 statistic) analysis. Using the Grading of
Recommendations Assessment, Development and Evaluation (GRADE) approach,
we assessed the quality of the evidence and the GRADE profiler (GRADEPRO)
was used to import data from Review Manager 5.3 (Review Manager) to create
Summary of findings (SoF) tables. Main Result(s): Eight RCTs with a
total of 8915 participants (4545 invasive strategies, 4370 conservative
strategies) were eligible for inclusion. We included three new studies and
1099 additional participants in this review update. In the all-study
analysis, evidence did not show appreciable risk reductions in all-cause
mortality (RR 0.87, 95% CI 0.64 to 1.18; eight studies, 8915 participants;
low quality evidence) and death or non-fatal MI (RR 0.93, 95% CI 0.71 to
1.2; seven studies, 7715 participants; low quality evidence) with invasive
strategies compared to conservative (selective invasive) strategies at six
to 12 months follow-up. There was appreciable risk reduction in MI (RR
0.79, 95% CI 0.63 to 1.00; eight studies, 8915 participants; moderate
quality evidence), refractory angina (RR 0.64, 95% CI 0.52 to 0.79; five
studies, 8287 participants; moderate quality evidence) and
re-hospitalisation (RR 0.77, 95% CI 0.63 to 0.94; six studies, 6921
participants; moderate quality evidence) with routine invasive strategies
compared to conservative (selective invasive) strategies also at six to 12
months follow-up. Evidence also showed increased risks in bleeding (RR
1.73, 95% CI 1.30 to 2.31; six studies, 7584 participants; moderate
quality evidence) and procedure-related MI (RR 1.87, 95% CI 1.47 to 2.37;
five studies, 6380 participants; moderate quality evidence) with routine
invasive strategies compared to conservative (selective invasive)
strategies. The low quality evidence were as a result of serious risk of
bias and imprecision in the estimate of effect while moderate quality
evidence was only due to serious risk of bias. Authors' conclusions: In
the all-study analysis, the evidence failed to show appreciable benefit
with routine invasive strategies for unstable angina and non-ST elevation
MI compared to conservative strategies in all-cause mortality and death or
non-fatal MI at six to 12 months. There was evidence of risk reduction in
MI, refractory angina and re-hospitalisation with routine invasive
strategies compared to conservative (selective invasive) strategies at six
to 12 months follow-up. However, routine invasive strategies were
associated with a relatively high risk (almost double the risk) of
procedure-related MI, and increased risk of bleeding complications. This
systematic analysis of published RCTs supports the conclusion that, in
patients with UA/NSTEMI, a selectively invasive (conservative) strategy
based on clinical risk for recurrent events is the preferred management
strategy. Copyright © 2016 The Cochrane Collaboration.

<106>
Accession Number
610074442
Title
Revascularisation of the left subclavian artery for thoracic endovascular
aortic repair.
Source
Cochrane Database of Systematic Reviews. 2016(4) (no pagination), 2016.
Article Number: CD011738. Date of Publication: 27 Apr 2016.
Author
Hajibandeh S.; Antoniou S.A.; Torella F.; Antoniou G.A.
Institution
(Hajibandeh, Hajibandeh, Torella) Royal Liverpool University Hospital,
Liverpool Vascular and Endovascular Service, Prescot Street, Liverpool
L78XP, United Kingdom
(Antoniou) University Hospital of Heraklion, University of Crete,
Department of Surgery, Souniou 11, Heraklion 19001, Greece
(Antoniou) The Royal Oldham Hospital, Pennine Acute Hospitals NHS Trust,
Department of Vascular and Endovascular Surgery, Manchester, United
Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Controversy exists as to whether revascularisation of the left
subclavian artery (LSA) confers improved outcomes in patients undergoing
thoracic endovascular aortic repair (TEVAR). Even though preemptive
revascularisation of the LSA has theoretical advantages, including a
reduced risk of ischaemic damage to vital organs, such as the brain and
the spinal cord, it is not without risks. Current practice guidelines
recommend routine revascularisation of the LSA in patients undergoing
elective TEVAR where achievement of a proximal seal necessitates coverage
of the LSA, and in patients who have an anatomy that compromises perfusion
to critical organs. However, this recommendation was based on very
low-quality evidence. Objective(s): To assess the comparative
efficacy of routine LSA revascularisation versus either selective or no
revascularisation in patients with descending thoracic aortic disease
undergoing TEVAR with coverage of the LSA origin. Search Method(s):
The Cochrane Vascular Trials Search Co-ordinator (TSC) searched the
Specialised Register (June 2015). In addition, the TSC searched the
Cochrane Register of Studies (CENTRAL (2015, Issue 5)).Trials databases
were also searched (June 2015). Selection Criteria: We had planned to
consider all randomised controlled trials (RCTs) that compared routine
revascularisation of the LSA with selective or no revascularisation, in
patients undergoing TEVAR. Data Collection and Analysis: Two review
authors independently assessed the title and abstract of articles
identified through literature searches. An independent third review author
was consulted in the event of disagreement. We had planned for two review
authors to independently extract data and assess the risk of bias of
identified trials using the criteria recommended in the Cochrane Handbook
for Systematic Reviews of Interventions. Main Result(s): We did not
identify any RCTs relevant to our review topic. Therefore, no quantitative
analysis was conducted. Authors' conclusions: High quality RCT evidence
for or against routine or selective revascularisation of the LSA in TEVAR
is not currently available. It is not possible to draw conclusions with
regard to the optimal management of LSA coverage in TEVAR, and whether
routine revascularisation, which was defined as the intervention of
interest in our review, confers beneficial effects, as indicated by
reduced mortality, cerebrovascular events, and spinal cord ischaemia. This
review highlights the need for continued research to provide RCT evidence
and define the role of LSA revascularisation in the context of TEVAR with
coverage of the LSA. Copyright © 2016 The Cochrane Collaboration.
Published by John Wiley & Sons, Ltd.

<107>
Accession Number
609924477
Title
A comparison of different antibiotic regimens for the treatment of
infective endocarditis.
Source
Cochrane Database of Systematic Reviews. 2016(4) (no pagination), 2016.
Article Number: CD009880. Date of Publication: April 19, 2016.
Author
Marti-Carvajal A.J.; Dayer M.; Conterno L.O.; Gonzalez Garay A.G.;
Marti-Amarista C.E.; Simancas-Racines D.
Institution
(Marti-Carvajal) Iberoamerican Cochrane Network, Valencia, Venezuela
(Dayer) Taunton and Somerset NHS Trust, Department of Cardiology, Musgrove
Park, Taunton, Somerset TA1 5DA, United Kingdom
(Conterno) Marilia Medical School, Department of General Internal Medicine
and Clinical Epidemiology Unit, Avenida Monte Carmelo 800, Fragata,
Marilia, Sao Paulo 17519-030, Brazil
(Gonzalez Garay) National Institute of Pediatrics, Methodology Research
Unit/Neonatology, Insurgentes Sur 3700 - C, Col. Insurgentes Cuicuilco,
Coyoacan, Mexico City, Distrito Federal 04530, Mexico
(Marti-Amarista) c/o Cochrane Heart Group, 1282 Marketplace dr Unit 2211,
Yorkville, Illinois 60560, United States
(Simancas-Racines) Universidad Tecnologica Equinoccial, Facultad de
Ciencias de la Salud Eugenio Espejo, Edificio Bloque D. Of. Centro
Cochrane, Avenida Occidental s/n, y Avenida Mariana de Jesus, Quito,
Casilla Postal 17-01-2764, Ecuador
Publisher
John Wiley and Sons Ltd
Abstract
Background: Infective endocarditis is a microbial infection of the
endocardial surface of the heart. Antibiotics are the cornerstone of
treatment, but their use is not standardised, due to the differences in
presentation, populations affected and the wide variety of micro-organisms
that can be responsible. Objective(s): To assess the existing
evidence about the clinical benefits and harms of different antibiotics
regimens used to treat people with infective endocarditis. Search
Method(s): We searched the Cochrane Central Register of Controlled Trials
(CENTRAL), MEDLINE, EMBASE Classic and EMBASE, LILACS, CINAHL and the
Conference Proceedings Citation Index on 30 April 2015. We also searched
three trials registers and handsearched the reference lists of included
papers. We applied no language restrictions. Selection Criteria: We
included randomised controlled trials assessing the effects of antibiotic
regimens for treating possible infective endocarditis diagnosed according
to modified Duke's criteria. We considered all-cause mortality, cure rates
and adverse events as the primary outcomes. We excluded people with
possible infective endocarditis and pregnant women. Data Collection
and Analysis: Three review authors independently performed study
selection, 'Risk of bias' assessment and data extraction in duplicate. We
constructed 'Summary of findings' tables and used GRADE methodology to
assess the quality of studies. We described the included studies
narratively. Main Result(s): Four small randomised controlled trials
involving 728 allocated/224 analysed participants met our inclusion
criteria. These trials had a high risk of bias. Drug companies sponsored
two of the trials. We were unable to pool the data due to the
heterogeneity in outcome definitions and the different antibiotics used.
The included trials compared the following antibiotic schedules. The first
trial compared quinolone (levofloxacin) plus standard treatment
(anti-staphylococcal penicillin (cloxacillin or dicloxacillin),
aminoglycoside (tobramycin or netilmicin) and rifampicin) versus standard
treatment alone reporting uncertain effects on all-cause mortality (8/31
(26%) with levofloxacin plus standard treatment versus 9/39 (23%) with
standard treatment alone; RR 1.12, 95% CI 0.49 to 2.56, very low quality
evidence). The second trial compared daptomycin versus low-dose gentamicin
plus an anti-staphylococcal penicillin (nafcillin, oxacillin or
flucloxacillin) or vancomycin. This showed uncertain effects in terms of
cure rates (9/28 (32.1%) with daptomycin versus 9/25 (36%) with low-dose
gentamicin plus anti-staphylococcal penicillin or vancomycin, RR 0.89 95%
CI 0.42 to 1.89; very low quality evidence). The third trial compared
cloxacillin plus gentamicin with a glycopeptide (vancomycin or
teicoplanin) plus gentamicin. In participants receiving gentamycin plus
glycopeptide only 13/23 (56%) were cured versus 11/11 (100%) receiving
cloxacillin plus gentamicin (RR 0.59, 95% CI 0.40 to 0.85; very low
quality evidence). The fourth trial compared ceftriaxone plus gentamicin
versus ceftriaxone alone and found no conclusive differences in terms of
cure (15/34 (44%) with ceftriaxone plus gentamicin versus 21/33 (64%) with
ceftriaxone alone, RR 0.69, 95% CI 0.44 to 1.10; very low quality
evidence). The trials reported adverse events, need for cardiac surgical
interventions, uncontrolled infection and relapse of endocarditis and
found no conclusive differences between comparison groups (very low
quality evidence). No trials assessed septic emboli or quality of life.
Authors' conclusions: Limited and very low quality evidence suggested that
there were no conclusive differences between antibiotic regimens in terms
of cure rates or other relevant clinical outcomes. However, because of the
very low quality evidence, this needs confirmation. The conclusion of this
Cochrane review was based on randomised controlled trials with high risk
of bias. Accordingly, current evidence does not support or reject any
regimen of antibiotic therapy for treatment of infective
endocarditis. Copyright © 2016 The Cochrane Collaboration.
Published by John Wiley & Sons, Ltd.

<108>
Accession Number
609129694
Title
Aspirin dosage for the prevention of graft occlusion in people undergoing
coronary surgery.
Source
Cochrane Database of Systematic Reviews. 2016(3) (no pagination), 2016.
Article Number: CD012113. Date of Publication: March 19, 2016.
Author
Alahdab F.; Jazayerli M.L.; Alhalabi O.; Hasan S.; Mallak M.; Alkhouli M.;
Haydour Q.; Murad M.H.
Institution
(Alahdab) Mayo Clinic, Evidence-based Practice Center, 1919 3rd Ave NE,
Apt 2, Rochester, MN 55906, United States
(Jazayerli, Alhalabi, Haydour) University of Damascus, Faculty of
Medicine, Damascus, Syrian Arab Republic
(Hasan) Damascus University, Almwasat University Hospital, Damascus,
Syrian Arab Republic
(Mallak) University of Damascus, Children's University Hospital, Damascus,
Syrian Arab Republic
(Alkhouli) Mayo Clinic, Rochester, United States
(Murad) Mayo Clinic, The Knowledge and Encounter Research Unit, 200 First
Street SW, Rochester, MN 55905, United States
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: To evaluate the use of different dose regimens of aspirin
to prevent graft occlusion in people who have undergone coronary artery
bypass grafting. Copyright © 2016 The Cochrane Collaboration.
Published by John Wiley & Sons, Ltd.

<109>
Accession Number
620551331
Title
Leukoreduction for the prevention of adverse reactions from allogeneic
blood transfusion.
Source
Cochrane Database of Systematic Reviews. 2015(12) (no pagination), 2015.
Article Number: CD009745. Date of Publication: 03 Dec 2015.
Author
Simancas-Racines D.; Osorio D.; Marti-Carvajal A.J.; Arevalo-Rodriguez I.
Institution
(Simancas-Racines, Osorio) Universidad Tecnologica Equinoccial, Facultad
de Ciencias de la Salud Eugenio Espejo, Edificio Bloque D. Of. Centro
Cochrane, Avenida Occidental s/n, y Avenida Mariana de Jesus, Quito,
Casilla Postal 17-01-2764, Ecuador
(Marti-Carvajal) Iberoamerican Cochrane Network, Valencia, Venezuela
(Arevalo-Rodriguez) Fundacion Universitaria de Ciencias de la Salud,
Hospital de San Jose/Hospital Infantil de San Jose, Division of Research,
Carrera 19 N 8a - 32, Bogota D.C., Bogota DC 11001, Colombia
Publisher
John Wiley and Sons Ltd
Abstract
Background: A blood transfusion is an acute intervention, implemented to
solve life and health-threatening conditions on a short-term basis.
However, blood transfusions have adverse events, some of them potentially
related to immune modulation or to a direct transmission of infectious
agents (e.g. cytomegalovirus). Leukoreduction is a process in which the
white blood cells are intentionally reduced in packed red blood cells
(PRBCs) in order to reduce the risk of adverse reactions. The potential
benefits of leukoreduced PRBCs in all types of transfused patients for
decreasing infectious and non-infectious complications remain unclear.
 Objective(s): To determine the clinical effectiveness of
leukoreduction of packed red blood cells for preventing adverse reactions
following allogeneic blood transfusion. Search Method(s): We ran the
most recent search on 10th November 2015. We searched the Cochrane
Injuries Group's Specialised Register, Cochrane Central Register of
Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE (OvidSP),
Embase(OvidSP), CINAHL Plus (EBSCO), LILACS (BIREME), and clinical trials
registers. In addition, we checked the reference lists of all relevant
trials and reviews identified in the literature searches. Selection
Criteria: Randomised clinical trials including patients of all ages
requiring PRBC allogeneic transfusion. Any study was eligible for
inclusion, regardless of the length of participant follow-up or country
where the study was performed. The primary outcome was transfusion-related
acute lung injury (TRALI). Secondary outcomes were death from any cause,
infection from any cause, non-infectious complications and any other
adverse event. Data Collection and Analysis: At least two review
authors independently performed study selection, 'Risk of bias'
assessments and data extraction. We estimated pooled relative risk for
dichotomous outcomes, and we measured statistical heterogeneity using I2
statistic. The random-effects model was used to synthesise results. We
conducted a trial sequential analysis to assess the risk of random errors
in cumulative meta-analyses. Main Result(s): Thirteen studies, most
including adult patients, met the eligibility criteria. We found no clear
evidence of an effect of leukoreduced PRBC versus non-leukoreduced PRBC in
patients that were randomised to receive transfusion for the following
outcomes: TRALI: RR 0.96, 95% CI 0.67 to 1.36, P = 0.80 from one trial
reporting data on 1864 trauma patients. The accrued information of 1864
participants constituted only 28.5% of the diversity-adjusted required
information size (DARIS) of 6548 participants. The quality of evidence was
low. Death from any cause: RR 0.81, 95% CI 0.58 to 1.12, I2 statistic =
63%, P = 0.20 from nine trials reporting data on 6485 cardiovascular
surgical patients, gastro-oncology surgical patients, trauma patients and
HIV infected patients. The accrued information of 6485 participants
constituted only 55.3% of the DARIS of 11,735 participants. The quality of
evidence was very low. Infection from any cause: RR 0.80, 95% CI 0.62 to
1.03, I2 statistic = 84%, P = 0.08 from 10 trials reporting data on 6709
cardiovascular surgical patients, gastro-oncology surgical patients,
trauma patients and HIV infected patients. The accrued information of 6709
participants constituted only 60.6% of the DARIS of 11,062 participants.
The quality of evidence was very low. Adverse events: The only adverse
event reported as an adverse event was fever (RR 0.81, 95% CI 0.64 to
1.02; I2 statistic= 0%, P = 0.07). Fever was reported in two trials on 634
cardiovascular surgical and gastro-oncology surgical patients. The accrued
information of 634 participants constituted only 84.4% of the DARIS of 751
participants. The quality of evidence was low. Incidence of other
non-infectious complications: This outcome was not assessed in any
included trial. Authors' conclusions: There is no clear evidence for
supporting or rejecting the routine use of leukoreduction in all patients
requiring PRBC transfusion for preventing TRALI, death, infection,
non-infectious complications and other adverse events. As the quality of
evidence is very low to low, more evidence is needed before a definitive
conclusion can be drawn. Copyright © 2015 The Cochrane
Collaboration.

<110>
Accession Number
620549278
Title
Mobile phone text messaging to improve adherence to cardiovascular disease
secondary prevention interventions.
Source
Cochrane Database of Systematic Reviews. 2015(8) (no pagination), 2015.
Article Number: CD011851. Date of Publication: 27 Aug 2015.
Author
Adler A.J.; Martin N.; Mariani J.; Tajer C.D.; Serrano N.C.; Casas J.P.;
Perel P.
Institution
(Adler, Martin) London School of Hygiene and Tropical Medicine, Department
of Non-communicable Disease Epidemiology, Keppel Street, London WC1E 7HT,
United Kingdom
(Mariani) Hospital El Cruce Nestor C. Kirchner, Department of Cardiology,
Av. Calchaqui 5401, Florencio Varela, Buenos Aires 1888, Argentina
(Tajer) Hospital de Alta Complejidad El Cruce, Department of
Cardiovascular Disease, Calchaqui 5401, Florencio Varela, Provincia de
Buenos Aires 1418857983, Argentina
(Serrano) Foundation Cardiovascular of Colombia, Calle 155A No. 23-58,
Bucaramanga, Santander 680006, Colombia
(Casas) University College London, UK, Institute of Health Informatics,
Faculty of Population Health Sciences, London, United Kingdom
(Perel) London School of Hygiene and Tropical Medicine, Department of
Population Health, Keppel Street, London WC1E 7HT, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: To determine whether mobile phone text messaging is
effective in enhancing adherence to recommended medication in patients
with established arterial occlusive events. Copyright © 2015 The
Cochrane Collaboration.

<111>
Accession Number
620549224
Title
Concomitant atrial fibrillation surgery for people undergoing cardiac
surgery.
Source
Cochrane Database of Systematic Reviews. 2015(8) (no pagination), 2015.
Article Number: CD011814. Date of Publication: 14 Aug 2015.
Author
Huffman M.D.; Karmali K.N.; Berendsen M.A.; Andrei A.-C.; Kruse J.;
Mccarthy P.M.; Malaisrie S.C.
Institution
(Huffman, Karmali) Northwestern University Feinberg School of Medicine,
Departments of Preventive Medicine and Medicine (Cardiology), 680 N. Lake
Shore Drive, Suite 1400, Chicago, IL 60611, United States
(Berendsen) Northwestern University, Galter Health Sciences Library, 303
E. Chicago Avenue, Chicago, IL 60611, United States
(Andrei) Northwestern University, Department of Surgery, 676 N.Saint Clair
St., Suite 1700, Chicago, IL 60611, United States
(Kruse) Northwestern Medicine, Bluhm Cardiovascular Institute, 201 East
Huron, Galter 11-140, Chicago, IL 60611, United States
(Mccarthy, Malaisrie) Northwestern University, Division of Cardiac
Surgery, 201 E. Huron Street, Galter 11-140, Chicago, IL 60611, United
States
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: To assess the effects of concomitant atrial fibrillation
surgery among people with atrial fibrillation who are undergoing cardiac
surgery on long-term (12 months or greater) health-related outcomes,
health-related quality of life, and costs. Copyright © 2015 The
Cochrane Collaboration.

<112>
Accession Number
620549121
Title
Preoperative statin therapy for patients undergoing cardiac surgery.
Source
Cochrane Database of Systematic Reviews. 2015(8) (no pagination), 2015.
Article Number: CD008493. Date of Publication: 13 Aug 2015.
Author
Kuhn E.W.; Slottosch I.; Wahlers T.; Liakopoulos O.J.
Institution
(Kuhn, Slottosch, Wahlers, Liakopoulos) Heart Center, University of
Cologne, Department of Cardiothoracic Surgery, Kerpener Strasse 62,
Cologne 50924, Germany
Publisher
John Wiley and Sons Ltd
Abstract
Background: Patients referred to cardiac surgery for cardiovascular
disease are at significant risk for the development of major postoperative
adverse events despite significant advances in surgical techniques and
perioperative care. Statins (5-hydroxy-3-methylglutaryl-co-enzyme A
(HMG-CoA) reductase inhibitors) have gained a pivotal role in the primary
and secondary prevention of coronary artery disease and are thought to
improve perioperative outcomes in patients undergoing cardiac surgery.
This review is an updated version of a review that was first published in
2012. Objective(s): To determine the effectiveness of preoperative
statin therapy in patients undergoing cardiac surgery. Search
Method(s): We searched the Cochrane Central Register of Controlled Trials
(CENTRAL) (2013, Issue 11), MEDLINE (1950 to November 2013 Week 3), EMBASE
(1980 to 3 December 2013 (Week 48)) and the metaRegister of Controlled
Trials. Additionally, we searched ongoing trials through the National
Research Register, the ClinicalTrials.gov registry and grey literature. We
screened online conference indices from relevant scientific meetings (2006
to 2014) to look for eligible trials. We applied no language restrictions.
 Selection Criteria: All randomised controlled trials comparing any
statin treatment before cardiac surgery, for any given duration and dose,
versus no preoperative statin therapy (standard of care) or placebo.
 Data Collection and Analysis: Two review authors evaluated trial
quality and extracted data from titles and abstracts identified by
electronic database searches according to predefined criteria.
Accordingly, we retrieved full-text articles of potentially relevant
studies that met the inclusion criteria to assess definitive eligibility
for inclusion. We reported effect measures as odds ratios (ORs) or
weighted mean differences (WMDs) with 95% confidence intervals (95% CIs).
 Main Result(s): We identified 17 randomised controlled studies
including a total of 2138 participants undergoing on-pump or off-pump
cardiac surgical procedures, and added to this review six studies with
1154 additional participants. Pooled analysis showed that statin treatment
before surgery reduced the incidence of postoperative atrial fibrillation
(AF) (OR 0.54, 95% CI 0.43 to 0.67; P value < 0.01; 12 studies, 1765
participants) but failed to influence short-term mortality (OR 1.80, 95%
CI 0.38 to 8.54; P value = 0.46; two studies, 300 participants) or
postoperative stroke (OR 0.70, 95% CI 0.14 to 3.63; P value = 0.67; two
studies, 264 participants). In addition, statin therapy was associated
with a shorter stay for patients on the intensive care unit (ICU) (WMD
-3.19 hours, 95% CI -5.41 to -0.98; nine studies, 721 participants) and in
the hospital (WMD -0.48 days, 95% CI -0.78 to -0.19; 11 studies, 1137
participants) when significant heterogeneity was observed. Results showed
no reduction in myocardial infarction (OR 0.48, 95% CI 0.21 to 1.13; seven
studies, 901 participants) or renal failure (OR 0.57, 95% CI 0.30 to 1.10;
five studies, 467 participants) and were not affected by subgroup
analysis. Trials investigating this safety endpoint reported no major or
minor perioperative side effects of statins. Authors' conclusions:
Preoperative statin therapy reduces the odds of postoperative atrial
fibrillation (AF) and shortens the patient's stay on the ICU and in the
hospital. Statin pretreatment had no influence on perioperative mortality,
stroke, myocardial infarction or renal failure, but only two of all
included studies assessed mortality. As analysed studies included mainly
individuals undergoing myocardial revascularisation, results cannot be
extrapolated to patients undergoing other cardiac procedures such as heart
valve or aortic surgery. Copyright © 2015 The Cochrane
Collaboration.

<113>
Accession Number
620645096
Title
Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or
low-birth-weight infants.
Source
Cochrane Database of Systematic Reviews. 2015(3) (no pagination), 2015.
Article Number: CD010061. Date of Publication: 11 Mar 2015.
Author
Ohlsson A.; Shah P.S.
Institution
(Ohlsson) University of Toronto, Departments of Paediatrics, Obstetrics
and Gynaecology and Institute of Health Policy, Management and Evaluation,
600 University Avenue, Toronto, ON M5G 1X5, Canada
(Shah) University of Toronto Mount Sinai Hospital, Department of
Paediatrics and Health Policy, Management and Evaluation, 600 University
Avenue, Toronto, ON M5G 1XB, Canada
Publisher
John Wiley and Sons Ltd
Abstract
Background: In preterm newborns, the ductus arteriosus frequently fails to
close and the infants require medical or surgical closure of the patent
ductus arteriosus (PDA). A PDA can be treated surgically or medically with
one of two prostaglandin inhibitors, indomethacin or ibuprofen. Case
reports suggest that paracetamol may be an alternative for the closure of
a PDA. Concerns have been raised that in neonatal mice paracetamol may
cause adverse effects on the developing brain, and an association between
prenatal exposure to paracetamol and later development of autism or autism
spectrum disorder has been reported. Objective(s): To determine the
efficacy and safety of intravenous or oral paracetamol compared with
placebo or no intervention, intravenous indomethacin, intravenous or oral
ibuprofen, or with other cyclo-oxygenase inhibitors for closure of a PDA
in preterm or low-birth-weight infants. Search Method(s): We used the
standard search strategy of the Cochrane Neonatal Review Group. This
included electronic searches of the Cochrane Central Register of
Controlled Trials (CENTRAL, Cochrane Library), MEDLINE, EMBASE and CINAHL.
We searched abstracts from the meetings of the Pediatric Academic
Societies and the Perinatal Society of Australia and New Zealand. We
searched clinicaltrials.gov; controlled-trials.com; anzctr.org.au; World
Health Organization International Clinical Trials Registry Platform at
who.int/ictrp for ongoing trials and the Web of Science for articles
quoting identified randomised controlled trials. We searched the first 200
hits on Google ScholarTM to identify grey literature. All
searches were conducted in December 2013. A repeat search of MEDLINE in
August 2014 did not identify any new trials. Selection Criteria: We
identified two randomised controlled trials (RCTs) that compared oral
paracetamol to oral ibuprofen for the treatment of an
echocardiographically diagnosed PDA in infants born preterm ( 34 weeks
postmenstrual age (PMA)). Data Collection and Analysis: We performed
data collection and analyses in accordance with the methods of the
Cochrane Neonatal Review Group. Main Result(s): Two unmasked studies
of treatment of PDA that enrolled 250 infants were included. The sequence
of randomisation and the allocation to treatment groups were concealed in
both studies. In one study the cardiologist assessing PDA closure was
blinded to group allocation of the infant. In the other study it was not
stated if that was the case or not. The quality of the trials, using
GRADE, was low for the primary outcome of PDA closure and moderate for all
other important outcomes. There was no significant difference between
treatment with oral paracetamol versus oral ibuprofen for failure of
ductal closure after the first course of drug administration (typical
relative risk (RR) 0.90, 95% confidence interval (CI) 0.67 to 1.22;
typical risk difference (RD) -0.04, 95% CI -0.16 to 0.08; I2 =
0 % for RR and 23% for RD). There were no significant differences between
the paracetamol and the ibuprofen groups in the secondary outcomes except
for 'duration for need of supplemental oxygen' (mean difference -12 days,
95% CI -23 days to -2 days; 1 study, n = 90) and for hyperbilirubinaemia
(RR 0.57, 95% CI 0.34 to 0.97; RD -0.15, 95% CI -0.29 to -0.01; number
needed to treat to benefit (NNTB) 7, 95% CI 3 to 100 in favour of
paracetamol; 1 study, n = 160). Authors' conclusions: Although a limited
number of infants with a PDA have been studied in randomised trials of low
to moderate quality according to GRADE, oral paracetamol appears to be as
effective in closing a PDA as oral ibuprofen. In view of a recent report
in mice of adverse effects on the developing brain from paracetamol, and
another report of an association between prenatal paracetamol and the
development of autism or autism spectrum disorder in childhood, long-term
follow-up to at least 18 to 24 months postnatal age must be incorporated
in any studies of paracetamol in the newborn population. Such trials are
required before any recommendations for the use of paracetamol in the
newborn population can be made. Copyright © 2015 The Cochrane
Collaboration.

<114>
Accession Number
620561249
Title
Tong-xin-luo capsule for patients with coronary heart disease after
percutaneous coronary intervention.
Source
Cochrane Database of Systematic Reviews. 2015(5) (no pagination), 2015.
Article Number: CD010237. Date of Publication: 21 May 2015.
Author
Mao C.; Fu X.-H.; Yuan J.-Q.; Yang Z.-Y.; Chung V.C.; Qin Y.; Huang Y.;
Tam W.W.S.; Kwong J.S.; Xie W.; Tang J.-L.
Institution
(Mao, Yang, Tang) The Chinese University of Hong Kong, Division of
Epidemiology, The Jockey Club School of Public Health and Primary Care,
Hong Kong SAR, Hong Kong
(Fu, Yuan, Qin, Huang) The Chinese University of Hong Kong, Division of
Epidemiology, School of Public Health and Primary Care, Shatin, Hong Kong,
New Territories, Hong Kong
(Chung) Chinese University of Hong Kong, Jockey Club School of Public
Health and Primary Care, Prince of Wales Hospital, Shatin, NT, Hong Kong,
SAR, Hong Kong
(Tam) National University of Singapore, Alice Lee Centre for Nursing
Studies, Yong Loo Lin School of Medicine, Singapore, Singapore
(Kwong) West China Hospital, Sichuan University, Chinese Cochrane Center,
Chinese Evidence-Based Medicine Center, No. 37, Guo Xue Xiang, Chengdu,
Sichuan 610041, China
(Xie) School of Chinese Medicine, Southern Medical University, Chinese
Medicine, No. 1838 Guangzhou Main North Road, Guangzhou, Guangdong 510515,
China
Publisher
John Wiley and Sons Ltd
Abstract
Background: Percutaneous coronary intervention (PCI) is a standard
treatment for coronary heart disease (CHD). Restenosis, defined as a 50%
reduction in luminal diameter at six months after PCI, indicates a need
for revascularisation. Restenosis has proven to be a major drawback to
PCI. Tong-xin-luo is one of the prophylactic strategies for cardiovascular
events in patients after PCI that is widely used in China, but its
efficacy and safety have not been systematically evaluated.
 Objective(s): To systematically assess the efficacy and safety of
Tong-xin-luo capsules in preventing cardiovascular events after PCI in
patients with CHD. Search Method(s): We searched the Cochrane Central
Register of Controlled Trials in The Cochrane Library, MEDLINE (OVID),
EMBASE (OVID), WanFang, Chinese Biomedical Database, Chinese Medical
Current Contents, and China National Knowledge Infrastructure from their
inception to June 2014. We also searched other resources, including
ongoing trials and research registries. We applied no language
restrictions. Selection Criteria: Randomised controlled trials of
participants with CHD after PCI were included. Participants in the
intervention group received Tong-xin-luo capsules for at least three
months. Data Collection and Analysis: Two review authors
independently extracted data and assessed the risk of bias. Any
disagreements were resolved by discussion with a third review author. The
primary outcomes included occurrence of angiographic restenosis and
adverse events; the secondary outcomes included myocardial infarction,
heart failure, angina, all cause mortality, mortality due to any
cardiovascular event, use of revascularisation, patient acceptability,
quality of life and cost-effectiveness. Dichotomous data were measured
with risk ratios (RRs) with 95% confidence intervals (CIs). Main
Result(s): Sixteen studies involving 1063 participants were identified.
The risk of bias for fifteen studies was high and along with imprecision
and possible publication bias, this lowered our confidence in the results.
There was low quality evidence that Tong-xi-luo reduced the rates of
angiographic restenosis (RR 0.16, 95% CI 0.07 to 0.34), myocardial
infarction (RR 0.32, 95% CI 0.16 to 0.66), heart failure (RR 0.26, 95% CI
0.11 to 0.62), and use of revascularisation (RR 0.26, 95% CI 0.15 to
0.45). There was very low quality evidence for the effect of Tong-xin-luo
on all-cause mortality (RR 0.38, 95% CI 0.06 to 2.56), angina (RR 0.24,
95% CI 0.17 to 0.34) and death due to any cardiovascular event (RR 0.31,
95% CI 0.08 to 1.12). Adverse events were seldom reported, and included
gastrointestinal reactions and nausea. Authors' conclusions: The addition
of Tong-xin-luo to conventional Western medicine may possibly prevent
restenosis and recurrence of cardiovascular events in patients with CHD
after PCI. However, the data are limited by publication bias and high risk
of bias for included studies. Further high-quality trials are required to
evaluate the potential effects of this intervention. Copyright ©
2015 The Cochrane Collaboration.

<115>
Accession Number
620563221
Title
Yoga for secondary prevention of coronary heart disease.
Source
Cochrane Database of Systematic Reviews. 2015(7) (no pagination), 2015.
Article Number: CD009506. Date of Publication: 01 Jul 2015.
Author
Kwong J.S.W.; Lau H.L.C.; Yeung F.; Chau P.H.
Institution
(Kwong) West China Hospital, Sichuan University, Chinese Cochrane Center,
Chinese Evidence-Based Medicine Center, No. 37, Guo Xue Xiang, Chengdu,
Sichuan 610041, China
(Lau) Room 2004, 20/F, Block J, Kam Yiu House, Kam Ying Court, Ma On Shan,
Shatin, N.T., Hong Kong
(Yeung) The Chinese University of Hong Kong, Department of Medicine and
Therapeutics, Shatin Hospital, M and G, 8/F, 33A Kung Kok Street, Ma On
Shan, Shatin, New Territories, Hong Kong
(Chau) The University of Hong Kong, School of Nursing, Li Ka Shing Faculty
of Medicine, 4/F, William M.W. Mong Block, 21 Sassoon Road, Pokfulam, Hong
Kong
Publisher
John Wiley and Sons Ltd
Abstract
Background: Coronary heart disease (CHD) is the major cause of early
morbidity and mortality in most developed countries. Secondary prevention
aims to prevent repeat cardiac events and death in people with established
CHD. Lifestyle modifications play an important role in secondary
prevention. Yoga has been regarded as a type of physical activity as well
as a stress management strategy. Growing evidence suggests the beneficial
effects of yoga on various ailments. Objective(s): To determine the
effectiveness of yoga for the secondary prevention of mortality and
morbidity in, and on the health-related quality of life of, individuals
with CHD. Search Method(s): This is an update of a review previously
published in 2012. For this updated review, we searched the Cochrane
Central Register of Controlled Trials (CENTRAL) in The Cochrane Library
(Issue 1 of 12, 2014), MEDLINE (1948 to February week 1 2014), EMBASE
(1980 to 2014 week 6), Web of Science (Thomson Reuters, 1970 to 12
February 2014), China Journal Net (1994 to May 2014), WanFang Data (1990
to May 2014), and Index to Chinese Periodicals of Hong Kong (HKInChiP)
(from 1980). Ongoing studies were identified in the metaRegister of
Controlled Trials (May 2014) and the World Health Organization
International Clinical Trials Registry Platform (May 2014). We applied no
language restrictions. Selection Criteria: We planned to include
randomised controlled trials (RCTs) investigating the influence of yoga
practice on CHD outcomes in men and women (aged 18 years and over) with a
diagnosis of acute or chronic CHD. Studies were eligible for inclusion if
they had a follow-up duration of six months or more. We considered studies
that compared one group practicing a type of yoga with a control group
receiving either no intervention or interventions other than yoga.
 Data Collection and Analysis: Two authors independently selected
studies according to prespecified inclusion criteria. We resolved
disagreements either by consensus or by discussion with a third author.
 Main Result(s): We found no eligible RCTs that met the inclusion
criteria of the review and thus we were unable to perform a meta-analysis.
Authors' conclusions: The effectiveness of yoga for secondary prevention
in CHD remains uncertain. Large RCTs of high quality are
needed. Copyright © 2015 The Cochrane Collaboration.

<116>
Accession Number
620563204
Title
Fresh frozen plasma for cardiovascular surgery.
Source
Cochrane Database of Systematic Reviews. 2015(7) (no pagination), 2015.
Article Number: CD007614. Date of Publication: 14 Jul 2015.
Author
Desborough M.; Sandu R.; Brunskill S.J.; Doree C.; Trivella M.; Montedori
A.; Abraha I.; Stanworth S.
Institution
(Desborough) NHS Blood and Transplant, Haematology/Transfusion Medicine,
Oxford, United Kingdom
(Sandu) The Liverpool Heart and Chest Hospital, Department of Anaesthesia,
13 Allerton Rd, Liverpool L18 1LY, United Kingdom
(Brunskill, Doree) NHS Blood and Transplant, Systematic Review Initiative,
Level 2, John Radcliffe Hospital, Headington, Oxford, Oxon OX3 9BQ, United
Kingdom
(Trivella) University of Oxford, Centre for Statistics in Medicine, Botnar
Research Centre, Windmill Road, Oxford OX3 7LD, United Kingdom
(Montedori) Regional Health Authority of Umbria, Health Planning Service,
Via Mario Angeloni 61, Perugia, Umbria 06124, Italy
(Abraha) Azienda Ospedaliera di Perugia, Servizio Immunotrasfusionale,
Perugia, Italy
(Stanworth) Oxford University Hospitals and the University of Oxford,
National Institute for Health Research (NIHR), Oxford Biomedical Research
Centre, Oxford OX3 9BQ, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Fresh frozen plasma (FFP) is a blood component containing
procoagulant factors, which is sometimes used in cardiovascular surgery
with the aim of reducing the risk of bleeding. The purpose of this review
is to assess the risk of mortality for patients undergoing cardiovascular
surgery who receive FFP. Objective(s): To evaluate the risk to
benefit ratio of FFP transfusion in cardiovascular surgery for the
treatment of bleeding patients or for prophylaxis against bleeding.
 Search Method(s): We searched 11 bibliographic databases and four
ongoing trials databases including the Cochrane Central Register of
Controlled Trials (CENTRAL, Issue 3, 2015), MEDLINE (OvidSP, 1946 to 21
April 2015), EMBASE (OvidSP, 1974 to 21 April 2015), PubMed
(e-publications only: searched 21 April 2015), ClinicalTrials.gov, World
Health Organization (WHO) ICTRP and the ISRCTN Register (searched 21 April
2015). We also searched the references of all identified trials and
relevant review articles. We did not limit the searches by language or
publication status. Selection Criteria: We included randomised
controlled trials in patients undergoing major cardiac or vascular surgery
who were allocated to a FFP group or a comparator (no plasma or an active
comparator, either clinical plasma (any type) or a plasma-derived blood
product). We included participants of any age (neonates, children and
adults). We excluded studies of plasmapheresis and plasma exchange.
 Data Collection and Analysis: Two authors screened all electronically
derived citations and abstracts of papers identified by the review search
strategy. Two authors assessed risk of bias in the included studies and
extracted data independently. We took care to note whether FFP was used
therapeutically or prophylactically within each trial. Main
Result(s): We included 15 trials, with a total of 755 participants for
analysis in the review. Fourteen trials compared prophylactic use of FFP
against no FFP. One study compared therapeutic use of two types of plasma.
The timing of intervention varied, including FFP transfusion at the time
of heparin neutralisation and stopping cardiopulmonary bypass (CPB) (seven
trials), with CPB priming (four trials), after anaesthesia induction (one
trial) and postoperatively (two trials). Twelve trials excluded patients
having emergency surgery and nine excluded patients with coagulopathies.
Overall the trials were small, with only four reporting an a priori sample
size calculation. No trial was powered to determine changes in mortality
as a primary outcome. There was either high risk of bias, or unclear risk,
in the majority of trials included in this review. There was no difference
in the number of deaths between the intervention arms in the six trials
(with 287 patients) reporting mortality (very low quality evidence). There
was also no difference in blood loss in the first 24 hours for
neonatal/paediatric patients (four trials with 138 patients; low quality
evidence): mean difference (MD) -1.46 ml/kg (95% confidence interval (CI)
-4.7 to 1.78 ml/kg); or adult patients (one trial with 120 patients): MD
-12.00 ml (95% CI -101.16 to 77.16 ml). Transfusion with FFP was inferior
to control for preventing patients receiving any red cell transfusion:
Peto odds ratio (OR) 2.57 (95% CI 1.30 to 5.08; moderate quality
evidence). There was a difference in prothrombin time within two hours of
FFP transfusion in eight trials (with 210 patients; moderate quality
evidence) favouring the FFP arm: MD -0.71 seconds (95% CI -1.28 to -0.13
seconds). There was no difference in the risk of returning to theatre for
reoperation (eight trials with 398 patients; moderate quality evidence):
Peto OR 0.81 (95% CI 0.26 to 2.57). Only one included study reported
adverse events as an outcome and reported no significant adverse events
following FFP transfusion. Authors' conclusions: This review has found no
evidence to support the prophylactic administration of FFP to patients
without coagulopathy undergoing elective cardiac surgery. There was
insufficient evidence about treatment of patients with coagulopathies or
those who are undergoing emergency surgery. There were no reported adverse
events attributable to FFP transfusion, although there was a significant
increase in the number of patients requiring red cell transfusion who were
randomised to FFP. Variability in outcome reporting between trials
precluded meta-analysis for many outcomes across all trials, and there was
evidence of a high risk of bias in most of the studies. Further adequately
powered studies of FFP, or comparable pro-haemostatic agents, are required
to assess whether larger reductions in prothrombin time translate into
clinical benefits. Overall the evidence from randomised controlled trials
for the safety and efficacy of prophylactic transfusion of FFP for cardiac
surgery is insufficient. Copyright © 2015 The Cochrane
Collaboration.

<117>
Accession Number
620563189
Title
Hyperbaric oxygen therapy for acute coronary syndrome.
Source
Cochrane Database of Systematic Reviews. 2015(7) (no pagination), 2015.
Article Number: CD004818. Date of Publication: 23 Jul 2015.
Author
Bennett M.H.; Lehm J.P.; Jepson N.
Institution
(Bennett) Prince of Wales Clinical School, University of NSW, Department
of Anaesthesia, Sydney, NSW, Australia
(Lehm) Prince of Wales Hospital, Department of Diving and Hyperbaric
Medicine, Barker St., Randwick, NSW 2031, Australia
(Jepson) Prince of Wales Hospital, Randwick, NSW, Australia
Publisher
John Wiley and Sons Ltd
Abstract
Background: Acute coronary syndrome (ACS), includes acute myocardial
infarction and unstable angina, is common and may prove fatal. Hyperbaric
oxygen therapy (HBOT) will improve oxygen supply to the threatened heart
and may reduce the volume of heart muscle that perishes. The addition of
HBOT to standard treatment may reduce death rate and other major adverse
outcomes. This an update of a review previously published in May 2004 and
June 2010. Objective(s): The aim of this review was to assess the
evidence for the effects of adjunctive HBOT in the treatment of ACS. We
compared treatment regimens including adjunctive HBOT against similar
regimens excluding HBOT. Where regimens differed significantly between
studies this is clearly stated and the implications discussed. All
comparisons were made using an intention to treat analysis where this was
possible. Efficacy was estimated from randomised trial comparisons but no
attempt was made to evaluate the likely effectiveness that might be
achieved in routine clinical practice. Specifically, we addressed: Does
the adjunctive administration of HBOT to people with acute coronary
syndrome (unstable angina or infarction) result in a reduction in the risk
of death? Does the adjunctive administration of HBOT to people with acute
coronary syndrome result in a reduction in the risk of major adverse
cardiac events (MACE), that is: cardiac death, myocardial infarction, and
target vessel revascularization by operative or percutaneous intervention?
Is the administration of HBOT safe in both the short and long term? Search
methods: We updated the search of the following sources in September 2014,
but found no additional relevant citations since the previous search in
June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant
journals were handsearched and researchers in the field contacted. We
applied no language restrictions. Selection Criteria: Randomised
studies comparing the effect on ACS of regimens that include HBOT with
those that exclude HBOT. Data Collection and Analysis: Three authors
independently evaluated the quality of trials using the guidelines of the
Cochrane Handbook and extracted data from included trials. Binary outcomes
were analysed using risk ratios (RR) and continuous outcomes using the
mean difference (MD) and both are presented with 95% confidence intervals.
We assessed the quality of the evidence using the GRADE approach.
 Main Result(s): No new trials were located in our most recent search
in September 2014. Six trials with 665 participants contributed to this
review. These trials were small and subject to potential bias. Only two
reported randomisation procedures in detail and in only one trial was
allocation concealed. While only modest numbers of participants were lost
to follow-up, in general there is little information on the longer-term
outcome for participants. Patients with acute coronary syndrome allocated
to HBOT were associated with a reduction in the risk of death by around
42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low
quality evidence). In general, HBOT was well-tolerated. No patients were
reported as suffering neurological oxygen toxicity and only a single
patient was reported to have significant barotrauma to the tympanic
membrane. One trial suggested a significant incidence of claustrophobia in
single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95%
CI 1.92 to 521). Authors' conclusions: For people with ACS, there is some
evidence from small trials to suggest that HBOT is associated with a
reduction in the risk of death, the volume of damaged muscle, the risk of
MACE and time to relief from ischaemic pain. In view of the modest number
of patients, methodological shortcomings and poor reporting, this result
should be interpreted cautiously, and an appropriately powered trial of
high methodological rigour is justified to define those patients (if any)
who can be expected to derive most benefit from HBOT. The routine
application of HBOT to these patients cannot be justified from this
review. Copyright © 2015 The Cochrane Collaboration.

<118>
Accession Number
616517301
Title
Beta-adrenergic blockers for perioperative cardiac risk reduction in
people undergoing vascular surgery.
Source
Cochrane Database of Systematic Reviews. 2017(6) (no pagination), 2015.
Article Number: CD006342. Date of Publication: 14 Jan 2015.
Author
Mostafaie K.; Bedenis R.; Harrington D.
Institution
(Mostafaie) David Geffen School of Medicine at UCLA, Department of
Medicine, 1000 West Carson, Torrance, CA 92604, United States
(Bedenis) University of Edinburgh, Centre for Population Health Sciences,
Edinburgh EH8 9AG, United Kingdom
(Harrington) David Geffen School of Medicine at UCLA, Los Angeles, CA,
United States
Publisher
John Wiley and Sons Ltd
Abstract
Background: People undergoing major vascular surgery have an increased
risk of postoperative cardiac complications. Beta-adrenergic blockers
represent an important and established pharmacological intervention in the
prevention of cardiac complications in people with coronary artery
disease. It has been proposed that this class of drugs may reduce the risk
of perioperative cardiac complications in people undergoing major
non-cardiac vascular surgery. Objective(s): To review the efficacy
and safety of perioperative beta-adrenergic blockade in reducing cardiac
or all-cause mortality, myocardial infarction, and other cardiovascular
safety outcomes in people undergoing major non-cardiac vascular surgery.
 Search Method(s): The Cochrane Peripheral Vascular Diseases Group
Trials Search Co-ordinator searched the Specialised Register (January
2014) and the Cochrane Central Register of Controlled Trials (CENTRAL;
2013, Issue 12). We searched trials databases and checked reference lists
of relevant articles. Selection Criteria: We included prospective,
randomised controlled trials of perioperative beta-adrenergic blockade of
people over 18 years of age undergoing non-cardiac vascular surgery.
 Data Collection and Analysis: Two review authors independently
performed study selection and data extraction. We resolved disagreements
through discussion. We performed meta-analysis using a fixed-effect model
with odds ratios (ORs) and 95% confidence intervals (CIs). Main
Result(s): We included two studies in this review, both of which were
double-blind, randomised controlled trials comparing perioperative
beta-adrenergic blockade (metoprolol) with placebo, on cardiovascular
outcomes in people undergoing major non-cardiac vascular surgery. We
included 599 participants receiving beta-adrenergic blockers (301
participants) or placebo (298 participants). The overall quality of
studies was good. However, one study did not report random sequence
generation or allocation concealment techniques, indicating possible
selection bias, and the other study did not report outcome assessor
blinding and was possibly underpowered. It should be noted that several of
the outcomes were only reported in a single study and neither of the
studies reported on vascular patency/graft occlusion, which reduces the
quality of evidence to moderate. There was no evidence that perioperative
beta-adrenergic blockade reduced all-cause mortality (OR 0.62, 95% CI 0.03
to 15.02), cardiovascular mortality (OR 0.34, 95% CI 0.01 to 8.32),
non-fatal myocardial infarction (OR 0.83, 95% CI 0.46 to 1.49; P value =
0.53), arrhythmia (OR 0.70, 95% CI 0.26 to 1.88), heart failure (OR 1.71,
95% CI 0.40 to 7.23), stroke (OR 2.67, 95% CI 0.11 to 67.08), composite
cardiovascular events (OR 0.87, 95% CI 0.55 to 1.39; P value = 0.57) or
re-hospitalisation at 30 days (OR 0.86, 95% CI 0.48 to 1.52). However,
there was strong evidence that beta-adrenergic blockers increased the odds
of intra-operative bradycardia (OR 4.97, 95% CI 3.22 to 7.65; P value <
0.00001) and intra-operative hypotension (OR 1.84, 95% CI 1.31 to 2.59; P
value = 0.0005). Authors' conclusions: This meta-analysis currently offers
no clear evidence that perioperative beta-adrenergic blockade reduces
postoperative cardiac morbidity and mortality in people undergoing major
non-cardiac vascular surgery. There is evidence that intra-operative
bradycardia and hypotension are more likely in people taking perioperative
beta-adrenergic blockers, which should be weighed with any
benefit. Copyright © 2015 The Cochrane Collaboration. Published
by John Wiley & Sons, Ltd.

<119>
Accession Number
620561940
Title
Remote ischaemic preconditioning for coronary artery bypass grafting.
Source
Cochrane Database of Systematic Reviews. 2015(11) (no pagination), 2015.
Article Number: CD011719. Date of Publication: 22 Nov 2015.
Author
Benstoem C.; Stoppe C.; Liakopoulos O.J.; Meybohm P.; Clayton T.C.; Yellon
D.M.; Hausenloy D.J.; Goetzenich A.
Institution
(Benstoem, Goetzenich) University Hospital Aachen, Department of
Cardiothoracic Surgery, Pauwelsstrasse 30, Aachen, North Rhine Westphalia
52074, Germany
(Stoppe) University Hospital Aachen, Department of Anesthesiology,
Pauwelsstrasse 30, Aachen, North Rhine Westphalia 52074, Germany
(Liakopoulos) Heart Center, University of Cologne, Department of
Cardiothoracic Surgery, Kerpener Str. 62, Cologne 50937, Germany
(Meybohm) University Hospital Frankfurt, Department of Anesthesiology,
Intensive Care and Pain Medicine, Theodor-Stern-Kai 7, Frankfurt am Main
60590, Germany
(Clayton) London School of Hygiene and Tropical Medicine, Department of
Medical Statistics, Keppel Street, London WC1E 7HT, United Kingdom
(Yellon) University College London Hospital and Medical School, Department
of Medicine, 67 Chenies Mews, London WC1E 6HX, United Kingdom
(Hausenloy) University College London, The Hatter Cardiovascular
Institute, 67 Chenies Mews, London WC1E 6HX, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: To assess the benefits and harms of remote ischaemic
preconditioning in patients undergoing coronary artery bypass grafting,
with or without valve surgery. Copyright © 2015 The Cochrane
Collaboration.

<120>
Accession Number
620561076
Title
Surgery for deep venous incompetence.
Source
Cochrane Database of Systematic Reviews. 2015(2) (no pagination), 2015.
Article Number: CD001097. Date of Publication: 23 Feb 2015.
Author
Goel R.R.; Abidia A.; Hardy S.C.
Institution
(Goel) East Lancashire Hospitals NHS Trust, Royal Blackburn Hospital
(Trust HQ), Vascular Surgery, Haslingden Road, Blackburn BB2 3HH, United
Kingdom
(Abidia) The Princess Alexandra Hospital, Department of Surgery, Hamstel
Road, Harlow, Essex CM20 1QX, United Kingdom
(Hardy) Blackburn Royal Infirmary, Department of Surgery, Bolton Road,
Blackburn BB2 3LR, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Chronic deep venous incompetence (DVI) is caused by
incompetent vein valves and/or blockage of large-calibre leg veins and
causes a range of symptoms including recurrent ulcers, pain and swelling.
Most surgeons accept that well-fitted graduated compression stockings
(GCS) and local care of wounds serve as adequate treatment for most
patients, but sometimes symptoms are not controlled and ulcers recur
frequently, or they do not heal despite compliance with conservative
measures. In these situations, in the presence of severe venous
dysfunction, surgery has been advocated by some vascular surgeons. This is
an update of the review first published in 2000. Objective(s): To
assess the effects of surgical management of deep venous incompetence in
terms of ulcer healing, ulcer recurrence and alleviation of symptoms.
 Search Method(s): For this update, the Cochrane Peripheral Vascular
Diseases Group Trials Search Co-ordinator searched the Specialised
Register (last searched October 2014) and the Cochrane Central Register of
Controlled Trials (CENTRAL) (2014, Issue 9). Selection Criteria:
Randomised controlled trials of surgical treatment for patients with DVI.
 Data Collection and Analysis: For this update, two review authors
(RRG and SCH) extracted data independently. All included studies required
full risk of bias assessment in line with current procedures of The
Cochrane Collaboration. Two review authors (RRG and SCH) independently
assessed risk of bias and consulted with a third review author (AA) when
necessary. Main Result(s): Four studies with 273 participants were
included. All included studies reported clinical outcomes following
valvuloplasty. We found no studies investigating other surgical procedures
for the treatment of patients with DVI. All included studies investigated
primary valve incompetence. We found no trials that investigated the
results of surgery for secondary valvular incompetence or the obstructive
form of DVI. Because different outcome measures were used, it was not
possible to pool the results of included studies. The methodological
quality of the included studies was low, mainly because information
regarding randomisation and blinding was missing, or because data were
incomplete or were presented poorly. Ulcer healing and ulcer recurrence
were not reported in one study, and the remaining three studies did not
include participants with ulcers or with active ulceration. Three studies
reported no significant complications of surgery and no incidence of DVT
during follow-up. One study did not report on the occurrence of
complications. Clinical changes were assessed by subjective and objective
measurements, as specified in the clinical, aetiological, anatomical, and
pathophysiological (CEAP) classification score. This requires vascular
laboratory measurements of lower limb haemodynamics before and after
surgery. Tests include an overall evaluation of venous function with
venous refilling time (VRT) or ambulatory venous pressure (AVP). Two small
trials comparing external valvuloplasty using limited anterior plication
in combination with ligation of incompetent superficial veins against
ligation alone (L) showed that ligation plus limited anterior plication
produced significant improvement in AVP: The mean difference was -15 mm Hg
(95% confidence interval (CI) -20.9 to -9.0) at one year and -15 mm Hg
(95% CI -21 to -8.9) at two years. Sustainable statistically significant
improvement in AVP and VRT was achieved by ligation and limited anterior
plication at 10 years in one study. However, AVP values after surgery
remained relatively high, causing its benefit to be questioned. Similarly,
another study including participants who were deteriorating preoperatively
showed sustained mild clinical improvement for seven years in those
subjected to valvuloplasty compared with participants undergoing
superficial venous surgery alone. However, this benefit was lost when the
condition of participants was stable preoperatively. One small study (n =
40) with grade 3 reflux and no participants with ulcers reported that
external valvuloplasty of the femoral vein combined with surgical repair
of the superficial venous system improved the haemodynamic status of the
lower limbs, restored valvular function more effectively and achieved
better outcomes than surgical repair of the superficial venous system
alone. Authors' conclusions: No evidence was found for benefit or harm of
valvuloplasty in the treatment of patients with DVI secondary to primary
valvular incompetence. The individual trials included in this review were
small; they used different methods of assessment and overall were of poor
quality. They did not include participants with severe DVI. Trials
investigating the effects of other surgical procedures on deep veins are
needed. Until the findings of such trials become available, the benefit of
valvuloplasty remains uncertain. Copyright © 2015 The Cochrane
Collaboration.

<121>
Accession Number
620562384
Title
Paracetamol (acetaminophen) for prevention or treatment of pain in
newborns.
Source
Cochrane Database of Systematic Reviews. 2015(6) (no pagination), 2015.
Article Number: CD011219. Date of Publication: 25 Jun 2015.
Author
Ohlsson A.; Shah P.S.
Institution
(Ohlsson) University of Toronto, Departments of Paediatrics, Obstetrics
and Gynaecology, Institute of Health Policy, Management and Evaluation,
600 University Avenue, Toronto, ON M5G 1X5, Canada
(Ohlsson) Mount Sinai Hospital, Department of Paediatrics, 600 University
Avenue, Toronto, ON M5G 1X5, Canada
(Shah) University of Toronto Mount Sinai Hospital, Department of
Paediatrics and Institute of Health Policy, Management and Evaluation, 600
University Avenue, Toronto, ON M5G 1XB, Canada
Publisher
John Wiley and Sons Ltd
Abstract
Background: Newborn infants have the ability to experience pain. Newborns
treated in neonatal intensive care units are exposed to numerous painful
procedures. Healthy newborns are exposed to pain if the birth process
consists of assisted vaginal birth by vacuum extraction or by forceps and
during blood sampling for newborn screening tests. Objective(s):
Primary objective To determine the efficacy and safety of paracetamol for
the prevention or treatment of procedural/postoperative pain or pain
associated with clinical conditions in neonates. Secondary objective To
review the effects of various doses and routes of administration (enteral,
intravenous or rectal) of paracetamol for the prevention or treatment of
pain in neonates. We designed the main comparisons according to intention
of use, that is, paracetamol for prevention or treatment of pain. We
included separate comparisons based on the painful
intervention/procedure/condition (heel lance, insertion of nasogastric
tube, insertion of intravenous catheter, lumbar puncture, assisted vaginal
birth, postoperative pain, birth trauma, congenital anomalies such as
myelomeningocoele and open cutaneous lesions) and the mode of
administration of paracetamol. Within these comparisons, we planned to
assess in subgroups (when possible) effects based on postmenstrual age
(PMA) at the birth of randomly assigned infants (< 28 weeks, 28 weeks to
31 + 6 weeks, 32 weeks to 36 + 6 weeks and >= 37 weeks) or based on birth
weight (or current weight) categories (<= 1000 grams, 1001 to 1500 grams,
1501 to 2500 grams and >= 2501 grams) Search methods: We used the standard
search strategy of the Cochrane Neonatal Review Group including electronic
searches of the Cochrane Central Register of Controlled Trials (CENTRAL)
(October 2014), MEDLINE (1966 to October 2014), EMBASE (1980 to October
2014) and the Cumulative Index to Nursing and Allied Health Literature
(CINAHL) (1982 to October 2014). We applied no language restrictions. We
conducted electronic searches of abstracts from meetings of the Pediatric
Academic Societies (2000 to 2014) and the Perinatal Society of Australia
and New Zealand (2010 to 2014). We searched clinical trial registries for
ongoing trials and the Web of Science for articles quoting identified
randomised controlled trials. We searched the first 200 hits on Google
ScholarTM to identify grey literature. Selection Criteria:
We included randomised and quasi-randomised controlled trials of
paracetamol for the prevention or treatment of pain in neonates (<= 30
days of age). Data Collection and Analysis: Two review authors
independently extracted data from the full-text articles using a
specifically designed form. We used this form to decide trial
inclusion/exclusion, to extract data from eligible trials and to request
additional published information from authors of the original reports. We
entered and cross-checked data using RevMan 5.3.3 software. When noted, we
resolved differences by mutual discussion and consensus. Main
Result(s): We included eight trials with low risk of bias, which assessed
paracetamol use for the treatment of pain in 614 infants. Painful
interventions studied included heel lance, assisted vaginal birth, eye
examination for ascertainment of retinopathy of prematurity (ROP) and
postoperative care following major surgery. Results of individual studies
could not be combined in meta-analyses as the painful conditions, the use
of paracetamol and comparison interventions and the outcome measures
differed. Paracetamol compared with water, cherry elixir or EMLA cream did
not significantly reduce pain following heel lance. The Premature Infant
Pain Profile score (PIPP) within three minutes following lancing was
higher in the paracetamol group than in the oral glucose group (mean
difference (MD) 2.21, 95% confidence interval (CI) 0.72 to 3.70; one
study, 38 infants). Paracetamol did not reduce "modified facies scores"
after assisted vaginal birth (one study, 119 infants). In another study (n
= 123), the Echelle de Douleur et d'Inconfort du Nouveau-Ne score at two
hours of age was significantly higher in the group that received
paracetamol suppositories than in the placebo suppositories group (MD
1.00, 95% CI 0.60 to 1.40). In that study, when infants were subjected to
a heel lance at two to three days of age, Bernese Pain Scale for Neonates
scores were higher in the paracetamol group than in the placebo group, and
infants spent a longer time crying (MD 19 seconds, 95% CI 14 to 24). For
eye examinations, no significant reduction in PIPP scores in the first or
last 45 seconds of eye examination was reported, nor at five minutes after
the eye examination. In one study (n = 81), the PIPP score was
significantly higher in the paracetamol group than in the 24% sucrose
group (MD 3.90, 95% CI 2.92 to 4.88). For postoperative care following
major thoracic or abdominal surgery, the total amount of morphine (mug/kg)
administered over 48 hours was significantly less among infants randomly
assigned to the paracetamol group than in those randomly assigned to the
morphine group (MD -157 mug/kg, 95% CI -27 to -288). No adverse events
were noted in any study. Authors' conclusions: Paracetamol does not
significantly reduce pain associated with heel lance or eye examinations.
Paracetamol given after assisted vaginal birth may increase the response
to later painful exposures. Paracetamol should not be used for painful
procedures given its lack of efficacy and its potential for adverse
effects. Paracetamol may reduce the total need for morphine following
major surgery, and for this aspect of paracetamol use, further research is
needed. Copyright © 2015 The Cochrane Collaboration.

<122>
Accession Number
620559963
Title
Antibiotic prophylaxis for preventing post solid organ transplant
tuberculosis.
Source
Cochrane Database of Systematic Reviews. 2014(3) (no pagination), 2014.
Article Number: CD008597. Date of Publication: 04 Mar 2014.
Author
Adamu B.; Abdu A.; Abba A.A.; Borodo M.M.; Tleyjeh I.M.
Institution
(Adamu, Abdu, Borodo) Aminu Kano Teaching Hospital, Department of
Medicine, No 1 Hospital Road, Kano PMB 3452, Nigeria
(Abba) King Saud University, Department of Medicine, Riyadh 11451, Saudi
Arabia
(Tleyjeh) King Fahad Medical City, Department of Medicine, Riyadh 11525,
Saudi Arabia
Publisher
John Wiley and Sons Ltd
Abstract
Background: Organ transplant recipients are at increased risk of infection
as a result of immunosuppression caused inadvertently by medical
treatment. Tuberculosis (TB) is a challenging infection to manage among
organ transplant recipients that can be transmitted from infected people
or triggered from latent infection. Organ transplant recipients have been
reported to be up to 300 times more likely to develop TB than the general
population. Consensus about the use of antibiotic prophylaxis to prevent
post solid organ transplant TB has not been achieved. Objective(s):
This review assessed the benefits and harms of antibiotic prophylaxis to
prevent post solid organ transplant TB. Search Method(s): We searched
the Cochrane Renal Group's Specialised Register up to 30 April 2013
through contact with the Trials' Search Co-ordinator using search terms
relevant to this review. Studies contained in the Specialised Register are
identified through search strategies specifically designed for CENTRAL,
MEDLINE and EMBASE and handsearching conference proceedings.
 Selection Criteria: All randomised controlled trials (RCTs) and
quasi-RCTs that compared antibiotic prophylaxis with a placebo or no
intervention for recipients of solid organ transplants were included.
 Data Collection and Analysis: Two authors independently assessed
studies for inclusion and extracted data. We derived risk ratios (RR) for
dichotomous data and mean differences (MD) for continuous data with 95%
confidence intervals (CI). Methodological risk of bias was assessed using
the Cochrane risk of bias tool. Main Result(s): We identified three
studies (10 reports) that involved 558 kidney transplant recipients which
met our inclusion criteria. All studies were conducted in countries that
have high prevalence of TB (India and Pakistan), and investigated
isoniazid, an oral antibacterial drug. Control in all studies was no
antibiotic prophylaxis. Prophylactic administration of isoniazid reduced
the risk of developing TB post-transplant (3 studies, RR 0.35 95% CI 0.14
to 0.89), and there was no significant effect on all-cause mortality (2
studies, RR 1.39, 95% CI 0.70 to 2.78). There was however substantial risk
of liver damage (3 studies, RR 2.74, 95% CI 1.22 to 6.17). Reporting of
methodological quality parameters was incomplete in all three studies.
Overall, risk of bias was assessed as suboptimal. Authors' conclusions:
Isoniazid prophylaxis for kidney transplant recipients reduced the risk of
developing TB post-transplant. Kidney transplant recipients in settings
that have high prevalence of TB should receive isoniazid during the first
year following transplant. There is however, significant risk of liver
damage, particularly among those who are hepatitis B or C positive.
Further studies are needed among recipients of other solid organ
transplants and in settings with low prevalence of TB to determine the
benefits and harms of anti-TB prophylaxis in those
populations. Copyright © 2014 The Cochrane Collaboration.

<123>
Accession Number
620559949
Title
Pulmonary perfusion versus no pulmonary perfusion during cardiopulmonary
bypass for cardiac surgery.
Source
Cochrane Database of Systematic Reviews. 2014(5) (no pagination), 2014.
Article Number: CD011098. Date of Publication: 01 May 2014.
Author
Buggeskov K.B.; Nielsen J.B.; Wetterslev J.
Institution
(Buggeskov) Copenhagen University Hospital, Rigshospitalet, Department of
Cardiothoracic Anaesthesiology, Blegdamsvej 9, Copenhagen 2100, Denmark
(Nielsen) Copenhagen University Hospital, Rigshospitalet, Department of
Cardiology, Juliane Maries Vej 20, Copenhagen 2100, Denmark
(Wetterslev) Rigshospitalet, Copenhagen University Hospital, Copenhagen
Trial Unit, Centre for Clinical Intervention Research, Department 7812,
Blegdamsvej 9, Copenhagen DK-2100, Denmark
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: To evaluate the efficacy and safety of single shot or
continuous pulmonary perfusion with either blood (oxygenated or
deoxygenated) or a solution used for perfusion and flushing of the organs
in the prevention of pulmonary related events following cardiopulmonary
bypass (CPB) dependent cardiac surgery. Copyright © 2014 The
Cochrane Collaboration.

<124>
Accession Number
620551512
Title
Totally percutaneous versus standard femoral artery access for elective
bifurcated abdominal endovascular aneurysm repair.
Source
Cochrane Database of Systematic Reviews. 2014(2) (no pagination), 2014.
Article Number: CD010185. Date of Publication: 27 Feb 2014.
Author
Jackson A.; Yeoh S.E.; Clarke M.
Institution
(Jackson) University of Edinburgh, Centre for Population Health Sciences,
Old Medical School, Teviot Place, Edinburgh EH8 9AG, United Kingdom
(Yeoh) University of Edinburgh, College of Medicine and Veterinary
Medicine, Edinburgh EH16 4TJ, United Kingdom
(Clarke) Freeman Hospital, Northern Vascular Centre, Freeman Road,
Newcastle upon Tyne NE7 7DN, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Abdominal aortic aneurysms (AAAs) are a vascular condition
with significant risk attached, particularly if they rupture. It is,
therefore, critical to identify and repair these as an elective procedure
before they rupture and require emergency surgery. Repair has
traditionally been an open surgical technique that required a large
incision across the abdomen. More recently endovascular aneurysm repairs
(EVARs) have become a common alternative. In this procedure, the common
femoral artery is exposed via a cut-down approach and a graft is
introduced to the aneurysm in this way. This review examines a totally
percutaneous approach to EVAR. This technique gives a minimally invasive
approach to femoral artery access that may reduce groin wound complication
rates and improve recovery time. The technique may, however, be less
applicable in patients with, for example, groin scarring or arterial
calcification. Objective(s): This review aims to compare the clinical
outcomes of percutaneous access with standard femoral artery access in
elective bifurcated abdominal endovascular aneurysm repair (EVAR).
 Search Method(s): The Cochrane Peripheral Vascular Diseases Group
Trials Search Co-ordinator searched their Specialised Register (last
searched July 2013), CENTRAL (2013, Issue 6) and clinical trials
databases. Reference lists of retrieved articles were checked.
 Selection Criteria: Only randomised controlled trials were
considered. The primary intervention was a totally percutaneous
endovascular repair. All device types were considered. This was compared
against standard femoral artery endovascular repair. Only studies
investigating elective repairs were considered. Studies reporting
emergency surgery for a ruptured abdominal aortic aneurysm (rAAA) and
those reporting aorto-uni-iliac repairs were excluded. Data
Collection and Analysis: All data were collected independently by two
review authors. Owing to the small number of trials identified, no formal
assessment of heterogeneity or sensitivity analysis was conducted.
 Main Result(s): Only one trial met the inclusion criteria, involving
a total of 30 participants, 15 undergoing the percutaneous technique and
15 treated by the standard femoral cut-down approach. There were no
significant differences between the two groups at baseline. No mortality
or failure of aneurysm exclusion was observed in either group. Three wound
infections occurred in the standard femoral cut-down group, whereas none
were observed in the percutaneous group. This was not statistically
significant. Only one major complication was observed in the study, a
conversion to the cut-down technique in the percutaneous access group. No
long-term outcomes were reported. One episode of a bleeding complication
was reported in the percutaneous group. Significant differences were
detected in surgery time (percutaneous 86.7 - 27 minutes versus
conventional 107.8 - 38.5 minutes; P < 0.05). The included study had a
small sample size and failed to report adequately the method of
randomisation, allocation concealment and the pre-selected outcomes.
Authors' conclusions: Only one small study was identified, which did not
provide adequate evidence to determine the efficacy and safety of the
percutaneous approach compared with endovascular aneurysm repairs. This
review has identified a clear need for further research into this
potentially beneficial technique. One ongoing study was identified in the
search, which may provide an improved evidence base in the
future. Copyright © 2014 The Cochrane Collaboration.

<125>
Accession Number
620562698
Title
Mammalian target of rapamycin inhibitors for heart transplant patients.
Source
Cochrane Database of Systematic Reviews. 2014(9) (no pagination), 2014.
Article Number: CD011206. Date of Publication: 19 Sep 2014.
Author
Penninga E.I.; Moller C.H.; Gustafsson F.; Gluud C.; Penninga L.
Institution
(Penninga) Bispebjerg Hospital, Department of Clinical Pharmacology,
Bispebjerg Bakke 23, Copenhagen DK-2400, Denmark
(Moller) Rigshospitalet, Copenhagen University Hospital, Department of
Cardiothoracic Surgery, Blegdamsvej 9, Copenhagen 2100, Denmark
(Gustafsson) Copenhagen University Hospital, Department of Cardiology B,
Blegdamsvej 9, Copenhagen DK-2100, Denmark
(Gluud) Copenhagen Trial Unit, Centre for Clinical Intervention Research,
Department 7812, Rigshospitalet, Copenhagen University Hospital, The
Cochrane Hepato-Biliary Group, Blegdamsvej 9, Copenhagen DK-2100, Denmark
(Penninga) Rigshospitalet, Copenhagen University Hospital, Copenhagen
Trial Unit, Centre for Clinical Intervention Research, Department 7812,
Blegdamsvej 9, Copenhagen DK-2100, Denmark
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: We will assess the benefits and harms of immunosuppressive
treatment with mTOR inhibitors for heart transplant recipients, both as an
add-on to other immunosuppressive agents, as well as a replacement for
other immunosuppressive agents (e.g., calcineurin inhibitors,
mycophenolate mofetil). More specifically, we will assess the short-term
efficacy of mTOR inhibitors compared with standard therapy regarding acute
rejection, the (long-term) effects of mTOR inhibitor treatment compared
with standard therapy regarding renal impairment and malignancy, and the
safety of mTOR inhibitor treatment regarding adverse
effects. Copyright © 2014 The Cochrane Collaboration.

<126>
Accession Number
620562526
Title
Statins for acute coronary syndrome.
Source
Cochrane Database of Systematic Reviews. 2014(9) (no pagination), 2014.
Article Number: CD006870. Date of Publication: 01 Sep 2014.
Author
Vale N.; Nordmann A.J.; Schwartz G.G.; de Lemos J.; Colivicchi F.; den
Hartog F.; Ostadal P.; Macin S.M.; Liem A.H.; Mills E.J.; Bhatnagar N.;
Bucher H.C.; Briel M.
Institution
(Vale) St Mary's Hospital, McGill University, Family Medicine, 377 Rue
Jean Brilliant, Montreal, QC H3T 1M5, Canada
(Nordmann) University Hospital Basel, Institute for Clinical Epidemiology
and Biostatistics, Hebelstrasse 10, Basel 4031, Switzerland
(Schwartz) VA Medical Center and University of Colorado, 1055 Clermont St,
Denver, CO, United States
(de Lemos) University of Texas Southwestern Medical School,
Cardiology/Internal Medicine, 5909 Harry Hines Blvd, Dallas, TX, United
States
(Colivicchi) S. Filippo Neri Hospital, Cardiovascular Department, 330
Viale Gorgia da Leontini, Rome 00124, Italy
(den Hartog) Gelderse Vallei Hospital, Cardiology Department, postbus
9025, Ede 6710 HN, Netherlands
(Ostadal) Na Homolce Hospital, Department of Cardiology, Prague, Czechia
(Macin) Instituto de Cardiologia, Coronary Intensive Care Unit, Juana F
Cabrel, Corrientes, Argentina
(Liem) Franciscus Gasthuis Rotterdam, Department of Cardiology, Rotterdam,
Netherlands
(Mills) University of Ottawa, Faculty of Health Sciences, 451 Smyth Road,
Ottawa, ON K1H 8M5, Canada
(Bhatnagar) McMaster University, Department of Clinical Epidemiology and
Biostatistics, 1200 Main Street West, Hamilton, ON L8N 3Z5, Canada
(Bucher, Briel) University Hospital Basel (USB), Basel Institute for
Clinical Epidemiology and Biostatistics, Basel, Switzerland
Publisher
John Wiley and Sons Ltd
Abstract
Background: The early period following the onset of acute coronary
syndrome (ACS) represents a critical stage of coronary heart disease, with
a high risk of recurrent events and deaths. The short-term effects of
early treatment with statins on patient-relevant outcomes in patients
suffering from ACS are unclear. This is an update of a review previously
published in 2011. Objective(s): To assess the effects, both harms
and benefits, of early administered statins in patients with ACS, in terms
of mortality and cardiovascular events. Search Method(s): We updated
the searches of CENTRAL (2013, Issue 3), MEDLINE (Ovid) (1946 to April
Week 1 2013), EMBASE (Ovid) (1947 to 2013 Week 14), and CINAHL (EBSCO)
(1938 to 2013) on 12 April 2013. We applied no language restrictions. We
supplemented the search by contacting experts in the field, by reviewing
the reference lists of reviews and editorials on the topic, and by
searching trial registries. Selection Criteria: Randomized controlled
trials (RCTs) comparing statins with placebo or usual care, with
initiation of statin therapy within 14 days following the onset of ACS,
follow-up of at least 30 days, and reporting at least one clinical
outcome. Data Collection and Analysis: Two authors independently
assessed risk of bias and extracted data. We calculated risk ratios (RRs)
for all outcomes in the treatment and control groups and pooled data using
random-effects models. Main Result(s): Eighteen studies (14,303
patients) compared early statin treatment versus placebo or no treatment
in patients with ACS. The new search did not identify any new studies for
inclusion. There were some concerns about risk of bias and imprecision of
summary estimates. Based on moderate quality evidence, early statin
therapy did not decrease the combined primary outcome of death, non-fatal
myocardial infarction, and stroke at one month (risk ratio (RR) 0.93, 95%
confidence interval (CI) 0.80 to 1.08) or four months (RR 0.93, 95% CI
0.81 to 1.06) of follow-up when compared to placebo or no treatment. There
were no statistically significant risk reductions from statins for total
death, total myocardial infarction, total stroke, cardiovascular death,
revascularization procedures, and acute heart failure at one month or at
four months, although there were favorable trends related to statin use
for each of these endpoints. Moderate quality evidence suggests that the
incidence of unstable angina was significantly reduced at four months
following ACS (RR 0.76, 95% CI 0.59 to 0.96). There were nine individuals
with myopathy (elevated creatinine kinase levels more than 10 times the
upper limit of normal) in statin-treated patients (0.13%) versus one
(0.015%) in the control groups. Serious muscle toxicity was mostly limited
to patients treated with simvastatin 80 mg. Authors' conclusions: Based on
moderate quality evidence, due to concerns about risk of bias and
imprecision, initiation of statin therapy within 14 days following ACS
does not reduce death, myocardial infarction, or stroke up to four months,
but reduces the occurrence of unstable angina at four months following
ACS. Serious side effects were rare. Copyright © 2014 The
Cochrane Collaboration.

<127>
Accession Number
622516472
Title
Co-enzyme Q10 supplementation for the primary prevention of cardiovascular
disease.
Source
Cochrane Database of Systematic Reviews. 2013(2) (no pagination), 2013.
Article Number: CD010405. Date of Publication: 28 Feb 2013.
Author
Flowers N.; Hartley L.; Rees K.
Institution
(Flowers, Hartley, Rees) Warwick Medical School, University of Warwick,
Division of Health Sciences, Coventry CV4 7AL, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: The primary objective is to determine the effectiveness of
CoQ10 supplementation for the primary prevention of CVD. Copyright
© 2013 The Cochrane Collaboration.

<128>
Accession Number
620551006
Title
Hormone therapy for preventing cardiovascular disease in post-menopausal
women.
Source
Cochrane Database of Systematic Reviews. 2013(4) (no pagination), 2013.
Article Number: CD002229. Date of Publication: 30 Apr 2013.
Author
Main C.; Knight B.; Moxham T.; Gabriel Sanchez R.; Sanchez Gomez L.M.;
Roquei Figuls M.; Bonfill Cosp X.
Institution
(Main) Peninsula College of Medicine and Dentistry, Peninsula Technology
Assessment Group (PenTAG), Noy Scott House, Barrack Road, Exeter EX2 5DW,
United Kingdom
(Knight) University of Exeter Medical School, NIHR Exeter Clinical
Research Facilt, Exeter, United Kingdom
(Moxham) Florida Atlantic University, Wimberly Library, 777 Glades Road,
Boca Raton, FL 33431, United States
(Gabriel Sanchez) Hospital Universitario de la Paz, Universidad Autonoma
de Madrid, Instituto de Investigacion IdiPAZ, Red Espanola de
Investigacion Cardiovascular RD/12/0042/0008, Diego De Leon 62, Planta 9,
Madrid 28006, Spain
(Sanchez Gomez) Instituto de Salud Carlos III, Agencia de Evaluacion
Tecnologias Sanitarias, Monforte de Lemos 5, Madrid, Spain
(Roquei Figuls) CIBER Epidemiologia y Salud Publica (CIBERESP),
Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB
Sant Pau), Sant Antoni Maria Claret 171, Edifici Casa de Convalescencia,
Barcelona, Catalunya 08041, Spain
(Bonfill Cosp) CIBER Epidemiologia y Salud Publica (CIBERESP), Spain -
Universitat Autonoma de Barcelona, Iberoamerican Cochrane Centre,
Biomedical Research Institute Sant Pau (IIB Sant Pau), Sant Antoni M.
Claret 171, Casa de Convalescencia, Barcelona, Catalonia 08041, Spain
Publisher
John Wiley and Sons Ltd
Abstract
Background: Evidence from systematic reviews of observational studies
suggest that hormone replacement therapy (HT) may have beneficial effects
in reducing the incidence of cardiovascular disease (CVD) events in
post-menopausal women. This is an updated version of a Cochrane review
first published in 2005 (Gabriel-Sanchez 2005). Objective(s): To
assess the effects of HT for the prevention of CVD in post-menopausal
women, and whether there are differential effects between use of single
therapy alone compared to combination HT and use in primary or secondary
prevention. Search Method(s): We searched the following databases to
April 2010: Cochrane Central Register of Controlled Trials (CENTRAL) on
The Cochrane Library, MEDLINE, EMBASE and LILACS. Selection Criteria:
Randomised controlled trials (RCTs) of women comparing orally administered
HT with placebo with a minimum of six-months follow-up. Data
Collection and Analysis: Two authors independently assessed study quality
and extracted data. Risk Ratios (RR) with 95% confidence intervals were
calculated for each outcome. Results were combined using fixed-effect
meta-analyses, and where possible, further stratified analyses conducted
to assess the effect of time on treatment. Additionally, univariate
meta-regression analyses were undertaken to assess whether length of trial
follow-up, single or combination treatment, or whether treatment for
primary or secondary prevention were potential predictors for a number of
CVD outcomes in the trials. Main Result(s): Four new trials were
identified through the update; one trial included in the previous review
was excluded. Therefore the review included 13 trials with a total of
38,171 post-menopausal women. Overall, single and combination HT in both
primary and secondary prevention conferred no protective effects for all
cause mortality, CVD death, non-fatal MI, or angina. There were no
significant differences in the number of coronary artery by-pass
procedures or angioplasties performed between the trial arms. However
there was an increased risk of stroke for both primary and secondary
prevention when combination and single HT was combined, RR 1.26 (95% CI
1.11 to 1.43), in venous thromboembolic events, RR 1.89 (95% CI 1.58 to
2.26) and in pulmonary embolism RR 1.84 (95% CI 1.42 to 2.37) relative to
placebo. The associated numbers needed-to-harm (NNH) were 164, 109 and 243
for stroke, venous thromboembolism and pulmonary embolism respectively.
Authors' conclusions: Treatment with HT in post-menopausal women for
either primary or secondary prevention of CVD events is not effective, and
causes an increase in the risk of stroke, and venous thromboembolic
events. HT should therefore only be considered for women seeking relief
from menopausal symptoms. Short-term HT treatment should be at the lowest
effective dose, and used with caution in women with predisposing risk
factors for CVD events. Copyright © 2013 The Cochrane
Collaboration.

<129>
Accession Number
620550985
Title
Interventions to support return-to-work for patients with coronary heart
disease.
Source
Cochrane Database of Systematic Reviews. 2013(9) (no pagination), 2013.
Article Number: CD010748. Date of Publication: 13 Sep 2013.
Author
Euler U.; Wegewitz U.E.; Schmitt J.; Adams J.; van Dijk J.L.; Seidler A.
Institution
(Euler) Medical Faculty Carl Gustav Carus, Technical University Dresden,
Institute and Policlinic for Occupational and Social Medicine,
Fetscherstrasse 74, Dresden 01307, Germany
(Wegewitz) Federal Institute for Occupational Safety and Health (BAuA),
Division 3: Work and Health, Noldnerstr. 40-42, Berlin D-10317, Germany
(Schmitt) Faculty of Medicine Carl Gustav Carus, TU Dresden, Center for
Evidence-Based Healthcare, Dresden, Germany
(Adams) Baylor Hamilton Heart and Vascular Hospital, Cardiac
Rehabilitation Unit, 411 N Washington, Suite 3100, Dallas, TX 75218,
United States
(van Dijk) Academic Medical Center, Dutch Center for Occupational
Diseases, Gebouw Hogeschool Amsterdam, 4e etage, Tafelbergdreef 51,
Amsterdam 1105 BD, Netherlands
(Seidler) Medical Faculty Carl Gustav Carus, Institute and Policlinic of
Occupational and Social Medicine, Dresden, Germany
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: To assess the effects of person-and work-directed
interventions aimed at enhancing return to work in patients with coronary
heart disease compared to usual care or no intervention. Copyright
© 2013 The Cochrane Collaboration.

<130>
Accession Number
620550893
Title
Interventions for protecting renal function in the perioperative period.
Source
Cochrane Database of Systematic Reviews. 2013(9) (no pagination), 2013.
Article Number: CD003590. Date of Publication: 11 Sep 2013.
Author
Zacharias M.; Mugawar M.; Herbison G.P.; Walker R.J.; Hovhannisyan K.;
Sivalingam P.; Conlon N.P.
Institution
(Zacharias) Dunedin Hospital, Department of Anaesthesia and Intensive
Care, Great King Street, Private Bag 192, Dunedin, New Zealand
(Mugawar) St Vincent's University Hospital, Department of Anaesthesia and
Intensive Care Medicine, Elm Park, Dublin 4, Ireland
(Herbison) Dunedin School of Medicine, University of Otago, Department of
Preventive and Social Medicine, PO Box 913, Dunedin 9054, New Zealand
(Walker) University of Otago, Department of Medicine, Dunedin School of
Medicine, PO Box 913, Dunedin 9015, New Zealand
(Hovhannisyan) Rigshospitalet, The Cochrane Anaesthesia Review Group,
Blegdamsvej 9, Afsnit 5211, rum 1204, Copenhagen 2100, Denmark
(Sivalingam) Princess Alexandra Hospital, Department of Anaesthesia,
Ipswich Road, Woolloongabba, Brisbane 4102, Australia
(Conlon) St Vincent's University Hospital, Department of Anaesthesia, Elm
Park, Dublin 4, Ireland
Publisher
John Wiley and Sons Ltd
Abstract
Background: Various methods have been used to try to protect kidney
function in patients undergoing surgery. These most often include
pharmacological interventions such as dopamine and its analogues,
diuretics, calcium channel blockers, angiotensin-converting enzyme (ACE)
inhibitors, N-acetyl cysteine (NAC), atrial natriuretic peptide (ANP),
sodium bicarbonate, antioxidants and erythropoietin (EPO).
 Objective(s): This review is aimed at determining the effectiveness
of various measures advocated to protect patients' kidneys during the
perioperative period. We considered the following questions: (1) Are any
specific measures known to protect kidney function during the
perioperative period? (2) Of measures used to protect the kidneys during
the perioperative period, does any one method appear to be more effective
than the others? (3) Of measures used to protect the kidneys during the
perioperative period,does any one method appear to be safer than the
others? Search methods: In this updated review, we searched the Cochrane
Central Register of Controlled Trials (CENTRAL) (The Cochrane Library,
Issue 2, 2012), MEDLINE (Ovid SP) (1966 to August 2012) and EMBASE (Ovid
SP) (1988 to August 2012). We originally handsearched six journals
(Anesthesia and Analgesia, Anesthesiology, Annals of Surgery, British
Journal of Anaesthesia, Journal of Thoracic and Cardiovascular Surgery,
and Journal of Vascular Surgery) (1985 to 2004). However, because these
journals are properly indexed in MEDLINE, we decided to rely on electronic
searches only without handsearching the journals from 2004 onwards.
 Selection Criteria: We selected all randomized controlled trials in
adults undergoing surgery for which a treatment measure was used for the
purpose of providing renal protection during the perioperative period.
 Data Collection and Analysis: We selected 72 studies for inclusion in
this review. Two review authors extracted data from all selected studies
and entered them into RevMan 5.1; then the data were appropriately
analysed. We performed subgroup analyses for type of intervention, type of
surgical procedure and pre-existing renal dysfunction. We undertook
sensitivity analyses for studies with high and moderately good
methodological quality. Main Result(s): The updated review included
data from 72 studies, comprising a total of 4378 participants. Of these,
2291 received some form of treatment and 2087 acted as controls. The
interventions consisted most often of different pharmaceutical agents,
such as dopamine and its analogues, diuretics, calcium channel blockers,
ACE inhibitors, NAC, ANP, sodium bicarbonate, antioxidants and EPO or
selected hydration fluids. Some clinical heterogeneity and varying risk of
bias were noted amongst the studies, although we were able to meaningfully
interpret the data. Results showed significant heterogeneity and indicated
that most interventions provided no benefit. Data on perioperative
mortality were reported in 41 studies and data on acute renal injury in 44
studies (all interventions combined). Because of considerable clinical
heterogeneity (different clinical scenarios, as well as considerable
methodological variability amongst the studies), we did not perform a
meta-analysis on the combined data. Subgroup analysis of major
interventions and surgical procedures showed no significant influence of
interventions on reported mortality and acute renal injury. For the
subgroup of participants who had pre-existing renal damage, the risk of
mortality from 10 trials (959 participants) was estimated as odds ratio
(OR) 0.76, 95% confidence interval (CI) 0.38 to 1.52; the risk of acute
renal injury (as reported in the trials) was estimated from 11 trials (979
participants) as OR 0.43, 95% CI 0.23 to 0.80. Subgroup analysis of
studies that were rated as having low risk of bias revealed that 19
studies reported mortality numbers (1604 participants); OR was 1.01, 95%
CI 0.54 to 1.90. Fifteen studies reported data on acute renal injury
(criteria chosen by the individual studies; 1600 participants); OR was
1.03, 95% CI 0.54 to 1.97. Authors' conclusions: No reliable evidence from
the available literature suggests that interventions during surgery can
protect the kidneys from damage. However, the criteria used to diagnose
acute renal damage varied in many of the older studies selected for
inclusion in this review, many of which suffered from poor methodological
quality such as insufficient participant numbers and poor definitions of
end points such as acute renal failure and acute renal injury. Recent
methods of detecting renal damage such as the use of specific biomarkers
and better defined criteria for identifying renal damage (RIFLE (risk,
injury, failure, loss of kidney function and end-stage renal failure) or
AKI (acute kidney injury)) may have to be explored further to determine
any possible benefit derived from interventions used to protect the
kidneys during the perioperative period. Copyright © 2013 The
Cochrane Collaboration.

<131>
Accession Number
620561255
Title
Intravenous versus inhalation anaesthesia for patients undergoing on-pump
or off-pump coronary artery bypass grafting.
Source
Cochrane Database of Systematic Reviews. 2013(2) (no pagination), 2013.
Article Number: CD010345. Date of Publication: 28 Feb 2013.
Author
Modolo N.S.; Modolo M.P.; Marton M.A.; Braz L.G.; Alves R.L.; El Dib R.
Institution
(Modolo, Braz, El Dib) Botucatu Medical School, Universidade Estadual
Paulista (UNESP), Department of Anaesthesiology, Distrito de Rubiao
Junior, s/n, Botucatu, Sao Paulo 18603-970, Brazil
(Modolo, Marton) Botucatu Medical School, UNESP - Univ Estadual Paulista,
Distrito de Rubiao Junior, s/n, Botucatu, Sao Paulo 18603-970, Brazil
(Alves) Universidade Federal da Bahia, Hospital Universitario Professor
Edgard Santos, Department of Anaesthesia, Rua Augusto Viana, s/nCanela,
Salvador, Brazil
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: To verify the efficacy and safe of intravenous versus
inhalation anaesthesia in decreasing mortality and morbidity for patients
undergoing on-pump or off-pump coronary artery bypass grafting
(CABG). Copyright © 2015 The Cochrane Collaboration.

<132>
Accession Number
620561163
Title
Antiplatelet and anticoagulation for patients with prosthetic heart
valves.
Source
Cochrane Database of Systematic Reviews. 2013(7) (no pagination), 2013.
Article Number: CD003464. Date of Publication: 09 Jul 2013.
Author
Massel D.R.; Little S.H.
Institution
(Massel) Cardiology, London Health Sciences Centre, University Campus, 339
Windermere Road, London, ON N6A 5A5, Canada
(Little) Cardiovascular Imaging Section, Department of Cardiology, The
Methodist DeBakey Heart and Vascular Center, Weill Medical College of
Cornell University, 6550 Fannin Street, SM-677, Houston, TX 77030, United
States
Publisher
John Wiley and Sons Ltd
Abstract
Background: Patients with prosthetic heart valves are at increased risk
for valve thrombosis and arterial thromboembolism. Oral anticoagulation
alone, or the addition of antiplatelet drugs, has been used to minimise
this risk. An important issue is the effectiveness and safety of the
latter strategy. Objective(s): This is an update of our previous
review; the goal was to create a valid synthesis of all available,
methodologically sound data to further assess the safety and efficacy of
combined oral anticoagulant and antiplatelet therapy versus oral
anticoagulant monotherapy in patients with prosthetic heart valves.
 Search Method(s): We updated the previous searches from 2003 and 2010
on 16 January 2013 and searched the Cochrane Central Register of
Controlled Trials (CENTRAL) on The Cochrane Library (2012, Issue 12),
MEDLINE (OVID, 1946 to January Week 1 2013), and EMBASE (OVID, 1980 to
2013 Week 02). We have also looked at reference lists of individual
reports, review articles, meta-analyses, and consensus statements. We
included reports published in any language or in abstract form.
 Selection Criteria: All reports of randomised controlled trials
comparing standard-dose oral anticoagulation to standard-dose oral
anticoagulation and antiplatelet therapy in patients with one or more
prosthetic heart valves. Data Collection and Analysis: Two review
authors independently performed the search strategy, assessed trials for
inclusion and study quality, and extracted data. We collected adverse
effects information from the trials. Main Result(s): One new study
has been identified and included in this update. In total, 13 studies
involving 4122 participants were included in this review update. Years of
publication ranged from 1971 to 2011. Compared with anticoagulation alone,
the addition of an antiplatelet agent reduced the risk of thromboembolic
events (odds ratio (OR) 0.43, 95% confidence interval (CI) 0.32 to 0.59; P
< 0.00001) and total mortality (OR 0.57, 95% CI 0.42 to 0.78; P = 0.0004).
Aspirin and dipyridamole reduced these events similarly. The risk of major
bleeding was increased when antiplatelet agents were added to oral
anticoagulants (OR 1.58, 95% CI 1.14 to 2.18; P = 0.006). For major
bleeding, there was no evidence of heterogeneity between aspirin and
dipyridamole and in the comparison of trials performed before and after
1990, around the time when anticoagulation standardisation with the
international normalised ratio was being implemented. A lower daily dose
of aspirin (< 100 mg) may be associated with a lower major bleeding risk
than higher doses. Authors' conclusions: Adding antiplatelet therapy,
either dipyridamole or low-dose aspirin, to oral anticoagulation decreases
the risk of systemic embolism or death among patients with prosthetic
heart valves. The risk of major bleeding is increased with antiplatelet
therapy. These results apply to patients with mechanical prosthetic valves
or those with biological valves and indicators of high risk such as atrial
fibrillation or prior thromboembolic events. The effectiveness and safety
of low-dose aspirin (100 mg daily) appears to be similar to higher-dose
aspirin and dipyridamole. In general, the quality of the included trials
tended to be low, possibly reflecting the era when the majority of the
trials were conducted (1970s and 1980s when trial methodology was less
advanced). Copyright © 2013 The Cochrane Collaboration.

<133>
Accession Number
620559938
Title
HMG CoA reductase inhibitors (statins) for preventing acute kidney injury
after surgical procedures requiring cardiac bypass.
Source
Cochrane Database of Systematic Reviews. 2013(4) (no pagination), 2013.
Article Number: CD010480. Date of Publication: 30 Apr 2013.
Author
Lewicki M.; Ng I.; Schneider A.G.
Institution
(Lewicki, Schneider) Monash University, Department of Epidemiology and
Preventive Medicine, Melbourne, VIC, Australia
(Ng) Royal Melbourne Hospital, Department of Anaesthesia and Pain
Management, Grattan Street, Parkville, VIC 3050, Australia
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: This review aims to look at the evidence that supports the
benefits of perioperative statins in prevention of AKI occurring in
hospitalised adults after surgery requiring cardiac bypass. The main
objectives are: To determine whether statin use is associated with the
prevention of development of AKI. To determine whether the use of statins
is associated with a reduction in in-hospital mortality. To determine
whether the use of statins is associated with a reduction in the need for
renal replacement therapy. To determine any adverse effects associated
with the use of statins. Copyright © 2013 The Cochrane
Collaboration.

<134>
Accession Number
620563070
Title
Nitrates for the prevention of cardiac morbidity and mortality in patients
undergoing non-cardiac surgery.
Source
Cochrane Database of Systematic Reviews. 2013(8) (no pagination), 2013.
Article Number: CD010726. Date of Publication: 31 Aug 2013.
Author
Zhao N.; Xu J.; Singh B.; Wu T.; Yu X.
Institution
(Zhao, Yu) Peking Union Medical College Hospital, Chinese Academy of
Medical Sciences and Peking Union Medical College, Department of
Anesthesiology, No.1, Shuaifuyuan, Dongcheng District, Beijing 100730,
China
(Xu) Peking Union Medical College Hospital, Chinese Academy of Medical
Sciences and Peking Union Medical College, Emergency Department, No.1,
Shuaifuyuan, Dongcheng District, Beijing 100730, China
(Singh) Mayo Clinic College of Medicine, Department of Medicine, Division
of Pulmonary and Critical Care Medicine, 200 First Street SW, Rochester,
MN 55905, United States
(Wu) West China Hospital, Sichuan University, Chinese Clinical Trial
Registry, Chinese Ethics Committee of Registering Clinical Trials, No. 37,
Guo Xue Xiang, Chengdu, Sichuan 610041, China
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: To assess the effects of nitrates as compared to other
interventions or placebo for reducing cardiac risk (such as death caused
by cardiac factors, angina pectoris, acute myocardial infarction, acute
heart failure, and cardiac arrhythmia) in patients undergoing non-cardiac
surgery. We also aim to identify the influence of different routes and
dosages of nitrates on patient outcomes. Copyright © 2013 The
Cochrane Collaboration.

<135>
Accession Number
620563012
Title
Antibiotic prophylaxis for the prevention of methicillin-resistant
Staphylococcus aureus (MRSA) related complications in surgical patients.
Source
Cochrane Database of Systematic Reviews. 2013(8) (no pagination), 2013.
Article Number: CD010268. Date of Publication: 19 Aug 2013.
Author
Gurusamy K.S.; Koti R.; Wilson P.; Davidson B.R.
Institution
(Gurusamy, Koti, Davidson) Royal Free Campus, UCL Medical School,
Department of Surgery, Royal Free Hospital, Rowland Hill Street, London
NW3 2PF, United Kingdom
(Wilson) University College London Hospitals, Department of Microbiology
and Virology, 60 Whitfield Street, London W1T 4EU, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Risk of methicillin-resistant Staphylococcus aureus (MRSA)
infection after surgery is generally low, but affects up to 33% of
patients after certain types of surgery. Postoperative MRSA infection can
occur as surgical site infections (SSIs), chest infections, or bloodstream
infections (bacteraemia). The incidence of MRSA SSIs varies from 1% to 33%
depending upon the type of surgery performed and the carrier status of the
individuals concerned. The optimal prophylactic antibiotic regimen for the
prevention of MRSA after surgery is not known. Objective(s): To
compare the benefits and harms of all methods of antibiotic prophylaxis in
the prevention of postoperative MRSA infection and related complications
in people undergoing surgery. Search Method(s): In March 2013 we
searched the following databases: The Cochrane Wounds Group Specialised
Register; The Cochrane Central Register of Controlled Trials (CENTRAL);
Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library);
NHS Economic Evaluation Database (The Cochrane Library); Health Technology
Assessment (HTA) Database (The Cochrane Library); Ovid MEDLINE; Ovid
MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO
CINAHL. Selection Criteria: We included only randomised controlled
trials (RCTs) that compared one antibiotic regimen used as prophylaxis for
SSIs (and other postoperative infections) with another antibiotic regimen
or with no antibiotic, and that reported the methicillin resistance status
of the cultured organisms. We did not limit our search for RCTs by
language, publication status, publication year, or sample size. Data
Collection and Analysis: Two review authors independently identified the
trials for inclusion in the review, and extracted data. We calculated the
risk ratio (RR) with 95% confidence intervals (CI) for comparing binary
outcomes between the groups and planned to calculated the mean difference
(MD) with 95% CI for comparing continuous outcomes. We planned to perform
meta-analysis using both a fixed-effect model and a random-effects model.
We performed intention-to-treat analysis whenever possible. Main
Result(s): We included 12 RCTs, with 4704 participants, in this review.
Eleven trials performed a total of 16 head-to-head comparisons of
different prophylactic antibiotic regimens. Antibiotic prophylaxis was
compared with no antibiotic prophylaxis in one trial. All the trials were
at high risk of bias. With the exception of one trial in which all the
participants were positive for nasal carriage of MRSA or had had previous
MRSA infections, it does not appear that MRSA was tested or eradicated
prior to surgery; nor does it appear that there was high prevalence of
MRSA carrier status in the people undergoing surgery. There was no
sufficient clinical similarity between the trials to perform a
meta-analysis. The overall all-cause mortality in four trials that
reported mortality was 14/1401 (1.0%) and there were no significant
differences in mortality between the intervention and control groups in
each of the individual comparisons. There were no antibiotic-related
serious adverse events in any of the 561 people randomised to the seven
different antibiotic regimens in four trials (three trials that reported
mortality and one other trial). None of the trials reported quality of
life, total length of hospital stay or the use of healthcare resources.
Overall, 221/4032 (5.5%) people developed SSIs due to all organisms, and
46/4704 (1.0%) people developed SSIs due to MRSA. In the 15 comparisons
that compared one antibiotic regimen with another, there were no
significant differences in the proportion of people who developed SSIs. In
the single trial that compared an antibiotic regimen with placebo, the
proportion of people who developed SSIs was significantly lower in the
group that received antibiotic prophylaxis with co-amoxiclav (or
cefotaxime if allergic to penicillin) compared with placebo (all SSI: RR
0.26; 95% CI 0.11 to 0.65; MRSA SSI RR 0.05; 95% CI 0.00 to 0.83). In two
trials that reported MRSA infections other than SSI, 19/478 (4.5%) people
developed MRSA infections including SSI, chest infection and bacteraemia.
There were no significant differences in the proportion of people who
developed MRSA infections at any body site in these two comparisons.
Authors' conclusions: Prophylaxis with co-amoxiclav decreases the
proportion of people developing MRSA infections compared with placebo in
people without malignant disease undergoing percutaneous endoscopic
gastrostomy insertion, although this may be due to decreasing overall
infection thereby preventing wounds from becoming secondarily infected
with MRSA. There is currently no other evidence to suggest that using a
combination of multiple prophylactic antibiotics or administering
prophylactic antibiotics for an increased duration is of benefit to people
undergoing surgery in terms of reducing MRSA infections. Well designed
RCTs assessing the clinical effectiveness of different antibiotic regimens
are necessary on this topic. Copyright © 2013 The Cochrane
Collaboration.

<136>
Accession Number
620562966
Title
Fibrinogen concentrate in bleeding patients.
Source
Cochrane Database of Systematic Reviews. 2013(8) (no pagination), 2013.
Article Number: CD008864. Date of Publication: 29 Aug 2013.
Author
Wikkelso A.; Lunde J.; Johansen M.; Stensballe J.; Wetterslev J.; Moller
A.M.; Afshari A.
Institution
(Wikkelso) University of Copenhagen Herlev Hospital, Department of
Anaesthesiology, Herlev, Denmark
(Lunde) Rigshospitalet, Copenhagen University Hospital, Juliane Marie
Centre - Anaesthesia and Surgical Clinic Department 4013, Delfingade 51,1,
Copenhagen 28893435, Denmark
(Johansen) Rigshospitalet, Copenhagen University Hospital, Department of
Anaesthesiology, Centre of Neuroanaesthesia, Copenhagen, Denmark
(Stensballe) Copenhagen University Hospital, Rigshospitalet, Department of
Anaesthesiology, Centre of Head and Orthopaedics Section for Transfusion
Medicine, Capital Region Blood Bank, Blegdamsvej 9, Copenhagen DK-2100 KBH
O, Denmark
(Wetterslev) Rigshospitalet, Copenhagen University Hospital, Copenhagen
Trial Unit, Centre for Clinical Intervention Research, Department 7812,
Blegdamsvej 9, Copenhagen DK-2100, Denmark
(Moller) University of Copenhagen Herlev Hospital, The Cochrane
Anaesthesia Review Group, Rigshospitalet Department of Anaesthesiology,
Herlev Ringvej, Herlev 2730, Denmark
(Afshari) Hopitaux Universitaires de Geneve, Pediatric and Neonatal
Intensive Care Service, Rue Willy-Donze, Geneva 1211, Switzerland
(Afshari) Rigshospitalet, Copenhagen University Hospital, Juliane Marie
Centre, Department of Anaesthesiology, Copenhagen, Denmark
Publisher
John Wiley and Sons Ltd
Abstract
Background: Hypofibrinogenaemia is associated with increased morbidity and
mortality, but the optimal treatment level, the use of preemptive
treatment and the preferred source of fibrinogen remain disputed.
Fibrinogen concentrate is increasingly used and recommended for bleeding
with acquired haemostatic deficiencies in several countries, but evidence
is lacking regarding indications, dosing, efficacy and safety.
 Objective(s): We assessed the benefits and harms of fibrinogen
concentrate compared with placebo or usual treatment for bleeding
patients. Search Method(s): We searched the following electronic
databases: the Cochrane Central Register of Controlled Trials (CENTRAL)
(The Cochrane Library 2013, Issue 8); MEDLINE (1950 to 9 August 2013);
EMBASE (1980 to 9 August 2013); International Web of Science (1964 to 9
August 2013); CINAHL (1980 to 9 August 2013); LILACS (1982 to 9 August
2013); and the Chinese Biomedical Literature Database (up to 10 November
2011), together with databases of ongoing trials. We contacted trial
authors, authors of previous reviews and manufacturers in the field.
 Selection Criteria: We included all randomized controlled trials
(RCTs), irrespective of blinding or language, that compared fibrinogen
concentrate with placebo/other treatment or no treatment in bleeding
patients, excluding neonates and patients with hereditary bleeding
disorders. Data Collection and Analysis: Three review authors
independently abstracted data; we resolved any disagreements by
discussion. Our primary outcome measure was all-cause mortality. We
performed subgroup and sensitivity analyses to assess the effects of
fibrinogen concentrate in adults and children in terms of various clinical
and physiological outcomes. We presented pooled estimates of the effects
of intervention on dichotomous outcomes as risk ratios (RRs) and on
continuous outcomes as mean differences, with 95% confidence intervals
(CIs). We assessed the risk of bias through assessment of trial
methodological components and the risk of random error through trial
sequential analysis. Main Result(s): We included six RCTs with a
total of 248 participants; none of the trials were determined to have
overall low risk of bias. We found 12 ongoing trials, from which we were
unable to retrieve any data. Only two trials provided data on mortality,
and one was a zero event study; thus the meta-analysis showed no
statistically significant effect on overall mortality (2.6% vs 9.5%, RR
0.28, 95% CI 0.03 to 2.33). Our analyses on blood transfusion data suggest
a beneficial effect of fibrinogen concentrate in reducing the incidence of
allogenic transfusions (RR 0.47, 95% CI 0.31 to 0.72) but show no effect
on other predefined outcomes, including adverse events such as thrombotic
episodes. Authors' conclusions: In the six available RCTs of elective
surgery, fibrinogen concentrate appears to reduce transfusion
requirements, but the included trials are of low quality with high risk of
bias and are underpowered to detect mortality, benefit or harm.
Furthermore, data on mortality are lacking, heterogeneity is high and
acute or severe bleeding in a non-elective surgical setting remains
unexplored. Currently, weak evidence supports the use of fibrinogen
concentrate in bleeding patients, as tested here in primarily elective
cardiac surgery. More research is urgently needed. Copyright ©
2013 The Cochrane Collaboration.

<137>
Accession Number
620562934
Title
Cyanoacrylate microbial sealants for skin preparation prior to surgery.
Source
Cochrane Database of Systematic Reviews. 2013(8) (no pagination), 2013.
Article Number: CD008062. Date of Publication: 21 Aug 2013.
Author
Lipp A.; Phillips C.; Harris P.; Dowie I.
Institution
(Lipp) Department of Care Sciences, University of South Wales, Faculty of
Health, Sport and Science, Glyn TaffCampus, Pontypridd, Rhondda Cynon Taff
CF37 1DL, United Kingdom
(Phillips, Dowie) Department of Care Sciences, University of Glamorgan,
Faculty of Health, Sport and Science, Room 7012, Glyn TaffCampus,
Pontypridd, Rhondda Cynon Taff CF37 1DL, United Kingdom
(Harris) Princess of Wales Hospital, Abertawe Bro Morgannwg University NHS
Trust, Main Theatres, Coity Road, Bridgend CF31 1RQ, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: Surgical site infections (i.e. incisions that become infected)
are a continuing concern in health care. Microbial sealant is a liquid
that can be applied to the skin immediately before surgery and is thought
to help reduce the incidence of surgical site infections (SSIs) by sealing
in the skin flora, thus preventing contamination and infection of the
surgical site. Objective(s): To assess the effects of the
preoperative application of microbial sealants (compared with no microbial
sealant) on rates of SSI in people undergoing clean surgery. Search
Method(s): For this first update we searched the following electronic
databases in July 2013: the Cochrane Wounds Group Specialised Register,
the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid
MEDLINE, Ovid MEDLINE - In-Process & Other Non-Indexed Citations, Ovid
EMBASE and EBSCO CINAHL. Selection Criteria: Randomised controlled
trials (RCTs) were eligible for inclusion if they involved people
undergoing clean surgery (i.e. surgery that does not involve the breathing
system, gut, genital or urinary tract or any part of the body with an
existing infection) in an operating theatre and compared the use of
preoperative microbial sealants with no microbial sealant. Data
Collection and Analysis: All review authors independently extracted data
on the characteristics, risk of bias and outcomes of the eligible trials.
 Main Result(s): Three trials (524 participants undergoing clean
surgery) met the inclusion criteria. The trials all compared cyanoacrylate
microbial sealant with no sealant, and, when pooled, we found there were
fewer SSIs with the use of microbial sealant (10/261 participants) than
with the control comparison (29/274 participants). The difference between
the two groups was statistically significant (risk ratio (RR) 0.36, 95% CI
0.18 to 0.72) but given the number of participants and quality of the
studies, they should be treated with caution. There were some adverse
events in one study, but these were not judged to be a result of the use
of microbial sealant. Authors' conclusions: In this first update there is
still insufficient evidence available to determine whether the use of
microbial sealants reduces the risk of surgical site infection or not.
Further rigorous, adequately-powered RCTs are required to investigate this
properly. Copyright © 2013 The Cochrane Collaboration.

<138>
Accession Number
620561650
Title
Music for stress and anxiety reduction in coronary heart disease patients.
Source
Cochrane Database of Systematic Reviews. 2013(12) (no pagination), 2013.
Article Number: CD006577. Date of Publication: 28 Dec 2013.
Author
Bradt J.; Dileo C.; Potvin N.
Institution
(Bradt) College of Nursing and Health Professions, Drexel University,
Department of Creative Arts Therapies, 1505 Race Street, rm 1041,
Philadelphia, PA 19102, United States
(Dileo) Boyer College of Music and Dance, Temple University, Department of
Music Therapy and The Arts and Quality of Life Research Center,
Philadelphia, United States
(Potvin) College of Nursing and Health Professions, Drexel University,
Department of Creative Arts Therapies, 1505 Race Street, rm 1041,
Philadelphia, PA 19102, United States
Publisher
John Wiley and Sons Ltd
Abstract
Background: Individuals with coronary heart disease (CHD) often suffer
from severe distress due to diagnosis, hospitalization, surgical
procedures, uncertainty of outcome, fear of dying, doubts about progress
in recovery, helplessness and loss of control. Such adverse effects put
the cardiac patient at greater risk for complications, including sudden
cardiac death. It is therefore of crucial importance that the care of
people with CHD focuses on psychological as well as physiological needs.
Music interventions have been used to reduce anxiety and distress and
improve physiological functioning in medical patients; however its
efficacy for people with CHD needs to be evaluated. Objective(s): To
update the previously published review that examined the effects of music
interventions with standard care versus standard care alone on
psychological and physiological responses in persons with CHD. Search
Method(s): We searched the Cochrane Central Register of Controlled Trials
(CENTRAL) on The Cochrane Library (2012, Issue 10), MEDLINE (OvidSP, 1950
to October week 4 2012), EMBASE (OvidSP, 1974 to October week 5 2012),
CINAHL (EBSCOhost, 1982 to 9 November 2012), PsycINFO (OvidSP, 1806 to
October week 5 2012), LILACS (Virtual Health Library, 1982 to 15 November
2012), Social Science Citation Index (ISI, 1974 to 9 November 2012), a
number of other databases, and clinical trial registers. We also conducted
handsearching of journals and reference lists. We applied no language
restrictions. Selection Criteria: We included all randomized
controlled trials and quasi-randomized trials that compared music
interventions and standard care with standard care alone for persons with
confirmed CHD. Data Collection and Analysis: Two review authors
independently extracted data and assessed methodological quality, seeking
additional information from the trial researchers when necessary. We
present results using weighted mean differences for outcomes measured by
the same scale, and standardized mean differences for outcomes measured by
different scales. We used post-intervention scores. In cases of
significant baseline difference, we used change scores (changes from
baseline). Main Result(s): We identified four new trials for this
update. In total, the evidence for this review rests on 26 trials (1369
participants). Listening to music was the main intervention used, and 23
of the studies did not include a trained music therapist. Results indicate
that music interventions have a small beneficial effect on psychological
distress in people with CHD and this effect is consistent across studies
(MD = -1.26, 95% CI -2.30 to -0.22, P = 0.02, I2 = 0%). Listening to music
has a moderate effect on anxiety in people with CHD; however results were
inconsistent across studies (SMD = -0.70, 95% CI -1.17 to -0.22, P =
0.004, I2 = 77%). Studies that used music interventions in people with
myocardial infarction found more consistent anxiety-reducing effects of
music, with an average anxiety reduction of 5.87 units on a 20 to 80 point
score range (95% CI -7.99 to -3.75, P < 0.00001, I2 = 53%). Furthermore,
studies that used patient-selected music resulted in greater
anxiety-reducing effects that were consistent across studies (SMD = -0.89,
95% CI -1.42 to -0.36, P = 0.001, I2 = 48%). Findings indicate that
listening to music reduces heart rate (MD = -3.40, 95% CI -6.12 to -0.69,
P = 0.01), respiratory rate (MD = -2.50, 95% CI -3.61 to -1.39, P <
0.00001) and systolic blood pressure (MD = -5.52 mmHg, 95% CI - 7.43 to
-3.60, P < 0.00001). Studies that included two or more music sessions led
to a small and consistent pain-reducing effect (SMD = -0.27, 95% CI -0.55
to -0.00, P = 0.05). The results also suggest that listening to music may
improve patients' quality of sleep following a cardiac procedure or
surgery (SMD = 0.91, 95% CI 0.03 to 1.79, P = 0.04). We found no strong
evidence for heart rate variability and depression. Only one study
considered hormone levels and quality of life as an outcome variable. A
small number of studies pointed to a possible beneficial effect of music
on opioid intake after cardiac procedures or surgery, but more research is
needed to strengthen this evidence. Authors' conclusions: This systematic
review indicates that listening to music may have a beneficial effect on
anxiety in persons with CHD, especially those with a myocardial
infarction. Anxiety-reducing effects appear to be greatest when people are
given a choice of which music to listen to. Furthermore, listening to
music may have a beneficial effect on systolic blood pressure, heart rate,
respiratory rate, quality of sleep and pain in persons with CHD. However,
the clinical significance of these findings is unclear. Since many of the
studies are at high risk of bias, these findings need to be interpreted
with caution. More research is needed into the effects of music
interventions offered by a trained music therapist. Copyright ©
2013 The Cochrane Collaboration.

<139>
Accession Number
620561453
Title
Warm versus cold blood, and any blood versus crystalloid, cardioplegia in
adults undergoing coronary artery bypass grafting surgery with
cardiopulmonary bypass.
Source
Cochrane Database of Systematic Reviews. 2013(7) (no pagination), 2013.
Article Number: CD010650. Date of Publication: 26 Jul 2013.
Author
Pufulete M.; Reeves B.; Rogers C.; Harris J.; Suleiman S.; Bryan A.
Institution
(Pufulete, Reeves, Rogers, Harris, Suleiman) University of Bristol, School
of Clinical Sciences, Level 7, Bristol Royal Infirmary, Queen's Building,
Upper Maudlin Street, Bristol BS2 8HW, United Kingdom
(Bryan) University Hospitals Bristol NHS Foundation Trust, Bristol Heart
Institute, Bristol Royal Infirmary, Queen's Building, Upper Maudlin
Street, Bristol BS2 8HW, United Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
This is the protocol for a review and there is no abstract. The objectives
are as follows: To review the benefits and harms of: (a) warm blood
cardioplegia (21 degreeC to 37 degreeC) versus cold blood cardioplegia (20
degreeC); and (b) blood cardioplegia versus crystalloid cardioplegia in
adults undergoing coronary artery bypass grafting (CABG) with
cardiopulmonary bypass (CPB). Copyright © 2013 The Cochrane
Collaboration.

<140>
Accession Number
620561402
Title
Leukodepletion for patients undergoing heart valve surgery.
Source
Cochrane Database of Systematic Reviews. 2013(7) (no pagination), 2013.
Article Number: CD009507. Date of Publication: 31 Jul 2013.
Author
Spencer S.; Tang A.; Khoshbin E.
Institution
(Spencer) Lancaster University, Faculty of Health and Medicine, Bailrigg,
Lancaster, Lancashire LA1 4YD, United Kingdom
(Tang) Victoria Hospital, Department of Cardiothoracic Surgery, Lancashire
Cardiac Centre, Blackpool, Lancashire FY3 8NR, United Kingdom
(Khoshbin) University Hospital of South Manchester, Cardiothoracic
Surgery, Southmoor Road, Wythemshawe, Manchester, Cheshire M23 9LT, United
Kingdom
Publisher
John Wiley and Sons Ltd
Abstract
Background: There is some evidence for the benefits of leukodepletion in
patients undergoing coronary artery surgery. Its effectiveness in higher
risk patients, such as those undergoing heart valve surgery, particularly
in terms of overall clinical outcomes, is currently unclear.
 Objective(s): To assess the beneficial and harmful effects of
leukodepletion on clinical, patient-reported and economic outcomes in
patients undergoing heart valve surgery. Search Method(s): We
searched the Cochrane Central Register of Controlled Trials (CENTRAL)
(2013, Issue 3 of 12) in The Cochrane Library, the NHS Economic
Evaluations Database (1960 to April 2013), MEDLINE Ovid (1946 to April
week 2 2013), EMBASE Ovid (1947 to Week 15 2013), CINAHL (1982 to April
2013) and Web of Science (1970 to 17 April 2013) on 19 April 2013. We also
searched the World Health Organization (WHO) International Clinical Trials
Registry Platform (ICTRP), the US National Institutes of Health (NIH)
clinical trials database and the International Standard Randomised
Controlled Trial Number Register (ISRCTN) in April 2013 for ongoing
studies. No language or time period restrictions were applied. We examined
the reference lists of all included randomised controlled trials and
contacted authors of identified trials. We searched the 'grey' literature
at OpenGrey and handsearched relevant conference proceedings.
 Selection Criteria: Randomised controlled trials comparing a
leukocyte-depleting arterial line filter with a standard arterial line
filter, on the arterial outflow of the heart-lung bypass circuit, in
elective patients undergoing heart valve surgery. Data Collection and
Analysis: Data were collected on the study characteristics, three primary
outcomes (1. post-operative in-hospital all-cause mortality within three
months, 2. post-operative all-cause mortality excluding inpatient
mortality < 30 days, 3. length of stay in hospital, 4. adverse events and
serious adverse events) and seven secondary outcomes (1. tubular or
glomerular kidney injury, 2. validated health-related quality of life
scales, 3. validated renal injury scales, 4. use of continuous veno-venous
haemo-filtration, 5. length of stay in intensive care, 6. costs of care).
Data were extracted by one author and verified by a second author.
Insufficient data were available to perform a meta-analysis or sensitivity
analysis. Main Result(s): Eight studies were eligible for inclusion
in the review but data on prespecified review outcomes were available from
only one, modestly powered (24 participants) study (Hurst 1997). There
were no differences between a leuko-depleting versus standard filter in
length of stay in the intensive care unit (ICU) (mean difference (MD) 0.80
days; 95% confidence interval (CI) -0.24 to 1.84) or length of hospital
stay (MD 0.20 days; 95% CI -1.78 to 2.18). Authors' conclusions: There are
currently insufficient good quality trials with valve surgery patients to
inform recommendations for changes in clinical practice. A future National
Institute for Health Research (NIHR)-funded feasibility study (recruiting
mid-year 2013) comparing leukodepletion with a standard arterial line
filter in patients undergoing elective heart valve surgery (the ROLO
trial) will be the largest study to date and will make a significant
contribution to future updates of this review. Copyright © 2013
The Cochrane Collaboration.

<141>
Accession Number
620561263
Title
Epidural analgesia for cardiac surgery.
Source
Cochrane Database of Systematic Reviews. 2013(6) (no pagination), 2013.
Article Number: CD006715. Date of Publication: 06 Jun 2013.
Author
Svircevic V.; Passier M.M.; Nierich A.P.; van Dijk D.; Kalkman C.J.; van
der Heijden G.J.
Institution
(Svircevic, Passier, Kalkman) University Medical Center Utrecht,
Department of Perioperative Care and Emergency Medicine, PO Box 85500,
Mailstop E 03.511, Utrecht 3508 GA, Netherlands
(Nierich) Isala Clinics, Thoracic Anaesthesiology and Intensive care, PO
Box 10500, Zwolle 8000 GM, Netherlands
(van Dijk) University Medical Center Utrecht, Division of Anesthesiology,
Intensive Care and Emergency Medicine, PO Box 85500, Utrecht 3508 GA,
Netherlands
(van der Heijden) Academic Center for Dentistry Amsterdam (ACTA),
Department of Social Dentistry, Gustav Mahlerlaan 3004, Amsterdam 1081LA,
Netherlands
Publisher
John Wiley and Sons Ltd
Abstract
Background: A combination of general anaesthesia (GA) with thoracic
epidural analgesia (TEA) may have a beneficial effect on clinical outcomes
by reducing the risk of perioperative complications after cardiac surgery.
 Objective(s): The objective of this review was to determine the
impact of perioperative epidural analgesia in cardiac surgery on
perioperative mortality and cardiac, pulmonary or neurological morbidity.
We performed a meta-analysis to compare the risk of adverse events and
mortality in patients undergoing cardiac surgery under general anaesthesia
with and without epidural analgesia. Search Method(s): We searched
the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue
12) in The Cochrane Library; MEDLINE (PubMed) (1966 to November 2012);
EMBASE (1989 to November 2012); CINHAL (1982 to November 2012) and the
Science Citation Index (1988 to November 2012). Selection Criteria:
We included randomized controlled trials comparing outcomes in adult
patients undergoing cardiac surgery with either GA alone or GA in
combination with TEA. Data Collection and Analysis: All publications
found during the search were manually and independently reviewed by the
two authors. We identified 5035 titles, of which 4990 studies did not
satisfy the selection criteria or were duplicate publications, that were
retrieved from the five different databases. We performed a full review on
45 studies, of which 31 publications met all inclusion criteria. These 31
publications reported on a total of 3047 patients, 1578 patients with GA
and 1469 patients with GA plus TEA. Main Result(s): Through our
search (November 2012) we have identified 5035 titles, of which 31
publications met our inclusion criteria and reported on a total of 3047
patients. Compared with GA alone, the pooled risk ratio (RR) for patients
receiving GA with TEA showed an odds ratio (OR) of 0.84 (95% CI 0.33 to
2.13, 31 studies) for mortality; 0.76 (95% CI 0.49 to 1.19, 17 studies)
for myocardial infarction; and 0.50 (95% CI 0.21 to 1.18, 10 studies) for
stroke. The relative risks (RR) for respiratory complications and
supraventricular arrhythmias were 0.68 (95% CI 0.54 to 0.86, 14 studies)
and 0.65 (95% CI 0.50 to 0.86, 15 studies) respectively. Authors'
conclusions: This meta-analysis of studies, identified to 2010, showed
that the use of TEA in patients undergoing coronary artery bypass graft
surgery may reduce the risk of postoperative supraventricular arrhythmias
and respiratory complications. There were no effects of TEA with GA on the
risk of mortality, myocardial infarction or neurological complications
compared with GA alone. Copyright © 2013 The Cochrane
Collaboration.

<142>
Accession Number
620561827
Title
Surgical versus medical treatment with cyclooxygenase inhibitors for
symptomatic patent ductus arteriosus in preterm infants.
Source
Cochrane Database of Systematic Reviews. 2013(3) (no pagination), 2013.
Article Number: CD003951. Date of Publication: 28 Mar 2013.
Author
Malviya M.N.; Ohlsson A.; Shah S.S.
Institution
(Malviya) Nice Hospital for Children and Newborns, Neonatal Intensive Care
Unit, Shantinagar, Hyderabad, India
(Ohlsson) University of Toronto, Departments of Paediatrics, Obstetrics
and Gynaecology, Institute of Health Policy, Management and Evaluation,
600 University Avenue, Toronto, ON M5G 1X5, Canada
(Shah) Aditya Birla Memorial Hospital, Neonatal and Pediatric Intensive
Care Services, Office no. 2, Arihant Building, 39/32 Karve Road, Pune
411004, India
Publisher
John Wiley and Sons Ltd
Abstract
Background: A patent ductus arteriosus (PDA) with significant left to
right shunt increases morbidity and mortality in preterm infants. Early
closure of the ductus arteriosus may be achieved pharmacologically or by
surgery. The preferred initial treatment of a symptomatic PDA, surgical
ligation or treatment with indomethacin, is not clear. Objective(s):
To compare the effect of surgical ligation of PDA versus medical treatment
with cyclooxygenase inhibitors (indomethacin, ibuprofen or mefenamic
acid), each used as the initial treatment, on neonatal mortality in
preterm infants with a symptomatic PDA. Search Method(s): For this
update we searched The Cochrane Library 2012, Issue 2, MEDLINE, EMBASE,
CINAHL, Clinicaltrials.gov, Controlled-trials.com, Proceedings of the
Annual Meetings of the Pediatric Academic Societies (2000 to 2011)
(Abstracts2ViewTM) and Web of Science on 8 February 2012.
 Selection Criteria: Randomised or quasi-randomised trials in preterm
or low birth weight neonates with symptomatic PDA and comparing surgical
ligation with medical treatment with cyclooxygenase inhibitors, each used
as the initial treatment for closure of PDA. Data Collection and
Analysis: The authors independently assessed methodological quality and
extracted data for the included trial. We used RevMan 5.1 for analyses of
the data. Main Result(s): One study reporting on 154 neonates was
found eligible. No significant difference between surgical closure and
indomethacin treatment was found for in-hospital mortality, chronic lung
disease, necrotising enterocolitis, sepsis, creatinine level or
intraventricular haemorrhage. There was a significant increase in the
surgical group in the incidence of pneumothorax (risk ratio (RR) 2.68; 95%
confidence interval (CI) 1.45 to 4.93; risk difference (RD) 0.25; 95% CI
0.11 to 0.38; number needed to treat to harm (NNTH) 4 (95% CI 3 to 9)) and
retinopathy of prematurity stage III and IV (RR 3.80; 95% CI 1.12 to
12.93; RD 0.11; 95% CI 0.02 to 0.20; NNTH 9 (95% CI 5 to 50)) compared to
the indomethacin group. There was a statistically significant decrease in
failure of ductal closure rate in the surgical group as compared to the
indomethacin group (RR 0.04; 95% CI 0.01 to 0.27; RD -0.32; 95% CI -0.43
to -0.21, number needed to treat to benefit (NNTB) 3 (95% CI 2 to 4)). No
new trials were identified for inclusion in the 2012 update. Authors'
conclusions: There are insufficient data to conclude whether surgical
ligation or medical treatment with indomethacin is preferred as the
initial treatment for symptomatic PDA in preterm infants. Copyright
© 2013 The Cochrane Collaboration.

<143>
Accession Number
620561350
Title
Preoperative statin therapy for patients undergoing cardiac surgery.
Source
Cochrane Database of Systematic Reviews. 2012(4) (no pagination), 2012.
Article Number: CD008493. Date of Publication: 18 Apr 2012.
Author
Liakopoulos O.J.; Kuhn E.W.; Slottosch I.; Wassmer G.; Wahlers T.
Institution
(Liakopoulos, Kuhn, Slottosch, Wahlers) Heart Center, University of
Cologne, Department of Cardiothoracic Surgery, Kerpener Strasse 62,
Cologne 50924, Germany
(Wassmer) University of Cologne, Department for Medical Statistics,
Informatics and Epidemiology, Kerpener Strasse 62, Cologne 50924, Germany
Publisher
John Wiley and Sons Ltd
Abstract
Background: Patients referred to cardiac surgery for cardiovascular
disease are at significant risk for the development of post-operative
major adverse events despite significant advances in surgical techniques
and perioperative care. Statins (HMG-CoA reductase inhibitors) have gained
a pivotal role in the primary and secondary prevention of coronary artery
disease, and are thought to improve perioperative outcomes in patients
undergoing cardiac surgery. Objective(s): To determine the
effectiveness of a preoperative statin therapy in patients undergoing
cardiac surgery. Search Method(s): We searched CENTRAL (Issue 2 of 4,
2010 on The Cochrane Library), MEDLINE (1950 to May, Week 1 2010), EMBASE
(1980 to 2010 Week 19), and the metaRegister of Controlled Trials.
Additionally, ongoing trials were searched through the National Research
Register, the ClinicalTrials.gov registry and grey literature. Conference
indices from relevant scientific meetings (2006-2009) were screened online
for eligible trials. No language restrictions were applied. Selection
Criteria: All randomized controlled trials comparing any statin treatment
before cardiac surgery, for any given duration and dose, to no
preoperative statin therapy (standard of care) or placebo. Data
Collection and Analysis: Two authors evaluated trial quality and extracted
data from titles and abstracts identified from the electronic database
searches according to pre-defined criteria. Accordingly, full text
articles of potentially relevant studies that met the inclusion criteria
were retrieved to assess definite eligibility for inclusion. Effect
measures are reported as odds ratios (OR) or weighted mean difference
(WMD) with 95% confidence intervals (95%-CI). Main Result(s): Eleven
randomized controlled studies including a total of 984 participants
undergoing on- or off-pump cardiac surgical procedures were identified.
Pooled analysis showed that statin pre-treatment before surgery reduced
the incidence of post-operative atrial fibrillation (AF) (OR 0.40; 95%-CI:
0.29 to 0.55; p<0.01), but failed to influence short-term mortality (OR
0.98, 95%-CI: 0.14 to 7.10; p=0.98) or post-operative stroke (OR 0.70,
95%-CI: 0.14 to 3.63; p=0.67). In addition, statin therapy was associated
with a shorter length of stay of patients on the intensive care unit (ICU)
(WMD: -3.39 hours; 95%-CI: -5.77 to -1.01) and in-hospital (WMD: -0.48
days; 95%-CI: -0.85 to -0.11) where significant heterogeneity was
observed. There was no reduction in myocardial infarction (OR 0.52;
95%-CI: 0.2. to 1.30) or renal failure (OR 0.41; 95%-CI: 0.15 to 1.12).
These results were unaffected after subgroup analysis. No major or minor
perioperative statin side-effects were reported from trials investigating
this safety endpoint. Authors' conclusions: Preoperative statin therapy
reduces the odds of post-operative atrial fibrillation (AF) and shortens
the stay on the ICU and in the hospital. Statin pretreatment had no
influence on perioperative mortality, stroke, myocardial infarction or
renal failure. Since analysed studies included mainly patients undergoing
myocardial revascularizations the results cannot be extrapolated to
patients undergoing other cardiac procedures such as heart valve or aortic
surgery. Copyright © 2013 The Cochrane Collaboration.

<144>
Accession Number
2014217288
Title
Restrictive versus liberal transfusion in patients with diabetes
undergoing cardiac surgery: An open-label, randomized, blinded outcome
evaluation trial.
Source
Diabetes, Obesity and Metabolism. 24(3) (pp 421-431), 2022. Date of
Publication: March 2022.
Author
Mistry N.; Shehata N.; Carmona P.; Bolliger D.; Hu R.; Carrier F.M.;
Alphonsus C.S.; Tseng E.E.; Royse A.G.; Royse C.; Filipescu D.; Mehta C.;
Saha T.; Villar J.C.; Gregory A.J.; Wijeysundera D.N.; Thorpe K.E.; Juni
P.; Hare G.M.T.; Ko D.T.; Verma S.; Mazer C.D.
Institution
(Mistry) Department of Anesthesia, St. Michael's Hospital, Institute of
Medical Sciences, University of Toronto, Toronto, ON, Canada
(Shehata) Division of Hematology, Departments of Medicine, Laboratory
Medicine and Pathobiology, Institute of Health Policy Management and
Evaluation, University of Toronto, Mount Sinai Hospital, Toronto, ON,
Canada
(Carmona) Department of Anesthesia and Critical Care, Hospital
Universitari and Politecnic La Fe, Valencia, Spain
(Bolliger) Clinic for Anaesthesia, Intermediate Care, Prehospital
Emergency Medicine and Pain Therapy, University Hospital Basel, Basel,
Switzerland
(Hu) Department of Anesthesia, Austin Hospital, Melbourne, VIC, Australia
(Carrier) Department of Anesthesiology & Department of Medicine, Critical
Care Division, Centre hospitalier de l'Universite de Montreal, Montreal,
QC, Canada
(Carrier) Carrefour de l'innovation et sante des populations, Centre de
recherche du CHUM, Montreal, QC, Canada
(Alphonsus) Department of Anaesthesia and Perioperative Medicine, Groote
Schuur Hospital and Faculty of Health Sciences, University of Cape Town,
Cape Town, South Africa
(Tseng) Division of Adult Cardiothoracic Surgery, Department of Surgery,
University of California San Francisco and San Francisco VA Medical
Center, San Francisco, CA, United States
(Royse, Royse) Department of Surgery, The Royal Melbourne Hospital,
Parkville, VIC, Australia
(Royse, Royse) Department of Surgery, The University of Melbourne,
Melbourne, VIC, Australia
(Royse) Outcomes Research Consortium, The Cleveland Clinic, Cleveland, OH,
United States
(Filipescu) Department of Cardiac Anaesthesia and Intensive Care Medicine,
Emergency Institute for Cardiovascular Diseases, Carol Davila University
of Medicine and Pharmacy, Bucharest, Romania
(Mehta) Department of Cardiac Anaesthesia, Epic Hospital, Ahmedabad, India
(Saha) Department of Anesthesiology and Perioperative Medicine, Kingston
General Hospital, Kingston, ON, Canada
(Villar) Fundacion Cardioinfantil-Instituto de Cardiologia, Bogota,
Colombia
(Villar) Universidad Autonoma de Bucaramanga, Bucaramanga, Colombia
(Gregory) Department of Anesthesiology, Perioperative and Pain Medicine,
Libin Cardiovascular Institute, Cumming School of Medicine, University of
Calgary, Calgary, AB, Canada
(Wijeysundera) Department of Anesthesia, St. Michael's Hospital, Li Ka
Shing Knowledge Institute, Institute of Health Policy, Management and
Evaluation, University of Toronto, Toronto, ON, Canada
(Thorpe) Applied Health Research Centre, Li Ka Shing Knowledge Institute
of St. Michael's Hospital, Dalla Lana School of Public Health, University
of Toronto, Toronto, ON, Canada
(Juni) Applied Health Research Centre, Li Ka Shing Knowledge Institute of
St. Michael's Hospital, Department of Medicine, University of Toronto,
Toronto, ON, Canada
(Hare) Department of Anesthesia, St. Michael's Hospital, Li Ka Shing
Knowledge Institute, Department of Physiology, University of Toronto,
Toronto, ON, Canada
(Ko) Division of Cardiology, Schulich Heart Centre, Sunnybrook Health
Sciences Centre, Institute of Health Policy, Management and Evaluation
University of Toronto, ICES, Toronto, ON, Canada
(Verma) Division of Cardiac Surgery, St. Michael's Hospital, Li Ka Shing
Knowledge Institute, Department of Surgery, Department of Pharmacology and
Toxicology, University of Toronto, Toronto, ON, Canada
(Mazer) Department of Anesthesia, St. Michael's Hospital, Li Ka Shing
Knowledge Institute, Institute of Medical Sciences, Department of
Physiology, University of Toronto, Toronto, ON, Canada
Publisher
John Wiley and Sons Inc
Abstract
Aim: To characterize the association between diabetes and transfusion and
clinical outcomes in cardiac surgery, and to evaluate whether restrictive
transfusion thresholds are harmful in these patients. Material(s) and
Method(s): The multinational, open-label, randomized controlled TRICS-III
trial assessed a restrictive transfusion strategy (haemoglobin [Hb]
transfusion threshold <75 g/L) compared with a liberal strategy (Hb <95
g/L for operating room or intensive care unit; or <85 g/L for ward) in
patients undergoing cardiac surgery on cardiopulmonary bypass with a
moderate-to-high risk of death (EuroSCORE >=6). Diabetes status was
collected preoperatively. The primary composite outcome was all-cause
death, stroke, myocardial infarction, and new-onset renal failure
requiring dialysis at 6 months. Secondary outcomes included components of
the composite outcome at 6 months, and transfusion and clinical outcomes
at 28 days. Result(s): Of the 5092 patients analysed, 1396 (27.4%)
had diabetes (restrictive, n = 679; liberal, n = 717). Patients with
diabetes had more cardiovascular disease than patients without diabetes.
Neither the presence of diabetes (OR [95% CI] 1.10 [0.93-1.31]) nor the
restrictive strategy increased the risk for the primary composite outcome
(diabetes OR [95% CI] 1.04 [0.68-1.59] vs. no diabetes OR 1.02
[0.85-1.22]; P<inf>interaction</inf> =.92). In patients with versus
without diabetes, a restrictive transfusion strategy was more effective at
reducing red blood cell transfusion (diabetes OR [95% CI] 0.28
[0.21-0.36]; no diabetes OR [95% CI] 0.40 [0.35-0.47];
P<inf>interaction</inf> =.04). Conclusion(s): The presence of
diabetes did not modify the effect of a restrictive transfusion strategy
on the primary composite outcome, but improved its efficacy on red cell
transfusion. Restrictive transfusion triggers are safe and effective in
patients with diabetes undergoing cardiac surgery. Copyright ©
2021 John Wiley & Sons Ltd.

<145>
Accession Number
2019193749
Title
Coronary artery bypass grafting versus medical therapy in patients with
stable coronary artery disease: An individual patient data pooled
meta-analysis of randomized trials.
Source
Journal of Thoracic and Cardiovascular Surgery. (no pagination), 2022.
Date of Publication: 2022.
Author
Gaudino M.; Audisio K.; Hueb W.A.; Stone G.W.; Farkouh M.E.; Di Franco A.;
Rahouma M.; Serruys P.W.; Bhatt D.L.; Biondi Zoccai G.; Yusuf S.; Girardi
L.N.; Fremes S.E.; Ruel M.; Redfors B.
Institution
(Gaudino, Audisio, Di Franco, Rahouma, Girardi) Department of
Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, United
States
(Hueb) Heart Institute of the University of Sao Paulo, Sao Paulo, Brazil
(Stone) The Zena and Michael A. Wiener Cardiovascular Institute, Icahn
School of Medicine at Mount Sinai, New York, NY, United States
(Farkouh) Peter Munk Cardiac Centre and the Heart and Stroke Richard Lewar
Centre, University of Toronto, Toronto, ON, Canada
(Serruys) International Centre for Circulatory Health, National Heart and
Lung Institute, Imperial College London, London, United Kingdom
(Bhatt) Brigham and Women's Hospital Heart and Vascular Center and Harvard
Medical School, Boston, Mass, United States
(Biondi Zoccai) Department of Medico-Surgical Sciences and
Biotechnologies, Sapienza University of Rome, Latina, Italy
(Biondi Zoccai) Mediterranea Cardiocentro, Napoli, Italy
(Yusuf) Population Health Research Institute, McMaster University,
Hamilton Health Sciences, Hamilton, ON, Canada
(Fremes) Schulich Heart Centre, Sunnybrook Health Sciences Centre,
University of Toronto, Toronto, ON, Canada
(Ruel) University of Ottawa Heart Institute, University of Ottawa, Ottawa,
ON, Canada
(Redfors) Department of Cardiology, Sahlgrenska University Hospital,
Gothenburg, Sweden
(Redfors) Clinical Trials Center, Cardiovascular Research Foundation, New
York, NY, United States
(Redfors) NewYork-Presbyterian Hospital/Columbia University Medical
Center, New York, NY, United States
Publisher
Elsevier Inc.
Abstract
Objectives: It is unclear whether coronary artery bypass grafting (CABG)
improves survival compared with medical therapy (MT) in patients with
stable coronary artery disease (CAD). The aim of this analysis was to
perform an individual-patient data-pooled meta-analysis of contemporary
randomized controlled trials that compared CABG and MT in patients with
stable CAD. Method(s): A systematic search was performed in January
2021 to identify randomized controlled trials enrolling adult patients
with stable CAD, randomized to CABG or MT. Only trials using at least
aspirin, beta-blockers, and statins in the MT arm were included.
Individual patient data were obtained from all eligible studies and
pooled. The primary outcome was all-cause mortality. Result(s): Four
trials involving 2523 patients (1261 CABG; 1262 MT) were included with a
median follow-up of 5.6 (4.0-9.2) years. CABG was associated with
increased risk of all-cause mortality within 30 days (hazard ratio [HR],
4.81; 95% confidence interval [CI], 1.95-11.83) but subsequent reduction
in the long-term risk of death (HR, 0.79; 95% CI, 0.69-0.89). As such, the
cumulative 10-year mortality rate was lower in patients treated with CABG
compared with MT (45.1% vs 51.7%, respectively; odds ratio, 0.70; 95% CI,
0.58-0.85). Age and race were significant treatment effect modifier
(interaction P = .003 for both). Conclusion(s): In patients with
stable CAD, initial allocation to CABG was associated with greater
periprocedural risk of death but improved long-term survival compared with
MT. The survival advantage for CABG became significant after the fourth
postoperative year and was particularly pronounced in younger and
non-White patients. Copyright © 2022 The American Association for
Thoracic Surgery

<146>
Accession Number
638457130
Title
OUTCOMES FOLLOWING ACUTE MYOCARDIAL INJURY AND TYPE 2 MYOCARDIAL
INFARCTION IN PATIENTS WITH AND WITHOUT CORONARY ARTERY DISEASE.
Source
Heart. Conference: British Cardiovascular Society Annual Conference, BCS
2022. Manchester United Kingdom. 108(Supplement 1) (pp A35), 2022. Date of
Publication: June 2022.
Author
Taggart C.; Gard A.; Bularga A.; Wereski R.; Kimenai D.; Chapman A.;
Lindahl B.; Mills N.L.; Eggers K.
Institution
(Taggart) BHF Centre for Cardiovascular Science, University of Edinburgh,
Edinburgh, United Kingdom
(Gard, Lindahl, Eggers) University of Uppsala, Sweden
(Bularga, Wereski, Kimenai, Chapman, Mills) BHF Centre for Cardiovascular
Sciences, University of Edinburgh, Edinburgh, United Kingdom
Publisher
BMJ Publishing Group
Abstract
Background Acute myocardial injury and type 2 myocardial infarction
typically occur in the setting of a concurrent illness. Differentiating
acute myocardial injury from type 2 myocardial infarction is challenging
as it relies on the assessment of myocardial ischaemia. Indeed, some have
questioned whether this distinction is important, as patients with both
conditions are at increased risk of future cardiovascular events. Whether
this risk is similar and the role of identifying those with coronary
artery disease is uncertain. Methods We conducted a secondary analysis of
a multi-centre randomised controlled trial of 48,282 consecutive patients
with suspected acute coronary syndrome. Patients with an adjudicated
diagnosis of acute myocardial injury and type 2 myocardial infarction were
stratified according to whether they were known previously to have
coronary artery disease defined as prior coronary revascularisation,
myocardial infarction, or angina. Cardiovascular death or myocardial
infarction adjusted for the competing risk of non-cardiovascular death and
all-cause death at one year was compared. Results In 9,115 patients with
elevated cardiac troponin concentrations, 1,676 (18%) and 1,121 (12%) had
acute myocardial injury and type 2 myocardial infarction, respectively.
Patients with either condition known to have coronary artery disease were
older (mean [standard deviation] age 78 [11] versus 73 [16] years) and
more likely to be female (55% versus 45%) than those with no prior
history. Coronary artery disease was previously identified in 40%
(454/1,121) and 30% (509/1,167) of those with type 2 myocardial infarction
and acute myocardial injury, respectively. Cardiovascular death or
myocardial infarction at one year was more common in patients known to
have coronary artery disease than those without for both acute myocardial
injury (23% [115/509]) versus 14% [158/1,167]; P<0.001) and type 2
myocardial infarction (20% [91/454] versus 10% [69/667]; log-rank P<0.001)
(Figure 1). Similarly all-cause death at one year was higher in patients
with known coronary artery disease for both acute myocardial injury (31%
[357/1,167] versus 18% [123/667]; P<0.001) and type 2 myocardial
infarction (40% [115/509] versus 30% [135/454]; P<0.001) (Figure 2).
Conclusion Coronary artery disease is recognised in around one third of
patients with acute myocardial injury and type 2 myocardial infarction and
is associated with higher rates of cardiovascular events and all-cause
death. Risk doubled in those with coronary artery disease and was similar
whether the index diagnosis was myocardial injury or infarction,
suggesting that coronary investigation and secondary prevention may have a
role in both conditions. (Figure Presented).

<147>
Accession Number
638456452
Title
PREDICTORS OF PERMANENT PACEMAKER INSERTION AFTER MITRAL VALVE REPLAEMENT.
Source
Heart. Conference: British Cardiovascular Society Annual Conference, BCS
2022. Manchester United Kingdom. 108(Supplement 1) (pp A17), 2022. Date of
Publication: June 2022.
Author
Malik J.; Ghauri H.; Iqbal R.
Institution
(Malik) Rawalpindi Institute of Cardiology, Rawal Road, Rawalpindi 46000,
Pakistan
(Ghauri) Rawalpindi Institute of Cardiology, Pakistan
(Iqbal) Wah Medical College, Pakistan
Publisher
BMJ Publishing Group
Abstract
Objective As the established surgical mitral valve replacement (MVR)
expands towards various contemporary techniques and access routes, the
predictors and burden of procedure-related complications including the
need for permanent pacemaker (PPM) implantation need to be identified.
Methods Digital databases were searched systematically to identify studies
reporting the incidence of PPM implantation after MVR. Detailed study and
patient-level baseline characteristics including the type of study, sample
size, follow-up, number of post-MVR PPM implantations, age, gender, and
baseline ECG abnormalities were abstracted. Results A total of 12 studies,
recruiting 37,124 patients were included in the final analysis. Overall,
2,820 (7.6%) patients required a PPM with the net rate ranging from 1.7%
to 10.96%. Post-MVR atrioventricular (AV) block was the most commonly
observed indication for PPM, followed by sinoatrial (SA) node dysfunction,
and bradycardia. Age, male gender, pre-existing comorbid conditions, prior
CABG, history of arrhythmias or using anti-arrhythmic drugs, AF ablation,
and double valve replacement were predictors of PPM implantation post-MVR.
Conclusion Age, male gender, comorbid conditions like diabetes and renal
impairment, prior CABG, double valve replacement, and anti-arrhythmic
drugs served as positive predictors of PPM implantation in patients
undergoing MVR. (Figure Presented).

<148>
Accession Number
638456137
Title
THE UTILITY OF EXERCISE-STRESS ECHOCARDIOGRAPHY FOR PRE-PREGNANCY RISK
STRATIFICATION IN PATIENTS WITH LEFT HEART OBSTRUCTION.
Source
Heart. Conference: British Cardiovascular Society Annual Conference, BCS
2022. Manchester United Kingdom. 108(Supplement 1) (pp A7-A8), 2022. Date
of Publication: June 2022.
Author
Malone S.; Steeds R.P.; Knight T.; Turvey-Haigh L.; Castleman J.; Morris
K.; Thorne S.; Hudsmith L.; Moody W.E.
Institution
(Malone) Queen Elizabeth, University Hospitals Birmingham, 48 Woodstock
Road, Birmingham WMD B139BN, United Kingdom
(Steeds, Turvey-Haigh, Hudsmith, Moody) Queen Elizabeth, University
Hospitals Birmingham, United Kingdom
(Knight, Castleman, Morris) Birmingham Women's and Children's, United
Kingdom
(Thorne) UHN Toronto General Hospital, Canada
Publisher
BMJ Publishing Group
Abstract
Introduction All women with cardiac disease wishing to embark on pregnancy
require appropriate pre-conception counselling. A variety of risk
stratification tools (mWHO, CARPREG II, ZAHARA) have been proposed to
inform shared-decision making and positively influence downstream
management. Although consensus guidelines recommend prepregnancy exercise
testing for all patients with known heart disease, thus far exercise
stress echocardiography (ESE) has not been routinely advised. There is,
however, potential for SE to provide complementary information among
patients with left heart obstruction, which confers a high risk of
maternal cardiovascular (CV) complications. We sought to determine the
relative value of ESE versus exercise ECG testing for the prediction of
adverse maternal CV events in patients with left heart obstruction.
Methods This was a retrospective observational cohort study; an electronic
database search identified 620 patients referred for ESE by cardiologists
with expertise in pregnancy, from January 2010 to July 2021 (Figure 1).
Left heart obstruction patients who conceived were included in analysis
(n=44, age 28+/-6 y). Baseline demographics were recorded and for each
pregnancy, mWHO, CARPREG II and ZAHARA risk scores were calculated.
Echocardiography procedures were performed by experienced operators (iE33
or EPIC, Philips Healthcare, Andover, Massachusetts) Patients underwent
semi-recumbent bicycle ergometer exercise stress using a WHO25 protocol.
An abnormal ESE was defined by the occurrence of: increase in AV mean
gradient >20 mmHg, increase in LVOT gradient to >50 mmHg, absence of left
ventricular contractile reserve, new dynamic severe MR, PASP >60 mmHg or
new wall motion abnormality. An abnormal exercise ECG test was defined by
the occurrence of chest pain, ST depression >=2 mm, a fall in systolic BP
or rise <20 mmHg, ventricular arrhythmia or METs <4. The occurrence of
pre-conception interventions, and post-conception adverse maternal CV and
obstetric events were recorded. Follow up was terminated at 6 months
post-partum. Results At baseline, out of the total of 44 patients, 24 had
at least mild congenital aortic stenosis, 8 had undergone previous aortic
valve replacement, and 12 had hypertrophic cardiomyopathy. Twenty-three
patients (52%) had an abnormal ESE and 21 patients (48%) had an abnormal
exercise ECG test. ESE helped guide 3 pre-conception aortic valve
replacements and 1 medical termination. In total, there were 7 adverse
maternal CV events (16%) and 10 adverse obstetric events (23%). Prior
cardiac medication (p=0.031) and multiple cardiac lesions (p=0.037) were
associated with adverse maternal CV events. Of those with abnormal ESE, 5
(22%) patients suffered an adverse maternal CV event, one of which had a
normal exercise ECG test. Patients with abnormal ESE accounted for 71% of
all adverse maternal CV events (RR= 2.1, 95% CI: 0.5-9.6, p=0.4) and 50%
of obstetric events (RR= 0.8, 95% CI: 0.3-2.5, p=1.0). The abnormal
exercise ECG group accounted for 57% of adverse maternal CV events
(RR=1.2, 95% CI: 0.3, 4.8), p=0.6) and 50% of obstetric events (RR= 0.91,
95% CI: 0.3-2.7, p= 1.0). Of the available risk scores, on ROC analysis, a
mWHO class of III-IV was the strongest predictor of CV events (AUC= 0.77,
RR: 9.7, 95% CI: 2.2- 42.2, P= 0.01). Conclusion Patients with abnormal
ESE results were twice as likely to suffer an adverse maternal CV event.
Abnormal ESE had a stronger association with the occurrence of adverse
maternal CV events than exercise ECG testing. These results suggest that
ESE provides additive prognostic information among high-risk patients with
left heart obstruction. (Figure Presented).

<149>
Accession Number
638455840
Title
Electrocautery smoke exposure and smoke evacuation in thoracic surgery: A
prospective randomized study.
Source
British Journal of Surgery. Conference: 109th Annual Swiss Congress of
Surgery. Berne Switzerland. 109(Supplement 3) (pp iii26), 2022. Date of
Publication: June 2022.
Author
Kocher G.J.; Dorn P.; Hutterli M.; Koss A.
Institution
(Kocher, Dorn) Department of Thoracic Surgery, Inselspital, Bern
University Hospital, Bern, Switzerland
(Hutterli, Koss) Mass Spectrometry,Tofwerk AG, Thun, Switzerland
Publisher
John Wiley and Sons Ltd
Abstract
Objective: Worldwide, health care professionals working in operating rooms
(ORs) are exposed to electrocautery smoke on a daily basis. Aims of this
studywere to determine the composition and concentrations of
electrocautery smoke in the OR using mass spectrometry and investigate
whether smoke evacuation systems, operative technique and distance to the
cautery source are effective in reducing exposure. Method(s):
Single-center study at our thoracic surgical unit including 122 surgical
procedures. Besides room air measurements away from the operating table
(n=35) and direct breath analysis (n=3), 84 minimally invasive and open
procedures were in each group 1:1 computer randomized to smoke evacuation
system (SES) versus no SES use and hazardous compounds were measured at
the height of the operating surgeons respiratory tract. Result(s):
Irritating, toxic, carcinogenic and mutagenic volaticle organic compounds
(VOCs) were observed in OR air, with some exceeding permissible exposure
limits (OSHA/NIOSH). Mean total concentration of harmful compounds at
surgeon height without SES was 273ppb (+/-189ppb) with a maximum total
concentration of harmful substances of 8991ppb > Maximum total VOC
concentrations were 1.6+/-1.2 ppm (minimally-invasive surgery) and
2.1+/-1.5 ppm (open surgery), and total maximum VOC concentrations were
1.8+/-1.3 ppm at the OR table and 1.4+/-1.0 ppm in OR air in general.
Neither difference was statistically significant. In open surgery, SES
significantly reduced maximum concentrations of specific VOCs at surgeon
height, including aromatics and aldehydes. Conclusion(s): Our data
indicate relevant exposure of health care professionals to volatile
organic compounds in the OR. Surgical technique and distance to cautery
devices did not significantly reduce exposure. SES reduced exposure to
specific harmful VOC's during open surgery.

<150>
Accession Number
2019272951
Title
Percutaneous Coronary Intervention of Native Artery Versus Bypass Graft in
Patients with Prior Coronary Artery Bypass Graft Surgery.
Source
Reviews in Cardiovascular Medicine. 23(7) (no pagination), 2022. Article
Number: 232. Date of Publication: 2022.
Author
Farag M.; Brilakis E.S.; Gasparini G.L.; Spratt J.C.; Egred M.
Institution
(Farag, Egred) Cardiothoracic Department, Freeman Hospital, Newcastle upon
Tyne NE7 7DN, United Kingdom
(Farag) School of Life and Medical Sciences, University of Hertfordshire,
Hertfordshire AL10 9AB, United Kingdom
(Brilakis) Minneapolis Heart Institute Foundation, Minneapolis, MN 55407,
United States
(Gasparini) Department of Invasive Cardiology, Humanitas Clinical and
Research Center IRCCS, Rozzano, Milan 20089, Italy
(Spratt) Department of Cardiology, St George's University Hospitals NHS
Foundation Trust, London SW17 0QT, United Kingdom
(Egred) Newcastle University Translational and Clinical Research
Institute, Newcastle upon Tyne NE1 7RU, United Kingdom
Publisher
IMR Press Limited
Abstract
Background: Percutaneous coronary intervention (PCI) is common in patients
with prior coronary artery bypass graft surgery (CABG), however, there is
limited data on the association between the PCI target-vessel and clinical
outcomes. In this article, we provide a state-of-the-art overview of the
contemporary management of patients with prior CABG and a clear indication
for revascularization. Method(s): We performed a structured
literature search of PubMed and Cochrane Library databases from inception
to March 2021. Relevant studies were extracted and synthesized for
narrative review. Result(s): Twenty-six observational studies
focusing on PCI of bypass graft versus native coronary artery lesions in
366,060 patients with prior CABG were included. The data from
observational studies suggest that bypass graft PCI is associated with
higher short- and long-term major adverse cardiac events compared to
native coronary artery PCI. Conclusion(s): Whenever feasible, native
coronary artery PCI should be the prioritized treatment for saphenous vein
graft failure. Prospective randomized trials are needed to elucidate the
optimal revascularization strategy for patients with prior
CABG. Copyright © 2022 The Author(s). Published by IMR Press.
This is an open access article under the CC BY 4.0 license.

<151>
Accession Number
2018229882
Title
Lifetime management when a redo is in the balance: Valve-in-valve
transcatheter aortic valve replacement or resurgical aortic valve
replacement in degenerated bioprostheses: A systematic review and
meta-analysis of short and midterm results.
Source
Catheterization and Cardiovascular Interventions. 100(1) (pp 131-132),
2022. Date of Publication: July 1, 2022.
Author
Alasnag M.
Institution
(Alasnag) King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia
Publisher
John Wiley and Sons Inc

<152>
Accession Number
2018229004
Title
Mid- to Long-Term Clinical and Echocardiographic Effects of
Post-procedural Permanent Pacemaker Implantation After Transcatheter
Aortic Valve Replacement: A Systematic Review and Meta-Analysis.
Source
Frontiers in Cardiovascular Medicine. 9 (no pagination), 2022. Article
Number: 911234. Date of Publication: 28 Jun 2022.
Author
Xu S.; Zhang E.; Qian Z.; Sun J.; Zou F.; Wang Y.; Hou X.; Zou J.
Institution
(Xu, Zhang, Qian, Sun, Wang, Hou, Zou) Department of Cardiology, The First
Affiliated Hospital of Nanjing Medical University, Nanjing, China
(Zou) Montefiore Medical Center, Bronx, NY, United States
Publisher
Frontiers Media S.A.
Abstract
Aims: To date, the prognostic effects of permanent pacemaker implantation
(PPI) after transcatheter aortic valve replacement (TAVR) remain
controversial. The purpose of this meta-analysis was to investigate the
mid- (1 year) to long-term (> 1 year) clinical and echocardiographic
effects of post-procedural PPI in patients after TAVR. Method(s):
PubMed, Embase, Web of Science, and Cochrane Library databases were
systematically searched from the establishment of databases up to 1
December 2021. Studies comparing clinical and echocardiographic outcomes
between patients with and without post-TAVR PPI of >= 1-year follow-up
were collected for further meta-analysis. Result(s): A total of 39
studies comprising of 83,082 patients were included in this meta-analysis.
At mid-term follow-up (1 year), the pooled results demonstrated a higher
risk of all-cause mortality in patients with post-procedural PPI than
those without following TAVR (relative risk (RR), 1.17; 95% CI, 1.10-1.24;
P < 0.00001). No significant differences were observed in cardiovascular
mortality (RR, 0.86; 95% CI, 0.71-1.03; P = 0.10) or heart failure
rehospitalization (RR, 0.91; 95% CI, 0.58-1.44; P = 0.69) at 1-year
follow-up. At long-term follow-up (> 1 year), post-TAVR PPI had negative
effects on all-cause mortality (RR, 1.18; 95% CI, 1.09-1.28; P < 0.0001)
and heart failure rehospitalization (RR, 1.42; 95% CI, 1.18-1.71; P =
0.0002). There was no difference in long-term cardiovascular mortality
between the two groups (RR, 1.15; 95% CI, 0.97-1.36; P = 0.11). Left
ventricular ejection fraction (LVEF) was not significantly different at
baseline (mean difference, 1.40; 95% CI, -0.13-2.93; P = 0.07), but was
significantly lower in the PPI group at 1-year follow-up (mean difference,
-3.57; 95% CI, -4.88 to -2.26; P < 0.00001). Conclusion(s): Our
meta-analysis provides evidence that post-TAVR PPI has negative clinical
and echocardiographic effects on patients at mid- to long-term follow-up.
Further studies are urgently needed to explore the cause of these
complications and optimize the treatment and management of patients
requiring permanent pacing after TAVR. Systematic Review Registration:
[https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021289935]
, identifier [CRD42021289935]. Copyright © 2022 Xu, Zhang, Qian,
Sun, Zou, Wang, Hou and Zou.

<153>
Accession Number
2018161681
Title
Treatment of Hyperlactatemia in Acute Circulatory Failure Based on
CO<inf>2</inf>-O<inf>2</inf>-Derived Indices: Study Protocol for a
Prospective, Multicentric, Single, Blind, Randomized, Superiority Study
(The LACTEL Study).
Source
Frontiers in Cardiovascular Medicine. 9 (no pagination), 2022. Article
Number: 898406. Date of Publication: 23 Jun 2022.
Author
Caruso V.; Besch G.; Nguyen M.; Pili-Floury S.; Bouhemad B.; Guinot P.-G.
Institution
(Caruso, Nguyen, Bouhemad, Guinot) Anaesthesiology and Critical Care
Department, Dijon Bourgogne University Hospital, Dijon, France
(Caruso, Nguyen, Bouhemad, Guinot) University of Burgundy Franche-Comte,
LNC UMR1231, Dijon, France
(Besch, Pili-Floury) Department of Anesthesiology and Intensive Care
Medicine, University Hospital of Besancon, Besancon, France
(Besch, Pili-Floury) EA3920, University of Franche-Comte, Besancon, France
Publisher
Frontiers Media S.A.
Abstract
Background: Hyperlactatemia is a biological marker of tissue hypoperfusion
with well-known diagnostic, prognostic, and therapeutic implications in
shock states. In daily clinical practice, it is difficult to find out the
exact mechanism underlying hyperlactatemia. Central venous to arterial
CO<inf>2</inf> difference (pCO<inf>2</inf> gap) is a better parameter of
tissue hypoperfusion than the usual ones (clinical examination and mixed
venous saturation). Furthermore, the ratio between the pCO<inf>2</inf> gap
and p(v-a)CO<inf>2</inf>/C(a-v)O<inf>2</inf> may be a promising indicator
of anaerobic metabolism, allowing for the identification of different
causes of tissue hypoxia and hyperlactatemia. The main aim of the study is
to demonstrate that initial hemodynamic resuscitation based on an
algorithm integrating the pCO<inf>2</inf> gap and
p(v-a)CO<inf>2</inf>/C(a-v)O<inf>2</inf> ratio vs. usual clinical practice
in acute circulatory failure improves lactate clearance. Method(s):
LACTEL is a randomized, prospective, multicentric, controlled study. It
compares the treatment of hyperlactatemia using an algorithm based on the
pCO<inf>2</inf> gap and P(v-a)CO<inf>2</inf>/C(a-v)O<inf>2</inf> ratio vs.
usual clinical practice in acute circulatory failure. A total of 90
patients were enrolled in each treatment group. The primary endpoint is
the number of patients with a lactate clearance of more than 10% 2 h after
inclusion. Lactate levels were monitored during the first 48 h of
treatment as hemodynamic parameters, biological markers of organ failure,
and 28-day mortality. Discussion(s): pCO<inf>2</inf> derivate indices
may be of better interest than routine clinical indices to differentiate
causes of hyperlactatemia and diagnose anaerobiosis. LACTEL results will
provide clinical insights into the role of these indices in the early
hemodynamic management of acute circulatory failure in the ICU. Clinical
Trial Registration: www.clinicaltrials.gov; identifier:
NCT05032521. Copyright © 2022 Caruso, Besch, Nguyen, Pili-Floury,
Bouhemad, Guinot and the Lactel Study Group.

<154>
Accession Number
2017459666
Title
Ultrasound-Guided Oblique Sagittal Anterior Quadratus Lumborum Block in
Total Hip Arthroplasty: A Randomized Controlled Trial.
Source
Pain Physician. 25(4) (pp E609-E617), 2022. Date of Publication: July
2022.
Author
Wang N.; Ruan B.; Wang M.; Chen L.; Ying T.; Ye W.; Li H.
Institution
(Wang, Ruan, Wang, Chen, Ying, Ye, Li) Department of Anesthesiology,
Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, China
Publisher
American Society of Interventional Pain Physicians
Abstract
Background: The anterior quadratus lumborum block (QLB) is gaining
popularity in total hip arthroplasty (THA) surgeries for postoperative
pain management and this technique rarely results in lower limb muscle
weakness. However, no studies have described the range of its blockade.
 Objective(s): The aim of the study was to confirm the range of cold
temperature sensory blockades, observe the opioid consumption after THA
surgery, assess the pain of the patients, and assess the safety of this
technique. Study Design: Randomized controlled study.
 Setting(s): Taizhou Hospital of Zhejiang Province. Method(s):
Patients who underwent primary THAs were randomized to take an oblique
sagittal anterior QLB with 30 mL of 0.375% ropivacaine (QLB+G group) or
with 30 mL of 0.9% saline (G group). The main purpose of the study was to
confirm the range of cold hypoesthesia. The other aim included the average
blood pressure, heart rate, surgical pleth index, and bispectral index
values fluctuation during the intraoperative period of expanding the
medullary cavity, the sufentanil, and remifentanil consumption during the
operation, the amount of time the patients stayed in the Postanesthesia
Care Unit, the 8 hours, 16 hours, and 24 hours total dosage of oxycodone,
the resting and exercise Visual Analog Scale (VAS) pain scores at 8 hours,
16 hours, and 24 hours after surgery, postoperative adverse events, and
safety. Result(s): The QLB+G group identified areas of cold
hypoesthesia after the block, but there were no areas of cold hypoesthesia
in the G group. The consumption of oxycodone in the 8 hours, 16 hours, and
24 hours after the surgery and the consumption of sufentanil during the
surgery were significantly smaller in the QLB+G group (P < 0.05). The
QLB+G group have lower pain scores at the resting 8 hours and exercise 8
hours, 16 hours, and 24 hours after the surgery (P < 0.05). The 2 groups
have comparable safety in the study. Limitation(s): This study only
tested the areas of cold hypoesthesia after the QLB, but not tested the
area of sensory loss. Using ice to test for hypoesthesia is subjective,
and may not reflect the actual area of the block. Conclusion(s):
Ultrasound-guided oblique sagittal anterior QLB can reduce the analgesics
required after and during THA and the postoperative VAS pain scores, but
it rarely affects muscle strength. Copyright © 2022, American
Society of Interventional Pain Physicians. All rights reserved.

<155>
Accession Number
2007393089
Title
How to screen for at-risk alcohol use in transplant patients? From
instrument selection to implementation of the AUDIT-C.
Source
Clinical Transplantation. 35(1) (no pagination), 2021. Article Number:
e14137. Date of Publication: January 2021.
Author
Verhalle L.; Van Bockstaele K.; Duerinckx N.; Vanhoof J.; Dierickx K.;
Neyens L.; Van Cleemput J.; Gryp S.; Kums D.; De Bondt K.; Schaevers V.;
Demuynck F.; Dewispelaere A.; Dobbels F.; Breunig C.; De Geest S.; Goris
K.; Pierco L.; Puttevils E.; Schoonis A.; Vandersmissen K.; Verheyen J.;
Wynants T.
Institution
(Verhalle, Van Bockstaele, Duerinckx, Vanhoof, Demuynck, Dewispelaere,
Dobbels) Academic Centre for Nursing and Midwifery, Department of Public
Health and Primary Care, KU Leuven, Leuven, Belgium
(Duerinckx, Van Cleemput, Gryp, Kums) Heart Transplant Program, Department
of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium
(Vanhoof) University Psychiatric Center, UPC KU Leuven, Leuven, Belgium
(Dierickx, Neyens, De Bondt) Department of Nephrology, University
Hospitals Leuven, Leuven, Belgium
(Schaevers) Lung Transplant Program, University Hospitals Leuven, Leuven,
Belgium
Publisher
John Wiley and Sons Inc
Abstract
Background: Given that drinking >2-3 units of alcohol daily might already
have adverse health effects, regular screening of at-risk drinking is
warranted. We aimed to select and pilot a short instrument to accurately
screen for at-risk drinking in transplant patients. Methodology and
results: Five consecutive steps were completed: A comprehensive literature
review identified 24 possible self-report instruments (step 1). These
instruments were scored on six yes/no criteria (ie, length, concept
measured, diagnostic accuracy, population, manual available, cost) (step
2). Four nurses piloted three instruments with the highest score and were
interviewed on their experiences with using the AUDIT-C, TWEAK, and Five
Shot. The AUDIT-C was the easiest to use and score, and items were clear.
Cognitive debriefings with 16 patients were conducted to verify clarity of
instructions and items, and suggestions were incorporated into a modified
version of the AUDIT-C (step 4). A convenience sample of 130
Dutch-speaking heart transplant patients completed the modified AUDIT-C
during a scheduled visit (Step 5), revealing that 27.6% of patients showed
at-risk drinking. Conclusion(s): The AUDIT-C might be a suitable
instrument to identify at-risk drinking in routine post-transplant
follow-up. Further validation, however, is indicated. Copyright ©
2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

<156>
[Use Link to view the full text]
Accession Number
2019234955
Title
Comparison of outcome of transcatheter aortic valve implantation in
patients with advanced age: A systematic review and meta-analysis.
Source
Medicine (United States). 99(31) (pp E21443), 2020. Date of Publication:
31 Jul 2020.
Author
Zhu S.; Li H.; Zhang G.; Liu S.; Li Z.
Institution
(Zhu, Li, Zhang, Liu) First Clinical Medical College, Lanzhou University,
China
(Li) Department of Hematology, The First Hospital of Lanzhou University,
Lanzhou 730000, China
Publisher
Lippincott Williams and Wilkins
Abstract
Background:Transcatheter aortic valve implantation (TAVI) is an effective
treatment to aortic stenosis in patients with advanced age. However, age
is recognized as one of the most important risk factors. The aim of our
study is to compare the outcome of TAVI between octogenarian patients and
young patients. Method(s):Randomized controlled trials, cohort
studies and propensity score matching studies will be included in our
systematic review and meta-analysis to evaluate clinical outcome in
octogenarian patients who undergo TAVI. PubMed, EMBASE, MEDLINE, Cochrane
Library and Web of Science will be searched using a comprehensive
strategy. The related conference proceedings and reference lists of the
included studies will also be checked to identify additional studies.
Retrieved records, extract information and assess the risk of bias will be
screened by two reviewers independently. STATA software will be used to
conduct data synthesis. There is no requirement of ethical approval and
informed consent. Result(s):This study will eventually be published
in a peer reviewed journal in the form of a scientific paper.
 Conclusion(s):This study will provide a comprehensive review of the
available evidence for the treatment of aortic stenosis in octogenarian
patients underwent TAVI. We hope it will provide a relatively
comprehensive reference for clinical practice and future relevant clinical
trials.PROSPERO registration number:CRD42020155189.Study protocol
registry:The protocol has been registered in PROSPERO, which is an
International Prospective Register of Systematic Reviews. The registration
number is CRD42020155189.Ethics and dissemination:Ethics approval and
patient consent are not required as this study is a systematic review and
meta-analysis. Copyright © 2020 Lippincott Williams and Wilkins.
All rights reserved.

<157>
[Use Link to view the full text]
Accession Number
2019234906
Title
The serratus anterior plane block for analgesia after thoracic surgery: A
meta-analysis of randomized controlled trails.
Source
Medicine (United States). 99(21) (no pagination), 2020. Article Number:
e20286. Date of Publication: 22 May 2020.
Author
Liu X.; Song T.; Xu H.-Y.; Chen X.; Yin P.; Zhang J.
Institution
(Liu, Song, Xu) Department of Anesthesiology, The First Hospital of Jilin
University, Jilin, Changchun, China
(Chen) Department of Anesthesiology, China-Japan Friendship Hospital,
Beijing, China
(Yin) Department of Anesthesiology, The Second Hospital of Shanxi Medical
University, Taiyuan, China
(Zhang) Department of Ophthalmology, The First Hospital of Jilin
University, Jilin, Changchun, China
Publisher
Lippincott Williams and Wilkins
Abstract
Background:The serratus anterior plane (SAP) block is a newer method that
can be used in patients undergoing thoracic surgeries. The postoperative
analgesia efficacy of SAP blocks for thoracic surgery remains
controversial. We conduct a meta-analysis to evaluate the analgesia of SAP
blocks after thoracic surgery. Method(s):We searched PubMed, Embase,
EBSCO, the Cochrane Library, Web of Science, and CNKI for randomized
controlled trials (RCTs) regarding the postoperative pain control of a SAP
block on thoracic surgery. All of the dates were screened and evaluated by
two researchers and meta-analysis was performed using RevMan5.3 software.
 Result(s):A total of 8 RCTs involving 542 patients were included. The
meta-analysis showed statistically significant differences between the two
groups with respect to postoperative pain scores at 2 h (standardized mean
difference [Std.MD] = -1.26; 95% confidence interval [CI] = -1.66 to
-0.86; P < .0001); 6 h (SMD = -0.50; 95%CI = -0.88 to -0.11; P = .01); 12
h (SMD = -0.63; 95%CI = -1.10 to -0.16; P = .009); 24 h (SMD = -0.99;
95%CI = -1.44 to -0.51; P < .0001); postoperative opioid consumption at 24
h (SMD = -0.83; 95%CI = -1.10 to -0.56; P < .00001); and postoperative
nausea and vomiting (PONV) rates (RR = 0.39; 95% CI = 0.21-0.73; P =
.003). Conclusion(s):The SAP block can play an important role in the
management of pain after thoracic surgery by reducing both pain scores and
24-h postoperative opioids consumption. In addition, there is fewer
incidence of PONV in the SAP block group. Copyright © 2020
Lippincott Williams and Wilkins. All rights reserved.

<158>
Accession Number
2018197887
Title
Postoperative Application of Dexmedetomidine is the Optimal Strategy to
Reduce the Incidence of Postoperative Delirium After Cardiac Surgery: A
Network Meta-Analysis of Randomized Controlled Trials.
Source
Annals of Pharmacotherapy. (no pagination), 2022. Date of Publication:
2022.
Author
Shang L.; Hou M.; Guo F.
Institution
(Shang, Hou, Guo) Department of Anesthesiology, The First Affiliated
Hospital of Shandong First Medical University Shandong Provincial
Qianfoshan Hospital, Shandong Institute of Anesthesia and Respiratory
Critical Medicine, Shandong, Jinan, China
Publisher
SAGE Publications Inc.
Abstract
Background: Previous pairwise meta-analyses demonstrated the efficacy and
safety of dexmedetomidine in preventing postoperative delirium (POD) after
cardiac surgery; however, the optimal time of applying dexmedetomidine
remains unclear. Objective(s): This network meta-analysis aimed to
determine the optimal time of using dexmedetomidine to reduce the
incidence of POD following cardiac surgery. Method(s): We first
retrieved eligible randomized controlled trials (RCTs) from previous
meta-analyses, and then an updated search was performed to identify
additional RCTs in PubMed, Embase, and the Cochrane library from January
1, 2021 to October 31, 2021. Two authors screened literature, collected
data, and evaluated bias risk of eligible studies. Finally, we performed
Bayesian network analysis using R version 3.6.1 with the "gemtc" and
"rjags" package. Result(s): Eighteen studies with 2636 patients were
included, and all studies were identified from previous meta-analyses.
Results showed that postoperative dexmedetomidine reduced the risk of POD
compared with normal saline (NS) (odds ratio [OR], 0.13; 95% credible
interval [CrI], 0.03-0.35) and propofol (PRO) (OR, 0.19; 95%CrI,
0.04-0.66). Postoperative dexmedetomidine was associated with a lower
incidence of POD compared with perioperative dexmedetomidine (OR, 0.21;
95% CrI, 0.04-0.82). Moreover, postoperative dexmedetomidine had the
highest probability of ranking best (90.98%), followed by intraoperative
dexmedetomidine (46.83%), PRO (36.94%), perioperative dexmedetomidine
(30.85%), and NS (60.02%). Conclusion and Relevance: Dexmedetomidine
reduces the incidence of POD compared with PRO and NS in patients
undergoing cardiac surgery, and postoperative application of
dexmedetomidine is the optimal time. Copyright © The Author(s)
2022.

<159>
Accession Number
638468482
Title
Concomitant tricuspid annuloplasty in patients with mild to moderate
tricuspid valve regurgitation undergoing mitral valve surgery:
meta-analysis.
Source
The Journal of cardiovascular surgery. (no pagination), 2022. Date of
Publication: 13 Jul 2022.
Author
Yokoyama Y.; Tsukagoshi J.; Takagi H.; Takayama H.; Kuno T.
Institution
(Yokoyama) Department of Surgery, St. Luke's University Health Network,
PA, Bethlehem, United States
(Tsukagoshi) Department of Surgery, University of Texas Medical Branch,
TX, Galveston, United States
(Takagi) Department of Cardiovascular Surgery, Shizuoka Medical Center,
Shizuoka, Japan
(Takayama) Department of Surgery, Columbia University Medical Center, NY,
NY, United States
(Kuno) Department of Cardiology, Montefiore Medical Center, Albert
Einstein College of Medicine, NY, NY, United States
Publisher
NLM (Medline)
Abstract
OBJECTIVE: Clinical effects of concomitant tricuspid annuloplasty (TA) in
patients with mild to moderate tricuspid regurgitation at the time of
mitral valve surgery (MVS) remains indefinite. We aimed to perform a
meta-analysis to determine the long-term clinical and echocardiographic
effects of concomitant TA in patients undergoing MVS. EVIDENCE
ACQUISITION: MEDLINE and EMBASE were searched through January 2022 to
identify randomized controlled trials (RCT) and observational studies with
adjusted outcomes that investigated outcomes of concomitant TA versus
conservative management for mild to moderate tricuspid regurgitation in
patients undergoing MVS. EVIDENCE SYNTHESIS: Two RCT and 11 observational
studies included in the meta-analysis with a total of 3,953 patients
underwent MVS with (n = 1,837) or without (n = 2,166) concomitant TA. Mean
follow-up period ranged from 24 to 115.5 months. MVS with concomitant TA
was associated with all-cause mortality (hazard ration [HR] 1.15; 95%
confidence interval [CI]: 0.81-1.55; p = 0.34, I2=0%) compared with MVS
alone. Similarly, heart failure events (HR 0.74; 95% CI: 0.46-1.20; p =
0.22, I2=0%) as well as rates of tricuspid reoperation (HR 0.55; 95% CI:
0.27-1.10; p = 0.09, I2=1%) were comparable between the groups. However,
MVS with concomitant TA was associated with a significant reduction in TR
progression (HR 0.30; 95% CI: 0.17-0.53; p < 0.00001, I2=11%).
 CONCLUSION(S): Concomitant TA for patients undergoing MVS was
associated with similar long-term clinical outcomes compared to MVS alone.
However, concomitant TA was associated with a significant reduction in TR
progression. Longer follow-up is necessary to assess the effect on further
clinical outcomes.

<160>
Accession Number
638464650
Title
Practice Changing Updates in Perioperative Medicine Literature 2020- 2021.
A Systematic Review.
Source
The American journal of medicine. (no pagination), 2022. Date of
Publication: 09 Jul 2022.
Author
Khambaty M.; Silbert R.E.; Devalapalli A.P.; Kashiwagi D.T.; Regan D.W.;
Sundsted K.K.; Mauck K.F.
Institution
(Khambaty, Devalapalli, Regan) Division of Hospital Internal Medicine,
Department of Medicine, Mayo Clinic and Mayo Clinic College of Medicine,
MN, Rochester, United States
(Silbert, Sundsted, Mauck) Division of General Internal Medicine,
Department of Medicine, Mayo Clinic and Mayo Clinic College of Medicine,
MN, Rochester, United States
(Kashiwagi) Division of Hospital Internal Medicine, Department of
Medicine, Mayo Clinic and Mayo Clinic College of Medicine, Rochester, MN,
USA; Division Chair, Internal Medicine, Sheikh Shakhbout Medical City in
partnership with Mayo Clinic, Abu Dhabi, United Arab Emirates
Publisher
NLM (Medline)
Abstract
Recent literature published in a variety of multidisciplinary journals has
significantly influenced perioperative patient care. Distilling and
synthetizing the clinically important literature can be challenging. This
review summarizes practice changing articles in perioperative medicine
from the years 2020 and 2021. Embase, Ovid, and EBM reviews databases were
queried from January 2020 to December 2021. Inclusion criteria were
original research, systematic review, metaanalysis, and important
guidelines. Exclusion criteria were conference abstracts, case reports,
letters, protocols, pediatric and obstetric articles, and cardiac surgery
literature. Two authors reviewed each reference using the Distiller SR
systematic review software (Evidence Partners Inc., Ottawa, Ontario,
Canada). A modified Delphi technique was used to identify nine practice
changing articles. We identified another 13 articles for tabular summaries
as they were relevant to an internist's perioperative evaluation of a
patient. Articles were selected to highlight the clinical implications of
new evidence in each field. We have also pointed out limitations of each
study and clinical populations where they are not
applicable. Copyright © 2022. Published by Elsevier Inc.

<161>
Accession Number
638461760
Title
Prothrombin Complex Concentrate vs Plasma for Post-Cardiopulmonary Bypass
Coagulopathy and Bleeding: A Randomized Clinical Trial.
Source
JAMA Surgery. (no pagination), 2022. Date of Publication: 2022.
Author
Smith M.M.; Schroeder D.R.; Nelson J.A.; Mauermann W.J.; Welsby I.J.;
Pochettino A.; Montonye B.L.; Assawakawintip C.; Nuttall G.A.
Institution
(Smith, Nelson, Mauermann, Nuttall) Division of Cardiovascular and
Thoracic Anesthesia, Department of Anesthesiology and Perioperative
Medicine, Mayo Clinic, College of Medicine and Science, 200 1st St SW,
Rochester, MN 55905, United States
(Schroeder) Department of Biomedical Statistics and Informatics, Mayo
Clinic, College of Medicine and Science, Rochester, MN, United States
(Welsby) Department of Anesthesiology, Duke University Medical Center,
Durham, NC, United States
(Pochettino) Division of Cardiovascular Surgery, Department of Surgery,
Mayo Clinic, College of Medicine and Science, Rochester, MN, United States
(Montonye) Anesthesia Clinical Research Unit, Mayo Clinic, College of
Medicine and Science, Rochester, MN, United States
(Assawakawintip) Department of Anesthesiology, Wetchakarunrasm Hospital,
Bangkok, Thailand
Publisher
American Medical Association
Abstract
Importance: Post-cardiopulmonary bypass (CPB) coagulopathy and bleeding
are among the most common reasons for blood product transfusion in
surgical practices. Current retrospective data suggest lower transfusion
rates and blood loss in patients receiving prothrombin complex concentrate
(PCC) compared with plasma after cardiac surgery. Objective(s): To
analyze perioperative bleeding and transfusion outcomes in patients
undergoing cardiac surgery who develop microvascular bleeding and receive
treatment with either PCC or plasma. Design, Setting, and
Participant(s): A single-institution, prospective, randomized clinical
trial performed at a high-volume cardiac surgical center. Patients were
aged 18 years or older and undergoing cardiac surgery with CPB. Patients
undergoing complex cardiac surgical procedures (eg, aortic replacement
surgery, multiple procedures, or repeated sternotomy) were preferentially
targeted for enrollment. During the study period, 756 patients were
approached for enrollment, and 553 patients were randomized. Of the 553
randomized patients, 100 patients met criteria for study intervention.
 Intervention(s): Patients with excessive microvascular bleeding, a
prothombin time (PT) greater than 16.6 seconds, and an international
normalized ratio (INR) greater than 1.6 were randomized to receive
treatment with either PCC or plasma. The PCC dose was 15 IU/kg or closest
standardized dose; the plasma dose was a suggested volume of 10 to 15
mL/kg rounded to the nearest unit. Main Outcomes and Measures: The
primary outcome was postoperative bleeding (chest tube output) from the
initial postsurgical intensive care unit admission through midnight on
postoperative day 1. Secondary outcomes were PT/INR, rates of
intraoperative red blood cell (RBC) transfusion after treatment, avoidance
of allogeneic transfusion from the intraoperative period to the end of
postoperative day 1, postoperative bleeding, and adverse events.
 Result(s): One hundred patients (mean [SD] age, 66.8 [13.7] years; 61
[61.0%] male; and 1 [1.0%] Black, 1 [1.0%] Hispanic, and 98 [98.0%] White)
received the study intervention (49 plasma and 51 PCC). There was no
significant difference in chest tube output between the plasma and PCC
groups (median [IQR], 1022 [799-1575] mL vs 937 [708-1443] mL). After
treatment, patients in the PCC arm had a greater improvement in PT (effect
estimate, -1.37 seconds [95% CI, -1.91 to -0.84]; P <.001) and INR (effect
estimate, -0.12 [95% CI, -0.16 to -0.07]; P <.001). Fewer patients in the
PCC group required intraoperative RBC transfusion after treatment (7 of 51
patients [13.7%] vs 15 of 49 patients [30.6%]; P =.04); total
intraoperative transfusion rates were not significantly different between
groups. Seven (13.7%) of 51 patients receiving PCCs avoided allogeneic
transfusion from the intraoperative period to the end of postoperative day
1 vs none of those receiving plasma. There were no significant differences
in postoperative bleeding, transfusions, or adverse events.
 Conclusions and Relevance: The results of this study suggest a
similar overall safety and efficacy profile for PCCs compared with plasma
in this clinical context, with fewer posttreatment intraoperative RBC
transfusions, improved PT/INR correction, and higher likelihood of
allogeneic transfusion avoidance in patients receiving PCCs. Trial
Registration: ClinicalTrials.gov Identifier: NCT02557672. Copyright
© 2022 American Medical Association. All rights reserved.

<162>
Accession Number
2004555956
Title
Understanding and addressing variation in health care-associated
infections after durable ventricular assist device therapy: Protocol for a
mixed methods study.
Source
JMIR Research Protocols. 9(1) (no pagination), 2020. Article Number:
e14701. Date of Publication: 2020.
Author
Chandanabhumma P.P.; Fetters M.D.; Pagani F.D.; Malani P.N.; Hollingsworth
J.M.; Funk R.J.; Aaronson K.D.; Zhang M.; Kormos R.L.; Chenoweth C.E.;
Shore S.; Watt T.M.F.; Cabrera L.; Likosky D.
Institution
(Chandanabhumma, Fetters) Mixed Methods Program, Department of Family
Medicine, University of Michigan, Ann Arbor, MI, United States
(Pagani, Watt, Cabrera, Likosky) Department of Cardiac Surgery, University
of Michigan, 1500 E Medical Center Dr, Ann Arbor, MI 48109, United States
(Malani, Chenoweth) Division of Infectious Diseases, Department of
Internal Medicine, University of Michigan, Ann Arbor, MI, United States
(Hollingsworth) Department of Urology, University of Michigan, Ann Arbor,
MI, United States
(Funk) Department of Strategic Management and Entrepreneurship, Carlson
School of Management, University of Minnesota, Minneapolis, MN, United
States
(Aaronson, Shore) Division of Cardiovascular Medicine, Department of
Internal Medicine, University of Michigan, Ann Arbor, MI, United States
(Zhang) Department of Biostatistics, School of Public Health, University
of Michigan, Ann Arbor, MI, United States
(Kormos) Department of Cardiothoracic Surgery, University of Pittsburgh
Medical Center, Pittsburgh, PA, United States
Publisher
JMIR Publications Inc.
Abstract
Background: Durable ventricular assist device (VAD) therapy is reserved
for patients with advanced heart failure who have a poor estimated 1-year
survival. However, despite highly protocolized management processes,
patients are at a unique risk for developing a health care-associated
infection (HAI). Few studies have examined optimal strategies for HAI
prevention after durable VAD implantation, despite variability in rates
across centers and their impact on short- and long-term outcomes.
 Objective(s): The objective of this study is to develop
recommendations for preventing the most significant HAIs after durable VAD
implantation. The study has 3 specific aims: (1) identify determinants of
center-level variability in HAI rates, (2) develop comprehensive
understanding of barriers and facilitators for achieving low center-level
HAI rates, and (3) develop and disseminate a best practices toolkit for
preventing HAIs that accommodates various center contexts. Method(s):
This is a sequential mixed methods study starting with a cross-sectional
assessment of current practices. To address aim 1, we will conduct (1) a
systematic review of HAI prevention studies and (2) in-depth quantitative
analyses using administrative claims, in-depth clinical data, and
organizational surveys of VAD centers. For aim 2, we will apply a mixed
methods patient tracer assessment framework to conduct semistructured
interviews, field observations, and document analysis informed by findings
from aim 1 at 5 high-performing (ie, low HAIs) and 5 low-performing (ie,
high HAI) centers, which will be examined using a mixed methods case
series analysis. For aim 3, we will build upon the findings from the
previous aims to develop and field test an HAI preventive toolkit, acquire
stakeholder input at an annual cardiac surgical conference, disseminate
the final version to VAD centers nationwide, and conduct follow-up surveys
to assess the toolkit's adoption. Result(s): The project was funded
by the Agency for Healthcare Research and Quality in 2018 and enrollment
for the overall project is ongoing. Data analysis is currently under way
and the first results are expected to be submitted for publication in
2019. Conclusion(s): This mixed methods study seeks to quantitatively
assess the determinants of HAIs across clinical centers and qualitatively
identify the context-specific facilitators and barriers for attaining low
HAI rates. The mixed data findings will be used to develop and disseminate
a stakeholder-acceptable toolkit of evidence-based HAI prevention
recommendations that will accommodate the specific contexts and needs of
VAD centers. Copyright © 2020 Journal of Medical Internet
Research. All rights reserved.

<163>
Accession Number
2015880690
Title
Short-term dual antiplatelet therapy in diabetic patients admitted for
acute coronary syndrome treated with a new-generation drug-eluting stent.
Source
Diabetes/Metabolism Research and Reviews. 38(5) (no pagination), 2022.
Article Number: e3530. Date of Publication: July 2022.
Author
Vranken N.P.A.; Rasoul S.; Luijkx J.J.P.; Pustjens T.F.S.; Postma S.;
Kolkman E.J.; Kedhi E.; Rifqi S.; Lee M.K.Y.; Ebelt H.; Merkely B.;
Verdoia M.; Wojakowski W.; van 't Hof A.A.W.J.; Suryapranata H.; De Luca
G.
Institution
(Vranken, Rasoul, Luijkx, Pustjens, van 't Hof) Department of Cardiology,
Zuyderland Medical Centre, Heerlen, Netherlands
(Postma, Kolkman) Diagram B.V., Zwolle, Netherlands
(Kedhi) Department of Cardiology, Erasmus Hospital, Brussels, Belgium
(Rifqi) Department of Cardiology, Dr. Kariadi Hospital, Semarang,
Indonesia
(Lee) Department of Cardiology, Queen Elizabeth Hospital, Hong Kong
(Ebelt) Department of Cardiology, Catholic Hospital of Johann Nepomuk,
Erfurt, Germany
(Merkely) Department of Cardiology, Semmelweis University Heart and
Vascular Center, Budapest, Hungary
(Verdoia) Division of Cardiology, Ospedale degli Infermi, ASL Biella,
Biella, Italy
(Verdoia, De Luca) Division of Clinical and Experimental Cardiology, AOU
Sassari, University of Sassari, Sassari, Italy
(Wojakowski) Department of Cardiology, Medical University of Silezia,
Katowice, Poland
(van 't Hof) Department of Cardiology, Isala, Zwolle, Netherlands
(Suryapranata) Department of Cardiology, Radboud University Medical
Centre, Nijmegen, Netherlands
Publisher
John Wiley and Sons Ltd
Abstract
Background: The optimal duration of dual antiplatelet therapy (DAPT) in
patients with diabetes mellitus (DM) admitted with acute coronary syndrome
(ACS) and treated with a drug-eluting stent (DES) remains unclear. This is
a prespecified sub-study from the Randomised Evaluation of short-term DUal
antiplatelet therapy in patients with acute Coronary syndromE treated with
a new generation DES (REDUCE) trial that was designed to determine the
efficacy and safety of short-term versus standard 12 months DAPT in
diabetic patients with ACS undergoing percutaneous coronary intervention
(PCI) using the COMBO stent. Method(s): In this study we included ACS
diabetic patients enroled in the REDUCE trial treated with the COMBO stent
and randomly assigned to either 3 or 12 months of DAPT. The primary study
endpoint was the composite of all-cause mortality, myocardial infarction
(MI), stent thrombosis (ST), stroke, target vessel revascularisation
(TVR), and bleeding complications at 12 and 24 months follow-up.
 Result(s): A total of 307 diabetic patients were included, of which
162 (52.8%) in the 3 months DAPT group and 145 (47.2%) in the 12 months
DAPT group. Patient characteristics, PCI success, and number of stents
used were similar in the 3 and 12 months DAPT groups. Occurrence of the
primary study endpoint at 12 and 24 months follow-up was comparable
between the two groups (3.1 vs. 3.5%, p = 0.865, and 15.8 vs. 14.9%, p =
0.824, respectively). Moreover, the prevalence of the specific clinical
outcome parameters (all-cause mortality), MI, ST, stroke, TVR, and
bleeding was similar in both study groups. Conclusion(s): This
sub-analysis shows similar clinical outcomes following 3 months DAPT as
compared to 12 months DAPT in diabetic patients undergoing PCI for ACS
using the COMBO stent. These results suggest that, even in this particular
subset of patients, short duration of DAPT might be considered safe.
Future larger studies are warranted to provide more precise estimations in
terms of safety and efficacy of short term DAPT in these high-risk
patients. Copyright © 2022 The Authors. Diabetes/Metabolism
Research and Reviews published by John Wiley & Sons Ltd.

<164>
Accession Number
2017985983
Title
Parasternal After Cardiac Surgery (PACS): a prospective, randomised,
double-blinded, placebo-controlled trial study protocol for evaluating a
continuous bilateral parasternal block with lidocaine after open cardiac
surgery through sternotomy.
Source
Trials. 23(1) (no pagination), 2022. Article Number: 516. Date of
Publication: December 2022.
Author
Larsson M.; Sartipy U.; Franco-Cereceda A.; Owall A.; Jakobsson J.
Institution
(Larsson, Sartipy, Franco-Cereceda, Owall) Department of Molecular
Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
(Larsson, Owall) Function Perioperative Medicine and Intensive Care,
Section for Cardiothoracic Anaesthesia and Intensive Care, Karolinska
University Hospital, Stockholm, Sweden
(Sartipy, Franco-Cereceda) Department of Cardiothoracic Surgery,
Karolinska University Hospital, Stockholm, Sweden
(Jakobsson) Institution for Clinical Sciences, Karolinska Institutet at
Danderyds Hospital, Stockholm, Sweden
(Jakobsson) Department of Anaesthesia and Intensive Care, Danderyds
Hospital, Stockholm, Sweden
Publisher
BioMed Central Ltd
Abstract
Background: Multimodal analgesia that provides optimal pain treatment with
minimal side effects is important for optimal recovery after open cardiac
surgery. Regional anaesthesia can be used to block noxious nerve signals.
Because sternotomy causes considerable pain that lasts several days, a
continuous nerve block is advantageous. Previous studies on continuous
sternal wound infusion or parasternal blocks with long-acting local
anaesthetics have shown mixed results. This study aims to determine
whether a continuous bilateral parasternal block with lidocaine, which is
a short-acting local anaesthetic that has a favourable safety/toxicity
profile, results in effective analgesia. We hypothesise that a 72-hour
continuous parasternal block with 0.5% lidocaine at a rate of 7 ml/hour on
each side provides effective analgesia and reduces opioid requirement. We
will evaluate whether recovery is enhanced. Method(s): In a
prospective, randomised, double-blinded manner, 45 patients will receive a
continuous parasternal block with either 0.5% lidocaine or saline. The
primary endpoint is cumulated intravenous morphine by patient-controlled
analgesia at 72 hours. Secondary end-points include the following: (1) the
cumulated numerical rating scale (NRS) score recorded three times daily at
72 hours; (2) the cumulated NRS score after two deep breaths three times
daily at 72 hours; (3) the NRS score at rest and after two deep breaths at
2, 4, 8 and 12 weeks after surgery; (4) oxycodone requirement at 2, 4, 8
and 12 weeks after surgery; (5) Quality of Recovery-15 score
preoperatively compared with that at 24, 48 and 72 hours, and at 2, 4, 8
and 12 weeks after surgery; (6) preoperative peak expiratory flow compared
with postoperative daily values for 3 days; and (7) serum concentrations
of interleukin-6 and lidocaine at 1, 24, 48 and 72 hours postoperatively
compared with preoperative values. Discussion(s): Adequate analgesia
is important for quality of care and vital to a rapid recovery after
cardiac surgery. This study aims to determine whether a continuous
parasternal block with a short-acting local anaesthetic improves analgesia
and recovery after open cardiac procedures. Trial registration: The study
was registered in the European Clinical Trials Database on 27/9/2019
(registration number: 2018-004672-35). Copyright © 2022, The
Author(s).

<165>
Accession Number
2017080626
Title
Diagnostic concordance and discordance between angiography-based
quantitative flow ratio and fractional flow reserve derived from computed
tomography in complex coronary artery disease.
Source
Journal of Cardiovascular Computed Tomography. 16(4) (pp 336-342), 2022.
Date of Publication: 01 Jul 2022.
Author
Kawashima H.; Kogame N.; Ono M.; Hara H.; Takahashi K.; Reiber J.H.C.;
Thomsen B.; de Winter R.J.; Tanaka K.; La Meir M.; de Mey J.; Schneider
U.; Doenst T.; Teichgraber U.; Wijns W.; Mushtaq S.; Pompilio G.;
Bartorelli A.L.; Andreini D.; Serruys P.W.; Onuma Y.
Institution
(Kawashima, Ono, Hara, Wijns, Serruys, Onuma) Discipline of Cardiology,
Saolta Group, Galway University Hospital, Health Service Executive and
CORRIB Core Lab, National University of Ireland Galway (NUIG), Galway,
Ireland
(Kawashima, Kogame, Ono, Hara, Takahashi, de Winter) Department of
Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam,
Netherlands
(Kawashima) Division of Cardiology, Department of Internal Medicine,
Teikyo University Hospital, Tokyo, Japan
(Reiber) Department of Radiology, Leiden University Medical Center,
Leiden, Netherlands
(Thomsen) GE Healthcare, Milwaukee, WI, United States
(Tanaka, La Meir, de Mey) Universitair Ziekenhuis Brussel, VUB, Brussels,
Belgium
(Schneider, Doenst, Teichgraber) Jena University Hospital,
Friedrich-Schiller-University of Jena, Jena, Germany
(Wijns, Serruys, Onuma) CURAM, The SFI Research Centre for Medical
Devices, Galway, Ireland
(Mushtaq, Pompilio, Bartorelli, Andreini) Centro Cardiologico Monzino,
IRCCS, Milan, Italy
(Pompilio) Department of Biomedical, Surgical and Dental Sciences,
University of Milan, Milan, Italy
(Bartorelli) Department of Biomedical and Clinical Sciences "Luigi Sacco",
University of Milan, Milan, Italy
(Andreini) Department of Clinical Sciences and Community Health,
Cardiovascular Section, University of Milan, Milan, Italy
(Serruys) NHLI, Imperial College London, London, United Kingdom
Publisher
Elsevier Inc.
Abstract
Background: Both quantitative flow ratio (QFR) and fractional flow reserve
derived from computed tomography (FFR<inf>CT</inf>) have shown significant
correlations with invasive wire-based fractional flow reserve. However,
the correlation between QFR and FFR<inf>CT</inf> is not fully investigated
in patients with complex coronary artery disease (CAD). The aim of this
study is to investigate the correlation and agreement between QFR and
FFR<inf>CT</inf> in patients with de novo three-vessel disease and/or left
main CAD. Method(s): This is a post-hoc sub-analysis of the
international, multicenter, and randomized SYNTAX III REVOLUTION trial, in
which both invasive coronary angiography and coronary computed tomography
angiography were prospectively obtained prior to the heart team
discussion. QFR was performed in an independent core laboratory and
compared with FFR<inf>CT</inf> analyzed by HeartFlowTM. The correlation
and agreement between QFR and FFR<inf>CT</inf> were assessed per vessel.
Furthermore, independent factors of diagnostic discordance between QFR and
FFR<inf>CT</inf> were evaluated. Result(s): Out of 223 patients, 40
patients were excluded from this analysis due to the unavailability of
FFR<inf>CT</inf> and/or QFR, and a total of 469 vessels (183 patients)
were analyzed. There was a strong correlation between QFR and
FFR<inf>CT</inf> (R = 0.759; p < 0.001), and the Bland-Altman analysis
demonstrated a mean difference of -0.005 and a standard deviation of
0.116. An independent predictor of diagnostic concordance between QFR and
FFR<inf>CT</inf> was the lesion location in right coronary artery (RCA)
(odds ratio 0.395; 95% confidence interval 0.174-0.894; P = 0.026).
 Conclusion(s): In patients with complex CAD, QFR and FFR<inf>CT</inf>
were strongly correlated. The location of the lesion in RCA was associated
with the highest diagnostic concordance between QFR and
FFR<inf>CT</inf>. Copyright © 2022 The Authors

<166>
Accession Number
638339170
Title
Trunk stabilising exercises promote sternal stability in patients after
median sternotomy for heart valve surgery: a randomised trial.
Source
Journal of physiotherapy. 68(3) (pp 197-202), 2022. Date of Publication:
01 Jul 2022.
Author
Essam El-Sayed Felaya E.-S.; Abd Al-Salam E.H.; Shaaban Abd El-Azeim A.
Institution
(Essam El-Sayed Felaya) Department of Physical Therapy for Internal
Medicine, Faculty of Physical Therapy, Cairo University, Giza, Egypt
(Abd Al-Salam) Department of Diagnostic Imaging, National Heart Institute,
Giza, Egypt
(Shaaban Abd El-Azeim) Department of Basic Science, Faculty of Physical
Therapy, Cairo University, Giza, Egypt
Publisher
NLM (Medline)
Abstract
QUESTION: What is the effect of trunk stabilising exercises on sternal
stability in women who have undergone heart valve surgery via median
sternotomy? DESIGN: Randomised controlled trial with concealed allocation,
assessor blinding and intention-to-treat analysis. PARTICIPANTS:
Thirty-six women aged 40 to 50 years who had undergone heart valve surgery
via median sternotomy 7 days before enrolment. INTERVENTION: All
participants in both groups received cardiac rehabilitation during
hospitalisation and three times per week for 4 weeks after discharge. In
addition, participants in the experimental group were prescribed a regimen
of trunk stabilising exercises to be performed three times per week for 4
weeks. At each exercise session, each of 11 exercises were to be performed
with five to ten repetitions. OUTCOME MEASURES: The primary outcome was
sternal separation (the distance between the two halves of the bisected
sternum). The secondary outcome was the Sternal Instability Scale from 0
(no instability) to 3 (an unstable sternum with substantial movement or
separation). Measures were taken before and after the 4-week intervention
period. RESULT(S): After the 4-week intervention period, the
experimental group had a greater decrease in sternal separation by 0.09 cm
(95% CI 0.07 to 0.11). The experimental group was twice as likely to
improve by at least one grade on the Sternal Instability Scale by 4 weeks
(RR 2.00, 95% CI 1.07 to 3.75). The experimental group was almost three
times as likely to have a clinically stable sternum (grade 0 on the
Sternal Instability Scale) by 4 weeks (RR 2.75, 95% CI 1.07 to 7.04).
 CONCLUSION(S): Trunk stabilising exercises were an effective and
feasible method of promoting sternal stability in women who underwent
heart valve surgery via median sternotomy. TRIAL REGISTRATION:
NCT04632914. Copyright © 2022 Australian Physiotherapy
Association. Published by Elsevier B.V. All rights reserved.

<167>
Accession Number
638279975
Title
The impact of coronary artery bypass grafting added to aortic valve
replacement on long-term outcomes in octogenarian patients: a
reconstructed time-to-event meta-analysis.
Source
Interactive cardiovascular and thoracic surgery. 35(2) (no pagination),
2022. Date of Publication: 09 Jul 2022.
Author
Gallingani A.; D'Alessandro S.; Singh G.; Hernandez-Vaquero D.; Celik M.;
Ceccato E.; Nicolini F.; Formica F.
Institution
(Gallingani) Cardiac Surgery Unit, Parma University Hospital, Parma, Italy
(D'Alessandro) Cardiac Surgery Unit, San Gerardo Hospital, Monza, Italy
(Singh) Department of Critical Care Medicine and Division of Cardiac
Surgery, University of Alberta, Edmonton, Canada
(Hernandez-Vaquero) Cardiac Surgery Department, Hospital Universitario
Central de Asturias, Oviedo, Spain
(Celik) Department of Cardiothoracic Surgery, Erasmus University Medical
Center, Rotterdam, Netherlands
(Ceccato, Nicolini, Formica) Medical Library, University of Parma, Parma,
Italy
(Nicolini, Formica) Department of Medicine and Surgery, University of
Parma, Parma, Italy
Publisher
NLM (Medline)
Abstract
The long-term results in studies comparing octogenarian patients who
received either isolated surgical aortic valve replacement (i-SAVR) or
coronary artery bypass grafting (CABG) in addition to SAVR are still
debated. We performed a reconstructed time-to-event data meta-analysis of
studies comparing i-SAVR and CABG+SAVR to evaluate the impact of CABG and
to analyse the time-varying effects on long-term outcome. We performed a
systematic review of the literature from January 2000 through November
2021, including studies comparing i-SAVR and CABG+SAVR, which reported at
least 3-year follow-up and that plotted Kaplan-Meier curves of overall
survival. The primary endpoint was overall long-term survival; secondary
endpoints were in-hospital/30-day mortality and postoperative outcomes.
The pooled hazard ratio (HR) and odds ratio) with 95% confidence interval
(CI) were calculated for primary and secondary endpoints, respectively.
Random-effect model was used in all analyses. Sixteen retrospective
studies were included (5382 patients, i-SAVR=2568 and CABG+SAVR=2814).
I-SAVR showed a lower incidence of in-hospital mortality compared to
CABG+SAVR (odds ratio=0.73; 95% CI= 0.60-0.89; P=0.002). Landmark analyses
showed a significantly higher all-cause mortality within 1 year from
surgery in CABG+SAVR (HR=1.17; 95% CI=1.01-1.36; P=0.03); after 1 year, no
significant difference was observed (HR=0.95; 95% CI=0.87-1.04; P=0.35).
Landmark analysis was confirmed by time-varying trend of HR. Late survival
of octogenarians did not differ significantly between the 2 interventions.
Interestingly, CABG added to SAVR was associated with both higher
in-hospital and within 1-year mortality after surgery, whereas this
difference was statistically non-significant at long-term
follow-up. Copyright © The Author(s) 2022. Published by Oxford
University Press on behalf of the European Association for Cardio-Thoracic
Surgery.

<168>
Accession Number
2016816683
Title
Preclosure of large bore venous access sites in patients undergoing
transcatheter mitral replacement and repair.
Source
Catheterization and Cardiovascular Interventions. 100(1) (pp 163-168),
2022. Date of Publication: July 1, 2022.
Author
Mohammed M.; Nona P.; Abou Asala E.; Chiang M.; Lemor A.; O'Neill B.;
Frisoli T.; Lee J.; Wang D.D.; O'Neill W.W.; Eng M.; Villablanca P.A.
Institution
(Mohammed, Abou Asala) Department of Medicine, Henry Ford Hospital,
Detroit, MI, United States
(Nona, Chiang, Lemor, O'Neill, Frisoli, Lee, Wang, O'Neill, Eng,
Villablanca) Center for Structural Heart Disease, Henry Ford Hospital,
Detroit, MI, United States
Publisher
John Wiley and Sons Inc
Abstract
Objective: We aim to report on the efficacy and safety of large bore
venous access (LBVA) preclosure with PercloseTM (Abbott Vascular Devices)
suture-mediated device use following transcatheter edge-to-edge (TEER) and
replacement (TMVR). Background(s): Patients requiring TEER and TMVR
require LBVA. Clinical outcome data on the use of suture-mediated devices
for LBVA site closure are limited. Method(s): Between 2012 and 2019,
354 consecutive high-risk patients with mitral valvular heart disease
underwent TEER (n = 287) with MitraClip and TMVR (n = 67) with Edwards
Sapien Valves. Patients had LBVA with 24 or 16 French sheaths. All
patients underwent preclosure of LBVA except for one that underwent manual
hemostasis. Result(s): There were no closure device failures. None of
the cases required surgical repair of the access site following venous
preclosure. Two cases had large hematomas (>6 cm) following Perclose in
each group. Six cases had small hematomas (<6 cm and >2 cm) with three in
each group. There was one major bleeding using Mitral Valve Academic
Research Consortium 2 definition (retroperitoneal bleed from arterial
puncture) unrelated to the venous closure. Transfusion related to vascular
access complication was required in five cases. There were two immediate
acute deep venous thromboses postprocedure; one of which occurred after
preclosure. There were no arteriovenous malformations, pseudoaneurysms, or
access site infections reported following Perclose. Conclusion(s): In
this large sample size analysis, Proglide preclosure technique is a
feasible and safe alternative approach to achieving hemostasis after
removal of LBVA sheaths in patients undergoing TEER and TMVR. Randomized
trials are needed to compare the different modalities of
hemostasis. Copyright © 2022 Wiley Periodicals LLC.

<169>
Accession Number
2016092562
Title
Valve-in-valve transcatheter aortic valve replacement or re-surgical
aortic valve replacement in degenerated bioprostheses: A systematic review
and meta-analysis of short and midterm results.
Source
Catheterization and Cardiovascular Interventions. 100(1) (pp 122-130),
2022. Date of Publication: July 1, 2022.
Author
Bruno F.; Elia E.; D'Ascenzo F.; Marengo G.; Deharo P.; Kaneko T.; Cuisset
T.; Fauchier L.; De Filippo O.; Gallone G.; Andreis A.; Fortuni F.;
Salizzoni S.; La Torre M.; Rinaldi M.; De Ferrari G.M.; Conrotto F.
Institution
(Bruno, Elia, D'Ascenzo, Marengo, De Filippo, Gallone, Andreis, Fortuni,
De Ferrari, Conrotto) Division of Cardiology, Department Cardiovascular
and Thoracic, Citta della Salute e della Scienza Hospital, University of
Turin, Turin, Italy
(Deharo, Cuisset) Departement de Cardiologie, CHU Timone, Marseille,
France
(Deharo, Cuisset) INSRRM, INRA, Aix Marseille University, Marseille,
France
(Kaneko) Division of Cardiac Surgery, Brigham and Women's Hospital,
Boston, MA, United States
(Fauchier) Service de Cardiologie, Centre Hospitalier Trousseau, Tours,
France
(Salizzoni, La Torre, Rinaldi) Division of Cardiosurgery, Department of
Cardiovascular and Thoracic, Citta della Salute e della Scienza Hospital,
University of Turin, Turin, Italy
Publisher
John Wiley and Sons Inc
Abstract
Introduction: Despite limited to short and midterm outcomes,
valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has
emerged as a valid alternative to re-surgical aortic valve replacement
(re-SAVR) for high- and intermediate-risk patients with degenerated
surgical bioprosthesis. Method(s): All studies comparing multivariate
adjustment between ViV TAVI and re-SAVR were screened. The primary
end-points were all-cause and cardiovascular (CV) mortality at 30 days and
at Midterm follow-up. Short-term complications were the secondary
endpoints. Result(s): We obtained data from 11 studies, encompassing
8570 patients, 4224 undergoing ViV TAVI, and 4346 re-SAVR. Four studies
included intermediate-risk patients and seven high-risk patients. 30-day
all-cause and CV mortality were significantly lower in ViV (odds ratio
[OR] 0.43, 95% confidence intervals [CIs] 0.29-0.64 and OR 0.44, 0.26-0.73
respectively), while after a mean follow-up of 717 (180-1825) days, there
was no difference between the two groups (OR 1.04, 0.87-1.25 and OR 1.05,
0.78-1.43, respectively). The risk of stroke (OR 1.03, 0.59-1.82), MI (OR
0.70, 0.34-1.44), major vascular complications (OR 0.92, 0.50-1.67), and
permanent pacemaker implantation (OR 0.67, 0.36-1.25) at 30 days did not
differ, while major bleedings and new-onset atrial fibrillation were
significantly lower in ViV patients (OR 0.41, 0.25-0.67 and OR 0.23,
0.12-0.42, respectively, all 95% CIs). Conclusion(s): In high- and
intermediate-risk patients with degenerated surgical bioprostheses, ViV
TAVI is associated with reduced short-term mortality, compared with
re-SAVR. Nevertheless, no differences were found in all-cause and CV
mortality at midterm follow-up. PROSPERO CRD42021226488. Copyright
© 2022 Wiley Periodicals LLC.

<170>
Accession Number
638432324
Title
Effect of perioperative use of oral triidothyronine for infants undergoing
complex congenital cardiac surgeries under cardiopulmonary bypass: A
double-blinded randomised controlled study.
Source
Annals of cardiac anaesthesia. 25(3) (pp 270-278), 2022. Date of
Publication: 01 Jul 2022.
Author
Karri S.; Mandal B.; Kumar B.; Puri G.; Thingnam S.; Kumar H.;
Unnikrishnan V.S.
Institution
(Karri, Mandal, Kumar, Puri) Department of Cardiac Anaesthesia, PGIMER,
Chandigarh, India
(Thingnam) Department of Cardiothoracic Surgery, PGIMER, Chandigarh, India
(Kumar) Department of Cardiothoracic Surgery ICU, PGIMER, Chandigarh,
India
(Unnikrishnan) Department of Pediatric Cardiac Surgery ICU, PGIMER,
Chandigarh, India
Publisher
NLM (Medline)
Abstract
Background: Thyroid hormone metabolism disrupts after cardiopulmonary
bypass both in adults and pediatric patients. This is known as Euthyroid
sick syndrome, and it is more evident in pediatric patients who were
undergoing complex cardiac surgeries compared to adults. This decrease in
serum T3 levels increases the incidence of low cardiac output, requirement
of inotropes, prolonged mechanical ventilation, and prolonged intensive
care unit (ICU) stay. Aims and Objectives: The primary objective was to
compare the mean Vasoactive-inotropic score (VIS) at 72 hours
postoperatively between T3 and Placebo groups. Material(s) and
Method(s): One hundred patients were screened, and 88 patients were
included in the study. Triidothyronine 1 mic/kg 10 doses 8th hourly was
given orally postoperatively to cases and sugar sachets to controls. The
blood samples for analysis of FT3, FT4, and TSH were taken every 24 hours
postoperatively, and baseline values were taken after induction. Mean VIS
scores, ejection Fraction (EF), Left ventricular outflow tract velocity
time integral (LVOT VTi), hemodynamics and partial pressure of oxygen/
fraction of inspired oxygen(PaO2/FiO2) were recorded daily.
 Result(s): The Mean VIS scores at 72 Hours postoperatively were
significantly less in the T3 group (5.49 +/- 6.2) compared to the Placebo
group (13.6 +/- 11.7). The PaO2/FiO2 ratios were comparatively more in the
T3 group than the Placebo group. The serum levels of FT3 FT4 were
significantly higher in the T3-supplemented group than the Placebo group.
The VIS scores were significantly lower from 48 hours postoperatively in
children < 6 months of age. Conclusion(s): In this study, we observed
that supplementing T3 postoperatively decreases the ionotropic requirement
from 72 hours postoperatively. This is more useful in children <6 months
of age undergoing complex cardiac surgeries.

<171>
Accession Number
638431669
Title
Preoperative anxiety among cardiac surgery patients and its impact on
major adverse cardiac events and mortality- A randomized, parallel-group
study.
Source
Annals of cardiac anaesthesia. 25(3) (pp 293-296), 2022. Date of
Publication: 01 Jul 2022.
Author
Mudgalkar N.; Kandi V.; Baviskar A.; Kasturi R.R.; Bandurapalli B.
Institution
(Mudgalkar) Department and Anaesthesia and Cardiac Anaesthesia, Prathima
Institute of Medical Sciences, Nagnur Road, Karimnagar, Telangana, India
(Kandi) Department and Microbiology, Prathima Institute of Medical
Sciences, Nagnur Road, Karimnagar, Telangana, India
(Baviskar) Department and Cardiac Surgery, Prathima Institute of Medical
Sciences, Nagnur Road, Karimnagar, Telangana, India
(Kasturi) Department and Cardiology, Prathima Institute of Medical
Sciences, Nagnur Road, Karimnagar, Telangana, India
(Bandurapalli) Department and Cardiac Anaesthesia, Prathima Institute of
Medical Sciences, Nagnur Road, Karimnagar, Telangana, India
Publisher
NLM (Medline)
Abstract
Background: Patients undergoing elective cardiac surgery often experience
pre-operative anxiety. Preoperative anxiety influences surgical outcome.
There are very few studies which have assessed the impact of clonidine and
Gabapentin in the treatment of anxiety especially in Indian populations
and its implications on major adverse cardiac events (MACE) and 30 days
mortality. Material(s) and Method(s): Adult patients aged 18 to 80
years old who were scheduled to have an elective coronary artery by-pass
graft (CABG) were included in the study. Those who satisfied the inclusion
criteria were given either Gabapentin (800 mg) or Clonidine (300 mcg)
90-120 minutes before the induction. State trait anxiety inventory (STAI)
was used to assess anxiety in baseline and taking just before operating
room. The primary endpoint was a reduction in the STAI associated with the
study drug, while the secondary endpoint was the incidence of MACE in the
perioperative period (30 days), which included composite episodes of
non-fatal cardiac arrest, chaotic rhythm, acute myocardial infarction,
congestive heart failure, cardiac arrhythmia, angina, and death.
 Result(s): A total of 75 patients were considered for the statistical
analysis. The demographic and clinical features of the study participants
were similar in both groups. Nearly 75-80% of participants had severe
anxiety in the preoperative period while 10-20% had moderate anxiety.
While both the drugs showed a reduction in the anxiety levels, the
clonidine group fared better (statistically insignificant). The incidence
of MACE was similar in both groups. Conclusion(s): The preoperative
anxiety levels were high among cardiac surgery patients. Both clonidine
and gabapentin were equally effective in reducing the levels of
preoperative anxiety. Preoperative STAI scores in the range of 32-53 is
not associated with MACE and 30-day mortality among cardiac surgery
patients.

<172>
Accession Number
2019194733
Title
Effect of High-Frequency Oscillatory Ventilation, Combined With Prone
Positioning, in Infants With Acute Respiratory Distress Syndrome After
Congenital Heart Surgery: A Prospective Randomized Controlled Trial.
Source
Journal of Cardiothoracic and Vascular Anesthesia. (no pagination), 2022.
Date of Publication: 2022.
Author
Zheng Y.-R.; Chen Y.-K.; Lin S.-H.; Cao H.; Chen Q.
Institution
(Zheng, Chen, Lin, Cao, Chen) Department of Cardiac Surgery, Fujian Branch
of Shanghai Children's Medical Center, Fuzhou, China
(Zheng, Chen, Lin, Cao, Chen) Fujian Children's Hospital, Fuzhou, China
(Zheng, Chen, Lin, Cao, Chen) Fujian Maternity and Child Health Hospital
College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics,
Fujian Medical University, Fuzhou, China
(Zheng, Chen, Lin, Cao, Chen) Fujian Key Laboratory of Women and
Children's Critical Diseases Research, Fujian Maternity and Child Health
Hospital, Fuzhou, China
Publisher
W.B. Saunders
Abstract
Objectives: This study aimed to evaluate the effect of high-frequency
oscillatory ventilation, (HFOV) combined with prone positioning, on
oxygenation and pulmonary ventilation in infants with acute respiratory
distress syndrome (ARDS) after congenital heart surgery. Design(s): A
randomized controlled trial. Setting(s): A single-center study at a
tertiary teaching hospital. Participant(s): Patients with
postoperative ARDS after congenital heart disease were divided randomly
into the following 2 groups: HFOV combined with prone position (HFOV-PP),
and HFOV combined with supine position (HFOV-SP). Intervention(s):
The primary outcomes were the PaO<inf>2</inf>/F<inf>I</inf>O<inf>2</inf>
ratio and the oxygenation index after the intervention, and the secondary
outcomes were respiratory variables, hemodynamics, complications, and
other short-term outcomes. Result(s): Sixty-five eligible infants
with ARDS were randomized to either the HFOV-PP (n = 32) or HFOV-SP (n =
33) group. No significant difference in baseline data was found between
the 2 groups (p > 0.05). Oxygenation was improved in both groups after
HFOV intervention. Compared with the HFOV-SP group, the HFOV-PP group had
significantly increased PaO<inf>2</inf>/F<inf>I</inf>O<inf>2</inf> and
oxygenation index and a shorter duration of invasive ventilation and
length of cardiac intensive care unit stay. No serious complications
occurred in the 2 groups. Conclusion(s): HFOV-PP significantly
improved oxygenation in infants with ARDS after cardiac surgery and had no
serious complications. Copyright © 2022 Elsevier Inc.

<173>
Accession Number
2019194096
Title
The effect of melatonin on cardiac biomarkers after coronary artery bypass
graft surgery: A double-blind, randomized pilot study.
Source
Journal of Cardiothoracic and Vascular Anesthesia. (no pagination), 2022.
Date of Publication: 2022.
Author
Nasseh N.; Khezri M.B.; Farzam S.; Shiravandi S.; Shafikhani A.A.
Institution
(Nasseh, Khezri, Shiravandi) Department of Anesthesiology, Faculty of
Medicine, Metabolic Diseases Research Center, Qazvin University of Medical
Sciences, Shahid Bahonar Ave., PO Box 3419759811, Qazvin, Iran, Islamic
Republic of
(Farzam) Department of Cardiovascular surgery, Faculty of Medicine, Qazvin
University of Medical Sciences, Qazvin, Iran, Islamic Republic of
(Shafikhani) Department of Occupational safety and Health Engineering,
Shahid Beheshti University of Medical Sciences, Tehran, Iran, Islamic
Republic of
Publisher
W.B. Saunders
Abstract
Objectives: Melatonin has emerged as an anti-inflammatory agent, potent
direct free-radical scavenger, and an indirect antioxidant in preventing
ischemia-reperfusion injury. This study aimed to evaluate melatonin's
effect on cardiac biomarkers after coronary artery bypass grafting (CABG).
 Design(s): A double-blind, randomized placebo-controlled pilot
clinical study. Setting(s): Booali Sina Hospital, Qazvin University
of Medical Sciences, Qazvin, Iran. Participant(s): One hundred
patients undergoing elective CABG. The patients were divided randomly into
control (C) and melatonin (M) groups (50 patients per group).
 Intervention(s): The M group received 3 mg of melatonin the night
before surgery, 3 mg in the morning, and routine cardiac surgery
medications. The C group received 1 placebo tablet rather than melatonin.
After surgery, the patients in the M group received 3 mg of melatonin, and
the C group received 1 placebo tablet at bedtime until the third day after
CABG. Measurements and Main Results: In both groups, creatine
kinase-MB (CPK-MB), cardiac troponin I, erythrocyte sedimentation rate
(ESR), and C-reactive protein (CRP) were measured before surgery and on
the first, second, and third postoperative days. Serum CPK-MB levels on
the second and third day after CABG were significantly lower in the M
group than in the C group (p < 0.05). Regarding cardiac troponin I, CRP,
and ESR markers, there were no significant changes in serum concentration
before surgery and on the first, second, and third days after surgery
between the 2 groups (p > 0.05). The mean length of hospitalization in the
ICU was lower in the M group (3.4 +/- 1.05) compared with the C group
(3.96 +/- 1.06, p = 0.01). Conclusion(s): Melatonin reduced the
postoperative level of CPK-MB and the length of hospitalization in the ICU
in patients who underwent cardiac surgery. Copyright © 2022

<174>
Accession Number
2019141466
Title
Application of patient decision aids in treatment selection of cardiac
surgery patients: a scoping review.
Source
Heart and Lung. 56 (pp 76-85), 2022. Date of Publication: 01 Nov 2022.
Author
Zhang D.; Zhou Y.; Liu J.; Zhu L.; Wu Q.; Pan Y.; Zheng Z.; Zha Z.; Zhang
J.; Chen Z.
Institution
(Zhang, Zhou, Liu, Zhu, Wu) Department of Nursing, Tongji Hospital, Tongji
Medical College, Huazhong University of Science and Technology, Wuhan,
China
(Zhang) School of Nursing, Tongji Medical College, Huazhong University of
Science and Technology, Wuhan, China
(Pan, Zheng, Zha, Zhang) Division of Cardiothoracic and Vascular Surgery,
Sino-Swiss Heart-Lung Transplantation Institute, Tongji Hospital, Tongji
Medical College, Huazhong University of Science and Technology, Hubei,
Wuhan, China
(Chen) School of Public Health, Tongji Medical College, Huazhong
University of Science and Technology, Hubei, Wuhan, China
Publisher
Elsevier Inc.
Abstract
Background: The choice of treatment is an unavoidable challenge faced in
the day to day medical decision making pertaining to patients with organic
heart disease. As a professional discipline, cardiac surgery focuses on
creating and using the most advanced evidence-based patient decision aids
(PtDAs) to achieve high-quality decision-making. Objective(s): To
describe the basic situation, influencing factors, and the outcome of
indicators of PtDAs among cardiac surgery patients. Method(s): Seven
electronic databases were systematically searched for relevant reviews on
the application of PtDAs among cardiac surgery patients. The
methodological framework proposed by Arskey and O'Malley was used to guide
the scoping review. The extracted data was analyzed qualitatively and
quantitatively. Result(s): After dual, blinded screening of titles
and abstracts, 12 articles were included in the review. 10 were
quantitative studies, 1 was a mixed study, 1 was a qualitative study.
 Conclusion(s): Compared with the burden of heart disease and the huge
evidence base, the application of PtDAs in cardiac surgery is obviously
insufficient. The published literature mainly provide information about
the factors to be solved from the perspective of researchers, and also
summarize obstacle factors. This is the basis for the application and
construction of PtDAs in cardiac surgery patients. Copyright ©
2022 The Authors

<175>
Accession Number
2018199925
Title
Lung transplantation and concomitant cardiac surgical procedures: A
systematic review and meta-analysis.
Source
Journal of Cardiac Surgery. (no pagination), 2022. Date of Publication:
2022.
Author
Meng E.; Jiang S.M.; Servito T.; Payne D.; El-Diasty M.
Institution
(Meng, Jiang, Servito, Payne, El-Diasty) Division of Cardiac Surgery,
Queen's University, Kingston, ON, Canada
Publisher
John Wiley and Sons Inc
Abstract
Background: Lung transplantation is an effective treatment option for
end-stage lung diseases. In some cases, these patients may also have
underlying cardiac disease which may require surgical intervention before
or during transplantation. Concomitant cardiac surgery may often be
preferred, as reduced lung function precludes these patients from
pre-transplant surgery. Our meta-analysis sought to examine the impact of
lung transplantation paired with concomitant cardiac surgery on long-term
mortality. Method(s): We conducted a systematic review of the
MEDLINE, Embase, and Cochrane databases. Our primary outcome was overall
mortality. Secondary outcomes included length of stay (LOS) in hospital
and serious postoperative complication rates. We used a meta-analytic
model to determine the differences in the above outcomes between patients
who underwent lung transplantation with or without concomitant cardiac
surgery. Result(s): Out of the 1876 articles screened, 7 met our
pre-determined inclusion criteria. Lung transplantation with concomitant
cardiac surgery was not associated with increased mortality compared to
lung transplantation alone (hazard ratio = 1.02; 95% confidence interval
[CI] = 0.80-1.31; I2 = 0%; p =.99). LOS in hospital was not
significantly different between groups (standardized mean difference =
0.32; 95% CI = -0.91 to 1.55). Postoperative complication rates were also
reported but not analyzed due to missing data. Conclusion(s): There
was no significant difference in mortality rates in patients undergoing
lung transplantation with or without concomitant cardiac surgery at 1, 3,
and 5 years. However, postoperative complication rates were higher in the
concomitant group. The decision to perform concomitant procedures should
be tailored to each patient's clinical condition. Copyright ©
2022 Wiley Periodicals LLC.

<176>
Accession Number
2018198248
Title
Long-term effects of cardiac rehabilitation after heart valve surgery -
results from the randomised CopenHeart<inf>VR</inf> trial.
Source
Scandinavian Cardiovascular Journal. 56(1) (pp 247-255), 2022. Date of
Publication: 2022.
Author
Sibilitz K.L.; Tang L.H.; Berg S.K.; Thygesen L.C.; Risom S.S.; Rasmussen
T.B.; Schmid J.-P.; Borregaard B.; Hassager C.; Kober L.; Taylor R.S.;
Zwisler A.-D.
Institution
(Sibilitz, Berg, Risom, Hassager, Kober) Department of Cardiology, The
Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen,
Denmark
(Tang, Zwisler) REHPA-The Danish Knowledge Centre for Rehabilitation and
Palliative Care and University of Southern Denmark, Odense, Denmark
(Tang) Department of Physiotherapy and Occupational Therapy,
Naestved-Slagelse-Ringsted Hospitals, Region Zealand, Denmark
(Tang) Department of Regional Health Research, University of Southern
Denmark, Odense, Denmark
(Berg, Risom, Rasmussen) Department of Clinical Medicine, Faculty of
Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
(Thygesen, Taylor) National Institute of Public Health, University of
Southern Denmark, Copenhagen, Denmark
(Risom) Institute for Nursing and Nutrition, University College
Copenhagen, Tagensvej, Denmark
(Rasmussen) Department of Cardiology, Herlev and Gentofte University
Hospital, Copenhagen, Denmark
(Schmid) Swiss Cardiovascular Centre Bern, Cardiovascular Prevention and
Rehabilitation Unit, University Hospital, Bern, Switzerland
(Borregaard) Department of Cardiothoracic and Vascular Surgery, Odense
University Hospital, Odense, Denmark
(Borregaard) Department of Cardiology, Odense University Hospital, Odense,
Denmark
(Taylor) Institute of Health and Well Being, University of Glasgow,
Glasgow, United Kingdom
(Taylor) Institute of Health Research, University of Exeter Medical
School, Exeter, United Kingdom
(Zwisler) Department of Cardiology, Odense University Hospital, University
of Southern Denmark, Odense, Denmark
Publisher
Taylor and Francis Ltd.
Abstract
Aims. The CopenHeart<inf>VR</inf> trial found positive effects of cardiac
rehabilitation (CR) on physical capacity at 4 months. The long-term
effects of CR following valve surgery remains unclear, especially
regarding readmission and mortality. Using data from he
CopenHeart<inf>VR</inf> Trial we investigated long-term effects on
physical capacity, mental and physical health and effect on mortality and
readmission rates as prespecified in the original protocol. Methods. A
total of 147 participants were included after heart valve surgery and
randomly allocated 1:1 to 12-weeks exercise-based CR including a
psycho-educational programme (intervention group) or control. Physical
capacity was assessed as peak oxygen uptake (VO<inf>2</inf> peak) measured
by cardiopulmonary exercise testing, mental and physical health by Short
Form-36 questionnaire, Hospital Anxiety and Depression Scale, and
HeartQol. Mortality and readmission were obtained from hospital records
and registers. Groups were compared using mixed regression model analysis
and log rank test. Results. No differences in VO<inf>2</inf> peak at 12
months or in self-assessed mental and physical health at 24 months (68% vs
75%, p =.120) was found. However, our data demonstrated reduction in
readmissions in the intervention group at intermediate time points; after
3, 6 (43% vs 59%, p =.03), and 12 (53% vs 67%, p =.04) months,
respectively, but no significant effect at 24 months. Conclusions.
Exercise-based CR after heart valve surgery reduces combined readmissions
and mortality up to 12 months despite lack of improvement in exercise
capacity, physical and mental health long-term. Exercise-based CR can
ensure short-term benefits in terms of physical capacity, and lower
readmission within a year, but more research is needed to sustain these
effects over a longer time period. These considerations should be included
in the management of patients after heart valve surgery. Copyright
© 2022 The Author(s). Published by Informa UK Limited, trading as
Taylor & Francis Group.

<177>
Accession Number
638446292
Title
Effect of Nitric Oxide via Cardiopulmonary Bypass on Ventilator-Free Days
in Young Children Undergoing Congenital Heart Disease Surgery: The NITRIC
Randomized Clinical Trial.
Source
JAMA - Journal of the American Medical Association. 328(1) (pp 38-47),
2022. Date of Publication: 05 Jul 2022.
Author
Schlapbach L.J.; Gibbons K.S.; Horton S.B.; Johnson K.; Long D.A.; Buckley
D.H.F.; Erickson S.; Festa M.; D'Udekem Y.; Alphonso N.; Winlaw D.S.;
Delzoppo C.; Van Loon K.; Jones M.; Young P.J.; Butt W.; Schibler A.
Institution
(Schlapbach, Gibbons, Johnson, Long, Alphonso) Child Health Research
Centre, The University of Queensland, Brisbane, QLD, Australia
(Schlapbach, Johnson) Paediatric Intensive Care Unit, Queensland
Children's Hospital, Children's Health Queensland, Brisbane, QLD,
Australia
(Schlapbach) Department of Intensive Care and Neonatology, And Children's
Research Center, University Children's Hospital Zurich, University of
Zurich, Zurich, Switzerland
(Horton) Cardiac Surgical Unit, Royal Children's Hospital, Melbourne, VIC,
Australia
(Horton, D'Udekem, Delzoppo, Butt) Faculty of Medicine, Department of
Paediatrics, University of Melbourne, Melbourne, VIC, Australia
(Horton, Butt) Clinical Sciences Theme, Murdoch Children's Research
Institute, Melbourne, VIC, Australia
(Long) School of Nursing, Centre for Healthcare Transformation, Queensland
University of Technology, Brisbane, QLD, Australia
(Buckley) Paediatric Intensive Care Unit, Starship Children's Hospital,
Auckland, New Zealand
(Erickson) Paediatric Critical Care, Perth Children's Hospital, Western
Australia, The University of Western Australia, Crawley, WA, Australia
(Festa) Kids Critical Care Research, Paediatric Intensive Care Unit,
Children's Hospital at Westmead, Westmead, NSW, Australia
(Festa) Sydney Children's Hospital Network, Sydney, NSW, Australia
(D'Udekem) Children's National Hospital, The George Washington University,
School of Medicine and Health Sciences, Seattle, WA, United States
(D'Udekem) Heart Research, Murdoch Children's Research Institute,
Melbourne, VIC, Australia
(Alphonso) Cardiac Surgery, Queensland Children's Hospital, Brisbane, QLD,
Australia
(Alphonso) School of Medicine, Children's Health Clinical Unit, University
of Queensland, Brisbane, QLD, Australia
(Winlaw) Heart Centre for Children, The Children's Hospital at Westmead,
Westmead, NSW, Australia
(Winlaw) Sydney Children's Hospital Network, Faculty of Medicine and
Health, University of Sydney, Sydney, NSW, Australia
(Delzoppo, Butt) Paediatric Intensive Care Unit, Royal Children's Hospital
Melbourne, Melbourne, VIC, Australia
(Van Loon) Department of Anaesthesiology, University Medical Center
Utrecht, Wilhelmina Children's Hospital, Utrecht, Netherlands
(Jones) Institute of Evidence Based Healthcare, Bond University, Gold
Coast, Australia
(Young) The Intensive Care Research Programme, Medical Research Institute
of New Zealand, Wellington, New Zealand
(Butt) Department of Critical Care, Melbourne Medical School, University
of Melbourne, VIC, Australia
(Butt) Central Clinical School, Faculty of Medicine, Monash University,
Melbourne, VIC, Australia
(Schibler) Critical Care Research Group, Wesley Medical Research, St
Andrew's War Memorial Hospital, Brisbane, QLD, Australia
Publisher
American Medical Association
Abstract
Importance: In children undergoing heart surgery, nitric oxide
administered into the gas flow of the cardiopulmonary bypass oxygenator
may reduce postoperative low cardiac output syndrome, leading to improved
recovery and shorter duration of respiratory support. It remains uncertain
whether nitric oxide administered into the cardiopulmonary bypass
oxygenator improves ventilator-free days (days alive and free from
mechanical ventilation). Objective(s): To determine the effect of
nitric oxide applied into the cardiopulmonary bypass oxygenator vs
standard care on ventilator-free days in children undergoing surgery for
congenital heart disease. Design, Setting, and Participant(s):
Double-blind, multicenter, randomized clinical trial in 6 pediatric
cardiac surgical centers in Australia, New Zealand, and the Netherlands. A
total of 1371 children younger than 2 years undergoing congenital heart
surgery were randomized between July 2017 and April 2021, with 28-day
follow-up of the last participant completed on May 24, 2021.
 Intervention(s): Patients were assigned to receive nitric oxide at 20
ppm delivered into the cardiopulmonary bypass oxygenator (n = 679) or
standard care cardiopulmonary bypass without nitric oxide (n = 685).
 Main Outcomes and Measures: The primary end point was the number of
ventilator-free days from commencement of bypass until day 28. There were
4 secondary end points including a composite of low cardiac output
syndrome, extracorporeal life support, or death; length of stay in the
intensive care unit; length of stay in the hospital; and postoperative
troponin levels. Result(s): Among 1371 patients who were randomized
(mean [SD] age, 21.2 [23.5] weeks; 587 girls [42.8%]), 1364 (99.5%)
completed the trial. The number of ventilator-free days did not differ
significantly between the nitric oxide and standard care groups, with a
median of 26.6 days (IQR, 24.4 to 27.4) vs 26.4 days (IQR, 24.0 to 27.2),
respectively, for an absolute difference of -0.01 days (95% CI, -0.25 to
0.22; P =.92). A total of 22.5% of the nitric oxide group and 20.9% of the
standard care group developed low cardiac output syndrome within 48 hours,
needed extracorporeal support within 48 hours, or died by day 28, for an
adjusted odds ratio of 1.12 (95% CI, 0.85 to 1.47). Other secondary
outcomes were not significantly different between the groups.
 Conclusions and Relevance: In children younger than 2 years
undergoing cardiopulmonary bypass surgery for congenital heart disease,
the use of nitric oxide via cardiopulmonary bypass did not significantly
affect the number of ventilator-free days. These findings do not support
the use of nitric oxide delivered into the cardiopulmonary bypass
oxygenator during heart surgery. Trial Registration: anzctr.org.au
Identifier: ACTRN12617000821392. Copyright © 2022 American
Medical Association. All rights reserved.

<178>
Accession Number
638451497
Title
Galectin-3 as a Predictor of Post Cardiac Surgery Atrial Fibrillation: A
Scoping Review.
Source
Current problems in cardiology. (pp 101314), 2022. Date of Publication:
08 Jul 2022.
Author
King M.; Stambulic T.; Kirupaharan S.; Baranchuk A.; Rabinovich G.A.;
Payne D.; El-Diasty M.
Institution
(King, Stambulic, Kirupaharan) Queen's University School of Medicine, ON,
Kingston, Canada
(Baranchuk) Division of Cardiology, Department of Medicine, Queen's
University, ON, Kingston, Canada
(Rabinovich) Laboratorio de Glicomedicina, Instituto de Biologia y
Medicina Experimental, Consejo Nacional de Investigaciones Cientificas y
Tecnicas, Buenos Aires, Argentina
(Payne, El-Diasty) Division of Cardiac Surgery, Department of Surgery,
Queen's University, ON, Kingston, Canada
Publisher
NLM (Medline)
Abstract
PURPOSE: Galectin-3 is associated with myocardial fibrosis, a known risk
factor for developing re-entrant circuits associated with atrial
fibrillation (AF). Previous studies have demonstrated increased galectin
levels in AF patients. Whether preoperative galectin-3 levels can predict
the incidence of postoperative atrial fibrillation (POAF) remains unknown.
 METHOD(S): This scoping review was conducted in accordance with the
2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses
(PRISMA) statement. Electronic searches were conducted in Medline, EMBASE,
Cochrane, and Google Scholar databases using a predetermined strategy.
Methodological variables, demographics and operative data were extracted.
Data extraction was performed manually by three reviewers. RESULT(S):
The search yielded 620 citations, of which 74 underwent full text review,
and 3 citations with 3 independent samples (n=1812) met full
inclusion/exclusion criteria and were included. Of the three studies that
reported on the association between preoperative galectin-3 levels and
POAF, two studies compared median galectin levels in patients who
developed POAF and those who did not. While Alexandre et al. reported a
significant difference (p=0.002), Bening et al did not find a significant
difference between POAF and non-POAF groups (p=0.3). A third study
reporting on the association between galectin-3 and atrial fibrillation
comparing 3rd and 1st tercile galectin-3 levels found a significant
association between preoperative galectin levels and POAF on univariate
analysis (OR 1.54; 95% CI 1.14-2.09). CONCLUSION(S): Galectin-3 is an
emerging biomarker that has been associated with the development of AF.
However, there is currently not enough evidence to establish its
prognostic role in post-cardiac surgery atrial fibrillation. Copyright
© 2022. Published by Elsevier Inc.

<179>
Accession Number
638448183
Title
Meta-analysis comparing percutaneous coronary intervention with coronary
artery bypass grafting for non-ST elevation acute coronary syndrome in
patients with multivessel or left main disease.
Source
Current problems in cardiology. (pp 101306), 2022. Date of Publication:
07 Jul 2022.
Author
Barssoum K.; Kumar A.; Rai D.; Kharsa A.; Chowdhury M.; Thakkar S.; Patel
H.P.; Amin A.; Tan B.; Ibrahim F.; Bandyopadhyay D.; Elkaryoni A.;
Elbadawi A.; Abtahian F.; Nanda N.C.; Depta J.
Institution
(Barssoum) Department of Internal Medicine, Unity Hospital, Rochester
Regional Health System, Rochester, NY, USA; Department of Internal
Medicine, Rochester General Hospital, Rochester NY, USA
(Kumar) Department of Internal Medicine, Cleveland Clinic Akron General,
Akron, OH, United States
(Rai, Kharsa, Chowdhury, Thakkar, Amin, Tan) Department of Internal
Medicine, Rochester General Hospital, United States
(Patel) Department of Internal Medicine, Louis A Weiss Memorial Hospital,
Chicago, United States
(Ibrahim) American University of Antigua, United States
(Bandyopadhyay) Department of Cardiovascular Medicine, Loyola University
Medical Center, Maywood, United States
(Elkaryoni, Abtahian, Depta) Department of Cardiology, Sands Constellation
Heart Institute, Rochester Regional Health, Rochester, NY, USA
(Elbadawi) Division of Cardiovascular Medicine, University of Texas
Medical Branch, TX, Galveston, United States
(Nanda) Division of Cardiovascular Disease, University of Alabama at
Birmingham, Birmingham, AL, USA
Publisher
NLM (Medline)
Abstract
OBJECTIVES: Outcomes of patients presenting with non-ST-elevation acute
coronary syndrome (NSTE-ACS) with multivessel coronary disease (MVD)
and/or unprotected left main coronary artery disease (CAD) revascularized
with percutaneous coronary intervention(PCI) or coronary artery bypass
grafting(CABG) is not well defined. DESIGN: MEDLINE/PubMed and EMBASE/Ovid
were queried for studies that investigated PCI vs. CABG in this disease
subset. The primary outcome was major cardiac adverse events (MACE) at 30
days and long-term follow-up (3 to 5 years). RESULT(S): The final
analysis included 9 studies with a total of 9299 patients. No significant
difference was observed between PCI and CABGin30 days MACE (risk ratio
[RR] 0.96; 95% confidence interval [CI] 0.38-2.39, all-cause mortality,
myocardial infarction, and stroke. A meta-regression analysis revealed
patients with a history of PCI had higher risk of MACE with PCI as
compared with CABG. At long-term follow-up, PCI compared with CABG was
associated with higher risk of MACE (RR 1.52; 95% CI 1.28-1.81),
myocardial infarction, and repeat revascularization, while no difference
was observed in the risk of stroke and all-cause mortality.
 CONCLUSION(S): In patients with NSTE-ACS and MVD and/or unprotected
left main CAD, no differences were observed in the clinical outcomes
between PCI and CABG at 30 days follow-up. With long-term follow-up, PCI
was associated with a higher risk of MACE. Copyright © 2022.
Published by Elsevier Inc.

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