EMBASE Cardiac Update AutoAlert: EPICORE Cardiac Surgery Blogger2

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<1>
Accession Number
2014817782
Author
Pedersen P.U.; Larsen P.; Hakonsen S.J.; Christensen B.N.
Institution
(Pedersen) Danish Centre of Systematic Reviews in Nursing: An affiliate
centre of The Joanna Briggs Institute, The Centre of Clinical Guidelines -
Danish National Clearing house for Nursing, Hoegh-Guldbergs Gade 6A,
Arhusc 8000, Denmark
(Larsen, Hakonsen) Danish Centre of Systematic Reviews in Nursing, Denmark
(Christensen) Library of Health Sciences, University of Aarhus, Denmark
Title
The effectiveness of perioperative oral hygiene in reduction of
postoperative respiratory tract infections after thoracic surgery in
adults: A systematic review.
Source
JBI Database of Systematic Reviews and Implementation Reports. 10 (28
SUPPL Supplement 28) (pp S200-S211), 2012. Date of Publication: 2012.
Publisher
Joanna Briggs Institute
Abstract
Review question/objective: The objective of this systematic review is to
identify, appraise and synthesise the best available evidence on the
effectiveness of systematic perioperative oral hygiene in reduction of
post-operative respiratory airway infections in adult patients undergoing
elective thoracic surgery.

<2>
Accession Number
20160200678
Author
Rababa'h A.M.; Deo S.V.; Altarabsheh S.E.; De Caro J.; Tarboush N.A.;
Alzoubi K.H.; Ababneh M.; McConnell B.K.; Markowitz A.H.; Park S.J.
Institution
(Rababa'h, Alzoubi, Ababneh) Department of Clinical Pharmacy, Jordan
University of Science and Technology, Irbid, Jordan
(Deo, Markowitz, Park) Department of Cardiovascular Surgery, Case Western
Reserve University, Cleveland, OH, United States
(Altarabsheh) Department of Cardiac Surgery, Queen Alia Heart Institute,
Amman, Jordan
(De Caro) Cleveland Health Sciences Library, Case Western Reserve
University, Cleveland, OH, United States
(Tarboush) Department of Physiology and Biochemistry, Faculty of Medicine,
University of Jordan, Amman, Jordan
(McConnell) Department of Pharmacological and Pharmaceutical Sciences,
College of Pharmacy, University of Houston, Texas Medical Center, Houston,
TX, United States
Title
N-acetyl cysteine therapy does not prevent renal failure in high-risk
patients undergoing open-heart surgery.
Source
Heart Surgery Forum. 19 (1) (pp E16-E22), 2016. Date of Publication:
February 2016.
Publisher
Carden Jennings Publishing Co. Ltd (375 Greenbrier Drive, Suite #100,
Charlottesville VA 22901-1618, United States)
Abstract
Background: Renal dysfunction is a common complication after
cardiovascular surgery. Controversial issues have been discussed regarding
the role of N-acetyl cysteine in the prevention of postoperative renal
dysfunction. The purpose of this meta-analysis is to assess whether
N-acetyl cysteine offers any protection against the development of acute
renal dysfunction after cardiac surgery. Methods: Multiple databases were
searched for randomized trials comparing the role of N-acetyl cysteine and
placebo in human patients undergoing cardiac surgery. Endpoints studied
were: the incidence of acute renal failure, hemodialysis, early mortality,
duration of hospital stay, and maximal change in creatinine values.
Dichotomous variables were compared using the risk difference (RD)
calculated with inverse weighting; continuous data was pooled as
(standardized) mean difference. Results are presented with 95% confidence
interval (P < .05 is significant); results are presented within 95%
confidence interval. Results: Thirteen randomized trials (713 and 707
patients in the N-acetyl cysteine and control groups, respectively) were
included in the present analysis; nine dealing with patients at high-risk
for acute renal failure. The incidence of postoperative acute renal
dysfunction was 23% and 36% in the N-acetyl cysteine and control cohorts,
respectively. N-acetyl cysteine therapy did not reduce acute renal
dysfunction in the high-risk cohort [RD -0.03 (-0.09 to 0.02); P = .22;
I² = 24%]. Maximal change in creatinine levels after surgery
was also comparable [standardized mean difference 0.07 (-0.23, 0.09); P =
.39]. Early mortality was 2.9% and 3.7% in the N-acetyl cysteine and
control cohorts respectively; [RD 0 (-0.03 to 0.02); P = .63;
I² = 20%]. Hospital stay (mean length of stay 10.4 and 10.1
days in the N-acetyl cysteine and control cohorts, respectively) was also
similar in both cohorts [WMD 0.17 (-0.02 to 0.37) days; P = .81].
Conclusion: Prophylactic N-acetyl cysteine therapy does not reduce the
incidence of renal dysfunction in high-risk patients undergoing cardiac
surgery.

<3>
Accession Number
20160197025
Author
Shimada Y.J.; Cannon C.P.; Liu Y.; Wilson C.; Kupfer S.; Menon V.; Cushman
W.C.; Mehta C.R.; Bakris G.L.; Zannad F.; White W.B.
Institution
(Shimada, Cannon, Liu) Harvard Clinical Research Institute, 930
Commonwealth Avenue West, Boston, MA 02215, United States
(Shimada) Cardiology Division, Massachusetts General Hospital, Harvard
Medical School, Boston, MA, United States
(Shimada, Cannon) Cardiovascular Division, Department of Medicine, Brigham
and Women's Hospital, Harvard Medical School, Boston, MA, United States
(Liu) Department of Biostatistics, Boston University, Boston, MA, United
States
(Wilson, Kupfer) Takeda Development Center Americas, Deerfield, IL, United
States
(Menon) Department of Cardiovascular Medicine, Cleveland Clinic
Foundation, Cleveland, OH, United States
(Cushman) University of Tennessee College of Medicine, Memphis Veterans
Affairs Medical Center, Memphis, TN, United States
(Mehta) Harvard School of Public Health, Boston, MA, United States
(Bakris) University of Chicago Medicine, Chicago, IL, United States
(Zannad) Institut Lorrain du Coeur et des Vaisseaux, Centre
d'Investigation Clinique Inserm, Universite de Lorraine, CHU,
Vandoeuvre-Les-Nancy, France
(White) Calhoun Cardiology Center, University of Connecticut School of
Medicine, Farmington, CT, United States
Title
Ischemic cardiac outcomes and hospitalizations according to prior
macrovascular disease status in patients with type 2 diabetes and recent
acute coronary syndrome from the Examination of Cardiovascular Outcomes
with Alogliptin versus Standard of Care trial.
Source
American Heart Journal. 175 (pp 18-27), 2016. Date of Publication: 01 May
2016.
Publisher
Mosby Inc.
Abstract
Background: Concerns raised regarding adverse cardiovascular (CV) outcomes
with new therapies for type 2 diabetes mellitus (T2DM) have led to several
large-scale CV outcome trials. The EXAMINE trial confirmed noninferiority
of the dipeptidyl dipeptidase 4 inhibitor alogliptin to placebo on major
adverse cardiac event rates in a post-acute coronary syndrome (ACS) T2DM
population. We present data on additional ischemic cardiac events and CV
hospitalizations in EXAMINE. Methods: Patients with T2DM and an ACS event
in the previous 15 to 90 days were randomly assigned to alogliptin or
placebo on a background of standard treatment for diabetes. The incident
rates of a 5-component composite end point of CV death, stroke, myocardial
infarction, unstable angina, and coronary revascularization as well as CV
hospitalization were calculated in all participants and according to
macrovascular disease at baseline. Results: There were no significant
differences between alogliptin (n = 2,701) and placebo (n = 2,679) in the
event rate of the 5-component composite endpoint with median follow-up 533
days (21.0% vs 21.5%, hazard ratio [HR] 0.98 [0.87-1.10], P =.72). No
differences were observed in terms of CV hospitalization (25.0% vs 25.4%,
HR 0.98 [0.88-1.09], P =.70) or coronary revascularization (10.6% vs
10.2%, HR 1.05 [0.88-1.09], P =.60). No interactions were observed for
treatment and prior macrovascular disease. Conclusions: EXAMINE
demonstrates that there was no increase in the risk of cardiac ischemic
events and CV hospitalizations with alogliptin in a high-risk post-ACS
patient population. Because these are major driver of overall health care
costs, these data suggest that there would be no adverse impact on health
care resource utilization.

<4>
Accession Number
20160205349
Author
Chan M.Y.; Du X.; Eccleston D.; Ma C.; Mohanan P.P.; Ogita M.; Shyu K.-G.;
Yan B.P.; Jeong Y.-H.
Institution
(Chan) Department of Medicine, Yong Loo Lin School of Medicine, National
University of Singapore, National University Heart Centre, National
University Health System, Singapore, Singapore
(Du, Ma) Beijing AnZhen Hospital, Capital Medical University, Beijing,
China
(Eccleston) University of Melbourne, Melbourne, VIC, Australia
(Mohanan) West Fort Hospital, Thrissur, India
(Ogita) Juntendo University School of Medicine, Tokyo, Japan
(Shyu) Shin Kong Wu Ho-Su Memorial Hospital, Taiwan (Republic of China)
(Yan) Chinese University of Hong Kong (Prince of Wales Hospital), Hong
Kong, Hong Kong
(Jeong) Gyeongsang National University Hospital, Gyeongsang National
University School of Medicine, Jinju, South Korea
Title
Acute coronary syndrome in the Asia-Pacific region.
Source
International Journal of Cardiology. 202 (pp 861-869), 2016. Date of
Publication: 01 Jan 2016.
Publisher
Elsevier Ireland Ltd
Abstract
More than 4.2 billion inhabitants populate the Asia-Pacific region. Acute
coronary syndrome (ACS) is now a major cause of death and disability in
this region with in-hospital mortality typically exceeding 5%. Yet, the
region still lacks consensus on the best approach to overcoming its
specific challenges in reducing mortality from ACS. The Asia-Pacific Real
world evIdenCe on Outcome and Treatment of ACS (APRICOT) project reviewed
current published and unpublished registry data, unmet needs in ACS
management and possible approaches towards improving ACS-related mortality
in the region. There was striking heterogeneity in the use of invasive
procedures, pharmacologic practice (hospitalization/post-discharge), and
in short- and long-term clinical outcomes across healthcare systems; this
heterogeneity was perceived to be far greater than in Western Europe or
the United States. 'Benchmark' short-term clinical outcomes are preferred
over long-term outcomes due to difficulties in follow-up, recording and
maintenance of medication adherence in a geographically large and
culturally diverse region. Key 'barriers' towards improving outcomes
include patient education (pain awareness, consequences of missing
medication and secondary prevention), geographical landscape (urban vs.
metropolitan), limited long-term adherence to guideline-based management
and widespread adoption of cost-based rather than value-based healthcare
systems. Initiatives to overcome these barriers should include
implementation of pre-hospital management strategies, toolkits to aid
in-hospital treatment, greater community outreach with online
patient/physician education and telemedicine, sustainable economic models
to improve accessibility to effective pharmacotherapies and the
acquisition of high-quality 'real-world' regional data to tailor secondary
prevention initiatives that meet the unique needs of countries in this
region.

<5>
Accession Number
20160200318
Author
Iafrancesco M.; Ranasinghe A.M.; Dronavalli V.; Adam D.J.; Claridge M.W.;
Riley P.; McCafferty I.; Mascaro J.G.
Institution
(Iafrancesco, Ranasinghe, Dronavalli, Adam, Claridge, Mascaro) Department
of Cardiothoracic Surgery/Thoracic Aortic Multidisciplinary Team, Queen
Elizabeth University Hospital, NHS Foundation Trust, Birmingham, United
Kingdom
(Iafrancesco, Adam, Claridge) Vascular Surgery Department, Thoracic Aortic
Multidisciplinary Team, Heart of England NHS Foundation Trust, Birmingham,
United Kingdom
(Riley, McCafferty) Department of Interventional Radiology/Thoracic Aortic
Multidisciplinary Team, Queen Elizabeth University Hospital, NHS
Foundation Trust, Birmingham, United Kingdom
Title
Open aortic arch replacement in high-risk patients: The gold standard.
Source
European Journal of Cardio-thoracic Surgery. 49 (2) (pp 646-651), 2016.
Article Number: ezv149. Date of Publication: 01 Feb 2016.
Publisher
European Association for Cardio-Thoracic Surgery
Abstract
OBJECTIVES: Open total aortic arch replacement (TAR) in high-risk patients
is considered by some to be associated with a prohibitively perioperative
risk. Recent reports describe hybrid techniques to treat this group. We
reviewed our outcomes of open surgery in a 'high-risk' group of patients.
METHODS: All patients who underwent open TAR between 2000 and 2013 were
identified from our prospectively maintained database. Patients comparable
with the ones who underwent hybrid repair in previous studies (logistic
EuroSCORE between 20 and 60 without intervention on the aortic root or on
the mitral/tricuspid valve) were selected for analysis. RESULTS:
Fifty-eight patients were identified. Median logistic EuroSCORE was 27.4
(range 20-57) and median age was 76 years (34.5% male). There were 11
resternotomies (18.9%) and 20 procedures were urgent/emergency (34.5%).
Preoperative comorbidities included chronic obstructive pulmonary disease
(31%), coronary artery disease (22.4%), peripheral vascular disease
(48.3%), previous stroke (5.2%), previous myocardial infarction (3.4%) and
left ventricular dysfunction (12%). Concomitant procedures included aortic
valve replacement/resuspension (58.7%), coronary artery bypass grafting
(22.4%), open descending aorta replacement (10.3%) and frozen elephant
trunk (19%). Overall in-hospital mortality, permanent stroke and spinal
cord injury rate were 6.9, 1.7 and 0%, respectively. There were no deaths
or stroke in the elective group. One-year, 5-year and 10-year estimates of
survival were 82.7, 70.0 and 37.8%, respectively. CONCLUSIONS: Open TAR
can be performed with low mortality and morbidity and excellent long-term
results even in high-risk patients. Total endovascular repair may
represent an option for patients not suitable for open surgery.

<6>
Accession Number
20160200311
Author
Lang P.; Manickavasagar M.; Burdett C.; Treasure T.; Fiorentino F.; Barua
A.; Batchelor T.; Fewtrell J.; Fitzmaurice G.; Eaton D.; Froeschle P.;
Ghosh-Dastidar M.; Jenvey L.; Khan H.; Kirk A.; Lim E.; Lobo T.; McManus
K.; Mitchell J.; Mohamed T.; Naidu B.; Page R.; Powell A.-M.; Pullinger
D.; Slight R.; Tideswell J.; Viviano A.; Wren M.; Zeinah M.
Institution
(Lang, Manickavasagar) Department of Cardiac Surgery, Brighton and Sussex
University Hospitals NHS Trust, Brighton, United Kingdom
(Burdett) Cambridge Centre for Cardiovascular Research Excellence,
Cambridge, United Kingdom
(Treasure) Clinical Operational Research Unit, University College London,
London, United Kingdom
(Fiorentino) Department of Cardiothoracic Surgery, National Heart and Lung
Institute, Imperial College London, London, United Kingdom
Title
Suction on chest drains following lung resection: Evidence and practice
are not aligned.
Source
European Journal of Cardio-thoracic Surgery. 49 (2) (pp 611-616), 2016.
Article Number: ezv133. Date of Publication: 01 Feb 2016.
Publisher
European Association for Cardio-Thoracic Surgery
Abstract
OBJECTIVES: A best evidence topic in Interactive CardioVascular and
Thoracic Surgery (2006) looked at application of suction to chest drains
following pulmonary lobectomy. After screening 391 papers, the authors
analysed six studies (five randomized controlled trials [RCTs]) and found
no evidence in favour of postoperative suction in terms of air leak
duration, time to chest drain removal or length of stay. Indeed, suction
was found to be detrimental in four studies. We sought to determine
whether clinical practice is consistent with published evidence by
surveying thoracic units nationally and performing a meta-analysis of
current best evidence. METHODS: We systematically searched MEDLINE, EMBASE
and CENTRAL for RCTs, comparing outcomes with and without application of
suction to chest drains after lung surgery. A meta-analysis was performed
using RevMan. &#xa9; software. A questionnaire concerning chest drain
management and suction use was emailed to a clinical representative in
every thoracic unit. RESULTS: Eight RCTs, published 2001-13, with 31-500
participants, were suitable for meta-analysis. Suction prolonged length of
stay (weighted mean difference [WMD] 1.74 days; 95% confidence interval
[CI] 1.17-2.30), chest tube duration (WMD 1.77 days; 95% CI 1.47-2.07) and
air leak duration (WMD 1.47 days; 95% CI 1.45-2.03). There was no
difference in occurrence of prolonged air leak. Suction was associated
with fewer instances of postoperative pneumothorax. Twenty-five of 39
thoracic units responded to the national survey. Suction is routinely used
by all surgeons in 11 units, not by any surgeon in 5 and by some surgeons
in 9. Of the 91 surgeons represented, 62 (68%) routinely used suction.
Electronic drains are used in 15 units, 10 of which use them routinely.
Conclusions: Application of suction to chest drains following
non-pneumonectomy lung resection is common practice. Suction has an effect
in hastening the removal of air and fluid in clinical experience but a
policy of suction after lung resection has not been shown to offer
improved clinical outcomes. Clinical practice is not aligned with Level 1a
evidence.

<7>
Accession Number
20160200276
Author
Singh A.; Schaff H.V.; Mori Brooks M.; Hlatky M.A.; Wisniewski S.R.; Frye
R.L.; Sako E.Y.
Institution
(Singh, Mori Brooks, Wisniewski) Department of Epidemiology, University of
Pittsburgh, Pittsburgh, PA, United States
(Schaff) Division of Cardiovascular Surgery, Mayo Clinic, Rochester, MN,
United States
(Hlatky) Department of Health Research and Policy, Stanford University,
School of Medicine, Stanford, CA, United States
(Frye) Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN,
United States
(Sako) Department of Cardiothoracic Surgery, University of Texas, Health
Science Center at San Antonio, San Antonio, TX, United States
Title
On-pump versus off-pump coronary artery bypass graft surgery among
patients with type 2 diabetes in the bypass angioplasty revascularization
investigation 2 diabetes trial.
Source
European Journal of Cardio-thoracic Surgery. 49 (2) (pp 406-416), 2016.
Article Number: ezv170. Date of Publication: 01 Feb 2016.
Publisher
European Association for Cardio-Thoracic Surgery
Abstract
OBJECTIVES: Conclusive evidence is lacking regarding the benefits and
risks of performing off-pump versus on-pump coronary artery bypass graft
(CABG) for patients with diabetes. This study aims to compare clinical
outcomes after off-pump and on-pump procedures for patients with diabetes.
METHODS: The Bypass Angioplasty Revascularization Investigation 2 Diabetes
(BARI 2D) trial enrolled patients with type 2 diabetes and documented
coronary artery disease, 615 of whom underwent CABG during the trial. The
procedural complications, 30-day outcomes, long-term clinical and
functional outcomes were compared between the off-pump and on-pump groups
overall and within a subset of patients matched on propensity score.
RESULTS: On-pump CABG was performed in 444 (72%) patients, and off-pump
CABG in 171 (28%). The unadjusted 30-day rate of death/myocardial
infarction (MI)/stroke was significantly higher after off-pump CABG (7.0
vs 2.9%, P = 0.02) despite fewer complications (10.3 vs 20.7%, P = 0.003).
The long-term risk of death [adjusted hazard ratio (aHR): 1.41, P =
0.2197] and major cardiovascular events (death, MI or stroke) (aHR: 1.47,
P = 0.1061) did not differ statistically between the off-pump and on-pump
patients. Within the propensity-matched sample (153 pairs), patients who
underwent off-pump CABG had a higher risk of the composite outcome of
death, MI or stroke (aHR: 1.83, P = 0.046); the rates of procedural
complications and death did not differ significantly, and there were no
significant differences in the functional outcomes. CONCLUSIONS: Patients
with diabetes had greater risk of major cardiovascular events long-term
after off-pump CABG than after on-pump CABG.

<8>
Accession Number
20160200271
Author
Jarral O.A.; Kidher E.; Patel V.M.; Nguyen B.; Pepper J.; Athanasiou T.
Institution
(Jarral, Kidher, Patel, Nguyen, Pepper, Athanasiou) Department of Surgery
and Cancer, Imperial College London, London, United Kingdom
Title
Quality of life after intervention on the thoracic aorta.
Source
European Journal of Cardio-thoracic Surgery. 49 (2) (pp 369-389), 2016.
Article Number: ezv119. Date of Publication: 01 Feb 2016.
Publisher
European Association for Cardio-Thoracic Surgery
Abstract
Surgery on the thoracic aorta is challenging and historically associated
with significant mortality and morbidity. In recent times, there has been
increased emphasis on the importance of health-related quality of life
(HRQOL) measures. It is seen as a development beyond isolated markers of
outcome such as operative mortality and is particularly applicable to
aortic surgery given the number of asymptomatic patients operated on (for
prognostic grounds), and rapidly advancing endovascular technologies which
require proper assessment. This systematic review provides an outline of
all available literature detailing HRQOL in patients receiving
intervention (both open and endovascular) on the thoracic aorta. In total,
30 studies were identified encompassing 4746 patients undergoing a variety
of procedures from aortic root replacement to thoracoabdominal aortic
aneurysm repair. While there were deficiencies in the underlying
literature such as lack of baseline HRQOL assessment, the majority of the
studies confirm that HRQOL after major aortic surgery (including on the
elderly and in emergency situations) is acceptable and compares well to
matched general populations. Strategies for improving the HRQOL in aortic
surgery are summarized and include the need for surgeons to plan cerebral
protection methods more carefully and to develop operative strategies to
avoid reoperation or reintervention, as this is associated with
deterioration of long-term HRQOL. Randomized studies measuring baseline
and follow-up HRQOL at specific set points are needed. Innovative research
methods could be employed in future studies with the aim of correlating
HRQOL with imaging or physiological/inflammation biomarkers, or other end
points such as aortic stiffness or wall shear stress to characterize
disease progression and prognosis.

<9>
Accession Number
20160201160
Author
Douglas P.S.; Pontone G.; Hlatky M.A.; Patel M.R.; Norgaard B.L.; Byrne
R.A.; Curzen N.; Purcell I.; Gutberlet M.; Rioufol G.; Hink U.; Schuchlenz
H.W.; Feuchtner G.; Gilard M.; Andreini D.; Jensen J.M.; Hadamitzky M.;
Chiswell K.; Cyr D.; Wilk A.; Wang F.; Rogers C.; De Bruyne B.
Institution
(Douglas, Patel, Chiswell, Cyr) Duke Clinical Research Institute, Duke
University School of Medicine, 7022 North Pavilion DUMC, Durham, NC 27715,
United States
(Pontone, Andreini) Centro Cardiologico Monzino, IRCCS, University of
Milan, Milan, Italy
(Hlatky) Department of Health Research and Policy, Stanford University
School of Medicine, Stanford, CA, United States
(Norgaard, Jensen) Department of Cardiology, Aarhus University Hospital,
Aarhus Skejby, Denmark
(Byrne, Hadamitzky) Deutsches Herzzentrum Munchen, Technische Universitat
Munchen, Munich, Germany
(Curzen) University Hospital Southampton NHS Trust, Southampton, United
Kingdom
(Purcell) Freeman Hospital, Newcastle Upon Tyne, United Kingdom
(Gutberlet) University of Leipzig Heart Centre, Leipzig, Germany
(Rioufol) Hospices Civils de Lyon and CARMEN INSERM 1060, Lyon, France
(Hink) Department of Cardiology, Johannes Gutenberg University Hospital,
Mainz, Germany
(Schuchlenz) LKH Graz West, Graz, Austria
(Feuchtner) Department of Radiology, Innsbruck Medical University,
Innsbruck, Austria
(Gilard) Department of Cardiology, Cavale Blanche Hospital, Brest, France
(Wilk, Wang, Rogers) HeartFlow, Redwood City, CA, United States
(De Bruyne) Cardiovascular Centre Aalst, Aalst, Belgium
Title
Clinical outcomes of fractional flow reserve by computed tomographic
angiography-guided diagnostic strategies vs. usual care in patients with
suspected coronary artery disease: The prospective longitudinal trial of
FFR<inf>CT</inf>: Outcome and resource impacts study.
Source
European Heart Journal. 36 (47) (pp 3359-3367), 2015. Date of Publication:
14 Dec 2015.
Publisher
Oxford University Press
Abstract
Aims In symptomatic patients with suspected coronary artery disease (CAD),
computed tomographic angiography (CTA) improves patient selection for
invasive coronary angiography (ICA) compared with functional testing. The
impact of measuring fractional flow reserve by CTA (FFR<inf>CT</inf>) is
unknown. Methods and results At 11 sites, 584 patients with new onset
chest pain were prospectively assigned to receive either usual testing (n
= 287) or CTA/FFR<inf>CT</inf> (n = 297). Test interpretation and care
decisions were made by the clinical care team. The primary endpoint was
the percentage of those with planned ICA in whom no significant
obstructive CAD (no stenosis >50% by core laboratory quantitative analysis
or invasive FFR < 0.80) was found at ICA within 90 days. Secondary
endpoints including death, myocardial infarction, and unplanned
revascularization were independently and blindly adjudicated. Subjects
averaged 61 +/- 11 years of age, 40% were female, and the mean pre-Test
probability of obstructive CAD was 49 +/- 17%. Among those with intended
ICA (FFR<inf>CT</inf>-guided = 193; usual care = 187), no obstructive CAD
was found at ICA in 24 (12%) in the CTA/FFR<inf>CT</inf> arm and 137 (73%)
in the usual care arm (risk difference 61%, 95% confidence interval 53-69,
P< 0.0001), with similar mean cumulative radiation exposure (9.9 vs. 9.4
mSv, P = 0.20). Invasive coronary angiography was cancelled in 61% after
receiving CTA/FFR<inf>CT</inf> results. Among those with intended
non-invasive testing, the rates of finding no obstructive CAD at ICA were
13% (CTA/FFR<inf>CT</inf>) and 6% (usual care; P = 0.95). Clinical event
rates within 90 days were low in usual care and CTA/FFR<inf>CT</inf> arms.
Conclusions Computed tomographic angiography/fractional flow reserve by
CTA was a feasible and safe alternative to ICA and was associated with a
significantly lower rate of invasive angiography showing no obstructive
CAD.

<10>
Accession Number
20160038054
Author
Hansen L.S.; Hjortdal V.E.; Jakobsen C.-J.
Institution
(Hansen, Jakobsen) Department of Anaesthesiology and Intensive Care,
Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N
8200, Denmark
(Hansen, Hjortdal) Department of Cardiothoracic Surgery, Aarhus University
Hospital, Aarhus N, Denmark
Title
Relocation of patients after cardiac surgery: Is it worth the effort?.
Source
Acta Anaesthesiologica Scandinavica. 60 (4) (pp 441-449), 2016. Date of
Publication: 01 Apr 2016.
Publisher
Blackwell Munksgaard
Abstract
Background Fast-track protocols may facilitate early patient discharge
from the site of surgery through the implementation of more expedient
pathways. However, costs may merely be shifted towards other parts of the
health care system. We aimed to investigate the consequence of patient
transfers on overall hospitalisation, follow-up and readmission rate after
cardiac surgery. Methods A single-centre descriptive cohort study using
prospectively entered registry data. The study included 4,515 patients who
underwent cardiac surgery at Aarhus University Hospital during the period
1 April 2006 to 31 December 2012. Patients were grouped and analysed based
on type of discharge: Directly from site of surgery or after transfer to a
regional hospital. The cohort was obtained from the Western Denmark Heart
Registry and matched to the Danish National Hospital Register. Results
Median overall length of stay was 9 days (7.0;14.4). Transferred patients
had longer length of stay, median difference of 2.0 days, p < 0.001. Time
to first outpatient consultation was 41(30;58) days in transferred
patients vs. 45(29;74) days, p < 0.001. 18.6% was readmitted within 30
days. Mean time to readmission was 18.4 +/- 6.4 days. Median length of
readmission was 3(1,6) days. There was no difference in readmissions
between groups. Leading cause of readmission was cardiovascular disease
with 48%. Conclusion Transfer of patients does not overtly reduce health
care costs, but overall LOS and time to first outpatient consultation are
substantially longer in patients transferred to secondary hospitals than
in patients discharged directly. Readmission rate is high during the month
after surgery, but with no difference between groups.

<11>
Accession Number
20151039229
Author
Setala P.; Kalliomaki M.-L.; Jarvela K.; Huhtala H.; Sisto T.; Puolakka P.
Institution
(Setala, Kalliomaki, Puolakka) Department of Anaesthesia, Tampere
University Hospital, PO Box 2000, Tampere FIN-33521, Finland
(Jarvela, Sisto) Heart Center, Tampere University Hospital, Tampere,
Finland
(Huhtala) School of Health Sciences, University of Tampere, Tampere,
Finland
Title
Postoperative hyperalgesia does not predict persistent post-sternotomy
pain; Observational study based on clinical examination.
Source
Acta Anaesthesiologica Scandinavica. 60 (4) (pp 520-528), 2016. Date of
Publication: 01 Apr 2016.
Publisher
Blackwell Munksgaard
Abstract
Background Persistent post-sternotomy pain is a common problem, but the
risk of developing it varies among patients. We sought to find out whether
the risk of persistent post-sternotomy pain could be predicted by
measuring the area of acute sensory dysfunction around the sternotomy
wound. The secondary aim was to determine risk factors for persistent
post-sternotomy pain. Patients and methods Hundred patients who were
scheduled to undergo elective coronary artery bypass surgery were
recruited to the study. Patients were excluded if they had undergone
previous cardiac surgery or if they lacked co-operation. Preoperative pain
scores were determined and the patients filled in questionnaires about
depression, anxiety, and pain. The area of sensory dysfunction around the
sternotomy wound was assessed by pin prick on postoperative day 4. The
presence of persistent post-sternotomy pain was determined at a follow-up
evaluation at 4-6 months after surgery. Results The sizes of the area of
hyperalgesia or overall sensory dysfunction were not associated with
persistent post-sternotomy pain. Independent risk factors for persistent
post-sternotomy pain were found to be smoking and high pain score on
postoperative day 1. The prevalence of persistent post-sternotomy pain in
our study population was 38% analyzed by only the questionnaire and 15%
according to the clinical examination. Conclusion Measuring the area of
hyperalgesia in the acute phase does not give any additional information
on the risk of developing a persistent post-sternotomy pain. We do thus
not recommend measuring the area in this particular group of patients.
Evaluation of pain by only a questionnaire risks to overestimate the
presence of persistent post-sternotomy pain as compared to clinical
examination.

<12>
Accession Number
2015527301
Author
Eldeen H.M.S.
Institution
(Eldeen) Anesthesia Department, Oncology Center, Mansoura University,
Egypt
(Eldeen) Anaesthesia and Surgical Intensive Care Department, Faculty of
Medicine, Mansoura University, Egypt
Title
Ultrasound guided pectoral nerve blockade versus thoracic spinal blockade
for conservative breast surgery in cancer breast: A randomized controlled
trial.
Source
Egyptian Journal of Anaesthesia. 32 (1) (pp 29-35), 2016. Date of
Publication: 01 Jan 2016.
Publisher
Central Society of Egyptian Anaesthesiologists (P.O. Box 167, Panorama
October 11811, Nasr City, Cairo, Egypt)
Abstract
Background Breast surgery is commonly performed in geriatric patients. In
this age group, patients commonly suffer from comorbidities, making
regional anesthesia the preferred option during surgery. Both segmental
thoracic spinal anesthesia (TSA), thoracic paravertebral (TPB) and
pectoral nerve (Pecs) blocks were tried successfully. This encouraged us
to compare between segmental thoracic spinal anesthesia (TSA) and pectoral
nerve (Pecs) block for surgeries in the thoracic region, namely breast
surgery. Methods Forty (ASA) I-II patients aged between 40-65 years with
cancer breast surgeries were enrolled in this study. In regard to
anesthetic choice, patients were randomly divided into two groups, with 20
patients in each: Group A, with pectoral nerve block and group B, with
thoracic spinal block. Standard monitoring in the form of mean blood
pressure (MBP) and heart rate (HR) was recorded. Onset time for sensory
block, time to reach peak sensory level, regression times of motor blocks
and sensory blocks. Intraoperative VAS and post-operative VAS were
recorded. Any postoperative complications such as bradycardia,
hypotension, nausea and vomiting were assessed. Results The time onset of
both sensory and motor blocks was compared; there was statistically
significant difference between both groups (P < 0.05). T1 was the highest
level of sensory block attained at 17.7 +/- 1.7 and 5.5 +/- 1.6 min after
injection in group A, and group B respectively and the total time for
block was significantly prolonged in group A (940.3 +/- 17.2 min) compared
to group B (315.5 +/- 44.3 min) as P < 0.0001. Regression times of motor
blocks and sensory blocks, were significantly prolonged in group A (994
+/- 55 min, 940 +/- 34 min) compared to group B (382 +/- 45 min, 351 +/-
35 min) as P < 0.0001. Also, there was significant prolongation of
duration of postoperative analgesia with significant reduction of total
fentanyl requirement during the first 24 h postoperative in group A
compared to group B. Regarding the hemodynamic variables (MBP, HR), there
were significant decrease in HR and mean blood pressure (MBP) between the
both groups throughout the intraoperative and early postoperative periods.
Conclusion In conclusion, both Pecs and TSB provide effective
intraoperative anesthesia and prolonged postoperative pain relief after
breast surgery, but the Pecs block is technically simple and easy to learn
with few contraindications, provides hemodynamic stability, and has a low
complication rate and it is therefore a safe and effective technique in
performing intraoperative anesthesia and controlling postoperative pain
after unilateral conservative breast surgery.

<13>
Accession Number
20160204166
Author
Romero J.; Lupercio F.; Diaz J.C.; Goodman-Meza D.; Haramati L.B.; Levsky
J.M.; Shaban N.; Pina I.; Garcia M.J.
Institution
(Romero) Ronald Reagan UCLA Medical Center, David Geffen School of
Medicine, UCLA, Los Angeles, CA, United States
(Romero, Lupercio, Diaz, Goodman-Meza, Haramati, Levsky, Shaban, Pina,
Garcia) Montefiore Medical Center, Albert Einstein College of Medicine,
Bronx, NY, United States
Title
Microvascular obstruction detected by cardiac MRI after AMI for the
prediction of LV remodeling and MACE: A meta-analysis of prospective
trials.
Source
International Journal of Cardiology. 202 (pp 344-348), 2016. Date of
Publication: 01 Jan 2016.
Publisher
Elsevier Ireland Ltd

<14>
Accession Number
20160199127
Author
Hemkens L.G.; Contopoulos-Ioannidis D.G.; Ioannidis J.P.A.
Institution
(Hemkens, Ioannidis) Stanford Prevention Research Center, Department of
Medicine, Stanford University School of Medicine, Stanford, CA 94305,
United States
(Hemkens) Basel Institute for Clinical Epidemiology and Biostatistics,
University Hospital Basel, Basel, Switzerland
(Contopoulos-Ioannidis) Department of Pediatrics, Division of Infectious
Diseases, Stanford University School of Medicine, Stanford, CA, United
States
(Contopoulos-Ioannidis, Ioannidis) Meta-Research Innovation Center at
Stanford (METRICS), Stanford University School of Medicine, Stanford, CA,
United States
(Ioannidis) Department of Health Research and Policy, Stanford University
School of Medicine, Stanford, CA, United States
(Ioannidis) Department of Statistics, Stanford University School of
Humanities and Sciences, Stanford, CA, United States
Title
Agreement of treatment effects for mortality from routinely collected data
and subsequent randomized trials: Meta-epidemiological survey.
Source
BMJ (Online). 352 (no pagination), 2016. Article Number: i493. Date of
Publication: 08 Feb 2016.
Publisher
BMJ Publishing Group
Abstract
Objective To assess differences in estimated treatment effects for
mortality between observational studies with routinely collected health
data (RCD; that are published before trials are available) and subsequent
evidence from randomized controlled trials on the same clinical question.
Design Meta-epidemiological survey. Data sources PubMed searched up to
November 2014. Methods Eligible RCD studies were published up to 2010 that
used propensity scores to address confounding bias and reported
comparative effects of interventions for mortality. The analysis included
only RCD studies conducted before any trial was published on the same
topic. The direction of treatment effects, confidence intervals, and
effect sizes (odds ratios) were compared between RCD studies and
randomized controlled trials. The relative odds ratio (that is, the
summary odds ratio of trial(s) divided by the RCD study estimate) and the
summary relative odds ratio were calculated across all pairs of RCD
studies and trials. A summary relative odds ratio greater than one
indicates that RCD studies gave more favorable mortality results. Results
The evaluation included 16 eligible RCD studies, and 36 subsequent
published randomized controlled trials investigating the same clinical
questions (with 17 275 patients and 835 deaths). Trials were published a
median of three years after the corresponding RCD study. For five (31%) of
the 16 clinical questions, the direction of treatment effects differed
between RCD studies and trials. Confidence intervals in nine (56%) RCD
studies did not include the RCT effect estimate. Overall, RCD studies
showed significantly more favorable mortality estimates by 31% than
subsequent trials (summary relative odds ratio 1.31 (95% confidence
interval 1.03 to 1.65; I²=0%)). Conclusions Studies of
routinely collected health data could give different answers from
subsequent randomized controlled trials on the same clinical questions,
and may substantially overestimate treatment effects. Caution is needed to
prevent misguided clinical decision making.

<15>
Accession Number
20151061444
Author
Sabate M.; Brugaletta S.; Cequier A.; Iniguez A.; Serra A.;
Jimenez-Quevedo P.; Mainar V.; Campo G.; Tespili M.; Den Heijer P.;
Bethencourt A.; Vazquez N.; Van Es G.A.; Backx B.; Valgimigli M.; Serruys
P.W.
Institution
(Sabate, Brugaletta) University Hospital Clinic, Institut d'Investigacions
Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
(Cequier) University Hospital of Bellvitge, Barcelona, Spain
(Iniguez) Hospital Do Meixoeiro, Vigo, Spain
(Serra) University Hospital of Sant Pau, Barcelona, Spain
(Jimenez-Quevedo) University Hospital San Carlos, Madrid, Spain
(Mainar) Hospital General of Alicante, Alicante, Spain
(Campo) University Hospital Ferrara, Ferrara, Italy
(Tespili) University Hospital Bolognini Seriate, Bergamo, Italy
(Den Heijer) Amphia Ziekenhuis, Breda, Netherlands
(Bethencourt) Hospital Son Espases, Palma de Mallorca, Spain
(Vazquez) Hospital Juan Canalejo, A Coruna, Spain
(Van Es, Backx) Cardialysis, Rotterdam, Netherlands
(Valgimigli) Erasmus MC, Rotterdam, Netherlands
(Valgimigli) University Hospital of Bern, Inselhospital, Bern, Switzerland
(Serruys) International Centre of Circulatory Health, Imperial College
London, London, United Kingdom
Title
Clinical outcomes in patients with ST-segment elevation myocardial
infarction treated with everolimus-eluting stents versus bare-metal stents
(EXAMINATION): 5-year results of a randomised trial.
Source
The Lancet. 387 (10016) (pp 357-366), 2016. Date of Publication: 23 Jan
2016.
Publisher
Lancet Publishing Group
Abstract
Summary Background Data for the safety and efficacy of new-generation
drug-eluting stents at long-term follow-up, and specifically in patients
with ST-segment elevation myocardial infarction, are scarce. In the
EXAMINATION trial, we compared everolimus-eluting stents (EES) with
bare-metal stents (BMS) in an all-comer population with ST-segment
elevation myocardial infarction. In this study, we assessed the 5-year
outcomes of the population in the EXAMINATION trial. Methods In the
multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands,
patients with ST-segment elevation myocardial infarction were randomly
assigned in a 1:1 ratio to receive EES or BMS. The random allocation
schedule was computer-generated and central randomisation (by telephone)
was used to allocate patients in blocks of four or six, stratified by
centre. Patients were masked to treatment assignment. At 5 years, we
assessed the combined patient-oriented outcome of all-cause death, any
myocardial infarction, or any revascularisation. Analysis was by intention
to treat. This trial is registered with ClinicalTrials.gov, number
NCT00828087. Findings 1498 patients were randomly assigned to receive
either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up
data were obtained for 731 patients treated with EES and 727 treated with
BMS (97% of both groups). The patient-oriented endpoint occurred in 159
(21%) patients in the EES group versus 192 (26%) in the BMS group (hazard
ratio 0.80, 95% CI 0.65-0.98; p=0.033). This difference was mainly driven
by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0.72,
0.52-0.10; p=0.047). Interpretation Our findings should be taken as a
point of reference for the assessment of new bioresorbable polymer-based
metallic stents or bioresorbable scaffolds in patients with ST-segment
elevation myocardial infarction. Funding Spanish Heart Foundation.

<16>
Accession Number
20151002309
Author
Lincoff A.M.; Mehran R.; Povsic T.J.; Zelenkofske S.L.; Huang Z.;
Armstrong P.W.; Steg P.G.; Bode C.; Cohen M.G.; Buller C.; Laanmets P.;
Valgimigli M.; Marandi T.; Fridrich V.; Cantor W.J.; Merkely B.;
Lopez-Sendon J.; Cornel J.H.; Kasprzak J.D.; Aschermann M.; Guetta V.;
Morais J.; Sinnaeve P.R.; Huber K.; Stables R.; Sellers M.A.; Borgman M.;
Glenn L.; Levinson A.I.; Lopes R.D.; Hasselblad V.; Becker R.C.; Alexander
J.H.
Institution
(Lincoff, Borgman) Cleveland Clinic Coordinating Center for Clinical
Research (C5Research), Department of Cardiovascular Medicine, Cleveland
Clinic, Cleveland, OH 44195, United States
(Mehran) Mount Sinai School of Medicine, New York, NY, United States
(Povsic, Huang, Sellers, Lopes, Hasselblad, Alexander) Duke Clinical
Research Institute, Duke Medicine, Durham, NC, United States
(Zelenkofske, Glenn) Regado Biosciences, Basking Ridge, NJ, United States
(Armstrong) Canadian VIGOUR Centre, University of Alberta, Edmonton, AB,
Canada
(Steg) Universite Paris-Diderot, Sorbonne Paris Cite, Paris, France
(Bode) University of Freiburg, Freiburg, Germany
(Cohen) University of Miami, Miller School of Medicine, Miami, FL, United
States
(Buller) St Michael's Hospital, Toronto, ON, Canada
(Laanmets, Marandi) North Estonia Medical Centre, Tallinn, Estonia
(Valgimigli) University Hospital of Ferrara, Institute of Cardiology,
Ferrara, Italy
(Fridrich) National Institute of Cardiovascular Diseases, Bratislava,
Slovakia
(Cantor) Southlake Regional Health Centre, Newmarket, ON, Canada
(Merkely) Semmelweis University Heart, Vascular Center, Budapest, Hungary
(Lopez-Sendon) Hospital Universitario la Paz, IdiPaz, Madrid, Spain
(Cornel) Medical Center Alkmaar, Alkmaar, Netherlands
(Kasprzak) Medical University of Lodz, Bieganski Hospital, Lodz, Poland
(Aschermann) General University Hospital, Prague, Czech Republic
(Guetta) Heart Institute Sheba Medical Center, Tel Aviv University, Tel
Hashomer, Israel
(Morais) Santo Andre's Hospital, Leiria, Portugal
(Sinnaeve) University Hospitals Leuven, Campus Gasthuisberg, Leuven,
Belgium
(Huber) Wilhelminen Hospital, Vienna, Austria
(Stables) Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
(Levinson) Perelman School of Medicine, University of Pennsylvania,
Philadelphia, PA, United States
(Becker) University of Cincinnati, College of Medicine, Cincinnati, OH,
United States
Title
Effect of the REG1 anticoagulation system versus bivalirudin on outcomes
after percutaneous coronary intervention (REGULATE-PCI): A randomised
clinical trial.
Source
The Lancet. 387 (10016) (pp 349-356), 2016. Date of Publication: 23 Jan
2016.
Publisher
Lancet Publishing Group
Abstract
Summary Background REG1 is a novel anticoagulation system consisting of
pegnivacogin, an RNA aptamer inhibitor of coagulation factor IXa, and
anivamersen, a complementary sequence reversal oligonucleotide. We tested
the hypothesis that near complete inhibition of factor IXa with
pegnivacogin during percutaneous coronary intervention, followed by
partial reversal with anivamersen, would reduce ischaemic events compared
with bivalirudin, without increasing bleeding. Methods We did a
randomised, open-label, active-controlled, multicentre, superiority trial
to compare REG1 with bivalirudin at 225 hospitals in North America and
Europe. We planned to randomly allocate 13200 patients undergoing
percutaneous coronary intervention in a 1:1 ratio to either REG1
(pegnivacogin 1 mg/kg bolus [>99% factor IXa inhibition] followed by 80%
reversal with anivamersen after percutaneous coronary intervention) or
bivalirudin. Exclusion criteria included ST segment elevation myocardial
infarction within 48 h. The primary efficacy endpoint was the composite of
all-cause death, myocardial infarction, stroke, and unplanned target
lesion revascularisation by day 3 after randomisation. The principal
safety endpoint was major bleeding. Analysis was by intention to treat.
This trial is registered at ClinicalTrials.gov, identifier NCT01848106.
The trial was terminated early after enrolment of 3232 patients due to
severe allergic reactions. Findings 1616 patients were allocated REG1 and
1616 were assigned bivalirudin, of whom 1605 and 1601 patients,
respectively, received the assigned treatment. Severe allergic reactions
were reported in ten (1%) of 1605 patients receiving REG1 versus one (<1%)
of 1601 patients treated with bivalirudin. The composite primary endpoint
did not differ between groups, with 108 (7%) of 1616 patients assigned
REG1 and 103 (6%) of 1616 allocated bivalirudin reporting a primary
endpoint event (odds ratio [OR] 1.05, 95% CI 0.80-1.39; p=0.72). Major
bleeding was similar between treatment groups (seven [<1%] of 1605
receiving REG1 vs two [<1%] of 1601 treated with bivalirudin; OR 3.49, 95%
CI 0.73-16.82; p=0.10), but major or minor bleeding was increased with
REG1 (104 [6%] vs 65 [4%]; 1.64, 1.19-2.25; p=0.002). Interpretation The
reversible factor IXa inhibitor REG1, as currently formulated, is
associated with severe allergic reactions. Although statistical power was
limited because of early termination, there was no evidence that REG1
reduced ischaemic events or bleeding compared with bivalirudin. Funding
Regado Biosciences Inc.

<17>
Accession Number
2015555201
Author
Cassese S.; Byrne R.A.; Ndrepepa G.; Kufner S.; Wiebe J.; Repp J.;
Schunkert H.; Fusaro M.; Kimura T.; Kastrati A.
Institution
(Cassese, Byrne, Ndrepepa, Kufner, Wiebe, Repp, Schunkert, Fusaro,
Kastrati) Deutsches Herzzentrum Munchen, Technische Universitat Munchen,
Munich 80636, Germany
(Schunkert, Kastrati) DZHK (German Centre for Cardiovascular Research),
Partner Site Munich Heart Alliance, Munich, Germany
(Kimura) Department of Cardiovascular Medicine, Kyoto University Hospital,
Kyoto, Japan
Title
Everolimus-eluting bioresorbable vascular scaffolds versus
everolimus-eluting metallic stents: A meta-analysis of randomised
controlled trials.
Source
The Lancet. 387 (10018) (pp 537-544), 2016. Date of Publication: 06 Feb
2016.
Publisher
Lancet Publishing Group
Abstract
Background Bioresorbable coronary stents might improve outcomes of
patients treated with percutaneous coronary interventions. The
everolimus-eluting bioresorbable vascular scaffold is the most studied of
these stent platforms; however, its performance versus everolimus-eluting
metallic stents remains poorly defined. We aimed to assess the efficacy
and safety of everolimus-eluting bioresorbable vascular scaffolds versus
everolimus-eluting metallic stents in patients with ischaemic heart
disease treated with percutaneous revascularisation. Methods We searched
Medline, Embase, the Cochrane Central Register of Controlled Trials
(CENTRAL), scientific sessions abstracts, and relevant websites for
randomised trials investigating everolimus-eluting bioresorbable vascular
scaffolds versus everolimus-eluting metallic stents published or posted
between Nov 30, 2006, and Oct 12, 2015. The primary efficacy outcome was
target lesion revascularisation and the primary safety outcome was
definite or probable stent (scaffold) thrombosis. Secondary outcomes were
target lesion failure (the composite of cardiac death, target-vessel
myocardial infarction, or ischaemia-driven target lesion
revascularisation), myocardial infarction, death, and in-device late lumen
loss. We derived odds ratios (ORs) and weighted mean differences with 95%
CIs, and calculated the risk estimates for the main outcomes according to
a random-effects model. This study is registered with PROSPERO, number
CRD42015026374. Findings We included six trials, comprising data for 3738
patients randomised to receive percutaneous coronary intervention with
either an everolimus-eluting bioresorbable vascular scaffold (n=2337) or
an everolimus-eluting metallic stent (n=1401). Median follow-up was 12
months (IQR 9-12). Patients treated with bioresorbable vascular scaffolds
had a similar risk of target lesion revascularisation (OR 0.97 [95% CI
0.66-1.43]; p=0.87), target lesion failure (1.20 [0.90-1.60]; p=0.21),
myocardial infarction (1.36 [0.98-1.89]; p=0.06), and death (0.95
[0.45-2.00]; p=0.89) as those treated with metallic stents. Patients
treated with a bioresorbable vascular scaffold had a higher risk of
definite or probable stent thrombosis than those treated with a metallic
stent (OR 1.99 [95% CI 1.00-3.98]; p=0.05), with the highest risk between
1 and 30 days after implantation (3.11 [1.24-7.82]; p=0.02). Lesions
treated with a bioresorbable vascular scaffold had greater in-device late
lumen loss than those treated with a metallic stent (weighted mean
difference 0.08 [95% CI 0.05-0.12]; p<0.0001). Interpretation Compared
with everolimus-eluting metallic stents, everolimus-eluting bioresorbable
vascular scaffolds had similar rates of repeat revascularisation at 1 year
of follow-up, despite inferior mid-term angiographic performance. However,
patients treated with a bioresorbable vascular scaffold had an increased
risk of subacute stent thrombosis. Studies with extended follow-up in a
larger number of patients are needed to fully assess the long-term
advantages of everolimus-eluting bioresorbable vascular scaffolds. Funding
None.

<18>
[Use Link to view the full text]
Accession Number
20160190453
Author
Han Y.; Xu B.; Xu K.; Guan C.; Jing Q.; Zheng Q.; Wang H.; Zhao X.; Li X.;
Yu P.; Zang H.; Wang Z.; Cao X.; Zhang J.; Pang W.; Li J.; Yang Y.; Dangas
G.D.
Institution
(Han, Xu, Jing, Li) Department of Cardiology, General Hospital of Shenyang
Military Region, 83, Wenhua Rd Shenhe District, Shenyang 110016, China
(Xu, Guan) Catheterization Laboratory, Fu Wai Hospital, National Center
for Cardiovascular Diseases, Beijing, China
(Yang) Department of Cardiology, Fu Wai Hospital, National Center for
Cardiovascular Diseases, Beijing, China
(Zheng) Department of Cardiology, Affiliated Tangdu Hospital, Fourth
Military Medical University, Xi'an, China
(Li) Department of Cardiology, Fourth Affiliated Hospital, Haerbin Medical
University, Haerbin, China
(Zhao) Department of Cardiology, Affiliated Changhai Hospital, Second
Military Medical University, Shanghai, China
(Wang) Department of Cardiology, Affiliated Xijing Hospital, Fourth
Military Medical University, Xi'an, China
(Zhao) Department of Cardiology, Jilin University First Hospital,
Changchun, China
(Li) Department of Cardiology, General Hospital of Jinan Military Region,
Jinan, China
(Yu) Department of Cardiology, Pingdu People's Hospital, Pingdu, China
(Zang) Department of Cardiology, NO. 463 Hospital of PLA, Shenyang, China
(Wang) Department of Cardiology, Xinxiang Central Hospital, Xinxiang,
China
(Cao) Department of Cardiology, NO. 252 Hospital of PLA, Baoding, China
(Zhang) Department of Cardiology, Cangzhou Central Hospital, Cangzhou,
China
(Pang) Department of Cardiology, Shengjing Hospital, Shenyang, China
(Dangas) Zena and Michael A. Wiener Cardiovascular Institute,
Interventional Cardiovascular Research and Clinical Trials Center, Mount
Sinai Medical Center, New York, United States
Title
Six versus 12 months of dual antiplatelet therapy after implantation of
biodegradable polymer sirolimus-eluting stent: Randomized substudy of the
I-LOVE-IT 2 trial.
Source
Circulation: Cardiovascular Interventions. 9 (2) (no pagination), 2016.
Article Number: e003145. Date of Publication: 01 Feb 2016.
Publisher
Lippincott Williams and Wilkins
Abstract
Background - There are no reports on a large-scale randomized trial
exploring optimal dual antiplatelet therapy (DAPT) duration after
biodegradable polymer sirolimus-eluting stent implantation. We sought to
report the outcomes of a randomized substudy of the prospective Evaluate
Safety and Effectiveness of the Tivoli DES and the Firebird DES for
Treatment of Coronary Revascularization (I-LOVE-IT 2) trial. Methods and
Results - In the prospective noninferiority randomized I-LOVE-IT 2 trial,
1829 patients allocated to the biodegradable polymer sirolimus-eluting
stent group were also randomized to receive either 6-month (n=909) or
12-month DAPT (n=920). The primary end points of this noninferiority
substudy were 12-month target lesion failure (composite of cardiac death,
target vessel myocardial infarction or clinically indicated target lesion
revascularization), and the major secondary end points were 12-month net
adverse clinical and cerebral events (composite of all-cause death, all
myocardial infarction, stroke, or major bleeding [Bleeding Academic
Research Consortium type >3]). The 12-month target lesion failure in
6-month DAPT group was comparable with the 12-month DAPT group (6.8%
versus 5.9%; difference and 95% confidence interval, 0.87% [-1.37% to
3.11%], P for noninferiority=0.0065). Further follow-up at 18 months
showed that incidence of target lesion failure and net adverse clinical
and cerebral events were similar between the 2 groups (7.5% versus 6.3%,
log-rank P=0.32; 7.8% versus 7.3%, log-rank P=0.60; respectively), as well
as their individual end point components. Conclusions - This study
indicated noninferiority in safety and efficacy of 6-month versus 12-month
DAPT after implantation of a novel biodegradable polymer sirolimus-eluting
stent.

<19>
Accession Number
20160189890
Author
Hamshere S.; Arnous S.; Choudhury T.; Choudry F.; Mozid A.; Yeo C.;
Barrett C.; Saunders N.; Gulati A.; Knight C.; Locca D.; Davies C.; Cowie
M.R.; Prasad S.; Parmar M.; Agrawal S.; Jones D.; Martin J.; McKenna W.;
Mathur A.
Institution
(Hamshere, Arnous, Choudhury, Choudry, Mozid, Yeo, Barrett, Knight, Locca,
Davies, Jones, Mathur) Department of Cardiology, St Bartholomew's
Hospital, Barts Health NHS Trust, West Smithfield, London EC1A 7BE, United
Kingdom
(Saunders, Agrawal) Stem Cell Laboratory, Barts Health NHS Trust and
Blizard Institute, Queen Mary University of London, London, United Kingdom
(Gulati, Prasad) Cardiovascular Magnetic Resonance Unit, Royal Brompton
Hospital, Imperial College London, Sydney Street, London SW3 6NP, United
Kingdom
(Davies, Mathur) Barts Health NIHR Cardiovascular Biomedical Research
Unit, London Chest Hospital, Barts Health NHS Trust, London E2 9JX, United
Kingdom
(Cowie) Imperial College London, Royal Brompton Hospital, London SW3 6NP,
United Kingdom
(Parmar) Cancer Division, Medical Research Council, Clinical Trials Unit,
London, United Kingdom
(Martin) British Heart Foundation Laboratories, Department of Medicine,
University College London, London WC1E 6JJ, United Kingdom
(McKenna) Institute of Cardiovascular Science, University College London,
Heart Hospital, UCLH, 16-18 Westmoreland Street, London W1G 8PH, United
Kingdom
Title
Randomized trial of combination cytokine and adult autologous bone marrow
progenitor cell administration in patients with non-ischaemic dilated
cardiomyopathy: The REGENERATEDCM clinical trial.
Source
European Heart Journal. 36 (44) (pp 3061-3069), 2015. Date of Publication:
2015.
Publisher
Oxford University Press
Abstract
Aims The REGENERATE-DCM trial is the first phase II randomized,
placebo-controlled trial aiming to assess if granulocyte
colony-stimulating factor (G-CSF) administration with or without
adjunctive intracoronary (IC) delivery of autologous bone marrow-derived
cells (BMCs) improves global left ventricular (LV) function in patients
with dilated cardiomyopathy (DCM) and significant cardiac dysfunction.
Methods and results Sixty patients with DCM and left ventricular ejection
fraction (LVEF) at referral of =45%, New York Heart Association (NYHA)
classification =2 and no secondary cause for the cardiomyopathy were
randomized equally into four groups: peripheral placebo (saline),
peripheral G-CSF, peripheral G-CSF and IC serum, and peripheral G-CSF and
IC BMC. All patients, except the peripheral placebo group, received 5 days
of G-CSF. In the IC groups, this was followed by bone marrow harvest and
IC infusion of cells or serum on Day 6. The primary endpoint was LVEF
change from baseline to 3 months, determined by advanced cardiac imaging.
At 3 months, peripheral G-CSF combined with IC BMC therapy was associated
with a 5.37% point increase in LVEF (38.30% +/- 12.97 from 32.93% +/-
16.46 P = 0.0138), which was maintained to 1 year. This was associated
with a decrease in NYHA classification, reduced NT-pro BNP, and improved
exercise capacity and quality of life. No significant change in LVEF was
seen in the remaining treatment groups. Conclusion This is the first
randomized, placebo-controlled trial with a novel combination of G-CSF and
IC cell therapy that demonstrates an improvement in cardiac function,
symptoms, and biochemical parameters in patients with DCM.

<20>
Accession Number
20160080804
Author
Takagi H.; Umemoto T.
Institution
(Takagi, Umemoto) Department of Cardiovascular Surgery, Shizuoka Medical
Center, 762-1 Nagasawa, Shimizu-cho, Suntogun, Shizuoka 411-8611, Japan
Title
Prosthesis-patient mismatch after transcatheter aortic valve implantation.
Source
Annals of Thoracic Surgery. 101 (3) (pp 872-880), 2016. Date of
Publication: 01 Mar 2016.
Publisher
Elsevier USA
Abstract
Background We reviewed currently available studies that investigated
prosthesis-patient mismatch (PPM) in transcatheter aortic valve
implantation (TAVI) with a systematic literature search and meta-analytic
estimates. Methods To identify all studies that investigated PPM in TAVI,
MEDLINE and EMBASE were searched through August 2015. Studies considered
for inclusion met the following criteria: the study population included
patients undergoing TAVI and outcomes included at least post-procedural
PPM prevalence. We performed three quantitative meta-analyses about (1)
PPM prevalence after TAVI, (2) PPM prevalence after TAVI versus surgical
aortic valve replacement (SAVR), and (3) late all-cause mortality after
TAVI in patients with PPM versus patients without PPM. Results We
identified 21 eligible studies that included data on a total of 4,000
patients undergoing TAVI. The first meta-analyses found moderate PPM
prevalence of 26.7%, severe PPM prevalence of 8.0%, and overall PPM
prevalence of 35.1%. The second meta-analyses of six studies, including
745 patients, found statistically significant reductions in moderate (p =
0.03), severe (p = 0.0003), and overall (p = 0.02) PPM prevalence after
TAVI relative to SAVR. The third meta-analyses of five studies, including
2,654 patients, found no statistically significant differences in late
mortality between patients with severe PPM and patients without PPM (p =
0.44) and between patients with overall PPM and patients without PPM (p =
0.97). Conclusions Overall, moderate, and severe PPM prevalence after TAVI
was 35%, 27%, and 8%, respectively, which may be less than that after
SAVR. In contrast to PPM after SAVR, PPM after TAVI may not impair late
survival.

<21>
Accession Number
20151054967
Author
Moscarelli M.; Fattouch K.; Casula R.; Speziale G.; Lancellotti P.;
Athanasiou T.
Institution
(Moscarelli) National Heart and Lung Institute, Imperial College London,
Department of Surgery and Cancer, London W2 1NY, United Kingdom
(Casula, Athanasiou) Department of Surgery and Cancer, Imperial College
London, London, United Kingdom
(Fattouch) GVM Care and Research, Villa Maria Eleonora, Palermo, Italy
(Speziale) GVM Care, Anthea Hospital, Bari, Italy
(Lancellotti) Department of Cardiology, University of Liege Hospital,
Liege, Belgium
Title
What is the role of minimally invasive mitral valve surgery in high-risk
patients? a meta-analysis of observational studies.
Source
Annals of Thoracic Surgery. 101 (3) (pp 981-989), 2016. Date of
Publication: 01 Mar 2016.
Publisher
Elsevier USA
Abstract
Background Minimally invasive valve surgery is related to certain better
postoperative outcomes. We aimed to assess the role of minimally invasive
mitral valve surgery in high-risk patients. Methods A systematic
literature review identified eight studies of which seven fulfilled
criteria for meta-analysis. Outcomes for a total of 1,254 patients (731
were conventional standard sternotomy and 523 were minimally invasive
mitral valve surgery) were submitted to meta-analysis using random effects
modeling. Heterogeneity and subgroup analysis with quality scoring were
assessed. The primary end point was early mortality. Secondary end points
were intraoperative and postoperative outcomes and long-term follow-up.
Results Minimally invasive mitral valve surgery conferred comparable early
mortality to standard sternotomy (p = 0.19); it was also associated with a
lower number of units of blood transfused (weighted mean difference,
-1.93; 95% confidence interval [CI], -3.04 to -0.82; p = 0.0006) and
atrial fibrillation rate (odds ratio, 0.49; 95% CI, 0.32 to 0.74; p =
0.0007); however, cardiopulmonary bypass time was longer (weighted mean
difference, 20.88; 95% CI, -1.90 to 43.65; p = 0.07). There was no
difference in terms of valve repair rate (odds ratio, 1.51; 95% CI, 0.89
to 2.54; p = 0.12), and the incidence of stroke was significantly lower in
the high-quality analysis with no heterogeneity (odds ratio, 0.35; 95% CI,
0.15 to 0.82; p = 0.02; chi², 1.67; I², 0%; p =
0.43). Conclusions Minimally invasive mitral valve surgery is a safe and
comparable alternative to standard sternotomy in patients at high risk,
with similar early mortality and repair rate and better postoperative
outcomes, although a longer cardiopulmonary bypass time is required.

<22>
Accession Number
20151040145
Author
Bin C.; Junsheng M.; Jianqun Z.; Ping B.
Institution
(Bin, Junsheng, Jianqun, Ping) Department of Cardiac Surgery, Beijing
Anzhen Hospital, Capital Medical University, Beijing 100029, China
Title
Meta-analysis of medium and long-term efficacy of loading statins after
coronary artery bypass grafting.
Source
Annals of Thoracic Surgery. 101 (3) (pp 990-995), 2016. Date of
Publication: 01 Mar 2016.
Publisher
Elsevier USA
Abstract
Background The aim of this study was to evaluate the medium- and long-term
efficacy of loading statins after coronary artery bypass grafting (CABG)
by comparing using a loading dose of statins or a regular dose of statins
in patients undergoing CABG. Methods We conducted a literature search of
numerous databases for randomized controlled trials on the efficacy of a
loading dose of statins in patients undergoing CABG. The quality of
included studies was evaluated according to the Newcastle-Ottawa Scale.
Statistical results of treatment were represented by weighted mean
difference, odds ratio, and 95% confidence interval. Results There were 8
studies including 8,676 patients (4,352 who had a loading dose of statins
and 4,324 who had a regular dose). Meta-analysis showed statistically
significant differences in the following in patients who took a loading
dose of statins: lower level of low-density lipoprotein cholesterol
(LDL-C) after CABG (p < 0.00001), fewer deaths caused by myocardial
infarction (p = 0.005), fewer patients with myocardial infarction (p =
0.004), fewer patients undergoing secondary CABG (p < 0.00001), and fewer
patients undergoing graft restenosis by intravascular ultrasonography (p <
0.0001). Conclusions Comparing patients receiving a loading dose of
statins with those receiving a regular dose after CABG, the medium- and
long-term efficacy of a loading dose showed significant reduction in
LDL-C, lower occurrence of adverse cardiac events, and reduction in graft
restenosis. Although the incidence of drug-related side effects was
slightly higher in the loading-dose group, in the majority of patients
they were not serious. Overall, a loading dose of statins is superior to
regular dosing of statins after CABG.

<23>
[Use Link to view the full text]
Accession Number
2015513902
Author
Bode L.G.M.; Rijen M.M.L.V.; Wertheim H.F.L.; Vandenbroucke-Grauls
C.M.J.E.; Troelstra A.; Voss A.; Verbrugh H.A.; Vos M.C.; Kluytmans
J.A.J.W.
Institution
(Bode, Wertheim, Verbrugh, Vos) Erasmus University, Department of Medical
Microbiology and Infectious Diseases, Rotterdam, Netherlands
(Rijen, Kluytmans) Amphia Hospital, Laboratory for Microbiology and
Infection Control, Breda, Netherlands
(Vandenbroucke-Grauls, Kluytmans) VU Medical Center, Department of Medical
Microbiology and Infection Control, Amsterdam, Netherlands
(Troelstra) University Medical Center, Department of Medical Microbiology,
Utrecht, Netherlands
(Voss) Can-Canisius Wilhelmina Hospital, Department of Medical
Microbiology and Infectious Diseases, Nijmegen, Netherlands
(Bode) Department of Medical Microbiology, Heidelberglaan 100, Utrecht
3584, Netherlands
Title
Long-term mortality after rapid screening and decolonization of
staphylococcus aureus carriers : Observational follow-up study of a
randomized, placebo-controlled trial.
Source
Annals of Surgery. 263 (3) (pp 511-515), 2016. Date of Publication: 2016.
Publisher
Lippincott Williams and Wilkins
Abstract
To identify patients who benefit most from Staphylococcus aureus screening
and decolonization treatment upon admission. Background: S. aureus
carriers are at increased risk of developing surgicalsite infections with
S. aureus. Previously, we demonstrated in a randomized, placebo-controlled
trial (RCT) that these infections can largely be prevented by detection of
carriage and decolonization treatment upon admission. In this study, we
analyzed 1-and 3-year mortality rates in both treatment arms of the RCT to
identify patient groups that should be targeted when implementing the
screen-and-treat strategy. Methods: Three years after enrolment in the
RCT, mortality dates of all surgical patients were checked. One-and 3-year
mortality rates were calculated for all patients and for various
subgroups. Results: After 3 years, 44 of 431 (10.2%) and 43 of 362 (11.9%)
patients had died in the mupirocin/chlorhexidine and placebo groups,
respectively. No significant differences in mortality rates were observed
between the treatment groups or the subgroups according to type of
surgery. In the subgroup of patients with clean procedures (382
cardiothoracic, 167 orthopedic, 61 vascular, and 56 other),
mupirocin/chlorhexidine reduced 1-year mortality: 11 of 365 (3.0%) died in
the mupirocin/chlorhexidine versus 21 of 301 (7.0%) in the placebo group
[hazard ratio=0.38 (95% CI: 0.18-0.81)]. Conclusions: Detection and
decolonization of S. aureus carriage not only prevents S. aureus
surgical-site infections but also reduces 1-year mortality in surgical
patients undergoing clean procedures. Such patients with a high risk of
developing S. aureus infections should therefore be the primary target
when implementing the screen-and-treat strategy in clinical practice.

<24>
Accession Number
20160187735
Author
Thiele H.; Desch S.; Piek J.J.; Stepinska J.; Oldroyd K.; Serpytis P.;
Montalescot G.; Noc M.; Huber K.; Fuernau G.; De Waha S.; Meyer-Saraei R.;
Schneider S.; Windecker S.; Savonitto S.; Briggs A.; Torremante P.; Vrints
C.; Schuler G.; Ceglarek U.; Thiery J.; Zeymer U.
Institution
(Thiele, Desch, Fuernau, De Waha, Meyer-Saraei) University Heart Center
Luebeck, Luebeck, Germany
(Thiele, Desch, Fuernau, De Waha, Meyer-Saraei) German Center for
Cardiovascular Research (DZHK), Luebeck, Germany
(Piek) Academic Medical Center, Amsterdam, Netherlands
(Stepinska) Institute of Cardiology, Warsaw, Poland
(Oldroyd) Western Infirmary, Glasgow, United Kingdom
(Serpytis) Vilnius University Hospital, Vilnius, Lithuania
(Montalescot) ACTION Study Group, Centre Hospitalier, Universitaire
Pitie-Salpetriere, Paris, France
(Noc) University Medical Center Ljubljana, Ljubljana, Slovenia
(Huber) Wilhelminenspital der Stadt Wien, Vienna, Austria
(Schneider, Zeymer) Institut fur Herzinfarktforschung, Ludwigshafen,
Germany
(Windecker) University of Bern, Inselspital, Bern, Switzerland
(Savonitto) Manzoni Hospital, Lecco, Italy
(Briggs) Institute of Health and Wellbeing, University of Glasgow,
Glasgow, United Kingdom
(Torremante) GABO:milliarium MbH and Co KG, Munich, Germany
(Vrints) Universitair Ziekenhuis Antwerp, Antwerp, Belgium
(Schuler) University of Leipzig-Heart Center, Leipzig, Germany
(Ceglarek, Thiery) University of Leipzig-Institute of Laboratory Medicine,
Leipzig, Germany
(Zeymer) Klinikum Ludwigshafen, Ludwigshafen, Germany
Title
Multivessel versus culprit lesion only percutaneous revascularization plus
potential staged revascularization in patients with acute myocardial
infarction complicated by cardiogenic shock: Design and rationale of
CULPRIT-SHOCK trial.
Source
American Heart Journal. 172 (pp 160-169), 2016. Date of Publication:
February 2016.
Publisher
Mosby Inc.
Abstract
Background In acute myocardial infarction complicated by cardiogenic shock
(CS), up to 80% of patients present with multivessel coronary artery
disease. Currently, the best revascularization strategy is unknown.
Therefore, a prospective randomized adequately powered clinical trial is
warranted. Study design The CULPRIT-SHOCK study is a 706-patient
controlled, international, multicenter, randomized, open-label trial. It
is designed to compare culprit lesion only percutaneous coronary
intervention (PCI) with possible staged non-culprit lesion
revascularization versus immediate multivessel PCI in patients with CS
complicating acute myocardial infarction. Patients will be randomized in a
1:1 fashion to one of the two treatment arms. The primary efficacy
endpoint of CULPRIT-SHOCK is 30-day mortality and severe renal failure
requiring renal replacement therapy. Secondary outcome measures such as
hemodynamic, laboratory, and clinical parameters will serve as surrogate
endpoints for prognosis. Furthermore, an intermediate- and long-term
follow-up at 6 and 12 months will be performed. Safety endpoints include
the assessment of bleeding and stroke. Conclusions The CULPRIT-SHOCK trial
will address the question of optimal revascularization strategy in
patients with multivessel disease and acute myocardial infarction
complicated by CS.

<25>
Accession Number
20160187739
Author
Nytroen K.; Yardley M.; Rolid K.; Bjorkelund E.; Karason K.; Wigh J.P.;
Dall C.H.; Arora S.; Aakhus S.; Lunde K.; Solberg O.G.; Gustafsson F.;
Prescott E.I.B.; Gullestad L.
Institution
(Nytroen, Yardley, Rolid, Bjorkelund, Arora, Aakhus, Lunde, Solberg,
Gullestad) Department of Cardiology, Oslo University Hospital
Rikshospitalet, Postbox 4950 Nydalen, Oslo 0424, Norway
(Nytroen, Yardley, Gullestad) Faculty of Medicine, University of Oslo,
Oslo, Norway
(Karason, Wigh) Sahlgrenska University Hospital, Gothenburg, Sweden
(Dall, Prescott) Department of Cardiology, Bispebjerg University Hospital,
Copenhagen, Denmark
(Gustafsson) Rigshospitalet University Hospital, Copenhagen, Denmark
Title
Design and rationale of the HITTS randomized controlled trial: Effect of
High-intensity Interval Training in de novo Heart Transplant Recipients in
Scandinavia.
Source
American Heart Journal. 172 (pp 96-105), 2016. Date of Publication:
February 2016.
Publisher
Mosby Inc.
Abstract
There is no consensus on how, when, and at what intensity exercise should
be performed and organized after heart transplantation (HTx). Most
rehabilitation programs are conducted in HTx centers, which might be
impractical and costly. We have recently shown that high-intensity
interval training (HIT) is safe, well tolerated, and efficacious in
maintenance HTx recipients, but there are no studies among de novo
patients, and whether HIT is feasible and superior to moderate training in
HTx recipients is unclear. A total of 120 clinically stable HTx recipients
older than 18 years will be recruited from 3 Scandinavian HTx centers.
Participants are randomized to HIT or moderate training, shortly after
surgery. All exercises are supervised in the patients' local communities.
Testing at baseline and follow-up includes the following:
VO<inf>2peak</inf> (primary end point), muscle strength, body composition,
quality of life, myocardial performance, endothelial function, biomarkers,
and progression of cardiac allograft vasculopathy. A subgroup (n = 90)
will also be tested at 3-year follow-up to assess long-term effects of
exercise. So far, the HIT intervention is well tolerated, without any
serious adverse events. We aim to test whether decentralized HIT is
feasible, safe, and superior to moderate training, and whether it will
lead to significant improvement in exercise capacity and less long-term
complications.

<26>
Accession Number
20160185217
Author
Fukada T.; Tsuchiya Y.; Iwakiri H.; Ozaki M.
Institution
(Fukada, Tsuchiya, Iwakiri, Ozaki) Department of Anesthesiology, Tokyo
Women's Medical University, School of Medicine, 8-1 Kawadacho Shinjukuku,
Tokyo 162-8666, Japan
Title
Is the Ambu aScope 3 Slim single-use fiberscope equally efficient compared
with a conventional bronchoscope for management of the difficult airway?.
Source
Journal of Clinical Anesthesia. 30 (pp 68-73), 2016. Date of Publication:
01 May 2016.
Publisher
Elsevier Inc.
Abstract
Study Objective The study objective was to evaluate whether the single-use
fiberoptic bronchoscope (FOB), Ambu aScope 3 Slim, was equally efficient
compared with the conventional reusable FOB, Olympus LF-GP, for nasal
fiberoptic intubation in a manikin. Design A randomized crossed-over
study. Setting The postanesthesia care unit of Tokyo Women's Medical
University Hospital. Subjects Twenty anesthesiologists who have
experienced > 50 one-lung ventilation thoracic surgery procedures were
invited to participate in this study. Interventions A 6.5-mm internal
diameter cuffed endotracheal tube (ET) was inserted into the manikin under
Ambu aScope 3 Slim (group A) or Olympus LF-GP (group C) guidance.
Measurements The following time parameters from the beginning of FOB
insertion through a nostril were compared between groups: until vocal cord
visualization (T1); visualization of the carina (T2); and proper ET
placement, as confirmed by the distance of the ET tip to carina (T3). Main
Results Mean (SD) T1 in group A and group C were 20 seconds (17 seconds)
and 14 seconds (12 seconds), respectively (P=.1050). Mean (SD) T2 in group
A and group C were 40 seconds (29 seconds) and 25 seconds (15 seconds),
respectively (P=.0287). Mean (SD) T3 in group A and group C were 70
seconds (33 seconds) and 50 seconds (22 seconds), respectively (P=.0098).
One case in group A had failed intubation Conclusions The Ambu aScope 3
Slim required more time to intubate than the conventional reusable FOB. It
requires more rigidity, similar to the conventional FOB for management of
the difficult airway.

<27>
Accession Number
20160183334
Author
Lonn E.; Bosch J.; Pogue J.; Avezum A.; Chazova I.; Dans A.; Diaz R.;
Fodor G.J.; Held C.; Jansky P.; Keltai M.; Keltai K.; Kunti K.; Kim J.-H.;
Leiter L.; Lewis B.; Liu L.; Lopez-Jaramillo P.; Pais P.; Parkhomenko A.;
Peters R.J.G.; Piegas L.S.; Reid C.M.; Sliwa K.; Toff W.D.; Varigos J.;
Xavier D.; Yusoff K.; Zhu J.; Dagenais G.; Yusuf S.
Institution
(Lonn, Yusuf) Department of Medicine, McMaster University, Hamilton, ON,
Canada
(Lonn, Bosch, Pogue, Yusuf) Population Health Research Institute, Hamilton
Health Sciences and McMaster University, Hamilton, ON, Canada
(Avezum) Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil
(Chazova) Russian Cardiology Research Complex, Moscow, Russian Federation
(Dans) College of Medicine of the University of the Philippines, Manula,
Philippines
(Diaz) Fundacion ECLA, Rosario, Argentina
(Fodor) University of Ottawa Heart Institute, Ottawa, ON, Canada
(Held) Department of Medical Sciences, Uppsala University, Uppsala, Sweden
(Jansky) University Hospital Motol, Prague, Czech Republic
(Keltai, Keltai) Hungarian Institute of Cardiology, Semmelweis University,
Budapest, Hungary
(Kunti) Diabetes Research Centre, University of Leicester, Leicester,
United Kingdom
(Kim) St. Paul's Hospital, The Catholic University of Korea, Seoul, South
Korea
(Leiter) Li Ka Shing Knowledge Institute and Keenan Research Centre for
Biomedical Science, St. Michael's Hospital, University of Toronto,
Toronto, ON, Canada
(Lewis) Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport
School of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
(Liu) Fu Wai Hospital, Chinese Academy of Medical Sciences, Beijing, China
(Lopez-Jaramillo) Fundacion Oftalmolgica de Santander (FOSCAL) and
Instituto Masira, Medical School, Universidad de Santander, Bucaramanga,
Colombia
(Pais, Xavier) Division of Clinical Research and Training, St. John's
Research Institute, Bangalore, India
(Parkhomenko) Ukranian Strazhesko Institute of Cardiology, Kiev, Ukraine
(Peters) Department of Cardiology, Academic Medical Center, Amsterdam,
Netherlands
(Piegas) Hospital do Coracao, Sao Paulo, Brazil
(Reid, Varigos) Department of Epidemiology and Preventive Medicine, Monash
University, Melbourne, Australia
(Sliwa) Hatter Institute for Cardiovascular Research in Africa, Department
of Medicine, University of Cape Town and Soweto Cardiovascular Research
Group, Johannesburg, South Africa
(Toff) Department of Cardiovascular Sciences, University of Leicester and
Leicester NIHR Biomedical Research Unit in Cardiovascular Disease,
Glenfield Hospital, Leicester, United Kingdom
(Yusoff) Universiti Teknologi MARA, Selangor, Malaysia
(Zhu) Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union
Medical College, Beijing, China
(Dagenais) Institut Universitaire de Cardiologie et Pneumologie de Quebec,
Universite Laval, QC, Canada
Title
Novel Approaches in Primary Cardiovascular Disease Prevention: The HOPE-3
Trial Rationale, Design, and Participants' Baseline Characteristics.
Source
Canadian Journal of Cardiology. 32 (3) (pp 311-318), 2016. Date of
Publication: 01 Mar 2016.
Publisher
Pulsus Group Inc.
Abstract
Background: Cholesterol and blood pressure (BP) can be effectively and
safely lowered with statin drugs and BP-lowering drugs, reducing major
cardiovascular (CV) events by 20%-30% within 5 years in high-risk
individuals. However, there are limited data in lower-risk populations.
The Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial is evaluating
whether cholesterol lowering with a statin drug, BP lowering with low
doses of 2 antihypertensive agents, and their combination safely reduce
major CV events in individuals at intermediate risk who have had no
previous vascular events and have average cholesterol and BP levels.
Methods: A total of 12,705 women 65 years or older and men 55 years or
older with at least 1 CV risk factor, no known CV disease, and without any
clear indication or contraindication to the study drugs were randomized to
rosuvastatin 10 mg/d or placebo and to candesartan/hydrochlorothiazide
16/12.5 mg/d or placebo (2 x 2 factorial design) and will be followed for
a mean of 5.8 years. The coprimary study outcomes are the composite of CV
death, nonfatal myocardial infarction (MI), and nonfatal stroke and the
composite of CV death, nonfatal MI, nonfatal stroke, resuscitated cardiac
arrest, heart failure, and arterial revascularization. Results:
Participants were recruited from 21 countries in North America, South
America, Europe, Asia, and Australia. Mean age at randomization was 66
years and 46% were women. Conclusions: The HOPE-3 trial will provide new
information on cholesterol and BP lowering in intermediate-risk
populations with average cholesterol and BP levels and is expected to
inform approaches to primary prevention worldwide (HOPE-3
ClinicalTrials.gov NCT00468923).

<28>
Accession Number
20160185505
Author
Martino H.; Brofman P.; Greco O.; Bueno R.; Bodanese L.; Clausell N.;
Maldonado J.A.; Mill J.; Braile D.; Moraes J.; Silva S.; Bozza A.; Santos
B.; De Carvalho A.C.
Institution
(Martino, Bozza, Santos, De Carvalho) Instituto Nacionalde Cardiologia,
Rua das Laranjeiras, 374/50 andar (PesquisaClinica), Rio de Janeiro, RJ
CEP 22240-006, Brazil
(Brofman) Santa Casa de Misericordiado Parana, Curitiba, Brazil
(Greco) Instituto de Molestias Cardiovasculares, Sao Jose do Rio Preto,
Brazil
(Bueno) Universidade Federal do Parana, Curitiba, Brazil
(Bodanese) Pontificia Universidade Catolica do Rio Grande do Sul, Porto
Alegre, Brazil
(Clausell) Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil
(Maldonado) Universidade Federal do Amazonas, Manaus, Brazil
(Mill) Universidade Federal do Espirito Santo, Vitoria, Brazil
(Braile) Instituto Domingo Braile, Sao Jose do Rio Preto, Brazil
(Moraes) Hospital Agamenon Magalhaes, Recife, Brazil
(Silva) Hospital Pro-Cardiaco, Rio de Janeiro, Brazil
Title
Multicentre, randomized, double-blind trial of intracoronary autologous
mononuclear bone marrow cell injection in non-ischaemic dilated
cardiomyopathy (the dilated cardiomyopathy arm of the MiHeart study).
Source
European Heart Journal. 36 (42) (pp 2898-2904), 2015. Date of Publication:
2015.
Publisher
Oxford University Press
Abstract
Aims: Pre-clinical and few clinical studies suggest that transplantation
of autologous bone marrow mononuclear cells (BMNC) improves heart function
in dilated cardiomyopathies. Our objective was to determine if
intracoronary injection of autologous BMNC improves the left ventricular
ejection fraction (LVEF) of patients with non-ischaemic dilated
cardiomyopathy (NIDCM). Methods and results: This study was a multicentre,
randomized, double-blind, placebo controlled trial with a follow-up of 12
months. Patients with NIDCM and LVEF <35% were recruited at heart failure
ambulatories in specialized hospitals around Brazil. One hundred and sixty
subjects were randomized to intracoronary injection of BMNC or placebo
(1:1). The primary endpoint was the difference in change of LVEF between
BMNC and placebo groups as determined by echocardiography. One hundred and
fifteen patients completed the study. Left ventricular ejection fraction
decreased from 24.0% (21.6-26.3) to 19.9% (15.4-24.4) in the BMNC group
and from 24.3% (22.1-26.5) to 22.1% (17.4-26.8) in the placebo group.
There were no significant differences in changes between cell and placebo
groups for left ventricular systolic and diastolic volumes and ejection
fraction. Mortality rate was 20.37% in placebo and 21.31% in BMNC.
Conclusion: Intracoronary injection of autologous BMNC does not improve
left ventricular function in patients with NIDCM.

<29>
Accession Number
72217083
Author
Frymoyer A.; Su F.; Grimm P.C.; Sutherland S.M.; Axelrod D.M.
Institution
(Frymoyer, Su, Grimm, Sutherland, Axelrod) Stanford University, Palo Alto,
CA, United States
Title
Theophylline population pharmacokinetics and dosing in children following
congenital heart surgery with cardiopulmonary bypass.
Source
Clinical Pharmacology and Therapeutics. Conference: 2016 Annual Meeting of
the American Society for Clinical Pharmacology and Therapeutics, ASCPT
2016 San Diego, CA United States. Conference Start: 20160309 Conference
End: 20160312. Conference Publication: (var.pagings). 99 (pp S84), 2016.
Date of Publication: February 2016.
Publisher
Nature Publishing Group
Abstract
BACKGROUND: Children undergoing cardiac surgery requiring cardiopulmonary
bypass (CPB) frequently develop acute kidney injury due to renal ischemia.
Theophylline (THEO), which improves renal perfusion via adenosine receptor
inhibition, is a potential targeted therapy. However, children undergoing
cardiac surgery and CPB commonly have alterations in drug pharmacokinetics
(PK), and the PK and optimal dosing strategy of THEO in this population
are not known. METHODS: Children who underwent cardiac surgery requiring
CPB and received aminophylline (intravenous salt formulation of THEO) as
part of a previous randomized controlled trial were studied. A
population-based PK model was developed from the available THEO
concentration data using nonlinear mixed-effects modeling (NONMEM).
RESULTS: A total of 71 children (median age: 5 months [90% range: 1 week -
10 years]) had 194 theophylline concentrations available for PK analysis.
A onecompartment model with linear elimination adequately described the PK
of THEO. Weight scaled via allometry was a significant predictor of
clearance and volume (p<0.001). After incorporating the allometric model
of weight, an exponential maturation function of age further improved
clearance predictions (p<0.001). For a 5- month old weighing 5.8 kg,
clearance was 0.130 L/h and volume 2.96 L. Applying the final PK model,
optimized empiric aminophylline dosing regimens were developed viaMonte
Carlo simulations. CONCLUSION: In children after cardiac surgery requiring
CPB, theophylline clearance is markedly reduced compared to prior reports
in non-cardiac children. Doses 50-75% lower will be needed to achieve
target drug concentrations of 5- 10 mg/L.

<30>
Accession Number
24518531
Author
Haase-Fielitz A.; Haase M.; Devarajan P.
Institution
(Haase-Fielitz, Haase, Devarajan) Department of Nephrology and
Hypertension, Diabetes, and Endocrinology, Otto-von-Guericke-University
Magdeburg, Germany
Title
Neutrophil gelatinase-associated lipocalin as a biomarker of acute kidney
injury: a critical evaluation of current status.
Source
Annals of clinical biochemistry. Part 3. 51 (pp 335-351), 2014. Date of
Publication: 01 May 2014.
Abstract
BACKGROUND: The early prediction of acute kidney injury (AKI) by current
clinical and laboratory methods remains inadequate. Neutrophil
gelatinase-associated lipocalin (NGAL) has emerged as a promising
non-invasive biomarker of kidney injury. We systematically reviewed the
utility of plasma and urine NGAL measurements for the prediction of AKI in
humans.
METHODS: We searched MEDLINE, PubMed and EMBASE for human biomarker
studies that included NGAL (January 2005 to October 2013). Studies
reporting on the use of NGAL for the early prediction and prognosis of AKI
were analysed in three common clinical settings: cardiac surgery, critical
illness and kidney transplantation.
RESULTS: We identified 58 manuscripts that met our inclusion and exclusion
criteria, reporting on more than 16,500 patients. Following cardiac
surgery, NGAL measurement in over 7000 patients was predictive of AKI and
its severity, with an overall area under the receiver operator
characteristic curve (AUC) of 0.82-0.83. Similar results were obtained in
over 8500 critically ill patients. In over 1000 patients undergoing kidney
transplantation, NGAL measurements predicted delayed graft function with
an overall AUC of 0.87. In all three settings, NGAL significantly improved
the prediction of AKI risk over the clinical model alone.
CONCLUSIONS: We identified several studies that collectively strongly
support the use of NGAL as a biomarker for the prediction of AKI. However,
we noted some limitations, including lack of published studies that adhere
to diagnostic study guidelines, heterogeneity in AKI definition, the lack
of uniformly applicable cut-off values and variability in the performance
of commercially available NGAL assays.