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Accession Number
2013473865
Authors
Rex S.
Institution
(Rex) Department of Anesthesiology, University Hospitals Leuven,
Herestraat 49, B-3000 Leuven, Belgium
(Rex) Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium
Title
Anesthesia for transcatheter aortic valve implantation: An update.
Source
Current Opinion in Anaesthesiology. 26 (4) (pp 456-466), 2013. Date of
Publication: August 2013.
Publisher
Lippincott Williams and Wilkins (250 Waterloo Road, London SE1 8RD, United
Kingdom)
Abstract
PURPOSE OF REVIEW: To summarize and highlight recent advances in the
periprocedural management of patients undergoing transcatheter aortic
valve implantation (TAVI). RECENT FINDINGS: TAVI has become the new
standard of care in inoperable patients with severe aortic valve stenosis
and has emerged as an alternative to surgical aortic valve replacement in
patients with high operative risk. Although TAVI is mainly performed via
the transfemoral route, other access options are available including the
transapical approach. Although TAVI has become a routine procedure, it is
still associated with potentially life-threatening complications. TAVI
should ideally be performed in a dedicated hybrid room by a
multidisciplinary team involving cardiac anesthesiologists. Owing to a
lack of validated risk scores, indication and treatment allocation still
have to rely on clinical judgment. Owing to the severity of the underlying
disease and the complexity of the procedure, TAVI patients require
extensive monitoring and installation. The avoidance of prolonged
hypotension is the most important goal to prevent hemodynamic
deterioration. Transfemoral TAVI procedures can be performed under
conscious sedation. Transesophageal echocardiography is an important tool
for procedural guidance and the instantaneous detection of complications.
SUMMARY: Anesthesiologists involved in TAVI must have detailed knowledge
of valvular heart disease, hemodynamics, echocardiography, the procedure,
and associated complications. 2013 Lippincott Williams & Wilkins.
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Accession Number
2013478768
Authors
Wit M.A.M. De Mulder M. Jansen E.K. Umans V.A.W.M.
Institution
(Wit, De Mulder, Umans) Department of Cardiology, Medical Centre Alkmaar,
Alkmaar, Netherlands
(Jansen) Department of Thoraxsurgery, VU Medical Centre, Amsterdam,
Netherlands
Title
Diabetes mellitus and its impact on long-term outcomes after coronary
artery bypass graft surgery.
Source
Acta Diabetologica. 50 (2) (pp 123-128), 2013. Date of Publication: April
2013.
Publisher
Springer Milan (Via Podgora 4, Milan I-20122, Italy)
Abstract
Diabetes mellitus (DM) is an important risk factor for accelerated
atherosclerosis and increases cardiovascular disease. Several studies
found a higher mortality rate in postoperative diabetic patients than in
non-diabetic patients. However, other studies found conflicting evidence
on bypass graft dysfunction in patients with diabetes mellitus. We
therefore investigated the influence of diabetes mellitus on the long-term
outcome after coronary artery bypass surgery (CABG). In this prospective
study, 936 consecutive CABG patients were included. These patients were
divided into three groups: patients without diabetes mellitus, patients
with diabetes mellitus using oral drugs (non-insulin-treated DM) and
patients with diabetes mellitus using insulin (insulin-treated DM). The
three groups were compared for mortality and (angiographic) bypass graft
dysfunction. Of the 936 included patients, 720 (76.8%) patients were
non-diabetics, 138 (14.7%) were non-insulin-treated DM, and 78 (8.3%)
patients were insulin-treated DM. Follow-up was achieved in all patients,
at a mean of 33 months. Mortality was significantly higher in patients
with insulin-treated DM, compared with non-insulin-treated DM or
non-diabetic patients (P = 0.003). Fourteen (1.5%) patients suffered a
myocardial infarction after CABG. A coronary angiography was performed in
77 (8.2%) patients during follow-up, proven bypass graft dysfunction was
found in 41 (53.2%) patients. There was no significant difference in
bypass graft dysfunction between the three groups. Diabetes mellitus has a
significant impact on long-term follow-up after coronary surgery.
Particularly insulin dependency is related to an increased mortality.
However, diabetes has no influence on angiographically proven bypass graft
dysfunction. 2010 Springer-Verlag.
<3>
Accession Number
23352817
Authors
Patel V.G. Brayton K.M. Tamayo A. Mogabgab O. Michael T.T. Lo N. Alomar M.
Shorrock D. Cipher D. Abdullah S. Banerjee S. Brilakis E.S.
Institution
(Patel) Veterans Administration North Texas Healthcare System, Dallas,
Texas, USA.
Title
Angiographic success and procedural complications in patients undergoing
percutaneous coronary chronic total occlusion interventions: a weighted
meta-analysis of 18,061 patients from 65 studies.
Source
JACC. Cardiovascular interventions. 6 (2) (pp 128-136), 2013. Date of
Publication: Feb 2013.
Abstract
This study sought to perform a weighted meta-analysis of the complication
risk during chronic total occlusion (CTO) percutaneous coronary
intervention (PCI). The safety profile of CTO PCI has received limited
study. We conducted a meta-analysis of 65 studies published between 2000
and 2011 reporting procedural complications of CTO PCI. Data on the
frequency of death, emergent coronary artery bypass graft surgery, stroke,
myocardial infarction, perforation, tamponade, stent thrombosis, major
vascular or bleeding events, contrast nephropathy, and radiation skin
injury were collected. A total of 65 studies with 18,061 patients and
18,941 target CTO vessels were included. Pooled estimates of outcomes were
as follows: angiographic success 77% (95% confidence interval [CI]: 74.3%
to 79.6%); death 0.2% (95% CI: 0.1% to 0.3%); emergent coronary artery
bypass graft surgery 0.1% (95% CI: 0.0% to 0.2%); stroke <0.01% (95% CI:
0.0% to 0.1%); myocardial infarction 2.5% (95% CI: 1.9% to 3.0%); Q-wave
myocardial infarction 0.2% (95% CI: 0.1% to 0.3%); coronary perforation
2.9% (95% CI: 2.2% to 3.6%); tamponade 0.3% (95% CI: 0.2% to 0.5%); and
contrast nephropathy 3.8% (95% CI: 2.4% to 5.3%). Compared with successful
procedures, unsuccessful procedures had higher rates of death (0.42% vs.
1.54%, p < 0.0001), perforation (3.65% vs. 10.70%, p < 0.0001), and
tamponade (0% vs. 1.65%, p < 0.0001). Among 886 lesions treated with the
retrograde approach, success rate was 79.8% with no deaths and low rates
of emergent coronary artery bypass graft surgery (0.17%) and tamponade
(1.2%). CTO PCI carries low risk for procedural complications despite high
success rates. Copyright 2013 American College of Cardiology Foundation.
Published by Elsevier Inc. All rights reserved.
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Accession Number
2013492403
Authors
Sangaralingham S.J. Burnett Jr. J.C. McKie P.M. Schirger J.A. Chen H.H.
Institution
(Sangaralingham, Burnett Jr., McKie, Schirger, Chen) Cardiorenal Research
Laboratory, Department of Medicine, Mayo Clinic, 200 First Street SW,
Rochester, MN 55905, United States
Title
Rationale and design of a randomized, double-blind, placebo-controlled
clinical trial to evaluate the efficacy of B-type natriuretic peptide for
the preservation of left ventricular function after anterior myocardial
infarction.
Source
Journal of Cardiac Failure. 19 (8) (pp 533-539), 2013. Date of
Publication: August 2013.
Publisher
Churchill Livingstone Inc. (650 Avenue of the Americas, New York NY 10011,
United States)
Abstract
Background B-type natriuretic peptide (BNP) is a hormone with pleiotropic
cardioprotective properties. Previously in our non-placebo-controlled
non-blinded pilot study (BELIEVE) in human ST-segment-elevation anterior
acute myocardial infarction (AMI), a 72-hour intravenous (IV) infusion of
recombinant human BNP (nesiritide) at a dose of 0.006 mug kg<sup>-1</sup>
min<sup>-1</sup> suppressed plasma aldosterone, reduced cardiac
dilatation, and improved left ventricular (LV) ejection fraction (LVEF) at
1 month compared with baseline. Methods and Design The BELIEVE II study is
a phase II, randomized, double-blind, placebo-controlled, single-center
clinical trial to assess the efficacy of 72-hour IV infusion of nesiritide
therapy (0.006 mug kg<sup>-1</sup> min <sup>-1</sup>) in humans with
first-time ST-segment-elevation anterior AMI and successful reperfusion,
in preventing adverse LV remodeling and preserving LV function. A total of
60 patients will be randomized to placebo or nesiritide therapy. The
primary efficacy end point is LV end-systolic and end-diastolic dimensions
determined by multiple gated acquisition scan between placebo and
nesiritide groups at 30 days; secondary end points include 30-day LVEF,
diastolic function, infarct size, LV mass, and combined total mortality
and heart failure hospitalization. Conclusions This will be the first
randomized, double-blind, placebo-controlled clinical trial to assess the
clinical efficacy of nesiritide in human ST-segment-elevation anterior
AMI. 2013 Elsevier Inc. All rights reserved.
<5>
Accession Number
2013470876
Authors
Singh I. Rajagopalan S. Srinivasan A. Achuthan S. Dhamija P. Hota D.
Chakrabarti A.
Institution
(Singh, Rajagopalan, Srinivasan, Achuthan, Dhamija, Hota, Chakrabarti)
Department of Pharmacology, Post Graduate Institute of Medical Education
and Research, Chandigarh 160012, India
Title
Preoperative statin therapy is associated with lower requirement of renal
replacement therapy in patients undergoing cardiac surgery: A
meta-analysis of observational studies.
Source
Interactive Cardiovascular and Thoracic Surgery. 17 (2) (pp 345-352),
2013. Date of Publication: August 2013.
Publisher
Oxford University Press (Great Clarendon Street, Oxford OX2 6DP, United
Kingdom)
Abstract
Objectives: Acute kidney injury (AKI) following cardiac surgery is a
common complication associated with serious morbidity and mortality.
Activation of inflammatory cascade and vascular endothelial dysfunction
plays a vital role during the perioperative period leading to AKI. Statins
are known to suppress inflammation and improve endothelial dysfunction
over and above the cholesterol lowering efficacy. Methods Observational
studies with a defined population in terms of preoperative statin therapy
and no preoperative statin therapy undergoing cardiac surgery (CABG,
isolated valve surgery or both) and with reported data on the incidence of
acute renal failure/injury and/or mortality were identified and analysed
for inclusion in the analysis. Outcomes evaluated were occurrence of
postoperative acute kidney injury/failure, requirement of any
postoperative renal replacement therapy and short-term all-cause mortality
rate. A meta-analysis was conducted and a pooled estimate of odds ratio
(OR) was calculated using the inverse variance method. Results A total of
17 studies with a total population of 24 998 statin users and 22 082
non-statin users were included in the final analysis. PST resulted in a
significantly lower incidence of renal replacement therapy in patients
undergoing CABG (OR: 0.56 [0.41-0.76]) but not in isolated valve surgery
(OR: 1.80 [0.73-4.44]). Also preoperative statin therapy resulted in a
significantly lower postoperative mortality (0.72 [0.61-0.84])
irrespective of the type of surgery. There was no effect of preoperative
statin therapy on the incidence of AKI in any of the sub-group of the
patients. Conclusions Patients undergoing CABG might derive benefit from
preoperative statin therapy in terms of reducing the need for
postoperative renal replacement therapy and mortality. However, the
uncertainty concerning the reno-protective efficacy of preoperative statin
therapy in patients undergoing isolated valve surgery needs further
investigation. 2013 The Author.
<6>
Accession Number
21505219
Authors
Bolland M.J. Grey A. Avenell A. Gamble G.D. Reid I.R.
Institution
(Bolland) Department of Medicine, University of Auckland, Private Bag 92
019, Auckland 1142, New Zealand.
Title
Calcium supplements with or without vitamin D and risk of cardiovascular
events: reanalysis of the Women's Health Initiative limited access dataset
and meta-analysis.
Source
BMJ (Clinical research ed.). 342 , 2011. Article Number: d2040. Date of
Publication: 2011.
Abstract
To investigate the effects of personal calcium supplement use on
cardiovascular risk in the Women's Health Initiative Calcium/Vitamin D
Supplementation Study (WHI CaD Study), using the WHI dataset, and to
update the recent meta-analysis of calcium supplements and cardiovascular
risk. Reanalysis of WHI CaD Study limited access dataset and incorporation
in meta-analysis with eight other studies. Data source WHI CaD Study, a
seven year, randomised, placebo controlled trial of calcium and vitamin D
(1g calcium and 400 IU vitamin D daily) in 36,282 community dwelling
postmenopausal women. Main outcome measures Incidence of four
cardiovascular events and their combinations (myocardial infarction,
coronary revascularisation, death from coronary heart disease, and stroke)
assessed with patient-level data and trial-level data. In the WHI CaD
Study there was an interaction between personal use of calcium supplements
and allocated calcium and vitamin D for cardiovascular events. In the
16,718 women (46%) who were not taking personal calcium supplements at
randomisation the hazard ratios for cardiovascular events with calcium and
vitamin D ranged from 1.13 to 1.22 (P = 0.05 for clinical myocardial
infarction or stroke, P = 0.04 for clinical myocardial infarction or
revascularisation), whereas in the women taking personal calcium
supplements cardiovascular risk did not alter with allocation to calcium
and vitamin D. In meta-analyses of three placebo controlled trials,
calcium and vitamin D increased the risk of myocardial infarction
(relative risk 1.21 (95% confidence interval 1.01 to 1.44), P = 0.04),
stroke (1.20 (1.00 to 1.43), P = 0.05), and the composite of myocardial
infarction or stroke (1.16 (1.02 to 1.32), P = 0.02). In meta-analyses of
placebo controlled trials of calcium or calcium and vitamin D, complete
trial-level data were available for 28,072 participants from eight trials
of calcium supplements and the WHI CaD participants not taking personal
calcium supplements. In total 1384 individuals had an incident myocardial
infarction or stroke. Calcium or calcium and vitamin D increased the risk
of myocardial infarction (relative risk 1.24 (1.07 to 1.45), P = 0.004)
and the composite of myocardial infarction or stroke (1.15 (1.03 to 1.27),
P = 0.009). Calcium supplements with or without vitamin D modestly
increase the risk of cardiovascular events, especially myocardial
infarction, a finding obscured in the WHI CaD Study by the widespread use
of personal calcium supplements. A reassessment of the role of calcium
supplements in osteoporosis management is warranted.
<7>
Accession Number
2013488837
Authors
Voeltz M.D. Manoukian S.V.
Institution
(Voeltz) Henry Ford Medical Group, Department of Internal Medicine, Wayne
State School of Medicine, Detroit, MI, United States
(Manoukian) Hospital Corporation of America, Nashville, TN, United States
Title
Cangrelor in patients undergoing cardiac surgery: The BRIDGE study.
Source
Expert Review of Cardiovascular Therapy. 11 (7) (pp 811-816), 2013. Date
of Publication: July 2013.
Publisher
Expert Reviews Ltd. (2 Albert Place, London N3 1QB, United Kingdom)
Abstract
The benefit of long-term dual antiplatelet therapy (DAPT) in patients with
acute coronary syndromes, drug-eluting stents and those at high risk for
thromboembolic events has been well established in a number of
well-designed randomized controlled studies. Current research in this area
has focused on the development of novel antiplatelet agents for clinical
use. The BRIDGE trial evaluated the use of cangrelor as a bridge to
coronary artery bypass graft surgery in patients receiving extended DAPT.
The BRIDGE trial results confirm the efficacy and safety of cangrelor in
this population. This study is novel as it attempts to address the lapse
in thienopyridine therapy required for many surgical and invasive
procedures. The future of antiplatelet agents, particularly cangrelor,
must also focus on bridging for high-risk patients undergoing noncoronary
artery bypass graft surgical procedures. Overall, the BRIDGE trial
represents a significant advance for patients appropriate for long-term
DAPT. 2013 Informa UK Ltd.
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Accession Number
2013488891
Authors
Bonderman D. Ghio S. Felix S.B. Ghofrani H.-A. Michelakis E. Mitrovic V.
Oudiz R.J. Boateng F. Scalise A.-V. Roessig L. Semigran M.J.
Institution
(Bonderman) Department of Internal Medicine II, Medical University of
Vienna, Vienna, Austria
(Ghio) Department of Cardiology, Fondazione IRCCS Policlinico San Matteo,
University Hospital, Pavia, Italy
(Felix) Department of Cardiology and Internal Medicine B, University
Medicine Greifswald, DZHK German Centre for Cardiovascular Research,
Greifswald, Germany
(Ghofrani) University of Giessen and Marburg Lung Center, German Center of
Lung Research, Giessen, Germany
(Michelakis) Department of Medicine, University of Alberta, Edmonton, AB,
Canada
(Mitrovic) Kerckhoff-Klinik Forschungsgesellschaft GmbH, Bad Nauheim,
Germany
(Oudiz) Los Angeles Biomedical Research Institute at Harbor, UCLA Medical
Center, Torrance, CA, United States
(Boateng) Bayer HealthCare Pharmaceuticals, New York, NY, United States
(Scalise) Bayer Hispania, Barcelona, Spain
(Roessig) Bayer Pharma AG, Berlin, Germany
(Semigran) Cardiology Division, Department of Medicine, Massachusetts
General Hospital and Harvard Medical School, Fruit St, Boston, MA 02114,
United States
Title
Riociguat for patients with pulmonary hypertension caused by systolic left
ventricular dysfunction: A phase IIb double-blind, randomized,
placebo-controlled, dose-ranging hemodynamic study.
Source
Circulation. 128 (5) (pp 502-511), 2013. Date of Publication: 30 Jul 2013.
Publisher
Lippincott Williams and Wilkins (530 Walnut Street,P O Box 327,
Philadelphia PA 19106-3621, United States)
Abstract
BACKGROUND - : Pulmonary hypertension caused by systolic left ventricular
dysfunction is associated with significant morbidity and mortality;
however, no treatment is approved for this indication. We hypothesized
that riociguat, a novel soluble guanylate cyclase stimulator, would have
beneficial hemodynamic effects in patients with pulmonary hypertension
caused by systolic left ventricular dysfunction. METHODS AND RESULTS - :
Overall, 201 patients with heart failure resulting from pulmonary
hypertension caused by systolic left ventricular dysfunction were
randomized to double-blind treatment with oral placebo or riociguat (0.5,
1, or 2 mg 3 times daily) for 16 weeks in 4 parallel arms. The primary
outcome was the placebo-corrected change from baseline at week 16 in mean
pulmonary artery pressure. Although the decrease in mean pulmonary artery
pressure in the riociguat 2 mg group (-6.1+/-1.3 mm Hg; P<0.0001 versus
baseline) was not significantly different from placebo (P=0.10), cardiac
index (0.4 Lminm; 95% confidence interval, 0.2-0.5; P=0.0001) and stroke
volume index (5.2 mLm; 95% confidence interval, 2.0-8.4; P=0.0018) were
significantly increased without changes in heart rate or systemic blood
pressure compared with placebo. Both pulmonary (-46.6 dynesscm; 95%
confidence interval, -89.4 to -3.8; P=0.03) and systemic vascular
resistance (-239.3 dynesscm; 95% confidence interval, -363.4 to -115.3;
P=0.0002) were significantly reduced with riociguat 2 mg. Riociguat
reduced the Minnesota Living With Heart Failure score (P=0.0002).
Discontinuation of treatment was similar between treatment groups.
CONCLUSIONS - : Although the primary end point of the study was not met,
riociguat was well tolerated in patients with pulmonary hypertension
caused by systolic left ventricular dysfunction and improved cardiac index
and pulmonary and systemic vascular resistance. 2013 American Heart
Association, Inc.
<9>
Accession Number
2013476985
Authors
Yang F. Tang G.-S. Mo L.-X. Wang M.-K. Lin Y. Zhang W.-K.
Institution
(Yang, Tang, Mo, Wang, Lin, Zhang) Department of General Surgery, The
Third Affiliated Hospital of Guiyang Medical College, Duyun 558004,
Guizhou, China
Title
Application of modified endoscopic thyroidectomy via chest and breast
areola approach for benign thyroid disease paiients.
Source
Academic Journal of Second Military Medical University. 34 (7) (pp
801-804), 2013. Date of Publication: 2013.
Publisher
Editorial Department of Acad J Sec Mil Med Univ (800 Xiangyin Road,
Shanghai 200433, China)
Abstract
Objective To study the safety and feasibility of modiiied endoscopic
thyroidectomy via chest and breast areola approach for benign thyroid
disease paiients. Methods A total of56 femaie benign thyroid disease
paiients, who recsived endoscopic thyroidectomy n our hospital from March
2011 to March 2012, were included in this study. And 28 of them underwent
modified endoscopic thyroidectomy (modified group). Taking the advantage
of movable female breast and the long rod-shaped endoscopic Instrument,
the operaiion was modfiied based on endoscopic thyroidectomy via chest and
breast areola approach, without subcutaneousdissection of the chest wall.
Another 28 paiients receded conventional approach treatment (conventional
group). The two groups were matched m mean age and disease causes. The
operation time, blood loss, postoperative pam degree, post-operation
hospital stay, and compiications were compared between the two groups.
Results The operation time, blood loss, post-operation hospital stay, and
post-operation drainage volume werenot significantly different between the
two groups. Compared with paiients n the conventional group, paiients n
modified group suffered significantly iess post-operation pain, with mean
visual analogue scaie scores bini 3. 0+/-1. 6 vs 4. 5+/-1. 8 (P=0. 042).
The modified group also had significantly reduced ineidenceof skin redness
and subcutaneous ecchymosis, edema and chanceof effuson on the antesor
chest wall (0 vs 21. 4%, P = 0. 01). There were no damages to recurrent
laryngeal nerve or parathyroid glands or postoperative hemorrhage n the 56
paiients. Concluiion The modfiied endoscopic thyroidectomy via chest and
breast areola approach is a safe and effective method, and it can greatiy
reduce the trauma of conventional endoscopic thyroidectomy.
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Accession Number
2013476599
Authors
Ma J. Xu W.-J. Xu G.-P.
Institution
(Ma, Xu, Xu) Department of Anesthesiology, The Friendship Hospital, Urumqi
830049, China
Title
Impact of perioperative use of clopidogrel on coronary bypass grafting
patients: A meta-analysis.
Source
Chinese Journal of Evidence-Based Medicine. 13 (7) (pp 827-835), 2013.
Date of Publication: 2013.
Publisher
West China University of Medical Science (37 Wainan Guoxue Xiang, Chengdu,
Sichuan 610041, China)
Abstract
Objective To systematically evaluate impact of perioperative use of
clopidogrel on coronary bypass grafting (CABG) patients for anti-platelet
treatment, in order to provide evidence for the rational drug use of such
patients in the perioperative period. Methods PubMed, EMbase, HighWire,
CENTRAL and its affiliated clinical trial registered data center, CBM and
CNKI were electronically searched from 2003 to November, 2012. Randomized
controlled trials (RCTs) and non-randomized clinical trials on
perioperative use of clopidogrel of CABG patients were collected.
References of included studies were also retrieved. Two reviewers
independently screened studies according to exclusion and inclusion
criteria, extracted data, and assessed the methodological quality. Ten,
meta-analysis was performed using RevMan 5.0 sofware. Results 18 studies
(including 10 RCTs and 8 non-randomized clinical trials) involving 14 592
patients were included. Te results of meta-analysis showed that: a) Among
10 included RCTs, preoperative use of clopidogrel for anti-platelet
treatment reduced the incidence of myocardial infarction obviously,
compared with the blank control group (RR=0.63, 95%CI 0.48 to 0.83,
P=0.000 9), but there is no significant difference between the two groups
in blood loss amount within 24 hours after operation (MD=130, 95%CI -6.21
to 266.22, P=0.06), the number of reoperation patients because of bleeding
(RR=1.42, 95%CI 0.92 to 2.20, P=0.12), and risk of postoperative
short-term death (RR=1.19, 95%CI 0.89 to 1.58, P=0.24); b) Among 8
non-randomized clinical trials, there was no significant difference
between the two groups in reducing the incidence of myocardial infarction
(RR=0.83, 95%CI 0.30 to 2.26, P=0.71), but preoperative use of clopidogrel
for anti-platelet treatment significantly increased blood loss amount
within 24 hours after operation (MD=82.42, 95%CI 35.18 to 129.66, P=0.000
6), the number of reoperation patients because of bleeding (RR=1.71, 95%CI
1.07 to 2.75, P=0.03), and risk of postoperative short-term death
(RR=1.89, 95%CI 1.15 to 3.12, P=0.01). Conclusion Current evidence shows
that, perioperative use of clopidogrel can reduce the incidence of
myocardial infarction, but doctors should consider cautiously the
increased risk of bleeding, re-operation and postoperative short-term
death. There is contradiction between the results of RCTs and those of
non-randomized clinical trials, which may result from the argument
intensity, quantity and sample size bias of the included studies. Te above
conclusion should be proved by large-scale high-quality RCT results in
future. 2013 Editorial Board of Chin J Evid-based Med.
<11>
Accession Number
2013482076
Authors
Alherbish A. Westerhout C.M. Fu Y. White H.D. Granger C.B. Wagner G.
Armstrong P.W.
Institution
(Alherbish, Westerhout, Fu, Armstrong) Canadian VIGOUR Centre, University
of Alberta, 2-132 Li Ka Shing Centre for Health Research Innovation,
Edmonton, AB T6G2E1, Canada
(White) Green Lane Cardiovascular Service, Auckland City Hospital,
Auckland, New Zealand
(Granger, Wagner) Duke Clinical Research Institute, Durham, NC, United
States
Title
The forgotten lead: Does aVR ST-deviation add insight into the outcomes of
ST-elevation myocardial infarction patients?.
Source
American Heart Journal. 166 (2) (pp 333-339), 2013. Date of Publication:
August 2013.
Publisher
Mosby Inc. (11830 Westline Industrial Drive, St. Louis MO 63146, United
States)
Abstract
Background Lead aVR ST-segment deviation has been associated with
increased mortality in ST-elevation myocardial infarction patients treated
with fibrinolysis. However, its prognostic value in a contemporaneous
population undergoing primary percutaneous coronary intervention is
unknown. Methods and Results A core laboratory examined the 12-lead
baseline electrocardiogram in 5,683 patients presenting within 6 hours of
symptom onset in the APEX-AMI trial, and readers were blinded to study
treatment and clinical outcomes. aVR ST-deviation was significantly
associated with 90-day death when compared with patients with no aVR
ST-deviation (aVR ST-depression [ST-D] 5%, aVR ST-elevation [ST-E] 10.2%,
no ST-deviation [N] aVR 3.8%, P <.001). After multivariable adjustment,
aVR ST-E was strongly associated with 90-day death in inferior myocardial
infarction (MI) (adjusted hazard ratio [HR] 5.87, 95% CI 2.09-16.5),
whereas aVR ST-D was associated with excess mortality in noninferior MI
(1.53, 1.06-2.22; P [interaction] <.001). aVR ST-E was also significantly
associated with the presence of left main coronary (N aVR 1.8%, aVR ST-E
7.7%, P <=.001) and multivessel coronary disease (N aVR 41.3%, aVR ST-E
53.3%, P <=.001). Conclusions Lead aVR ST-deviation is common, occurring
in one-third of all ST-elevation myocardial infarction patients and
independently associated with increased 90-day death. Myocardial
infarction location modulates the prognostic significance of aVR
ST-deviation such that lead aVR ST-E in inferior MI and ST-D in
noninferior MI represent 2 high-risk groups. There was also more frequent
advanced coronary disease in patients with aVR ST-E. 2013 Mosby, Inc.
<12>
Accession Number
2013482080
Authors
Lima E.G. Hueb W. Garcia R.M.R. Pereira A.C. Soares P.R. Favarato D.
Garzillo C.L. D'Oliveira Vieira R. Rezende P.C. Takiuti M. Girardi P. Hueb
A.C. Ramires J.A.F. Kalil Filho R.
Institution
(Lima, Hueb, Garcia, Pereira, Soares, Favarato, Garzillo, D'Oliveira
Vieira, Rezende, Takiuti, Girardi, Hueb, Ramires, Kalil Filho) Department
of Atherosclerosis, Heart Institute (InCor) Hospital das Clinicas,
Universidade de Sao Paulo, Sao Paulo, Brazil
Title
Impact of diabetes on 10-year outcomes of patients with multivessel
coronary artery disease in the Medicine, Angioplasty, or Surgery Study II
(MASS II) trial.
Source
American Heart Journal. 166 (2) (pp 250-257), 2013. Date of Publication:
August 2013.
Publisher
Mosby Inc. (11830 Westline Industrial Drive, St. Louis MO 63146, United
States)
Abstract
Introduction Diabetes mellitus is a major cause of coronary artery disease
(CAD). Despite improvement in the management of patients with stable CAD,
diabetes remains a major cause of increased morbidity and mortality. There
is no conclusive evidence that either modality is better than medical
therapy alone for the treatment of stable multivessel CAD in patients with
diabetes in a very long-term follow-up. Our aim was to compare 3
therapeutic strategies for stable multivessel CAD in a diabetic population
and non-diabetic population. Methods It was compared medical therapy (MT),
percutaneous coronary intervention (PCI), and coronary artery bypass graft
(CABG) in 232 diabetic patients and 379 nondiabetic patients with
multivessel CAD. Endpoints evaluated were overall and cardiac mortality.
Results Patients (n = 611) were randomized to CABG (n = 203), PCI (n =
205), or MT (n = 203). In a 10-year follow-up, more deaths occurred among
patients with diabetes than among patients without diabetes (P =.001) for
overall mortality. In this follow-up, 10-year mortality rates were 32.3%
and 23.2% for diabetics and non-diabetics respectively (P =.024).
Regarding cardiac mortality, 10-year cardiac mortality rates were 19.4%
and 12.7% respectively (P =.031).Considering only diabetic patients and
stratifying this population by treatment option, we found mortality rates
of 31.3% for PCI, 27.5% for CABG and 37.5% for MT (P =.015 for CABG vs MT)
and cardiac mortality rates of 18.8%, 12.5% and 26.1% respectively (P
=.005 for CABG vs MT). Conclusions/ interpretation Among patients with
stable multivessel CAD and preserved left ventricular ejection fraction,
the 3 therapeutic regimens had high rates of overall and cardiac-related
deaths among diabetic compared with non-diabetic patients. Moreover,
better outcomes were observed in diabetic patients undergoing CABG
compared to MT in relation to overall and cardiac mortality in a 10-year
follow-up. 2013 Mosby, Inc.
<13>
Accession Number
2013481788
Authors
Chatterjee S. Sardar P. Mukherjee D. Lichstein E. Aikat S.
Institution
(Chatterjee, Lichstein) Maimonides Medical Center, 864 49th Street Apt
C11, Brooklyn, NY 11220, United States
(Sardar) New York Medical College, Metropolitan Hospital Center, New York,
NY, United States
(Mukherjee) Texas Tech University, Health Sciences Center, El Paso, TX,
United States
(Aikat) Gill Heart Institute, University of Kentucky, Lexington, KY,
United States
Title
Timing and route of amiodarone for prevention of postoperative atrial
fibrillation after cardiac surgery: A network regression meta-analysis.
Source
PACE - Pacing and Clinical Electrophysiology. 36 (8) (pp 1017-1023), 2013.
Date of Publication: August 2013.
Publisher
Blackwell Publishing Inc. (350 Main Street, Malden MA 02148, United
States)
Abstract
Background We attempted to evaluate if an oral-only regimen was as
effective in preventing postoperative atrial fibrillation (POAF) after
cardiac surgery, in comparison to a regimen that included intravenous (IV)
administration using a network meta-analysis of available data, and also
attempted to assess if preoperative administration at least 1 day before
surgery was superior to postoperative prophylaxis (at least 1 day after
surgery). Methods We searched PubMed, EMBASE, CINAHL, and Cochrane Central
Register of Controlled Trials' databases for randomized controlled trials
conducted between 1990 and 2011 that assessed rates of POAF with
amiodarone. Finally an interaction odds ratio was computed to assess the
efficacy of an oral-only regimen of amiodarone compared to one including
IV administration and to evaluate if preoperative amiodarone was superior
to postoperative prophylaxis. Results Twenty-three studies (total N =
3,950) were included. Both regimens of amiodarone improved risk of POAI
oral-only risk ratio (RR) was 0.59 (95% confidence interval [CI]
0.49-0.70; P < 0.01) and regimen including IV RR was 0.57 (95% CI
0.43-0.75, P < 0.01). The interaction odds ratio was 1.17 (95% CI
0.72-1.89, P = 0.533). Both preoperative amiodarone (P < 0.01) and
postoperative prophylaxis were effective (P = 0.0009), irrespective of
duration. Conclusions This systematic review suggests a regimen of both
oral-only and one including IV administration, as well pre- and
postoperative administration of amiodarone is effective in prevention of
POAF after cardiac surgery. 2013 Wiley Periodicals, Inc.
<14>
Accession Number
2013471419
Authors
Khin N.A. Yang P. Hung H.M.J. Maung-U K. Chen Y.-F. Meeker-O'Connell A.
Okwesili P. Yasuda S.U. Ball L.K. Huang S.-M. O'Neill R.T. Temple R.
Institution
(Khin, Maung-U, Yasuda, Temple) Office of Drug Evaluation i, Office of New
Drugs, Center for Drug Evaluation and Research, Silver Spring, MD, United
States
(Yang, Hung, Chen) Office of Biostatistics, Office of Translational
Sciences, Center for Drug Evaluation and Research, Silver Spring, MD,
United States
(Meeker-O'Connell, Okwesili) Office of Scientific Investigations, Center
for Drug Evaluation and Research, US Food and Drug Administration, Silver
Spring, MD, United States
(Ball) Office of International Programs, Office of Global Regulatory
Operations and Policy, US Food and Drug Administration, Silver Spring, MD,
United States
(Huang) Office of Clinical Pharmacology, Office of Translational Sciences,
Center for Drug Evaluation and Research, Silver Spring, MD, United States
(O'Neill) Office of Translational Sciences, Center for Drug Evaluation and
Research, US Food and Drug Administration, Silver Spring, MD, United
States
(Temple) Center for Drug Evaluation and Research, US Food and Drug
Administration, Silver Spring, MD, United States
Title
Regulatory and scientific issues regarding use of foreign data in support
of new drug applications in the United States: An FDA perspective.
Source
Clinical Pharmacology and Therapeutics. 94 (2) (pp 230-242), 2013. Date of
Publication: August 2013.
Publisher
Nature Publishing Group (Houndmills, Basingstoke, Hampshire RG21 6XS,
United Kingdom)
Abstract
Globalization of clinical research has led to an increase in clinical
trials conducted outside of the United States that are submitted to the US
Food and Drug Administration (FDA) in new drug applications. This article
discusses the FDA's experience with these submissions in specific
therapeutic areas, including the extent of this practice, differences
between the effectiveness and safety outcomes of studies conducted inside
and outside the United States, and the FDA's approach to acceptance of
these trials. 2013 American Society for Clinical Pharmacology and
therapeutics.
<15>
[Use Link to view the full text]
Accession Number
2013479502
Authors
Rodseth R.N. Biccard B.M. Chu R. Lurati Buse G.A. Thabane L. Bakhai A.
Bolliger D. Cagini L. Cahill T.J. Cardinale D. Chong C.P.W. Cnotliwy M. Di
Somma S. Fahrner R. Lim W.K. Mahla E. Le Manach Y. Manikandan R. Pyun W.B.
Rajagopalan S. Radovic' M. Schutt R.C. Sessler D.I. Suttie S.
Vanniyasingam T. Waliszek M. Devereaux P.J.
Institution
(Rodseth, Biccard) Department of Anaesthetics, Inkosi Albert Luthuli
Central Hospital, Nelson R. Mandela School of Medicine, Private Bag 7,
Congella, 4013, South Africa
(Rodseth) Population Health Research Institute, Hamilton, ON, Canada
(Rodseth) Department of Outcomes Research, Cleveland Clinic, Cleveland,
OH, United States
(Chu) Department of Clinical Epidemiology and Biostatistics, Faculty of
Health Sciences, United States
(Vanniyasingam) Department of Mathematics and Statistics, McMaster
University, Hamilton, ON, Canada
(Lurati Buse, Bolliger) Department of Anaesthesia and Intensive Care
Medicine, University Hospital Basel, Basel, Switzerland
(Thabane) Departments of Clinical Epidemiology and
Biostatistics/Anesthesia/ Pediatrics, McMaster University, St Joseph's
Healthcare, Hamilton, ON, Canada
(Thabane) Population Health Research Institute, Hamilton Health Sciences,
Hamilton, ON, Canada
(Bakhai) Barnet and Chase Farm Hospital NHS Trust, Barnet Hospital,
Barnet, United Kingdom
(Cagini) Department of Surgical Science, University of Perugia, Ospedale
S.Maria, Perugia, Italy
(Cahill) Department of Cardiovascular Medicine, University of Oxford, John
Radcliffe Hospital, Oxford, United Kingdom
(Cardinale) Cardioncology Unit, European Institute of Oncology, Milan,
Italy
(Chong, Lim) Departments of Aged Care, Northern Clinical Research Centre,
Northern Hospital, Epping, VIC, Australia
(Chong, Lim) Department of Medicine, Austin and Northern Health,
University of Melbourne, VIC, Australia
(Cnotliwy) Department of Vascular and General Surgery and Angiology,
Pomeranian Medical University, Szczecin, Poland
(Di Somma) Department of Medical-Surgery Sciences and Translational
Medicine, University la Sapienza, Sant'Andrea Hospital, Rome, Italy
(Fahrner) Division of Visceral Surgery and Medicine, University Hospital
Berne, Inselspital Berne, Bern, Switzerland
(Mahla) Department of Anesthesia and Intensive Care Medicine, Medical
University of Graz, Graz, Austria
(Le Manach) Departments of Anesthesia, Clinical Epidemiology and
Biostatistics, Wigan, United Kingdom
(Devereaux) Depts. of Medicine, Clinical Epidemiology and Biostatistics,
Population Health Research Institute, Hamilton Health Sciences, Wigan,
United Kingdom
(Manikandan) Departments of Urology, Stepping Hill Hospital, Stockport and
Wrightington, Wigan and Leigh NHS Foundation Trust, Wigan, United Kingdom
(Pyun) Divison of Cardiology, Department of Internal Medicine, Ewha Womans
University, Seoul, South Korea
(Rajagopalan) Department of Vascular Surgery, University of Aberdeen and
Aberdeen Royal Infirmary, NHS Grampian, Foresterhill, Aberdeen, United
Kingdom
(Radovic') University of Belgrade, School of Medicine, Belgrade, Serbia
(Schutt) Department of Internal Medicine, University of Virginia,
Charlottesville, VA, United States
(Sessler) Department of Outcomes Research, Cleveland Clinic, United States
(Suttie) Department of Vascular Surgery, Ninewells Hospital and Medical
School, Dundee, United Kingdom
(Waliszek) M. Pirogow Provincial Specialist Hospital, Lodz, Poland
Title
Postoperative B-type natriuretic peptide for prediction of major cardiac
events in patients undergoing noncardiac surgery: Systematic review and
individual patient meta-analysis.
Source
Anesthesiology. 119 (2) (pp 271-283), 2013. Date of Publication: August
2013.
Publisher
Lippincott Williams and Wilkins (530 Walnut Street,P O Box 327,
Philadelphia PA 19106-3621, United States)
Abstract
BACKGROUND: It is unclear whether postoperative B-type natriuretic
peptides (i.e., BNP and N-terminal proBNP) can predict cardiovascular
complications in noncardiac surgery. METHODS: The authors undertook a
systematic review and individual patient data meta-analysis to determine
whether postoperative BNPs predict postoperative cardiovascular
complications at 30 and 180 days or more. RESULTS: The authors identified
18 eligible studies (n = 2,051). For the primary outcome of 30-day
mortality or nonfatal myocardial infarction, BNP of 245 pg/ml had an area
under the curve of 0.71 (95% CI, 0.64-0.78), and N-terminal proBNP of 718
pg/ml had an area under the curve of 0.80 (95% CI, 0.77-0.84). These
thresholds independently predicted 30-day mortality or nonfatal myocardial
infarction (adjusted odds ratio [AOR] 4.5; 95% CI, 2.74-7.4; P < 0.001),
mortality (AOR, 4.2; 95% CI, 2.29-7.69; P < 0.001), cardiac mortality
(AOR, 9.4; 95% CI, 0.32-254.34; P < 0.001), and cardiac failure (AOR,
18.5; 95% CI, 4.55-75.29; P < 0.001). For greater than or equal to 180-day
outcomes, natriuretic peptides independently predicted mortality or
nonfatal myocardial infarction (AOR, 3.3; 95% CI, 2.58-4.3; P < 0.001),
mortality (AOR, 2.2; 95% CI, 1.67-86; P < 0.001), cardiac mortality (AOR,
2.1; 95% CI, 0.05-1,385.17; P < 0.001), and cardiac failure (AOR, 3.5; 95%
CI, 1.0-9.34; P = 0.022). Patients with BNP values of 0-250, greater than
250-400, and greater than 400 pg/ml suffered the primary outcome at a rate
of 6.6, 15.7, and 29.5%, respectively. Patients with N-terminal proBNP
values of 0-300, greater than 300-900, and greater than 900 pg/ml suffered
the primary outcome at a rate of 1.8, 8.7, and 27%, respectively.
CONCLUSIONS: Increased postoperative BNPs are independently associated
with adverse cardiac events after noncardiac surgery. Copyright 2013, the
American Society of Anesthesiologists, Inc. Lippincott Williams &Wilkins.
<16>
Accession Number
2013449360
Authors
Kleinbongard P. Thielmann M. Jakob H. Peters J. Heusch G. Kottenberg E.
Institution
(Kleinbongard, Heusch) Institute for Pathophysiology, University of
Duisburg-Essen, Essen, Germany
(Thielmann, Jakob) Department of Thoracic and Cardiovascular Surgery,
University of Duisburg-Essen, Essen, Germany
(Peters, Kottenberg) Klinik fur Anasthesiologie und Intensivmedizin,
Universitatsklinikum Essen, University of Duisburg-Essen, Essen, Germany
(Kleinbongard) Institut fur Pathophysiologie, Universitatsklinikum Essen,
Hufelandstr. 55, 45122 Essen, Germany
Title
Nitroglycerin does not interfere with protection by remote ischemic
preconditioning in patients with surgical coronary revascularization under
isoflurane anesthesia.
Source
Cardiovascular Drugs and Therapy. 27 (4) (pp 359-361), 2013. Date of
Publication: August 2013.
Publisher
Springer New York (233 Spring Street, New York NY 10013-1578, United
States)
<17>
Accession Number
2013214446
Authors
Knaut M. Kolberg S. Brose S. Jung F.
Institution
(Knaut, Kolberg, Brose, Jung) Department of Cardiac Surgery, Heart Centre
Dresden, Technical University, Dresden, Germany
Title
Epicardial microwave ablation of permanent atrial fibrillation during a
coronary bypass and/or aortic valve operation: Prospective, randomised,
controlled, mono centre study (EPIMIK).
Source
Applied Cardiopulmonary Pathophysiology. 17 (1) (pp 11-19), 2013. Date of
Publication: 2013.
Publisher
Pabst Science Publishers (Eichengrund 28, Lengerich D-49525, Croatia)
Abstract
Atrial fibrillation (AF), one of the most common arrhythmias, is the
aetiology behind a high percentage of strokes. Recently simplified
ablation procedures became more relevant in the surgical treatment of AF.
One advantage of microwave ablation (MW) is that it can be used
epicardially. We report our results of a prospective, randomized,
controlled, mono centre trail. In two arms, with and without ablation, we
treated patients with documented permanent atrial fibrillation with an
indication for cardiac surgery, where opening of the left atrium was not
required. Methods: Patients, who were scheduled for aortic valve
replacement and/or coronary artery bypass grafting suffering from
permanent AF, were included in the registry. After inclusion the patients
were randomized either to epicardial MW (EMW) as a concomitant procedure
during their operation (Group A) or equivalent operations without ablation
therapy (group B). Follow-up was one year. EMW was performed under
extracorporeal circulation on the beating heart creating a box lesion
including the anterior part of the pulmonary veins with connection lines
on the roof and bottom of the left atrium and an additional line to the
left atrial appendage. Results: 45 Patients (17 female/28 male) with AVD
and/or CAD and pAF were included. Preoperative duration of pAF was 5.2
years (0.1-45 years). Preoperative data were as follows: mean age: 74
years (63-83 years), mean ejection fraction: 56% (30-83%), left atrial
diameter: 46.1mm (40--59mm). 20 patients got aortic valve replacement, 17
had CABG, and 8 operations were combined procedures (AVR and CABG). All
ablation procedures were performed on-pump beating heart. We observed no
device related complications. During the follow-up, restoration of the
sinus rhythm rate after one year is 52.4% in the ablated patients in
contrast to 10.5% in the control group. The 30-day survival rate in group
A was 87.5% and 95.2% in group B (n.s.) Pacemaker implants after one year
were required in 12.5% in group A and 25% in group B Conclusion: Our
results demonstrate that EMW is an effective treatment option for patients
with permanent AF. The procedure is less invasive than the endocardial
approach and prolongs concomitant heart surgery only minimally without
lengthening of the ischemic time. We think, that EMW ablation is a
promising concept with a good benefit/risk ratio for the treatment of pAF,
especially in patients where opening of the left atrium is not required as
part of the original procedure. A more extended lesion line concept,
closer to the classic Maze procedure lines is suggested to achieve higher
success rates. EMW has become part of our daily routine for the treatment
of AF in patients scheduled for bypass grafting and/ or aortic valve
replacement.
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