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<1>
Accession Number
2010334313
Authors
Vidlund M. Holm J. Hakanson E. Friberg T. Sunnermalm L. Vanky F.
Svedjeholm R.
Institution
(Holm, Vanky, Svedjeholm) Department of Cardiothoracic Surgery, Linkoping
Heart Center, University Hospital, SE-581 85 Linkoping, Sweden
(Hakanson) Department of Cardiothoracic Anesthesia, Linkoping Heart
Center, University Hospital, Linkoping, Sweden
(Vidlund, Friberg, Sunnermalm) Department of Cardiothoracic Surgery and
Anesthesia, University Hospital Orebro, Sweden
Title
The S-100B substudy of the GLUTAMICS trial: Glutamate infusion not
associated with sustained elevation of plasma S-100B after coronary
surgery.
Source
Clinical Nutrition. 29 (3) (pp 358-364), 2010. Date of Publication: June
2010.
Publisher
Churchill Livingstone (1-3 Baxter's Place, Leith Walk, Edinburgh EH1 3AF,
United Kingdom)
Abstract
Background & aims: Concerns have been raised about potential neurological
injury related to exogenous glutamate. In cardiac surgery glutamate has
been administered as a putative cardioprotective agent by cardioplegia or
intravenous infusion. In the GLUTAMICS trial, in addition to surveillance
of clinical neurological injuries, a prespecified subgroup was analyzed
with regard to postoperative S-100B levels to detect potential subclinical
neurological injury related to glutamate infusion. Methods: Sixty-nine
patients operated on for unstable coronary syndrome were randomized to
intravenous infusion of glutamate (n=35) or saline (n=34) perioperatively.
Plasma levels of S-100B were obtained on the third postoperative day.
Results: S-100B in the glutamate group and the control group were 0.079
+/- 0.034. mug/L and 0.090 +/- 0.042. mug/L respectively (p=0.245). There
were no patients with stroke or mortality. Three patients in the control
group and two in the glutamate group had postoperative confusion. These
patients had significantly elevated S-100B compared with those without
confusion (0.132 +/- 0.047vs 0.081 +/- 0.036. mug/L; p=0.003). Overall, 21
patients had S-100B above reference level (>=0.10. mug/L) and these
patients had significantly more calcifications in the ascending aorta on
epiaortic scanning. Conclusions: Intravenous glutamate infusion during
surgery for unstable coronary artery disease did not initiate a sustained
elevation of plasma S-100B. Thus, no evidence for subclinical neurological
injury related to glutamate infusion was found. In contrast, postoperative
elevation of plasma S-100B was linked to calcification of the ascending
aorta and postoperative confusion. 2009 Elsevier Ltd and European Society
for Clinical Nutrition and Metabolism.
<2>
Accession Number
2010389599
Authors
Arazi H.C. Doiny D.G. Torcivia R.S. Grancelli H. Waldman S.V. Nojek C.
Fornari M.C. Badimon J.J.
Institution
(Arazi, Doiny, Torcivia, Grancelli, Waldman, Nojek) Department of
Cardiology, FLENI, Montaneses 2325 (1430), Buenos Aires, Argentina
(Fornari) Laboratorio de Analisis Clinicos Fornari Bioalpha SA, Riobamba
921, Buenos Aires, Argentina
(Nojek) Trinidad Palermo, Cardiology Section, Cervino 4720, Buenos Aires,
Argentina
(Badimon) Atherothrombosis Research Center, Cardiovascular Institute,
Mount Sinai School of Medicine, New York, United States
Title
Impaired anti-platelet effect of aspirin, inflammation and platelet
turnover in cardiac surgery.
Source
Interactive Cardiovascular and Thoracic Surgery. 10 (6) (pp 863-867),
2010. Date of Publication: June 2010.
Publisher
European Association for Cardio-Thoracis Surgery (3 Park Street, Windsor,
Berkshire SL4 1LU, United Kingdom)
Abstract
A reduced platelet inhibitory response to acetyl salicylic acid (ASA) has
been associated with an increased risk of graft thrombotic occlusion after
coronary artery bypass grafting (CABG). We performed a prospective,
observational study of 18 patients on 100 mg/day ASA before and after
CABG. We assessed antiplatelet response to ASA and its relationship with
platelet turnover, inflammatory markers, and soluble thrombomodulin (sTM)
levels. All patients showed optimal response to ASA preoperatively but had
higher values during follow-up. Platelet aggregation and platelet count in
the perioperative period were significantly associated (P=0.05). Platelet
turnover was defined as the average daily turnover (ADTO). The lowest
inhibitory value (28% of patients >=6 ) was recorded at the same time of
the highest platelet turnover (>10% daily in 77.77% of patients), one week
after CABG. ADTO >10% was associated with an increased risk of platelet
aggregation >=6 . Levels of sTM were significantly higher one week after
CABG (median 13 vs. 3 ng/ml preoperatively, P=0.0011). There is a
transient impairment in ASA antiplatelet effect after CABG related to an
increased platelet turnover caused by the inflammatory process. This could
be responsible for the high risk of occlusive thrombosis. 2010 Published
by European Association for Cardio-Thoracic Surgery. All rights reserved.
<3>
Accession Number
2010389761
Authors
Dibra A. Tiroch K. Schulz S. Kelbaek H. Spaulding C. Laarman G.J.
Valgimigli M. Di Lorenzo E. Kaiser C. Tierala I. Mehilli J. Campo G.
Thuesen L. Vink M.A. Schalij M.J. Violini R. Schomig A. Kastrati A.
Institution
(Dibra, Tiroch, Schulz, Mehilli, Schomig, Kastrati) Deutsches Herzzentrum,
Technische Universitat, Lazarettstr. 36, 80636 Munich, Germany
(Kelbaek) Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
(Spaulding) Assistance Publique-Hopitaux de Paris (AP-HP), Cochin
Hospital, Paris 5 Medical School Rene Descartes University and INSERM
U780-Avenir, Paris, France
(Laarman) King's College Hospital, London, United Kingdom
(Valgimigli, Campo) University of Ferrara, Ferrara, Italy
(Di Lorenzo) A.O.R.N. S. G Moscati, Avellino, Italy
(Kaiser) University of Basel, Basel, Switzerland
(Tierala) Helsinki University Central Hospital, Helsinki, Finland
(Thuesen) Skejby Sygehus, Skejby, Denmark
(Vink) Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands
(Schalij) Leiden University Medical Center, Leiden, Netherlands
(Violini) San Camillo Hospital, Rome, Italy
Title
Drug-eluting stents in acute myocardial infarction: Updated meta-analysis
of randomized trials.
Source
Clinical Research in Cardiology. 99 (6) (pp 345-357), 2010. Date of
Publication: June 2010.
Publisher
D. Steinkopff-Verlag (P.O. Box 100462, Darmstadt D-64204, Germany)
Abstract
Background Use of drug-eluting stents in patients with acute myocardial
infarction (AMI) remains an "off label" indication due to concerns
regarding their performance in this patient subset. Methods We searched
Medline, the Cochrane Central Register of Controlled Trials, and
Internet-based sources of information on clinical trials in cardiology for
randomized trials comparing drug-eluting stents with bare-metal stents in
patients with AMI. Hazard ratios for the composite of death or recurrent
myocardial infarction, (primary safety endpoint), reintervention (primary
efficacy endpoint), death, recurrent myocardial infarction, and stent
thrombosis were calculated performing a meta-analysis of 14 randomized
trials with 7,781 patients. Results There was no difference in the hazard
of death or recurrent myocardial infarction (hazard ratio, 0.91; [95% CI
0.75-1.09]) between patients treated with drug-eluting stents versus
patients treated with bare-metal stents. Treatment with drug-eluting
stents resulted in a significant reduction in the hazard of reintervention
(0.41 [95% CI 0.32-0.52]). The hazards of death (0.90 [95% CI 0.71-
1.15]), myocardial infarction (0.81 [95% CI 0.63-1.04]), and stent
thrombosis (0.84 [95% CI 0.61-1.17]) were not significantly different
between patients treated with drugeluting stents versus patients treated
with bare-metal stents. Conclusions Use of drug-eluting stents in patients
with AMI is safe and markedly reduces the need for reintervention as
compared to bare-metal stents. Springer-Verlag 2010.
<4>
Accession Number
2010389766
Authors
Bauer T. Mollmann H. Weidinger F. Zeymer U. Seabra-Gomes R. Eberli F.
Serruys P. Vahanian A. Silber S. Wijns W. Hochadel M. Nef H.M. Hamm C.W.
Marco J. Gitt A.K.
Institution
(Bauer, Mollmann, Nef, Hamm) Kerckhoff-Klinik, Kardiologie, Benekestr.
2-8, 61231 Bad Nauheim, Germany
(Weidinger) Krankenhaus Rudolfstiftung, Vienna, Australia
(Zeymer, Hochadel, Gitt) Herzzentrum Ludwigshafen, Institut fur
Herzinfarktforschung Ludwigshafen, Universitat Heidelberg, Ludwigshafen,
Germany
(Seabra-Gomes) Instituto do Coracao, Lisbon, Portugal
(Eberli) Stadtspital Triemli, Zurich, Switzerland
(Serruys) Thoraxcenter, Erasmus MC, Rotterdam, Netherlands
(Vahanian) Bichat Hospital, Paris, France
(Silber) Kardiologische Gemeinschaftspraxis und Praxisklinik, Munich,
Germany
(Wijns) Cardiovascular Center, Aalst, Belgium
(Marco) Centre Cardiothoracique de Monaco, Monaco Cedex, Monaco
Title
Use of platelet glycoprotein IIb/IIIa inhibitors in diabetics undergoing
PCI for non-ST-segment elevation acute coronary syndromes: Impact of
clinical status and procedural characteristics.
Source
Clinical Research in Cardiology. 99 (6) (pp 375-383), 2010. Date of
Publication: June 2010.
Publisher
D. Steinkopff-Verlag (P.O. Box 100462, Darmstadt D-64204, Germany)
Abstract
Abstract Background The most recent ESC guidelines for percutaneous
coronary intervention (PCI) recommend the use of glycoprotein IIb/IIIa
inhibitors (GPI) in high risk patients with non-ST-segment elevation acute
coronary syndromes (NSTE-ACS), particularly in diabetics. Little is known
about the adherence to these guidelines within Europe. Methods and results
Between May 2005 and April 2008 a total of 47,407 consecutive patients
undergoing PCI were prospectively enrolled into the PCI-Registry of the
Euro Heart Survey Programme. In the present analysis we examined the use
of GPI in 2,922 diabetics who underwent PCI for NSTE-ACS. In this high
risk population only 22.2% received a GPI; 8.9% upstream and 13.4% during
PCI. The strategy of the individual institution had a major impact on the
usage of GPI. In the multiple regression analysis clinical instability and
complex lesion characteristics were strong independent determinants for
the use of GPI, whereas renal insufficiency was negatively associated with
its use. After adjustment for confounding variables no significant
differences in hospital mortality could be observed between the cohorts,
but a significantly higher rate of non-fatal postprocedural myocardial
infarction was observed among patients receiving GPI upstream. Conclusions
Despite the recommendation for its use in the current ESC guidelines, only
a minority of the diabetics in Europe undergoing PCI for NSTE-ACS received
a GPI. The use of GPI was mainly triggered by high-risk interventional
scenarios. The Author(s) 2010.
<5>
[Use Link to view the full text]
Accession Number
2010390650
Authors
Schroeder A.R. Axelrod D.M. Silverman N.H. Rubesova E. Merkel E. Roth S.J.
Institution
(Schroeder, Axelrod, Silverman, Merkel, Roth) Department of Pediatrics,
Stanford University, School of Medicine, Palo Alto, CA, United States
(Rubesova) Department of Radiology, Stanford University, School of
Medicine, Palo Alto, CA, United States
(Schroeder) Department of Pediatrics, Santa Clara Valley Medical Center,
San Jose, CA, United States
Title
A continuous heparin infusion does not prevent catheter-related thrombosis
in infants after cardiac surgery.
Source
Pediatric Critical Care Medicine. 11 (4) (pp 489-495), 2010. Date of
Publication: July 2010.
Publisher
Lippincott Williams and Wilkins (530 Walnut Street, Philadelphia PA
19106-3621, United States)
Abstract
Objective: To determine whether a continuous infusion of heparin reduces
the rate of catheter-related thrombosis in neonates and infants post
cardiac surgery. Central venous and intracardiac catheters are used
routinely in postoperative pediatric cardiac patients. Catheter-related
thrombosis occurs in 8% to 45% of pediatric patients with central venous
catheters. Design: Single-center, randomized, placebo-controlled,
double-blinded trial. Setting: Cardiovascular intensive care unit,
university-affiliated children's hospital. Patients: Children <1 yr of age
recovering from cardiac surgery. Interventions: Patients were randomized
to receive either continuous heparin at 10 units/kg/hr or placebo. The
primary end point was catheter-related thrombosis as assessed by serial
ultrasonography. Results: Study enrollment was discontinued early based on
results from an interim futility analysis. Ninety subjects were enrolled
and received the study drug (heparin, 53; placebo, 37). The
catheter-related thrombosis rate in the heparin group, compared with the
placebo group, was 15% vs. 16% (p = .89). Subjects in the heparin group
had a higher mean partial thromboplastin time (52 secs vs. 42 secs, p =
.001), and this difference was greater for those aged <30 days (64 secs
vs. 43 secs, p = .008). Catheters in place <=7 days had both a greater
risk of thrombus formation (odds ratio, 4.3; p = .02) and catheter
malfunction (odds ratio, 11.2; p = .008). We observed no significant
differences in other outcome measures or in the frequency of adverse
events. Conclusions: A continuous infusion of heparin at 10 units/kg/hr
was safe but did not reduce catheter-related thrombus formation. Heparin
at this dose caused an increase in partial thromboplastin time values,
which, unexpectedly, was more pronounced in neonates. Copyright 2010 by
the Society of Critical Care Medicine and the World Federation of
Pediatric Intensive and Critical Care Societies.
<6>
[Use Link to view the full text]
Accession Number
2010293813
Authors
Melsop K. Brooks M.M. Boothroyd D.B. Hlatky M.A.
Institution
(Melsop, Boothroyd, Hlatky) Stanford University School of Medicine,
Stanford, CA, United States
(Brooks) University of Pittsburgh, Graduate School of Public Health,
Pittsburgh, PA, United States
Title
Effect of race on the clinical outcomes in the bypass angioplasty
revascularization investigation trial.
Source
Circulation: Cardiovascular Quality and Outcomes. 2 (3) (pp 186-190),
2009. Date of Publication: May 2009.
Publisher
Lippincott Williams and Wilkins (351 West Camden Street, Baltimore MD
21201-2436, United States)
Abstract
Background-In observational studies, clinical outcomes for black patients
with coronary disease have been worse than for white patients. There are
few data from randomized trials comparing the outcomes of coronary
revascularization between black patients and white patients. Methods and
Results-We analyzed data from the Bypass Angioplasty Revascularization
Investigation randomized trial. At study entry, the 113 black patients had
significantly higher rates of diabetes, hypertension, smoking, heart
failure, and abnormal left ventricular function than the 1653 white
patients. Black patients had significantly higher mortality than white
patients (hazard ratio, 2.16; P<0.001), which remained significant after
statistical adjustment for differences in baseline clinical
characteristics (hazard ratio, 1.59; P=0.003). In a substudy of economic
and quality of life outcomes, the 67 black patients had similar frequency
of physician visits and use of evidence-based cardiac medications but
significantly worse physical function scores than the 885 white patients.
The effect of random assignment to either surgery or angioplasty on
clinical outcomes was not significantly modified by race (interaction
probability values >=0.18). Conclusions-Clinical outcomes of black
patients after coronary revascularization were worse than those of white
patients in a clinical trial setting with similar treatment and access to
care. The differences in outcome between black and white patients were not
completely attributable to the greater levels of comorbidity among black
patients at study entry. (Circ Cardiovasc Qual Outcomes. 2009;2:186-190.)
2009 American Heart Association, Inc.
<7>
Accession Number
2010328920
Authors
Heneghan C. Tyndel S. Bankhead C. Wan Y. Keeling D. Perera R. Ward A.
Institution
(Heneghan, Tyndel, Bankhead, Perera, Ward) Department of Primary Health
Care, University of Oxford, Oxford, United Kingdom
(Wan) Department of Health Statistics Fourth Military Medical University,
Xi'an, China
(Keeling) Department of Haematology, Oxford Radcliffe Hospitals, Oxford,
United Kingdom
Title
Optimal loading dose for the initiation of warfarin: A systematic review.
Source
BMC Cardiovascular Disorders. 10 , 2010. Article Number: 18. Date of
Publication: 19 Apr 2010.
Publisher
BioMed Central Ltd. (34 - 42 Cleveland Street, London W1T 4LB, United
Kingdom)
Abstract
Background: Selection of the right warfarin dose at the outset of
treatment is not straightforward, and current evidence is lacking to
determine the optimal strategy for initiation of therapy.Methods: We
included randomized controlled trials in patients commencing
anticoagulation with warfarin, comparing different loading dose or
different regimens.We searched Medline, EMBASE, the Cochrane Library and
the NHS Health Economics Database up to June 2009. Primary outcomes were
time to stable INR and adverse events. We summarised results as proportion
of INRs in range from date of initiation and compared dichotomous outcomes
using relative risks (RR) and calculated 95% confidence intervals
(CIs).Results: We included 11 studies of 1,340 patients newly initiated on
warfarin. In two studies that used single INR measures, a loading dose of
10 mg compared to 5 mg led to more patients in range on day five. However,
in two studies which measured two consecutive INRs, a loading dose of 10
mg compared to 5 mg did not lead to more patients in range on day five (RR
= 0.86, 95% CI, 0.62 to 1.19, p = 0.37). Patients receiving a 2.5 mg
initiation does took longer to achieve the therapeutic range, whilst those
receiving a calculated initiation dose achieved target range 0.8 days
quicker (4.2 days vs. 5 days, p = 0.007). More elderly patients receiving
an age adjusted dose achieved a stable INR compared to the Fennerty
protocol (48% vs. 22% p = 0.02) and significantly fewer patients on the
age adjusted regimens had high out-of-range INRs. Two studies report no
significant differences between genotype guided and 5 mg or 10 mg
initiation doses and in the one significant genotype study the control
group INRs were significantly lower than expected.Conclusion: Our review
findings suggest there is still considerable uncertainty between a 10 mg
and a 5 mg loading dose for initiation of warfarin. In the elderly, lower
initiation doses or age adjusted doses are more appropriate, leading to
less higher INRs. Currently there is insufficient evidence to warrant
genotype guided initiation, and adequately powered trials to detect
effects on adverse events are currently warranted. 2010 Heneghan et al;
licensee BioMed Central Ltd.
<8>
Accession Number
2010328946
Authors
Cuthbertson B.H. Campbell M.K. Stott S.A. Vale L. Norrie J. Kinsella J.
Cook J. Brittenden J. Grant A.
Institution
(Cuthbertson) Department of Critical Care Medicine, Sunnybrook Health
Sciences Centre, Toronto, ON, Canada
(Cuthbertson, Campbell, Vale, Cook) Health Services Research Unit, Health
Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, United
Kingdom
(Stott) Intensive Care Unit, Aberdeen Royal infirmary, Westburn Road,
Aberdeen, United Kingdom
(Norrie) Robertson Centre for Biostatistics, University of Glasgow,
Glasgow, United Kingdom
(Kinsella) Department of Anaesthesia Pain and Critical Care, University of
Glasgow, Glasgow, United Kingdom
(Brittenden) Department of Surgery, University of Aberdeen, Foresterhill,
Aberdeen, United Kingdom
(Grant) Institute of Applied Health Sciences, Health Sciences Building,
University of Aberdeen, Foresterhill, Aberdeen, United Kingdom
(Vale) Health Economics Research Unit, Polwarth Building, University of
Aberdeen, Foresterhill, Aberdeen, United Kingdom
Title
A pragmatic multi-centre randomised controlled trial of fluid loading and
level of dependency in high-risk surgical patients undergoing major
elective surgery: Trial protocol.
Source
Trials. 11 , 2010. Article Number: 41. Date of Publication: 16 Apr
2010.
Publisher
BioMed Central Ltd. (34 - 42 Cleveland Street, London W1T 4LB, United
Kingdom)
Abstract
Background: Patients undergoing major elective or urgent surgery are at
high risk of death or significant morbidity. Measures to reduce this
morbidity and mortality include pre-operative optimisation and use of
higher levels of dependency care after surgery. We propose a pragmatic
multi-centre randomised controlled trial of level of dependency and
pre-operative fluid therapy in high-risk surgical patients undergoing
major elective surgery.Methods/Design: A multi-centre randomised
controlled trial with a 2 $ 2 factorial design. The first randomisation is
to pre-operative fluid therapy or standard regimen and the second
randomisation is to routine intensive care versus high dependency care
during the early post-operative period. We intend to recruit 204 patients
undergoing major elective and urgent abdominal and thoraco-abdominal
surgery who fulfil high-risk surgical criteria. The primary outcome for
the comparison of level of care is cost-effectiveness at six months and
for the comparison of fluid optimisation is the number of hospital days
after surgery.Discussion: We believe that the results of this study will
be invaluable in determining the future care and clinical resource
utilisation for this group of patients and thus will have a major impact
on clinical practice.Trial Registration: Trial registration number -
ISRCTN32188676. 2010 Cuthbertson et al; licensee BioMed Central Ltd.
<9>
Accession Number
2010330536
Authors
McKenna C. Burch J. Suekarran S. Walker S. Bakhai A. Witte K. Harden M.
Wright K. Woolacott N. Lorgelly P. Fenwick L. Palmer S.
Institution
(McKenna, Walker, Harden, Wright, Woolacott, Palmer) Centre for Health
Economics, University of York, York, United Kingdom
(Burch, Suekarran) Centre for Reviews and Dissemination, University of
York, York, United Kingdom
(Bakhai) Barnet General Hospital, Barnet, United Kingdom
(Witte) University of Leeds and Leeds General Infirmary, Leeds, United
Kingdom
(Lorgelly, Fenwick) Section of Health Policy and Public Health, University
of Glasgow, Glasgow, United Kingdom
Title
A systematic review and economic evaluation of the clinical effectiveness
and cost-effectiveness of aldosterone antagonists for postmyocardial
infarction heart failure.
Source
Health Technology Assessment. 14 (24) (pp i-161), 2010. Date of
Publication: 2010.
Publisher
National Co-ordinating Centre for HTA (Bouldrewood, Mail Point 728,
Highfield, Southhampton, United Kingdom)
Abstract
Background: Two aldosterone inhibitors are currently licensed for heart
failure (HF) in the UK: spironolactone and eplerenone. Recent clinical
guidelines recommend eplerenone after an acute myocardial infarction (MI)
for patients with symptoms and/or signs of HF and left ventricular
dysfunction. Objectives: The primary objective was to evaluate relative
clinical effectiveness and cost-effectiveness of spironolactone and
eplerenone in patients with postMI HF and explore the possibility of
conducting an indirect comparison of spironolactone and eplerenone. A
second objective was to undertake value-ofinformation (VOI) analyses to
determine the need for further research to identify research questions
critical to decision-making and to help inform the design of future
studies. Data sources: Relevant databases including MEDLINE, EMBASE and
CENTRAL were searched between September and December 2008. Randomised
controlled trials (RCTs) of spironolactone, eplerenone, canrenone or
potassium canrenoate were included if conducted in a postMI HF population.
Trials of general HF patients with a subgroup of postMI HF patients were
considered if they had at least 100 ischaemic participants per arm and the
authors provided subgroup data when contacted. Adverse events summary data
were sought from recognised reference sources and RCTs or observational
studies in any population that recruited more than 100 articipants. Review
methods: The comparative clinical effectiveness and cost-effectiveness of
spironolactone and eplerenone was derived using Bayesian meta regression
drawing on a wider 'network' of aldosterone trials to those considered in
the main clinical effectiveness review. An alternative scenario was also
considered assuming a 'class effect' for the aldosterone antagonists in
terms of major clinical events, but allowing for potential differences in
side effect profiles. Cost-effectiveness was assessed using incremental
cost-effectiveness ratios (ICERs) where appropriate. Uncertainty in
cost-effectiveness results was also presented and used to inform future
research priorities using VOI analyses based on expected value of perfect
information (EVPI). A probabilistic decision analytic model was developed
to estimate cost-effectiveness of spironolactone, eplerenone and standard
care for management of postMI HF, provide estimates relevant to the NHS
and explore alternative approaches to an indirect comparison between
spironolactone and eplerenone. The model incorporated a lifetime horizon
to estimate outcomes in terms of quality-adjusted life-years (QALYs) and
costs from the NHS persepctive. In the base-case analysis, 2-year
treatment duration was assumed, consistent with the follow-up in the main
RCTs. Other scenarios were explored to examine the robustness of
alternative assumptions including impact of different treatment durations.
Results: Searches yielded five RCTs: two spironolactone trials of poor
methodological quality and three trials of which only one (of eplerenone)
specifically examined postMI HF (Eplerenone Post-Acute Myocardial
Infarction Heart Failure Efficacy and Survival Study, EPHESUS). One trial
of spironolactone (Randomised Aldactone Evaluation Study, RALES) and one
of canrenone (Antiremodelling Effect of Aldosterone receptors blockade
with canrenone In mild Chronic Heart Failure, AREA IN-CHF) comprised
general HF, but data were available for an ischaemic subgroup. Structural
similarity of spironolactone and eplerenone suggests that they may be
interchangeable, but formal indirect comparison between the three trials
was severely limited by trial differences. Relative safety data were
limited from RCTs and observational sources. Hyperkalaemia rates varied,
but were generally higher than for placebo; data were insufficient to
assess discontinuation because of hyperkalaemia. Gynaecomastia rates were
higher with spironolactone.Adverse event data were sparse. Systematic
review of economic evidence identified three main published studies but
none used a UK perspective or attempted to compare cost-effectiveness in
postMI HF. The new decision model indicated that eplerenone was the most
cost-effective strategy for postMI HF (ICER of eplerenone compared with
standard care was 4457 per QALY, increasing to 7893 per QALY if treatment
continued over the patient's lifetime); in neither scenario did
spironolactone appear cost-effective. The ICER of eplerenone was
consistently under the 20,000-30,000 per QALY threshold used to establish
value for money in the NHS. Uncertainty resulted in EVPI estimates between
820M (base-case) and 1265M (lifetime treatment duration scenario). When
class effect for mortality and hospitalisations was assumed spironolactone
emerged as the most costeffective treatment and EVPI estimates were
negligible. If class effect is considered more plausible than the results
of the evidence synthesis model then there would be limited value in
additional research. Limitations: Exchangeability between trials was poor
and there was a lack of robust data in RCTs. Conclusions: Only two
good-quality trials of aldosterone inhibitors in the postMI HF population
were found, but lack of exchangeability with respect to study populations,
meant that a comparison between these drugs could not be done. It
consistently emerged that, compared with usual care, use of an aldosterone
antagonist appears to be a highly costeffective strategy for the
management of postMI HF patients in the NHS. An adequately powered,
wellconducted RCT that directly compares spironolactone and eplerenone is
required to provide more robust evidence on the optimal management of
postMI HF patients. 2010 Queen's Printer and Controller of HMSO.
<10>
Accession Number
2010333711
Authors
Moss A.J.
Institution
(Moss) Cardiology Division of the Department of Medicine, University of
Rochester Medical Center, Rochester, NY, United States
Title
What we have learned from the family of multicenter automatic
defibrillator implantation trials.
Source
Circulation Journal. 74 (6) (pp 1038-1041), 2010. Date of Publication:
2010.
Publisher
Japanese Circulation Society (14 Yoshida Kawaharacho, Sakyo-ku, Kyoto 606,
Japan)
Abstract
Electrical device therapy began 50 years ago with the external
defibrillator, and was followed subsequently with the introduction of
implantable cardiac pacemakers, defibrillators, and resynchronization
devices to prevent bradycardia, sudden arrhythmic death, and heart
failure. During the past 20 years the Multicenter Automatic Defibrillator
Implantation Trial (MADIT) research group has carried out a series of
trials, including the MADIT-I, MADIT-II, and MADIT-III (MADIT-CRT), that
have focused on improving the outcomes for patients with ischemic and
nonischemic cardiac disease. The most recent MADIT-CRT trial showed that a
cardiac resynchronization therapy device with defibrillator (CRT-D) was
effective in reducing the risk of heart failure or death, whichever came
first, in cardiac patients who were asymptomatic or minimally symptomatic
(New York Heart Association class I or II) with reduced ejection fraction
<=0.30 and wide QRS complex >=130 ms when compared with an implantable
cardiac defibrillator (ICD) device. The family of MADIT ICD and CRT-D
trials have provided a firm foundation for improving the clinical
management of at-risk cardiac patients as the second decade of the
21<sup>st</sup> century begins.
<11>
Accession Number
2010333732
Authors
Miyazaki S. Kasai T. Miyauchi K. Miyazaki T. Akimoto Y. Takagi A. Aihara
K. Kawamura M. Suwa S. Kojima S. Sumiyoshi M. Daida H.
Institution
(Miyazaki, Miyazaki, Kawamura, Suwa, Kojima, Sumiyoshi) Department of
Cardiology, Juntendo Shizuoka Hospital, Shizuoka, Japan
(Kasai, Miyauchi, Akimoto, Takagi, Aihara, Daida) Department of
Cardiology, Juntendo University, School of Medicine, Tokyo, Japan
Title
Changes of matrix metalloproteinase-9 level is associated with left
ventricular remodeling following acute myocardial infarction among
patients treated with trandolapril, valsartan or both.
Source
Circulation Journal. 74 (6) (pp 1158-1164), 2010. Date of Publication:
2010.
Publisher
Japanese Circulation Society (14 Yoshida Kawaharacho, Sakyo-ku, Kyoto 606,
Japan)
Abstract
Background: Inhibition of the renin-angiotensin system (RAS) with
angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor
blockers (ARBs) can suppress left ventricular (LV) remodeling after acute
myocardial infarction (AMI), possibly through the modifications of matrix
metalloproteinase (MMP)-9. Whether LV remodeling is suppressed in
association with MMP-9 suppression in post-AMI/-percutaneous coronary
intervention (PCI) patients treated with ACE inhibitor and/or ARB was
examined. The presence of any differences in LV remodeling and MMP-9
levels across the groups was also investigated. Methods and Results:
Sixty-five patients were initiated into each of 3 treatments;
trandolapril, valsartan or a combination of both (half-dose-trandolapril
plus half-dose-valsartan). Changes in MMP-9, LV end-diastolic and
end-systolic volume index (LVEDVI and LVESVI) after 12 months were
assessed. Overall, MMP-9 significantly decreased, although neither LVEDVI
nor LVESVI increased significantly. AMMP-9 was significantly correlated
with LVEDVI (r=0.36) or LVESVI (r=0.39). In comparison, across groups, it
was found that MMP-9, LVEDVI and LVESVI at 12 months were significantly
lower in the combination therapy group than in the trandolapril group.
There were no significant differences between the valsartan group and
combination therapy group, or between the valsartan group and the
trandolapril group. Conclusions: LV remodeling might be suppressed in
association with MMP-9 suppression in AMI patients treated with PCI and
regular dose or half-dose-combination of RAS inhibitors. Furthermore, a
half-dose-combination might suppress LV remodeling more effectively than
trandolapril alone.
<12>
Accession Number
2010388947
Authors
Dabrowski W. Rzecki Z. Wosko J. Biernacka J. Kotlinska E. Czajkowski M.
Institution
(Dabrowski, Rzecki, Wosko, Biernacka, Kotlinska) Department of
Anaesthesiology and Intensive Therapy, Medical University of Lublin,
Jaczewskiego 8, Lublin 20-954, Poland
(Czajkowski) Department of Cardiac Surgery, Medical University of Lublin,
Poland
Title
Volatile anaesthetics reduce serum S100beta concentrations in patients
undergoing elective cardiac surgery.
Source
Applied Cardiopulmonary Pathophysiology. 14 (2) (pp 139-148), 2010. Date
of Publication: 2010.
Publisher
Pabst Science Publishers (Eichengrund 28, Lengerich D-49525, Germany)
Abstract
Background: The effect of volatile anaesthetics on plasma S100beta protein
has not been welldocumented in cardiac surgery patients. The aim of the
study was to analyse the effect of sevoflurane or isoflurane anaesthesia
on plasma S100beta concentration in patients undergoing elective,
uncomplicated coronary artery bypass graft surgery. Methods: One hundred
thirty seven patients were prospectively randomized and allocated into
three groups: A patients, who didn't receive volatile anaesthetics, B who
received sevoflurane and C who received isoflurane. S100beta was measured
during anaesthesia and postoperative days 1 and 2. Results: In all
patients, S100beta increased during anaesthesia and at the postoperative
day 1 and 2. In group A, S100beta increased during anaesthesia and
postoperative days 1 and 2 but in groups B and C only during anaesthesia.
Plasma S100beta concentrations were significantly higher in group A than
in group B and C. Conclusions: 1) cardiac surgery resulted in S100beta
elevation, 2) isoflurane and sevoflurane significantly reduced plasma
S100beta concentrations.
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Accession Number
20197560
Authors
Temporelli P.L. Scapellato F. Eleuteri E. Imparato A. Giannuzzi P.
Institution
(Temporelli) Division of Cardiology, Salvatore Maugeri Foundation, IRCCS,
Via Revislate 13, Veruno, Italy.
Title
Doppler echocardiography in advanced systolic heart failure: a noninvasive
alternative to Swan-Ganz catheter.
Source
Circulation. Heart failure. 3 (3) (pp 387-394), 2010. Date of
Publication: May 2010.
Abstract
BACKGROUND: Although several studies have demonstrated a good correlation
between Doppler echocardiographic and invasive measurements of single
hemodynamic variables, the accuracy of echocardiography in providing a
comprehensive assessment in individual patients has not been validated.
The aim of this study was to assess the accuracy and clinical
applicability of Doppler echocardiography in determining the entire
hemodynamic profile in stable patients with advanced systolic heart
failure. METHODS AND RESULTS: Doppler echocardiography and Swan-Ganz
catheterization were simultaneously performed in 43 consecutive patients
with advanced heart failure. Echocardiographic data required for
estimation of right atrial, pulmonary artery systolic, and pulmonary
capillary wedge pressures; cardiac output; and pulmonary vascular
resistance were obtained and compared with hemodynamic data. For all
variables, invasive and noninvasive hemodynamic values were highly
correlated (P<0.0001), with very low bias and narrow 95% confidence
limits. In 16 patients with elevated pulmonary vascular resistance (>3
Wood U) and pulmonary capillary wedge pressures (>20 mm Hg) at baseline,
hemodynamic and Doppler measurements were simultaneously repeated after
unloading manipulations. Absolute values and changes of pulmonary vascular
resistance and pulmonary capillary wedge pressures after unloading were
still accurately predicted (r =0.96 and r =0.92, respectively).
CONCLUSIONS: Doppler echocardiography may offer a valid alternative to
invasive cardiac catheterization for the comprehensive hemodynamic
assessment of patients with advanced heart failure, and it may assist in
monitoring and optimization of therapy in potential heart transplant
recipients.
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Accession Number
20299607
Authors
Udelson J.E. Feldman A.M. Greenberg B. Pitt B. Mukherjee R. Solomon H.A.
Konstam M.A.
Institution
(Udelson) Tufts Medical Center, 750 Washington Street, Boston, MA 02111,
USA.
Title
Randomized, double-blind, multicenter, placebo-controlled study evaluating
the effect of aldosterone antagonism with eplerenone on ventricular
remodeling in patients with mild-to-moderate heart failure and left
ventricular systolic dysfunction.
Source
Circulation. Heart failure. 3 (3) (pp 347-353), 2010. Date of
Publication: May 2010.
Abstract
BACKGROUND: Aldosterone antagonism has been studied in patients with
advanced heart failure (HF) and also in patients with post-myocardial
infarction and left ventricular (LV) dysfunction with HF symptoms. Few
data are available on effects of aldosterone antagonism in patients with
mild-to-moderate HF. METHODS AND RESULTS: In a multicenter, randomized,
double-blind, placebo-controlled study in patients with mild-to-moderate
HF and LV systolic dysfunction, patients with New York Heart Association
class II/III HF and LV ejection fraction (EF) < or =35% were randomly
assigned to receive eplerenone 50 mg/d versus placebo in addition to
contemporary background therapy. Quantitative radionuclide ventriculograms
to assess LV volumes and ejection fraction were performed at baseline and
again after 9 months of double-blind treatment and were analyzed in a
central core laboratory, blinded to treatment. The primary efficacy
analysis was the between-group comparison of the change in LV
end-diastolic volume index. Secondary analyses examined changes in LV
end-systolic volume index and ejection fraction as well as markers of
collagen turnover. Of the total 226 patients enrolled, 117 were randomly
assigned to receive eplerenone and 109 to receive placebo. There was high
use of contemporary background therapy at baseline, with > 90% use of
angiotensin-converting enzyme inhibitors and/or angiotensin receptor
blockers and > 90% use of beta-blockers. Over 36 weeks of treatment, there
was no apparent between-group difference in the changes in end-diastolic
volume index or end-systolic volume index. There was a reduction in the
collagen turnover marker procollagen type I N-terminal propeptide and
plasma B-type natriuretic peptide in the eplerenone group compared with
placebo (P=0.01 and P=0.04, respectively). There was no change in symptom
status or quality-of-life measures. CONCLUSIONS: In a clinically stable,
well-treated population of patients with mild-to-moderate HF symptoms and
LV dysfunction, 36 weeks of treatment of aldosterone antagonism with
eplerenone at a dose of 50 mg daily had no detectable effect on parameters
of LV remodeling.
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