Implantable Defibrillators for the Prevention of Mortality in Patients With Nonischemic Cardiomyopathy: A Meta-analysis of Randomized Controlled Trials

ContextImplantable cardioverter defibrillator (ICD) therapy is effective in primary and secondary prevention of sudden cardiac death among patients with prior myocardial infarction and depressed ejection fraction. However, conclusive evidence of survival benefit in patients with nonischemic cardiomyopathy (NICM) is still lacking.ObjectiveTo determine whether ICD therapy reduces all-cause mortality in patients with NICM.Data SourcesMEDLINE (1966-2004), EMBASE (1991-2004), the Cochrane Central Register of Controlled Trials (through first quarter, 2004), reports presented at scientific meetings (2003-2004), and bibliographic review of secondary sources. Search terms included defibrillator, randomized controlled trials, clinical trials, andsudden death.Study SelectionEligible studies were prospective randomized controlled trials of ICD or combined cardiac resynchronization therapy and defibrillator (CRT-D) vs medical therapy enrolling at least some individuals with NICM and reporting all-cause mortality as an outcome. Of 675 potentially relevant articles screened initially, 8 reports of randomized trials enrolling a total of 2146 patients with NICM were included.Data ExtractionIncluded studies were reviewed to determine the number of patients randomized, mean duration of follow-up, primary end point, mortality of ICD cohort, and mortality of control cohort.Data SynthesisFive primary prevention trials enrolling 1854 patients with NICM were identified; pooled analysis suggested a significant reduction in total mortality among patients randomized to ICD or CRT-D vs medical therapy (risk ratio [RR], 0.69; 95% confidence interval [CI], 0.55-0.87; P = .002). Mortality reduction remained significant even after elimination of CRT-D trials. Two of the 3 secondary prevention trials presented subgroup estimates for ICD efficacy in NICM. Pooled analysis of these secondary prevention trials (n = 256 patients with NICM) indicated an equivalent but nonsignificant mortality reduction with ICD therapy (RR, 0.69; 95% CI, 0.39-1.24; P = .22). Analysis of all 7 trials combined demonstrated a statistically significant 31% overall reduction in mortality with ICD therapy (RR, 0.69; 95% CI, 0.56-0.86; P = .002).ConclusionICD therapy appears to significantly reduce mortality in selected patients with NICM.

[1]  Hugh Calkins,et al.  Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. , 2004, The New England journal of medicine.

[2]  D. DeMets,et al.  Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. , 2004, The New England journal of medicine.

[3]  W. Grimm,et al.  Noninvasive Arrhythmia Risk Stratification in Idiopathic Dilated Cardiomyopathy: Results of the Marburg Cardiomyopathy Study , 2003, Circulation.

[4]  F. Marchlinski,et al.  Characterization of Endocardial Electrophysiological Substrate in Patients With Nonischemic Cardiomyopathy and Monomorphic Ventricular Tachycardia , 2003, Circulation.

[5]  F. Morady,et al.  Amiodarone versus implantable cardioverter-defibrillator:randomized trial in patients with nonischemic dilated cardiomyopathy and asymptomatic nonsustained ventricular tachycardia--AMIOVIRT. , 2003, Journal of the American College of Cardiology.

[6]  R. Passman,et al.  Predictors of appropriate implantable cardioverter-defibrillator therapy in patients with idiopathic dilated cardiomyopathy. , 2002, The American journal of cardiology.

[7]  K. Kuck,et al.  Primary Prevention of Sudden Cardiac Death in Idiopathic Dilated Cardiomyopathy: The Cardiomyopathy Trial (CAT) , 2002, Circulation.

[8]  J. Oss,et al.  PROPHYLACTIC IMPLANTATION OF A DEFIBRILLATOR IN PATIENTS WITH MYOCARDIAL INFARCTION AND REDUCED EJECTION FRACTION , 2002 .

[9]  W. Grimm,et al.  Implantable defibrillator event rates in patients with idiopathic dilated cardiomyopathy, nonsustained ventricular tachycardia on Holter and a left ventricular ejection fraction below 30%. , 2002, Journal of the American College of Cardiology.

[10]  A. Russo,et al.  Occurrence of implantable defibrillator events in patients with syncope and nonischemic dilated cardiomyopathy. , 2001, The American journal of cardiology.

[11]  A. Hallstrom,et al.  Follow‐Up of Patients with Unexplained Syncope and Inducible Ventricular Tachyarrhythmias: Analysis of the AVID Registry and an AVID Substudy , 2001 .

[12]  S. Connolly,et al.  Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg . Canadian Implantable Defibrillator Study. , 2000, European heart journal.

[13]  I. Olkin,et al.  Improving the quality of reports of meta‐analyses of randomised controlled trials: the QUOROM statement , 2000, Revista espanola de salud publica.

[14]  R. Cappato,et al.  Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest : the Cardiac Arrest Study Hamburg (CASH). , 2000, Circulation.

[15]  G. Fonarow,et al.  Improved survival in patients with nonischemic advanced heart failure and syncope treated with an implantable cardioverter-defibrillator. , 2000, The American journal of cardiology.

[16]  M Gent,et al.  Canadian implantable defibrillator study (CIDS) : a randomized trial of the implantable cardioverter defibrillator against amiodarone. , 2000, Circulation.

[17]  K. Lee,et al.  A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. , 1999, The New England journal of medicine.

[18]  F. Morady,et al.  Outcome of patients with nonischemic dilated cardiomyopathy and unexplained syncope treated with an implantable defibrillator. , 1999, Journal of the American College of Cardiology.

[19]  W. Grimm,et al.  Programmed ventricular stimulation for arrhythmia risk prediction in patients with idiopathic dilated cardiomyopathy and nonsustained ventricular tachycardia. , 1998, Journal of the American College of Cardiology.

[20]  M. Keller,et al.  A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. , 1997, The New England journal of medicine.

[21]  A. Moss,et al.  Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. , 1996, The New England journal of medicine.

[22]  C. Begg,et al.  Operating characteristics of a rank correlation test for publication bias. , 1994, Biometrics.

[23]  R. Brian Haynes,et al.  Developing optimal search strategies for detecting clinically sound studies in MEDLINE. , 1994, Journal of the American Medical Informatics Association : JAMIA.

[24]  D. Wilber,et al.  Sudden death in idiopathic dilated cardiomyopathy. , 1992, American heart journal.

[25]  A. Kadish,et al.  Implantable cardioverter defibrillator: use in patients with no symptoms and at high risk. , 1996, American heart journal.