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Original Article
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Volume 350:2151-2158 May 20, 2004 Number 21
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Prophylactic Defibrillator Implantation in Patients with Nonischemic Dilated Cardiomyopathy
Alan Kadish, M.D., Alan Dyer, Ph.D., James P. Daubert, M.D., Rebecca Quigg, M.D., N.A. Mark Estes, M.D., Kelley P. Anderson, M.D., Hugh Calkins, M.D., David Hoch, M.D., Jeffrey Goldberger, M.D., Alaa Shalaby, M.D., William E. Sanders, M.D., Andi Schaechter, B.S.N., R.N., Joseph H. Levine, M.D., for the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators

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ABSTRACT

Background Patients with nonischemic dilated cardiomyopathy are at substantial risk for sudden death from cardiac causes. However, the value of prophylactic implantation of an implantable cardioverter–defibrillator (ICD) to prevent sudden death in such patients is unknown.

Methods We enrolled 458 patients with nonischemic dilated cardiomyopathy, a left ventricular ejection fraction of less than 36 percent, and premature ventricular complexes or nonsustained ventricular tachycardia. A total of 229 patients were randomly assigned to receive standard medical therapy, and 229 to receive standard medical therapy plus a single-chamber ICD.

Results Patients were followed for a mean (±SD) of 29.0±14.4 months. The mean left ventricular ejection fraction was 21 percent. The vast majority of patients were treated with angiotensin-converting–enzyme (ACE) inhibitors (86 percent) and beta-blockers (85 percent). There were 68 deaths: 28 in the ICD group, as compared with 40 in the standard-therapy group (hazard ratio, 0.65; 95 percent confidence interval, 0.40 to 1.06; P=0.08). The mortality rate at two years was 14.1 percent in the standard-therapy group (annual mortality rate, 7 percent) and 7.9 percent in the ICD group. There were 17 sudden deaths from arrhythmia: 3 in the ICD group, as compared with 14 in the standard-therapy group (hazard ratio, 0.20; 95 percent confidence interval, 0.06 to 0.71; P=0.006).

Conclusions In patients with severe, nonischemic dilated cardiomyopathy who were treated with ACE inhibitors and beta-blockers, the implantation of a cardioverter–defibrillator significantly reduced the risk of sudden death from arrhythmia and was associated with a nonsignificant reduction in the risk of death from any cause.


Source Information

From the Clinical Cardiology Trials Office, Division of Cardiology, Department of Medicine, Northwestern University Medical School, Chicago (A.K., A.D., R.Q., J.G., A. Schaechter); the University of Rochester Medical Center, Rochester, N.Y. (J.P.D.); New England Medical Center, Boston (N.A.M.E.); Marshfield Clinic, Marshfield, Wisc. (K.P.A.); Johns Hopkins Hospital, Baltimore (H.C.); St. Francis Hospital, Roslyn, N.Y. (D.H., J.H.L.); the University of North Carolina at Chapel Hill, Chapel Hill (W.E.S.); and the Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (A. Shalaby).

Address reprint requests to Dr. Kadish at 251 E. Huron, Feinberg 8-536, Chicago, IL 60611, or at a-kadish{at}northwestern.edu.

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