Prophylactic Defibrillator Implantation in Patients with Nonischemic Dilated Cardiomyopathy

Alan Kadish, Alan Dyer, James P. Daubert, Rebecca Quigg, N. A.Mark Estes, Kelley P. Anderson, Hugh Calkins, David Hoch, Jeffrey Goldberger, Alaa Shalaby, William E. Sanders, Andi Schaechter, Joseph H. Levine

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1490 Scopus citations

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 non-sustained 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 percentconfidence 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.

Original languageEnglish (US)
Pages (from-to)2151-2158
Number of pages8
JournalNew England Journal of Medicine
Volume350
Issue number21
DOIs
StatePublished - May 20 2004

ASJC Scopus subject areas

  • Medicine(all)

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    Kadish, A., Dyer, A., Daubert, J. P., Quigg, R., Estes, N. A. M., Anderson, K. P., Calkins, H., Hoch, D., Goldberger, J., Shalaby, A., Sanders, W. E., Schaechter, A., & Levine, J. H. (2004). Prophylactic Defibrillator Implantation in Patients with Nonischemic Dilated Cardiomyopathy. New England Journal of Medicine, 350(21), 2151-2158. https://doi.org/10.1056/NEJMoa033088