"Mortality and Morbidity with an Implantable Cardioverter–Defibrillator in Patients with Nonischemic Dilated Cardiomyopathy". The New England Journal of Medicine. 2004. 350(21):2151-2158. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Design 5 Population 5.1 Inclusion Criteria 5.2 Exclusion Criteria 5.3 Baseline Characteristics 6 Interventions 7 Outcomes 7.1 Primary Outcomes 7.2 Secondary Outcomes 8 Funding 9 Further Reading
In patients with nonischemic dilated cardiomyopathy, does prophylactic implantation of an implantable cardioverter–defibrillator (ICD) reduce the risk of sudden death from arrhythmia and overall mortality when added to standard medical therapy?
In patients with nonischemic dilated cardiomyopathy and left ventricular dysfunction, the addition of an ICD to standard medical therapy including ACE inhibitors and beta-blockers resulted in a significant reduction in the risk of sudden death from arrhythmia and a nonsignificant reduction in overall mortality.
Patients with nonischemic dilated cardiomyopathy have an increased risk of sudden cardiac death. This study, known as the DEFINITE trial, assessed whether prophylactic ICD implantation in addition to standard medical therapy can lower this risk.
- Multicenter, randomized, controlled trial - N=458 patients with nonischemic dilated cardiomyopathy - Standard medical therapy (n=229) vs. standard medical therapy plus ICD (n=229) - Mean follow-up: 29.0±14.4 months - Analysis: Intention-to-treat
- Inclusion Criteria: Nonischemic dilated cardiomyopathy, left ventricular ejection fraction <36%, presence of premature ventricular complexes or nonsustained ventricular tachycardia, symptoms of heart failure - Exclusion Criteria: NYHA class IV heart failure, recent electrophysiological testing, permanent pacemakers, imminent cardiac transplantation, familial cardiomyopathies associated with sudden death, acute myocarditis, congenital heart disease - Baseline Characteristics: Similar in both groups with mean left ventricular ejection fraction of 21%
- Patients were randomized to either standard medical therapy for heart failure, including ACE inhibitors and beta-blockers, or to the same therapy plus a single-chamber ICD.
- Primary Outcomes: Risk of death from any cause (hazard ratio with ICD, 0.65; 95% CI, 0.40 to 1.06; P=0.08) - Secondary Outcomes: Sudden death from arrhythmia (hazard ratio with ICD, 0.20; 95% CI, 0.06 to 0.71; P=0.006)
- Funded by St. Jude Medical. Data collection and analysis independently performed at Northwestern University. Authors disclosed various relationships with medical device companies.
- Full text article available through the NEJM website