Data Source
The Sudden Cardiac Death in Heart Failure Trial enrolled 2,521 patients with ischemic or non-ischemic cardiomyopathy, New York Heart Association (NYHA) class II or III heart failure and an EF ≤ 35% from September 16, 1997 to July 18, 2001. Follow-up ended on October 31, 20038. After starting vasodilator therapy for heart failure, the patients were randomly assigned to placebo (n=847), amiodarone (n=845), or single-lead, shock-only, ICD (n=829). After 46 months of follow-up, there was a 23% reduction of all-cause mortality among patients assigned to ICD in comparison to those assigned to placebo or amiodarone.8
Ischemic cardiomyopathy was defined as decreased left ventricular systolic function with either a documented history of myocardial infarction or >75% stenosis of a major coronary artery. Non-ischemic cardiomyopathy was defined as decreased left ventricular systolic function without a flow-limiting stenosis. A detailed review of SCD-HeFT methods has been published previously.9
For the present analysis, a de-identified, publicly-available version of the SCD-HeFT database was accessed through the NHLBI Biorepository program BioLINCC.10 This study met the criteria for exempt status after evaluation by the Institutional Review Board at our institution.