Competing risk analysis of cause-specific mortality in patients with an implantable cardioverter-defibrillator: The EVADEF cohort study

Background Although implantable cardioverter-defibrillator (ICD) therapy has been evaluated in randomized controlled trials, enrolling highly selected patients, mortality events in ICD patients have received little attention in routine medical care. We sought to assess the 24-month total and cause-specific mortality rates and their predictors in "real life" patients with an ICD. Methods The Evaluation Medico-Economique du Defibrillateur Automatique Implantable study was a French multicenter, prospective, observational cohort study of ICD patients with a 2-year follow-up. Cause-specific mortality rates and predictors at implantation of sudden cardiac death (SCD) or progressive heart failure (HF) death were assessed using competing risk methodology. Results From June 2001 to June 2003, 2,296 unselected patients were implanted and followed until June 2005. During a mean follow-up of 20.5 +/- 6.7 months, 274 deaths occurred: 29 (10.6%) were SCD and 146 (53.3%) were HF deaths, corresponding to 24-month cause-specific mortality rates of 1.4% (95% confidence interval 0.9%-1.9%) and 6.9% (95% confidence interval 5.8%-8.0%), respectively. Among the characteristics at implantation, ejection fraction (EF) < 30% and history of atrial fibrillation were independently associated with SCD; age, high New York Heart Association class, systemic hypertension, prior atrial fibrillation, QRS duration, EF < 30%, and lack of beta-blocker therapy were independently associated with HF death. Conclusions In this large cohort of "daily" patients, the 2-year incidence of SCD (1.4%) was comparable with the event rate observed in randomized controlled trials; HF remained the predominant mode of death. An EF < 30% at implantation appears to be the most important predictor of ICD-unresponsive SCD. (Am Heart J 2009; 157:391-7.)