Clinical InvestigationsElectrophysiologyCompeting risk analysis of cause-specific mortality in patients with an implantable cardioverter-defibrillator: The EVADEF cohort study
Section snippets
Study design
The Évaluation Médico-Économique du Défibrillateur Automatique Implantable (EVADEF) study was a multicenter prospective cohort study of ICD patients conducted in 22 centers in France (Appendix A). This study was designed to evaluate the medical benefit of ICD in France, with a specific focus on cause-of-death analysis. The project was set up under the auspices of the French Society of Cardiology, initiated by its working group on arrhythmias, solicited and funded by the French Ministry of
Results
A total of 2,396 patients who underwent ICD implantation in the 22 participating French centers were included. Among those, 100 patients were lost to follow-up or withdrew their consent. The remaining 2,296 patients contributed to the 2-year follow-up for 3,916 patient-years and were included in our analysis. This population represented up to 70% of the overall ICD implantation activity in France between June 2001 and June 2003.
Discussions
The EVADEF cohort study represents one of the most important “real-life” ICD patient evaluations reported to date. In this setting, we have demonstrated that the results from randomized controlled trials, on which our guidelines are based, may be effectively applied to routine standard medical care. Sudden cardiac death was diagnosed in only 1.4% of patients after a 2-year follow-up, with an increase in incidence of HF mortality, which represented most cardiovascular deaths. Moreover, whereas
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This study was supported by a special grant from the French Ministry of Health (Paris, France) (Soutien aux Innovations Diagnostiques et Thérapeutiques Coûteuses).
Presented in part at the Annual Congresses of the American Heart Association (Chicago, IL, November 11-14, 2006) and the European Society of Cardiology (Barcelona, Spain, September 2-5, 2006; Vienna, Austria, September 1-5, 2007).
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The investigators of the Évaluation Médico-Économique du Défibrillateur Automatique Implantable (EVADEF) Study are listed in Appendix A.