Long-term follow-up of patients with indication for a implantable defibrillator for primary prevention of death.

BACKGROUND: Recent MADIT II and SCD-HeFT trials have led to an expansion of indications for use of prophylactic Implantable Cardioverter Defibrillator (ICD) in patients with severe left-ventricular impairment. This therapy has not been fully adopted in our health care system, mainly due to its high cost. OBJECTIVE: To assess total mortality of SCD-HeFT-like patients from our daily practice who are under stable, optimal medical treatment and who have not received an ICD; and to compare it to that of the placebo arm of the SCD-HeFT Trial. METHODS: SCD-HeFT-like patients identified from office medical records were included in our study. Total mortality was assessed by telephone contact. Statistical analysis was performed by Student's t-Test, Mann-Whitney Test or chi2 test, depending on the type of variable. Cumulative mortality rates were calculated according to the Kaplan-Meier method. RESULTS: Our study comprised 102 patients (seventy-four of which were men) with a median age of 64 years, and an overall median ejection fraction of 25%. We found no differences between our patients and SCD-HeFT patients across these 3 variables. Over a 19.6-month follow-up period, 21 patients died (20.6%) vs. 28.8% of the SCD-HeFT patients. This difference was not statistically significant (p = 0.08). CONCLUSION: SCD-HeFT-like patients from our practice had no difference in mortality rate than patients enrolled in the placebo arm of the SCD-HeFT trial. These results suggest that the SCD-HeFT population is representative of our patients.