The risk of sudden cardiac death (SCD) among patients with end-stage renal disease receiving maintenance dialysis is high. At present, there are no known therapies to effectively reduce this risk, and there are few data on the feasibility and value of prophylactic implantable cardioverter-defibrillator implantation (ICD) for the prevention of SCD.
Researchers in The Netherlands conducted the ICD2 (Implantable Cardioverter-Defibrillator in Dialysis Patients) trial to examine the efficacy of ICD implantation in 200 patients on dialysis with a left ventricular ejection fraction ≥35%. SCD was the primary end point of interest.
The prospective, randomized, controlled study was stopped for futility reasons following inclusion of 188 patients (97 in the ICD group and 91 in the control group). Among the 188 patients, SCD occurred in 19 (11/97 in the ICD group and 8/91 in the control group). At 5 years of follow-up, the cumulative SCD incidence was 9.7% in the ICD group and 9.7% in the controls; hazard ratio, 1.32. Overall, 99 of the 188 patients died (52 in the ICD group and 47 in the control group). In the ICD group, 5-year survival probability was 50.6% versus 54.5% in the control group. There were 25 adverse events related to ICD implantation among 80 patients in the ICD group.
“In a well-screened and well-treated population undergoing dialysis, prophylactic ICD therapy did not reduce the rate of SCD or all-cause mortality, which remained high,” the researchers said.
Clinical Trial Registration:
URL: http://www.controlled-trials.com. Unique identifier: ISRCTN20479861