Prophylactic Use of Implantable Cardioverter-Defibrillators in the Prevention of Sudden Cardiac Death in Dialysis Patients: The Prospective Randomized Controlled ICD2 Trial

Background: End-stage renal disease patients on dialysis are reported to be at high risk of sudden cardiac death (SCD) and, to date, no therapy has been shown to be effective in reducing this. The feasibility and value of prophylactic implantable cardioverter-defibrillator (ICD) implantation to prevent SCD is uncertain. Methods: We conducted the ICD2 trial, a prospective, randomized controlled study investigating the value and safety of ICD implantation to prevent SCD in 200 patients on dialysis with a left ventricular ejection fraction ≥35%, after adequate screening and optimization of other treatments. The primary endpoint was SCD. Secondary endpoints were all-cause mortality and ICD-related complications. Results: The trial was stopped as per the recommendation of the data and safety monitoring board for futility reasons after inclusion of 188 patients, 97 in the ICD group and 91 in the control group. The median duration of follow-up was 6.8 years (interquartile range, 3.8-8.8). SCD occurred in 19/188 ...