The objective of this study was to assess the operative risk and efficacy of implantable defibrillators for preventing sudden death in patients with heart failure awaiting transplantation. The average waiting time for elective cardiac transplantation is 6 months to 1 year. Sudden cardiac death is the major source of mortality in outpatients in stable condition awaiting cardiac transplantation. The efficacy of implantable defibrillator therapy in this population is not established. We analyzed the operative risk, time to appropriate shock, and sudden death in 15 patients determined to be at high risk of sudden death who were accepted onto the outpatient cardiac transplant waiting list. Nonfatal postoperative complications occurred in two (13%) subjects with epicardial defibrillating lead systems and in none with transvenous lead systems. Defibrillation energies were 16 +/- 2 J versus 24 +/- 2 J with epicardial and transvenous lead systems, respectively. Sudden death free survival until transplantation was 93%. Most of the patients (60%) had an appropriate shock during a mean follow-up of 11 +/- 12 months. The mean time to an appropriate shock was 3 +/- 3 months. Hospital readmission was required in three (20%) subjects to await transplantation on an urgent basis. However, two of these subjects had received appropriate shocks before readmission. In selected patients at high risk for sudden death while on the outpatient cardiac transplant waiting list, the operative risk is low and adequate defibrillation energies can be obtained to allow implantable defibrillator placement. Most subjects will have an appropriate shock as outpatients before transplantation, and sudden death free survival is excellent.(ABSTRACT TRUNCATED AT 250 WORDS)