Primary preventive cardioverter‐defibrillator implantation (Pro‐ ICD ) in patients awaiting heart transplantation. A prospective, randomized, controlled 12‐year follow‐up study

Summary The aim of this study was to evaluate whether short‐term primary preventive cardioverter‐defibrillator ( ICD ) implantation as bridge to heart transplantation ( HTX ) provides any survival benefit. Thirty‐three patients awaiting HTX were randomized to either conventional therapy (control group) or primary preventive ICD implantation ( ICD group). Fourteen patients had ischemic cardiomyopathy ( ICM ) and 19 patients had dilated cardiomyopathy ( DCM ). Sixteen patients were randomized to the ICD group and 17 patients were randomized to the control group. Twenty patients (61%) were transplanted after a waiting time of 10 ± 9 months. The remaining 13 patients (39%) were not transplanted because of clinical improvement ( n  = 5), cerebral hemorrhage ( n  = 3), or death ( n  = 5). On the waiting list, 3 ICD patients with DCM developed slow VT s without ICD intervention, two patients with ICM (6%) had fast VT terminated by the ICD , and no arrhythmic death was observed. After 11.9 years (median), 13 of 20 HTX patients (65%) and 5 of 13 non‐ HTX patients (38%) were alive. Survivors had a higher LVEF (22 ± 6 vs. 17 ± 4%, P  = 0.0092) and a better exercise capacity (75 ± 29 vs. 57 ± 24 Watt, P  = 0.0566) at baseline as compared to nonsurvivors. This study may not support the general use of primary preventive ICD s as a short‐term bridge to heart transplantation.