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

Abstract

SummaryThe 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 AE 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 VTs 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 AE 6 vs. 17 AE 4%, P = 0.0092) and a better exercise capacity (75 AE 29 vs. 57 AE 24 Watt, P = 0.0566) at baseline as compared to nonsurvivors. This study may not support the general use of primary preventive ICDs as a short-term bridge to heart transplantation.

Multiple Autonomic and Repolarization Investigation of Sudden Cardiac Death in Dilated Cardiomyopathy and Controls

“…In contrast, the annual incidence of sustained ventricular tachycardia is remarkably low, namely 3–4%. 6, 7 The high proportion of the remaining patients without cardiac events 8 raises the question how to discriminate high- and low-risk patients. In patients with ischemic and non-ischemic cardiomyopathy noninvasive assessments of autonomic tone and cardiac electrical substrate have been developed to identify high-risk patients.…”

Implantable cardiac defibrillator and mortality in non-ischaemic cardiomyopathy: an updated meta-analysis

“…Five included symptomatic patients with LVEF ≤35% (table 1); one restricted patients to those listed for heart transplantation 16. Mean age ranged from 52 to 64 years; 67%–94% were male patients, and those in NYHA class III–IV varied from 20%–100%.…”

“…All studies except one16 were deemed to be at low risk of bias. Studies reported no crossover or comparable frequency of crossover in each of the treatment arms.…”

Implantable cardioverter defibrillators for primary prevention in patients with nonischemic cardiomyopathy: A systematic review and meta‐analysis

“…Three remaining RCTs retrieved were not included in the meta‐analysis for different reasons. The comparison of medical therapy, pacing and defibrillation in heart failure trial (COMPANION), the resynchronization reverses remodeling in systolic left ventricular dysfunction trial (REVERSE), and the primary preventive cardioverter‐defibrillator implantation in patients awaiting heart transplantation trial (Pro‐ICD) . Baseline characteristics for these trials are summarized in Table .…”

“…The comparison of medical therapy, pacing and defibrillation in heart failure trial (COMPANION), 30 the resynchronization reverses remodeling in systolic left ventricular dysfunction trial (REVERSE), 31 trial (Pro-ICD). 32 Baseline characteristics for these trials are summarized in Table 2.…”