Results:

The study cohort was comprised of 937 patients from six observational studies. Patients were 53 ± 12 years of age, and 80% were male. In 93% of the patients, bridge-to-transplantation was the indication for LVAD implantation. A continuous-flow (CF) LVAD was present in 361 patients (39% of patients). Mean left ventricular ejection fraction was 16 ± 6%. A significant proportion of patients were taking beta-blockers (59%), angiotensin-converting enzyme inhibitors (65%), and aldosterone receptor antagonists (44%). An ICD was present in 355 patients (38%). During a mean follow-up of 7 months, 241 patients (26%) died (16% in the ICD group vs. 32% in the no-ICD group). Presence of an ICD was associated with a 39% RR reduction in all-cause mortality (RR, 0.61; 95% CI, 0.46-0.82; p < 0.01). Approximately six patients (95% CI, 4.8-9.9) needed to be treated with an ICD for an average of 7 months to prevent one death. Among the subgroup of patients with CF-LVAD (n = 361), an ICD was present in 245 patients (68%), whereas 116 patients (32%) did not have an ICD. Mortality in the ICD group was 14% compared with 25% in the no-ICD group. Therefore, ICD use was associated with an 11% absolute risk reduction and a 24% RR reduction with a statistically nonsignificant trend toward improved survival in these CF-LVAD patients (RR, 0.76; 95% CI, 0.51-1.12; p = 0.17). Data on infection were available for 839 of the 937 patients from five studies. The incidence of infection was significantly lower in patients with ICDs (18 of 293 patients) than in patients without an ICD (96 of 546 patients), 6% vs. 18% (p < 0.01).