Clinical question: Do prophylactic implantable cardioverter defibrillators (ICDs) reduce long-term mortality in patients with symptomatic nonischemic systolic heart failure (NISHF)?
Background: ICDs are associated with significant reductions in the rate of sudden cardiac death and mortality in NISHF patients. However, no trials of NISHF patients have shown an effect on total mortality.
Study design: Multicenter, nonblinded, randomized controlled prospective trial.
Setting: Danish ICD centers.
Synopsis: A total of 1,116 patients with symptomatic NISHF (left ventricular ejection fraction of less than 35%) were randomized to either receive an ICD or usual clinical care. The primary outcome, death from any cause, occurred in 120 patients (21.6%) in the ICD group (4.4 events/100 person-years) and in 131 patients (23.4%) in the control group. The hazard ratio for death from any cause in the ICD group, as compared with the control group, was 0.87 (95% CI , 0.68-1.12; P = .28). The HR for death from any cause in the ICD group, as compared with the control group, was 0.87 (95% CI, 0.68-1.12; P = .28)
Bottom line: Prophylactic ICD implantation in patients with symptomatic NISHF does not reduce long-term mortality.