Lars Køber, MD, from Rigshospitalet, and colleagues conducted a randomized controlled trial assessed in patients with symptomatic systolic heart failure not caused by coronary artery disease who were assigned to receive an ICD (556 patients) or usual clinical care (560 patients).
The trial revealed after a median follow-up time of 67.6 months (hazard ratio, 0.87; 95% confidence interval, 0.68 to 1.12), that the primary outcome of death from all causes occurred in 21.6% of the ICD group and 23.4% of the control group. Sudden cardiac death occurred in 4.3% of the ICD patients and was almost doubled to 8.2% in the control group, respectively (hazard ratio, 0.50; 95% confidence interval, 0.31 to 0.82). Device-related infection occurred in 4.9% of the patients in the ICD and 3.6% of patients in the control groups, respectively (P=0.029).
"Prophylactic ICD implantation is a class 1 recommendation in patients with heart failure and reduced left ventricular systolic function in both European and American guidelines," Lars Køber explains. "However, the evidence is much weaker for patients with non-ischemic aetiology. Until now, there has been the limited data on ICDs in this population, and our trial fills that gap by suggesting ICDs should not be routinely implanted in all patients with systolic heart failure."