Outcomes after Implantable Cardioverter-Defibrillator Generator Replacement for Primary Prevention of Sudden Cardiac Death

Background-The effectiveness of implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden death in patients with an ejection fraction (EF) ≤35% and clinical heart failure is well established. However, outcomes after replacement of the ICD generator in patients with recovery of EF to >35% and no previous therapies are not well characterized. Methods and Results-Between 2001 and 2011, generator replacement was performed at 2 tertiary medical centers in 253 patients (mean age, 68.3±12.7 years; 82% men) who had previously undergone ICD placement for primary prevention but subsequently never received appropriate ICD therapy. EF had recovered to >35% in 72 of 253 (28%) patients at generator replacement. During median (quartiles) follow-up of 3.3 (1.8-5.3) years after generator replacement, 68 of 253 (27%) experienced appropriate ICD therapy. Patients with EF ≤35% were more likely to experience ICD therapy compared with those with EF >35% (12% versus 5% per year; hazard ratio, 3.57; P=0.001). On multivariable analysis, low EF predicted appropriate ICD therapy after generator replacement (hazard ratio, 1.96 [1.35-2.87] per 10% decrement; P=0.001). Death occurred in 25% of patients 5 years after generator replacement. Mortality was similar in patients with EF ≤35% and >35% (7% versus 5% per year; hazard ratio, 1.10; P=0.68). Atrial fibrillation (3.24 [1.63-6.43]; P<0.001) and higher blood urea nitrogen (1.28 [1.14-1.45] per increase of 10 mg/dL; P<0.001) were associated with mortality. Conclusions-Although approximately one fourth of patients with a primary prevention ICD and no previous therapy have EF >35% at the time of generator replacement, these patients continue to be at significant risk for appropriate ICD therapy (5% per year). These data may inform decisions on ICD replacement.