Defibrillation testing and clinical outcomes after implantable cardioverter–defibrillator implantation in patients in atrial fibrillation at the time of implant: An analysis from the SIMPLE trial

BACKGROUND The Shockless IMPLant Evaluation (SIMPLE) trial showed that defibrillation testing (DT) at the time of implantable cardioverter-defibrillator (ICD) implant did not improve shock efficacy or reduce mortality. There are no data regarding the risk of complications, including stroke, among patients with atrial fibrillation (AF) who undergo DT. OBJECTIVE The purpose of this prospectively planned substudy of SIMPLE was to evaluate the effect of DT vs no DT on clinical outcomes among patients with AF. METHODS We compared efficacy (failed appropriate shock/arrhythmic death) and safety between patients who had AF on their immediate preprocedural ECG to the rest of the study patients. Then among patients with AF we compared these outcomes between patients randomized to DT vs no DT. RESULTS Of the 2500 patients enrolled in SIMPLE, 251 (10%) were in AF immediately before ICD implant. AF patients had an increased risk of failed appropriate shock/arrhythmic death adjusted hazard ratio [HR] 1.64; 95% confidence interval [CI] 1.13-2.39; P = .009) and higher all-cause mortality (adjusted HR 1.58; 95% CI 1.2-2.08; P = .001). Among AF patients, perioperative complications and stroke did not significantly differ between DT vs no-DT groups (9.2% vs 5.4 0 /0; P = .2; and 1.7% vs 1.5%; P >.999, respectively). Failed appropriate shock or arrhythmic death occurred in 35 of 251 AF patients (14%), and the no-DT group proved not inferior to the DT group (HR 0.58; 95 0 /0 CI 0.30-1.15; P-noninferiority = .006). CONCLUSION ICD recipients with AF are at increased risk for adverse outcomes; however, DT does not improve arrhythmic survival or shock efficacy. There is no evidence that DT increased the occurrence of perioperative stroke.