Evaluation of stroke incidence with duty-cycled multielectrode-phased radiofrequency ablation of persistent atrial fibrillation results of the VICTORY AF Study

Introduction The VICTORY AF Study was designed to evaluate the risk of the procedure and/or device-related strokes in patients with PersAF on warfarin undergoing ablation with a phased radiofrequency (RF) system. Methods The VICTORY AF trial was a prospective, multicenter, single-arm, investigational study. PersAF patients on vitamin K antagonism without major structural heart disease or history of stroke/transient ischemic attack undergoing phased RF ablation for atrial fibrillation (AF) were included. The primary outcome was the incidence of the procedure and/or device-related stroke within 30 days of the ablation by a board-certified neurologist's assessment. The secondary outcomes were an acute procedural success, 6 months effectiveness (defined as the reduction in AF/atrial flutter episodes lasting >= 10 minutes by 48-hour Holter 6 months postablation) and the number of patients with pulmonary vein (PV) stenosis. Results A total of 129 (108 PersAF, 21 long-standing PersAF) patients were treated (mean age: 60.6 +/- 7.7; 79.8% male, 54.3% CHA2Ds2-VASc score >= 2). Two nondisabling strokes were reported (1.6%); one before discharge and the second diagnosed at the 30-day visit. Due to slow enrollment, the study was terminated before reaching the 95% one-sided upper confidence boundary for stroke incidence. Acute procedural success was 93.8%, and at 6 months, 72.8% of patients demonstrated >= 90% reduction in AF burden, 78.9% were off all antiarrhythmic drugs. There were no patients with PV stenosis of greater than 70%. Conclusions VICTORY AF demonstrated a 1.6% incidence of stroke in PersAF undergoing ablation with a phased RF system which did not meet statistical confidence due to poor enrollment. The secondary outcomes suggest comparable efficacy to phased RF in the tailored treatment of permanent AF trial. Rigorous clinical evaluation of the stroke risk of new AF ablation technologies as well as restriction to Vitamin K antagonist anticoagulation appears to be unachievable goals in a clinical multicenter IDE trial of AF ablation in the current era.