Voltage-guided pulmonary vein isolation for atrial fibrillation

Abstract

BackgroundBipolar voltage amplitude is capable of helping determine the ideal lesion size index (LSI) setting during radiofrequency ablation for atrial fibrillation (AF). ObjectiveWe aimed to determine whether voltage-guided pulmonary vein isolation (PVI) is noninferior to conventional LSI-guided PVI in patients with nonvalvular AF. MethodsThis was a multicenter randomized trial conducted during a period of 12 months. The primary efficacy end points of the study were AF recurrence, atrial flutter, and atrial tachycardia, and the noninferiority margin was set at a hazard ratio of 1.4. The primary safety end point was a composite of procedure-related complications. ResultsA total of 370 patients underwent randomization; 189 and 181 were assigned to the voltage (underwent voltage-guided PVI) and control (underwent conventional LSI-guided PVI) groups, respectively. The primary efficacy end point occurred in 22 patients (12.0%) in the voltage group and 23 patients (12.9%) in the control group (1-year Kaplan-Meier event-free rate estimates, 88.0% and 87.1%, respectively; hazard ratio, 1.00; 95% confidence interval, 0.80–1.25). The primary safety end points were 4.8% in the voltage group and 6.6% in the control group (P = .2791). PVI time was significantly shorter in the voltage group (35.7 ± 14.5 minutes vs 39.7 ± 14.7 minutes; P < .001). ConclusionVoltage-guided PVI was noninferior to conventional LSI-guided PVI with respect to efficacy in the treatment of patients with AF, and its use significantly reduced procedure time.UMIN Clinical Trials Registry: UMIN000042325