Background: Bipolar voltage amplitude is capable of helping determine the ideal lesion size index (LSI) setting during radiofrequency ablation for atrial fibrillation (AF).
Objective: We aimed to determine whether voltage-guided pulmonary vein isolation (PVI) is noninferior to conventional LSI-guided PVI in patients with nonvalvular AF.
Methods: This 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.
Results: A 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).
Conclusion: Voltage-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.
Keywords: Atrial fibrillation; Bipolar voltage; High-voltage zone; Lesion size index; Pulmonary vein isolation; Radiofrequency; Recurrence.
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