Efficacy and Safety of a Voltage-Guided Stepwise Strategy for Pulmonary Vein Isolation: A Randomized Comparison With Conventional Circumferential Antral Pulmonary Vein Isolation

Background Catheter ablation is an established rhythm control therapy for atrial fibrillation. However, as the extent of ablation increases, the risk of complications may also rise. This has motivated strategies that achieve pulmonary vein isolation with less lesion creation while preserving safety and effectiveness. Methods In this prospective, multicenter, randomized non-inferiority trial, 130 patients undergoing first-time ablation for paroxysmal or non-paroxysmal atrial fibrillation were assigned 1:1 to a voltage-guided stepwise pulmonary vein isolation approach or conventional circumferential antral pulmonary vein isolation with voltage blinded to operators. The primary end point was recurrence of atrial tachyarrhythmia within 12 months after ablation. Results At 12 months, recurrence occurred in 23/65 (35.4%) in the stepwise group versus 13/65 (20.0%) in the control group (risk difference 15.4 percentage points; 90% confidence interval, 2.7–28.1), and non-inferiority was not demonstrated (one-sided P=0.520). The treatment group had a higher risk of recurrent atrial tachyarrhythmia than the control group (hazard ratio, 2.05; 95% confidence interval, 1.04–4.06), with longer procedure times and more frequent acute pulmonary vein reconnection after the initial lesion set. The treatment group had fewer acute complications than the control group (1.5% versus 9.2%; P=0.115), and esophageal thermal injury was observed only in the control group (3 cases). Conclusions Voltage-guided stepwise pulmonary vein isolation failed to demonstrate non-inferiority to conventional circumferential antral pulmonary vein isolation for 12-month atrial tachyarrhythmia recurrence. ClinicalTrials.gov ID: NCT07354737