Background: Durable pulmonary vein isolation (PVI) for atrial fibrillation (AF) remains challenging. The visually guided laser balloon (VGLB) is a unique single-shot technology designed to simplify PVI.
Objective: This study aimed to assess the real-world safety and long-term effectiveness of the third-generation VGLB system for treating paroxysmal and persistent AF.
Methods: This prospective, multicenter registry enrolled 427 patients undergoing VGLB-PVI. Safety was assessed in all patients, whereas the primary effectiveness endpoint (12-month freedom from AF) was analyzed in 392 patients who completed follow-up. Cox regression models were used to identify predictors of recurrence.
Results: Acute PVI was achieved in all targeted veins. The system demonstrated a favorable safety profile; permanent phrenic nerve palsy occurred in 1 patient (0.2%). After a 3-month blanking period, the 12-month freedom from AF recurrence off antiarrhythmic drugs was 73.8%. This rate increased to 77.7% for procedures performed after the initial 15-case operator learning curve. Multivariate analysis identified procedures within the learning curve (hazard ratio [HR] 1.68), congestive heart failure (HR 2.04), and anatomic variants (HR 1.79) as independent predictors of recurrence.
Conclusion: In this large, real-world registry, third-generation VGLB ablation is a safe and effective strategy for achieving long-term freedom from AF. Operator experience beyond the initial learning curve is a key determinant of success, confirming VGLB as a viable and effective PVI option.
Keywords: Atrial fibrillation; Catheter ablation; Effectiveness; Laser balloon; Learning curve; Pulmonary vein isolation; Safety; Single-shot ablation.
© 2025 Heart Rhythm Society. Published by Elsevier Inc.