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.
Atrial fibrillation laser balloon ablation: Multicenter international study / Martignani, C.; Rovaris, G.; Tilz, R. R.; Schiavone, M.; Ciconte, G.; Giaccardi, M.; Miracapillo, G.; Giomi, A.; Arena, G.; Spadotto, A.; Montemerlo, E.; Salerno, R.; Piazzi, E.; Pozzi, M.; Forleo, G. B.; Angeletti, A.; Ziacchi, M.; Massaro, G.; Diemberger, I.; Biffi, M.; Giacopelli, D.; Bartoli, L.; Heeger, C. H.. - In: HEART RHYTHM O2. - ISSN 2666-5018. - 6:12(2025), pp. 1870-1876. [10.1016/j.hroo.2025.09.004]
Atrial fibrillation laser balloon ablation: Multicenter international study
Ciconte G.;Salerno R.;
2025-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
