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Multicenter Study Comparative Study Clinical Trial
The durability of pulmonary vein isolation using the visually guided laser balloon catheter: multicenter results of pulmonary vein remapping studies.
- Srinivas R Dukkipati, Petr Neuzil, Josef Kautzner, Jan Petru, Dan Wichterle, Jan Skoda, Robert Cihak, Petr Peichl, Antonio Dello Russo, Gemma Pelargonio, Claudio Tondo, Andrea Natale, and Vivek Y Reddy.
- Helmsley Electrophysiology Center, Mount Sinai School of Medicine, New York, NY 10029, USA.
- Heart Rhythm. 2012 Jun 1; 9 (6): 919-25.
BackgroundThe visually guided laser ablation (VGLA) catheter is a compliant, variable-diameter balloon that delivers laser energy around the pulmonary vein (PV) ostium under real-time endoscopic visualization. While acute PV isolation has been shown to be feasible, limited data exist regarding the durability of isolation.ObjectiveWe sought to determine the durability of PV isolation following ablation using the balloon-based VGLA catheter.MethodsThe VGLA catheter was evaluated in patients with paroxysmal atrial fibrillation (3 sites, 10 operators). Following transseptal puncture, the VGLA catheter was advanced through a 12-F deflectable sheath and inflated at the target PV ostium. Under endoscopic guidance, the 30° aiming arc was maneuvered around the PV and laser energy was delivered to ablate tissue in a contiguous/overlapping manner. At ∼3 months, all patients returned for a PV remapping procedure.ResultsIn 56 patients, 202 of 206 PVs (98%) were acutely isolated. At 105 ± 44 (mean ± SD) days, 52 patients returned for PV remapping at which time 162 of 189 PVs (86%) remained isolated and 32 of 52 patients (62%) had all PVs still isolated. On comparing the operators performing <10 vs ≥ 10 procedures, the durable PV isolation rate and the percentage of patients with all PVs isolated were found to be 73% vs 89% (P = .011) and 57% vs 66% (P = .746), respectively. After 2 procedures and 12.0 ± 1.9 months of follow-up, the drug-free rate of freedom from atrial fibrillation was 71.2%.ConclusionsIn this multicenter, multioperator experience, VGLA resulted in a very high rate of durable PV isolation with a clinical efficacy similar to that of radiofrequency ablation.Copyright © 2012 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
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