Pulmonary Vein Isolation Using a Visually-Guided Laser Balloon Catheter: The First 200-Patient Multicenter Clinical Experience
Background—Because of the technical difficulty with achieving pulmonary vein (PV) isolation in the treatment of patients with paroxysmal atrial fibrillation (PAF), novel catheter designs to facilitate the procedure are in development. A visually-guided laser ablation (VGLA) catheter was designed to allow the operator to directly visualize target tissue for ablation, and then deliver laser energy to perform point-to-point circumferential ablation. Single center studies have demonstrated favorable safety and efficacy. We sought to determine the multicenter feasibility, efficacy, and safety of performing PV isolation using the VGLA catheter.
Methods and Results—This study includes the first 200 PAF patients treated with the VGLA catheter (33 operators, 15 centers). After transseptal puncture, the VGLA catheter was used to perform PV isolation. Electrical isolation was assessed using a circular mapping catheter. Using the VGLA catheter, 98.8% (95% CI, 97.8-99.5%) of targeted PVs were isolated using a mean of 1.07 catheters/patient. Fluoroscopy and procedure times were 31±21 (mean±sd) and 200±54 min respectively, and improved with operator experience. There were no instances of stroke, TIA, atrio-esophageal fistulas or significant PV stenosis. There was a 2% incidence of cardiac tamponade and 2.5% incidence of phrenic nerve palsy. At 12 months, the drug-free rate of freedom from atrial arrhythmias after one or two procedure was 60.2% (95% CI, 52.7-67.4%)
Conclusions—In this multicenter experience of the first 200 patients treated with the VGLA catheter, PV isolation can be achieved in virtually all patients using a single VGLA catheter with an efficacy similar to radiofrequency ablation.
- Received September 6, 2012.
- Accepted March 15, 2013.