title: Pulmonary vein isolation using a visually guided laser balloon catheter: the first 200-patient multicenter clinical experience.
abstract: BACKGROUND
  Because of the technical difficulty with achieving pulmonary vein (PV) isolation in the treatment of patients with paroxysmal atrial fibrillation, 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.
  
  
  RESULTS
  This study includes the first 200 paroxysmal atrial fibrillation patients treated with the VGLA catheter (33 operators, 15 centers). After transseptal puncture, the VGLA catheter was used to perform PV isolation. Electric isolation was assessed using a circular mapping catheter. Using the VGLA catheter, 98.8% (95% confidence interval, 97.8%-99.5%) of targeted PVs were isolated using a mean of 1.07 catheters per patient. Fluoroscopy and procedure times were 31±21 (mean±SD) and 200±54 minutes, respectively, and improved with operator experience. There were no instances of stroke, transient ischemic attack, atrioesophageal fistulas, or significant PV stenosis. There was a 2% incidence of cardiac tamponade and a 2.5% incidence of phrenic nerve palsy. At 12 months, the drug-free rate of freedom from atrial arrhythmias after 1 or 2 procedures was 60.2% (95% confidence interval, 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.
authors.affiliation: Helmsley Electrophysiology Center, Mount Sinai School of Medicine, New York, NY 10029, USA.
authors.forename: Srinivas R
authors.initials: SR
authors.lastname: Dukkipati
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.forename: Petr
authors.initials: P
authors.lastname: Neuzil
authors.forename: Ian
authors.initials: I
authors.lastname: Woollett
authors.forename: Josef
authors.initials: J
authors.lastname: Kautzner
authors.forename: H Thomas
authors.initials: HT
authors.lastname: McElderry
authors.forename: Boris
authors.initials: B
authors.lastname: Schmidt
authors.forename: Edward P
authors.initials: EP
authors.lastname: Gerstenfeld
authors.forename: Shephal K
authors.initials: SK
authors.lastname: Doshi
authors.forename: Rodney
authors.initials: R
authors.lastname: Horton
authors.forename: Andreas
authors.initials: A
authors.lastname: Metzner
authors.forename: Andre
authors.initials: A
authors.lastname: d'Avila
authors.forename: Jeremy N
authors.initials: JN
authors.lastname: Ruskin
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.forename: Vivek Y
authors.initials: VY
authors.lastname: Reddy
mesh_terms: D000328:Adult; D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000601:surgery*; D062906:Cardiac Catheters; D017115:Catheter Ablation / Q000295:instrumentation* / Q000379:methods*; D016001:Confidence Intervals; D004562:Electrocardiography / Q000379:methods; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007834:Lasers; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011183:Postoperative Complications / Q000503:physiopathology; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000601:surgery*; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
keywords: atrial fibrillation; catheter ablation; lasers; pulmonary vein isolation; visual guidance