title: Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.
abstract: BACKGROUND
  Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance.
  
  
  OBJECTIVE
  This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF.
  
  
  METHODS
  Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority.
  
  
  RESULTS
  A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB.
  
  
  CONCLUSIONS
  Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000).
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Srinivas R
authors.initials: SR
authors.lastname: Dukkipati
authors.affiliation: Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Frank
authors.initials: F
authors.lastname: Cuoco
authors.affiliation: William Beaumont Hospital, Royal Oak, Michigan.
authors.forename: Ilana
authors.initials: I
authors.lastname: Kutinsky
authors.affiliation: Regional Cardiology Associates, Sacramento, California.
authors.forename: Arash
authors.initials: A
authors.lastname: Aryana
authors.affiliation: Duke Center for Atrial Fibrillation and the Clinical Cardiac Electrophysiology Section, Duke University Medical Center, Durham, North Carolina.
authors.forename: Tristram D
authors.initials: TD
authors.lastname: Bahnson
authors.affiliation: Mid-America Cardiology, Kansas City, Kansas.
authors.forename: Dhanunjaya
authors.initials: D
authors.lastname: Lakkireddy
authors.affiliation: Sentara Cardiovascular Research Institute, Norfolk, Virginia.
authors.forename: Ian
authors.initials: I
authors.lastname: Woollett
authors.affiliation: Prairie Heart Institute, Springfield, Illinois.
authors.forename: Ziad F
authors.initials: ZF
authors.lastname: Issa
authors.affiliation: Texas Cardiac Arrhythmia Institute, Austin, Texas.
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: vivek.reddy@mountsinai.org.
authors.forename: Vivek Y
authors.initials: VY
authors.lastname: Reddy
mesh_terms: D000368:Aged; D017222:Angioplasty, Balloon, Laser-Assisted / Q000379:methods* / Q000706:statistics & numerical data; D001281:Atrial Fibrillation / Q000601:surgery*; D017115:Catheter Ablation; D004724:Endoscopy / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D059032:Learning Curve; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000601:surgery; D016896:Treatment Outcome
keywords: antiarrhythmic drug; atrial fibrillation; catheter ablation; paroxysmal