Multielectrode Pulmonary Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation: A Multinational Multicenter Randomized Clinical Trial

Circ Arrhythm Electrophysiol. 2016 Apr;9(4):e003151. doi: 10.1161/CIRCEP.115.003151.

Abstract

Background: Single-shot ablation techniques may facilitate safe and simple pulmonary vein isolation to treat paroxysmal atrial fibrillation. Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation-paroxysmal atrial fibrillation is the first multinational, multicenter, prospective, noninferiority randomized clinical trial comparing multielectrode-phased radiofrequency ablation (MEA) to standard focal irrigated radiofrequency ablation (STA) using 3-dimensional navigation.

Methods and results: Patients with paroxysmal atrial fibrillation were randomized to MEA (61 patients) or STA (59 patients). Preprocedure transesophageal echocardiogram and computed tomography/magnetic resonance imaging (also 6-month postprocedure) were performed. Mean age was 57 years, 25% female sex, BMI was 28, CHA2DS2-VASc score was 0 to 1 in 82%, 8% had previous right atrial ablation, whereas all had at least 1 antiarrhythmic drug failure. The MEA group had significantly shorter mean procedure time (96±36 versus 166±46 minutes, P<0.001) and fluoroscopy time (23±9 versus 27±9 minutes, P=0.023). The total radiofrequency energy duration was 22±8 minutes for MEA versus 36±13 minutes for STA (P<0.001) with confirmed pulmonary vein isolation in all patients. Hospital admission was 1 day in both groups, without major adverse events either during the procedure or during 30-day follow-up. Two patients in the STA group had 1 PV with asymptomatic narrowing >50%. Freedom of atrial fibrillation for MEA and STA was 86.4% and 89.7% at 6 months, dropping to 76.3% and 81.0% at 12 months.

Conclusions: In this multicenter, randomized clinical trial, MEA and STA had similar rates of single-procedure acute pulmonary vein isolation without serious adverse events in the first 30 days. MEA had slightly lower long-term arrhythmia freedom, but showed marked and significantly shorter procedure, fluoroscopy, and radiofrequency energy times.

Clinical trial registration: URL: www.clinicaltrials.gov; Unique identifier: NCT01696136.

Keywords: atrial fibrillation; catheter ablation; fluoroscopy; freedom; pulmonary vein.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / physiopathology
  • Atrial Fibrillation / surgery*
  • Catheter Ablation / instrumentation*
  • Echocardiography, Transesophageal
  • Electrocardiography
  • Electrodes*
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Heart Conduction System / physiopathology
  • Heart Conduction System / surgery*
  • Humans
  • Magnetic Resonance Imaging, Cine
  • Male
  • Middle Aged
  • Prospective Studies
  • Pulmonary Veins / surgery*
  • Tachycardia, Paroxysmal / diagnosis
  • Tachycardia, Paroxysmal / physiopathology
  • Tachycardia, Paroxysmal / surgery*
  • Tomography, X-Ray Computed
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01696136