PO-06-169 PULMONARY VEIN ISOLATION USING THE RADIOFREQUENCY BALLOON CATHETER: A MULTICENTER EXPERIENCE

Background: The multielectrode radiofrequency balloon catheter (RFB) is a novel ablation device for pulmonary vein isolation (PVI), which combines “single-shot” ablation technology and 3D-mapping integration. Initial experience demonstrated a favorable safety and mid-term efficacy. Objective: This multicenter study sought to evaluate the efficacy of PVI with the RFB beyond one year and determine predictors of arrhythmia recurrence. Methods: Consecutive patients with paroxysmal atrial fibrillation (AF) undergoing PVI with the RFB were prospectively included in a European multicenter registry. The primary safety endpoint was defined as any major periprocedural complications. The primary efficacy endpoint was any atrial tachyarrhythmias (ATas) lasting >30 seconds occurring during the follow-up after a 3-month blanking period. Baseline and procedural data were analyzed with respect to ablation outcomes. Results: A total of 211 patients (63±11 years; 32% female) from 5 European centers were enrolled. PVI was achieved using solely the RFB in 98.6% of the patients, with a mean of 5.1±2 applications and a mean time-to-isolation of 9.1±2.3 sec. In 3 patients (1.4%), touch-up point-by-point ablation was needed due to technical issues. Procedure time was 71±28 min, dwell time was 27±14 min and fluoroscopy time was 17±10 min. Major complications occurred in 3 patients (1.4%; 1 cardiac tamponade, 2 persistent phrenic nerve palsies). After a mean follow-up of 15±6 months, ATas recurrence occurred in 43 (20.4%) patients, including 35 (81.4%) with AF and 8 (18.6%) with atrial tachycardia/atrial flutter. At multivariable Cox regression analysis, female sex and left atrial end-systolic volume index resulted as independent predictors of ATas recurrence (HR 2.63, 95%CI 1.09-6.33, p=0.031 and HR 1.05, 95%CI 1.01-1.08, p=0.013, respectively). Conclusion: PVI with the RFB is associated with a rate of ATas recurrence of 20% at 15 months. Females and patients with higher left atrial volumes had a higher risk of arrhythmia relapse. [Formula presented]