B-PO02-078 PROSPECTIVE RANDOMIZED MULTICENTER COMPARISON OF THIRD GENERATION CRYOBALLOON AND LASER BALLOON CATHETERS FOR PULMONARY VEIN ISOLATION ABLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION

Abstract

Cryoballoon (CB) and Laser balloon (LB) catheters have emerged as alternative modalities for pulmonary vein isolation (PVI) of patients with paroxysmal atrial fibrillation (PAF). To compare clinical efficacy, safety, and procedural characteristics of 3rd generation CB (Arctic Front Advance-Short Tip; CB3) and LB (Heartlight X3; LB3) catheters for first-time PVI in PAF patients. Symptomatic PAF patients were prospectively randomized 1:1 to undergo PVI with CB3 or LB3 catheters (CB3: n=115; LB3 n=115). Follow up included 3,6, and 12 month office visits. 14-day Holter monitoring guided by symptoms. Primary efficacy endpoint was defined as freedom from atrial tachyarrhythmia (AAT) between 91 to 365 days after first-ablation procedure. Secondary endpoints included procedural parameters and procedural complications. Procedure time, left atrial time, and fluoroscopy time were based on standard definitions. 230 PAF patients underwent PVI with CB3 (n=115) and LB3 (n=115). There were no significant differences in baseline characteristics between groups. Mean age was 65.3 + 12.3 for CB3 and 63.1 + 11.5 for LB3 (p=0.158). On 9 month follow up, 17.2% of CB and 11.4% of LB3 patients (p=0.939) had recurrence of AAT after 90-day blanking period. Procedure time was 91.7 + 33.8 for CB3 vs 91.1 + 27.7 mins for LB3 (p=0.87). LA dwell time was 68.9 + 26.1 for CB3 vs 74.2 + 22.2 min for LB3(p=0.11). Fluoroscopy time was 13.8 + 7.0 vs 8.7 + 5.7 min for CB3 and LB3 groups (p<0.001), respectively. Total therapy time per PV was 6.5 + 3.9 for CB3 vs 5.6 + 2.4 min for LB3(<0.001). Of the PVs treated, 98.7% (450/456) were isolated with CB3 and 99.1% (445/449) were isolated with LB3. First pass isolation rate was 78.0% (351/450) for CB3 vs 93.7% (417/445) for LB3 (p<0.001). Hematomas occurred in four CB3 and two LB3 patients (p=0.458), respectively. No phrenic palsy events were observed in either group. Third generation CB and LB catheters offer improved safety and comparable efficacy for treatment of AAT in patients with PAF. Although procedure and LA dwell time were similar between balloon catheters, PVI with LB3 was associated with lower fluoroscopy usage, higher first pass PV isolation rate, and shorter total therapy time to achieve isolation per PV.