Efficacy and safety of a novel cryoballoon ablation system: multicentre comparison of 1-year outcome

Abstract

Aims: The aim of the study was to compare the 1-year efficacy and safety of a novel cryoballoon (NCB) ablation system (POLARx; Boston Scientific) for pulmonary vein isolation (PVI) compared with the standard cryoballoon (SCB) system (Arctic Front, Medtronic).

Methods and results: Consecutive patients with atrial fibrillation (AF) undergoing PVI using the NCB and the SCB at two centres were included. We report 1-year efficacy after 12 months, short-term safety and hospitalizations within the blanking period, and predictors for AF recurrence. In case of repeat procedures, pulmonary vein (PV) reconnection patterns were characterized. Eighty patients (age 66 ± 10 years, ejection fraction 57 ± 10%, left atrial volume index 39 ± 13 mL/m2, paroxysmal AF in 64%) were studied. After a single procedure and a follow-up of 12 months, 68% in the NCB group and 70% in the SCB group showed no recurrence of AF/atrial tachycardias (P = 0.422). One patient in the NCB group suffered a periprocedural stroke with full recovery. There were no differences regarding hospitalizations during follow-up between the groups. PV reconnection observed during 12 repeat procedures (4 NCB, 8 SCB) pattern was comparable between the groups with more reconnections in the right-sided compared with the left-sided PVs.

Conclusion: In this multicentre study comparing two currently available cryoballoon ablation systems for PVI, no differences were observed in the efficacy and safety during a follow-up of 12 months.

Keywords: Cryoballoon ablation • Arctic Front • POLARx • Atrial fibrillation • Recurrence • Safety.