Efficacy and safety of a novel cryoballoon ablation system: multicentre comparison of 1-year outcome
Sven Knecht, Christian Sticherling, Laurent Roten, Patrick Badertscher, Philipp Krisai, Laurève Chollet, Thomas Küffer, Florian Spies, Gian Völlmin, Antonio Madaffari, Aline Mühl, Samuel H. Baldinger, Helge Servatius, Hildegard Tanner, Stefan Osswald, Tobias Reichlin, Michael Kühne
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.