Cryoballoon atrial fibrillation ablation: Single‐center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform
Adriano Nunes Kochi, Massimo Moltrasio, Fabrizio Tundo, Stefania Riva, Ciro Ascione, Maria Antonietta Dessanai, Francesca Pizzamiglio, Giulia Vettor, Selene Cellucci, Alessio Gasperetti, Claudio Tondo, Gaetano Fassini
Abstract
INTRODUCTION: Catheter ablation is superior to drugs regarding atrial fibrillation (AF) recurrence, symptoms improvement, and mortality reduction in heart failure. POLARx™ is a novel cryoballoon, with technical improvements seeking to improve outcomes. So far, its clinical evidence is restricted to a case report. METHODS: To compare the POLARx™ cryoballoon procedural safety and efficacy to the already established Arctic Front Advance PRO™ (AFAP) in a single-center cohort study, consecutive patients undergoing AF cryoablation with the POLARx™ were enrolled. Data were prospectively gathered. POLARx™ patients were compared with a historical cohort of patients submitted to AF cryoablation with the AFAP. RESULTS: -VASc 1, left-atrium size 34 ml/m², and 65% were receiving anticoagulation. The primary end-point, all pulmonary veins isolation, was 100% in both groups. The complication rate was similar (0% POLARx™ vs. 5.7% AFAP, p = .39). The median total procedural time was longer in the POLARx™ group (90 min vs. 60 min, p < .001), but the overall time-to-isolation (TTI; 44.8 s vs. 39 s, p = .253) and ablation time (15 min vs. 13.7 min, p = .122) was similar between POLARx™ and AFAP groups, respectively. Despite equal TTI, the POLARx™ had a lower minimal temperature reached (-57°C vs -47°C, p < .001). CONCLUSION: The novel POLARx™ cryoballoon had similar efficacy and safety compared with the AFAP. It was also associated with longer procedural times, similar TTI, and lower minimum temperature reached.