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Cryoballoon atrial fibrillation ablation: Single‐center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform
Author(s) -
Kochi Adriano N.,
Moltrasio Massimo,
Tundo Fabrizio,
Riva Stefania,
Ascione Ciro,
Dessanai Maria A.,
Pizzamiglio Francesca,
Vettor Giulia,
Cellucci Selene,
Gasperetti Alessio,
Tondo Claudio,
Fassini Gaetano
Publication year - 2021
Publication title -
journal of cardiovascular electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 1045-3873
DOI - 10.1111/jce.14930
Subject(s) - medicine , cryoablation , pulmonary vein , atrial fibrillation , single center , ablation , balloon , cohort , catheter ablation , cardiology , surgery
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 Seventy patients were analyzed, 20 in POLARx™, and 50 in the AFAP group. They all underwent first‐time pulmonary vein isolation, 77% were male, 94% had paroxysmal AF, median age was 62.5 years, median CHA 2 DS 2 ‐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.