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  • Open Access

22 February 2024

10 Pages

Early Clinical Outcomes and Advantages of a Novel-Size Adjustable Second-Generation Cryoballoon: A Proof-of-Concept Study

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1
Department of Clinical Electrophysiology & Cardiac Pacing, Centro Cardiologico Monzino IRCCS, 20138 Milan, Italy
2
Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy
3
Boston Scientific Italy, 20134 Milan, Italy
4
Department of Biomedical, Surgical and Dental Sciences, University of Milan, 20100 Milan, Italy

Abstract

(1) Background/Objective Balloon-guided catheter ablation (CA) has emerged as an alternative option for atrial fibrillation (AF) management. The recent introduction of a novel-size adjustable second-generation cryoballoon (CB) system offers innovations, but clinical outcomes remain unexplored. This study aims to assess the acute performance of the POLARx FIT™ CB system in AFCA. (2) Methods: Consecutive patients undergoing AF ablation with the POLARx FIT™ CB system in our center were included. The primary outcome was the rate of 31 mm balloon-size utilization, with secondary outcomes including acute pulmonary vein isolation (PVI) rate, periprocedural complications, and in-hospital AF recurrences. (3) Results: Twenty-four patients with a mean age of 59.5 years, predominantly male (87.5%), and exhibiting paroxysmal AF (91.7%) were enrolled. Procedural characteristics demonstrated a high acute success rate (100% PV isolation) with a favorable safety profile. Notably, the 31 mm CB configuration was utilized in 51% of applications, showcasing its adaptability in challenging anatomies. No major complications occurred, with two patients experiencing in-hospital self-limiting AF recurrences. (4) Conclusions: This study represents the first comprehensive assessment of the POLARx FIT™ CB system in AF ablation. While acknowledging the study’s limitations, this novel CB emerges as a promising tool, warranting further exploration in larger studies with extended follow-up periods.

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