1Agaplesion Markus Krankenhaus Medizinische Klinik III - CCB Frankfurt am Main, Deutschland
Background: The cryoballoon (CB) has evolved into a well-established technology for achieving pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).
Purpose: This study evaluates the procedural data of the novel size-adjustable CB, POLARx Fit using the 31mm diameter for the first application.
Methods: Symptomatic AF patients (paroxysmal/persistent AF) who underwent CB-based PVI with the POLARx FIT CB were enrolled, and procedural data were analyzed. The first application with the POLARX Fit CB employed a 31mm balloon diameter, while additional applications were delivered using the 28mm diameter. All procedures adhered to a 4-minute freeze protocol, with a bonus freeze delivery in cases of time-to-isolation (TTI) exceeding 75 seconds. Conscious sedation was administered, and the procedural endpoint was electrical pulmonary vein isolation.
Results: A total of 70 patients were enrolled, with an average age of 69 ± 11 years. The majority of patients were male (72.9%), and the left atrial diameter was 41 ± 6 mm. Paroxysmal AF was present in 54.3% of cases. Procedure time averaged 48 ± 14 minutes, and fluoroscopy time was 7 ± 3 minutes. All 275 identified veins were successfully isolated using solely the CB. The complication rate was low (1.4%), with one persistent phrenic nerve palsy. Additionally, 12 transient phrenic nerve injuries were observed, all resolving before discharge. The real-time PVI rate was 85.3%, and the single-shot isolation rate was 86%, with a time to sustained block of 45 ± 27 seconds.
Conclusion: The 31mm strategy with the POLARx Fit CB demonstrated high effectiveness with low complication rates and achieved high rates of single-shot PVIs.