Cryoballoon Pulmonray vein isolation using a 31mm strategy with the novel size-adjustable cryoballoon

Lukas Urbanek (Frankfurt am Main)1, S. Bordignon (Frankfurt am Main)1, D. Schaack (Frankfurt am Main)1, S. Tohoku (Frankfurt am Main)1, J. Hirokami (Frankfurt am Main)1, S. Chen (Frankfurt am Main)1, K. Plank (Frankfurt am Main)1, B. Schmidt (Frankfurt am Main)1, K. R. J. Chun (Frankfurt am Main)1

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.

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