Abstract 1162 Cryo-Balloon Ablation for the Treatment of Atrial Fibrillation: 12 month follow up results of a Multicenter Study

Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5
Cryo-Balloon Ablation for the Treatment of Atrial Fibrillation: 12 month follow up results of a Multicenter Study
A. Luik¹, A. Anic², A. Haas¹, K. Schmidt¹, S.-C. Yap³
¹Med. IV, Schwerpunkt Kardiologie, Angiologie und Internistische Intensivmedizin, Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe; ²Department of Cardiology, Clinical Hospital Center Split, Split, HR; ³Thoraxcenter, Department of Experimental Echocardiographie, Erasmus MC, Rotterdam, NL;
Background: Recently a novel cryo balloon system (POLARx, Boston Scientific) became available for the treatment of atrial fibrillation (AF). This cryo balloon has a similar size as the 28-mm Arctic Front Advance Pro (AFA, Medtronic) but keeps constant pressure and remains stable in size. Aim: The aim of this study was to compare safety and efficacy of the novel POLARx system versus the third-generation Arctic Front Advance Pro system (AFA, Medtronic). Methods: This is a multicenter study including consecutive patients from three experienced European Centers who underwent first-time cryo balloon pulmonary vein isolation (PVI). Endpoint of the study was procedural safety and efficacy. Six- and twelve-months outcomes were evaluated. Results: 110 patients (POLARx n=57, AFA n=53) were included. There were no differences between groups with regard to age, sex, type of AF, and left atrial dimension. A total of 422 PVs were targeted (POLARx n=216, AFA n=206). Isolation of the PVs could be obtained in 99,5% and 100% with POLARx and AFA, respectively. Although procedure time and balloon in body time was a bit longer (Procedure time: POLARx 81min vs. AFA 67min; p<0.001) due to a short learning curve, other procedure-related variables, including the median number of CBA per patient, fluoroscopy time, radiation dose and additional CTI ablation were similar between groups. Cryoablation with POLARx was associated with shorter time to balloon temperature -30°C (27 seconds vs 31 seconds, P<0.001), lower balloon nadir temperature (-55°C vs -47°C, P<0.001), and longer thawing time till 0°C (16 seconds vs 9 seconds, P<0.001). There were no differences in time to isolation (TTI) (POLARx: 45 seconds vs AFA: 42 seconds, P=0.207), No statistical differences were found concerning the safety parameters. The six-month follow up showed no statistical difference between groups. Twelve-month follow-up is completed in 60% of the cohort. Up to date no statistical difference has been detected between groups. The full follow-up will be available at the DGK annual congress Conclusion: The POLARx cryoablation system is as effective and safe for pulmonary vein isolation in patients with atrial fibrillation. No differences in twelve-month outcomes have been shown between POLARx and AFA.
https://dgk.org/kongress_programme/jt2022/aP1158.html