Abstract 788 Safety, efficacy of two competing cryoballoon technologies for atrial fibrillation ablation: results of a multicenter study

Clin Res Cardiol (2021) DOI DOI https://doi.org/10.1007/s00392-021-01843-w
Safety, efficacy of two competing cryoballoon technologies for atrial fibrillation ablation: results of a multicenter study
A. Luik¹, A. Anic², A. Haas¹, 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; ³Department of Cardiology, University Medical Center Rotterdam, 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, efficacy and biophysical parameters of the novel POLARx system with the currently established 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. Follow-up was 30 days to rule out procedure related complications. 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. Procedure time and balloon in body time was longer (Procedure time: POLARx 81min vs. AFA 67min; p<0.001) in the POLARx group. 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), however, POLARx was associated with a lower balloon temperature at TTI (-46°C vs -37°C, P<0.001). No statistical difference were found concerning the safety parameters. Two phrenic nerve palsies occurred in each group. One patient in the POLARx group experienced a moderate left sided hemiparesis at the end of the procedure. CT and MRI imaging showed no pathological demarcations. The patient fully recovered without further treatment. Conclusion: The POLARx cryablation system is as effective as AFA. Although POLARx is associated with faster cooling rates and lower balloon temperatures than AFA, TTI was comparable between both systems.
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