Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w
Novel or established cryoballoon ablation system for pulmonary vein isolation: The prospective ICE-AGE-1 Study
C.-H. Heeger1, T. Inderhees1, N. Nussbickel1, M. Feher2, B. Kirstein1, H. L. Phan3, S. Hatahet2, J. Vogler1, C. Eitel1, A. Traub3, K.-H. Kuck4, R. R. Tilz1
1Klinik für Rhythmologie, Universitätsklinikum Schleswig-Holstein, Lübeck; 2Med. Klinik II / Kardiologie, Elektrophysiologie, Universitätsklinikum Schleswig-Holstein, Lübeck; 3Medizinische Klinik II / Kardiologie, Angiologie, Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Lübeck; 4Kardiologie, LANS Cardio Hamburg, Hamburg;

Background: Cryoballoon (CB) ablation provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome data. The novel POLARx CB incorporates unique features which may translate into improved safety, efficacy and outcome. The ICE-AGE 1 study aimed to assess efficacy, safety and one-year clinical follow-up of the POLARx CB in comparison to the Arctic Front Advanced Pro CB (AFA-pro).

Methods: A total of 103 consecutive patients with paroxysmal or persistent atrial fibrillation (AF) were prospectively enrolled, underwent POLARx based PVI (POLARx group) and were compared to 102 consecutive patients previously treated with the AFA-pro CB (AFA-pro group).

Results: The mean age was 68.7 ± 10.2 (POLARx) and 65.7 ± 12 (AFA-pro, p > 0.05) years. A total of 412 (POLARx) and 404 (AFA-pro) pulmonary veins (PV) were identified and all PVs were successfully isolated utilizing the POLARx and AFA-pro CB4, respectively. A significant difference in the mean minimal CB temperatures (-56 ± 8 °C (PolarX) vs.  -47 ± 10 °C (AFA-pro), p <0.01) was observed. Real-time PVI was visualized in 71% of POLARx patients and 46% of AFA-pro CB4 patients (p < 0.001). The mean procedure time was 55 ± 17 minutes (POLARx) vs. 59±19 minutes (AFA-pro CB4, p = 0.053). No differences were observed for periprocedural complications. One-year follow-up was available in 45 (POLARx) and 43 (AFA-pro) patients. The one-year arrhythmia recurrence free survival was comparable (POLARx: 36/45 patients (80 %) and AFA-pro CB4: 33/43 patients (77 %), p > 0.05).

Conclusions: The novel POLARx CB showed similar safety, efficacy and one year arrhythmia recurrence free survival compared to the AFA-pro CB. A higher rate of real-time electrical PV recordings and significantly lower balloon temperatures were observed using the POLARx as compared to AFA-pro CB4.

https://dgk.org/kongress_programme/jt2023/aP875.html