Outcomes after cryoballoon ablation of paroxysmal atrial fibrillation with the PolarX or the Arctic Front Advance Pro: a prospective multicentre experience

• Published in: EP Europace
• Main Authors: Tanese, Nikita, Almorad, Alexandre, Pannone, Luigi, Defaye, Pascal, Jacob, Sophie, Kilani, Mouna, Ben, Chierchia, Gianbattista, Venier, Sandrine, Cardin, Christèle, Jacon, Peggy, Combes, Stéphane, Deschamps, Elodie, Menè, Roberto, de Asmundis, Carlo, Boveda, Serge
• Other Authors: Clinique Pasteur, Clinique Pasteur Toulouse, Hospital San Raffaele Scientific Institute, Hospital San Raffaele & University Vita-Salute Milano, Heart Rhythm Management Center, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universiteit Ziekenhuis, Vrije Universiteit Brussel (VUB), Arrythmia Departement University Hospital of Grenoble-Alpes and Grenoble Alpes University, Laboratoire d épidémiologie des rayonnements ionisants (IRSN/PSE-SANTE/SESANE/LEPID), Service de recherche sur les effets biologiques et Sanitaires des rayonnements ionisants (IRSN/PSE-SANTE/SESANE), Institut de Radioprotection et de Sûreté Nucléaire (IRSN)-Institut de Radioprotection et de Sûreté Nucléaire (IRSN), 2 Heart Rhythm Management Center, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universiteit Ziekenhuis, Vrije Universiteit Brussel (VUB), Heart Rhythm Management Department, Clinique Pasteur, Toulouse, France
• Format: Article in Journal/Newspaper
• Language: English
• Published: HAL CCSD 2023
• Subjects: Atrial fibrillation; Cryoballoon; Cryoablation; Atrial fibrillation ablation; Paroxysmal atrial fibrillation; [SDV]Life Sciences [q-bio]; Arctic; Meier
• Online Access: https://hal.science/hal-04286975; https://hal.science/hal-04286975/document; https://hal.science/hal-04286975/file/euad005.pdf; https://doi.org/10.1093/europace/euad005

International audience The aim of this study was to compare procedural efficacy and safety, including 1-year freedom from AF recurrence, between the novel cryoballoon system PolarX (Boston Scientific) and the Arctic Front Advance Pro (AFA-Pro) (Medtronic), in patients with paroxysmal AF undergoing PVI. Methods and results This multicentre prospective observational study included 267 consecutive patients undergoing a first cryoablation procedure for paroxysmal AF (137 PolarX, 130 AFA-Pro). Kaplan-Meier curves with the log-rank test was used to compare the 1year freedom from AF recurrence between both groups. Multivariate Cox model was performed to evaluate whether the type of procedure (PolarX vs. AFA-Pro) had an impact on the occurrence of AF recurrences after adjustment on potentially confounding factors. The PolarX reaches lower temperatures than the AFA-Pro (LSPV 52 ± 5, vs. 59 ± 6; LIPV 49 ± 6 vs. 56 ± 6; right superior pulmonary vein: 49 ± 6 vs. 57 ± 7; right inferior pulmonary vein: 52 ± 6 vs. 59 ± 6; P < 0.0001). A higher rate of transient phrenic nerve palsy was found in patients treated with the PolarX system (15% vs. 7%, P = 0.05). After a mean follow-up of 15 ± 5 months, 20 patients (15%) had recurrences in AFA-Pro group and 27 patients (19%) in PolarX group (P = 0.35). Based on survival analysis, no significant difference was observed between both groups with a 12-month free of recurrence survival of 91.2% (85.1-95.4%) vs. 83.7% (76.0%-89.1%) (log-rank test P = 0.11). In multivariate Cox model hazard ratio of recurrence for PolarX vs. AFA-Pro was not significant [HR = 1.6 (0.9-2.8), P = 0.12]. Conclusion PolarX and AFA-Pro have comparable efficacy and safety profiles for pulmonary veins isolation in paroxysmal atrial fibrillation.