Background/Objectives: Single-shot devices are important tools for efficient pulmonary vein isolation (PVI) in atrial fibrillation (AF). In addition to the standard cryo-balloon (CB) catheter, a novel multi-electrode radiofrequency balloon-catheter (RFB, Heliostar, Biosense Webster, Irvine, CA, USA) with 3D-mapping-integration is available. Currently, there is no evidence allowing for a direct comparison between RFB-PVI and CB-PVI in a matched population. The study aimed to assess the procedural data, safety profiles, and outcomes of RFB-PVI versus CB-PVI. Methods: In this prospective registry study, symptomatic AF patients undergoing first-time PVI from January 2019 to April 2023, using RFB or CB, were included, with patients matched in a 1:2 ratio to reduce potential confounders. Results: The results from 171 consecutive RFB patients and 342 matched CB patients showed comparable recurrence-free survival after 12 months (81.3% RFB vs. 76.8% CB, p = 0.359). The RFB group had a longer procedure duration (88 vs. 73 min, p < 0.001) and longer fluoroscopy time (18.9 vs. 14.5 min, p < 0.001). Conclusions: In conclusion, the novel RFB system enables efficient and safe PVI, which is broadly comparable to the established CB system. However, the 3D-mapping integration in RFB did not reduce fluoroscopy time compared to CB.
Keywords: atrial fibrillation; cryo-balloon; pulmonary vein isolation; radiofrequency balloon; single-shot device.