Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term follow-up in a multi-center real world scenario
Marc D. Lemoine, Thomas Fink, Celine Mencke, Ruben Schleberger, Ilaria My, Julius Obergassel, Leonard Bergau, Vanessa Sciacca, Laura Rottner, Julia Moser, Shinwan Kany, Fabian Moser, Paula Münkler, Leon Dinshaw, Paulus Kirchhof, Bruno Reißmann, Feifan Ouyang, Philipp Sommer, Christian Sohns, Andreas Rillig, Andreas Metzner
Abstract
Abstract Purpose Pulsed-field ablation (PFA) is a new energy source to achieve pulmonary vein isolation (PVI) by targeted electroporation of cardiomyocytes. Experimental and controlled clinical trial data suggest good efficacy of PFA-based PVI. We aimed to assess efficacy, safety and follow-up of PFA-based PVI in an early adopter routine care setting. Methods Consecutive patients with symptomatic paroxysmal or persistent atrial fibrillation (AF) underwent PVI using the Farawave® PFA ablation catheter in conjunction with three-dimensional mapping at two German high-volume ablation centers. PVI was achieved by applying 8 PFA applications in each PV. Results A total of 138 patients undergoing a first PVI (67 ± 12 years, 66% male, 62% persistent AF) were treated. PVI was achieved in all patients by deploying 4563 applications in 546 PVs (8.4 ± 1.0/PV). Disappearance of PV signals after the first application was demonstrated in 544/546 PVs (99.6%). More than eight PFA applications were performed in 29/546 PVs (6%) following adapted catheter positioning or due to reconnection as assessed during remapping. Mean procedure time was 78 ± 22 min including pre- and post PVI high-density voltage mapping. PFA catheter LA dwell-time was 23 ± 9 min. Total fluoroscopy time and dose area product were 16 ± 7 min and 505 [275;747] cGy*cm 2 . One pericardial tamponade (0.7%), one transient ST-elevation (0.7%) and three groin complications (2.2%) occurred. 1-year follow-up showed freedom of arrhythmia in 90% in patients with paroxysmal AF ( n = 47) and 60% in patients with persistent AF ( n = 82, p = 0.015). Conclusions PFA-based PVI is acutely highly effective and associated with a beneficial safety and low recurrence rate. Graphical abstract