TY - JOUR
T1 - Pulsed-field ablation-based pulmonary vein isolation
T2 - acute safety, efficacy and short-term follow-up in a multi-center real world scenario
AU - Lemoine, Marc D.
AU - Fink, Thomas
AU - Mencke, Celine
AU - Schleberger, Ruben
AU - My, Ilaria
AU - Obergassel, Julius
AU - Bergau, Leonard
AU - Sciacca, Vanessa
AU - Rottner, Laura
AU - Moser, Julia
AU - Kany, Shinwan
AU - Moser, Fabian
AU - Münkler, Paula
AU - Dinshaw, Leon
AU - Kirchhof, Paulus
AU - Reissmann, Bruno
AU - Ouyang, Feifan
AU - Sommer, Philipp
AU - Sohns, Christian
AU - Rillig, Andreas
AU - Metzner, Andreas
PY - 2023/6
Y1 - 2023/6
N2 - 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*cm2. 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:
AB - 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*cm2. 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:
KW - Prospective observational study, real-world
KW - Pulmonary vein isolation
KW - Catheter ablation
KW - Atrial fibrillation
KW - Pulsed-field ablation
U2 - 10.1007/s00392-022-02091-2
DO - 10.1007/s00392-022-02091-2
M3 - Article
SN - 1861-0684
VL - 112
SP - 795
EP - 806
JO - Clinical Research in Cardiology
JF - Clinical Research in Cardiology
IS - 6
ER -