DGK Herztage 2025. Clin Res Cardiol (2025). https://doi.org/10.1007/s00392-025-02737-x
1Universitätsklinikum Essen Klinik für Kardiologie und Angiologie Essen, Deutschland
Background:
Pulsed field ablation (PFA) is increasingly used for first pulmonary vein isolation (PVI).
Up to now, single-shot devices lack the possibility to perform a 3D electroanatomical map before of after PVI. A novel 3D-mapping integrated PFA system with a variable-loop circular catheter, which combines 3D-mapping and PFA within one device, has recently been introduced.
Objective:
To evaluate the initial clinical experience with a 3D-integrated variable-loop circular PFA catheter.
Methods:
All patients underwent PVI using the novel 3D-integrated variable-loop circular PFA catheter. Procedures were performed under deep sedation using Midazolam, Propofol and Fentanyl. After left atrial access a 3D-map was created, followed by PVI using the PFA system with at least 4 applications per vein. After ablation, PVI was confirmed by a 3D-map. Study endpoints included acute pulmonary vein isolation, total procedure time, fluoroscopy time and dose and the rate of primary serious adverse events within 7 days.
Results:
A total of 24 patients (median age 70.5 years [25th-75th interquartile (IQR) 60–77 years]; 65% male, 50% paroxysmal AF) underwent PVI with the novel 3D-integrated variable-loop circular PFA catheter. The median CHA2DS2-VA score was 3 (IQR: 1–4).
Total procedure time including pre- and post-ablation mapping was 71 ± 16 min. Mean fluoroscopy time and mean fluoroscopy dose was 8.4 ± 3.6 min and 789 ± 658 µGym², respectively. The mean left atrial dwell time was 49 ± 10 min. Mapping time before PFA was 11 ± 6 min and after PFA 10 ± 6 min. An average of 18 ± 2 PFA applications were delivered per patient, with 4.6 ± 0.8, 4.4 ± 0.6, 4.8 ± 1.1, and 4.4 ± 0.6 applications per left superior PV, left inferior PV, right superior PV, and right inferior PV, respectively. Acute effectiveness was achieved in 100% (96/96) of treated pulmonary veins.
No primary serious adverse events, such as deaths, clinical strokes, phrenic nerve injury, clinical coronary artery spasm or renal failure, occurred.
Conclusion:
The novel 3D-integrated variable-loop circular pulsed field ablation catheter is safe and effective for PVI. Through its 3D-integrated mapping it offers several potential advantages over the currently available PFA systems.