Background:
Pulsed field ablation (PFA) has emerged as a promising energy source for pulmonary vein isolation (PVI). The novel 3D-integrated variable loop circular PFA catheter allows for both mapping and ablation within a single device. While acute procedural outcomes have been shown to be safe and effective, follow-up data on rhythm outcomes and durability of PVI remain limited.
Objective:
To evaluate the clinical and electrophysiological outcomes at first follow-up after PVI using a 3D-integrated variable loop circular PFA catheter.
Methods:
Only patients undergoing first-time PVI with the novel 3D-integrated variable loop circular PFA catheter were included. Following the initial procedures with complete acute PVI in all patients and analysis of procedure-related adverse events, follow-up evaluation was performed after approximately three months, including clinical assessment, 12-lead ECG, and 24-hour Holter monitoring. Procedural data from the index ablation were included for correlation with clinical outcomes. Study endpoints included rhythm outcomes, recurrence of atrial arrhythmia, discontinuation of oral anticoagulation and procedure-related adverse events during follow-up.
Results:
A total of 50 patients (median age 67 years [25th–75th IQR 59.8–76.3 years]; 70% male, 54% paroxysmal AF) underwent PVI with the novel 3D-integrated variable loop circular PFA catheter. The mean CHA₂DS₂-VA score was 2.4 (IQR 1–4).The mean total procedure time including pre- and post-ablation mapping was 73,1 ± 16,2 min, mean fluoroscopy time 8.6 ± 3.5 min, and median left atrial dwell time 44 (IQR 36-51) min. Given the unique capability of the variable loop catheter to enable immediate remapping within the same procedure, applications were differentiated between initial ablation and additional applications performed after remapping to ensure complete vein isolation. The median number of initial applications was 18 (IQR 16.75–19), and an additional 2 (IQR 0–3) applications were delivered post-remap. At the time of analysis, 28 patients had completed the first follow-up. No procedure- or device-related complications occurred. Five patients (18%) could discontinue oral anticoagulation after confirmation of maintained sinus rhythm and a CHA₂DS₂-VA score of 0. Atrial arrhythmia recurrence was observed in five patients (18%) with a median time to recurrence of 38.5 days after the index procedure. One patient converted spontaneously, one underwent electrical cardioversion, two required repeat ablation for pulmonary vein reconnection, and in one case patient refused reablation of atrial fibrillation.
Conclusion:
The novel 3D-integrated variable loop circular PFA catheter demonstrated durable pulmonary vein isolation and favorable early rhythm outcomes without procedure- or device-related complications, highlighting its safety and clinical applicability.
