Safety and efficacy of pulmonary vein isolation using pulsed field ablation with or without 3D mapping system for paroxysmal atrial fibrillation

FUNDING ACKNOWLEDGEMENTS: Type of funding sources: None. BACKGROUND: Pulsed field ablation (PFA) has recently been introduced as a novel routine ablation technology for paroxysmal atrial fibrillation (PAF). PFA can be performed "cryo-style" using fluoroscopy only, or additional pre- and post-ablation high-density 3D bipolar voltage maps can be performed to assess lesion formation and acute pulmonary vein isolation. We compared 6-month outcome after PFA using fluoroscopy only (X-ray) vs. PFA guided by 3D mapping (3D). METHODS: In PAF patients, PVI in conscious sedation using a steerable sheath and a pentaspline over-the-wire basket and flower PFA catheter was performed. In a subset of patients, pre- and post-ablation high-density bipolar voltage 3D maps (Carto 3D) were performed. Procedural parameters, acute success, in-hospital safety and arrhythmia recurrence were assessed over 6-month follow-up. Efficacy was evaluated by freedom from a ≥ 30-sec. recurrence of AF/atrial flutter (AFL)/atrial tachycardia (AT). Follow-up included 7-day Holter ECGs and/or telephonic interviews at days 90 and 180 after ablation. RESULTS: This study included a total of 101 patients (mean age: 65±10 years; 42% female) in whom 6-month follow-up data were available. There were no selection criteria for the use of 3D mapping. Pre- and post-ablation high-density maps were performed in 34/101 (34%) of patients. Mean CHA2DS2-VASc-score was 2,1±1,6. Median duration since first AF diagnosis was 21 [3-60] months. Skin-to skin procedure time was 56±20 in the X-ray group vs. 118±22 min in the 3D group, respectively (p<0,0001). Fluoroscopy time was 17±7 in the X-ray group vs. 21±6 in the 3D group, respectively (p<0,01). Acute pulmonary vein isolation rate was 100% in both groups. Primary adverse events occurred in 0% of patients in the X-ray group vs. 2/34 (6%) in the 3D group (2 pericardial tamponades), respectively (p=ns). During a mean follow-up of 204±82 days, 54/67 (81%) in the X-ray group vs. 27/34 (79%) in the 3D group remained free of any symptomatic or documented AF/AFL/AT episode after a single procedure (p=ns). In 4/13 (31%) patients in the X-ray group, a re-do procedure was performed, 2 patients had durable PVI with typical or atypical atrial flutter, 1 patient had reconnection of both posterior carinae and 1 patient had typical atrial flutter degenerating in AF. In 3/7 (43%) patients in the 3D group, a re-do procedure was performed, 2 patients had durable PVI with typical or atypical atrial flutter and 1 patient had reconnection of the LIPV. CONCLUSIONS: PVI using PFA with or without 3D mapping system resulted in a similar 6-month atrial arrhythmia recurrence rate and safety profile. Procedure and fluoroscopy times were significantly shorter in the fluoroscopy only group.