Is pulmonary vein isolation using pulse field ablation safe and efficient ? data from a prospective registry

FUNDING ACKNOWLEDGEMENTS: Type of funding sources: None. BACKGROUND: Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. Real-life clinical data are still limited regarding safety and efficacy of PFA. PURPOSE: To assess safety and mid-term efficacy of PVI performed using PFA. METHODS: We included all patients who underwent PVI for symptomatic atrial fibrillation (AF) using PFA in our hospital between June 2021 and June 2022. All procedures were performed under general anaesthesia. After patients received IV heparin and achieved ACT > 300 s, a 12 Fr multi-electrode pentaspline PFA catheter was advanced through a 13 Fr deflectable sheath into the left atrium. The catheter was positioned so that the splines achieved circumferential contact at the PV antra. Two applications (2.5 sec and 2 kV per application) were performed in "basket" configuration, then the catheter was slightly rotated (30-40°) before delivery of 2 additional applications. This sequence of ablation was repeated in "flower" configuration. This protocol was applied at each pulmonary vein. PVI was assessed with the PFA catheter. A 24-hour holter monitoring was performed at 4-month and one-year follow-up. RESULTS: The population consisted of 102 patients (73 paroxysmal AF, 29 persistent AF) with a mean age of 56 ± 13 yo. The mean procedure duration was 38 ± 9 min, and mean fluoroscopy duration was 8 ± 4 min (4 ± 4.2 Gy.cm2). The pulmonary vein signal completely disappeared after the first PFA application for each targeted vein and PVI was confirmed for all veins in all patients at the end of the procedure. Pericardial effusion requiring percutaneous drainage occurred in 1 patient during the early phase of our experience (patient n°8). There was no other complication. At 4-month follow-up, 91/102 patients (89%) were asymptomatic with no recurrence of AF. At one-year follow-up, 34/38 patients (89%) had no reccurence of documented atrial arrhythmia. 6 patients underwent a redo procedure : pulmonary vein reconnection was observed in 4/6. CONCLUSION: PVI performed with PFA appeared safe and efficient with short procedure and acceptable fluoroscopy durations. Further data are required regarding long-term efficacy. [Figure: see text]