Background: Pulsed-field ablation (PFA) is a new energy source to perform pulmonary vein isolation (PVI) by targeted electroporation of cardiomyocytes. Integrated into a single-shot device, PFA has the potential to improve the efficacy and safety of PVI compared to thermal energy sources.

Aim: To assess feasibility, efficacy and safety of PFA for index PVI in a multi-center real world setting.

Methods: All consecutive patients with symptomatic paroxysmal or persistent atrial fibrillation (AF) underwent PVI using PFA (Farawave®, Farapulse Inc, Menlo Park, CA, USA) at the University Heart and Vascular Center UKE Hamburg and at the Herz- and Diabeteszentrum NRW, Bad Oeynhausen. The left atrium was accessed by a single transseptal puncture and PVs were located by selective PV angiographies. 3D voltage mapping of the left atrium was performed before and after PVI.

Results: A total of 102 patients (mean age 67±12 years, 64% male, 60% persistent AF, 86 from UKE) were included. PVI was achieved in all patients aiming for 8 PFA applications per vein by deploying 3379 applications in 405 PVs mean (8.4 per vein). PV signals disappeared after the first of eight applications in 403/405 PVs (99%). More than eight applications were required in 21 PVs due to difficulties in positioning (3x left superior PV, 6x right superior PV, 6x right inferior PV) or due to reconnection after remapping (2x LIPV, 3x RSPV, 1x RIPV). Mean procedure time was 81±23 minutes including pre- and post PVI high-density voltage mapping. PFA catheter left atrial dwell time was 26±10 min, with a reduction during the first 50 procedures from 40 to 24 min. Mean total fluoroscopy times were 17.3±6.7 and 9.5±5.2 min for LA PFA catheter fluoroscopy time. One pericardial tamponade and two minor groin complications, not related to the PFA catheter. No other complications occurred, especially no phrenic nerve palsy, stroke, hemoptysis, atrio-oesophageal fistula or acute symptomatic PV stenosis.

Conclusion: In this multi-center real world setting, PV isolation by pulsed-field ablation is effective, timely and not associated with of major complications.