Methods, efficacy and safety on routine clinical use of pulsed field ablation for pulmonary vein isolation in patients with 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 (AF). It is also used as off-label therapy for persistent AF. Only a few small clinical studies have been published on the mid- and long-term outcome. We present data on methods, efficacy and safety on routine clinical use of pulsed field ablation for pulmonary vein isolation in patients with atrial fibrillation. METHODS: In patients with AF, 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 using a pentaspline diagnostic catheter were performed. Procedural parameters, acute success and in-hospital safety were assessed. RESULTS: A total of 5 operators treated 304 patients (mean age 67 years (range 32-85), female 42%, mean BMI 28 kg/m2 (range 20-42), mean CHA2DS2-VaSc score of 2 (range 0-7), first-time ablation 100%, paroxysmal/persistent/longstanding persistent AF 47/17/36%, respectively. Mean duration since first AF diagnosis was 79 months (range 0-332). Most procedures were performed under deep conscious sedation using propofol and midazolam, without intubation (99%). Pre- and post-ablation high-density maps were performed in 27% of cases. Mean procedure time was 75 min. (range 23–245). Mean left atrial dwell time of the PFA catheter was 25 min. (range 8-98). Fluoroscopy time and dose area product were 18 min. (range 6-50) and 5,74 Gy.cm2 (range 0,40-36,50), respectively. Pulmonary vein isolation (PVI) was successful in 100%. There were no phrenic nerve palsies or esophageal complications. Major complications (2,6%) were pericardial tamponade (2,0%) and stroke (0,7%); one of these strokes was lethal (0,3%). Minor complications (1,0%) were vascular access related (0,7%) and transient ischemic attack (TIA) (0,3%). CONCLUSIONS: In a large, single center cohort of unselected patients, initial experience with de novo PFA for PVI in patients with AF seems to be fast and effective. There were no PFA-specific complications, but the frequency of catheter complications (tamponade, stroke) in this relatively old patient population with a relatively long history of AF demonstrates that there is still room for improvement. The number of complications improved significantly over the course of time, indicating that the learning curve could have negatively influenced the incidence of complications.