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 (Carto 3D) were performed. Procedural parameters, acute success and in-hospital safety were assessed. 

Results:

A total of 4 operators treated 218 patients (mean age 66 years (range 35–86), female 43%, mean BMI 28 kg/m2 (range 20-42), mean CHA2DS2-VaSc score of 2,5 (range 0-7), first-time ablation 93%, paroxysmal AF/persistent AF/re-do 72/21/7%). Mean duration since first AF diagnosis was 42 months (range 1-336). Most procedures were performed under deep conscious sedation without intubation (99%). Pre- and post-ablation high-density maps were performed in 28% of cases. Mean procedure time was 59 min. (range 23–245). Mean left atrial dwell time of the PFA catheter was 44 min. (range 19-237). Fluoroscopy time and dose area product were 17 min. (range 6-49) and 4,11 Gy.cm2 (range 0,40-36,05), respectively. Pulmonary vein isolation (PVI) was successful in 100%. There were no phrenic nerve palsies or esophageal complications. Major complications (3,7%) were pericardial tamponade (2,8%) and stroke (0,9%); one stroke resulted in death (0,5%). Minor complications (1,4%) were vascular (0,5%) and transient ischemic attack (TIA) (0,9%).

Conclusions:

In a large, single center cohort of unselected patients, 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 demonstrates that there is still room for improvement.