Differences in acute outcomes and complications of pulmonary vein isolation using pulsed field ablation with or without 3D mapping system for paroxysmal atrial fibrillation

Abstract

Abstract 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). It is also used as off-label therapy for persistent AF. 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 acute outcome after PFA using fluoroscopy only (X-ray) vs. PFA guided by 3D mapping (3D). 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%). There were no selection criteria for the use of 3D mapping. Pre- and post-ablation high-density maps were performed in 28% of cases. Skin-to skin procedure time was 54±22 in the X-ray group vs. 123±35 min in the 3D group, respectively (p<0,0001). Fluoroscopy time was 17±7 in the X-ray group vs. 20±6 in the 3D group, respectively (p<0,01). Acute pulmonary vein isolation rate was 100% in both groups. 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%). They occurred in 3,2% of patients in the X-ray group (3 pericardial tamponades, 2 strokes) vs. 4,8% in the 3D group (3 pericardial tamponades), respectively (p=ns). 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, PVI using PFA with or without 3D mapping system resulted in a similar acute outcome and safety profile. Procedure and fluoroscopy times were significantly shorter in the fluoroscopy only group. There were no PFA-specific complications, but the frequency of catheter complications in this relatively old patient population demonstrates that there is still room for improvement.