Characterization of sedation strategies in real-world use of pulsed field ablation Sub-analysis of the EU-PORIA registry

Abstract Background With the introduction of pulsed field ablation (PFA) to treat atrial fibrillation (AF), there is interest in studying workflow and sedation strategies to optimize integration into clinical practice. This sub-analysis characterizes early real-world use of general anesthesia versus deep sedation during AF ablation using the pentaspline PFA catheter. Methods EU-PORIA is an all-comer AF registry enrolling consecutive patients at seven high-volume centers in Europe. Patients were treated based on institutional standard-of-care. During follow-up, any episode of atrial tachycardia (AT) or AF >30s was considered an arrhythmia recurrence. Results EU-PORIA enrolled 1233 patients, of which 250 (20%) and 983 (80%) cases were performed using general anesthesia and deep sedation, respectively. Patients treated with general anesthesia were more often male and non-paroxysmal AF. In the general anesthesia group, 72% received pulmonary vein isolation (PVI)-only versus 90% in the deep sedation group (p<0.01), and 3D mapping was used in 60% of general anesthesia and 27% of deep sedation cases (p<0.01). Procedure and fluoroscopy times were shorter with deep sedation (51[36-84] vs 75[60-90] min; 13[8-19] vs 19[15-26] min; p<0.01). There were no differences in the incidence of serious adverse events. At 1-year follow-up, 74.8% and 73.8% of patients in the general anesthesia and deep sedation groups, respectively, were free from recurrent AF/AT (p=0.87). Conclusion AF ablation using deep sedation with the pentaspline PFA catheter demonstrated a safety and efficacy profile consistent with procedures performed under general anesthesia. This characterization of real-world use warrants further evaluation to understand optimal sedation strategies with PFA technologies.