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

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.