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

Abstract Background/Introduction With the introduction of pulsed field ablation (PFA) to treat patients with atrial fibrillation (AF), there has been interest in studying workflow and sedation strategies to better understand how this new technology can be integrated into clinical practice. Purpose Characterize the use of general anesthesia (GA) versus deep sedation during real-world use of the pentaspline PFA catheter to treat AF. Methods EU-PORIA is an all-comer AF registry enrolling consecutive patients treated with the pentaspline PFA catheter 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 lasting longer than 30 seconds was considered an arrhythmia recurrence. Results EU-PORIA enrolled 1233 patients, of which 250 ablation cases were performed under GA and 983 cases were performed with deep sedation. Six out of the 7 participating centers employed a single sedation strategy (2 GA; 4 deep sedation), with one center doing a mix of both sedation and GA. The patient population treated with GA had fewer female patients (30% vs 40%; p=0.04), a lower prevalence of hypertension (43% vs 57%; p<0.01), and fewer paroxysmal AF patients (54% vs 62%; p<0.01). The ablation strategy was performed based on operator’s discretion. In the GA group, 72% of patients received a pulmonary vein isolation (PVI)-only ablation approach versus 90% of patients in the sedation group (p<0.01). The most common additional lesion set performed was posterior wall isolation which accounted for 23% and 7% of cases in the GA and sedation groups, respectively (p<0.01). Procedure times and fluoroscopy times were significantly shorter in the sedation group versus the GA group (51 [36-84] min vs 75[60-90] min; 13 [8-19] min vs 19 [15-26] min; p<0.01 for both). Mapping was used in 60% of cases in the GA group versus only 26% of cases in the sedation group. Overall, there were no differences in the incidence of serious adverse events, and no difference in chronic treatment success. At 1-year follow-up, 74.8% of patients (187/250) in the GA group and 73.8% of patients (725/983) in the sedation group were free from recurrent AF/AT. Conclusion(s) In this registry, the use of deep sedation for AF ablation with the pentaspline PFA catheter demonstrated a safety and efficacy profile consistent with those procedures performed under GA. The majority of the deep sedation procedures were PVI-only and performed in a less progressed AF disease state. It is worth noting that there may be certain patient populations and center restrictions where GA will remain the necessary approach for AF ablation. This characterization of real-world use warrants further evaluation to understand optimal sedation strategies that can be used with PFA technologies.