EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation - Lessons from the multicenter EU-PORIA Registry.

BACKGROUND AND AIMS

Pulsed field ablation (PFA) is a new, non-thermal ablation modality for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). The multi-center EU-PORIA (EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation) registry sought to determine the safety, efficacy, and learning curve characteristics for the pentaspline, multielectrode PFA catheter.

METHODS

All-comer AF patients from seven high-volume centers were consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analyzed by operator ablation experience and primary ablation modality.

RESULTS

In total, 1,233 patients (61% male, mean age 66±11years, 60% paroxysmal AF) were treated by 42 operators. In 169 patients (14%), additional lesions outside the PVs were performed, most commonly at the posterior wall (n=127). Median procedure and fluoroscopy times were 58 [IQR: 40-87] and 14 [9-21] min, respectively, with no differences due to operator experience. Major complications occurred in 21/1233 procedures (1.7%) including pericardial tamponade (14; 1.1%) and transient ischemic attack or stroke (n=7; 0.6%), of which one was fatal. Prior cryo-balloon users had less complications. At a median follow-up of 365 [323-386] days, the Kaplan-Meier estimate of arrhythmia-free survival was 74% (80% for paroxysmal and 66% for persistent AF). Freedom from arrhythmia was not influenced by operator experience. In 149 (12%) patients a repeat procedure was performed due to AF recurrence and 418/584 (72%) PVs were durably isolated.

CONCLUSION

The EU-PORIA registry demonstrates a high single-procedure success rate with an excellent safety profile and short procedure times in a real-world, all-comer AF patient population.