EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atRIAl fibrillation: lessons from the multi-centre EU-PORIA registry

Abstract

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.

Early recurrences predict late therapy failure after pulsed field ablation of atrial fibrillation

“…Over a median follow‐up of 367 days (IQR: 253–400), overall freedom from AF/AT recurrence after BP was 74.2%, 81.8% for PAF, and 64.8% for persAF. Our findings can be considered in line to what previously published: The recently published EU‐PORIA registry showed a 74% success rate at 1 year in a larger cohort of 1233 patients 15 . However, Reddy et al 5 recorded a higher success rate of 87% at one1 year, but in younger patients compared to our cohort.…”

“…The promised preferential tissue ablation with no esophageal lesions or phrenic nerve palsies was confirmed in our study collective. Similar results were reported in the multinational MANIFEST‐PF survey including 1758 patients and the EU‐PORIA registry including 1233 patients 11,15 . Interestingly, the latter study found less cardiac tamponades in operators with single shot device ablation experience 15 .…”

“…Our findings can be considered in line to what previously published: The recently published EU-PORIA registry showed a 74% success rate at 1 year in a larger cohort of 1233 patients. 15 However, Reddy et al 5 recorded a higher success rate of 87% at one1 year, but in younger patients compared to our cohort. Compared with the traditional thermal ablation technologies, the present results show a similar success rate of this newly introduced energy form for PVI.…”

“…Similar results were reported in the multinational MANIFEST-PF survey including 1758 patients and the EU-PORIA registry including 1233 patients. 11,15 Interestingly, the latter study found less cardiac tamponades in operators with single shot device ablation experience. 15 Detailed discussion of main complications can be found in the "5-S-Study" by Schmidt et al 8…”

“…11,15 Interestingly, the latter study found less cardiac tamponades in operators with single shot device ablation experience. 15 Detailed discussion of main complications can be found in the "5-S-Study" by Schmidt et al 8…”