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. 2023 Jul 4;25(7):euad185.
doi: 10.1093/europace/euad185.

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

Boris Schmidt  1   2 , Stefano Bordignon  1 , Kars Neven  3   4 , Tobias Reichlin  5 , Yuri Blaauw  6 , Jim Hansen  7 , Raquel Adelino  8 , Alexandre Ouss  9 , Anna Füting  3   4 , Laurent Roten  5 , Bart A Mulder  6 , Martin H Ruwald  7 , Roberto Mené  8 , Pepijn van der Voort  9 , Nico Reinsch  3   4 , Thomas Kueffer  5 , Serge Boveda  8 , Elizabeth M Albrecht  10 , Christopher W Schneider  10 , Kyoung Ryul Julian Chun  1
Affiliations

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

Boris Schmidt et al. Europace. .

Abstract

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

Methods and results: All-comer AF patients from seven high-volume centres were consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analysed by operator ablation experience and primary ablation modality. In total, 1233 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 (interquartile range: 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 ischaemic attack or stroke (n = 7; 0.6%), of which one was fatal. Prior cryoballoon users had less complication. 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.

Keywords: Ablation; Atrial fibrillation; Electroporation; Pulsed field ablation.

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Conflict of interest statement

Conflict of interest: B.S. is a consultant for and has received honoraria as well as research funding from Abbott, Medtronic, Boston Scientific, and Biosense Webster. S.B. has received honoraria from Medtronic and Biosense Webster. K.R.J.C. is a consultant for and has received honoraria as well as research funding from Abbott, Medtronic, Boston Scientific, and Biosense Webster. S.B. is consultant for Medtronic, Boston Scientific, Microport, and Zoll. R.A.: none. R.M.: none. T.R. has received research grants from the Goldschmidt-Jacobson Foundation, the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel support fund, all for work outside the submitted study. He has received speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense-Webster, Biotronik, Boston-Scientific, Daiichi Sankyo, Farapulse, Medtronic, and Pfizer-BMS, all for work outside the submitted study. He has received support for his institution’s fellowship program from Abbott/SJM, Biosense-Webster, Biotronik, Boston-Scientific, and Medtronic for work outside the submitted study. L.R. received research grants from Medtronic and speaker/consulting honoraria from Abbott and Medtronic. T.K.: none. K.N. is a consultant for Biosense Webster, Boston Scientific, Field Medical, and LifeTech Scientific. A.F.: educational grant from Boston Scientific. N.R.: consultant for Boston Scientific. J.H.: speakers fees from Boston Scientific and Biosense Webster. M.H.R.: none. A.O.: none. P.v.d.V.: none. Y.B. has received research grants from Medtronic and Atricure. He has received speaker/consulting honoraria from Abbott/SJM and Boston-Scientific, all for work outside the submitted study. B.A.M.: none. C.W.S. and E.M.A.: salaried employees of Boston Scientific.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Overview of EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation (EU-PORIA) patients and distribution per centre and per operator. (A) Enrolment per centre. (B) Catheter ablation procedures per operator. (C) Operator experience and primary ablation modality.
Figure 2
Figure 2
Kaplan–Meier curve of atrial fibrillation (AF)/atrial tachycardia (AT)-free survival for (A) all patients and (B) patients who underwent an index pulsed field ablation (PFA) procedure.
Figure 3
Figure 3
Kaplan–Meier curves of atrial fibrillation (AF)/atrial tachycardia (AT)-free survival in patients who underwent an index pulsed field ablation (PFA) procedure by (A) operator experience and (B) operator ablation primary modality.
See this image and copyright information in PMC

Comment in

References

    1. Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol 2014;6:213–20. - PMC - PubMed
    1. Meyre P, Blum S, Berger S, Aeschbacher S, Schoepfer H, Briel Met al. Risk of hospital admissions in patients with atrial fibrillation: a systematic review and meta-analysis. Can J Cardiol 2019;35:1332–43. - PubMed
    1. Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne Jet al. Cryoablation or drug therapy for initial treatment of atrial fibrillation. N Engl J Med 2021;384:305–15. - PubMed
    1. Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan Aet al. Early rhythm-control therapy in patients with atrial fibrillation. N Engl J Med 2020;383:1305–16. - PubMed
    1. Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani Set al. Cryoballoon ablation as initial therapy for atrial fibrillation. N Engl J Med 2021;384:316–24. - PubMed

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