Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry
Lucas V.A. Boersma, Gábor Széplaki, Antonio Dello Russo, Ignacio García‐Bolao, Michael Efremidis, Nándor Szegedi, Stephan Willems, Haris M. Haqqani, Estelle Gandjbakhch, Francesco Solimene, George Andrikopoulos, Martin Fiala, Pascal Defaye, Armin Luik, Patrick Lugenbiel, Lars Eckardt, Alexandre Ouss, J. Herzet, Javier Ramos Maqueda, Sélim Abbey, Joaquín Osca, Azlan Hussin, N Cielen, Madeline Johnson, Elizabeth M. Albrecht, Brad Sutton, Johan Vijgen
Abstract
AIMS: Clinical studies with protocol-mandated workflow and monitoring have analysed performance of pulsed field ablation (PFA) for treating atrial fibrillation (AF). The FARADISE registry captures global use of the pentaspline PFA catheter in real-world clinical practice with a follow-up of 3 years. METHODS AND RESULTS: FARADISE is a prospective, non-randomized, multi-national registry (NCT05501873) that enrolled subjects clinically indicated for ablation using the pentaspline PFA catheter per medical judgement and hospital standard-of-care. Procedural characteristics, safety, and clinical effectiveness up to 12-months were collected. In total, 1158 AF patients received PFA across 48 centres in 21 countries (64 ± 11 years, 33% female, 90% de novo, 65% paroxysmal AF). Pulmonary vein isolation (PVI)-only procedures were performed in 80.8% of paroxysmal vs. 57.5% for non-paroxysmal patients (P < 0.01). Median procedure, left atrial dwell, and fluoroscopy times were 51[40-70], 31[24-41], and 12[8-17] min, respectively. The rate of early onset serious adverse events was 1.5% and did not differ by ablation strategy or AF indication. At 1-year, clinical effectiveness was 80.8% for paroxysmal AF and 67.7% for non-paroxysmal AF, with no difference within indication by lesion set (paroxysmal: 81.2% PVI-only vs. 79.0% PVI+, P = 0.65; non-paroxysmal: 67.5% PVI-only vs. 67.7% PVI+, P = 0.79). Acute results reinforce a short procedural learning curve with no difference in 1-year effectiveness by operator experience. CONCLUSION: The FARADISE registry provides a snapshot of real-world clinical use of the pentaspline PFA catheter. Acute results demonstrate favourable procedural and safety outcomes regardless of AF indication. One-year outcomes are encouraging, with no differences seen within indication based on ablation strategy.