| Title: |
Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry |
| Authors: |
Boersma LVA; Széplaki G; Dello Russo A; García-Bolao I; Efremidis M; Szegedi N; Willems S; Haqqani H; Gandjbakhch E; Solimene F; Andrikopoulos G; Fiala M; Defaye P; Luik A; Lugenbiel P; Eckardt L; Ouss A; Herzet JM; Maqueda JR; Abbey S; Osca J; Hussin A; Cielen N; Johnson M; Albrecht EM; Sutton BS; Vijgen J |
| Contributors: |
Boersma, Lva; Széplaki, G; Dello Russo, A; García-Bolao, I; Efremidis, M; Szegedi, N; Willems, S; Haqqani, H; Gandjbakhch, E; Solimene, F; Andrikopoulos, G; Fiala, M; Defaye, P; Luik, A; Lugenbiel, P; Eckardt, L; Ouss, A; Herzet, Jm; Maqueda, Jr; Abbey, S; Osca, J; Hussin, A; Cielen, N; Johnson, M; Albrecht, Em; Sutton, B; Vijgen, J |
| Publication Year: |
2025 |
| Collection: |
Università Politecnica delle Marche: IRIS |
| Subject Terms: |
Atrial fibrillation; Learning curve; Pulsed field ablation; Real-world |
| Description: |
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 FARADISE is a prospective, non-randomized, multi-national registry (NCT05501873) that enrolled subjects clinically indi- and results cated 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 |
| Document Type: |
article in journal/newspaper |
| Language: |
unknown |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/40888735; info:eu-repo/semantics/altIdentifier/wos/WOS:001561358100001; volume:27; issue:9; numberofpages:13; journal:EUROPACE; https://hdl.handle.net/11566/348958; https://pubmed.ncbi.nlm.nih.gov/40888735/ |
| DOI: |
10.1093/europace/euaf182 |
| Availability: |
https://hdl.handle.net/11566/348958; https://doi.org/10.1093/europace/euaf182; https://pubmed.ncbi.nlm.nih.gov/40888735/ |
| Rights: |
info:eu-repo/semantics/openAccess ; license:Creative commons ; license uri:http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.C67EB3AC |
| Database: |
BASE |