Pulsed-field ablation of atrial fibrillation with a pentaspline catheter across National Health Service England centres

Abstract

Introduction: Pulsed-field ablation (PFA) is a novel modality for pulmonary vein isolation in patients with atrial fibrillation (AF). We describe the initial uptake and experience of PFA using a pentaspline catheter across selected National Health Service England (NHSE) centres.

Methods: Data collected by NHSE Specialised Services Development Programme regarding AF ablation procedures using a single-shot, pentaspline, multielectrode PFA catheter (FARAWAVE, Boston Scientific) between June 2022 and August 2024 were aggregated and analysed to examine procedural metrics, acute efficacy and safety outcomes over 3-month follow-up.

Results: 1034 procedures were submitted. The patients were 32.1% female, mean age 63.8±10.7 years, 53.1% paroxysmal AF and 89.7% first-time AF ablation. Procedures were performed by 48 consultant operators at nine NHSE centres, with a mean of 115 procedures per centre (range 25-264). 93.7% of procedures were performed under general anaesthesia. Median skin-to-skin procedure time was 74 min (IQR 55-96 min) and fluoroscopy time 20 min (IQR 15-27 min). Electroanatomical mapping was used in 15.3%. In first-time ablation cases, acute isolation of all pulmonary veins was achieved in 99.5% of patients. Left atrial (LA) posterior wall ablation using the PFA catheter was performed in 11.0% of cases; additional LA radiofrequency ablation was performed in 0.6%. The major and minor acute procedural complication rates were, respectively, 1.3% and 3.1%, with no reports of periprocedural death or atrio-oesophageal fistula. 63.8% of patients were discharged on the day of procedure. Follow-up data were available for 870 procedures (84.1%). In the 3 months following ablation, hospitalisation for arrhythmia occurred in 3.2%, with 0.9% rehospitalised for procedural-related complications.

Conclusion: In this real-world, nationwide registry of a pentaspline PFA catheter, efficacy, safety and efficiency outcomes were comparable to those from previous PFA studies in patients with AF.

Keywords: Ablation Techniques; Atrial Fibrillation; Catheter Ablation; Electrophysiology.

Figure 1. Cumulative atrial fibrillation pulsed-field ablation case numbers over time across all centres included in the report. Notably, centres returned their completed data between January and August 2024. As such, while the data collection captured consecutive cases from the introduction of FARAPULSE in each centre, the date of last case submission varied between centres. This is reflected in the flattening of the curve from January 2024 onwards.

Figure 2. Mean skin-to-skin procedure time by operator case number. Data presented for cases of pulmonary vein isolation alone in the 25 consultant operators who performed at least 15 procedures. Case 1=operator’s first FARAPULSE PVI case; Case 30=operator’s 30th case. For operators performing more than 30 cases, data censored at the operator’s 30th case to ensure a minimum of 10 operators per case number. PVI, pulmonary vein isolation.