Key result
Pulsed-field ablation using a pentaspline catheter achieved acute pulmonary vein isolation in 99.5% of first-time atrial fibrillation ablation cases, with a major acute complication rate of 1.3%.
Why the study?
Pulsed-field ablation is a novel modality for pulmonary vein isolation in AF, prompting evaluation of the initial uptake and experience using a pentaspline catheter across selected National Health Service England centres.
What are the real-world procedural metrics, efficacy, and safety outcomes of pulsed-field ablation using a pentaspline catheter in patients with atrial fibrillation?
Observational (n=1,034)
Yes
What are the real-world procedural metrics, efficacy, and safety outcomes of pulsed-field ablation using a pentaspline catheter in patients with atrial fibrillation?
Real-world use of a pentaspline pulsed-field ablation catheter for atrial fibrillation demonstrates high acute efficacy and a favorable safety profile, consistent with previous clinical trials.
Supports real-world pentaspline PFA use in AF; extends trial data yet leaves long-term outcomes open.
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.
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Mills et al. (2024) conducted an observational in Atrial fibrillation (n=1,034). Pulsed-field ablation (pentaspline catheter) was evaluated on Acute isolation of all pulmonary veins in first-time ablation cases. Pulsed-field ablation using a pentaspline catheter achieved acute pulmonary vein isolation in 99.5% of first-time atrial fibrillation ablation cases, with a major acute complication rate of 1.3%.
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