Mills Mark T, Trivedi Saket, Lovell Matthew J, Murgatroyd Francis, Calvert Peter, Luther Vishal, Gupta Dhiraj, Martin Claire, Zeriouh Sarah, Mellor Greg, Balasubramaniam Richard, Sopher Mark, Boullin Julian, Arujuna Aruna, Chalil Shajil, Gall Scott, Chen Zhong, Saba Magdi, Buckley Una, Somani Riyaz, Chin Shui Hao, Jones David, Kaba Riyaz A, O'Neill Mark, Wong Tom, Todd Derick M
Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, UK
Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK.
Open Heart. 2024 Dec 18;11(2):e003094. doi: 10.1136/openhrt-2024-003094.
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.
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.
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.
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.
脉冲场消融(PFA)是一种用于房颤(AF)患者肺静脉隔离的新型方法。我们描述了在英格兰国民健康服务体系(NHSE)选定中心使用五棱形导管进行PFA的初步应用情况和经验。
汇总并分析NHSE专门服务发展计划收集的关于2022年6月至2024年8月期间使用单次发射、五棱形、多电极PFA导管(FARAWAVE,波士顿科学公司)进行房颤消融手术的数据,以检查手术指标、急性疗效和3个月随访期内的安全性结果。
共提交了1034例手术数据。患者中女性占32.1%,平均年龄63.8±10.7岁,阵发性房颤患者占53.1%,首次进行房颤消融的患者占89.7%。手术由NHSE九个中心的48位顾问医生实施,每个中心平均实施115例手术(范围25 - 264例)。93.7%的手术在全身麻醉下进行。皮肤到皮肤的手术中位时间为74分钟(四分位间距55 - 96分钟),透视时间为20分钟(四分位间距15 - 27分钟)。15.3%的手术使用了电解剖标测。在首次消融病例中,99.5%的患者实现了所有肺静脉的急性隔离。11.0%的病例使用PFA导管进行了左心房(LA)后壁消融;0.6%的病例额外进行了LA射频消融。主要和次要急性手术并发症发生率分别为1.3%和3.1%,无围手术期死亡或房室食管瘘的报告。63.8%的患者在手术当天出院。870例手术(84.1%)有随访数据。在消融后的3个月内,3.2%的患者因心律失常住院,0.9%的患者因手术相关并发症再次住院。
在这个关于五棱形PFA导管的全国性真实世界注册研究中,房颤患者的疗效、安全性和效率结果与先前PFA研究的结果相当。