Klinik für Kardiologie, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, Gebäude Ost 70, 20246 Hamburg, Germany.
Department of Internal Medicine and Cardiology, University Hospital Brno, Brno, Czech Republic.
Europace. 2024 Mar 1;26(3). doi: 10.1093/europace/euae053.
Pulmonary vein isolation (PVI) is a well-established strategy for the treatment of paroxysmal atrial fibrillation (PAF). Despite randomized controlled trials and real-world data showing the promise of pulsed-field ablation (PFA) for this treatment, long-term efficacy and safety data demonstrating single-procedure outcomes off antiarrhythmic drugs remain limited. The aim of the FARA-Freedom Study was to evaluate the long-term efficacy and safety of PFA using the pentaspline catheter for PAF.
FARA-Freedom, a prospective, non-randomized, multicentre study, enrolled patients with PAF undergoing de novo PVI with PFA, who were followed for 12 months with weekly transtelephonic monitoring and a 72-h Holter ECG at 6 and 12 months. The primary safety endpoint was a composite of device- or procedure-related serious adverse events out to 7 days post-ablation and PV stenosis or atrioesophageal (AE) fistula out to 12 months. Treatment success is a composite of acute PVI and chronic success, which includes freedom from any documented atrial tachyarrhythmia longer than 30 s, use of antiarrhythmic drugs or cardioversion after a 3-month blanking period, or use of amiodarone or repeat ablation at any time. The study enrolled 179 PAF patients (62 ± 10 years, 39% female) at 13 centres. At the index procedure, all PVs were successfully isolated with the pentaspline PFA catheter. Procedure and left atrial dwell times, with a 20-min waiting period, were 71.9 ± 17.6 and 41.0 ± 13.3 min, respectively. Fluoroscopy time was 11.5 ± 7.4 min. Notably, monitoring compliance was high, with 88.4 and 90.3% with weekly events and 72-h Holter monitors, respectively. Freedom from the composite primary effectiveness endpoint was 66.6%, and 41 patients had atrial tachyarrhythmia recurrence, mostly recurrent atrial fibrillation (31 patients). The composite safety endpoint occurred in two patients (1.1%), one tamponade and one transient ischaemic attack. There was no coronary spasm, PV stenosis, or AE fistula. There were four cases of transient phrenic nerve palsy, but all resolved during the index procedure.
In this prospective, non-randomized, multicentre study, PVI using a pentaspline PFA catheter was effective in treating PAF patients despite rigourous endpoint definitions and high monitoring compliance and demonstrated favourable safety.
Clinical Trials.gov Identifier: NCT05072964 (sponsor: Boston Scientific Corporation).
肺静脉隔离（PVI）是治疗阵发性心房颤动（PAF）的一种成熟策略。尽管随机对照试验和真实世界的数据表明脉冲场消融（PFA）在这种治疗中有很大的潜力，但证明单次程序抗心律失常药物治疗效果的长期疗效和安全性数据仍然有限。FARA-Freedom 研究的目的是使用五边形导管评估 PFA 治疗 PAF 的长期疗效和安全性。
FARA-Freedom 是一项前瞻性、非随机、多中心研究，纳入了 179 例新发 PVI 伴 PFA 的 PAF 患者，随访 12 个月，每周进行远程电话监测，在 6 个月和 12 个月时进行 72 小时动态心电图监测。主要安全性终点是消融后 7 天内与器械或手术相关的严重不良事件的复合终点，以及 12 个月内的肺静脉狭窄或食管（AE）瘘的复合终点。治疗成功是急性 PVI 和慢性成功的综合结果，包括无任何 30 秒以上记录的房性心动过速，在 3 个月的空白期后使用抗心律失常药物或电复律，或任何时候使用胺碘酮或重复消融。研究纳入了 13 个中心的 179 例 PAF 患者（62±10 岁，39%为女性）。在指数手术中，所有的肺静脉均成功地用五边形 PFA 导管隔离。手术和左心房驻留时间分别为 71.9±17.6 分钟和 41.0±13.3 分钟，等待时间为 20 分钟。透视时间为 11.5±7.4 分钟。值得注意的是，监测的依从性很高，每周事件监测的依从率为 88.4%，72 小时动态心电图监测的依从率为 90.3%。无主要有效性终点复合事件的发生率为 66.6%，41 例患者出现房性心动过速复发，主要是复发性心房颤动（31 例）。复合安全性终点发生在 2 例患者（1.1%），1 例为心脏压塞，1 例为短暂性脑缺血发作。没有发生冠状动脉痉挛、肺静脉狭窄或食管（AE）瘘。有 4 例短暂性膈神经麻痹，但均在指数手术期间得到解决。
在这项前瞻性、非随机、多中心研究中，尽管采用了严格的终点定义和高监测依从性，但使用五边形 PFA 导管进行 PVI 治疗 PAF 患者是有效的，并显示出良好的安全性。
临床试验.gov 标识符：NCT05072964（赞助商：波士顿科学公司）。
Zotero 插件
