Department of Cardiology, Homolka Hospital, Prague, Czech Republic; Helmsley Electrophysiology Center, Department of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 3):1786-1801. doi: 10.1016/j.jacep.2023.04.002. Epub 2023 Apr 16.
Because of its safety, "single-shot" pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF) ablation procedures are performed with focal catheters to permit flexibility of lesion sets beyond PVI.
This study sought to determine the safety and efficacy of a focal ablation catheter able to toggle between radiofrequency ablation (RFA) or PFA to treat paroxysmal or persistent AF.
In a first-in-human study, a focal 9-mm lattice tip catheter was used for PFA posteriorly and either irrigated RFA (RF/PF) or PFA (PF/PF) anteriorly. Protocol-driven remapping was at ∼3 months postablation. The remapping data prompted PFA waveform evolution: PULSE1 (n = 76), PULSE2 (n = 47), and the optimized PULSE3 (n = 55).
The study included 178 patients (paroxysmal/persistent AF = 70/108). Linear lesions, either PFA or RFA, included 78 mitral, 121 cavotricuspid isthmus, and 130 left atrial roof lines. All lesion sets (100%) were acutely successful. Invasive remapping of 122 patients revealed improvement of PVI durability with waveform evolution: PULSE1: 51%; PULSE2: 87%; and PULSE3: 97%. After 348 ± 652 days of follow-up, the 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias were 78.3% ± 5.0% and 77.9% ± 4.1% for paroxysmal and persistent AF, respectively, and 84.8% ± 4.9% for the subset of persistent AF patients receiving the PULSE3 waveform. There was 1 primary adverse event-inflammatory pericardial effusion not requiring intervention.
AF ablation with a focal RF/PF catheter allows efficient procedures, chronic lesion durability, and good freedom from atrial arrhythmias-for both paroxysmal and persistent AF. (Safety and Performance Assessment of the Sphere-9 Catheter and the Affera Mapping and RF/PF Ablation System to Treat Atrial Fibrillation; NCT04141007 and NCT04194307).
由于其安全性，已开发出“单次”脉冲场消融（PFA）导管用于肺静脉隔离（PVI）。然而，大多数心房颤动（AF）消融程序都是使用焦点导管进行的，以便在 PVI 之外灵活设置病变集。
本研究旨在确定一种能够在射频消融（RFA）或 PFA 之间切换的焦点消融导管用于治疗阵发性或持续性 AF 的安全性和疗效。
在首例人体研究中，使用 9mm 网格尖端的焦点导管进行后部 PFA，并在前部进行灌洗 RFA（RF/PF）或 PFA（PF/PF）。消融后约 3 个月进行协议驱动的重新映射。重新映射数据提示 PFA 波形演变：PULSE1（n=76）、PULSE2（n=47）和优化的 PULSE3（n=55）。
该研究纳入了 178 名患者（阵发性/持续性 AF=70/108）。线性病变，无论是 PFA 还是 RFA，包括 78 个二尖瓣、121 个三尖瓣峡部和 130 个左心房房顶线。所有病变集（100%）均急性成功。对 122 名患者进行的侵入性重新映射显示，随着波形演变，PVI 耐久性得到改善：PULSE1：51%；PULSE2：87%；和 PULSE3：97%。随访 348±652 天后，阵发性和持续性 AF 的 1 年 Kaplan-Meier 无心房心律失常估计分别为 78.3%±5.0%和 77.9%±4.1%，接受 PULSE3 波形的持续性 AF 患者亚组为 84.8%±4.9%。仅发生 1 例主要不良事件-无需干预的炎症性心包积液。
使用焦点 RF/PF 导管进行 AF 消融可实现高效的程序、慢性病变持久性和良好的无心房心律失常-对阵发性和持续性 AF 均有效。（Sphere-9 导管和 Affera 映射及 RF/PF 消融系统治疗心房颤动的安全性和性能评估；NCT04141007 和 NCT04194307）。
