采用新型可变环双相脉冲场消融导管联合三维标测系统对阵发性心房颤动的消融：多中心 inspIRE 研究的 1 年结果。
Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study.
机构信息
Department of Cardiology, AZ Sint Jan, Brugge, Belgium (M.D.).
Onze Lieve Vrouwziekenhuis Hospital, Dienst Cardiologie, Aalst, Belgium (T.D.P.).
出版信息
Circ Arrhythm Electrophysiol. 2023 Mar;16(3):e011780. doi: 10.1161/CIRCEP.122.011780. Epub 2023 Feb 3.
BACKGROUND
The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable-loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation.
METHODS
Subjects underwent pulmonary vein (PV) isolation with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions, and PV stenosis. Wave II (pivotal phase) tested (1) primary safety, incidence of early-onset primary adverse events, and (2) primary effectiveness, confirmed PV isolation with freedom from documented atrial arrhythmia at 12 months. The study design specified an interim analysis to determine early success once 30 subjects reached the 12-month follow-up and all subjects reached 3-month follow-up.
RESULTS
Across 13 centers in Europe/Canada, 226 subjects were enrolled, met criteria for safety and effectiveness evaluations, and received PFA (Wave I, 40; Wave II, 186). Wave I demonstrated no esophageal thermal lesions or PV stenosis. Among 39 subjects with cerebral magnetic resonance imaging, silent cerebral lesions were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10-second pause between PFA applications, were implemented; subsequently, only 4 of 33 subjects had silent cerebral lesions. In the Wave II phase, no primary adverse events were reported. Upon declaring early success, 83 subjects reached 12-month follow-up. With 100% entrance block, PV isolation without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness end point per Kaplan-Meier at the time of interim analysis was 70.9%; 12-month freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively. Total procedure and transpired PFA times were 70.1±27.7 and 26.7±14.0 minutes, respectively.
CONCLUSIONS
The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; unique identifier: NCT04524364.
背景
inspIRE 研究（经脉冲场消融 [PFA] 系统联合不可逆电穿孔 [IRE] 治疗阵发性心房颤动 [PAF] 的研究）评估了一种完全集成的双相脉冲场消融（PFA）系统的安全性和有效性，该系统使用可变环圆形导管治疗药物难治性阵发性心房颤动。
方法
受试者接受 PFA 系统行肺静脉（PV）隔离，每条静脉至少应用 12 次；给予腺苷/异丙肾上腺素以确认入口阻断。波 I 评估初始安全性，包括食管损伤、无症状性脑损伤和 PV 狭窄。波 II（关键阶段）测试（1）主要安全性，早期不良事件的发生率，和（2）主要有效性，在 12 个月时确认无记录的房性心律失常的 PV 隔离。研究设计规定了中期分析，以确定 30 名受试者达到 12 个月随访和所有受试者达到 3 个月随访后早期成功。
结果
在欧洲/加拿大的 13 个中心，共纳入 226 名受试者，符合安全性和有效性评估标准，并接受 PFA（波 I：40 名；波 II：186 名）。波 I 未发现食管热损伤或 PV 狭窄。在 39 名接受脑磁共振成像的受试者中，在最初的 6 名受试者中的 4 名中发现了无症状性脑损伤，此后，包括在 PFA 应用之间暂停 10 秒在内的工作流程改进措施得到了实施；此后，仅在 33 名受试者中的 4 名中发现无症状性脑损伤。在波 II 阶段，未报告主要不良事件。在宣布早期成功后，83 名受试者达到 12 个月随访。在 100%入口阻断的情况下，97.1%的目标静脉实现了无急性再连接的 PV 隔离。在中期分析时，根据 Kaplan-Meier 分析，波 II 的主要有效性终点为 70.9%；12 个月时无症状性心房颤动/心房扑动/房性心动过速复发和再次消融的无复发率分别为 78.9%和 92.3%。总手术和发生的 PFA 时间分别为 70.1±27.7 和 26.7±14.0 分钟。
结论
inspIRE 试验证实了新型映射集成 PFA 系统的安全性和有效性。
注册
网址：https://www.
临床试验
gov；独特标识符：NCT04524364。
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