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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.3026

摘要内容如下：

重要性

左心耳切除可改善心房颤动的导管消融结果。

目的

评价经皮左心耳结扎辅助导管肺静脉电隔离治疗非阵发性心房颤动的安全性和有效性。

设计、设置和参与者

这项多中心、前瞻性、开放标签、随机临床试验评估了经皮左心耳结扎辅助计划肺静脉隔离治疗非阵发性房颤的安全性和有效性，该试验持续时间不到3年。符合条件的患者以2:1的比例随机接受左心耳结扎和肺静脉隔离或单纯肺静脉隔离。使用2:1的随机化比率旨在提供更多的器械经验和安全性数据。患者于2015年10月至2019年12月在53个美国站点入组，最后一次随访时间为2021年4月21日。

干预措施

左心耳结扎加肺静脉隔离与单纯肺静脉隔离的比较。

主要成果和措施

主要终点采用贝叶斯自适应分析。主要疗效是在接受肺静脉隔离12个月后，未出现持续时间超过30秒的房性心律失常。通过肺静脉隔离后6个月和12个月的动态心电图监测、症状事件监测或肺静脉隔离后12个月的任何心电图描记来评估心律。主要安全性是预先定义的严重不良事件与手术后30天预先指定的10%性能目标的复合。肺静脉隔离术后12个月评价左心耳关闭情况。

结果

总体而言，404名患者随机接受左心耳结扎加肺静脉隔离，206名患者随机接受单纯肺静脉隔离。左心耳结扎和肺静脉隔离组的主要有效率为64.3%，而单纯肺静脉隔离组为59.9%（差异，4.3%[Bayesian 95%可信区间，-4.2%至13.2%]；后验优势概率，0.835），不符合建立优势的统计标准（0.977）。达到主要安全性，30天严重不良事件发生率为3.4%（贝叶斯95%可信区间，2.0%至5.0%；后验概率，1.0），其小于预先指定的阈值10%。在肺静脉隔离后12个月，84%的患者观察到左心耳完全闭合（0mm残余交通），99%的患者观察到小于或等于5mm的残余交通。

结论和相关性

对于非阵发性房颤患者，经皮左心耳结扎辅助肺静脉隔离与单纯肺静脉隔离相比，在12个月时不符合预先规定的无房性心律失常的疗效标准，但符合预先规定的安全性标准，并且在12个月时显示出较高的关闭率。

试用注册

ClinicalTrials.gov标识符：NCT02513797。

英文原文如下：

Abstracts

Importance  Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation.

Objective  To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation.

Design, Setting, and Participants  This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years. Eligible patients were randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. Use of a 2:1 randomization ratio was intended to provide more device experience and safety data. Patients were enrolled from October 2015 to December 2019 at 53 US sites, with the final follow-up visit on April 21, 2021.

Interventions  Left atrial appendage ligation plus pulmonary vein isolation compared with pulmonary vein isolation alone.

Main Outcomes and Measures  A bayesian adaptive analysis was used for primary end points. Primary effectiveness was freedom from documented atrial arrythmias of greater than 30 seconds duration 12 months after undergoing pulmonary vein isolation. Rhythm was assessed by Holter monitoring at 6 and 12 months after pulmonary vein isolation, symptomatic event monitoring, or any electrocardiographic tracing obtained through 12 months after pulmonary vein isolation. Primary safety was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. Left atrial appendage closure was evaluated through 12 months after pulmonary vein isolation.

Results  Overall, 404 patients were randomized to undergo left atrial appendage ligation plus pulmonary vein isolation and 206 were randomized to undergo pulmonary vein isolation alone. Primary effectiveness was 64.3% with left atrial appendage ligation and pulmonary vein isolation and 59.9% with pulmonary vein isolation only (difference, 4.3% [bayesian 95% credible interval, -4.2% to 13.2%]; posterior superiority probability, 0.835), which did not meet the statistical criterion to establish superiority (0.977). Primary safety was met, with a 30-day serious adverse event rate of 3.4% (bayesian 95% credible interval, 2.0% to 5.0%; posterior probability, 1.0) which was less than the prespecified threshold of 10%. At 12 months after pulmonary vein isolation, complete left atrial appendage closure (0 mm residual communication) was observed in 84% of patients and less than or equal to 5 mm residual communication was observed in 99% of patients.

Conclusions and Relevance  Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months.

Trial Registration  ClinicalTrials.gov Identifier: NCT02513797.

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