The NCDR Left Atrial Appendage Occlusion Registry,Journal of the American College of Cardiology

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The NCDR Left Atrial Appendage Occlusion Registry
Journal of the American College of Cardiology ( IF 21.7 ) Pub Date : 2020-04-01 , DOI: 10.1016/j.jacc.2019.12.040
James V Freeman ₁ , Paul Varosy ₂ , Matthew J Price ₃ , David Slotwiner ₄ , Fred M Kusumoto ₅ , Chidambaram Rammohan ₆ , Clifford J Kavinsky ₇ , Zoltan G Turi ₈ , Joseph Akar ₁ , Cristina Koutras ₉ , Jeptha P Curtis ₁ , Frederick A Masoudi ₂

Affiliation

BACKGROUND Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited. OBJECTIVES The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years. METHODS The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates. RESULTS A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 4 to 56) and for physicians was 12 (interquartile range: 0 to 14). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare. CONCLUSIONS The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.

中文翻译：

NCDR 左心耳闭塞登记处

背景 2 项随机试验评估了左心耳封堵术 (LAAO) 预防心房颤动患者中风的效果；批准后的临床数据有限。目的本研究的目的是描述国家心血管数据登记处 (NCDR) LAAO 登记处，并介绍美国 Watchman 手术前 3 年的患者、医院和医生特征以及院内不良事件发生率。方法作者描述了 LAAO 注册结构和治理、结果裁决过程以及数据质量和收集过程。它们描述了患者人群、执行医院和住院不良事件发生率的特征。结果来自 495 家医院的 38,158 次手术由 1、2016 年 1 月至 2018 年 12 月期间，美国有 318 名医生被纳入。平均患者年龄为 76.1 ± 8.1 岁，平均 CHA2DS2-VASc（充血性心力衰竭、高血压、65 岁及以上、糖尿病、既往中风或短暂性脑缺血发作、血管疾病、女性）评分为 4.6 ± 1.5，平均 HAS-BLED（高血压、肾/肝功能异常、中风、出血史或易感性、不稳定的国际标准化比率、老年人、药物/酒精）评分为 3.0 ± 1.1。每年为医院执行的 LAAO 程序的中位数为 30（四分位距：4 到 56），医生为 12（四分位距：0 到 14）。7% 的程序被取消或中止；在部署设备的案例中，98.1% 的植入漏气小于 5 毫米。2.16% 的患者发生了严重的院内不良事件；最常见的并发症是需要干预的心包积液 (1.39%) 和大出血 (1.25%)，而中风 (0.17%) 和死亡 (0.19%) 很少见。结论 LAAO Registry 已招募了 38,000 多名植入该设备的患者。与参加关键试验的患者相比，患者通常年龄更大，合并症更多；然而，主要的院内不良事件发生率低于这些试验报告的。与参加关键试验的患者相比，患者通常年龄更大，合并症更多；然而，主要的院内不良事件发生率低于这些试验报告的。与参加关键试验的患者相比，患者通常年龄更大，合并症更多；然而，主要的院内不良事件发生率低于这些试验报告的。

更新日期：2020-04-01

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