The NCDR Left Atrial Appendage Occlusion Registry
The NCDR Left Atrial Appendage Occlusion Registry
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DOI：
10.1016/j.jacc.2019.12.040
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发表时间：
2020-04-07
影响因子：
24
通讯作者：
Masoudi, Frederick A.
中科院分区：
文献类型：
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作者：
Freeman, James, V;Varosy, Paul;Masoudi, Frederick A.
左心耳封堵术（LAAO）预防房颤患者卒中的效果已在2项随机试验中进行了评价;批准后的临床数据是有限的。结论本研究的目的是描述国家心血管数据登记处（NCDR）LAAO登记处和目前的患者，医院，和医生的特征，美国Watchman手术前3年的医院不良事件发生率。方法作者描述了LAAO登记结构，管理、结果裁定过程以及数据质量和收集过程。他们描述了患者人群、执行医院和院内不良事件发生率。结果在2016年1月至2018年12月期间，美国495家医院的1，318名医生共进行了38，158次手术。患者平均年龄为76.1 ± 8.1岁，平均CHA（2）DS（2）-VASc（充血性心力衰竭，高血压，65岁及以上，糖尿病，既往卒中或短暂性脑缺血发作，血管疾病，65至74岁，女性）评分为4.6 +/- 1.5，平均HAS-BLED（高血压、肾/肝功能异常、卒中、出血史或易感性、不稳定的国际标准化比值、老年人、药物/酒精伴随）评分为3.0 ± 1.1。医院进行的LAAO手术的年中位数为30例（四分位数范围：18 - 44），医生为12例（四分位数范围：8 - 20）。7%的病例取消或中止手术;在展开器械的病例中，98.1%的病例植入了器械，38，000例患者植入了器械。患者通常年龄较大，合并症多于关键性试验入组的患者;然而，主要院内不良事件发生率低于这些试验中报告的发生率。(C)2020年由美国心脏病学会基金会。
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 CHA(2)DS(2)-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, 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: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with 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. (C) 2020 by the American College of Cardiology Foundation.