Indications for Left Atrial Appendage Occlusion in the United States and Associated In-Hospital Outcomes: Results From the NCDR LAAO Registry.
Indications for Left Atrial Appendage Occlusion in the United States and Associated In-Hospital Outcomes: Results From the NCDR LAAO Registry.
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DOI：
10.1161/circoutcomes.121.008418
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发表时间：
2022-08
影响因子：
6.9
通讯作者：
Freeman, James, V
中科院分区：
文献类型：
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作者：
Daimee, Usama A.;Wang, Yongfei;Masoudi, Frederick A.;Varosy, Paul D.;Friedman, Daniel J.;Du, Chengan;Koutras, Cristina;Reddy, Vivek Y.;Saw, Jacqueline;Price, Matthew J.;Kusumoto, Fred M.;Curtis, Jeptha P.;Freeman, James, V
美国食品和药物管理局批准左心耳闭塞（LAAO）与Watchman装置用于中风风险增加且适合口服抗凝但有适当理由寻求非药物替代的患者。这些宽泛的标准提出了在临床实践中如何解释的问题。在美国当代现实实践的大量患者中，缺乏全面评估Watchman植入适应症的研究。我们使用NCDR LAAO Registry来确定2016年至2018年期间进行的Watchman手术。我们评估了美国Watchman植入的手术指征，并评估了手术指征与院内不良事件之间的关系。总共包括38,314个程序。患者平均年龄76.1±8.1岁，男性占58.9%。CHA2DS2-VASc平均评分为4.8±1.5分，ha - bled平均评分为3.0±1.1分。有过中风或短暂性脑缺血发作（TIA）的占40.2%，有过出血的占70.1%，其中以胃肠道出血最为常见（41.9%）。Watchman植入最常见的手术指征是血栓栓塞风险增加（64.8%）和大出血史（64.3%），其次是高跌倒风险（35.5%）。大多数（71.9%）有≥2个手术指征。高跌倒风险患者发生院内不良事件的风险增加（调整后OR=1.12, p=0.025），但在手术适应证方面院内不良事件的风险无差异。在NCDR LAAO登记处的患者中，Watchman最常见的手术指征是血栓栓塞风险增加、大出血史和跌倒风险高。大多数患者有多种手术指征。高跌倒风险导致院内不良事件的风险适度增加。
The Food and Drug Administration approved left atrial appendage occlusion (LAAO) with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a non-drug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the U.S. We used the NCDR LAAO Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the U.S. and evaluated the association between procedural indications and in-hospital adverse events. A total of 38,314 procedures were included. The mean patient age was 76.1 ± 8.1 years, and 58.9% were male. The mean CHA2DS2-VASc score was 4.8 ± 1.5, while the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke or transient ischemic attack (TIA) was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥ 2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR=1.12, p=0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication. Among patients in the NCDR LAAO Registry, the most common procedural indications for the Watchman were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.