Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States.
Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States.
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美国经导管左心房封堵术后1年的临床结局。
DOI：
10.1016/j.jcin.2022.02.009
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发表时间：
2022-04-11
影响因子：
11.3
通讯作者：
Masoudi, Frederick A.
中科院分区：
文献类型：
--
作者：
Price, Matthew J.;Slotwiner, David;Du, Chengan;Freeman, James, V;Turi, Zoltan;Rammohan, Chidambaram;Kusumoto, Fred M.;Kavinsky, Clifford;Akar, Joseph;Varosy, Paul D.;Koutras, Christina;Curtis, Jeptha P.;Masoudi, Frederick A.
报告美国市售经导管左心耳封堵术（LAAO）后的1年临床结局。国家NCDR LAAO登记处的启动是为了满足医疗保险覆盖的条件，并允许评估临床结果。在如此大的“真实世界”患者队列中，经导管LAAO术后1年血栓栓塞事件的发生率此前尚未报告。纳入了2016年1月1日至2018年12月31日期间入组NCDR LAAO登记研究接受Watchman手术的患者。主要终点为缺血性卒中。使用Kaplan-Meier方法估计1年累积事件发生率。研究人群包括36，681例患者。平均年龄为76.0±8.1岁，平均CHA 2DS 2-VASc为4.8±1.5，平均HAS-BLED为3.0±1.1。25.5%存在既往卒中，69.5%存在临床相关出血，11.9%存在颅内出血。中位随访时间为374天（IQR 212，425）。Kaplan-Meier估计的1年缺血性卒中发生率为1.53%（95% CI，1.39%-1.69%），缺血性卒中或全身性栓塞发生率为2.19%（95% CI，2.01%-2.38%），死亡率为8.52%（95% CI，8.19%-8.87%）。1年大出血的估计发生率为6.93%（95% CI，6.65%-7.21%）。大多数出血事件发生在出院至术后45天之间。本研究描述了在美国接受经导管LAAO的国家患者队列的重要结局。临床医生和患者在考虑这种疗法时可以将这些数据整合到共享决策中。我们在NCDR LAAO登记研究中探讨了使用第一代Watchman器械进行经导管左心耳封堵术（LAAO）的临床安全性和有效性。在36，681例患者中，1年Kaplan-Meier估计的缺血性卒中发生率为1.53（95%CI，1.39%~ 1.69%），缺血性卒中或全身性栓塞发生率为2.19%出血率为6.93%（95%CI，6.65%~ 7.21%），全因死亡率为8.52%（95%CI，8.19%~ 8.87%）。临床医生和患者在考虑这种疗法时可以将这些数据整合到共享决策中。
To report the 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States. The national NCDR LAAO Registry was initiated to meet a condition of Medicare coverage and allow for the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of “real-world” patients have not been previously reported. Patients entered into the NCDR LAAO registry for a Watchman procedure between January 1, 2016 and December 31, 2018 were included. The primary endpoint was ischemic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates. The study population consisted of 36,681 patients. The mean age was 76.0±8.1 years, the mean CHA2DS2-VASc was 4.8±1.5 and the mean HAS-BLED was 3.0±1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR 212, 425). The Kaplan-Meier estimated 1-year rate of ischemic stroke was 1.53% (95% CI, 1.39%–1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI, 2.01%–2.38%), and the rate of mortality was 8.52% (95% CI, 8.19%–8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI, 6.65%–7.21%). Most bleeding events occurred between discharge and 45 days following the procedure. This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision-making when considering this therapy. We explored the clinical safety and effectiveness of transcatheter left atrial appendage occlusion (LAAO) with the first-generation Watchman device in the NCDR LAAO registry. Among 36,681 patients, the 1-year Kaplan-Meier estimated rate of ischemic stroke was 1.53 (95% CI, 1.39%–1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI, 2.01%–2.38%), the rate of bleeding was 6.93% (95% CI, 6.65%–7.21%), and the rate of all-cause mortality was 8.52% (95% CI, 8.19%–8.87%). Clinicians and patients can integrate these data in shared decision-making when considering this therapy.
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5.5
作者：
Boersma, Lucas V.;Barr, Craig S.;Gold, Michael R.
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Reddy, Vivek Y.