Munir Muhammad Bilal, Khan Muhammad Zia, Darden Douglas, Pasupula Deepak K, Balla Sudarshan, Han Frederick T, Reeves Ryan, Hsu Jonathan C
Section of Electrophysiology, Division of Cardiology, University of California San Diego, La Jolla, California, USA.
Division of Cardiovascular Medicine, West Virginia University Heart & Vascular Institute, Morgantown, West Virginia, USA.
J Cardiovasc Electrophysiol. 2021 Jan;32(1):83-92. doi: 10.1111/jce.14804. Epub 2020 Nov 11.
To determine trends in real-world utilization and in-hospital adverse events from Watchman implantation since its approval by the Food and Drug Administration in 2015.
The risk of embolic stroke caused by atrial fibrillation is reduced by oral anticoagulants, but not all patients can tolerate long-term anticoagulation. Left atrial appendage occlusion with the Watchman device has emerged as an alternative therapy.
This was a retrospective cohort study utilizing data from National Inpatient Sample for calendar years 2015-2017. The outcomes assessed in this study were associated complications, in-hospital mortality, and resource utilization trends after Watchman implantation. Trends analysis were performed using analysis of variance. Multivariable adjusted logistic regression analysis was performed to determine predictors of mortality.
A total of 17 700 patients underwent Watchman implantation during the study period. There was a significantly increased trend in the number of Watchman procedures performed over the study years (from 1195 in 2015 to 11 165 devices in 2017, p < .01). A significant decline in the rate of complications (from 26.4% in 2015% to 7.9% in 2017, p < .01) and inpatient mortality (from 1.3% in 2015% to 0.1% in 2017, p < .01) were noted. Predictors of in-hospital mortality included a higher CHA DS -VASc score (odds ratio [OR]: 2.61 per 1-point increase, 95% confidence interval [CI]: 1.91-3.57), chronic blood loss anemia (OR: 3.63, 95% CI: 1.37-9.61) and coagulopathy (OR: 4.90, 95% CI: 2.32-10.35).
In contemporary United States clinical practice, Watchman utilization has increased significantly since approval in 2015, while complications and in-patient mortality have declined.
确定自2015年获得美国食品药品监督管理局批准以来，Watchman植入术在实际应用中的趋势以及院内不良事件。
口服抗凝药可降低心房颤动引起的栓塞性中风风险，但并非所有患者都能耐受长期抗凝治疗。使用Watchman装置进行左心耳封堵已成为一种替代疗法。
这是一项回顾性队列研究，利用了2015 - 2017历年的国家住院患者样本数据。本研究评估的结果是Watchman植入术后的相关并发症、院内死亡率和资源利用趋势。采用方差分析进行趋势分析。进行多变量调整逻辑回归分析以确定死亡率的预测因素。
在研究期间，共有17700例患者接受了Watchman植入术。在研究年份中，Watchman手术数量有显著增加趋势（从2015年的1195例增加到2017年的11165例，p <.01）。并发症发生率（从2015年的26.4%降至2017年的7.9%，p <.01）和住院死亡率（从2015年的1.3%降至2017年的0.1%，p <.01）显著下降。院内死亡率的预测因素包括较高的CHA₂DS₂-VASc评分（比值比[OR]：每增加1分2.61，95%置信区间[CI]：1.91 - 3.57）、慢性失血性贫血（OR：3.63，95% CI：1.37 - 9.61）和凝血病（OR：4.90，95% CI：2.32 - 10.35）。
在当代美国临床实践中，自2015年批准以来，Watchman的使用显著增加，而并发症和住院死亡率有所下降。
