Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA; Center for Outcomes Research and Evaluation, Yale New Haven Health Services Corporation, New Haven, Connecticut, USA.
Division of Cardiology, Maine Health, Scarborough, Maine, USA.
J Am Coll Cardiol. 2022 May 10;79(18):1785-1798. doi: 10.1016/j.jacc.2022.02.047.
Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols.
This study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies.
We evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression.
Among 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up.
In contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes.
经皮左心耳封堵术（LAAO）的关键性试验采用了特定的术后治疗方案。
本研究旨在评估 Watchman 装置在临床实践中 LAAO 后的治疗模式，并比较不同出院抗栓策略的不良事件风险。
我们评估了 2016 年至 2018 年期间在国家心血管数据注册中心接受 Watchman 装置 LAAO 的患者。我们评估了对完整术后试验方案的依从性，包括标准化随访、影像学和抗栓药物，然后评估了最常用的抗栓策略，并通过多变量 COX 脆弱性回归比较了 45 天和 6 个月时的不良事件发生率和风险。
在 31994 例成功进行 LAAO 的患者中，只有 12.2%接受了关键性试验中研究的完整术后治疗方案；最常见的方案偏差是出院抗栓药物。最常见的出院药物策略是华法林和阿司匹林（36.9%）、直接口服抗凝剂（DOAC）和阿司匹林（20.8%）、仅华法林（13.5%）、仅 DOAC（12.3%）和双联抗血小板治疗（5.0%）。在多变量 Cox 脆弱性回归中，通过 45 天随访，与华法林和阿司匹林组相比，单独使用华法林（HR：0.692；95%CI：0.569-0.841）和单独使用 DOAC（HR：0.731；95%CI：0.574-0.930）的不良事件风险显著降低。单独使用华法林在 6 个月随访时仍具有较低的风险。
在美国的当代实践中，医生很少使用 Watchman 装置关键性试验中美国食品药品监督管理局批准的完整术后治疗方案。植入后使用华法林或 DOAC 而不联合使用阿司匹林的出院患者发生不良结局的风险较低。
