Safety and Effectiveness of Left Atrial Appendage Closure in Atrial Fibrillation (SAFELY-AF)

项目总结。房颤(房颤)是最常见的心律失常，且显著增加 中风和全身血栓的风险。口服抗凝治疗一直是减少 房颤患者中风和全身性栓塞的风险，但研究一致表明，30%-50%的 口服抗凝治疗的患者不接受抗凝剂治疗。左心耳 闭塞(LAAO)代表了一种新的、日益重要的基于设备的预防中风的方法 和房颤患者的血栓栓塞症。随机试验评估了LAAO预防中风和 心房颤动中的血栓栓塞，但试验结果不一致，留下了重要的空白 关于此程序的安全性和有效性的知识。这项提案的目标是“安全和 左心耳闭塞治疗房颤(SAFE-AF)的有效性“，是利用来自 大型国家登记册--LAAO程序，以加强我们对《公约》的使用和效力的了解 拉奥在现实世界的实践中。国家心血管数据登记处的LAAO登记处代表 全球最大的LAAO程序预期登记。通过与波士顿的一项新合作 科学和美国心脏病学会(ACC)，我们提出了一系列研究，将增强我们的 了解LAAO在现实世界实践中的使用和有效性。首先，我们将使用患者级别的数据 来自LAAO设备的关键随机试验和来自NCDR LAAO注册的数据以检查 植入装置后患者特征和结果的差异。我们将进一步确定 患者、医生和医院预测装置植入后不良结果的指标并使用本产品 制定风险评分以确定主要不良事件的信息。该信息将被并入 进入ACC的共享决策(SDM)工具，旨在促进患者的共享决策 和医生对LAAO手术的看法。最后，我们将进行比较有效性研究，使用 尖端计算方法来表征不同方法之间的关联 围术期抗血栓和抗凝治疗和装置植入后的患者结果。

PROJECT SUMMARY. Atrial fibrillation (AF) is the most common cardiac arrhythmia and markedly increases the risk for stroke and systemic embolism. Oral anticoagulation has been the mainstay of therapies to reduce the risk of stroke and systemic embolism in AF, but studies have consistently shown that between 30-50% of patients for whom oral anticoagulation is indicated are not treated with anticoagulants. Left atrial appendage occlusion (LAAO) represents a new and increasingly important device-based approach for preventing stroke and thromboembolism in AF patients. Randomized trials have evaluated LAAO for the prevention of stroke and thromboembolism in atrial fibrillation, but the trial results were inconsistent, leaving important gaps in knowledge regarding the safety and effectiveness of this procedure. The goal of this proposal, “Safety and Effectiveness of Left Atrial Appendage Occlusion in Atrial Fibrillation (SAFELY-AF)”, is to leverage data from a large national registry of LAAO procedures to enhance our understanding of the use and effectiveness of LAAO in real-world practice. The National Cardiovascular Data Registry’s LAAO Registry represents the largest prospective registry of LAAO procedures worldwide. Through a novel collaboration with Boston Scientific and the American College of Cardiology (ACC), we propose a series of studies that will enhance our understanding of the use and effectiveness of LAAO in real-world practice. First, we will use patient-level data from the pivotal randomized trials of LAAO devices and data from the NCDR LAAO Registry to examine differences in patient characteristics and outcomes following device implantation. We will further identify patient, physician, and hospital predictors of adverse outcomes following device implantation and use this information to develop a risk score to determine major adverse events. This information will be incorporated into the ACC’s shared decision making (SDM) tool, developed to promote shared decision-making for patients and physicians regarding LAAO procedures. Finally, we will conduct comparative-effectiveness research, using cutting-edge computational approaches to characterize the association between different approaches to periprocedural antithrombotic and anticoagulant therapies and patient outcomes following device implantation.