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

左心耳封堵术治疗心房颤动 (SAFELY-AF) 的安全性和有效性

• 批准号: 10221038
• 负责人: James Freeman
• 金额: $ 71.81万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10221038
• 关键词: Address; Adverse event; Age; American; Anticoagulant therapy; Anticoagulants; Anticoagulation; Arrhythmia; Atrial Fibrillation; Boston; Cardiology; Cardiovascular system; Certification; Cessation of life; Characteristics; Clinical Trials; Collaborations; Community Practice; Comparative Effectiveness Research; Data; Data Analyses; Devices; Effectiveness; Embolism; Event; Feedback; Goals; Hemorrhage; Hospitals; Intracranial Hemorrhages; Ischemic Stroke; Knowledge; Lead; Left; Medical; Oral; Outcome; Patient risk; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Physicians; Procedures; Provider; Public Health; Publishing; Race; Registries; Risk; Risk Factors; Safety; Series; Standardization; Stroke; Stroke prevention; Subgroup; Thromboembolism; United States; United States Centers for Medicare and Medicaid Services; Update; Use Effectiveness; adverse outcome; auricular appendage; base; clinical practice; clinically relevant; college; comorbidity; data registry; demographics; experience; high risk; implantation; improved; innovation; mortality; novel; patient registry; patient subsets; predictive modeling; prospective; randomized trial; risk of major adverse events; sex; shared decision making; stroke risk; therapy outcome; tool

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.

项目摘要。心房颤动（AF）是最常见的心律失常，并且明显增加 中风和全身性栓塞的风险。口服抗凝药物一直是降低病情的主要疗法 AF 中风和全身性栓塞的风险，但研究一致表明 30-50% 需要口服抗凝药物的患者不接受抗凝药物治疗。左心耳 闭塞（LAAO）代表了一种新的且日益重要的基于设备的预防中风的方法 和 AF 患者的血栓栓塞。随机试验评估了 LAAO 预防中风的作用 心房颤动中的血栓栓塞，但试验结果不一致，留下了重要空白 有关该程序的安全性和有效性的知识。该提案的目标是“安全和 左心耳封堵治疗心房颤动 (SAFELY-AF) 的有效性”，是利用来自 LAAO 程序的大型国家登记册，以增强我们对 LAAO 程序的使用和有效性的了解 LAAO 在现实世界中的实践。国家心血管数据登记处的 LAAO 登记处代表 全球最大的 LAAO 手术前瞻性登记处。通过与波士顿的新颖合作 科学与美国心脏病学会 (ACC) 合作，我们提出了一系列研究，以增强我们的研究能力 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 NCDR LAAO 登记处的数据来检查 设备植入后患者特征和结果的差异。我们将进一步确定 患者、医生和医院对设备植入后不良后果的预测因素并使用此 信息来制定风险评分以确定主​​要不良事件。该信息将被纳入 纳入 ACC 的共享决策 (SDM) 工具，该工具旨在促进患者的共享决策 以及有关 LAAO 手术的医生。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 围手术期抗血栓和抗凝治疗以及装置植入后的患者结果。