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， 中风和全身性栓塞的风险。口服抗凝剂一直是治疗的支柱，以减少 房颤患者中风和全身性栓塞的风险，但研究一致表明， 需要口服抗凝剂的患者不用抗凝剂治疗。左心耳 闭塞（LAAO）代表了一种新的且日益重要的预防卒中的基于器械的方法 和血栓栓塞。随机试验评价了LAAO预防卒中的作用， 房颤血栓栓塞，但试验结果不一致，留下了重要的差距， 了解本程序的安全性和有效性。该提案的目标是“安全和 房颤患者左心房封堵术的有效性（SAFELY-AF）"，旨在利用来自 LAAO程序的大型国家登记册，以提高我们对LAAO程序的使用和有效性的理解。 在现实世界中的实践。国家心血管数据登记中心的LAAO登记中心代表了 全球最大的LAAO手术前瞻性登记研究。通过与波士顿的新颖合作， 科学和美国心脏病学会（ACC），我们提出了一系列的研究，将提高我们的 了解LAAO在现实世界实践中的使用和有效性。首先，我们将使用患者水平的数据 来自LAAO器械的关键随机试验和来自NCDR LAAO登记研究的数据， 器械植入后患者特征和结局的差异。我们将进一步确定 器械植入后不良结局的患者、医生和医院预测因素，并使用此 信息，以制定风险评分，以确定主要不良事件。这些信息将被纳入 ACC的共享决策（SDM）工具，旨在促进患者的共享决策 和医生进行LAAO手术。最后，我们将使用 尖端的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器械植入后的患者结局。