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

基本信息

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
项目类别：
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

项目摘要

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，并且明显增加口服抗凝药物一直是降低中风和全身性栓塞风险的主要疗法。持续性房颤患者发生中风和全身性栓塞的风险，但研究表明，30-50% 的患者需要口服抗凝药物的患者不接受左心耳治疗。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随机试验评估了 LAAO 预防中风和血栓栓塞的作用。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“安全性和有效性”。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现实世界实践中的 LAAO 国家心血管数据登记处的 LAAO 登记处代表了通过与波士顿的新颖合作，全球最大的 LAAO 手术前瞻性登记处。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我们将进一步确定设备植入后患者特征和结果的差异。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制定风险评分以确定重大不良事件的信息将被纳入。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最后，我们将使用 LAAO 程序进行比较有效性研究。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。