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：
10431910
负责人：
James Freeman
金额：
$ 70.1万
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 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10431910
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 Fibrinolytic Agents Goals Hemorrhage Hospitals Intracranial Hemorrhages Ischemic Stroke Knowledge Lead Left Medical Oral Outcome Patient risk Patient-Focused Outcomes Patients 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）是最常见的心律不齐，明显增加中风和系统性栓塞的风险。口服抗凝治疗是减少疗法的中流 AF中中风和全身栓塞的风险，但研究一直表明，30-50％表明未用抗凝剂治疗口服抗凝的患者。留下心房附件闭塞（LAAO）代表了一种预防中风的新的且日益重要的基于设备的方法 AF患者的血栓栓塞和血栓栓塞。随机试验已评估LAAO的预防中风和心房颤动中的血栓栓塞，但试验结果不一致，留下了重要的差距有关此程序的安全性和有效性的知识。该提议的目的是：“安全和左心窝闭塞在心房颤动（安全-af）中的有效性是为了利用来自一个的数据 LAAO程序的大型国家注册表，以增强我们对 Laao在现实世界中的实践中。国家心血管数据注册表的LAAO注册表代表全球LAAO程序的最大前瞻性注册表。通过与波士顿的小说合作科学和美国心脏病学院（ACC），我们提出了一系列研究，以增强我们的了解LAAO在现实世界实践中的使用和有效性。首先，我们将使用患者级数据从LAAO设备的关键随机试验和NCDR LAAO注册表的数据进行检查设备植入后，患者特征和结果的差异。我们将进一步确定设备植入后的病人，身体和医院预测因素，并使用此信息以开发风险评分以确定重大不良事件。此信息将合并进入ACC共享的决策（SDM）工具，该工具开发了，以促进患者共享决策以及有关LAAO程序的医生。最后，我们将使用尖端计算方法，以表征不同方法之间的关联植入装置后，围围骨性抗血栓和抗凝剂疗法和患者结局。

项目成果

期刊论文数量（7）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

To Occlude or Not to Occlude the Left Atrial Appendage in Women-Reply.

封堵或不封堵女性左心耳-回复。

DOI：
10.1001/jamacardio.2021.5933
发表时间：
2022
期刊：
JAMA cardiology
影响因子：
24
作者：
Darden,Douglas;Freeman,JamesV;Hsu,JonathanC
通讯作者：
Hsu,JonathanC

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States.

DOI：
10.1016/j.jcin.2022.02.009
发表时间：
2022-04-11
期刊：
JACC-CARDIOVASCULAR INTERVENTIONS
影响因子：
11.3
作者：
Price, Matthew J.;Slotwiner, David;Du, Chengan;Freeman, James, V;Turi, Zoltan;Rammohan, Chidambaram;Kusumoto, Fred M.;Kavinsky, Clifford;Akar, Joseph;Varosy, Paul D.;Koutras, Christina;Curtis, Jeptha P.;Masoudi, Frederick A.
通讯作者：
Masoudi, Frederick A.

Clinical Impact of Residual Leaks Following Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry.

DOI：
10.1016/j.jacep.2022.03.001
发表时间：
2022-06
期刊：
JACC-CLINICAL ELECTROPHYSIOLOGY
影响因子：
7
作者：
Alkhouli, Mohamad;Du, Chengan;Killu, Ammar;Simard, Trevor;Noseworthy, Peter A.;Friedman, Paul A.;Curtis, Jeptha P.;V. Freeman, James;Holmes, David R.
通讯作者：
Holmes, David R.

Indications for Left Atrial Appendage Occlusion in the United States and Associated In-Hospital Outcomes: Results From the NCDR LAAO Registry.

DOI：
10.1161/circoutcomes.121.008418
发表时间：
2022-08
期刊：
CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES
影响因子：
6.9
作者：
Daimee, Usama A.;Wang, Yongfei;Masoudi, Frederick A.;Varosy, Paul D.;Friedman, Daniel J.;Du, Chengan;Koutras, Cristina;Reddy, Vivek Y.;Saw, Jacqueline;Price, Matthew J.;Kusumoto, Fred M.;Curtis, Jeptha P.;Freeman, James, V
通讯作者：
Freeman, James, V

Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials.

DOI：
10.1016/j.jcin.2022.02.029
发表时间：
2022-05-09
期刊：
JACC-CARDIOVASCULAR INTERVENTIONS
影响因子：
11.3
作者：
Friedman, Daniel J.;Du, Chengan;Wang, Yongfei;Agarwal, Vratika;Varosy, Paul D.;Masoudi, Frederick A.;Holmes, David R.;Reddy, Vivek Y.;Price, Matthew J.;Curtis, Jeptha P.;Freeman, James V.
通讯作者：
Freeman, James V.