Optimizing Available Data Sources for Post-Marketing Surveillance: Real-World Use of Left Atrial Appendage Occlusion

优化上市后监测的可用数据源：左心耳封堵术的实际使用

• 批准号: 10701790
• 负责人: Kamil Faridi
• 金额: $ 19.2万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-09 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10701790
• 关键词: Achievement; Adopted; Adverse event; Advisory Committees; Agreement; American; Anticoagulation; Area; Atrial Fibrillation; Award; Biometry; Biostatistical Methods; Cardiology; Cardiovascular system; Clinical; Clinical Investigator; Code; Data; Data Sources; Databases; Devices; Effectiveness; Eligibility Determination; Evaluation; Event; Faculty; Future; Goals; Hemorrhage; Hospitals; Incidence; Interview; Ischemic Stroke; K-Series Research Career Programs; Left; Link; Machine Learning; Measures; Medical; Medicare; Medicare claim; Medicine; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Methodology; Methods; Modeling; Monitor; Oral; Outcome; Outcome Assessment; Outcome Measure; Outcomes Research; Patient Care; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Performance; Pharmacoepidemiology; Pharmacy facility; Physical Function; Population; Procedures; Program Development; Qualitative Methods; Qualitative Research; Quality of life; Registries; Reporting; Research; Research Personnel; Research Project Grants; Resources; Risk; Risk Reduction; Safety; Site; Specificity; Statistical Methods; Stroke; Technology; Training; Training Programs; adverse outcome; anxiety reduction; auricular appendage; cardiac device; career; career development; clinical practice; college; comparative effectiveness; comparative effectiveness analysis; comparison intervention; cost; data registry; design; experience; follow-up; high risk; improved; innovation; insight; interest; machine learning method; medical schools; member; mortality; novel; patient oriented; patient oriented research; patient registry; post-market; preservation; programs; randomized, clinical trials; skills; stroke risk; success; surveillance data

PROJECT SUMMARY/ABSTRACT Atrial fibrillation is a major cause of ischemic stroke and stroke-associated mortality worldwide. Though risk of ischemic stroke in patients with atrial fibrillation is reduced with oral anticoagulation (OAC), many are not suitable candidates for long-term OAC due to high bleeding risk. To help treat such patients, transcatheter left atrial appendage occlusion (LAAO) with the Watchman device was developed and approved as an alternative to OAC. However, efficient methods for evaluating clinical outcomes associated the Watchman device and other novel cardiovascular technologies are needed for long-term surveillance after regulatory approval. In this mentored patient-oriented career development award, Dr. Kamil Faridi will use a national registry of LAAO procedures linked to Medicare claims data to evaluate how different data sources and innovative statistical approaches can be utilized for evaluating the long-term safety and effectiveness of the Watchman device in real-world practice. In Aim 1, he will use traditional and advanced statistical methods to compare ischemic stroke and bleeding events identified with administrative claims data to site-reported events in a national registry of patients who undergo transcatheter LAAO. In Aim 2, he will use linked pharmacy claims data to evaluate registry-reported OAC use and compare outcomes between LAAO patients and medically managed patients with atrial fibrillation in real-world practice. To supplement quantitative strategies for post-marketing surveillance, in Aim 3 he will use qualitative methods to explore patient-reported perspectives and quality of life among patients referred for transcatheter LAAO. Accomplishing these research aims will lay the groundwork for future studies examining real-world surveillance of other cardiovascular therapies and other clinically important outcomes. This project will be led by Dr. Kamil Faridi, an early career investigator, cardiologist, and faculty member at the Yale School of Medicine with a track record of success in the field of cardiovascular outcomes research. During this 5-year program, Dr. Faridi will pursue additional training in machine learning, pharmacoepidemiology, comparative effectiveness and qualitative methods applied to patient-oriented research. This will be accomplished with a comprehensive career development program designed to provide Dr. Faridi with the skills needed to become a successful clinical researcher in cardiovascular medicine. His long-term career goal is to become an independent investigator with specific expertise in the areas of post- marketing surveillance and real-world data utilization for novel cardiovascular therapies, with the ultimate aim of improving patient care. Over the course of the research and training program, Dr. Faridi will be guided by an exceptional mentorship team and advisory committee consisting of established clinical investigators with expertise in cardiovascular medicine, outcomes research, and advanced biostatistical and qualitative methods. With implementation of this research project and the resources provided for training and career development, Dr. Faridi will be well prepared to transition to research independence by the end of the award period.

项目概要/摘要 心房颤动是全世界缺血性中风和中风相关死亡的主要原因。虽然有风险 口服抗凝药 (OAC) 可减少心房颤动患者的缺血性卒中，但许多患者并不能 由于出血风险高，适合长期 OAC 治疗。为了帮助治疗此类患者，经导管左 开发并批准使用 Watchman 装置进行心耳封堵 (LAAO) 作为替代方案 到 OAC。然而，评估临床结果的有效方法与 Watchman 设备和 在监管部门批准后，还需要其他新型心血管技术进行长期监测。在这个 卡米尔·法里迪 (Kamil Faridi) 博士将使用 LAAO 的国家注册中心 与医疗保险索赔数据相关的程序，以评估不同数据源和创新统计的效果 方法可用于评估 Watchman 设备的长期安全性和有效性 现实世界的实践。在目标 1 中，他将使用传统和先进的统计方法来比较缺血性 中风和出血事件通过行政索赔数据确定为国家现场报告的事件 接受经导管 LAAO 患者的登记。在目标 2 中，他将使用链接的药房索赔数据 评估注册报告的 OAC 使用情况并比较 LAAO 患者和医疗管理患者之间的结果 现实世界中的房颤患者。补充上市后的量化策略 监测，在目标 3 中，他将使用定性方法来探索患者报告的观点和生活质量 转诊接受经导管 LAAO 的患者。完成这些研究目标将为我们奠定基础 用于未来研究检查其他心血管治疗和其他临床治疗的真实世界监测 重要成果。该项目将由卡米尔·法里迪 (Kamil Faridi) 博士领导，他是一位早期职业调查员、心脏病专家和 耶鲁大学医学院的教员，在心血管领域拥有成功的记录 结果研究。在这个为期 5 年的计划中，Faridi 博士将接受机器学习方面的额外培训， 药物流行病学、比较有效性和定性方法应用于以患者为导向的 研究。这将通过一个全面的职业发展计划来实现，该计划旨在提供 Faridi 博士拥有成为心血管医学领域成功临床研究员所需的技能。他的 长期职业目标是成为一名在后领域具有特定专业知识的独立调查员 新型心血管疗法的营销监督和真实世界数据利用，最终目标 改善患者护理。在研究和培训计划的过程中，法里迪博士将受到一位 卓越的导师团队和咨询委员会由资深临床研究人员组成 心血管医学、结果研究以及先进的生物统计和定性方法方面的专业知识。 随着该研究项目的实施以及为培训和职业发展提供的资源， 法里迪博士将在奖励期结束前做好过渡到独立研究的准备。

项目成果

Trends in Spending and Claims for P2Y12 Inhibitors by Medicare and Medicaid From 2015 to 2020.

• DOI: 10.1161/jaha.122.028869
• 发表时间: 2023-04-18
• 期刊: JOURNAL OF THE AMERICAN HEART ASSOCIATION
• 影响因子: 5.4
• 作者: Essa, Mohammed;Ross, Joseph S. S.;Dhruva, Sanket S. S.;Desai, Nihar R. R.;Yeh, Robert W. W.;Faridi, Kamil F. F.
• 通讯作者: Faridi, Kamil F. F.

Impact of Preprocedure Imaging for Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry.

术前影像对左心耳闭塞的影响：NCDR LAAO 登记处的见解。

• DOI: 10.1016/j.jcin.2023.05.008
• 发表时间: 2023
• 期刊: JACC. Cardiovascular interventions
• 作者: Clarke,John-RossD;Higgins,AngelaY;Wang,Yongfei;Faridi,KamilF;Curtis,JepthaA;Freeman,JamesV;Friedman,DanielJ
• 通讯作者: Friedman,DanielJ