Applying Digital Health to the AF Ablation NCDR, Enabling Longitudinal Follow-up

将数字健康应用于房颤消融 NCDR，实现纵向随访

• 批准号: 10672387
• 负责人: GREGORY M MARCUS
• 金额: $ 70.72万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-16 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10672387
• 关键词: Ablation; Address; Alcohol consumption; American; Assessment tool; Atrial Fibrillation; Cardiac; Cardiac Electrophysiologic Techniques; Cardiac ablation; Cardiology; Cardiovascular system; Cellular Phone; Cessation of life; Characteristics; Clinical; Complication; Country; Cryosurgery; Current Procedural Terminology Codes; Data; Data Collection; Databases; Disease; Effectiveness; Electrophysiology (science); Enrollment; Female; Fistula; Funding; Future; Goals; Guidelines; Health Personnel; Heavy Drinking; Hospitalization; Hospitals; ICD-9; Incidence; Infrastructure; Institution; International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10); Intervention; Laboratories; Life Style; Longitudinal Studies; Methods; National Heart, Lung, and Blood Institute; Outcome; Paper; Participant; Patient Outcomes Assessments; Patients; Procedures; Professional Organizations; Prospective cohort; Publishing; Quality of life; Radiofrequency Interstitial Ablation; Recommendation; Registries; Reporting; Research; Research Personnel; Research Project Grants; Resources; Risk; Running; Safety; Secure; Sorting; Testing; Time; United States National Institutes of Health; Visit; Work; administrative database; biomedical referral center; clinically relevant; college; data registry; digital; digital health; effectiveness evaluation; experience; follow-up; heart rhythm; high risk; implantation; indexing; interest; lifestyle factors; mHealth; member; mobile application; mortality; operation; participant enrollment; patient registry; prospective; randomized trial; remote consent; secondary analysis; sex; smartphone application; standard of care; symptomatic improvement; tool; transmission process

PROJECT SUMMARY/ABSTRACT Atrial fibrillation ablation is the most common procedure performed in electrophysiology laboratories and continues to grow more rapidly than any other EP procedure. A recent NHLBI report highlighted the research needs and priorities for catheter ablation of AF, emphasizing the importance of real-world evidence and the lack of longitudinal, multi-center, data collection platforms to inform patients and healthcare providers. The current proposal seeks to merge two extant resources to help fulfill those needs: the AF Ablation National Cardiovascular Data Registry (NCDR) and the NIH-supported Eureka mobile health research platform. The AF Ablation NCDR is a well-established quality assessment tool currently already in operation in 200 institutions around the US, utilizing comprehensive and carefully vetted and regularly audited data collection forms to ascertain detailed information regarding patient, procedure, and institution-level information. However, the AF Ablation NCDR does not capture longitudinal information regarding procedural effectiveness, safety, or patient reported outcomes. Eureka, co-developed and run by the proposed PI of the current project, is a digital infrastructure built to facilitate mobile health-based research, providing established workflows to obtain remote consent, actively engage with and collect information directly from research participants via a mobile app, employ technical integrations to passively collect data from smartphones, and utilizes a reliable and secure backend database to curate and transmit the resultant data. We propose to co-enroll AF Ablation NCDR patients into a customized Eureka tenant, enabling longitudinal data collection in a pragmatic fashion. While the overarching goal of this project will be to leverage these efforts to efficiently construct a resource available for multiple secondary analyses, ancillary projects, and future projects for interested investigators, we will demonstrate the utility of the merged infrastructure to pursue three immediately clinically relevant Aims. In Aim 1, we will determine the relative influences of patient-level, procedural-level, and institution-level characteristics as predictors of AF Ablation effectiveness and risk in this multi-center, real-world, prospective cohort, specifically testing the hypotheses that female sex, cryoablation (rather than radiofrequency ablation), and procedures performed in non-teaching hospitals will each be associated with reduced effectiveness and more frequent complication. In Aim 2, we will seek to determine how lifestyle factors may influence AF Ablation outcomes, specifically testing the hypothesis that reduced alcohol consumption after ablation is associated with greater effectiveness. In Aim 3, we will seek to demonstrate how this large multi-center database may be useful in characterizing rare but especially clinically relevant complications, specifically to describe the incidence and predictors of atrioesophageal fistula. Taken together, we will work to create a practically useful platform that cultivates original research to inform optimal approaches to AF ablation procedures in the real world.

项目摘要/摘要 心房颤动消融是在电生理实验室和 比任何其他EP程序的增长速度更快。 NHLBI最近的一份报告强调了这项研究 导管消融AF的需求和优先事项，强调了现实世界证据的重要性和 缺乏纵向，多中心，数据收集平台，以告知患者和医疗保健提供者。这 当前的提议试图合并两个现有的资源以帮助满足这些需求：AF消融国家 心血管数据注册中心（NCDR）和NIH支持的尤里卡移动健康研究平台。 AF 烧料NCDR是目前在200家机构中运营的一个公认的质量评估工具 在美国各地，利用全面，仔细审查和定期审核的数据收集表 确定有关患者，程序和机构级信息的详细信息。但是，AF 消融NCDR不会捕获有关程序有效性，安全性或患者的纵向信息 报告的结果。尤里卡（Eureka）由当前项目的拟议PI共同开发并运行 为了促进基于移动健康的研究而建立的基础设施，提供既定的工作流程以获取远程 同意，通过移动应用程序直接从研究参与者那里积极互动并收集信息， 采用技术集成以被动地从智能手机收集数据，并利用可靠可靠的安全 后端数据库策划和传输所得数据。我们建议共同摄取AF消融NCDR 患者进入定制的尤里卡租户，以务实的方式收集纵向数据。尽管 该项目的总体目标是利用这些努力有效地构建可用的资源 对于有关感兴趣的研究人员的多次次级分析，辅助项目和未来项目，我们将 展示合并基础设施的实用性，以追求三个立即与临床相关的目标。 在AIM 1中，我们将确定患者级，程序级别和机构级别的相对影响 在这个多中心，现实世界中，特征是AF消融效率和风险的预测因素 队列，专门检验了女性性别，冷冻化（而不是射频消融）的假设， 在非教学医院执行的程序将与效力降低和 更频繁的并发症。在AIM 2中，我们将寻求确定生活方式因素如何影响AF消融 结果，专门检验了以下假设，即消融后降低酒精消耗与 更大的有效性。在AIM 3中，我们将寻求展示这个大型多中心数据库 可用于表征罕见但尤其是临床相关的并发症，特别是描述 心动过管瘘的发生率和预测因子。综上所述，我们将努力创建一个实际有用的 培养原始研究的平台以为真实的AF消融程序提供最佳方法 世界。