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: 10278345
• 负责人: GREGORY M MARCUS
• 金额: $ 55.09万
• 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/10278345
• 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; Clinical Research; Code; Complication; Country; Cryosurgery; Current Procedural Terminology Codes; Custom; Data; Data Collection; Databases; Disease; Effectiveness; Electrophysiology (science); Enrollment; Female; Fistula; Funding; Future; Goals; Guidelines; Health Personnel; Heavy Drinking; 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; Testing; Time; United States National Institutes of Health; Visit; Work; administrative database; base; 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; patient registry; prospective; randomized trial; remote consent; secondary analysis; sex; smartphone Application; standard of care; symptomatic improvement; tool

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 房颤消融是电生理实验室最常见的手术， 继续以比任何其他EP程序更快的速度增长。NHLBI最近的一份报告强调了这项研究 房颤导管消融的需求和优先事项，强调真实世界证据和 缺乏纵向的、多中心的数据收集平台来通知患者和医疗保健提供者。这个 目前的提案寻求合并两个现有的资源，以帮助满足这些需求：房颤消融国家 心血管数据注册中心(NCDR)和NIH支持的Eureka移动健康研究平台。田径队 消融NCDR是一种成熟的质量评估工具，目前已在200个机构中使用 在美国各地，利用全面、仔细审查和定期审计的数据收集表格 确定有关患者、程序和机构级信息的详细信息。然而，AF 消融NCDR不能捕获有关程序有效性、安全性或患者的纵向信息 报告结果。Eureka是由当前项目的拟议PI共同开发和运行的，是一个数字 为促进基于移动健康的研究而构建的基础设施，提供已建立的工作流以获取远程 同意，积极参与并通过移动应用程序直接从研究参与者那里收集信息， 采用技术集成被动地从智能手机收集数据，并利用可靠和安全的 后端数据库来管理和传输结果数据。我们建议联合登记房颤消融NCDR 将患者添加到定制的Eureka租户中，以务实的方式实现纵向数据收集。而当 该项目的总体目标将是利用这些努力有效地构建可用的资源 对于感兴趣的调查人员的多个二次分析、辅助项目和未来项目，我们将 展示合并后的基础设施的效用，以实现三个直接与临床相关的目标。 在目标1中，我们将确定患者级别、程序级别和机构级别的相对影响 多中心、真实世界、前瞻性的房颤消融效果和风险的预测因素 队列，具体测试女性性别、冷冻消融(而不是射频消融)、 而在非教学医院进行的程序将分别与降低有效性和 更常见的并发症。在目标2中，我们将寻求确定生活方式因素如何影响房颤消融 结果，特别是测试消融后减少酒精摄入量与 更大的成效。在目标3中，我们将试图演示这个大型多中心数据库可能是如何 有助于描述罕见但尤其与临床相关的并发症，特别是描述 房性食管瘘的发生率和预测因素。综上所述，我们将努力创造一个实用的 培养原创研究的平台，为真实的房颤消融程序提供最佳方法 世界。