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.

项目总结/摘要 心房颤动消融术是在电生理实验室中进行的最常见的手术， 比任何其他EP手术都增长得更快。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，强调真实世界证据的重要性， 缺乏纵向的、多中心的数据收集平台，以告知患者和医疗保健提供者。的 目前的建议旨在合并两个现存的资源，以帮助满足这些需求：房颤消融国家 心血管数据登记（NCDR）和NIH支持的尤里卡移动的健康研究平台。的AF 消融NCDR是一个完善的质量评估工具，目前已在200个机构中运行 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未捕获关于手术有效性、安全性或患者的纵向信息 报告的结果。尤里卡是一个数字项目，由当前项目的拟议PI共同开发和运行 为促进移动的健康研究而建立的基础设施，提供既定的工作流程， 同意，积极参与并通过移动的应用程序直接从研究参与者收集信息， 采用技术集成从智能手机被动收集数据，并利用可靠和安全的 后端数据库来管理和传输结果数据。我们建议共同入组AF消融NCDR 将患者转变为定制的尤里卡租户，以务实的方式实现纵向数据收集。而 该项目的总体目标是利用这些努力，有效地构建一个可用的资源 对于多个次要分析、辅助项目和感兴趣的研究者的未来项目，我们将 展示合并后的基础设施的效用，以实现三个直接临床相关的目标。 在目标1中，我们将确定患者层面、程序层面和机构层面的相对影响 在这项多中心、真实世界、前瞻性研究中， 队列，专门检验女性、冷冻消融（而非射频消融） 在非教学医院进行的手术将与有效性降低有关， 更频繁的并发症。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，特别是测试消融术后饮酒量减少与 更高的效率。在目标3中，我们将试图展示这个大型多中心数据库如何 用于表征罕见但特别是临床相关的并发症，特别是描述 心房食管瘘的发病率和预测因素。总之，我们将努力创造一个实际有用的 培养原创研究的平台，为真实的房颤消融手术提供最佳方法 世界