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

项目概要/摘要 心房颤动消融是电生理学实验室中最常见的手术 其增长速度持续快于任何其他 EP 手术。 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，强调现实世界证据的重要性和 缺乏纵向、多中心的数据收集平台来告知患者和医疗保健提供者。的 当前的提案旨在合并两个现有资源来帮助满足这些需求： AF Ablation National 心血管数据注册中心 (NCDR) 和 NIH 支持的 Eureka 移动健康研究平台。 The AF Ablation NCDR 是一种完善的质量评估工具，目前已在 200 家机构中运行 在美国各地，利用全面、仔细审查和定期审核的数据收集表格 确定有关患者、手术和机构级别信息的详细信息。 However, the AF 消融 NCDR 不会捕获有关手术有效性、安全性或患者的纵向信息 reported outcomes. Eureka 由当前项目的拟议 PI 共同开发和运行，是一个数字 为促进移动健康研究而建立的基础设施，提供既定的工作流程来获取远程信息 同意，通过移动应用程序积极参与研究参与者并直接收集信息， 采用技术集成从智能手机被动收集数据，并利用可靠、安全的 后端数据库来管理和传输结果数据。我们建议共同注册 AF 消融 NCDR 患者进入定制的尤里卡租户，以务实的方式实现纵向数据收集。同时 该项目的总体目标是利用这些努力来有效地构建可用资源 对于感兴趣的研究人员的多项二次分析、辅助项目和未来项目，我们将 展示合并基础设施在实现三个与临床直接相关的目标方面的效用。 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 在这个多中心、真实世界、前瞻性的研究中，特征作为 AF 消融有效性和风险的预测因子 队列，专门测试以下假设：女性、冷冻消融（而不是射频消融）、 在非教学医院进行的手术均会降低有效性和 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 AF 消融 结果，特别检验了消融后饮酒量减少与以下因素相关的假设： greater effectiveness.在目标 3 中，我们将寻求演示这个大型多中心数据库的用途 可用于表征罕见但特别是临床相关的并发症，特别是描述 房食管瘘的发病率和预测因素。总之，我们将努力创建一个实用的 培养原创性研究的平台，为真实的房颤消融手术提供最佳方法 世界。

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.