Medical School of Chinese PLA, Department of Pulmonary Vessel and Thrombotic Disease, Sixth Medical Center, Chinese PLA General Hospital, Beijing, People's Republic of China.
Department of Cardiology, Second Medical Centre, National Clinical Research Centre for Geriatric Diseases, Chinese PLA General Hospital, Beijing, People's Republic of China.
Vasc Health Risk Manag. 2023 Jul 31;19:485-494. doi: 10.2147/VHRM.S407974. eCollection 2023.
Guideline-recommended integrated care based on the ABC (Atrial fibrillation Better Care) pathway for "general" patients with atrial fibrillation (AF) improves clinical outcomes, as demonstrated in our prior mobile Atrial Fibrillation Application (mAFA)-II cluster randomized trial. The present study aims to investigate whether mAFA III-supported structured follow-up rehabilitation packages adapted to patient risk profiles and different treatment patterns (eg, for patients receiving drug treatment only, AF ablation, or left atrial appendage occlusion [LAAO]) will improve guideline adherence and reduce the risk of adverse cardiovascular events.
In this prospective, observational mAFA III pilot cohort study, patients with AF aged ≥ 18 years will be enrolled using the mAFA III App for self-management. Assuming an annual rate of composite outcome of "ischaemic stroke or systemic embolism, all-cause death and cardiovascular hospitalization" of 29.3% for non-ABC pathway compliance compared with 20.8% for ABC pathway compliance, at least 1475 patients would be needed to detect the outcome of the A, B and C components of the ABC pathway, assuming a withdrawal rate of 20% in the first year. The primary endpoint is adherence to guidelines regarding the A, B and C components of the ABC pathway. Ancillary analyses will be performed to determine the impact of the ABC pathway using smart technologies on the outcomes among the "high-risk" population (eg, ≥75 years old, with multimorbidities, with polypharmacy) and the application of artificial intelligence machine-learning AF risk prediction management in assessing AF recurrence. The individualised anticoagulants with AF burden will be monitored by smart devices.
ISRCTN13724416.
基于 ABC（心房颤动更好护理）路径的指南推荐的综合护理，适用于“一般”心房颤动（AF）患者，可改善临床结局，这在前瞻性移动心房颤动应用（mAFA）-II 集群随机试验中得到了证实。本研究旨在探讨 mAFA III 支持的结构化随访康复方案是否能根据患者的风险概况和不同的治疗模式（例如，仅接受药物治疗、房颤消融或左心耳封堵术 [LAAO] 的患者）进行调整，从而改善指南的依从性并降低不良心血管事件的风险。
在这项前瞻性、观察性的 mAFA III 试点队列研究中，将使用 mAFA III 应用程序对年龄≥18 岁的 AF 患者进行自我管理。假设非 ABC 路径依从性的复合结局“缺血性卒中或全身性栓塞、全因死亡和心血管住院”的年发生率为 29.3%，而 ABC 路径依从性的年发生率为 20.8%，则需要至少 1475 例患者才能检测到 ABC 路径的 A、B 和 C 部分的结果，假设第一年的退出率为 20%。主要终点是 ABC 路径的 A、B 和 C 部分的指南依从性。辅助分析将用于确定使用智能技术的 ABC 路径对“高危”人群（例如，≥75 岁、有多种合并症、多药治疗）的结果的影响，以及人工智能机器学习房颤风险预测管理在评估房颤复发中的应用。智能设备将监测房颤负担的个体化抗凝药物。
ISRCTN87575737。
