Abstract

Abstract Introduction Long-term continuous cardiac monitoring in high-risk populations increases the chances of detecting atrial fibrillation and related arrhythmias[1]. In-hospital ECG monitoring is usually too brief to detect cardiac risk factors, while the availability and usability of ambulatory ECG is often lacking. Digital health tools are an attractive option for user-friendly, accurate, scalable mid-to-long-term cardiac risk monitoring[2]. These tools can also act as a driver to organize personalized care around the patient but that requires innovation in the reimbursement system. Recently Belgium established the mHealthBelgium validation pyramid[3], a 3-stage framework for reimbursement of digital health tools. Methods We used our remote monitoring platform to build a digital health solution for cardiac monitoring that provides direct diagnostic value and supports the care path for patients with cryptogenic stroke or transient ischemic attack. Our CE-certified solution has a cardiac chest patch to record ECG and motion data and a docking station at the patient’s home to securely send data to the cloud where data analytics is done. Our annotation flow detects atrial fibrillation and other stroke-relevant risk factors, reducing data burden for healthcare providers (HCP). HCPs interact with the raw and annotated data through a dashboard that generates reports and integrates with medical record systems. On-demand logistics allows hospitals to monitor as many patients as needed without delay and a pay-per-use model allows flexible monitoring periods and obviates the need for up-front device purchase. Results Since January 2022, more than 529 patients have been monitored with a median recording duration of 14 days±12 days. Approximately 205,500 hours of continuous ECG data was collected and 13421 potential risk factors were annotated, including 7227 potential atrial events (fibrillation or flutter) in 374 patients (>70%). In 45% of cases (n = 242), one or more events were confirmed by HCPs as clinically relevant. Our solution has progressed through the first two stages of the mHealth system by demonstrating CE-certification and interoperability with the government eHealth platform. For the final stage (M3), we have submitted one of the first dossiers in Belgium for improving the stroke care path with a more fit-for-purpose technology and coupling reimbursement to this specific use case instead of fee-for-service coding. Our proposal includes a real-world outcome data study. Conclusion We validate the importance and utility of remote monitoring of cardiac risk factors within the stroke care path. Retrospective results show that in 45% of cases, clinically relevant events were detected indicating that meaningful remote patient data is compatible with HCP workflows. The solution is progressing through a new care path-based reimbursement system that serves as a model for organizing value-based care around the patient's needs.Care path with remote patient monitoringReduced time to diagnosis with RPM

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