Background: Insertable Cardiac Monitors (ICM) available today rely on in-office visits for reprogramming to optimize sensitivity and manage false positive alerts. A novel system with remote programming capability has been developed to reduce the burden of in-office visits and enable same-day response to remote daily monitoring data. The CARMEL study was designed to evaluate its performance and reliability.
Objective: To evaluate the technical performance of a novel remote programming system for cardiac monitoring.
Methods: An adhesive wearable cardiac monitor (CM) was developed to be functionally equivalent to the ICM to test the programming and transmission functionality without risks of device insertion in a non-indicated group of patients (pts). The system consisted of a smart phone mobile monitor which communicated at scheduled intervals bi-directionally with the CM via Bluetooth and with the server (LATITUDE Clarity, Boston Scientific) via cellular or Wi-Fi network (Figure). Programming was tested with both in-person and remote proximity to the test subject.
Results: Volunteers (20) were prospectively enrolled and wore the CM for up to 14 days. Over 190 monitoring days 185 automatic daily CM and 975 server communications occurred at expected intervals. In 20 pts, 23 programming sessions were completed in-person. In 14 pts, 21 programming sessions were completed remotely. CM was successfully reprogrammed in all sessions (44/44).
Conclusion: This is the first report of remote programming for an ICM system. Remote programming is feasible in ICM recipients, was reliable in this pilot study and has the potential to substantially reduce clinic workload.