Burden of Remote Monitoring Alerts in Patients with a Cardiac Implantable Electronic Device

Remote monitoring (RM), also known as home monitoring, of patients with cardiac implantable electronic devices (CIEDs), is associated with various benefits including rapid clinical response to patient and device events, fewer in-person evaluations, and cost reductions. Further, various studies have identified a mortality benefit. Though now considered the standard of care for the follow-up of all CIEDs, RM can be clinically onerous. Originally developed as a more intense, efficient and convenient substitute for the standard in-person clinic evaluation, RM has progressed to involve relatively frequent contact between devices and clinics, with some device manufacturers facilitating daily remote transmissions. As the CIED population expands, so does RM burden, with inevitably rising alert volumes. We seek to assess the RM transmission burden in a multicentre cohort via the use of an integrated software system. This is a retrospective, observational study. We will undertake analysis of a large multi-centre cohort of patients who received RM during a twelve-month period using PaceMate LIVETM, a software system with automatic integration of all RM transmissions and alerts from multiple device vendors, streamlined into a single user interface. The cohort will consist of 26,713 consecutive patients who received remote monitoring from November 2018 to November 2019. De-identified data will be provided from PaceMateTM, who provides a remote monitoring service for thousands of patients. The data will be derived from the PaceMate LIVE registry database. The data will include CIED type, CIED manufacturer, patient age, and any RM alerts transmitted to PaceMate LIVE. All transmissions have been analysed upon receipt by cardiac technicians certified by the International Board of Heart Rhythm Examiners via a service that is available 24 hours a day, 7 days a week for immediate (where possible, depending on the burden of RM transmissions cued for analysis) analysis and processing of all RM transmissions and alerts. Alerts have been categorised as either: 1. Red: high acuity requiring urgent clinical response; 2. Yellow: lesser acuity requiring non-urgent response; or 3. Green: Scheduled or patient-initiated transmissions that did not reach alert criteria. As per PaceMate protocol, after alert analysis, a concise written alert summary was transmitted to patient’s relevant clinic, via the same streamlined user interface, obviating the need for clinic staff to re-analyse electrogram and electrocardiogram tracings. This allows immediate shelving of any transmission not requiring a clinical response. Programming of alerts (as yellow or red) was left to the discretion of the treating physician, as was the clinical response to actionable alerts. The exposure is remote monitoring of patients with a cardiac implantable electronic device (permanent pacemaker, implantable cardioverter defibrillator, or implantable loop recorder). The exposure is not experimental but rather part of routine clinical practice in the care of this patient population. The observational period for this study is 12 months, however these patients are already receiving routine remote monitoring.