Technical Reliability and Clinical Safety of a Remote Monitoring System for Antiarrhythmic Cardiac Devices

Abstract

Introduction and objectives: In recent years, physicians have experienced a huge increase in workload associated with cardiac devices. Remote monitoring enables these devices to be monitored at a distance and could reduce the number of hospital visits. The aim of this study was to assess the technical reliability and clinical safety of the Home Monitoring™ remote monitoring system (Biotronik GmbH, Germany). Methods: The study included 162 patients: 115 with pacemakers, 44 with implantable cardioverter-defibrillators (ICDs) and three with ICDs incorporating cardiac resynchronization therapy (CRT). Patients were followed up for a mean of 303±244 days. We compared the survival time free of event alerts in patients with pacemakers and in those with ICDs. The remote monitoring system's reliability was evaluated by comparing the data it transmitted with clinical observations made immediately afterwards. Results: The mean percentage of days monitored was 88.2%. The incidence of event alerts was higher in pacemaker than ICD patients (45% vs. 34%; P=.01). Event alerts preceded the following hospital visit by 76±47 days. In the ICD group, the data sent by the monitoring system were judged as true-positives in 42% of cases, as true-negatives in 57% and as false-positives in 1%. No false-negative was observed. In the ICD group, the remote monitoring system had a sensitivity of 100% and a specificity of 97% (positive predictive value 96%, negative predictive value 100%). Conclusions: Remote monitoring was a reliable and safe method for following up patients with cardiac devices. Its routine use could enable the early detection of device malfunctions or arrhythmic events.