Effectiveness of remote monitoring of {CIEDs} in detection and treatment of clinical and device-related cardiovascular events in daily practice: the {HomeGuide} Registry

The HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management.The workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27 pacemakers, 27 single-chamber implantable cardioverter defibrillators (ICDs), 22 dual-chamber ICDs, 24 ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51): 2033 (82) were detected during HM sessions; 438 (18) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3 [confidence interval (CI), 82.586.0] and 97.4 (CI, 96.598.2), respectively. Overall, 95 of asymptomatic and 73 of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 114 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: 0.56 (CI, 0.530.58), P 0.0001. Resource consumption: 3364 HM sessions performed (76 by nurses), median committed monthly manpower of 55.5 (IQR, 22.0107.0) min health personnel/100 patients.Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption.