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


RESULTS
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), 82.5-86.0%] and 97.4% (CI, 96.5-98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1-14 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, 0.53-0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0-107.0) min × health personnel/100 patients.


CONCLUSIONS
Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption.
Department of Cardiology, San Filippo Neri Hospital, via Martinotti 20, Rome, Italy. renatopietroricci@tin.it
Renato Pietro
RP
Ricci
Loredana
L
Morichelli
Antonio
A
D'Onofrio
Leonardo
L
Calò
Diego
D
Vaccari
Gabriele
G
Zanotto
Antonio
A
Curnis
Gianfranco
G
Buja
Nicola
N
Rovai
Alessio
A
Gargaro
D000368:Aged; D000369:Aged, 80 and over; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects / Q000451:nursing; D058406:Cardiac Resynchronization Therapy; D058409:Cardiac Resynchronization Therapy Devices; D017147:Defibrillators, Implantable; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation* / Q000451:nursing; D004867:Equipment Design; D005260:Female; D006331:Heart Diseases / Q000175:diagnosis / Q000451:nursing / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D017216:Telemedicine / Q000379:methods*; D013686:Telemetry; D013997:Time Factors; D016896:Treatment Outcome; D057188:Workflow
Implantable cardioverter defibrillators; Pacemakers; Remote monitoring; Telemedicine