Remote monitoring of cardiovascular implanted electronic devices: a paradigm shift for the 21st century

Figures & data

Table 1. Technical aspects of currently available remote monitoring platforms.

	CareLink^™ (Medtronic)	Home Monitoring^™ (BIOTRONIK)	LATITUDE^™ (Boston Scientific)	Merlin.net^™ (St. Jude Medical)	SMARTVIEW^™ (Sorin)
Compatible CIEDs	Pacemaker, ICD, CRT-D, CRT-P, ILR	Pacemaker, ICD, CRT-D and CRT-P	ICD, CRT-D	Pacemaker, ICD, CRT-D and CRT-P	ICD, CRT-D
Data transmission	Landline, GSM	Landline, GSM, GPRS	Landline	Landline, GSM, GPRS, 3G	Landline, GPRS
Frequency of follow-up	Daily monitoring, scheduled follow-up	Daily monitoring, daily follow-up	Daily monitoring, scheduled follow-up	Daily monitoring, scheduled follow-up	Daily monitoring, scheduled follow-up
Notification	Voice message, pager, SMS, e-mail, technician call, mobile device application	SMS, e-mail, fax	Fax, phone call, SMS, e-mail	SMS, e-mail, fax	SMS, e-mail, fax
Battery drain	Each transmission reduces service life by 0.7–1.8 days or 0.03–0.05%	Approximately 2% of battery power over device lifetime	Unknown	Approximately 3 months over a 9-year service life for pacemakers	Approximately 0.3–0.8 years over device lifetime

Availability of platforms, and some features, varies by country and device.

CIED: Cardiovascular implantable electronic devices; CRT-D: Cardiac resynchronization therapy-defibrillation; CRT-P: Cardiac resynchronization therapy-pacing; GPRS: General packet radio service; GSM: Global system for mobile communications; ICD: Implantable cardioverter defibrillator; ILR: Implantable loop recorder; SMS: Short messaging service.

Table 2. Ongoing studies of remote monitoring registered on ClinicalTrials.gov^† as of January 2012.

Study	NCT identifier	Sponsor	Design	Outcomes	Locations	Status
Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator Recipients	NCT01459874	San Filippo Neri General Hospital	Observational	Utility of the organizational model	Italy	Ongoing
REMOTE-IPG	NCT00631709	Medtronic	Observational	Quality, satisfaction, costs	Canada	Completed February 2010
Investigation on Routine Follow-up in Congestive Heart Failure Patients with Remotely Monitored ICD SysTems (InContact)	NCT01200381	St. Jude Medical	Randomized – in clinic versus remote follow-ups	Heart failure clinical composite response	Germany	Recruiting
Clinical Evaluation of Remote Monitoring with Direct Alerts to Reduce Time from Event to Clinical Decision (REACT)	NCT01090349	St. Jude Medical	Randomized – alerts on versus alerts off	Time from detection of event to clinical decision	Germany and UK	Ongoing
Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation (Educ@t)	NCT01006746	BIOTRONIK France	Observational	Qualitative measures	France	Ongoing
Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients (SAN REMO 2)	NCT01230073	Deutsches Herzzentrum Muenchen	Randomized, parallel assignment, open label – remote monitoring versus conventional follow-up	Patient satisfaction	Germany	Not yet recruiting
Benefits of Implantable Cardioverter Defibrillator Follow-up using Remote Monitoring (ECOST)	NCT00989417	BIOTRONIK SE & Co. KG	Randomized, parallel assignment, open label	Adverse events	France	Preliminary results presented at ESC 2011
Evaluate the Benefits of Pacemaker Follow-Up with Home Monitoring (COMPAS)	NCT00989326	BIOTRONIK France	Randomized, parallel assignment, open label	Adverse events	France	Preliminary results presented at Cardiostim 2010
Home Monitoring in ICD Patients (Monitor-ICD)	NCT00787683	Charité University, Berlin,	Randomized, parallel assignment, open label	Costs	Germany	Recruiting
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D	NCT00395642	BIOTRONIK	Nonrandomized, single-arm, multicenter feasibility study	Patient compliance	USA	Completed January 2008
EuroEco	NCT00776087	BIOTRONIK	Randomized, parallel assignment, open label	Costs	Europe	Ongoing
Health Economic Evaluation of Remote Follow Follow-up for ICD Patients (TARIFF)	NCT01075516	St. Jude Medical	Observational	Costs	Italy	Recruiting
Strategy of Early Detection and Active Management of Supraventricular Arrhythmia with Telecardiology (SETAM)	NCT01108692	BIOTRONIK	Randomized, parallel assignment, single blind	Time to clinical decision (antithrombotic and/or antiarrhythmic drugs)	France	Recruiting
MORE-CARE	NCT00885677	Medtronic	Randomized, parallel assignment, open label	Time to clinical decision, morbidity/mortality, and healthcare utilization	Europe and Israel	Recruiting
RAPID-RF	NCT00334451	Boston Scientific	Observational registry	Alert notifications and resulting medical interventions	USA	Completed
Evolution of Management Strategies of Heart Failure Patients with Implantable Defibrillators (EVOLVO)	NCT00873899	Regione Lombardia	Observational	Cardiac or device-related clinic visits	Italy	Recruiting
Care Link Evaluation	NCT01023022	Medtronic	Observational	Patient and clinician satisfaction, costs	Poland	Recruiting
Evaluation of the ‘Tele-follow-up’ for the Follow-up of Implantable Defibrillators (EVATEL)	NCT00598026	Rennes University Hospital	Randomized, parallel assignment, open label	Noninferiority of remote monitoring with respect to safety	France	Preliminary results presented at the European Society of Cardiology 2011
Cardiac Rhythm Monitoring after Acute Decompensation for Heart Failure (CARRYING ON)	NCT01216670	Medtronic	Post-market, open-label, pilot trial of the Reveal XT™ implantable loop recorder	Clinical and arrhythmic events in patients with low ejection fraction	Italy	Recruiting
Comparison between Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Impact on Hospital Length of Stay because of Heart Failure (ConnectOptiVol)	NCT00730548	Medtronic	Randomized, parallel assignment, open label	Length of hospital stay – OptiVol® with remote monitoring versus standard care	Germany	Recruiting
Psychosomatic Effects of Implantable Cardioverter Defibrillator with Home Monitoring Function (QUANTUM)	NCT00325221	BIOTRONIK	Randomized, parallel assignment, open label	Hospital Anxiety and Depression Scale anxiety score	Germany, Austria and Switzerland	Ongoing
The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with Implanted ICD and CRT-D Devices	NCT00559988	BIOTRONIK	Randomized, parallel assignment	Stroke, systemic embolism and major bleeding	North America, Europe and Australia	Recruiting

^†All trials available at [106].

ECOST: Effectiveness and Cost of ICD Follow-up Schedule with Telecardiology; EuroEco: European Health Economic Trial on Home Monitoring in ICD Therapy; EVATEL: Evaluation Telecardiologies; ICD: Implanted cardioverter defibrillator; MORE-CARE: Monitoring Resynchronization Devices and Cardiac Patients; RAPID-RF: Remote Active Monitoring in Patients with Heart Failure; REMOTE-IPG: Remote monitoring transmission evaluation of implantable pulse generators; TRIAGE-CRT: Telemonitoring in Patients with CHF and Indication of CRT-D.

Clinicaltrials.gov.http://clinicaltrials.gov

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