ISHNE/EHRA Expert Consensus on Remote Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs)

Abstract

We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices (CIEDs) with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), devices for cardiac resynchronization therapy (CRT) (both, with and without defibrillation properties), loop recorders, and haemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology (ISHNE) and the European Heart Rhythm Association (EHRA) combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.

E-Health and Telemedicine: Current Situation and Future Challenges

“…This generates an enormous clinical workload which increases further when devices approach ERI, or in response to product advisories and recalls. The application of e-Health and Telemedicine for remote monitoring of patients with implanted devices may provide mechanism(s) for facilitating these tasks [21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]. Data are promising and it can be expected that remote monitoring systems will develop into dedicated monitoring and therapy platforms.…”

Necessity of Face-to-Face Encounters With Recipients of Cardiovascular Implantable Electronic Devices With Remote Monitoring

“…13 The management of remote monitoring is presently performed in each center either by direct access of a physician to the transmitted data or by delegation to an allied professional specifically trained to perform this task during office hours. Most hospitals do not respond to alert events outside office hours 3 even if the system detects critical events, because of budgetary limitations and/or unavailability of suitable personnel.…”

“…Until then, patients may be requested to sign a written informed consent to be made aware of these facts. 12, 13 Thirdly, remote monitoring is expected to become a standard follow-up tool for patients with CIEDs. Presently, tasks including device evaluation, transmitted data analysis, internet data import/export, patient education, event notification, schedule checks of office-visits, etc.…”

“…First, in the present insurance system, the reimbursement of medical fees is approved every 4 month for patients with CIEDs only when it is accompanied by face-to-face encounters. This frequency of reimbursement should be shortened to at least once a month, 13 even if there were no face-to-face encounters for the next interval of 6-12 months, 8 because more than 90% of the follow-up days are actually monitored and data are analyzed on a daily basis by medical professionals. 10 Furthermore, a meta-analysis showed that management of heart failure patients by remote monitoring is cost-saving because of a substantial reduction in healthcare resource utilization, mostly driven by a reduction in the number of hospitalizations.…”

Remote Monitoring Leads to Early Recognition and Treatment of Critical Arrhythmias in Adults After Atrial Switch Operation for Transposition of the Great Arteries

“…8 The aim of the present study was to clarify if a cardiac deviceintegrated RM system in TGA patients following atrial switch repair enables physicians to improve medical care by early recognition of arrhythmias or lead-related problems.…”