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2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic

Learn about the new recommendations on Practical Management of the Remote Device Clinic.

Aileen M. Ferrick, PhD, ACNP, RN, FHRS (Co-Chair), Satish R. Raj, MD, MSCI, FHRS (Co-Chair), Thomas Deneke, MD, PhD, FHRS (EHRA Vice-Chair), Pipin Kojodjojo, MBBS, PhD, FHRS (APHRS Vice-Chair), Nestor Lopez-Cabanillas, MD (LAHRS Vice-Chair), Haruhiko Abe, MD, PhD, Serge Boveda, MD, PhD, FEHRA, FESC, Derek S. Chew, MD, MSc, FHRS, Jong-Il Choi, MD, PhD, MHS, Nikolaos Dagres, MD, Aarti S. Dalal, DO, FACC, FHRS, CEPS-P, Brynn E. Dechert, APN, FHRS, CCDS, Camille G. Frazier-Mills, MD, MHS, CCDS, Olivia Gilbert, MD, MSc, FACC, Janet K. Han, MD, FACC, FHRS, Sherri Hewit, PharmD, Christine Kneeland, BSN, Starr DeEllen Mirza, Suneet Mittal, MD, FHRS, Renato Pietro Ricci, MD, Mary Runte, PhD, Susan Sinclair, NZCS, PGDHSc,
Ricardo Alkmim-Teixeira, MD, PhD, Bert Vandenberk, MD, PhD, Niraj Varma, MA, MD, PhD

Highlights from the 2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic

An underlying impediment to worldwide adoption of RM is the irregular availability of reimbursement. This international consensus document delivers a strong message to health care payors to provide adequate reimbursement, according to the country or regional health system, for costs of the RM system itself (hardware, software, and industry service); physician interpretation and effort of allied health professionals; and administrative and nonclinical personnel.

Varma N. Highlights from the 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Heart Rhythm O2. 2023 Aug 28;4(9):526-527. doi: 10.1016/j.hroo.2023.08.001. PMID: 37744939; PMCID: PMC10513915.

Remote Monitoring of Cardiac Implantable Electronic Devices and Disease Management 

A 2023 study led by Professor Niraj Varma explores the evolution of remote monitoring in managing Cardiac Implantable Electronic Devices (CIEDs). The findings highlight a shift from periodic in-office appointments to continuous, personalized remote monitoring, suggesting more efficient and patient-specific care. This change could extend in-office visits to every 24 months for stable patients, impacting healthcare workflow, reimbursement, and data management.

Varma N, Braunschweig F, Burri H, Hindricks G, Linz D, Michowitz Y, Ricci RP, Nielsen JC. Remote monitoring of cardiac implantable electronic devices and disease management. Europace. 2023 Aug 2;25(9):euad233. doi: 10.1093/europace/euad233. PMID: 37622591; PMCID: PMC10451003.

Alert-driven vs. Scheduled Remote Monitoring of Implantable Cardiac Defibrillators: A Cost-Consequence Analysis from the TRUST Trial

Alert-driven remote patient monitoring (RPM) or fully virtual care without routine evaluations may reduce clinic workload and promote more efficient resource allocation, principally by diminishing nonactionable patient encounters.

Chew DS, Piccini JP, Au F, et al. Alert-driven vs scheduled remote monitoring of implantable cardiac defibrillators: A cost-consequence analysis from the TRUST trial. Heart Rhythm. 2023;20(3):440-447. doi:10.1016/j.hrthm.2022.12.003

Clinician Use of Data Elements from Cardiovascular Implantable Electronic Devices in Clinical Practice

The present study investigated clinicians’ frequency of use of CIED data in clinical practice and revealed preferences and challenges with using CIED reports in clinical decision-making. The survey findings suggest that CIED data reports are comprehensive, providing an abundance of important information. However, improvements can be made to organize reports better to enhance the use of actionable data in clinical practice.

Daley C, Coupe A, Allmandinger T, Shirazi J, Wagner S, Drouin M, Ahmed R, Toscos T, Mirro M. Clinician use of data elements from cardiovascular implantable electronic devices in clinical practice. Cardiovasc Digit Health J. 2023 Jan 20;4(1):29-38. doi: 10.1016/j.cvdhj.2022.10.007. PMID: 36865585; PMCID: PMC9972003.

Remote Monitoring of CIEDs—For Both Safety, Economy, and Convenience?

The review summarizes some of the recent research in the field of remote monitoring of cardiac devices. Specifically highlighting major follow-up improvements regarding safety, economic, and patient satisfaction.

Lappegård KT, Moe F. Remote Monitoring of CIEDs-For Both Safety, Economy and Convenience? Int J Environ Res Public Health. 2021 Dec 28;19(1):312. doi: 10.3390/ijerph19010312. PMID: 35010572; PMCID: PMC8751026.

Remote Monitoring Alert Burden: An Analysis of Transmission in >26,000 Patients

This study sought to determine the remote monitoring (RM) alert burden in a multicenter cohort of patients with a cardiac implantable electronic device (CIED).

O’Shea CJ, Middeldorp ME, Hendriks JM, et al. Remote Monitoring Alert Burden: An Analysis of Transmission in >26,000 Patients. JACC Clin Electrophysiol. 2021;7(2):226-234. doi:10.1016/j.jacep.2020.08.029

HRS/EHRA/APHRS/LAHRS/ACC/AHA Worldwide Practice Update for Telehealth and Arrhythmia Monitoring During and After a Pandemic

The Covid-19 crisis has accelerated the use of remote patient management in various medical fields, especially among professionals dealing with heart rhythm issues. Catalyzed by the pandemic, the practice of cardiac remote monitoring is here to stay.

Varma N, Marrouche NF, Aguinaga L, et al. HRS/EHRA/APHRS/LAHRS/ACC/AHA Worldwide Practice Update for Telehealth and Arrhythmia Monitoring During and After a Pandemic. J Am Coll Cardiol. 2020;76(11):1363-1374. doi:10.1016/j.jacc.2020.06.019

Improved Survival in Patients Enrolled Promptly into Remote Monitoring Following Cardiac Implantable Electronic Device Implantation

The retrospective, national, observational cohort study highlights that initiating remote monitoring within 90 days of CIED implantation, compared to delayed initiation, was associated with a lower patient mortality rate. This advantage was observed across all CIED device types.

Mittal S, Piccini JP, Snell J, Prillinger JB, Dalal N, Varma N. Improved survival in patients enrolled promptly into remote monitoring following cardiac implantable electronic device implantation. J Interv Card Electrophysiol. 2016 Aug;46(2):129-36. doi: 10.1007/s10840-016-0112-y. Epub 2016 Feb 10. PMID: 26860839; PMCID: PMC4923102.

Remote Monitoring of Cardiac Implantable Electronic Devices (CIED)

With increasing indications and access to cardiac implantable electronic devices (CIEDs) worldwide, the number of patients needing CIED follow-up continues to rise. In parallel, the technology available for managing these devices has advanced considerably. In this setting, remote monitoring (RM) has emerged as a complement to routine in-office care. Rigorous studies, randomized and otherwise, have demonstrated advantages to patients with CIED management systems which incorporates RM resulting in authoritative guidelines from relevant professional societies recommending RM for all eligible patients. In addition to clinical benefits, CIED management programs that include RM have been shown to be cost-effective and associated with high patient satisfaction.

Zeitler EP, Piccini JP. Remote monitoring of cardiac implantable electronic devices (CIED). Trends Cardiovasc Med. 2016 Aug;26(6):568-77. doi: 10.1016/j.tcm.2016.03.012. Epub 2016 Mar 31. PMID: 27134007; PMCID: PMC4958580.

Use of Remote Monitoring is Associated with Lower Risk of Adverse Outcomes Among Patients with Implanted Cardiac Defibrillators

The study was conducted to examine the association between the use of remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICD) and all-cause mortality and rehospitalization among patients undergoing initial ICD implant. Upon completion, it was determined that using RPM on patients undergoing first-time ICD implantation is at risk of significantly lower risk of adverse outcomes.

Akar JG, Bao H, Jones PW, Wang Y, Varosy PD, Masoudi FA, Stein KM, Saxon LA, Normand SL, Curtis JP. Use of Remote Monitoring Is Associated With Lower Risk of Adverse Outcomes Among Patients With Implanted Cardiac Defibrillators. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1173-80. doi: 10.1161/CIRCEP.114.003030. Epub 2015 Jun 19. PMID: 26092577.

2015 HRS Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Implantable Electronic Devices

Cardiovascular implantable electronic devices (CIEDs) have evolved significantly since the publication of the 2008 Heart Rhythm Society (HRS) consensus statement1 outlining recommended monitoring strategies. Novel embedded technologies have created the ability of the devices to monitor their own function, record arrhythmias and other physiological parameters, and communicate this information to health care providers without the active participation of the patient. CIEDs with wireless remote monitoring (RM) capabilities stand at the forefront of a new class of medical devices that will unobtrusively acquire vital data beyond the walls of health care facilities and seamlessly transmit the information back to health care providers. This document focuses on implantable devices for managing heart rhythm disorders.

Slotwiner D, Varma N, Akar JG, Annas G, Beardsall M, Fogel RI, Galizio NO, Glotzer TV, Leahy RA, Love CJ, McLean RC, Mittal S, Morichelli L, Patton KK, Raitt MH, Ricci RP, Rickard J, Schoenfeld MH, Serwer GA, Shea J, Varosy P, Verma A, Yu CM. HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm. 2015 Jul;12(7):e69-100. doi: 10.1016/j.hrthm.2015.05.008. Epub 2015 May 14. PMID: 25981148.

Rationale and design of the MONITOR-ICD study: A randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators

Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial.

Zabel M, Müller-Riemenschneider F, Geller JC, Brachmann J, Kühlkamp V, Dissmann R, Reinhold T, Roll S, Lüthje L, Bode F, Eckardt L, Willich SN; MONITOR-ICD investigators. Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators. Am Heart J. 2014 Oct;168(4):430-7. doi: 10.1016/j.ahj.2014.04.021. Epub 2014 Jun 13. PMID: 25262251.

Canadian Cardiovascular Society/Canadian Heart Rhythm Society Joint Position Statement on the Use of Remote Monitoring for Cardiovascular Implantable Electronic Device Follow-up

Remote monitoring (RM) is a form of telemedicine technology that permits implanted pacemakers and implantable cardioverter-defibrillators to transmit diagnostic information for review by health care professionals without patients needing to visit the device follow-up clinic. A bedside transmitter in the patient’s home conveys the device data using standard telecommunication protocol to a protected internet-accessible RM data server, which authorized health care professionals can access at any time using standard web browser software. Evidence indicates it can accelerate identification of clinical events and potential device problems.

Yee R, Verma A, Beardsall M, Fraser J, Philippon F, Exner DV. Canadian Cardiovascular Society/Canadian Heart Rhythm Society joint position statement on the use of remote monitoring for cardiovascular implantable electronic device follow-up. Can J Cardiol. 2013 Jun;29(6):644-51. doi: 10.1016/j.cjca.2012.11.036. Epub 2013 Mar 5. PMID: 23465345.

Remote Monitoring of Cardiovascular Devices: A Time and Activity Analysis

Expanding indications for cardiovascular implantable electronic devices are accompanied by an increasing burden of device clinic follow-up. Remote monitoring (RM) may be less time-consuming compared to in-office follow-up; however, its effect on the device clinic workflow has not been clarified.
Cronin EM, Ching EA, Varma N, Martin DO, Wilkoff BL, Lindsay BD. Remote monitoring of cardiovascular devices: a time and activity analysis. Heart Rhythm. 2012 Dec;9(12):1947-51. doi: 10.1016/j.hrthm.2012.08.002. Epub 2012 Aug 3. PMID: 22864266.

Clinical Benefits of Remote Versus Transtelephonic Monitoring of Implanted Pacemakers

This study aimed to evaluate remote pacemaker interrogation for the earlier diagnosis of clinically actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation.

Crossley GH, Chen J, Choucair W, Cohen TJ, Gohn DC, Johnson WB, Kennedy EE, Mongeon LR, Serwer GA, Qiao H, Wilkoff BL; PREFER Study Investigators. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers. J Am Coll Cardiol. 2009 Nov 24;54(22):2012-9. doi: 10.1016/j.jacc.2009.10.001. PMID: 19926006.

Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial

Monitoring implantable cardiac device function and patient condition is important. The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) trial tested the hypothesis that remote home monitoring with automatic daily surveillance (HM) is safe and effective for implantable cardioverter-defibrillator follow-up for one year and enables rapid physician evaluation of significant events.
Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation. 2010;122(4):325-332. doi:10.1161/CIRCULATIONAHA.110.937409

2008 HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations

This document represents expert consensus concerning the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs). The views expressed are of the international writing group consisting of seven cardiac electrophysiologists representing the Heart Rhythm Society (HRS), six from the European Heart Rhythm Association (EHRA) as well as one heart failure specialist representing the Heart Failure Society of America and another from the Heart Failure Association of the European Society of…Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM, Hayes DL, Howlett JG, Kautzner J, Love CJ, Morgan JM, Priori SG, Reynolds DW, Schoenfeld MH, Vardas PE; Heart Rhythm Society; European Heart Rhythm Association; American College of Cardiology; American Heart Association; European Society of Cardiology; Heart Failure Association of ESC; Heart Failure Society of America. HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. Heart Rhythm. 2008 Jun;5(6):907-25. doi: 10.1016/j.hrthm.2008.04.013. PMID: 18551743.