Cardiovascular Implantable Electronic Devices (CIEDs), that is implantable cardioverter defibrillators, pacemakers, and implantable cardiac monitors, are first-line tools for the therapeutic or diagnostic management of cardiac rhythm disorders. After CIEDs implantation, regular follow-up of these medical devices is required to evaluate device integrity, to interrogate the device for recorded arrhythmias, and possibly to reprogram the device. Remote monitoring (RM) of CIEDs is an important alternative to in-office follow-up of these medical devices as it offers continuous surveillance of both CIEDs and patients, in order to improve the safety and cost-effective delivery of health care.1, 2, 3
Presently, RM could further enhance patients' safety by achieving the required social distancing due to the COVID-19 pandemic. In a recent update (April 15, 2020), the Heart Rhythm Society (HRS) Task Force on the management of CIEDs urged health care professionals that “Every effort should be made to perform CIED interrogation via remote monitoring rather than in-person visits”. https://www.hrsonline.org/COVID19-Challenges-Solutions/hrs-covid-19-task-force-update-april-15-2020.
To achieve a nationwide sustainable implementation of RM of CIEDs in Greece, the e-Cardiology Unit of the 1st University Department of Cardiology at Hippokration Hospital proposed the following roadmap. The number of patients with a CIED in Greece was calculated based on data from the European Heart Rhythm Association (EHRA) for implants in Greece from 2008 to today4 (Fig. 1 ) and the annual data of the Cardiology Clinic of the University Hospital of Heraklion from 1998 to 2006.5 On the basis of the historical data, the implants from 2019 to 2029 were anticipated by accounting for a 5% annual increase. The survival of patients with CIEDs was projected for the 10-year period (2019 to 2029) based on clinical studies assuming a 95% annual survival rate.6, 7, 8 Thus, the prevalence of CIED patients in Greece was cumulatively calculated and presented in Fig. 2 . In the proposed roadmap, RM of CIEDs will be achieved with the mediation of six central tertiary university hospitals (Central Hubs). Special computers that interrogate the CIEDs will be installed in the health centers or in the secondary hospitals of each territory (Control Stations). The data will be transmitted from these Control Stations to the Central Hubs, where experts organized in a specialized unit will rate the priority of transmission. Continuous monitoring requires the presence of two cardiologists on a rolling shift per Central Hub (16 hours). Transmissions of actionable arrhythmic or technical events will then be sent to the implanter of each patient at the respective implantation center. Control stations will be settled in health centers which are at least 50 km away from any of the six Central Hubs. In cases of CIED patients who are residents of small islands, a personal transmitter will be provided. Patients' informed consent, as well as strict implementation of the EU General Data Protection Regulation (GDPR) 2016/679 and the EU Medical Device Regulation (MDR) 2017/745, are prerequisites for the commencement of this project.
Fig. 1.
Cardiovascular Implantable Electronic Devices in Greece from 2008 to 2017.
Fig. 2.
The prevalence of CIED patients in Greece from 2019 to 2029.
In conclusion, with respect to HRS recommendations, both arrhythmia consultations and follow-up CIED clinics should amplify RM of CIED patients during the pandemic, and the proposal presented herein provides a blueprint for streamlining this process.
Conflict of interest
The authors have no potential conflict of interest to declare.
Funding
None.
Acknowledgment
The authors would like to sincerely thank Panagiotis Alivanoglou from Medtronic Hellas for his contribution in the data collection and statistical analysis.
Footnotes
Peer review under responsibility of Hellenic Society of Cardiology.
References
- 1.Dilaveris P., Piotrowicz R. Remote monitoring of implantable cardioverter defibrillators. Hellenic J Cardiol. 2014 Jan-Feb;55(1):1–3. [PubMed] [Google Scholar]
- 2.Dubner S., Auricchio A., Steinberg J.S., et al. ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs) Ann Noninvasive Electrocardiol. 2012;17:36–56. doi: 10.1111/j.1542-474X.2011.00484.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Ricci R.P., Morichelli L., Santini M. Home monitoring remote control of pacemaker and implantable cardioverter defibrillator patients in clinical practice: impact on medical management and health-care resource utilization. Europace. 2008;10:164–170. doi: 10.1093/europace/eum289. [DOI] [PubMed] [Google Scholar]
- 4.Raatikainen M.J.P., Arnar D.O., Merkely B., et al. A Decade of Information on the Use of Cardiac Implantable Electronic Devices and Interventional Electrophysiological Procedures in the European Society of Cardiology Countries: 2017 Report from the European Heart Rhythm Association. Europace. 2017 Aug 1;19(suppl 2):ii1–ii90. doi: 10.1093/europace/eux258. [DOI] [PubMed] [Google Scholar]
- 5.Kanoupakis E.M., Fanourgiakis J.A., Mavrakis H.E., et al. Long-term clinical outcomes in implantable cardioverter defibrillator recipients on the island of Crete. Hellenic J Cardiol. 2016;57(4):247–252. doi: 10.1016/j.hjc.2016.05.004. [DOI] [PubMed] [Google Scholar]
- 6.Brunner M., Olschewski M., Geibel A., Bode C., Zehender M. Long-term survival after pacemaker implantation. Prognostic importance of gender and baseline patient characteristics. Eur Heart J. 2004 Jan;25(1):88–95. doi: 10.1016/j.ehj.2003.10.022. [DOI] [PubMed] [Google Scholar]
- 7.Hawkins N.M., Grubisic M., Andrade J.G., et al. Long-term complications, reoperations and survival following cardioverter-defibrillator implant. Heart. 2018 Feb;104(3):237–243. doi: 10.1136/heartjnl-2017-311638. [DOI] [PubMed] [Google Scholar]
- 8.Theuns D.A., Schaer B.A., Soliman O.I., et al. The prognosis of implantable defibrillator patients treated with cardiac resynchronization therapy: comorbidity burden as predictor of mortality. Europace. 2011 Jan;13(1):62–69. doi: 10.1093/europace/euq328. [DOI] [PMC free article] [PubMed] [Google Scholar]