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Remote monitoring for active cardiovascular implantable electronic devices: a European survey

Franck Halimi, Francesco Cantù
DOI: http://dx.doi.org/10.1093/europace/euq399 1778-1780 First published online: 19 November 2010

Abstract

This survey sampled today's European practices in the use of remote monitoring (RM) for the follow-up of active cardiovascular implantable electronic devices. Eighty-five per cent of the responding centres are currently using RM. For the majority, RM is expected to increase importantly within 5 years, and it has already led to a new organization of care based on dedicated allied professionals and/or the creation of RM units. There are still major limitations for the development of RM, such as ethical and legal aspects, reimbursement issues, and the lack of specific national- and European-updated guidelines which need to be informed.

  • Pacemaker
  • Implantable cardioverter-defibrillator
  • Telemedicine
  • Remote monitoring
  • Remote follow-up

Introduction

In the past decade, the ageing demographic and developing evidence base has led to new recommendations for the use of active cardiovascular implantable electronic devices (CIEDs) such as cardiac resynchronization therapy (CRT) for heart failure and implantable cardioverter-defibrillator (ICD) in primary prevention for sudden cardiac death and consequently to a large burden of patient-device follow-up (FU). Remote monitoring (RM) has the potential to provide very similar levels of information on device performance as standard in-office interrogation; it is also able to generate symptom triggered or automatic alerts that immediately notify change in patient status. The aim of this survey is to evaluate the use of RM in today's European practice and to focus on specific issues that still need to be clarified.

Results

Responding centres

Sixty-one centres, members of the SIC network, answered an electronic questionnaire in August 2010 on the EHRA website (European countries: 14, Tunisia: 1). Responses to this survey came from centres with a wide range of device FUs per year (<500: 29.5%, 500–1000: 11.5%, >1000: 59%). Remote monitoring appears to be used ‘sometimes’ (45.9% of the centres), ‘frequently’ (39.3%), and ‘never’ (14.8%).

Remote monitoring organization

For the 51 centres that are very conversant with RM, 41.2% use the system for both remote FU visits and alert surveillance, 33.3% for RM visits alternating with in-office FUs, and 25.5% only as an enhancement to device surveillance for the FU of alerts, either automatic or patient activated. Management of the collected data in these centres is delegated to a dedicated allied professional in 58.8%, collected through a structured RM unit in 27.5%, or reviewed by the electrophysiologist himself in 13.7%.

Perceived value of remote monitoring

This is presented for each type of device in Table 1, and the estimated number of patients followed per centre in 2010 and expected in 5 years in Table 2. For a great majority, RM will in the future increase the continuity of care (76.8%) and the patient's quality of life (78.6%) and will decrease the time for device check (55.4%), the expenses for patient's FU (66.1%), and the number of in-person visit (85.7%).

View this table:
Table 1

In your opinion, what is the value of remote monitoring for the follow-up of patients equipped with the following devices? Rank between 0 (no value) and 5 (very valuable) for each category

012345Response count
PM5.4% (3)14.3% (8)16.1% (9)23.2% (13)23.2% (13)17.9% (10)56
CRTP1.8% (1)3.6% (2)14.3% (8)16.1% (9)44.6% (25)19.6% (11)56
ICD in primary prevention0.0% (0)5.4% (3)5.4% (3)10.7% (6)41.1% (23)37.5% (21)56
ICD in secondary prevention0.0% (0)1.8% (1)10.7% (6)10.7% (6)41.1% (23)35.7% (20)56
CRTD1.8% (1)5.4% (3)3.6% (2)8.9% (5)39.3% (22)41.1% (23)56
Answered question56
Skipped question5
  • PM, pacemaker; CRTP, cardiac resynchronization therapy + PM; ICD, implantable cardioverter-defibrillator; CRTD, cardiac resynchronization therapy + ICD.

  • Values in bold indicate the response with the highest percentage of answers for each category.

View this table:
Table 2

What is the estimated number of patients followed with remote monitoring in your centre in 2010 and expected in 5 years?

NoneA fewMostEverybodyResponse count
PM 201028.6% (16)62.5% (35)8.9% (5)0.0% (0)56
PM 20157.1% (4)35.7% (20)42.9% (24)14.3% (8)56
ICD 201012.5% (7)41.1% (23)35.7% (20)10.7% (6)56
ICD 20157.1% (4)7.1% (4)42.9% (24)42.9% (24)56
  • PM, pacemaker; ICD, implantable cardioverter–defibrillator.

  • Values in bold indicate the response with the highest percentage of answers for each category.

Regulatory issues

The clinical responsibility issue leads to different attitudes: patients are informed that RM is an elective FU system but not for use in an emergency scenario (41%), the same approach but with written consent detailing level of care (41%), or there is no specific approach (26.2%). For 3.3%, it is the inability to resolve the challenge of duty of care responsibility that currently prevents uptake of RM. Guidelines and/or recommendations for the use of RM are available from national scientific societies in 4.9% of the responding centres, from national healthcare systems in 1.6%, from both in 0%, and totally absent in 93.4%.

Reimbursement

Specific reimbursement for RM FUs in the 15 different countries answering the survey is established as a per RM FU episode in 8.9%, as a fixed fee per patient per year in 5.4%, charged as a service by private companies in 8.9%, but in 82.1% there is no reimbursement structure.

Remote monitoring in children

To the specific issue of RM in pacing-dependent children and young adults with an old ventricular lead in situ, a device equipped with RM is specifically implanted to check lead parameters rigorously in 16.1%, only if the risk of lead fracture is significant in 32.1%, other strategies are adopted (e.g. multisite pacing) in 3.6%, but for 48.2% of the responders, the previous options have never been considered but will in the future. In children and young adults, pacemakers (PMs) and ICDs equipped with an RM capability is always implanted in 21.4%, only in selected patients based on age, anticipated growth, and underlying cardiac disease in 37.5%, not used in 16.1%, not used currently but should be considered in the future in 25%.

Discussion

Remote monitoring is becoming a new standard for the FU of patients implanted with an active CIED.1,2 Results of this survey reflect today's practices in the field of telemonitoring in a broad European group of centres. Remote monitoring appears to be already commonly used in ∼85% of the centres, whereas only 15% of them have no experience of these systems. Within experimented centres, almost 75% are currently using RM FUs alternately with face-to-face visits, and alert surveillance is provided in ∼65%. Management of collected data is mainly dedicated to an allied professional or a structured RM unit, reflecting the need for specific organization around RM. The benefit of RM for patients’ FU is unanimously agreed with the greatest added value seen for CRTs and ICDs. It seems very likely that RM will, in the future, increase the continuity of care and the patient's quality of life and decrease the time for device check, the cost for patients’ FU, and the number of in-person visits, all contributing to a better quality of care.3 A majority of the responding centres believe that in 2015 most of the PMs will be equipped with RM, and most or even every ICD will be followed by telemonitoring, leading to a new medical practice approach. Clinical responsibility related to remote FUs remains unclear and may in some cases be the reason for not using such systems. There is a shared concern for responsibility issues with an absolute necessity to explain the advantages of RM to the patients, eventually to get written consent, and to say that alert FU is not a 24-hours-a-day surveillance of emergencies. In 2010, there is an extraordinary lack of national guidelines and/or recommendations for the use of RM. An HRS/EHRA expert consensus on the monitoring of CIEDs was published in 2008, but this document does not replace European or national guidelines.4 Specific reimbursement is another major problem since 82% of the specialist physicians and hospitals/clinics have no established reimbursement mechanism for RM. Remote monitoring may be helpful for device FU in pacing-dependent children and young adults. Almost half of the responders had never considered RM for this patient group often implanted with aging ventricular leads, but will in the future. In recent years, there has been an exponential growth in the number of implanted devices. Appropriate FU is critical to achieve clinical benefit and to anticipate the occurrence of adverse events. Remote monitoring has the potential to provide better continuity of care, but should then be associated with a redesigned organization of the care system, including physicians, allied professionals and dedicated 24 h service telemonitoring units. Although more than half of the users activate alerts, there is neither consistency of approach nor professional guidelines. Ethical and legal considerations, along with the reimbursement issue, are also major limitations for the development of RM and should find appropriate solutions soon. This survey shows that, in spite of these ongoing concerns, RM is already part of the medical practice for active CIEDs FU and should increase rapidly within 5 years in Europe.

Funding

This work was supported by the European Heart Rhythm Association.

Acknowledgements

We acknowledged to Svya Karaim-Fanchon and the EHRA team for their active support.

Conflict of interest: none declared.

References

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