Cardiac arrhythmias currently affect millions of people in Europe and the United States; one common arrhythmia, atrial fibrillation, accounts for more than 20 million patients alone. As Europe’s population ages, the healthcare system is being confronted with a problem of sweeping demographic change. Over the past decade, the number of cardiovascular devices, including pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) devices implanted in Europe to save patients’ lives and help improve their quality of life has increased by nearly 28%.1 To cope with the ever-increasing number of device patients, it is essential that we seek out more efficient methods for monitoring these patients, without compromising the quality of their care.
Without remote monitoring all cardiac device patients are subject to calendar-based and sometimes intrusive in-person follow-ups to manage their long-term care, ensure their devices are functioning properly and track the development of any new arrhythmias. It is not possible, however, to sufficiently track the medical status of an ICD patient you only see two times per year or a pacemaker patient you see only once. In the meantime, you lack critical information on that patient’s health, while on the other hand, you routinely see patients who do not need your attention. The solution to this dilemma is continuous remote monitoring, which enables physicians and clinics to direct their attention to the right patient at the right time. This improves both the patient’s health and the workload per patient, as has been repeatedly demonstrated by clinical studies.
The clinical and economic benefits emerging from one remote monitoring service, BIOTRONIK Home Monitoring, have been established by seven clinical trials involving over 3800 patients. There is now a clear consensus among health professionals that remote monitoring represents the future standard of care for device patients.* Cardiac devices with remote monitoring are known to save lives and improve patient outcomes by enabling the early detection of symptomatic and asymptomatic arrhythmias. Additionally, we have seen that once properly integrated into the workflow of a clinic and adequately reimbursed at the federal level, this technology can actually lower costs for the healthcare system as a whole. In this article, I will explore how a wider embrace of remote monitoring stands to benefit patients while reducing the overall cost of care and improving clinical efficiency.
The gold standard for remote monitoring
The Berlin Pacemaker and ICD Centre, known as HIZ Berlin, currently monitors more than 1000 patients remotely using BIOTRONIK Home Monitoring, which is the gold standard for remote monitoring. An innovator in the field of telecardiology, BIOTRONIK first launched Home Monitoring in 2000. Since then, more than 800,000 such devices have been implanted in over 60 countries.
Home Monitoring is the most patient-oriented technology available for device patients, as it enables the daily, fully automated transmission of a patient’s cardiovascular data to a physician from anywhere in the world. Crucially, since no patient interaction is needed, it leads to the best possible compliance. Only Home Monitoring meets the Heart Rhythm Society’s guidelines for automaticity and ease of use – so simple to use, in fact, that it is even possible with elderly patients, including those with dementia.
Every day, Home Monitoring technology transmits important clinical and technical data from the patient’s implant to the CardioMessenger, an external wireless data transmitter about the size of a mobile phone. The CardioMessenger then transmits the data to the BIOTRONIK service centre, where it is processed and forwarded to the clinic via a secured website. The responsible nurse can then promptly analyse the patient’s data and take any measures deemed necessary, whether it is coordinating with their primary care doctor or calling them in for an in-person follow-up. All crucial patient information is automatically sent directly to the clinic via email or SMS. Home Monitoring patients are free to go about their daily lives with the peace of mind that their data is regularly and reliably overseen.
The clinical benefits of remote monitoring for patients
In their respective guidelines, the following professional organisations all recommend use of a remote monitoring system:
- Heart Rhythm Society (HRS)
- European Society of Cardiology (ESC)
- German Cardiac Society (DGK)
Though most patients are indicated for remote monitoring according to these societies’ guidelines (see Table 1), there is a great deal of evidence demonstrating its clinical benefits for many specific patient populations. It is clear, for example that reliable telemonitoring is of the utmost importance to heart failure (HF) patients, whose constantly changing clinical status and frequent comorbidities require particular vigilance. HF patients are quite a sick and elderly population, so they need monitoring that works completely automatically; all a patient must do is plug in their CardioMessenger.
Fig. 1: Reproduced with permission from the Lancet: Home Monitoring reduces mortality by more than 50%.
Clinical evidence now supports the use of remote monitoring in the following patient populations:
- For HF patients, the IN-TIME trial showed that Home Monitoring can reduce mortality by over 50%.3 (see Figure 1).
- For ICD patients, the ECOST trial showed that Home Monitoring can reduce the risk of inappropriate shocks by 52% and the rate of hospitalisation due to those shocks by 72%.4
- For pacemaker patients, the COMPAS trial demonstrated that Home Monitoring can reduce hospitalisations due to atrial arrhythmia or stroke by 66%.5 (see Figure 2).
Fig. 2: Home monitoring: reduces hospitalisation
due to AF and stroke. Reproduced with permission.
I can say from personal experience that stroke is a highly relevant concern for cardiac device patients, and I believe that Home Monitoring is the best tool physicians have at their disposal to prevent it in device patients. Every week, four or five patients in my care present with new atrial fibrillation (AF), which can manifest suddenly and without previous symptoms. AF is a significant risk factor for stroke,6 and causes about 15% of all ischaemic strokes and as many as 30% of strokes occurring in people in their 80s.7 Such complications, however, can be prevented with timely intervention, typically a prescription for anticoagulants and drugs to stabilise the sinus rhythm, for instance beta-blockers. My clinic receives an alert when a Home Monitoring patient experiences AF, so we can act immediately to prevent stroke or hospitalisation.
For older and immobile patients, Home Monitoring is also of particular benefit, as it enables us to follow-up on their data remotely, without having to arrange for costly or time-consuming transport to the clinic. For these uniquely vulnerable patients, Home Monitoring saves them the hassle of an in-person follow-up for up to an entire year, while ensuring their continued safety and peace of mind.
The benefits of remote monitoring for physicians and clinics
Aside from Home Monitoring’s manifest advantages for patients, there are many positive aspects for busy clinics like HIZ Berlin. Improving clinical efficiency has become imperative as the device patient population continues to grow. At HIZ Berlin, Home Monitoring is becoming more and more essential as a patient management tool. Of the more than 8500 cardiac device patients under my care, more than 1000 have Home Monitoring, though it is our goal to greatly increase this proportion, so that one quarter of all patients use the service.
Use of remote monitoring has markedly improved workflow by lowering the daily time necessary per patient case. For the Home Monitoring patients at HIZ Berlin, one nurse supported by two working students, is able to oversee all daily transmissions working just three hours per day, Monday to Friday, and one hour per day on weekends. She is responsible for contacting patients directly to coordinate their care or schedule follow-up appointments as necessary. I make all decisions regarding patient care, which are then implemented by the nurse.
A major improvement that Home Monitoring provides for both physicians and patients is that it can reduce the number of unnecessary follow-up appointments. In fact, the TRUST trial showed Home Monitoring can reduce the need for in-office follow-ups by 45% (see Figure 3), while simultaneously improving patient retention.8 The periodic alert notifications provided by Home Monitoring for device issues such as battery status, and clinically relevant arrhythmic events, mean that physicians see some patients less frequently, which improves clinical workflow and helps ensure our resources are directed where they are truly needed.
If implemented on a wider scale in hospitals, clinics and private practices across the EU, this could lead to substantial financial savings for the healthcare system by helping to streamline workflows in hospitals and clinics. Indeed, a sub-analysis of the ECOST trial found that remote monitoring of French ICD patients led to savings of €315 per patient per year.9 Additionally, the EuroEco trial, which examined follow-up related costs for hospitals and physicians per ICD patient in six European countries, were encouraging. Investigators consistently found across all countries studied that a patient on Home Monitoring does not increase costs as compared to a patient followed conventionally.10
While some patients with Home Monitoring end up visiting us less often in person, they do not feel any less supported by our clinic. Many of my patients report that they actually feel more secure in the knowledge that there is a dedicated nurse responsible for contacting them regarding any change in their device or cardiac status, thereby easing potential anxiety and improving their quality of life. Clinical studies show that my patients are no exception: in one survey, 92% of patients stated that the service gave them a sense of security, while 98% believed Home Monitoring had positive effects on their health.11
Fig. 3: Home monitoring reduces the burden of in-office follow-ups. Reproduced with permission.
Comprehensive reimbursement: the missing piece
As outlined above, Home Monitoring offers patients greatly improved safety and peace of mind, while helping clinicians to save time, money and man power. The consensus of the German, European and US cardiology societies to recommend remote monitoring demonstrates that the numerous benefits for patients, physicians and the healthcare system alike are widely recognised. In the future, I expect that nearly all cardiac device patients will benefit from this indispensable technology.
Though the evidence in favour of remote monitoring is clear, there still remains essential work to do in the area of reimbursement. Across the EU, there are differing legal norms regarding the reimbursement of remote monitoring-based care. In France, for example, remote follow-ups are not currently reimbursed by health insurance providers, though in-person follow-ups are. In Germany, however, remote-follow ups are reimbursed, but most insurance providers do not pay for the data transmitter and the transmission costs.
To ensure patients receive the full benefit of remote monitoring and encourage this practice to spread, private and public health insurance providers must reimburse the following:
- The initial remote monitoring implant.
- The patient device or data transmitter.
- Remote follow-ups and daily monitoring of patient and device status.
These conditions have to be met before remote monitoring can lead to public health benefits on a wider scale. To ensure that more patients receive the follow-up care recommended by physicians and healthcare professional organisations worldwide, and to tackle the demographic and economic concerns of tomorrow, remote monitoring should become the standard of care today.
*A note on terminology: According to the 2015 HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices,2 the term remote monitoring refers here to the automated, daily transmission of data from the patient device based on preselected alerts related to device functionality and the patient’s clinical status. This should be distinguished from so-called remote interrogation, which is the routine and scheduled remote follow-up, essentially the same as an in-person follow-up except conducted remotely.
- EuroEco data on file.
- Slotwiner D et al. HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm 2015;12:69–100.
- Hindricks G et al. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet 2014;384:583–90.
- Guedon-Moreau L et al. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J 2013;34:605-614.
- Mabo P et al. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J 2012;33:1105–11.
- Go AS et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001;285(18):2370–5.
- Gattellari M et al. The management of non-valvular atrial fibrillation (NVAF) in Australian general practice: bridging the evidence-practice gap. A national, representative postal survey. BMC Fam Pract 2008;9:62.
- Varma N et al. 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;122:325–32.
- Guedon-Moreau L et al. Costs of remote monitoring vs. ambulatory follow-ups of implanted cardioverter defibrillators in the randomized ECOST study. Europace 2014;16:1181–8.
- Heidbuchel H et al. EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring. Eur Heart J 2015;36:158–69.
- Ricci RP et al. Long-term patient acceptance of and satisfaction with implanted device remote monitoring. Europace 2010;12:674–9.