Remote monitoring of cardiac implantable electronic devices (CIED)

https://doi.org/10.1016/j.tcm.2016.03.012Get rights and content

Abstract

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 patient 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. Finally, RM programs hold promise for the future of CIED research in light of the massive data collected through RM databases converging with unprecedented computational capability. This review outlines the available data associated with clinical outcomes in patients managed with RM with an emphasis on randomized trials; the impact of RM on patient satisfaction, cost-effectiveness, and healthcare utilization; and possible future directions for the use of RM in clinical practice and research.

Section snippets

Background

Cardiac implantable electronic devices (CIEDs) including pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and implanted rhythm monitors have evolved significantly over the last few decades in a number of ways. First and foremost, indications for their use have expanded, and access to these technologies has improved such that CIEDs have become increasingly prevalent all over the world [1], [2].

Secondly, CIEDs have an ever-improving

Logistics of remote monitoring

Despite RM having become a common feature among device manufacturers, differences between RM systems remain—some of which are clinically relevant (Table 1). Therefore, in order to establish a successful RM relationship between patient and provider, the logistics of the system must be well understood including those tasks that are the responsibility of patients versus providers versus those of the health system. In addition, despite increasing similarities between manufacturers, differences

Patient participation

As with any healthcare interaction, patient engagement plays an important role, and in the case of RM, active patient participation is essential. While high-quality data have demonstrated RM to be acceptable to patients [4], [5], [6], [7], convenient [7], [8], and associated with good quality of life [9] compliance with RM can be challenging. Patients must actually use the RM systems and comply with transmission schedules and other responsibilities (e.g., maintaining up to date contact

Responsibilities of physicians and other providers

As the group with the ultimate responsibility for managing patients with CIED, physicians are adapting to the needs of patients with CIED managed with RM, which begins with educating patients about RM options and facilitating enrollment. In large cohorts of CIED patients, RM enrollment rates are mediocre [13], [14]. Reasons for low enrollment are not entirely clear, but at least part of the deficiency is explained by institutional variation. For example, Akar et al. [13] demonstrated that 13.3%

Health system and infrastructure

As described, RM relies on interoperability between the implanted CIED, the home transmitting device, existing telecommunications technology, and servers that communicate with physician offices typically through web-based platforms. In some cases, technological limitations of the health system and/or the infrastructure may not support RM for a particular patient [14]. For example, in the absence of an available landline or reliable cellular service, some CIEDs cannot be followed remotely. In

Review of clinical evidence

RM has been studied extensively in regard to a wide range of important outcomes including mortality, healthcare utilization, incidence of inappropriate shocks, and others. Because of the nature of RM, data collected by device manufacturers lends itself well to observational registry-based studies. In some cases, the sheer number of patients included in these registries makes the evidence compelling. However, in other cases, high-quality randomized data are available.

Mortality

The influence of RM on all-cause mortality has been analyzed in several randomized studies. While not designed or powered to detect differences in mortality, the COMPAS trial was an early study, which randomized pacemaker patients to active RM versus usual care and no difference was found between groups (13 versus 18 patient deaths, p = 0.37) [18].

In a 2014 study of heart failure patients with high-voltage devices (ICD or CRT-D), those randomized to Home Monitoring™ (Biotronik, Berlin,

Healthcare utilization

At the point of care, a single center study from the Cleveland Clinic demonstrated that follow-up via RM was much less resource intensive than an in-office visit (11.5 versus 27.7 min, p < 0.01) [29]. A number of studies have evaluated the differences in other aspects of healthcare utilization between patients managed with RM versus not. In the 2010 TRUST trial, a significant reduction in healthcare utilization (scheduled and unscheduled office and hospital visits) was observed among ICD

Time to clinical decision-making

Related to unscheduled hospitalizations and in-office visits, remote monitoring is expected to compress the time between the occurrence of an ICD alert (e.g., arrhythmia) and a clinical decision or change in clinical management. Randomized data support this hypothesis. For example, in the CONNECT study of 1997 patients from 136 sites with a Medtronic ICD or CRT-D randomized to RM versus standard care those patients receiving RM had a reduction in time to a clinical decision from a median of 22

Inappropriate shocks

The significance of inappropriate and unnecessary ICD shocks on both quality of life and cardiovascular outcomes has become increasingly recognized. Thus, there is an increased focus on the avoidance of inappropriate and all-cause shocks in CIED management through tailored software algorithms and programming related to atrial fibrillation, electromagnetic interference, and T-wave oversensing to name a few. In other cases, inappropriate shocks may be caused by device or lead malfunction [31]. In

Heart failure disease management

Since the proportion of patients with a CIED with heart failure has grown considerably over the last few decades, the impact of RM on this population is particularly important. The Implant-based Multiparameter Telemonitoring of Patients with Heart Failure (IN-TIME) study assessed whether RM would improve outcomes in this specific population using a single RM platform. Mortality was greater in the conventionally managed patients (no RM) as discussed above. However, there was no effect on heart

Atrial fibrillation disease management

Besides heart failure disease management, RM allows for earlier detection of atrial fibrillation [35], [36] over standard follow-up. The Cryptogenic Stroke and Underlying AF (CRYSTAL AF) study in 2014 clearly demonstrated that in patients with cryptogenic stroke, RM with an implantable monitor identified significantly more patients with atrial fibrillation within 6 months compared with standard follow-up (8.9% versus 1.4%, HR = 6.4, 95% CI: 1.9–21.7, p < 0.001) [37]. This is important because

Cost-effectiveness

Apart from primary analyses focused on cardiovascular outcomes and other end points, several randomized studies have embedded cost-effectiveness studies including ECOST and EVOLVO [39], [40]. In the former case, cost savings of €315 per patient-year were accrued to the French healthcare system in patients randomized to RM versus usual care (p = 0.05). In EVOLVO, RM proved to be cost-effective within the Italian healthcare system with savings of €888.10 per patient. Findings from these

Mega cohorts

One consequence of RM programs and the improving availability to store, handle, and analyze “big data” is the development of “mega cohorts.” Each CIED manufacturer has developed an RM system specific to its devices (Table 1) that can act as a repository for all of the CIED data that are collected, stored, and transmitted. In turn, these data collection and transmission systems can be leveraged to provide important longitudinal information including device integrity data and clinical information

Relevant guidelines and recommendations

In the past 3 years, as clinical evidence related to RM has grown significantly, some relevant professional society groups have produced guidelines and recommendations for the integration of RM in the care of patients with CIEDs [12], [16], [49], [50]. Most recently, HRS has published an expert consensus statement on RM for CIEDs, [12] which builds on a 2008 expert consensus document by HRS and the European Heart Rhythm Association [51]. The newer guidelines leverage the extensive body of

Future directions

RM technologies continue to evolve. To date, RM has been a one-way street: patients connect to a system that allows transmission of stored CIED information to a provider. If technological barriers and privacy concerns can be adequately addressed, there may be opportunity to program CIEDs remotely. This may be particularly important for patients in remote geographic locations, those with urgent/emergent need based on a clinical event, and for the administration of software upgrades or execution

Conclusion

Supported by high-quality clinical evidence and endorsed by authoritative guidelines and recommendations from professional societies, RM now plays a central role in the management of many patients with CIEDs. This role includes an expanding range of capabilities, which requires patients, providers, and health systems to adapt to achieve the maximum benefit. With thoughtful interaction of patients with CIED, providers, and healthcare systems, the utilization of RM holds tremendous potential to

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    Dr. Zeitler was funded by National Institutes of Health, United States (NIH) T-32 training grant #2 T32 HL 69749-11 A1, however, no relationships exist related to the analysis presented. Dr. Piccini receives grants for clinical research from ARCA Biopharma, Boston Scientific Corporation, Gilead Foundation, Johnson & Johnson, United States, ResMed Foundation, Spectranetics, and St. Jude Medical, United States, and serves as a consultant to BMS/Pfizer, GlaxoSmithKline, Janssen Pharmaceuticals, Medtronic, and Spectranetics.

    The authors have indicated that there no conflict of intrest.

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