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Automatic remote monitoring: milestones reached, paths to pave

Niraj Varma, Pedro Brugada
DOI: http://dx.doi.org/10.1093/europace/eut118 i69-i71 First published online: 4 June 2013
  • CIEDs
  • Monitoring
  • Follow-up
  • Remote monitoring

Automatic remote Home Monitoring™ is a transforming technology in the evolution of cardiovascular implantable electronic devices (CIEDs).1 However, innovations are usually greeted guardedly, especially ones which demand changes in clinical habits. When and how these should be applied are obvious questions to physicians and patients alike. Automatic remote monitoring (RM)—with its finer distinctions of operation, i.e. remote follow-up vs. remote (or continuous) monitoring2—has been no exception. During a decade after its introduction, clinical implementation has progressed from initial curiosity and occasional use, through studies demonstrating reliability and clinical applications, to several large-scale prospective trials.3 Their results have been impressive and remarkably consistent, improving upon current standard of care and opening new avenues for exploration. Notably, when directly compared with recommended conventional in-person follow-up (the TRUST control arm providing this first evaluation), Home Monitoring™ secured greater retention of patients and also improved punctuality and adherence to scheduled evaluations.4,5 The safe and effective replacement of the bulk of ‘routine’ in-clinic evaluations has a huge implication for resource utilization. This effect was coupled with capability for same day discovery of problems (even when asymptomatic), with appropriate technology, and clinical infrastructure in place.6 This was an outlandish concept even a few years ago when advance to 5.7 months with remote management was considered ‘early’.7

The most obvious application of RM is for detection of system dysfunction.8 Most triggered alerts demanded reprogramming. Correct programming itself imparts survival benefit.9 Needs are anticipated to change over time. Remote monitoring has significant value under these conditions, e.g. to reduce inappropriate shocks.10 Although safety concerns underpinned original post-implant follow-up schedules, e.g. for assessing pacing thresholds, integrity of components, and charging capacitors, these issues now belong to a different era. Current generation devices require no such maintenance, have extreme reliability, and perform an array of autoregulatory functions. Nevertheless, early detection of system perturbations, especially for components subject to advisories, remains an imperative. In this regard, automatic RM has unprecedented power for their early discovery.

The benefits of continuous monitoring extend to disease management, e.g. for the current epidemics of heart failure and atrial fibrillation.1113 Non-implantable technologies, depending on patient compliance and following non-specific parameters, have been unhelpful.14 Preliminary signals indicate benefit from RM.12,15 Device-based physiological information and diagnostics indicate that several interdependent cardiovascular factors (arrhythmias and paced burden shifts, intrathoracic impedance, vagal withdrawal, intracardiac haemodynamics) may change several days to weeks before ultimate hospitalization.16 A combined risk score incorporating all of these individual factors may improve their predictive value,17 creating an opportunity for early pre-emptive intervention. Success will depend on accurate longitudinal parameter trends (preferably updated daily) and early notification for out-of-bounds parameter groups. These can be delivered by RM. Although results with thoracic impedance have been inconsistent,18 other sensors appear more positive.11 In this regard, CHAMPION trial results are sentinel, illustrating that action taken on remotely acquired data (from a CIED with no inherent therapeutic ability) reduced patient morbidity and averted hospitalization.19 This changes the paradigm of CIED function.

Remote monitoring leads to clinical efficiencies. Although demanding adjustment to different workflow patterns (and mindsets), especially for alert notifications, this is more than balanced by the great reduction of routine non-actionable in-person evaluations. This was amply demonstrated by Ricci.20 Prior to implementation of this innovative technology, all involved personnel, including patients, were primed to process and expectations. The results were astonishing. Approximately 1 hour of health personnel manpower was required per 100 patients with a range of CIEDs. Details regarding handling of actionable encounters are awaited. For instance, an actionable alert notification received from a patient with a cardiac resynchronization therapy (CRT) device may require considerable effort to resolve when considering actions undertaken to contact the patient and the responsible physician. The results highlighted the key role of a trained dedicated allied professional, especially important for maintaining early reaction ability. However, resources to operate such a virtual clinic may not be universally available. Other options, to be fully developed, include industry-supported units (e.g. in Asia-Pacific21) or third-party service providers directing information from all proprietary technologies to a single readily accessible (web-based) platform. Patient engagement is important to successful remote management.20 Communication, initially education regarding its function to enhance overall clinical management (and not an emergency system), should be continued since heart disease is a dynamic condition and needs (medications, programming, in-person evaluations) change with time. This is obviously essential when retrieved data drive treatment, e.g. physician-directed patient self-management based on direct haemodynamic measurements.11 Patient acceptance and satisfaction has been high.20

Engineering differences may affect clinical application since operating characteristics of automatic systems differ among different manufacturers. Results from one system may not extend to another. Levels of automaticity and reliability themselves vary. For example, Home Monitoring™ eliminates the need for patient operation, making it particularly suitable for children22 and the elderly. This feature, coupled with excellent transmission reliability (>90% of daily transmissions successfully completed) was a strong determinant of the >99% success of remote evaluations when data were accessed by receiving facilities, and for Food and Drug Administration approval for early detection.23,24 In comparison, when using another proprietary platform, more than half of all alert transmissions were ineffective.15 This, when linked with the design feature of signalling an alert only once, seriously undermines any application of this particular technology as an early warning mechanism. Individualizing alert parameters (important for appropriate notification) is web-based with Home Monitoring™, but with other systems requires an in-person reprogramming, adding to unnecessary hospital evaluations. Transmissions may affect battery longevity heavily in some remote technologies,25 but daily transmissions had negligible impact when using Home Monitoring™ 25a—important since cost and morbidity of premature battery change have immense implications. Only the Boston Latitude system provides weight and blood pressure data. Thus, physicians need to tailor selection of a RM system to each patient, and manufacturers need to align design elements according to clinical need.6 Remote programming, which arouses great interest from patients and physicians alike, and feasible from an engineering point of view, has been withheld from clinical practice because of security concerns. This area is to be watched with interest.

Given all the advantages of automatic RM illustrated—why is adoption slow? Even in the USA, with established reimbursement, adoption remains at ∼50% (ALTITUDE study group). Although some high volume centres regard it as standard of care, this practice has not diffused into the general community. In the rest of the world, CIED implant rate itself varies, and follow-up practice diverse. There are several reasons. Apart from the need to gain familiarity, concerns exist about liability posed and data overload, and above all cost. Liability concerns centre around alerts received but not acted on, although RM is not an emergency system. However, the authors are unaware of any legal challenges occurring in over a decade of use of automatic RM. The counter argument is that, since RM outperforms traditional methods, future questions may be directed to why the security of comprehensive coverage was not chosen.

Data management is a potential challenge. Although RM results in lesser in-person evaluations, receiving facilities have to handle a significant volume of remotely acquired data. However, appropriate programming and a degree of inbuilt processing resulted in a low event notification rate with Home Monitoring™, and when sent, alerts carried high predictive value for actionability.20,26,27 Parameter deviations that do not affect patient outcome do not demand emergency attention.28 Increasing sophistication of data handling mechanisms may improve problem discovery. The ability to process several parameters and notify deviation in a pre-specified combination improves the specificity of alerts, e.g. for lead fracture or heart failure detection.17,29 Transferring this computing responsibility from implanted unit (necessarily limited) to an external service centre is an important advantage of wirelessly transmitted data with high frequency and may enable some detection algorithms.30 Access to Internet-based information systems provides a framework for multidisciplinary communication and collaboration as the breadth of monitored parameter expands. For example, in any individual patient, an electrophysiologist may monitor device function (e.g. arrhythmias, paced burden) and from the same remotely retrieved datastream, heart failure experts assess diagnostic information regarding heart failure, breaching traditional subspecialty barriers. This effect may improve patient care.31 This practice may be facilitated by RM interfacing with electronic medical records, thus placing all relevant data in a single central database accessible by all treating physicians. Patients may be included in this loop, to access results and recommendations rapidly. This level of connectivity is anticipated to occur in the near future.

Cost of purchasing and using this innovative technology is an undoubted barrier to adoption. Professional organizations have an important role for catalysing adoption and reimbursement. Thus, based on much of compelling evidence for superiority of automatic remote Home Monitoring™ over traditional methods reviewed in this Supplement, the 2012 European Heart Rhythm Association/Heart Rhythm Society (EHRA/HRS) consensus document strongly advocated for its application in patients with CRT.32 The EHRA and Eucomed (European Medical Technology Industry Association) produced an economic analysis and recommendations for reimbursement,33 drawing distinctions between remote follow-up and remote monitoring. Any reimbursement model needs to include cost of infrastructure to run a remote management service (preferably with an allied professional), yet account for savings ensuing with productivity gains as physicians are released to their other duties and patient hospitalizations averted (and their survival improved34). There is no universal formula given the diversity of healthcare models.35,36 Each has to navigate its own structure. The cost of the implantable technology cannot be ignored. Costs to the manufacturer result from embedded transmission system, the transceiver, warranties, and running costs of cellular transmissions. Enabled devices command premium rates, beyond already formidable levels, for self-paying patients. This is a hurdle in Asia, where perhaps there is greatest need given demographics, disease patterns, and distances.21

In conclusion, current era RM technologies enable rigorous CIED surveillance and are poised for remarkable gains in disease management. Results from large randomized prospective trials of all types of CIEDs from different manufacturers, and conducted in different countries, consistently indicate superior performance to conventional care for achieving the current follow-up goals of patient retention and early problem discovery, yet promoting clinical efficiencies. This forms compelling evidence to assert automatic Home Monitoring™ of patients with CIEDs as a new standard.

Conflict of interest: N.V.: Modest—Biotronik, Boston Scientific, Medtronic, St Jude Medical. Chair and PI of the TRUST trial; member ALTITUDE Steering Committee. P.B. has no conflicts of interest to disclose.


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