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Remote Monitoring of Patients with Implanted Cardiac Devices – A Review
Abstract and Figures
There has been a rapid growth in the number of patients with cardiovascular implantable electronic devices (CIEDs), due to the consistent good results from large randomised trials and changing worldwide demographics with progressive ageing in all developed countries. Early generations of CIEDs provided only basic operations and stored only rudimentary data, but the evolution of all types of CIEDs (pacemakers, defibrillators, cardiac resynchronisation devices, implantable monitors) has led to their increased complexity and the development of a myriad of specialised features. As an outgrowth of this increased sophistication, once implanted, CIEDs can provide significant amounts of important clinical information, allowing to identify the presence of significant arrhythmias, assess drug efficacy, evaluate heart failure status and continuously monitor device function. With the advent of new methods of remote monitoring, the information recorded by these devices can be accessible in real time and thus lead to more timely clinical decision-making. This article summarises the impact of remote monitoring on clinical practice today and how the use of remote monitoring may evolve to affect the practice of medicine in the future.
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... Outside of autopsy practices, research in cardiology has examined the differing clinical needs for digitally dependent patients during life and the roles of data streams in anticipating death [14]. The first implantable pacemaker was introduced in 1958, since which time the design of these devices has advanced significantly [25,26]. Walsh et al. give a comprehensive overview of the wireless technologies entering that market that stream physiological data to the Cloud [27]. ...
Background
Our case report provides the first clinical evaluation of autopsy practices for a patient death that occurs on the cloud. We question how autopsy practices may require adaptation for a death that presents via the ‘Internet of Things’, examining how existing guidelines capture data related to death which is no longer confined to the patient's body.
Case presentation
The patient was a British man in his 50s, who came to the attention of the medical team via an alert on the cloud-based platform that monitored his implanted cardioverter defibrillator (ICD). The patient had a background of congenital heart disease, with previous ventricular fibrillation cardiac arrest, for which the ICD had been implanted two years earlier. Retrospective analysis of the cloud data demonstrated a gradually decreasing nocturnal heart rate over the previous three months, falling to a final transmission of 24 beats per minute (bpm). In the patient post-mortem the ICD was treated as medical waste, structural tissue changes precluded the effective evaluation of device hardware, potential issues related to device software were not investigated and the cause of death was assigned to underlying heart failure. The documentation from the attending law enforcement officials did not consider possible digital causes of harm and relevant technology was not collected from the scene of death.
Conclusion
Through this patient case we explore novel challenges associated with digital deaths including; (1) device hardware issues (difficult extraction processes, impact of pathological tissue changes), (2) software and data limitations (impact of negative body temperatures and mortuary radio-imaging on devices, lack of retrospective cloud data analysis), (3) guideline limitations (missing digital components in autopsy instruction and death certification), and (4) changes to clinical management (emotional impact of communicating deaths occurring over the internet to members of family). We consider the implications of our findings for public health services, the security and intelligence community, and patients and their families. In sharing this report we seek to raise awareness of digital medical cases, to draw attention to how the nature of dying is changing through technology, and to motivate the development of digitally appropriate clinical practice.
... The chronic nature of their conditions means that a lapse of attention or knowledge could result in their condition suddenly worsening, accompanied by a trip to the hospital emergency room. This is especially true in patients with cardiac diseases, where RPM could improve outcomes by more timely identification of new or worsening medical conditions (such as arrhythmia or heart failure (HF)) and the detection of device-related problems [3] and also decrease in the cost in the management of these patients [4,5]. ...
Purpose of review:
With the evolution in digital medicine to identify and monitor cardiac electrophysiological (EP) conditions, increased access to cardiac implantable electronic devices (CIEDs), and reimbursements for non-face-to-face care, remote patient monitoring (RPM) is becoming a key part of the EP service line. RPM of cardiac electrophysiological conditions including the use of CIEDs has improved the quality of care and high patient satisfaction and proved to be cost-effective. The focus of this review is literature on RPM in EP, evidence from randomized trials, and observational studies including those of Apple Watch and future of CIEDs.
Recent findings:
RPM has progressed to use implantable devices and wearable technologies like sensors embedded in smartphones and apps. American College of Cardiology recently launched a digital transformation network to support digital navigation and RPM across different cardiovascular diseases. The information presented here can inform healthcare providers of the most widely implemented and effective forms of RPM for patients with chronic EP conditions.
... 12,24 For example, Boston Scientific manages a database of .150.000 patients and 7 million transfers with their Latitude system, while Medtronic through the Discovery Link database provides study data from .100.000 patients associated with 3000 organizations. 39 When remote monitoring data are regularly transmitted to the hospital in a standard format and incorporated into hospital-based electronic health records along with the patient's activity and wellness status (possibly transmitted automatically from a personal health record), they can assist clinical decision support and influence adoption of clinical guidelines. 40 Additionally, systematic analysis can inform the care protocols, workflows, and resource allocation in the healthcare facility. ...
AimsTo provide a European perspective on reimbursement issues surrounding remote monitoring of cardiac implantable electronic devices in view of the anticipated costs and benefits.Methods and resultsReview of recent literature addressing clinical, economic, sociocultural, and technological factors associated with remote monitoring. When healthcare transformation is urgently needed, remote monitoring offers opportunities to innovate and cope with escalating costs and constrained resources, while improving patient safety, quality, and access to care as reflected in clinical studies. The introduction of remote monitoring into daily practice requires analysis of reimbursement policies to address funding scope, payment method, payer, price and allocation, and alignment with health system objectives and goals to ensure financial and operational sustainability of resources, infrastructure, and processes. Remote monitoring policies should gradually transition from activity-based, added-value services in a care-and-cure setting, to performance and outcome-oriented highlighting prevention, surveillance, and empowerment. By encouraging and rewarding innovation and interoperability, proprietary remote monitoring technologies can open up using standards and connect to support a growing evidence base that guides clinical decision support and planning of future policies.Conclusion
Careful planning, sharing of experiences, and gradual adoption of reimbursement models that focus on outcome, performance, and cost-effectiveness are key aspects of containing escalating costs and improving quality and access to healthcare. Despite differences in health systems and payment methods in Europe, policy-makers, professional societies, payers, providers, and the industry need to join forces to transform healthcare and make innovation happen. Published on behalf of the European Society of Cardiology. All rights reserved.
... Technology can act as workforce multiplier as physicians make better diagnoses and treatment decisions and gain up to 30% in productivity by saving time in accessing and analysing clinical information [31]. Cardiac implant vendors offer cardiologists medical apps that allow them to receive and review alerts from patients, together with a variety of useful analytics [32]. 8 Advances in technology make data collection on smartphones cheaper and more convenient allowing individuals to quantify their biometrics and share them with their social network [8]. ...
Smartphones, mobile applications ('apps'), social media, analytics, and the cloud are profoundly changing the practice of medicine and the way health decisions are made. With the constant progress of technology, the measurement of vital signals becomes easier, cheaper, and practically a standard approach in clinical practice. The interest in measuring vital signals goes beyond medical professionals to the general public, patients, informal caregivers, and healthy individuals, who frequently lack any formal medical training. On smartphone platforms such as iOS and Android, a proliferation of health or medical 'apps' acquire and analyse a variety of vital signs through embedded sensors, interconnected devices or peripherals utilising on occasion analytics and social media. Smartphone vendors compete with traditional medical device manufacturers in the grey area between health care, wellness, and fitness, as US and EU regulatory bodies are setting and revising rules for these new technologies. On the other hand, in the absence of robust validation results, clinicians are hesitant to trust measurements by apps or recommend specific apps to their patients, partly also due to lack of a cost reimbursement policy. This review focuses on the acquisition and analysis on smartphones of three important vital signs in the cardiovascular and respiratory field as well as in rehabilitation i.e. heart or pulse rate, blood pressure, and blood oxygenation. The potential, pitfalls, and perspectives on mobile devices and smartphone apps for health management by patients and healthy individuals are discussed.
In many popular and medical accounts, pacemakers and internal cardioverter defibrillators (ICDs) are often portrayed as almost magical technologies. Once implanted in bodies, they will work automatically by themselves and don’t require any agency of their ‘users.’ As I argue in this book, any discourse or policy that assumes a passive role of people living with technologies inside their bodies silences the fact that keeping cyborg bodies alive involves their active engagement. To understand the agency of ‘wired heart cyborgs,’ as I call them, this first introductory chapter provides a critical intervention in dominant discourses that conceptualize cyborgs as passive or merely as a linguistic or metaphorical entity. These approaches are problematic because they silence the lived experiences and voices of cyborgs, adopt a narrow focus on cyborgs as individuals, and neglect the materiality of hybrid bodies. Inspired by recent feminist post-humanist studies on the intimate relationships between bodies and technologies, this chapter argues that it is important to re-materialize the cyborg. The chapter describes conceptual tools used in the book in order to account for the ways in which wired heart cyborgs sense and make sense of their materially transformed bodies.
This chapter presents the clinical evidence for m-Health in its current mobile phone-centric format and evaluates the existing clinical landscape for different healthcare services. It focuses on some examples of chronic and noncommunicable diseases and conditions that typically have high levels of prevalence and cost burdens globally, and where mobile phone interventions have been successfully evaluated. The chapter discusses three chronic conditions, namely, diabetes, heart and cardiovascular diseases (CVDs), and chronic obstructive pulmonary disease (COPD). For other conditions, there has been varying levels of m-Health interventions; the chapter also discusses some of these and the clinical evidence for these interventions in less detailed form. There is much hype that smartphones are becoming the hub of future medicine, driven by massive consumer- or patient-led mobile healthcare services. Any future m-Health framework therefore needs to be developed against the background of the smartphone- and App-centric view.
The interface between eHealth technologies and disease management in chronic conditions such as chronic heart failure (CHF) has advanced beyond the research domain. The substantial morbidity, mortality, health resource utilization and costs imposed by chronic disease, accompanied by increasing prevalence, complex comorbidities and changing client and health staff demographics, have pushed the boundaries of eHealth to alleviate costs whilst maintaining services. Whilst the intentions are laudable and the technology is appealing, this nonetheless requires careful scrutiny. This review aims to describe this technology and explore the current evidence and measures to enhance its implementation.
This survey analyses some details of follow-up of patients with cardiac implantable electronic devices (CIEDs) in 40 centres-the members of the European Heart Rhythm Association (EHRA) research network. Results of this survey show that practices of CIED follow-up are not homogeneous between EHRA research network centres, and recommended clinical evaluation of the patients regarding possible device up-grade is not always performed. Remote device monitoring appears to be an evolving practice, mostly used in implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillator recipients.
The remote monitoring of implantable cardioverter defibrillators (ICDs) recently emerged as an attractive technological innovation that proved to be reasonably safe in partially replacing the in-clinic follow-ups of ICD patients with no or only mild symptoms. Apart from the fact that strong evidence about any additional clinical benefits and/or cost-efficiency are still awaited, legal and organizational hurdles remain in place, hampering any possibility for adoption of remote cardiac monitoring. This paper identifies a number of legal and organizational constraints which urgently need to be addressed. An elaboration of the specific juridical guidance for the interpretation and application of the relevant legislation is called for.
One quarter of strokes are of unknown cause, and subclinical atrial fibrillation may be a common etiologic factor. Pacemakers can detect subclinical episodes of rapid atrial rate, which correlate with electrocardiographically documented atrial fibrillation. We evaluated whether subclinical episodes of rapid atrial rate detected by implanted devices were associated with an increased risk of ischemic stroke in patients who did not have other evidence of atrial fibrillation.
We enrolled 2580 patients, 65 years of age or older, with hypertension and no history of atrial fibrillation, in whom a pacemaker or defibrillator had recently been implanted. We monitored the patients for 3 months to detect subclinical atrial tachyarrhythmias (episodes of atrial rate >190 beats per minute for more than 6 minutes) and followed them for a mean of 2.5 years for the primary outcome of ischemic stroke or systemic embolism. Patients with pacemakers were randomly assigned to receive or not to receive continuous atrial overdrive pacing.
By 3 months, subclinical atrial tachyarrhythmias detected by implanted devices had occurred in 261 patients (10.1%). Subclinical atrial tachyarrhythmias were associated with an increased risk of clinical atrial fibrillation (hazard ratio, 5.56; 95% confidence interval [CI], 3.78 to 8.17; P<0.001) and of ischemic stroke or systemic embolism (hazard ratio, 2.49; 95% CI, 1.28 to 4.85; P=0.007). Of 51 patients who had a primary outcome event, 11 had had subclinical atrial tachyarrhythmias detected by 3 months, and none had had clinical atrial fibrillation by 3 months. The population attributable risk of stroke or systemic embolism associated with subclinical atrial tachyarrhythmias was 13%. Subclinical atrial tachyarrhythmias remained predictive of the primary outcome after adjustment for predictors of stroke (hazard ratio, 2.50; 95% CI, 1.28 to 4.89; P=0.008). Continuous atrial overdrive pacing did not prevent atrial fibrillation.
Subclinical atrial tachyarrhythmias, without clinical atrial fibrillation, occurred frequently in patients with pacemakers and were associated with a significantly increased risk of ischemic stroke or systemic embolism. (Funded by St. Jude Medical; ASSERT ClinicalTrials.gov number, NCT00256152.).
We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers, implantable cardioverter defibrillators, devices for cardiac resynchronization therapy (both with and without defibrillation properties), loop recorders, and hemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology and the European Heart Rhythm Association combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.
The relationship between shocks, device programming, and atrial fibrillation (AF) with a rapid ventricular rate (AF + RVR) using continuous daily monitoring has not been studied in large number of patients with implantable cardioverter-defibrillators (ICDs).
The aim of this analysis was to determine the impact of ICD programming and ventricular rate control during AF on ICD shocks.
An observational cohort analysis was performed with dual-chamber ICD and cardiac resynchronization therapy-defibrillator devices. The primary endpoint was spontaneous all-cause shocked episodes per 100 patient-years. Shock reduction programming strategies were entered into a multivariable model including slowest ventricular tachycardia/ventricular fibrillation (VT/VF) detection threshold, number of intervals to detect VF (NID), supraventricular tachycardia (SVT) discriminators ON, antitachycardia pacing (ATP) ON for fast VTs (FVTs) and AF + RVR (AF ≥1 hour for ≥1 day with average ≥110 beats per minute). We also characterized the predictive ability of AF + RVR to identify patients at risk of subsequent shocks.
There were 106,513 patients at 2858 institutions, with 2.5 ± 1.4 years of follow-up, 75% being male, age 67 ± 12 years, 59% with dual-chamber ICDs, and 11% with AF + RVR. A total of 22,062 patients (21%) received 82,396 shocks. After adjusting for all variables, AF + RVR, slower VT/VF detection threshold, and shorter VF NID were found to be associated with more shocks (P < .05 for all). Continuous monitoring of AF + RVR identified patients at up to 5-fold increased risk of shocks.
Faster VT/VF detection thresholds, longer detection durations, use of SVT discriminators, and delivery of ATP reduces all-cause ICD shocks. Continuous monitoring of AF + RVR identifies patients at the highest risk of future ICD shocks.
We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers, implantable cardioverter defibrillators, devices for cardiac resynchronization therapy (both with and without defibrillation properties), loop recorders, and hemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology and the European Heart Rhythm Association combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.
Ann Noninvasive Electrocardiol 2012;17(1):36–56