Telemonitoring

Noninvasive Remote Monitoring

Telemonitoring refers to the transmission of symptom scores, physiological data including heart rate, blood pressure, oxygen saturation, and weight directly to care providers either via automated electronic means or by web-based or phone-based data entry. Over time these interventions have evolved from automated phone response systems to web, to interactive television-based systems, to mobile phone or PDA-based systems to complex systems, which wirelessly transmit recorded physiological data [120]. Anker has subclassified telemonitoring systems into those which function as nonreactive data collection devices (such as event recorders), those with a delayed analytic and decision-making structure (e.g., only within office hours), those with continuously operating analytic and decision-making infrastructure, and complex systems that integrate invasive and noninvasive data [123]. Metaanalyses have consistently found these interventions to be associated with reduced mortality and heart failure hospitalizations. In the most recent analysis by Inglis, noninvasive telemonitoring reduced all-cause mortality (RR 0.80; 0.68–0.94) in 17 studies with 3740 participants. Heart failure-related hospitalizations were reduced also (RR 0.71; 0.60–0.83) in 8 studies with 2148 subjects [120].

Of note, several interesting prespecified subgroup analyses were performed as part of this metaanalysis. Firstly, the telemonitoring modality was considered. Automated phone response systems were assessed in four studies enrolling 2445 patients, and pooled results suggested no impact on either total mortality (RR 1.01; 0.80–1.28) or on heart failure hospitalization (0.99; 0.86–1.14). In contrast mobile or PDA-based data collection systems were assessed in four studies enrolling 734 patients, and while the effect on total mortality was not significant (RR 0.71; 0.46–1.11), a significant impact on heart failure hospitalization rates was found (RR 0.58; 0.44–0.77). Further, 12 studies that randomized 2885 patients to complex telemonitoring systems that automated data transmission demonstrated significant reductions in total mortality (RR 0.81; 0.68–0.96) and heart failure hospitalization rates (0.78; 0.64–0.94) [120]. This strongly supports the intuitive notion that ease of use and more automated, less patient-dependent systems are more likely to work.

Further subgroup analysis explored the responsiveness of these telemonitoring systems, finding that pooled heart failure hospitalization outcomes from both studies in which the data were acted up on during office hours (RR 0.71; 0.56–0.89) and those that were operational around the clock (RR 0.71; 0.57–0.87) were very similar.

4.06.3 Technological advances in remote cardiac monitoring

Cardiovascular telemonitoring in the digital telehealth era is undergoing rapid change in no small part due to technological advances. Early approaches to telehealth monitoring included simple measures of clinical status—weight, ambulatory blood pressure monitoring, and clinical symptomology. Improvements in modern telecommunications have been crucial in facilitating the virtual visit, patient counseling, and home monitoring, with mixed clinical outcomes results (Chaudhry et al., 2007; Koehler et al., 2018; Ong et al., 2016; Rahimi et al., 2020).

Advancements in wireless technology and miniaturizing sensors have led to much excitement in the realm of remote hemodynamic monitoring. Historically, right heart catheterization utilizing the Swan Ganz Catheter has been the gold standard in assessing filling pressures and accurately quantifying volume status. Remote wireless PAP sensors have demonstrated notable efficacy in identifying subclinical congested heart failure and reducing heart failure hospitalizations. The CardioMEMS HF System, a small sensor implanted in a branch of the pulmonary artery with a specialized delivery system, is the first such implantable PAP sensor to obtain Food and Drug Administration (FDA) approval in New York Heart Association (NYHA) Class III heart failure patients with prior heart failure hospitalization in 2014. The system is leadless and is powered and interrogated through an external antenna. The pressure-sensitive surface of the device responds to changes in PAP resulting in shifts in resonant frequency (Abraham and Perl, 2017). The sensor is thought to endothelialize after adequate antithrombotic treatment, typically 1 month of dual antiplatelet therapy, followed by life-long aspirin monotherapy. Additional wireless PAP sensor platforms are being developed and studied, including the Cordella™ Pulmonary Artery Pressure Sensor System (Endotronix, Inc., Woodridge, IL). Similar to the CardioMEMs, the Cordella™ is implanted in a branch in the pulmonary artery but is paired with the Cordella™ Heart Failure System, providing additional information on clinical vital signs such as blood pressure, heart rate, weight and oxygen saturation.

While promising data continues to accumulate for remote PAP sensors, there are potential pitfalls with relying on these data as surrogates for volume status, as in instances of World Health Organization (WHO) non-Group 2 pulmonary hypertension. In such instances, it is critical to identify the gradient between the pulmonary artery diastolic pressure and the pulmonary capillary wedge pressure (PCWP), which is less dependent on blood flow, stroke volume, and change in the PCWP, rather on distensibility and compliance of the pulmonary arteries. Moreover, in patients with advanced heart failure there may be mismatch between right and left-sided filling pressures. (Lindenfeld et al., 2021) As such, direct left atrial pressure monitoring has garnered increasing interest with concurrent improvements in transseptal puncture techniques, following the evolving sphere of transcatheter mitral valve interventions. The first such device is the HeartPOD (Abbott, Abbott Park, IL) device, an implantable sensor lead coupled to a subcutaneous antenna coil, and early clinical data highlighted the potential of left atrial pressure (LAP)-guided hemodynamic monitoring, although early clinical data was tempered by procedure-related complications (Abraham et al., 2016a). Broad optimism with this approach has led to development of a wireless LAP sensor, V-LAP™ (Vectorious Medical Technologies, Tel Aviv, Israel), which is currently undergoing clinical investigation (ClinicalTrials.gov Identifier: NCT03775161). Emerging approaches to the remote volume assessment have included inferior vena cava (IVC) monitoring of IVC dimensions, presently undergoing an early safety and feasibility trial (FUTURE-HF; NCT04203576).

The growing indications for CIEDs in patients with heart failure have resulted in innovations aiming at expanding functionality of these devices, through serial measurement of intrathoracic impedance, or thoracic dielectric sensing. Intrathoracic impedance acts as surrogate for volume overload, decreasing as fluid increases in the pulmonary tree. Two CIED-based systems, OptiVol (Medtronic), and HeartLogic (Boston Scientific), incorporate physiologic parameters such as the patient's activity level and heart rate variability with thoracic impedance and have been demonstrated to be more sensitive than daily weight monitoring in predicting fluid accumulation (Abraham et al., 2011b). Additionally, implantable loop recorders (ILRs), initially designed to detect cardiac arrhythmia, are being modified and assessed for utility in remote cardiac monitoring of patients with heart failure.

Noninvasive remote cardiac monitoring has become increasingly popular among patients, especially with direct-to-consumer products which have demonstrated efficacy in arrhythmia monitoring, specifically detection of atrial fibrillation (Perez et al., 2019). A variety of noninvasive approaches to arrhythmia monitoring include both continuous monitors as well as wearable technologies with integration with user-owned personal devices. Noninvasive approaches are now being adapted in the care of patients with heart failure as new wearable devices to monitor thoracic impedance are developed. These devices range in from simple electrodes, self-adhesive patches, to wearable undergarment vests or chest belts which can combine impedance monitoring with multiparameter data collection to detect pulmonary congestion (Uriel et al., 2018; Wheatley-Guy et al., 2020) or reduce heart failure readmissions (Amir et al., 2017; Lala et al., 2021; Shochat et al., 2016). Future approaches include combining noninvasive remote cardiac monitoring with machine-learning analytics to detect impending heart failure hospitalization (Stehlik et al., 2020).

3.1 Medico-economic evaluations and feedback

The medical reality of a chronic disease is: permanent symptoms, regular medical and health care interventions (scheduled and unscheduled), a frequent need for hospitalization (frequent complications), permanent treatment and care (no cure), funding for numerous procedures, and an impaired quality of life and independence. Telemedicine and, more specifically, home medical telemonitoring, allow for better management of all these parameters.

The development of telemedicine and telemonitoring, nevertheless, faces many obstacles, most of which have been identified in the European Commission’s 2014–2020 action plans for health⁴. These action plans have four main objectives: (1) to promote health, prevent disease, and create the conditions for healthy lifestyles, taking into account the principle of integrating health issues into all policies; (2) to protect EU citizens from serious cross-border health threats; (3) to contribute to innovative, efficient, and sustainable health systems; and (4) to improve access to better and safer health care for EU citizens. These plans identify in particular the lack of an interporerability framework, the lack of knowledge of what telemedicine and digital health solutions can bring, the confidence of healthcare professionals, evidence of efficiency, and also report legal and fragmented reimbursement frameworks, often insufficient or non-existent, high investment costs (including for (ARS) [Agence régionale de santé, French Regional Health Agency], uncontrolled judicial or legal aspects – although France has been at the forefront of this field since the 2009 HPST law – and the absence of economic models. These obstacles to the deployment of telemedicine are not all of equal importance and must be considered differently according to the different acts of telemedicine. In this context, remote monitoring, based on new and complex organizations, is identified, with coordination tools, as a major lever in optimizing the management of patients with chronic pathologies. Nevertheless, currently published evaluations remain divergent on the medico-economic efficiency of such projects. This situation does not (yet) allow decision-makers to deploy on a large scale and set up sustainable financial frameworks, and thus create the conditions for a market for industrialists. One point, however, seems to be reflected in these evaluations: the measurement of efficiency will increasingly depend on the consideration of patient-centered qualitative criteria.

In its April 2012 summary report, SYNTEC numérique, one of the French professional trade unions in the digital industry and member of the SYNTEC federation⁵, also insisted on the fact that the sustainability of telemedicine will undoubtedly depend more and more on the participation of patients in the financing of telemonitoring services: “the deployment of telemedicine in France was first prompted by health professionals, mainly in the hospital sphere. This led to the first projects being oriented toward medical uses (tele-expertise, remote interpretation). From now on, and this seems obvious for remote monitoring but also for remote consultation, telemedicine must, in order to develop, seek the support of patients […] If joint investments by public authorities and industrialists are necessary to initiate the development of telemedicine, the sustainability of the sector depends on informing and training patients, through reflection based on their uses of telemedicine, and even ultimately through their participation in the financing of telemedicine services. This strong support from patients would establish a strong growth driver for the development of telemedicine, and would attest to the maturity of the market” [TEL 12].

4.07.1.3.5 Digital-based symptom monitoring

Self-management strategies with telemonitoring, remote monitoring of symptoms and health status utilizing digital technology are promising strategies to improve health outcomes of those with chronic lung disease. Mobile and online applications are digital technology means to assist with self-management. As of 2018, there were reportedly 325,000 mobile health apps available worldwide with approximately 200 apps launched daily (Abernethy et al., 2022). A surge in ease and availability of health apps draws questions about the potential applications of these apps in the clinical setting for self-management of patients with chronic lung disease. Studies regarding mobile health applications, particularly concerning COPD management, unfortunately have reported inconsistent findings. Several systematic reviews, meta-analyzes, and literature reviews indicate that COPD self-management mobile applications yielded mixed results with some studies showing no significant effects (Shaw et al., 2020; Li et al., 2020), others showing positive effects (Nici et al., 2014; Yang et al., 2018), and even negative effects of intervention (Yang et al., 2018). Studies reporting negative results including increased mortality suggest that high-risk patients had delayed assessment by trained professionals and delayed treatment due to overconfidence of self-management (Nici et al., 2014). These studies regarding self-management of COPD using mobile applications are reflective of earlier studies regarding other self-management methods (Nici et al., 2014). However, evidence bases for COPD targeted self-management applications are less developed compared to other chronic diseases such as type 2 diabetes and heart failure, for which more robust studies indicate digital self-management support is a safe option (Hanlon et al., 2017). Further, study of COPD targeted applications is difficult due to variability in interventions and outcome measures (Li et al., 2020). Success of self-management applications in diabetes and heart failure gives insight into the potential success of these applications with COPD. However, there is a need for further research in this area as well as standardization of practice.

Self-management with digital technologies in patients with asthma is another application of this technology for chronic pulmonary disease. In one study, participants were asked to answer a questionnaire regarding their asthma symptoms, medication use, and provider care as a tool to remind patients to discuss questions and concerns with physicians as well as improve their own self-care behaviors. This simple online intervention was found to improve asthma control among users (Pool et al., 2017). This use of applications highlights another use of digital symptom monitoring beyond that of self-management and exemplifies the utility to this tool for personalized asthma management and care with corroboration between patient and provider. Another study utilized a sensor to gather asthma symptom relevant information. This study found that continuous symptoms monitoring was useful for providers to review with patients to identify symptom triggers to help clinician personalize patient asthma management as well as give patients tools to be more involved with their self-management, such as trigger avoidance (Venkataramanan et al., 2019).

5.6 Harmonizations and phase shifts

The time-saving of home telemonitoring, based on the principles of compliance and concordance, is mainly based on three modes of time-sensitive management of the disease – by proxy, by chrono-responsibility and by empowerment – which are carriers of values whose examination makes it possible to enlighten the telemedical perspective on the patient today. Thus, the value of power of attorney is fundamentally pastoral, in the sense of Nikolas Rose³⁰. Because of their control of the operational methods of telemonitoring, the practitioner imposes themself as an authority figure holding knowledge about the disease, which is constantly updated, to which the cardiac patient has no immediate access. In this context, their typical profile is both that of a “patient guided” by the practitioner, and that of a “patient out of step” with the protocol. Delayed cardiac patient update, at the teleconsultation stage, is a late harmonization practice.

The chrono-responsibility of dialyzed telepatient care is a very particular method of discipline, both useful and constraining, which presupposes the negotiated caregiver–care receiver interactions of moral feelings (trust, respect) and specific home care practices based on the shared expertise of the practitioner. As in the case of telemonitoring of the cardiac patient, the practitioner exercises a pastoral responsibility, an essential condition for the proper conduct of home care, but by delegating to the patient a certain number of tasks according to a programmed chronology. The value of co-responsibility in the management of telemonitoring operational modes is, therefore, the correlate of the chrono-responsibility of the dialysis patient on a daily basis. Like the value of power of attorney, mentioned above, the value of co-responsibility nevertheless constitutes the principle of compliance, which tends to relegate the patient’s knowledge or subjectivity to the margins of the telemonitoring protocol. A similar, but perhaps more radical, conception of coresponsibility also seems to be emerging through the empowerment of the interactive patient (diabetic patient) by intermediary object. Indeed, the responsibility for the care is validated by the automated system that transmits in real time the recommended dose of insulin to the patient. The practitioner is certainly not absent from the loop since the application gives them access to blood glucose readings. However, this automated validation is a “systemic” mode of protocol compliance.

An examination of the values underlying the time-sensitive management methods of the disease sheds light on the specific features of the harmonization logic specific to telehomecare. This logic is based on an imperative of compliance for therapeutic efficiency purposes without however including the patient in the decision-making loop. It also results in a permanent and “prudential” telemonitoring of the person, more or less sensitive to their pace of life, based on a quantitative conception of the disease and care. Finally, this logic contributes to blurring the boundaries not only between the patient’s experience and the experience measured by the empowering objects, but also between the value systems and the modes of representation of the participants in telecare. However, the logic of harmonizing telemonitoring practices and times cannot mask a certain number of discrepancies between the caregiver’s concepts of the disease and that of the patient, between the disease observed and the disease experienced, between the evolutionary internalization of the person’s perspective and the externalization of the telemedical perspective centered on the illness in its clinical intimacy.

Thus, the telemonitored chronic patient may sometimes be led to experience a situation of psychic individuation, in the Simondonian sense of the term³¹. The person may become out of phase with themselves and their illness as a result of the dynamics of telemonitoring. On the one hand, this phase shift can induce a potential withdrawal into oneself and the possibility of a cleavage for the patient, who is likely to develop a “double” awareness of their disease, inside and outside of oneself, but it can also generate antagonism between individual and technical perceptions of the disease. Affection, far from being an object of pure quantification or an inseparable experience of the patient, is a complex, ambivalent reality in the context of telemonitoring, which notably calls for a better understanding of the person’s “inner time” as well as a rapprochement, if not reconciliation, of the patient’s “subjective time” and the “objective time” of the telemonitoring device. This approximation seems possible through mediation by the instigators of telemonitoring projects sensitive to the multiple temporality of the patient. The implementation of the conditions of this mediation seems all the more urgent today as the so-called “autonomized” and “empowered” patient gradually acquires the mastery of “new technologies”, a kind of digital version of the self-study techniques analyzed by Michel Foucault, which lead them to replace the practitioner. To achieve this mediation, a holistic approach to the temporality of the patient, centered not only on the chronology of their illness but also on their body experience, appears to be an interesting avenue for reflection.

By placing the emphasis on the therapeutic value of the recognition of experiential existence, the analysis of telecare ultimately points to the patient’s “capability”. According to Amartya Sen’s definition, capability refers to an individual’s actual ability to choose various combinations of functioning, in other words to test the freedom that they actually enjoy³³. In the context of telecare, this freedom, for the patient, is that of sharing experience in order to optimize care. The possibility of expressing this freedom can also contribute, on the one hand, to remedying the discrepancies imposed by telemonitoring protocols and, on the other hand, to reclassifying the status of “chronic patient” or “telepatient”: no longer as an “object” but as a “subject” of care whose experience is part of multiple temporalities and makes sense in therapeutic management.

What lessons can be learned from examining the chrono-diversity of home telemonitoring, which underlies chronic patient care and its temporality regime and illuminates the contemporary telemedical perspective?

First, in order for the patient’s temporality experience in a telemonitoring context to be possible as a form of knowledge, it is necessary to give meaning to the sick body in its digital reconfiguration, to examine the potential effects of the dynamics of telemonitoring on the person and to elucidate its status in light of the reexamination of the principles of conformity and concordance specific to telemonitoring.

Second, just as the new medical spirit based on observation and its methods, initiated by Bichat according to Michel Foucault, was “nothing other than an epistemological reorganization of the disease where the limits of the visible and the invisible follow a new design” [FOU 09, pp. 269 − 270], the contemporary telemedical spirit seems to be nothing more than an epistemological reorganization of care practices. The management of chronic disease in the context of home telemonitoring takes concrete form in particular through the development of two types of knowledge. On the one hand, the knowledge built by the patient (or biological knowledge of oneself) and, on the other hand, the knowledge acquired through telemonitoring (or biomedical knowledge about the individual being telemonitored)³⁴. However, this knowledge is not used in equivalent terms. Thus, the consideration of subjective knowledge about chronic disease, generally delegated to social or family caregivers, still appears marginal where it might be useful, including on a therapeutic level, to give a more central place to lay knowledge about the disease and its temporality in the telemonitoring protocol.

The examination of the chrono-diversity of telemonitoring devices and participants, and more particularly the examination of the temporal figures of the chronic patient being telemonitored, make it possible to clarify the specificities of the temporal distribution particular to the home telemonitoring of chronic disease by emphasizing in particular the therapeutic interest of a resolutely holistic approach to care that presupposes jointly taking into account the physical and psychological experience of the patient. This double observation thus makes it possible, in the latter instance, to highlight the major ethical challenge facing telemedicine today: how to reconcile medical technicality with human care.

6.3.8 Words from people in independent home dialysis

Remote Patient Monitoring and Wearables

Remote patient monitoring is certainly not a new idea for clinical medicine. The Holter monitor has been available for decades to help physicians continuously track ECG readings for 24 hours or longer. But the long list of remote monitoring tools now available greatly expands the clinician’s ability to understand what is happening in a patient’s body over time. The need for such longitudinal data is obvious. Taking a single blood pressure reading or doing a static blood glucose test during an office visit doesn’t provide much insight into what’s going on while a patient is not in the office. And since patients spend 99% of their time outside the clinical setting, that brief snapshot can be quite misleading.

Many thought leaders are convinced that remote patient monitoring improves patient care, but surveys suggest that many health-care professionals are still not convinced. An analysis from the New England Journal of Medicine Catalyst Insights Council asked respondents to rate various patient engagement initiatives. “Remotely monitoring using wireless devices/wearable” was listed as the least effective way to engage patients while having physicians, nurses, or other clinicians spend more time with patients was listed as the most effective tactic [7]. (The survey consisted of 340 responses from health-care executives, clinical readers, and clinicians involved in direct patient care.) There is also uncertainty about the benefits of remote patient monitoring in the scientific literature. Of course, remote patient monitoring can take so many different forms that it’s impossible to make a blanket statement about its effectiveness. But a randomized controlled trial (RCT) that included more than 1400 patients (median age 73 years) who had been hospitalized for heart failure generated less than encouraging results. Michael Ong, MD, from the University of California, Los Angeles, and his colleagues divided the group into an intervention arm, which received health coaching phone calls along with the collection of vital signs that included blood pressure, heart rates, symptoms, and weight with the help of electronic devices, and a control arm that received the usual care [8]. Ong et al. couldn’t find any significant difference in hospital readmission rates 180 days after discharge for any cause: 50.8% were readmitted despite having all the extra attention and access to all the high-tech monitoring devices versus 49.2% in the usual care arm. Similarly, the investigators detected no difference in 30-day readmission or 180-day mortality. The experimental group did, however, report better quality of life at 180 days.

Similarly, Bloss et al. conducted a prospective RCT of adults with diabetes, hypertension, and cardiac arrhythmia who had either received standard care or used one or more mobile devices, including the Withings BP monitor, Sanofi iBGStar blood glucose meter, the AliveCor Mobile electrocardiogram (ECG), and an iPhone for 6 months. Patients in the experimental group also had access to an online management system to help them negotiate the process of monitoring their data. Data from the resulting health insurance claims were disappointing: “There was little evidence of differences in health-care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health-care utilization outcomes.” [9].

On the other hand, Essentia Health, a Minnesota-based system that includes 16 hospitals and 68 clinics, has been using home telemonitoring with a body weight scale to keep track of CHF patients. Patients weigh themselves every morning and answer a few basic questions about their symptoms. Their responses are transmitted via telephone line to the computers that triage the incoming data and alert clinicians to those in need of additional attention. Essentia have been able to reduce 30-day readmission rates to less than 2% with the program. The average readmission rate for CHF patients is 25% [10,11].

The Spyglass Consulting Group has published a study that involved more than 100 interviews with health-care organizations that use telemedicine. Although it concluded that remote patient monitoring “provides significant benefits and outcomes to chronically ill patients,” the analysis was a marketing study and details on the study methodology were not readily available [12]. (The report costs $2495 and the report does not indicate that the analysis went through the rigorous peer-review process that is required for publication in scientific journals.)