Remote Monitoring Research Articles

Same term, but unequal understanding: differences in digital public health intervention features

Abstract Digital technologies have transformed healthcare delivery and public health, with many countries integrating interventions such as online consultations, electronic health records, and telemedicine to improve population health and healthcare accessibility. Multinational assessments for benchmarking system maturity ask for the degree of implementation of such tools. However, are these interventions as comparable as they claim to be? This talk presents a qualitative analysis of 179 digital public health (DiPH) interventions described in scientific articles. We categorized interventions based on their implementation stages, public health functions, and reported and non-technical features. Telemedicine, health apps, and electronic health record interventions dominated the diverse landscape. While these technology groups already differed greatly in their functions, we identified equally significant differences in the reported intervention characteristics within the groups. For example, telemedicine was not only used in healthcare settings for patients and health professionals but also in primary prevention and research for researchers, policymakers, and healthy individuals. Different interventions reported varying functions, such as remote monitoring, self-monitoring, alarm systems, patient motivation, and user empowerment modules. So, is there one common telemedical intervention? No. Instead, all individual technologies differed to varying degrees. The analysis underscored the diversity of DiPH interventions among and within intervention groups and highlighted the importance of precise terminology for effective planning and evaluation. Instead of using broad classifications like ‘telemedicine,’ interventions should be defined and communicated based on specific technological functions, non-technical characteristics, use cases, and user groups. This approach will promote cross-disciplinary collaboration and foster international comparability across DiPH systems.

Heart failure hospitalization reduction and long-term safety with remote pulmonary artery pressure monitoring: results of the CardioMEMS HF System OUS Post-Market Study

Abstract Background Heart failure (HF) is increasing in prevalence and is responsible for frequent hospitalization and readmissions, despite current guideline recommended therapies. Hemodynamic guided HF management using frequently remotely obtained pulmonary artery (PA) pressure information using a permanently implanted PA sensor (CardioMEMSTM HF System, Abbott) consistently reduced HF hospitalizations (HFH) in multiple healthcare settings. The safety and efficacy of the CardioMEMS HF System has been shown previously in several clinical studies, which reported significant reductions in HFH compared to a control (CHAMPION: 33%, 18M; GUIDE-HF: 28%, 1 yr; and MONITOR-HF: 44%, 1 yr) and longitudinally (MEMS-HF: 62%, 1 yr; and CardioMEMS US PAS: 57%, 1 yr) across varying health systems. Purpose The CardioMEMS HF System OUS Post-Market Study (COAST) aimed to evaluate the safety and effectiveness of hemodynamic guided HF management in patients with NYHA Class III HF in varying health systems across Europe and Australia. Methods COAST is a prospective, multi-centre, open-label clinical trial that consented 321 patients at 38 European and Australian centres. The primary endpoint is a combination of safety (freedom from DSRCs and freedom from pressure sensor failure at 2 years after implant) and efficacy endpoints (annualized HFH rate at 1-year vs the HFH rate in the year prior to enrolment). In this analysis we report these primary results of the study. Results Out of 321 consented patients, 17 subjects were withdrawn before implant, while the PA sensor was implanted successfully in 299 out of 304 patients who underwent the procedure (98.3% success rate). Seventy-three percent (73%) of the patients were male, the mean age was 68.4±11.7 years with ischemic cardiomyopathy in 45.4%. At baseline, all patients had NYHA Class III symptoms and an average EQ-5D-5L VAS score of 60.0±21.6. After 2 years follow-up there was 100% freedom from DSRCs and 99.7% freedom from pressure sensor failure. The annualized HFH rate after 1 year decreased by 69%, from 1.586 (pre-implant) to 0.488 (post-implant) (p<0.0001). The patient’s quality of life (EQ-5D-5L VAS) increased 8.1 units (68.2 ± 20.1, p=0.0008). Conclusion The COAST Study demonstrated that hemodynamic-guided remote HF management using PA pressure information is both safe and effective, with consistent implant safety and low risk for long-term sensor failure. At 1 year post implant, HFH were significantly reduced and quality of life improved. These results are also consistent with long-term clinical follow-up (2 yr) in other geographies with no late-stage adverse events or adverse events from sensor implant, demonstrating the generalizability of this type of hemodynamic-guided HF management.

Treated obstructive sleep apnoea and incident arrhythmias

Abstract Background Obstructive sleep apnoea (OSA) is prevalent in approximately 15% of western populations. Cardiovascular disease and arrhythmia are extremely common in this group with significant morbidity overlap. Whilst treatment of OSA with continuous positive airways pressure (CPAP) appears to reduce hypertension, bradycardia and recurrence of atrial fibrillation (AF), large randomised control trials and meta-analyses do not demonstrate a significant reduction of incident tachyarrhythmias such as atrial fibrillation or sudden cardiac death. Some smaller studies suggest that AF may have up to 20% incidence. Analysis of these studies suggest that there may be significant heterogeneity in both CPAP usage and OSA phenotype, confounding the results. Furthermore, standard arrhythmia detection often underestimates paroxysmal arrhythmias. This on-going trial investigates a treated OSA population using CPAP monitoring and implantable loop recorders (ILR). Purpose This study aims to identify the incidence of arrhythmia in a treated OSA population with comprehensive arrhythmia monitoring and CPAP usage. It also explores the mechanisms linking OSA and arrhythmia such as heart rate variability and turbulence and cardiac biomarkers in order to identify at risk sub populations. Methods Continuous moderate-to-severe OSA patients were recruited from a major UK sleep centre after ECG and medical history confirmed the absence of arrhythmia. Each patient was then randomised to receive either standard-care or standard-care with an ILR with 24-hour heart rate variability/turbulence measurements, echocardiography (where possible) and cardiac biomarkers at baseline and 12 months. All patients had remote CPAP usage monitoring (where possible). The trial ended at 36 months after enrolment. Results 200 patients were recruited to the trial. Current mean average follow-up is 28 months in this on-going trial. Mean age and apnoea hypopnea index at enrolment was 53 years and 43.8 respectively. To date we have diagnosed atrial fibrillation in 15% of the ILR group compared to 2% in the standard care group. Other arrhythmias detected in the ILR group include two with supraventricular tachycardia and 2 with significant pauses but not requiring further treatment. Final analysis of arrhythmia incidence with CPAP usage and heart rate variability/turbulence, and cardiac biomarkers is ongoing with final results due by the time of final submission. Conclusion Arrhythmias, particularly AF, are highly incident in OSA despite CPAP treatment. This study may determine if heterogenous CPAP usage confounds the above observation and whether there may be predictors of arrhythmia that may indicate a need for arrhythmia screening in the OSA population.

Empowering patients with heart failure: a digital health solution improved self-care and metabolic outcomes in a randomized controlled trial

Abstract Background/Introduction Heart failure is a common cause of morbidity and mortality and poses a significant burden on patients and healthcare providers. Purpose The aim of the study was to evaluate whether a digital health program improves quality of life and clinical outcomes for patients with heart failure. Methods A single-center, randomized controlled trial (RCT) was conducted with patients receiving standard of care (SoC) at a heart failure outpatient clinic. Patients were randomized (1:1) to receive either SoC alone or SoC with an additional six-month digital health program. The program consisted of remote patient monitoring (RPM) with symptom tracking, disease-specific education, and lifestyle coaching, designed to empower patients with heart failure. After the main program concluded, a six-month maintenance program was initiated, consisting of recurrent educational materials, with reduced coaching- and RPM frequency. The primary endpoint was the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at six months. Secondary endpoints included the European Heart Failure Self-care Behaviour Scale-9 (EHFScB-9), 6-question heart failure knowledge questionnaire, and metabolic outcomes. Here we report on the Intention-to-Treat (ITT) population analysis for the primary and significant secondary endpoints at six and 12 months. Results The ITT included 175 participants, 86 in the program group and 89 in the control. Program group: mean age (SD) 64.7 (13.2), 66.3% male, 87.2% with NYHA stages I-II. Control group: mean age (SD) 66.2 (11.1) years, 69.7% male, 87.6% with NYHA stages I-II. Median compliance with RPM was 93% and in-app retention was 80% at six months. Results for primary and secondary endpoints are presented in Table 1 and Figure 1. No statistical difference was observed in the KCCQ score between groups at six or 12 months. The program group had statistically significant improvements in EHFScB-9 score at six and 12 months and in heart failure knowledge at 12 months compared to the control group. Metabolic outcomes: a significant difference in glucose levels was also observed between groups at six months, and in HbA1c and triglycerides levels at 12 months. Conclusions The difference between groups in the primary endpoint of heart failure symptoms and quality of life, as measured by the KCCQ-12, was not statistically significant. However, significant differences were observed in self-care behaviour and heart failure knowledge, as well as metabolic outcomes at six and 12 months, when compared with standard care alone. These findings, along with good retention and engagement, indicate the value to patients of digital health interventions in the management of heart failure.

Rationale and design of healthy at home for COPD: an integrated remote patient monitoring and virtual pulmonary rehabilitation pilot study

Chronic obstructive pulmonary disease (COPD) is a common, costly, and morbid condition. Pulmonary rehabilitation, close monitoring, and early intervention during acute exacerbations of symptoms represent a comprehensive approach to improve outcomes, but the optimal means of delivering these services is uncertain. Logistical, financial, and social barriers to providing healthcare through face-to-face encounters, paired with recent developments in technology, have stimulated interest in exploring alternative models of care. The Healthy at Home study seeks to determine the feasibility of a multimodal, digitally enhanced intervention provided to participants with COPD longitudinally over 6 months. This paper details the recruitment, methods, and analysis plan for the study, which is recruiting 100 participants in its pilot phase. Participants were provided with several integrated services including a smartwatch to track physiological data, a study app to track symptoms and study instruments, access to a mobile integrated health program for acute clinical needs, and a virtual comprehensive pulmonary support service. Participants shared physiologic, demographic, and symptom reports, electronic health records, and claims data with the study team, facilitating a better understanding of their symptoms and potential care needs longitudinally. The Healthy at Home study seeks to develop a comprehensive digital phenotype of COPD by tracking and responding to multiple indices of disease behavior and facilitating early and nuanced responses to changes in participants’ health status. This study is registered at Clinicaltrials.gov (NCT06000696).

Positioning Imatinib for Pulmonary Arterial Hypertension (PIPAH) study

Abstract Introduction Pulmonary arterial hypertension (PAH) is characterised by pre-capillary pulmonary vascular remodelling. Imatinib, a tyrosine kinase inhibitor, was the first treatment investigated in PAH patients with the primary aim of targeting vascular remodelling. A Phase 3 study showed that imatinib 400mg daily reduces pulmonary vascular resistance and increases exercise capacity but only 43% of patients continued the drug for 6 months. Concerns about safety prevented regulatory approval. Purpose To identify a safe and tolerated dose of oral Imatinib and evaluate efficacy in the dose range 100-400mg daily. Methods Oral Imatinib was added to the background therapy of 17 patients with PAH; prior intracranial haemorrhage was excluded by cross sectional imaging and none were receiving an anticoagulant. The first patient started on 100mg daily. The next 12 patients were recruited serially at a minimum of 4 week intervals and started on 200mg, 300mg or 400mg, according to a Bayesian adaptive design (Continuous Reassessment Method, CRM). Patients 14-17 were recruited as an extension cohort to better understand the safety and tolerability of the 100mg and 200mg doses. The primary endpoint was safety and tolerability at 4 weeks. Imatinib was continued for up to 24 weeks. Thirteen patients had implanted devices that provided remote daily measurements of cardiopulmonary haemodynamics and heart rate and rhythm and physical activity. Non-invasive measures of systemic blood pressure, weight and oxygen saturations were made remotely. We compared the time-haemodynamic response relationship with that produced by licensed treatments in a similar patient cohort. Results The recommended starting dose from the CRM was 200mg daily. The most common side effect was nausea. Imatinib reduced mean pulmonary artery pressure (P<0.01), increased cardiac output (P=0.08) and reduced total pulmonary resistance (TPR, P<0.001, Figure). There was a clear dose-TPR response relationship (r2=0.52, p<0.01). A reduction in TPR was evident within the first week and plateaued at 4-5 weeks. Withdrawal of Imatinib led to an increase to baseline in TPR over 4-5 weeks. This contrasts with a sharp fall in TPR with licensed therapy and rapid increase on treatment withdrawal. There was a small reduction in systemic vascular resistance (P<0.05) with Imatinib that reached plateau before TPR. Conclusions Oral Imatinib 200mg daily is well tolerated and effective as an add-on treatment in PAH. The time course of the initial haemodynamic response and the gradual return to baseline on withdrawal distinguishes Imatinib from licensed treatments and is supportive of a mechanism of action beyond reliance on vasodilation. Remote monitoring enables the safe evaluation of the withdrawal of an investigational drug in patients established on best medical therapy.Figure 1.

Home Transcutaneous Electrical Stimulation Rehabilitation Program for Patients With Ankylosing Spondylitis: Crossover Trial.

Maintaining physical function and preserving spinal flexibility have been challenging in managing ankylosing spondylitis (AS). Most rehabilitation programs, including manual therapy, massage, hydrotherapy, and acupuncture, cannot be performed at home. The effect of transcutaneous electrical nerve stimulation (TENS) was validated in treating AS, but no home TENS system has explored its efficacy to date. This study aims to evaluate the efficacy of a home TENS system with a novel treatment program for patients with AS. The modified WeHeal TS-200 TENS and galvanic response system provided home-based TENS treatment for patients with AS. Patients were divided into a 2-month course group and a 1-month course group. After the first treatment course, patients went through a washout period for the same duration of their treatment course. Participants could decide whether to accept the second course of treatment. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Schober test, finger-to-floor flexion test, enthesis score, cytokines, chemokines, inflammatory factors, and immunoglobulins were measured to evaluate its efficacy. The clinical trial protocol (1096607481) received approval from the Ministry of Health and Welfare in Taiwan. A total of 9 patients (5 in a 2-month course group and 4 in a 1-month course group) completed the first treatment course, and 5 patients (4 in a 2-month course group and 1 in a 1-month course group) completed the sequential treatment course. The weighted results showed that patients reported an improving BASFI score (mean difference -0.9, SD 1.7; P=.03) after treatment. Looking into the trajectories, declined BASFI and BASDAI scores were noticed during treatments; this score increased during the washout period. There were improving trends in the Schober test (mean difference 1.9, SD 4.9; P=.11) and finger-to-floor flexion test (mean difference -0.6, SD 9.5; P=.79), but the results were not statistically significant. The response of cytokines, chemokines, inflammatory factors, and immunoglobulins before and after treatment did not show a consistent trend, and all results were not statistically significant (all P>.05). The home TENS device demonstrated a potential role in AS management. It may improve accessibility and adherence for patients with AS and provide remote monitoring for clinicians. Further research can compare the effectiveness of electrotherapy at home or in a medical setting and focus on integrating the home TENS system and exercise program to enhance patients' physical functions and spinal flexibility.

Remote management of worsening heart failure events and subsequent rate of emergency department admission

Abstract Background Worsening heart failure (WHF) is the leading cause of hospitalization among individuals aged ≥ 65 years and constitutes a substantial burden for both the patient and the healthcare systems. Moreover, heart failure contributes to exacerbate the pressure on emergency departments which are involved in 64% of heart failure hospital admission (1). Remote management of heart failure as been shown to reduce the number of days lost due to unplanned cardiovascular hospitalizations and all-cause mortality (2, 3), but little is known about the effect on the emergency healthcare use. We aimed to describe the effect of a telemonitoring program on the rate of emergency admissions for WHF in chronic heart failure patients. Methods All patients enrolled in the heart failure remote management program of two French centers between 13 April 2020 and 31 January 2023 were included in the study. Follow-up data were collected until 31 January 2023. Inclusion criteria were chronic heart failure (HF) with New York Heart Association ≥II and an elevated B-type natriuretic peptide (BNP > 100 pg/mL or N-terminal-pro-BNP > 1000 pg/mL). Remote evaluation included measurements of body weight, blood pressure, heart rate, symptoms, biochemical parameters, and data from cardiac implantable electronic devices when available. Results A total of 1,095 patients (72±11.8 years old, 69.7% male), were followed for a median [IQR] of 437 [182; 739] days with a mean adherence to the remote monitoring system of 67.6±30.3%. Over this period, 198 (18.1%) patients had 949 WHF events, the majority of whom were remotely detected: 830 (87.5%). Overall, 246 (26%) of the WHF episodes required hospitalisation and 109 (11%) prompted an emergency department visit. When the WHF event was remotely detected, hospitalization was only required in 127 (15%) cases and the rate of emergency department visit was reduced to 3%. Conclusion In HF patients engaged in a multiparametric remote management program, the rate of emergency department admission is very low. Adopting such a strategy for patients with chronic HF may be useful in reducing emergency department overcrowding.Baseline characteristics of patientsPatients course and use of resources

Leveraging digital adherence technologies to enhance public health: insights from TB care in Ukraine

Abstract Background Effective tuberculosis (TB) care is vital for public health, especially in war-affected Ukraine. In response to the complex healthcare delivery landscape, where traditional directly observation treatment methods became impractical, digital adherence technologies (DATs) emerged as a promising solution, offering more autonomy for people, and remote monitoring capabilities for healthcare providers. Intervention The PATH-led USAID-funded Support TB Control Efforts in Ukraine (STBCEU) project implemented smart pill boxes in eleven Ukrainian regions. These devices equipped with built-in reminders helped people adhere to their medication regimen, and signaled healthcare providers when the box was opened. Results Since April 2022, STBCEU has supported 2,022 people with TB who used smart pill boxes during their treatment, including 489 (24%) with drug-resistant TB (DR-TB). A total of 482 people continue utilizing boxes. Of 1,540 people with TB who completed the use of boxes, 1,207 people (78%) successfully completed TB treatment with an average of 84% treatment adherence rate digitally reported by the technology. Conclusions The integration of smart pill boxes in TB management has enhanced people-centered care, ensuring treatment continuity even in challenging circumstances and providing healthcare providers with real-time adherence data. The innovation contributed to TB control efforts and health equity through expanding opportunities for people to choose their treatment model based on their needs, available resources and community support programs. Leveraging digital solutions proved to be essential in strengthening healthcare systems. In the realm of TB management, DATs enhance differentiated care, embodying a harmonious integration of technology automation and provider interventions. Key messages • Integration of smart pill boxes enhanced patient-centered care, providing real-time adherence data and empowering individuals to choose personalized treatment models. • Digital technologies like smart pill boxes transformed TB care, offering tailored support for patients and remote monitoring capabilities for healthcare providers even in challenging circumstances.

Rancang Bangun Pakan Ikan Otomatis dan Kontroling Suhu Serta Monitoring pH Air Berbasis IoT

This research proposes the design of an automatic fish feeding system equipped withtemperature control and water pH monitoring based on the Internet of Things (IoT). Thissystem aims to increase efficiency in aquarium or fish pond management by integratingvarious control and monitoring functions in real-time. In this system, the automatic fishfeeder uses a programmable dispenser mechanism to provide feed in predeterminedamounts and times. Temperature control is carried out using temperature sensors andheating or cooling actuators, to maintain water temperature conditions within the optimalrange. In addition, water pH monitoring is carried out through a pH sensor connected tothe system to ensure the water quality remains ideal for fish health. Data from these sensorsis sent in real-time to the IoT platform, enabling remote monitoring and control via webbasedor mobile applications. The results of implementing this system show increasedefficiency in feeding, increasing operational efficiency, reducing human error, andproviding quality fish, as well as maintaining more stable and optimal environmentalconditions. The implementation of this system shows great potential in modern aquacultureapplications by utilizing IoT technology for better and responsive management.

Can a chest pain virtual ward be used to safely manage patients with low-risk acute coronary syndrome?

Abstract Background Acute coronary syndrome (ACS) accounts for approximately 2-6% of emergency department (ED) presentations and contributes at least 20% of the overall acute hospital admissions(1-3). Patients presenting with low-risk ACS may be suitable for remote monitoring(4) while awaiting angiogram in chest pain virtual ward(CPVW) thereby improving patient flow and resource utilisation. Purpose We aimed to assess outcomes for patients with low-risk ACS admitted in a district general hospital with a view to establish an onboarding pathway for CPVW whilst ensuring a safe monitoring without effecting the readmission rate or all-cause mortality. Methods We retrospectively analysed the Myocardial Ischaemia National Audit Project (MINAP) registry of from March 2022 to April 2023 for patients who presented to ED with a diagnosis of confirmed ACS. Patients were stratified into low-risk (GRACE score <140, HEART score <4, non-dynamic ECG, non-dynamic troponin, without ongoing chest pain), all other patients were deemed intermediate-to-high-risk ACS. Baseline demographics, the total length of acute admission days, waiting time before and after coronary investigation ,adverse events (escalation of therapy, death)whilst awaiting for invasive inpatient angiogram were calculated. The primary endpoint was 30-day readmission and all-cause mortality. Results 1077 patients were coded as ACS diagnosis in ED. 561(52.1%) had a confirmed diagnosis of ACS. Data to allow stratification was available for 538 patients, included in final analysis. 377(70.1%) were male with a mean age of 66.8 ± SD 13.1 years. A significant number of patients had other comorbidities, including hypertension (66.1%), diabetes (45.3%), hyperlipidaemia (51.3%), and previous history of IHD (46.5%). Total number of patients stratified into low-risk ACS was 55(10.2%), intermediate-to-high-risk group contained 483(89.8%) patients. The median total-length-of-stay (LOS) for low-risk ACS patients was 4 days(IQR 2-7), waiting time to have an inpatient angiogram was 3 days(IQR 0-5), and discharge time post-angiogram was 1 day(IQR 0-2). 4 patients(7.3%) in low-risk cohort required CCU admission for GTN infusion due to ongoing chest pain, among them 3 patients(5.5%) had abnormal coronary angiogram. 5 patients(9.1%) in low-risk cohort were readmitted due to chest pain post-angiogram and no patients had 30-days or 1-year all-cause mortality. The result depicts 51 patients from low-risk cohort would have been eligible for CPVW reducing the LOS from median 4 days to 1-2 days, this is a saving of 102-153 acute bed days per year. Assuming the costing of a bed day is £320 this equates to £32,640 - £48,960 cost saving without any adverse outcomes. Conclusion Our data suggests that there is a large cost saving with minimal risk in managing patients with low-risk ACS via a CPVW. This pathway of management is likely to have benefit in patient flow and resource utilisation in our district general hospital trust.Comparison of different ACS cohortsCPVW flow-diagram

Beyond telehealth in heart failure, how a nurse-led mobile team unit improves management and reduces re-admission in elderly patients living in a rural area

Abstract Introduction Telehealth plays a crucial role in improving access to healthcare for elderly patients with heart failure (HF), particularly those who live in under-resourced geographic areas, have physical disabilities, or have difficulties with transportation. However, extending and improving telehealth faces significant obstacles, primarily due to its inadequacy to fully assess a patient's clinical status. While some components of HF can be measured remotely, others, such as cardiac and lung examinations, require in-person clinical evaluation. This leads to imprecise assessments of HF severity, excessive medical consultations, and inappropriate emergency transfers or hospitalization. We conducted an evaluation of a specialized mobile team unit (MTU) for HF care in a rural area. The team consisted of nurses trained in performing electrocardiograms (ECGs) and point-of-care ultrasound (POCUS) to extend telemonitoring services to elderly patients with HF in the comfort of their homes. This approach offers a direct and optimal evaluation of the patient's condition. Purpose This study aimed to evaluate the added value of an MTU in assessing and optimizing treatment for HF in elderly patients, ultimately leading to decreased hospitalization or medical request rates. Materials and methods This retrospective analysis examined data from elderly patients diagnosed with HF, who participated in a 6-month telemonitoring program, and received MTU visits. MTU was activated by the telemonitoring team, in patients presenting signs of decompensation, with an imprecise assessment of severity based on digital data only. Results During six months, 165 elderly patients were included in the telemonitoring platform after index HF hospitalization. The mobile team traveled over 3,040 kilometers in a rural area with limited cardiological care. They visited 84 patients (50.9%), offering personalized education and physical assessments to all of the patients, 45% received additional imaging (EKG, POCUS). This resulted in 30% therapeutic adjustments, 90% fewer General practitioner (GP) /Cardiologist consultations and 54% avoided readmissions: 20% of hospitalizations were avoided immediately and 34% likely avoided in the near future, demonstrating the intervention's 80% effectiveness. Conclusion Monitoring heart failure (HF) in elderly patients can be challenging, especially in rural areas with limited access to care, few caregivers, cognitive impairments, or difficulty using e-health platforms. This study emphasizes the benefits of a nurse-led mobile team unit in providing a reliable direct assessment of HF severity. This home intervention provides education, strengthens the decision-making capacity of the remote monitoring platform, assists with patient management, and significantly reduces the readmission rate.

Prospective longitudinal evaluation of AI-ECG in newly diagnosed heart failure (PLANE-HF)

Abstract Background * In the United Kingdom, there are one million people suffering from heart failure (HF), with more than 60,000 new cases annually (1). * Monitoring for declining left ventricular ejection fraction (LVEF) could optimise treatment approaches and avert healthcare episodes. * Easy home-based tracking of cardiac function would be transformative. * Previous studies have validated the capability of artificial intelligence-enabled electrocardiogram (AI-ECG) to correlated with changes in LVEF (2). * We hypothesize that longitudinal changes in AI-ECG probability score is associated with changes in the left ventricular (LV) function. Method * A prospective multicentre longitudinal study recruiting newly diagnosed HF with reduced ejection fraction (HFrEF) cases to investigate application of AI-ECG using longitudinal single-lead ECG recordings via patient-administered smart ECG-stethoscope examination – Figure 1. * A total of 36 patients were included in the analysis, with invitation to return for repeat echocardiography at 6-8 weeks. * Adjusted logistic regression was performed to analyze changes in LVEF by 10% as the outcome variable, investigating the relationship with the trajectory of AI-ECG probability scores. This study was approved by the UK Health Research Authority (reference 22/LO/0701). Result * Out of 36 patients, 19 patients had ischaemic and 17 had a non-ischaemic HF. * The mean age was 56.3 years, 97.2% patients were male and 46.6% were White. * 328 longitudinal single-lead ECGs were captured and used in the analysis. * 12 (33.3%) patients had an increase of their LVEF by 10%; preceding AI-ECGs was predictive of this recovery (OR 1.36; 95% CI, 1.05 – 1.65, p value = 0.016 – Table 1) Clinical Importance: * Individualised predictions of deterioration and improvement * Proactive medication adjustment * Enhanced triage for echocardiography Conclusion * AI-ECG designed to identify left ventricular systolic dysfunction (LVSD) can predict changes in LVEF% among newly diagnosed HFrEF patients. * Such results can place AI-ECG as a remote monitoring tool to track improvement or deterioration in patients’ LVEF%, which facilitate a proactive management and prevention strategies.

Prospective assessment of risk factors for appropriate ICD intervention in patients with ischemic cardiomyopathy: results of PARCADIA trial

Abstract Background There is still a big unmet need for better risk stratification tools to identify patients at high risk for sudden cardiac death in the era of primary prevention ICD therapy. Scar burden on late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) imaging may be a risk marker for the prediction of ventricular arrhythmia in post-myocardial infarction (MI) patients. Purpose The aim of the PARCADIA trial was to assess whether scar characteristics, determined via LGE-CMR, or other baseline risk markers are associated with appropriate ICD therapy. Methods In this prospective, multi-center, clinical trial, we enrolled post-MI patients with an indication for de novo primary prevention ICD. Main exclusion criteria were indication for cardiac resynchronization therapy and NYHA class IV. Prior to the ICD implantation, LGE-CMR was performed to analyze the amount of scar tissue (LGE core mass + grey zone mass) and LV function / volumes. A 24h Holter recording was performed to collect information on potential triggers like premature ventricular beats (PVB) and sympathetic-vagal balance based on heart rate variability (HRV). Follow-ups were performed in-office every 6 months, including remote monitoring. Appropriate ICD therapy was used as primary endpoint and adjudicated by a clinical event committee. Results 199 patients were enrolled at 5 investigational sites in Europe. Patients mean age was 64.3 years, with a mean LVEF of 27.7 %, timing from the index MI was 9.1 years, and 42.7% received a primary PCI on index MI. After a median follow-up duration of 47.7 months, 23.1% of patients received appropriate ICD therapy. In 135 patients (67.8%), quality of LGE-CMR was sufficient for detailed analysis. The mean LGE core mass (20.5 vs. 19,7 g) and grey zone mass (10.5 vs. 11.4 g) was not different in patients with or without appropriate ICD therapy, also not when corrected for LV mass. However, LVEF (28.5 vs. 32.9 %) was lower, while diastolic myocardial mass (141 vs. 125 g), and end-diastolic volume (265.0 vs. 226.7 ml) were significantly higher in patients with appropriate ICD therapy. On 24h Holter the mean PVB burden (3695 vs. 1643 beats), and non-sustained ventricular tachycardia (12 vs. 0.9), were higher in patients with appropriate ICD therapy, while the HRV (96.1 vs. 113.1 SDNN) was lower. In univariate analysis the variables LVEF, timing to index MI, primary PCI on index MI, PVB burden and HRV appeared to be predictors for appropriate ICD intervention, while in multivariate analysis LVEF and PVB burden remained predictive. Conclusion In post-MI patients with appropriate ICD therapy, scar burden was not different from patients without appropriate ICD therapy. Only LVEF and PVB burden were independent predictors of increased arrhythmogenicity. Improved CMR analysis on scar characteristics (conduction channels) to identify potential arrhythmogenic regions might be the topic for future research.

Automatic telephonic follow up in heart failure by a natural language processing artificial intelligence: pilot program

Abstract Introduction Heart failure (HF) burden on public health is substantial and efficient patient management strategies are needed. Traditional methods of HF monitoring face limitations in scalability and effectiveness. Artificial Intelligence (AI) might offer novel solutions for enhanced resource management and alleviation of healthcare burdens. Purpose To study the feasibility of implementing automatic remote monitoring via phone calls operated by AI in a HF unit. Methods We conducted a non-randomized, open, pilot trial employing an AI technology based on natural language processing for autonomous telephone outreach for the follow up of HF patients. 86 patients from a tertiary hospital HF unit undergoing pharmacological titration and education were enrolled. The AI conducted weekly calls to gather symptomatology, vital signs, and health status changes, which were then displayed on a virtual platform featuring alerts preconfigured by the research team. These alerts guided patient communication and intervention as deemed necessary by a specialized nurse. Results Characteristics of patients are shown in Table 1. The AI followed these patients for a median of 251.5 days. 2773 telephonic calls were performed. We estimate an equivalent to 1445h of work (17.2 days/month). Adherence was high during the study, with 98% of the calls completed. 1427 alerts were generated, being the most frequent weight change (251; 17.6%), orthopnea (220; 15.4%) and fatigue (187; 13.1%). It led to 487 remote interventions, most of them consisting in calling the patient for assessment (409; 84.0%), but also in adjusting medication remotely (34; 7.0%). See Figure 2. A HF telemedicine specialized nurse required 205min per week for alert review, 2.38min/patient-week. 2 patients died, one from cardiovascular causes, and 7 patients had a HF hospitalization, 42.9% with previous alarms. 20 events of worsening HF were recorded, comprising hospitalization, emergency visit or IV diuretic administration. Oral diuretic dose was increased in 22 occasions, 15 of them remotely in response to an alert raised by the AI operator. At 6 months functional class globally improved (p = 0.028), but NTproBNP increased (p=0.0472). Quality of life was evaluated at baseline and at 6 months, with no change in EQ5D5L (median 0.717, change -0.005, p 0.71) or PHQ4 (median 2.88, change -0.29, p 0.7792), but KCCQ12 total score worsened (median 74.49, change -2.32, p 0.048). Experience was rated with 8.97/10 in a satisfaction questionnaire. All patients recommended the program, remarking a closer follow up, better communication and a safety feeling. Conclusions AI enables closer monitoring of patients with HF, maintaining contact with stable patients while also allowing for resource allocation and tracking of higher-risk patients or those experiencing changes in symptoms. A randomized clinical trial comparing to standard follow-up is needed to evaluate this promising technology.Table 1Figure 2

Development of a minimally invasive technique to measure the interstitial fluid pressure for remote monitoring of heart failure

Abstract Background Heart failure (HF) induces fluid interstitial retention, leading to oedema and elevated interstitial fluid pressure (IFP).1-3 There is a clinical need for remotely assessing IFP and understanding its correlation with cardiopulmonary haemodynamics for early treatment optimization in HF. IFP can be measured from a preserved fluid pocket formed by a subcutaneous perforated capsule in animals.4 However, the structural understanding of tissue neovascularization within a perforated capsule and the temporal relationship between altered cardiopulmonary haemodynamics and IFP remains unknown. Purpose To determine the neovascularisation of the perforated capsule over time and demonstrate the relationship between haemodynamic metrics of congestion (CVP, PAP, and LVEDP) and IFP during HF development. Methods Ten 45-55kg swine were implanted with subcutaneous perforated capsules. Perforated capsule characterisation included MicroCT using MicroFil cast (Fig. 1A) and microscopy initially at 3 and 6 weeks. A perforated capsule containing a PTFE (polytetrafluoroethylene) membrane was subcutaneously implanted in animals and chronic stability was studied at 90 using MicroCT and microscopy. After 3 weeks of perforated capsule implantation, HF was induced under general anaesthesia with 12-16 mg/kg/hour of esmolol (i.v.) and 0.9% NaCl (10% body weight, i.v.) and fluid was removed to euvolemia via ultrafiltration (Fig 2A). Concurrent measurements of IFP from perforated capsules and haemodynamic metrics of congestion were made using interventional techniques. Results MicroCT and microscopy have demonstrated perforated capsule neovascularization containing a central fluid pocket at 3 weeks and loss at 6 weeks due to continued tissue growth (Fig 1B-E). The perforated capsule at 90 days demonstrated fluid pocket preservation due to the PTFE membrane on MicroCT and microscopy (Fig. 1F-G). During the development of HF and offloading, there is a strong correlation between IFP and haemodynamic metrics of congestion (Fig. 2B). Conclusion We have developed a minimally invasive technique for continuous IFP measurement demonstrating a relationship between IFP and cardiac filling pressure in HF. IFP assessment offers a direct measure of fluid status and an indirect measure of haemodynamics, facilitating early treatment optimisation.

Validation of diagnostic wearable ECG data from high-risk patients and integration into the atrial fibrillation catheter ablation pathway

Abstract Background Wearables like the Apple Watch (AW) offer non-invasive, long-term monitoring and patient-led, single-lead ECG recordings. Although validated for Atrial Fibrillation (AF) detection in the general population, the accuracy and clinical utility of the single-lead ECG recording feature for the diagnosis of AF has not been evaluated in patients at high risk of atrial arrhythmias.(1) An evaluation of the accuracy of the Wearable-derived labels is important to determine the feasibility of integrating AW-based remote monitoring into clinical pathways. Objective To evaluate the accuracy and data burden from AW-based, patient-led ECG monitoring in patients undergoing AF catheter ablation. Methods Patients referred for first-time AF catheter ablation to the Study Institution between January 2022 and March 2023 were invited to enrol in the AF Follow-up with Apple Watch (AFFU-AW) Trial. Patients randomised to the active arm of the study received 12 months of post-ablation follow-up using a loaned Apple Watch. Participants underwent an education session and were asked to perform daily ECGs; sending through any labelled as AF, inconclusive, or in the context of symptoms. The accuracy of the automated ECG labelling was determined against blinded, independent labelling by two experienced Electrophysiologists. Results 1093 remote transmissions were emailed in for evaluation from 52 patients to the Study team. This was a median of 6 [2, 17] per patient and a receiver burden of 2 [1, 4] ECGs per day. 475 were categorised by the AW as AF with a sensitivity of 0.71 and specificity of 0.96 compared to expert labelling. 342 (31%) were not categorised by the wearable, with an ‘inconclusive’ interpretation (161 [47%]) or ‘high heart rate’ (108 [32%]) as the most cited reasons. 178 (55%) of the uncategorised ECGs were subsequently overread as AF. Accompanying symptoms were reported with 324 (30%) ECGs, most commonly palpitations. Conclusion This is the first reported evaluation of the AF diagnostic feature based on AW ECG recordings as part of a remote patient rhythm surveillance pathway after catheter ablation. The high positive predictive value of ‘Sinus Rhythm’ and ‘AF’ labels and the high specificity of the ‘AF’ label are comparable to diagnostic algorithms in implantable loop recorders.(2) The source code to automate data curation and structured databasing of wearable ECGs has been made available for care providers to integrate the service into device monitoring workflows.(3)

Measurement inaccuracy reported via the Manufacturer and User Facility Device Experience database for an implantable pulmonary artery pressure sensor: recalibration direction and magnitude results

Abstract Introduction Remote monitoring using an implantable pulmonary artery pressure (PAP) sensor (CardioMEMS HF system) in patients with heart failure (HF) has been consistently shown to reduce HF hospitalizations [1]. The success of this approach relies on the accurate measurement of diastolic PAP (dPAP) over time to allow early interventions such as diuretic intensification [2]. However, it remains unclear how the measurement accuracy changes over time after the initial calibration at the time of device implantation. Purpose This study aims to identify measurement inaccuracy events and to quantify the magnitude and direction of required device recalibration for CardioMEMS devices as reported in a large-scale regulatory device database. Methods We used the publicly accessible Manufacturer and User Facility Device Experience (MAUDE) data maintained by the US Food and Drug Administration (FDA). The summary search was performed for the CardioMEMS pulmonary artery pressure sensor for the entire product life cycle from January 2009 to February 2024 [3,4]. The entries related to the measurement accuracy under ‘Device Problems’ categories were obtained. Tested accuracy was reported to have been within ±10mmHg of a reference pressure measurement throughout simulated use for 10 years [5]. Normal range for dPAP is ~8mmHg to 15mmHg [6]. Results A total of 2656 entries were obtained. Following categories were identified for the reported entries: device sensing problem (N=999, 38%); incorrect measurement (N=1349, 52%); incorrect measurement, inappropriate waveform (N=279, 11%), and incorrect, inadequate, or imprecise results or readings (N=29, 1%). After excluding 56 entries for missing information, 2600 entries were included for the analysis. A total of 1676 (64%) entries reported the need for recalibration of the CardioMEMS device. A mean PAP difference (defined as the difference of the mean PAP reference value measured at the time of recalibration minus the CardioMEMS reading obtained during the reference measurement) is shown in Figure 1. Compared to the reference pressure values at the time of recalibration, 488 (29%) of CardioMEMS readings were higher and 1188 (71%) were lower. The absolute recalibration pressure difference was 14.5 ± 9.3 mmHg (mean ± standard deviation, range 0.02-59.3 mmHg). The recalibration by more than 10 mmHg was reported in 1040 (40%) entries. Conclusions Suspected measurement inaccuracy with CardioMEMS device is not uncommon and often necessitate recalibration. Almost one-half (40%) of the recalibrations required more than 10 mmHg correction. These results should inform clinicians to consider recalibration along the course of CardioMEMS monitoring if there is discordance between clinical assessment and the values from the device.Figure 1.Figure 2

Synthetic assessment of cardiac autonomic modulation and Baevsky stress index in patients with synucleinopathies

Abstract Background The Baevsky Stress Index (BSTRi), calculated from Heart Rate Variability (HRV) data, has been proposed for quantitative assessment of physiological stress, with higher scores indicating higher levels of physical and/or psychological stress [1]. Cardiac autonomic modulation can be synthetically quantified by calculating the parasympathetic (PNSi) and the sympathetic (SNSi) indexes. The values of the BSTRi, SNSi, and PNSi in patients with synucleinopathies of different prognoses have not been reported yet. Purpose To quantify, in patients with Parkinson's disease (PD) and Multisystem Atrophy (MSA), the BSTRi, its correlation with the PNSi and the SNSi indexes, and their potential value for a synthetic assessment of cardiac autonomic modulation and early differential diagnosis between PD and MSA. Methods Holter ECG data of 66 patients with Parkinsonian syndromes were retrospectively analyzed after 10 years of follow-up. Out of them, 34 patients with a certain diagnosis of PD (17) and MSA (17) were selected for this study. HRV was analyzed with the Kubios software (version 4.0), providing automatic calculation of the BSTRi, PNSi, and SNSi [2], as well as of time domain (TD), frequency domain (FD), nonlinear (NL), and time-varying (TV) HRV parameters. HRV was calculated from selected short-term intervals (of 5 minutes), during daily activity (ACT5’), and non-REM sleep (NREM5’), and from 24-hours Holter recordings. Patients’ HRV findings were compared with those of 51 age-matched healthy subjects (HS). Results An example of individual automatic graphic summary is shown in Figure 1. Both short-term and 24-hour BSTRi and SNSi values were significantly (p < 0.05) higher in PD and MSA compared to those of HS, in all investigated conditions. Short-term PNSi was significantly higher in HS than in PD in all conditions, but only during NREM5’ in MSA patients (Table 1). No significant difference was found between the indexes of PD and MSA patients. As in HS (R=92), BSTRi was positively correlated with the SNSi in MSA (average R= 0.83 and 0.89 during ACT5’ and NREM5’, respectively), but less evident in PD (R=0.67). The inverse correlation between PNSi and SNSi (R=0.75 in HS) was lost in both MSA and PD. Conclusions Higher values of BSTRi in PD and MSA compared to HS suggest that patients with synucleinopathies do experience higher levels of psychophysiological stress, which may affect their quality of life negatively. However, since no significant difference was found in this study between BSTRi values of PD and MSA patients, BSTRi seems at present unreliable for early differentiation between the two diseases. Telematic assessment of BSTRi, SNSi, and PNSi could be useful for remote monitoring of PD and MSA patients’ psychophysiological stress, to provide timely intervention and adaptive treatment.Fig.1 Example of graphic summary (ACT5')

Patient-reported outcomes (PROs) programs for monitoring symptoms among patients treated with immunotherapy: A scoping review.

Monitoring toxicities among patients receiving immune checkpoint inhibitors (ICIs) using patient-reported outcome (PRO) measures (PROMs) is relatively recent. This scoping review aims to guide decision-making in the development of PROMs ICI programs. Four electronic databases were searched from inception to January 2024. Data on PROMs ICI programs (eg, PROMs used, frequency) were extracted. Two authors with established inter-rater reliability screened titles, abstracts, and full texts. A narrative synthesis identified patterns in the data. 22 articles described 16 unique multicomponent, electronic PRO programs, mainly developed for remote monitoring of toxicities between appointments. Patients typically completed 18-26 items from the PRO-CTCAE or CTCAE weekly, with high adherence/satisfaction. Commonly monitored symptoms were diarrhea, fatigue, shortness of breath, cough, nausea, decreased appetite, rash, joint pain, pain, and mood. Other features of PROM programs included clinician alerts, with some program only flagging symptoms that had an impact on treatment. Some program also or only sent alerts to patients to contact their clinicians and gave access to symptom management information. In terms of efficacy, the only consistent finding was an increase in QOL. The findings of this scoping review provide some indication as to which components of a PROM program are promising. However, as the evidence-based for PROMs among patients receiving ICIs is growing, many questions remain, including which symptoms to monitor, using which PROM, and at what frequency. More trials are needed to answer these questions and to determine how best to implement PROM ICI programs in clinical practice.