Telemedicine Chapter 11: Telemedicine and Ischemic Heart Disease
Hanlon, Peter et al (2017) [Systematic Review] Telehealth Interventions to Support Self-Management of Long-Term Conditions: A Systematic Metareview of Diabetes, Heart Failure, Asthma, Chronic Obstructive Pulmonary Disease, and Cancer1
Background: Self-management support is one mechanism by which telehealth interventions have been proposed to facilitate management of long-term conditions.
Objective: The objectives of this meta-review were to 1. assess the impact of telehealth interventions to support self-management on disease control and health care utilization; and 2. identify components of telehealth support and their impact on disease control and the process of self-management. Our goal was to synthesise evidence for telehealth-supported self-management of diabetes, heart failure, asthma, chronic obstructive pulmonary disease (COPD) and cancer to identify components of effective self-management support. Methods: We performed a meta-review [a systematic review of systematic reviews] of randomized controlled trials of telehealth interventions to support self-management in 6 exemplar long-term conditions. We searched 7 databases for reviews published from January 2000 to May 2016 and screened identified studies against eligibility criteria. We weighted reviews by quality, size, and relevance. We then combined our results in a narrative synthesis and using harvest plots.
Results: We included 53 systematic reviews, comprising 232 unique RCTs. Reviews concerned diabetes (type 1: n=6; type 2, n=11; mixed, n=19), heart failure (n=9), asthma (n=8), COPD (n=8), and cancer (n=3). Findings varied between and within disease areas. The highest-weighted reviews showed that blood glucose telemonitoring with feedback and some educational and lifestyle interventions improved glycemic control in type 2, but not type 1, diabetes, and that telemonitoring and telephone interventions reduced mortality and hospital admissions in heart failure, but these findings were not consistent in all reviews. Results for the other conditions were mixed, although no reviews showed evidence of harm. Analysis of the mediating role of self-management, and of components of successful interventions, was limited and inconclusive. More intensive and multifaceted interventions were associated with greater improvements in diabetes, heart failure, and asthma.
Conclusions: While telehealth-mediated self-management was not consistently superior to usual care, none of the reviews reported any negative effects, suggesting that telehealth is a safe option for delivery of self-management support, particularly in conditions such as heart failure and type 2 diabetes, where the evidence base is more developed. Largerscale trials of telehealth-supported self-management, based on explicit self-management theory, are needed before the extent to which telehealth technologies may be harnessed to support self-management can be established.
Vegesna, Ashok et al (2017) [Systematic Review]Remote Patient Monitoring via Non-Invasive Digital Technologies: A Systematic Review2
Background: We conducted a systematic literature review to identify key trends associated with remote patient monitoring (RPM) via noninvasive digital technologies over the last decade.
Materials and methods: A search was conducted in EMBASE and Ovid MEDLINE. Citations were screened for relevance against predefined selection criteria based on the PICOTS (Population, Intervention, Comparator, Outcomes, Timeframe, and Study Design)format. We included studies published between January 1, 2005 and September 15, 2015 that used RPM via noninvasive digital technology (smartphones/personal digital assistants [PDAs], wearables, biosensors, computerized systems, or multiple components of the formerly mentioned) in evaluating health outcomes compared to standard of care or another technology. Studies were quality appraised according to Critical Appraisal Skills Programme.
Results: Of 347 articles identified, 62 met the selection criteria. Most studies were randomized control trials with older adult populations, small sample sizes, and limited follow-up. There was a trend toward multicomponent interventions (n = 26), followed by smartphones/PDAs (n = 12), wearables (n = 11), biosensor devices (n = 7), and computerized systems (n = 6). Another key trend was the monitoring of chronic conditions, including respiratory (23%), weight management (17%), metabolic (18%), and cardiovascular diseases (16%). Although substantial diversity in health-related outcomes was noted, studies predominantly reported positive findings.
Conclusions: This review will help decision makers develop a better understanding of the current landscape of peer-reviewed literature, demonstrating the utility of noninvasive RPM in various patient populations. Future research is needed to determine the effectiveness of RPM via noninvasive digital technologies in delivering patient healthcare benefits and the feasibility of large-scale implementation. Conflict of interest statement: AV is a postdoctoral student from Jefferson College of Population Health and a US HEOR Fellow at Novartis Pharmaceuticals Corporation. MT is a postdoctoral student from Scott and White Health Plan, University of Texas at Austin and a US HEOR Fellow at Novartis Pharmaceuticals Corporation. SA and MA are employees of Novartis Pharmaceuticals Corporation. Novartis Pharmaceuticals Corporation provided funding for this work.
Randomised Controlled Trials
Hale, Timothy M et al (2019) [Randomised Controlled Trial] A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study3
Background: Heart failure (HF)is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality. With an aging population, the cost associated with managing HF is expected to more than double from US $31 billion in 2012 to US $70 billion by 2030. Readmission rates for HF patients are high-25% are readmitted at 30 days and nearly 50% at 6 months. Low medication adherence contributes to poor HF management and higher readmission rates. Remote telehealth monitoring programs aimed at improved medication management and adherence may improve HF management and reduce readmissions.
Objective: The primary goal of this randomized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program. We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department (ED) visits, increased medication adherence, and improved health-related quality of life (HRQoL) compared to usual care. Methods: Participants were randomized to usual care or use of the remote medication monitoring system for 90 days. Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants. Participants completed questionnaires at enrollment and closeout to gather data on medication adherence, health status, and HRQoL. Electronic medical records were reviewed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period.
Results: Use of the medication monitoring system was associated with an 80% reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care. Objective device data indicated high adherence rates (95%-99%) among intervention group participants despite finding no significant difference in self-reported adherence between study arms. The intervention group had poorer heart function and HRQoL at baseline, and HRQoL declined significantly in the intervention group compared to controls.
Conclusions: The MedSentry medication monitoring system is a promising technology that merits continued development and evaluation. The MedSentry medication monitoring system may be useful both as a standalone system for patients with complex medication regimens or used to complement existing HF telemonitoring interventions. We found significant reductions in risk of all-cause hospitalization and the number of all-cause length of stay in the intervention group compared to controls. Although HRQoL deteriorated significantly in the intervention group, this may have been due to the poorer HF-functioning at baseline in the intervention group compared to controls. Telehealth medication adherence technologies, such as the MedSentry medication monitoring system, are a promising method to improve patient self-management,the quality of patient care, and reduce health care utilization and expenditure for patients with HF and other chronic diseases that require complex medication regimens. Trial registration: ClinicalTrials.gov NCT01814696
Roberts, Lisa Met al (2019) [Randomised Controlled Trial] Wearable Technology To Reduce Sedentary Behavior And CVD Risk In Older Adults: A Pilot Randomized Clinical Trial4
Background: Physical exercise is associated with decreased cardiovascular disease (CVD) risk, but recent large-scale trials suggest that exercise alone is insufficient to reduce CVD events in high-risk older adults.
Purpose: This pilot randomized clinical trial aimed to collect critical data on feasibility, safety, and protocol integrity necessary to design a fully powered randomized controlled trial (RCT) and evaluate the impact of combining structured exercise with an intervention designed to enhance non-exercise physical activity (EX+NEPA) compared to EX alone.
Methods: Forty participants aged ≥60 years with moderate-to-high risk of coronary heart disease events were randomly assigned to either the EX+NEPA or EX groups and followed for 20 weeks. Both groups underwent a twice-weekly, 8-week center-based exercise intervention with aerobic and resistance exercises. EX+NEPA group also received a wearable activity tracking device along with behavioral monitoring and feedback throughout the study. Study outcomes were evaluated at 8 and 20 weeks.
Results: Data are presented as adjusted mean change of the differences over time with 95% confidence intervals at 20 weeks. Relative to EX, the change in steps/day at 20 weeks was 1994 (-40.27, 4028) higher for EX+NEPA. For sedentary time at close-out, the EX+NEPA group was -6.8 (-45.2, 31.6) min/day relative to EX. The between-group differences for systolic and diastolic blood pressure were -9.9 (-19.6, -0.3) and -1.8 (-6.9, 3.3) mmHg, respectively.
Conclusion: The addition of wearable technology intervention appeared to positively influence daily activity patterns and changes in blood pressure – potentially improving risk factors for CVD. A fully powered randomized trial is needed to ultimately test this hypothesis.
Bravo-Escobar, Raquel et al (2018) [Randomised Controlled Trial]
Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: A randomised, controlled clinical trial5
Background: Previous studies have documented the feasibility of home-based cardiac rehabilitation programmes in low-risk patients with ischemic heart disease, but a similar solution needs to be found for patients at moderate cardiovascular risk. The objective of this study was to analyse the effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic cardiopathology at moderate cardiovascular risk.
Methods: A randomised, controlled clinical trial was designed wherein 28 patients with stable coronary artery disease at moderate cardiovascular risk, who met the selection criteria for this study, participated. Of these, 14 were assigned to the group undergoing traditional cardiac rehabilitation in hospital [control group] and 14 were assigned to the home-based mixed surveillance programme [experimental group]. The patients in the experimental group went to the cardiac rehabilitation unit once a week and exercised at home, which was monitored with a remote electrocardiographic monitoring device (NUUBO®). The in-home exercises comprised of walking at 70% of heart rate reserve during the first month, and 80% during the second month, for 1 h per day at a frequency of 5 to 7 days per week. A two-way repeated measures analysis of variance (ANOVA) was performed to evaluate the effects of time (before and after intervention) and time-group interaction regarding exercise capacity, risk profile, cardiovascular complications, and quality of life.
Results: No significant differences were observed between the traditional cardiac rehabilitation group and the home-based with mixed surveillance group for exercise time and METS achieved during the exertion test, and the recovery rate in the first minute (which increased in both groups after the intervention). The only difference between the two groups was for quality of life scores (10.93 [IC95%: 17.251, 3.334, p = 0.007] vs -4.314 [IC95%: -11.414, 2.787; p = 0.206]). No serious heart-related complications were recorded during the cardiac rehabilitation programme.
Conclusions: The home-based cardiac rehabilitation programme with mixed surveillance appears to be as effective and safe as the traditional model in patients with ischemic heart disease who are at moderate cardiovascular risk. However, the cardiac rehabilitation programmes carried out in hospital seems to have better results in improving the quality of life. Trial registration: Retrospectively registered NCT02796404 (May 23, 2016).
Vanezis, Andrew Peter et al (2018) [Randomised Controlled Trial]Daily remote ischaemic conditioning following acute myocardial infarction: a randomised controlled trial6
Background: Remote ischaemic conditioning (rIC)is a cardioprotective tool which has shown promise in preclinical and clinical trials in the context of acute ischaemia. Repeated rIC post myocardial infarction may provide additional benefits which have not previously been tested clinically.
Methods: The trial assessed the role of daily rIC in enhancing left ventricular ejection fraction (LVEF) recovery in patients with impaired LVEF (<45%) after ST segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (P-PCI). Patients were recruited from four UK hospitals and randomised to receive either 4 weeks of daily rIC or sham conditioning using the autoRIC Device (CellAegis) starting on day 3 post P-PCI. The primary endpoint was the improvement in LVEF over 4 months assessed by cardiac MRI (CMR). Seventy-three patients (38 cases, 35 controls) completed the study. Results: The treatment and control groups were well matched at baseline including for mean LVEF (42.8% vs 44.3% respectively, p=0.952). There was no difference in the improvement in LVEF over 4 months between the treatment and control groups: 4.8%±7.8% vs 4.6%±5.9% respectively, p=0.924. No differences were seen in the secondary outcome measures including changes in infarct size and left ventricular end-diastolic and systolic volumes, major adverse cardiac and cerebral event, mean Kansas City Cardiomyopathy Questionnaire score and change in N-terminal pro-brain natriuretic peptide levels.
Conclusions: Daily rIC starting on day 3 and continued for 4 weeks following successful P-PCI for STEMI did not improve LVEF as assessed by CMR after 4 months when compared with a matched control group. Trial registration: ClinicalTrials.gov NCT01664611
Varma, Niraj et al (2018) [Randomised Controlled Trial] Automatic remote monitoring utilizing daily transmissions: Transmission reliability and implantable cardioverter defibrillator battery longevity in the TRUST trial7
Aims: Benefits of automatic remote home monitoring (HM) among implantable cardioverter defibrillator (ICD) patients may require high transmission frequency. However, transmission reliability and effects on battery longevity remain uncertain. We hypothesized that HM would have high transmission success permitting punctual guideline based follow-up, and improve battery longevity. This was tested in the prospective randomized TRUST trial.
Methods and Results: Implantable cardioverter defibrillator patients were randomized post-implant 2:1 to HM (n = 908) (transmit daily) or to conventional in-person monitoring [conventional management (CM), n = 431 (HM disabled)]. In both groups, five evaluations were scheduled every 3 months for 15 months. Home Monitoring technology performance was assessed by transmissions received vs. total possible, and number of scheduled HM checks failing because of missed transmissions. Battery longevity was compared in HM vs. CM at 15 months, and again in HM 3 years post-implant using continuously transmitted data. Transmission success per patient was 91% (median follow-up of 434 days). Overall, daily HM transmissions were received in 315 795 of a potential 363 450 days (87%). Only 55/3759 (1.46%) of unsuccessful scheduled evaluations in HM were attributed to transmission loss. Shock frequency and pacing percentage were similar in HM vs. CM. Fifteen month battery longevity was 12% greater in HM (93.2 ± 8.8% vs. 83.5 ± 6.0% CM, P < 0.001). In extended follow-up of HM patients, estimated battery longevity was 50.9 ± 9.1% (median 52%) at 36 months.
Conclusion: Automatic remote HM demonstrated robust transmission reliability. Daily transmission load may be sustained without reducing battery longevity. Home Monitoring conserves battery longevity and tracks long term device performance. Clinical trial registration: ClinicalTrials.gov; NCT00336284.
Walker, Paul P et al (2018) [Randomised Controlled Trial] Telemonitoring in chronic obstructive pulmonary disease (chromed)a randomized clinical trial8
Rationale: Early detection of chronic obstructive pulmonary disease (COPD) exacerbations using telemonitoring of physiological variables might reduce the frequency of hospitalization. Objectives: To evaluate the efficacy of home monitoring of lung mechanics by the forced oscillation technique and cardiac parameters in older patients with COPD and comorbidities.
Methods: This multicenter, randomized clinical trial recruited 312 patients with Global Initiative for Chronic Obstructive Lung Disease grades II to IV COPD (median age, 71 yr [interquartile range, 66-76 yr]; 49.6% grade II, 50.4% grades III-IV), with a history of exacerbation in the previous year and at least one nonpulmonary comorbidity. Patients were randomized to usual care (n = 158) or telemonitoring (n = 154) and followed for 9 months. All telemonitoring patients self-assessed lung mechanics daily, and in a subgroup with congestive heart failure (n = 37) cardiac parameters were also monitored. An algorithm identified deterioration, triggering a telephone contact to determine appropriate interventions.
Measurements and main results: Primary outcomes were time to first hospitalization (TTFH) and change in the EuroQoL EQ-5D utility index score. Secondary outcomes included: rate of antibiotic/corticosteroid prescription; hospitalization; the COPD Assessment Tool, Patient Health Questionnaire-9, and Minnesota Living with Heart Failure questionnaire scores; quality-adjusted life years; and healthcare costs. Telemonitoring did not affect TTFH, EQ-5D utility index score, antibiotic prescriptions, hospitalization rate, or questionnaire scores. In an exploratory analysis, telemedicine was associated with fewer repeat hospitalizations (-54%; P = 0.017).
Conclusions: In older patients with COPD and comorbidities, remote monitoring of lung function by forced oscillation technique and cardiac parameters did not change TTFH and EQ-5D. Clinical trial registered with www.clinicaltrials.gov (NCT 01960907).
Background: There is growing interest in using wearable devices to remotely monitor patient behaviors. However, there has been little evaluation of how often these technologies are used to monitor sleep patterns over longer term periods, particularly among more high-risk patients.
Objective: The goal of the research was to evaluate the proportion of time that patients with ischemic heart disease used wearable devices to monitor their sleep and identify differences in characteristics of patients with higher versus lower use.
Methods: We evaluated wearable device data from a previously conducted clinical trial testing the use of wearable devices with personalized goal-setting and financial incentives. Patients with ischemic heart disease established a sleep baseline and were then followed for 24 weeks. The proportion of days that sleep data was collected was compared over the 24 weeks and by study arm. Characteristics of patients were compared to groups with high, low, or no sleep data.
Results: The sample comprised 99 patients with ischemic heart disease, among which 79% (78/99) used the wearable device to track their sleep. During the 6-month trial, sleep data were collected on 60% (10,024/16,632) of patient-days. These rates declined over time from 77% (4292/5544)in months 1 and 2 to 58% (3188/5544)in months 3 and 4 to 46% (2544/5544)in months 5 and 6. Sleep data were collected at higher rates among the intervention group compared with control (67% vs 55%, P<.001). In the main intervention period (months 3 and 4), patients with higher rates of sleep data were on average older (P=.03), had a history of smoking (P=.007), and had higher rates of commercial health insurance (P=.03).
Conclusions: Among patients with ischemic heart disease in a physical activity trial, a high proportion used wearable devices to track their sleep; however, rates declined over time. Future research should consider larger evaluations coupled with behavioral interventions. Trial registration: https://clinicaltrials.gov/ct2/show/NCT02531022
Conflicts of Interest: MP is supported by career development awards from the Department of Veterans Affairs Health Services Research and Development and the Doris Duke Charitable Foundation. MP is founder of Catalyst Health, a technology and behavior change consulting firm. MP also has received research funding from Deloitte, which is not related to the work described in this manuscript. The remaining authors declare no conflict of interest.
Delahaye, C et al (2019) Analysis of remote monitoring of patients with subcutaneous defibrillator10
Remote monitoring is associated with a high level of evidence in endovascular ICD recipients. Subcutaneous cardioverter are more and more used but there is no data about remote monitoring for these devices. The aim of this study is to provide a qualitative and quantitative analysis of transmissions received by remote monitoring follow-up on a cohort of patients with subcutaneous ICD versus a control cohort of patients with endovascular ICD, and to evaluate the clinical relevance of these transmissions.
Method: From September 2015 to January 2017, we prospectively and consecutively enrolled all patients undergoing a subcutaneous or endovascular ICD implantation. All transmissions from remote follow-up and reactions to these transmissions were collected. The relevance of alerts was evaluated by a ratio: number of alerts per patient/number of alerts leading to a reaction or intervention.
Results: A total of 146 patients were included: 69 in the subcutaneous DAI group (44,6 ± 15.6 years old; 25% ischemic cardiopathy), 77 in the endovascular ICD group (64,8 ± 13.9 years old; 77% ischemic cardiopathy) with a mean follow-up of 493 ± 129.6 days. A total of 2393 transmissions were collected including 988 in the endovascular group (41%) and 1405 in the S-ICD group (59%). Twenty-nine internal electrical shocks were collected: 10 in the intravenous ICD cohort and 9 in the subcutaneous ICD patients. The clinical relevance of these transmissions was lower in the subcutaneous group with only 2% of transmissions leading to a medical intervention compared to 14% in the endovascular group (P < 10–3). The ratio: total alert per patient/relevant alert per patient was 3.2% ± 1.1 in the subcutaneous DAI group and 16% ± 4.7 in the endovascular group (P = 0.0391).
Conclusion: Remote monitoring of patients with subcutaneous ICD is associated with a higher burden of transmissions with a lower clinical impact compared to patients with endovascular ICDs.
Background: Under usual care, people with an implantable cardioverterdefibrillator (ICD), cardiac resynchronization therapy with or without a defibrillator (CRT-D and CRT-P, respectively), or a permanent pacemaker have follow-up in-person clinic visits. Remote monitoring of these devices allows the transfer of the information stored in the device so that it can be accessed by the clinic personnel via a secured website.
Methods: We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, and patient preferences for remote monitoring of ICDs, CRTs, and permanent pacemakers plus clinic visits compared with clinic visits alone. This is an update of a 2012 health technology assessment. In addition to the eligible randomized controlled trials (RCTs)from the 2012 publication, we included RCTs identified through a systematic literature search on June 1, 2017. We assessed the risk of bias of each study using the Cochrane risk of bias tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE)Working Group criteria. We conducted an economic evaluation to determine the cost-effectiveness of remote monitoring blended with in-clinic follow-up compared to in-clinic follow-up alone in patients with an ICD, a CRT-D, or a pacemaker. We determined the budget impact of blended remote monitoring in patients implanted with ICD, CRT-D, CRT-P, or pacemaker devices from the perspective of the Ontario Ministry of Health and Long-Term Care. To understand patient experiences with remote monitoring, we interviewed 16 patients and family members.
Results: Based on 15 RCTs in patients with implanted ICDs or CRT-Ds, remote monitoring plus clinic visits resulted in fewer patients with inappropriate ICD shocks within 12 to 37 months of follow-up (moderate quality evidence; absolute risk difference -0.04 (95% confidence interval -0.07 to -0.01)), fewer total clinic visits (moderate quality evidence), and a shorter time to detection and treatment of events (moderate quality evidence) compared with clinic visits alone. There was a similar risk of major adverse events (moderate quality evidence). Based on 6 RCTs in patients with pacemakers, remote monitoring plus clinic visits reduced the arrhythmia burden (high quality evidence), the time to detection and treatment of arrhythmias (high quality evidence), and the number of clinic visits (moderate quality evidence) compared with clinic visits alone. Here again, there was a similar risk of major adverse events (high quality evidence). Results from the economic evaluation showed that among ICD and CRT-D recipients, blended remote monitoring [remote monitoring plus in-clinic follow ups] was more costly [incremental value of $4,354 per person] and more effective, providing higher quality-adjusted life years [incremental value of 0.19], compared to inclinic follow-up alone. Among pacemaker recipients, blended remote monitoring was less costly [with an incremental saving of $2,370 per person] and more effective [with an incremental value of 0.12 quality-adjusted life years] than with in-clinic follow-up alone. We estimated that publicly funding remote monitoring could result in cost savings of $14 million over the first five years. Participants using remote monitoring reported that these devices provide important medical and safety benefits in managing their heart condition. Remote cardiac monitoring provides patients and their family members with an increased freedom. Their belief that the device will help with earlier detection of technical or clinical problems reduces the amount of stress and distraction their condition causes in their lives.
Conclusions: Remote monitoring of ICDs, CRT-Ds, and pacemakers plus clinic visits resulted in improved outcomes without increasing the risk of major adverse events compared with clinic visits alone. Remote monitoring is a cost-effective option for patients implanted with cardiac electronic devices. Patients reported positive experiences using remote monitoring, and perceived that the device provided important medical and safety benefits.
The objective of this systematic literature review is to examine the impact of interventions to improve cardiovascular disease healthcare provided to people living in rural areas. Systematic electronic searches were conducted in Medline, CINAHL, Embase, Scopus, and Web of Knowledge in July 2018. We included clinical trials assessing the effectiveness of interventions to improve cardiovascular disease healthcare in rural areas. Study eligibility assessment, data extraction, and critical appraisal were undertaken by two reviewers independently. We identified 18 trials (18 interventions). They targeted myocardial infarction (5 interventions), stroke 8., and heart failure 5.. All the interventions for myocardial infarction were based on organizational changes: eg implementation of mobile coronary units. They consistently reduced time to treatment and decreased mortality. All the interventions for heart failure were based on the provision of patient education. They consistently improved patient knowledge and self-care behaviour, but mortality reductions were reported in only some of the trials. Among the interventions for stroke, those based on the implementation of telemedicine (tele-stroke systems or tele-consultations) improved monitoring of stroke survivors; those based on new or enhanced rehabilitation services did not consistently improve mortality or physical function; whereas educational interventions effectively improved patient knowledge and behavioural outcomes.
In conclusion, a number of different strategies based on enhancing structures and providing patient education have been proposed to improve cardiovascular disease healthcare in rural areas. Although available evidence show that these interventions can improve healthcare processes, their impact on mortality and other important health outcomes still remains to be established.
Shufelt, Chrisandra et al (2019) A protocol integrating remote patient monitoring patient reported outcomes and cardiovascular biomarkers13
We describe the protocol, design, and methodology of the Prediction, Risk, and Evaluation of Major Adverse Cardiac Events (PRE-MACE) study as a multicomponent remote patient monitoring in cardiology. Using biosensor, biomarkers, and patient-reported outcomes in participants with stable ischemic heart disease, the PRE-MACE study is designed to measure crosssectional correlations and establish the ability of remote monitoring to predict major adverse cardiovascular event (MACE) biomarkers and incident MACE at baseline and 12-month follow-up. It will further assess the adherence and cost-effectiveness of remote monitoring and blood sampling over the initial months. Despite medication and lifestyle changes, patients with cardiovascular disease can experience MACE due to under-treatment, poor adherence, or failure to recognize clinical or biochemical changes that presage MACE. Identifying patients using remote monitoring to detect MACE forerunners has potential to improve outcomes, avoid MACE, and reduce resource utilization. Data collection will include: 1. continuous remote monitoring using wearable biosensors; 2. biomarker measurements using plasma and at-home micro-sampling blood collection; and 3. patientreported outcomes to monitor perceived stress, anxiety, depression, and health-related quality of life. Two hundred participants will be followed for 90 days with a subset (n = 80) monitored for 180 days. All participants will be followed up for MACE at 12 months. The PRE-MACE study will utilize remote monitoring with biosensors, biomarkers, and patient-reported outcomes to identify intermediate biomarkers of MACE in patients with stable ischemic heart disease. If shown to be effective, this intervention can be utilized between health visits to predict MACE and reduce financial impact of MACE.
Castrillon, Reinel et al (2018) Electrical Performance of PEDOT:PSS-based Textile Electrodes for Wearable ECG Monitoring: A Comparative Study14
Background: Wearable textile electrodes for the detection of biopotentials are a promising tool for the monitoring and early diagnosis of chronic diseases. We present a comparative study of the electrical characteristics of four textile electrodes manufactured from common fabrics treated with a conductive polymer, a commercial fabric, and disposable Ag/AgCl electrodes. These characteristics will allow identifying the performance of the materials when used as ECG electrodes. The electrodes were subjected to different electrical tests, and complemented with conductivity calculations and microscopic images to determine their feasibility in the detection of ECG signals.
Methods: We evaluated four electrical characteristics: contact impedance, electrode polarization, noise, and long-term performance. We analyzed PEDOT:PSS treated fabrics based on cotton, cotton-polyester, lycra and polyester; also a commercial fabric made of silver-plated nylon Shielde® Med-Tex P130, and commercial Ag/AgCl electrodes. We calculated conductivity from the surface resistance and, analyzed their surface at a microscopic level. Rwizard was used in the statistical analysis. Results: The results showed that textile electrodes treated with PEDOT:PSS are suitable for the detection of ECG signals. The error detecting features of the ECG signal was lower than 2% and the electrodes kept working properly after 36 h of continuous use. Even though the contact impedance and the polarization level in textile electrodes were greater than in commercial electrodes, these parameters did not affect the acquisition of the ECG signals. Fabrics conductivity calculations were consistent to the contact impedance.
Pignatelli, Niccolo et al (2018) Low-Cost Mobile Device for Screening of Atherosclerosis and Coronary Arterial Disease15
In the context of global health, telemedicine, and low-resource settings, we present a non-invasive smart-phone based device that can be used to screen for atherosclerosis, which is the leading factor for ischemic heart attacks and strokes. Using a custom Android mobile application, our device computes Pulse Wave Velocity (PWV) using the pulse signals from photoplethysmographic probes, which are simultaneously clipped onto the ear, index finger, and big toe of a human subject. As distinct from other designs which require the use of an ECG reference, our mobile device uses only photo-plethysmographic signals and is entirely powered by the mobile phone via the USB port. Using the ear signal as a reference, we derived PWV values from two locations: the right index finger, and the right big toe. We present data from a recent clinical study with 78 participants (age 26 to 74) who were divided into three groups: Coronary Arterial Disease (CAD), hypertensive group (PreCAD), and Healthy controls. The CAD group was clinically diagnosed and confirmed with a CT-scan and calcium scoring. PWV values derived from the finger was found to have too much variance to be clinically useful. However, PWV values derived from the toe location showed significant differences between the groups, even after accounting for age. Measured PWV values were: 10.07 (8.51-12.01)for the older CAD group, 9.39 (7.44-9.75)for the younger CAD group, 8.26 (7.26-9.22)for the older Pre-CAD group, 10.57 m/s (8.5-11.2)for the younger Pre-CAD group, 7.13 m/s (5.97-7.69) for older healthy controls, and 6.71 m/s (4.86-7.26)for the younger healthy control subjects. These results demonstrate good potential value of this mobile PWV device as a simple low-cost screening tool for atherosclerosis and coronary arterial disease.
Telemedicine has been used to remotely diagnose and treat patients, yet previously applied telemonitoring approaches have been fraught with adherence issues. The primary goal of this study was to evaluate the adherence rates using a consumer-grade continuous-time heart rate and activity tracker in a mid-risk cardiovascular patient population. As a secondary analysis, we show the ability to utilize the information provided by this device to identify information about a patient’s state by correlating tracker information with patient-reported outcome survey scores. We showed that using continuous-time activity trackers with heart rate monitors can be effective in a telemonitoring application, as patients had a high level of adherence (90.0% median usage) and low attrition (0.09% decrease per day) over a 90-day period. Furthermore, data collected correlated significantly with clinically relevant patient surveys (r2=0.15 for PROMIS global health scores, p < .00001), and therefore might provide an effective signal for identifying patients in need of intervention.
Zhang, Haoshi et al (2017) A wearable 12-lead ECG acquisition system with fabric electrodes17
Continuous electrocardiogram (ECG) monitoring is significant for prevention of heart disease and is becoming an important part of personal and family health care. In most of the existing wearable solutions, conventional metal sensors and corresponding chips are simply integrated into clothes and usually could only collect few leads of ECG signals that could not provide enough information for diagnosis of cardiac diseases such as arrhythmia and myocardial ischemia. In this study, a wearable 12-lead ECG acquisition system with fabric electrodes was developed and could simultaneously process 12 leads of ECG signals. By integrating the fabric electrodes into a Tshirt, the wearable system would provide a comfortable and convenient user interface for ECG recording. For comparison, the proposed fabric electrode and the gelled traditional metal electrodes were used to collect ECG signals on a subject, respectively. The approximate entropy (ApEn) of ECG signals from both types of electrodes were calculated. The experimental results show that the fabric electrodes could achieve similar performance as the gelled metal electrodes. This preliminary work has demonstrated that the developed ECG system with fabric electrodes could be utilized for wearable health management and telemedicine applications.
Brunetti, Natale Daniele et al (2016) Innovations in telemedicine for cardiovascular care18
Cardiovascular disease is one of the main fields of application for telemedicine. The greatest impact has been shown in early diagnosis, in second consultation, between non-cardiologist and cardiologist and between cardiologists, and in follow-up and secondary prevention of cardiovascular disease. At present, the main area of implementation for telemedicine in cardiovascular disease is represented by pre-hospital triage, with telemedicine electrocardiogram in acute myocardial infarction. Significant results have also been achieved in the second opinion consultation of pediatric subjects with congenital cardiovascular disease, home-monitoring and the management of patients affected by chronic heart failure or with an implanted device.
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