The kinocardiograph for assessment of fluid status in patients with acute decompensated heart failure.

AIMS: To improve telemonitoring strategies in heart failure patients, there is a need for novel non-obtrusive sensors that monitor parameters closely related to intracardiac filling pressures. This proof-of-concept study aims to evaluate the responsiveness of cardiac kinetic energy (KE) measured with the Kinocardiograph (KCG), consisting of a seismocardiographic (SCG) sensor and a ballistocardiographic (BCG) sensor, during treatment of patients with acute decompensated heart failure. METHODS AND RESULTS: Eleven patients with acute decompensated heart failure who were hospitalized for treatment with intravenous diuretics received daily KCG measurements. The KCG measurements were compared with the diameter of the inferior vena cava (IVC) and body weight. Follow-up stopped at discharge, that is, in the recompensated state. Median (interquartile range) weight and IVC diameter decreased significantly after diuretic treatment [weight 74.5 (67.6-98.7) to 73.3 (66.7-95.6) kg, P = 0.003; IVC diameter 2.47 (2.33-2.99) to 1.78 (1.65-2.47) cm, P = 0.03]. In contrast with BCG measurements, significant changes in median KE measured with SCG were observed during the passive filling phase of the diastole [SGG: 0.48 (0.39-0.60) to 0.69 (0.56-0.84), P = 0.026; BCG: 0.68 (0.46-0.73) to 0.68 (0.59-0.82), P = 0.062], the active filling phase of the diastole [SCG: 0.38 (0.30-0.61) to 0.31 (0.09-0.47), P = 0.016; BCG: 0.29 (0.17-0.39) to 0.26 (0.20-0.34), P = 0.248], and the ratio between the passive and active filling phases [SCG: 2.76 (1.68-5.30) to 5.02 (3.13-10.17), P = 0.006; BCG: 5.87 (3.57-7.55) to 5.27 (3.95-9.43), P = 0.790]. The correlations between changes in KE during the passive and active filling phases, using SCG, and changes in weight or IVC were non-significant. Systolic KE did not show significant changes. CONCLUSION: KE measured with the KCG using SCG is highly responsive to changes in fluid status. Future research is needed to confirm its accuracy in a larger study population and specifically its application for detection of clinical deterioration in the home-environment.

Telerehabilitation in patients with recent hospitalisation due to acute decompensated heart failure: protocol for the Tele-ADHF randomised controlled trial.

BACKGROUND: Cardiac rehabilitation in patients with chronic heart failure (CHF) has favourable effects on exercise capacity, the risk at hospital (re-)admission and quality of life. Although cardiac rehabilitation is generally recommended it is still under-utilised in daily clinical practice, particularly in frail elderly patients after hospital admission, mainly due to low referral and patient-related barriers. Cardiac telerehabilitation (CTR) has the potential to partially solve these barriers. The purpose of this study is to evaluate the effects of CTR as compared to standard remote care after hospital admission on physical functional capacity in CHF patients. METHODS: In this randomised controlled trial, 64 CHF patients will be recruited during hospitalisation for acute decompensated heart failure, and randomised to CTR combined with remote patient management (RPM) or RPM alone (1:1). All participants will start with RPM after hospital discharge for early detection of deterioration, and will be up titrated to optimal medical therapy before being randomised. CTR will start after randomisation and consists of an 18-week multidisciplinary programme with exercise training by physical and occupational therapists, supported by a (remote) technology-assisted dietary intervention and mental health guiding by a physiologist. The training programme consists of three centre-based and two home-based video exercise training sessions followed by weekly video coaching. The mental health and dietary programme are executed using individual and group video sessions. A wrist-worn device enables remote coaching by the physical therapist. The web application is used for promoting self-management by the following modules: 1) goal setting, 2) progress tracking, 3) education, and 4) video and chat communication. The primary outcome measure is physical functional capacity evaluated by the Short Physical Performance Battery (SPPB) score. Secondary outcome measures include frailty scoring, recovery after submaximal exercise, subjective health status, compliance and acceptance to the rehabilitation programme, and readmission rate. DISCUSSION: The Tele-ADHF trial is the first prospective randomised controlled trial designed for evaluating the effects of a comprehensive combined RPM and CTR programme in recently hospitalised CHF patients. We hypothesize that this intervention has superior effects on physical functional capacity than RPM alone. TRIAL REGISTRATION: Netherlands Trial Registry (NTR) NL9619, registered 21 July 2021.

Home-Based Exercise Program for Patients With Combined Advanced Chronic Cardiac and Pulmonary Diseases: Exploratory Study.

BACKGROUND: As chronic cardiac and pulmonary diseases often coexist, there is a need for combined physical home-based rehabilitation programs, specifically addressing older patients with advanced disease stages. OBJECTIVE: The primary aim of this study is to evaluate the completion and adherence rates of an 8-week, home-based exercise program for patients with advanced cardiopulmonary disease. The secondary end points include patient satisfaction; adverse events; and program efficacy in terms of change in functional capacity, level of dyspnea, and health-related quality of life. METHODS: The participants received a goal-oriented, home-based exercise program, and they used a wrist-worn activity tracker to record their exercise sessions. Activity tracker data were made visible on a digital platform, which was also equipped with several other features such as short instruction videos on how to perform specific exercises. The participants received weekly coaching by a physiotherapist and an occupational therapist through video communication. RESULTS: In all, 10 patients with advanced combined cardiopulmonary disease participated (median age 71, IQR 63-75 years), and 50% (5/10) were men. Of the 10 participants, 9 (90%) completed the 8-week program. Median adherence to the exercise prescription was 75% (IQR 37%-88%), but it declined significantly when the program was divided into 2-week periods (first 2 weeks: 86%, IQR 51%-100%, and final 2 weeks: 57%, IQR 8%-75%; P=.03). The participants were highly satisfied with the program (Client Satisfaction Questionnaire: median score 29, IQR 26-32, and Purpose-Designed Questionnaire: median score 103, IQR 92-108); however, of the 9 participants, 4 (44%) experienced technical issues. The Patient-Specific Complaints Instrument scores declined, indicating functional improvement (from median 7.5, IQR 6.1-8.9, to median 5.7, IQR 3.8-6.7; P=.01). Other program efficacy metrics showed a trend toward improvement. CONCLUSIONS: Home-based cardiopulmonary telerehabilitation for patients with severe combined cardiopulmonary disease is feasible in terms of high completion and satisfaction rates. Nevertheless, a decrease in adherence during the program was observed, and some of the participants reported difficulties with the technology, indicating the importance of the integration of behavior change techniques, using appropriate technology. TRIAL REGISTRATION: Netherlands Trial Register NL9182; https://www.trialregister.nl/trial/9182.

The kinocardiograph for assessment of changes in haemodynamic load in patients with chronic heart failure with reduced ejection fraction.

AIMS: The kinocardiograph (KCG) is an unobtrusive device, consisting of a chest sensor, which records local thoracic vibrations produced in result of cardiac contraction and ejection of blood into the great vessels [seismocardiography (SCG)], and a lower back sensor, which records micromovements of the body in reaction to blood flowing through the vasculature [ballistocardiography (BCG)]. SCG and BCG signals are translated to the integral of cardiac kinetic energy (iK) and cardiac maximum power (Pmax), which might be promising metrics for future telemonitoring purposes in heart failure (HF). As a first step of validation, this study aimed to determine whether iK and Pmax are responsive to exercise-induced changes in the haemodynamic load of the heart in HF patients. METHODS AND RESULTS: Fifteen patients with stable HF with reduced ejection fraction performed a submaximal exercise protocol. KCG and cardiac ultrasound measurements were obtained both at rest and at submaximal exercise. BCG iK over the cardiac cycle (CC) increased significantly (0.0026 ± 0.0017 to 0.0052 ± 0.0061 mJ.s.; P = 0.01) during exercise, in contrast to a non-significant increase in SCG iK CC. BCG Pmax CC increased significantly (0.92 ± 0.89 to 2.03 ± 1.95 mJ/s; P = 0.02), in contrast to a non-significant increase in SCG Pmax CC. When analysing the systolic phase of the CC, similar patterns were found. Cardiac output (CO) ratio (i.e. CO exercise/CO rest) showed a moderate, significant correlation with BCG Pmax CC ratio (r = +0.65; P = 0.008) and with SCG Pmax CC ratio (r = +0.54; P = 0.04). CONCLUSIONS: iK and Pmax measured with the KCG, preferentially using BCG, are responsive to changes in the haemodynamic load of the heart in HF patients. The combination of the BCG and SCG sensor might be of added value to fully understand changes in haemodynamics and to discriminate between an HF patient and a healthy individual.

Quality Assessment of an Integrated Care Pathway Using Telemonitoring in Patients with Chronic Heart Failure and Chronic Obstructive Pulmonary Disease: Protocol for a Quasi-Experimental Study.

BACKGROUND: Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) often coexist and are associated with a high morbidity and reduced quality of life (QoL). Although these diseases share similarities in symptoms and clinical course, and exacerbations of both diseases often overlap, care pathways for both conditions are usually not integrated. This results in frequent outpatient consultations and suboptimal treatment during exacerbations, leading to frequent hospital admissions. Therefore, we propose an integrated care pathway for both diseases, using telemonitoring to detect deterioration at an early stage and a single case manager for both diseases. OBJECTIVE: This study aims to investigate whether an integrated care pathway using telemonitoring in patients with combined CHF and COPD results in a higher general health-related QoL (HRQoL) as compared with the traditional care pathways. Secondary end points include disease-specific HRQoL, level of self-management, patient satisfaction, compliance to the program, and cost-effectiveness. METHODS: This is a monocenter, prospective study using a quasi-experimental interrupted time series design. Thirty patients with combined CHF and COPD are included. The study period of 2.5 years per patient is divided into a preintervention phase (6 months) and a postintervention phase (2 years) in which end points are assessed. The intervention consists of an on-demand treatment strategy based on monitoring symptoms related to CHF/COPD and vital parameters (weight, blood pressure, heart rate, oxygen saturation, temperature), which are uploaded on a digital platform. The monitoring frequency and the limit values of the measurements to detect abnormalities are determined individually. Monitoring is performed by a case manager, who has the opportunity for a daily multidisciplinary meeting with both the cardiologist and the pulmonologist. Routine appointments at the outpatient clinic are cancelled and replaced by telemonitoring-guided treatment. RESULTS: Following ethical approval of the study protocol, the first patient was included in May 2018. Inclusion is expected to be complete in May 2021. CONCLUSIONS: This study is the first to evaluate the effects of a novel integrated care pathway using telemonitoring for patients with combined CHF and COPD. Unique to this study is the concept of remote on-demand disease management by a single case manager for both diseases, combined with multidisciplinary meetings. Moreover, modern telemonitoring technology is used instead of, rather than as an addition to, regular care. TRIAL REGISTRATION: Netherlands Trial Register NL6741; https://www.trialregister.nl/trial/6741. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20571.

Usefulness of Modern Activity Trackers for Monitoring Exercise Behavior in Chronic Cardiac Patients: Validation Study.

BACKGROUND: Improving physical activity (PA) is a core component of secondary prevention and cardiac (tele)rehabilitation. Commercially available activity trackers are frequently used to monitor and promote PA in cardiac patients. However, studies on the validity of these devices in cardiac patients are scarce. As cardiac patients are being advised and treated based on PA parameters measured by these devices, it is highly important to evaluate the accuracy of these parameters in this specific population. OBJECTIVE: The aim of this study was to determine the accuracy and responsiveness of 2 wrist-worn activity trackers, Fitbit Charge 2 (FC2) and Mio Slice (MS), for the assessment of energy expenditure (EE) in cardiac patients. METHODS: EE assessed by the activity trackers was compared with indirect calorimetry (Oxycon Mobile [OM]) during a laboratory activity protocol. Two groups were assessed: patients with stable coronary artery disease (CAD) with preserved left ventricular ejection fraction (LVEF) and patients with heart failure with reduced ejection fraction (HFrEF). RESULTS: A total of 38 patients were included: 19 with CAD and 19 with HFrEF (LVEF 31.8%, SD 7.6%). The CAD group showed no significant difference in total EE between FC2 and OM (47.5 kcal, SD 112 kcal; P=.09), in contrast to a significant difference between MS and OM (88 kcal, SD 108 kcal; P=.003). The HFrEF group showed significant differences in EE between FC2 and OM (38 kcal, SD 57 kcal; P=.01), as well as between MS and OM (106 kcal, SD 167 kcal; P=.02). Agreement of the activity trackers was low in both groups (CAD: intraclass correlation coefficient [ICC] FC2=0.10, ICC MS=0.12; HFrEF: ICC FC2=0.42, ICC MS=0.11). The responsiveness of FC2 was poor, whereas MS was able to detect changes in cycling loads only. CONCLUSIONS: Both activity trackers demonstrated low accuracy in estimating EE in cardiac patients and poor performance to detect within-patient changes in the low-to-moderate exercise intensity domain. Although the use of activity trackers in cardiac patients is promising and could enhance daily exercise behavior, these findings highlight the need for population-specific devices and algorithms.