Comparison of whole body versus thoracic bioimpedance in relation to ultrafiltration volume and systolic blood pressure during hemodialysis.

In contrast to whole body bioimpedance, which estimates fluid status at a single point in time, thoracic bioimpedance applied by a wearable device could enable continuous measurements. However, clinical experience with thoracic bioimpedance in patients on dialysis is limited. To test the reproducibility of whole body and thoracic bioimpedance measurements and to compare their relationship with hemodynamic changes during hemodialysis, these parameters were measured pre- and end-dialysis in 54 patients during two sessions. The resistance from both bioimpedance techniques was moderately reproducible between two dialysis sessions (intraclass correlations of pre- to end-dialysis whole body and thoracic resistance between session 1 and 2 were 0.711 [0.58-0.8] and 0.723 [0.6-0.81], respectively). There was a very high to high correlation between changes in ultrafiltration volume and changes in whole body thoracic resistance. Changes in systolic blood pressure negatively correlated to both bioimpedance techniques. Although the relationship between changes in ultrafiltration volume and changes in resistance was stronger for whole body bioimpedance, the relationship with changes in blood pressure was at least comparable for thoracic measurements. These results suggest that thoracic bioimpedance, measured by a wearable device, may serve as an interesting alternative to whole body measurements for continuous hemodynamic monitoring during hemodialysis.NEW & NOTEWORTHY We examined the role of whole body and thoracic bioimpedance in hemodynamic changes during hemodialysis. Whole body and thoracic bioimpedance signals were strongly related to ultrafiltration volume and moderately, negatively, to changes in blood pressure. This work supports the further development of a wearable device measuring thoracic bioimpedance longitudinally in patients on hemodialysis. As such, it may serve as an innovative tool for continuous hemodynamic monitoring during hemodialysis in hospital or in a home-based setting.

Short-Term Exercise Progression of Cardiovascular Patients throughout Cardiac Rehabilitation: An Observational Study.

Cardiac rehabilitation (CR) is a highly recommended secondary prevention measure for patients with diagnosed cardiovascular disease. Unfortunately, participation rates are low due to enrollment and adherence issues. As such, new CR delivery strategies are of interest, as to improve overall CR delivery. The goal of the study was to obtain a better understanding of the short-term progression of functional capacity throughout multidisciplinary CR, measured as the change in walking distance between baseline six-minute walking test (6MWT) and four consecutive follow-up tests. One-hundred-and-twenty-nine patients diagnosed with cardiovascular disease participated in the study, of which 89 patients who completed the whole study protocol were included in the statistical analysis. A one-way repeated measures ANOVA was conducted to determine whether there was a significant change in mean 6MWT distance (6MWD) throughout CR. A three-way-mixed ANOVA was performed to determine the influence of categorical variables on the progression in 6MWD between groups. Significant differences in mean 6MWD between consecutive measurements were observed. Two subgroups were identified based on the change in distance between baseline and end-of-study. Patients who increased most showed a linear progression. In the other group progression leveled off halfway through rehabilitation. Moreover, the improvement during the initial phase of CR seemed to be indicative for overall progression. The current study adds to the understanding of the short-term progression in exercise capacity of patients diagnosed with cardiovascular disease throughout a CR program. The results are not only of interest for CR in general, but could be particularly relevant in the setting of home-based CR.

Towards personalized fluid monitoring in haemodialysis patients: thoracic bioimpedance signal shows strong correlation with fluid changes, a cohort study.

BACKGROUND: Haemodialysis (HD) patients are burdened by frequent fluid shifts which amplify their comorbidities. Bioimpedance (bioZ) is a promising technique to monitor changes in fluid status. The aim of this study is to investigate if the thoracic bioZ signal can track fluid changes during a HD session. METHODS: Prevalent patients from a single centre HD unit were monitored during one to six consecutive HD sessions using a wearable multi-frequency thoracic bioZ device. Ultrafiltration volume (UFV) was determined based on the interdialytic weight gain and target dry weight set by clinicians. The correlation between the bioZ signal and UFV was analysed on population level. Additionally regression models were built and validated per dialysis session. RESULTS: 66 patients were included, resulting in a total of 133 HD sessions. Spearman correlation between the thoracic bioZ and UFV showed a significant strong correlation of 0.755 (p < 0.01) on population level. Regression analysis per session revealed a strong relation between the bioZ value and the UFV (R2 = 0.982). The fluid extraction prediction error of the leave-one-out cross validation was very small (56.2 ml [- 121.1-194.1 ml]) across all sessions at all frequencies. CONCLUSIONS: This study demonstrated that thoracic bioZ is strongly correlated with fluid shifts during HD over a large range of UFVs. Furthermore, leave-one-out cross validation is a step towards personalized fluid monitoring during HD and could contribute to the creation of autonomous dialysis.

Wearable Monitoring and Interpretable Machine Learning Can Objectively Track Progression in Patients during Cardiac Rehabilitation.

Cardiovascular diseases (CVD) are often characterized by their multifactorial complexity. This makes remote monitoring and ambulatory cardiac rehabilitation (CR) therapy challenging. Current wearable multimodal devices enable remote monitoring. Machine learning (ML) and artificial intelligence (AI) can help in tackling multifaceted datasets. However, for clinical acceptance, easy interpretability of the AI models is crucial. The goal of the present study was to investigate whether a multi-parameter sensor could be used during a standardized activity test to interpret functional capacity in the longitudinal follow-up of CR patients. A total of 129 patients were followed for 3 months during CR using 6-min walking tests (6MWT) equipped with a wearable ECG and accelerometer device. Functional capacity was assessed based on 6MWT distance (6MWD). Linear and nonlinear interpretable models were explored to predict 6MWD. The t-distributed stochastic neighboring embedding (t-SNE) technique was exploited to embed and visualize high dimensional data. The performance of support vector machine (SVM) models, combining different features and using different kernel types, to predict functional capacity was evaluated. The SVM model, using chronotropic response and effort as input features, showed a mean absolute error of 42.8 m (±36.8 m). The 3D-maps derived using the t-SNE technique visualized the relationship between sensor-derived biomarkers and functional capacity, which enables tracking of the evolution of patients throughout the CR program. The current study showed that wearable monitoring combined with interpretable ML can objectively track clinical progression in a CR population. These results pave the road towards ambulatory CR.

Using Biosensors and Digital Biomarkers to Assess Response to Cardiac Rehabilitation: Observational Study.

BACKGROUND: Cardiac rehabilitation (CR) is known for its beneficial effects on functional capacity and is a key component within current cardiovascular disease management strategies. In addition, a larger increase in functional capacity is accompanied by better clinical outcomes. However, not all patients respond in a similar way to CR. Therefore, a patient-tailored approach to CR could open up the possibility to achieve an optimal increase in functional capacity in every patient. Before treatment can be optimized, the differences in response of patients in terms of cardiac adaptation to exercise should first be understood. In addition, digital biomarkers to steer CR need to be identified. OBJECTIVE: The aim of the study was to investigate the difference in cardiac response between patients characterized by a clear improvement in functional capacity and patients showing only a minor improvement following CR therapy. METHODS: A total of 129 patients in CR performed a 6-minute walking test (6MWT) at baseline and during four consecutive short-term follow-up tests while being equipped with a wearable electrocardiogram (ECG) device. The 6MWTs were used to evaluate functional capacity. Patients were divided into high- and low-response groups, based on the improvement in functional capacity during the CR program. Commonly used heart rate parameters and cardiac digital biomarkers representative of the heart rate behavior during the 6MWT and their evolution over time were investigated. RESULTS: All participating patients improved in functional capacity throughout the CR program (P<.001). The heart rate parameters, which are commonly used in practice, evolved differently for both groups throughout CR. The peak heart rate (HRpeak) from patients in the high-response group increased significantly throughout CR, while no change was observed in the low-response group (F4,92=8.321, P<.001). Similar results were obtained for the recovery heart rate (HRrec) values, which increased significantly over time during every minute of recuperation, for the high-response group (HRrec1: P<.001, HRrec2: P<.001, HRrec3: P<.001, HRrec4: P<.001, and HRrec5: P=.02). The other digital biomarkers showed that the evolution of heart rate behavior during a standardized activity test differed throughout CR between both groups. These digital biomarkers, derived from the continuous measurements, contribute to more in-depth insight into the progression of patients' cardiac responses. CONCLUSIONS: This study showed that when using wearable sensor technology, the differences in response of patients to CR can be characterized by means of commonly used heart rate parameters and digital biomarkers that are representative of cardiac response to exercise. These digital biomarkers, derived by innovative analysis techniques, allow for more in-depth insights into the cardiac response of cardiac patients during standardized activity. These results open up the possibility to optimized and more patient-tailored treatment strategies and to potentially improve CR outcome.

The Added Value of In-Hospital Tracking of the Efficacy of Decongestion Therapy and Prognostic Value of a Wearable Thoracic Impedance Sensor in Acutely Decompensated Heart Failure With Volume Overload: Prospective Cohort Study.

BACKGROUND: Incomplete relief of congestion in acute decompensated heart failure (HF) is related to poor outcomes. However, congestion can be difficult to evaluate, stressing the urgent need for new objective approaches. Due to its inverse correlation with tissue hydration, continuous bioimpedance monitoring might be an effective method for serial fluid status assessments. OBJECTIVE: This study aimed to determine whether in-hospital bioimpedance monitoring can be used to track fluid changes (ie, the efficacy of decongestion therapy) and the relationships between bioimpedance changes and HF hospitalization and all-cause mortality. METHODS: A wearable bioimpedance monitoring device was used for thoracic impedance measurements. Thirty-six patients with signs of acute decompensated HF and volume overload were included. Changes in the resistance at 80 kHz (R80kHz) were analyzed, with fluid balance (fluid in/out) used as a reference. Patients were divided into two groups depending on the change in R80kHz during hospitalization: increase in R80kHz or decrease in R80kHz. Clinical outcomes in terms of HF rehospitalization and all-cause mortality were studied at 30 days and 1 year of follow-up. RESULTS: During hospitalization, R80kHz increased for 24 patients, and decreased for 12 patients. For the total study sample, a moderate negative correlation was found between changes in fluid balance (in/out) and relative changes in R80kHz during hospitalization (rs=-0.51, P<.001). Clinical outcomes at both 30 days and 1 year of follow-up were significantly better for patients with an increase in R80kHz. At 1 year of follow-up, 88% (21/24) of patients with an increase in R80kHz were free from all-cause mortality, compared with 50% (6/12) of patients with a decrease in R80kHz (P=.01); 75% (18/24) and 25% (3/12) were free from all-cause mortality and HF hospitalization, respectively (P=.01). A decrease in R80kHz resulted in a significant hazard ratio of 4.96 (95% CI 1.82-14.37, P=.003) on the composite endpoint. CONCLUSIONS: The wearable bioimpedance device was able to track changes in fluid status during hospitalization and is a convenient method to assess the efficacy of decongestion therapy during hospitalization. Patients who do not show an improvement in thoracic impedance tend to have worse clinical outcomes, indicating the potential use of thoracic impedance as a prognostic parameter.

Intrathoracic fluid changes from preconception to postpartum as measured by bio-impedance monitoring.

Intrathoracic impedance was remotely monitored from preconception to postpartum in a woman with an implantable cardioverter defibrillator. At 6 and 20 weeks, two significant changes were recorded, suggestive for thoracic fluid accumulation. After normal outcome, postpartum intrathoracic impedance returned to preconception values. The obtained results from this case report show that these measurements can be obtained with an implanted device. Current devices for measuring cardiac output by impedance technique allow evaluating thoracic fluid changes non-invasively. As such, non-invasive impedance monitoring may be a potential new method for continuous monitoring of maternal vascular changes during any time window between preconception and postpartum, to be assessed in a large cross sectional observational study.

Protocol-driven remote monitoring of cardiac resynchronization therapy as part of a heart failure disease management strategy.

BACKGROUND: Cardiac resynchronisation therapy (CRT) is an established treatment for heart failure (HF) with reduced ejection fraction. CRT devices are equipped with remote monitoring functions, which are pivotal in the detection of device problems, but may also facilitate disease management. The aim of this study was to provide a comprehensive overview of the clinical interventions taken based on remote monitoring. METHODS: This is a single centre observational study of consecutive CRT patients (n = 192) participating in protocol-driven remote follow-up. Incoming technical- and disease-related alerts were analysed together with subsequently triggered interventions. RESULTS: During 34 ± 13 months of follow-up, 1372 alert-containing notifications were received (2.53 per patient-year of follow-up), comprising 1696 unique alerts (3.12 per patient-year of follow-up). In 60%, notifications resulted in a phone contact. Technical alerts constituted 8% of incoming alerts (0.23 per patient-year of follow-up). Rhythm (1.43 per patient-year of follow-up) and bioimpedance alerts (0.98 per patient-year of follow-up) were the most frequent disease-related alerts. Notifications included a rhythm alert in 39%, which triggered referral to the emergency room (4%), outpatient cardiology clinic (36%) or general practitioner (7%), or resulted in medication changes (13%). Sole bioimpedance notifications resulted in a telephone contact in 91%, which triggered outpatient evaluation in 8% versus medication changes in 10%. Clinical outcome was excellent with 97% 1-year survival. CONCLUSIONS: Remote CRT follow-up resulted in 0.23 technical- versus 2.64 disease-related alerts annually. Rhythm and bioimpedance notifications constituted the majority of incoming notifications which triggered an actual intervention in 22% and 15% of cases, respectively.

Effective Orifice Area during Exercise in Bileaflet Mechanical Valve Prostheses.

BACKGROUND: The aims of this study were to investigate the evolution of the transprosthetic pressure gradient and effective orifice area (EOA) during dynamic bicycle exercise in bileaflet mechanical heart valves and to explore the relationship with exercise capacity. METHODS: Patients with bileaflet aortic valve replacement (n = 23) and mitral valve replacement (MVR; n = 16) prospectively underwent symptom-limited supine bicycle exercise testing with Doppler echocardiography and respiratory gas analysis. Transprosthetic flow rate, peak and mean transprosthetic gradient, EOA, and systolic pulmonary artery pressure were assessed at different stages of exercise. RESULTS: EOA at rest, midexercise, and peak exercise was 1.66 ± 0.23, 1.56 ± 0.30, and 1.61 ± 0.28 cm2, respectively (P = .004), in aortic valve replacement patients and 1.40 ± 0.21, 1.46 ± 0.27, and 1.48 ± 0.25 cm2, respectively (P = .160), in MVR patients. During exercise, the mean transprosthetic gradient and the square of transprosthetic flow rate were strongly correlated (r = 0.65 [P < .001] and r = 0.84 [P < .001] for aortic valve replacement and MVR, respectively), conforming to fundamental hydraulic principles for fixed orifices. Indexed EOA at rest was correlated with exercise capacity in MVR patients only (Spearman ρ = 0.68, P = .004). In the latter group, systolic pulmonary artery pressures during exercise were strongly correlated with the peak transmitral gradient (ρ = 0.72, P < .001). CONCLUSIONS: In bileaflet mechanical valve prostheses, there is no clinically relevant increase in EOA during dynamic exercise. Transprosthetic gradients during exercise closely adhere to the fundamental pressure-flow relationship. Indexed EOA at rest is a strong predictor of exercise capacity in MVR patients. This should be taken into account in therapeutic decision making and prosthesis selection in young and dynamic patients.

Mitral valve area during exercise after restrictive mitral valve annuloplasty: importance of diastolic anterior leaflet tethering.

BACKGROUND: Restrictive mitral valve annuloplasty (RMA) for secondary mitral regurgitation might cause functional mitral stenosis, yet its clinical impact and underlying pathophysiological mechanisms remain debated. OBJECTIVES: The purpose of our study was to assess the hemodynamic and clinical impact of effective orifice area (EOA) after RMA and its relationship with diastolic anterior leaflet (AL) tethering at rest and during exercise. METHODS: Consecutive RMA patients (n = 39) underwent a symptom-limited supine bicycle exercise test with Doppler echocardiography and respiratory gas analysis. EOA, transmitral flow rate, mean transmitral gradient, and systolic pulmonary arterial pressure were assessed at different stages of exercise. AL opening angles were measured at rest and peak exercise. Mortality and heart failure readmission data were collected for at least 20 months after surgery. RESULTS: EOA and AL opening angle were 1.5 ± 0.4 cm(2) and 68 ± 10°, respectively, at rest (r = 0.4; p = 0.014). EOA increased significantly to 2.0 ± 0.5 cm(2) at peak exercise (p < 0.001), showing an improved correlation with AL opening angle (r = 0.6; p < 0.001). Indexed EOA (EOAi) at peak exercise was an independent predictor of exercise capacity (maximal oxygen uptake, p = 0.004) and was independently associated with freedom from all-cause mortality or hospital admission for heart failure (p = 0.034). Patients with exercise EOAi <0.9 cm(2)/m(2) (n = 14) compared with ≥0.9 cm(2)/m(2) (n = 25) had a significantly worse outcome (p = 0.048). In multivariate analysis, AL opening angle at peak exercise (p = 0.037) was the strongest predictor of exercise EOAi. CONCLUSIONS: In RMA patients, EOA increases during exercise despite fixed annular size. Diastolic AL tethering plays a key role in this dynamic process, with increasing AL opening during exercise being associated with higher exercise EOA. EOAi at peak exercise is a strong and independent predictor of exercise capacity and is associated with clinical outcome. Our findings stress the importance of maximizing AL opening by targeting the subvalvular apparatus in future repair algorithms for secondary mitral regurgitation.

The figure-of-eight artifact in the echocardiographic assessment of percutaneous disc occluders: impact of imaging depth and device type.

PURPOSE: Echocardiography is increasingly important in the guidance and follow-up of percutaneous transcatheter device closures. It was recently shown that the Amplatzer left atrial appendage occluder frequently presents as a figure-of-eight artifact due to interaction of device mesh and ultrasound waves. It remains unknown whether this can be translated to other types of disc occluders. Furthermore, the morphology of this figure-of-eight artifact appears to be different in the transesophageal and transthoracic image of the same device. The aim of this study was to evaluate the echocardiographic appearance of different types of disc occluders, and to clarify differences in morphology of the figure-of-eight artifact. METHODS: A mathematical model of an epitrochoid curve was used for numerical simulation of disc occluder appearance at various imaging depths. In addition, an in vitro setup was used for echocardiographic analysis of different types of disc occluders at adjustable imaging depth and position. RESULTS: Mathematically, decreasing the imaging depth resulted in a more asymmetric figure-of-eight, i.e. with small upper part and wide lower part. In vitro results were in close agreement with the mathematical results. In addition, in vitro a figure-of-eight artifact was obtained in all different types of disc occluder devices. CONCLUSIONS: Different types of percutaneous disc occluders all present as a figure-of-eight artifact on echocardiography when imaged from a coronal imaging position. The morphology of the artifact depends on the imaging depth, with a more asymmetric figure-of-eight morphology at smaller probe-to-device distance. This clarifies the differences observed between transesophageal and transthoracic imaging.

Pulmonary homograft endocarditis and aortic autograft failure after Ross procedure: a double stentless bioprosthesis approach.

The case is reported of a 38-year-old male patient with pulmonary homograft acute infective endocarditis and aortic root dilation that occurred 13 years after a Ross procedure for bicuspid aortic valve regurgitation. Aortic and pulmonary root replacements were performed, using a Freestyle stentless aortic root bioprosthesis in both cases, with excellent hemodynamics on postoperative echocardiography. In addition, preoperative systemic septic embolization had occurred despite an absence of left-sided endocarditis, presumably due to an intrapulmonary shunt. This case report demonstrates the feasibility of a double stentless bioprosthesis approach, and stresses the need to remain vigilant for septic embolization even in isolated right-sided endocarditis.

Clinical validation of a low-power and wearable ECG patch for long term full-disclosure monitoring.

BACKGROUND: Detection of intermittent atrial fibrillation (AF) is done using a 24-h Holter. Holter recordings are powerful but lack the comfort and have limited recording times resulting in under diagnosing of intermittent AF. OBJECTIVE: Within this work we evaluated and compared a novel miniaturized three-channel ECG monitoring patch versus a 24-h Holter system. METHODS: Both patients with a chronic AF rhythm (n=5) as well as patients with an AF rhythm that underwent electrical reconversion (n = 5) were equipped with both a 24-h Holter and ECG patch. RESULTS: Alignment of raw data of both ECG systems allowed cross-correlation analysis. Overall good correlations of up to 85% were obtained. RR-interval analysis of both systems resulted in very high correlations of 99% and higher. AF analysis showed correct identification of AF on both ECG systems. CONCLUSIONS: The performance of our ECG patch matches that of the 24-h Holter and could provide a suitable tool for long-term monitoring applications.

Functional impact of transmitral gradients at rest and during exercise after restrictive annuloplasty for ischemic mitral regurgitation.

OBJECTIVES: Restrictive mitral valve annuloplasty combined with coronary artery bypass grafting is the treatment of choice for ischemic mitral regurgitation. Postoperative functional mitral stenosis and its potential impact on functional capacity remain the object of debate. The aim of this study was to assess functional and hemodynamic outcome at rest and during exercise in a population with ischemic mitral regurgitation after a standardized restrictive mitral valve annuloplasty. METHODS: A total of 23 patients with ischemic mitral regurgitation who were previously treated with coronary artery bypass grafting and restrictive mitral valve annuloplasty underwent a semi-supine (bicycle) exercise test with Doppler echocardiography and ergospirometry. The surgical technique was identical in all patients, using a complete semi-rigid ring downsized by 2 sizes after measuring the height of the anterior mitral leaflet, to achieve a coaptation length of at least 8 mm. RESULTS: At a mean follow-up of 28 ± 15 months, mean transmitral gradients at rest and maximal exercise were 4.4 ± 1.8 mm Hg and 8.2 ± 4.2 mm Hg, respectively (P < .001). Transmitral gradients did not correlate with exercise capacity (maximal oxygen uptake) or pulmonary artery pressures. Patients with a resting mean gradient of 5 mm Hg or greater (n = 9) reached a significantly higher maximal oxygen uptake; however, they had a better ejection fraction and cardiac output at rest and reached a higher cardiac output at peak exercise. CONCLUSIONS: Transmitral gradients after restrictive mitral valve annuloplasty for ischemic mitral regurgitation did not correlate with functional capacity as measured by maximal oxygen uptake during semi-supine bicycle testing. Functional capacity and transmitral gradients are determined not only by the severity of mitral stenosis but also by hemodynamic factors, such as ejection fraction and cardiac output. Transmitral gradients should be interpreted with respect to patient hemodynamics and not necessarily be considered as detrimental for functional capacity.