Correlation of Non-invasive CPM Wearable Device With Measures of Congestion in Heart Failure in Exercise

Fluid status and congestion can be determined by the CPM wearable device and correlates with non-invasive measures and biochemical markers of congestion and changes in congestion.

Heart Failure is common, affecting 1-2% of the general population, with the prevalence increasing to over 10% in those over the age of 80. Heart Failure is associated with high morbidity, with many patients requiring frequent and often lengthy hospitalization for treatment with intra venous diuretics. In the recent Heart Failure audit of England and Wales, of over 68000 patients admitted to hospital with a primary diagnosis of Heart Failure between 2017 and 2018, median length of stay was 6-9 days, depending on whether patients were managed by specialist cardiologists. Heart Failure hospitalizations account for approximately 5% of all emergency admissions leading to 2% of all NHS inpatient bed-days. Heart Failure accounts for almost 2% of the total NHS budget, with approximately 70% of these costs due to Heart Failure hospitalizations. The hallmark of decompensation is the development of congestion. This is usually manifested by the development or worsening of pulmonary edema or peripheral edema. Patients often present to hospital when the degree of congestion becomes severe enough to cause symptoms, most often shortness of breath, and therefore require treatment through decongestion with vasodilators and intra venous diuretics. However, a number of studies have shown that the presence of congestion can be detected days to weeks prior to hospitalization leaving a window of opportunity in which treatment aimed at averting a costly hospitalization could occur. Furthermore, congestion can be altered by exercise and may be more pronounced on exercise. Detecting these early signs of congestion has so far only been possible using invasive monitoring devices such as specially designed pacemakers (Heart Logic™, Boston Scientific) or implantable pressure monitors (Cardio MEMS™, Abbott)

Analog Devices Inc have developed a wearable patch-like device called the Cardio- Pulmonary Management (CPM) wearable device which is applied to a patient's chest to assess congestion levels by measuring a number of physiological parameters over approximately five minutes. The goal of this Prospective Uncontrolled Clinical Investigation is to determine if the CPM wearable device can accurately detect the presence of congestion by correlating the findings from the device with changes in congestion status in patients receiving hemodialysis (Cohort A) and if the correlations are different before and after exercise in patients receiving treatment for decongestion for heart failure as an inpatient (Cohort B) as measured by lung spirometry, lung ultrasound Trans Thoracic Echocardiography and Biomarkers

Eligibility Criteria:
Inclusion Criteria:

Written informed consent Male or female ≥18 years of age

Cohort A

1. Established on hemodialysis for \>90 days
2. Undergoing hemodialysis with target volume removal ≥1.5 liters fluid

Cohort B Meet ESC criteria for diagnosis of Heart Failure including

1. Heart failure with reduced (HF-REF), mid-range (HF-mREF) and preserved (HF-PEF) ejection fractions
2. Requiring treatment with intravenous (IV) diuretics

Exclusion Criteria:

1. Unable to consent to inclusion in study due to cognitive impairment
2. Allergies or skin sensitivities to silicone- based adhesive
3. Skin breakdown or dermatological condition on the left chest or breast areas or chest wall deformity where the device is placed
4. Pregnancy or breast-feeding
5. Currently uncontrolled cardiac arrhythmia
6. Hemodynamically significant mitral stenosis (at least moderate in severity on TTE)
7. Conditions that may confound congestion assessments including

A. Severe obstructive lung disease B. Severe fibrotic lung disease C. Severe liver disease D. Relevant active malignancy E. Active viral or bacterial bronchopneumonia-CXR within 4 weeks showing consolidation F. Pulmonary contusion G. Pneumothorax H. Pneumonectomy I. Lobectomy J. Pulmonary embolism within the previous 3 months K. Indwelling intercostal chest drain L. Left ventricular assist device (LVAD) M. COVID-19 infection. N. Increased Body Mass Index where satisfactory Echocardiographic images not possible

Cohort B only - inability to perform exercise safely