STTR Phase I: Wireless point-of-care sensor for continuous fluid status monitoring of patients with congestive heart failure

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project will provide the market with a novel non-invasive method for measuring fluid status in patients with congestive heart failure (CHF). The ability to detect volume status changes prior to the onset of heart failure symptoms has tremendous patient care and economic impact. According to the American Heart Association, the annual cost of CHF is $31B in the US. The majority of this cost is due to hospitalization. Nearly 50% of patients with CHF who are discharged from the hospital will be readmitted within 6 months. Most of these admissions are deemed preventable by CMS, thus forcing the hospitals to absorb the costs. The expected cost to hospital systems is >$200M per year in CMS fines for hospital readmissions. Non-invasive outpatient CHF monitoring has the potential for earlier detection of fluid overload prior to CHF symptoms. If successful, the outcome of this technology will allow caregivers to assess the patient and adjust medications or diet on an outpatient bases before hospitalization is warranted. Low-cost, ease of use, and unobtrusive design are aimed to reduce ethnic and cultural barriers to healthcare and enhance adoption. The proposed project will lead to the successful development of a low-cost, wearable sensor array and mobile application for real-time volume status assessment of patients with CHF. Patients with CHF often have fluid accumulating in the tissues and lungs due to worsening cardiac function, poor medical compliance, or diet. Current outpatient monitors such as blood pressure and weight, fail in their primary endpoint to detect volume overload before the patient has symptoms of edema, fatigue, and shortness of breath. Currently, fluid status is measured with invasive monitoring modalities such as pulmonary artery and central venous catheter pressure and waveform analysis. There is a great need for accurate non-invasive detection of early intravascular fluid changes in patients with CHF prior to heart failure symptoms and need for hospitalization. Monitoring of the peripheral venous system signifies a fundamental paradigm shift from peripheral arterial based monitors. However, peripheral veins are anatomically connected to the pulmonary artery that is invasively measured in patients with CHF. It is logical therefore that peripheral veins, not arteries reflect pulmonary arterial congestion seen in patients with heart failure.