Vixiar Medical, Inc — Department of Health and Human Services STTR Phase I: NHLBI

Description

Congestive heart failure CHF is the most common reason for hospitalization in the U S with over million admissions per year Patients admitted with CHF usually need IV diuretics to promote fluid removal The readmission rate is high over by days and by days post discharge This also presents an enormous economic burden hospitalizations account for a large percentage of the $ billion spent yearly on heart failure One of the reasons for the high readmission rate is that it can be very challenging to detect elevated cardiac filling pressure until symptoms recur that prompt a return to the hospital There is much enthusiasm for the potential of remote noninvasive monitoring to predict and reduce heart failure readmissions but daily weights vital signs and symptoms have limited sensitivity and specificity or are later indicators We have developed the first device for assessing cardiac filling pressure noninvasively that can be used at home It records finger photoplethysmography ppg continuously while also guiding and recording a standardized Valsalva maneuver into an expiratory pressure transducer The latest prototype is hand held battery powered and communicates wirelessly with an iPad capable of remote transmission The device is easy to use employs technology that is robust and inexpensive and testing takes only minutes We have shown that the output measure correlates with the invasive gold standard measures of left heart filling pressure left ventricular end diastolic pressure LVEDP and pulmonary capillary wedge pressure PCWP More importantly we have shown that it identifies clinically meaningful categories of elevated LVEDP and PCWP Most recently we have shown that LVEDP derived from the device on the day of discharge has high specificity for predicting heart failure readmission need for outpatient IV diuresis or death within days after discharge Sensitivity and specificity for predicting readmission may be improved by following LVEDP over time at home In this Fast Track project we intend in Phase I to develop further the automated waveform analysis algorithms remote transmission capabilities and prototyping necessary to conduct a home based observational clinical study In the clinical study in Phase II post discharge heart failure patients will test themselves at home twice a day for up to days and the data will be transmitted remotely We will determine if LVEDP obtained twice daily predicts heart failure events a combination of heart failure readmission need for outpatient IV diuresis or death within days after discharge Our team has extensive combined expertise in waveform analysis software development medical device prototyping project engineering heart failure clinical investigation and prior success in medical device start ups If the outcome of our observational clinical study is successful the next step would be to conduct a multi center interventional trial to determine if guiding therapy based on daily device testing reduces post discharge heart failure events The device has the potential to improve quality of life reduce health care costs and improve survival in patients with heart failure Congestive heart failure is the most common reason for hospitalization and the readmission rate is high which is a substantial health and cost burden We have developed a noninvasive test for detecting congestion before symptoms develop that may reduce re hospitalizations reduce health care cost and improve quality of life in patients with heart failure We will determine in patients testing themselves each day at home after a hospital discharge how well the device predicts readmissions for heart failure