New Non-invasive Technology for Monitoring Lung Fluid Content in Heart Failure Patients

Problem: readmissions due to heart failure (HF) is a major burden. Decompensated HF is a leading cause of rehospitalizations and mortality for HF. There are several factors contributing to HF readmission, as well as to HF-associated and all-cause mortality. Pulmonary fluid overload plays a crucial role in these outcomes. Was proven that detection an early pre-clinical stage of lung fluid accumulation enables preemptive treatment which capable to reduce HF readmissions and all-cause death.

Today, there is no an effective technology for non-invasive patient’s pulmonary congestion monitoring in-hospital and at home.

CardioSet proposed and developed device and vest for sensitive measurement of lung fluid accumulation at pre-clinical stage in hospital and in out-hospital setting including home lung fluid monitoring.

Technology: accumulation of lung fluid into the lung change lung impedance (LI). Using of non-invasive methods for “pure” LI measurement is impossible. All non-invasive methods measure impedance of whole chest (transthoracic impedance), which contains LI and impedance of chest wall (parasitic or noise signal). Noise signal is 10 times higher than LI. CardioSet proposed the method for differentiation between LI signal and noise signal. Such approach enabled highly sensitive measurement of small changes in lung fluid content and beginning preemptive treatment at preclinical stage of HF exacerbation.

Technology efficacy: Were conducted 4 clinical trials. Was found that using CardioSet technology reduced length of hospital stay and all-cause death in HF patients during hospital stay, reduced by 60% HF readmissions and by 40% all-cause death in out-hospital setting. Results were presented at Late Braking Clinical Trail Session of ACC in Chicago 2016.

CardioSet is at the stage of preparing industrial prototype of device and vest and getting FDA approval.

Using CardioSet technology could prevent a million of HF readmissions in out hospital setting. prevent premature discharges and reduce 30-day readmission rate.