A non-invasive, automated platform for hemodynamic assessment of patients at risk of heart failure or pulmonary hypertension

PROJECT SUMMARY Heart failure (HF) and abnormal heart function directly affects 6 million people in the U.S. and is a leading cause of death. Early intervention is key to reducing mortality and morbidity, yet early diagnosis, particularly for those with asymptomatic disease, is challenging. Effective diagnosis and management of HF and accompanying pulmonary hypertension (PH) requires accurate measurement of four hemodynamic parameters, including ejection fraction (EF), cardiac output (CO), pulmonary artery pressure (PAP), and pulmonary capillary wedge pressure (PCWP). Currently obtained by a combination of echocardiography and cardiac catheterization these assessments can only be performed by skilled medical personnel with specialized training. In addition, cardiac catheterization is highly invasive, requires significant expensive resources, and is associated with risks to the patient. There is an unmet need for an accurate, non-invasive, low cost hemodynamic measurement tool that can be operated without specialized training with accuracy equivalent to cardiac catheterization and sonography. Such a device would enable earlier, safer, and more affordable diagnosis, improved surveillance capabilities, more frequent monitoring of at-risk patients, and better clinical decision support for clinicians in guiding therapies. Non-invasive alternatives to catheterization are not currently available, and there are no technologies that currently exist for simultaneous measurement of EF, CO, PAP and PCWP. Sensydia Corporation is developing a low cost, non-invasive “Cardiac Performance System” (CPS) for hemodynamic measurement with the goal of achieving comparable accuracy to that of gold-standard techniques. CPS acquires and automatically analyzes acoustic and electrocardiogram signals from a set of easily applied sensors to accurately measure EF, CO, PAP, and PCWP. Sensydia has developed fully functioning hardware and prototype software for CPS that uses proprietary algorithms to analyze the acquired signals. Sensydia has been granted 510(k) clearance for measurement of EF; however, further algorithm development and testing are required to achieve a system that can also measure CO, PAP, and PCWP with similar accuracies. In Phase I of this Fast- Track STTR project, PAP and PCWP algorithms will be further refined and tested to meet desired thresholds of accuracy for clinical use using an existing training dataset of CPS and catheterization data obtained by the Sensydia/University of Pittsburgh Medical Center (UPMC) team and will be assessed based on Bland-Altman bias and limits of agreement. In collaboration with a team of experienced cardiologists and anesthesiologists at UPMC, the CO, PAP and PCWP algorithms will then be prospectively validated in a new, independent dataset from patients undergoing cardiac catheterization. Phase II will focus on demonstrating clinical utility and feasibility of routine use in a preoperative clinic setting. Finally, an integrated software application for reporting CPS data and diagnosis based on AHA/ACC guidelines will be developed and assessed in a useability study with UPMC physicians.