CorVista’s ML Algorithms Can Detect PCWP Elevation

CorVista Health is sharing preliminary results of its machine learning-based algorithm for non-invasively estimating pulmonary capillary wedge pressure (PCWP) elevation, a key indicator of heart failure with preserved ejection fraction.

PCWP currently is measured through an invasive right heart catheterization (iRHC) procedure that requires a cardiologist, pulmonologist, or intensivist. The CorVista capture device collects non-invasive cardiac signals for 3.5 minutes in patients at rest, which could potentially provide an alternative to iRHC in certain patient populations. The data demonstrate that machine learning signal analysis of a symptomatic population may provide a non-invasive alternative to measuring PCWP elevation, thereby potentially detecting HFpEF and PH subtypes earlier than currently possible.

Key findings presented in a poster, titled, “Point-of-Care Testing for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning on Non-invasive Signals”:

• The machine learning-based test achieved 0.92 ROC-AUC, 90% sensitivity, and 76% specificity when tested in 283 patients, showing a strong diagnostic performance consistently across multiple subgroups defined by sex, body mass index (BMI) and age—both confirming and ruling out disease with a high degree of certainty.
• Univariate analysis identified 247 features within the collected signal features that differentiate subjects with PCWP > 18mmHg vs PCWP ≤ 18mmHg when measured via iRHC.
• The model has a positive likelihood ratio of 3.8 and negative likelihood ratio of 0.13, indicating the test has a strong impact on post-test probability in both test-positive and test-negative cases.
• The model resulted in a diagnostic odd ratio of 29, indicating that a positive result was 29 times more likely to be observed in a patient with heart failure than a patient without.

“Heart failure with preserved ejection fraction can be challenging to diagnose in part because its symptoms overlap with many other conditions and although echocardiography is an excellent modality for estimating left ventricular ejection fraction (EF), its sensitivity for diagnosing diastolic dysfunction is rather abysmal,” CorVista Health Executive Vice President/Chief Scientific Officer Charles R. Bridges, M.D., said. “The new data provide preliminary results for the feasibility of our non-invasive machine learning-based test to detect elevated PCWP with a high level of accuracy. HFpEF represents over 50% of all cases of heart failure and has the highest morbidity and mortality. The underdiagnosis of HFpEF is arguably the largest unmet need in cardiovascular medicine today, representing approximately $25 billion in direct costs to the U.S. healthcare system annually. Moreover, PH is also vastly underdiagnosed, and it is critically important to differentiate subtypes of pulmonary hypertension which have distinct often lifesaving guideline-directed treatments.”

The exploration of a PCWP add-on to the CorVista System represents a major advancement in cardiology, with potential implications for early diagnosis, cost reduction, and broader access to cardiovascular care. The CorVista System Add-On for elevated PCWP is currently an investigational device limited by federal law (or United States) law to investigational use and is not available for commercial distribution. The system is designed to be deployed anywhere with an internet connection – addressing the unmet need in rural and underserved populations with limited access to traditional standard of care.

The CorVista System is a point-of -care digital health solution that detects multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze heart signals and detect issues such as blocked arteries or high pressure in the lungs—all in under 30 minutes, allowing clinicians to interpret results and guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension last spring, with additional indications, including heart failure, in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking the first major advancement in PH diagnostics in more than 40 years.

CorVista Health aims to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. The firm is dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations.