A right heart catheter for pressure-volume loop risk stratification for percutaneous valve repair in tricuspid regurgitation

The National Heart, Lung, and Blood Institute awarded Bridgesource Medical, Corp. $320,727 on September 1, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to develop a right heart catheter device that uses pressure-volume loop analysis to identify which patients with tricuspid regurgitation will benefit from percutaneous valve repair procedures.

The device addresses a critical clinical gap in patient selection for tricuspid valve interventions. Approximately 1.5 million U.S. patients are eligible for intervention, but existing echocardiography and imaging methods produce falsely reassuring assessments of right ventricular function in the presence of tricuspid regurgitation. This diagnostic uncertainty leads to catastrophic outcomes in some patients, including right ventricular failure and prolonged intensive care stays on extracorporeal membrane oxygenation. Pressure-volume loop analysis, the gold standard for measuring cardiac function in a load-independent manner, has been limited to research applications. Bridgesource will translate this measurement technique into a clinically deployable catheter-based tool.

Work is performed in Austin, Texas. The award runs through August 31, 2027. This is a Phase I Small Business Innovation Research project, and Bridgesource Medical is a for-profit medical device company that develops cardiovascular and respiratory technologies targeting the elderly population. The company has received seven prior NIH grants ranging from $225,000 to $4.6 million supporting development of investigative prototypes, preclinical validation data, and clinical feasibility studies intended to support regulatory clearance and commercialization.

Abstract

Tricuspid regurgitation (TR) is a common and serious finding in older patients (>70 years), with mortality 1 year after diagnosis with severe TR exceeding 20%. TR has traditionally been treated conservatively because IT occurs commonly in older patients who have poor outcomes with open heart surgery. However, recent development of transcatheter interventions for tricuspid valve repair or replacement have led to an increase in the number of older patients eligible for surgical intervention. Despite 1.5 million patients being eligible for intervention in the US, determining who will benefit is still unclear. While many patients gain considerable quality of life benefit following intervention, others have catastrophic outcomes that include extended and grueling stays on extracorporeal membrane oxygenation in the intensive care unit. Right ventricular failure immediately following tricuspid procedures occurs at a much higher rate than similar procedures for other valves. This failure occurs when the patient's right ventricle is too weak to withstand increases in load on the right heart that result from closure of the low resistance leaky tricuspid valve. Unfortunately, existing clinical measurements of right ventricular function at baseline by echocardiography or other imaging methods are heavily confounded by TR and can lead to function appearing "pseudo- normal". Substantial clinical uncertainty therefore exists as to which patients will be able to withstand a tricuspid valve procedure. Improved patient selection requires more accurate measures of right ventricular function. Pressure-volume (PV) loop analysis is the gold standard assessment of cardiac function and measures cardiac reserve in a load-independent manner that is not confounded by TR. Until now, this technique has been limited to research because IT required an additional procedure over the clinical standard of care. Bridgesource medical corporation and clinical collaborators propose to solve these issues by incorporating pressure-volume measurements onto a standard right heart catheter to measure simultaneous right ventricular volumes in addition to pressures, enabling acquisition and analysis of PV loops. This development allows use of PV loop analysis in standard clinical practice, because right heart catheterization is part of the standard workup leading to a TR procedure and no second catheter or additional surgery is required. This new right heart catheter will provide a more accurate risk stratification for patients with TR and prevent excessive morbidity and mortality particularly in older patients whose right ventricles cannot tolerate the procedure.