During the Heart Failure Society of America (HFSA) 2022 Scientific Meeting, Daxor Corporation announced new data from multiple studies validating the benefits of the company’s BVA-100 blood test for patients with heart failure. Photo credit: Daxor Corporation.
October 5, 2022 — New data presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2022, held Sept. 30-Oct. 3 in Washington, DC, shed light on the impact of an FDA-cleared blood volume analysis test to benefit patients with heart failure.
During the HFSA Meeting, Daxor Corporation announced new data from multiple studies validating the benefits of the company’s BVA-100 blood test for patients with heart failure. A summary of a study shortening length of stay was published separately on ITN. This news overview highlights each of the additional study presented and their findings.
In one study, data from Mayo Clinic in Rochester, NY, titled “Impact of Right Ventricular Dysfunction of Blood Volume Expansion in Heart Failure,” researchers measured blood volume in 139 heart failure patients at the time of hospital discharge (post-diuretic therapy and considered to have a normal blood volume) utilizing the Daxor BVA-100 diagnostic blood test. The company reported that blood volume expansion was present in over 50% of the overall cohort with normal blood volume only present in 27% at the time of hospital discharge and risk for right ventricular dysfunction was highlighted as being particularly challenging.
Despite treatment to resolve volume abnormalities, the study author noted “Persistent intravascular volume expansion is more common at the time of discharge despite diuretic intervention in heart failure,” said Wayne Miller, M.D., PhD, principal investigator.
The company announced poster presentations at HFSA 2022 on BVA-100 that showed the ability to reduce mortality in this population by 85% on a one-year basis (from 35.5% to 5%) and a second study showed a reduction in the hospital length of stay by 2.5 days or 55%. The implications for the potential reduction in both mortality and costs have led to new ongoing trials funded by the National Institute of Health (NIH) and others.
Daxor Corporation also announced findings of a study titled “Heart Failure Outcomes with Volume-guided Management in an Over-65 Population.” This study showed this cohort of patients experienced markedly better outcomes vs. controls for 30-day readmissions (12.0% vs 27.0%, P< .001), 30-day mortality (2.3% vs 11.8%, P< .001), and 365-day mortality (5.6% vs 36.8%, P< .001) rates.
Jonathan Feldschuh, Chief Scientific Officer for Daxor, stated, “This study shows the substantial benefit of BVA-guided care for Medicare patients with heart failure. Reducing the mortality rate by 81% on a 30-day basis and 85% on a one-year basis (from 36.8% to 5.6%) for one of the leading causes of death in the U.S. has been shown to be attainable with BVA in this 216-patient study. The study also showed a 56% lower rate of 30-day rehospitalization which points to a strong economic benefit for payers.”
“Understanding the impact of treatment decisions on outcomes for the over-65 population is of relevance to U.S. healthcare, as decisions made by the Centers for Medicare & Medicaid Services (CMS) regarding reimbursement, outcome-based incentives and penalties applied to health providers, and indication guidelines have an enormous impact on how healthcare is provided,” said John E. Strobeck, M.D., PhD, principal investigator.
Additionally, two studies from Duke Heart utilizing the Daxor BVA-100 diagnostic in patients with an implantable pulmonary pressure monitor highlighted that the commonly used pressure metric does not correlate with actual blood volume. “The clinical implications are significant, as managing patients for cardiovascular congestion based on pressure measures alone might not be sufficient. Pressure measures provide complementary but different information. Pressure is not volume,” said Marat Fudim, M.D., principal investigator.
Jonathan Feldschuh, Chief Scientific Officer for Daxor, said of these studies, “Heart failure management is centered around effective volume management, pressure measures are no substitute for direct 98% accurate measurement of blood volume with the Daxor BVA system. These two studies add to the considerable evidence that shows why BVA is the most accurate and effective diagnostic tool for volume measurement in heart failure with significant outcome and cost improvement for patient care when used to guide treatment.”
Highlights from the two studies included:
The “Pressure-Volume Profiles in Heart Failure with Reduced Ejection Fraction and Heart Failure with Preserved Ejection Fraction” study compared the differences in pressure-volume profiles between two common HF phenotypes. Patients with reduced ejection fraction had overall higher pressures and blood volume than those with preserved ejection fraction, however there was lack of correlation between pressure and volume in both HF phenotypes.
“Correlation Between Pressure and Volume in Ambulatory Heart Failure: Sex-Specific Analysis” found that differences in cardiac structure and physiology exist between women and men with HF. Despite similar baseline characteristics, men had higher absolute total blood volume and greater total blood volume percent deviation compared to women with similar pressures. Overall, there was a discordance between pressure and volume measures in both men and women suggesting preferential response to diuretics to improve congestion in men.
Heart failure is the leading cause of death in the United States, but also a $30 billion dollar burden set to double in the next 8 years, with the average patient staying in the hospital for 5.5 days for treatment and having an over 33% one-year mortality rate, according to a statement released by Daxor Corporation announcing the new data. The statement noted that the BVA blood test provides unique diagnostic capabilities for patients with heart failure, allowing doctors to treat and diagnose accurately. BVA-100 is FDA-cleared, covered by both public and private insurance, and in use in hospitals throughout the U.S., but acknowledged that many are unaware of its benefits in both in-patient and out-patient settings.
For additional information: https://www.daxor.com/company-overview/