SOURCE: Daxor Corp.

Daxor Corp.

July 27, 2016 09:00 ET

In Heart Failure, One Size Does Not Fit All: New Mayo Clinic BVA Study Published in Journal of the American College of Cardiology-Heart Failure Highlights the Need for Individualized Decongestive Strategies

NEW YORK, NY--(Marketwired - Jul 27, 2016) - Daxor Corporation (NYSE MKT: DXR), an investment company with medical instrumentation and biotechnology operations, announces an important recent publication illuminating the ability of direct blood volume analysis (BVA) to characterize the heterogeneous blood volume profiles and needs of hospitalized heart failure patients (HHF. Published by Wayne L. Miller, MD, PhD, and Brian P. Mullan, MD, of the Mayo Clinic, the new dataset appears in the June issue of the Journal of the American College of Cardiology--Heart Failure as "Volume Overload Profiles in Patients With Preserved and Reduced Ejection Fraction Chronic Heart Failure."

Miller and Mullan studied 55 heart failure patients. 35 of the patients had decompensated heart failure with reduced ejection fractions. Such patients usually have enlarged weakened hearts and can only pump a reduced fraction of their blood with each pulse. 20 of the patients studied had heart failure with a preserved or relatively normal ejection fraction. As expected, nearly all patients were hypervolemic. Importantly, however, the heterogeneity in the magnitude of the intravascular blood volume derangement was high, with deviations from predicted normal total blood volume ranging from −5.2% to +77% in heart failure with preserved ejection fraction and from 0% to +107% in heart failure with reduced ejection fraction. These results highlight the need for individualized decongestion strategies informed by knowledge of the directly measured and quantified plasma volume (PV) and red blood cell volume (RBCV) status of the individual patient. Heart failure patients are traditionally treated with powerful diuretics which cause loss of water and sodium. They are particularly susceptible to kidney damage. 35% to 45% of all heart failure patients are dead within one year of admission to a hospital for heart failure.

Suggestive differences emerged between the heart failure patients with preserved ejection fractions and heart failure patients with reduced ejection fractions. Patients with preserved ejection fraction were more likely to be characterized by red blood cell (RBC) deficits and compensating plasma volume (PV) expansion. Patients with true anemia were found in 35% of patients with preserved ejection fractions patients vs. 14% of heart failure with reduced ejection fractions patients. In contrast, polycythemia, a condition with excess red blood cells, was more prevalent in heart failure patients with reduced ejection fractions at 63% vs. 45% for heart failure patients with preserved ejections fractions: for these patients excesses in both PV and RBCV were contributing to intravascular overload. Additional differences were observed in responses to therapy. Heart failure patients with reduced ejection fractions mobilized more intravascular fluid than heart failure patients with a preserved ejection fraction patients during decongestion; for heart failure patients with a preserved ejection fraction patients, more total body fluid loss occurred, but almost all of it came from the interstitial space with the total intravascular blood volume remaining essentially unchanged.

Persistent intravascular overload at discharge was prevalent across both subsets in this observational study, confirming previous findings (see, eg, Miller, JACC-HF 2014) that even substantial weight loss combined with symptom resolution cannot be considered clinically reliable in determining the adequacy of decongestion.

In an accompanying editorial (in the same medical journal) by Dr. Carmen Tschope and Burkert Pieske, MD of the University of Medicine Berlin noted that failure to recognize individual differences in heart failure patients has been a key driver of the poor results seen with conventional one-size-fits-all decongestion strategies. Their article entitled "One Size Does Not Fit All: How to Individualize Decongestive Therapy Strategies in Heart Failure." noted, "The establishment of quantitative blood volume analysis could be key to an individualized approach" that would optimize decongestive therapy strategies for each patient while preventing or limiting adverse effects.

Dr. Joseph Feldschuh, Chief Scientific Officer for Daxor, stated: "The new Mayo Clinic data confirm the urgency of tailoring treatment according to the individual blood volume derangement of each heart failure patient. My hope is that the individualized care which blood volume analysis makes possible will potentiate a meaningful advance in the management of acute decompensated heart failure. Notably, the first interventional BVA heart failure dataset, presented at the American College of Cardiology Congress in April of this year by Dr. John Strobeck, MD, PhD, and Dr. Miller, has already shown that markedly lower mortality and readmissions rates vs. the Medicare benchmarks are achievable with individualized care guided by blood volume measurement."

Blood volume derangements are a hallmark of heart failure, and the accurate measurement and management of congestion is a core concern for physicians in this setting. Clinical signs and symptoms alone are well understood to be inadequately sensitive and specific in the evaluation of volume status. Indirect metrics such as hemodynamic pressures, although informative in other respects, have demonstrated poor correlation with measured total blood volume. Alternative direct technologies utilizing dyes and fluorescing markers have repeatedly failed to deliver accurate results. Only BVA enables clinicians to measure a patient's blood volume directly and with 98% accuracy. Additionally, BVA is the only metric for quantifying RBC volume status to deliver consistent accuracy regardless of plasma expansion or depletion.

Michael Feldschuh, President and CEO of Daxor, stated: "This important new Mayo Clinic dataset highlights the urgency of realizing the potential of individualized heart failure care guided by BVA to meaningfully improve clinical and resource utilization outcomes. I am encouraged by the advance in our clinical understanding of this heart failure with a poor prognosis, these data represent the potential for improved treatment based on fundamental science. Treatment and hospitalization of heart failure patients is the #1 expense for Medicare. Blood volume measurement enables patients to be treated on an outpatient basis to avoid hospitalization."

Daxor Corporation manufactures and markets the BVA-100 Blood Volume Analyzer, which is used in conjunction with Volumex, Daxor's single-use diagnostic kit. For more information regarding BVA and the Daxor BVA-100, visit Daxor's website at www.Daxor.com.

Contact Information

  • Daxor contact information:
    Michael Feldschuh
    President and CEO
    212-330-8500
    Email Contact
    or
    Lisa Quartley
    Senior Vice President, Marketing and Commercial Development
    212-330-8500
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