Daxor Corporation, a company based in New York, has developed the BVA-100, a blood volume analysis test. The test is the first to be FDA approved for the quantification of blood volume and composition. Following the injection of a radio-labeled tracer, a blood sample is obtained from the patient and analyzed. The entire process takes less than one hour and provides clinicians with information on total blood volume, red blood cell volume, and plasma volume.
Blood volume adjustments are important in a wide variety of disease states, but in many cases clinicians have to rely on indirect measurements of blood volume, meaning that they do not have completely accurate information with which to make treatment decisions. The BVA-100 aims to provide an objective and accurate measurement of blood volume to take the guesswork out of making blood volume adjustments.
The test has proven to be useful during the current COVID-19 pandemic, with patients on ventilation requiring frequent fluid adjustments, such as blood transfusions.
See a video about Daxor’s technology and blood volume analysis below:
Medgadget had the opportunity to talk to Michael Feldschuh, CEO of Daxor, about this technology and its role during the pandemic.
Conn Hastings, Medgadget: Please give us an overview of the importance of blood volume analysis in terms of diagnostics and clinical decision making.
Michael Feldschuh, Daxor: Blood Volume Analysis (BVA) is important because a healthy blood volume is a biological imperative central to tissue perfusion — it is vital to all organ systems and cells in the body as blood contains red cells to carry oxygen, important proteins, and plasma as a conduit. The importance of ensuring that patients are at an optimal blood volume is known to all clinicians and interventions which correct volume derangements are routinely made and critical to organ and tissue health and survival. The challenge has been how to measure the optimal blood volume and to know that a patient is at “euvolemia” — ensuring adequate tissue perfusion and homeostatic response.
Heterogeneity of volume status is common in many conditions and challenging to manage without an accurate diagnostic that directly measures blood volume versus an accurate patient-specific norm. Patients with identical clinical symptoms often have different etiologies and underlying blood volume derangements, increasing the risk that iatrogenic interventions will be harmful (for example giving vasopressors when more fluid would be appropriate or over-diuresing a patient which can lead to acute kidney injury). The BVA-100 test reveals this variability permitting precise individualized therapeutic strategies instead of a “one-size-fits-all” approach and ends the debate at the bedside of the patient’s volume status.
Medgadget: What conditions and diseases can affect blood volume? Can returning blood volumes to ideal levels help in treating such conditions?
Michael Feldschuh: Treating a patient’s blood volume and its composition is central to a broad range of chronic and acute indications including but not limited to congestive heart failure, sepsis, blood loss due to trauma or surgical procedures, hypertension, renal failure and syncope. Maintaining a normal blood volume is like “walking a tightrope”, too much or too little can have serious consequences.
Fluid management is a significant challenge for patients in the ICU. A randomized control trial (RCT) on volume management guided by the BVA-100 test was conducted on patients in the SICU at a leading trauma center. The results showed a 66% reduction in mortality versus the prior standard of care when BVA was used to guide treatment. Ventilator use and length of stay also trended down as well.
Heart failure also represents one of the largest areas of healthcare spending and one of the most significant treatment challenges for approximately 6 million US patients. In a landmark peer-reviewed study published in the Journal of the American College of Cardiology – Heart Failure, BVA guided care was proven to reduce heart failure 30-day mortality by 82%, 30-day readmissions by 56%, and 1-year mortality by 86%. This study highlights the value of our technology and its potential to improve heart failure outcomes.
There have been dozens of peer-reviewed studies that have established the value of the BVA-100 test for clinical use, confirming that accurate blood volume measurement leads to better informed physicians, better treatment strategies, and improves patient outcomes and resource utilization.
Medgadget: What are the problems with surrogate measures of blood volume that clinicians sometimes use in the absence of a device such as the BVA-100?
Michael Feldschuh: Physicians predominantly rely on clinical assessment and a range of surrogate or indirect measures (i.e. hemoglobin, hematocrit, pressure measures, hemodynamics, ultrasound, levels of brain natriuretic peptide, etc.) to estimate patient blood volume in the absence of the direct BVA-100 test. A multitude of studies have shown these indirect tests for assessing volume are vastly inferior in that they lack specificity and sensitivity compared with the BVA-100 test. Treatment goals for volume assessment can be a high-stakes guessing game without accurate knowledge of both the patient’s actual and ideal total blood volume. The BVA-100 provides objective and actionable data and ends the debate at the bedside so the patient’s optimal blood volume can be restored.
Medgadget: How does the BVA-100 test work? Is it easy to use?
Michael Feldschuh: The BVA-100 test is a simple blood test with results available within 1-hour. The test uses a radiolabeled tracer that is injected into the patient at the bedside, blood is drawn from the patient, and a precise calculation of the patient’s volume derangement and insights into the capillary leak is determined by the dilution of the tracer. The “indicator dilution” method is considered the “gold standard” for this measurement. This is why the BVA-100 test has generated over 45,000 test results, and has been used in over 100 studies, drug trials, and case studies since its launch.
Medgadget: How are blood volume measurements relevant to COVID-19 patient outcomes and treatment?
Michael Feldschuh: COVID-19 patients with ARDS/respiratory distress end up on ventilators and typically need fluid adjustments, which can mean more or less supportive fluids such as saline or even blood transfusions. There is no one adjustment they all need — circulatory support needs to be individualized. The benefit of the BVA-100 test is it enables care teams to immediately adjust patients to their optimal blood volume by allowing them to see if a patient is too under or over resuscitated. Correct fluid adjustments ensure circulatory integrity and optimal tissue perfusion.
Medgadget: How has the BVA-100 test been used to date during the COVID-19 pandemic?
Michael Feldschuh: Institutions have been using and collecting data on BVA guided care COVID-19 patients to assist with fluid management. In a randomized control trial (RCT) conducted at a Level-1 trauma center on patients suffering predominantly from ARDS/sepsis/septic shock/hemorrhagic shock patients who received BVA guided care showed significant benefits including 66% lower mortality, days on ventilators, and ICU length of stay. This study group had a similar patient profile as those with COVID-19 in the ICU in that they have significant challenges in maintaining blood volume and endothelial damage.
A RCT on COVID-19 patients is not available yet, but clinical usage so far has shown the BVA-100 test provides significant insights into volume derangements and capillary permeability; the albumin transudation rate which is a unique metric of the BVA-100 test. It is an indicator of the rate at which fluids may be escaping the intravascular space — high rates of capillary permeability have been shown to be a significant prognostic marker of ICU mortality. The virus damages the capillary system, and a high leak rate is important to understanding the disease process; it can be used for triage, guide treatment and measure response to intervention giving physicians a true understanding of the status of the patient. For example, a declining leak rate would indicate that the patient is improving versus a patient with a sustained or worsening leak rate. We look forward to sharing more findings specific to COVID-19 when the data become available.