Clinical Applications

U.S. Annual Heart Failure Burden

7 Million Patients
Over 1 Million Hospitalizations
27% Readmitted Within 30-Days
30% 1-Year Mortality Rate
$30+ Billion Economic Burden

Outcomes Improved with Individualized Care Guided
by BVA

Peer-reviewed study in the Journal of the American College of Cardiology – Heart Failure

N = 245

56% reduction in 30-day readmissions

82% reduction in 30-day mortality

86% reduction in 365-day mortality

62% identified as anemic

View Study

In a peer-reviewed study, BVA performed on admission results
in a 2.6 days reduction in length of stay.

View Study

The American College of Cardiology Guidelines state that blood volume should be assessed for every heart patient to guide optimal treatment.

“Blood volume analysis offers providers a unique opportunity to reduce heart failure readmissions and mortality in both the HFpEF and HFrEF populations. We have used the technology at our center extensively and have found it to be hugely informative and cost-effective.“

John Jefferies M.D., MPH, FACC, FAHA, FAAP, FHFSA, FRCPE

Chen J, Normand S-LT, Wang Y, et al. National and regional trends in heart failure hospitalization and mortality rates for Medicare beneficiaries: 1998-2008.  J Am Med Assoc 2011;306:1669-78.

Heidenreich et al. Forecasting the Future of Cardiovascular Disease in the United States.  A Policy Statement from the American Heart Association.  Circulation. 2011;123:933-944.

2013 ACCF/AHA Guideline for the Management of Heart Failure, JACC  Vol. 62, No. 16, 2013.

https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm

U.S. Annual Critical Care Burden

Up to 50% Population Spends Last Year of Life in ICU
Up to $3,000 Per Day in ICU
20% Total Hospital Expenditure Incurred in ICU

Blood Volume Measurements Improved Survival

Prospective randomized control trial in Surgical ICU
N=100, 70% Septic Shock / Sepsis / ARDS

66% reduction in mortality

20% reduction in LOS

36 hour earlier treatment decisions

44% change in treatment strategy

“An important aspect of care was the earlier treatment of intravascular volume deviations in the BVA group, before the abnormality became clinically manifested.”

Mihae Yu, M.D. – Queens Hospital

66% reduction in mortality

44% change in treatment strategy

View Study

Persistently Elevated Albumin Transudation Rate Associated With Higher Mortality

Rate at which the albumin transudates out of circulation shown to be predictive of ICU mortality in cohort with 70% respiratory failure.

Retrospective Study in Surgical ICU

N = 164

View Study

“Blood Volume Analvsis is never more important than it is today. In fields such as surgery; managing blood loss, transfusion, and intravascular volume can no longer be guided by hematocrit alone. It is just too crude an instrument in the patient with significant derangements. Management must also take into account actual blood volume if we are going to make our best and most guided decisions in the surgical critical care and perioperative arenas.“

Mark T. Nelson, M.D., MEd

Civetta, Taylor, & Kirby’s Critical Care, Fourth Edition 2009

Other Indications

Blood Volume Analysis Clinical Utility

BVA measures blood volume with superior accuracy in a broad range of medical and surgical conditions.

Anemia

Anemia is a condition that develops when blood lacks enough healthy red blood cells or hemoglobin. Anemia can be caused by many conditions such as blood loss during surgery, chemotherapy or kidney disease. Many clinicians rely on the hematocrit test as a surrogate measure of blood volume. An accurate measure of red blood cell volume can provide specific information about the extent of red cell depletion and guide appropriate therapy.

Blood loss during surgery or trauma

Four million patients receive blood transfusions annually. Without an accurate true measure of blood volume, physicians are faced with a difficult choice of administering a transfusion that may cause infection or other complications, or withholding a transfusion from a patient who may suffer significant complications such as kidney damage or a thrombotic event from low blood volume (hypovolemia).

A recent study showed  the average post surgical RBCV loss was 38% and  not hemodilution as hypothesized using Hct as a surrogate measure.   The investigator concluded that standard transfusion triggers may not be sensitive and specific enough to adequately individualize resuscitation.

Chronic Fatigue Syndrome

Over one million people in the US are reported to suffer from chronic fatigue syndrome (CFS), a complicated disorder characterized by extreme fatigue. Preliminary studies have shown that some patients with CFS have low blood volume. Accurately measuring total blood volume can help distinguish CFS patients from patients whose symptoms are unrelated to blood volume abnormalities.

Hypertension 

Around 85 million people in the US have hypertension or high blood pressure  and many are inadequately treated.   Hypertension is caused by excess blood volume or vasoconstriction (excessive tightening of the blood vessels).  Hypertension is treated with two types of medications – vasodilators which relax the blood vessels, or diuretics which causes fluid loss and a decrease in blood volume.   

Blood volume is rarely measured when managing patients with high blood pressure. There are more than fifty drugs currently approved for hypertension therapy. Treatment  guided by blood volume analysis eliminates the guesswork in choosing which therapy is best for each patient.

Orthostatic hypotension

Orthostatic hypertension or postural hypotension is a common form of low blood pressure. It occurs after a change in body position, typically when a person rises from a sitting or lying position. Blood volume measurement can help guide preventative therapy.

Preoperative screening

Preoperative screening of blood volume can help identify blood volume abnormalities. Patients with low blood volume can be treated in advance to build up their blood volume to normal levels prior to surgery. Patients who have a normal blood volume at the onset of surgery are less likely to require a transfusion.

Red cell mass

Red cell mass is a test most commonly ordered by hematologists to assess the total amount of red blood cells in patients undergoing chemotherapy. The original method of performing this test used a complicated and time-consuming method based on a chromium isotope called Cr51. This isotope has since been taken off the market. The BVA-100 test provides an accurate measurement of total red blood cell volume enabling physicians easy and safe access to critical information.

Renal failure

Renal failure occurs when blood flow to the kidneys is interrupted or when the kidneys become overloaded with toxins.  There are more than 500,000 people in kidney failure, with over 250,000 on renal dialysis treatments. These patients experience significant changes in their blood volume during treatment and may also suffer from severe anemia requiring additional therapy to stimulate red blood cell production.   

Syncope

Syncope is loss of consciousness (fainting) due to a drop in blood pressure. Hypovolemia (low blood volume) and anemia (low red cell volume) have been shown to be prevalent in syncope. Blood volume measurement can help define the condition and guide an appropriate treatment plan.

Discover More

Important Safety Information

The information provided on this website is for general informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

 

The data provided by the BVA is to assist qualified healthcare professionals in patient diagnosis and management. The uses and benefits of the BVA test described on this website are based on scientific literature and clinical experience. However, individual patient outcomes may vary. This website is not intended to promote any off-label uses of the BVA device. Decisions regarding the use of the BVA test and the interpretation of its results must be made by a qualified healthcare professional. Daxor is not responsible for any actions or decisions taken based on the information provided on this website.

 

BVA™ and Volumex® Indication and Important Risk Information

 

Indications and Intended Use

 

The Daxor BVA is an automated system that is used to measure/calculate the red cell mass (mL), plasma volume (mL) and total blood volume (mL), along with the related deviations from ideal values by amount (mL) and percentage (%) in adults. In addition, the Normalized Hematocrit (%) and Albumin Transudation Rate (%/min) are calculated.

 

It is an in vitro medical device composed of a microprocessor, software, touchscreen, and gamma counter and accessory convenience kit. The Daxor BVA is intended to calculate human blood volumes by the method of tracer diffusion (Indicator dilution technique) with I-131 as the tracer after injection of I-131 Human Serum Albumin.

 

The Daxor BVA provides a Quantitative Assessment of total blood and plasma volumes using an automated system.

 

Data inputs to the software come from the measured characteristics of patient venous whole blood samples collected in K3EDTA vacutainer tubes (hematocrit and tracer concentration) and tracer calibration standards. The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically input to this calculation program. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red cell volumes are reported, with statistics showing the quality of the results.

 

For in vitro diagnostic use in a Clinical Laboratory setting and operated by laboratory technicians. Rx use only.

 

Contraindications and Clinical Postponement

 

Volumex is contraindicated for use in pregnant women. Furthermore, safety and effectiveness have not been established in pediatric or nursing patients. While there are otherwise no known contraindications for Volumex, the procedure should be deferred if the patient is unwilling to consent, if reliable venous access cannot be established, or if the patient is clinically unstable (e.g., experiencing chest pain or shortness of breath) unless under direct physician oversight.

 

Safety Precautions and Radiation Management

 

Minimize radiation exposure for patients and workers; radiopharmaceuticals must only be handled by qualified, licensed handlers. Lugol’s Solution may be administered starting 24 hours pre-injection to protect the thyroid. Keep the BVA at least 3 meters from interference sources like MRI or electrosurgical equipment.

 

Potential Adverse Events

 

Potential risks include theoretical allergic reactions and injection site infiltration; the total weekly dosage must not exceed 200 microcuries. Ensure accurate, current height and weight are used for “ideal” volume calculations.

 

Device and Material Caution

 

Visually inspect Volumex; discard if particulates are present or if coloration is darker than very pale yellow. Total weekly dosage must not exceed 200 microcuries. Accurate patient height and weight measurements are required to calculate “ideal” volumes; do not use patient history. Clean the unit enclosure with mild detergent or 10% bleach, but never use alcohol on the screen.

 

Disposal Procedures

 

Dispose of empty Volumex syringes in an appropriate sharps container after assaying. Blood samples and cartridges may be discarded as standard medical waste in a biohazard container.