GE Healthcare today announced the U.S. Food and Drug Administration (FDA)
approval of a new indication for AdreView™ (Iobenguane I 123 Injection), the
first and only FDA approved molecular imaging agent to link nerve function in
the heart to a patient's mortality risk.^1 AdreView is approved for the
scintigraphic assessment of myocardial sympathetic innervation (cardiac nerve
activity) to assist in the evaluation of patients with New York Heart
Association (NYHA) Class II or Class III heart failure and left ventricular
ejection fraction (LVEF) ≤ 35%.^2
“Predicting disease progression in heart failure patients can be difficult,
and there are currently a limited number of prognostic tools available to help
clinicians understand the likelihood for heart failure progression,” said
James Arrighi, MD, Associate Professor of Medicine, Brown University,
Providence, RI and current president of the American Society of Nuclear
Cardiology. “Now, with AdreView, we have a tool that will provide clinicians
with a numeric score to help stratify mortality risk, and may help to promote
more informed clinical decision-making.”
Increased myocardial sympathetic activity is a prominent feature of heart
failure^3 and is often associated with decline in left ventricular function,
worsening heart failure symptoms, and sudden cardiac death.^1,4 This increase
leads to a depletion of norepinephrine (NE) storage and uptake.^5 AdreView
provides a means for assessing the neuronal capacity for uptake and storage of
NE.^2 While current prognostic tests look at the effect of the disease on
heart muscle and blood flow, imaging with AdreView uses the heart to
mediastinum (H/M) ratio to assess the functionality of the sympathetic nerves.
With AdreView, the H/M ratio is a measure of radioactivity uptake in the heart
compared to that of a reference region in the mediastinum (the mass of tissues
and organs between the two pleural sacs that separate the heart from the
lungs).^2,6 This measurement has a typical range of 1-2.4 and can accurately
identify patients with lower than average one- and two- year mortality risk.
In clinical studies, an AdreView Score (H/M ratio) of ≥1.6 was associated with
a 99% probability of survival at one year (negative predictive value, NPV).^2
In patients with congestive heart failure, AdreView utility has not been
established for selecting therapy, monitoring response to therapy, or to
identify a patient with a high risk for death.^2
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