Technology | March 22, 2013

FDA Approves GE Healthcare's AdreView SPECT Tracer for Risk Evaluation in Heart Failure Patients

AdreView is the first and only imaging agent approved for visualization of myocardial sympathetic innervation in certain heart failure patients

FDA Approval GE Healthcare's AdreView Nuclear Imaging SPECT systems

March 22, 2013 — GE Healthcare 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 percent.[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, M.D., associate professor of medicine, Brown University, Providence, R.I., 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 percent 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]

“GE Healthcare is committed to providing innovative and effective medical products that will aid physicians in determining mortality risk in patients with cardiovascular disease, and we are pleased that the FDA has approved AdreView for this indication in heart failure patients,” said Terri Moench, general manager, SPECT, GE Healthcare medical diagnostics. “The use of imaging tests is consistent with current trends towards gaining improved and earlier understanding of heart disease at a molecular level and may enable providers to help deliver better care to more people.”

The safety and efficacy of AdreView were evaluated in two open-label, multicenter, international trials in 985 patients with NYHA class II or class III heart failure with LVEF ?35 percent. A total of 110 patients without a history of heart disease also received a single dose of AdreView. The endpoint for analysis was all-cause mortality, an outcome confirmed by review of an independent adjudication committee. By 12 months following enrollment among the 964 heart failure patients in the efficacy population, 50 (5%) patients had died, 61 (6%) had missing follow-up information and three patients had missing H/M ratios. One-year mortality rates in relation to AdreView H/M ratio were: <1.2: 13.4%; 1.2-1.6: 5.5%; ?1.6: 1.0%. By 23 months following enrollment (the requirement for designation of two-year follow-up), 96 (10%) patients had died, 201 (21%) patients had missing follow-up information and three patients were missing H/M ratio data. Two-year mortality rates in relation to AdreView H/M ratio were: <1.2: 22.0%; 1.2-1.6: 11.5%; ?1.6: 3.3%.[2]

For more information: newsroom.gehealthcare.com

 

References:

1. Jacobson AF, Senior R, Cerqueira MD, et al. Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure: results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) Study. J Am Coll Cardiol. 2010;55:2212-2221

2. AdreView Prescribing Information, GE Healthcare. 2013.

3. Leimbach WN Jr., Wallin BG, Victor RG, Aylward PE, Sundlof G, Mark AL. "Direct evidence from intraneural recordings for increased central sympathetic outflow in patients with heart failure." Circulation 1986;73:913–9.

4. Brunner-La Rocca HP, Esler MD, Jennings GL, Kay DM. "Effect of cardiac nervous activity on mode of death in congestive heart failure." Eur Heart J 2001;22:1136–43.

5. Eisenhafer G, Friberg P, Rundqvist B, et al. "Cardiac sympathetic nerve function in congestive heart failure." Circulation. 1996;93:1667-1676.

6. The American Heritage Medical Dictionary. http://medical-dictionary.thefreedictionary.com/mediastinum. Accessed March 2013.

7. Hall MJ, Levant S, DeFrances C. "Hospitalization for Congestive Heart Failure: United States, 2000-2010." U.S. Department of Health and Human Services. Centers for Disease Control and Prevention. 2012.

8. Go AS, Mozaffarian D, Roger VL, et al. "Heart disease and stroke statistics — 2013 update: A report from the American Heart Association." Circulation.2013;127:e6-e245.

9. National Heart, Lung, and Blood Institute. "Congestive Heart Failure: A New Epidemic in the United States." Data Fact Sheet. September 1996

 

Related Content

NIH Study of Brain Energy Patterns Provides New Insights into Alcohol Effects

NIH scientists present a new method for combining measures of brain activity (left) and glucose consumption (right) to study regional specialization and to better understand the effects of alcohol on the human brain. Image courtesy of Ehsan Shokri-Kojori, Ph.D., of NIAAA.

News | Neuro Imaging | March 22, 2019
March 22, 2019 — Assessing the patterns of energy use and neuronal activity simultaneously in the human brain improve
Improving Molecular Imaging Using a Deep Learning Approach
News | Nuclear Imaging | March 21, 2019
Generating comprehensive molecular images of organs and tumors in living organisms can be performed at ultra-fast speed...
PET Scans Show Biomarkers Could Spare Some Breast Cancer Patients from Chemotherapy
News | PET Imaging | March 18, 2019
A new study positron emission tomography (PET) scans has identified a biomarker that may accurately predict which...
Researchers Create New Method for Developing Cancer Imaging Isotopes

Prototype fluidic system for zirconium-89 purification. Image taken through a hot cell window at the Department of Radiology, University of Washington. Image courtesy of Matthew O’Hara, Pacific Northwest National Laboratory

News | Radiopharmaceuticals and Tracers | March 14, 2019
A team of researchers at the University of Washington announced they developed a new automated system for producing...
Siemens Healthineers Announces First U.S. Install of Biograph Vision PET/CT
News | PET-CT | March 06, 2019
Siemens Healthineers’ new Biograph Vision positron emission tomography/computed tomography (PET/CT) system has been...
ImaginAb Enrolls First Patient in Phase II PET Agent Clinical Trial
News | Radiopharmaceuticals and Tracers | January 30, 2019
ImaginAb Inc. announced the enrollment of the first patient in the Phase II clinical trial of the company’s CD8+ T Cell...
FDA Clears United Imaging Healthcare uExplorer Total-Body Scanner
Technology | PET-CT | January 23, 2019
January 23, 2019 — United Imaging Healthcare (United Imaging) announced U.S.
MIM Software Inc. Receives FDA 510(k) Clearance for Molecular Radiotherapy Dosimetry
Technology | Nuclear Imaging | January 16, 2019
MIM Software Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for molecular radiotherapy...
Videos | SPECT-CT | December 12, 2018
This is a walk around of the new Spectrum Dynamics Veriton SPECT-CT nuclear imaging system introduced at the 2018 ...