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Osprey Medical's AVERT system reduces necessary contrast — but not kidney injuries: study

by Lauren Dubinsky, Senior Reporter | May 05, 2016
Medical Devices Molecular Imaging X-Ray
Osprey Medical's AVERT system
Osprey Medical's AVERT system with contrast monitoring technology is able to dramatically reduce the volume of contrast media without compromising image quality, but it doesn't reduce contrast-induced acute kidney injury (CI-AKI).

"I think that reduction of contrast media volume is extremely important and this technology was able to achieve a reduction of contrast media injection," Dr. Roxana Mehran, director of interventional cardiovascular research and clinical trials at Icahn School of Medicine at Mount Sinai, told HCB News. "This was a high-risk group and I think they weren't able to show the benefits."

CI-AKI occurs when renal function suddenly deteriorates after contrast media, also known as radiographic dye, is administered during an interventional cardiac procedure. It affects about 20 to 30 percent of patients, especially those with diabetes or previous renal impairment.
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The AVERT system allows the clinician to control the amount of contrast that is used during the procedure. When the right amount of contrast has been injected into the coronary, the remaining contrast travels into a reservoir instead of the aorta.

The study included 578 patients at 39 sites who were deemed to be at risk of CI-AKI while undergoing coronary angiography with or without percutaneous coronary intervention (PCI). Out of the 568 patients with CI-AKI, PCI was performed on 239 of them.

The treatment group included hydration and AVERT and the control group only received hydration. The researchers aimed to evaluate the total amount of contrast that was used and determine the incidence of CI-AKI.

The researchers found that there were no significant differences in CI-AKI or adverse event rates between the groups. However, in a post-hoc analysis, they found that in certain groups — patients with a glomerular filtration rate between 40 and 60 — CI-AKI was significantly reduced.

"There's no question in my mind that reducing contrast media volume is a good thing and that we still need to do whatever we can do reduce the amount injected into the patient," said Mehran.

The findings were presented at the Society for Cardiovascular Angiography and Interventions 2016 Scientific Sessions yesterday in Orlando, Florida.

Going forward, the researchers are planning on studying patients with moderate chronic kidney disease in a prospective randomized trial.

"We have to redesign the study to the right patient population, and I think we will be able to show the benefit [of the AVERT system], said Mehran."

Other attempts to prevent CI-AKI have not been very successful either. At the American College of Cardiology conference last month, a study found that the investigational drug, CMX-2043, was ineffective in preventing CI-AKI.

Hydrating a patient before the imaging procedure still remains the best way to prevent CI-AKI, but that process is time-consuming and cannot be performed in emergency situations.

Research is also being done to try to replace the synthesized contrast agents with natural compounds like sugar and salt. The natural compounds don't remain in the body, but all of the MR, PET and CT contrasts that are synthesized in a lab like iodine and Gadolinium do.

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