Study Presented for Osprey Medical's Avert Contrast Modulation System

May 4, 2016—The Society for Cardiovascular Angiography and Interventions (SCAI) announced the presentation of a study demonstrating that the Avert contrast modulation system (Osprey Medical Inc.) significantly reduced the volume of radiographic dye without decreasing image quality in patients who are at risk of developing acute kidney injury (AKI) after undergoing a coronary angiography or percutaneous coronary intervention (PCI). However, the Avert device did not reduce contrast-induced AKI (CI-AKI). The results were presented as a late-breaking clinical trial at the SCAI 2016 scientific sessions in Orlando, Florida.

In the SCAI announcement, the study’s Lead Investigator Roxana Mehran, MD, commented, “Physicians are extremely careful about the volume of dye they administer to patients; the greater the volume, the more problems a physician can encounter.” Dr. Mehran is Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute of the Icahn School of Medicine at Mount Sinai in New York, New York.

Dr. Mehran concluded, “The bottom line is the Avert system is safe, easy to use, and reduces contrast media volume without sacrificing image quality. While the use of this device did not result in a significant reduction of CI-AKI, there was one exception. A post hoc analysis showed that in certain groups—patients with a glomerular filtration rate between 40 to 60—CI-AKI was significantly reduced. The next step would be to study patients with moderate chronic kidney disease in a prospective randomized trial.”

SCAI noted that minimizing contrast media volume (CMV) in patients at risk of AKI is a critical preventative measure. CI-AKI is associated with increased morbidity and mortality and affects an estimated 20% to 30% of patients, particularly those with diabetes or previous renal impairment.

With the Avert system, the operator can control the volume of dye used during an interventional procedure. Once the appropriate amount of dye has been injected, the remaining dye goes into a reservoir, rather than into the aorta.

As summarized by SCAI, the prospective, randomized multicenter study enrolled 578 patients (at 39 sites), who were considered to be at risk of CI-AKI while undergoing coronary angiography with or without PCI. The treatment group (n = 292) included hydration and Avert; the control group (n = 286) received hydration only. The study’s objectives were to assess total CMV used and determine the incidence of CI-AKI, which was defined as a 0.3-mg/dL increase in serum creatinine within 72 hours postprocedure.

Of the 568 patients with CI-AKI, PCI was performed in 239 (42.2%). The use of Avert resulted in a 15.5% relative reduction in CMV in all patients (86 ± 51 mL vs 101 ± 71 mL; P = .002) and a 22.8% relative reduction in CMV for PCI patients (114 mL ± 55 vs 147 ± 81 mL; P = .001). There were no significant differences in CI-AKI (27% vs 26.2%; P = .72) or adverse event rates between the two groups, reported SCAI in the announcement.