Study Confirms Safety Of Ultrasound Contrast Agent

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Optison ™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent designed by GE Healthcare to improve suboptimal echocardiograms, may be used without concern about its affects on pulmonary arterial systolic pressure (PASP) or pulmonary vascular resistance (PVR), according to results of a study released by the company today.

The results—presented at the American Society of Echocardiography (ASE) 22nd Annual Scientific Sessions—indicate that Optison does not significantly affect PASP or PVR compared to baseline in patients with normal or elevated pulmonary arterial systolic pressure.

The phase-four, single-blind, cross-over, placebo-controlled study compared the effects of Optison and 5% dextrose (control) on PASP and PVR assessed during right heart cardiac catheterization. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.

Overall, following Optison treatment, average PASP values were about the same as baseline (55.2 mm Hg at baseline compared with 55.6 mm Hg at two minutes after injection, 54.1 mm Hg at six minutes after injection, and 54.6 mm Hg at 10 minutes after injection). Similar results were observed in each treatment arm (Optison followed by control or control followed by Optison) and in both treatment arms combined. There were no serious adverse events.

Lead study author Michael Main, MD, of Saint Luke’s Mid America Heart Institute, tells imagingBiz that the study not only confirms Optison’s lack of effect on pulmonary hemodynamics, including patients with elevated pulmonary artery systolic pressure at baseline; it also should “reassure clinicians that ultrasound contrast agents are safe for routine use—including administration in patients with advanced cardiopulmonary disease.”