VIDIO Study Shows Benefits of Philips Volcano’s IVUS Technology for Diagnosing Iliofemoral Venous Obstructions
March 4, 2016—Royal Philips announced clinical trial data demonstrating the benefits of the Philips Volcano intravascular ultrasound (IVUS) technology compared to conventional contrast-enhanced x-ray imaging of the veins (also known as multiplanar x-ray venography) in the diagnosis of iliofemoral venous obstruction.
Paul J. Gagne, MD, presented the findings at the American Venous Forum 28th Annual Meeting, which was held February 24–26 in Orlando, Florida. Dr. Gagne, who is Chief of Vascular Surgery at Norwalk Hospital in Norwalk, Connecticut, serves as global Principal Investigator of the study, VIDIO—Venogram Versus Intravascular Ultrasound for Diagnosing Iliofemoral Vein Obstruction.
According to the company, VIDIO is a 100-patient prospective multicenter study showing that 29% of patients were assessed to be free of lesions based on their x-ray venogram results, but had lesions detected by the Philips Volcano phased-array IVUS technology. In total, IVUS detected 88% more lesions than multiplanar x-ray venography (as assessed by investigators at the point-of-care).
In Philips’ press release, Dr. Gagne commented, “These results of the VIDIO study clearly show that IVUS is better at detecting lesions than multiplanar x-ray venography, the prior imaging gold standard. IVUS is now my preferred imaging modality of choice for identifying this treatable condition and the VIDIO study shows how well these patients can do with the appropriate treatment.”
As summarized by Philips, the VIDIO study was designed to prospectively compare the diagnostic performance of conventional multiplanar venography versus IVUS for diagnosing and treating iliac/common femoral vein obstruction and to characterize patient response to iliofemoral vein intervention in terms of clinical improvement and quality of life over 6 months of follow-up.
Between July 2014 and July 2015, the study enrolled 100 patients with advanced venous insufficiency (CEAP score—the Clinical-Etiologic-Anatomic-Pathophysiologic classification system for chronic venous disorders—of 4, 5, and 6) at 11 centers in the United States and three in Europe. Each patient had a multiplanar venogram performed, with an initial lesion characterization and treatment strategy recorded by the interventionist based on the venogram.
An assessment with Philips Volcano phased-array IVUS was then performed, with a second lesion characterization and treatment strategy recorded by the interventionist. Stent treatment was subsequently performed at the discretion of the interventionist. All patients were followed for 6 months after the index procedure.
From investigator readings at the time of the index procedures in all 100 patients in the study, IVUS detected 88% more lesions than multiplanar venography (124 vs 66; P < .0001). In addition, 29% of patients were ruled negative by venograms, while showing positive findings from IVUS (19 vs 48), advised Royal Philips.