Intravascular ultrasound detects more iliofemoral lesions than X-ray venogram in clinical trial

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Philips’ intravascular ultrasound (IVUS) technology holds benefits for the diagnosis of iliofemoral venous obstruction, in comparison to conventional contrast-enhanced X-ray imaging, according to a clinical trial.

The trial data was presented by Paul J Gagne, chief of Vascular Surgery at Norwalk Hospital, Norwalk, USA at the American Venous Forum 28th Annual Meeting.

In the 100-patient prospective multicentre “Venogram Versus Intravascular Ultrasound for Diagnosing Iliofemoral Vein Obstruction (VIDIO)” study, 29% of patients were assessed to be free of lesions based on their X-ray venogram results but had lesions detected by Philips Volcano’s phased-array IVUS technology. The study found that IVUS in total detected 88% more lesions than multiplanar X-ray venography (as assessed by investigators at the point-of-care).

“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,” says Gagne, global principal investigator of the study. “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.”

“We are pleased to be advancing the science of deep venous diagnosis and intervention,” notes Neil Hattangadi, business leader of Peripheral Vascular at Philips Image Guided Therapy. “The VIDIO study shows the critical role that our IVUS technology can play in identifying venous obstruction and guiding therapy, and the contribution it can make to Philips’ goal of delivering personalised care.”

The VIDIO study was designed to prospectively compare the diagnostic performance of conventional multiplanar venography vs IVUS for diagnosing and treating Iliac/common femoral vein obstruction; and to characterise patient response to iliofemoral vein intervention in terms of clinical improvement and quality of life over six months of follow up.

Between July 2014 and July 2015, the study enrolled 100 patients with advanced venous insufficiency (Comprehensive Classification System for Chronic Venous Disorders score four, five, and six) at 11 US and three European centres. Each patient had a multiplanar venogram performed, with an initial lesion characterisation and treatment strategy recorded by the interventionalist based on the venogram. An assessment with Philips Volcano phased-array IVUS was then performed, with a second lesion characterisation and treatment strategy recorded by the interventionalist. Stenting treatment was subsequently performed at the discretion of the interventionalist. All patients were followed for six months after the index procedure.

Across the full 100 patients enrolled, according to investigator readings at the time of the index procedure, IVUS detected 88% more lesions than multiplanar venography (124 vs 66, p<0.0001). In addition, 29% of patients were ruled negative by venograms, while showing positive findings from IVUS (19 vs 48).