New bioprosthetic venous valve offers hope for patients suffering from chronic venous insufficiency

Dr. Dorsey and patient
Surgeon Chelsea Dorsey, MD, and team care for patients with a broad range of vascular diseases.
Chronic venous insufficiency (CVI) is a vascular condition affecting millions of people in the United States in which veins in the leg cannot efficiently carry blood back to the heart for oxygenation.

For patients suffering from the condition, malfunctioning valves can cause blood to flow backwards and pool in the veins in the legs, which can lead to significant downstream affects for some people. Along with aching, throbbing and tired legs, patients with CVI can also develop varicose veins as well as discolored, infected and ulcerated skin on their lower legs.

Treatments such as laser ablation and sclerotherapy exist for problems in the leg’s superficial veins. But for patients with deep vein CVI, therapy is often limited to conservative measures, such as wearing compression stockings, elevating the legs, maintaining a healthy weight, and local wound care for hard-to-heal ulcers in the skin.

“For many patients, especially individuals who have to be on their feet for long periods of time for work or caregiving, it can be quite debilitating,” said vascular surgeon Chelsea Dorsey, MD, Director of the University of Chicago Medicine Vein Clinic. “It can really affect someone's ability to get through the day, especially if patients develop difficult-to-heal skin wounds that can take weeks, months or even years to heal.”

The University of Chicago Medicine is participating in a clinical trial that will determine the safety and effectiveness of a new bioprosthetic valve for patients with severe deep vein CVI. UChicago Medicine is currently the only institution in Illinois to be participating in the study, which involves nearly two dozen centers across the United States. Dorsey successfully operated on the study’s first patient in Illinois in August.

“It's been literally decades of not really having treatment options for this patient population, so to have a potential alternative for patients is something I haven't seen in my career,” said Dorsey, who hopes to enroll at least five UChicago Medicine patients in the trial.

Vein walls are usually lined with paired flaps called valves that open in one direction to help blood flow out of the leg and towards the heart; these valves intermittently close to prevent the blood from flowing backwards. In people with CVI, the valves are damaged, leading blood to pool in the legs causing pain, swelling, discoloration and stubborn ulcers.

Blood clots, or deep venous thromboses, are one condition that can increase the risk of developing CVI. Blood clots can scar the inside wall of veins and impact valve function. Being overweight, carrying multiple pregnancies and spending long hours on your feet can also increase your risk of developing CVI, as can a family history of varicose veins and spider veins. CVI is also more common in women and seen more often as people age.

The Surgical Anti-Reflux Venous Valve Endoprosthesis (SAVVE) clinical trial focuses on adults with severe deep venous insufficiency – patients who are likely to already have significant swelling, skin changes, discoloration or ulcers.

The device is called a VenoValve and consists of a pig’s aortic valve – the same tissue used in some heart valve replacements – stitched to a roughly inch-long metal scaffold.

The procedure begins with an incision on the inner thigh to access the femoral vein. An incision is made in the vein to implant the bioprosthetic device, and sutures are used to secure it in place and close up the vein and skin.

The physician then uses a Doppler probe or ultrasound to ensure blood in the femoral vein is flowing correctly and that the valve is opening and closing.

The implantation is relatively straightforward but not risk-free, Doresy said. Aside from the usual risks of surgery such as bleeding and infection, there’s a small chance the device could embolize, stop working or develop a clot around it.

A 2020 first-in-human study found no device-related safety problems, and all 11 trial participants reported a significant reduction in pain six months after surgery. In August 2021, the FDA labelled the VenoValve a breakthrough device. This designation helps manufacturers of certain promising medical devices to efficiently navigate the FDA approval process.

“Essentially, we’re placing a functioning valve back into one of the major veins in the leg to help get that blood up and out of the lower extremity,” said Dorsey. “It’s exciting to participate in a trial for a new device with the potential to truly solve the problem, reduce patients’ pain and get them back to an active life. We’re obviously at the beginning stages of understanding the impact of this procedure, but the idea of potentially helping millions of patients is thrilling.”
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Chelsea Dorsey, MD

Chelsea Dorsey, MD, provides comprehensive care for individuals with arterial and venous conditions. Her treatment algorithms involve medical management, minimally invasive interventions and open surgery.

Learn more about Dr. Dorsey

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