If you have chronic venous insufficiency (CVI), the valves in your veins – most often in the leg – don’t work properly, causing blood to pool in your legs and putting increased pressure on the walls of the veins . This condition can be caused by valve malfunction, which can be hereditary, or it can be due to the destruction of the valve after deep vein thrombosis (DVT), involving a potentially dangerous blood clot.
More than two million people in the United States suffer from CVI, which can be debilitating with leg pain, swelling, enlarged veins, skin discoloration, and open sores or ulcers on the lower leg .
Miami Heart and Vascular Institute is the only center in Florida – and one of two dozen nationally – to participate in the SAVVE clinical trial, which uses a new device approved by the United States Food and Drug Administration (FDA) – the VenoValve. The artificial valve is surgically implanted in the femoral vein, the large vessel deep in the thigh. SAVVE stands for Surgical Antireflux Venous Valve Endoprosthesis.
The VenoValve, manufactured by the Californian company enVeno Medical, is designed to act as a one-way valve to help restore proper blood flow to the leg – and return enough blood to the heart. The goal of the VenoValve is to resolve the symptoms of severe CVI and return the patient to a more normal and active life. An earlier clinical study of the VenoValve found that 10 out of 11 patients who received the device went from severe symptoms of CVI to mild or no symptoms.
“Our heart pumps blood through the arteries and carries oxygenated blood everywhere, and then the veins’ job is to bring the blood back to the heart,” explains Michele Taubman, MD, vascular surgeon at Miami Heart and Vascular Institute, who is leading the Institute’s contribution to the SAVVE trial. “To do this, the veins have these one-way valves that open and close with each heartbeat and they push blood through our legs, for example, against gravity.”
Dr. Taubman explains how CVI develops over time. “These one-way valves can get a little tired or stretched, either just with age or it’s in our genetics. And it’s more common in heavier people. Also, if you’ve had a history of DVT or from SVT (superficial vein thrombosis), so either a clot in your deep vein or in your superficial vein.If you have a clot sitting there, the valve can’t open and close – it’s just stuck open .
Dr. Taubman hopes to implant the VenoValve in at least 10 patients. Three patients have had the procedure to treat their CVI since April, mostly patients in their 70s and 80s, both men and women.
There is currently no effective treatment to fix the valves in the deep veins of the leg. Doctors may recommend compression stockings or a leg lift to treat leg swelling and pain, but these are temporary measures and do not treat the underlying condition, Dr. Taubman said.
If you or a family member experience leg pain, swelling, skin discoloration, ulcers, or enlarged veins in or on the lower leg, you may be a candidate for the SAVVE trial. Call 786-596-4746 for more information about the lawsuit.