If you have chronic venous insufficiency (CVI), valves in your veins – most commonly 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 may be caused by valve dysfunction, which can be hereditary, or it can be due to valve destruction after a deep vein thrombosis (DVT), involving a potentially dangerous blood clot.
More than two million people in the U.S. 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 Cardiac & Vascular Institute is the only center in Florida – and one of about two dozen nationwide — taking part in the SAVVE clinical trial, which is putting to use a new device approved by the U.S. Food and Drug Administration (FDA) — the VenoValve. The artificial valve is surgically implanted into the femoral vein, the large vessel deep in the thigh. SAVVE stands for Surgical Antireflux Venous Valve Endoprosthesis.
The VenoValve, made by California-based enVVeno Medical, is designed to act as a one-way valve to help restore proper blood flow up the leg – and to return sufficient blood back to the heart. The VenoValve’s purpose is to resolve the symptoms of severe CVI and return a patient back to a more normal and active life. A prior clinical study of the VenoValve found that 10 of the 11 patients who received the device improved from severe CVI symptoms to mild or no symptoms at all.
“Our heart pumps blood through the arteries and takes the oxygenated blood everywhere, and then the veins’ job is to bring the blood back to the heart again,” explains Michele Taubman, M.D., vascular surgeon at Miami Cardiac & Vascular Institute, who is leading the Institute’s contribution to the SAVVE trial. “To accomplish that, the veins have these one-way valves that open and close with every heartbeat and they are pushing the blood in our legs, for example, against gravity.”
Dr. Taubman explains how CVI develops over time. “Those one-way valves can get kind of fatigued or stretched out, either just with age or it’s in our genetics. And it’s more prevalent in heavier people. Also, if you’ve had a history of a DVT or an SVT (superficial vein thrombosis), so either a clot in your deep vein or your superficial vein. If you have a clot sitting there, then the valve can’t open and close — it’s just stuck in the open position.”
Dr. Taubman hopes to implant the VenoValve in at least 10 patients. Three patients have undergone the procedure to treat their CVI since April, mostly patients in their 70s and 80s, both men and women.
There are currently no effective treatments to fix the valves in the deep veins of the leg. Doctors may recommend compression stockings or leg elevation to address leg swelling and pain, but they are temporary measures and do not address the underlying condition, said Dr. Taubman.
If you or a family member are experiencing 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 on the trial.