Norfolk, Va.- August 18, 2004 — In an important step toward establishing minimally invasive treatment options for patients with life-threatening aneurysms or trauma involving the thoracic (chest) aorta, surgeons at Sentara Norfolk General Hospital will perform the first thoracic endograft procedure today as part of an FDA-approved clinical trial. The purpose of the trial is to evaluate the performance of a new stent graft system manufactured by Medtronic, Inc., trial sponsor.
The "VALOR" Trial is being conducted at 35 clinical sites in the United States and will involve approximately 500 patients. Sentara Norfolk General Hospital is the only site in Hampton Roads selected to participate and one of two sites in the state.
"This is an extremely important trial because it will allow us to explore the safety and effectiveness of a stent graft device that could potentially save thousands of patients with thoracic aortic aneurysms who die each year because of rupture," said Gordon Stokes, M.D., Sentara vascular surgeon.
It is estimated that about 21,000 people are diagnosed annually in the U.S. with thoracic aortic aneurysms. Most patients are older and often have other serious conditions such as heart disease, lung problems, high blood pressure and diabetes, making it difficult for them to survive an open chest operation — the traditional treatment of choice.
In an open chest operation, the thoracic aortic aneurysm is repaired by cutting open the aneurysm and replacing it with a synthetic vessel tube. Open operations can traditionally lead to more complications especially in older, frail patients.
Some patients are deemed ineligible for open surgical repair because of their weakened state. Without an endovascular approach, medical management or "watchful waiting" is used as a treatment option and can lead to increased mortality and morbidity in these patients.
Through participation in the VALOR Trial, Sentara can now offer a new treatment option where a catheter is used to place a stent graft inside the thoracic aorta. Once the stent is in place, it is expanded to fit within the diameter of the aorta, relieving pressure on the aneurysm and essentially eliminating the chance of rupture. Both a vascular surgeon and a cardiac surgeon are involved in the procedure.
"The stenting procedure is less risky than open surgery and more aggressive than watchful waiting, " said Robert Hagberg, M.D., cardiac surgeon. "Since the procedure is minimally invasive, it only requires a small incision to accommodate entry of the stent instead of an open chest incision.
"As a result, length of stay in the hospital and recovery time at home are greatly reduced with less pain for the patient," according to Marc Glickman, M.D., vascular surgeon and principal investigator for the Valor Trial.
The new procedure has a number of benefits for the patient. Patients who undergo the two-hour-long thoracic stent graft procedure are hospitalized for one-to-three days compared to two-to-three weeks with the standard open chest operation, which takes five hours to complete. Stent graft patients can typically resume their normal activities within a week following the procedure, in contrast to the two or three months of recovery time required for those undergoing the traditional operation.
Aneurysms can occur at any age, although they are more common in people who smoke, have family histories of aneurysms and among people over age 60. High blood pressure and emphysema are also risk factors. The aorta is the body’s largest artery and other major arteries branch from it, transporting newly oxygenated blood to organs throughout the body. Aneurysms can be signaled by chest or back pain.