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New clinical trial under way for thoracic aortic aneurysms may be less painful and speed recovery ti

Houston, TX - 10/13/2003

A clinical trial is under way at The Methodist Hospital to study the use of stent grafts to treat thoracic aortic aneurysms, now treated surgically with a large 24-inch incision across the chest and abdomen.

A thoracic aortic aneurysm (TAA) is a life-threatening condition that develops in the chest portion of the aorta, which is the main blood vessel of the heart. When that area weakens, it allows the pressure within the artery to push outward, creating a bulge that could rupture. As many as 78 percent of untreated patients with a TAA dies within five years, usually from a rupture.  TAAs are much less common than abdominal aortic aneurysms, but are being diagnosed much more frequently than in the past.

“Treating patients is essential, but many physicians are reluctant because the surgery is significant, and can lead to many complications,” said Dr. Alan Lumsden, of the Methodist DeBakey Heart Center and principal investigator.  “If the newly-designed stent grafts are proven effective in treating these aneurysms, it would spare patients from a highly-invasive surgical procedure that has considerable risks.”

Stent grafts are inserted into the aneurysm via the arteries in the groin similar to the technique of coronary angioplasty and stenting.

The new method can reduce the need for blood transfusions, reduce procedure-related complications, reduce mortality rates and speed recovery times, Lumsden said. The stent devices are made of Dacron, and are stronger and more flexible than those previously studied.

Because the force of blood is stronger in the chest, a stronger stent is required. Lumsden expects that if the clinical trials prove successful, it will lead to speedy Food and Drug Administration approval because of the need for an alternative to surgery for this treatment. This trial is conducted jointly with the Veteran’s Administration Medical Center.

The stent procedure takes place in an operating room or endovascular suite, taking from one to four hours, far less time than the open surgery. The Methodist Hospital recently opened an imaging operating suite specifically designed for these advanced catheter-based procedures.

After the patient is sedated, a small incision is made in the groin area and a sheath is inserted to deploy the stent graft into the aneurysm, creating a seal above and below the aneurysm. The graft then provides a new pathway, or tube, for the blood, reducing the pressure on the aneurysm walls.

“If this less invasive procedure ultimately gets approved by the FDA, it could be a life-saving alternative for many high risk patients facing a long recovery from surgery,” Lumsden said.

Symptoms of a TAA are not always present, but they can cause chest or back pain, shortness of breath, hoarseness, and difficulty swallowing. Rupture of an aneurysm can cause loss of consciousness, shock and death.