Clinical Trial of Thoracic Stent Graft Begins at Memorial Regional Hospital
New Grafting Procedure Expected to Reduce Complications
June 2001 — Beginning this month, two doctors at Memorial Regional Hospital will participate in a nationwide clinical trial for a minimally invasive procedure to repair dissections and aneurysms of the descending thoracic aorta.
Using live X-ray images, Drs. Michael Cohn and David Feldbaum will be able to manipulate a small device through the femoral artery until it reaches the site of the aorta that needs repair. This device, called a stent graft, reinforces the vulnerable area of the aorta to prevent a fatal rupture.
Because this procedure requires only two small incisions in the patient's upper legs, it is expected to result in fewer complications than the conventional method of surgery, in which a new prosthetic aortic graft is sewn into place via a major incision in the patient's chest.
For patients with severe heart disease, kidney disease, or other conditions that would make them poor candidates for conventional surgery, the experimental technique offers new hope.
"This method of repair is performed under regional or local anesthesia and involves very little blood loss," says Dr. Feldbaum. "Most patients will need only one or two days to recuperate in the hospital."
Previous Results Show Promise
Memorial Regional Hospital is one of only two sites in Florida chosen to participate in the clinical trial for this procedure, which has already shown promise in a smaller-scale trial.
Dr. Cohn took part in that trial when he was at the Hospital of the University of Pennsylvania and is optimistic that the expanded clinical testing will prove just as successful.
"At Pennsylvania, we performed the procedure on about 20 patients, and it was very effective," he says. "It did not have the risks that are inherent to conventional surgery."
Dr. Feldbaum, who performed the procedure on about 35 people at Carolina Heart Institute, agrees. "A minimally invasive approach is less stressful for the patient and causes less blood loss. Unlike conventional open surgery, it allows the patient to return to an active lifestyle very quickly."
Early Intervention is Crucial
Aortic dissections and aneurysms are damaged areas of the aorta, a major blood vessel. The damage is usually the result of atherosclerosis (clogged arteries), but other factors include high blood pressure, diabetes, syphilis, smoking, or physical trauma.
Left untreated, dissections and aneurysms can be fatal, which is why early intervention is crucial.
Ten to 20 percent of patients who have an aortic dissection or aneurysm in the thoracic (chest) area also have an aneurysm in the part of the aorta that extends into the abdomen. These abdominal aortic aneurysms (AAA) can be treated through conventional open surgery, but more and more doctors are learning to perform a minimally invasive endovascular repair technique that uses an aortic stent graft. This FDA-approved procedure is performed through the femoral artery in the patient's leg and is remarkably similar to the thoracic stent graft procedure now being tested.
Doctors Cohn and Feldbaum have been performing the minimally invasive technique for AAA repair at Memorial Regional Hospital since March of last year and have successfully treated well over a hundred people.
"Many of our cases are high-risk patients who are referred to us by other vascular centers here and abroad," says Dr. Feldbaum, who travels the country to train other physicians in the new technique.