New Aneurysm Device Put to Use

A new stent used to treat aneurysms is now being put to use nationwide. The stent was approved by the Food and Drug Administration in March 2005, and the University of Pennsylvania has just started FDA-required training for surgeons nationwide on how to use the device. The University of Pennsylvania will be one of seven training centers for the stent.

The GORE TAG Thoracic Endoprosthesis is a flexible tube that comes in a range of lengths and diameters and is used to treat aneurysms in the chest. The device is manufactured by W.L. Gore and Associates, Incorporated, the same company that makes Gore-Tex products. This stent is the first FDA-approved grafting system for treating aneurysms of the descending thoracic aorta, the large artery in the chest that connects the heart with all of the blood vessels in the abdomen, pelvis, and lower extremities.

An aneurysm is a diseased, weakened, and bulging section of an artery wall. Thoracic aortic aneurysms are diagnosed in about 15,000 people annually. Thoracic aortic aneurysms are the result of several different factors, including aging, smoking, high blood pressure, high cholesterol, infection, and genetic disorders such as Marfan syndrome. Three out of four people with thoracic aortic aneurysms are asymptomatic and are diagnosed when they are being tested or treated for other health conditions. A ruptured aortic aneurysm has a very high death rate due to massive internal bleeding.

Traditional aneurysm surgery is high-risk and requires a 12-inch incision in the chest and removal of the diseased portion of the aorta while the patient is kept alive on a heart-lung machine.

To implant the new stent device, the surgeon makes a 2 to 3 inch incision in the abdomen or groin, introduces a catheter with the compressed stent into an artery, and guides it to the diseased part of the aorta. The stent is then opened and expands to the width of the aorta, creating a new aortic lining and sealing off blood flow into the aneurysm.

Compared with traditional surgery, the stent had 66% fewer aneurysm-related deaths and less blood loss (472 mL vs 2402 mL). Using the stent resulted a faster recovery and a shorter hospital stay: 3 days with the use of the stent versus 10 days for traditional surgery. The new stent offers a particular advantage for elderly or very sick patients who might not be able to tolerate the stress of traditional surgery.

At this time, it is unclear how long the stents will last. The stents have been used in clinical trials since 1999, and the stents have held up for patients who have had them inserted in the last three to four years. W.L. Gore and Associates has stated that they have not had any aneurysm ruptures through two years of use.


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