FDA Approves Device for Treatment of Thoracic Aortic Aneurysms
By Randolph L. Geary, M.D., FACS, Professor, Vascular Surgery

from Clinical Update, Fall 2005

Abstract: Vascular surgeons at Wake Forest University Baptist Medical Center are the first in the Triad to offer a minimally invasive treatment for thoracic aortic aneurysms—a condition that can be fatal if not treated. The new treatment, a tube that is threaded from an artery in the leg to the aneurysm within the chest to reinforce the vessel, is an alternative to traditional surgery.

Aneurysmal dilation of the thoracic aorta can lead to life-threatening complications, the most dreaded being rupture that is commonly fatal. The risk of rupture increases with increasing aneurysm diameter and with other factors such as uncontrolled hypertension, rapid growth and symptoms of pain. Treatment of thoracic aortic aneurysms has traditionally been medical for small aneurysms and in patients unfit for surgery, or an open surgical repair that requires a thoracotomy, with associated risks and prolonged post-operative recovery in many of these generally older patients.

Recently, aortic stent-grafts or “endografts” have been developed for treating the much more common aneurysms of the abdominal aorta. These grafts can be inserted into an aneurysm from the femoral artery, requiring a small incision in the groin in contrast to the large open operation required to replace the aneurysmal artery directly. Endografts have revolutionized the treatment of abdominal aortic aneurysms, reducing the post-operative stay to about one day with minimal recovery time following surgery. This technology has since been adapted to the treatment of thoracic aortic aneurysms and initial studies have demonstrated remarkable results. The Food and Drug Administration (FDA) has recently reviewed these new studies and granted approval for the first such device, the GORE TAG^® thoracic stent graft.

Wake Forest University Baptist Medical Center vascular surgeons have been using these devices since 1999 to treat abdominal aortic aneurysms with well over 100 implants to date and excellent results. Given their favorable experience with abdominal aortic endografts, Medical Center vascular surgeons are now the first in the Piedmont Triad region of North Carolina to offer the new GORE TAG device to patients with aneurysms of the descending thoracic aorta.

This is a significant breakthrough for a very difficult problem. Open surgery, the gold standard, is tough on healthy patients and many cannot tolerate the stress of surgery because of other medical problems. The most feared complication of open repair is paraplegia, particularly in patients with extensive aneurysms. The new GORE TAG device is inserted through a small incision in the groin or lower abdomen, and most patients are awake during the procedure under regional anesthesia. Patients are observed in the hospital for three to four days afterwards but are up walking the next day. This is remarkable compared to the difficult recovery after open repair, and studies done for FDA approval showed fewer deaths and complications.