In a New York City metro-area first, a 93-year-old Bronx man underwent implantation of a new stent graft at NewYork-Presbyterian Hospital, the only center on the Eastern Seaboard with access to this investigational device. The new stent graft was implanted under an FDA-approved clinical trial protocol.
The stent graft is designed to treat a complex form of abdominal aortic aneurysms in which the weakened, enlarged vessel wall is too close to the arteries leading to the kidneys. These complex aneurysms cannot be safely treated with currently available aortic stent grafts and would otherwise require major surgery. Without treatment, patients with aortic aneurysms are at risk for sudden death.
The unique device, known as a fenestrated endograft, is a tubular, fabric graft with supporting metal stents that features custom-positioned holes (fenestrations) that ensure proper blood flow through the aorta and to the kidneys and nearby organs.
The three-hour procedure was performed under local anesthesia on July 1 at NewYork-Presbyterian Hospital/Columbia University Medical Center as part of an ongoing FDA-sanctioned clinical trial at three national sites (including NewYork-Presbyterian Hospital/Weill Cornell Medical Center). The fenestrated endograft was placed through a small incision in the groin, into the patient's arteries replacing the enlarged blood vessel and allowing for the safe passage of blood to the lower extremities.
Because every patient's anatomy is slightly different, each device, the Zenith Fenestrated AAA Endovascular Graft by Cook Medical, is custom manufactured from a 3-D computer model based on a spiral CT scan of the patient.
Approximately 10 percent of abdominal aortic aneurysm patients have an affected area close to branching arteries for the kidneys, small bowel and liver.
"Until now, stenting these patients with a traditional endograft has been difficult or impossible. Since most of these patients are aged 70 and older, often with medical complications, open surgery is usually not an option. This new stent graft can give these patients a new lease on life," says lead surgeon Dr. James McKinsey, site chief of the Division of Vascular Surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center and associate professor of clinical surgery at Columbia University College of Physicians and Surgeons.
While the fenestrated endograft procedure takes more time and skill than repair of standard aneurysms, "there is not much difference for the patient, who can leave the hospital in a few days and return to normal activities in a week," says Dr. Angeliki Vouyouka, who performed the surgery alongside Dr. McKinsey. She is a vascular surgeon at NewYork-Presbyterian Hospital and assistant professor of surgery at Weill Cornell Medical College.
As with more common varieties of endovascular repair, advantages of the fenestrated endograft are expected to include less pain, fewer complications, reduced hospital stay and quicker recovery compared with open surgery.
Symptoms for abdominal aortic aneurysms may include a pulsing feeling in the abdomen, or unexplained severe pain in their abdomen or lower back.
"Often abdominal aortic aneurysms have no symptoms, so screening is very important," says Dr. McKinsey.
Any person aged 50 and older with a family history of abdominal aortic aneurysm, or anyone aged 65 and older with cardiovascular risk factors, should be screened by a vascular surgeon for the condition. Risk for abdominal aortic aneurysm increases with age, with an estimated 5 percent of men age 60 and older diagnosed with the condition.
NewYork-Presbyterian Hospital at both Columbia University Medical Center and Weill Cornell Medical Center is one of only a few sites in the U.S. that are currently approved to study the fenestrated graft. The device is already approved for general use in Canada, the European Union, Australia and New Zealand.
http://www.med.cornell.edu and http://www.nyp.org