Newswise — In a two-hour procedure at the University of Virginia Health System, a 72-year-old retired mail carrier from Etowah, North Carolina became the first person in the United States to be implanted with a new, high-tech graft just approved by the U. S. Food and Drug Administration to treat potentially-deadly aneurysms in the thoracic aorta without open surgery.
The patient, Malcolm Langston, is recovering well and his aneurysm is no longer life- threatening, according to U.Va. doctors. Langston's aneurysm, a bulge in his aorta about the size of a small peach, was discovered during a CT scan of his chest three weeks ago after he went to his local doctor complaining of a chest cold. "I never felt any pain from the aneurysm at all," Langston said. "I am so thankful to not have to worry about it any more." Called the TAG Thoracic Endoprosthesis and manufactured by the medical products division of W.L. Gore & Associates, Inc., the device implanted at U.Va. is made up of a tiny tubular graft made of a Teflon-like material enclosed in a special wire mesh 'corset.' A team of a dozen U.Va. doctors and nurses were involved in Langston's case. The team was led by Dr. Michael Dake, professor and chairman of the department of radiology at U. Va., along with U. Va. cardiothoracic surgeon Dr. Benjamin Peeler and U. Va. radiologists Dr. Alan Matsumoto and Dr. Daniel Leung. "A large number of interested U.S. physicians and patients have eagerly awaited the approval and release of the TAG device," Dake said. "Today marks the beginning of a new era of less invasive repair of thoracic aortic aneurysm, which will provide a safer alternative to traditional surgery in some patients. Ultimately, the use of this technology may be expanded to manage a variety of challenging aortic diseases with less risk, offering new hope for improved results over current treatment of these aneurysms." Dake is one of the innovators of the TAG device. The aorta is the body's largest artery, responsible for carrying blood from the heart to the vital organs and limbs. Thoracic aortic aneurysms (TAA) occur when the aorta weakens and bulges out like a balloon. The disease affects about 15,000 people in the U.S. every year and can lead to shock, bleeding and sudden death without quick treatment. The actor John Ritter died of a ruptured aorta in 2003 at age 54.
To implant the device, surgeons first make an incision in the patient's groin. Radiologists then insert the Gore TAG device through an artery to the diseased aorta using a catheter. Once it reaches the site of the aneurysm, the 'corset' is unfurled, leaving the graft in place inside the aorta to cover the aneurysm bulge. Blood can then flow normally and the risk of rupture is lowered. Clinical data from a trial by W. L. Gore demonstrated that, after one month, a group of aneurysm patients implanted with the TAG device had one-third the mortality rate, less than one-fourth the rate of paraplegia and fewer strokes than a control group. There were also no aneurysm ruptures of the TAG device after two years, according to Gore. Blood loss from a procedure was also eighty percent less in endovascular surgery when compared to open surgery, according to Gore, and patients got out of the hospital faster. Stays in the intensive care unit were cut to one day from three days. Hospital stays were shortened to three days from ten days.
Malcolm Langston is expected to be ready to return home in a few days and he has already invited his U.Va. caregivers to the mountains of North Carolina for a visit. "The nurses in this hospital are the best I've ever met in my life," he said.
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