Repairing a life-threatening bulge in a major stomach artery by threading a patch up from the groin appears to sharply cut the short-term risk of death and complications, compared with traditional surgery, Dutch researchers found.
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It is the second study in a month to suggest the newer technique is an improvement over cutting open the patient’s abdomen.
About 40,000 Americans a year have a bulging weak spot, or aneurysm, in their abdominal aorta repaired, a number sure to grow given the aging U.S. population.
The Dutch study found the less-invasive procedure reduced the risk of death within 30 days by three-fourths. A larger British study found the technique cut short-term death rates by two-thirds.
“This is a very encouraging study,” former American Heart Association president Dr. Sidney C. Smith said of the latest research. “A growing body of evidence suggests that this procedure can be performed safely, with a trend toward lower complications and mortality.”
Still, experts said patients getting either procedure must be watched for problems for several years to see which is safer in the long term.
“This is only half of the answer everybody is looking for: Is the new procedure better?” said lead researcher Dr. Jan Blankensteijn, chief of vascular surgery at Radboud University Nijmegen Medical Centre in the Netherlands.
The study was reported in Thursday’s New England Journal of Medicine.
Blankensteijn said he suspects continuing follow-up of his team’s patients and other studies now under way will rate the procedures as equal because the new one appears to result in more long-term problems, such as the patch tearing or slipping out of place. That makes it preferable for patients in their mid-70s and older who are likely to live only a few more years, he said.
“They’re more frail, so they’re much more likely to be hurt by the open repair,” he said.
The abdominal aorta distributes blood to the lower body. In about 6 percent of men and 2 percent of women over 65, the aorta wall weakens, causing a bulge. Sudden rupture kills about 80 percent of patients, so surgeons repair it if possible.
Traditional surgery vs. newer approach
In traditional surgery, the stomach is cut open and a polyester patch is sewn over the aneurysm inside the aorta.
In the new technique, tiny incisions are made at the groin and a device called an endograft — a polyester patch with a tiny metal scaffold called a stent inside — is threaded into place with the use of a thin tube. The patch is unfolded and the stent inflated to hold it open.
Blankensteijn estimated nearly 50 percent of U.S. aneurysm repairs are done this way.
Endografts were approved for U.S. use in 1999. Some early versions caused complications; one made by Guidant Corp. was pulled from the market in 2003 after the company admitted covering up problems that may have led to deaths.
Donna-Bea Tillman, director of the Food and Drug Administration’s Office of Device Evaluation, said there are no signs of safety problems with the three devices now on the market.
In the Dutch study of 345 patients, two people who received endografts died, compared with eight who had conventional surgery.
On average, the endograft patients lost less than one-fourth as much blood, spent one-fourth as long in intensive care and went home in a week instead of two. The endograft patients were less than half as likely to have moderate or severe heart or lung problems, but twice as likely to have the graft leak or become blocked.
“I would expect that when we do get longer-term data on endografts, it’s going to be good,” said Dr. Kenneth Ouriel, chairman of surgery at the Cleveland Clinic.
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