WEDNESDAY, Oct. 13, 2004 (HealthDayNews) -- An operation using only tiny incisions to repair a potentially fatal weakness of the major heart artery had a lower short-term death rate than conventional surgery in a European trial -- but the longer-term benefits of the procedure still are not clear, physicians say.
The trial included 345 patients with abdominal aortic aneurysms, a bulge in the body's largest heart vessel that can be caused by injury, infection or congenital conditions. About 200,000 new cases are diagnosed in the United States each year, with an estimated 15,000 deaths occurring when the blood vessel bursts. It is the third leading cause of death in men over 60.
In the study, 171 patients had conventional surgery, with the weak spot being patched through a large abdominal incision. Another 174 patients underwent a procedure called endovascular repair, in which the weak spot is strengthened by a patch or tube threaded upward from small incisions in the groin.
Eight of the patients who had conventional surgery died in the following month, a mortality rate of 4.6 percent, said a report in the Oct. 13 issue of the New England Journal of Medicine. Only two of those who had endovascular repair died, a mortality rate of 1.2 percent.
So far, so good, said study author Dr. Jan D. Blankensteijn, a professor of vascular surgery at the Radboud University Hospital in the Netherlands. But the story is far from over, he added.
"We have answered the obligatory first part of the question, whether the results are better at the 30-day mark," Blankensteijn said. "If it weren't, then the entire business would be over. But it is still necessary before a widespread change of practice be advised to evaluate the long-term results."
Endovascular repair gets patients out of the hospital faster and shortens their recovery period. But two European registries have reported a higher long-term failure rate for those patients -- 3 percent a year, 10 times higher than the failure rate for conventional surgery.
Blankensteijn said the patients in the newly reported study will be followed for several years to determine if endovascular repair holds up as well as conventional surgery. For people with abdominal aneurysms and their surgeons, he advised that the decision on which procedure should be done must be based on a cold-blooded assessment of each patient, considering variables such as age and other medical conditions.
"If you are a patient with not a very long term of life ahead -- a 70-year-old male with cardiac problems with a probable survival time of three to five years -- endovascular repair is the sensible choice," he said. "Who cares about failure five or six years from now if you have only three years to live?
"But a 60-year-old, relatively healthy man should be seriously concerned about the durability of the graft. For him, there would be a strong argument for conventional repair," he added.
Dr. Kenneth Ouriel, chairman of surgery at the Cleveland Clinic, has a differing outlook. The European results, however promising they look to the untrained eye, do not clinch the case for short-term safety of endovascular rescue because the number of patients was too small to produce definitive statistics, Ouriel said. For example, while the mortality rate reported for endovascular patients was 1.2 percent, a statistical analysis showed that it would be as low as 0.1 percent or as high as 4.2 percent for a larger group of patients, he said.
"We're about 90 percent sure, not 95 percent sure, which is the threshold we want," Ouriel said.
Nevertheless, Ouriel said, "this is definitely something people should consider." He quickly added qualifications, however. "You have to think twice about it. Lots of patients don't think in terms of the long term. We have to wait for the results two, three, five years out."
A strategy of watchful waiting until the picture becomes clearer is recommended for many people, especially those with smaller, less-dangerous aneurysms, said Dr. Frank A. Lederle, professor of medicine at the Veterans Affairs Medical Center in Minneapolis, who wrote an accompanying editorial.
"Now is a very good time to wait," Lederle said. "The technology is improving rapidly and the surgeons are gaining expertise in doing it. The data will be coming out quickly in the next few years. If you can wait a few years, it is probably the smart thing to do."
Ouriel's decision on endovascular repair is based on a patient's individual profile, with age only one factor. Ouriel performed endovascular rescue on Bob Dole, the former U.S. Senator and 1996 Republican presidential candidate, in 2001, when Dole was 77 years old.
"He's doing very well now," Ouriel said.
More information
The causes, symptoms and treatment of abdominal aneurysm can be found at MedlinePlus.