A cutting-edge way of repairing dangerously enlarged blood vessels in the abdomen is better than the traditional treatment, Dutch doctors said on Wednesday, but a U.S. doctor immediately called the finding premature and possibly wrong.
About 11,000 people in the United States die suddenly each year from a ruptured abdominal aortic aneurysm, where the aorta, the body’s largest blood vessel, gradually swells until, like an overstretched balloon, it breaks. Doctors can spot the problem with ultrasound, but they usually don’t look for it because the stretching occurs gradually, without symptoms.
Traditionally, surgeons opened the abdomen to repair the aorta, a procedure known as open repair. Hoping to avoid the complications of major surgery, doctors have been experimenting with a less-invasive technique known as endovascular repair.
In endovascular repair, small holes are cut in the groin so a device made of fabric and metal, known as an endograft, can be threaded into the aorta. Once at the weakened area, the device is expanded to provide an artificial lining for the aorta, taking the pressure off the already weakened artery walls.
A study of 345 patients at 28 medical centers in the Netherlands and Belgium found that those who received traditional surgery were twice as likely to die or have severe complications from the operation compared to people who got the endograft.
The study appears in Thursday’s edition of The New England Journal of Medicine.
“Endovascular repair is preferable to open repair over the first 30 days after the procedure,” concluded the team, led by Monique Prinssen of the University Medical Center in Utrecht in the Netherlands.
But in an editorial also published in the Journal, Frank Lederle, of the Veterans Affairs Medical Center in Minneapolis, said doctors should not accept the conclusion that endografts are better because the study did not look at long-term complications and other issues.
Lederle said other research has shown that one in 33 endografts fail each year, which is 10 times the failure rate in traditional surgery.
He also said data from the Cleveland Clinic show that “long-term results after endovascular repair appear to be much worse for larger aneurysms, the ones most in need of repair.”
And not only do patients who get the grafts need a CT scan each year, but the treatments are more costly, he said.
“Numerous studies have found endovascular repair to be more expensive than open repair, primarily because of the high price of the grafts (about $13,000 per patient),” Lederle said.
He said a report by the Food and Drug Administration, later withdrawn after objections from the maker of one type of endograft, concluded that the death rate with endovascular repair will probably be higher than with open repair, once everything is taken into consideration.
Revision date: June 21, 2011
Last revised: by Jorge P. Ribeiro, MD