FDA OKs Aneurysm Patches

Thousands of Americans with a time bomb in their abdomens, a weak spot on the body's largest blood vessel like the one that killed actor George C. Scott last week, may choose an easier treatment than grueling surgery.

Until now, patching aneurysms has required slicing open the entire abdomen and moving aside delicate organs to reach the problem. The surgery itself kills up to 10 percent of patients, and even those who do well can require months of recuperation.

On Tuesday, the Food and Drug Administration approved an alternative: Two patches that doctors can use to repair aneurysms through just a small incision in the leg.

In studies of more than 800 patients, the Guidant Corp.'s Ancure and Medtronic Inc.'s AneuRx patches successfully repaired aneurysms more than 90 percent of the time. The procedure cut surgical complications in half and let patients go home from the hospital in just two or three days instead of a week.

Surgeons involved in the studies say the patches could revolutionize care, especially for elderly patients who could not survive open surgery and thus have had no other option.

"It's made a huge difference in terms of patient discomfort and patient acceptance of aneurysm repair," said Dr. Wesley Moore of the University of California, Los Angeles.

But the patches are not risk-free, the FDA warned. Some people particularly women, who often have smaller blood vessels may not be good candidates, and doctors must be specially trained to safely use the complex devices, the agency said.

In addition, Guidant and Medtronic must continue studying the patches to prove they hold up over time like surgical repair does.

The aorta is the largest blood vessel, like a river running from the heart to the groin with tributaries that branch off, carrying blood around the body. An aneurysm is a weak bulge in the aorta's wall.

If the bulge gets big enough, the pressure from blood flowing past it can cause it to burst, which kills 15,000 Americans a year.

Doctors estimate that 1.5 million older Americans have abdominal aortic aneurysms, called "AAAs." But because AAAs often cause no symptoms until they break, only about 200,000 patients are aware of the problem.

The companies began shipping the patches to surgeons immediately. Each device costs around $10,000, and Medtronic estimated the total cost of patch surgery to be $18,000 to $20,000. In contrast, regular AAA surgery costs about $16,000.

But the patches may prove more cost-effective, Medtronic insisted, because no one has yet estimated how much money they could save by preventing the complications and the further treatment those require that often plague receipients of open-abdominal surgery.

The FDA said a surgery team should always be available in case a patient failed the patch procedure and needed immediate open-abdomen surgery.

Also troubling was that some patches leaked. It is unclear how risky that is, but the FDA urged proper follo-up monitoring of patients.