FDA Approves New Procedure For Some Patients With High Stroke Risk
Posted September 16, 2004 6:05 a.m. EDT
RALEIGH, N.C. — Stroke is the third leading cause of death in the United States.
For years, the standard procedure for people with blockages in the carotid arteries in the neck was open surgery.
The Food and Drug Administration just approved a minimally invasive procedure for high-risk patients.
The procedure leaves no scars and gets the patient back to normal much more quickly.
Earlier this summer, 87-year-old Charles Dubose's doctors discovered his two front carotid arteries were 90 percent blocked. He was on the verge of a stroke.
Most people in his condition face surgery that requires cutting into the neck and arteries to clean out the blockage.
A month ago, through a clinical trial at WakeMed's Heart Center, Dr. Ravish Sacher implanted a tiny stent graft.
Surgeons go through the leg and place a catheter in the trouble spot in the carotid artery. An umbrella device opens to catch any particles that might break off and cause a stroke. A balloon expands the blocked area and the stent keeps it open.
Now, with full approval of the procedure by the Food and Drug Administration, Dubose is getting a second stent.
When the job is done the catheter and umbrella come out. The stent is in place and there is good blood flow.
The FDA only approved the procedure for high-risk patients. Dubose is high risk because of his age, high blood pressure and high cholesterol.
"If a patient is not high risk, we don't know, so far, if something is better for them than surgery. That remains to be studied and is going to be the subject of future trials," Sacher said.
A day later, Dubose said he could feel the difference.
"My head feels clearer now and the blood's flowing," he said.
The problems that lead to stroke are the same problems that lead to heart attacks. Some factors be controlled. Keep your cholesterol under 200, do not smoke, watch your weight and get plenty of exercise.