Rebecca Hartong was hospitalized for a week last year after undergoing surgery, general anesthesia "and a few thousand other things" to repair a clogged carotid artery, which supplies blood to the head.
When the same artery again began to narrow dangerously this year, leaving her at risk for a deadly stroke, she opted for a new, less invasive procedure in which a flexible steel tube called a stent is used to widen the blockage.
"I didn't want any more invasive surgery," said Mrs. Hartong, 73, a retired nurse from Palmetto. "This sounded pretty good."
Within 72 hours after undergoing the relatively simple procedure at Tampa General Hospital last week, Mrs. Hartong was home with only a small incision to show for her experience. Her neck was free of pain.
Until now, the stent procedure has been done locally on only 12 patients, including Mrs. Hartong, who had complicated medical problems that made surgery too risky. Nationwide, the use of stents to treat carotid artery disease has been controversial.
Doctors have debated whether it is appropriate to use the treatment on patients who could withstand surgery, because research shows that surgery is safe and effective, said Dr. Avery Evans, a neurointerventional radiologist who has been performing the stenting procedure at Tampa General with Dr. Bruce Zweibel.
A study is under way to determine whether stents can repair damaged carotid arteries as well as surgery over time. Tampa General was approved Friday as one of the sites for the national clinical trial in which half the patients who agree to participate will have an operation, and the remainder, selected at random from willing participants, will get a stent. The procedure could be available to patients by the end of the year, said Dr. Erfan Albackery, a Tampa stroke neurologist involved in the study.
"We believe anything safe to prevent stroke, we have to try it," Albackery said. Stroke is one of the leading causes of death in the United States.
Schneider Worldwide, the company sponsoring the research and manufacturer of the stent used in the carotid procedure, is seeking to compile information during the next four to five years to determine how safe the procedure is.
Among the questions researchers hope to answer about the long-term effectiveness of the small mesh tubes: Could the lining of the artery grow through the open sides of the stent and create another clog? Could the bare steel tubing rub against the artery and eventually cause a different type of damage?
Dr. Mike Schollmeyer, Schneider's U.S. medical director, said the only data compiled so far were based on pioneering work by two University of Alabama doctors who used stents in high-risk patients too old or too sick for surgery. There are no data to show how otherwise healthy patients will fare with the stents.
Many people discover carotid artery disease either after they have a stroke or when they have preliminary symptoms: a weakness or numbness on one side of the body that goes away, temporary blindness or darkening vision in one eye, or a facial droop.
Mrs. Hartong passed out last year while giving blood. An ultrasound test showed that a 1-inch section of the carotid artery, just behind her jaw, had narrowed. Her artery was 95 percent blocked, and doctors warned her she was at risk for a stroke, she said.
"They kind of said you could live the rest of your life with it or you could have a stroke tomorrow. I'm not one for waiting to see if I had a stroke," she said.
Mrs. Hartong, who goes to Tampa Jai Alai and roots for her hometown Cleveland Indians, had undergone radiation years ago for cancer, which left the tissue in her neck with a "woody" texture, her doctors said. That made her a poor candidate for surgery.
In the stent procedure, Evans made a small incision on the right side of her groin, then threaded a wire-thin catheter through her arteries until it reached the site of the damaged carotid artery. Mrs. Hartong was sedated, but remained conscious and was able to talk to the doctors during the three-hour procedure.
Once the guiding catheter was in place, Evans and Zweibel opened the artery with angioplasty, by inflating a tiny balloon at the site of the blockage. The third step was threading the closed stent, a collapsed silver cylinder not much thicker than a paper clip, to the artery. Then they deployed the stent, which slowly opened and widened the arterial wall. The doctors monitored the movement of the catheter and the placement of the stent on two large TV screens just above their patient's feet.
The participants in the new study will be examined closely during the next two years with CT scans and ultrasounds, as doctors look to see if the vessels remain open. After that, the patients will be examined every six months until researchers have sufficient data to rate the new procedure.
"The bottom line is, how is this patient going to do in the long run?" Evans said. "We're doing this study because we just don't know which is the best therapy. We may find out that stents are not as good. And that's important information for us to know."
For information about the study at Tampa General Hospital, call 253-4046.
New stroke treatment
Tampa General Hospital is testing an alternative to surgery for the treatment of narrowing carotid arteries. Doctors are inserting a small metal tube, a stent, into the artery to hold it open and keep blood flowing. Here's how the stent works:
1. Narowing of the carotid artery in the neck blocks the blood flow to the brain, which could result in a stroke.
2. To open the blocked artery, a collapsed metal alloy stent is placed in the artery. It's moved to the blockage through a small catheter inserted in the groin.
3. The spring-like metal stent is delivered to the obstructed site and allowed to expand. The catheter is removed, leaving the stent in the artery to keep blood flowing.