Karon Owens ended up in a ground-breaking study and might have avoided a stroke—all because two other medical problems inspired her to get a general checkup. Within two months in 2006, Karon, 66, had to have her gallbladder removed, then two lumps removed from her breast, which fortunately turned out to be benign. Even though she felt fine after all that, she decided it was probably a good idea to get an overall physical from her primary care physician near her home outside of Boaz, Alabama. It was.
“A nurse practitioner was examining me, and she was listening to my carotid artery on my left side,” Karon says. “She said, ‘Is this the side that you had the bruit on?’ and I said, ‘What’s a bruit?’ ”
A bruit (pronounced BROO’e) is a distinctive whooshing sound in the carotid artery in the neck that is easily detected with a stethoscope. The carotid artery supplies blood to the head, and a bruit is an indication that there is fatty buildup in the artery, called atherosclerosis, which is a major risk factor for stroke. Carotid artery disease causes about 20 percent of the 700,000 strokes Americans suffer annually.
As is the usual next step, Karon was referred to a neurologist who did an ultrasound of the artery. When the results came back, the nurse practitioner delivered the news again. “She told me, ‘Karon, we need to call the big guns in on this. This is too complicated for us.’”
That’s when Karon was introduced to UAB neurosurgeon Mark R. Harrigan, M.D., and the CREST study. UAB is participating in a nationwide National Institutes of Health study called CREST, which stands for the Carotid Revascularization Endarterectomy versus Stenting Trial. It is comparing two methods to treat carotid artery stenosis (blockages).
Carotid endarterectomy, also referred to as CEA, is the usual treatment for carotid artery disease. It involves surgically removing cholesterol plaque and other debris in open surgery via an incision in the neck and carotid artery.
Carotid stenting is a minimally invasive procedure that involves inserting a tubular device to open the blocked artery. Like more commonly familiar coronary artery stents, a carotid stent is inserted via a small incision in the femoral artery in the groin area.
Carotid stenting is easier on the patient, reduces recovery time dramatically and is less risky than open endarterectomy surgery, Dr. Harrigan says. “But, we still do not know that it has long-term efficacy in lowering the risk of stroke.”
One reason is that because also like coronary stents, carotid stents don’t remove the fatty buildup, but just push it aside.
CREST will provide much-needed research data, Dr. Harrigan says. The study randomly determines which patients get carotid endarterectomy surgery and which get a stent.
Because there haven’t been extensive clinical trials in this country, carotid stenting isn’t FDA approved for the general public except in cases where patients have conditions making open surgery very risky. About a fourth of patients fall into that category, which includes people who have had a prior carotid endarterectomy, have inaccessible lesions, severe heart or lung problems, or the need for both coronary and carotid revascularization.
There is also limited data on how women respond to either procedure. That’s why CREST and volunteers such as Karon Owens are so important, Dr. Harrigan says, and a key reason Karon says she was eager to join the study.
When she signed up for the study, Karon had no idea she would have complications causing her to undergo both procedures about six months apart.
The first time Dr. Harrigan saw her, he determined Karon’s blockage wasn’t severe enough to require surgery. Things had changed dramatically when she came back three months later.
Karon: “The blockage had increased from about 40 to 50 percent to 80 to
99 percent. Dr. Harrigan put me in the CREST study. It’s a randomized study…they decided that I would get the endarterectomy surgery.”
The surgery was performed by UAB neurosurgeon Winfield S. Fisher, M.D., who is a CREST-designated CEA surgeon. A three-month postoperative checkup showed Karon was doing fine. But, once again, things changed quickly. Just a couple of months later, she had symptoms on a trip that she at first attributed to fatigue or age, but were actually indications that her carotid artery was becoming blocked again.
Karon: “I really had not had symptoms from the first time the bruit was found. But, I flew to Colorado for my grandson’s wedding (a few months after the surgery), and on the trip out, I started having trouble with my vision. I started seeing patterns, little purple fan-like patterns. I have eye problems, so I thought, ‘When I get back, I have got to make an appointment with my optometrist.’ Then I noticed my memory wasn’t as quick as it should have been. I couldn’t recall some things immediately. But, I just thought I was forgetting things because I’m getting older.”
Those are two classic signs of arterial blockage that could lead to a stroke, or that a TIA (temporary reduction in blood flow to the brain) is occurring, and no one should dismiss them, Dr. Harrigan says.
Dr. Harrigan: “Look for any spells of numbness or weakness, especially on one side of the body, any trouble speaking, any trouble with your vision, particularly in one eye only. If any of those symptoms occur, it should be a red flag you are having either a stroke or at high risk of having a stroke and should be seen right away. The key symptom is interruption of vision on one side. Mrs. Owens came back with several episodes of left-sided visual changes that we felt were likely to be amaurosis fugax, which is a medical term for interference with vision due to interruption of blood flow to the retina on one side.”
Karon reported those symptoms in her six-month checkup, shortly after they appeared.
Karon: During an ultrasound I noticed that the staff quit talking, they looked serious and started calling out numbers. They said, ‘You are 80 to 99 percent blocked again.’ They sent me straight to the emergency room.”
The blockage was likely caused by scar tissue, rather than cholesterol buildup, because it happened so soon after the surgery, Dr. Harrigan says. He inserted a carotid stent that same day. Patients are awake during the approximately 90-minute procedure, avoiding general anesthesia.
Dr. Harrigan: “That’s a feature of carotid stenting that provides a big advantage over surgery. It’s easier and safer for the patient. You don’t want general anesthesia for carotid stenting. You can have continuous monitoring of the patient’s neurologic status, so, if there’s a problem, you can recognize it and act on it more quickly.”
Karon says she didn’t feel anything but a tiny sensation when the stent opened up. She says she has lots of nervous energy, and Dr. Harrigan even had to tell her to quit talking to him during the procedure because she needed to be still. A checkup about a month later showed no problems.
Dr. Harrigan: “That’s the beauty of carotid stenting; we don’t usually see problems. People usually tell us it’s well tolerated…I can’t remember when someone didn’t say, ‘It wasn’t a big deal.’ They’re usually home the next day. They have to take their aspirin, that’s key, and do dual-antiplatelet treatment (blood thinners) for one month. But, that’s about it. For open surgery, they’re usually in the hospital for several days. For the general public, the typical scenario with carotid stenting is off of work for a week or so after the procedure, if that, because they’re spared the general anesthesia. With endarterectomy, it’s about a solid month.”
Stenting patients can resume other normal activities very soon, too, which for Karon means painting watercolors, building children’s furniture, daily laps on a walking track around her 30-acre farm, harvesting and cooking home-grown vegetables and helping her husband, Tommy, grow hay for horses. She has an upbeat attitude about what she has gone through, but is a bit perplexed why she has had so many problems, considering her healthy lifestyle on the farm.
Karon: “You could call it an idyllic life. It is wonderful. My diet is mostly vegetables that we grow ourselves, and chicken. I eat very little meat. I just don’t understand why this is happening to me. I’ve had no indications whatsoever that this was going on.”
Dr. Harrigan: “That happened despite healthy living and a good lifestyle. She’s a nonsmoker, high functioning, clean-living person. She reminds me of my own mother; they’re the same age, and they’re both healthy-living people, they both are watercolor artists. Mrs. Owens, despite having a healthy lifestyle and making a real effort to control risk factors, developed atherosclerosis anyway.”
She did have some risk factors, though, Dr. Harrigan says.
Dr. Harrigan: “Mrs. Owens has diabetes and hypertension, and those are the two classic medical risk factors for atherosclerosis.”
Karon is still part of CREST and will be tracked and given follow-up treatment for five years, like all participants.
Karon says she had no hesitation about her treatment being randomly chosen when she entered the trial or undergoing emergency stenting later.
Karon: “I felt I was in capable hands. There’s no reason to be nervous or afraid because there’s no purpose to fear. You just get it done; take care of it. And, I felt I was in the right place and with the right doctors for that. To know that maybe, just maybe, I’m helping someone somewhere down the road, that is a good feeling. And I’m getting extremely good care in the meantime. I was so impressed with the hospital and the staff. They were just wonderful. There’s no reason to hang back and worry and let it hang over your head. Just handle it. Fortunately, I found the right people to handle it.”
UAB is still recruiting participants for the CREST study. For more information, please call (205) 996-2536.
To learn more about stroke, go to uabhealth.org/strokeanimation.
Learn about another UAB patient, Nita Collinsworth, who suffered a type of stroke known as a brain aneurysm. Her story unveils the state-of-the-art treatment she received, which led to her miraculous recovery. To find out more, visit uabhealth.org/mystory.