New heart-valve surgery less invasive
URBANA — Robert Wells went nearly nine decades with his heart doing just fine, or so he thought.
Then he had a small heart attack earlier this year, and his doctor found more than just blocked arteries.
It turned out Wells, 90, of Camargo, also had a heart valve disease called aortic stenosis that mostly affects older adults.
When it gets severe — and Wells' aortic stenosis was considered severe — the standard treatment is open heart surgery to replace the valve.
Wells was considered too old to withstand open heart surgery, he says. But he was a candidate for a new, less invasive treatment intended for folks in just his situation.
In November 2011, the Food and Drug Administration approved the TAVR — transcatheter aortic valve replacement — procedure for people with severe aortic stenosis who are too old or sick for open heart surgery.
TAVR uses a catheter inserted into the leg to replace the valve.
The procedure isn't widely available in Illinois yet, but Carle Foundation Hospital began offering it in May, and Wells — who was 89 at the time — was Carle's first TAVR patient.
Dr. Matthew Gibb, a Carle interventional cardiologist, says he placed stents in Wells' two diseased arteries two weeks beforehand, to correct that condition and also reduce the risk for the upcoming TAVR procedure.
A retired pipefitter, Wells says he spent four days in the hospital after his TAVR procedure, with the final day being an extra one to get a pacemaker.
After his TAVR procedure, he says, he wasn't in pain and the shortness of breath he remembers from beforehand was gone. Once he got back home, he was soon out mowing his lawn.
"They said it was like I could get back to doing the biggest part of what I was doing before I had the heart attack," he recalls.
TAVR has been in use in Europe since 2007, and it has been hailed by many as a game changer for inoperable aortic stenosis patients.
Once symptoms such as shortness of breath, fainting, fatigue and chest discomfort start appearing, about half of people who have this condition die within two years without treatment, Gibb says.
"It's one of the surest paths to dying," he says.
Doctors used to have to let the disease run its course. Now, for an older patient who might be given another good-quality five or 10 years, TAVR "becomes a pretty good discussion," Gibb says.
And it could become a discussion for a growing number of people and their doctors as the population ages — especially since Medicare approved TAVR for coverage last year when five conditions are met, among them two cardiac surgeons independently examining and evaluating the patient.
It has been estimated 300,000 people in the U.S. have symptomatic aortic stenosis, and about one-third of them are not open heart surgery candidates because of their age, other health conditions or both.
Gibb, who is also the medical director at Carle's Heart and Vascular Institute and one of five Carle physicians doing the TAVR procedure, says Carle has already done six of these procedures and anticipates doing about 10 a month.
How do people wind up with aortic stenosis in the first place?
Sometimes people were born with a valve abnormality and sometimes it results from childhood rheumatic fever, but the top cause is related to aging, Gibb says. Calcium deposits narrow the valve opening over time, reducing the blood flow. The heart has to keep working harder, and it grows weaker.
Gibb says there is also some age-related degeneration of the valve that results in less flexibility. He describes it to patients as "arthritis of the valve," because it's similar to the age-related degenerative arthritis that can affect joints such as hips and knees, he says.
In the TAVR procedure, a collapsible valve is threaded to the heart through a catheter inserted into the femoral artery in the thigh and guided by X-ray. Once it reaches the diseased valve, it's expanded to stay in place and help the blood flow properly again.
"You're re-creating a circle," Gibb says.
The valve (called the Sapien transcatheter heart valve) is FDA-approved only for patients who aren't eligible for open heart surgery and who have calcium buildup.
But even patients who qualify according to the product label still have to be evaluated carefully for risks and benefits.
Risks associated with TAVR included death, stroke, perforation of the blood vessels, ventricle or valvular structures, damage to the conduction system in the heart, significant bleeding and leaks around the new valve, according to the FDA.
After one year, 69 percent of the Sapien valve patients were alive compared with 50 percent of patents who got an alternate treatment, the FDA says.
Carle evaluates each patient with a team and comes to a decision with the patient and patient's family, Gibb says.
Gibb calls TAVR one of the more studied procedures, and he contends it stacks up well compared with other treatments that improve quality of life for the elderly.
"In my experience, this is the most careful rollout of a new technology I've ever seen, and rightfully so," he says.
Preparing to offer the procedure at Carle took a year, Gibb says. The first five cases were presented to the valve maker, Irvine, Calif.-based Edwards Lifesciences, and the company sent a proctor to be present at Carle's first five TAVR procedures, Gibb says.
Carle considered the procedure important for an elderly population that doesn't want to have to travel for this kind of care and needs follow-up close to home, he says.
Presence Covenant Medical Center isn't planning to invest in the procedure, spokeswoman Crystal Senesac says.
Edwards lists nine TAVR locations in Illinois, with the closest being the Prairie Heart Institute at St. John's Hospital, Springfield, which began offering TAVR procedures in January 2012. Edwards says Carle's Heart and Vascular Institute will be added to the locations list when it has completed more TAVR procedures.
Meanwhile, Gibb says all of Carle's TAVR patients to date — who ranged in age from 81 to 89 — are doing well.
One patient he recalls couldn't climb more than three steps beforehand, and is now out and around, doing shopping and other errands again, he says.
"We've had some dramatic improvements," Gibb says.
Wells' wife, Frances, says she and her husband are now looking forward to celebrating their 67th wedding anniversary in September. Her husband has always enjoyed working out in the yard so much, and he would have been so unhappy being left unable to do that, she says.
"He came back the same old Bob."
More about TAVR:
Medicare coverage summary: http://go.cms.gov/KGhzuh