UMMC as Magnet Center
When the 92-year-old patient came to University of Maryland Medical Center, simple activities such as eating and brushing his teeth caused him to lose his breath. His was a classic case of aortic stenosis, in which his diseased aortic valve made normal blood flow to the rest of the body impossible. Once such symptoms — which may also include chest pain, fainting and dizziness — appear, half of patients die within two years. Despite his advanced age, he was exactly the type of patient the University of Maryland Heart Center is focusing on to benefit from a newer, less invasive approach to replace aortic valves without the rigors of open chest surgery.
The University of Maryland Medical Center is one of only a few centers in the region to offer two types of transcatheter aortic valve replacement (TAVR), which uses a catheter delivery system to pass a replacement valve — supported in a metal mesh frame and mounted on a delivery balloon — through a small incision in the femoral artery to the site of the diseased valve. There, the bovine valve is deployed and is immediately functional. Approved by the U.S. Food and Drug Administration in 2011, TAVR was shown the year before in a randomized study published in The New England Journal of Medicine (May 2012) to decrease the death risk from any cause by 20% for high-risk, nonsurgical patients compared with standard therapies a year after the procedure.
“Our 92-year-old patient was using oxygen at home and was profoundly short of breath,” says Anuj Gupta, M.D., assistant professor of medicine at University of Maryland School of Medicine. “Now he’s off oxygen completely and is walking around. He feels tremendously better and is now able to live back home with his wife. Everything went better than we could have asked for.”
The only center in Maryland in trial
TAVR is the newest approach by the Heart Center to treat patients with aortic valve disease. UMMC offers a wider array of options than any other system in the state including: traditional, open-chest aortic valve replacement; minimally invasive aortic valve replacement; aortic valve bypass or balloon aortic valvuloplasty to increase the size of the valve; and commercial and investigational TAVR options. Patients previously deemed inoperable because of other health conditions such as emphysema or diabetes may be eligible for the first of UMMC’s transcatheter valve options, a commercially approved version targeted at those for whom open surgery is too risky. Moderate- to high-risk patients are evaluated for participation in the Partner II Clinical Trial — the second option. “We are testing the safety and effectiveness of a new smaller delivery system and lower profile valve,” says principal investigator Bartley P. Griffith, M.D., professor of surgery at the University of Maryland School of Medicine. He adds, “At the University of Maryland, we are constantly seeking more minimally invasive techniques that can bring treatment to patients who otherwise might have limited options.” These patients will be screened for randomization to either traditional aortic valve replacement or the new transcatheter valve.
“The main advantage of TAVR is that it’s obviously minimally invasive and people recover a lot sooner,” says Teng C. Lee, M.D., assistant professor of surgery. “Most patients are back to their normal activities sooner, and those on oxygen are on less as well. We’ve seen a remarkable recovery — they come back to the clinic and you can’t tell they had an operation.”
Major risks averted at UMMC
TAVR improves lives, but it comes with its own significant risks. While patients are more likely to survive one year after surgery, the 2010 NEJM study also found that they had a somewhat higher incidence of strokes and other major vascular complications compared with open surgery. The problem, Dr. Lee explains, is that manipulating the aortic valve area during transcatheter surgery could loosen debris from arterial walls that can travel to the brain, causing ischemic strokes. “This is its one major disadvantage,” he adds. In fact, in late spring 2012, an FDA Advisory Panel unanimously voted in favor of recommending approval of this newest transcatheter heart valve for the treatment of high-risk patients with severe, symptomatic aortic stenosis, stating its benefits far outweigh the risks for this set of patients.
UMMC patients benefiting from the procedure have so far avoided major vascular complications, with none of the seven undergoing TAVR suffering a neurological event. This fortunate outcome may be attributed to patient selection, Dr. Gupta says.
“Physicians should consider referring patients to us,” Dr. Gupta says. “Anyone with severe aortic stenosis should be evaluated, because we have a potential treatment option for every patient.” Patients referred to the Heart Valve Clinic are evaluated by a multidisciplinary team and offered the best possible option for treatment of their heart condition.
This page was last updated: November 7, 2013