Since October 2007, Emory University Hospital has been one of approximately 20 hospitals nationwide, and the only site in Georgia, studying a new non-surgical treatment option for patients with failing aortic valves. The life threatening heart condition,aortic stenosis, affects tens of thousands of Americans each year when the aortic valve tightens or narrows, preventing blood from flowing through normally.
As part of the Phase II clinical trial, researchers have been performing transcatheter aortic valve implantation (TAVI) comparing this procedure with traditional, open-heart surgery or medical therapy in high-risk patients with aortic stenosis.
During the TAVI procedure, doctors create a small incision in the groin or chest wall and then feed the new valve, mounted on a wire mesh on a catheter, and place it where the new valve is needed. This offers a non-invasive way for doctors to treat patients who are too ill or frail to endure the traditional open-heart surgical approach.
The study, published Wednesday in The New England Journal of Medicine (NEJM) followed 358 patients who received either catheter-delivered valves or standard non-surgical treatment.
The findings showed that patients who had replacement heart valves delivered by catheter were more likely to survive a year than patients who were treated without replacing their original valves. According to the authors, catheter-delivered valves “should be the new standard of care” for patients who are not able to undergo surgery.
“These results show great promise for patients with severe aortic stenosis and help us make a giant step forward in our battle against this common disease,” says Peter Block, MD, professor of medicine, Emory School of Medicine and principal investigator of the study at Emory. “They are especially important since the number of people with failing valves is expected to greatly increase as baby boomers continue to age.â€
Aortic valve stenosis often occurs with age, most commonly among elderly patients over 70 years of age, but can surface earlier in life in those with rheumatic heart disease or congenital abnormalities of the valve.
Approximately 90 patients have received new valves at Emory since the clinical trial started in 2007. Researchers hope to receive FDA approval in late 2011.