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Five-year results of groundbreaking aortic valve replacement study announced at ACC

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Jennifer Johnson McEwen
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SAN DIEGO, Calif. – The final results of a promising non-surgical treatment option for aortic stenosis, under study at Emory since 2007, were announced this week in a late-breaking clinical trial presentation at the American College of Cardiology meeting in San Diego.

The original PARTNER 1 (Placement of Aortic Transcatheter Valves) study was the pivotal transcatheter aortic valve replacement (TAVR) trial for the SAPIEN valve, developed by Edwards Lifesciences.

The valve offers a non-surgical treatment option for patients with failing aortic valves. Emory University Hospital was one of more than 20 sites nationwide, and the first in Georgia, to study TAVR with the SAPIEN valve. Emory researchers, Vasilis Babaliaros, MD and Vinod H. Thourani, MD, are Emory co-principal investigators of the PARTNER trial. They also serve as co-directors of Emory's Structural Heart and Valve Center.

According to Thourani, results of the five-year PARTNER study showed that high-risk patients with severe aortic stenosis had similar outcomes at five years in both arms of the PARTNER I trial. He says this is a finding that researchers are considering a "win" for the intervention.

"We know now that in high risk patients with severe aortic stenosis, the transcatheter aortic valve does not differ from the traditional open surgical valve replacement," says Thourani, professor of surgery, division of cardiothoracic surgery, Emory University School of Medicine.

"This is a win for the intervention because we now have long-term data that the function of the new transcatheter valve does not show any deterioration," says Thourani.

Aortic stenosis is a life-threatening heart condition that affects tens of thousands of Americans each year when the aortic valve tightens or narrows, preventing blood from flowing through normally.

During the TAVR procedure, doctors create a small incision in the groin or chest wall and then feed the new valve made of cow heart tissue, 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 not candidates for traditional surgery.

"This is a landmark trial in the treatment of heart disease," says Emory Heart & Vascular Center cardiologist Vasilis Babaliaros, associate professor of medicine (cardiology), Emory University School of Medicine.

"Because of this device we are able to help even more patients with valvular heart disease, including the countless number of patients who are too sick or weak to undergo open-heart surgery to replace their diseased valves."  

During the same late breaking clinical trials session at the ACC meeting, results of the PARTNER Sapien 3 trial in intermediate risk patients were also presented. 

According to Thourani, who was a national co-principal investigator for the Sapien 3 trial, results showed that TAVR can be performed in patients who are less ill, than patients previously studied, with extremely low mortality and complications.

"This is one of the most exciting trials to be performed in the field of aortic valve disease," notes Thourani. 

"As one of the top three enrollers for this trial nationally, our team at Emory eagerly brought this lifesaving procedure to a number of our patients in Georgia and throughout the Southeast."

Thourani, Babaliaros and their Emory colleagues hit a major milestone this month when they performed their 1000th TAVR procedure at Emory University Hospital.

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