Heart Valve Study Yields Positive Results

September 2010

In cooperation with Emory interventional cardiologists Dr. Peter Block and Dr. Vasilis Babaliaros, Dr. Robert Guyton and Dr. Vinod Thourani have been the Local Surgical Co-PIs since 2007 of a multi-center Phase II clinical trial comparing transcatheter aortic valve implantation (TAVI) with traditional, open-heart surgery or medication therapy in high-risk patients with aortic stenosis. The promising findings of the study, published in the September 9, 2010, edition of the New England Journal of Medicine (NEJM), show that patients treated with TAVI 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.

TAVI is a groundbreaking non-surgical method of replacing diseased aortic heart valves in patients suffering from severe aortic stenosis that are too frail or sick to withstand the traditional open-heart surgical approach. The life threatening heart condition affects tens of thousands of Americans each year when the aortic valve tightens or narrows, preventing blood from flowing through normally.

During the 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. Once the catheter is properly positioned in the opening of the aortic valve, the new valve is rapidly expanded. As it expands it pushes the diseased, native valve aside, allowing blood to flow normally through the implanted valve to the rest of the body.

The trial followed 358 patients at 20 hospitals nationwide who received either catheter-delivered valves or standard non-surgical treatment. Emory University Hospital was the only site in Georgia participating in the trial. Collaborating with cardiologists of the Emory Heart & Vascular Center, Dr. Guyton and Dr. Thourani's surgical teams have performed approximately 90 TAVI procedures since the trial began.

Transcatheter aortic valve implantation is not yet approved by the U.S. Food and Drug Administration (FDA) and therefore is only available in a few centers throughout the country, including Emory, the first center in the Southeast and one of the five largest centers in the country. It is anticipated that this valve will receive FDA approval in late 2011.