Posts Tagged ‘TAVI’

Emory’s Heart & Vascular Team Make Big Strides in Fight Against Heart Valve Stenosis

Transcatheter Aortic Valve ReplacementEmory physicians recently completed their 200th Transcatheter Aortic Valve Replacement and the United States Food and Drug Administration (FDA) also approved the new transcatheter heart valve, under study at Emory since 2007, to treat severe aortic stenosis.

The device called the SAPIEN valve, developed by Edwards Lifesciences, offers a new non-surgical treatment option for patients with failing aortic valves. Emory University Hospital was one of 23 sites nationwide, and the only one in Georgia, to study transcatheter aortic valve replacement (TAVR) with the SAPIEN valve.

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 major milestone in the treatment of heart disease, the development of this procedure and this FDA approval will allow us to help even more patients with valvular heart disease and could mean the difference between life or death for a countless number of patients who are too sick or weak to undergo open-heart surgery to replace their diseased valves.

My colleague, Peter Block, MD, helped lead the Emory clinical trial, along with surgical colleagues, Robert Guyton, MD and Vinod Thourani, MD.

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Dr. Vasilis Babaliaros Emory Heart & VascularAbout Vasilis Babaliaros, MD
Dr. Babaliaros is an Interventional Cardiologist at the Emory Heart & Vascular Center.  He specializes in structural heart diseases. Dr. Babaliaros traveled to France to learn the new lifesaving approach, training for several years alongside cardiologist Alain Cribier, MD, who successfully implanted the world’s first transcatheter heart valve in 2002.  He is an Assistant Professor of Medicine at Emory University School of Medicine.

Revealing Results from Heart Valve Study at Emory

Glenrose Gay of Vidalia: first Emory heart patient to receive new transcatheter aortic valve procedure. Pictured here with Dr. Peter Block (left) and Dr. Vasilis Babaliaros.

As we’ve mentioned in previous posts, Emory University Hospital has been engaged in a clinical trial for patients suffering from severe aortic stenosis since October of 2007. To review: in aortic stenosis, the aortic valve narrows, restricting blood flow from the heart to the body.

Emory is the first hospital in the Southeast to study the non-surgical treatment known as transcatheter aortic valve implantation (TAVI). This procedure involves the replacement of the narrowed valve with a better-functioning synthetic valve from outside the body. We place a small incision into the groin or chest wall, and then feed a wire mesh valve through a catheter, or tube, placing it where the new valve is needed. The technique is ideal for those who are too ill or too frail to endure open-heart surgery.

Emory is one of approximately 20 nationwide hospitals participating in this study; Phase II of the trial compares TAVI to traditional, open-heart surgery or medication therapy in high-risk patients with aortic stenosis.

Last Wednesday, the initial findings of the study were published in The New England Journal of Medicine (NEJM). Specifically, the trial followed 358 patients who received either catheter-delivered valves or standard non-surgical treatment. The results reflected that patients who had replacement heart valves via catheter were more likely to survive a year following surgery than patients who were treated without the replacement of their original valves. The authors of the study went as far to say that catheter-delivered valves “should be the new standard of care” for patients who are unable to undergo surgery.

Although TAVI has yet to be approved by the FDA, we anticipate that the catheter-implanted valves will receive FDA approval by late 2011.

These results are particularly groundbreaking, as the number of people with failing valves is expected to greatly increase as baby boomers continue to age. Overall, this is a giant step forward in our battle against this common disease.

Do you have questions about the heart valve study, or about aortic valve stenosis? If so, be sure to let me know in the comments section.