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.