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.

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  • niketa trivedi

    when will this be a reality for mitral valve? and what about people with prothetic mitral valves who may need replacement

    • Dr. Block

      The mitral valve transcatheter replacement technology is still not in clinical trials and likely will not be available even in a trial or at least another 6 months to a year. If a mitral valve replacement is a tissue prosthesis (bovine) then if it fails it might be treated with catheter technology – placing a new valve inside the old one. That technology is available and has been used outside the US. We are hoping to begin that procedure within 6 months.

  • Tom D.

    Dr. Block,

    I have been diagnosed with a congenital birth defect of the aortic valve causing aortic stenosis. I’m in my late 50’s who has had 6 1/2 hours of back surgery earlier this year to repair a broken vertabrae. I am somewhat still rehabbing my legs/back and somewhat dependent on a walker for most ambulation. I’m concerned that if traditional valve replacement surgery is performed I will have a difficult time with rapid recovery if I am restricted from significant use of my arms to get me up and down. Does the transcatheter approach require the same limited arm use restrictions?



    • Hi Tom,

      Thanks for the comment. Congenital aortic stenosis usually is an abnormality of the aortic valve in which only 2 cusps are present rather than 3. These can, through wear and tear, become thickened and stiff over time causing valve stenosis which may need replacement. Unfortunately at the present time all of the transcatheter valve trials exclude people with congenital so-called bicuspid valves. Surgery is presently the option available if needed.
      If surgery is performed restriction of arm use is not a problem. There may be some pain from the chest incision but use of the arms is not restricted after surgery.

    • Dr. Block

      Hi Tom,

      While I can’t speak to your specific situation without seeing you in-person, I can give you some general information that should help out.

      A congenital aortic valve defect probably means that a person was born with a bicuspid aortic valve (2 leaflets instead of three). Such valves are not ideal for transcatheter valve replacement as the opening is more difficult to seal properly with a transcatheter valve. We have had some experience with this and some have gone well, others have had some residual leakage.

      In addition, if a patient has had a long surgery to fix their back and their heart tolerated this well, it is likely the aortic stenosis is not that severe yet and the heart is still well compensated.
      In the future, if a patients valve became more of a problem and developed symptoms of heart failure or chest pain it would be best to re-visit what changes have occurred in the research on transcatheter valves. Newer valves still in trials may be better for such a situation, and advances in design may change the indications.

      I should add, that the surgical valve replacement for a biscupid valve is a great operation and the results have excellent long term outcomes. The recovery time is not as long as it used to be and results are excellent.

      Thank you for your question, I hope this helped!