ROYAL OAK, Mich., March 15 /PRNewswire/ -- Cardiologists at William Beaumont Hospital, Royal Oak, Mich., today announced they have treated the first U.S. patient in a new clinical trial of a heart valve implanted without open-heart surgery.
On March 10, doctors inserted a new aortic heart valve in a 76-year-old man from Casco, Mich., through a procedure performed in a cardiac catheterization lab without having to open the patient’s chest and stop his heart, as in traditional open-heart valve surgery.
The experimental procedure marks the launch of a research study approved by the Food and Drug Administration in January to assess a breakthrough technology that could save the lives of thousands of people with heart valve disease who have no other treatment options.
“This experimental procedure may offer hope to seriously ill, high-risk patients who are not candidates for traditional open-heart surgery,” says William O’Neill, M.D., Beaumont’s chief of Cardiovascular Disease and principal investigator of the U.S. multi-center trial called REVIVAL. “If proven successful through our research, it could revolutionize the way heart- valve disease is treated for some patients, especially for those who are too sick to have open-heart surgery.”
The procedure, known as percutaneous (or “through the skin”) heart valve replacement, utilizes the Cribier-Edwards aortic heart valve, a technology being developed by Edwards Lifesciences Corporation of Irvine, Calif., that was invented by Alain Cribier, M.D., chief of Cardiology, University Hospital in Rouen, France. Dr. Cribier was present at the March 10 procedure at Beaumont, performed by Dr. O’Neill together with cardiologists Theodore Schreiber, M.D., and George Hanzel, M.D.
During the procedure, the replacement tissue valve is compressed to about the diameter of a pencil in size, then is threaded through a patient’s circulatory system into the heart via a catheter (a thin tube) that has been inserted into the patient’s leg. The valve is positioned within the patient’s existing aortic valve and expanded by a balloon to about the diameter of a quarter. This secures the replacement valve into place and pushes the diseased valve’s leaflets against the aortic wall.
Unlike conventional valve-replacement surgery, the procedure can be performed on a beating heart under local anesthesia in about half the time (two hours vs four to six hours). Recovery time is also reduced from months to weeks and the risk of infection may be reduced.
Participation in the Beaumont phase one randomized research study of the experimental procedure is limited to 20 people with a documented history of heart valve disease who are too sick for open-heart valve surgery. For information on the study, call 248-898-4044.
About 300,000 people worldwide have heart-valve repair or replacement surgery each year. There are many others who are not referred for treatment or who can’t or won’t have surgery.
Non-surgical aortic heart-valve replacement has proven to be feasible through laboratory testing and through clinical trials in Europe. A European patient was the first in the world to undergo the procedure in 2002 and about 40 cases have been performed outside the U.S.
Beaumont is Michigan’s, and one of the nation’s, most experienced providers of heart care, ranking 16th on the U.S. News & World Report list of the “Top 50" hospitals for heart and heart surgery. The Beaumont Heart Center is a comprehensive, state-of-the-art facility that’s dedicated to the prevention, diagnosis and treatment of heart problems. Beaumont’s Ministrelli Women’s Heart Center is the first in Michigan devoted exclusively to the prevention, diagnosis, and research of heart disease in women. Visit Beaumont on the Web at http://www.beaumonthospitals.com/ .
William Beaumont Hospital
CONTACT: Brian Bierley (radio/TV/online),bbierley@beaumonthospitals.com , or Ilene Wolff (print),iwolff@beaumonthospitals.com , of William Beaumont Hospital, +1-248-551-0740
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