Heart valve transplant through leg quicker and benefits high risk cases

An experimental procedure marks the launch of a research study approved by the Food and Drug Administration in January. The breakthrough technology could save the lives of thousands of people with heart valve disease who have no other treatment options. In a new clinical trial the first U.S. patient has received a heart valve implant without open-heart surgery.

On March 10, cardiologists at William Beaumont Hospital, Royal Oak, Michigan, inserted a new aortic heart valve in a 76-year-old man in 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.

William O'Neill, M.D., Beaumont's chief of Cardiovascular Disease and principal investigator of the U.S. multi-centre trial called REVIVAL, says the experimental procedure could benefit seriously ill, high-risk patients who are not candidates for traditional open-heart surgery. If it proves successful the procedure could revolutionize heart- valve disease treatment for some patients.

The procedure, known as percutaneous (or "through the skin") heart valve replacement, uses an aortic heart valve, invented by Alain Cribier, M.D., chief of Cardiology, University Hospital in Rouen,France, and is a technology being developed by Edwards Lifesciences Corporation of Irvine, Calif. 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.The replacement tissue valve is compressed to the diameter of a pencil in size, and is then threaded through the patient's circulatory system into the heart via a catheter 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 against the aortic wall.The procedure can be done on a beating heart under local anaesthesia in about half the time, two hours, unlike conventional valve-replacement surgery which takes 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.

300,000 people worldwide have heart-valve repair or replacement surgery each year; many others are not referred for treatment. The feasibility of non-surgical aortic heart-valve replacement has been proven through laboratory tests and 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 Heart Centre, Michigan, is one of the U.S.'s most experienced providers of heart care, and ranks high on the U.S. News & World Report list and 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 Centre is the first in Michigan devoted exclusively to the prevention, diagnosis, and research of heart disease in women.

http://www.beaumonthospitals.com