A procedure that lets doctors replace defective heart valves without major surgery is undergoing a trial at Beaumont Hospital in Royal Oak, Mich.
The procedure, much like angioplasty, avoids the need to cut open the chest. Doctors say it holds hope for hundreds of thousands of Americans too frail for traditional surgery, which involves a large chest incision, stopping of the heart and use of a heart-lung machine.
Each year, about 100,000 Americans undergo traditional heart-valve surgery, but many more are considered unsuitable for it.
In the new procedure, surgeons thread a tiny replacement valve through the femoral vein in the upper thigh.
Fred Grande, 76, of Richmond, Mich., was the first U.S. patient in the Beaumont study. He had the operation Thursday and went home Sunday.
The study first will enroll 30 patients to further test the safety of the procedure. Edwards Lifesciences, the Irvine, Calif., company that developed the procedure, plans to expand the study to 10 sites and 150 patients.
Percutaneous, or through-the-skin, valve replacement is aimed at 300,000 Americans with aortic valve stenosis, a problem that mostly affects the elderley and causes hardening and narrowing of the aortic valve.
When diseased, the aortic valve shrinks, stiffens and develops microcracks, causing the heart to enlarge and become unable to pump blood efficiently. Symptoms include shortness of breath, chest pain and fainting, O'Neill said.
For about 200,000 people who are too frail to undergo the surgery, there are few options other than medication and careful monitoring.
"People who are good candidates for traditional valve-replacement surgery shouldn't even consider this," said William O'Neill, M.D., chief of cardiology at Beaumont.
The new procedure is performed much like angioplasty, but it is much more complicated, he said.
"It's a pretty intricate dance, to get it all orchestrated," O'Neill told the Detroit Free Press.
O'Neill, who has performed 40,000 angioplasty and heart-cauterization procedures, said the operation is "the most complicated procedure I've ever done."
Alain Cribier, M.D., chief of cardiology at University Hospital, Rouen, France, and inventor of the procedure, came to Beaumont to advise the team for Grande's operation.