ATLANTA – Many Americans with leaky heart valves soon might be able to get them fixed without open-heart surgery. A study showed that a tiny clip implanted through an artery was safer and nearly as effective as surgery, doctors reported Sunday.
The device is already on sale in Europe, and its maker, Abbott Laboratories, hopes to win approval to sell it in the United States next year.
About 8 million people in the U.S. and Europe have leaky mitral valves – the valve between the heart’s left upper and lower chambers. The worst cases can lead to heart failure.
In the study, six times more people who had surgery suffered complications during the next month than those who got Abbott’s MitraClip. Deaths, strokes and blood transfusions were less common with the device. The clip was not dramatically less effective than surgery after one year.
Doctors called the study the first big test of repairing or replacing heart valves through arteries rather than drastic surgery.
The MitraClip is only for the mitral valve. Other devices for other heart valves are in late-stage testing, and many doctors believe they will transform how these conditions are treated.
“We have opened the door for a new therapeutic option for patients,” said Dr. Ted Feldman of NorthShore University Health System in Evanston, Ill.
He led the new study and gave results Sunday at an American College of Cardiology conference. The study was sponsored by Evalve Inc., which developed the device. Evalve was sold last year to North Chicago, Ill.-based Abbott, and Feldman consults for the firm.
Some surgeons were not convinced the device is close to surgery’s effectiveness and said patients need to be studied longer.
“It’s a partial victory for the device,” Dr. James McClurken, a surgeon at Temple University in Philadelphia, said of the result. McClurken also is the conference chairman.