Mini clip proves safer than heart-valve surgery

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. Elizabeth Taylor reportedly got one last fall — the 77-year-old actress told fans about it on Twitter.

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. Not all are so bad they need treatment, but the worst cases can lead to heart failure over time.

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 a watershed — 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 in the near future.

"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 for more than one year.

"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.

The study used an outdated method of surgery that minimizes its true benefit, said Dr. J. Scott Millikan, a surgeon at the Billings Clinic in Montana.

"Clearly this is a very exciting technology," but the study's leaders "set the bar for success way too low" for the device, he said.