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Study: Clip implant 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 yesterday.

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 United States and Europe have leaky mitral valves, the valves between the heart's left upper and lower chambers. Not all are so bad that they need treatment, but the worst cases can lead over time to heart failure.

In the study, six times more people who had surgery experienced 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.

"We have opened the door for a new therapeutic option for patients," said Dr. Ted Feldman of North Shore University Health System in Evanston, Ill.

He led the new study and gave the results yesterday at an American College of Cardiology conference.

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 and the conference chairman, said.

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