Release date: 2010-03-23
Abbott Laboratories, Inc. has developed a "pocket clip" that treats mitral regurgitation by implanting the heart through the artery. Studies have shown that the safety of this device is higher than that of thoracotomy, and the effectiveness is slightly less. Abbott has introduced this device in the European market.
This device is popular with many surgeons, but some people question its long-term effectiveness.
The device, called the MitraClip, looks like a pocket peg, made of metal and wrapped with a layer of fiber. During the operation, the doctor performs general anesthesia on the patient, then inserts a tube into the femoral artery and introduces it into the heart. The â€œMitra clipâ€ at one end of the tube clamps the two valves of the mitral valve to solve the problem of mitral regurgitation.
Dr. Ted Feldman, who led the development work, introduced the "Mitra Clip" at the annual meeting of the American College of Cardiology on the 14th. The Associated Press quoted him as saying: "We have provided patients with a new treatment option."
The researchers conducted a comparative study in which the first group of 184 patients were implanted with Mitra clips, the second group of 79 patients underwent mitral valve surgery, and the incidence of complications was compared within 30 days after surgery. Symptoms included severe stroke. , mitral valve reoperation, heart attack, kidney failure, major bleeding and death.
It was found that 136 of the first group of patients were successfully implanted with the Mitra clip, and 10% of them had complications. Of the second group of patients undergoing thoracotomy, 57% had complications, two of them died, two had severe stroke, and four underwent emergency cardiac surgery.
The researchers believe that the "Metra clip" is safer than thoracotomy.
As for the treatment effect, the researchers used the surgery as a measure of whether the mitral valve required surgery due to dysfunction after one year. The results showed that the effective rate of â€œMitra clipâ€ was 72.4%, and the effective rate of thoracotomy was 87.8%.
Feldman said that the latter works better, "but it is not much better." If patients can choose, especially considering safety, are they still willing to undergo thoracotomy?
"From a certain point of view, the more attractive thing about the 'Mitra Clip' is that if it doesn't work, patients can still choose surgery," Feldman said.
The Mitra Clip is only effective for mitral regurgitation. According to Abbott, devices for other heart valve problems are in the final testing phase.
Abbott launched the "Mitra Clip" in the European market 18 months ago. The famous American movie star Elizabeth Taylor became "adventurous" last fall and posted a good post on the microblog "Twitter" website. Abbott hopes to get US approval and push the device to the US market next year. According to statistics, there are 8 million patients with mitral regurgitation in Europe and America.
Many surgeons believe that the "Mitra Clip" is the first attempt to repair or replace the heart valve through the artery without thoracotomy. It is a milestone.
However, some surgeons are not convinced of the effectiveness of this device and believe that it is necessary to observe postoperative effects for more than one year.
Dr. James McKruken, President of the American Heart Association's current annual meeting, said: "This device has only partially won."
Dr. Scott Milliken of the Billings Clinic in Montana said, "There is no doubt that this is a very exciting technology," but the researchers set the threshold for success for the device too low.
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