ATLANTA -- Leaky heart valves can be fixed without major surgery by guiding a tiny, clothespin-like clip into place from an incision in a vein in the groin, doctors said Sunday.
The clip was designed to fix leaky mitral valves, diagnosed in 250,000 people in the USA each year. Doctors say the new research heralds a new era, one in which major heart defects can be repaired without slicing open the chest to reach the heart.
"This is a huge advance," says study leader Ted Feldman of NorthShore University Health System in Evanston, Ill. "We've had patients who can't feed themselves because they're exhausted just lifting a fork. A few days later, they're walking around."
Leaky mitral valves sap the efficiency of the heart, overloading it with blood and preventing it from pumping enough to meet the body's needs. Over time, the chronic overload expands the heart, weakening it and causing life-threatening heart failure.
In the past, Feldman says, doctors have been able to offer patients only two options for treatment. If the condition is severe -- and the patient isn't too old or too sick to tolerate surgery -- doctors will slice into the chest, split the breastbone and stitch up the valve or replace it with a mechanical device. As many as 100,000 patients now have mitral valve surgery in the USA each year, Feldman says.
When patients can't tolerate surgery, doctors prescribe heart-failure medications, he says.
"What we have now is a third option," Feldman said at the annual meeting of the American College of Cardiology. The device, called MitraClip by its maker, Abbott, is available in Europe and is awaiting Food and Drug Administration approval.
Feldman says the clip is guided into the heart using a similar technique used in angioplasty patients to open clogged arteries.
Instead of inflating a balloon inside a blood vessel, doctors guide the clip into the heart, where it secures the valve's leaflets. When the clip is in place, it ensures that the heart can pump blood only in one direction, out through the aorta to the rest of the body.
The study was designed to compare the MitraClip to surgery in 279 patients with moderate to severe mitral leakage. The clip was installed in 184 patients; 95 patients had surgery.
Researchers analyzed data from 137 device patients and 79 who had surgery. One year later, 72% of the clip patients and 88% of the surgery patients were alive, did not need additional valve surgery and no longer had serious leakage, which demonstrated that the clip was statistically not inferior to surgery.
Only 9.6% of patients in the device group had complications within 30 days; 12 had enough blood loss to warrant transfusion. In contrast, 57% of surgery patients had complications, including two deaths, two strokes and four patients who needed emergency surgery, Feldman says.
Donald Glower, a Duke University surgeon who helped carry out the trial, says the clip probably will be especially helpful for patients too frail to have surgery; others, whose valves are too far gone, still need surgery.
"It will take many years for this to become a mature technology," he says, "so we'll know who should get it and who shouldn't."
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