Clip Closes Door on Leaky Heart Valves
Novel Procedure May Offer Option to Surgery for Mitral Valve Regurgitation
March 17, 2010 (Atlanta) -- A clothespin-type device that clips together the
partially open doors of leaky heart valves may spare some patients the need for
open heart surgery, doctors say.
In a new study, the clip was safer and worked nearly as well as surgery for
people with the leaky valve condition known as mitral valve regurgitation.
But the patients were only followed for one year -- not enough time to truly
gauge the effectiveness of the new technique, some experts say.
Repairing Mitral Valves
About 250,000 Americans are diagnosed with mitral valve regurgitation each
year. The mitral valve is like a saloon door that opens to let blood flow into
the heart's main pumping chamber. When it fails to close properly, blood flows
backward, sapping the efficiency of the heart. Over time, as the heart
continues to weaken, patients can develop life-threatening heart failure.
For people with severe symptoms, such as breathlessness when walking across
the room, doctors typically offer surgery, which involves splitting open the
chest to repair or replace the valve. About 100,000 Americans have mitral valve
surgery each year, says study head Ted Feldman, MD, of NorthShore University
Health System in Evanston, Ill.
If the patient is too old or has too many other health problems to tolerate
surgery, heart failure medications are given, he says.
These are the patients most likely to benefit from the new device, called
MitraClip, experts say. It's already on the market in Europe and is awaiting
The tiny clip is mounted onto a catheter and then threaded into the heart
through an incision in an artery in the groin. The technique is similar to that
used in angioplasty procedures to open clogged heart arteries.
Clip May Help Repair Leaky Mitral Valves: Study Details
The new study involved 279 patients: 184 were assigned to get the MitraClip
and 95 to surgery. The clip procedure was attempted in 178 patients and
successful in 137.
The findings were reported at the annual meeting of the American College of
Ten percent of people treated with the clip experienced major complications
within 30 days, compared to 57% who underwent surgery. There were no deaths
with the clip; two surgery patients died.
As for effectiveness, the study was designed to show that the device was not
substantially inferior to surgery at one year and by that test, it passed.
After one year, 72% of MitraClip patients and 88% of surgery patients did not
have serious leakage, which showed the clip was not statistically inferior to
surgery, Feldman says.
Unlike surgery patients, who can be in the hospital for nearly a week after
open heart procedures, people treated with the clip are often up and walking
around within a day or two, Feldman says.
"We have opened the door for a new option for patients," Feldman says.