Clip Closes Door on Leaky Heart Valves
Novel Procedure May Offer Option to Surgery for Mitral Valve Regurgitation
Clip May Help Repair Leaky Mitral Valves: Study Details continued...
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.
Clip May Help Repair Leaky Mitral Valves: Experts Comment
Some surgeons expressed concerns that the new device is not as good as surgery.
"The first issue is, how will it hold up after 12 months?" says J. Scott Millikan, MD, a surgeon at the Billings Clinic in Montana.
"A year may not be enough time to gauge its effectiveness," he tells WebMD, adding that surgical repair often holds up for more than a decade.
"This represents a step forward, but we need more study, larger studies," Millikan says.
Feldman notes that if the clip fails, surgery is still an option, so it makes sense to use the less drastic treatment first.
ACC President Alfred Bove, MD, of Temple University in Philadelphia, says he is concerned about the 41 failed attempts at clip repair.
Feldman says it’s a new technique and doctors are getting better at performing it.
Donald Glower, MD, a heart surgeon at Duke University who was involved with the study, says the clip probably will be especially helpful for patients too old, frail, or sick to have surgery.
The study was funded by Evalve Inc., which developed the device. Evalve was sold last year to Abbott; Feldman consults for the firm.
The device costs about $22,000 in Europe; the price in the U.S. has not been set.