A new device called the MitraClip is getting significant publicity after initial results of the Everest II study were recently released. The MitraClip is a small prosthesis used to treat severe Mitral Regurgitation (a condition in which too much blood is going through the mitral valve in the wrong direction). This noninvasive repair process invloves implanting the clip onto the mitral valve of the heart by a simple needlestick in the groin.
The procedure is very similar to a heart catheterization for placing stents in which a wire is guided up through a blood vessel into the heart. According to the manufacturer’s website (Abbott), “The Guide Catheter is inserted into the femoral vein at the groin and provides access to the mitral valve. The Clip is used to grasp and fasten together the valve leaflets.” Once the clip is holding the mitral valve together in the middle, the valve is no longer able to allow so much blood to flow backwards. There is still plenty of flow forward around the clip.
The new study Everest II which is testing this device in up to 47 sites throughout the US and Canada has reported that “quality of life, and rates of re-hospitalization for heart failure improved significantly in the MitraClip-treated patients at one year” according to MedPage Today’s article. This was determined only after they compared “high-risk” surgical candidates. According to Bob Baeten, PA-C, at Piedmont Hospital in Atlanta, the new methodology for testing this device may be preventing it from getting better results. He states, “We’re testing this on the sickest of the sick rather than the patients who could recover easily from surgery. It’s the patients who get turned down for surgery that are tested with the MitraClip. These people are already very ill which is why they were turned down for surgery in the first place.”
It should be noted that the MitraClip has been approved and used commercially in Europe for 3 years now. The device is still seeking approval here in the U.S. The only way an American citizen can obtain this noninvasive mitral valve repair currently is by entering into a study at participating study locations .