To view a video interview of Dr. Grossi, go to youtube.com
My Take
Study Leaves Questions Unanswered
Pure functional mitral regurgitation is probably responsible for about a third of all mitral regurgitation cases. We can identify functional mitral regurgitation by echocardiography. On echo, the mitral leaflets look normal but the valve has a central regurgitation because the annulus is distorted secondary to enlargement of the ventricle.
The Coapsys device is intended for patients at a relatively early stage of ventricular dilatation and moderate mitral regurgitation. One limitation of the trial is that it relied on current grading methods for mitral regurgitation severity, which are very imprecise.
The RESTOR-MV trial was underpowered. It serves as a demonstration study, and shows that the device has utility in some patients, but the study was not large enough or long enough to produce meaningful conclusions. It leaves unanswered several big questions, such as what happens to the patients' heart failure long term, and what occurs if patients require later heart surgery. How much scarring does the device cause, and will it allow subsequent valve repair?
In don't think that surgeons will favor placing such a device. It's imprecise. It reshapes the ventricle, but the heart ends up distorted and probably undergoes pericardial scarring. Questions remain about the device's impact on long-term ventricular and mitral valve function.