Medical Technology Directory

medical technology evaluations at your fingertips

Comparative Effectiveness Review of Percutaneous Mitral Valve Repair

April 13, 2018

Health Problem: The mitral valve (MV) in the heart normally prevents blood from flowing backward from the left ventricle into the left atrium during ventricular contraction, but this valve can fail due to wear or direct damage or due to changes in the shape of the heart. The resulting backward flow or regurgitation forces the ventricle to pump harder to maintain adequate output of oxygenated blood into the body.

Technology Description: The MitraClip Mitral Valve Repair System (Abbott Vascular Inc.) and the Carillon Mitral Contour System (Cardiac Dimensions Inc.) are minimally invasive devices for repair of a damaged or leaking MV. The goal of percutaneous MV repair is to restore normal MV function without need for open heart surgery. The MitraClip is a Y-shaped device that attaches directly to the MV. Both arms of the clip open to form graspers that each grab 1 of the 2 leaflets of the MV to reduce excessive blood flow through the damaged valve. In contrast, the Carillon device has 2 hoops that are held together by a connecting wire. This device is implanted in the coronary sinus next to the MV. After implantation, the connecting wire pushes against the wall of the coronary sinus, pressing against 1 side of the MV and moving 1 leaflet of the valve toward the other leaflet to reduce blood flow through the valve.

Controversy: Percutaneous MV repair avoids the risks of open surgery, cardiopulmonary bypass, and cardiac arrest, but the repairs may be inferior and less durable than the repairs that can be made during conventional or minimally invasive open surgery. In addition, complications that occur during percutaneous MV repair may require conversion to open heart surgery.

Key Questions:

  • Is percutaneous MV repair using the MitraClip system or the Carillon system an effective treatment for MV regurgitation (MR) in patients who are not candidates for conventional open MV surgery?
  • Do the lower risks of percutaneous MV repair make it a better choice than conventional open MV surgery for patients with high surgical risk who could undergo either procedure?
  • What are the risks of percutaneous MV repair using the MitraClip and Carillon devices?
  • Have definitive patient selection criteria been established for percutaneous MV repair with the MitraClip system or Carillon system?