Focus of the Report: This report focuses on the use of the MitraClip Mitral Valve Repair System (Abbott Vascular Inc.) for treatment of secondary (or functional) mitral valve regurgitation (MR).

Technology Description: The MitraClip Mitral Valve Repair System is a minimally invasive device for repair of a damaged or leaking mitral valve (MV) in the heart. The goal of percutaneous MV repair is to restore normal MV function without the 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.

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 an effective treatment for secondary (functional) MR?

  • How does percutaneous MV repair using the MitraClip system compare with conventional surgical MV repair/replacement and optimal medical treatment in patients with secondary (functional) MR?

  • What are the risks of percutaneous MV repair using the MitraClip system?

  • Have definitive patient selection criteria been established for percutaneous MV repair with the MitraClip system?

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