Focus of the Report: This report focuses on the use of transcatheter mitral valve replacement (TMVR) for treating mitral regurgitation (MR), backward flow of blood due to a damaged or leaking mitral valve (MV) in the heart.

Technology Description: TMVR is a treatment for MR that uses percutaneous access through a peripheral artery to place a bioprosthetic valve within the MV. The goal of TMVR is to restore normal MV function without the need for open heart surgery. Another name for TMVR is transcatheter mitral valve implantation (TMVI). Through percutaneous access, a catheter is guided to the implantation site. A bioprosthetic valve is then deployed and implanted to support the stenotic valve.

Controversy: TMVR avoids the risks of open surgery, cardiopulmonary bypass (CPB), and intraoperative cardiac arrest, but the replacement may be inferior and less durable than what can be accomplished during conventional open or minimally invasive surgery. In addition, complications that occur during TMVR may require conversion to open heart surgery. Current guidelines recognize MV repair as the preferred treatment option in patients with MR refractory to medical therapy and who are not suitable candidates for surgery. This has led to challenges in establishing a robust evidence base evaluating TMVR.

Key Questions:

  • Is TMVR an effective treatment for MR in patients who are not candidates for conventional open MV surgery?

  • How does TMVR compare with other MR surgeries or optimal medical treatment?

  • Is TMVR safe?

  • Have definitive patient selection criteria been established for TMVR?

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