Valves and Other Devices for Structural Mitral Valve Disease

12th Biennial Meeting of the International Andreas Gruentzig Society:  Rio de Janeiro - February 2-6, 2014

From Session 2 — Structural

    Moderator:      Jim Zidar
    Panelists:      Steve Bailey, Robert Bersin, Larry Dean, Bill O’Neill

Framing the question at hand, what is the state of the current knowledge?

The mitral valve orifice is much larger than the aortic valve and poses more design challenges.  Valve replacement needs exploration for degenerative mitral valve disease. Some new designs are coming into pre-clinical studies, but accurate placement, sizing and delivery are all technical challenges of sizable magnitude.  Nonetheless, new developments have been launched in this space by Neovasc, Edwards and Tendyne. Initial patient selection will likely follow the Partner Trial enrolling the very highest risk or inoperable patient for open MVR.

What are the Gaps in the current knowledge?

We are very early in the device development cycle for this valve problem and our experience is very limited.  Will treatment move towards valve replacement or designing unique MV clip approaches? If we move to valve replacement, these would be very large valves, and will pose durability and delivery questions?  We need a better understanding of how to size the mitral annulus.  It is uncertain whether a trans-apical or a trans-septal approach would be more appropriate?

Our Summary and Recommendations:

We are in the infancy of this field, yet it is clearly an unmet clinical need.  While we need to encourage the advances of the 3 companies involved to date, all have chosen the transapical approach.  Specific mitral valve designs need to be pursued with an eventual move towards percutaneous trans-septal approach.  Collaboration between cardiac surgeons, interventional cardiologists, EP and heart failure specialists will be important to success in this endeavor.