TMVR: What Have We Learned From Tendyne and M3?

Presented at the 15th Biennial International Andreas Gruentzig Society Meeting, February 3-7, 2019

Program Agenda               Faculty Disclosures              Vendor Acknowledgment

5.2 / IAGS 2019
Session 5: Structural Session 2 – Mitral & Tricuspid
TMVR: What Have We Learned From Tendyne and M3?
Problem Presenter: Paul Sorajja, MD


Summary of problem or issue

Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy with demonstrated feasibility, and it is now being evaluated in pivotal clinical trials. Most patients who are candidates for TMVR are those with secondary mitral regurgitation (MR). The recently published results of the COAPT study, where transcatheter repair was found to be life-saving in patients with secondary MR, have now made the choice of pursuing transcatheter mitral repair versus replacement much more challenging.


Gaps in knowledge

The strategies of transcatheter repair and TMVR result in different degrees of MR relief.  It is not known if these differences are clinically important, particularly when weighed against the potential risks associated with TMVR procedures, which are currently more invasive in comparison to repair approaches, as well as complications that may arise from a prosthesis, such as bleeding and leaflet durability. 


Possible solutions and future directions

It is highly likely that future approaches to choosing either transcatheter repair or replacement will follow current practice for open surgery, in which the likelihood of successful mitral repair based on anatomic evaluation will be a key factor. In other words, a repair approach will be pursued when the likelihood of repair is high (eg, >90% of grade 0 or 1 residual MR), and replacement will be considered for those with anatomy that would pose significant challenges for complete MR relief with repair. In addition, having technologies that permit both transcatheter repair and replacement in a complementary fashion also would be important. Such permissive therapies would help physicians pursue either repair or replacement freely and sequentially (eg, annuloplasty followed by replacement), without fear of being unable to treat residual MR.