Abbott made history in January when it became the first company in the world to receive market approval for a transcatheter mitral valve implantation (TMVI) device. Its Tendyne system now has a CE-mark indication for the management of patients with mitral regurgitation who cannot undergo mitral valve surgery or percutaneous edge-to-edge repair (MitraClip). TMVI devices have been in the pipeline for years but, until now, none have been commercially available. In this interview, Nicolas Dumonteil (Clinique Pasteur, Toulouse, France) talks to Cardiovascular News about what the approval of Tendyne means for the management of patients with mitral regurgitation.
Why do you think it has taken so long to get a TMVI device on to the market?
Despite being one of the most common heart valve conditions, mitral valve disease is complex and patient anatomy varies. The mitral valve’s dimensions and features require bigger valves with a more involved design than those for the aortic valve, for example. Therefore, ensuring the proper concept, validating it in preclinical studies, and then completing the initial feasibility study for CE mark approval took some time. Bringing a device to market that was safe and efficient in reducing mitral regurgitation, which Tendyne achieves with some unique features, was important.
By having a device such as Tendyne, which is fully repositionable and retrievable during implantation, physicians have the best possible treatment options for their patients requiring a valve repair/replacement. The CE mark approval means that physicians no longer have to ask whether they can treat a patient with severe mitral regurgitation but, instead, can now consider how best to treat them.
What do you think is different about the design of Tendyne that meant it did not encounter the challenges were seen with Fortis and other TMVI valves that have not made it to market?
The device has an innovative (and unique) anchoring and fixation system with a tether and apical pad, which can be adapted to a broad range of patient anatomies. The quality of the delivery catheter supports the simplicity of the procedure—making it safe, reliable and reproducible.
Left ventricular outflow tract obstruction is a feared complication with TMVI. How can the risk of this be reduced?
Although left ventricular outflow tract obstruction is a feared complication, its determinants are quite well understood. Therefore, in almost all cases, it is anticipated rather than noticed after valve implantation. And if there is a high risk of this complication, we can cancel the procedure. However, the question is how can the risk of left ventricular outflow tract obstruction be reduced to expand the range of anatomical feasibility for TMVI? The risk will be reduced with prosthesis frame design refinement and an even deeper understanding of anticipation of this issue during screening (based on computed tomography).
What safety and efficacy data are available for the Tendyne valve?
Clinical data from the Tendyne global early feasibility study demonstrated excellent procedural safety. A key finding from the study was that 98.9% of Tendyne patients experienced mitral regurgitation elimination at discharge, which was sustained through one year in this patient population.
What further safety and efficacy data are needed for the valve?
This valve was evaluated in the context of the aforementioned study in highly selected centres, with conservative inclusion/exclusion criteria. We are now focusing on a post-approval study of the device, and we will continue to assess Tendyne as an option to treat patients experiencing the debilitating symptoms of mitral regurgitation. We are committed to providing a rigorous evaluation that will hopefully demonstrate the safety and efficiency of Tendyne in a larger population
In your view, how does TMVI sit alongside transcatheter mitral valve repair? Is it an alternative therapy or a complementary one?
Both TMVI and transcatheter mitral valve repair have a successful track record and a place, but the best treatment option ultimately depends on the condition of the patient and their anatomy. While some patients may qualify for transcatheter repair, others may need a full replacement. TMVI has to be understood as part of a portfolio of therapies in the hands of physicians.
Do you think TMVI has the potential to develop in the same way that TAVI has—that is, expand into different risk populations until it becomes a standard therapy for all?
Yes, I hope it will follow the same pathway, requiring, of course, a robust and rigorous scientific validation with controlled trials comparing the device with other therapies.
