The Tendyne device: a breakthrough in mitral valve replacement
Special article by Patrick W. Serruys, Editor-in-Chief, EuroIntervention
Over the last few years, we have seen an explosion of devices targeting the repair or replacement of the mitral valve. Five years ago, there was tremendous hype in the field which generated the impression that many of these devices would be a good and permanent solution for patients with mitral disease that could not be treated surgically.
It turns out, as many experts had warned, that the treatment of mitral leaflets is a much more complex issue than the aortic valve, since mitral regurgitation is a disease involving the annulus, leaflets, cordae, papillary muscles and the remodelling of the left ventricle.
The only therapy that has evolved (and is now well accepted by the community) is the MitraClip. In terms of mitral valve replacement, the development has been extremely slow for two reasons:
- The complexity of the disease as mentioned above
- Physicians who were once again forced to treat compassionate patients – and we know, unfortunately, that the outcome of these patients is grim.
However, in this complex and difficult landscape, the “Royal Brompton” group have succeeded in applying a reasonably simple technique for mitral valve replacement. Duncan et al in “Transcatheter Mitral Valve Replacement: Long-Term Outcomes of First-In-Man Experience with an Apically Tethered Device - A Case Series from a Single Centre” report that four of their five initial patients treated with the Tendyne device are surviving at 18 months and two years, with a significant reduction of NYHA class and exercise capacity. Transthoracic echocardiography demonstrated valve stability, absent transvalvular mitral regurgitation, significant reductions in tricuspid regurgitation, and systolic pulmonary arterial pressures. It is a significant achievement that deserves an EEP. In the meantime, the list of patients treated with mitral valve replacement has increased, but is still around 200 patients worldwide.