Abstract
Mitral valve regurgitation (MR) has a high incidence in the western world, and mortality is high for untreated severe MR. Catheter based repair was introduced with MitraClip in 2003, and some additional devices later came into the market. To expand the transcatheter treatment options for mitral valve disease, the first transcatheter mitral valve implantation (TMVI) was performed by Søndergaard et al. 2012, only 10 years after the first transcatheter aortic valve implantation (TAVI), however, the development has been much slower for the TMVI than for TAVI. From 2012, studies were started for several devices to prove feasibility and safety. However, there were big challenges in valve design; delivery systems and anchoring in addition to anatomical issues (avoid LVOT obstruction and paravalvular leak, big size of annulus). The main valves in studies were CardiaQ (later bought by Edwards Lifesciences, Irvine, United States), Tiara (Neovasc Inc., Richmond, Canada), Twelve (later Intrepid, Medtronic, MN, United States) and Tendyne™ (Abbott, MN, United States). I will focus on the Tendyne™ valve that is the only CE approved transcatheter mitral valve implant. It is available in a large number of sizes and is repositionable and retrievable. The results for the 100 first patients included in the early feasibility study (EFS) at 1 and 2 years are promising. Initially feasible for MR, but further investigations show promising results also for implant in mitral annular calcification.
Highlights
The mortality rate for untreated severe mitral regurgitation (MR) is up to 50% at 5 years [1, 2], and the incidence in the western world of such patients is 1–2%, with a prevalence of 10% for patients >75 years [3]
Tendyne is available in a large number of sizes that can cover a large range of annular dimensions
Coumadin postoperatively may help avoid valve thrombosis and long- term degeneration, which will continue to be evaluated with longer-term data in larger patient cohorts
Summary
The mortality rate for untreated severe mitral regurgitation (MR) is up to 50% at 5 years [1, 2], and the incidence in the western world of such patients is 1–2%, with a prevalence of 10% for patients >75 years [3]. Additional pathologies are common in patients with mitral valve disease such as aortic stenosis, tricuspid regurgitation, left ventricular dys-synchrony, atrial fibrillation or heart failure. The Tendyne valve is currently available in 13 sizes with the standard profile and low profile frame, which means that that it is possible to tailor the prosthesis size to many different patient anatomies. This sizing strategy is distinct from other TMVI systems that are only available in 2–4 sizes, see Table 1. The Tendyne Mitral Valve System has successfully been implanted in nine patients with severe MAC under compassionate use [20] Figure 10. It has been feasible to implant a Tendyne with anaortic prosthesis in place, either surgical or transcatheter, without altering the function of the prosthesis [23], Figure 12
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