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Current Devices in TMVI and Their Limitations: Focus on Tendyne
1Oslo University Hospital, Oslo, Norway.
Frontiers in Cardiovascular Medicine
|January 11, 2021
Summary
Transcatheter mitral valve implantation (TMVI) offers a new option for mitral valve disease. The Tendyne™ valve shows promising results for mitral regurgitation and mitral annular calcification in early studies.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Severe mitral regurgitation (MR) has high incidence and mortality, with limited treatment options.
- Transcatheter mitral valve repair (TMVR) devices like MitraClip exist, but transcatheter mitral valve implantation (TMVI) development lags behind transcatheter aortic valve implantation (TAVI).
- Significant challenges in TMVI include valve design, delivery systems, anchoring, and anatomical considerations like left ventricular outflow tract (LVOT) obstruction and paravalvular leak.
Purpose of the Study:
- To evaluate the feasibility and safety of transcatheter mitral valve implantation (TMVI) devices.
- To focus on the Tendyne™ valve, the only CE-approved TMVI device, assessing its performance in mitral regurgitation and mitral annular calcification.
- To present promising results from the early feasibility study (EFS) of the Tendyne™ valve.
Main Methods:
- Review of early feasibility studies (EFS) for transcatheter mitral valve implantation (TMVI) devices.
- Focus on the Tendyne™ valve, including its features (CE approval, size availability, repositionability, retrievability).
- Analysis of 1- and 2-year outcomes for the first 100 patients treated with the Tendyne™ valve.
Main Results:
- The Tendyne™ valve is the sole CE-approved transcatheter mitral valve implant, available in multiple sizes and offering repositionability.
- Early feasibility study results for the first 100 patients treated with the Tendyne™ valve at 1 and 2 years are promising.
- The Tendyne™ valve demonstrates initial feasibility for mitral regurgitation and promising results for implantation in cases of mitral annular calcification.
Conclusions:
- Transcatheter mitral valve implantation (TMVI) is expanding treatment options for mitral valve disease.
- The Tendyne™ valve shows promising safety and efficacy for mitral regurgitation and mitral annular calcification.
- Continued investigation and development of TMVI devices like Tendyne™ are crucial for managing complex mitral valve pathologies.
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