Transcatheter Mitral Valve Replacement

The Tendyne Device

Alison Duncan,

Alison Duncan

Royal Brompton Hospital, Royal Brompton and Harefield NHS Foundation Trust, London, UK

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Alison Duncan,

Alison Duncan

Royal Brompton Hospital, Royal Brompton and Harefield NHS Foundation Trust, London, UK

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Book Editor(s):Ron Waksman,

Ron Waksman

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA

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Toby Rogers,

Toby Rogers

Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA

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First published: 12 March 2021

https://doi.org/10.1002/9781119763741.ch23

Citations: 1

Summary

Mitral regurgitation (MR) is a leading cause of valvular heart disease, but up to half of patients with moderate to severe MR are not referred for conventional mitral valve surgery due to advanced age or multiple comorbidities. Transcatheter mitral valve implantation (TMVI) is an emerging alternative technology, and the only evice with a “Conformite Europeenne” mark and the largest successful experience to date is the Tendyne TMVI device, designed specifically for placement in the native mitral annulus. This chapter reviews the development of the Tendyne TMVI system, preprocedural planning and selection criteria, implantation technique, periprocedural and early clinical outcome, and long-term follow-up and durability. Successful deployment results in complete relief of mitral regurgitation in most cases, with instantaneous and sustained improvements in cardiac physiology and significant immediate and longer-term symptomatic improvement.

References

Nkomo, V.T., Gardin, J.M., Skelton, T.N. et al. (2006). Burden of valvular heart diseases: a population-based study. Lancet 368: 1005–1011.
10.1016/S0140-6736(06)69208-8
PubMed Web of Science® Google Scholar
Iung, B., Baron, G., Butchart, E.G. et al. (2003). A prospective survey of patients with valvular heart disease in Europe: the euro heart survey on Valvular heart disease. Eur. Heart J. 24: 1231–1243.
10.1016/S0195-668X(03)00201-X
PubMed Web of Science® Google Scholar
Mirabel, M., Iung, B., Baron, G. et al. (2007). What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur. Heart J. 28: 1358–1365.
10.1093/eurheartj/ehm001
PubMed Web of Science® Google Scholar
Feldman, T., Kar, S., Elmariah, S. et al. (2015). Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II. J. Am. Coll. Cardiol. 66: 2844–2854.
10.1016/j.jacc.2015.10.018
PubMed Web of Science® Google Scholar
Cheung, A., Webb, J., Verheye, S. et al. (2014). Short-term results of transapical transcatheter mitral valve implantation for mitral regurgitation. J. Am. Coll. Cardiol. 64: 1814–1819.
10.1016/j.jacc.2014.06.1208
PubMed Web of Science® Google Scholar
Bapat, V., Lim, Z.Y., Boix, R., and Pirone, F. (2015). The Edwards Fortis transcatheter mitral valve implantation system. EuroIntervention 11: W73–W75.
10.4244/EIJV11SWA21
PubMed Web of Science® Google Scholar
Abdul-Jawad Altisent, O., Dumont, E., Dagenais, F. et al. (2015). Initial experience of transcatheter mitral valve replacement with a novel transcatheter mitral valve: procedural and 6-month follow-up results. J. Am. Coll. Cardiol. 66: 1011–1019.
10.1016/j.jacc.2015.06.1322
PubMed Web of Science® Google Scholar
Ma, L., Tozzi, P., Huber, C.H. et al. (2005). Double-crowned valved stents for off-pump mitral valve replacement. Eur. J. Cardiothorac. Surg. 28: 194–198.
10.1016/j.ejcts.2004.12.068
PubMed Web of Science® Google Scholar
Lozonschi, L., Quaden, N., Edwards, N. et al. (2008). Transapical mitral valved stent implantation. Ann. Thorac. Surg. 86: 745–748.
10.1016/j.athoracsur.2008.05.039
PubMed Web of Science® Google Scholar
Lutter, G., Quaden, R., Osaki, S. et al. (2009). Off-pump transapical mitral valve replacement. Eur. J. Cardiothorac. Surg. 36: 124–128.
10.1016/j.ejcts.2009.02.037
PubMed Web of Science® Google Scholar
Lozonschi, L., Bombien, R., and Osaki, S. (2010). Transapical mitral valved stent implantation: a survival series in swine. J. Thorac. Cardiovasc. Surg. 140: 422–426.
10.1016/j.jtcvs.2009.12.030
PubMed Web of Science® Google Scholar
Lutter, G., Quaden, R., Iino, K. et al. (2010). Mitral valved stent implantation. Eur. J. Cardiothorac. Surg. 38: 350–355.
10.1016/j.ejcts.2010.02.022
PubMed Web of Science® Google Scholar
Attmann, T., Pokorny, S., and Lozonschi, L. (2011). Mitral valved stent implantation: an overview. Minim. Invasive Ther. Allied Technol. 20: 78–84.
10.3109/13645706.2011.554559
PubMed Web of Science® Google Scholar
Iino, K., Boldt, J., Lozonschi, L. et al. (2012). Off-pump transapical mitral valve replacement: evaluation after one month. Eur. J. Cardiothorac. Surg. 41: 512–517.
10.1093/ejcts/ezr106
PubMed Web of Science® Google Scholar
Lutter, G., Pokorny, S., Frank, D. et al. (2013). Transapical mitral valve implantation: the Lutter valve. Heart Lung Vessel. 5 (4): 201–206.
CAS PubMed Google Scholar
Muller, D., Farivar, R., Jansz, R. et al. (2017). Transcatheter mitral valve replacement for patients with symptomatic mitral regurgitation a global feasibility trial. J. Am. Coll. Cardiol. 69 (4): 381–391.
10.1016/j.jacc.2016.10.068
PubMed Web of Science® Google Scholar
Dahle, G., Helle-Valle, T., Beitnes, J.O. et al. (2019). Single-Centre first experience with transapical transcatheter mitral valve replacement with an apical tether: factors influencing screening outcomes. Interact. Cardiovasc. Thorac. Surg. https://doi.org/10.1093/icvts/ivy343. [Epub ahead of print].
Google Scholar
Niikura, H., Gössl, M., Kshettry, V. et al. (2019). Causes and clinical outcomes of patients who are ineligible for Transcatheter mitral valve replacement. JACC Cardiovasc. Interv. 12 (2): 196–204.
10.1016/j.jcin.2018.10.042
PubMed Web of Science® Google Scholar
Sorajja, P., Gössl, M., Babaliaros, V. et al. (2019 Sep 17). Novel transcatheyer mitral valve prosthesis for patients with severe mitral annular calcification. J Am Coll Cardiol. 74 (11): 1431–1440. https://doi.org/10.1016/j.jacc.2019.07.069.
10.1016/j.jacc.2019.07.069
PubMed Web of Science® Google Scholar
Taramasso, M., Sorajja, P., Dahle, G. et al. (2020 Jul 28: EIJ-D-19-00947. doi: https://doi.org/10.4244/EIJ-D-19-00947). Transapical transcatheter mitral valve implantation in patients with prior aortic valve replacement: a feasibility report. EuroIntervention Online ahead of print.
Google Scholar
Duncan, A., Daqa, A., Yeh, J. et al. (2017). Transcatheter mitral valve replacement: long-term outcomes of first-in-man experience with an apically tethered device- a case series from a single centre. EuroIntervention 13 (9): e1047–e1057.
10.4244/EIJ-D-17-00154
PubMed Web of Science® Google Scholar
Blanke, P., Dvir, D., Cheung, A. et al. (2014). A simplified D-shaped model of the mitral annulus to facilitate CT-based sizing before transcatheter mitral valve implantation. J. Cardiovasc. Comput. Tomogr. 8 (6): 459–467.
10.1016/j.jcct.2014.09.009
PubMed Web of Science® Google Scholar
Blanke, P., Naoum, C., Webb, J. et al. (2015). Multimodality imaging in the context of transcatheter mitral valve replacement: establishing consensus among modalities and disciplines. JACC Cardiovasc. Imaging 8 (10): 1191–1208.
10.1016/j.jcmg.2015.08.004
PubMed Web of Science® Google Scholar
Murphy, D.J., Ge, Y., Don, C.W. et al. (2017). Use of cardiac computerized tomography to predict neo-left ventricular outflow tract obstruction before transcatheter mitral valve replacement. J. Am. Heart Assoc. 6 (11): e007353.
10.1161/JAHA.117.007353
PubMed Web of Science® Google Scholar
Leipsic, J. and Blanke, P. (2019). Predicting left ventricular outflow tract obstruction after transcatheter mitral valve replacement: from theory to evidence. JACC Cardiovasc. Interv. 12 (2): 194–195.
10.1016/j.jcin.2018.12.010
PubMed Web of Science® Google Scholar
Kohli, K., Wei, Z.A., Yoganathan, A.P. et al. (2018). Transcatheter mitral valve planning and the neo-LVOT: utilization of virtual simulation models and 3D printing. Curr. Treat. Options Cardiovasc. Med. 20 (12): 99.
10.1007/s11936-018-0694-z
PubMed Google Scholar
Moat, N., Duncan, A., Lindsay, A. et al. (2015). Transcatheter mitral valve replacement for the treatment of mitral regurgitation: in-hospital outcomes of an apically tethered device. J. Am. Coll. Cardiol. 65: 2352–2353.
10.1016/j.jacc.2015.01.066
PubMed Web of Science® Google Scholar
Quarto, C., Davies, S., Duncan, A. et al. (2016). Transcatheter mitral valve implantation: 30-day outcome of first-in-man experience with an apically tethered device. Innovations 11: 174–178.
10.1097/imi.0000000000000278
PubMed Google Scholar
Blanke, P., Park, J.K., Grayburn, P. et al. (2017). Left ventricular access point determination for a coaxial approach to the mitral annular landing zone in transcatheter mitral valve replacement. J. Cardiovasc. Comput. Tomogr. 11 (4): 281–287.
10.1016/j.jcct.2017.04.002
PubMed Web of Science® Google Scholar
Lutter, G., Lozonschi, L., Ebner, A. et al. (2014). First-in-human off-pump transcatheter mitral valve replacement. JACC Cardiovasc. Interv. 7 (9): 1077–1078.
10.1016/j.jcin.2014.06.007
PubMed Web of Science® Google Scholar
Sorajja, P., Moat, N., Badhwar, V. et al. (2019). J. Am. Coll. Cardiol. 73: 1250–1260.
10.1016/j.jacc.2018.12.066
PubMed Web of Science® Google Scholar
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) – ClinicalTrials.gov Identifier: NCT03433274
Google Scholar
Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects with Mitral Annular Calcification – ClinicalTrials.gov Identifier: NCT03539458
Google Scholar

Citing Literature

Transcatheter Mitral Valve Therapies