Advertisement
Canadian Journal of Cardiology

Clinical characteristics and outcomes of patients screened for but DEemed CLInically Not suitablE for Transcatheter Mitral Valve Replacement

Published:January 19, 2023DOI:https://doi.org/10.1016/j.cjca.2023.01.017

      ABSTRACT

      Background

      Transcatheter therapies are a recognized alternative intervention in patients with severe mitral regurgitation who are at high surgical risk. The purpose of this study was to characterize patients screened for transcatheter mitral valve replacement (TMVR), establish the clinical and anatomical reasons for unsuitability, and determine clinical course and early outcomes.

      Methods

      International multicenter registry was conducted of consecutive patients screened for TMVR at 12 centers in Europe, the United States and Canada between April 2015 and September 2018. Patient-level retrospective data were collected for all patients screened.

      Results

      From a total of 294 patients, 87 (30%) patients were suitable for and underwent TMVR while 207 (70%) patients were unsuitable for TMVR. There was no difference in STS predicted risk of mortality (6.3±4.3% vs 6.7±6.1%, p=0.52) for mitral valve replacement between the groups. The most common reasons for TMVR unsuitability were mitral annular size outside therapeutic range (28%) and small predicted neo-LVOT (25%). Pre-procedural multidetector computed tomographic demonstrated that patients unsuitable for TMVR had smaller predicted neo-left ventricular outflow tract (LVOT) area (318±192mm2 vs 495±202mm2, p=0.04). At 30-days, there was no difference in rates of rehospitalization (8% vs 8%, p=0.21), stroke (1% vs 2%, p=0.42), or mortality (4% vs 10%, p=0.10), unadjusted for procedural risk, between unsuitable for TMVR and TMVR groups, respectively.

      Conclusions

      Two-thirds of patient’s failed screening as anatomically unsuitable for TMVR. The findings of this study have important clinical implications, highlighting an unmet clinical need and provide a target for design innovation in future iterations of TMVR devices

      Graphical abstract

      Keywords

      Abbreviations and acronyms:

      LVOT (left ventricular outflow tract), NYHA (New York Heart Association), TMVR (transcatheter mitral valve replacement)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Canadian Journal of Cardiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Nkomo V.T.
        • Gardin J.M.
        • Skelton T.N.
        • Gottdiener J.S.
        • Scott C.G.
        • Enriquez-Sarano M.
        Burden of valvular heart diseases: a population-based study.
        Lancet (London, England). 2006; 368: 1005-1011https://doi.org/10.1016/S0140-6736(06)69208-8
        • Mirabel M.
        • Iung B.
        • Baron G.
        • et al.
        What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery?.
        Eur Heart J. 2007; 28: 1358-1365https://doi.org/10.1093/eurheartj/ehm001
        • Levi N.
        • Meerkin D.
        Transcatheter Repair of the Mitral Valve: Relevant Pathophysiology, Investigation, and Management.
        Can J Cardiol. 2021; 37: 1027-1040https://doi.org/10.1016/j.cjca.2021.03.010
      1. Demir OM, Bolland M, Curio J, et al. Transcatheter Mitral Valve Replacement: Current Evidence and Concepts. Interv Cardiol (London, England). 2021;16:e07. doi:10.15420/icr.2020.25

        • Regueiro A.
        • Ye J.
        • Fam N.
        • et al.
        2-Year Outcomes After Transcatheter Mitral Valve Replacement.
        JACC Cardiovasc Interv. 2017; 10: 1671-1678https://doi.org/10.1016/j.jcin.2017.05.032
        • Duncan A.
        • Daqa A.
        • Yeh J.
        • et al.
        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. 2017; 13: e1047-e1057https://doi.org/10.4244/EIJ-D-17-00154
        • Muller D.W.M.
        • Sorajja P.
        • Duncan A.
        • et al.
        2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation.
        J Am Coll Cardiol. 2021; 78: 1847-1859https://doi.org/10.1016/j.jacc.2021.08.060
        • Zahr F.
        • Song H.K.
        • Chadderdon S.M.
        • et al.
        30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results.
        JACC Cardiovasc Interv. 2022; 15: 80-89https://doi.org/10.1016/j.jcin.2021.10.018
        • Muller D.W.M.M.
        • Farivar R.S.
        • Jansz P.
        • et al.
        Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial.
        J Am Coll Cardiol. 2017; 69: 381-391https://doi.org/10.1016/j.jacc.2016.10.068
        • Bapat V.
        • Rajagopal V.
        • Meduri C.
        • et al.
        Early Experience With New Transcatheter Mitral Valve Replacement.
        J Am Coll Cardiol. 2018; 71: 12-21https://doi.org/10.1016/j.jacc.2017.10.061
        • Baldetti L.
        • Melillo F.
        • Beneduce A.
        • et al.
        Transcatheter Mitral Valve Implantation: Who are we Treating and What may we Expect?.
        Am J Cardiol. 2019; 123: 1884-1885https://doi.org/10.1016/j.amjcard.2019.02.048
        • Regueiro A.
        • Granada J.F.
        • Dagenais F.
        • Rodés-Cabau J.
        Transcatheter Mitral Valve Replacement: Insights From Early Clinical Experience and Future Challenges.
        J Am Coll Cardiol. 2017; 69: 2175-2192https://doi.org/10.1016/j.jacc.2017.02.045
        • Del Val D.
        • Ferreira-Neto A.N.
        • Wintzer-Wehekind J.
        • et al.
        Early Experience With Transcatheter Mitral Valve Replacement: A Systematic Review.
        J Am Heart Assoc. 2019; 8e013332https://doi.org/10.1161/JAHA.119.013332
        • McCarthy P.M.
        • Kislitsina O.N.
        • Malaisrie S.C.
        • Davidson C.J.
        Transcatheter Mitral Valve Replacement with Intrepid.
        Interv Cardiol Clin. 2019; 8: 287-294https://doi.org/10.1016/j.iccl.2019.02.002
        • Niikura H.
        • Gössl M.
        • Sorajja P.
        Transcatheter Mitral Valve Replacement with Tendyne.
        Interv Cardiol Clin. 2019; 8: 295-300https://doi.org/10.1016/j.iccl.2019.02.003
        • Webb J.
        • Hensey M.
        • Fam N.
        • et al.
        Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System.
        JACC Cardiovasc Interv. 2020; 13: 2418-2426https://doi.org/10.1016/j.jcin.2020.06.040
        • Stone G.W.
        • Adams D.H.
        • Abraham W.T.
        • et al.
        Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium.
        J Am Coll Cardiol. 2015; 66: 308-321https://doi.org/10.1016/j.jacc.2015.05.049
        • Stone G.W.
        • Lindenfeld J.
        • Abraham W.T.
        • et al.
        Transcatheter Mitral-Valve Repair in Patients with Heart Failure.
        N Engl J Med. 2018; 379: 2307-2318https://doi.org/10.1056/NEJMoa1806640
        • Scotti A.
        • Munafò A.
        • Adamo M.
        • et al.
        Transcatheter Edge-to-Edge Repair in COAPT-Ineligible Patients: Incidence and Predictors of 2-Year Good Outcome.
        Can J Cardiol. 2022; 38: 320-329https://doi.org/10.1016/j.cjca.2021.12.003
        • Cheung A.
        • Webb J.
        • Schaefer U.
        • et al.
        Transcatheter mitral valve replacement in patients with previous aortic valve replacement.
        Circ Cardiovasc Interv. 2018; 11: 1-6https://doi.org/10.1161/CIRCINTERVENTIONS.118.006412
        • Ben Ali W.
        • Ludwig S.
        • Duncan A.
        • et al.
        Characteristics and outcomes of patients screened for transcatheter mitral valve implantation: 1-year results from the CHOICE-MI registry.
        Eur J Heart Fail. 2022; 24: 887-898https://doi.org/10.1002/ejhf.2492
        • Coisne A.
        • Pontana F.
        • Tchétché D.
        • et al.
        Transcatheter mitral valve replacement: factors associated with screening success and failure.
        EuroIntervention. 2019; 15: e983-e989https://doi.org/10.4244/EIJ-D-19-00444
        • Ludwig S.
        • Ruebsamen N.
        • Deuschl F.
        • et al.
        Screening for transcatheter mitral valve replacement: A decision tree algorithm.
        EuroIntervention. 2021; 16: 251-258https://doi.org/10.4244/eij-d-19-01051