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:



      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.


      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.


      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.


      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


      Abbreviations and acronyms:

      LVOT (left ventricular outflow tract), NYHA (New York Heart Association), TMVR (transcatheter mitral valve replacement)
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