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
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
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Article info
Publication history
Accepted:
January 16,
2023
Received in revised form:
December 2,
2022
Received:
March 21,
2022
Publication stage
In Press Journal Pre-ProofFootnotes
Funding: None
Conflicts of Interest Disclosure
Alison Duncan reports the following disclosures: Consultant and Proctor, and have received honoraria from, Abbott, Edwards, and Medtronic. Paul A. Grayburn reports the following disclosures: research support from Abbott Vascular, Boston Scientific, Cardiovalve, Edwards Lifesciences, W.L. Gore, Medtronic, Neochord; and Advisory Board/Consultant for Abbott Vascular, Cardiovalve, Edwards Lifesciences, W.L. Gore, Medtronic, 4C Medical. Maurizio Taramasso reports the following disclosures: consultant or consultancy fees from Abbott, Edwards Lifesciences, Boston Scientific, Shenqi Medical, 4tech, Simulands, MTEx, Occlufit, Mitraltech, CoreMedic. Sebastian Ludwig reports the following disclosures: travel compensation from Edwards Lifesciences. Lars Sondergaard reports the following disclosures: consultant fees/institutional research grants from Abbott, Boston Scientific, Medtronic and SMT. Azeem Latib reports the following disclosures: consultant (honoraria) ‐ Edwards Lifesciences, Abbott Vascular; Boston Scientific, Medtronic, Philips, WL Gore; Scientific Advisory Boards (equity) ‐ Tioga, Supira, NeoChord, CorFlow, VVital, and Institutional Funding to Montefiore Medical Center from ‐ Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific. None of the other authors have any conflict of interest or relationships with industry that could have influenced this manuscript.
Identification
Copyright
© 2023 Published by Elsevier Inc. on behalf of the Canadian Cardiovascular Society.
