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Clinical Trial
. 2021 Nov 9;78(19):1847-1859.
doi: 10.1016/j.jacc.2021.08.060.

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation

David W M Muller  1 , Paul Sorajja  2 , Alison Duncan  3 , Brian Bethea  4 , Gry Dahle  5 , Paul Grayburn  6 , Vasilis Babaliaros  7 , Mayra Guerrero  8 , Vinod H Thourani  9 , Francesco Bedogni  10 , Paolo Denti  11 , Nicolas Dumonteil  12 , Thomas Modine  13 , Paul Jansz  14 , Michael L Chuang  15 , Philipp Blanke  16 , Jonathon Leipsic  16 , Vinay Badhwar  17
Affiliations
Free article
Clinical Trial

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation

David W M Muller et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Transcatheter mitral valve replacement (TMVR) is feasible for selected patients with severe mitral regurgitation (MR) who are poor candidates for valve surgery. Intermediate-term to long-term TMVR outcomes have not been reported.

Objectives: This study sought to evaluate the safety and effectiveness through 2-year follow-up of TMVR in high-surgical-risk patients with severe MR.

Methods: The first 100 patients enrolled in the Expanded Clinical Study of the Tendyne Mitral Valve System, an open-label, nonrandomized, prospective study of transapical TMVR, were followed for 2 years.

Results: The patients (aged 74.7 ± 8.0 years, 69.0% male) had symptomatic (66.0% New York Heart Association [NYHA] functional class III or IV) grade 3+ or 4+ MR that was secondary or mixed in 89 (89.0%). Prostheses were successfully implanted in 97 (97.0%) patients. At 2 years, all-cause mortality was 39.0%; 17 (43.6%) of 39 deaths occurred during the first 90 days. Heart failure hospitalization (HFH) fell from 1.30 events per year preprocedure to 0.51 per year in the 2 years post-TMVR (P < 0.0001). At 2 years, 93.2% of surviving patients had no MR. No patient had >1+ MR. The improvement in symptoms at 1 year (88.5% NYHA functional class I or II) was sustained to 2 years (81.6% NYHA functional class I or II). Among survivors, the left ventricular ejection fraction was 45.6 ± 9.4% at baseline and 39.8 ± 9.5% at 2 years (P = 0.0012). Estimated right ventricular systolic pressure decreased from 47.6 ± 8.6 mm Hg to 32.5 ± 10.4 mm Hg (P < 0.005).

Conclusions: In this study, the impact of TMVR on severity of MR, reduction in HFH rate, and improvement in symptoms was sustained through 2 years. All-cause mortality and the need for HFH was highest in the first 3 months postprocedure. (Expanded Clinical Study of the Tendyne Mitral Valve System; NCT02321514).

Keywords: heart failure; mitral regurgitation; mitral valve prosthesis; prognosis; transcatheter mitral valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures The present paper is an analysis of the first 100 patients treated in the Expanded Clinical Study of the Tendyne Mitral Valve System (Global Feasibility Study; NCT02321514) supported by Abbott. Dr Muller has served as a consultant for Medtronic, Abbott, and Edwards Lifesciences; and has received research grant support from Abbott and Medtronic. Dr Sorajja has served as a consultant for Abbott Structural, Boston Scientific, and Medtronic. Dr Duncan has served as a proctor and consultant for Abbott, Edwards Lifesciences, Medtronic, and Neochord. Dr Bethea has served as a consultant for Abbott. Dr Grayburn has served as a consultant for Abbott, Edwards Lifesciences, Valtech Cardio, and Neochord; and has received research grants from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Valtech Cardio, and Neochord. Drs Babaliaros and Denti have served as a consultant for Edwards Lifesciences and Abbott. Dr Guerrero has served as a consultant for Edwards Lifesciences and Abbott; and has received research grant support from Edwards Lifesciences. Dr Thourani has served as a consultant for and received research grant support from Abbott. Dr Dumonteil has served as a proctor and consultant for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Modine has served as a proctor and consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Blanke has received institutional grant support from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, MVRX, and Neovasc. Dr Leipsic has received institutional grant support from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, MVRX, and Neovasc. Dr Badhwar has served as an uncompensated consultant for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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