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

David W.M. Muller, Paul Sorajja, Alison Duncan, Brian Bethea, Gry Dahle, Paul Grayburn, Vasilis Babaliaros, Mayra Guerrero, Vinod H. Thourani, Francesco Bedogni, Paolo Denti, Nicolas Dumonteil, Thomas Modine, Paul Jansz, Michael L. Chuang, Philipp Blanke, Jonathon Leipsic, Vinay Badhwar

Research output: Contribution to journalArticlepeer-review

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)

Original languageEnglish (US)
Pages (from-to)1847-1859
Number of pages13
JournalJournal of the American College of Cardiology
Volume78
Issue number19
DOIs
StatePublished - Nov 9 2021

Keywords

  • heart failure
  • mitral regurgitation
  • mitral valve prosthesis
  • prognosis
  • transcatheter mitral valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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