1. 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation
- Author
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Paul Sorajja, Gry Dahle, Jonathon Leipsic, Vasilis C. Babaliaros, Michael L Chuang, Paul Jansz, Philipp Blanke, Thomas Modine, Paul A. Grayburn, Francesco Bedogni, Mayra Guerrero, Vinod H. Thourani, Paolo Denti, Alison Duncan, Vinay Badhwar, Nicolas Dumonteil, David W.M. Muller, and Brian Bethea
- Subjects
Male ,Cardiac Catheterization ,medicine.medical_specialty ,medicine.medical_treatment ,Long Term Adverse Effects ,Severity of Illness Index ,Ventricular Dysfunction, Left ,Postoperative Complications ,Internal medicine ,Mitral valve ,medicine ,Humans ,In patient ,Prospective cohort study ,Aged ,Heart Valve Prosthesis Implantation ,Mitral regurgitation ,Ejection fraction ,business.industry ,Mitral valve replacement ,Mitral Valve Insufficiency ,Stroke Volume ,medicine.disease ,Treatment Outcome ,medicine.anatomical_structure ,Echocardiography ,Heart Valve Prosthesis ,Heart failure ,Ventricular pressure ,Cardiology ,Mitral Valve ,Female ,Cardiology and Cardiovascular Medicine ,business - 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 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 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 )
- Published
- 2021