2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation
| Autor: | 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, Brian Bethea |
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| Rok vydání: | 2021 |
| Předmět: |
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 |
| Zdroj: | Journal of the American College of Cardiology. 78:1847-1859 |
| ISSN: | 0735-1097 |
| Popis: | 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 ) |
| Databáze: | OpenAIRE |
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