David W M Muller1, Paul Sorajja2, Alison Duncan3, Brian Bethea4, Gry Dahle5, Paul Grayburn6, Vasilis Babaliaros7, Mayra Guerrero8, Vinod H Thourani9, Francesco Bedogni10, Paolo Denti11, Nicolas Dumonteil12, Thomas Modine13, Paul Jansz14, Michael L Chuang15, Philipp Blanke16, Jonathon Leipsic16, Vinay Badhwar17. 1. Cardiology Department, St Vincent's Hospital, Sydney, New South Wales, Australia. Electronic address: dmuller@stvincents.com.au. 2. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA. 3. Royal Brompton Hospital, London, United Kingdom. 4. MedStar Union Memorial Hospital, Baltimore, Maryland, USA. 5. Oslo University Hospital, Oslo, Norway. 6. Baylor University Medical Center, Dallas, Texas, USA. 7. Emory University Hospital, Atlanta, Georgia, USA. 8. Mayo Clinic, Rochester, Minnesota, USA. 9. Piedmont Heart Institute, Atlanta, Georgia, USA. 10. IRCCS Policlinico San Donato, Milan, Italy. 11. Ospedale San Raffaele, Milan, Italy. 12. Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France. 13. Unité Médico Chirurgicale de Valvulopathie, CHU de Bordeaux, Bordeaux, France. 14. Department of Cardiothoracic Surgery, St Vincent's Hospital Sydney, Sydney, New South Wales, Australia. 15. Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. 16. St Paul's Hospital, Vancouver, British Columbia, Canada. 17. West Virginia University Heart and Vascular Institute, Morgantown, West Virginia, USA.
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).
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).
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