PMID- 34736561 OWN - NLM STAT- MEDLINE DCOM- 20220103 LR - 20220103 IS - 1558-3597 (Electronic) IS - 0735-1097 (Linking) VI - 78 IP - 19 DP - 2021 Nov 9 TI - 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. PG - 1847-1859 LID - S0735-1097(21)06220-3 [pii] LID - 10.1016/j.jacc.2021.08.060 [doi] AB - 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). CI - Copyright (c) 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. FAU - Muller, David W M AU - Muller DWM AD - Cardiology Department, St Vincent's Hospital, Sydney, New South Wales, Australia. Electronic address: dmuller@stvincents.com.au. FAU - Sorajja, Paul AU - Sorajja P AD - Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA. FAU - Duncan, Alison AU - Duncan A AD - Royal Brompton Hospital, London, United Kingdom. FAU - Bethea, Brian AU - Bethea B AD - MedStar Union Memorial Hospital, Baltimore, Maryland, USA. FAU - Dahle, Gry AU - Dahle G AD - Oslo University Hospital, Oslo, Norway. FAU - Grayburn, Paul AU - Grayburn P AD - Baylor University Medical Center, Dallas, Texas, USA. FAU - Babaliaros, Vasilis AU - Babaliaros V AD - Emory University Hospital, Atlanta, Georgia, USA. FAU - Guerrero, Mayra AU - Guerrero M AD - Mayo Clinic, Rochester, Minnesota, USA. FAU - Thourani, Vinod H AU - Thourani VH AD - Piedmont Heart Institute, Atlanta, Georgia, USA. FAU - Bedogni, Francesco AU - Bedogni F AD - IRCCS Policlinico San Donato, Milan, Italy. FAU - Denti, Paolo AU - Denti P AD - Ospedale San Raffaele, Milan, Italy. FAU - Dumonteil, Nicolas AU - Dumonteil N AD - Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France. FAU - Modine, Thomas AU - Modine T AD - Unite Medico Chirurgicale de Valvulopathie, CHU de Bordeaux, Bordeaux, France. FAU - Jansz, Paul AU - Jansz P AD - Department of Cardiothoracic Surgery, St Vincent's Hospital Sydney, Sydney, New South Wales, Australia. FAU - Chuang, Michael L AU - Chuang ML AD - Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. FAU - Blanke, Philipp AU - Blanke P AD - St Paul's Hospital, Vancouver, British Columbia, Canada. FAU - Leipsic, Jonathon AU - Leipsic J AD - St Paul's Hospital, Vancouver, British Columbia, Canada. FAU - Badhwar, Vinay AU - Badhwar V AD - West Virginia University Heart and Vascular Institute, Morgantown, West Virginia, USA. LA - eng SI - ClinicalTrials.gov/NCT02321514 PT - Clinical Study PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 SB - IM CIN - J Am Coll Cardiol. 2021 Nov 9;78(19):1860-1862. PMID: 34736562 MH - Aged MH - Cardiac Catheterization/*methods MH - Echocardiography/methods MH - Female MH - *Heart Valve Prosthesis MH - *Heart Valve Prosthesis Implantation/adverse effects/methods MH - Humans MH - Long Term Adverse Effects/*mortality MH - Male MH - *Mitral Valve/diagnostic imaging/surgery MH - *Mitral Valve Insufficiency/diagnosis/mortality/physiopathology/surgery MH - *Postoperative Complications/diagnosis/epidemiology MH - Severity of Illness Index MH - Stroke Volume MH - Treatment Outcome MH - *Ventricular Dysfunction, Left/diagnosis/etiology/physiopathology OTO - NOTNLM OT - heart failure OT - mitral regurgitation OT - mitral valve prosthesis OT - prognosis OT - transcatheter mitral valve replacement COIS- 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. EDAT- 2021/11/06 06:00 MHDA- 2022/01/04 06:00 CRDT- 2021/11/05 05:37 PHST- 2021/05/04 00:00 [received] PHST- 2021/08/16 00:00 [revised] PHST- 2021/08/23 00:00 [accepted] PHST- 2021/11/05 05:37 [entrez] PHST- 2021/11/06 06:00 [pubmed] PHST- 2022/01/04 06:00 [medline] AID - S0735-1097(21)06220-3 [pii] AID - 10.1016/j.jacc.2021.08.060 [doi] PST - ppublish SO - J Am Coll Cardiol. 2021 Nov 9;78(19):1847-1859. doi: 10.1016/j.jacc.2021.08.060.