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

被引：100

作者：

Muller, David W. M. ^{[1
]}

Sorajja, Paul ^{[2
]}

Duncan, Alison ^{[3
]}

Bethea, Brian ^{[4
]}

Dahle, Gry ^{[5
]}

Grayburn, Paul ^{[6
]}

Babaliaros, Vasilis ^{[7
]}

Guerrero, Mayra ^{[8
]}

Thourani, Vinod H. ^{[9
]}

Bedogni, Francesco ^{[10
]}

Denti, Paolo ^{[11
]}

Dumonteil, Nicolas ^{[12
]}

Modine, Thomas ^{[13
]}

Jansz, Paul ^{[14
]}

Chuang, Michael L. ^{[15
]}

Blanke, Philipp ^{[16
]}

Leipsic, Jonathon ^{[16
]}

Badhwar, Vinay ^{[17
]}

机构：

[1] St Vincents Hosp, Cardiol Dept, Sydney, NSW, Australia

[2] Abbott NW Hosp, Minneapolis Heart Inst, Minneapolis, MN USA

[3] Royal Brompton Hosp, London, England

[4] MedStar Union Mem Hosp, Baltimore, MD USA

[5] Oslo Univ Hosp, Oslo, Norway

[6] Baylor Univ, Med Ctr, Dallas, TX USA

[7] Emory Univ Hosp, Atlanta, GA USA

[8] Mayo Clin, Rochester, MN USA

[9] Piedmont Heart Inst, Atlanta, GA USA

[10] IRCCS Policlin San Donato, Milan, Italy

[11] Osped San Raffaele, Milan, Italy

[12] Clin Pasteur, Grp CardioVasc Interventionnel, Toulouse, France

[13] CHU Bordeaux, Unite Med Chirurg Valvulopathie, Bordeaux, France

[14] St Vincents Hosp Sydney, Dept Cardiothorac Surg, Sydney, NSW, Australia

[15] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[16] St Pauls Hosp, Vancouver, BC, Canada

[17] West Virginia Univ, Heart & Vasc Inst, Morgantown, WV 26506 USA

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2021年 / 78卷 / 19期

关键词：

heart failure; mitral regurgitation; mitral valve prosthesis; prognosis; transcatheter mitral valve replacement; TRIAL DESIGN PRINCIPLES; END-POINT DEFINITIONS; HEART-FAILURE; EUROPEAN ASSOCIATION; CONSENSUS DOCUMENT; CARDIOLOGY ESC; REPAIR; FEASIBILITY; REDUCTION; PROGNOSIS;

D O I：

10.1016/j.jacc.2021.08.060

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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) (J Am Coll Cardiol 2021;78:1847-1859) (c) 2021 by the American College of Cardiology Foundation.

引用

页码：1847 / 1859

页数：13

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