Transcatheter Mitral Valve Therapy in the United States,Journal of the American College of Cardiology

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Transcatheter Mitral Valve Therapy in the United States
Journal of the American College of Cardiology ( IF 24.0 ) Pub Date : 2021-10-25 , DOI: 10.1016/j.jacc.2021.07.058
Michael Mack ₁ , John D Carroll ₂ , Vinod Thourani ₃ , Sreekanth Vemulapalli ₄ , John Squiers ₁ , Pratik Manandhar ₅ , G Michael Deeb ₆ , Wayne Batchelor ₇ , Howard C Herrmann ₈ , David J Cohen ₉ , George Hanzel ₁₀ , Thomas Gleason ₁₁ , Ajay Kirtane ₁₂ , Nimesh Desai ₁₃ , Kim Guibone ₁₄ , Karen Hardy ₁₅ , Joan Michaels ₁₆ , J Michael DiMaio ₁ , Barbara Christensen ₁₆ , Susan Fitzgerald ₁₆ , Carole Krohn ₁₇ , Ralph G Brindis ₁₈ , Fred Masoudi ₁₉ , Joseph Bavaria ₁₃

Affiliation

Baylor Scott & White Health, Dallas, Texas, USA.
Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Department of Surgery, Piedmont Hospital, Atlanta, Georgia, USA.
Duke Clinical Research Institute, Durham, North Carolina, USA; Division of Cardiology, Department of Medicine, Duke University Health Care System, Durham, North Carolina, USA.
Duke Clinical Research Institute, Durham, North Carolina, USA.
Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA.
Inova Medical Group, Fairfax, Virginia, USA.
Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Cardiovascular Research Foundation, New York, New York, USA; St Francis Hospital, Roslyn, New York, USA.
Emory University, Atlanta, Georgia, USA.
University of Maryland, Baltimore Maryland, USA.
Cardiovascular Research Foundation, New York, New York, USA; Department of Medicine, Columbia University, New York, New York, USA.
Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
CommonSpirit Health, Lexington, Kentucky, USA.
American College of Cardiology, Washington, DC, USA.
The Society of Thoracic Surgeons, Chicago, Illinois, USA.
Philip R. Lee Institute for Health Policy Studies, University of California-San Francisco, San Francisco, California, USA.
Ascension Health, St Louis, Missouri, USA.

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763)

中文翻译：

美国的经导管二尖瓣治疗

胸外科医师协会/美国心脏病学会经导管瓣膜治疗登记处收集了几乎所有在美国使用经批准的装置接受经导管边缘到边缘修复 (TEER) 和经导管二尖瓣置换术 (TMVR) 的患者的数据。报告了 2014 年至 2020 年 3 月 31 日期间为 TEER 或 TMVR 提交的所有数据。共有 37,475 名患者接受了二尖瓣经导管手术，包括 33,878 名 TEER 和 3,597 名 TMVR。TEER 的年度手术量从 2014 年的每年 1,152 次增加到 2019 年的每年 10,460 次，分布在 403 个地点，而 TMVR 从每年 84 次增加到每年 1,120 次，分布在 301 个中心。TEER 的死亡率在 30 天 (5.6%-4.1%) 和 1 年 (27.4%-22.0%) 时有所下降。TMVR 在二尖瓣中瓣治疗中的早期超说明书使用数据获得美国批准食药监局2017年和2019年30天死亡率为3.9%。过去 6 年的结果总体改善是显而易见的。（STS/ACC TVT 注册二尖瓣模块；NCT02245763）

更新日期：2021-11-30

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