尚小珂,虞奇峰,杨洁琰,王雪丽 ,陈松 ,孙明,吴春林,张雄,王美莹,张长东,柳梅,董念国

• 1:华中科技大学同济医学院附属协和医院心脏大血管外科
• 2:华中科技大学同济医学院附属协和医院实验室

摘要(Abstract)：

二尖瓣反流（M R）是最常见的心脏瓣膜疾病之一，经导管二尖瓣置换术（TMVR）逐步成为治疗MR的重要研究及发展方向。本文阐述了TMVR产品目前研发遇到的技术难点以及TMVR未来的发展趋势，对多款国内外TMVR产品设计特点进行比较分析，概括了TMVR产品设计开发时需要考虑的重点与难点，如锚定、瓣周漏、流出道梗阻等。最后对TMVR产品未来的市场前景进行了展望。

关键词(KeyWords)： 经导管二尖瓣置换术;二尖瓣反流;瓣周漏;瓣膜锚定;左心室流出道梗阻

Abstract:

Keywords:

基金项目(Foundation): “十三五”国家重点研发计划项目（2016YF0101100）;; “十四五”国家重点研发计划项目（2021YF1101900）

作者(Author): 尚小珂,虞奇峰,杨洁琰,王雪丽 ,陈松 ,孙明,吴春林,张雄,王美莹,张长东,柳梅,董念国

参考文献(References)：

• [1] Ludwig S,Perrin N,Coisne A,et al. Clinical outcomes of transcatheter mitral valve replacement:two-year results of the CHOICE-MI Registry[J]. EuroIntervention,2023,19(6):512-525. DOI:10.4244/EIJ-D-22-01037.
• [2] Xu H, Liu Q, Cao K, et al. Distribution, characteristics,and management of older patients with valvular heart disease in China[J]. JACC Asia,2022,2(3):354-365. DOI:10.1016/jacasi.2021.11.013.
• [3] Iung B, Vahanian A. Epidemiology of acquired valvular heart disease[J]. Can J Cardiol,2014,30(9):962-970. DOI:10.1016/j.cjca.2014.03.022.
• [4]徐亚鹏，王海山，杨夏燕，等.经导管二尖瓣置换产品设计开发及临床研究进展[J].中国介入心脏病学杂志，2022, 30(10):791-796. DOI:10. 3969/j. issn. 1004-8812. 2022. 10. 011.
• [5]潘文志，周达新，葛均波.中国二尖瓣反流患者人群数量的估测[J].中国胸心血管外科临床杂志，2021, 28(5):495-498. DOI:10.7507/1007-4848.202012080.
• [6] Taramasso M, Candreva A, Pozzoli A, et al. Current challenges in interventional mitral valve treatment[J]. J Thorac Dis,2015,7(9):1536-1542. DOI:10.3978/j.issn.2072-1439.2015.04.58.
• [7] Head SJ, van Leeuwen WJ, Van Mieghem NM, et al. Surgical or transcatheter mitral valve intervention:complex disease requires complex decisions[J]. EuroIntervention,2014,9(10):1133-1135. DOI:10.4244/EIJV9I10A191.
• [8]中国医师协会心血管内科医师分会结构性心脏病学组，亚太结构性心脏病俱乐部.中国经导管二尖瓣缘对缘修复术临床路径（2022版）精简版[J].中国介入心脏病学杂志，2023,31(3):161-173. DOI:10. 3969/j. issn. 1004-8812. 2023. 03. 001.
• [9] Bapat V, Buellesfeld L, Peterson MD, et al. Transcatheter mitral valve implantation(TMVI)using the Edwards FORTIS d e v i c e[J]. E u r o I n t e r v e n t i o n, 2 0 1 4, 1 0 S u p p l U:U120-U128. DOI:10.4244/EIJV10SUA18.
• [10]张新鑫，朱黎明，焦国庆.经导管二尖瓣置换术治疗二尖瓣反流的研究进展[J].山东医药，2022, 62(34):108-111. DOI:10. 3969/j. issn. 1002-266X. 2022.34.027.
• [11] Davidson LJ, Davidson CJ. Transcatheter treatment of valvular heart disease:a review[J]. JAMA,2021,325(24):2480-2494. DOI:10.1001/jama.2021.2133.
• [12]潘文志，周达新，葛均波.经导管二尖瓣置换术的应用现状与展望[J].上海医药，2017,38(3):11-15. DOI:10.3969/j.issn.1006-1533.2017.03.003.
• [13] Mylotte D, Piazza N. Transcatheter mitral valve implantation:a brief review[J]. EuroIntervention,2015,11 Suppl W:W67-W70. DOI:10.4244/EIJV11SWA19.
• [14] S?ndergaard L,De Backer O,Franzen OW,et al.First-in-human case of transfemoral cardiaq mitral valve implantation[J]. Circ Cardiovasc Interv,2015,8(7):e002135. DOI:10.1161/CIRCINTERVENTIONS.115.002135.
• [15] De Backer O, Piazza N, Banai S, et al. Percutaneous transcatheter mitral valve replacement:an overview of devices in preclinical and early clinical evaluation[J]. Circ Cardiovasc Interv,2014,7(3):400-409. DOI:10.1161/CIRCINTERVENTIONS.114.001607.
• [16] Mack M, Carroll JD, Thourani V, et al.Transcatheter mitral valve therapy in the united states:a report from the STS/ACC TVT registry[J]. Ann Thorac Surg,2022,113(1):337-365. DOI:10.1016/j.athoracsur.2021.07.030.
• [17]严道医声网.刘洋：经导管二尖瓣置换的技术难点及研究进展（直播回看|2023长安国际心血管病论坛（CIC 2023））[EB/OL].(2023-05)[2023-06-15]. https：//www.drvoice.cn/v2/speaker/1377805402480641.
• [18] Russo G, Gennari M, Gavazzoni M, et al.Transcatheter mitral valve implantation:current status and future perspectives[J].Circ Cardiovasc Interv,2021,14(9):e010628. DOI:10.1161/CIRCINTERVENTIONS.121.010628.
• [19]严道医声网. TCT 2022|零死亡零卒中——美敦力经股二尖瓣置换瓣膜Intrepid EFS研究中期结果发布[EB/OL].(2022-09)[2023-06-15]. https://mp.weixin.qq.com/s?__biz=MzA5Mj g3OTA4MQ==&mid=2651167491&idx=1&sn=c246d4fcfb92623554745e995d93cfdb&chksm=8b975a85bce0d3936ecfbb6aefbf35f3b396735d0509abac0322afdbad5fcdcfd70b3c7fd5b5&scene=27.
• [20]严道医声网.心通医疗自主研发的经导管二尖瓣置换系统于中山医院成功开展首例临床应用，30天随访结果优异[EB/OL].(2022-08)[2023-06-15]. https://mp.weixin.qq.com/s?__biz=Mz A5Mjg3OTA4MQ==&mid=2651153843&idx=4&sn=259fd7ecbe133826b99e607ad52a00c4&chksm=8b97a435bce02d236a5155664ad18fc314cda51e437c8fa59829ca1aad8db1cd31703cbdd098&scene=27.
• [21]严道医声网.中国首款二尖瓣置换系统Mi-thos?正式进入注册临床研究[EB/OL].(2021-02)[2023-06-15]. https：//www.drvoice.cn/v2/article/6609?sourceId=11&sourceType=19.
• [22]严道医声网. MitraFix?经导管人工二尖瓣系统正式进入注册临床研究[EB/OL].(2021-05)[2023-06-15]. https://mp.weixin.qq.com/s/nC1e4iaSV6J9HB7c3XrNqA.
• [23]严道医声网.岁末寒冬闻喜讯，蹄疾步稳拓新局|武汉协和医院顺利完成TrudeltaTM经导管二尖瓣瓣膜系统全国首例临床置入[EB/OL].(2022-01)[2023-06-15]. https://www.drvoice.cn/v2/article/8349.
• [24] Cohen DJ, Ludwig S, Piazza N. Transcatheter mitral valve replacement will remain a niche therapy:pros and cons[J].EuroIntervention,2023,18(15):1222-1225. DOI:10.4244/EIJ-E-22-00044.
• [25] Muller DWM,Sorajja P,Duncan A,et al. 2-year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation[J]. J Am Coll Cardiol,2021,78(19):1847-1859. DOI:10.1016/j.jacc.2021.08.060.
• [26] Niikura H, G?ssl M, Kshettry V, et al. Causes and clinical outcomes of patients who are ineligible for transcatheter mitral valve replacement[J]. JACC Cardiovasc Interv,2019,12(2):196-204. DOI:10.1016/j.jcin.2018.10.042.
• [27] Ben Ali W, Ludwig S, Duncan A, et al.Characteristics and outcomes of patients screened for transcatheter mitral valve implantation:1-year results from the CHOICE-MI registry[J].Eur J Heart Fail,2022,24(5):887-898. DOI:10.1002/ejhf.2492.
• [28] Preston-Maher GL, Torii R, Burriesci G. A Technical review of minimally invasive mitral valve replacements[J]. Cardiovasc Eng Technol,2015,6(2):174-184. DOI:10.1007/s13239-014-0203-9.
• [29] Regueiro A, Granada JF, Dagenais, et al.Transcatheter mitral valve replacement:insights from early clinical experience and future challenges[J]. J Am Coll Cardiol,2017,69(17):2175-2192. DOI:10.1016/j.jacc.2017.02.045.
• [30]蛋壳研究院，突围二尖瓣：百亿美金，十八般兵器与三重门蛋壳研究院赛道估值报告系列之TMV（经导管二尖瓣器械）.[EB/OL].(2022-01)[2023-06-15]. https：//www.vbdata.cn/reportDetail?rid=5c6d5b105c7969aa35d695f461d2d86e.
• [31] Blanke P, Naoum C, Dvir D, et al. Predicting LVOT obstruction in transcatheter mitral valve implantation:concept of the Neo-LVOT[J]. JACC Cardiovasc Imaging,2017,10(4):482-485. DOI:10.1016/j.jcmg.2016.01.005.
• [32] Goode D, Dhaliwal R, Mohammadi H. Transcatheter mitral valve replacement:state of the art[J]. Cardiovasc Eng Technol,2020,11(3):229-253. DOI:10.1007/s13239-020-00460-4.
• [33]李然犀，范嘉祺，戴晗怡，等.经导管二尖瓣置换术后左心室流出道梗阻风险的术前评估研究进展[J].中国介入心脏病学杂志，2022,30(11):850-854. DOI:10. 3969/j. issn.1004-8812. 2022. 11. 009.
• [34]刘威，潘湘斌.二尖瓣反流介入治疗研究现状及中国二尖瓣反流介入领域展望[J].中国循环杂志，2021,36(4):407-411. DOI:10.3969/j.issn.1000-3614.2021.04.016.
• [35] Eleid MF, Collins JD, Mahoney P, et al. Emerging approaches to management of left ventricular outfl ow obstruction risk in transcatheter mitral valve replacement[J]. JACC Cardiovasc Interv,2023,16(8):885-895. DOI:10.1016/j.jcin.2023.01.357.
• [36]严道医声网.尚小珂：二尖瓣介入治疗新进展产品与病例分享（微创）（直播回看|首届中部结构性心脏病会议暨江西省医学会介入心血管病学分会第三次学术会议（CSHC2023））[EB/OL].(2023-06)[2023-06-15]. https：//www.drvoice.cn/v2/speaker/1379486894841859.
• [37] Yang L, Huang X, Deng L, et al. Pre-mounted dry TAVI valve with improved endothelialization potential using REDVloaded PEGMA hydrogel hybrid pericardium[J]. J Mater Chem B,2020,8(13):2689-2701. DOI:10.1039/C9TB00879A.
• [38] Hu X, Li S, Peng P, et al. Prosthetic heart valves for transcatheter aortic valve replacement[J]. BMEMat, 2023,1(2):e12026. DOI:10.1002/bmm2.12026.
• [39] Ribeiro HB, Nombela-Franco L, Mu?oz-García AJ,et al. Predictors and impact of myocardial injury after transcatheter aortic valve replacement:a multicenter registry[J]. J Am Coll Cardiol,2015,66(19):2075-2088. DOI:10.1016/j.jacc.2015.08.881.
• [40] Firas Zahr. TCT 2021:Intrepid TMVR Early Feasibility:Thirty-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement.[EB/OL].(2021-11)[2 0 2 3-0 6-1 5]. h t t p s：//w w w. t c t m d. c o m/s l i d e/intrepid-tmvr-early-feasibility-thirty-day-outcomes-followingtransfemoral-transseptal.
• [41]马翔，王宝珠，马依彤. 2022年度全球瓣膜病领域大事件盘点[J].中国介入心脏病学杂志，2023,31(1):19-24.DOI:10. 3969/j. issn. 1004-8812. 2023. 01. 004.
• [42]葛均波.结构性心脏病的定义、范畴及其现状和未来[J].上海医学，2021,44(4):217-220. DOI:10.19842/j.cnki.issn.0253-9934.2021.04.001.