刘洪序,刘光祖,陈扬,陈浩,陈阳,刘世栋,宋兵

• 1:兰州大学第一临床医学院
• 2:兰州大学第一医院心血管外科

摘要(Abstract)：

目的 应用Meta分析评价经导管二尖瓣置换术（TMVR）治疗二尖瓣关闭不全（MR）的安全性及有效性。方法 计算机检索PubMed、EMbase、the Cochrane Library、 Web of Science、中国期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、维普（VIP）、万方数据库（Wanfang Data），检索时限均从建库至2023年9月，由2名研究员独立筛选文献、提取资料后，采用MINORS评价工具评价纳入研究的质量，并采用Stata 17.0软件进行Meta分析，并根据手术路径进行亚组分析。结果 最终纳入9篇研究，共计635例样本量。Meta分析结果显示：瓣膜置入成功率的合并结果为96.2%[95%CI(93.3%～98.4%)]。亚组分析结果显示，经心尖成功率为94.7%[95%CI(87.7%～99.2%)]，经股成功率为92.5%[95%CI(80.7%～99.5%)]。此外术后30 d死亡率的合并结果为9.1%[95%CI(4.4%～15.0%)]，术后30 d纽约心脏病协会心功能分级≤Ⅱ级的合并结果为68.4%[95%CI(61.5%～75.0%)]，术后30 d内大出血的合并结果为20.9%[95%CI(9.8%～34.3%)]，术中中转开胸的合并结果为3.0%[95%CI(0.0%～9.0%]，术后30 d新发心房颤动的合并结果为12.2%[95%CI(5.3%～21.1%)],30 d脑血管事件的合并结果为1.3%[95%CI(0.2%～3.0%)]，术后1年死亡率的合并结果为28.0%[95%CI(23.4%～32.8%)]。结论 应用TMVR治疗MR安全有效。本研究在研究数量及质量上有限，存在一定的局限性，尚需更大样本量的随机对照试验加以证实。

关键词(KeyWords)： 经导管二尖瓣置换术;二尖瓣关闭不全;Meta分析

Abstract:

Keywords:

基金项目(Foundation): 甘肃省自然科学基金项目（22JR11RA037）

作者(Author): 刘洪序,刘光祖,陈扬,陈浩,陈阳,刘世栋,宋兵

参考文献(References)：

• [1] Del Forno B, De Bonis M, Agricola E,et al. Mitral valve regurgitation:a disease with a wide spectrum of therapeutic options[J]. Nat Rev Cardiol,2020,17(12):807-827.DOI:10.1038/s41569-020-0395-7.
• [2]中国医师协会心血管内科医师分会，中国康复医学会心脏介入治疗和康复专业委员会，中国医院协会心脏康复管理专业委员会.经导管二尖瓣缘对缘修复术患者心脏康复中国专家共识[J].中国介入心脏病学杂志，2023,31(4):252-265.DOI:10.3969/j.issn.1004-8812.2023.04.002.
• [3] Otto CM, Nishimura RA, Bonow RO,et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease:a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines[J]. J Am Coll Cardiol,2021,77(4):e25-e197. DOI:10.1016/j.jacc.2020.11.018.
• [4] Vahanian A, Beyersdorf F, Praz F,et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease[J]. Eur J Cardiothorac Surg,2021,60(4):727-800. DOI:10.1093/ejcts/ezab389.
• [5] Iung B, Delgado V, Rosenhek R,et al. Contemporary presentation and management of valvular heart disease:the EURObservational research programme valvular heart disease II survey[J]. Circulation,2019,140(14):1156-1169.DOI:10.1161/circulationaha.119.041080.
• [6] Yang Y, Wang Z, Chen Z,et al. Current status and etiology of valvular heart disease in China:a population-based survey[J].BMC Cardiovasc Disord,2021,21(1):339. DOI:10.1186/s12872-021-02154-8.
• [7] Badhwar V, Smith AJ, Cavalcante JL. A pathoanatomic approach to the management of mitral regurgitation[J]. Trends Cardiovasc Med.,2016,26(2):126-134. DOI:10.1016/j.tcm.2015.05.007.
• [8] Goel SS, Bajaj N, Aggarwal B,et al. Prevalence and outcomes of unoperated patients with severe symptomatic mitral regurgitation and heart failure:comprehensive analysis to determine the potential role of MitraClip for this unmet need[J]. J Am Coll Cardiol,2014,63(2):185-186. DOI:10.1016/j.jacc.2013.08.723.
• [9] El Sabbagh A, Reddy YNV, Nishimura RA. Mitral valve regurgitation in the contemporary era:insights into diagnosis,management,and future directions[J]. JACC Cardiovasc Imaging,2018,11(4):628-643. DOI:10.1016/j.jcmg.2018.01.009.
• [10] Praz F, Brugger N, Kassar M,et al. Interventional treatment of mitral valve regurgitation:an alternative to surgery?[J].Swiss Med Wkly,2019,149:w20023. DOI:10.4414/smw.2019.20023.
• [11] Mirabel M, Iung B, Baron G,et al. What are the characteristics of patients with severe,symptomatic,mitral regurgitation who are denied surgery?[J]. Eur Heart J,2007,28(11):1358-1365. DOI:10.1093/eurheartj/ehm001.
• [12] Del Val D, Ferreira-Neto AN, Wintzer-Wehekind J,et al.Early experience with transcatheter mitral valve replacement:a systematic review[J]. J Am Heart Assoc,2019,8(17):e013332. DOI:10.1161/jaha.119.013332.
• [13] Nishimura RA, Vahanian A, Eleid MF,et al. Mitral valve disease--current management and future challenges[J].Lancet,2016,387(10025):1324-1334. DOI:10.1016/s0140-6736(16)00558-4.
• [14] S?ndergaard L, De Backer O, Franzen OW,et al. Firstin-human case of transfemoral CardiAQ mitral valve implantation[J]. Circ Cardiovasc Interv,2015,8(7):e002135. DOI:10.1161/circinterventions.115.002135.
• [15] 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.
• [16] Bapat V, Rajagopal V, Meduri C,et al. Early experience with new transcatheter mitral valve replacement[J]. J Am Coll Cardiol,2018,71(1):12-21. DOI:10.1016/j.jacc.2017.10.061.
• [17] Coisne A, Pontana F, TchétchéD,et al. Transcatheter mitral valve replacement:factors associated with screening success and failure[J]. EuroIntervention,2019,15(11):e983-e989.DOI:10.4244/eij-d-19-00444.
• [18] Zahr F, Song HK, Chadderdon SM,et al. 30-day outcomes following transfemoral transseptal transcatheter mitral valve replacement:intrepid TMVR early feasibility study results[J].JACC Cardiovasc Interv,2022,15(1):80-89. DOI:10.1016/j.jcin.2021.10.018.
• [19] Webb J, Hensey M, Fam N,et al. Transcatheter mitral valve replacement with the transseptal EVOQUE system[J].JACC Cardiovasc Interv,2020,13(20):2418-2426. DOI:10.1016/j.jcin.2020.06.040.
• [20] Regueiro A, Ye J, Fam N,et al. 2-year outcomes after transcatheter mitral valve replacement[J]. JACC Cardiovasc Interv,2017,10(16):1671-1678. DOI:10.1016/j.jcin.2017.05.032.
• [21] Webb JG, Murdoch DJ, Boone RH,et al. Percutaneous transcatheter mitral valve replacement：fi rst-in-human experience with a new transseptal system[J]. J Am Coll Cardiol,2019,73(11):1239-1246. DOI:10.1016/j.jacc.2018.12.065.
• [22] Wilde N, Tanaka T, Vij V,et al. Characteristics and outcomes of patients undergoing transcatheter mitral valve replacement with the Tendyne system[J]. Clin Res Cardiol,2023. DOI:10.1007/s00392-023-02155-x.
• [23] 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.
• [24] Lazam S,Vanoverschelde JL, Tribouilloy C,et al. Twentyyear outcome after mitral repair versus replacement for severe degenerative mitral regurgitation:analysis of a large,prospective,multicenter,international registry[J]. Circulation,2017,135(5):410-422. DOI:10.1161/circulationaha.116.023340.
• [25] Jung JC, Jang MJ, Hwang HY. Meta-analysis comparing mitral valve repair versus replacement for degenerative mitral regurgitation across all ages[J]. Am J Cardiol,2019,123(3):446-453. DOI:10.1016/j.amjcard.2018.10.024.
• [26] Alperi A, Granada JF, Bernier M,et al. Current Status and Future Prospects of Transcatheter Mitral Valve Replacement:JACC state-of-the-art review[J]. J Am Coll Cardiol,2021,77(24):3058-3078. DOI:10.1016/j.jacc.2021.04.051.
• [27] Kargoli F, Pagnesi M, Rahgozar K,et al. Current devices and complications related to transcatheter mitral valve replacement:the bumpy road to the top[J]. Front Cardiovasc Med,2021,8:639058. DOI:10.3389/fcvm.2021.639058.
• [28] Latib A,Ancona MB,Ferri L,et al. Percutaneous direct annuloplasty with cardioband to treat recurrent mitral regurgitation after MitraClip implantation[J]. JACC Cardiovasc Interv,2016,9(18):e191-e192. DOI:10.1016/j.jcin.2016.06.028.
• [29] Messika-Zeitoun D, Nickenig G, Latib A,et al. Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system:1 year outcomes[J]. Eur Heart J,2019,40(5):466-472. DOI:10.1093/eurheartj/ehy424.
• [30] Maisano F, Alfi eri O, Banai S,et al. The future of transcatheter mitral valve interventions:competitive or complementary role of repair vs. replacement?[J]. Eur Heart J,2015,36(26):1651-1659. DOI:10.1093/eurheartj/ehv123.
• [31] Regueiro A, Granada JF, Dagenais F,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.
• [32] Tsang W. Recent advances in understanding and managing mitral valve disease[J]. F1000Res,2019,8:F1000 Faculty Rev-1686. DOI:10.12688/f1000research.16066.1.
• [33]牛冠男，宋光远，吴永健.经导管二尖瓣置换术在特殊类型二尖瓣疾病患者中的应用[J].中国介入心脏病学杂志，2021,29(08):473-476. DOI:10.3969/j.issn.1004-8812.2021.08.009.
• [34] Xiling Z, Puehler T, Sondergaard L,et al. Transcatheter mitral valve repair or replacement:competitive or complementary?[J].J Clin Med,2022,11(12):3377. DOI:10.3390/jcm11123377.
• [35]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.
• [36]陈旭东，张逸杰，韦洋.经导管二尖瓣置换治疗原发性二尖瓣反流的研究进展[J].心血管病学进展，2023,44(2):137-141. DOI:10.16806/j.cnki.issn.1004-3934.2023.02.009.
• [37] 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):2075-88. DOI:10.1016/j.jacc.2015.08.881.
• [38]尚小珂，虞奇峰，杨洁琰，等.经导管二尖瓣置换技术难点概述[J].中国介入心脏病学杂志，2023,31(8):609-614.DOI:10.3969/j.issn.1004-8812.2023.08.008.
• [39] Mack M, Carroll JD, Thourani V,et al. Transcatheter mitral valve therapy in the United States:a report from the STSACC TVT registry[J]. J Am Coll Cardiol,2021,78(23):2326-2353. DOI:10.1016/j.jacc.2021.07.058.
• [40] Lim DS, Kar S, Spargias K,et al. Transcatheter valve repair for patients with mitral regurgitation:30-day results of the CLASP study[J]. JACC Cardiovasc Interv,2019,12(14):1369-1378. DOI:10.1016/j.jcin.2019.04.034.
• [41] Gammie JS, Bartus K, Gackowski A,et al. Beating-heart mitral valve repair using a novel ePTFE cordal implantation device:a prospective trial[J]. J Am Coll Cardiol,2018,71(1):25-36. DOI:10.1016/j.jacc.2017.10.062.
• [42] Takagi H, Hari Y, Kawai N,et al. Transcatheter mitral valve replacement for mitral regurgitation-A meta-analysis[J]. J Card Surg,2018,33(12):827-835. DOI:10.1111/jocs.13963.