ISSN 1671-5411 CN 11-5329/R
Volume 17 Issue 9
Oct.  2020
Turn off MathJax
Article Contents
Jia-You TANG, Lin-He LU, Yang LIU, Lan-Lan LI, Yan-Yan MA, Shi-Qiang YU, Jin-Cheng LIU, Jian YANG. Transcatheter mitral valve implantation using a novel system: preclinical results. J Geriatr Cardiol 2020; 17(9): 566-573. doi: 10.11909/j.issn.1671-5411.2020.09.001
Citation: Jia-You TANG, Lin-He LU, Yang LIU, Lan-Lan LI, Yan-Yan MA, Shi-Qiang YU, Jin-Cheng LIU, Jian YANG. Transcatheter mitral valve implantation using a novel system: preclinical results. J Geriatr Cardiol 2020; 17(9): 566-573. doi: 10.11909/j.issn.1671-5411.2020.09.001

Transcatheter mitral valve implantation using a novel system: preclinical results

doi: 10.11909/j.issn.1671-5411.2020.09.001
More Information
  • Corresponding author: Jian YANG, Department of Cardiovascular Surgery, Xijing Hospital, 710032, Xi'an, China. E-mail:
  • Received Date: 2020-04-21
  • Accepted Date: 2020-08-17
  • Rev Recd Date: 2020-08-07
  • Available Online: 2020-09-28
  • Publish Date: 2020-10-17
  •  Background This preclinical study in sheep sought to demonstrate the initial safety and feasibility of a novel transcatheter mitral valve system (Mi-thos valve) composed of a self-expanding frame and a bovine pericardial tissue bioprosthesis. Methods The valve was implanted in 26 sheep using a transapical approach for short- and long-term evaluation. The technical feasibility, safety, durability, and valve function were evaluated during and 6 months after the procedure using intracardiac and transthoracic echocardiography, multisliced computed tomography, histological analysis, and electron microscopy. Results The success rate of valve implantation was 100%, and the immediate survival rate after surgery was 84%. Five animals died within 90 min after the development of the prosthetic valve due to an acute left ventricular outflow tract obstruction (n = 2) and sudden intraoperative ventricular fibrillation (n = 3). Twelve animals died within 1 month due to acute left heart dysfunction. Mild (n = 5) and moderate (n = 2) paravalvular leakage occurred in seven animals, and two moderate PVL animals died of chronic heart failure within three months. Multimodality imaging studies of the remaining seven animals showed excellent function and alignment of the valves, with no coronary artery obstruction, no left ventricular outflow tract obstruction, no severe transvalvular gradients and no paravalvular leakage. Macroscopic evaluation demonstrated stable, secure positioning of the valve, with full endothelialization of the valve leaflets without injury to the ventricular or atrial walls. Histological and electron microscopic examinations at six months showed no obvious macro- or microcalcification in the leaflets. Conclusions Preclinical studies indicate that transcatheter implantation of the Mi-thos valve is technically safe and feasible. The durability, functionality, and lack of leaflet calcification were all verified in animal experiments. The information from these preclinical studies will be applied to patient selection criteria and the first-in-human studies.
  • *The authors contributed equally to this paper
  • loading
  • [1]
    Bonow RO, O'Gara PT, Adams DH, et al. 2020 Focused update of the 2017 ACC expert consensus decision pathway on the management of mitral regurgitation. J Am Coll Cardiol 2020; 75: 2236-2270.
    O'Gara PT, Grayburn PA, Badhwar V, et al. 2017 ACC expert consensus decision pathway on the management of mitral regurgitation: a report of the American College of Cardiology task force on expert consensus decision pathways. J Am Coll Cardiol 2017; 70: 2421-2449. doi: 10.1016/j.jacc.2017.09.019
    Karagodin I, Singh A, Lang RM. Pathoanatomy of Mitral Regurgitation. Struct Heart 2020; 4: 254-263. doi: 10.1080/24748706.2020.1765055
    Tommaso CL, Fullerton DA, Feldman T, et al. SCAI/AATS/ ACC/STS operator and institutional requirements for transcatheter valve repair and replacement. Part Ⅱ. Mitral valve. J Am Coll Cardiol 2014; 64: 1515-1526. doi: 10.1016/j.jacc.2014.05.005
    Rumsfeld JS, Holmes DR Jr., Stough WG, et al. Insights from the early experience of the Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapy Registry. J Am Coll Cardiol Interv 2015; 8: 377-381. doi: 10.1016/j.jcin.2014.09.022
    Taramasso M, Gaemperli O, Maisano F. Treatment of degenerative mitral regurgitation in elderly patients. Nat Rev Cardiol 2015; 12: 177-183. doi: 10.1038/nrcardio.2014.210
    Mylotte D, Piazza N. Transcatheter mitral valve implantation: A brief review. EuroIntervention 2015; 11 (Suppl W): W67-W70. doi: 10.4244/eijv11swa19
    Urena M, Himbert D, Vahanian A. Pushing the boundaries of transcatheter mitral valve replacement. J Am Coll Cardiol 2019; 73: 2535-2537.
    Ruiz CE, Kliger C, Perk G, et al. Transcatheter therapies for the treatment of valvular and paraavalvular regurgitation in acquired and congenital valvular heart disease. J Am Coll Cardiol 2015; 66: 169-183. doi: 10.1016/j.jacc.2015.05.034
    Overtchouk P, Piazza N, Granada JF, Modine T. Predictors of adverse outcomes after transcatheter mitral valve replacement. Expert Rev Cardiovasc Ther 2019; 17: 625-632. doi: 10.1080/14779072.2019.1653186
    Vogelhuber J, Weber M, Sinning JM, Nickenig G.[Transcatheter mitral valve replacement: current status]. Herz 2019; 44: 602-610.[Article in German]. doi: 10.1007/s00059-019-04851-9
    Maisano F, Alfieri O, Banai S, et al. The future of transcatheter mitral valve interventions: Competitive or complementary role of repair vs. replacement? Eur Heart J 2015; 36: 1651-1659. doi: 10.1093/eurheartj/ehv123
    Baldetti L, Melillo F, Beneduce A, et al. Transcatheter mitral valve implantation: who are we treating and what may we expect? Am J Cardiol 2019; 123: 1884-1885. doi: 10.1016/j.amjcard.2019.02.048
    Coisne A, Pontana F, Tchetche D, et al. Transcatheter mitral valve replacement: factors associated with screening success and failure. Eurointervention 2019; 15: e983-e989. doi: 10.4244/EIJ-D-19-00444
    Blanke P, Naoum C, Dvir D, et al. Predicting LVOT Obstruction in Transcatheter Mitral Valve Implantation: Concept of the Neo-LVOT. JACC Cardiovasc Imaging 2017; 10: 482-485. doi: 10.1016/j.jcmg.2016.01.005
    Ussia GP, Quadri A, Cammalleri V, et al. Percutaneous transfemoral-transseptal implantation of a second-generation cardiac mitral valve bioprosthesis: First procedure description and 30-day follow-up. EuroIntervention 2016; 11: 1126-1151. doi: 10.4244/EIJY15M09_01
    Sondergaard L, De Backer O, Franzen OW, et al. First-in- human case of transfemoral CardiAQ mitral valve implantation. Circ Cardiovasc Interv 2015; 8: e002135.
    Sondergaard L, Brooks M, Ihlemann N, et al. Transcatheter mitral valve implantation via transapical approach: An early experience. Eur J Cardiothorac Surg 2015; 48: 873-877. doi: 10.1093/ejcts/ezu546
    Verheye S, Cheung A, Leon M, Banai S. The Tiara transcatheter mitral valve implantation system. EuroIntervention 2015; 11 (Suppl W): W71-W72. doi: 10.4244/eijv11swa20
    Urena M, Vahanian A, Sondergaard L. Patient selection for transcatheter mitral valve implantation: why is it so hard to find patients? Eurointervention 2018; 14(AB): B83-B90. doi: 10.4244/EIJ-D-18-00510
    Langhammer B, Huber C, Windecker S, Carrel T. Surgical antegrade transcatheter mitral valve implantation for symptomatic mitral valve disease and heavily calcified annulus. Eur J Cardiothorac Surg 2017; 51: 382-385.
    Bapat V, Lim ZY, Boix R, Pirone F. The Edwards Fortis transcatheter mitral valve implantation system. EuroIntervention 2015; 11 (Suppl W): W73-W75.
    Werner N, Kilkowski C, Sutor D, et al. Transcatheter Mitral Valve Implantation (TMVI) Using Edwards SAPIEN 3 Prostheses in patients at very high or prohibitive surgical risk: a single-center experience. J Interv Cardiol 2020; 2020: 9485247.
    Abdul-Jawad Altisent O, Dumont E, et al. Transcatheter mitral valve implantation with the Fortis device: Insights into the evaluation of device success. J Am Coll Cardiol Interv 2015; 8: 994-995. doi: 10.1016/j.jcin.2015.01.036
    Badhwar V, Sorajja P, Duncan A, et al. Mitral regurgitation severity predicts one-year therapeutic benefit of Tendyne transcatheter mitral valve implantation. Eurointervention 2019; 15: e1065-e1071. doi: 10.4244/EIJ-D-19-00333
  • 加载中


    通讯作者: 陈斌,
    • 1. 

      沈阳化工大学材料科学与工程学院 沈阳 110142

    1. 本站搜索
    2. 百度学术搜索
    3. 万方数据库搜索
    4. CNKI搜索

    Figures(7)  / Tables(1)

    Article Metrics

    Article views (212) PDF downloads(13) Cited by()
    Proportional views


    DownLoad:  Full-Size Img  PowerPoint