Skip to main content
SpringerLink
Log in

Development of self-expanding valved stents with autologous tubular leaflet tissues for transcatheter valve implantation

  • Original Article
  • Tissue Engineering / Regenerative Medicine
  • Published:
Journal of Artificial Organs Aims and scope Submit manuscript

Abstract

In this study, self-expanding valved stents were prepared by in-body tissue architecture technology. As molds, plastic rods (outer diameter; 14 or 25 mm), mounted with specially designed self-expanding stents, whose strut was a combination of two wavy rings and three pillars, were embedded into the subcutaneous pouches of goats or beagles for 1 month. Upon harvesting, the molds were fully encapsulated with membranous connective tissues, in which the stent strut was completely embedded. The tubular tissues with the stents were obtained by removing the internal rods. About a half of the tubular tissues as a leaflet part was folded inside the remaining tubular tissues having ring strut as a conduit part. When the overlapped tubular tissues were fixed at the three pillars, two different-sized self-expanding valved stents (internal diameter; 14 or 25 mm) with autologous tubular leaflet tissues were obtained as Stent-Biovales. After shape formation of the leaflets at the closed form, regurgitation rate was approximately 5 and 22 % at pulmonary and aortic condition, respectively. The Stent-Biovalves developed here may be useful as a heart valve for patients undergoing transcatheter heart valve implantation.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Dore A, Glancy DL, Stone S, Menashe VD, Somerville J. Cardiac surgery for grown-up congenital heart patients: survey of 307 consecutive operations from 1991–1994. Am J Cardiol. 1997;80:906–13.

    Article  CAS  PubMed  Google Scholar 

  2. Simon P, Kasimir MT, Seebacher G, Weigel G, Ullrich R, Salzer-Muhar U, Rieder E, Wolner E. Early failure of the tissue engineered porcine heart valve SYNERGRAFT in pediatric patients. Eur J Cardiothorac Surg. 2003;23:1002–6.

    Article  CAS  PubMed  Google Scholar 

  3. Cannegieter SC, Rosendaal FR, Wintzen AR, van der Meer FJ, Vandenbroucke JP, Briët E. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med. 1995;333:11–7.

    Article  CAS  PubMed  Google Scholar 

  4. Schoen FJ, Levy RJ. Tissue heart valves: current challenges and future research perspectives. J Biomed Mater Res. 1999;47:439–65.

    Article  CAS  PubMed  Google Scholar 

  5. Nakayama Y, Ishibashi-Ueda H, Takamizawa K. In vivo tissue-engineered small-caliber arterial graft prosthesis consisting of autologous tissue (biotube). Cell Transplant. 2004;13:439–49.

    Article  PubMed  Google Scholar 

  6. Hayashida K, Kanda K, Yaku H, Ando J, Nakayama Y. Development of an in vivo tissue-engineered, autologous heart valve (the biovalve): preparation of a prototype model. J Thorac Cardiovasc Surg. 2007;134:152–9.

    Article  PubMed  Google Scholar 

  7. Hayashida K, Kanda K, Oie T, Okamoto Y, Ishibashi-Ueda H, Onoyama M, Tajikawa T, Ohba K, Yaku H, Nakayama Y. Architecture of an in vivo-tissue engineered autologous conduit “Biovalve”. J Biomed Mater Res B Appl Biomater. 2008;86:1–8.

    Article  PubMed  Google Scholar 

  8. Nakayama Y, Yahata Y, Yamanami M, Tajikawa T, Ohba K, Kanda K, Yaku H. A completely autologous valved conduit prepared in the open form of trileaflets (type VI biovalve): mold design and valve function in vitro. J Biomed Mater Res B Appl Biomater. 2011;99:135–41.

    Article  PubMed  Google Scholar 

  9. Nakayama Y, Takewa Y, Sumikura H, Yamanami M, Matsui Y, Oie T, Kishimoto Y, Arakawa M, Ohnuma K, Tajikawa T, Kanda K, Tatsumi E. In-body tissue-engineered aortic valve (Biovalve type VII) architecture based on 3D printer molding. J Biomed Mater Res B Appl Biomater. 2015;103:1–11.

    Article  PubMed  Google Scholar 

  10. Yamanami M, Yahata Y, Uechi M, Fujiwara M, Ishibashi-Ueda H, Kanda K, Watanabe T, Tajikawa T, Ohba K, Yaku H, Nakayama Y. Development of a completely autologous valved conduit with thesinus of Valsalva using in-body tissue architecture technology: a pilot study in pulmonary valve replacement in a beagle model. Circulation. 2010;122:S100–6.

    Article  PubMed  Google Scholar 

  11. Takewa Y, Yamanami M, Kishimoto Y, Arakawa M, Kanda K, Matsui Y, Oie T, Ishibashi-Ueda H, Tajikawa T, Ohba K, Yaku H, Taenaka Y, Tatsumi E, Nakayama Y. In vivo evaluation of an in-body, tissue-engineered, completely autologous valved conduit (biovalve type VI) as an aortic valve in a goat model. J Artif Organs. 2013;16:176–84.

    Article  CAS  PubMed  Google Scholar 

  12. Sumikura H, Nakayama Y, Ohnuma K, Takewa Y, Tatsumi E. In vitro evaluation of a novel autologous aortic valve (Biovalve) with a pulsatile circulation circuit. Artif Organs. 2014;38:282–9.

    Article  PubMed  Google Scholar 

  13. Mizuno T, Takewa Y, Sumikura H, Ohnuma K, Moriwaki T, Yamanami M, Oie T, Tatsumi E, Uechi M, Nakayama Y. Preparation of an autologous heart valve with a stent (Stent-Biovalve) using the stent eversion method. J Biomed Mater Res B Appl Biomater. 2014;102:1038–45.

    Article  PubMed  Google Scholar 

  14. Cox JL, Ad N, Myers K, Gharib M, Quijano RC. Tubular heart valves: a new tissue prosthesis design–preclinical evaluation of the 3F aortic bioprosthesis. J Thorac Cardiovasc Surg. 2005;130:520–7.

    Article  PubMed  Google Scholar 

  15. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607.

    Article  CAS  PubMed  Google Scholar 

  16. Cribier A. Development of transcatheter aortic valve implantation (TAVI): a 20-year odyssey. Arch Cardiovasc Dis. 2012;105:146–52.

    Article  PubMed  Google Scholar 

  17. Dasi LP, Simon HA, Sucosky P, Yoganathan AP. Fluid mechanics of artificial heart valves. Clin Exp Pharmacol Physiol. 2009;36:225–37.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  18. Marom G, Halevi R, Haj-Ali R, Rosenfeld M, Schäfers HJ, Raanani E. Numerical model of the aortic root and valve: optimization of graft size and sinotubular junction to annulus ratio. J Thorac Cardiovasc Surg. 2013;146:1227–31.

    Article  PubMed  Google Scholar 

  19. Sun W, Abad A, Sacks MS. Simulated bioprosthetic heart valve deformation under quasi-static loading. J Biomech Eng. 2005;127:905–14.

    Article  PubMed  Google Scholar 

  20. Thubrikar MJ, Nolan SP, Aouad J, Deck JD. Stress sharing between the sinus and leaflets of canine aortic valve. Ann Thorac Surg. 1986;42:434–40.

    Article  CAS  PubMed  Google Scholar 

  21. Grande-Allen KJ, Cochran RP, Reinhall PG, Kunzelman KS. Re-creation of sinuses is important for sparing the aortic valve: a finite element study. J Thorac Cardiovasc Surg. 2000;119:753–63.

    Article  CAS  PubMed  Google Scholar 

  22. Yoganathan AP, He Z. Casey Jones S. Fluid mechanics of heart valves. Annu Rev Biomed Eng. 2004;6:331–62.

    Article  CAS  PubMed  Google Scholar 

  23. Katayama S, Umetani N, Sugiura S, Hisada T. The sinus of Valsalva relieves abnormal stress on aortic valve leaflets by facilitating smooth closure. J Thorac Cardiovasc Surg. 2008;136:1528–35.

    Article  PubMed  Google Scholar 

  24. Brown JM, O’Brien SM, Wu C, Sikora JA, Griffith BP, Gammie JS. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg. 2009;137:82–90.

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

The authors thank Ms. Manami Sone for her technical support in this study. This study was funded in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan.

Conflict of interest

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

  1. Division of Medical Engineering and Materials, National Cerebral and Cardiovascular Center Research Institute, 5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565, Japan

    Marina Funayama & Yasuhide Nakayama

  2. College of Bioresource Sciences, Nihon University, Kanagawa, Japan

    Marina Funayama

  3. Department of Artificial Organs, National Cerebral and Cardiovascular Center Research Institute, Osaka, Japan

    Hirohito Sumikura, Yoshiaki Takewa & Eisuke Tatsumi

Authors
  1. Marina Funayama
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Hirohito Sumikura
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Yoshiaki Takewa
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Eisuke Tatsumi
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Yasuhide Nakayama
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yasuhide Nakayama.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Funayama, M., Sumikura, H., Takewa, Y. et al. Development of self-expanding valved stents with autologous tubular leaflet tissues for transcatheter valve implantation. J Artif Organs 18, 228–235 (2015). https://doi.org/10.1007/s10047-015-0820-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10047-015-0820-6

Keywords

Search

Navigation