Tissue Engineering Heart Valves – a Review of More than Two Decades into Preclinical and Clinical Testing for Obtaining the Next Generation of Heart Valve Substitutes

1 Iung B, A Vahanian. Epidemiology of valvular heart disease in the adult. Nature Reviews Cardiology. 2011; 8(3): 162–72. IungB VahanianA Epidemiology of valvular heart disease in the adult Nature Reviews Cardiology. 2011 8 3 162 72 10.1038/nrcardio.2010.20221263455 Search in Google Scholar

2 Aikawa E, Schoen FJ. Calcific and Degenerative Heart Valve Disease. In Cellular and Molecular Pathobiology of Cardiovascular Disease. Ed: Willis MS, Homeister JW, Stone JR. Elsevier, London, 2014, 161–80. AikawaE SchoenFJ Calcific and Degenerative Heart Valve Disease In Cellular and Molecular Pathobiology of Cardiovascular Disease Ed: WillisMS HomeisterJW StoneJR Elsevier London 2014 161 80 10.1016/B978-0-12-405206-2.00009-0 Search in Google Scholar

3 Gillinov AM, Blackstone EH, Nowicki ER, et al. Valve repair versus valve replacement for degenerative mitral valve disease. Journal of Thoracic and Cardiovascular Surgery. 2008; 135:885–93. GillinovAM BlackstoneEH NowickiER Valve repair versus valve replacement for degenerative mitral valve disease Journal of Thoracic and Cardiovascular Surgery. 2008 135 885 93 10.1016/j.jtcvs.2007.11.03918374775 Search in Google Scholar

4 Daneshmand MA, Milano CA, Rankin JS, et al. Mitral valve repair for degenerative disease: a 20-year experience. Annals of Thoracic Surgery. 2009; 88:1828–37. DaneshmandMA MilanoCA RankinJS Mitral valve repair for degenerative disease: a 20-year experience Annals of Thoracic Surgery. 2009 88 1828 37 10.1016/j.athoracsur.2009.08.00819932244 Search in Google Scholar

5 Habib G, Thuny F, Avierinos JF. Prosthetic valve endocarditis: current approach and therapeutic options. Progress In Cardiovascular Diseases. 2008;50:274–81. HabibG ThunyF AvierinosJF Prosthetic valve endocarditis: current approach and therapeutic options Progress In Cardiovascular Diseases. 2008 50 274 81 10.1016/j.pcad.2007.10.00718156006 Search in Google Scholar

6 Friedewald VE, Bonow RO, Borer JS, et al. The editor's roundtable: cardiac valve surgery. American Journal Of Cardiology. 2007; 99: 1269–78. FriedewaldVE BonowRO BorerJS The editor's roundtable: cardiac valve surgery American Journal Of Cardiology. 2007 99 1269 78 10.1016/j.amjcard.2007.02.04017478156 Search in Google Scholar

7 Chiang YP, Chikwe J, Moskowitz AJ, et al. Survival and long-term outcomes following bioprosthetic vs mechanical aortic valve replacement in patients aged 50 to 69 years. JAMA. 2014; 312:1323–9. ChiangYP ChikweJ MoskowitzAJ Survival and long-term outcomes following bioprosthetic vs mechanical aortic valve replacement in patients aged 50 to 69 years JAMA. 2014 312 1323 9 10.1001/jama.2014.1267925268439 Search in Google Scholar

8 Zhu AS, Grande-Allen KJ. Heart valve tissue engineering for valve replacement and disease modeling. Current Opinion in Biomedical Engineering. 2018; 5:35–41. ZhuAS Grande-AllenKJ Heart valve tissue engineering for valve replacement and disease modeling Current Opinion in Biomedical Engineering. 2018 5 35 41 10.1016/j.cobme.2017.12.006 Search in Google Scholar

9 Jacobs JP, Mavroudis C, Quintessenza JA, Chai, et al. Reoperations for pediatric and congenital heart disease: an analysis of the Society of Thoracic Surgeons (STS) congenital heart surgery database. In Seminars in Thoracic and Cardiovascular Surgery: Pediatric Cardiac Surgery Annual. 2014; 17(1): 2–8. JacobsJP MavroudisC QuintessenzaJA Chai Reoperations for pediatric and congenital heart disease: an analysis of the Society of Thoracic Surgeons (STS) congenital heart surgery database In Seminars in Thoracic and Cardiovascular Surgery: Pediatric Cardiac Surgery Annual. 2014 17 1 2 8 10.1053/j.pcsu.2014.01.006427614724725711 Search in Google Scholar

10 Boroumand S, Asadpour S, Akbarzadeh A, et al. Heart valve tissue engineering: an overview of heart valve decellularization processes. Regenerative medicine. 2018; 13(1): 41–54. BoroumandS AsadpourS AkbarzadehA Heart valve tissue engineering: an overview of heart valve decellularization processes Regenerative medicine. 2018 13 1 41 54 10.2217/rme-2017-006129360011 Search in Google Scholar

11 Masoumi N, Jean A, Zugates JT, et al. Laser microfabricated poly(glycerol sebacate) scaffolds for heart valve tissue engineering. Journal Of Biomedical Materials Research Part A 2013; 101: 104–14. MasoumiN JeanA ZugatesJT Laser microfabricated poly(glycerol sebacate) scaffolds for heart valve tissue engineering Journal Of Biomedical Materials Research Part A 2013 101 104 14 10.1109/NEBC.2011.5778693 Search in Google Scholar

12 Fallahiarezoudar E, Ahmadipourroudposht M, Idris A, et al. A review of: application of synthetic scaffold in tissue engineering heart valves. Materials Science and Engineering: C. 2015; 48:556–65. FallahiarezoudarE AhmadipourroudposhtM IdrisA A review of: application of synthetic scaffold in tissue engineering heart valves Materials Science and Engineering: C. 2015 48 556 65 10.1016/j.msec.2014.12.016 Search in Google Scholar

13 Jiao T, Clifton RJ, Converse GL, et al. Measurements of the effects of decellularization on viscoelastic properties of tissues in ovine, baboon, and human heart valves. Tissue Engineering Part A. 2012; 18(3–4):423–31. JiaoT CliftonRJ ConverseGL Measurements of the effects of decellularization on viscoelastic properties of tissues in ovine, baboon, and human heart valves Tissue Engineering Part A. 2012 18 3–4 423 31 10.1089/ten.tea.2010.0677 Search in Google Scholar

14 Shojima T, Yoshikawa K, Hori H, et al. In vivo recellularization of plain decellularized xenografts with specific cell characterization in the systemic circulation: histological and immunohistochemical study. Artificial Organs. 2006; 30(4): 233–41. ShojimaT YoshikawaK HoriH In vivo recellularization of plain decellularized xenografts with specific cell characterization in the systemic circulation: histological and immunohistochemical study Artificial Organs. 2006 30 4 233 41 10.1111/j.1525-1594.2006.00210.x Search in Google Scholar

15 Honge JL, Funder J, Hansen E, et al. Recellularization of aortic valves in pigs. Journal Of Cardiothoracic Surgery. 2011; 39(6):829–34. HongeJL FunderJ HansenE Recellularization of aortic valves in pigs Journal Of Cardiothoracic Surgery. 2011 39 6 829 34 10.1016/j.ejcts.2010.08.054 Search in Google Scholar

16 Harken DE. Heart valves: ten commandments and still counting. The Annals of Thoracic Surgery. 48 (Suppl. 3), 18–19 (1989). HarkenDE Heart valves: ten commandments and still counting The Annals of Thoracic Surgery 48 Suppl. 3 18 19 1989 10.1016/0003-4975(89)90623-1 Search in Google Scholar

17 Hasan A, Ragaert K, Swieszkowski W, et al. Biomechanical properties of native and tissue engineered heart valve constructs. Journal Of Biomechanics. 2014; 47:1949. HasanA RagaertK SwieszkowskiW Biomechanical properties of native and tissue engineered heart valve constructs Journal Of Biomechanics. 2014 47 1949 10.1016/j.jbiomech.2013.09.02324290137 Search in Google Scholar

18 van Geemen D, Soares ALF, Oomen PJA, et al. Age-dependent changes in geometry, tissue composition and mechanical properties of fetal to adult cryopreserved human heart valves. PloS one. 2016; 11(2): e0149020. van GeemenD SoaresALF OomenPJA Age-dependent changes in geometry, tissue composition and mechanical properties of fetal to adult cryopreserved human heart valves PloS one. 2016 11 2 e0149020 10.1371/journal.pone.0149020475093626867221 Search in Google Scholar

19 Langer R, Vacanti JP. Tissue engineering. Science. 1993; 260: 920–6. LangerR VacantiJP Tissue engineering Science. 1993 260 920 6 10.1201/9781420051834.sec1 Search in Google Scholar

20 Schmidt JB, Tranquillo RT. Tissue Engineered Heart valves. In Heart valves From Design to Clinical Implantation. EDS: Iaizzo PA, Bianco RW, Hill A, et al. Spinger Science+ Business Media, New York, 2013, 261–80. SchmidtJB TranquilloRT Tissue Engineered Heart valves In Heart valves From Design to Clinical Implantation EDS: IaizzoPA BiancoRW HillA Spinger Science+ Business Media New York 2013 261 80 10.1007/978-1-4614-6144-9_11 Search in Google Scholar

21 Chen Q, Bruyneel A, Carr C, et al. Bio-mechanical properties of novel bi-layer collagen-elastin scaffolds for heart valve tissue engineering. Procedia Engineering. 2013; 59: 247–54. ChenQ BruyneelA CarrC Bio-mechanical properties of novel bi-layer collagen-elastin scaffolds for heart valve tissue engineering Procedia Engineering. 2013 59 247 54 10.1016/j.proeng.2013.05.118 Search in Google Scholar

22 Long JL, Tranquillo RT. Elastic fiber production in cardiovascular tissue-equivalents. Matrix biology. 2003; 22(4): 339–50. LongJL TranquilloRT Elastic fiber production in cardiovascular tissue-equivalents Matrix biology. 2003 22 4 339 50 10.1016/S0945-053X(03)00052-0 Search in Google Scholar

23 Duan B, Hockaday LA, Kang KH, et al. 3D bioprinting of heterogeneous aortic valve conduits with alginate/gelatin hydrogels. Journal of biomedical materials research Part A. 2013; 101(5): 1255–64. DuanB HockadayLA KangKH 3D bioprinting of heterogeneous aortic valve conduits with alginate/gelatin hydrogels Journal of biomedical materials research Part A. 2013 101 5 1255 64 10.1002/jbm.a.34420369436023015540 Search in Google Scholar

24 Mela P, Hinderer S, Kandil HS, et al. Tissue-engineered heart valves. In Principles of heart valve engineering. Ed: Arash Kheradvar. Elsevier Academic Press. California, USA, 2019, pag 135. MelaP HindererS KandilHS Tissue-engineered heart valves In Principles of heart valve engineering Ed: KheradvarArash Elsevier Academic Press California, USA 2019 135 10.1016/B978-0-12-814661-3.00006-X Search in Google Scholar

25 Boroumand S, Asadpour S, Akbarzadeh A, et al. Heart valve tissue engineering: an overview of heart valve decellularization processes. Regenerative medicine. 2018; 13(1): 41–54. BoroumandS AsadpourS AkbarzadehA Heart valve tissue engineering: an overview of heart valve decellularization processes Regenerative medicine. 2018 13 1 41 54 10.2217/rme-2017-006129360011 Search in Google Scholar

26 Fallon AM, Goodchild TT, Cox JL, et al. In vivo remodeling potential of a novel bioprosthetic tricuspid valve in an ovine model. Journal of Thoracic and Cardiovascular Surgery. 2014; 148 (1): 333–40. FallonAM GoodchildTT CoxJL In vivo remodeling potential of a novel bioprosthetic tricuspid valve in an ovine model Journal of Thoracic and Cardiovascular Surgery. 2014 148 1 333 40 10.1016/j.jtcvs.2013.10.04824360254 Search in Google Scholar

27 Haupt J, Lutter G, Gorb S et al. Detergent-based decellularization strategy preserves macro-and microstructure of heart valves. Interactive cardiovascular and thoracic surgery. 2018; 26(2): 230–6. HauptJ LutterG GorbS Detergent-based decellularization strategy preserves macro-and microstructure of heart valves Interactive cardiovascular and thoracic surgery. 2018 26 2 230 6 10.1093/icvts/ivx31629155942 Search in Google Scholar

28 Iop L, Paolin A, Aguiari P, et al. Decellularized cryopreserved allografts as off-the-shelf allogeneic alternative for heart valve replacement: in vitro assessment before clinical translation. Journal of cardiovascular translational research. 2017; 10(2): 93–103. IopL PaolinA AguiariP Decellularized cryopreserved allografts as off-the-shelf allogeneic alternative for heart valve replacement: in vitro assessment before clinical translation Journal of cardiovascular translational research. 2017 10 2 93 103 10.1007/s12265-017-9738-028281241 Search in Google Scholar

29 VeDepo MC, Buse EE, Quinn, et al. Species-specific effects of aortic valve decellularization. Acta biomaterialia. 2017; 50:249–58. VeDepoMC BuseEE Quinn Species-specific effects of aortic valve decellularization Acta biomaterialia. 2017 50 249 58 10.1016/j.actbio.2017.01.00828069510 Search in Google Scholar

30 Crapo PM, Gilbert TW and Badylak SF. An overview of tissue and whole organ decellularization processes. Biomaterials. 2011; 32: 3233–43. CrapoPM GilbertTW BadylakSF An overview of tissue and whole organ decellularization processes Biomaterials. 2011 32 3233 43 10.1016/j.biomaterials.2011.01.057308461321296410 Search in Google Scholar

31 Bloch O, Erdbrugger W, Volker W, et al. Extracellular matrix in deoxycholic acid decellularized aortic heart valves. Medical Science Monitor. 2012; 18: 487–92. BlochO ErdbruggerW VolkerW Extracellular matrix in deoxycholic acid decellularized aortic heart valves Medical Science Monitor. 2012 18 487 92 10.12659/MSM.883618 Search in Google Scholar

32 Somers P, De Somer F, Cornelissen M, et al. Decellularization of heart valve matrices: search for the ideal balance. Artificial Cells Blood Substitutes And Immobilization Biotechnology. 2012; 40: 151–62. SomersP De SomerF CornelissenM Decellularization of heart valve matrices: search for the ideal balance Artificial Cells Blood Substitutes And Immobilization Biotechnology. 2012 40 151 62 10.3109/10731199.2011.637925 Search in Google Scholar

33 Zhou J, Fritze O, Schleicher M, et al. Impact of heart valve decellularization on 3-D ultrastructure, immunogenicity and thrombogenicity. Biomaterials. 2010; 31: 2549–54. ZhouJ FritzeO SchleicherM Impact of heart valve decellularization on 3-D ultrastructure, immunogenicity and thrombogenicity Biomaterials. 2010 31 2549 54 10.1016/j.biomaterials.2009.11.088 Search in Google Scholar

34 Erdbrugger W, Konertz P, Dohmen M, et al. Decellularized xenogenic heart valves reveal remodeling and growth potential in vivo. Tissue Engineering. 2006; 12:2059–68. ErdbruggerW KonertzP DohmenM Decellularized xenogenic heart valves reveal remodeling and growth potential in vivo Tissue Engineering. 2006 12 2059 68 10.1089/ten.2006.12.2059 Search in Google Scholar

35 Meyer SR, Chiu B, Churchill TA, et al. Comparison of aortic valve allograft decellularization techniques in the rat. Journal Of Biomedical Materials Research Part A. 2006; 79: 254–62. MeyerSR ChiuB ChurchillTA Comparison of aortic valve allograft decellularization techniques in the rat Journal Of Biomedical Materials Research Part A. 2006 79 254 62 10.1002/jbm.a.30777 Search in Google Scholar

36 Sierad LN, Shaw EL, Bina, et al. Functional heart valve scaffolds obtained by complete decellularization of porcine aortic roots in a novel differential pressure gradient perfusion system. Tissue Engineering Part C: Methods. 2015; 21(12): 1284–96. SieradLN ShawEL Bina Functional heart valve scaffolds obtained by complete decellularization of porcine aortic roots in a novel differential pressure gradient perfusion system Tissue Engineering Part C: Methods. 2015 21 12 1284 96 10.1089/ten.tec.2015.0170 Search in Google Scholar

37 Theodoridis K, Tudorache I, Calistru A, et al. Successful matrix guided tissue regeneration of decellularized pulmonary heart valve allografts in elderly sheep. Biomaterials. 2015; 52: 221–8. TheodoridisK TudoracheI CalistruA Successful matrix guided tissue regeneration of decellularized pulmonary heart valve allografts in elderly sheep Biomaterials. 2015 52 221 8 10.1016/j.biomaterials.2015.02.023 Search in Google Scholar

38 Ye X, Zhao Q, Sun X, et al. Enhancement of mesenchymal stem cell attachment to decellularized porcine aortic valve scaffold by in vitro coating with antibody against CD90: a preliminary study on antibody-modified tissue-engineered heart valve. Tissue Engineering Part A. 2009; 15: 1–11. YeX ZhaoQ SunX Enhancement of mesenchymal stem cell attachment to decellularized porcine aortic valve scaffold by in vitro coating with antibody against CD90: a preliminary study on antibody-modified tissue-engineered heart valve Tissue Engineering Part A. 2009 15 1 11 10.1089/ten.tea.2008.0001 Search in Google Scholar

39 Mi HY, Salick MR, Jing X, et al. Characterization of thermoplastic polyurethane/polylactic acid (TPU/PLA) tissue engineering scaffolds fabricated by microcellular injection molding. Materials Science And Engineering. 2013; 33 (8): 4767–76. MiHY SalickMR JingX Characterization of thermoplastic polyurethane/polylactic acid (TPU/PLA) tissue engineering scaffolds fabricated by microcellular injection molding Materials Science And Engineering. 2013 33 8 4767 76 10.1016/j.msec.2013.07.037 Search in Google Scholar

40 Chen GP, Ushida T, Tateishi T. Development of biodegradable porous scaffolds for tissue engineering. Materials Science & Engineering C-Materials For Biological Applications. 2001; 17: 63–9. ChenGP UshidaT TateishiT Development of biodegradable porous scaffolds for tissue engineering Materials Science & Engineering C-Materials For Biological Applications. 2001 17 63 9 10.1016/S0928-4931(01)00338-1 Search in Google Scholar

41 Sodian R, Hoerstrup SP, Sperling, et al. Early in vivo experience with tissue-engineered trileaflet heart valves. Circulation. 2000; 102: Iii–22. SodianR HoerstrupSP Sperling Early in vivo experience with tissue-engineered trileaflet heart valves Circulation. 2000 102 Iii 22 10.1161/01.CIR.102.suppl_3.III-22 Search in Google Scholar

42 Sung HJ, Meredith C, Johnson, et al. The effect of scaffold degradation rate on three-dimensional cell growth and angiogenesis. Biomaterials. 2004; 25(26): 5735–42. SungHJ MeredithC Johnson The effect of scaffold degradation rate on three-dimensional cell growth and angiogenesis Biomaterials. 2004 25 26 5735 42 10.1016/j.biomaterials.2004.01.06615147819 Search in Google Scholar

44 Baji A, Mai YW, Wong SC, et al. Electrospinning of polymer nanofibers: effects on oriented morphology, structures and tensile properties. Composites Science And Technology. 2010; 70: 703–18. BajiA MaiYW WongSC Electrospinning of polymer nanofibers: effects on oriented morphology, structures and tensile properties Composites Science And Technology. 2010 70 703 18 10.1016/j.compscitech.2010.01.010 Search in Google Scholar

45 Mendelson K, Schoen FJ. Heart valve tissue engineering: concepts, approaches, progress, and challenges. Annals of biomedical engineering. 2006; 34(12): 1799–819. MendelsonK SchoenFJ Heart valve tissue engineering: concepts, approaches, progress, and challenges Annals of biomedical engineering. 2006 34 12 1799 819 10.1007/s10439-006-9163-z170550617053986 Search in Google Scholar

46 Hinton RB, Yutzey KE Heart valve structure and function in development and disease. Annual Review Of Physiology. 2011; 73: 29–46. HintonRB YutzeyKE Heart valve structure and function in development and disease Annual Review Of Physiology 2011 73 29 46 10.1146/annurev-physiol-012110-142145420940320809794 Search in Google Scholar

47 Ikada Y. Challenges in tissue engineering. Journal Of The Royal Society Interface. 2006; 3: 589–601. IkadaY Challenges in tissue engineering Journal Of The Royal Society Interface. 2006 3 589 601 10.1098/rsif.2006.0124166465516971328 Search in Google Scholar

48 Tedder ME, Simionescu A, Chen, et al. Assembly and testing of stem cell-seeded layered collagen constructs for heart valve tissue engineering. Tissue Engineering Part A. 2011; 17(1–2): 25–36. TedderME SimionescuA Chen Assembly and testing of stem cell-seeded layered collagen constructs for heart valve tissue engineering Tissue Engineering Part A. 2011 17 1–2 25 36 10.1089/ten.tea.2010.0138301192220673028 Search in Google Scholar

49 Weymann A, Schmack B, Okada T, et al. Reendothelialization of human heart valve neoscaffolds using umbilical cord-derived endothelial cells. Circulation Journal. 2012: CJ–12. WeymannA SchmackB OkadaT Reendothelialization of human heart valve neoscaffolds using umbilical cord-derived endothelial cells Circulation Journal 2012 CJ 12 10.1253/circj.CJ-12-054023001070 Search in Google Scholar

50 Hong H, Dong NG, Shi JW et al. Fabrication of a novel hybrid heart valve leaflet for tissue engineering: an in vitro study. Artificial Organs. 2009; 33: 554–7. HongH DongNG ShiJW Fabrication of a novel hybrid heart valve leaflet for tissue engineering: an in vitro study Artificial Organs. 2009 33 554 7 10.1111/j.1525-1594.2009.00742.x19566733 Search in Google Scholar

51 Kolios G, Moodley Y. Introduction to stem cells and regenerative medicine. Respiration. 2013; 85(1): 3–10. KoliosG MoodleyY Introduction to stem cells and regenerative medicine Respiration. 2013 85 1 3 10 10.1159/00034561523257690 Search in Google Scholar

52 Takahashi K, Yamanaka S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell. 2006;126:663–76. TakahashiK YamanakaS Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors Cell. 2006 126 663 76 10.1016/j.cell.2006.07.024 Search in Google Scholar

53 Ilic D, Polak JM. Stem cells in regenerative medicine: introduction. British Medical Bulletin. 2011;98:117–126. IlicD PolakJM Stem cells in regenerative medicine: introduction British Medical Bulletin. 2011 98 117 126 10.1093/bmb/ldr012 Search in Google Scholar

54 Evans MJ, Kaufman MH. Establishment in culture of pluripotential cells from mouse embryos. Nature. 1981;292:154–6. EvansMJ KaufmanMH Establishment in culture of pluripotential cells from mouse embryos Nature. 1981 292 154 6 10.1038/292154a0 Search in Google Scholar

55 Mahla RS. Stem cells applications in regenerative medicine and disease therapeutics. International journal of cell biology. 2016. MahlaRS Stem cells applications in regenerative medicine and disease therapeutics International journal of cell biology 2016 10.1155/2016/6940283 Search in Google Scholar

56 Jana S, Tranquillo RT, Lerman A. Cells for tissue engineering of cardiac valves. Journal of tissue engineering and regenerative medicine. 2016; 10(10):804–24. JanaS TranquilloRT LermanA Cells for tissue engineering of cardiac valves Journal of tissue engineering and regenerative medicine. 2016 10 10 804 24 10.1002/term.2010 Search in Google Scholar

57 Gong Z, Niklason LE. Use of human mesenchymal stem cells as alternative source of smooth muscle cells in vessel engineering. Methods in Molecular Biology. 2011; 698: 279–94. GongZ NiklasonLE Use of human mesenchymal stem cells as alternative source of smooth muscle cells in vessel engineering Methods in Molecular Biology. 2011 698 279 94 10.1007/978-1-60761-999-4_21 Search in Google Scholar

58 Wang S, Qu X, Zhao RC. Clinical applications of mesenchymal stem cells. Journal of hematology & oncology. 2012; 5(1):1–9. WangS QuX ZhaoRC Clinical applications of mesenchymal stem cells Journal of hematology & oncology. 2012 5 1 1 9 10.1186/1756-8722-5-19 Search in Google Scholar

59 Lichtenberg A, Tudorache I, Cebotari S, et al. Preclinical testing of tissue-engineered heart valves re-endothelialized under simulated physiological conditions. Circulation. 2006; 114: 559. LichtenbergA TudoracheI CebotariS Preclinical testing of tissue-engineered heart valves re-endothelialized under simulated physiological conditions Circulation. 2006 114 559 10.1161/CIRCULATIONAHA.105.001206 Search in Google Scholar

60 Dohmen PM, Lembcke A, Holinski, et al. Ten years of clinical results with a tissue-engineered pulmonary valve. The Annals of thoracic surgery. 2011; 92(4): 1308–14. DohmenPM LembckeA Holinski Ten years of clinical results with a tissue-engineered pulmonary valve The Annals of thoracic surgery. 2011 92 4 1308 14 10.1016/j.athoracsur.2011.06.009 Search in Google Scholar

61 Herring M, Smith J, Dalsing M, et al. Endothelial seeding of polytetrafluoroethylene femoral popliteal bypasses: the failure of low-density seeding to improve patency. Journal of vascular surgery. 1994; 20(4):650–5. HerringM SmithJ DalsingM Endothelial seeding of polytetrafluoroethylene femoral popliteal bypasses: the failure of low-density seeding to improve patency Journal of vascular surgery. 1994 20 4 650 5 10.1016/0741-5214(94)90291-7 Search in Google Scholar

62 Aleksieva G, Hollweck T, Thierfelder N, et al. Use of a special bioreactor for the cultivation of a new flexible polyurethane scaffold for aortic valve tissue engineering. Biomedical engineering online. 2012; 11(1): 1–11. AleksievaG HollweckT ThierfelderN Use of a special bioreactor for the cultivation of a new flexible polyurethane scaffold for aortic valve tissue engineering Biomedical engineering online. 2012 11 1 1 11 10.1186/1475-925X-11-92353860823206816 Search in Google Scholar

63 Amrollahi P, Tayebi L. Bioreactors for heart valve tissue engineering: a review. Journal of Chemical Technology & Biotechnology. 2016; 91(4): 847–56. AmrollahiP TayebiL Bioreactors for heart valve tissue engineering: a review Journal of Chemical Technology & Biotechnology. 2016 91 4 847 56 10.1002/jctb.4825 Search in Google Scholar

64 Converse GL, Buse EE, Neill KR, et al. Design and efficacy of a single-use bioreactor for heart valve tissue engineering. Journal of Biomedical Materials Research Part B: Applied Biomaterials. 2015; 105(2): 249–59. ConverseGL BuseEE NeillKR Design and efficacy of a single-use bioreactor for heart valve tissue engineering Journal of Biomedical Materials Research Part B: Applied Biomaterials. 2015 105 2 249 59 10.1002/jbm.b.3355226469196 Search in Google Scholar

65 Reimer J, Syedain Z, Haynie B, et al. Implantation of a tissue-engineered tubular heart valve in growing lambs. Annals of biomedical engineering. 2017; 45(2): 439–51. ReimerJ SyedainZ HaynieB Implantation of a tissue-engineered tubular heart valve in growing lambs Annals of biomedical engineering. 2017 45 2 439 51 10.1007/s10439-016-1605-7506482827066787 Search in Google Scholar

66 Moreira R, Velz T, Alves N, et al. Tissue-engineered heart valve with a tubular leaflet design for minimally invasive transcatheter implantation. Tissue Engineering Part C: Methods. 2015; 21(6): 530–540. MoreiraR VelzT AlvesN Tissue-engineered heart valve with a tubular leaflet design for minimally invasive transcatheter implantation Tissue Engineering Part C: Methods. 2015 21 6 530 540 10.1089/ten.tec.2014.0214444259725380414 Search in Google Scholar

67 Harpa M, Movileanu I, Sierad L, et al. In vivo testing of xenogeneic acellular aortic valves seeded with stem cells. Revista Romana de Medicina de Laborator. 2016; 24(3): 343 HarpaM MovileanuI SieradL In vivo testing of xenogeneic acellular aortic valves seeded with stem cells Revista Romana de Medicina de Laborator. 2016 24 3 343 10.1515/rrlm-2016-0031651653531098341 Search in Google Scholar

68 Harpa M, Movileanu I, Sierad LN, et al. Pulmonary heart valve replacement using stabilized acellular xenogeneic scaffolds effects of seeding with autologous stem cells. Revista Romana de Medicina de Laborator. 2015; 23(4): 415–430. HarpaM MovileanuI SieradLN Pulmonary heart valve replacement using stabilized acellular xenogeneic scaffolds effects of seeding with autologous stem cells Revista Romana de Medicina de Laborator. 2015 23 4 415 430 10.1515/rrlm-2015-0046 Search in Google Scholar

69 Gallo M, Naso F, Poser H, et al. Physiological performance of a detergent decellularized heart valve implanted for 15 months in Vietnamese pigs: surgical procedure, follow-up, and explant inspection. Artificial organs. 2012; 36(6): 138–50. GalloM NasoF PoserH Physiological performance of a detergent decellularized heart valve implanted for 15 months in Vietnamese pigs: surgical procedure, follow-up, and explant inspection Artificial organs. 2012 36 6 138 50 10.1111/j.1525-1594.2012.01447.x22512408 Search in Google Scholar

70 Quinn RW, Bert AA, Converse GL, et al. Performance of allogeneic bioengineered replacement pulmonary valves in rapidly growing young lambs. Journal of Thoracic and Cardiovascular Surgery. 2016; 152(4):1156–65. QuinnRW BertAA ConverseGL Performance of allogeneic bioengineered replacement pulmonary valves in rapidly growing young lambs Journal of Thoracic and Cardiovascular Surgery. 2016 152 4 1156 65 10.1016/j.jtcvs.2016.05.05127641300 Search in Google Scholar

71 Iwai S, Torikai K, Coppin CM, et al. Minimally immunogenic decellularized porcine valve provides in situ recellularization as a stentless bioprosthetic valve. Journal Of Artificial Organs. 2007; 10: 29–35. IwaiS TorikaiK CoppinCM Minimally immunogenic decellularized porcine valve provides in situ recellularization as a stentless bioprosthetic valve Journal Of Artificial Organs. 2007 10 29 35 10.1007/s10047-006-0360-117380294 Search in Google Scholar

72 Hopkins RA, Bert AA, Hilbert SL, et al. Bioengineered human and allogeneic pulmonary valve conduits chronically implanted orthotopically in baboons: Hemodynamic performance and immunologic consequences. Journal of Thoracic and Cardiovascular Surgery. 2013; 145:1098–1107. HopkinsRA BertAA HilbertSL Bioengineered human and allogeneic pulmonary valve conduits chronically implanted orthotopically in baboons: Hemodynamic performance and immunologic consequences Journal of Thoracic and Cardiovascular Surgery. 2013 145 1098 1107 10.1016/j.jtcvs.2012.06.024 Search in Google Scholar

73 Handbook of cardiac anatomy, physiology, and devices. Ed: Iaizzo, PA. Springer Science & Business Media, Switzerland, 2009. Handbook of cardiac anatomy, physiology, and devices Ed: IaizzoPA Springer Science & Business Media Switzerland 2009 10.1007/978-1-60327-372-5 Search in Google Scholar

74 Shinoka T, Breuer CK, Tanel RE, et al. Tissue engineering heart valves: valve leaflet replacement study in a lamb model. The Annals of thoracic surgery. 1995; 60: S513–S516. ShinokaT BreuerCK TanelRE Tissue engineering heart valves: valve leaflet replacement study in a lamb model The Annals of thoracic surgery. 1995 60 S513 S516 10.1016/S0003-4975(21)01185-1 Search in Google Scholar

75 O’Brien MF, Goldstein S, Walsh S, et al. The Syner Graft valve: a new acellular (nonglutaraldehyde-fixed) tissue heart valve for autologous recellularization first experimental studies before clinical implantation. In Seminars in thoracic and cardiovascular surgery. 1999; 11: 194–200 O’BrienMF GoldsteinS WalshS The Syner Graft valve: a new acellular (nonglutaraldehyde-fixed) tissue heart valve for autologous recellularization first experimental studies before clinical implantation In Seminars in thoracic and cardiovascular surgery 1999 11 194 200 Search in Google Scholar

76 Dohmen PM, Ozaki S, Nitsch R, et al. A tissue engineered heart valve implanted in a juvenile sheep model. Medical Science Monitor. 2003; 9(4): 97–104. DohmenPM OzakiS NitschR A tissue engineered heart valve implanted in a juvenile sheep model Medical Science Monitor. 2003 9 4 97 104 Search in Google Scholar

77 Leyh RG, Wilhelmi M, Walles T, et al. Acellularized porcine heart valve scaffolds for heart valve tissue engineering and the risk of cross-species transmission of porcine endogenous retrovirus. The Journal of thoracic and cardiovascular surgery. 2003; 126(4): 1000–1004. LeyhRG WilhelmiM WallesT Acellularized porcine heart valve scaffolds for heart valve tissue engineering and the risk of cross-species transmission of porcine endogenous retrovirus The Journal of thoracic and cardiovascular surgery. 2003 126 4 1000 1004 10.1016/S0022-5223(03)00353-2 Search in Google Scholar

78 Dohmen P, Da Costa F, Yoshi L S, et al. An experimental study of decellularized xenografts implanted into the aortic position with 4 months of follow up. Journal of Clinical and Experimental Cardiology. 2012; 4:2. DohmenP Da CostaF YoshiL S An experimental study of decellularized xenografts implanted into the aortic position with 4 months of follow up Journal of Clinical and Experimental Cardiology. 2012 4 2 10.4172/2155-9880.S4-004 Search in Google Scholar

79 Hennessy RS, Go JL, Hennessy RR, et al. Recellularization of a novel off-the-shelf valve following xenogenic implantation into the right ventricular outflow tract. PloS one. 2017; 12(8): e0181614. HennessyRS GoJL HennessyRR Recellularization of a novel off-the-shelf valve following xenogenic implantation into the right ventricular outflow tract PloS one. 2017 12 8 e0181614 10.1371/journal.pone.0181614553866128763463 Search in Google Scholar

80 Dohmen PM, Fd C, Lopes SV, et al. Results of a decellularized porcine heart valve implanted into the juvenile sheep model. In The heart surgery forum. 2005; 8(2): E100–4 DohmenPM FdC LopesSV Results of a decellularized porcine heart valve implanted into the juvenile sheep model In The heart surgery forum. 2005 8 2 E100 4 10.1532/HSF98.2004114015769723 Search in Google Scholar

81 Zafar F, Hinton RB, Moore RA, et al. Physiological growth, remodeling potential, and preserved function of a novel bioprosthetic tricuspid valve: tubular bioprosthesis made of small intestinal submucosa-derived extracellular matrix. Journal of the American College of Cardiology. 2015; 66(8): 877–888. ZafarF HintonRB MooreRA Physiological growth, remodeling potential, and preserved function of a novel bioprosthetic tricuspid valve: tubular bioprosthesis made of small intestinal submucosa-derived extracellular matrix Journal of the American College of Cardiology. 2015 66 8 877 888 10.1016/j.jacc.2015.06.109126293756 Search in Google Scholar

82 Van Rijswijk, Jan W, Talacua H, et al. Failure of decellularized porcine small intestinal submucosa as a heart valved conduit. The Journal of thoracic and cardiovascular surgery. 2020; 160(4): e201–e215. Van Rijswijk JanW TalacuaH Failure of decellularized porcine small intestinal submucosa as a heart valved conduit The Journal of thoracic and cardiovascular surgery. 2020 160 4 e201 e215 10.1016/j.jtcvs.2019.09.16432151387 Search in Google Scholar

83 Motta SE, Lintas V, Fioretta ES, et al. Human cell-derived tissue-engineered heart valve with integrated Valsalva sinuses: towards native-like transcatheter pulmonary valve replacements. NPJ Regenerative medicine. 2019; 4(1): 1–10. MottaSE LintasV FiorettaES Human cell-derived tissue-engineered heart valve with integrated Valsalva sinuses: towards native-like transcatheter pulmonary valve replacements NPJ Regenerative medicine. 2019 4 1 1 10 10.1038/s41536-019-0077-4657286131240114 Search in Google Scholar

84 Driessen-Mol A, Emmert MY, Dijkman PE, et al. Transcatheter implantation of homologous “off-the-shelf” tissue-engineered heart valves with self-repair capacity: long-term functionality and rapid in vivo remodeling in sheep. Journal of the American College of Cardiology. 2014; 63(13): 1320–1329. Driessen-MolA EmmertMY DijkmanPE Transcatheter implantation of homologous “off-the-shelf” tissue-engineered heart valves with self-repair capacity: long-term functionality and rapid in vivo remodeling in sheep Journal of the American College of Cardiology. 2014 63 13 1320 1329 10.1016/j.jacc.2013.09.082 Search in Google Scholar

85 Motta SE, Fioretta ES, Dijkman PE, et al. Development of an off the-shelf tissue-engineered sinus valve for transcatheter pulmonary valve replacement: a proof-of-concept study. Journal of cardiovascular translational research. 2018; 11(3): 182–191. MottaSE FiorettaES DijkmanPE Development of an off the-shelf tissue-engineered sinus valve for transcatheter pulmonary valve replacement: a proof-of-concept study Journal of cardiovascular translational research. 2018 11 3 182 191 10.1007/s12265-018-9800-6 Search in Google Scholar

86 Dohmen PM, Lembcke A, Hotz H, et al. Ross operation with a tissue-engineered heart valve. Annals of Thoracic Surgery. 2002; 74(5): 1438–1442. DohmenPM LembckeA HotzH Ross operation with a tissue-engineered heart valve Annals of Thoracic Surgery. 2002 74 5 1438 1442 10.1016/S0003-4975(02)03881-X Search in Google Scholar

87 Simon P, Kasimir MT, Seebacher G, et al. Early failure of the tissue engineered porcine heart valve SYNERGRAFT® in pediatric patients. European journal of cardio-thoracic surgery. 2003; 23(6): 1002–1006. SimonP KasimirMT SeebacherG Early failure of the tissue engineered porcine heart valve SYNERGRAFT® in pediatric patients European journal of cardio-thoracic surgery. 2003 23 6 1002 1006 10.1016/S1010-7940(03)00094-0 Search in Google Scholar

88 Rüffer A, Purbojo A, Cicha I, et al. Early failure of xenogenous de-cellularised pulmonary valve conduits—a word of caution!. European journal of cardio-thoracic surgery. 2010; 38(1): 78–85. RüfferA PurbojoA CichaI Early failure of xenogenous de-cellularised pulmonary valve conduits—a word of caution! European journal of cardio-thoracic surgery. 2010 38 1 78 85 10.1016/j.ejcts.2010.01.04420219384 Search in Google Scholar

89 Konertz W, Angeli E, Tarusinov G, et al. Right ventricular outflow tract reconstruction with decellularized porcine xenografts in patients with congenital heart disease. Journal of Heart Valve Disease. 2011; 20(3): 341. KonertzW AngeliE TarusinovG Right ventricular outflow tract reconstruction with decellularized porcine xenografts in patients with congenital heart disease Journal of Heart Valve Disease. 2011 20 3 341 Search in Google Scholar

90 Perri G, Polito A, Esposito C, et al. Early and late failure of tissue-engineered pulmonary valve conduits used for right ventricular outflow tract reconstruction in patients with congenital heart disease. European journal of cardio-thoracic surgery. 2012; 41(6): 1320–1325. PerriG PolitoA EspositoC Early and late failure of tissue-engineered pulmonary valve conduits used for right ventricular outflow tract reconstruction in patients with congenital heart disease European journal of cardio-thoracic surgery. 2012 41 6 1320 1325 10.1093/ejcts/ezr22122219487 Search in Google Scholar

91 Voges I, Bräsen JH, Entenmann A, et al. Adverse results of a decellularized tissue-engineered pulmonary valve in humans assessed with magnetic resonance imaging. European Journal of Cardio-Thoracic Surgery. 2013; 44(4): e272–e279. VogesI BräsenJH EntenmannA Adverse results of a decellularized tissue-engineered pulmonary valve in humans assessed with magnetic resonance imaging European Journal of Cardio-Thoracic Surgery. 2013 44 4 e272 e279 10.1093/ejcts/ezt32823818571 Search in Google Scholar

92 Breitenbach I, El-Essawi A, Pahari D, et al. Early failure of decellularized xenogenous pulmonary valve conduit (Matrix-P-Plus) for reconstruction of the right ventricular outflow tract in the Ross procedure. The Thoracic and Cardiovascular Surgeon. 2014; 62(S 01): OP123. BreitenbachI El-EssawiA PahariD Early failure of decellularized xenogenous pulmonary valve conduit (Matrix-P-Plus) for reconstruction of the right ventricular outflow tract in the Ross procedure The Thoracic and Cardiovascular Surgeon. 2014 62 S 01 OP123 10.1055/s-0034-1367197 Search in Google Scholar

93 Christ T, Paun AC, Grubitzsch H, et al. Long-term results after the Ross procedure with the decellularized AutoTissue Matrix P® bioprosthesis used for pulmonary valve replacement. European Journal of Cardio-Thoracic Surgery. 2019; 55(5): 885–892. ChristT PaunAC GrubitzschH Long-term results after the Ross procedure with the decellularized AutoTissue Matrix P® bioprosthesis used for pulmonary valve replacement European Journal of Cardio-Thoracic Surgery. 2019 55 5 885 892 10.1093/ejcts/ezy37730508165 Search in Google Scholar

94 Dohmen PM, Lembcke A, Holinski S, et al. Mid-term clinical results using a tissue-engineered pulmonary valve to reconstruct the right ventricular outflow tract during the Ross procedure. The Annals of thoracic surgery. 2007; 84(3): 729–736. DohmenPM LembckeA HolinskiS Mid-term clinical results using a tissue-engineered pulmonary valve to reconstruct the right ventricular outflow tract during the Ross procedure The Annals of thoracic surgery. 2007 84 3 729 736 10.1016/j.athoracsur.2007.04.07217720368 Search in Google Scholar

95 Dohmen PM, Lembcke A, Holinski S, et al. Ten years of clinical results with a tissue-engineered pulmonary valve. The Annals of thoracic surgery. 2011; 92(4): 1308–1314. DohmenPM LembckeA HolinskiS Ten years of clinical results with a tissue-engineered pulmonary valve The Annals of thoracic surgery. 2011 92 4 1308 1314 10.1016/j.athoracsur.2011.06.00921958777 Search in Google Scholar

96 Boethig D, Horke A, Hazekamp M, et al. A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data. European Journal of Cardio-Thoracic Surgery. 2019; 56(3):503–509. BoethigD HorkeA HazekampM A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data European Journal of Cardio-Thoracic Surgery. 2019 56 3 503 509 10.1093/ejcts/ezz054673576330879050 Search in Google Scholar

97 Tudorache I, Horke A, Cebotari S, et al. Decellularized aortic homo-grafts for aortic valve and aorta ascendens replacement. European Journal of Cardio-thoracic Surgery. 2016; 50(1): 89–97. TudoracheI HorkeA CebotariS Decellularized aortic homo-grafts for aortic valve and aorta ascendens replacement European Journal of Cardio-thoracic Surgery. 2016 50 1 89 97 10.1093/ejcts/ezw013491387526896320 Search in Google Scholar