Evaluation of bovine pericardium performance after liquid nitrogen freezing and thinning_Journal of Biomedical Engineering

Authors：

JIN Chang ^1,2 , WU Zebin ^1,2 , JIN Yongfu ³ ,  WANG Lizhen ^1,2 , ZHONG Shengping ³ ,  FAN Yubo ^1,2

1. Key Laboratory for Biomechanics and Mechanobiology of Ministry of Education, School of Biological Science and Medical Engineering, Beihang University, Beijing 100083, P.R.China;
2. Beijing Advanced Innovation Centre for Biomedical Engineering, Beihang University, Beijing 102402, P.R.China;
3. KingstronBio (Changshu) Co., Ltd, Changshu, Jiangsu 215500, P.R.China;

Corresponding author：

WANG Lizhen, Email: lizhenwang@buaa.edu.cn; FAN Yubo, Email: yubofan@buaa.edu.cn

Keywords：

bovine pericardium; transcatheter aortic valve; liquid nitrogen freezing; thinning

DOI：

10.7507/1001-5515.201901033

Video：

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In the present study, the performance of the liquid nitrogen frozen and thinned bovine pericardium was studied and compared with the porcine pericardium. The microstructure and mechanical properties of the bovine pericardium were observed and tested by hematoxylin-eosin (HE) staining and tensile test respectively. In all conditions, porcine pericardium was selected as a control group. The results showed that there was little difference in the performance of bovine pericardium after being frozen by liquid nitrogen. The secant modulus and ultimate strength of the thinned bovine pericardium were similar to those of porcine pericardium, however, the elastic modulus was a little higher than porcine pericardium. The study suggested that the performance of the thinned bovine pericardium was similar to those of porcine pericardium. It was easy for the thinned bovine pericardium to obtain a relatively ideal thickness and expected performance, therefore, the thinned bovine pericardium can be used as the materials of transcatheter aortic valve leaflets.

Citation： JIN Chang, WU Zebin, JIN Yongfu, WANG Lizhen, ZHONG Shengping, FAN Yubo. Evaluation of bovine pericardium performance after liquid nitrogen freezing and thinning. Journal of Biomedical Engineering, 2019, 36(5): 827-833. doi: 10.7507/1001-5515.201901033 Copy

1.	Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation, 2002, 106(24): 3006-3008.
2.	Mack M J, Leon M B, Smith C R, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet, 2015, 385(9986): 2477-2484.
3.	Kapadia S R, Leon M B, Makkar R R, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet, 2015, 385(9986): 2485-2491.
4.	Toggweiler S, Gurvitch R, Leipsic J, et al. Percutaneous aortic valve replacement:vascular outcomes with a fully percutaneous procedure. J Am Coll Cardiol, 2012, 59(2): 113-118.
5.	Stortecky S, Wenaweser P, Diehm N, et al. Percutaneous management of vascular complications in patients undergoing transcatheter aortic valve implantation. JACC Cardiovasc Interv, 2012, 5(5): 515-524.
6.	Hayashida K, Lefèvre T, Chevalier B, et al. Transfemoral aortic valve implantation: new criteria to predict vascular complications. Eur Heart J, 2011, 32(1): 889.
7.	Schoen F J, Levy R J. Tissue heart valves: Current challenges and future research perspectives. J Biomed Mater Res, 1999, 47(4): 439-465.
8.	Webb J G, Wood D A. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol, 2012, 60(6): 483-492.
9.	Fanning J P, Platts D G, Walters D L, et al. Transcatheter aortic valve implantation (TAVI): Valve design and evolution. Int J Cardiol, 2013, 168(3): 1822-1831.
10.	Dove J S, Tian B, Schneider R, et al. Methods of conditioning sheet bioprosthetic tissue: US 20110238167A1. 2011-09-29.
11.	Schneider R, Tian B, Dove J S, et.al. Methods of conditioning sheet bioprosthetic tissue: US 20130110097A1. 2013-05-02.
12.	Tian B, Schneider R, Dove J S, et.al. Methods of conditioning sheet bioprosthetic tissue: US 20130116676A1. 2013-05-09.
13.	Kutty J K, Chalekian A J, Kurane A A. Methods of preparing a tissue swatch for a bioprosthetic device: US20140257472. 2014-09-11.
14.	Armiger L C, Thomson R W, Strickett M G, et al. Morphology of heart valves preserved by liquid nitrogen freezing. Thorax, 1985, 40(10): 778-786.
15.	Mirabet V, Carda C, Solves P, et al. Long-term storage in liquid nitrogen does not affect cell viability in cardiac valve allografts. Cryobiology, 2008, 57(2): 113-121.
16.	Adam M, Hu J F, Lange P, et al. The effect of liquid nitrogen submersion on cryopreserved human heart valves. Cryobiology, 1990, 27(6): 605-614.
17.	Sánchez-Arévalo F M, Farfán M, Covarrubias D, et al. The micromechanical behavior of lyophilized glutaraldehyde-treated bovine pericardium under uniaxial tension. J Mech Behav Biomed Mater, 2010, 3(8): 640-646.
18.	Hiester E D, Sacks M S. Optimal bovine pericardial tissue selection sites. I. Fiber architecture and tissue thickness measurements. J Biomed Mater Res, 1998, 39(2): 207-214.
19.	Hiester E D, Sacks M S. Optimal bovine pericardial tissue selection sites. II. Cartographic analysis. J Biomed Mater Res, 1998, 39(2): 215-221.
20.	乐以伦, 万昌秀, 吕素维. 一种新的生物瓣材料—Ⅳ、牦牛心包纤维组织的编织形态及其一维拉伸性能. 生物医学工程学杂志, 1987, 4(4): 257-264.
21.	钟生平, 乐以伦, 周成飞, 等. 一种新的生物瓣材料—Ⅴ、耗牛心包材料的力学各向异性. 生物医学工程学杂志, 1987, 4(4): 265-270.
22.	Zioupos P, Barbenel J C, Fisher J. Anisotropic elasticity and strength of glutaraldehyde fixed bovine pericardium for use in pericardial bioprosthetic valves. J Biomed Mater Res, 1994, 28(1): 49-57.
23.	Caballeros A, Sulejmanil F, Martin C, et al. Evaluation of transcatheter heart valve biomaterials: biomechanical characterization of bovine and porcine pericardium. J Mech Behav Biomed Mater, 2017, 75: 486-494.
24.	Gauvin R, Marinov G, Mehri Y, et al. A comparative study of bovine and porcine pericardium to highlight their potential advantages to manufacture percutaneous cardiovascular implants. J Biomater Appl, 2013, 28(4): 552-565.
25.	McGregor C, Byrne G, Rahmani B A, et al. Physical equivalency of wild type and galactose α 1,3 galactose free porcine pericardium; a new source material for bioprosthetic heart valves. Acta Biomater, 2016, 41: 204-209.
26.	Braga-Vilela A S, Pimentel E R, Marangoni S, et al. Extracellular matrix of porcine pericardium: biochemistry and collagen architecture. J Membr Biol, 2008, 221(1): 15-25.
27.	Martin C, Sun Wei. Comparison of transcatheter aortic valve and surgical bioprosthetic valve durability: A fatigue simulation study. J Biomech, 2015, 48(12): 3026-3034.

1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation, 2002, 106(24): 3006-3008.
2. Mack M J, Leon M B, Smith C R, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet, 2015, 385(9986): 2477-2484.
3. Kapadia S R, Leon M B, Makkar R R, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet, 2015, 385(9986): 2485-2491.
4. Toggweiler S, Gurvitch R, Leipsic J, et al. Percutaneous aortic valve replacement:vascular outcomes with a fully percutaneous procedure. J Am Coll Cardiol, 2012, 59(2): 113-118.
5. Stortecky S, Wenaweser P, Diehm N, et al. Percutaneous management of vascular complications in patients undergoing transcatheter aortic valve implantation. JACC Cardiovasc Interv, 2012, 5(5): 515-524.
6. Hayashida K, Lefèvre T, Chevalier B, et al. Transfemoral aortic valve implantation: new criteria to predict vascular complications. Eur Heart J, 2011, 32(1): 889.
7. Schoen F J, Levy R J. Tissue heart valves: Current challenges and future research perspectives. J Biomed Mater Res, 1999, 47(4): 439-465.
8. Webb J G, Wood D A. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol, 2012, 60(6): 483-492.
9. Fanning J P, Platts D G, Walters D L, et al. Transcatheter aortic valve implantation (TAVI): Valve design and evolution. Int J Cardiol, 2013, 168(3): 1822-1831.
10. Dove J S, Tian B, Schneider R, et al. Methods of conditioning sheet bioprosthetic tissue: US 20110238167A1. 2011-09-29.
11. Schneider R, Tian B, Dove J S, et.al. Methods of conditioning sheet bioprosthetic tissue: US 20130110097A1. 2013-05-02.
12. Tian B, Schneider R, Dove J S, et.al. Methods of conditioning sheet bioprosthetic tissue: US 20130116676A1. 2013-05-09.
13. Kutty J K, Chalekian A J, Kurane A A. Methods of preparing a tissue swatch for a bioprosthetic device: US20140257472. 2014-09-11.
14. Armiger L C, Thomson R W, Strickett M G, et al. Morphology of heart valves preserved by liquid nitrogen freezing. Thorax, 1985, 40(10): 778-786.
15. Mirabet V, Carda C, Solves P, et al. Long-term storage in liquid nitrogen does not affect cell viability in cardiac valve allografts. Cryobiology, 2008, 57(2): 113-121.
16. Adam M, Hu J F, Lange P, et al. The effect of liquid nitrogen submersion on cryopreserved human heart valves. Cryobiology, 1990, 27(6): 605-614.
17. Sánchez-Arévalo F M, Farfán M, Covarrubias D, et al. The micromechanical behavior of lyophilized glutaraldehyde-treated bovine pericardium under uniaxial tension. J Mech Behav Biomed Mater, 2010, 3(8): 640-646.
18. Hiester E D, Sacks M S. Optimal bovine pericardial tissue selection sites. I. Fiber architecture and tissue thickness measurements. J Biomed Mater Res, 1998, 39(2): 207-214.
19. Hiester E D, Sacks M S. Optimal bovine pericardial tissue selection sites. II. Cartographic analysis. J Biomed Mater Res, 1998, 39(2): 215-221.
20. 乐以伦, 万昌秀, 吕素维. 一种新的生物瓣材料—Ⅳ、牦牛心包纤维组织的编织形态及其一维拉伸性能. 生物医学工程学杂志, 1987, 4(4): 257-264.
21. 钟生平, 乐以伦, 周成飞, 等. 一种新的生物瓣材料—Ⅴ、耗牛心包材料的力学各向异性. 生物医学工程学杂志, 1987, 4(4): 265-270.
22. Zioupos P, Barbenel J C, Fisher J. Anisotropic elasticity and strength of glutaraldehyde fixed bovine pericardium for use in pericardial bioprosthetic valves. J Biomed Mater Res, 1994, 28(1): 49-57.
23. Caballeros A, Sulejmanil F, Martin C, et al. Evaluation of transcatheter heart valve biomaterials: biomechanical characterization of bovine and porcine pericardium. J Mech Behav Biomed Mater, 2017, 75: 486-494.
24. Gauvin R, Marinov G, Mehri Y, et al. A comparative study of bovine and porcine pericardium to highlight their potential advantages to manufacture percutaneous cardiovascular implants. J Biomater Appl, 2013, 28(4): 552-565.
25. McGregor C, Byrne G, Rahmani B A, et al. Physical equivalency of wild type and galactose α 1,3 galactose free porcine pericardium; a new source material for bioprosthetic heart valves. Acta Biomater, 2016, 41: 204-209.
26. Braga-Vilela A S, Pimentel E R, Marangoni S, et al. Extracellular matrix of porcine pericardium: biochemistry and collagen architecture. J Membr Biol, 2008, 221(1): 15-25.
27. Martin C, Sun Wei. Comparison of transcatheter aortic valve and surgical bioprosthetic valve durability: A fatigue simulation study. J Biomech, 2015, 48(12): 3026-3034.

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