Biocompatibility of bioprosthetic heart valve materials with a non-glutaraldehyde-based chemical treatment_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

 WEN Xiaoxiao ¹ , ZHANG Kun ¹ , PAN Kongrong ¹ , WANG Wentao ¹ ,  PAN Wenzhi ²

1. Peijia Medical Limited, Suzhou, 215000, Jiangsu, P. R. China;
2. Department of Cardiology, Zhongshan Hospital, Fudan University, Research Unit of Cardiovascular Techniques and Devices, Chinese Academy of Medical Sciences, Shanghai, 200032, P. R. China;

Corresponding author：

WEN Xiaoxiao, Email: wenxiaoxiao@peijiamedical.com; PAN Wenzhi, Email: peden@sina.com

Keywords：

Bioprosthetic heart valve; bovine pericardium; carbodiimide; biocompatibility; toxic reaction

DOI：

10.7507/1007-4848.202112069

Video：

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Objective To study the biocompatibility of bioprosthetic heart valve material with a non-glutaraldehyde-based treatment, and to provide the safety data for the clinical application. Methods All the tests were conducted according to GB/T16886 standards. The in vitro cytotoxicity was determined by methyl thiazolyl tetrazolium assay. Fifteen guinea pigs were divided into a test group (n=10) and a control group (n=5) in the skin sensitization test. Three New Zealand white rabbits were used in the intradermal reactivity test. Five sites on both sides of the rabbit back were set as test sites and control sites, respectively. In the acute systemic toxicity test, a total of 20 ICR mice were randomly assigned to 4 groups: a test group (polar medium), a control group (polar medium), a test group (non-polar medium) and a control group (non-polar medium), 5 in each group. Forty SD rats were divided into a test group (n=20) and a control group (n=20) in the subchronic systemic toxicity test. Results The viability of the 100% extracts of the bioprosthetic heart valve material with a non-glutaraldehyde-based treatment was 75.2%. The rate of positive reaction was 0.0%. The total intradermal reactivity test score was 0. There was no statistical difference in the body weight between the test group and control group in the acute systemic toxicity test. There was no statistical difference in the body weight, organ weight, organ weight/body weight ratio, blood routine test or blood biochemistry between the test group and control group in the subchronic systemic toxicity test. Conclusion The bioprosthetic heart valve material with a non-glutaraldehyde-based treatment has satisfying biocompatibility, which conforms to relevant national standards. The material might be a promising material for application in valve replacement.

Citation： WEN Xiaoxiao, ZHANG Kun, PAN Kongrong, WANG Wentao, PAN Wenzhi. Biocompatibility of bioprosthetic heart valve materials with a non-glutaraldehyde-based chemical treatment. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2022, 29(12): 1653-1659. doi: 10.7507/1007-4848.202112069 Copy

1.	Yang Y, Wang Z, Chen Z, et al. Current status and etiology of valvular heart disease in China: A population-based survey. BMC Cardiovasc Disord, 2021, 21(1): 339.
2.	Kostyunin AE, Yuzhalin AE, Rezvova MA, et al. Degeneration of bioprosthetic heart valves: Update 2020. J Am Heart Assoc, 2020, 9(19): e018506.
3.	Li KYC. Bioprosthetic heart valves: Upgrading a 50-year old technology. Front Cardiovasc Med, 2019, 6: 47.
4.	Botes L, Laker L, Dohmen PM, et al. Advantages of decellularized bovine pericardial scaffolds compared to glutaraldehyde fixed bovine pericardial patches demonstrated in a 180-day implant ovine study. Cell Tissue Bank, 2022. [Epub ahead of print].
5.	Gao M, Wang Y, He Y, et al. Comparative evaluation of decellularized porcine liver matrices crosslinked with different chemical and natural crosslinking agents. Xenotransplantation, 2019, 26(1): e12470.
6.	Welzel C, Dittfeld C, Jannasch A, et al. Hemocompatibility assays offer a new option for evaluation of decellularized bovine pericardium for application in cardiac surgery. Thorac Cardiov Surg, 2021, 69(S 01): DGTHG-eP33.
7.	Brill FHH, Becker B, Todt D, et al. Virucidal efficacy of glutaraldehyde for instrument disinfection. GMS Hyg Infect Control, 2020, 15: Doc34.
8.	Lin Q, Lim JYC, Xue K, et al. Sanitizing agents for virus inactivation and disinfection. View (Beijing), 2020: e16.
9.	Simionescu DT. Prevention of calcification in bioprosthetic heart valves: challenges and perspectives. Expert Opin Biol Ther, 2004, 4(12): 1971-1985.
10.	Jorge-Herrero E, Fernández P, Turnay J, et al. Influence of different chemical cross-linking treatments on the properties of bovine pericardium and collagen. Biomaterials, 1999, 20(6): 539-545.
11.	Tam H, Zhang W, Infante D, et al. Fixation of bovine pericardium-based tissue biomaterial with irreversible chemistry improves biochemical and biomechanical properties. J Cardiovasc Transl Res, 2017, 10(2): 194-205.
12.	Tam H, Zhang W, Feaver KR, et al. A novel crosslinking method for improved tear resistance and biocompatibility of tissue based biomaterials. Biomaterials, 2015, 66: 83-91.
13.	Sung HW, Chang WH, Ma CY, et al. Crosslinking of biological tissues using genipin and/or carbodiimide. J Biomed Mater Res A, 2003, 64(3): 427-438.
14.	Chang Y, Tsai CC, Liang HC, et al. In vivo evaluation of cellular and acellular bovine pericardia fixed with a naturally occurring crosslinking agent (genipin). Biomaterials, 2002, 23(12): 2447-2457.
15.	Sung HW, Hsu HL, Shih CC, et al. Cross-linking characteristics of biological tissues fixed with monofunctional or multifunctional epoxy compounds. Biomaterials, 1996, 17(14): 1405-1410.
16.	Zhuravleva IY, Karpova EV, Oparina LA, et al. Cross-linking method using pentaepoxide for improving bovine and porcine bioprosthetic pericardia: A multiparametric assessment study. Mater Sci Eng C Mater Biol Appl, 2021, 118: 111473.
17.	Cipriano PR, Billingham ME, Oyer PE, et al. Calcification of porcine prosthetic heart valves: A radiographic and light microscopy study. Circulation, 1982, 66(5): 1100-1104.
18.	Schoen F J, Harasaki H, Kim K M, et al. Biomaterial-associated calcification: Pathology, mechanisms, and strategies for prevention. J Biomed Mater Res, 1988, 22(A1 Suppl): 11-36.
19.	Tod TJ, Dove JS. The association of bound aldehyde content with bioprosthetic tissue calcification. J Mater Sci Mater Med, 2016, 27(1): 8.
20.	杨春蓉. 交联对胶原生物学和物理性能的影响. 中国组织工程研究与临床康复, 2009, 13(3): 521-524.
21.	Luo Y, Huang S, Ma L. A novel detergent-based decellularization combined with carbodiimide crosslinking for improving anti-calcification of bioprosthetic heart valve. Biomed Mater, 2021, 16(4): 0450221.
22.	Yang C. Enhanced physicochemical properties of collagen by using EDC/NHS-crosslinking. Bull Mater Sci, 2012, 35(5): 913-918.
23.	Guo G, Jin L, Jin W, et al. Radical polymerization-crosslinking method for improving extracellular matrix stability in bioprosthetic heart valves with reduced potential for calcification and inflammatory response. Acta Biomater, 2018, 82: 44-55.
24.	Jorge-Herrero E, Fonseca C, Barge AP, et al. Biocompatibility and calcification of bovine pericardium employed for the construction of cardiac bioprostheses treated with different chemical crosslink methods. Artif Organs, 2010, 34(5): E168-E176.
25.	Umashankar PR, Mohanan PV, Kumari TV. Glutaraldehyde treatment elicits toxic response compared to decellularization in bovine pericardium. Toxicol Int, 2012, 19(1): 51-58.

1. Yang Y, Wang Z, Chen Z, et al. Current status and etiology of valvular heart disease in China: A population-based survey. BMC Cardiovasc Disord, 2021, 21(1): 339.
2. Kostyunin AE, Yuzhalin AE, Rezvova MA, et al. Degeneration of bioprosthetic heart valves: Update 2020. J Am Heart Assoc, 2020, 9(19): e018506.
3. Li KYC. Bioprosthetic heart valves: Upgrading a 50-year old technology. Front Cardiovasc Med, 2019, 6: 47.
4. Botes L, Laker L, Dohmen PM, et al. Advantages of decellularized bovine pericardial scaffolds compared to glutaraldehyde fixed bovine pericardial patches demonstrated in a 180-day implant ovine study. Cell Tissue Bank, 2022. [Epub ahead of print].
5. Gao M, Wang Y, He Y, et al. Comparative evaluation of decellularized porcine liver matrices crosslinked with different chemical and natural crosslinking agents. Xenotransplantation, 2019, 26(1): e12470.
6. Welzel C, Dittfeld C, Jannasch A, et al. Hemocompatibility assays offer a new option for evaluation of decellularized bovine pericardium for application in cardiac surgery. Thorac Cardiov Surg, 2021, 69(S 01): DGTHG-eP33.
7. Brill FHH, Becker B, Todt D, et al. Virucidal efficacy of glutaraldehyde for instrument disinfection. GMS Hyg Infect Control, 2020, 15: Doc34.
8. Lin Q, Lim JYC, Xue K, et al. Sanitizing agents for virus inactivation and disinfection. View (Beijing), 2020: e16.
9. Simionescu DT. Prevention of calcification in bioprosthetic heart valves: challenges and perspectives. Expert Opin Biol Ther, 2004, 4(12): 1971-1985.
10. Jorge-Herrero E, Fernández P, Turnay J, et al. Influence of different chemical cross-linking treatments on the properties of bovine pericardium and collagen. Biomaterials, 1999, 20(6): 539-545.
11. Tam H, Zhang W, Infante D, et al. Fixation of bovine pericardium-based tissue biomaterial with irreversible chemistry improves biochemical and biomechanical properties. J Cardiovasc Transl Res, 2017, 10(2): 194-205.
12. Tam H, Zhang W, Feaver KR, et al. A novel crosslinking method for improved tear resistance and biocompatibility of tissue based biomaterials. Biomaterials, 2015, 66: 83-91.
13. Sung HW, Chang WH, Ma CY, et al. Crosslinking of biological tissues using genipin and/or carbodiimide. J Biomed Mater Res A, 2003, 64(3): 427-438.
14. Chang Y, Tsai CC, Liang HC, et al. In vivo evaluation of cellular and acellular bovine pericardia fixed with a naturally occurring crosslinking agent (genipin). Biomaterials, 2002, 23(12): 2447-2457.
15. Sung HW, Hsu HL, Shih CC, et al. Cross-linking characteristics of biological tissues fixed with monofunctional or multifunctional epoxy compounds. Biomaterials, 1996, 17(14): 1405-1410.
16. Zhuravleva IY, Karpova EV, Oparina LA, et al. Cross-linking method using pentaepoxide for improving bovine and porcine bioprosthetic pericardia: A multiparametric assessment study. Mater Sci Eng C Mater Biol Appl, 2021, 118: 111473.
17. Cipriano PR, Billingham ME, Oyer PE, et al. Calcification of porcine prosthetic heart valves: A radiographic and light microscopy study. Circulation, 1982, 66(5): 1100-1104.
18. Schoen F J, Harasaki H, Kim K M, et al. Biomaterial-associated calcification: Pathology, mechanisms, and strategies for prevention. J Biomed Mater Res, 1988, 22(A1 Suppl): 11-36.
19. Tod TJ, Dove JS. The association of bound aldehyde content with bioprosthetic tissue calcification. J Mater Sci Mater Med, 2016, 27(1): 8.
20. 杨春蓉. 交联对胶原生物学和物理性能的影响. 中国组织工程研究与临床康复, 2009, 13(3): 521-524.
21. Luo Y, Huang S, Ma L. A novel detergent-based decellularization combined with carbodiimide crosslinking for improving anti-calcification of bioprosthetic heart valve. Biomed Mater, 2021, 16(4): 0450221.
22. Yang C. Enhanced physicochemical properties of collagen by using EDC/NHS-crosslinking. Bull Mater Sci, 2012, 35(5): 913-918.
23. Guo G, Jin L, Jin W, et al. Radical polymerization-crosslinking method for improving extracellular matrix stability in bioprosthetic heart valves with reduced potential for calcification and inflammatory response. Acta Biomater, 2018, 82: 44-55.
24. Jorge-Herrero E, Fonseca C, Barge AP, et al. Biocompatibility and calcification of bovine pericardium employed for the construction of cardiac bioprostheses treated with different chemical crosslink methods. Artif Organs, 2010, 34(5): E168-E176.
25. Umashankar PR, Mohanan PV, Kumari TV. Glutaraldehyde treatment elicits toxic response compared to decellularization in bovine pericardium. Toxicol Int, 2012, 19(1): 51-58.

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Biocompatibility of bioprosthetic heart valve materials with a non-glutaraldehyde-based chemical treatment

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