Hemocompatibility of bioprosthetic heart valve materials respectively based on glutaraldehyde and non-glutaraldehyde treatment_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

 WEN Xiaoxiao ¹ , PAN Wenzhi ² , ZHANG Kun ¹ , PAN Kongrong ¹ , ZHOU Daxin ² , GE Junbo 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

Keywords：

Bioprosthetic heart valve; bovine pericardium; glutaraldehyde; carbodiimide; hemocompatibility

DOI：

10.7507/1007-4848.202202007

Video：

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Objective To study the hemocompatibility of bioprosthetic heart valve materials respectively based on glutaraldehyde and non-glutaraldehyde treatment. Methods Fresh bovine pericardium was treated with glutaraldehyde or non-glutaraldehyde after adipose tissue was removed. To evaluate the hemocompatibility of the two bioprosthetic heart valve materials, hemolysis test, in vitro fibrinogen adsorption experiment, platelet adhesion experiment, thrombin-antithrombin complex (TAT) test, complement activation assay and ex vivo circulation experiment were performed. Results The hemolysis test results demonstrated that both of the materials showed hemolytic rates lower than 5%. The results of TAT test and complement activation assay showed no statistical differences among the two materials and the blank control group. Compared to the bioprosthetic heart valve materials with glutaraldehyde-based treatment, the materials with non-glutaraldehyde-based treatment showed significantly decreased fibrinogen adsorption, platelet adhesion and thrombosis. Conclusion Compared to the bioprosthetic heart valve materials with glutaraldehyde-based treatment, the materials with non-glutaraldehyde-based treatment show better hemocompatibility.

Citation： WEN Xiaoxiao, PAN Wenzhi, ZHANG Kun, PAN Kongrong, ZHOU Daxin, GE Junbo. Hemocompatibility of bioprosthetic heart valve materials respectively based on glutaraldehyde and non-glutaraldehyde treatment. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2023, 30(9): 1323-1328. doi: 10.7507/1007-4848.202202007 Copy

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4.	Liu J, Jing H, Qin Y, et al. Nonglutaraldehyde fixation for off the shelf decellularized bovine pericardium in anticalcification cardiac valve applications. ACS Biomater Sci Eng, 2019, 5(3): 1452-1461.
5.	Yu T, Yang W, Zhuang W, et al. A bioprosthetic heart valve cross-linked by a non-glutaraldehyde reagent with improved biocompatibility, endothelialization, anti-coagulation and anti-calcification properties. J Mater Chem B, 2021, 9(19): 4031-4038.
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9.	Laughlin M, Kapales M, Thakali K, et al. Glutaraldehyde fixation of venous valve tissue: A benchmark for alternative fixation methods. Phlebology, 2022, 37(4): 296-302.
10.	Denzinger M, Held M, Scheffler H, et al. Hemocompatibility of different burn wound dressings. Wound Repair Regen, 2019, 27(5): 470-476.
11.	Brubert J, Krajewski S, Wendel HP, et al. Hemocompatibility of styrenic block copolymers for use in prosthetic heart valves. J Mater Sci Mater Med, 2016, 27(2): 32.
12.	Yang F, Xu L, Kuang D, et al. Polyzwitterion-crosslinked hybrid tissue with antithrombogenicity, endothelialization, anticalcification properties. Chem Eng J (Lausanne), 2021, 410: 128244.
13.	Liu J, Li B, Jing H, et al. Curcumin-crosslinked acellular bovine pericardium for the application of calcification inhibition heart valves. Biomed Mater, 2020, 15(4): 045002.
14.	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).
15.	秦政, 楊欽博, 蘇白海. 血液接觸生物材料的血液相容性評價研究進展. 高分子通報, 2021, (2): 1-8.
16.	Vroman L. The life of an artificial device in contact with blood: Initial events and their effect on its final state. Bull N Y Acad Med, 1988, 64(4): 352.
17.	Song C, Li Y, Wang B, et al. A novel anticoagulant affinity membrane for enhanced hemocompatibility and bilirubin removal. Colloids Surf B Biointerfaces, 2021, 197: 111430.
18.	夏利軍, 阮長耿. 纖維蛋白原結構與血栓形成. 血栓與止血學, 1996, 3(2): 86-87.
19.	Horbett TA. Fibrinogen adsorption to biomaterials. J Biomed Mater Res A, 2018, 106(10): 2777-2788.
20.	Martins MC, Wang D, Ji J, et al. Albumin and fibrinogen adsorption on PU-PHEMA surfaces. Biomaterials, 2003, 24(12): 2067-2076.
21.	Slack SM, Horbett TA. Changes in fibrinogen adsorbed to segmented polyurethanes and hydroxyethylmethacrylate-ethylmethacrylate copolymers. J Biomed Mater Res, 1992, 26(12): 1633-1649.
22.	Dewanjee MK, Didisheim P, Kaye MP, et al. Platelet deposition on and calcification of bovine pericardial valve. Eur Heart J, 1984, 5 (Suppl D): 1-5.
23.	Tan J, McClung WG, Brash JL. Non-fouling biomaterials based on blends of polyethylene oxide copolymers and polyurethane: Simultaneous measurement of platelet adhesion and fibrinogen adsorption from flowing whole blood. J Biomater Sci Polym Ed, 2013, 24(4): 497-506.
24.	Milburn JA, Ford I, Mutch NJ, et al. Thrombin-anti-thrombin levels and patency of arterio-venous fistula in patients undergoing haemodialysis compared to healthy volunteers: A prospective analysis. PLoS One, 2013, 8(7): e67799.
25.	Hessler S, Rüth M, Sauvant C, et al. Hemocompatibility of EpoCore/EpoClad photoresists on COC substrate for optofluidic integrated Bragg sensors. Sens Actuators B Chem, 2017, 239: 916-922.
26.	Mollahosseini A, Abdelrasoul A, Shoker A. A critical review of recent advances in hemodialysis membranes hemocompatibility and guidelines for future development. Mater Chem Phys, 2020, 248: 122911.
27.	Aytemiz D, Suzuki Y, Shindo T, et al. In vitro and in vivo evaluation of hemocompatibility of silk fibroin based artificial vascular grafts. Int J Chem, 2014, 6(2): 1-14.

1. Chabchoub S, Mansouri S, Salah RB. Detection of valvular heart diseases using impedance cardiography ICG. Biocybern Biomed Eng, 2018, 38(2): 251-261.
2. Yacoub MH, Takkenberg JJ. Will heart valve tissue engineering change the world? Nat Clin Pract Cardiovasc Med, 2005, 2(2): 60-61.
3. Head SJ, ?elik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J, 2017, 38(28): 2183-2191.
4. Liu J, Jing H, Qin Y, et al. Nonglutaraldehyde fixation for off the shelf decellularized bovine pericardium in anticalcification cardiac valve applications. ACS Biomater Sci Eng, 2019, 5(3): 1452-1461.
5. Yu T, Yang W, Zhuang W, et al. A bioprosthetic heart valve cross-linked by a non-glutaraldehyde reagent with improved biocompatibility, endothelialization, anti-coagulation and anti-calcification properties. J Mater Chem B, 2021, 9(19): 4031-4038.
6. Ding K, Zheng C, Huang X, et al. A PEGylation method of fabricating bioprosthetic heart valves based on glutaraldehyde and 2-amino-4-pentenoic acid co-crosslinking with improved antithrombogenicity and cytocompatibility. Acta Biomater, 2022, 144: 279-291.
7. Simionescu DT. Prevention of calcification in bioprosthetic heart valves: Challenges and perspectives. Expert Opin Biol Ther, 2004, 4(12): 1971-1985.
8. Whelan A, Williams E, Fitzpatrick E, et al. Collagen fibre-mediated mechanical damage increases calcification of bovine pericardium for use in bioprosthetic heart valves. Acta Biomater, 2021, 128: 384-392.
9. Laughlin M, Kapales M, Thakali K, et al. Glutaraldehyde fixation of venous valve tissue: A benchmark for alternative fixation methods. Phlebology, 2022, 37(4): 296-302.
10. Denzinger M, Held M, Scheffler H, et al. Hemocompatibility of different burn wound dressings. Wound Repair Regen, 2019, 27(5): 470-476.
11. Brubert J, Krajewski S, Wendel HP, et al. Hemocompatibility of styrenic block copolymers for use in prosthetic heart valves. J Mater Sci Mater Med, 2016, 27(2): 32.
12. Yang F, Xu L, Kuang D, et al. Polyzwitterion-crosslinked hybrid tissue with antithrombogenicity, endothelialization, anticalcification properties. Chem Eng J (Lausanne), 2021, 410: 128244.
13. Liu J, Li B, Jing H, et al. Curcumin-crosslinked acellular bovine pericardium for the application of calcification inhibition heart valves. Biomed Mater, 2020, 15(4): 045002.
14. 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).
15. 秦政, 楊欽博, 蘇白海. 血液接觸生物材料的血液相容性評價研究進展. 高分子通報, 2021, (2): 1-8.
16. Vroman L. The life of an artificial device in contact with blood: Initial events and their effect on its final state. Bull N Y Acad Med, 1988, 64(4): 352.
17. Song C, Li Y, Wang B, et al. A novel anticoagulant affinity membrane for enhanced hemocompatibility and bilirubin removal. Colloids Surf B Biointerfaces, 2021, 197: 111430.
18. 夏利軍, 阮長耿. 纖維蛋白原結構與血栓形成. 血栓與止血學, 1996, 3(2): 86-87.
19. Horbett TA. Fibrinogen adsorption to biomaterials. J Biomed Mater Res A, 2018, 106(10): 2777-2788.
20. Martins MC, Wang D, Ji J, et al. Albumin and fibrinogen adsorption on PU-PHEMA surfaces. Biomaterials, 2003, 24(12): 2067-2076.
21. Slack SM, Horbett TA. Changes in fibrinogen adsorbed to segmented polyurethanes and hydroxyethylmethacrylate-ethylmethacrylate copolymers. J Biomed Mater Res, 1992, 26(12): 1633-1649.
22. Dewanjee MK, Didisheim P, Kaye MP, et al. Platelet deposition on and calcification of bovine pericardial valve. Eur Heart J, 1984, 5 (Suppl D): 1-5.
23. Tan J, McClung WG, Brash JL. Non-fouling biomaterials based on blends of polyethylene oxide copolymers and polyurethane: Simultaneous measurement of platelet adhesion and fibrinogen adsorption from flowing whole blood. J Biomater Sci Polym Ed, 2013, 24(4): 497-506.
24. Milburn JA, Ford I, Mutch NJ, et al. Thrombin-anti-thrombin levels and patency of arterio-venous fistula in patients undergoing haemodialysis compared to healthy volunteers: A prospective analysis. PLoS One, 2013, 8(7): e67799.
25. Hessler S, Rüth M, Sauvant C, et al. Hemocompatibility of EpoCore/EpoClad photoresists on COC substrate for optofluidic integrated Bragg sensors. Sens Actuators B Chem, 2017, 239: 916-922.
26. Mollahosseini A, Abdelrasoul A, Shoker A. A critical review of recent advances in hemodialysis membranes hemocompatibility and guidelines for future development. Mater Chem Phys, 2020, 248: 122911.
27. Aytemiz D, Suzuki Y, Shindo T, et al. In vitro and in vivo evaluation of hemocompatibility of silk fibroin based artificial vascular grafts. Int J Chem, 2014, 6(2): 1-14.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Hemocompatibility of bioprosthetic heart valve materials respectively based on glutaraldehyde and non-glutaraldehyde treatment

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