Biocompatibility of bioprosthetic heart valve materials with a non-glutaraldehyde-based chemical treatment
- VernacularTitle:一种非戊二醛化学体系处理的生物瓣膜材料的生物相容性研究
- Author:
Xiaoxiao WEN
1
;
Kun ZHANG
1
;
Kongrong PAN
1
;
Wentao WANG
1
;
Wenzhi PAN
1
Author Information
1. Department of Cardiology, Zhongshan Hospital, Fudan University, Research Unit of Cardiovascular Techniques and Devices, Chinese Academy of Medical Sciences, Shanghai, 200032, P. R. China
- Publication Type:Journal Article
- Keywords:
Bioprosthetic heart valve;
bovine pericardium;
carbodiimide;
biocompatibility;
toxic reaction
- From:
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
2022;29(12):1653-1659
- CountryChina
- Language:Chinese
-
Abstract:
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.
