Abstract
Calcification is a major factor that limits the durability of bioprosthetic valve. A novel bovine pericardial tissue treated with aldehyde capping chemistry and glycerolization was evaluated for its resistance to calcification in comparison with porcine tissues treated with amino oleic acid and bovine pericardial tissue with ethanol rinsing in a rabbit intramuscular model. Tissue discs from the test and control tissues were implanted in rabbits for 60 days. The explanted discs were subject to X-ray imaging, calcium quantification and histology analysis. The test tissue showed 95 and 96 % reduction in calcification in comparison with amino oleic acid treatment and ethanol rinsing treatment, respectively. In addition, the test tissue showed the least inflammatory response as evidenced by a reduced amount of macrophages and giant cells in histology analysis. Furthermore, the aldehyde analysis of the pre-implanted samples showed associated reduction in free aldehyde levels with the test tissue. The reduction in calcification is consistent with previously reported results and is hypothesized to be attributed to the capping of free aldehydes in the test tissue.
Highlights
Bioprosthetic heart valves have been widely used to replace diseased native valves
There are a number of mechanisms underlying tissue calcification including the presence of residual phospholipids and residual free aldehyde functional groups due to glutaraldehyde fixation in tissue preparations, which can be directly correlated to bioprosthetic tissue calcification [4,5,6,7,8]
Effective targeting of free aldehydes within the tissue, has been more challenging, as most currently available tissue valves rely on the use of glutaraldehyde both during the glutaraldehyde cross-linking process as well as their long-term storage within glutaraldehyde-based preservatives, both sources for the development of free aldehydes
Summary
Bioprosthetic heart valves have been widely used to replace diseased native valves. Tissue valves, constructed either from porcine aortic valves or from bovine pericardium, have become favored over mechanical valves due to their biocompatibility, hemodynamic superiority and the elimination of the need for life-long anti-coagulant regimens. Most anti-calcification technologies involve the reduction of phospholipids through the use of various detergents. This approach has proven effective in inhibiting calcification as evidenced by numerous in vivo studies [9,10,11,12]. Effective targeting of free aldehydes within the tissue, has been more challenging, as most currently available tissue valves rely on the use of glutaraldehyde both during the glutaraldehyde cross-linking process as well as their long-term storage within glutaraldehyde-based preservatives, both sources for the development of free aldehydes. The few commercially available technologies targeting free aldehydes have inherent limitations providing long-term protection against calcification via these free aldehydes, as evidenced by the current literature [13, 14]
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