Abstract
Glutaraldehyde-fixed bovine pericardium is currently the most popular biomaterial utilized in the creation of bioprosthetic heart valves. However, recent studies indicate that glutaraldehyde fixation results in calcification and structural valve deterioration, limiting the longevity of bioprosthetic heart valves. Additionally, glutaraldehyde fixation renders the tissue incompatible with constructive recipient cellular repopulation, remodeling and growth. Use of unfixed xenogeneic biomaterials devoid of antigenic burden has potential to overcome the limitations of current glutaraldehyde-fixed biomaterials. Heart valves undergo billion cycles of opening and closing throughout the patient’s lifetime. Therefore, understanding the response of unfixed tissues to cyclic loading is crucial to these in a heart valve leaflet configuration. In this manuscript we quantify the effect of cyclic deformation on cycle dependent strain, structural, compositional and mechanical properties of fixed and unfixed tissues. Glutaraldehyde-fixed bovine pericardium underwent marked cyclic dependent strain, resulting from significant changes in structure, composition and mechanical function of the material. Conversely, unfixed bovine pericardium underwent minimal strain and maintained its structure, composition and mechanical integrity. This manuscript demonstrates that unfixed bovine pericardium can withstand cyclic deformations equivalent to 6 months of in vivo heart valve leaflet performance.
Highlights
Valvular heart disease (VHD) accounts for substantial morbidity and mortality in developed countries such as the United States, where the population prevalence of moderate to severe VHD is approximately 2.5% [1]
Our results show a substantial drop in the ultimate tensile strength of glutaraldehyde-fixed bovine pericardium at 10 million cycles compared to baseline, again supporting alterations in the materials structure and composition as being instrumental to the observed cycle dependent strain
The potential damage inflicted by the glutaraldehyde fixation process and the resultant limited longevity, inhibited recellularization capacity and inability to be remodeled, means superior alternatives to fixed-tissue bioprosthetic valves must be developed [5, 12, 41, 50]
Summary
Valvular heart disease (VHD) accounts for substantial morbidity and mortality in developed countries such as the United States, where the population prevalence of moderate to severe VHD is approximately 2.5% [1]. VHD incidence increases with age reaching approximately 13.2% in patients 75 years and older. Surgical valve replacement is the only clinically proven long-term treatment for VHD, with 100,000 valve replacements performed annually in the United States [1]. Both mechanical and biological heart valves are available, biological heart valves (BHVs) offer superior hemodynamics and eradicate the requirement of lifelong anticoagulation therapy [1, 3].
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