Mechanical degradation of biological heart valve tissue induced by low diameter crimping: An early assessment

Abstract Transcatheter aortic valve implantation (TAVI) has become today an increasingly attractive procedure to relieve patients from aortic valve disease. However, the procedure requires crimping biological tissue within a metallic stent for low diameter catheter insertion purpose. This step induces specific stress in the leaflets especially when the crimping diameter is small. One concern about crimping is the potential degradations undergone by the biological tissue, which may limit the durability of the valve once implanted. The purpose of the present work is to study the effect of low diameter crimping on the mechanical performances of pericardium valve prototypes. The prototypes were compressed to a diameter of 1 mm within braided stents for 20 min. SEM observations performed on crimped material show that crimped leaflets undergo degradations characterized by apparent surface defects. Moreover mechanical extension tests were performed on pericardium strips before and after crimping. The strips (15 mm long, 5 mm wide) were taken from both crimped and native leaflets considering 2 different valve diameters, 19 and 21 mm. In order to prevent the premature drying of the pericardium tissue during the procedure, the biological tissue was kept in contact with a formaldehyde solution. Results show that the ultimate strength value decreases nearly by up to 50%. The modifications observed in the material may jeopardize the long term durability of the device. However, further tests are necessary with a larger amount of samples to confirm these early results.