Background and aims of the study: The use of human pericardium pretreated for 10 min with 0.625% glutaraldehyde (GLUT) in valvular repair or intracardiac reconstruction has produced good results. However, to date, no investigations have been made to determine the mechanical changes that occur in the tissue following such pretreatment.
Methods: Human pericardial samples were harvested from 25 patients and immersed in GLUT for increasing times (5, 10, 30, 60 min and 6 months). Either untreated human pericardium or bovine pericardium treated for six months with GLUT served as controls. Tensile tests were performed with a uniaxial load machine and a pulsative bench. Fatigue testing was for 14 days; each sample was tested at 1,200 cycles/min at a controlled pressure of 90-120 mmHg.
Results: Untreated tissue thickness was 0.44+/-0.16 mm, but after six months GLUT treatment it was 0.53+/-0.15 mm (p<0.001). There was a 13.7% shrinkage of tissue after six months immersion. Strain was significantly greater in treated tissue than in untreated tissue, while stiffness decreased with the duration of GLUT immersion. Young's modulus was significantly lower after six months GLUT treatment (0.26+/-0.06 MPa) compared with untreated, and 5-, 10- and 30-min GLUT treatment (0.32+/-0.15, 0.35+/-0.09, 0.32+/-0.09 and 0.36+/-0.10 MPa (p<0.05)), respectively. Creep was greater after six months GLUT treatment (0.5+/-0.03%) than in untreated and 10-, 30- and 60-min treatments (0.3+/-0.50, 0.27+/-0.01, 0.27+/-0.02, 0.3+/-0.01% (p<0.05)), respectively. Ultimate tensile stress (UTS) was greater in 10-min treated pericardium than in untreated tissue: 38.46+/-11.75 versus 22.17+/-8.30 MPa (p<0.05) respectively. Strain at rupture was greater in the 6-month group (30.62+/-2.54%) than for untreated and 10-, 30- and 60-min GLUT immersion 16.3+/-0.73, 21.85+/-0.75, 20.12+/-1.04 and 18.87+/-0.86% (p<0.05), respectively. Fatigue testing showed an increased length after five and 10 min, and six months, with a lengthening of 14.66, 12.53, 7.66%, respectively compared with 3.5% for untreated tissue (p<0.05). There were three failures in the untreated group (n = 5), none in the 5- and 10-min groups, and one in the 6-month group (p<0.05).
Conclusion: Brief immersion of human pericardial tissue in 0.625% glutaraldehyde reduces the tissue's stiffness and improves its durability for use in cardiac surgery.