Calcification potential of small intestinal submucosa in a rat subcutaneous model.

Glutaraldehyde treatment of collagen biomaterials promotes calcification, poor host-tissue incorporation, and ultimately mechanical failure of bioprotheses. Porcine small-intestinal submucosa (SIS) is a biomaterial which has been investigated for several applications including arterial and venous grafts and repair of tendon, ligament, body wall, and urinary bladder defects. The calcification potential of peracetic acid (PAA)-sterilized SIS was studied. Four test samples, (1) native (cleaned, untreated) SIS, (2) SIS sterilized with 0.1% PAA, (3) SIS treated with 0.25% glutaraldehyde for 20 min, and (4) commercially available glutaraldehyde-preserved porcine bioprosthetic heart valve cusp segments (GPV), were each implanted subcutaneously in each of 24 weanling rats. Six rats were euthanatized at 1, 2, 4, and 8 weeks. Evaluation of calcium concentration by atomic absorption spectroscopy and extent of mineralization and fibrosis by light microscopy were performed. Atomic absorption revealed no calcification in native or peracetic acid-treated SIS at any time point compared with preimplant calcium concentration. Statistically significant (P < 0.0001) calcification occurred in glutaraldehyde-treated materials (SIS and GPV) at each evaluation as compared to native and peracetic acid-treated samples. Histopathology indicated native and peracetic acid-treated SIS showed no implant mineralization (P < 0.0001) and little peri-implant fibrosis (P < 0.0001). Results suggested that native and peracetic acid-treated SIS have a low calcification potential and further study of this biomaterial is warranted. Copyright 1997 Academic Press.