Acute Swine Model for Assessing Biocompatibility of Biomedical Interface Materials.

We established an acute animal model for early, straightforward, and reproducible assessment of a biocompatible material interface. Bilateral femoral artery-to-vein shunts were created in 12 pigs: two tubes per shunt, the left two coated and the right two uncoated. We evaluated two groups: uncontrolled flow (UF; shunt flow unregulated) and controlled flow (CF; shunt flow ∼50 mL/min). For each case on each side, two shunts were evaluated: one for 1 h and the other for 3 h. Arterial blood gas and complete blood count were recorded at baseline, 1, and 3 h. Mean shunt flows were 532 ± 88 mL/min UF and 52 ± 8 mL/min CF. Differences in flow were much smaller in CF (0.5 mL/min; 1% of mean flow) than UF (24.8 mL/min; 5% of mean flow). In UF, significant changes occurred: in pH, from start of shunting through 1 h; in pO and pCO, from start through 3 h. This swine model using bilateral femoral shunts with controlled blood flow provides a reliable, reproducible, easily implemented method by which to evaluate biocompatibility of device coatings at an early stage of investigation.