In Vivo Evaluation of a New Type I Collagen Hemostatic Plug for High-Risk, Large-Core Biopsies

Abstract

To evaluate in a swine model the hemostatic properties of a new, expansile type I collagen plug for use in high-risk renal biopsies. Highly purified bovine type I collagen was formed into porous cylindrical plugs and compressed radially to fit into a 5-F delivery system. On hydration these collagen plugs demonstrated radial expansion with approximately 1,600% volumetric expansion ratio. Direct exposure of both kidneys was performed in a 25-kg swine, and a bolus of 3,000 U of heparin was administered to create a coagulopathic state. A 14-gauge Temno coaxial biopsy gun was utilized in performing nine pairs of renal biopsies. The first biopsy of each biopsy pair represented the control biopsy (without collagen plug placement), whereas the second biopsy of each pair represented the plugged biopsy. The presence and duration of hemorrhage from each biopsy site was monitored visually. The biopsy sites without collagen plug showed immediate hemorrhage in nine of nine cases (100%), and in two of nine cases (22%) pulsatile bleeding was noted. With the use of the collagen plug, seven of nine (78%) sites showed immediate hemorrhage, but in no case was pulsatile bleeding noted. Mean bleeding duration was 156 seconds for the control biopsies versus 73 seconds for the biopsy sites plugged with collagen (P = .03, Mann-Whitney rank sum test). Bleeding duration was less than 1 minute in only one of nine (11%) control biopsies compared to six of nine (67%) collagen plug biopsies. A recently developed, expansile collagen hemostatic plug significantly decreases the duration of hemorrhage at renal biopsy sites in an anticoagulated swine model.