Increased burst pressure in gastrointestinal staple-lines using reinforcement with a bioprosthetic material

Background: Leakage at an anastomosis is a major and often catastrophic complication of gastrointestinal (GI) surgery. Staple-line reinforcement with one of the several materials commercially available has been utilized to reduce the incidence of this complication. The bioprosthetic material, small intestinal submucosa (SIS, Surgisis (R); Cook, Inc., Bloomington, IN) has found widespread applications in surgery. However, its ability to improve the durability of staple-lines in GI surgery in terms of burst pressure has not been documented. We hypothesized that SIS reinforcement of staple-lines in healthy living GI tissue would increase durability, as determined by leak rates at increased intraluminal pressures, compared to unreinforced staple-lines. Methods: Two healthy Yorkshire-Cross pigs were subjected to midline laparotomy and underwent small intestinal division (n=28) with GIA stapling devices. Half of the staple-lines were reinforced with SIS. The staple-lines were then exposed to increased intraluminal pressures by means of a constant-rate dye solution infusion, until staple-lines exhibited visible leakage of the dye solution. The intraluminal pressure was recorded at the time of visible leakage. Results: Staple-lines reinforced with SIS had significantly better durability as determined by analysis of variance and Kaplan-Meier survival calculations, with respect to leak rate as a function of intraluminal pressure (P < 0.003). The mean burst pressure of the unreinforced staple-lines was 53 mmHg, while those staple-lines reinforced with SIS had a mean burst pressure of 83 mmHg. Conclusion: Reinforcement of stapled GI anastomoses with SIS significantly increases anastomotic burst pressure. These findings suggest a role for this material in GI surgery.