Peri- and postoperative anastomotic leakage from blood vessel anastomosis is a common and potentially life-threatening complication. As an adjunctive therapy providing an additional layer of safety, a new biodegradable, polyurethane-based adhesive was developed. It consists of two components: an isocyanate-functionalized prepolymer and an amino-based curing agent. The adhesive was investigated in a porcine animal model to seal sutured blood vessel anastomoses of arteries, veins, aortas and prosthetic aortic graft replacements. The material-determined properties of the adhesive like viscosity, processing and polymerization time as well as bonding strength were well suited for this application. The adhesive stopped perioperative suture-line bleedings and stayed on all anastomoses until sacrifice. Hematological and serological inflammation marker assessments were unobtrusive. The histological evaluation showed a mild to moderate local tissue reaction to the adhesive constituting a physiological, non-adverse tissue-biomaterial interaction. The adhesive did not interfere with vascular wound healing. The adhesive demonstrated to be suitable to improve the outcome of cardiovascular surgeries by securing the classical sutured anastomoses in a fast, easy and safe manner. However, further studies are required to quantitatively evaluate efficacy in terms of anastomotic leakage prevention as well as long-term tissue compatibility and degradation.
Keywords: anastomotic leakage; biodegradable polyurethane sealant; cardiovascular graft implantation; hemostasis; suture line reinforcement; synthetic tissue adhesive; vascular anastomosis.
© 2022 The Authors. Journal of Biomedical Materials Research Part B: Applied Biomaterials published by Wiley Periodicals LLC.