Evaluation of a novel anastomotic device in the animal model: A feasibility, safety, and efficacy study

Background: A novel device was designed to assist with microvascular arterial anastomoses. This study compares the safety and efficacy of the anastomosis-assisting device with manual suturing in an ovine model. Methods: Arteries with a diameter ranging from 2 to 4 mm were transected and anastomosed at four locations. A comparison was done between manual anastomoses and anastomoses performed with a novel anastomotic device in seven sheep. All the device-assisted anastomoses were performed by a single surgeon. At day 45 +/- 7, anastomotic sites were dissected to determine patency, and samples were obtained for pathology. Results: Thirteen of 13 (100%) samples from the VessealT group demonstrated patency both on the day the anastomoses were performed and after the 45-day follow-up period. All four additional anastomoses performed using the VessealT were found patent. In the hand-suturing group, six of six (100%) samples demonstrated patency on the day of the anastomoses and five of six (83%) were patent after the follow-up period. No thromboses or adverse events were observed in the anastomoses in either group. No difference in histopathology of the anastomoses was observed between the groups. Conclusions: The anastomosis-assisting device is a safe and efficacious alternative to hand suturing. The patency rates of device-assisted anastomoses were greater than those of manual suturing and pose no additional risk, as demonstrated by clinical observation, histopathology, and macroscopic evaluation. The VessealT anastomosis-assisting device may be a viable alternative to manual suturing, with an ergonomic and intuitive design, short learning curve, and consistent results. (c) 2023 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.