Safety and efficacy of Symani robotic-assisted microsurgery: Assessment of vascular anastomosis patency, thrombus, and stenosis in a randomized preclinical study.

[INTRODUCTION] The Symani surgical system undergoes scrutiny in this study as part of a series of preclinical investigations. Previous studies compared the precision of robotic-assisted anastomoses with manual techniques. This study aimed to evaluate the critical, histological, and gross parameters at the site of anastomosis and at distant sites in a rat model to provide insights into the safety and efficacy of robotic-assisted microsurgery to enhance its potential for clinical adoption.

[MATERIALS AND METHODS] Experienced microsurgeons performed arterial and venous anastomoses in 16 Wistar rats, randomized into four treatment groups: robotic artery, robotic vein, manual artery, and manual vein. Various parameters were evaluated at two time points (T0 and T30) on the day of the procedure and at Day 28 (T28d). In the second phase of the study, the animals underwent necropsy, histopathologic analysis, micro-CT scans, and angiography imaging of the anastomosis sites, major organs, and distant target organs by a blinded assessor.

[RESULTS] Patency rates were 100% at T0 and T30 for all anastomoses and stayed at 100% on T28d for the robotic subgroups; however, it decreased to 87.5% for manual arterial anastomoses owing to a case of obstructive thrombus. No evidence of clot migration was observed. Blood flow parameters and procedure times did not differ significantly. The blinded semiquantitative histological analysis revealed no significant disparities between the robotic and manual anastomoses across various pathological indicators. No gross abnormalities were detected in musculoskeletal examinations.

[CONCLUSION] This preclinical study demonstrated the safety of the Symani surgical system. Results suggest equivalence between robotic and manual techniques regarding thrombus formation at the anastomotic site and distal organs.