Implementation of the versius robotic surgical system for thoracic surgery: First clinical evaluation of feasibility and performance.

ABSTRACT

OBJECTIVES: The aim of this study is to demonstrate the ability of the Versius Surgical System to successfully and safely complete a range of thoracic procedures aligned with Stage 2a (Development) of the Idea, Development, Exploration, Assessment and Long-term follow-up framework for surgical innovation. METHODS: This prospective study included the first 30 consecutive patients who underwent robotic surgery with Versius by two surgeons without prior robotic experience between 01/04/2023 and 30/12/2023 [25 lung resections (wedge, segmentectomy and lobectomy) and 5 thymectomies]. There was no specific predetermined selection criteria for each case. The primary outcome was safe completion of the procedure without unplanned conversion. Secondary outcomes included intraoperative and postoperative complications, intraoperative device-related outcomes, and pathology results. RESULTS: Twenty-eight (93.3%) cases were completed without conversion. Both conversions were to thoracoscopy, one due to a "console alarm" and the other due to a pulmonary artery bleeding. In lung resections, median console time was 103 (90-129) min. Five (20%) patients experienced postoperative complications, most frequent was persistent air leak (16%). Median length-of-stay was 3 (2-4) days. Neither readmissions nor mortality was observed. In thymectomies, no intraoperative or postoperative complications, readmissions, reinterventions or mortality were observed. Median console time was 77 (75-89) min and median length of stay was 1 (1-1) day. CONCLUSIONS: This phase 2a IDEAL-D study confirms lung resections and thymectomies are feasible with the use of Versius system, laying the foundation for larger phase 2 b and 3 clinical studies within the IDEAL-D framework.