One-Year Outcomes of the First Human Trial on Robot-Assisted Lymphaticovenous Anastomosis for Breast Cancer-Related Lymphedema.

[BACKGROUND] Lymphaticovenous anastomosis, a supermicrosurgical technique, creates bypasses between the lymphatic and venous systems. The quality of lymphaticovenous anastomosis depends on the surgeon's dexterity and precision, and is subject to imperfections caused by the physiologic tremor of the human hand. A dedicated robot for microsurgery has been created to overcome these limitations (MUSA, MicroSure, Eindhoven, The Netherlands). This study describes 1-year clinical outcomes of the first-in-human trial of robot-assisted and manual lymphaticovenous anastomosis in patients with breast cancer-related lymphedema.

[METHODS] In this prospective pilot study, women with breast cancer-related lymphedema were randomized into the robot-assisted or manual lymphaticovenous anastomosis group. Outcomes were quality of life, arm circumference, conservative treatment frequency, arm dermal backflow stage, and anastomosis patency.

[RESULTS] Twenty women were included, of whom eight underwent robot-assisted lymphaticovenous anastomosis surgery and 12 underwent manual surgery. In both groups, quality of life significantly improved at 12 months (robot-assisted surgery, p = 0.045; manual surgery, p = 0.001). Arm circumference did not decrease (robot-assisted surgery, p = 0.094; manual surgery, p = 0.240). Daily use of compression garments decreased by 61.9 percent (robot-assisted surgery) and 70.2 percent (manual surgery). The frequency of manual lymphatic drainage remained similar compared with baseline. Arm dermal backflow stage was reduced in one patient in the robot-assisted group and in five cases in the manual group. Overall, 76.5 percent of the anastomoses were patent (robot-assisted surgery, 66.6 percent; manual surgery, 81.8 percent).

[CONCLUSIONS] After evaluating 1-year follow-up data, this study confirms the feasibility of robot-assisted lymphaticovenous anastomosis surgery. Clinical outcomes were comparable between robot-assisted and manual lymphaticovenous anastomosis. This encourages further research using the new microsurgical robot MUSA for lymphaticovenous anastomosis and other (super)microsurgical procedures.

[CLINICAL QUESTION/LEVEL OF EVIDENCE] Therapeutic, II.