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

Abstract

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 (robotassisted 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.

Robotic-Assisted Microsurgery and Its Future in Plastic Surgery

“…Although operation times were longer and anastomosis scored lower using the Structures Assessment of Microsurgery Skills (SAMS) and University of Western Ontario Microsurgical Skills Acquisition Instrument (UWOMSA), all anastomosis demonstrated patency in both groups. The 1-year follow-up study confirmed the feasibility of this approach with an anastomosis patency rate of 66.6% in the RAS group compared with 81.8% in the control group, indicating no significant differences [ 28 ]. Pricing for the MUSA system will be substantially lower than competitors due to the use of micro-/supermicrosurgery instruments.…”

First-in-Human Integrated Use of a Dedicated Microsurgical Robot with a 4K 3D Exoscope: The Future of Microsurgery

“…Super microsurgical operations (defined as anastomosis of vessels with a diameter between 0.3–0.8 mm) are currently considered as the frontier of microsurgery. A prospective randomized pilot trial on lymphedema reconstructions has confirmed the safety and feasibility of the MUSA system in these super microsurgical operations [ 6 , 16 ].…”

Robotic-assisted microsurgery for lymphedema treatment

“…Currently, there are two robotic microsurgery systems available. The robotic system MUSA® (MicroSure, Eindhoven, The Netherlands) developed in 2014 is the first available system of its kind [25] . It is equipped with dedicated supermicrosurgical instruments.…”

“…However, it is mounted to the surgical table with fixed joysticks. Its feasibility for microsurgery has been demonstrated in both preclinical and clinical models [14,25] . The second available system is the Symani® Surgical System [Medical Microinstruments (MMI), Pisa, Italy] which was designed the second available system is the Symani® Surgical System (Medical Microinstruments (MMI), Wilmington, DE, USA) which was designed to provide movable manipulators istead of fixed handling joysticks [Figure 1].…”

“…The available but limited literature reporting the first experiences of the robotic system application in lymphatic reconstructive procedures [15,25] , including the personal experience of the senior author of this manuscript, suggests the technical feasibility of the technique, with clinical outcomes comparable between robotic-assisted and conventional lymphatic surgery [26,27] [Table 1]. However, potential drawbacks of these initial applications of the new technology definitely exist and are analyzed below.…”