Safe Technical Innovation

Abstract

INTRODUCTION In 2016, Sarfati et al1 described the feasibility of robotic-assisted nipple-sparing mastectomy (RNSM) in a cohort of 4 cadaveric breasts. During the ensuing years, surgeons, predominately in Europe and Asia, have developed innovative techniques to explore the utility of RNSM. Early adopters of RNSM cite superior visualization, greater stability with tremor elimination, enhanced precise movement with more degrees of freedom, better access to small or difficult to reach spaces, and improved ergonomics compared with traditional nipple sparing mastectomy (NSM).2–4 However, these benefits come with a prolonged operative time, uncertainty surrounding its oncologic safety, and potentially increased costs. Recently, Toesca et al5 reported outcomes from the first randomized controlled trial comparing RNSM to open NSM. Among 80 women with breast cancer or a BRCA mutation, RNSM took significantly longer but produced better quality of life for patients after surgery as determined by the Breast-Q and Body Image Scale instruments. Overall, postoperative complications were equivalent between study arms, but no skin or nipple necrosis was observed for the 40 patients that underwent RNSM compared with 12.5% of patients after open NSM. Long-term follow-up with comparisons of oncologic outcomes is expected in a future report. While RNSM may relieve some of the technical challenges to traditional NSM and provide superior cosmetic outcomes, concerns over safety and effectiveness remain due to lack of long-term data on local disease recurrence, disease-free survival, and overall survival. As a response to the rising number of RNSMs performed in community hospitals and outside of a clinical trial setting, the U.S. Food and Drug Administration (FDA) issued a safety communication in early 2019 directed towards patients with or at high risk of developing breast cancer and health care providers that were performing RNSM.6 As the first step to addressing these concerns, we opened the first US investigator-initiated clinical trial assessing the safety, efficacy, and potential risks of RNSM with the daVinci Xi surgical system.7 While the technical details of performing RNSM has been reported previously, prior studies did not discuss the logistics of implementing a successful new Robotic Breast Operation (RoBO) program. In this article, we discuss the development and implementation of a RoBO program (Table 1). TABLE 1. - Process for Implementation of a Robotic Breast Operation Program Task 1. Apply for investigator device exemption approval from the FDA 2. Engage multiple stakeholders throughout the institution 3. Develop technical expertise required to perform robotic-assisted breast surgery in a safe and timely fashion a. Obtain foundational robotic skills via modules and bedside assisting other robotic procedures b. Perform breast surgery on cadaver models i. Include key intraoperative personnel in the exercise to perform all aspects of the procedure including positioning, robotic device docking, port placement, instrument exchanges, robotic device undocking, and specimen removal 4. Establish team members and responsibilities a. Involve the same operative personnel whenever possible to establish familiarity with roles and responsibilities 5. Schedule the first case a. Optimal patient selection is important b. Transparent discussion with the patient regarding equipoise and experiemental nature of the procedure in addition to the risks/benefits with study participation 6. Monitor outcomes and provide feedback to team members for performance improvement a. Provide feedback to patients and team members 7. Communicate with oversight—FDA and IRB—especially regarding adverse events 8. Publish and disseminate the data for peer review and critique FDA indicates U.S. Food and Drug Administration; IRB, Institutional Review Board. REGULATORY CONCERNS Persistent concerns about the performance of off-labeled use of robotic-assisted mastectomy led to an u