This study demonstrates that the single-port da Vinci SP was feasible in patients undergoing robotic nipple-sparing mastectomy.
Key Points
Question
Is the single-port da Vinci SP (Intuitive Surgical) robotic system suited for nipple-sparing mastectomies?
Findings
In this case series of 20 patients, 40 breasts, the single-port da Vinci SP was used to perform bilateral robotic nipple-sparing mastectomies. Median operative time was 277 minutes, and no immediate operative or oncologic complications (hematoma, positive margins, or recurrence) were observed; postoperatively, 95% skin sensation and 55% nipple sensation were preserved.
Meaning
In this study, the single-port da Vinci SP was appropriate for the procedure.
Abstract
Importance
Robotic-assisted nipple-sparing mastectomies with multiport robots have been described in the US since 2015; however, significant hurdles to multiport robotic surgery exist in breast surgery.
Objective
To demonstrate that the single-port da Vinci SP (Intuitive Surgical) robotic system is feasible in patients undergoing robotic nipple-sparing mastectomy (rNSM).
Design, Setting, and Participants
An initial case series of 20 patients at a large university hospital underwent bilateral single-port robotic nipple-sparing mastectomies (SPrNSM) with tissue expander reconstruction from February 1, 2020, through January 4, 2023. Participants included women who met surgical criteria for nipple-sparing mastectomies, per standard of care.
Intervention
Surgery using a single-port robot and the surgical technique of the authors.
Main Outcomes and Measures
Age, indication, body mass index, breast size, operative time, conversion to open surgery, systemic complications, postoperative skin necrosis, and reported skin and nipple areolar complex (NAC) sensation.
Results
Twenty women aged 29 to 63 years (median, 40 years) underwent bilateral SPrNSM. Eleven patients completed prophylactic surgery due to a high risk for breast cancer (more than 20% lifetime risk) and 9 patients had breast cancer. Breast size ranged from A through D cup with median B cup and a body mass index range of 19.7 through 27.8 (median 24.4). The total duration of the procedure from incision to skin closure for both sides ranged from 205 minutes to 351 minutes (median, 277). The median robotic time for bilateral SPrNSM was 116 minutes and varied by cup size (A cup, 95 minutes; B cup, 140 minutes; C cup, 118 minutes; D cup, 114 minutes) with no inflection point in learning curve. No cases were converted to open and no immediate complications, such as hematoma, positive margins, or recurrence, were seen. In the first 10 patients prior to routine sensation testing, 20 resected breasts had measurable NAC sensation at a range from 4 to 36 months post–index resection (65%). In the second 10 patients of the cohort, measurable NAC was preserved in 13 of 20 resected breasts 2 weeks following the index operation (65%).
Conclusion and Relevance
In this case series, SPrNSM with immediate reconstruction was feasible and performed safely by an experienced breast surgeon with limited previous robotic training. Further studies confirming the preliminary data demonstrating improved NAC and skin sensation following SPrNSM are warranted.
Trial Registration
ClinicalTrials.gov Identifier: NCT05245812
Introduction
The advent of robotic-assisted surgery in 1985 and its widespread use in gastrointestinal, urologic, and gynecologic surgeries has led to its use in nontraditional surgical fields lacking natural endoscopic viewing space, including thyroidectomy, oropharyngeal surgery, and plastic and reconstructive surgery.1 Robotic-enhanced dexterity, binocular 3-dimensional imaging, 3-axis motion of surgical instruments, and improved ergonomics have allowed surgical operations to be accomplished with safety and efficacy equal to those of open surgery, but with reduced time to recovery and improved cosmesis.2,3
Since the initial description by Toesca et al in 2015,4 robotic nipple-sparing mastectomy (rNSM) using a multiport robotic platform has demonstrated both acceptable safety and oncologic outcomes compared with conventional open nipple-sparing mastectomies (NSM).5,6,7,8 However, the inherent limitations of a multiarm platform with small working spaces leading to robotic arm collisions, limited ergonomic use of the arms, and limited robotic camera mobility have led to the development of the da Vinci single-port (SP) robotic platform (Intuitive Surgical) with a flexible 3-dimensional camera and robotic arms with increased range of motion limiting collisions. Initial single institution studies using the SP robotic platform in rNSM procedures for high-risk genetic mutations or breast cancer demonstrated feasibility in a small cohort of patients in Asia.9,10
Oncologic efficacy after open NSM is well established; however, patient-reported outcomes, including postoperative skin and nipple areolar complex (NAC) sensation, remain understudied. Despite the association between intact NAC and skin sensation and postoperative quality of life metrics, most studies document self-reported NAC sensation of 27% to 40%.11,12 The use of rNSM has a theoretical benefit compared with open NSM of preserving both skin and NAC sensation due to the location of incision and decreased operative trauma; however, this remains unstudied.
Although rNSM has demonstrated acceptable long-term oncologic outcomes and safety profile, the use of the SP robotic system has not gained widespread applicability due to concerns over surgeon learning curve, the lack of uniformity in postresection breast reconstruction, and absence of patient-reported outcomes following resection and reconstruction. The aim of the present prospective study was to assess the safety, feasibility, and patient-reported outcomes in rNSM using the SP robotic system with immediate prepectoral expander placement in a single-institution experience within the US.
Methods
This single-institution prospective registry trial was reviewed and approved by the US Food and Drug Administration under an Investigational Device Exemption (G220001). The protocol was registered with ClinicalTrials.org (NCT05245812) and approved by the UT Southwestern Medical Center institutional review board (STU-2022-0091). All patients enrolled in this prospective registry study signed an informed consent obtained by the operating surgeon (D.F.) after discussion of risks and benefits of the procedure.
Patient Selection
Selection criteria included the following: prophylactic mastectomy for risk reduction of breast cancer, treatment of ductal carcinoma in situ or clinically node negative T1-T2 breast cancer, and patients who otherwise qualify for open nipple-sparing mastectomy and immediate reconstruction with regard to patient anatomic factors and/or tumor location. Exclusion criteria included evidence of tumor involvement of the skin, evidence of tumor within 1 cm of the nipple-areolar complex, previous breast implants, greater than D cup breast size, grade 3 nipple ptosis, previous history of radiation to the chest wall, and smoking more than 20 cigarettes per day. All patients were all imaged preoperatively with mammogram and magnetic resonance imaging, per clinical standard of care.
Operative Technique
Prior to performing rNSM using the daVinci SP Robotic Surgical System (Intuitive Surgical) in human patients, initial cadaveric studies were completed by a single surgeon without previous robotic surgery experience (D.F.) proctored by a senior surgeon with significant robotic experience (H.Z.) who assisted at bedside. Four breasts in 2 cadavers were used for the initial procedures. These initial cases functioned as pilot cases in the operating room and troubleshooting sessions to address the setup and method of dissection with the robot. Following demonstrated feasibility in human cadaveric procedures, SPrNSM was used in human patients with the same surgical team (D.F. and H.Z.) for the first 10 operative cases. Following the first 10 cases, the surgeon (D.F.) was assisted by a bedside physician assistant (B.S.).
The patients were placed in supine position with anesthesia at the patient’s feet. The patient’s arms were loosely tucked with a slight elbow bend to facilitate lateral chest wall visualization and positioned in 12° of reverse Trendelenburg. A surgical incision was made in the lower hair-bearing area of the axilla to facilitate sentinel lymph node dissection and lengthened if needed to facilitate gland removal. Following skin incision, the lateral breast tissue was dissected off of the lateral pectoralis muscle to facilitate a working space for placement of a GelPOINT Mini (Applied Medical). An SP trocar was then placed through the diaphragm of the GelPOINT and the SP robotic platform was docked (Figure 1B). From incision to GelPOINT placement constituted the predocking time. The breasts were insufflated to 8 mm Hg to facilitate visualization as previously described.13 The camera, scissors with cautery, and 2 bipolar graspers were mounted on the robotic boom and the AirSeal insufflation system (CONMED) was used to facilitate smoke evacuation.
Figure 1. Using the Single-Port Robot for Nipple-Sparing Mastectomy.
Dissection of the breast tissue off of the pectoralis with the cauterizing scissors began at the superior portion of the gland with the robotic cauterized scissors moving concentrically facing the clavicle, the sternum, and then the inferior portion of the breast. Positioning the patient in 12° of reverse Trendelenburg allowed gravity to help the gland and fluid fall away from the operative field. The 2 additional arms provided counter traction of the gland, allowing increased visualization and aiding in dissection free from the pectoralis, including the pectoralis fascia. The bedside assistant aided in conveying the position of the instruments on the clock face of the breast by applying gentle pressure on the flap within the view of the camera. Hemostasis was achieved with monopolar and/or bipolar electrocautery. All of the dissection done with the robot constituted the robotic console time. Following gland detachment from the pectoralis, the diaphragm of the GelPOINT was removed and the breast was desufflated. The breast was removed from the cavity through the GelPOINT capsule and marked appropriately prior to pathological examination. If the breast was too large to extract from the initial incision, the incision was lengthened to facilitate removal.
Immediate reconstruction was performed by plastic and reconstructive surgery following the SPrNSM (N.H.). Reconstruction began by placing an appropriately sized expander covered in acellular dermal matrix in the breast pocket in a prepectoral position. This device and the matrix were appropriately secured to the chest wall. The expander was filled based on the skin envelope laxity and pocket size. The axillary incision was then closed with subcuticular absorbable suture.14 Final reconstruction was completed with a breast implant or autologous reconstruction surgery at least 3 months after the index mastectomy at the discretion of the plastic surgeon and patient preference. Before and after photos demonstrate the cosmetic results and final incision (Figure 1D).
Nipple Areolar Complex and Breast Skin Sensation Measurement
The original goal of the study was to demonstrate feasibility and safety of SPrNSM by a previously inexperienced robotic surgeon. However, following the 10th patient follow-up (20 total procedures), enrolled patients were anecdotally noted to have intact nipple areolar complex (NAC) and breast skin sensation. Therefore, for the subsequent 10 patients, NAC and breast skin sensation were measured using the Semmes-Weinstein Monofilament test for fine touch at baseline, 1 to 2 weeks post–index operation, and every 6 months thereafter. The filaments vary in diameter to measure degrees of fine sensation (0.07 g, 0.4 g, 2 g, 4 g, 300 g). The breast surgeon (D.F.) conducted all sensory assessments to reduce operator-dependent variations in measurement. The details of the Semmes-Weinstein test have been previously described elsewhere.13 For the initial 10 patients, NAC and skin sensation testing was completed only postoperatively during routine clinic visits with no preoperative baseline testing.
Clinicopathological Variables
Clinicopathological variable factors including age, body mass index, breast size, tumor size and location, presence and number of metastatic lymph nodes, flap necrosis, nipple sensation, operative times, receipt of chemotherapy, radiation therapy, and/or endocrine therapy were recorded. Postoperative complications, including ischemia and necrosis of the skin and nipple, hematoma, seroma, or infection, were recorded and assessed by the Clavien-Dindo classification within the first 30 days following index operation. Categorical factors are described as numbers and percentages. Continuous factors were summarized by median and ranges.
Results
Twenty female patients (40 total procedures) were prospectively enrolled in the study and underwent bilateral SPrNSM with immediate reconstruction with prepectoral implants, between February 1, 2020, and January 4, 2023. The Table details the demographic and clinicopathological features of the included cohort. Patient age ranged from 29 to 63 years (median, 40 years). Race documented for the 20 women studied was as follows: 1 African American/Black, 5 Hispanic/Latina, 13 White, and 1 other (chose not to disclose). No issues with insurance were encountered. Preoperative breast cup size was A in 5 patients (20%), B in 9 patients (45%), C in 4 patients (20%), and D in 2 patients (10%).
Table. Patient Characteristics and Complications.
| Characteristic | No. (%) (N = 20) |
|---|---|
| Age, median (range), y | 40 (29-63) |
| Racea | |
| African American/Black | 1 (5) |
| Hispanic/Latina | 5 (25) |
| White | 13 (65) |
| Other (prefer not to disclose) | 1 (5) |
| Ptosis grade | |
| 0 | 8 (40) |
| 1 | 12 (60) |
| Preoperative breast cup size | |
| A | 5 (25) |
| B | 9 (45) |
| C | 4 (20) |
| D | 2 (10) |
| BMI,b median (range) | 24.4 (19.7-27.8) |
| Germline mutation | |
| BRCA1/2 | 8 (40) |
| ATM | 2 (10) |
| None | 10 (50) |
| Chemotherapy | |
| Neoadjuvant | 3 (15) |
| Adjuvant | 1 (5) |
| None | 16 (80) |
| Final pathology | |
| Benign | 11 (55) |
| DCIS | 2 (10) |
| Invasive cancer | 7 (35) |
| T stage (N = 9) | |
| Tis | 2 (22) |
| T1 | 6 (66) |
| T2 | 1 (11) |
| N stage (N = 9) | |
| N0 | 7 (77) |
| N1 | 2 (22) |
| ER/PR receptor status (N = 9) | |
| Positive | 5 (55) |
| Negative | 4 (45) |
| ERBB2 receptor status (N = 7) | |
| Positive | 0 |
| Negative | 7 (100) |
| Axillary operation | |
| None | 8 (40) |
| SLNB | 11 (55) |
| SLNB plus ALND | 1 (5) |
| Adjuvant radiation | |
| Done | 2 (10) |
| Not done | 18 (90) |
| Adjuvant endocrine therapy | |
| Done | 5 (25) |
| Not done | 15 (75) |
| Nipple/skin ischemia | 1 (5) |
| Hematoma | 0 |
| Infection | 1 (5) |
Abbreviations: ALND, axillary lymph node dissection; BMI, body mass index; DCIS, ductal carcinoma in situ; ER, estrogen receptor; PR, progesterone receptor; SLNB, sentinel lymph node biopsy.
Race was self-reported.
Calculated as weight in kilograms divided by height in meters squared.
Indications for bilateral NSM included 11 patients for breast cancer risk reduction (8 with BRCA1/2 mutations, 2 with ATM mutations, and 2 with more than 20% calculated lifetime risk of breast cancer) (55%) and 9 patients with breast cancer (45%). One of the patients with a BRCA2 mutation was found to have a small focus of invasive cancer on final pathology. Sentinel lymph node biopsy was performed in 12 patients (60%) with 1 patient undergoing axillary lymph node dissection following pathological confirmation of carcinoma in the sentinel node. Sentinel lymph node biopsies were performed for an area of high risk found on preoperative magnetic resonance imaging (3 patients) and cancer staging (9 patients). Three patients received neoadjuvant chemotherapy for triple negative invasive ductal carcinoma. None of the included patients had positive surgical margins on permanent pathological review.
Total operative times ranged from 205 to 351 minutes (median, 277 minutes) from initial skin incision to final skin closure for both sides. Median robotic predocking time (including sentinel lymph node biopsy when performed) was 45 minutes (range, 19-59 minutes). Median robotic console time was 124 minutes (range, 70-201 minutes) (Figure 2). Robotic console time decreased significantly from patient 1 to 20 with no inflection point demonstrating learning curve optimization. The median tissue expander reconstruction time was 30 minutes for bilateral reconstruction (range, 18-42 minutes). Median robotic console time was associated with preoperative breast cup size: A, 95 minutes; B, 140 minutes; C, 118 minutes; and D, 114 minutes. While breast density changed the way in which the tissue responded to dissection, the technical ease of the procedure was linked to breast size rather than tissue density. The median final incision was 4 cm (range, 2.5-7.0 cm). The median specimen size was 318 g (range, 116-652 g).
Figure 2. Operative Time in Minutes for All Patients by Cup Size.
None of the enrolled cohort were converted from a robotic to open procedure. Median operative blood loss was 30 mL (range, 30-300 mL). Postoperative complications were evaluated within the first 30 days after the index operation. Bilateral skin necrosis was observed in 1 patient (2.5% of total procedures) requiring operative revision. The skin necrosis was attributed to extensive use of ice packs in the postoperative period following hospital discharge. Another patient developed a unilateral expander infection on removal of a drain 2 weeks postoperatively, prompting an expander removal and washout. No other complications, including hematoma or infection, were observed in the postoperative period.
Nipple areolar complex and breast skin sensation data are summarized in Figure 3 and Figure 4. In the second 10 patients of the cohort, measurable NAC was preserved in 13 of 20 resected breasts 2 weeks following the index operation (65%). At 6 months, sensation was preserved in 10 patients (50%). Measurable skin breast sensation was preserved in 90% (n = 20) and 100% (n = 10) at 2 weeks and 6 months postoperatively, respectively. In the first 10 patients prior to routine sensation testing, 65% (n = 20) had measurable NAC sensation at a range from 4 to 36 months postindex resection. No patients were lost to follow-up.
Figure 3. Postoperative Sensation Data for Patients 1 to 10.
The innermost circle represents sensation to the nipple, the area between the nipple and the next largest circle represents sensation to the areola in quadrants, and the area between the areola and the outermost circle represents the sensation to the quadrants of the breast.
Figure 4. Postoperative Sensation Data for Patients 11 to 20.
The innermost circle represents sensation to the nipple, the area between the nipple and the next largest circle represents sensation to the areola in quadrants, and the area between the areola and the outermost circle represents the sensation to the quadrants of the breast.
Discussion
The current study demonstrated that SPrNSM with immediate reconstruction with prepectoral implants is feasible and can be performed safely by an experienced breast surgeon with limited previous robotic training. In this initial pilot study, SPrNSM was associated with an overall complication rate of 7.5% that was attributed to postoperative expander infection and skin necrosis from prolonged ice pack use. No complications were directly associated with the use of the robot. Furthermore, NAC and skin sensation were preserved in most studied patients. As this finding is not seen in the open approach, we credit the increased sensation to the gentle dissection the robot allows. To our knowledge, this study represents the largest and only documented study of rNSM in the US.
Open nipple-sparing mastectomy with preservation of the NAC has demonstrated oncologic safety with local recurrence rates similar to that of skin-sparing mastectomies.15,16 The innovation of limiting the incision and completing the dissection with robotic assistance has demonstrated feasibility, oncologic principles, and surgical safety in trials in Asia and Europe but has not been studied in the US.17 In a systematic review and meta-analysis comparing the postoperative complication rates of rNSM with conventional NSM, no statistically significant differences were found with overall complication rates (rNSM 4.3% vs NSM 7.0%; P = .07).18 The largest worldwide study using the daVinci SP Robotic Surgical System to perform an rNSM consisted of 81 cases (70 patients) in Asia. Go et al10 demonstrated Clavien-Dindo Classification Grade III complications in 6 patients with nipple ischemia (2.5%), requiring intervention in 1 patient. The current study included 1 Grade III complication (2.5%) consisting of NAC ischemia requiring debridement, which compares favorably with a large systemic review by Headon et al19 demonstrating a 5.9% rate of nipple necrosis.
Learning curves, originally described in psychology and expanded on in the surgical era of laparoscopic and robotic surgery, constitute a graphical representation of performance as a function of experience.20 Robotic breast surgery has been slow to gain acceptance in the US, largely due to concerns about the technical proficiency needed to master the procedure with comparable oncological and safety outcomes seen in open NSM.21 In the current study, the operative surgeon, although experienced in open NSM, had initial limited proficiency in robotic procedures. Cadaveric practice, while very helpful with this initial study in terms of how to effectively use the robot in this context, may not be necessary for future surgeons as the technique has been described. The ease of use of the SP robotic system with built-in lack of inherent collision seen in multiarm platforms likely contributed to a favorable learning curve and can likely be translated to other high-volume breast surgery programs.
Despite the widespread acceptance of open NSM in well-selected patients, use of an open approach still has significant limitations, most notably poor cosmesis with associated high rate of insensate breast tissue, especially at the NAC. Although not the primary intended outcome of our study, we demonstrated intact NAC and skin sensation rates greater than seen in open NSM. Dossett et al11 demonstrated that NAC sensation was preserved in both NAC in only 28% following open NSM. Studies linking age, incision type, and smoking status were all linked to rates of nipple necrosis and could be extrapolated to nipple sensation, as the nerves and vessels exist together in the skin.22,23 As nipple sensation comes from the fourth intercostal nerve, limiting the lateral incision and moving it to the axilla could aid in sensory preservation. However, in our study, the intercostal nerves were not identified or intentionally preserved. Additionally, the gentle nature of the insufflation could account for the lack of traction parathesias seen in these patients. It is still unclear as to whether the preservation of sensation is due to the incision or the technique with minimal skin flap retraction. However, the observation of 95% skin sensation and 55% nipple sensation has not been reported and is worthy of further study.
Strengths and Limitations
The strengths of this study are its prospective design and study of SPrNSM in a cohort of NSM-eligible patients under the auspices of US Food and Drug Administration–approved investigational device exemption. However, despite these strengths there are several important limitations. First, this was a single-surgeon, single-institution study with a high proficiency of robotic procedures performed in nonbreast surgery. Although it is unclear whether these results are generalizable and SPrNSM can be performed with similar results outside the study institution, the favorable learning curve warrants widespread studies to confirm feasibility, oncologic, and surgical safety. Second, documentation of sensation testing was not initially included in the study design. However, after anecdotal evidence in the first 10 patients demonstrated improved sensation, sensation testing was included. Further studies are warranted to focus on patient reported outcomes such as sensation, satisfaction, and quality of life following SPrNSM.
Conclusions
In conclusion, SPrNSM with immediate reconstruction with prepectoral implants is feasible and can be performed safely by an experienced breast surgeon with limited previous robotic training. Further studies confirming the preliminary data demonstrating improved NAC and skin sensation following SPrNSM are warranted.
Data sharing statement
References
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Supplementary Materials
Data sharing statement