Robot-assisted Nipple-sparing Mastectomy Research Articles

Abstract PO4-22-12: Robot-assisted nipple-sparing mastectomy using da Vinci SP single-port system: primary results from the pilot trial RASPIM-01

Abstract Background Robot-assisted breast surgery was developed in 2014 for nipple-sparing mastectomy through a concealable lateral chest wall incision smaller. Although successful experiences have been reported using a multi-arm surgical robotic system, collisions between robotic arms and instruments often result in the discontinuation of console workflow and limit the performance of the surgical robot. Compared to multi-armed robot systems, the SP system is single-armed, equipped with flexible instruments containing multiple joints that may avoid instrument collision, a controllable camera reducing visual dead spots, and a designated non-third-party port that allows single-port entry and full deployment of the instrument. The RASPIM-01 trial (NCT05448963) is a single-armed pilot study assessing the feasibility of robot-assisted nipple-sparing mastectomy (NSM) using a new SP system. Method This study is a pilot trial conducted in a single-arm, non-randomized design with a recruitment of 30 participants. The SP surgical robot is used in NSM through the lateral chest wall incisions. The major inclusion criteria are 1) Breast cancer with preoperative clinical tumor sizes less than 5 cm, with an adequate tumor-skin distance of at least 3mm, and without nipple-areolar involvement in at least 1cm around the nipple by image, 2) Breast cancer up to clinical stage IIIA (T3, N1-2) showing adequate response to neoadjuvant therapy and meeting criteria 1), 3) Germline pathogenic/likely pathogenic BRCA1 or 2 variant carriers with or without a breast cancer diagnosis, requiring unilateral or bilateral therapeutic mastectomy or prophylactic mastectomy. Exclusion criteria include extensive breast skin or nipple involvement such as inflammatory breast cancer, Paget’s disease, nipple discharge associated with malignancy, image suggestive of cancer involvement of the nipple and subareolar tissue, and stage III breast cancer without response to neoadjuvant therapy, and previous radiotherapy of the surgical side breast. The endpoint measurements include Primary endpoint: The ability to complete nipple-sparing mastectomy with an SP system in the per-protocol population without additional assistant port or conversion to open surgery. Statistical analysis includes point estimation with a 95% confidence interval to analyze the mean or proportion of key performance parameters. No interim analysis will be performed due to the limited number intended to recruit. Results The study recruited 30 breast cancer patients and conducted 30 NSMs, while no prophylactic mastectomy case was recruited. The median age was 44 years old, BMI was 22.4 (18.9-30.0) kg/m2. Median tumor size was 3.0 (1.0-14.6) cm, and axillary lymph node metastases were present in 7 cases (23.3%). T2 (13 cases, 43.3%) tumors were the majority, followed by Tis (10 cases, 33.3%), T1 (5 cases, 16.7%), and T3 (2 cases, 6.7%). The anatomical stages of invasive cancer were Ia (16.7%), IIa (26.7%), IIb (16.7%), and IIIa (6.7%), among them 9 (30.3%) received neoadjuvant chemotherapy before surgery. All NSMs met the primary endpoint of successful completion using the SP robot system without conversion to open mastectomy or the addition of an assistant port. Median console time was 108.5 (73-285) min and docking time was 2.5 (1-9) min. Specimen weight was 311.6 (107-838) gm, while 2 (6.7%) cases had their nipple excised due to cancer-involved margin reported from the frozen section. Twenty-six (86.6%) cases received autologous free flap reconstruction, among which 25 (83.3%) cases received DIEP, and 1 (3.3%) received PAP reconstruction. Four cases received implant (2 cases, 6.7%) or tissue expander (3 cases, 6.7%). Conclusion This is the first NSM clinical trial operated with SP surgical robot system and met its primary endpoint showing the feasibility to conduct NSM. Secondary and exploratory endpoints data will be reported after the completion of clinical follow-ups. Citation Format: Wen-Ling Kuo, Chia-Huei Chu, Jung-ju Huang. Robot-assisted nipple-sparing mastectomy using da Vinci SP single-port system: primary results from the pilot trial RASPIM-01 [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-22-12.

Trends in Operation Times for Robot-assisted Nipple-sparing Mastectomy Performed by Expert Breast Surgeons

Trends in Operation Times for Robot-assisted Nipple-sparing Mastectomy Performed by Expert Breast Surgeons

Early experience of direct-to-implant breast reconstruction using acellular dermal matrix after robot-assisted nipple-sparing mastectomy.

This study aimed to analyze the novel operative outcomes of breast mound reconstruction followed by robot-assisted mastectomy in retrospective review. Patients who underwent nipple-sparing mastectomy with a robotic device (Da Vinci Xi) and immediate prosthetic reconstruction prepectorally via lateral incision from June 2018 to July 2019 were enrolled. Patient characteristics, complications, and satisfaction via BREAST-Q were analyzed. The surgical technique was described in detail. Thirty-nine cases, including 7 bilateral cases (total 46 breasts), underwent robot-assisted nipple-sparing mastectomy followed by immediate prosthetic implant reconstruction prepectorally. The median patient age was 46.63 years (range: 21-63 years). The mean operation time for each prepectoral breast mound reconstruction using the direct-to-implant technique was 126.55 min. Overall satisfaction of robotic use was evaluated as superior to the conventional reconstruction method using BREAST-Q. Major infection was found in seven cases (15.2%), and complete nipple loss was found in three cases (6.6%). Severe complications requiring breast implant removal in the surgical technique occurred in four breasts (8.7%). Two cases were due to the coexistence of infection and skin necrosis; in one case, the skin flap had undergone the congestive phase on postoperative day (POD) 3 and required additional surgery to change the expander. Other complications were resolved by conservative care or minor revision. This report is the first concerning robot-assisted NSM followed by prepectoral ADM-wrapped prosthetic reconstruction. In our experience, this procedure seems to be not inferior to other methods. Further prospective research to evaluate oncologic outcomes is warranted.

Robot-assisted nipple-sparing mastectomy and immediate breast reconstruction with gel implant and latissimus dorsi muscle flap: Our initial experience.

This study reports the preliminary results of da Vinci robot XI robot-assisted nipple-sparing mastectomy immediate breast reconstruction (R-NSMIBR) with gel implant and latissimus dorsi muscle flap. A total of 15 patients who underwent R-NSMIBR with gel implant and latissimus dorsi muscle flap surgery for breast cancer between September 2022 and November 2022 were evaluated. Mean total operative time for R-NSMIBR was 361.9±77.0min. As the learning curve increased, the robot arm docking time decreased rapidly from the initial 25-10min. Average total blood loss was 27.8±10.7mL and posterior surgical margin positivity rate was 0%. Perioperative complications and local recurrences or deaths were not observed at a mean follow-up of 3±1month 15 patients were satisfied with postoperative aesthetic results. R-NSMIBR with a gel implant and latissimus dorsi muscle flap could be a new therapeutic option for breast reconstruction.

Abstract P2-14-03: Learning curve for Robotic assisted nipple sparing mastectomy: a single institution experience

Abstract Backgrounds/Aims: Nipple sparing mastectomy (NSM) is popularly performed as this surgical technique is oncological safety and better cosmetic outcomes. Robot assisted NSM (RANSM) is emerging because of its exceptional advantages: hidden incisions, high resolution, wider visualization and ergonomically moving. Although several studies reported that RANSM has shown a short learning curve, there were few reports about learning curve of this cutting-edge surgical technique. In this study, we reported the learning curve and feasibility of RANSM. Methods: A retrospective and prospective study was conducted for women who underwent RANSM with immediate breast reconstruction at Samsung Medical Center from July 2019 to April 2022. All RANSM were performed by a single surgeon. We divided the total cases in half and set up two phases; an early phase (case 1st to 23th) and a late phase (case 24th to 46th). The total operation time, mastectomy time, docking time, pre-console time and console time was defined as the interval between the creation of the skin incision and the end of the reconstructive surgery, the interval between the time of skin incision and the time of the specimen out of the operation field, the interval between the preparation for docking and the end of docking, the interval between the creation of the skin incision and the end of robot docking, and the time spent by a surgeon to operate the console for mastectomy. To evaluate the impact of case experience accumulation on the operation time of RANSM, the cumulative sum (CUSUM) method was used to analyze the learning curve. Clinicopathologic characteristics, perioperative complications, and operation time were collected. Results: Overall, 42 women underwent 46 RANSM procedures conducted. The median patient age was 44.5 years old (26-59 years) and the median breast weight was 338.5 gram (101.4-817 gram). BRCA 1 mutation carriers were 2 patients and BRCA 2 mutation carriers were 3 patients. 5 patients with BRCA 1/2 mutation carriers underwent contralateral risk-reducing RANSM. Clinicopathologic characteristics of patients between the early phase and late phase were summarized in Table 1. There were no significant differences in almost clinicopathologic characteristics. Median time of total operation, mastectomy, docking time, pre-console time, and console time was 344.0 minutes (254.0-480.0 minutes), 238.5 minutes (166-394 minutes), 6.5 minutes (1-25 minutes), 61.5 minutes (29-180 minutes), and 64.5 minutes (33-134 minutes), respectively. Comparing the early phase and the late phase, median total operation time was 357 minutes (273-480 minutes) and 321 minutes (254-459 minutes), (p = 0.067); median mastectomy time was 245 minutes (204-394 minutes) and 229 minutes (166-376 minutes), (p = 0.070); docking time 7.0 minutes (3-25 minutes) and 5.0 minutes (1-20 minutes),(p = 0.093); pre-console time was 70.0 minutes (49-162 minutes) and 54.0 minutes (29-180 minutes),(p = 0.028); console time was 71.0 minutes (40-134 minutes) and 60.0 minutes (33-105 minutes), (p = 0.095). In the learning curve analysis, it took the 21th procedure in RANSM to decrease the breast operation time. Clavien-Dindo grade III postoperative complication was two cases (8.6%, one case was infection and one case was nipple ischemia) in only early phase and none in the late phase. Clavien-Dindo grade II postoperative complication was absent in all phases. Clavien-Dindo grade I postoperative complications were seven cases (30.4%, all cases were nipple crust) in the early phase and one case (4.3%, one case was nipple crust) in the late phase. Nipple ischemia was found in two cases (8.6%) but only one case required nipple excision given in the early phase. Conclusions: It has shown that the breast operation time improved from the 21th procedure of RANSM. RANSM is technically feasible and acceptable with a short learning curve. TABLE 1. Basic characteristics of patients between the early phase and late phase Citation Format: Yeon JIn Kim, Soo Yeon Chung, Byung Joo Chae, Jonghan Yu, Jeong Eon Lee, Jai Min Ryu. Learning curve for Robotic assisted nipple sparing mastectomy: a single institution experience [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-14-03.

Abstract P2-14-20: Comparison of robot-assisted nipple sparing mastectomy with conventional nipple sparing mastectomy: a single-center experience

Abstract Purpose: Robot-assisted nipple-sparing mastectomy (RANSM) improves cosmetic outcomes compared to conventional nipple-sparing mastectomy (CNSM) since RANSM is performed with minimal incisions. However, there are few studies on the feasibility and surgical outcome of RANSM. The aim of this study was to compare the surgical outcomes of RANSM and CNSM in breast cancer patients. Method: A retrospective observational study was conducted at our institution between January 2021 and December 2021. A total of 54 patients diagnosed with breast malignancy that underwent either a robotic-assisted or conventional nipple-sparing mastectomy were included. The demographics of the patient’s sex, age, body mass index (BMI), breast weight, and preoperative diagnosis were investigated. The surgical method, operation time (including docking time and console time in the case of robotic surgery), postoperative complications, length of hospital stay, pain score, and adjuvant therapy were analyzed. Result: A total of 57 breasts in 54 female patients were included in the study: 36 invasive ductal carcinoma patients, 11 ductal carcinoma cases, 6 invasive lobular carcinoma, 2 mucinous carcinoma, one solid papillary carcinoma and one lobular carcinoma in situ. A median age of 49(27-66), mean BMI of 22 (18.89-26.28), and mean breast weight was 246 g (120-305g). The mean operation time was 122 minutes (robotic 140 vs. conventional 118), and the average docking time was five minutes and console time 60 minutes in the robot-assisted surgery. There was only one postoperative complication in the robot group and ten cases in the conventional group. The mean hospital stay was 12.6 days (RANSM 10.75 vs. CNSM 12.92), and the average pain score was 3.53 (RANSM 3.50 vs. CNSM 3.54). None needed adjuvant therapy in the robot group. In the conventional surgical group, four patients underwent adjuvant radiotherapy and sixteen patients underwent chemotherapy including six neoadjuvant cases. Conclusion: Our results showed that RANSM had advantages of shorter hospitalization and lower pain scores although it had slightly longer operation time and could not applicable in relatively large breasts. In the near future, RANSM may be considered as the surgery of choice over CNSM in breast cancer patients. Citation Format: Ji Young You, Haemin Lee, Eun-Shin Lee, Seung Pil Jung. Comparison of robot-assisted nipple sparing mastectomy with conventional nipple sparing mastectomy: a single-center experience. [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-14-20.

Abstract OT3-21-01: A pilot study of robot-assisted nipple-sparing mastectomy followed by immediate breast reconstruction using da Vinci SP ® single-port system

Abstract Introduction- Robotic mastectomy is a novel breast surgery approach accessed from a concealable anterior axillary incision showing better cosmetic outcomes with a scarless front view. The oncological safety awaits further follow-up from clinical trials or registered studies to mature. Compared to older da Vinci systems with multiple arms, the new SP system is single-armed, equipped with flexible instruments and a camera that may avoid instrument collision and dead spots in the surgical field. This trial (NCT05448963) is not only the leading SP mastectomy trial in Asia but also the first one that incorporates autologous flap reconstruction. Methods- -Objectives: To determine the performance, technical algorithm, safety data, and patient-reported outcomes in single-port-accessed nipple-sparing mastectomy using da Vinci SP® system. -Study design: This study is a pilot clinical study conducted in a single-arm, non-randomized design with a goal to recruit 30 participants. The da Vinci SP ® surgical robot is applied in the nipple-sparing mastectomy and axillary lymph node dissection (if indicated) of each enrolled patient in Chang Gung Memorial Hospital Linkou Medical Center. The post-mastectomy reconstructive method may use autologous flaps or implants depending on the type of build, technical feasibility, and flap site availability of the patient. The eligibility criteria include: I. Meet at least one of the following indications of NSM for breast cancer: 1. Preoperative clinical tumor sizes less than 5 cm, with an adequate tumor-skin distance of at least 3mm and above, and without nipple-areolar involvement in at least 1cm around the nipple by image 2. Breast cancer up to stage IIIa (T3, N1-2) as the initial clinical stage showing adequate response to neoadjuvant therapy and meeting criteria 1. 3. Germline pathogenic/likely pathogenic BRCA1 or 2 mutation carriers (actionable mutations including pathogenic and likely pathogenic mutations) with a breast cancer diagnosis or requiring unilateral or bilateral prophylactic mastectomy as a risk reduction procedure II. Age equal to or above 20 years III. ECOG (Eastern Cooperative Oncology Group) performance score 0-1 IV. ASA anesthesia risk class 1~2, and with adequate organ functions Endpoint measures: -Primary endpoint: Ability to complete nipple-sparing mastectomy with da Vinci SP system in the per-protocol population. -Secondary endpoints: Safety measured by adverse events through 30-day post-operative follow up -Exploratory endpoints: Surgical time, blood loss, hospital stay, breast specimen weight, cancer resection margin, nipple-preservation rate morbidity and mortality rate within 30 days of operation, and reoperation within 30 days post-surgery -Statistical analysis: Point estimation with a 95% confidence interval will be used to analyze the mean or proportion of key performance parameters. No interim analysis will be performed due to the limited number intended to recruit. -Trial status: Active recruitment Conclusion: The single-port robotic system features single port access with multi-jointed instruments which is particularly designed for narrow surgical spaces such as mastectomy. The feasibility of applying da Vinci SP systems to robotic nipple-sparing mastectomy and robiotic axillary lymph node dissection will be demonstrated in this study. Citation Format: Wen-Ling Kuo, Chia-Huei Chu, Jung-ju Huang. A pilot study of robot-assisted nipple-sparing mastectomy followed by immediate breast reconstruction using da Vinci SP ® single-port system [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-21-01.

Analysis of robot-assisted nipple-sparing mastectomy usingthe da Vinci SP system.

As patients tend to be diagnosed with breast cancer at an early stage, the demand for better cosmetic outcomes has increased. Several studies revealed that robot-assisted nipple-sparing mastectomy (RNSM) shows favorable outcomes. The aim of the study was to reveal the feasibility of RNSM using the da Vinci single-port(SP) system with a minimal incision, hidden in the arm. From 2018 to 2021, 81 cases (70 patients) were retrospectively reviewed. Clinicopathologic characteristics, operative outcomes, and postoperative complications were evaluated. The operative outcomes were analyzed using the Mann-Whitney U test. The median age was 42 years (range, 26-60 years). Bilateral RNSM was performed in 11 (27.2%) patients. The median size of the initial skin incision was 40 mm (range, 20-55 mm). Immediate reconstruction with direct-to-implant was performed in 54 (66.7%) patients and deep inferior epigastric perforator(DIEP) flaps in 15 (18.5%) patients. Postoperative complications of Clavien-Dindo Classification III occurred in six (7.5%) patients. Patients reconstructed with a DIEPflap had large breasts with more severe ptosis, yet grade III complications did not occur. RNSM using the SP system can be applied for curative and risk-reducing mastectomy, regardless of breast size or ptosis grade.

Abstract P3-21-02: Robotic nipple sparing mastectomy in the management of breast cancer and prophylactic surgeries with SP system

Abstract Background: Robot-assisted nipple-sparing mastectomy (R-NSM) improves cosmetic outcomes over conventional nipple-sparing mastectomy (CNSM). However, data on the feasibility and safety of the R-NSM are limited. The aim of this study was to present the results of early experience of R-NSM with SP system.Methods: Preliminary analysis of R-NSM using da Vinci SP system for breast cancer and prophylactic cases during the period October 2020 thru April 2021 from Asan Medical Center , Seoul, S Korea. Data on clinicopathologic characteristics, type of surgery, method of breast reconstruction, complications and recurrence were analyzed to determine the performance and safety of R-NSM using da Vinci SP system Results: During the period October 2020 thru April 2021, a total of 41 robotic breast surgery procedures were performed in 39 female patients with breast cancer ( 35 invasive, 4 non-invasive ), and 2 patients who underwent surgery for prophylactic reasons. Five patients were bilateral and 29 were unilateral. Immediate breast reconstruction (IBR) was performed in all patients. Autologous reconstruction was performed in 16 cases, and implants were used in 23 cases. The mean age of all 41 patients was 47 years (range 31-58) and mean BMI was 23.1 (range 17.9-32.7). In two patients, neoadjuvant chemotherapy was performed before surgery. For 39 cancer cases the mean tumor size was 3.6 cm (range 0.0-8.0 cm). 14 cases had multiple tumors. Sentinel node biopsy was performed in all patients, and axillary dissection was performed in 6 cases. The pathologic stage was 12.8% DCIS, 51.3% stage I, 28.2% stage II, and 7.7 stage III. The mean operation time for R-NSM with IBR was 361 min (range 168- 788) and without IBR was 172 min ( range 80- 325). The mean hospital stay was 6.1 days (range 4-9). There were no conversions to open surgery. In three patients, nipples were removed as tumor positives from the retroareolar frozen section during surgery. The mean estimated blood loss was less than 10cc and 4 patients received transfusion but they pre-operative hemoglobin deficiency and required transfusion right after surgery. There were no procedure related reoperation and readmission and no cases of mortality during 60 day follow up period.. There were no major perioperative complications. There were 4 patient who experienced partial nipple necrosis and did not require medical intervention and were resolved. The conventional NSM method had low cosmetic satisfaction due to the enlarged skin incision on the front of the breast. When the incision is made smaller, the surgical field of view is narrow and it is difficult to perform precise surgery due to difficulty in the surgical procedure. Conclusion: From our preliminary experience, R-NSM alone or combined with IBR is a safe procedure, with clinical outcomes results, and is promising new technology for breast cancer patients indicated for mastectomy. Citation Format: Sae Byul Lee, Hyun Ho Han, Jisun Kim, BeomSeok Ko. Robotic nipple sparing mastectomy in the management of breast cancer and prophylactic surgeries with SP system [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-21-02.

Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM)

IntroductionNipple-sparing mastectomy (NSM) can be performed for the treatment of breast cancer and risk reduction, but total mammary glandular excision in NSM can be technically challenging. Minimally invasive robot-assisted NSM...

Robotic harvest of a latissimus dorsi flap using a single-port surgical robotic system in breast reconstruction

Robot-assisted surgery is evolving to incorporate a higher number of minimally invasive techniques. There is a growing interest in robotic breast reconstruction that uses autologous tissue. Since a traditional latissimus dorsi (LD) flap leads to a long donor scar, which can be an unpleasant burden to patients, there have been many attempts to decrease the scar length using minimally invasive approaches. This study presents the case of a patient who underwent a robot-assisted nipple-sparing mastectomy followed by immediate breast reconstruction with an LD flap using a single-port robotic surgery system. With the assistance of a single-port robot, a simple docking process using a short and less visible incision is possible. Compared to multiport surgery systems, single-port robots can reduce the possibility of collision between robotic arms and provide a clear view of the medial border of the LD where the curvature of the back restricts the visual field. We recommend the use of single-port robots as a minimally invasive approach for harvesting LD flaps.

Post-Operative Complications and Nipple Necrosis Rates Between Conventional and Robotic Nipple-Sparing Mastectomy.

PurposeThis study is to directly compare surgical outcomes between conventional nipple-sparing mastectomy (CNSM) and robot-assisted nipple-sparing mastectomy (RNSM).Materials and MethodFor this case–control study, 369 cases of 333 patients who underwent CNSM or RNSM with immediate reconstruction between November 2016 and January 2019 at Severance Hospital in Seoul, Republic of Korea were reviewed. Patients with stage IV breast cancer (n = 1), receiving neoadjuvant chemotherapy (n = 43), or subjected to previous operations (n = 14) or radiotherapy on the breasts were excluded. The main outcomes were comparing rates of post-operative complications, of high-grade post-operative complications as defined by the Clavien-Dindo classification, and nipple necrosis between the CNSM and the RNSM groups.ResultsA total of 311 cases, including 270 CNSMs and 41 RNSMs, were analyzed. The rates of post-operative nipple necrosis (p = 0.026, 2.4 vs. 15.2%) and of high-grade post-operative complications (p = 0.031, 34.8 vs. 17.1%) in the RNSM group were significantly lower than those in the CNSM group.ConclusionRNSM was associated with lower rates of high-grade post-operative complications and nipple necrosis than CNSM for patients with small breast volumes and less ptotic breasts.

Comparison between Gasless and Gas-Inflated Robot-Assisted Nipple-Sparing Mastectomy.

PurposeNipple-sparing mastectomy (NSM) includes various techniques, including conventional or endoscopic mastectomies. Since the introduction of robot-assisted NSM (RANSM) in 2015, 2 main methods have been used: gasless and gas-inflated techniques. The aim of this study was to compare clinicopathologic characteristics, surgical outcomes, and postoperative complications between patients treated with gasless RANSM and those treated with gas-inflated RANSM.MethodsWe conducted a retrospective study of women who underwent gasless or gas-inflated RANSM with immediate breast reconstruction between November 2016 and May 2019. The indications for RANSM were early breast cancer, interstitial mastopathy, or BRCA1/2 mutation carriers. Clinicopathologic characteristics, surgical outcomes, and postoperative complications were analyzed. The severity of complications was graded using the Clavien-Dindo system.ResultsA total of 58 RANSM procedures were performed in 46 women: 15 cases of gasless RANSM and 43 cases of gas-inflated RANSM. The proportion of node-negative disease was higher in the gas-inflated group (97.1%) than in the gasless group (69.2%, p = 0.016). Adjuvant radiotherapy was administered in 30.6% of the cases in the gasless group and only 5% of the cases in the gas-inflated group. Other clinicopathological factors were not significantly different between the groups. Regarding surgical outcomes, the initial incision was 1 cm longer in the gasless group (5.17 ± 0.88 cm) than that in the gas-inflated group (4.20 ± 1.05 cm; p = 0.002). The final incision was also longer in the gasless group (5.17 ± 0.88 cm) than that in the gas-inflated group (4.57 ± 1.07 cm; p = 0.040). Operation time, complication rate, and complication grade were not significantly different between the 2 groups.ConclusionIn this study, there were no significant differences in surgical outcomes or postoperative complications between gasless and gas-inflated RANSM, except for a longer incision with the gasless technique. Both techniques are reasonable options for RANSM followed by immediate reconstruction.

Clinical Perspectives on Robot-assisted Nipple-sparing Mastectomy

Clinical Perspectives on Robot-assisted Nipple-sparing Mastectomy

Residual breast tissue after robot-assisted nipple sparing mastectomy

IntroductionWhile the long-term oncologic safety of robot-assisted nipple sparing mastectomy (RNSM) remains to be elucidated, histologically detected residual breast tissue (RBT) can be a surrogate for oncologically sound mastectomy. The objective of this study is to determine the presence of RBT after RNSM. MethodsBetween August 2019–January 2020, we completed 5 cadaveric RNSMs. Full thickness biopsies from the mastectomy skin flap were obtained from predefined locations radially around the mastectomy skin envelop and nipple areolar complex to histologically evaluate for RBT. ResultsThe first case was not technically feasible due to inability to obtain adequate insufflation. Five mastectomy flaps were analyzable. The average mastectomy flap thickness was 2.3 mm (range 2–3 mm) and the average specimen weight was 382.72 g (range 146.9–558.3 g). Of 70 total biopsies, RBT was detected in 11 (15.7%) biopsies. Most common location for RBT was in the nipple-areolar complex, with no RBT detected from the peripheral skin flaps. ConclusionsIn this cadaveric study, RNSM is feasible leaving minimal RBT on the mastectomy flap. The most common location for RBT is in the periareolar location consistent with previous published findings after open NSM. Clinical studies are underway to evaluate the safety of RNSM.

Robot-assisted Nipple-sparing Mastectomy With Immediate Breast Reconstruction: An initial Experience of the Korea Robot-endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG).

The aim of this study was to present the results of early experience of robot-assisted nipple sparing mastectomy (RANSM). RANSM improves cosmetic outcomes over conventional nipple-sparing mastectomy. However, data on the feasibility and safety of the RANSM are limited. Patients who underwent RANSM with immediate breast reconstruction as part of the Korea Robot-endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) from November 2016 to January 2020 were enrolled. clinicopathologic characteristics, perioperative complications, and operation time were collected. Overall, 73 women underwent 82 RANSM procedures conducted by 11 breast surgeons at 8 institutions. The median patient age was 45.5 years old (20-66 years), and 52 (63.4%) patients were premenopausal. Invasive breast cancer was noted in 55 cases (40 cases were stage i, 11 cases were stage ii, and 4 cases were stage iii, respectively) and ductal carcinoma in-situ was recorded in 20 cases. Of those, 3 patients with BRCA1/2 mutation carriers underwent contralateral risk-reducing RANSM. The median length of hospitalization was 12.0 days (5.0-24.0 days). The incision location was the mid-axillary line and the median incision length was 50.0 mm (30.0-60.0 mm). Median total operation time, median total mastectomy time, and median reconstruction time was 307.0 minutes (163.0-796.0 minutes), 189.5 minutes (97.5-325.0 minutes), and 119.5 minutes (45.0-689.0 minutes). Only 2 cases (2.5%) required reoperation. Nipple ischemia was found in 9 cases (10.9%) but only 1 case (1.2%) required nipple excision given that 8 cases (9.7%) resolved spontaneously. Skin ischemia was observed in 5 cases (6.1%) and only 2 (2.4%) cases needed skin excision whereas 3 cases (3.6%) resolved spontaneously. There was no conversion to open surgery orcases of mortality. The mean time for mastectomy among surgeons who performed more than 10 cases was 182.3 minutes (± 53.7, minutes) and 195.4 minutes (± 50.4, minutes). This was the first report of RANSM conducted in the KoREa-BSG. RANSM is technically feasible and acceptable with a short learning curve. Further prospective research to evaluate surgical and oncologic outcomes is needed.

Robot-assisted nipple-sparing mastectomy: systematic review.

The growing volume of studies of robot-assisted nipple-sparing mastectomy requires critical assessment. This review synthesizes the data on safety, feasibility, oncological and cosmetic outcomes, and patient-reported outcome measures (PROMs) for robot-assisted nipple-sparing mastectomy. A systematic review was performed using MEDLINE, MEDLINE In-Process/ePubs, Embase/Embase Classic, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, LILACS, PubMed, ClinicalTrials.Gov, WHO ICTRP and the grey literature. Original studies reporting on patients with breast cancer or at increased risk of breast cancer undergoing robot-assisted nipple-sparing mastectomy were included. Risk of bias was assessed using the Institute of Health Economics Case Series Quality Appraisal Checklist. Of 7177 titles screened, eight articles were included, reporting on 249 robot-assisted nipple-sparing mastectomies in 187 women. The indication was either therapeutic (58·6 per cent) or prophylactic (41·4 per cent), with immediate reconstruction performed in 96·8 per cent. Surgical techniques followed a similar approach, with variations in incision, robot models, camera and insufflation. Postoperative morbidity included skin complications, lymphocele, infection, seroma, haematoma and skin ischaemia/necrosis. Complications specific to the nipple-areolar complex included ischaemia and necrosis. There were two conversions owing to haemorrhage, but no intraoperative deaths. Three patients had positive margins. Follow-up time ranged from 3·4 to 44·8 months. Locoregional recurrences were not observed. PROMs and objective cosmetic outcomes were reported inconsistently. Data on nipple sensitivity were not reported. Robot-assisted nipple-sparing mastectomy is feasible with acceptable short-term outcomes but it remains in the assessment phase.

P003: Robot-assisted breast surgery - Is this for US?

Introduction: Breast cancer patients are offered option of immediate reconstruction after nipple sparing mastectomy if oncologically acceptable in surgically fit patients. Robot assisted surgery has revolutionised other surgical specialties through provision of enhanced 3D vision, dexterity and ease of accessing difficult anatomical area through a remote, smaller skin incision. In this systematic review, current evidence is reviewed to establish feasibility and role of robot-assisted nipple sparing mastectomy procedures and immediate implant reconstructions within the NHS.

Exploration of Robotic Direct to Implant Breast Reconstruction.

Breast reconstruction has undergone significant innovation over the past 50 years. Both the development of nipple sparing mastectomy and the use of acellular dermal matrices have facilitated the concept of direct to implant (DTI) reconstruction. The next step in this evolution is further limiting the length of incisions as well as placing access in a more remote location. A robot-assisted surgical approach for DTI reconstruction (R-DTI) with an acellular dermal matrix scaffold is feasible and addresses limitations with open approaches and ergonomics. The authors performed a cadaveric exploration to demonstrate proof of concept and feasibility for an R-DTI following a robot-assisted nipple sparing mastectomy. Tremor stabilization, direct visualization, endo-wristed robotic instrumentation, and exposure were noted as key benefits over existing open DTI reconstruction techniques. Additionally, the ability to have a more remote access to entry at the perimeter of the breast eliminated incisional tension which can jeopardize reconstructive results. Further exploration and procedure refinements are warranted.

Robot-assisted Nipple-sparing Mastectomy with Immediate Breast Reconstruction: An Initial Experience

Seeking smaller and indistinct incisions, physicians have attempted endoscopic breast surgery in breast cancer patients. Unfortunately, there are some limitations in the range of movement and visualization of the operation field. Potentially addressing these limitations, we investigated the outcomes of gas and gasless robot-assisted nipple-sparing mastectomy (RANSM) with immediate breast reconstruction (IBR). Ten patients underwent 12 RANSM with IBR between November 2016 and April 2018. Patients with tumors measuring >5 cm in diameter, tumor invasion of the skin or nipple-areolar complex, proven metastatic lymph nodes, or planned radiotherapy were excluded. Age, breast weight, diagnosis, tumor size, hormone receptor status, and operation time were retrospectively collected. Postoperative outcomes including postoperative complications and final margin status of resected were analyzed. The median total operation time and console time were 351 min (267–480 min) and 51 min (18–143 min), respectively. The learning curve presented as a cumulative sum graph showed that the console time decreased and then stabilized at the eighth case. There was no open conversion or major postoperative complication. One patient had self-resolved partial nipple ischemia, and two patients experienced partial skin ischemia. We deemed that RANSM with IBR is safe and feasible for early breast cancer, benign disease of the breast, and BRCA 1/2 mutation carriers. RANSM is an advanced surgical method with a short learning curve.