Consensus Statement on Robotic Mastectomy

Expert Panel From International Endoscopic and Robotic Breast Surgery Symposium (IERBS) 2019

Hung-Wen Lai, MD, PhD; Antonio Toesca, MD; Benjamin Sarfati, MD, MSc; Hyung Seok Park, MD, PhD; Gilles Houvenaeghel, MD; Jesse C. Selber, MD, MPH; Fiona Tsui-Fen Cheng, MD, MS; Wen-Ling Kuo, MD, PhD; Nickolas Peradze, MD; Seung Yong Song, MD, PhD; Chi Wei Mok, MBBS, FRCSEd

Disclosures

Annals of Surgery. 2020;271(6):1005-1012.

Abstract and Introduction

Abstract

Objectives: To achieve a consensus statement on robotic mastectomy.

Background: Robotic-assisted surgery has gained much attention especially the results of few case series reporting on the technical feasibility, safety and early oncologic outcomes of robotic-assisted mastectomy in a few centers worldwide. The aim of this consensus statement was to develop and provide standardized guidelines on robotic mastectomy based on consensus statement by a panel of experts from indications to outcome measures and indicators, thereby providing a valuable guide for breast surgeons worldwide.

Methodology: An internationally representative expert panel of 10 surgeons was invited to participate in the generation of a consensus statement. 52 statements were created in 6 domains: indications, contraindications, technical considerations, patient counseling, outcome measures and indicators, training and learning curve assessment. Experts were asked to vote if they agree, disagree or of the opinion that the statement should be rephrased. Two electronic rounds via online survey of iterative rating and feedback were anonymously completed, followed by a final round of in-person meeting during the inaugural International Endoscopic and Robotic Breast Surgery Symposium 2019 from May 24 to 25, 2019. Consensus was reached when there was at least 80% agreement on each statement.

Results: A total of 53 statements with at least 80% agreement were generated after 3 rounds of voting; 21 statements from first round of voting, 20 statements from second round of voting and 12 statements from the final round of in-person meeting. All experts agreed that the consensus statement served as expert recommendations but not mandatory for a successful and safe practice of robotic mastectomy.

Conclusion: Robotic mastectomy is a promising technique and could well be the future of minimally invasive breast surgery whereas proving to be safe and feasible. The first consensus statement on robotic mastectomy from an international panel of experts serves as an extremely important milestone and provides recommendations for breast surgeons keen to embark on this technique.

Introduction

Robotic-assisted nipple sparing mastectomy (R-NSM) was first reported in 2015 by Toesca et al whereby a case series of 3 patients who were BReast CAncer gene mutation carries received risk reducing mastectomy and the authors concluded that the technique resulted in a feasible and safe operation with better aesthetic outcomes.^[1] Over the course of next few years, there were a few case reports and series^[1–12] reporting on respective institutional experience in the development of R-NSM with authors from one of the institutions reporting on the learning curve evaluation of this technique in a separate study.^[13] Single port with gas inflation systems were most frequently used techniques,^[2,5,7,9,14] alternatively gasless R-NSM was also reported.^[15] In terms of reconstructive options, most authors perform immediate direct to implant reconstruction^[7,9,14] except for 2 studies whereby pedicled^[6,16,17] and free autologous^[18] flap were used. It has to be noted that these studies were mostly retrospective in nature and the numbers were small, hence limiting its widespread applicability of the study results.

The advantages reported in all studies were similar and that include better visualization with 3-dimensional optics and improved ergonomics from instruments with high degree of freedom of movement. The 3 main disadvantages of this technique were attributed to prolonged operative time, increased cost and availability of robotic surgical platform.

Indications of R-NSM as reported in 4 case series^[2,5,7,14] were early breast cancer, tumor less than 5 cm with no evidence of skin, chest wall or nipple areolar complex (NAC) involvement.

In terms of outcome measures, R-NSM was proven to be feasible and safe in all studies with low conversion rate, reasonable learning curve^[13] and low complications rate. Of notable mention was the very low (0%) NAC necrosis rate across all studies^[2,5,7,14] in which the authors of 1 study^[7] attributed the low NAC necrosis rate to placement of incision far from the NAC and better visualization with 3-dimensional optics on a robotic surgical platform. Oncologic outcomes were not reported as the follow up duration was relatively short in all studies. More recently, authors from one of the institutions presented the first oncological outcome data showing a local recurrence-free survival of 100% with a mean duration follow up of 19 months.^[19] Excellent aesthetic outcomes were reported in all studies and in addition, 1 study described patient-reported satisfaction rate in which majority of patients were satisfied with the operation especially with regards to placement and length of incision.^[7] Robotic nipple sparing mastectomy was discussed as the next step in the evolution of minimally invasive breast surgery in a recent article.^[20]

However, a recent US Food and Drug Administration (FDA) safety communication^[21] seemed to be casting a doubt and raising a need for closer scrutiny and evaluation of this technique to ensure oncological safety are not compromised with the use of this technique in the management of breast cancer. The purpose of this consensus statement was to create an internationally endorsed statement on robotic mastectomy from indications to outcome measures and indicators, thereby providing a valuable guide for breast surgeons worldwide.

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Abstract and Introduction
Methods
Results
Discussion
References

Table 1. Panel of Experts For Consensus Statement on Robotic Mastectomy – International Endoscopic and Robotic Breast Surgery Symposium (IERBS) 2019
Expert	Specialty	Country
Antonio Toesca	Breast surgery	Italy
Benjamin Sarfati	Plastic surgery	France
Hung-Wen Lai	Breast surgery	Taiwan
Hyung Seok Park	Breast surgery	South Korea
Jesse C. Selber	Plastic surgery	USA
Fiona Tsui-Fen Cheng	Breast surgery	Taiwan
Wen-Ling Kuo	Breast surgery	Taiwan
Nickolas Peradze	Breast surgery	Italy
Gilles Houvenaeghel	Breast surgery	France
Seung Yong Song	Plastic surgery	South Korea

Table 2. Final Consensus Statements on Robotic Mastectomy With Modified Delphi Methodology
Domains	Sub-domains	Statements
Indications	Patient factors	1. Robotic mastectomy is suitable for women with small to moderate breast size
	Patient factors	2. Robotic mastectomy is suitable for women with breast cup size C and below
	Disease factors	3. Robotic mastectomy is suitable for women with clinical tumor size of up to 5 cm (T3 and below), with adequate tumor-skin distance of at least 3mm and above with no NAC involvement on preoperative imaging
		4. Robotic mastectomy is suitable for women with breast cancer up to clinical stage IIIA (up to T3, N1–2) with cautious considerations in selected cases with adequate response to neoadjuvant therapy and possible suboptimal cosmesis informed to patient in view of need for adjuvant radiotherapy
		5. Robotic mastectomy is suitable for women requiring sentinel lymph node biopsy, where radioisotope alone is sufficient except in selected cases with neoadjuvant chemotherapy, dual modality is advised
		6. Robotic mastectomy is suitable for women with clinically node negative disease
		7. Robotic mastectomy is suitable for women with low disease burden in the axilla in selected cases with good tumor biology such as luminal A subtype or micro-metastasis on sentinel lymph node biopsy
		8. Robotic mastectomy is suitable in women with no clinical and radiological evidence of skin involvement
		9. Robotic mastectomy is suitable in women with tumor in any quadrants
	Prophylactic	10. Robotic mastectomy is suitable in women indicated for prophylactic mastectomy
Contraindications	Patient factors	11. Robotic mastectomy is not contraindicated but less than ideal and technically challenging for women with ptotic breast or cup size D and above in view of possible suboptimal cosmesis in cases of either direct-to-implant reconstruction or absence of contra-lateral mastopexy/reduction mammoplasty
	Patient factors	12. Robotic mastectomy is not recommended during the initial learning curve for women with poor performance status and multiple co-morbidities in view of possible long operation time to avoid risks of post-op complications
	Disease factors	13. Robotic mastectomy is not recommended for women with clinical NAC involvement, as the main indication for robotic mastectomy is total skin and nipple sparing mastectomy
		14. Robotic mastectomy is not recommended for women with inflammatory breast cancer or T4d lesion
		15. Robotic mastectomy is not recommended for women with clinical evidence of skin involvement or T4b lesion
		16. Direct to implant reconstruction is possible but not ideal for women with clinical or radiological evidence of pectoralis major involvement, with the premise that extent of excision does not preclude adequate remnant submuscular pocket in cases of direct to implant reconstruction
		17. Robotic mastectomy is not recommended for women with clinical or radiological evidence of chest wall invasion
	Out of indications	18. Robotic mastectomy is not recommended for indications other than stated in this consensus statements until at least a Level III and above evidence is available
Technical considerations	Preoperative diagnostic imaging	19. Breast MRI or intra-op frozen section of sub-nipple biopsies (either one must be performed) is recommended for women with no clinical evidence of NAC involvement
	Positioning	20. Most common and hence recommended ipsilateral upper limb position would be above the head, however, other positions used include: 90 degrees out on an arm board or downward with hand placed on hip and change in position might be required in different stages of the operation
	Incision	21. Most common and hence recommended incision would be along the anterior axillary line at the NAC level, with selected cases to benefit from placement of incision in the axilla where axillary dissection is required
	Incision	22. Recommended incision size is dependent on breast volume or cup size with a 3–6 cm incision generally adequate for intact specimen retrieval and also direct to implant breast reconstruction cases
	Skin flap development	23. Tumescent technique is recommended for skin flap dissection in robotic mastectomy
	Skin flap development	24. Meticulous blunt dissection with scissors without the use of coagulation after tumescent injection is recommended for skin flap dissection in robotic mastectomy
	Instruments used	25. Sharp dissection with monopolar scissors is used for dissection of breast parenchyma off pectoralis major fascia
	Intraoperative frozen section analysis of sub-nipple biopsies	26. Intraoperative frozen section analysis of sub-nipple biopsies are recommended in robotic mastectomy, which if positive intraoperatively or on final histopathologic examination, option of conversion to skin sparing mastectomy should be offered to patient
	Reconstruction options	27. Sub-pectoral placement of implant is recommended and safer in the event of skin flap necrosis; however, aesthetic outcome may not be optimal
		28. Pre-pectoral placement of implant is recommended in cases where skin flap viability is not of concern and the need for adjuvant radiotherapy is obviated
		29. Use of biological acellular dermal or synthetic matrices is not routinely recommended for implant-based reconstruction, subject to surgeons' preferences and availability
		30. Autologous reconstruction techniques are feasible in selected cases of robotic mastectomy, subject to patients' preference and surgeons' expertise
	Postoperative drainage	31. Standard postoperative drainage as per conventional methods are recommended
Patient counseling	Cautionary advice	32. Patients should be counseled regarding positive sub-nipple biopsies and conversion to skin sparing mastectomy
		33. Patients should be counseled regarding possible complication arising from robotic mastectomy
		34. Patients should be counseled regarding indications and contraindications of robotic mastectomy as part of preoperative counseling
Outcome measures	Surgical outcomes and safety indicators	35. Operative time should be monitored as one of the surgical outcomes indicator
		36. Complications should be recorded with a validated grading system (for example Clavien-Dindo classification) to allow for a standardized comparison
		37. Conversion to either skin sparing mastectomy or conventional nipple sparing mastectomy should be monitored as one of the surgical outcomes and safety indicator
		38. NAC ischemia or necrosis should be monitored as one of the surgical outcomes and safety indicator
		39. Intraoperative blood loss should be monitored as one of the surgical outcomes and safety indicator
		40. Complications and morbidities assessment should be monitored as one of the surgical outcomes and safety indicator
		41. Margin involvement should be monitored as one of the surgical outcomes and safety indicator
	Oncological outcomes indicators	42. Local recurrence should be monitored as one of the oncologic outcomes indicator
		43. Distant recurrence, disease free and overall survival should be monitored as one of the oncologic outcomes indicator
		44. Recurrence at the NAC should be monitored as one of the oncologic outcomes indicator
	Aesthetic outcomes	45. A validated and standardized questionnaire should be used to evaluate the aesthetic outcomes in robotic mastectomy
		46. A validated and standardized questionnaire should be used to compare the aesthetic outcomes between robotic mastectomy and conventional techniques
		47. Breast symmetry should be included in the assessment of aesthetic outcomes
		48. Postoperative breast size and shape should be included in the assessment of aesthetic outcomes
		49. Satisfaction with wound size should be included in the assessment of aesthetic outcomes
		50. Satisfaction with wound length should be included in the assessment of aesthetic outcomes
		51. Satisfaction with wound placement should be included in the assessment of aesthetic outcomes
		52. Cost-effectiveness analysis should be performed to investigate the cost-benefit of robotic mastectomy
Training and learning curve assessment		53. Hours on simulators, number of adequate cases for observership and proctorship and cumulative cases to be considered an ''expert'' are highly variable between experts and dependent on various factors. Hence, no recommendations could be offered at this point in time.