Question

What is the strategy for nipple sparing mastectomy in high-risk patients?

Recommendation

Inform the patient that sparing the nipple entails a risk of nipple necrosis, and thus an elevated risk of prosthesis loss.

 

Inform the patient about the advantages and disadvantages of various nipple-sparing techniques.

 

Inform the patient that the greater the cup size and degree of ptosis, the greater the risk of complications.

 

Inform the patient that the reduction in risk following nipple-sparing mastectomy may be less than following skin-sparing mastectomy.

Introduction

The nipple-areola complex is usually removed during a prophylactic mastectomy. The loss of the nipple can increase the feeling of mutilation. A nipple sparing technique is used in some clinics. The potential increase in residual risk of breast cancer remains unclear. However, the ‘nipple sparing’ mastectomy has become increasingly popular in recent years. In theory, this technique may lead to an increased risk of local recurrence, as gland tissue remains under the nipple-areola complex.

A definition of the size and ptosis grade of the breast(s) at which the nipple can no longer be preserved due to the risk of complications (partial and total nipple necrosis and nipple malposition) will also be necessary.

Conclusions

very low

(GRADE)

Aesthetic result

 

A nipple sparing, prophylactic mastectomy with reconstruction appears to achieve good aesthetic results.

 

Sources (Saccini et al, 2006; Sahin et al, 2013)

 

very low

(GRADE)

Short-term oncologic safety

 

The chance of developing a primary breast carcinoma after nipple sparing, prophylactic mastectomy appears to be low at 12 and at 24 months.

 

Sources (Saccini et al, 2006; Sahin et al, 2013)

 

-

Complications during and after the procedure; long-term oncologic safety

 

Comparative studies do not allow conclusions to be drawn regarding the incidence of complications during and after the procedure and long-term oncologic safety between prophylactic skin sparing mastectomy versus nipple/skin sparing mastectomy.

Literature summary

In one retrospective follow-up study (Sacchini et al, 2006), 55 patients (who were not tested for BRCA gene mutation carrier status) underwent a nipple sparing, prophylactic mastectomy with breast reconstruction for reasons that are not entirely clear (42 bilateral; 13 unilateral due to contralateral breast cancer). After an average follow-up of 2 years, 94% of patients were satisfied with the aesthetic result. Two patients developed a local recurrence after 24 months and 62 months, respectively. Both recurrences were not in the direct vicinity of the nipple. The outcome measures quality of life, complications during and after the procedure were not examined.

 

In a second prospective study (Sahin et al, 2013), 21 patients underwent prophylactic nipple sparing mastectomy (all bilateral procedures followed by implant reconstruction). The reason for prophylactic mastectomy was a first or second degree family member with breast cancer or multiple cysts with microcalcifications on the mammogram. No malignancies were found. Average follow-up was 12 months. General satisfaction and aesthetic result, assessed with the Michigan Breast Satisfaction Questionnaire, were 100% and 90.4%, respectively.

 

Level of evidence of the literature

The level of evidence for the outcome measures aesthetic result and oncologic safety is very low, as these were not comparative studies (limitations to study design) and the studies were of limited size (imprecision).

The level of evidence for outcome measures complications during and after the procedure is unknown.

Search and select

In order to answer the primary question, a systematic literature review was performed for the following question:

What is the difference between a prophylactic skin sparing mastectomy and a nipple/skin sparing mastectomy on the incidence of breast cancer and postoperative complications, aesthetic result, and patient satisfaction?

 

Search and selection (Method)

Medline (OVID), Embase and Cochrane databases were searched for mastectomy with reconstruction of a healthy breast in patients with a high risk of breast cancer. The search justification is listed in the appendix to this chapter. The literature search yielded 40 results. Studies that met the following selection criteria were included in the literature summary: original studies; comparative studies (RCT, CCT) or follow up studies; comparison of various treatment techniques in patients who have a healthy breast removed preventively and have it reconstructed due to the risk of breast cancer; and at least one of the following outcome measures: quality of life, cosmetic result or oncologic advantage.

 

Eleven studies were selected based on title and abstract. After reading the full articles, one study was included in the literature summary (Sacchini et al, 2006). After the search date, one prospective study was published that was also included in the literature summary (Sahin et al, 2013). The evidence tables are presented in the appendix to this chapter. The reasons for not including the other ten studies may also be found in the appendix to this chapter.

Considerations

A nipple/skin sparing mastectomy followed by immediate reconstruction may provide a better aesthetic result in certain cases than a skin sparing mastectomy followed by immediate reconstruction. Preserving the nipple can play a significant part for some women. Additionally, it avoids the need for an additional intervention and/or tattoo. Preserving the nipple as part of skin sparing mastectomy undercuts the risk reducing intent of the prophylactic mastectomy, as the primary goal is to remove as much breast tissue as possible during this prophylactic procedure. On the contrary, a substantial amount of breast tissue remains in nipple sparing procedures along with the associated elevated risk of breast cancer. The magnitude of this theoretically elevated risk of developing a carcinoma in the remaining breast tissue is unknown and future studies will have to provide insights.

 

In addition to the oncologic risk mentioned above, the potential malposition of the nipple-areola complex due to redistribution of the breast’s skin envelope during skin sparing mastectomy and replacement of the original breast tissue with an implant or autologous tissue must be discussed. As must the potential loss of sensation and function of the nipple.

 

The chances of the preserved nipple surviving completely, in terms of projection, color and appearance, must also be discussed with the patient if this option is selected.

 

An explanation of the disadvantages and limitations of various surgical nipple sparing techniques will need to be discussed with patients in order to allow an informed choice to be made.

Authorization date and validity

Last review : 01-03-2015

Last authorization : 01-03-2015

The Board of the Dutch Society for Plastic and Reconstructive Surgery (NVPC) will assess whether this guideline is still up-to-date in 2018 at the latest. If necessary, a new working group will be appointed to revise the guideline. The guideline’s validity may lapse earlier if new developments demand revision at an earlier date.

As the holder of this guideline, the NVPC is chiefly responsible for keeping the guideline up to date. Other scientific organizations participating in the guideline or users of the guideline share the responsibility to inform the chiefly responsible party about relevant developments within their fields.

Initiative and authorization

Initiative : Nederlandse Vereniging voor Plastische Chirurgie

Authorized by:
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging voor Radiotherapie en Oncologie

General details

Guideline development was funded by the Quality Fund for Medical Specialists (SKMS) and The Netherlands Organization for Health Research and Development (ZonMw).

Scope and target group

Guideline goal

To develop a multidisciplinary, evidence-based guideline for breast reconstruction in women undergoing breast conserving therapy or mastectomy for breast cancer, or following prophylactic mastectomy.

 

Guideline scope

The guideline focuses on all patients with an indication for breast reconstruction following breast conserving therapy or mastectomy. Additionally, the guideline may be applied to breast reconstruction in patients who have undergone surgical treatment for a benign breast condition. The guideline does not comment on the treatment of breast cancer. We refer the reader to the NABON guideline for the treatment of breast cancer (www.richtlijnendatabase.nl), which this guideline complements.

 

Unfortunately, circumstances did not permit a medical oncologist representing the NVMO to participate in the working group. Thus, the current version lacks a module on chemotherapy and breast reconstruction. The working group strives to create such a module for this guideline in the near future.

 

Intended audience for the guideline

The guideline aims to provide practical guidance for plastic surgeons and members of the multidisciplinary breast cancer team (surgical oncologist, medical oncologist, radiation oncologist, radiologist, pathologist, psychologist, breast care nurse specialist). A version for patients has recently been developed (https://www.b-bewust.nl/pif_borstreconstructie).

Members of the guideline panel

A multidisciplinary working group was appointed to develop the guideline in October 2011, consisting of representatives from all relevant specialties involved in the care for patients with breast reconstruction (see above for working group membership). Working group members were mandated by their professional organizations. The working group worked on developing the guideline for 2 years. The working group is responsible for the full text of this guideline.

 

  • Dr. M.A.M. Mureau (President), MD, PhD, plastic surgeon, Erasmus MC Cancer Institute, Erasmus University Medical Center Rotterdam
  • Professor Dr. R.R.W.J. van der Hulst, MD, PhD, plastic surgeon, Maastricht University Medical Center/Orbis Medical Center/Viecuri Medical Center, Maastricht
  • Dr. L. A.E. Woerdeman, MD, PhD, plastic surgeon, Antoni van Leeuwenhoek / Netherlands Cancer Institute, Amsterdam
  • Drs. A.A.W.M van Turnhout, MD, plastic surgeon, Tergooi Hospital, Hilversum Site
  •  N.A.S. Posch, MD, plastic surgeon, Haga Hospital, The Hague
  • Dr. M.B.E. Menke-Pluijmers, MD, PhD, oncologic surgeon, Albert Schweitzer Hospital, Dordrecht
  • Dr. E.J.T. Luiten, MD, PhD, oncologic surgeon, Amphia Hospital, Breda
  • Drs. A.H. Westenberg, MD, radiotherapist/oncologist, Arnhem Radiotherapy Institute, Arnhem
  • Dr. J.P. Gopie, PhD, psychologist, Leiden University Medical Center, Leiden
  • Dr. H.M. Zonderland, MD, PhD, radiologist, Academic Medical Center, Amsterdam
  • Drs. M. Westerhof, MSc, Netherlands Breast Cancer Association, Utrecht
  •  E.M.M. Krol-Warmerdam MA, V&VN Nurse Specialists, Leiden University Medical Center, Leiden

 

With support from

  • Drs. B.S. Niël-Weise, MD, microbiologist / epidemiologist, senior advisor, Knowledge Institute for Medical Specialists

Declaration of interest

Working group members declared any (financial) ties with commercial companies, organizations or institutions involved in the field covered by the guideline for the past five years in writing. An overview is available on request from the office of the Knowledge Institute for Medical Specialists (KIMS).

Patient involvement

Patients are represented by a delegate from the Netherlands Breast Cancer Association in this guideline.

Method of development

Evidence based

Implementation

Guideline implementation and practical applicability of the recommendations was taken into consideration during various stages of guideline development. Factors that may promote or hinder implementation of the guideline in daily practice were given specific attention.

 

The guideline is distributed digitally among all relevant professional groups. The guideline can also be downloaded from the Dutch Society for Plastic and Reconstructive Surgery website: www.nvpc.nl, the guideline website: www.richtlijnendatabase.nl and the Quality Organization for Medical Specialists.

Methods and proces

AGREE

The guideline has been drafted in accordance with the requirements outlined in the ‘Guidelines 2.0’ report of the Guideline Advisory Committee of the Council on Science, Education and Quality (WOK). This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (www.agreecollaboration.org), an instrument designed to assess the quality of guidelines with broad international support.

 

Primary questions and outcome measures

Based on the outcomes of the bottleneck analysis, the president and advisor formulated draft primary questions. These were discussed and defined together with the working group. Subsequently, the working group determined which outcome measures were relevant for the patient for each primary question, examining both desired and undesirable effects. The working group valuated these outcomes based on their relative importance as crucial, important and unimportant.

 

Literature search and selection strategy

Specific search terms were used to identify published scientific studies related to each individual primary question in Medline, Cochrane and, where necessary, Embase. Additionally, the references of the selected articles were screened for additional relevant studies. Studies offering the highest level of evidence were sought out first. Working group members selected articles identified by the search based on predetermined criteria. The selected articles were used to answer the primary question. The searched databases, the search string or terms used during the search and selection criteria applied are listed in the chapter for each individual primary question.

 

Quality assessment of individual studies

Individual studies were assessed systematically based on predefined methodological quality criteria in order to assess the risk of biased study results. These assessments may be found in the column ‘Study quality assessment’ in an evidence table.

 

Literature summary

The relevant study results from all selected articles were presented clearly in evidence tables. The key findings from the literature are described in the literature summary. If studies were sufficiently similar in design, data were also summarized quantitatively (meta-analysis) using Review Manager 5.

 

Assessment of the level of scientific evidence

A)   With regard to intervention questions:

The level of scientific evidence was determined using the GRADE method. GRADE is short for ‘Grading Recommendations Assessment, Development and Evaluation’ (see http://www.gradeworkinggroup.org/) (Atkins et al, 2004).

 

B)    With regard to questions about the value of diagnostic tests, harm or adverse effects, etiology and prognosis:

GRADE cannot be used (yet) for these types of questions. The level of evidence of the conclusion was determined based on the accepted EBRO method (van Everdingen et al, 2004).

 

Formulation of conclusions

With regard to questions about the value of diagnostic tests, harm or adverse effects, etiology and prognosis, the scientific evidence is summarized in one or more conclusions, listing the level of evidence for the most relevant data.

 

For interventions, the conclusion does not refer to one or more articles, but is drawn based on the body of evidence. The working group looked at the net benefits of each intervention. This was done by determining the balance between favorable and unfavorable effects for the patient.

 

Considerations

When making recommendations, scientific evidence was considered together with other key aspects, such as working group member expertise, patient preferences, costs, availability of facilities and/or organizational aspects. Insofar as they are not part of the systematic literature review, these aspects are listed under ‘Considerations’.

 

Formulation of recommendations

Recommendations provide an answer to the primary question, and are based on the best scientific evidence available and the most important considerations. The level of scientific evidence and the importance given to considerations by the working group jointly determine the strength of the recommendation. In accordance with the GRADE method, a low level of evidence for conclusions in the systematic literature review does not rule out a strong recommendation, while a high level of evidence may be accompanied by weak recommendations. The strength of the recommendation is always determined by weighing all relevant arguments.

 

Development of indicators

Along with developing a draft guideline, internal quality indicators were developed to allow monitoring of the implementation of the guideline in daily practice. More information about the method for indicator development may be requested from KIMS.

 

Knowledge gaps

During the development of this guideline, systematic searches were conducted for research contributing to answering the primary questions. For each primary question, the working group determined whether (additional) scientific research is desirable.

 

Commentary and authorization phase

The draft guideline was submitted to the (scientific) organizations involved for comment. The guideline was also submitted to the following organizations for comment: Netherlands Breast Cancer Association (BVN), Netherlands Society for Medical Oncology (NVMO), Dutch College of General Practitioners (NHG), Healthcare Insurers Netherlands (ZN), The Dutch Healthcare Authority (NZA), Health Care Insurance Board (CvZ), the Health Care Inspectorate (IGZ), Achmea, CZ, Menzis and VGZ. Comments were collected and discussed with the working group. The draft guideline was updated and finalized by the working group based on the comments. The final guideline was submitted for authorization to the (scientific) organizations involved and authorized by them.

 

Legal standing of guidelines

Guidelines are not legal prescriptions, but contain evidence-based insights and recommendations that care providers must meet in order to provide high quality care. As these recommendations are primarily based on ‘general evidence for optimal care for the average patient’, care providers may deviate from the guideline based on their professional autonomy when they deem it necessary for individual cases. Deviating from the guideline may even be necessary in some situations. If care providers choose to deviate from the guideline, this should be done in consultation with the patient, where relevant. Deviation from the guideline must always be justified and documented.