Question

What is the role of an immediate or delayed breast reconstruction in high-risk patients?

Recommendation

In case of prophylactic mastectomy and the wish for reconstruction, recommend immediate reconstruction.

Introduction

Prophylactic mastectomy is a drastic operation. The Cochrane review by Lostumbo et al (2010) found bilateral mastectomy in BRCA1 and 2 gene mutation carriers results in a decrease in cancer rates and an improvement in survival. Contralateral prophylactic mastectomy after primary breast cancer is also associated with a reduction in the incidence of (contralateral) breast cancer, but the results on survival are inconsistent. Studies of the psychological effects reveal that the fear of breast cancer is significantly reduced, but that satisfaction with the cosmetic results and body image varies greatly (Gopie et al, 2012; den Heijer et al, 2012). Within this context, it is important to provide advice regarding the advantages and disadvantages of various reconstruction possibilities. This chapter examines whether immediate or delayed reconstruction is preferred.

 

Definition of high-risk patients:

This refers to carriers of BRCA1 or 2 gene mutations and women with a significant family history of breast cancer.

Conclusions

very low

(GRADE)

Postoperative complications

 

The risk of postoperative complications may be higher in delayed rather than immediate reconstruction in patients who undergo prophylactic mastectomy.

 

Sources (Barton et al, 2005)

 

-

Aesthetic result and patient satisfaction

 

Comparative research does not allow an answer to the question of the difference in aesthetic result and patient satisfaction between immediate breast reconstruction and no or delayed reconstruction in patients with prophylactic mastectomy.

Literature summary

In a retrospective cohort of 214 patients with bilateral prophylactic mastectomy, 178 patients underwent immediate breast reconstruction (definition of ‘immediate’: within 2 days of mastectomy) with use of implants, autologous tissue or a combination of both methods. Thirty-six patients underwent a delayed reconstruction (Barton et al, 2005). Average follow-up was 7.4 years. In the group of patients with delayed reconstructions there were more patients with at least one complication than in the group with an immediate reconstruction (not statistically significant, p=0.055). The outcome measure complication encompassed minor local complications, local complications requiring additional intervention, irreversible complications and systemic complications. The outcome measures aesthetic result and patient satisfaction were not studied.

 

Level of evidence of the literature

The level of evidence for the outcome measure postoperative complications is very low, as this is a retrospective cohort study (limitations to study design) of limited size (imprecision).

 

The level of evidence for the outcome measures aesthetic result and patient satisfaction was not assessed, as these were not studied.

Search and select

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

What is the difference in aesthetics, patient satisfaction and the incidence of postoperative complications between immediate breast reconstruction and no or delayed reconstruction in patients with prophylactic mastectomy?

 

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 75 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 (Barton et al, 2005). 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

Various studies have compared immediate and delayed breast reconstructions. However, all but one of these studies were performed in patients with breast cancer. A number of aspects from this literature may potentially be extrapolated to the prophylactic patient group. In patients with breast cancer, immediate reconstruction appears to result in a better aesthetic result and greater psychosocial well-being compared to women who undergo delayed reconstruction (Elder et al, 2005; Al-Ghazal et al, 2000; Kroll et al, 1995; Kroll et al, 1997; d’Souza et al, 2011). Additionally, women with breast cancer who have their healthy contralateral breast amputated are more satisfied with their breasts (Koslow et al, 2013), while complication rates are similar (Crosby et al, 2011).

 

Young women and women with no history of breast cancer are more likely to elect immediate reconstruction after prophylactic amputation (Semple et al, 2013).

 

Immediate reconstruction has a number of advantages. For example, the skin can be spared, providing an aesthetic advantage. It avoids one additional surgery which, in addition to the advantages for the patient, is also more cost-effective. Patients are generally well-prepared and have had the time to discuss the intervention. Immediate reconstruction in cases of preventive mastectomy has a positive impact on psychological well-being, taking into account that proper support is essential to processing the loss. Changes in sexual and relationship dynamics and body image require special attention (Gopie et al, 2012; den Heijer et al, 2012).

 

Performing immediate breast reconstruction can also have various disadvantages. These may be medical in nature, such as severe comorbidity. Additionally, operative time is increased and more complications may arise. The literature described in this guideline does not support these conclusions. However, the quality of the evidence is poor. In terms of logistics, an immediate reconstruction can be challenging, as various teams (surgical oncologists and plastic surgeons) must be available at the same time.

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.