Patient information breast reconstruction
Uitgangsvraag
What information should the patient receive regarding latissimus dorsi breast reconstruction?
Aanbeveling
When speaking with patients about breast reconstruction with a latissimus dorsi and implant, discuss that:
- the risk of complications is low compared with other techniques;
- the majority of capsular contractures occur late;
- seroma formation at the back wound is relatively common;
- the risk of permanent loss of shoulder function is low;
- there appears to be a patient preference for placing the back scar under the bra strap;
- this generally results in high patient satisfaction.
Overwegingen
Acceptor site complications
The most commonly reported complications are wound healing problems, (partial) flap necrosis, infected implants requiring removal, and capsular contracture. The incidence of these complications in most publications is less than 10% (Mimoun et al, 2006; Mast et al, 2006; Sternberg et al, 2006; Foustanos et al, 2007; Hankins et al, 2008; Agaoglu et al, 2009; Hardwicke et al, 2011). This is relatively low compared with the risk of complications after other breast reconstruction methods.
The reported incidence of capsular contracture around the prosthesis placed under the latissimus dorsi muscle also varies greatly, ranging from 0 to 56%, depending on follow-up duration, use of a tissue expander and the need for postoperative radiation therapy (Tarantino et al, 2006; Hardwicke et al, 2011). In a retrospective, descriptive study of 277 breast reconstructions using a latissimus dorsi with a prosthesis, with an average follow-up of 47 months (1-119 months), Hardwicke et al (2011) reported a capsular contracture rate of 3.6% (0.93% per year). There were 102 immediate and 175 delayed reconstructions, and 45.5% of patients underwent preoperative or postoperative radiation therapy. Chemotherapy was a significant protective factor for capsular contracture, and postoperative radiation therapy resulted in an 11 times higher risk of capsular contracture compared with preoperative radiation therapy (Hardwick et al, 2011).
Another retrospective study with 68 breast reconstructions using latissimus dorsi and an implant, with the currently longest follow-up of 14.9 years on average (range 10-22 years), reported a need for late repeat surgery for capsular contracture in 50% of patients (Tarantino et al, 2006). This prosthesis replacement or even removal (in 10% of cases) occurred after an average of 6.9 years (0.5-16 years). A Kaplan-Meier analysis showed that after 7.5 years of follow-up, there is a clear deviation in the curve, indicating most capsular contractions occur very late. Furthermore, 66% of patients experienced cranial displacement of the prosthesis (Tarantino et al, 2006).
A retrospective follow-up study in 65 patients with an immediate autologous latissimus dorsi (ALD) breast reconstruction after skin-sparing mastectomy, with an average follow-up of 34 months (1.6-89.9 months) reported no acceptor site complications such as skin or flap necrosis (Kim et al, 2012).
A prospective, longitudinal study in 182 patients with an immediate ALD (n=100) or LD with an implant (LDI; n=82) reconstruction, with or without subsequent chemotherapy or radiation therapy, showed 51/82 early acceptor site complications after LDI reconstructions, compared with 27/100 after ALD reconstruction (Winters et al, 2013). Eleven of the 82 patients (13.4%) with an LDI reconstruction experienced implant-related complications after 12 months (Winters et al, 2013).
Donor site complications
Shoulder function: the latissimus dorsi is responsible for adduction and internal rotation of the shoulder. Using the muscle for a breast reconstruction may impair shoulder function. In a prospective, comparative cohort study of shoulder mobility in 87 women, no difference in average shoulder function was found in 41 women after mastectomy and latissimus dorsi breast reconstruction compared with 46 women who underwent mastectomy only after 4 weeks (De Oliviera et al, 2010). Both groups did show temporary and clear deterioration of shoulder function one week postoperatively, which improved to almost normal after 4 weeks (De Oliviera et al, 2010). Another prospective observational study in 58 women also found a temporary decrease in average subjective shoulder function after 6 to 12 weeks, assessed using the standardized, validated and reliable Disabilities of the Arm, Shoulder and Hand (DASH) patient questionnaire (Button et al, 2010). Average subjective shoulder function normalized after 3 months, and remained stable over the 3 year follow-up period. No difference was found between ‘quilting’ of the back wound or not, and a poor preoperative DASH score was a risk factor for poor postoperative shoulder function (Button et al, 2010).
A retrospective follow-up study with 68 patients and a mean follow-up duration of 14.9 years (10 to 22 years) found over a third of the 51 questioned patients experienced subjective deterioration of shoulder function, using an unvalidated questionnaire (Tarantino et al, 2006). Preoperative measurements and comparisons between different groups were lacking, and selection bias may have affected the results.
Seroma formation: excessive seroma formation at the donor site is relatively common, despite placement of vacuum drains (Gruber et al, 2011; Kim et al, 2012; Winters et al, 2013). Risk factors include age, high BMI and comorbidity (Gruber et al, 2011). A systematic review of five comparative studies including 440 patients showed that the use of ‘quilting’ sutures when closing the back wound lowers the risk of seroma formation, seroma volume and the number of seroma aspirations (Saijd et al, 2011). Drain and seroma volume can be reduced further by also using tissue glue (Saijd et al, 2011). One randomized, placebo-controlled study in 49 patients showed a different effective strategy consists of a single outpatient injection of 80 mg of triamcinolone into the seroma cavity following aspiration. This resulted in significantly fewer follow-up aspirations, lower aspiration volume and faster resolving of the seroma (Taghizadeh et al, 2008).
Position of donor site scar: the latissimus dorsi flap skin island can be harvested diagonally along the skin lines, horizontally to ensure scars are hidden under the bra strap, vertically along the lateral thorax, and obliquely to the skin lines, depending on patients factors and preferences (Hammond, 2008; Hammond, 2009; Durkin et al, 2010). In a study of 250 women, however, the majority of women preferred a horizontal scar at or below the bra strap, allowing easy covering with clothing (Bailey et al, 2010).
Patient satisfaction
Patient satisfaction with the cosmetic result and body image after latissimus dorsi reconstruction is generally good, regardless of whether the reconstruction is performed immediately or delayed (McKeown et al, 2009), whether or not radiation therapy was administered (Spear et al, 2007; McKeown et al, 2009; Thomson et al, 2008; Winters et al, 2013) and whether or not an implant was used (Thomson et al, 2008; Winters et al, 2013).
In a retrospective, comparative study in 34 DIEP flap patients and 21 latissimus dorsi patients with an average follow-up of 3.5 years, patient satisfaction and quality of life was examined using a standardized questionnaire and the SF-36, respectively. Additionally, the cosmetic result was assessed by a panel of three plastic surgeons (Lindegren et al, 2012). The investigators found no significant difference in patient satisfaction and quality of life between patients with a DIEP flap or latissimus dorsi reconstruction. However, the panel was more satisfied with breast volume (p=0.024) and shape (p=0.039) for DIEP flap reconstructions, but less satisfied with the donor scar (p=0.001). Additionally, panel members were less satisfied than patients about the cosmetic result of latissimus dorsi reconstructions (p=0.018). There was reasonable agreement between the three panel members, but almost no agreement between the panel and the patients (Lindegren et al, 2012). The authors concluded that plastic surgeons appear to overestimate the results of technically complex procedures.
The retrospective follow-up study by Kim et al (2012) in 65 patients with immediate LDI reconstruction also found high patients satisfaction (76.9% reporting 7 or higher on a scale of 1-10). Additionally, the aesthetic result was considered good by both the surgeon (mean 7.7) and nurse (mean 7.9), generally with good agreement between both (r=0.917, p<0.001; Kim et al, 2012). This study also found poor agreement between patient and panel satisfaction (Kim et al, 2012).
Winters et al (2013) studied health-related quality of life (HRQL) in 182 patients following immediate LDI (n=82) or ALD (n=100) breast reconstruction in a prospective, longitudinal study, both preoperatively and three, six and 12 months postoperatively. The average HRQL worsened after three months, and recovered spontaneously after 12 months (Winters et al, 2013). No significant differences in HRQL were found between LDI and ALD reconstructions, or between patients with or without postoperative radiation therapy. Early complications in particular had a negative impact on HRQL during the first 12 months, as did the need for chemotherapy (Winters et al, 2013).
Onderbouwing
Achtergrond
Comprehensive preoperative information is essential to ensure patients can make a well-informed choice. Additionally, good preoperative information provision can result in a lower risk of dissatisfied patients.
Samenvatting literatuur
No systematic literature review was performed for budgetary reasons. This will be done in the near future, and this section will subsequently be updated.
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 01-03-2015
Laatst geautoriseerd : 01-03-2015
Geplande herbeoordeling : 01-01-2019
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.
Algemene gegevens
Guideline development was funded by the Quality Fund for Medical Specialists (SKMS) and The Netherlands Organization for Health Research and Development (ZonMw).
Doel en doelgroep
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).
Samenstelling werkgroep
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
Belangenverklaringen
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).
Inbreng patiëntenperspectief
Patients are represented by a delegate from the Netherlands Breast Cancer Association in this guideline.
Methode ontwikkeling
Evidence based
Implementatie
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.
Werkwijze
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.