DIEP flap surgery without imaging studies
Uitgangsvraag
Is performing DIEP flap surgery without prior imaging studies justified?
Aanbeveling
Always perform preoperative mapping prior to DIEP flap surgery.
Overwegingen
The advantage of HHUS is that women do not need to undergo preoperative investigations. In experienced hands, preoperative mapping using HHUS is possible. However, the method is not standardized and thus results are not reproducible. No good studies on the topic have been published. HHUS is highly suitable for tracing the course of the selected perforator during surgery; however the high sensitivity can also lead to identification of perforators that are too small (Masia et al, 2006).
Preoperative investigations such as Color Duplex US, CTA and MRA are standardized and more reproducible. However, no good comparative studies of HHUS and Color Duplex US have been published, so the evidenced positive effects of preoperative imaging studies compared to no preoperative studies are almost entirely accounted for by CTA.
The information obtained from these studies allows the surgical strategy to be discussed in advance, and adjusted as necessary, allowing selection of the perforator(s) with the most optimal characteristics [size; location (lateral versus medial system); subcutaneous, subfascial and intramuscular course].
The availability of this information results in less stress for the surgeons, in part due to shortening of operative time. Rozen (A) et al (2008) performed a psychometric test, showing a statistically significant reduction in stress if CTA was performed compared with HHUS of Color Duplex-US (41% reduction, p=0,007). This information also leads to fewer flap and donor site complications.
The length of operating room use is one of the factors that makes the intervention so expensive. One hour in the operating room costs about €800, while a CTA costs about €200. This is another reason why time savings favor preoperative imaging.
The disadvantage of preoperative imaging studies is the additional time required for the patient. The disadvantage of CTA is radiation burden: 6-8 mSv for the abdomen alone, doubling for thorax-abdomen (Ghattaura et al, 2010; Kuekrek et al, 2011). This is a significant consideration, as the population in question is healthy. This may result in the popularity of MRA increasing. The potential complications of the contrast agents are generally mild.
In summary:
The literature search identified a number of comparative studies of limited scientific value and with a low level of evidence. However, the studies did reveal important advantages for preoperative imaging studies prior to a DIEP procedure, some statistically significant, some indicating a trend. These advantages are: more accurate selection of surgical strategy, shorter operative time and thus a reduction in flap and donor site related complications, and reduced stress among the surgeons. These advantages have been described for CTA and MRA, but not for Color Duplex US. The disadvantages of CTA and MRA are generally insignificant compared with these advantages.
Onderbouwing
Achtergrond
The abdominal wall is the most common donor site for an autologous breast reconstruction, initially for pedicled TRAM flap reconstructions, but increasingly also for free TRAM and DIEP flap procedures. The latter two are technically more complex, in part due to the significant variation in vascularization and perforators, both per patient and per hemi-abdomen. These perforators were initially identified perioperatively; however, mapping may also be performed preoperatively.
Success of the DIEP flap largely depends on the risk of flap necrosis; this risk is determined in part by the quality of the selected perforators.
During preoperative mapping of these perforators, anatomic course, diameter, and localization of the perforators can be determined, minimizing operative time spent searching for perforators and allowing immediate selection of the perforator with the best quality (Saba et al, 2013).
Imaging techniques have been developed for preoperative mapping. The question is whether performing a DIEP flap reconstruction without using one of these imaging techniques can still be justified.
Conclusies
a) CTA versus HHUS
|
low (GRADE) |
Operative time
Preoperative mapping of perforators using CTA versus perioperative HHUS appears to reduce operative time by at least one hour.
Sources (Minqiang et al, 2010; Ghattaura et al, 2010; Casey et al, 2009; Tong et al, 2012) |
|
very low (GRADE) |
(Partial) flap necrosis
There is a trend toward a reduction in the risk of (partial) flap necrosis if perforators are mapped using CTA prior to surgery, rather than during surgery using HHUS.
Sources (Minqiang et al, 2010; Casey et al, 2009) |
|
very low (GRADE) |
Abdominal hernia / abdominal weakness and bulge
The risk of abdominal hernia/abdominal weakness and bulge appears to be lower if perforators are mapped using CTA prior to surgery, rather than during surgery using HHUS.
Sources (Ghattaura et al, 2010; Casey et al, 2009) |
b) MRA versus HHUS
|
very low (GRADE) |
Operative time
There is a trend indicating operative time is about 20 minutes shorter if perforators are mapped preoperatively using MRA and not during surgery using HHUS.
Source (Schaverien et al, 2011) |
|
very low (GRADE) |
(Partial) flap necrosis
There is a trend towards a reduction in the risk of (partial) flap necrosis if perforators are mapped preoperatively using MRA and not during surgery using HHUS.
Source (Schaverien et al, 2011) |
Samenvatting literatuur
a) CTA versus HHUS
Four observational studies examined this question (Minqiang et al, 2010; Ghattaura et al, 2010; Casey et al, 2009; Tong et al, 2012). The evidence tables are presented in the appendix to this chapter. The four studies compared the effects of mapping perforators using CTA to those of perioperative mapping using HHUS in patients with an indication for immediate or delayed autologous breast reconstruction.
Results
None of the studied outcome measures allowed pooling of results due to the clinical heterogeneity in study populations.
Operative time
All four studies examined operative time as an outcome measure. For unilateral reconstructions with prior CTA, three studies found a statistically significant shorter operative time of at least one hour (Ghattaura et al, 2010; Casey et al, 2009; Tong et al, 2012). For bilateral reconstructions with prior CTA, two studies found a statistically significant shorter operative time of at least one hour (Casey et al, 2009; Tong et al, 2012) and one study found no statistically significant shorter duration (Ghattaura et al, 2010). Minqiang et al (2010) also found that preoperative CTA reduced operative time by at least one hour. The authors did not specify whether this applied to unilateral or bilateral reconstructions.
(Partial) flap necrosis
Two studies examined (partial) flap necrosis as an outcome measure. There was a trend towards less (partial) flap necrosis in the group of reconstructions performed after preoperative CTA (Minqiang et al, 2010; Casey et al, 2009).
Abdominal hernia / abdominal weakness and bulge
Two studies examined these outcome measures, and found that patients in the CTA group had significantly fewer complications (Casey et al, 2009, Ghattaura et al, 2010). However, this result was only statistically significant in the study by Casey et al (2009).
Level of evidence of the literature
The level of evidence for the outcome measure operative time is low, as the studies were not randomized in a patient group where multiple factors may have affected operative time, such as the timing of reconstruction (immediate or delayed), the surgical technique used, the expertise and skill of the surgeon, or patient-related factors such as obesity (highly significant limitations in study design).
The level of evidence for the outcome measures (partial) flap necrosis and abdominal weakness and bulge is very low, as the studies were not randomized (highly significant limitations in study design) and the number of complications was low (imprecision).
b) MRA versus HHUS
Schaverien (2011) compared the effects of mapping perforators using MRA to those of perioperative mapping using HHUS in patients with an indication for immediate or delayed autologous breast reconstruction.
Results
Operative time
Operative time was on average 20 minutes shorter if MRA was performed preoperatively; this difference was not statistically significant (Schaverien et al, 2011).
(Partial) flap necrosis Patients who underwent a preoperative MRA had significantly less partial flap necrosis. This reduction was not statistically significant for the outcome measure total flap necrosis.
Level of evidence of the literature
The level of evidence for the outcome measures operative time and (partial) flap necrosis is low, as the study was not randomized (significant limitations in study design) and only one study of limited size examined these outcome measures (imprecision).
c) Color-Duplex US versus HHUS
No comparative studies examined this question.
Zoeken en selecteren
In order to answer the primary question, a systematic literature review was performed for the following question:
What are the effects of preoperative mapping of perforators using Color Duplex US, CTA or MRA compared with perioperative mapping of perforators using HHUS on the occurrence of postoperative complications (partial flap necrosis; total flap necrosis; abdominal hernia) and operative time in patients undergoing autologous breast reconstruction using a DIEP flap?
Search and selection (Method)
Medline (OVID) was searched for studies on preoperative imaging studies in autologous breast reconstructions using a DIEP flap. The search justification is listed in the appendix. The literature search yielded 225 results. Studies that met the following selection criteria were included in the literature summary: original studies; comparative studies; systematic review of comparative studies; comparison of preoperative perforator mapping (Color Duplex US, CTA, MRA) with perioperative perforator mapping (HHUS); N>20; and postoperative complications and operative time as outcome measures.
Five studies were included in the literature analysis: Minqiang et al (2010); Ghattaura et al (2010); Casey et al (2009); Tong et al (2012); Schaverien et al (2011). One comparative study was not included after reading the full text, as this study compared CTA to a mix of 80% preoperative Color Duplex US and HHUS (Rozen (8) et al, 2008).
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.