Evidence-Based Clinical Practice Guideline: Breast Reconstruction with ...

Evidence-Based Clinical Practice Guideline: Breast Reconstruction with Expanders and Implants

INTRODUCTION

The American Cancer Society estimates that nearly 230,000 American women were diagnosed with invasive breast cancer in 2011.1 Many of these individuals will require mastectomy and total reconstruction of the breast. The diagnosis and subsequent process can create significant confusion and distress for the affected persons and their families and, consequently, surgical treatment and reconstructive procedures are of utmost importance in the breast cancer care continuum. In 2011, the American Society of Plastic Surgeons? (ASPS) reported an increase in the rate of breast reconstructions, citing nearly 100,000 procedures, of which the majority employed expanders/implants.2 The 3% increase in reconstructions over the course of just one year highlights the significance of maintaining patient safety and optimizing surgical outcomes.

Rationale and Goals These guidelines were developed from a comprehensive review of the scientific literature and reflect the consensus of the Post-Mastectomy Expander/Implant Breast Reconstruction Guideline Work Group of the American Society of Plastic Surgeons.

Scope These guidelines specifically address the risk factors, treatment, anticipated outcomes, and follow-up of patients undergoing breast reconstruction with expanders/implants for the treatment of cancerous defects. Graded practice recommendations can be found in Appendix A.

Intended Users This guideline is intended to be used by the multidisciplinary team that provides care for patients with breast cancer through the use of breast cancer treatment, mastectomy and breast reconstruction. Healthcare practitioners should evaluate each case individually and treat patient preference as a key role in decision making. This guideline is also intended to serve as a resource for healthcare practitioners and developers of clinical practice guidelines and recommendations.

Disclaimer Evidence-based guidelines are strategies for patient management, developed to assist physicians in clinical decision making. This guideline was developed through a comprehensive review of the scientific literature and consideration of relevant clinical experience, and describes a range of generally acceptable approaches to diagnosis, management, or prevention of specific diseases or conditions. This guideline attempts to define principles of practice that should generally meet the needs of most patients in most circumstances.

However, this guideline should not be construed as a rule, nor should it be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed at obtaining the appropriate results. It is anticipated that it will be necessary to approach some patients' needs in different ways. The ultimate judgment regarding the care of a particular patient must be made by the physician in light of all the circumstances presented by the patient, the available diagnostic and treatment options, and available resources.

This guideline is not intended to define or serve as the standard of medical care. Standards of medical care are determined on the basis of all the facts or circumstances involved in an individual case and are subject to change as scientific knowledge and technology advance and as practice patterns evolve. This guideline reflects the state of current knowledge at the time of publication. Given the inevitable changes in the state of scientific information and technology, this guideline will be reviewed, updated and revised periodically.

Funding Source The Evidence-Based Clinical Practice Guideline on Post-Mastectomy Breast Reconstruction with Expanders and Implants was funded exclusively by the American Society of Plastic Surgeons; no outside commercial funding was received to support the development of this document.

Conflict of Interest All contributors and preparers of the guideline, including ASPS staff and consultants, disclosed all relevant conflicts of interest via an on-line disclosure reporting database. In accordance with the Institute of Medicine's recommendations for guideline development, members with a conflict of interest represented less than half of the Breast Reconstruction Guideline Work Group.3

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Loree Kalliainen, MD, Work Group Advisor, has no relevant disclosures; Amy Alderman, MD, Work Group Chair, has no relevant disclosures; Amy Ahuja, MPH, has no relevant disclosures; Bob Basu, MD, has a Research Support Recipient and Consultant relationship with LifeCell Corporation/KCI; Phillip Blondeel, MD, has no relevant disclosures; Robert Buchanan, MD, has no relevant disclosures; Hiram Cody, III, MD, has no relevant disclosures; Diana Frame, MPH, has no relevant disclosures; Nolan Karp, MD, has a Research Support Recipient relationship with Allergan; Carol Lee, MD, has no relevant disclosures; Valerie Lemaine, MD, has a Grant Recipient relationship with Allergan; Raman Mahabir, MD, has no relevant disclosures; Galen Perdikis, MD, has no relevant disclosures; Neal Reisman, MD, JD, has Consultant Relationships with Allergan and LifeCell Corporation/KCI; Karie Rosolowski, MPH, has no relevant disclosures; Kathryn Ruddy, MD, MPH, has no relevant disclosures; Mark Schusterman, MD, has no relevant disclosures; DeLaine Schmitz, RN, MSHL, has no relevant disclosures; Jaime Schwartz, MD, has no relevant disclosures; Jennifer Swanson, BS, M.Ed., has no relevant disclosures.

METHODOLOGY

Work Group Selection Process ASPS Members were invited to apply to the Work Group via society email and fax communication. All applicants were also required to submit an online conflict of interest disclosure form for membership consideration. Members of the Health Policy Committee reviewed and selected work group members to ensure a diverse representation of United States regions, practice type (large multispecialty group practice, small group practice, solo practice, and academic practice), and clinical, research, and evidence-based medicine experiences and expertise. Three stakeholder organizations, including the American Society of Breast Surgeons, American College of Radiology, and American Society of Clinical Oncology, were also invited to participate in the guideline development process by nominating one member from their respective organizations to serve on the work group.

Clinical Question Development Work Group Members utilized the Nominal Group Technique to reach consensus on the clinical questions to be addressed in the evidence-based guideline. The Nominal Group Technique is ideal for face-to-face meetings and is designed to encourage equal participation in Work Group discussions and project contributions. The Work Group completed five rounds of the consensus process. Before the Introductory Meeting, all Work Group Members submitted ninety-seven potential clinical questions, which were compiled and dispersed at the Introductory Meeting for consideration and discussion.

The clinical questions were ranked according to the following criteria to assess for potential impact: 1) relevance to guideline scope; 2) addresses a gap in care; 3) can be developed into an actionable recommendation; 4) can be developed into an implementable recommendation; 5) is controversial or of significant interest; 6) is important to public health. The Work Group agreed on the

following clinical questions to address in this evidence-based guideline, including:

1. In patients undergoing surgical treatment for breast cancer, what is the optimal time to discuss breast reconstruction options?

2. In patients undergoing mastectomy for the treatment of breast cancer, what is the optimal time for implant-based reconstruction (i.e., immediate versus delayed) when radiation treatment is not required?

3. In patients undergoing mastectomy for the treatment of breast cancer, what is the optimal time for implant-based reconstruction (i.e., immediate versus delayed) when radiation treatment is required?

4. In patients undergoing breast reconstruction following mastectomy, what are the risk factors when undergoing immediate implant-based reconstruction?

5. In patients requiring radiation therapy and undergoing immediate breast reconstruction after mastectomy, when is the optimal time for radiation therapy?

6. In patients undergoing implant-based reconstruction after mastectomy, what is the optimal duration of antibiotic prophylaxis for prevention of postoperative infections?

7. In patients undergoing mastectomy and implant-based breast reconstruction, what are the outcomes associated with utilizing acellular dermal matrix during reconstruction?

8. In patients undergoing mastectomy and implant-based breast reconstruction, what are the screening recommendations to monitor for cancer recurrence?

9. In patients undergoing breast reconstruction following mastectomy, what are the oncologic outcomes associated with undergoing immediate implant-based reconstruction?

The systematic review process yielded relevant evidence for six questions. The questions on radiation therapy were combined based on available evidence. Additionally, three clinical questions were addressed through supplemental research and cumulative work group clinical expertise.

Literature Search and Admission of Evidence Published studies were sought by using electronic and manual search strategies. The primary search, executed from December 2011 to February 2012, was conducted in PubMed with the following keywords, MEDLINE Medical Subject Headings (indicated as [MeSH]), publication types (indicated as [ptyp]), Boolean operators, and limits:

1. (Mammaplasty[MeSH] AND reconstruction) OR "breast reconstruction"

2. Case reports[ptyp] OR Editorial[ptyp] OR Comment[ptyp] OR Letter[ptyp] OR News[ptyp] OR Newspaper article[ptyp] OR In Vitro[ptyp] OR Legal Cases[ptyp] OR Legislation[ptyp]

3. #1 NOT #2; Limits: English, Humans

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Recent studies that may not have been indexed (e.g. publishersupplied and pre-MEDLINE citations) were sought using a keyword search strategy similar to item 1 above, without MeSH terms or limits on publication type, up through the search cut-off date of December 31, 2011. Supplemental electronic searches were performed in the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Cochrane Library. In addition, a manual review of reference lists from the previous two years and studies accepted per the conditions designated for the literature search, supplemented the electronic searches.

Study selection for each clinical question was accomplished through two levels of study screening. Level I screening was performed by a single reviewer and involved a review of the titles and abstracts downloaded from the literature search noted above. At Level II screening, the full article was obtained, and the study was reviewed for fit with inclusion and exclusion criteria as outlined in Appendix B. The reason for exclusion (e.g. no outcomes of interest) was noted for all articles reviewed at Level II that were ultimately found ineligible for inclusion in the guideline. Work Group Members reviewed the list of excluded articles and the reasons for exclusion to determine whether articles should be excluded or reconsidered for inclusion.

Articles were selected for inclusion if they were relevant to clinical questions about risk factors, treatment options, and postoperative complications and if they were deemed high or moderate quality per the critical appraisal process, which is described below. The literature search identified a total of 2,749 articles that were subject to Level I screening, for a total of 295 remaining articles. After Level II screening and critical appraisal, the results were narrowed to 178 articles, of which ultimately 62 studies were deemed relevant and of high to moderate quality. These studies were used to develop practice recommendations. Additional references were included if considered

necessary for discussion; however, these references were not critically appraised and are clearly documented in the guideline text. Details of literature search terms and search results are provided in Appendix B.

Critical Appraisal of the Literature The ASPS evidence-based process includes a rigorous critical appraisal process. Each study is appraised by at least two reviewers. If a discrepancy exists between the reviewers, the literature is appraised by a third reviewer, and the level of evidence is determined by consensus. Studies are appraised and assigned levels of evidence according to the ASPS Evidence Rating Scales for therapy, risk, and diagnosis, which can be can be found in Appendix C. Checklists appropriate for the clinical question (therapy, prognosis/risk, or diagnosis) and study design (randomized controlled trial, cohort/comparative, casecontrol, etc) are employed. The checklists used by ASPS are similar to commonly used appraisal tools, (e.g., checklists developed by the Critical Appraisal Skills Programme (CASP) and the Centre for Evidence Based Medicine (CEBM)). Evidence ratings are not assigned to studies with inadequately described methods and/or worrisome biases.

Development of Clinical Practice Recommendations Recommendations were developed through a consensus process. After a thorough review of the evidence, Guideline Work Group Members jointly drafted statements for each recommendation during conference call meetings and online discussions. After each meeting, members had an opportunity to individually comment and revise the draft recommendations via an email discussion. Guideline Work Group Members participated in several rounds of revisions until unanimous consensus was achieved on each recommendation statement. Each recommendation in this guideline is accompanied by a grade indicating the strength of supporting evidence, taking into account the overall level of evidence and the judgment of the guideline developers. Grading is determined as follows:

Grade

Descriptor

A Strong Recommendation

B Recommendation

C Option

D Option

Qualifying Evidence

Implications for Practice

Level I evidence or consistent findings from multiple studies of levels II, III, or IV

Levels II, III, or IV evidence and findings are generally consistent

Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.

Generally, clinicians should follow a recommendation but should remain alert to new information and sensitive to patient preferences.

Levels II, III, or IV evidence, but findings are inconsistent

Clinicians should be flexible in their decision-making regarding appropriate practice, although they may set bounds on alternatives; patient preference should have a substantial influencing role.

Level V: Little or no systematic empirical evidence

Clinicians should consider all options in their decision-making and be alert to new published evidence that clarifies the balance of benefit versus harm; patient preference should have a substantial influencing role.

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Peer Reviewer Process The American Society for Therapeutic Radiology and Oncology (ASTRO) and The National Accreditation Program for Breast Centers (NAPBC) were invited to peer review this guideline. In addition, a total of 30 physicians and surgeons were invited to peer review the guideline. Peer review was also performed by volunteers from the ASPS Healthy Policy, Patient Safety, Coding and Payment Policy, and Quality and Performance Measurement Committees. Peer reviewers were given two weeks to review this guideline using an abbreviated version of the Appraisal of Guidelines Research & Evaluation Instrument developed by the AGREE Collaboration.

Guideline Approval Process After the peer review process, the guideline draft was reviewed and modified by the Post-Mastectomy Expander/Implant Breast Reconstruction Guideline Work Group to address peer review comments. The final guideline was approved by the ASPS Executive Committee during its March 2013 meeting.

Plan for Updating Guideline In accordance with the National Guideline Clearinghouse's inclusion criteria, this guideline will be updated within five years to reflect changes in scientific evidence, practice parameters, and treatment options.

BACKGROUND

Definitions ? Immediate breast reconstruction is defined as: A breast reconstruction procedure performed at the time of the mastectomy. ? Delayed breast reconstruction is defined as: A breast reconstruction procedure performed any time after the mastectomy. ? Acellular dermal matrix is defined as: A dermal graft used primarily to provide support and/or additional soft tissue coverage with expander/implant breast reconstruction.

Diagnostic Criteria The patient usually presents to the plastic surgeon's office with a history of prior diagnosis and/or treatment for breast cancer. Patients who have had breast cancer may have had only a biopsy of the mass, a lumpectomy, or a simple mastectomy (alone or with axillary lymph node sampling or removal). Any of these surgical treatments may have been supplemented with radiation treatment to the breast and/or regional lymph nodes. Other cancer related treatments may include a modified radical mastectomy, chemotherapy and/or radiation, which may have an effect on the reconstructive site.

Physical Examination Physical examination of the breast defect should include documentation of the size and configuration of the missing tissue. The presence of scarring and radiation changes and the condition of the pectoralis major muscle, nipple areola complex, and the contralateral breast should also be noted.

RECOMMENDATIONS

Considerations for Surgical Planning Patient Education The systematic literature search process did not retrieve any studies meeting inclusion criteria. Consequently, other widely accepted sources contributed to the creation of an expert clinical opinion for best practice.

While existing federal law through the 1998 Women's Health and Cancer Rights Act mandates insurance coverage for reconstructive surgery, there are limited additional mandated provisions that ensure women have the necessary information to be able to make an informed decision about their reconstructive options. In 2005, the American College of Surgeons created the National Accreditation Program for Breast Centers (NAPBC), which is a consortium of national and professional organizations that have developed standards for breast cancer care. Section 2.18 of the Standards for accreditation specifies that all appropriate patients undergoing mastectomy be offered a preoperative referral to a board certified reconstructive/plastic surgeon.4 Despite this standard being applied at many breast centers throughout North America, disparities in access to reconstructive surgery remain.5-8 Key national studies conducted at the University of Michigan and Dana Farber Cancer Institute have analyzed why many women did not receive reconstruction. They found that the two main limiting factors were the patient's ability to understand their options and breast surgeons' failures to refer their patients to a reconstructive surgeon.7, 9 In response, New York enacted a law known as the Information and Access to Breast Reconstruction Surgery Act, that went one step further to ensure that patients were made aware of their options and coverage for breast reconstruction. This law mandates that hospitals providing mastectomy or lumpectomy surgery must provide the patient written information on breast reconstruction prior to obtaining consent for oncologic surgery. The law also details the minimum amount of information that must be provided including: a description of the various reconstructive options and the advantages and disadvantages of each, information assuring the coverage by both public and private insurance plans, instructions on how a patient may access reconstructive care including the potential transfer of care to a facility that provides reconstructive care and any other information as may be required by the commissioner.10 Following suit, New Mexico and California also enacted similar patient-communication measures. Additionally, in 2012, a bipartisan effort led to the introduction of the Breast Cancer Education Act in the US House of Representatives. The bill would require the Department of Health and Human Services to plan and implement an education campaign to inform mastectomy patients of breast reconstruction availability and coverage, and of prostheses and other replacement options.11 In the ideal situation, the patient would meet with both the oncology and reconstructive surgeon at the same time. Realistically, given time constraints and scheduling conflicts of both parties, as long as the above requirements are met, the patient will be able to make an informed decision.

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Recommendation: Patients undergoing mastectomy should be offered a preoperative referral to a plastic surgeon. The adoption of this approach by practicing surgeons would benefit breast cancer patients nationwide and would result in enhanced patient education of reconstructive options. Recommendation Grade: D

Immediate versus Delayed Reconstruction The decision to start reconstruction at the time of the mastectomy should consider the psychosocial benefits to the patient of expediting the reconstructive process balanced by the potential increased surgical risk of starting reconstruction prior to the completion of adjuvant therapy. Beginning the reconstructive process at the time of the mastectomy has the advantage of preserving the skin envelope and shape, as well as maintaining the inframammary fold definition. Immediate reconstructions have the potential to help patients more quickly recover from the psychological impact of the breast amputation and can result in a smaller burden on patients' work or home life as fewer operations are required to reconstruct their breasts.

Commonly, the decision for immediate versus delayed reconstruction hinges on whether post-mastectomy radiation is indicated. Although studies comparing immediate versus delayed reconstruction and radiation therapy versus no radiation therapy have been published, randomized control trial data is not available. In one case series, logistic regression analysis identified timing of reconstruction to be an independent risk factor for postoperative complications, with a higher complication rate among those with immediate procedures.12 Likewise, a retrospective cohort study found that patients who received immediate breast reconstruction were twice as likely to experience a postoperative complication compared with those who received delayed breast reconstruction (odds ratio 2.06 [95% CI 1.21-3.52]; p=0.008). In addition, patients who received immediate breast reconstruction were 5.2 times more likely to have a Baker Grade II, III, or IV capsular contracture compared to patients who received delayed breast reconstruction (p ................
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