CME

ASPS Clinical Practice Guideline Summary on Reconstruction with Expanders and Implants

Amy Alderman, M.D., M.P.H. Learning Objectives: After reading this article, participants should be able to: Karol Gutowski, M.D. 1. Understand the evidence regarding the timing of expander/ breast re- Amy Ahuja, M.P.H. construction in the setting of . 2. Discuss the implications of a Diedra Gray, M.P.H. patient’s risk factors for possible outcomes and complications of expander/implant Postmastectomy . 3. Implement proper prophylactic antibiotic protocols. 4. Use Expander/Implant Breast the guidelines to improve their own clinical outcomes and reduce complications. Reconstruction Guideline Summary: In March of 2013, the Executive Committee of the American Society Work Group of Plastic Surgeons approved an evidence-based guideline on breast reconstruc- Arlington Heights, Ill. tion with expanders and implants, as developed by a guideline-specific work group commissioned by the society’s Health Policy Committee. The guideline addresses ten clinical questions: patient education, immediate versus delayed reconstruction, risk factors, radiation therapy, chemotherapy, hormonal therapy, antibiotic prophylaxis, acellular dermal matrix, monitoring for recur- rence, and oncologic outcomes associated with implant-based reconstruction. The evidence indicates that patients undergoing should be offered a preoperative referral to a plastic surgeon. Evidence varies regarding the as- sociation between postoperative complications and timing of postmastectomy expander/implant breast reconstruction. Evidence is limited regarding the opti- mal timing of expand/implant reconstruction in the setting of radiation therapy but suggests that irradiation to the expander or implant is associated with an increased risk of postoperative complications. Evidence also varies regarding the association between acellular dermal matrix and surgical complications in the setting of postmastectomy expander/implant reconstruction. Data support the use of an appropriate preoperative antibiotic, but antibiotics should be dis- continued within 24 hours of the procedure, unless a surgical drain is present. Furthermore, postmastectomy expander/implant breast reconstruction does not adversely affect oncologic outcomes. (Plast. Reconstr. Surg. 134: 648e, 2014.)

he American Cancer Society estimates that decision-making process can be overwhelming for nearly 230,000 American women are diag- patients. The American Society of Plastic Surgeons nosed annually with invasive breast can- (ASPS) is committed to providing decision sup- T1 cer. Many women will undergo a mastectomy port, access to reconstruction, and quality care for and therefore have the option of breast recon- all patients. Fortunately, through advocacy efforts, struction. The cancer diagnosis and treatment the ASPS has reported a 3 percent increase in the use of breast reconstruction in just 1 year, with From the American Society of Plastic Surgeons. nearly 100,000 procedures performed in 2011, Received for publication October 4, 2013; accepted Novem- and the majority of these procedures involve a ber 8, 2013. tissue expander and implant.2 The increased use A complete list of the guideline authors is as follows: Amy Al- derman, M.D., M.P.H.; Loree Kalliainen, M.D.; Amy Ahuja, M.P.H.; Bob Basu, M.D.; Phillip Blondeel, M.D.; Hiram Cody Disclosure: Dr. Basu has a research support re- III, M.D.; Diana Frame, M.P.H.; Nolan Karp, M.D.; Carol cipient and consultant relationship with LifeCell Lee, M.D.; Valerie Lemaine, M.D., M.P.H.; Raman Mahabir, Corp.; Dr. Karp has a research support recipient re- M.D.; Galen Perdikis, M.D.; Neal Reisman, M.D., J.D.; Karie lationship with Allergan, Inc.; Dr. Lemaine has a Rosolowski, M.P.H.; Kathryn Ruddy, M.D., M.P.H.; Mark grant recipient relationship with Allergan, Inc.; Dr. Schusterman, M.D.; DeLaine Schmitz, R.N., M.S.H.L.; Jaime Schwartz has a consultant relationship with Mentor Schwartz, M.D.; and Jennifer Swanson, B.S., M.Ed. Worldwide, LLC, and Covidien. None of the other Copyright © 2014 by the American Society of Plastic Surgeons authors has any relevant disclosures. DOI: 10.1097/PRS.0000000000000541

648e www.PRSJournal.com 6OLUME .UMBERs"REAST2ECONSTRUCTION'UIDELINE of postmastectomy breast reconstruction over the GUIDELINE DEVELOPMENT PROCESS course of just 1 year highlights the significance of The ASPS evidence-based clinical practice maintaining patient safety and optimizing surgical guidelines are developed using an objective, outcomes. transparent approach, to minimize bias. A pro- Breast reconstruction is a common consider- spective systematic review of the current litera- ation for patients undergoing mas- ture on breast reconstruction with expanders and tectomy. Breast reconstruction can be performed implants was completed. A complete summary of in an immediate or delayed setting using a vari- the methods used to conduct the systematic review ety of techniques, including an implant-based and complete the critical appraisal process for the approach or an autologous tissue technique. A guideline can be found at: http://www.plastic- significant number of implant-based breast recon- .org/Documents/medical-professionals/ struction procedures are two-stage processes, health-policy/evidence-practice/breast-recon- involving the insertion of a tissue expander. Once struction-expanders-with-implants-guidelines.pdf. the expansion process is complete, the final Committee Composition implant can be placed, using either a - or silicone gel–filled device. The guideline work group was chaired by Amy Alderman, M.D., M.P.H., as selected by the ASPS Health Policy Committee. The Health Policy Com- DISCLAIMER mittee also selected additional work group mem- Evidence-based guidelines are strategies for bers after a thorough review of applicants. The patient management, developed to assist physi- work group composition was a diverse represen- cians in clinical decision making. This guideline tation of U.S. regions; practice type; and clinical, was developed through a comprehensive review of research, and evidence-based medicine experi- the scientific literature and consideration of rel- ence and expertise. Three stakeholder organiza- evant clinical experience, and describes a range tions, including the American Society of Breast of generally acceptable approaches to diagnosis, Surgeons, the American College of , and management, or prevention of specific diseases the American Society of Clinical Oncology, were or conditions. This guideline attempts to define also invited to participate in the guideline devel- opment process, which was facilitated by ASPS principles of practice that should generally meet staff. All workgroup members declared potential the needs of most patients in most circumstances. conflicts of interest, and these were present in a However, this guideline should not be con- minority of workgroup members, consistent with strued as a rule, nor should it be deemed inclusive the Institute of Medicine’s recommendations for of all proper methods of care or exclusive of other guideline development.3 methods of care reasonably directed at obtaining the appropriate results. It is anticipated that it will be necessary to approach some patients’ needs in LITERATURE SEARCH different ways. The ultimate judgment regarding A comprehensive search of PubMed, the the care of a particular patient must be made by Cumulative Index to Nursing and Allied Health the physician in light of all the circumstances pre- Literature, and the Cochrane Library was per- sented by the patient, the available diagnostic and formed by a guideline development methodolo- gist using various combinations of the following treatment options, and available resources. search terms: “ AND reconstruction” This guideline is not intended to define or OR “breast reconstruction,” and a wide range of serve as the standard of medical care. Standards MeSH indexing terms. The initial search identi- of medical care are determined on the basis of fied a total of 2749 articles that were subject to all the facts or circumstances involved in an indi- Level I screening, which were then narrowed to 62 vidual case and are subject to change as scientific studies, deemed relevant and of high to moderate knowledge and advance and as prac- quality (Table 1). These studies were evaluated by tice patterns evolve. This guideline reflects the means of the ASPS critical appraisal process and state of current knowledge at the time of publi- were used to develop practice recommendations. cation. Given the inevitable changes in the state Recommendations were developed through a of scientific information and technology, this consensus process. After a thorough review of the guideline will be reviewed, updated, and revised evidence, Guideline Work Group members jointly periodically. drafted statements for each recommendation

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Table 1. ASPS Scale for Grading Recommendations Grade Descriptor Qualifying Evidence Implications for Practice A Strong recommendation Level I evidence or consistent Clinicians should follow a strong recommendation findings from multiple unless a clear and compelling rationale for an studies of levels II, III, or IV alternative approach is present. B Recommendation Levels II, III, or IV evidence Generally, clinicians should follow a recommendation and findings are generally but should remain alert to new information and consistent sensitive to patient preferences. C Option Levels II, III, or IV evidence, Clinicians should be flexible in their decision-making but findings are inconsistent regarding appropriate practice, although they may set bounds on alternatives; patient preference should have a substantial influencing role. D Option Level V: Little or no systematic Clinicians should consider all options in their decision- empirical evidence making and be alert to new published evidence that clarifies the balance of benefit versus harm; patient preference should have a substantial influencing role. during conference call meetings and online dis- Recommendation cussions. After each meeting, members had an Evidence is varied and conflicting on the asso- opportunity to individually comment and revise ciation between postoperative complications and the draft recommendations by means of an e-mail the timing of postmastectomy expander/implant discussion. Guideline Work Group members breast reconstruction and is often confounded participated in several rounds of revisions until by the use of radiation therapy. The inconsistent unanimous consensus was achieved on each rec- research findings and a lack of definitive evi- ommendation statement. Each recommendation dence should alert physicians to evaluate each in this guideline is accompanied by a grade indi- case individually12–17 (Level II, III, IV Evidence: cating the strength of supporting evidence, taking Grade C). into account the overall level of evidence and the judgment of the guideline developers. Clinical Question: Risk Factors [Smoking, , Breast Size, , Radiation Therapy CLINICAL QUESTIONS AND (Overview, Previous Radiation Therapy, Radiation RECOMMENDATIONS Therapy to Expander, Radiation Therapy to Implant, Optimal Timing of Radiation Therapy Clinical Question: Patient Education and Reconstruction, Overall), Chemotherapy, In patients undergoing surgical treatment for breast Hormonal Therapy] cancer, what is the optimal time to discuss breast recon- In patients undergoing breast reconstruction follow- struction options? ing mastectomy, what are the risk factors when undergo- ing immediate implant-based reconstruction? Recommendation Patients undergoing mastectomy should be Recommendations offered a preoperative referral to a plastic sur- Smoking geon. The adoption of this approach by practic- Smoking is associated with an increased ing surgeons would benefit breast cancer patients risk of complications and an increased risk of nationwide and would result in enhanced patient reconstructive failure in patients undergoing education of reconstructive options4–11 (Grade D). postmastectomy expander/implant breast recon- struction. Patients should be informed of the Clinical Question: Immediate versus Delayed increased risks and advised on smoking cessation Reconstruction as a means of preventing surgical complications. In patients undergoing mastectomy for the treatment In addition, it should be recognized that the of breast cancer, what is the optimal time for implant- necessity to proceed with surgery may preclude based reconstruction (i.e., immediate versus delayed) timely smoking cessation14,16,18–24 (Level II, III, IV when radiation treatment is not required? Evidence: Grade A). In patients undergoing mastectomy for the treatment Obesity of breast cancer, what is the optimal time for implant- A body mass index of 25 or greater is associated based reconstruction (i.e., immediate versus delayed) with an increased risk of postoperative complica- when radiation treatment is required? tions and reconstructive failure among patients

650e 6OLUME .UMBERs"REAST2ECONSTRUCTION'UIDELINE undergoing postmastectomy expander/implant with an increased risk of complications and/ breast reconstruction. These risks are even higher or reconstructive failure in patients undergoing among patients with a body mass index greater postmastectomy expander/implant breast recon- than 30. Obese patients should be informed of struction. Patients should be counseled regarding their increased surgical risks with expander/ associated complications12,14,16–18,21,26,29–47 (Level II, implant reconstructions and advised on practical III, IV Evidence: Grade B). weight loss solutions. In addition, it should be rec- ognized that the necessity to proceed with surgery Chemotherapy: Recommendation may preclude timely weight management14,20–22,24–27 Preoperative chemotherapy does not appear (Level III, IV Evidence: Grade A). to be a significant risk factor for either postopera- Breast Size tive complications or implant failure in patients Preoperative breast size (specifically, C or undergoing postmastectomy expander/implants larger) may be associated with an increased risk of breast reconstruction17,21,23,36,48–51 (Level II, III, IV and an increased risk of reconstruc- Evidence: Grade C). tive failure in patients undergoing expander/ implant postmastectomy breast reconstruction. Hormonal Therapy: Recommendation However, much of the currently available evidence Hormonal therapy may increase the risk of does not control for body mass index, which is postoperative complications and reconstruction associated with both preoperative breast size and failure in patients undergoing postmastectomy complication rates. Given the limited evidence expander/implant breast reconstruction. How- and contradictory literature, physicians should be ever, inconsistent research findings and a lack 14,23,27,28 aware of this potential complicating factor of definitive evidence should alert physicians to (Level III, IV Evidence: Grade D). evaluate each case individually16,23 (Level II, IV Diabetes Evidence: Grade D). There is no evidence to indicate that diabetes is a significant independent risk factor for the develop- Clinical Question: Antibiotic Prophylaxis ment of either postoperative complications or recon- structive failure in patients undergoing expander/ In patients undergoing implant-based reconstruc- implant postmastectomy breast reconstruction. tion after mastectomy, what is the optimal duration of However, this information should not deter sur- antibiotic prophylaxis for prevention of postoperative geons from continuing to practice glycemic control infections? in the perioperative period for breast cancer patie Recommendation 14,16,18,21,26 nts (Level II, III, IV Evidence: Grade B). Patients undergoing postmastectomy ex pander/implant breast reconstruction should Clinical Question: Radiation Therapy to receive a preoperative dose of an appropriate Expander intravenous antibiotic initiated 60 minutes or less In patients undergoing mastectomy and radiation from the time of incision (within 2 hours for anti- therapy for the treatment of breast cancer, does radiation therapy to the expander affect surgical outcomes? biotics with longer infusion times). Unless a drain is present, antibiotics should be discontinued Clinical Question: Radiation Therapy to Implant within 24 hours of the completion of the proce- In patients undergoing mastectomy and radiation dure. If a drain is present, the role of antibiotics therapy for the treatment of breast cancer, does radiation is less clear and should be left to physician prefer- therapy to the implant affect surgical outcomes? ence. Of note, documenting a drain in proxim- ity to the implant as a reason for continuation of Clinical Question: Optimal Timing of Radiation intravenous antibiotics beyond the 24-hour post- Therapy and Reconstruction operative period or switching to postoperative In patients requiring radiation therapy and under- antibiotics within 24 hours of procedure com- going immediate breast reconstruction after mastectomy, pletion is compliant with current Surgical Care when is the optimal time for radiation therapy? Improvement Project guidelines. Presently, there Radiation Therapy, Overall: is limited evidence on postoperative antibiotic Recommendation prophylaxis. Overall, surgeons should adhere to Evidence indicates that radiation therapy, their specific state and hospital guidelines on anti- regardless of when it is administered, is associated biotic administration52–55 (Grade D).

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Clinical Question: Acellular Dermal Matrix promote evidence-based clinical practice and In patients undergoing mastectomy and implant- to improve the quality of care for breast cancer based breast reconstruction, what are the outcomes patients. The recommendations address the risk associated with using acellular dermal matrix during factors, treatment, anticipated outcomes, and fol- reconstruction? low-up of patients undergoing breast reconstruc- tion with expanders/implants for the treatment Recommendation of mastectomy defects. The recommendations Evidence on acellular dermal matrix in post- are linked to improvements in health outcomes mastectomy expander/implant breast reconstruc- to improve the quality of care delivered to the tion is varied and conflicting. Surgeons should breast cancer population. The full guideline, evaluate each clinical case individually and objec- including the development methodology, opera- tively determine the use of acellular dermal mat- 20,25,28,33,56–60 tive procedure, evidence summaries, and coding rix (Level III Evidence: Grade C). recommendations, can be accessed at http:// www.plasticsurgery.org/Documents/medical- Clinical Question: Monitoring for Cancer professionals/health-policy/evidence-practice/ Recurrence breast-reconstruction-expanders-with-implants- In patients undergoing mastectomy and implant- guidelines.pdf. based reconstruction, what are the screening recommen- dations to monitor for cancer recurrence? Amy Alderman, M.D., M.P.H. 444 East Algonquin Road Recommendation Arlington Heights, Ill. 60005-4664 Clinical examination is sufficient to detect local cancer recurrence in patients undergoing expander/implant postmastectomy breast recon- REFERENCES struction. Imaging studies are not required as part 1. American Cancer Society. Breast cancer facts & figures 2011– of routine surveillance. On the basis of clinical 2012. Available at: http://www.cancer.org/cancer/breast- suspicion, imaging studies can be used for clini- cancer/detailedguide/breast-cancer-key-statistics. Accessed August 12, 2014. cal indications on a case-by-case basis. Diagnostic 2. American Society of Plastic Surgeons. 2011 reconstructive imaging is indicated if there is any clinical evi- statistics. Available at: http://www.plasticsurgery. dence of recurrence61–63 (Grade D). org/news/plastic-surgery-statistics/2011-plastic-surgery- statistics.html. Accessed August 12, 2014. Clinical Question: Effect of Implant-Based 3. Institute of Medicine of the National Academies. Clinical practice guidelines we can trust. Available at: http://www. Reconstruction on Oncologic Outcomes iom.edu/Reports/2011/Clinical-Practice-Guidelines-We- In patients undergoing breast reconstruction Can-Trust.aspx. Accessed August 12, 2014. following mastectomy, what are the oncologic outcomes 4. National Accreditation Program for Breast Centers. NAPBC associated with undergoing immediate implant-based standards. Available at: http://napbc-breast.org/standards/ reconstruction? standards.html. Accessed August 12, 2014. 5. Alderman AK, McMahon L, Wilkins EG. The national utiliza- Recommendation tion of immediate and early delayed breast reconstruction Postmastectomy expander/implant breast and the impact of sociodemographic factors. Plast Reconstr Surg. 2003;11:695–703; discussion 704–705. reconstruction does not adversely affect oncologic 6. Alderman AK, Wei Y, Birkmeyer JD. Use of breast reconstruc- outcomes. The need for postmastectomy radiation tion after mastectomy following the Women’s Health and therapy is often, but not always, apparent before Cancer Rights Act. JAMA 2006;295:387–388. surgery; accordingly, decisions regarding the 7. Alderman AK, Hawley ST, Janz NK, et al. Racial/ethnic sequencing of postmastectomy breast reconstruc- disparities in the use of post-mastectomy breast reconstruc- tion: Results from a population-based study. J Clin Oncol. tion and radiation therapy are best made by a multi- 2009;27:5325–5330. disciplinary team including the oncologic surgeon, 8. Katz SJ, Hawley ST, Abrahamse P, et al. Does it matter where plastic surgeon, medical oncologist, and radiation you go for ? Attending surgeon’s influence on oncologist64–70 (Level III Evidence: Grade B). variation in receipt of mastectomy for breast cancer. Med Care 2010;48:892–899. 9. Alderman AK, Hawley ST, Waljee J, Mujahid M, Morrow M, CONCLUSIONS Katz SJ. Understanding the impact of breast reconstruction Currently in the United States, expander/ on the surgical decision-making process for breast cancer. Cancer 2008;112:489–494. implant reconstruction is the most commonly 10. N.Y. Pub Health Law §2803-0. performed technique for postmastectomy breast 11. Breast Cancer Patient Education Act of 2012, JR 5937, 112th reconstruction.71 This guideline is designed to Cong, 2nd Sess (2012).

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APPENDIX A. ASPS EVIDENCE RATING AND GRADES OF RECOMMENDATION SCALES

Evidence Rating Scale for Therapeutic Studies Level of Evidence Qualifying Studies I High-quality, multicenter or single-center, randomized controlled trial with adequate power; or systematic review of these studies II Lesser-quality, randomized controlled trial; prospective cohort or comparative study; or systematic review of these studies III Retrospective cohort or comparative study; case-control study; or systematic review of these studies IV Case series with pre/post test; or only post test V Expert opinion developed by means of consensus process; case report or clinical example; or evidence based on physiology, bench research or “first principles”

Evidence Rating Scale for Diagnostic Studies Level of Evidence Qualifying Studies I High-quality, multicenter or single-center, cohort study validating a diagnostic test (with “gold” standard as refer- ence) in a series of consecutive patients; or a systematic review of these studies II Exploratory cohort study developing diagnostic criteria (with “gold” standard as reference) in a series of consecu- tive patient; or a systematic review of these studies III Diagnostic study in nonconsecutive patients (without consistently applied “gold” standard as reference); or a systematic review of these studies IV Case-control study; or any of the above diagnostic studies in the absence of a universally accepted “gold” standard V Expert opinion developed by means of consensus process; case report or clinical example; or evidence based on physiology, bench research or “first principles”

Evidence Rating Scale for Prognostic/Risk Studies Level of Evidence Qualifying Studies I High-quality, multicenter or single-center, prospective cohort or comparative study with adequate power; or a systematic review of these studies II Lesser-quality prospective cohort or comparative study; retrospective cohort or comparative study; untreated con- trols from a randomized controlled trial; or a systematic review of these studies III Case-control study; or systematic review of these studies IV Case series with pre/post test; or only post test V Expert opinion developed by means of consensus process; case report or clinical example; or evidence based on physiology, bench research or “first principles”

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