Breast Reconstruction After Mastectomy: A Systematic Review and Meta ...

Comparative Effectiveness Review Number 245

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Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis

Comparative Effectiveness Review

Number 245

Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis

Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857

Contract No. 75Q80120D00001

Prepared by: Brown Evidence-based Practice Center Providence, RI

Investigators: Ian J. Saldanha, M.B.B.S., M.P.H., Ph.D. Wangnan Cao, Ph.D. Justin M. Broyles, M.D. Gaelen P. Adam, M.L.I.S., M.P.H. Monika Reddy Bhuma, B.D.S., M.P.H. Shivani Mehta, M.P.H. Laura S. Dominici, M.D. Andrea L. Pusic, M.D. Ethan M. Balk, M.D., M.P.H.

AHRQ Publication No. 21-EHC027 July 2021

This report is based on research conducted by the Brown Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 75Q80120D00001). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

The information in this report is intended to help healthcare decision makers--patients and clinicians, health system leaders, and policymakers, among others--make well-informed decisions and thereby improve the quality of healthcare services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.

AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.

AHRQ appreciates appropriate acknowledgment and citation of its work. Suggested language for acknowledgment: This work was based on an evidence report, Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis, by the Evidence-based Practice Center Program at the Agency for Healthcare Research and Quality (AHRQ).

Suggested citation: Saldanha IJ, Cao W, Broyles JM, Adam GP, Bhuma MR, Mehta S, Dominici LS, Pusic AL, Balk EM. Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis. Comparative Effectiveness Review No. 245. (Prepared by the Brown Evidence-based Practice Center under Contract No. 75Q80120D00001.) AHRQ Publication No. 21-EHC027. Rockville, MD: Agency for Healthcare Research and Quality; July 2021. DOI: . Posted final reports are located on the Effective Health Care Program search page.

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Preface

The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of healthcare in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new healthcare technologies and strategies.

Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews can help clarify whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about AHRQ EPC systematic reviews, see .

AHRQ expects that these systematic reviews will be helpful to health plans, providers, purchasers, government programs, and the healthcare system as a whole. Transparency and stakeholder input are essential to the Effective Health Care Program. Please visit the website (effectivehealthcare.) to see draft research questions and reports or to join an email list to learn about new program products and opportunities for input.

If you have comments on this systematic review, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to epc@ahrq..

David Meyers, M.D. Acting Director Agency for Healthcare Research and Quality

Arlene S. Bierman, M.D., M.S. Director Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality

Christine Chang, M.D., M.P.H. Acting Director Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality

Jill Huppert, M.D., M.P.H. Task Order Officer Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality

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Acknowledgments

The authors gratefully acknowledge the following individuals for their contributions to this project: Associate Editor Timothy Wilt, M.D., M.P.H., from the Minnesota Evidence-based Practice Center, Minneapolis, MN; Task Order Officer Jill Huppert, M.D., M.P.H., from AHRQ; and Acting EPC Program Director Christine Chang, M.D., M.P.H., from AHRQ.

Key Informants

In designing the study questions, the EPC consulted several Key Informants who represent the end-users of research. The EPC sought the Key Informant input on the priority areas for research and synthesis. Key Informants are not involved in the analysis of the evidence or the writing of the report. Therefore, in the end, study questions, design, methodological approaches, and/or conclusions do not necessarily represent the views of individual Key Informants.

Key Informants must disclose any financial conflicts of interest greater than $5,000 and any other relevant business or professional conflicts of interest. Because of their role as end-users, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any conflicts of interest.

The list of Key Informants who provided input to this report follows:

Binita Ashar, M.D. Center for Devices and Radiological Health Food and Drug Administration Silver Spring, MD

Katelyn Donnelly, M.P.H. American Society of Plastic Surgeons The Plastic Surgery Foundation Arlington Heights, IL

Phyllis Greenberger, M.S.W. HealthyWomen Middletown, NJ

Priscilla McAuliffe, M.D., Ph.D. Department of Surgery University of Pittsburgh School of Medicine Pittsburgh, PA

Terence Myckatyn, M.D. Department of Surgery Washington University School of Medicine in St. Louis St. Louis, MO

Anne Taylor, M.D. Aesthetica Surgery & Spa Worthington, OH

Myelin Torres, M.D. * Department of Radiation Oncology Emory University School of Medicine Atlanta, GA

*Also provided input on Draft Report. Also a Technical Expert Panel member.

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Technical Expert Panel

In designing the study questions and methodology at the outset of this report, the EPC consulted several technical and content experts. Broad expertise and perspectives were sought. Divergent and conflicted opinions are common and perceived as healthy scientific discourse that results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design, methodologic approaches, and/or conclusions do not necessarily represent the views of individual technical and content experts.

Technical Experts must disclose any financial conflicts of interest greater than $5,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified.

The list of Technical Experts who provided input to this report follows:

Michele Manahan, M.D. Department of Plastic and Reconstructive Surgery Johns Hopkins University School of Medicine Baltimore, MD

Steven Nagel, M.D.* Center for Devices and Radiological Health Food and Drug Administration Silver Spring, MD

Edwin Wilkins, M.D. Department of Plastic Surgery University of Michigan School of Medicine Ann Arbor, MI

Sung Yoon, M.D.* Center for Devices and Radiological Health Food and Drug Administration Silver Spring, MD

William Sikov, M.D.* Department of Medicine Warren Alpert Medical School of Brown University Providence, RI

*Also provided input on Draft Report.

Peer Reviewers

Prior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report do not necessarily represent the views of individual reviewers.

Peer Reviewers must disclose any financial conflicts of interest greater than $5,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential nonfinancial conflicts may be retained. The TOO

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and the EPC work to balance, manage, or mitigate any potential nonfinancial conflicts of interest identified.

The list of Peer Reviewers follows:

Melissa Camp, M.D., M.P.H. Department of Surgery Johns Hopkins University School of Medicine Baltimore, MD

Kilian Salerno, M.D. Radiation Oncology Branch, Center for Cancer Research National Cancer Institute Bethesda, MD

Olivia Ho, M.D., M.S. Department of Plastic and Reconstructive Surgery Mayo Clinic Rochester, MN

Sameer Nath, M.D. Department of Radiation Oncology University of Colorado Anschutz Medical Campus Aurora, CO

Jean Wright, M.D. Department of Radiation Oncology and Molecular Radiation Sciences Johns Hopkins University School of Medicine Baltimore, MD

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Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis

Structured Abstract

Objectives. This systematic review evaluates breast reconstruction options for women after mastectomy for breast cancer (or breast cancer prophylaxis). We addressed six Key Questions (KQs): (1) implant-based reconstruction (IBR) versus autologous reconstruction (AR), (2) timing of IBR and AR in relation to chemotherapy and radiation therapy, (3) comparisons of implant materials, (4) comparisons of anatomic planes for IBR, (5) use versus nonuse of human acellular dermal matrices (ADMs) during IBR, and (6) comparisons of AR flap types.

Data sources and review methods. We searched Medline?, Embase?, Cochrane CENTRAL, CINAHL?, and from inception to March 23, 2021, to identify comparative and single group studies. We extracted study data into the Systematic Review Data Repository Plus (SRDR+). We assessed the risk of bias and evaluated the strength of evidence (SoE) using standard methods. The protocol was registered in PROSPERO (registration number CRD42020193183).

Results. We found 8 randomized controlled trials, 83 nonrandomized comparative studies, and 69 single group studies. Risk of bias was moderate to high for most studies. KQ1: Compared with IBR, AR is probably associated with clinically better patient satisfaction with breasts and sexual well-being but comparable general quality of life and psychosocial well-being (moderate SoE, all outcomes). AR probably poses a greater risk of deep vein thrombosis or pulmonary embolism (moderate SoE), but IBR probably poses a greater risk of reconstructive failure in the long term (1.5 to 4 years) (moderate SoE) and may pose a greater risk of breast seroma (low SoE). KQ 2: Conducting IBR either before or after radiation therapy may result in comparable physical well-being, psychosocial well-being, sexual well-being, and patient satisfaction with breasts (all low SoE), and probably results in comparable risks of implant failure/loss or need for explant surgery (moderate SoE). We found no evidence addressing timing of IBR or AR in relation to chemotherapy or timing of AR in relation to radiation therapy. KQ 3: Silicone and saline implants may result in clinically comparable patient satisfaction with breasts (low SoE). There is insufficient evidence regarding double lumen implants. KQ 4: Whether the implant is placed in the prepectoral or total submuscular plane may not be associated with risk of infections that are not explicitly implant related (low SoE). There is insufficient evidence addressing the comparisons between prepectoral and partial submuscular and between partial and total submuscular planes. KQ 5: The evidence is inconsistent regarding whether human ADM use during IBR impacts physical well-being, psychosocial well-being, or satisfaction with breasts. However, ADM use probably increases the risk of implant failure/loss or need for explant surgery (moderate SoE) and may increase the risk of infections not explicitly implant related (low SoE). Whether or not ADM is used probably is associated with comparable risks of seroma and unplanned repeat surgeries for revision (moderate SoE for both), and possibly necrosis (low SoE). KQ 6: AR with either transverse rectus abdominis (TRAM) or deep inferior epigastric perforator (DIEP) flaps may result in comparable patient satisfaction with breasts (low SoE), but TRAM flaps probably increase the risk of harms to the area of flap harvest (moderate SoE). AR

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