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Acellular Dermal Matrix in Postmastectomy Breast Reconstruction Acellular Dermal Matrix in Postmastectomy Breast Reconstruction Ahmed M. S. Ibrahim Publication of this thesis was financially supported by personal funds. There was no internal or external financial support. There are no financial interests in any of the products, devices, drugs or procedures mentioned in this thesis. ISBN: 978-94-6169-529-1 © 2014 Ahmed M. S. Ibrahim Cover Design: Adapted from “Nude Study” by Auguste Rodin Lay-out and printing: Optima Grafische Communicatie, Rotterdam, The Netherlands Acellular Dermal Matrix in Postmastectomy Breast Reconstruction Acellulaire dermale matrix bij borstreconstructies na mastectomie Proefschrift ter verkrijging van de graad van doctor aan de Erasmus Universiteit Rotterdam op gezag van de rector magnificus Prof.dr. H.A.P. Pols en volgens besluit van het College voor Promoties. De openbare verdediging zal plaatsvinden op woensdag 12 november 2014 om 15.30 uur door Ahmed Mohamed Said Ibrahim geboren te Londen, Verenigd Koninkrijk PROMOTIECOmmissiE Promotor: Prof.dr. S.E.R. Hovius Overige leden: Prof.dr. J.F. Lange Prof.dr. D.J.O. Ulrich Prof.dr. J. Feijen Copromotoren: Dr. M.A.M. Mureau S.J. Lin, MD, FACS For my parents, who inspire me to be the best physician that I can be “Wherever the art of Medicine is loved, there is also a love of Humanity.” – Hippocrates Contents Chapter 1 General Introduction and Outline of Thesis 9 Chapter 2 Acellular Dermal Matrices in Breast Surgery: Tips and Pearls 31 Chapter 3 Acellular Dermal Matrices in Breast Surgery: A Comprehensive 49 Review Chapter 4 Analysis of the NSQIP Database in 19,100 Patients Undergoing 69 Implant Based Breast Reconstruction: Complication Rates with Acellular Dermal Matrix Chapter 5 Use of Acellular Dermal Matrix in Reconstructive Breast Surgery: 87 A Survey of Current Practice among Plastic Surgeons Chapter 6 Does Acellular Dermal Matrix Really Improve Aesthetic Outcome 103 in Tissue Expander/Implant Based Breast Reconstruction? Chapter 7 General Discussion 119 Chapter 8 English Summary 147 Chapter 9 Nederlandse Samenvatting 155 Chapter 10 Appendices Acknowledgments 165 Curriculum Vitae 169 List of Publications 171 PhD Portfolio Summary 177 Chapter 1 General Introduction and Outline of Thesis General Introduction and Outline of Thesis hapter 1 C OVERVIEW OF THESIS Over the last decade the use of acellular dermal matrix (ADM) in reconstructive breast surgery has been transformative. Some authors have gone as far as to suggest that it is the single most important advancement in prosthetic breast reconstruction.1-6 ADMs are able to provide numerous solutions for the many issues related to inadequate tis- sue coverage and support such as capsular contracture, implant rippling, and implant malposition.1, 7-10 The notion of a living bra is a fascinating one for both plastic surgeons and patients alike.1 This advent has mirrored the increased use of nipple and skin sparing mastectomy, BRCA testing, and superior implants where patients are achieving better outcomes than with breast conserving treatments with lumpectomy and radiation.1 Despite the numerous advantages associated with ADM use, controversies remain. As such this thesis will focus on the current state of the art for ADM use in post-mastectomy breast reconstruction. BREAST CANCER The Centers of Disease Control and Prevention (CDC) reports that breast cancer is the most common form of cancer affecting women today.11 In 2013, the National Cancer Institute estimated 234,580 new breast cancer cases and 40,030 deaths in the United States alone.12 This has been paralleled by the large number of breast reconstruction pro- cedures performed annually.13 Twenty percent of breast cancers are linked to a positive family history.14 The discovery of the BRCA gene in 1994 was a major breakthrough and since then other genes, albeit with less penetrating ability, have recently been discovered (RAD51C and RAD51D).15-17 In recent years, numerous advances have been made in every aspect of breast cancer care including early detection, diagnosis, and treatment.18, 19 This has resulted in significant improvements in disease-free and breast cancer related sur- vival. Despite these advances, mastectomy remains an important surgical option for the management of this condition. Though mastectomy is not considered a high risk surgical procedure there are obvious aesthetic, functional, and psychological concerns20-22 as well as potential long-term effects (such as chronic pain) that may affect overall quality of life.23 Studies have shown however, that patients who undergo mastectomy followed by reconstruction experience improvements in overall well being including improved body image and feelings of sexuality.24-26 11 Chapter 1 BREAST RECONSTRUCTION Breast reconstruction is aimed at restoring a normal appearing breast. The presence of a breast mound alone lacks the characteristics of a native breast.24 There is now a line of evidence suggesting that reconstruction following mastectomy yields far superior improvements in physical measures and quality of life than mastectomy alone.27 An overwhelming majority of these reconstructive procedures are tissue expander/implant based because of their relatively straight forward operative technique and reduced op- erative time.28, 29 Currently, the rate of prophylactic mastectomy of the contralateral side in women diagnosed with early-stage breast cancer is on the rise.23, 30 This is particularly noticeable in younger women.23, 30-34 One study demonstrated a significant increase in the mastectomy rate from 33% to 60% over a 13 year period.35 Another publication reported that 98% of women would opt to undergo this procedure to decrease their risk of cancer; 95% felt that it gave them peace of mind, and 94% claimed that they believed it would prolong their life.23 This, despite numerous studies demonstrating similar survival and local control rates with breast conserving therapy and radiation compared to mastectomy.36, 37 These figures suggest a trend toward early implant based breast reconstruction. Furthermore, the increased use of acellular dermal matrix (ADM) to support these procedures is indicative that a paradigm shift in the management of breast cancer is in progress.24 The desire to construct better breasts has resulted in considerable innovations in re- constructive breast surgery over the course of the last half century particularly since the introduction of silicone breast implants.24 In recent years it has become one of the most popular plastic surgery procedures in the United States.24 Initially, complications were focused primarily on the implants themselves which led to significant improve- ments in their design including more cohesive gels, barrier layers to reduce gel leakage and a wider range of implant profiles. All of these enhancements have contributed to a more positive attitude about the safety of implants use.24 Moreover, improved surgical planning has resulted in better outcomes. Such measures consist of tissue analysis and optimization of muscle coverage with the dual plane among numerous modifications.38-40 Despite the advancements made, reoperation rates in women undergoing post-mas- tectomy breast reconstruction are estimated at greater than 1 in 3.24 This glaring fact emphasizes the inadequacy of traditional approaches when performing implant based breast reconstruction. Following mastectomy, the implant is placed below the pectoralis major muscle which in turn covers the superior and medial poles of the implant. The exposed lateral and inferior poles can then be covered either by elevating the pectoralis minor or serratus anterior, or with subcutaneous tissue.7, 41, 42 In the event that coverage 12 General Introduction and Outline of Thesis hapter 1 C is inadequate, implant malposition, animation deformity, capsular contracture, or visible rippling may result.6, 8, 43, 44 Alternatively, some patients may already have an inherent deficiency of the soft tissue envelope.7 Some argue that these potential complications can be alleviated by proper implant selection and technique but a more permanent solu- tion to these issues is needed.24 The incorporation of ADMs into tissue expander/implant based breast reconstructions serves as a useful option to aid in resolving a lot of these problems.24 ACELLULAR DERMAL MATRIX Basic Scientific Concept Acellular Dermal Matrix (ADM) is a bioprosthetic material synthesized from animal or human cadaveric sources that have been denuded of the cellular components that cause inflammation and rejection.45-47 The resulting product is a biologic mesh that enhances angiogenesis, normal tissue in-growth, and intrinsic regeneration by cell repopulation thereby promoting improved integration and post-operative healing with minimal resorption.47 The professed function of these meshes is to provide a regenera- tive framework that supports new collagen deposition and matrix remodeling.48-53 The diverse proprietary processes, decellularization, and sterilization methods employed by the various manufacturers may affect how a given mesh is reacted upon by the recipient tissue. These variations in mesh preparation may affect the biomolecular structure and biochemical properties of the collagen scaffold. This in turn will shape foreign body rec- ognition and antigen presentation.48 Due to the proprietary nature of mesh production and the heterogeneous nature of mesh/host interactions, it is difficult to determine the effect of biologic manufacture on mesh efficacy and recognition.48 Uses of Acellular Dermal
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