Acellular Dermal Matrix in Primary Breast Reconstruction

Supplemental Article Acellular Dermal Matrix in Primary Breast Reconstruction Hani Sbitany, MD; and Howard N. Langstein, MD Traditional implant-based breast reconstruction is relatively simple to perform but challenging to consistently perform well. The addition of acellular dermal matrices (ADM) in implant-based breast reconstruction can offer many potential advantages relative to traditional techniques. 1,2 As such, these products are gaining increased acceptance among reconstructive breast surgeons. The reported clinical benefits of ADM are multiple, and they include (1) an increased ability for the surgeon to define placement of both the inframammary fold and the expander/implant position, (2) an increased layer of protection between the prosthetic implant and the potentially poorly-vascularized mastectomy skin, (3) a larger initial submuscular pocket leading to improved utilization of native mastectomy flaps, (4) and more rapid expansion and time to complete reconstruction. 3-5 Other reported advantages include the potential for improved management of the threatened implant and a reduced need for explantation, as well as a potential for a reduction in the incidence of capsular contracture. 6-9 ADM products are biological allografts harvested from either a cadaveric human source or an animal source. They include varying amounts of cutaneous dermis and are purified extensively to ensure no remaining living cellular elements. As such, they consist only of the original dermal collagen matrix, thus eliminating the potential for inflammation or rejection. This collagen matrix, once placed in a recipient, is infiltrated by the host s fibroblasts Aesthetic Surgery Journal 31(7S) 30S 37S 2011 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: http://www.sagepub.com/ journalspermissions.nav DOI: 10.1177/1090820X11417577 www.aestheticsurgeryjournal.com Abstract The use of acellular dermal matrix (ADM) in many plastic surgery procedures, including breast reconstruction, has increased dramatically in recent years. While expander/implant reconstruction can be performed successfully with standard techniques, the introduction of ADM has added a new tool with which to achieve lasting, predictable results. This article is a summary of existing literature on ADM for primary implant reconstruction, to provide a more thorough understanding of the benefits of ADM in single- and to two-stage breast reconstruction and to identify the areas where further investigation is needed. Keywords breast reconstruction, complications, immediate, implants, tissue expanders Accepted for publication March 22, 2011. and revascularized by the host s blood vessels such that it functions as an incorporated scaffolding for native tissue ingrowth. Currently, there are a number of commercially-available ADM products. These include AlloDerm and Strattice (LifeCell Corp., Branchburg, New Jersey), DermaMatrix (Synthes Corp., West Chester, Pennsylvania), Allomax (Davol, Inc., Warwick, Rhode Island), and FlexHD (Ethicon Inc., Somerville, New Jersey). The various proprietary ADM formulations differ in terms of the specific cleansing and purification processes, the amount of collagen crosslinking, and the methods of storage. The most popular reason to utilize ADM in breast reconstruction is to improve consistency and reproducibility in implant-based reconstruction by utilizing acellular dermis as a pectoralis major muscle extension. The strategy is to place the acellular dermis as an inferior or Dr. Sbitany is a Reconstructive Microsurgery Fellow in the Division of Plastic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania. Dr. Langstein is Chief of the Division of Plastic Surgery at the University of Rochester, Rochester, New York. Corresponding Author: Dr. Hani Sbitany, Division of Plastic Surgery, University of Pennsylvania, 10 Penn Tower, 3400 Spruce Street, Philadelphia, PA 19104, USA. E-mail: Hani.Sbitany@gmail.com

Sbitany and Langstein 31S inferolateral sling to cover the lower pole of the implant. In so doing, additional volume may be instilled at the time of expander placement, maximizing the use of available, preserved mastectomy skin, thus reducing the overall number of expansions. Native mastectomy skin is always preferable to expanded skin. This technique also offers more precise control of the inframammary fold and better preservation of implant location. Despite the multitude of potential benefits, acceptance of techniques utilizing ADM in breast reconstruction has not been universal. This is in large part due to concerns regarding the increased potential for complications. Specifically, there have been reports of increased risk of seroma and infection with these products. In addition, some surgeons have been slow to adopt such techniques due to the cost of the various matrices. Even with the increased number of competing products now available on the market, the cost is not inconsequential. Those promoting the advantages of ADM, however, point out that such cost is worth incurring when considering the benefits that these products afford and the shorter time to complete reconstruction for the patient. Another potential benefit of ADM is the ability to avoid a subserratus dissection to achieve full muscular coverage. Techniques utilizing either serratus or serratus fascia for lateral expander/implant coverage have been well described and are extremely effective. 10 However, intraoperative dissection of this muscle can be challenging, and the fascia between the serratus and the pectoralis is often thin and prone to tear. 11 In addition, many feel that such techniques increase the potential for postoperative pain. ADM, when placed as a lower pole sling, allows for the avoidance of a subserratus fascial dissection and offers more reliable coverage in this area when expansion commences. Finally, a substantial benefit of ADM is the potential for improved aesthetic outcomes of the reconstructed breast. There have been some preliminary reports that ADMassisted reconstructions have improved cosmesis compared to traditional techniques, but more studies are required to demonstrate this unequivocally. This is a difficult comparison because many experienced surgeons can achieve excellent results without ADM, but it may be easier to consistently achieve these results with ADM. Specifically, ADM techniques allow a surgeon to achieve more control of the implant pocket at the time of mastectomy precision of the inframammary fold, control of the lateral fold (which can direct medial fullness), and offloading of the mastectomy flaps (which can allow more intraoperative fill). This all leads to improved lower-pole projection. For all these reasons, many surgeons believe that they more consistently and reliably produce an aesthetically-superior breast mound with ADM. Although difficult to quantify, this improved result is felt to justify the cost of the biological mesh implant. Operative Techniques As in most procedures, patient selection is key to achieving good results. In general, obese patients with large breasts are poor candidates for ADM-assisted reconstruction. Even with aggressive flap trimming and large intraoperative implant fill volumes, those with redundant mastectomy flaps will have a large dead space above the acellular dermis, leading to seroma and delayed vascularization of the matrix, thus increasing complication rates. Additionally, patients with evidence of poorly-perfused mastectomy flaps are at increased risk of complications with ADM-assisted reconstruction. These patients will often require aggressive mastectomy flap debridement and will likely not tolerate the excessive filling of the implant afforded by the ADM. They are best served by complete submuscular coverage of the expander/implant or immediate latissimus dorsi flap replacement of the threatened mastectomy flap. The ideal patients for ADM-assisted prosthetic breast reconstruction are those with medium- or large-size breasts undergoing bilateral reconstructions. It is these patients who benefit most from release of the pectoralis muscle and subsequent maintenance of excess mastectomy skin. Other excellent candidates, assuming that they have wellperfused mastectomy flaps, include women with small breasts undergoing unilateral reconstructions or those undergoing unilateral reconstructions who desire a larger breast with a contralateral balancing augmentation mammaplasty. In terms of technique, the most common method of ADM placement is as an inferolateral-hammock (Figure 1). 1 This technique is carried out as follows. Upon completion of the mastectomy by the oncologic surgeon, the inferior border of the pectoralis major is elevated off the chest wall along its inferior and lower medial border, and a pocket is dissected beneath it, sufficient to accommodate the tissue expander. After adequate hydration, a 6-16-cm piece of thick ADM is sewn to the released inferior and medial margin of the pectoralis major (Figure 2). This suture line continues for the length of the ADM and follows the curving lateral contour of the pectoralis major. The medial and inferior edges of the ADM are then sutured to the chest wall at a line approximately 1.5 cm below the inframammary fold. The lateral extent of this suture line mimics the inferolateral contour of the future breast and extends onto the serratus anterior fascia. The lateral portion of the pocket may be left open and the expander inserted through this opening. Alternatively, the lateral border of the ADM may be sutured to the chest wall to devise a fully closed pocket within which the expander sits. While there have been various technical modifications reported to place ADM, the majority involve only slight technical changes to this standard method. A dual-plane tissue expander placement with ADM has been recently published. 12 The reported advantage of this modification is primarily in aesthetic outcome for example, the ability to produce a more natural-appearing, ptotic breast mound. In the end, however, there exists little clinical difference in the majority of techniques utilized to place ADM. Intraoperative expansion of the tissue expander is much greater with ADM techniques, due to the increased

32S Aesthetic Surgery Journal 31(7S) Figure 1. A cross-sectional depiction of ADM placed as an inferolateral hammock to enlarge the breast implant pocket. The ADM (in white) is seen along the lower border of the implant. Courtesy of Veronica Lopez-Moreno. Figure 2. Intraoperative view of ADM (inferior) in relation to the released pectoralis major muscle (superior) and the underlying implant. Following this step, the borders of the ADM and the pectoralis major muscle are sutured to form a closed pocket over the implant. size of the expander pocket. The amount of expansion possible intraoperatively is limited in most cases only by the tension placed on the overlying mastectomy flaps. There have been some reports of increased mastectomy flap necrosis with ADM-assisted techniques; in most cases, this is likely due to overfilling of the tissue expanders. It is preferable to expand the implant to the point that there is no longer a space between the ADM and the overlying mastectomy flaps, thus minimizing the space where fluid could potentially accumulate. This technique also ensures direct contact between the ADM and the underside of the mastectomy flap (the blood supply for ADM revascularization). Once there is contact between the two tissues, expansion should proceed with extreme caution, to a point where there is minimal stretching of the mastectomy flaps. Undue stretch and tension on the newly devascularized skin will lead to necrosis. In our experience, such techniques lead to intraoperative installation of an average of 85% of total volume, compared to 33% for submuscular coverage techniques. 13 When expansion is performed correctly in this manner, mastectomy flap necrosis will be minimized. Outcomes In addition to the clinical advantages afforded by ADM procedures, the safety and efficacy of these techniques have now been widely reported. A recent 12-year series demonstrated the excellent and safe outcomes achievable in the setting of infection and previously irradiated breasts. 14 The utility of ADM in such settings is attributable to its retained ability to revascularize, even in such adverse settings. 15 Early reports in the literature demonstrated the safety and equivalent rates of morbidity for ADM-assisted techniques in single-stage breast reconstruction. 1,16-18 More recently, there have been multiple reports comparing morbidity of ADMassisted techniques to the more widely practiced two-stage expander-implant reconstruction. 13,19-27 In addition, six of these studies compared the morbidity rates to those encountered with traditional techniques utilizing full submuscular coverage for expander/implant reconstruction. 13,14,24-27 Table 1 summarizes those studies reporting outcomes of two-stage expander-implant reconstruction with ADM, as well as those comparing it to traditional submuscular coverage techniques. Table 2 further summarizes the frequency of chemoradiation administration in the cohorts presented by each study. When the outcomes of these series are tabulated in meta-analysis format, frequency of complications can be compared between those patients in the ADM cohort and those undergoing full submuscular coverage of the tissue expanders (Table 3). An in-depth analysis of this literature shows the rate of most types of complications (hematoma, cellulitis or wound infection, and infection requiring tissue expander removal) to be comparable between ADMassisted breast reconstruction and traditional submuscular coverage techniques. The rate of partial mastectomy flap necrosis was found to be higher in the ADM group (9.3%) relative to the submuscular group (7.2%), although this difference was not statistically significant. Despite this higher rate of skin flap compromise overlying the ADM, the fact that the two cohorts maintained similar explantation rates is another

Sbitany and Langstein 33S Table 1. Manuscripts Reporting Outcomes of Two-Stage Expander-/Implant-Based Breast Reconstruction With ADM Study a No. of Patients, Reconstructed Breasts Collection Period Mean Postoperative Follow-up Period Antibiotic Administration Protocol Study Design Bindingvale et al 21 ADM 20, 29 1 year 10 months Retrospective case series Spear et al 22 ADM 43, 58 1.25 years 25.9 months Oral antibiotics for duration of Jackson-Pratt drains (7-14 days) Namnoun 23 ADM 20, 29 21 months Intravenous clindamycin + fluoroquinolone 24 hours; same regimen by mouth on discharge Sbitany et al 13,b Prospective case series Retrospective case series ADM 50, 92 3 years Oral Gram+ coverage for 5 days Matched, retrospective 50, 84 (full submuscular coverage) 3 years Nahabedian 14,b ADM 76, 100 2.5 years 17 months Oral antibiotics while drains in place Chun et al 24,b 285, 376 (partial submuscular, dual plane, coverage) 11 years ADM, 269 6 years Cefazolin or clindamycin until drains removed Lanier et al 25,c, 146 (total or partial submuscular coverage, depending on surgeon) Matched, retrospective Matched, retrospective ADM, 75 3 years 203 days Oral cefadroxil while drains in place Matched, retrospective, 52 (full submuscular coverage) 238 days Antony et al 26,b ADM 96, 153 4.3 years Matched, retrospective 2025, 2910 (full submuscular coverage) Nguyen et al 27,b ADM 41, 75 10 years Matched, retrospective 163, 246 (extent of muscle coverage not indicated) Dashes ( ) indicate value not addressed in the article. a ADM versus submuscular coverage. b This study compares ADM results to more traditional techniques utilizing full submuscular coverage.

34S Aesthetic Surgery Journal 31(7S) Table 2. Treatment Characteristics of Patients in Nine Studies Reporting Outcomes of Two-Stage Expander-/Implant-Based Breast Reconstruction With ADM Reconstructions, No. (%) Study a Mean Age, years Preoperative Radiation Postoperative Radiation Adjuvant Chemotherapy Bindingvale et al 21 ADM 50 5 (7.7) Spear et al 22 ADM 50.3 5 (5.2) 8 (13.8) 20 (34.5) Namnoun 23 ADM 1 (3.4) Sbitany et al 13 ADM 48.6 6 (12) 51.7 4 (6) Nahabedian 14 ADM 48.2 9 (12) 13 (17) Chun et al 24 ADM 47.0 22 (8.2) 16 (5.9) 91 (33.8) 46.2 7 (4.8) 12 (8.2) 57 (39) Lanier et al 25 ADM 51 3 (5.8) 3 (5.8) 27 (51.9) 50 7 (9.3) 8 (10.7) 34 (45.3) Antony et al 26 ADM 44.5 15 (15.6) 9 (9.4) 27 (28.1) 48.1 226 (11.1) 230 (11.4) 734 (36.2) Nguyen et al 27 ADM 49.1 28 (37.3) b 47.7 69 (28.0) b Dashes ( ) indicate value not addressed in the article. a ADM versus submuscular coverage. b Cumulative value for both preoperative and postoperative radiation; no distinction made between the two categories in the article. testament to the ability of ADM to provide a full layer of protection overlying the prosthetic. In cases of skin flap or incisional breakdown, incorporated ADM has the ability to protect implants and reduce the need for implant removal. In many of these cases without ADM covering, explantation would almost certainly be required. Of all the complications assessed, only the differing incidence of seroma between the two cohorts was found

Sbitany and Langstein 35S Table 3. Complication Rates for Versus Acellular Dermal Matrix-Assisted Reconstruction Cohorts in the Nine Studies Analyzed in Table 1 Outcome Cellulitis/wound infection not requiring surgical intervention Coverage Cohort a Acellular Dermal Matrix-Assisted 2.8 (1.7 4.0) 3.4 (0.9 6.0).09 Hematoma 1.2 (0.8 1.7) 2.0 (1.8 2.1).11 Seroma 4.3 (2.0 6.6) 8.4 (2.3 14.6).03 Infection requiring expander/implant removal Partial mastectomy flap necrosis a Confidence interval (95%) given in parentheses. 3.2 (1.5 5.0) 3.4 (2.1 4.8).18 7.2 (4.9 9.2) 9.3 (4.8 13.9).08 to be statistically significant (4.3% for the submuscular cohort vs 8.4% for the ADM cohort, P =.03). This finding is not surprising given the nature of the material. While it is clearly not possible to eliminate all seromas, many of these can likely be attributed to the learning curve that accompanies the use of a new product such as ADM. It is possible that a number of these are preventable with certain techniques. There is clearly a learning curve seroma rates drop with increased experience, as surgeons learn that proper intraoperative fill reduces the dead space above the matrix, leading to improved vascularization. 28 Despite the higher incidence of seroma in the ADM cohort, the rate of infection requiring explantation was found to be comparable between the two groups (3.2% vs 3.4%, P =.18). This illustrates that regardless of the occurrence of untoward fluid collection postoperatively, the ultimate safety profile of the two techniques does not differ. This is no doubt in large part due to the experience of the authors reporting their data in utilizing these techniques and their ability to ensure that seroma accumulation is handled in such a manner as to minimize its ability to threaten the underlying implant. Thus, despite the higher incidence of seroma in some reports, when ADM is utilized to assist in pocket formation, the final endpoint of a successful initial reconstruction is similar in the two groups. The concern regarding increased seroma production in association with ADM is twofold. Collection of fluid within the implant pocket may lead to inoculation and a subsequently higher rate of peri-implant infection. Alternatively, as mentioned above, collection of serous fluid between the ADM and the overlying mastectomy skin may inhibit vascularization and incorporation of the ADM, thus leading to reconstructive failure. Despite these P concerns, many have shown that the vigilant draining of both pockets postoperatively, as well as the use of a standard no-touch technique when handling the ADM intraoperatively, should minimize these occurrences. 28 In our experience, there are certain steps that can be taken to minimize both the risk of seroma and the subsequent bacterial inoculation of a seroma when it does occur. Drain management when utilizing ADM is critical. In all cases, it is important to place two drains into each breast. When no portion of the implant pocket is left open along the lateral border, a drain placed within the ADM/ pectoralis major pocket is of benefit. Without this drain, egress of fluid from around the expander is limited. In addition, every effort should be made to allow the course of at least one drain to traverse through the dissected or exposed portions of the axilla, as this area can produce moderate serous drainage. Finally, when considering the human-derived AlloDerm, the ADM has a distinct polarity that must be identified intraoperatively. There is a dermal side rendered by a dermatome at the time of harvest; this side has cut ends of blood vessels that can assist in early vascularization. The dermal side can be identified by its smooth, shiny appearance. In addition, this side appears to absorb blood that it contacts. It is crucial that this side be placed in contact with the underside of the mastectomy flap, rather than the implant. This side has been shown to be more likely to revascularize. This is in contrast to the basement membrane side, which is dull and rough in appearance and seems to repel blood that it contacts. This side is placed down such that it contacts the implant. Placing the ADM in correct orientation will maximize the potential for revascularization and minimize the occurrence of serous fluid accumulation. The porcine ADM Strattice does not appear to have this polarity, and either side may be placed in contact with the mastectomy flap, although, theoretically, the dermis should be situated facing up whenever possible. When a seroma develops despite the presence of drains, it must be immediately addressed to maintain continued contact between the ADM and overlying mastectomy skin. If a seroma develops while the drains are still in place, serious consideration should be given to the prompt placement of an additional drain. Conversely, if seroma develops after the drains are removed, it must be immediately aspirated, and the expander should be filled additionally at that time. This allows improved incorporation of the ADM, reducing the risk of infection. Seromas that develop beneath the ADM are rare and should not interfere with ADM vascularization, but they may require aspiration if persistent. Analysis of tissue expander characteristics between the ADM and submuscular cohorts illustrates that ADM affords significantly higher intraoperative fill volumes and fewer total fills necessary to achieve final expander volume (Table 4). Spear et al have clearly shown that ADM can afford a shorter period to completed implantbased breast reconstruction, although more studies are

36S Aesthetic Surgery Journal 31(7S) Table 4. Expander/Implant Characteristics for Versus Acellular Dermal Matrix-Assisted Reconstruction Cohorts in the Nine Studies Analyzed in Table 1 Outcome Mean intraoperative fill volume (given as percentage of final total volume) Mean no. of fills necessary to achieve final total volume a Confidence interval (95%) given in parentheses. needed to measure the time-shortening benefit of ADM. 22 Perhaps the biggest potential benefit of ADM-assisted breast reconstruction is in single-stage or direct-to-implant reconstruction. Salzberg has the largest experience in this arena and has demonstrated safe, aesthetic, one-stage reconstructions following skin-, areolar-, and nipple-sparing mastectomies. His approach is to place a permanent silicone gel prosthesis supported by AlloDerm or Strattice as an internal hammock. 16,29 Proper single-stage reconstruction requires reliable mastectomy flaps. It also helps if the patient wishes to achieve a slightly smaller breast size postoperatively, allowing the native breast skin to be draped on the implant pocket without undue tension. This approach, predominantly with Strattice and gel implants, is becoming popular in Europe, since it can avoid the necessity of a second stage and save costs, despite the initial expense of the bioprosthetic. Conclusions When placed in the proper patients, ADM offers great advantages in both single-stage and two-stage implantbased breast reconstruction. Patients benefit not only from a more consistently achievable aesthetic outcome but also from shorter times to complete reconstruction and the need for less expander fills and maintenance. The largest published experience exists for AlloDerm and Strattice, both of which appear safe and effective. As surgeon experience continues to grow, so will the applications of ADM in implant-based breast reconstruction. Disclosures Dr. Langstein is a paid member of the Speaker s Bureau for the Life Cell Corporation. Funding Cohort a Coverage ADM-Assisted P 24.2 (18.2 30.3) 68.5 (51.1 85.9).01 5.1 (4.5 5.4) 2.4 (1.8 2.8).03 Publication of the articles in this supplement was supported by a grant from LifeCell. References 1. Zienowicz RJ, Karacaoglu E. Implant-based breast reconstruction with allograft. Plast Reconstr Surg 2007;120:373-381. 2. Gamboa-Bobadilla GM. Implant breast reconstruction using acellular dermal matrix. Ann Plast Surg 2006;56:22-25. 3. Nahabedian MY. Breast reconstruction with tissue expanders and implants. In: Procedures Is Reconstructive and Aesthetic Breast Surgery. New York, NY: Elsevier; 2009:1-19. 4. Spear SL, Pelletiere CV, Lockwood M. Immediate breast reconstruction with tissue expanders and AlloDerm. In: Spear SL, Wiley SC, Robb GL, Hammond DC, Nahabedian MY, eds. Surgery of the Breast. Philadelphia, PA: Lippincott Williams & Wilkins; 2006:484-488. 5. Spear SL. 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