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Systematic Review of the Impact of Acellular Dermal Matrix on Aesthetics and Patient Satisfaction in Tissue Expander-to-Implant Breast Reconstructions

DeLong, Michael R. M.D.; Tandon, Vickram J. M.D.; Farajzadeh, Matthew B.S.; Berlin, Nicholas L. M.D., M.P.H.; MacEachern, Mark P. M.L.I.S.; Rudkin, George H. M.D.; Da Lio, Andrew L. M.D.; Cederna, Paul S. M.D.

Plastic and Reconstructive Surgery: December 2019 - Volume 144 - Issue 6 - p 967e-974e
doi: 10.1097/PRS.0000000000006212
Breast: Original Articles
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Background: Acellular dermal matrix is used in most postmastectomy implant-based breast reconstructions in the United States. It is believed to be safe, despite a slightly increased complication rate. Although never established in a unifying study, the primary advantage of acellular dermal matrix is believed to be an enhanced aesthetic result, thus justifying the added expense. The purpose of this study was to assess the aesthetic benefits of acellular dermal matrix in expander-to-implant breast reconstruction.

Methods: A systematic review adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology was performed including all original studies examining aesthetic outcomes of expander-to-implant breast reconstructions with acellular dermal matrix compared to muscular coverage. Direct-to-implant and prepectoral studies were excluded from the evaluation. The results were aggregated and reported as a summary.

Results: Among 883 studies identified, 49 full-text articles were reviewed and nine articles ultimately met inclusion criteria. All nine studies were not randomized. Of these, three articles (1448 total patients) evaluated reconstruction aesthetic outcomes by patient satisfaction, whereas six articles evaluated the aesthetic outcomes by external observer (504 total patients). None of the articles evaluating patient satisfaction reported a difference between acellular dermal matrix and muscular reconstruction. Five of the six articles using objective outcomes demonstrated significant improvement in aesthetic outcome in the acellular dermal matrix group.

Conclusions: Although little evidence exists evaluating the aesthetic benefits of acellular dermal matrix for expander-to-implant breast reconstruction, the data suggest that objective observers consider acellular dermal matrix–assisted expander-to-implant breast reconstructions aesthetically superior to reconstruction with only muscular coverage, but patients appear to be equally satisfied with both reconstructive options.

Los Angeles, Calif.; and Ann Arbor, Mich.

From the Division of Plastic Surgery, Department of Surgery, University of California at Los Angeles; the Section of Plastic Surgery, University of Michigan; and the Taubman Health Sciences Library, University of Michigan School of Medicine.

Received for publication September 27, 2018; accepted February 14, 2019.

Presented at Plastic Surgery The Meeting 2018, Annual Meeting of the American Society of Plastic Surgeons, in Chicago, Illinois, September 28 through October 1, 2018.

Disclosure:The authors report no financial conflicts of interest. This study was not funded.

Related digital media are available in the full-text version of the article on www.PRSJournal.com.

Paul S. Cederna, M.D., Department of Biomedical Engineering, 2130 Taubman Center, 1500 East Medical Center Drive, Ann Arbor, Mich. 48109-0340, cederna@med.umich.edu, Instagram: @paulcederna

Breast reconstruction restores a sense of wholeness to women who undergo mastectomy by reducing the psychosocial morbidity associated with absent breast deformity.1 For this reason, the Women’s Health and Cancer Rights Act was passed in 1998 to ensure all-payer insurance coverage of breast reconstruction procedures for all women undergoing oncologic mastectomy.2 Patient demand, mandated insurance coverage, and the high incidence of breast cancer in the United States3 have made breast reconstruction one of the most common procedures performed by plastic surgeons, with more than 100,000 cases performed nationally in 2017.4

Both autologous and prosthetic reconstructive options have reported advantages and limitations, but implant-based reconstruction remains the most common approach.5 The process of implant-based reconstruction has seen substantial evolution since its first description, with novel techniques and materials. Modern surgeons are now describing direct-to-implant reconstructions and prepectoral implant placement, but these procedures are often reserved for select patients and remain in the minority of reconstructions to date.6,7 The most common reconstructive method involves the placement of a temporary tissue expander in a submuscular pocket under the pectoralis major muscle to sequentially inflate the skin envelope over a period of months until a desired shape and size is achieved for staged implant exchange. However, the inferior border of the pectoralis muscle is unable to cover the inferior aspect of the implant in most cases. Therefore, to provide complete vascularized tissue coverage and contain the implant in a fixed position on the chest wall, surgeons will often elevate the serratus muscle or a fascial sling to create a total submuscular pocket.8

In the 1990s, acellular dermal matrix, a decellularized detergent-washed dermal allograft or xenograft, was introduced to the reconstructive market and was quickly adopted for use during breast reconstruction.9 Surgeons were attracted to the reduced operating times and postoperative pain. In addition, the pliability, biocompatibility, and off-the-shelf availability made acellular dermal matrix an excellent tool for covering the inferior pole of the reconstructed breast, helping to ensure precise placement of the tissue expander or implant. Despite the added cost of nearly $5000 per breast,10 acellular dermal matrix is now used in the majority of implant-based reconstructions.11

With medical reimbursement paradigms evolving toward bundled payment schemes and other payment models, it is essential to assess the added value for components of procedures that are nonessential and expensive. Extensive research has demonstrated an acceptable safety profile for acellular dermal matrix and its use in breast reconstruction; however, there was no clear benefit in overall complication rates.12 Many surgeons advocate that the primary benefit of acellular dermal matrix is the more precise control over implant positioning and pocket shape, resulting in an enhanced aesthetic outcome with improved patient satisfaction. However, aesthetic outcomes are difficult to measure, and no study has unequivocally confirmed the aesthetic benefits of acellular dermal matrix in breast reconstruction. The purpose of this study was to perform a systematic review of the literature using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to evaluate evidence for the aesthetic benefits and potential impact on patient satisfaction of acellular dermal matrix compared to muscular coverage alone in tissue expander-to-implant breast reconstruction.

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PATIENTS AND METHODS

A search for studies pertaining to breast reconstruction and acellular dermal matrix in any year of publication was conducted of the Ovid MEDLINE, Embase (Elsevier), Cumulative Index to Nursing and Allied Health Literature (EBSCOhost), and Cochrane Central Register of Controlled Trials (Wiley Online Library) databases on April 15, 2018. Each search consisted of controlled terms (e.g., Medical Subject Headings) and title or abstract keywords. No language, date, or publication type restrictions were incorporated into the searches. Duplicate citations were removed in Endnote X6 (Clarivate Analytics, Philadelphia, Pa.). The final set of citations were imported into Distiller SR (Evidence Partners, Ottawa, Ontario, Canada) for eligibility screening. The reproducible Ovid MEDLINE search is available in Appendix 1. (See Appendix, Supplemental Digital Content 1, which shows searches for the Ovid databases MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, and MEDLINE Epub Ahead of Print, http://links.lww.com/PRS/D795.) The remaining searches are available in Appendix 2. (See Appendix, Supplemental Digital Content 2, which shows literature searches for systematic review of the aesthetic benefits of acellular dermal matrix in tissue expander-to-implant breast reconstructions, http://links.lww.com/PRS/D796.)

Abstracts were reviewed for relevance to breast reconstruction and the inclusion of aesthetic outcomes or patient satisfaction endpoints. All included articles compared the aesthetic outcomes between acellular dermal matrix use and muscular coverage alone in tissue expander-to-implant reconstructions. Studies describing prepectoral expander placement or direct-to-implant reconstruction were excluded, given the separate nature of these procedures and added variability. Studies involving flap or dermal graft inferior pole coverage were also excluded. Abstract-only studies were also excluded, as were non-English language studies. Review articles and meta-analyses were also excluded because they reported redundant data from other investigations and did not contribute original data. Studies that included either immediate or delayed reconstruction were included.

Full-text article consensus review was then conducted by two plastic surgery residents according to the same inclusion and exclusion criteria. Articles that were ultimately included in the study were then summarized. Inconsistent methodology between the studies reviewed and lack of validated aesthetic outcomes for breast reconstruction prevented a formal meta-analysis.

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RESULTS

A total of 883 abstracts met the initial search criteria. After the first round of abstract review, 49 full-text articles were reviewed. Of these, nine satisfied all criteria for inclusion in our study as described earlier under Patients and Methods (Fig. 1).13–21 All nine of the included studies were retrospective reviews published between 2011 and 2018. Seven of the articles described the use of acellular dermal matrix as an inferior sling with pectoralis muscle release, whereas two articles did not specify the technique for acellular dermal matrix use.13,15,16,18–21 Only two articles reported rate of nipple-sparing mastectomy. Tsay et al. observed no difference between the acellular dermal matrix and non–acellular dermal matrix group,13 but Sorkin et al. reported a statistically significantly higher rate of nipple-sparing mastectomy in the acellular dermal matrix group (21.8 percent versus 12.0 percent).14 Four articles reported relative rates of implant characteristics between acellular dermal matrix and non–acellular dermal matrix groups. In the article by Tsay et al., the acellular dermal matrix group had a statistically significantly higher percentage of patients with silicone implants (91 percent versus 56 percent) compared to saline implants.13 Forsberg et al., Ibrahim et al., and Freeman et al. observed similar implant characteristics between acellular dermal matrix and non–acellular dermal matrix groups.16,18,19

Fig. 1.

Fig. 1.

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Patient Satisfaction

Three of the articles, with 1448 total patients, evaluated aesthetic outcomes as measured by patient satisfaction (Table 1).14,15,21 Two of these articles used the BREAST-Q validated questionnaire to assess outcomes,14,21 and the third article used a 1 to 5 scoring scheme for several patient-reported satisfaction metrics.15 All three of the patient-satisfaction articles reported no significant difference in expander-to-implant outcomes between total submuscular placement and the use of acellular dermal matrix.14,15,21

Table 1. - Summary of the Patient-Reported Outcomes Articles
Reference Design Patients Outcome Follow-Up* Result
Hanna et al., 201315 Nonrandomized review, single institution 75 (100 breasts) Patient satisfaction 1–5 scale Average 8.8 mo No difference
Wu et al., 201321 Nonrandomized review, single institution 76 BREAST-Q 12 mo No difference
Sorkin et al., 201714 Nonrandomized review, MROC* 1297 BREAST-Q 24 mo after expander placement No difference
M
ROC, Mastectomy Reconstruction Outcomes Consortium.
*
Follow-up is listed after implant exchange unless otherwise noted.

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External Observer Aesthetics

Six article, with 504 total patients, evaluated aesthetic outcomes as measured by external observers (Table 2).13,16–20 Five of these articles had varied panels of evaluators scoring blinded photographs (Table 2),16–20 whereas the final article used three-dimensional photography and anatomical measurements (i.e., projection) compared to ideal values.13 No studies evaluated both patient satisfaction and external observer aesthetics. Five of the six external observer articles reported significant improvement in the aesthetic result in the acellular dermal matrix group.13,16,17,19,20 The sixth article used patient photographs scored on several patient characteristics by external observers, and the overall appearance score was the same between the two groups.18 However, this article was primarily focused on complication profiles, and included only six patients in the aesthetic component of the analysis. The remaining five articles, representing 498 of the 504 patients, unanimously reported improved aesthetics in patients with acellular dermal matrix inferior pole coverage, as scored by blinded observers or three-dimensional measurements.

Table 2. - Summary of the External Observer Articles
Reference Design Patients Outcome Measure Follow-Up* Overall Result Specific Improvements†
Vardanian et al., 201120 Nonrandomized review single institution 203 (307 breasts) Blinded patient photographs by 4 individuals (1 surgeon, 1 secretary, 2 medical students) Average, 29 mo Superior aesthetics with ADM Bottoming out, inframammary fold problems, rippling, mechanical shifts
Nguyen et al., 201217 Nonrandomized review, single surgeon 111 Blinded patient photographs by 3 plastic surgeons >90 days Superior aesthetics with ADM Implant placement, volume, inframammary fold quality
Forsberg et al., 201419 Nonrandomized review, single institution 122 patients (183 breasts) Blinded patient photographs by 18 individuals (6 plastic surgeons, 6 plastic surgery residents, 6 medical students) >12 mo Superior aesthetics with ADM Natural contour, symmetry of shape, symmetry of size, position on chest wall
Ibrahim et al., 201516 Nonrandomized review, single institution 38 Blinded patient photographs by 5 plastic surgeons Average 1.7 yr Superior aesthetics with ADM Contour and placement
Freeman et al., 201618 Nonrandomized review, single surgeon 6 (for aesthetic analysis) Blinded patient photographs by 31 physicians Unclear No difference overall aesthetic outcome Defects other than scarring, projection, inframammary fold quality higher in non-ADM group
Tsay et al., 201813 Nonrandomized review, single institution 24 (39 breasts) Three-dimensional imaging 6–9 mo Superior aesthetics with ADM Medial volume, lateral volume, inferior pole curvature, point of maximal projection
A
DM, acellular dermal matrix.
*
Follow-up is listed after implant exchange unless otherwise noted.
All improvements are observed with superior scores in the ADM group, unless otherwise noted.

The specific elements of the aesthetic appearance differed in each study, but the significant differences are summarized in Table 2. In particular, inframammary fold and inferior breast contour appear to be improved most consistently.

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Revision Rates

Revision rates to improve aesthetic outcomes were reported in five of the nine articles.13,15,17,19,20 None of these articles reported a significant difference in revision procedures between acellular dermal matrix and non–acellular dermal matrix cohorts. However, Forsberg et al. reported a nonsignificant trend toward the non–acellular dermal matrix group requiring more contralateral procedures for symmetry (34.1 percent versus 21.6 percent) and more pocket revision procedures (36.5 percent versus 18.9 percent).19 Similarly, Nguyen et al. reported a higher reoperation rate for cosmetic reasons in the non–acellular dermal matrix group (61 percent versus 54.5 percent),17 and Hanna et al. reported higher revision rates in the non–acellular dermal matrix group (18.1 percent versus 12.9 percent),15 although these differences did not reach statistical significance.

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DISCUSSION

The vast majority of surgeons in the United States use acellular dermal matrix to perform tissue expander-to-implant breast reconstruction.22 Although acellular dermal matrix is considered a useful adjunct for controlling the inferior pole and providing an additional layer of coverage, the additional cost is a deterrent, particularly in evolving reimbursement paradigms. A rigorous evaluation of the benefits of use are important to justify this added expense.

Numerous studies have reported on the safety profile for acellular dermal matrix use in expander-to-implant breast reconstruction.23–28 Generally, the use of acellular dermal matrix is not believed to improve complication rates. Specifically, the literature supports a reduced capsular contracture rate but an increased risk of seroma and infection.12,23,25,29–30 The primary advantage of acellular dermal matrix is to improve control of the inferior pole and implant position, thus enhancing the aesthetic outcome for our patients. These benefits have not been universally accepted clinically or unequivocally supported scientifically in the literature.

There have been no level I randomized clinical trials assessing either patient satisfaction or aesthetic outcomes in patient undergoing tissue expander-to-implant reconstruction with or without acellular dermal matrix. We identified nine retrospective studies that directly addressed this topic; however, these outcomes were generally considered secondary to primary clinical outcomes such as complication rates or time to exchange. In addition, with one exception, all studies were single-institution investigations, which limits the generalizability of the reported results

Existing data did tend to report consistent results when the studies were divided into two groups based on the method for determining aesthetics. One group of three articles suggested that patients are equally satisfied with their final result, whether acellular dermal matrix is used or not. The other group, including six articles, almost unanimously reported improved aesthetic results with the use of acellular dermal matrix, as determined by external observers or three-dimensional imaging. In particular, these studies tended to consistently report improvements in inframammary fold positioning and inferior breast contours.

The contradictory results observed between the two studies is likely attributable to differing methodologies. Without a direct comparator, patients are likely to be equally satisfied by their overall experience regardless of the reconstructive strategy. However, when there is a control group and a reference to compare against, external observers can appreciate an improved aesthetic result in patients who received acellular dermal matrix. Based on these results, we speculate that acellular dermal matrix does improve the aesthetic outcome, but patients are unaware of the difference without a reference point. Essentially, the absolute aesthetic outcome can be improved by using acellular dermal matrix; however, without external comparators, patients are unable to appreciate the difference.

However, improved aesthetic outcome may have quantifiable value by reducing revision procedures. Only five of the nine articles reported revision procedures for aesthetic reasons, and some trends were reported with the non–acellular dermal matrix group requiring revisions more often, although none of these reached significance. It is not clear whether there is no difference, or whether these studies were underpowered to detect a difference.

In addition, it is possible that patient-reported outcomes and external observation outcomes may vary differently with time after surgery. Although the data included in the articles reviewed are not comprehensive enough to perform a thorough aggregated temporal analysis, an estimation of variability of these outcomes with time can be made by considering each article as a separate time point. Because there is consistency in outcomes among articles, with external observers considering reconstruction with acellular dermal matrix aesthetically superior to reconstruction without acellular dermal matrix, but no difference in patient-reported outcomes regardless of time since surgery, it can be posited that these two outcomes are invariable and persistent, independent of time since surgery.

A slightly more in-depth review can be performed by examining two of the nine articles that did evaluate outcomes at different time points. Sorkin et al. corroborate a consistent equivalence in patient-reported outcomes over time by demonstrating an improvement in psychological well-being over time (1 week, 3 months, 1 year, and 2 years) in each group.14 However, Tsay et al. report a temporal change in their cohort evaluated. Their group observed an improvement in medial and lateral pole volumes, point of maximal projection, and lower pole curvature measurements between acellular dermal matrix and no acellular dermal matrix in the early postoperative period (1 to 3 months), but a convergence in outcomes over time; only point of maximal projection and inferior pole curvature remained significantly improved in the acellular dermal matrix group in the late postoperative period (6 to 9 months).13

We do acknowledge certain limitations to our study that may temper our reported results. All the data presented were not randomized and are subject to inherent biases from patient selection. Our methodology was also restricted to summarizing the current literature, without sufficient consistency in data to allow a formal meta-analysis. Certain additional variables such as implant shape, size, texturing, and the type of mastectomy are likely to play an important role in ultimate patient satisfaction and aesthetic outcome. This information was only reported in the minority of the included studies; however, it is important to note that the Sorkin et al. study actually observed a higher prevalence of nipple-sparing mastectomies in the acellular dermal matrix cohort, which further strengthens their conclusions that patient satisfaction is not improved by acellular dermal matrix.14 Furthermore, the recent introduction of expanders designed with tabs allows for secure placement on the chest wall, and may not require acellular dermal matrix to maintain appropriate positioning.31 The studies included in our review do not specifically mention whether tabbed expanders were used, so it is unclear how this new technology would affect the aesthetic outcome without acellular dermal matrix.

These results, however, should open the discussion regarding the ultimate goals of breast reconstruction: patient satisfaction and psychological well-being versus the final appearance. As the plastic surgeon, we have the responsibility to provide the best outcome possible with the available tools, even if patients are unaware of the difference. It can be a challenging proposition to knowingly provide a patient with an aesthetic outcome that is less than optimal because we believe the patient will not notice the difference and it reduces cost. However, benefits of breast reconstruction are often reported as an improvement in postmastectomy psychological dysphoria, favoring patient satisfaction as the primary outcome of interest.1 In addition, the question is raised: If patients are equally satisfied with both options, and if there is a possibility that acellular dermal matrix slightly increases complication rates, should acellular dermal matrix be used at all?

These issues in determining the role for acellular dermal matrix in breast reconstruction is not entirely novel. Certain strategies have been advocated to achieve an acceptable compromise between cost, complications, and aesthetics. Some authors have advocated the selective use of acellular dermal matrix by implementing an algorithm aimed at identifying specific patients who would benefit from the use of acellular dermal matrix for inferior pocket control. These studies report a substantial cost savings with maintained cosmetic results when their algorithm is used.32 Other authors have described the use of dermal flaps as an autologous replacement for acellular dermal matrix, which may provide a cheaper alternative for inferior pole control in appropriate patients.33 These may provide acceptable approaches that simultaneously maintain an optimal result while limiting the added expense for acellular dermal matrix.

Ultimately, despite the increased complication rates, acellular dermal matrix–assisted reconstruction continues to dominate the breast reconstruction paradigm. Our study demonstrates external observer-perceived improved aesthetic outcomes with its use, which may partially explain the rationale for its continued popularity. Whether the continued use of acellular dermal matrix in breast reconstruction in most patients is justified is a complicated decision, and will likely need to be addressed as reimbursement schemes change in the coming years. Given the lack of high-quality evidence currently available, our specialty would benefit from rigorous level I randomized clinical trials to conclusively determine the appropriate use of acellular dermal matrix in tissue expander-to-implant breast reconstructions.

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CONCLUSIONS

There is a paucity of high-level evidence evaluating the aesthetic benefits of acellular dermal matrix for expander-to-implant breast reconstruction. The existing data suggest that objective observers generally consider tissue expander-to-implant breast reconstructions with acellular dermal matrix to be aesthetically superior to reconstruction with submuscular coverage, but patients are equally satisfied with both reconstructive options. Deciding which of these outcomes is more important will be crucial for determining the relative value of acellular dermal matrix in expander-to-implant breast reconstruction.

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REFERENCES

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