The rate of two-stage breast reconstruction with initial placement of a tissue expander followed subsequently by exchange for a permanent implant continues to increase, and this is currently the most common method of breast reconstruction.1–3 Although there have been many recent changes to the types of expanders and implants, the basic tenet for coverage of the prosthesis remains unchanged. The pectoralis major and serratus muscles were first used for total muscle coverage of the expander to minimize the risk of exposure of the prosthesis in the setting of mastectomy skin flap necrosis.4 , 5
In 2005, the first series in which AlloDerm (LifeCell Corp., Branchburg, N.J.) was used as a sling for coverage of the lower pole of the expander was reported.6 Since this first reported experience, there have been multiple studies touting the benefits of acellular dermal matrix in prosthetic breast reconstruction, including superior coverage of the implant, increased initial fill volumes, and improved cosmetic results.7–9 In addition, there has also been a massive influx of different types of acellular dermal matrices into the market.10–14 Meanwhile, there have also been multiple studies stating that acellular dermal matrices may actually result in a higher rate of complications.15–17
Clearly, there is no consensus regarding what the ideal method should be for prosthetic breast reconstruction and which acellular dermal matrix is superior. However, the original method with total muscle coverage may still be the optimal method for implant-based breast reconstruction while also minimizing operative costs.
PATIENTS AND METHODS
A retrospective review was performed of all patients undergoing two-stage, tissue expander–based breast reconstruction at a single academic cancer center between August of 2002 and December of 2013. All reconstructions were performed by three plastic surgeons who routinely perform prosthetic breast reconstruction in their practice, and all skin-sparing mastectomies were performed by six breast surgeons. There were no patients who underwent nipple-sparing mastectomies or modified radical mastectomies in the study population. Patients who underwent single-stage, direct-to-implant reconstruction or delayed placement of a tissue expander were excluded from the study. In addition, there were no patients who had prepectoral placement of tissue expanders with acellular dermal matrix during the study period. All patients undergoing prosthetic breast reconstruction were analyzed in terms of demographics, medical comorbidities, smoking status, cancer stage, and cancer treatment, including chemotherapy and radiation therapy. Further evaluation of the tissue expanders, including initial fill volumes, time to drain removal, number of expansions, and time to expander exchange was also performed. Long-term follow-up of all patients was performed at least 2 years after the second stage of the reconstruction to evaluate the rate of revisions to the reconstructed breasts.
The rate of complications and overall costs for the initial procedure were also examined. Major complications were defined as any complication requiring operative intervention such as evacuation of a hematoma, débridement of mastectomy skin flap necrosis, removal of the expander, salvage with an autologous tissue flap, or cellulitis requiring hospital admission for intravenous antibiotics. Minor complications included conservative management of mastectomy skin flap necrosis with local wound care, aspiration of seromas, and treatment of cellulitis with oral antibiotics.
All patients undergoing total muscle coverage had the expander placed beneath the pectoralis major muscle. The serratus muscle was elevated to provide coverage of the inferolateral aspect of the tissue expander. In the acellular dermal matrix group, rectangular pieces of AlloDerm regenerative tissue matrix or ready-to-use AlloDerm was used exclusively as the only source of acellular dermal matrix and secured along the inframammary fold to cover the inferior aspect of the expander, whereas the remainder was covered by the pectoralis major muscle. The decision to use acellular dermal matrix was based solely on clinical need if the pectoralis muscle was inadequate for coverage of the tissue expander (e.g., attenuated muscle, partially resected muscle, or damage to the muscle caused by the mastectomy), which also removes the potential for selection bias. A shaped, textured tissue expander was used in all cases, and intraoperative expansion was performed to allow primary closure without tension on the mastectomy skin flaps. All patients had two drains placed during the initial operation that were left in place until the output was less than 30 cc/day for 2 consecutive days. All patients received an intravenous dose of antibiotics before the operation and were continued on oral antibiotics for 1 week after surgery.
Chi-square test or Fisher’s exact test was used to perform a univariate analysis to analyze the association of each patient characteristic to developing a complication and the need for reoperation. Characteristics with a value of p < 0.25 were entered into the final multiple logistic regression model. The association between total muscle coverage or placement of AlloDerm with each outcome was examined in univariate analysis. All analyses were performed using SAS 9.2 software (SAS Institute, Inc., Cary, N.C.), and values of p < 0.05 were considered statistically significant.
A total of 284 patients underwent implant-based breast reconstruction over the 12-year study period, performed by three plastic surgeons. Two hundred thirty-one patients underwent reconstruction of 408 breasts with total muscle coverage, whereas the remaining 43 patients had AlloDerm placed in 73 breasts. There was no significant difference in the age of the patients between the total muscle and acellular dermal matrix groups (47.6 years versus 49.4 years; p = 0.27) or in the average body mass index (25.0 kg/m2 versus 24.2 kg/m2; p = 0.40). Further evaluation of the medical comorbidities failed to demonstrate any differences in the incidence of diabetes, hypertension, or active smoking status. Assessment of the differences in the treatment of malignancy also did not show any difference in the rate of chemotherapy or radiation treatment (Table 1).
Use of AlloDerm allowed for increased initial fill volumes of the tissue expander (Table 2) (167 ± 139 ml versus 54 ± 47 ml; p = 0.00003), which translated into a decreased number of total expansions (8.1 versus 5.8; p = 0.000051) and time to full expansion (60.2 days versus 43.3 days; p = 0.0002). However, there was no significant difference in the length of time from the initial placement of the tissue expander to the exchange of the tissue expander for the permanent implant (162.4 days versus 162.3 days; p = 0.13). There was also no difference in the time for drain removal between the two groups (11.3 days versus 13.3 days; p = 0.94).
The total overall complication rate was significantly higher in the acellular dermal matrix group compared to the total muscle group (Table 3) (20.5 percent versus 8.8 percent; p = 0.005), and the rate of major complications was also significantly higher when AlloDerm was used (13.7 percent versus 5.1 percent; p = 0.0001). In particular, removal of the tissue expander was attributable to severe infection that did not respond to conservative management with antibiotics or tissue expander exposure or extrusion. The degree of plastic surgeon experience or breast surgeon was also not found to be a significant factor in developing either minor or major complications. Lastly, the multivariable logistic regression evaluation did not demonstrate any association with radiation treatment and the development of complications (Table 4).
Long-term evaluation for a minimum of 2 years after exchange of the tissue expander for the permanent implant demonstrated no significant difference in the rate of revisions to the reconstructed breasts regardless of whether AlloDerm or total muscle coverage was used (16.4 percent versus 17.6 percent; p = 0.89). The most common reason for revision surgery was exchange of the implant for a larger implant followed by fat grafting in both groups. There were also no differences in the development of capsular contracture regardless of whether acellular dermal matrix was used or not (1.4 percent versus 1.2 percent; p = 0.76), and no patients underwent treatment for animation deformity. Finally, the use of AlloDerm increased the cost of the initial procedure by an average of $2217 for each breast.
Prosthetic breast reconstruction accounts for approximately 60 percent of all breast reconstructions performed in the United States.1 The method of implant-based breast reconstruction has certainly evolved over the past several decades, from two-stage tissue expander reconstruction, to the development of acellular dermal matrices, to single-stage, prepectoral reconstruction. Despite these advancements, there is no consensus regarding the ideal method for prosthetic breast reconstruction.
The use of acellular dermal matrix in implant-based breast reconstruction has become more common because of the perceived benefits of creating improved definition of the inframammary fold and allowing for greater intraoperative expansion. In a study of 100 consecutive patients undergoing prosthetic breast reconstruction with 50 patients using AlloDerm and the other 50 patients having full muscle coverage, there were no significant differences in the rate of seroma, infection, or breast cellulitis. The authors also reported a decreased number of fills, resulting in a shorter mean overall time to complete the reconstruction.18 In a systematic review of nine previously published articles regarding implant-based reconstruction, Sbitany and Serletti concluded that acellular dermal matrix had a safety profile similar to full muscle coverage. Although there was an increased risk of postoperative seroma, there was no significant difference in the rates of infection or need for explantation of the tissue expander.19
However, there remains a considerable amount of debate regarding the potential for increased complications with the placement of acellular dermal matrix. For instance, Chun et al. reported a significantly higher risk of seroma and infection with the use of AlloDerm in 283 patients. The use of AlloDerm was found to increase the odds of seroma by 4.24 times and the odds of infection by 5.37 times. As a result, the authors state the use of acellular dermal matrix should be tempered based on careful patient selection and that the routine use of AlloDerm is unwarranted.20
Perhaps the largest study in the literature of 628 immediate two-stage tissue expander reconstructions demonstrated even more dramatic conclusions, where the use of AlloDerm resulted in a significant increase in major complications (15.3 percent versus 5.4 percent; p = 0.001), including infection necessitating intravenous antibiotics, mastectomy skin flap necrosis requiring débridement, and explantation of the tissue expanders. Consequently, the authors have decreased the use of AlloDerm and reverted to total muscle coverage as the primary means of two-stage, tissue expander–based reconstruction in their institution.21 A more recent study evaluating 14,249 patients from the Tracking Outcomes and Operations in Plastic Surgery database also demonstrated an absolute increase in rate of tissue expander or implant loss of 0.7 percent with the use of acellular dermal matrix.16
Similarly, the current study also demonstrates a significantly increased risk of complications with the use of AlloDerm in two-stage tissue expander breast reconstruction. There was not only a difference in minor complications such as development of seromas, but also a significantly higher risk of hospital admission and operative intervention. In addition, we did not find a decreased time to completion of the second stage of reconstruction with the use of AlloDerm despite a higher initial fill volume and fewer expansions. This may be attributed to the need for adjuvant treatments including chemotherapy and/or radiation therapy, which was not different between the two patient cohorts. Lastly, the use of AlloDerm did not decrease the number of additional revision operations after at least 2 years’ follow-up beyond the exchange for the permanent implant.
Furthermore, the use of AlloDerm was associated with significantly higher total costs of the operation compared to total muscle coverage. These costs reflect only the cost of the acellular dermal matrix ($2217 for unilateral and $4434 for bilateral), which is absorbed by the institution with no additional charges or fees to the patients or their insurance companies. In the current era in which emphasis is placed on decreasing hospital costs and medical expenditures, the use of AlloDerm certainly increases the costs of the initial operation, which is compounded by the added costs from managing the complications. A recent study regarding the financial costs of implant-based breast reconstruction confirmed our results that the use of acellular dermal matrix was more expensive than muscle alone and that complications resulted in further increased costs by 5.1 percent compared to only 1.9 percent.22 As a result, total muscle coverage is the primary option for implant-based breast reconstruction at our institution, and the use of AlloDerm is strictly reserved for cases where the muscle is attenuated or inadequate to provide complete coverage of the tissue expander.
Although the use of acellular dermal matrix does result in increased costs and risks of complications, there are certainly potential benefits. The use of AlloDerm significantly increased the initial fill volume and decreased the number of expansions. Placement of acellular dermal matrix may also result in improved lower pole expansion, which has been shown to result in improved aesthetic outcomes but was not evaluated in this study.8 The incidence of hyperanimation deformity has also been shown to decrease and may be completely avoided with the prepectoral method.23
The current study provides a very comprehensive evaluation of immediate two-stage, implant-based breast reconstruction. We focused not only on the results of the immediate perioperative period such as complications, initial fill volumes, and time to completion of the reconstruction but also on cost analysis and long-term assessments greater than 2 years after exchange of the tissue expander for the permanent implant. These data would be extremely beneficial in counseling patients undergoing two-stage, prosthetic breast reconstruction not only regarding the first-stage tissue expander placement but also about what can be expected in the future in terms of additional revisions.
Certainly, this study has several limitations, including the retrospective nature of the current study, which is similar to the previous studies published in the literature. Although a randomized controlled study would be the ideal method of determining the best option for two-stage, prosthetic breast reconstruction, this may not be possible because of patient variability in terms of quality of the muscle and mastectomy skin flaps. Moreover, the cohort of patients with AlloDerm in this study is much smaller than that of patients without acellular dermal matrix. Lastly, the cost analysis includes only the initial operation but not the costs from the complications. This would be extremely difficult to quantify because there is no numeric cost from conservative management of minor complications and no reimbursement for major operative intervention during the 90-day global period. Even though there is no increased dollar amount, more frequent clinic visits for monitoring and patient reassurance can be time-consuming and laborious.
The rate of prosthetic breast reconstruction continues to increase, and it is the primary means of reconstruction after mastectomy. The use of acellular dermal matrix has become more popular for two-stage, tissue expander reconstruction but is associated with significantly increased complications compared with total muscle coverage alone. Perhaps development of an acellular dermal matrix that has a safety profile similar to that of total muscle coverage without the associated risk of complications as demonstrated with AlloDerm would be optimal.
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