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A Matched-Pair Analysis of Prepectoral with Subpectoral Breast Reconstruction: Is There a Difference in Postoperative Complication Rate?

Momeni, Arash M.D.; Remington, Austin C. M.D.; Wan, Derrick C. M.D.; Nguyen, Dung M.D.; Gurtner, Geoffrey C. M.D.

Plastic and Reconstructive Surgery: October 2019 - Volume 144 - Issue 4 - p 801-807
doi: 10.1097/PRS.0000000000006008
Breast: Original Articles
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Discussion
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Background: The development of acellular dermal matrices has revolutionized implant-based breast reconstruction. The most recent development has been the introduction of prepectoral breast reconstruction. However, concerns have been expressed related to the quality of soft-tissue coverage and infectious complications. Thus, the authors felt it prudent to perform a matched-pair analysis of clinical outcomes following prepectoral and subpectoral tissue expander placement.

Methods: A retrospective study of patients who underwent immediate breast reconstruction by means of prepectoral (group 1) and dual-plane subpectoral (group 2) tissue expander placement was performed. Patients in each group were matched for age, body mass index, history of radiotherapy, and type of acellular dermal matrix. Of note, patients in group 1 received perioperative antibiotic prophylaxis for less than 24 hours, whereas patients in group 2 received antibiotic prophylaxis for at least 1 week.

Results: A total of 80 patients (138 breast reconstructions) were included in the study (group 1, n = 40; group 2, n = 40). No difference in total postoperative complication rate (p = 0.356) and mastectomy skin necrosis rate (p = 1.0) was noted. Observed differences in major complications (p = 0.06), major infection (p = 0.09), and loss of reconstruction (p = 0.09) were not found to be significant.

Conclusion: Immediate prepectoral tissue expander insertion with anterior acellular dermal matrix coverage and less than 24 hours of antibiotic prophylaxis is safe and compares favorably to subpectoral tissue expander placement with an inferior acellular dermal matrix sling and a prolonged course of antibiotics.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Palo Alto, Calif.

From the Division of Plastic and Reconstructive Surgery, Stanford University Medical Center.

Received for publication February 25, 2018; accepted January 30, 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:Dr. Momeni is a consultant for Allergan, AxoGen, Sientra, and Stryker. Dr. Gurtner was a consultant for Novadaq. No compensation or support was received for this study. The remaining authors have no disclosures related to the content of the article.

Arash Momeni, M.D., Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, 770 Welch Road, Suite 400, Palo Alto, Calif. 94304, amomeni@stanford.edu

Breast cancer represents a significant public health concern, as evidenced by estimates of the American Cancer Society that approximately 266,120 new cases of invasive breast cancer, with an additional 63,960 new cases of in situ disease, will be diagnosed in the United States in 2018.1 These estimates represent an increase from previous years. Paralleling the increasing incidence of breast cancer, an increasing number of breast reconstructions are being performed in the United States. In 2016, a total of 109,256 breast reconstructions were performed according to the American Society of Plastic Surgeons statistics. This represents a 39 percent increase since 2000.2 It is important to understand that the increase in the number of breast reconstructions is attributable to an increase in not autologous breast reconstruction but rather implant-based breast reconstruction.3 Indeed, implant-based reconstruction represents by far the most common reconstructive modality in the United States today.4

Although postmastectomy breast reconstruction has historically been categorized into two distinct reconstructive modalities (i.e., autologous and implant-based reconstruction), modern breast reconstruction is characterized by substantial heterogeneity with respect to surgical technique within each group. Examples for the heterogeneity within the implant-based reconstruction group include timing (staged versus direct-to-implant), plane of implant placement (total submuscular versus subpectoral versus prepectoral), and use of acellular dermal matrices.5–7

The most recent technical evolution has been the introduction of prepectoral breast reconstruction.8,9 Although the concept of prepectoral implant placement is not new—in fact, subcutaneous implant placement was commonly performed in the 1970s10,11—the availability of novel surgical techniques (e.g., skin-sparing mastectomy, fat grafting), products (acellular dermal matrix), and technology (perfusion imaging) has resulted in substantial improvements of clinical outcomes using this approach.

Despite the numerous advantages of prepectoral breast reconstruction, including decreased chest pain, prevention of animation deformity, shortening of recovery time, and greater control of breast shape and form,12–16 concerns have been expressed related to the quality of soft-tissue coverage and infectious complications postoperatively. In light of the existing debate, particularly related to the safety of prepectoral breast reconstruction, we felt it prudent to perform a comparative analysis of clinical outcomes following immediate prepectoral and dual-plane subpectoral breast reconstruction.

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PATIENTS AND METHODS

Sample Selection

Institutional review board approval was obtained before this study was conducted. A retrospective study of patients who underwent immediate breast reconstruction by means of tissue expander placement was performed. An institutional database (i.e., Stanford Translational Research Integrated Database Environment)17 was used to identify patients meeting inclusion criteria. Two study cohorts were created: patients who underwent immediate prepectoral tissue expander placement with complete anterior acellular dermal matrix coverage (group 1) versus immediate dual-plane subpectoral tissue expander placement with use of an inferior acellular dermal matrix sling for lower pole support (group 2). It is important to note that a major difference between the study groups was the duration of perioperative antibiotic prophylaxis. Patients in group 1 received perioperative antibiotic prophylaxis for less than 24 hours (i.e., only while they remained in the hospital), whereas patients in group 2 received antibiotic prophylaxis for at least 1 week. The antibiotic choice was determined by the goal to cover for Gram-positive skin flora and thus included cefazolin. Clindamycin was administered to patients with a documented penicillin allergy.

The acellular dermal matrix used in all patients was either AlloDerm (LifeCell/Allergan, Madison, N.J.) or DermACELL (Novadaq/Stryker, Kalamazoo, Mich.). Of note, a 16 × 20-cm sheet of acellular dermal matrix was used in all cases of prepectoral tissue expander placement (group 1), whereas 6 × 16-cm or 8 × 16-cm sheets were used in group 2. Absorbable sutures were used for acellular dermal matrix fixation in all patients. Saline was used in all patients for intraoperative expansion. Patients were excluded if they had undergone (1) direct-to-implant breast reconstruction, (2) staged implant-based breast reconstruction without the use of acellular dermal matrix, (3) immediate autologous reconstruction, or (4) immediate hybrid breast reconstruction (i.e., free or pedicled flap transfer with simultaneous implant placement).

The objective of the study was to determine whether any differences in outcome existed between the two study groups following the first stage of reconstruction. The study endpoint was successful expansion with ability to proceed to the second reconstructive stage. We hypothesized that patients undergoing prepectoral tissue expander placement with less than 24 hours of antibiotic prophylaxis would have a similar rate of successful expansion without a higher rate of postoperative complications, including postoperative infections.

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Parameters of Interest

Parameters retrieved included age (in years), body mass index (in kilograms per meter squared), race, history of radiation therapy, type of mastectomy (i.e., nipple-sparing mastectomy versus skin-sparing mastectomy), intraoperative tissue expander fill (in percentage of total volume), final tissue expander fill volume (in milliliters), interval between first- and second-stage procedures (in months), and type of second stage procedure (i.e., expander-implant exchange versus delayed-immediate free tissue transfer versus delayed-immediate hybrid breast reconstruction). In addition, we collected information related to preexisting comorbidities (i.e., diabetes mellitus, hypertension, coronary artery disease, and chronic obstructive pulmonary disease).

Patients in the two study groups were matched for age, body mass index, history of radiotherapy, and type of acellular dermal matrix. Postoperative complications were categorized into minor, defined as those treated in the outpatient setting, and major, defined as any complication that required hospital admission or surgical treatment in the operating room.18 Mastectomy skin necrosis was defined as a disruption of wound healing secondary to partial or full-thickness necrosis of mastectomy skin flaps. Seroma and hematoma were defined as collections of serous fluid and blood, respectively, that required percutaneous or surgical drainage. Red breast syndrome was defined as otherwise asymptomatic breast erythema in the distribution of the acellular dermal matrix.19 Capsular contracture was not captured, as the study endpoint was the second reconstructive procedure.

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Surgical Technique

Prepectoral Tissue Expander Placement.

After completion of the mastectomy, the quality of mastectomy skin flaps was determined. A combination of clinical assessment and fluorescence-imaging (SPY Elite Fluorescence Imaging System; Stryker) was typically used for this purpose. Following confirmation of adequate perfusion to the skin and soft-tissue envelope, a 16 × 20-cm sheet of acellular dermal matrix was brought to the surgical field and placed in a saline bath. Tissue expander selection was determined based on the desired width of the breast pocket. On the back table, the acellular dermal matrix was draped over the deflated tissue expander and trimmed to provide anterior coverage. Of note, and inferior-cuff technique was chosen (i.e., the acellular dermal matrix was draped over the inferior edge of the tissue expander and covered the posterior surface for approximately 2 to 3 cm). The lateral free ends of the acellular dermal matrix were secured with absorbable sutures, thus creating the inferior cuff. The acellular dermal matrix was then inserted into the breast pocket. Two suture lines secured the acellular dermal matrix inferiorly: one along the free superior edge of the posterior cuff, and a second along the inframammary fold. Next, the deflated tissue expander was inserted after pocket irrigation with triple-antibiotic irrigation (i.e., gentamicin, cefazolin, and bacitracin), and the acellular dermal matrix was draped over the device and secured circumferentially to the pectoralis major muscle/chest wall. The tissue expander was inflated until the mastectomy skin folds were eliminated while still ensuring adequate skin flap perfusion.

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Subpectoral Tissue Expander Placement.

After mastectomy, the sternocostal insertion of the pectoralis major muscle was detached and a subpectoral pocket created. A 6 × 16-cm or 8 × 16-cm sheet of acellular dermal matrix was routinely used for soft-tissue reinforcement inferiorly. The acellular dermal matrix was secured to the chest wall along the inframammary fold with absorbable suture. The tissue expander was inserted after pocket irrigation with triple-antibiotic irrigation (i.e., gentamicin, cefazolin, and bacitracin) and the pectoralis major muscle was secured to the free superior edge of the acellular dermal matrix with absorbable suture.

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Statistical Analysis

Within the cohort, means and standard deviations were used to present continuous variables, whereas frequencies and percentages were used to summarize categorical variables. Each breast was not analyzed independently, as this approach inflates the sample size and does not control for intrapatient factors. Associations between categorical variables were tested with chi-square analysis or a two-tailed Fisher’s exact test. A Kruskal-Wallis test was used for continuous variables. Values of p < 0.05 were considered to be significant. Statistical analysis tests were run using Stata Version 14.0 (StataCorp, College Station, Texas).

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RESULTS

A total of 80 patients were included in the study. Forty patients who underwent prepectoral tissue expander placement with anterior acellular dermal matrix coverage and less than 24 hours of prophylactic antibiotics (group 1) were matched with 40 patients who underwent subpectoral tissue expander placement with inferior acellular dermal matrix support and antibiotic prophylaxis for at least 1 week (group 2). In both groups, bilateral reconstructions were performed in 29 patients, thus accounting for a total of 69 breast reconstructions in each group. Successful matching is demonstrated by the fact that no differences were present with respect to age (p = 0.893), body mass index (p = 0.777), history of radiotherapy (p = 1.0), and type of acellular dermal matrix (p = 1.00). Patient and procedure characteristics are listed in Tables 1 and 2. Nipple-sparing mastectomy was the most common ablative approach in both study groups [group 1, 57 of 69 breasts (82.6 percent); group 2, 52 of 69 breasts (75.4 percent)].

Table 1. - Patient Characteristics
Characteristic Prepectoral (%) Subpectoral (%) p Total (%)
Total no. of patients 40 40 80
Total no. of breasts 69 69 138
Mean age ± SD, yr 51.3 ± 12.7 50.9 ± 10.0 0.893 51.1 ± 11.3
Mean interval between stage 1 and 2 ± SD, mo 5.6 ± 2.2 6.7 ± 2.5 0.050* 6.2 ± 2.4
Mean BMI ± SD, kg/m2 26.1 ± 4.4 25.9 ± 4.4 0.777 26.0 ± 4.4
Race
 White 26 (65.0) 25 (62.5) 0.816 51 (63.8)
 Asian 6 (15.0) 7 (17.5) 0.762 13 (16.3)
 Hispanic 7 (17.5) 5 (12.5) 0.531 12 (15.0)
 Black 1 (2.5) 1 (2.5) 1.000 2 (2.5)
 Other 0 (0) 2 (5.0) 0.152 2 (2.5)
Radiotherapy
 None 28 (70.0) 26 (65.0) 0.633 54 (67.5)
 Neoadjuvant 4 (10.0) 4 (10.0) 1.000 8 (10.0)
 Adjuvant 8 (20.0) 10 (25.0) 0.592 18 (22.5)
B
MI, body mass index.
*
Statistically significant.

Table 2. - Procedure Characteristics
Characteristic Prepectoral (%) Subpectoral (%) p Total (%)
Bilateral 29 (72.5) 29 (72.5) 1.000 58 (72.5)
Operative fill volume, % <0.001*
 Median 50.0 10.4 23.2
 Range 0–100.0 0–55.0 0–75.0
Final fill volume, ml 0.459
 Median 450 465 450
 Range 240–650 190–745 240–745
ADM type
 AlloDerm 31 (77.5) 31 (77.5) 1.000 62 (77.5)
 DermACELL 9 (22.5) 9 (22.5) 1.000 18 (22.5)
Reconstruction type
 E/I 17 (43.6) 38 (95.0) <0.001* 55 (69.6)
 Free abdominal tissue 7 (17.9) 2 (5.0) 0.077 9 (11.4)
 Hybrid 15 (38.5) 0 (0) <0.001* 15 (19.0)
A
DM, acellular dermal matrix; E/I, expander to implant.

The interval between stages 1 and 2 was a mean of 5.6 and 6.7 months in groups 1 and 2, respectively (p = 0.05). Although the intraoperative fill volume was higher in group 1 (p < 0.001), final tissue expander fill volume was not significantly different between study groups (p = 0.459) (Table 2). The majority of reconstructions were performed with AlloDerm (31 patients in each group), with the remainder of the reconstructions being performed with DermACELL (nine patients in each group) (p = 1.0). Of note, when stratified for acellular dermal matrix type, no significant differences in clinical outcomes were noted between AlloDerm and DermACELL.

Significant differences were noted regarding the second reconstructive procedure. Although almost all patients in group 2 underwent expander-implant exchange, with only two patients undergoing delayed-immediate free tissue transfer, only 43.6 percent of patients in group 1 proceeded to undergo expander-implant exchange (p < 0.001), with 17.9 percent undergoing delayed-immediate free tissue transfer (p = 0.077) and 38.5 percent undergoing hybrid breast reconstruction (p < 0.001) (Table 2).

Postoperative complications were noted 13 (32.5 percent) and 17 patients (42.5 percent) in groups 1 and 2, respectively (p = 0.356). Minor complications were quite similar between study groups [group 1, n = 12 (30 percent); group 2, n = 9 (22.5 percent); p = 0.446]. A greater difference was noted with respect to major complications; however, this failed to reach statistical significance [group 1, n = 3 (7.5 percent); group 2, n = 9 (22.5 percent); p = 0.06] (Table 3).

Table 3. - Postoperative Complications*
Complication Prepectoral (%) Subpectoral (%) p Total (%)
Any complication 13 (32.5) 17 (42.5) 0.356 30 (37.5)
 Major complication 3 (7.5) 9 (22.5) 0.060 12 (15.0)
 Minor complication 12 (30.0) 9 (22.5) 0.446 21 (26.3)
Infection
 Outpatient 2 (5.0) 1 (2.5) 0.556 3 (3.8)
 Inpatient 1 (2.5) 5 (12.5) 0.090 6 (7.5)
MSN
Outpatient 4 (10.0) 2 (5.0) 0.396 6 (7.5)
Inpatient 2 (5.0) 4 (10.0) 0.396 6 (7.5)
Seroma 4 (10.0) 4 (10.0) 1.000 8 (10.0)
Loss of reconstruction 1 (2.5) 5 (12.5) 0.090 6 (7.5)
M
SN, mastectomy skin necrosis.
*
Some patients experienced more than one complication.

Interestingly, no difference was seen with respect to postoperative infection rate. The observed higher rate of postoperative infection necessitating inpatient management in group 2 did not reach statistical significance (p = 0.09). Mastectomy skin necrosis was noted in six patients (15 percent) in each group. Interestingly, the majority of cases of mastectomy necrosis in group 1 were treated on an outpatient basis, whereas patients in group 2 underwent inpatient management more commonly; the difference, however, was not statistically significant (p = 0.396). Seroma rates were identical in both study groups [n = 4 (10 percent); p = 1.0]. Finally, only one patient (2.5 percent) in group 1 experienced loss of reconstruction, whereas this was noted in five patients (12.5 percent) in group 2 (p = 0.09).

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DISCUSSION

Tremendous advances have been made in implant-based breast reconstruction over the past four decades. Similarly, the goals of postmastectomy reconstruction have changed. Whereas Snyderman and Guthrie10 reported in their 1971 publication on implant-based breast reconstruction that “it produces no cosmetic triumphs,” contemporary goals of reconstruction and patient expectations are that external signs of mastectomy should best be minimized. Indeed, cosmetically appealing reconstructive outcomes are now routinely obtained.

In light of excellent cosmetic results being obtainable following implant-based reconstruction, a prudent question is how the procedure can be further optimized. The drive to continuously improve surgical procedures is nicely exemplified in microsurgical breast reconstruction. Once transverse rectus abdominis musculocutaneous flap survival was reliably achieved, clinical and research focus shifted to reconstructive modalities that would decrease patient morbidity without compromising clinical outcome.20,21 One can surmise that the equivalent trend in implant-based breast reconstruction is the introduction of prepectoral breast reconstruction. The absence of pectoralis major muscle manipulation is analogous to the extent of abdominal wall manipulation during superficial inferior epigastric artery flap harvest. It is rather surprising therefore how surgeons are so focused on abdominal wall morbidity in autologous reconstruction, yet seem to tolerate the morbidity associated with subpectoral implant placement. Favorable postoperative outcomes (e.g., decreased pain, lack of animation deformity) have been reported following prepectoral breast reconstruction.12–16 Nevertheless, surgeons continue to voice concerns related to the safety of the procedure given the lack of muscle coverage over the implant, concerns over mastectomy skin viability, and risk of implant infection given the more tenuous soft-tissue coverage.

Sigalove et al. have demonstrated that prepectoral breast reconstruction can be performed in a safe manner with predictable results.12 A common criticism of such centers is that the quality of the mastectomy skin flap might be different, thus translating into the advantage of being able to deliver such good results consistently. The present study addresses that concern, as it represents a comparative analysis of well-matched cohorts at the same institution. Thus, the quality of mastectomy skin flaps in each group was comparable. As such, the clinical conditions, including the type of mastectomy (i.e., skin-sparing versus nipple-sparing mastectomy), at the time of reconstruction were similar in both groups. It is important to highlight that no crossover occurred between study groups secondary to assessment of mastectomy skin flap quality (e.g., none of the patients initially intended to undergo prepectoral reconstruction underwent subpectoral tissue expander placement because of concerns related to mastectomy skin flap quality). This allowed us to ascribe differences in mastectomy skin necrosis rate, if any, to parameters related to the reconstructive part of the procedure (e.g., intraoperative tissue expander fill volume). The observed mastectomy skin necrosis rate in each group was 15 percent and falls within what is reported in literature (i.e., 5 to 30 percent).22 Interestingly, despite higher intraoperative expander fill volumes in the prepectoral group (p < 0.001), no significant difference in postoperative mastectomy skin necrosis rate was noted between study groups (p = 0.396). Although the intraoperative fill volumes in this study were rather low in both groups, the ability to safely fill implants with larger volumes is evidenced by the favorable results reported following prepectoral direct-to-implant reconstruction.6,23

Another area of concern following expander-based breast reconstruction is postoperative infection, with reported rates ranging from 0 to 50 percent.24 Despite published data demonstrating that perioperative (i.e., <24 hours) prophylactic antibiotic administration is sufficient, continuation of prophylactic antibiotics beyond the perioperative period and in some cases even until the drains are removed remains a common practice.25,26 Interestingly, prolonged antibiotic use has been associated with an increased risk of more severe infections.24 The findings of this study corroborate the notion that prolonged antibiotic administration does not translate into lower surgical-site infection rates. In fact, although not statistically significant, a higher rate of postoperative infection necessitating inpatient management was noted for patients in group 2 (p = 0.09). Although no conclusions can be drawn regarding the superiority of either approach based on our findings, it is fair to conclude that prepectoral tissue expander placement with perioperative antibiotic prophylaxis only (i.e., <24 hours) is as safe as subpectoral expander placement. Concerns related to a more tenuous soft-tissue coverage of the expander seem unfounded in the context of postoperative infection rate. Furthermore, it is important to mention that, although not statistically significant, a higher expander loss rate was noted in group 2 (12.5 percent versus 2.5 percent; p = 0.09) secondary to infectious complications.

Despite favorable outcomes with acellular dermal matrix, a higher incidence of complications—notably, infection and seroma—has been reported when compared to prosthetic reconstruction without acellular dermal matrix use.27,28 Despite widespread acceptance that seroma rates tend to be higher, prolonged drain placement (up to 3 weeks) and novel tissue expander devices [e.g., Sientra AlloX229 (Sientra, Inc., Santa Barbara, Calif.)] provide means to address this potential problem. In this study, however, no difference between seroma rates was noted (p = 1.00), despite the fact that a substantially larger amount of acellular dermal matrix was used in group 1. This finding corroborates previously published data.30

Limitations of the present study are related to the retrospective study design. Furthermore, the retrospective nature resulted in the inability to control for mastectomy specimen weight because of the lack of availability of this data point. Given the number of patients included in the study, the lack of statistical significance related to some of the clinical outcome parameters may be a reflection of inadequate power to detect a difference. The small sample size was, furthermore, the reason for not using propensity score matching, as this method typically requires large samples. The observed differences regarding the second reconstructive procedure are related to surgeon preference, with the senior author (A.M.) commonly performing hybrid or delayed-immediate autologous reconstructions at the second stage. Given that this study focused on outcomes following the first stage of reconstruction with the study endpoint being successful expansion and ability to proceed with the second stage of reconstruction, we feel that differences related to the second stage do not reflect a limitation.

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CONCLUSION

Our study findings demonstrate, in a well-matched patient population, that immediate prepectoral tissue expander insertion with anterior acellular dermal matrix coverage and less than 24 hours of antibiotic prophylaxis is safe and compares favorably to subpectoral tissue expander placement with an inferior acellular dermal matrix sling and a prolonged course of antibiotics.

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ACKNOWLEDGMENT

STRIDE (Stanford Translational Research Integrated Database Environment) is a research and development project at Stanford University to create a standards-based informatics platform supporting clinical and translational research. The project described was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through grant UL1 RR025744. The content of is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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