Abstract
Background: Post-mastectomy implant-based reconstruction can be performed as direct-to-implant (DTI) or two-staged reconstruction (TSR). Rigorous studies have explored postoperative complications between TSR or DTI, yet few have stratified outcomes by relevant populations, pre-operative findings, mastectomy characteristics, or plane of implant placement. We sought to compare the outcomes between these cohorts at our institution. Methods: All patients who underwent skin- or nipple-sparing mastectomy followed by DTI or TSR from 2011 to 2021 at a large academic medical center were included. Data included demographics, ADM use, mastectomy weight, plane of implant placement, and postoperative complications. Results: 295 patients were included. 271 (91.9%) received TSR, and 24 (8.1%) underwent DTI. Compared to TSR, DTI had a higher rate of NAC necrosis (P = .007) and dehiscence (P = .016). There was no difference in rate of other complications. Regardless of procedure, higher BMI (P = .002), higher grade ptosis (P = .01), and larger mastectomy weights (P = .022) were associated with increased risk of complication. Pre-pectoral placement was not associated with risk of NAC or mastectomy skin necrosis. Prior tobacco use was associated with higher risk of infection (P = .036) and dehiscence (P = .025). Neoadjuvant and adjuvant chemotherapy was associated with increased risk of capsular contracture(P = .009). Conclusions: Our study suggests that TSR may be preferred to minimize risk of NAC necrosis and wound dehiscence, especially in high-risk patients. Pre-pectoral placement did not significantly affect risk of mastectomy or NAC necrosis and should be considered in all cases to minimize morbidity. Higher risk conditions for alloplastic reconstruction include higher degrees of ptosis, history of tobacco use, and higher BMIs.
Keywords: breast reconstruction, tissue expander, direct-to-implant, mastectomy, breast implant, mastectomy skin necrosis
Résumé
Introduction: La reconstruction par implant après une mastectomie peut être effectuée directement (RDI) ou en deux étapes (RDÉ). Des études rigoureuses ont exploré les complications postopératoires entre la RDÉ et la RDI, mais peu d'entre elles ont stratifié les résultats selon les populations pertinentes, les observations préopératoires, les caractéristiques de la mastectomie ou le plan de l'implant. Les auteurs ont cherché à comparer les résultats entre ces cohortes dans leur établissement. Méthodologie: Toutes les patientes qui ont subi une mastectomie d'épargne de la peau ou du mamelon suivie d'une RDI ou d'une RDÉ entre 2011 et 2021 dans un grand centre universitaire ont été incluses dans l'étude. Les données incluaient les caractéristiques démographiques, l'utilisation des matrices dermiques acellulaires, le poids de la mastectomie, le plan de l'implant et les complications postopératoires. Résultats: Au total, 295 patientes ont participé. Ainsi, 271 (91,9 %) ont reçu une RDÉ et 24 (8,1 %), une RDI. Par rapport à la RDÉ, la RDI est liée à un plus fort taux de nécrose du complexe aérolo-mamelonnaire (p=0,007) et de déhiscence de la plaie (p=0,016). Il n'y avait pas de différence dans le taux des autres complications. Quelle que soit l'intervention, un IMC plus élevé (p=0,002), une ptôse de grade plus élevé (p=0,01) et un poids plus élevé de la mastectomie (p=0,022) étaient associés à un plus fort risque de complication. Un foyer prépectoral n'était pas lié au risque de nécrose du complexe aérolo-mamelonnaire ou de la peau de la mastectomie. Auparavant, le tabagisme était lié à un risque plus marqué d'infection (p=0,036) et de déhiscence de la plaie (p=0,025). La chimiothérapie néoadjuvante et adjuvante était reliée à un plus grand risque de contracture capsulaire (p=0,009).Conclusions: D'après la présente étude, la RDÉ peut être préférable pour réduire le risque de nécrose du complexe aérolo-mamelonnaire et de déhiscence de la plaie, particulièrement chez les patientes à haut risque. Un foyer prépectoral n'avait pas d'incidence significative sur le risque de mastectomie ou de nécrose du complexe aérolo-mammelonnaire et devrait être envisagé dans tous les cas pour limiter la morbidité. Les affections à plus haut risque de reconstruction alloplastique incluaient des ptôses de plus haut grade, des antécédents de tabagisme et un IMC plus élevé.
Mots-clés: directement à l'implant, expanseur tissulaire, implant mammaire, mastectomie, nécrose cutanée de la mastectomie, reconstruction mammaire
Introduction
The rate of breast reconstruction after mastectomy has increased substantially over the past 20 years. An estimated 107 000 women underwent breast reconstruction in 2019. 1 With the recent rise in skin and nipple-sparing mastectomies (SSM and NSM respectively), a larger proportion of patients have chosen implant-based reconstruction. Two-staged reconstruction (TSR), in which an expander is inserted at the time of mastectomy and later replaced with a permanent implant, has historically been the most common surgical approach. However, direct-to-implant reconstruction (DTI), in which a permanent implant is placed as a single stage procedure at the time of mastectomy, has gained popularity. 2
Touted benefits of DTI reconstruction include the avoidance of a second procedure, maintenance of the patient's breast size prior to mastectomy, decreased need for fat grafting, and improved control over final nipple positioning. 3 The most important factors for successful DTI breast reconstruction are mastectomy skin flap quality and perfusion, 3 as these factors determine the development of post-operative mastectomy skin necrosis (MSN). The current literature has reported conflicting evidence regarding MSN rates between the conventional TSR approach and DTI breast reconstruction.4-8 A systematic review in 2017 among patients who underwent Wise-pattern skin-sparing mastectomy reported an increase in MSN and overall complications for DTI reconstruction compared to TSR. 7 However, some more recent studies, including a propensity-score matched comparison with 1740 patients, showed no difference in necrosis rates between patients who underwent either type of reconstruction. 8 Although there are rigorous studies that have explored the post-operative complication rates between DTI and TSR, 2 none have stratified these outcomes by relevant populations, preoperative physical exam findings, mastectomy characteristics, or implant placement – all of which could potentially impact the overall complication rates.
This retrospective cohort study compared rates of MSN associated with DTI or TSR after SSM or NSM. Secondary outcomes included other postoperative complications such as nipple-areolar-complex (NAC) necrosis, hematoma, seroma, infection, and capsular contracture. The results of primary and secondary outcomes were stratified by body mass index (BMI), implant/expander placement location (pre-pectoral vs submuscular/dual-plane), acellular dermal matrix (ADM) use, mastectomy type, mastectomy weight, and degree of pre-operative breast ptosis. Uniquely, the majority of the mastectomies were performed by a single breast surgeon and thus internally controlled for inter surgeon mastectomy technique and skin flap quality variability.
Methods
Following Institutional Review Board (IRB) approval, all patients who underwent SSM or NSM followed by immediate DTI or TSR between 2011 through 2021 at a large academic center were included in this study. This cohort represented patients from multiple breast and plastic surgeons. Patients who underwent delayed reconstruction were excluded from this study. All NSM skin incisions were inframammary fold (IMF). All SSM incisions were circum-areolar elliptical incisions.
Demographic data extracted from each group included age, race, ethnicity, and BMI. Extracted disease-related data included cancer type and stage, and adjuvant radiotherapy and/or chemotherapy status. Preoperative physical exam related data included the degree of ptosis. Intraoperative parameters included ADM use, mastectomy weight, and location of implant placement. Post-operative data included presence of MSN, NAC necrosis, seroma, hematoma, infection, or capsular contracture. Early complications (within 90 days of the first surgery) and late complications (90 days to 1 year) were evaluated. MSN was defined as the presence of either partial or full thickness necrosis of the mastectomy skin flap. A NAC necrosis grading scale was used to determine NAC necrosis from minimal to complete necrosis. 9 Infection was defined as cellulitis or abscess requiring antibiotic treatment or operative intervention. Seroma was defined as the presence of fluid collection after drains had been removed. Hematoma was defined as a collection of blood as evidenced by the presence of blood upon drainage. Capsular contracture was graded by the Baker Classification I-IV (I- Soft, II – Minimal, implant palpable, not visible; III – moderate, palpable, and visible; IV – severe, hard, painful with distortion). 10
Statistical analysis included Fisher's Exact tests for categorical variables and Mann-Whitney tests for continuous variables. Categorical variables were presented as numbers with percentages and continuous variables were presented as means with standard deviations (SD). Statistical significance was determined by a P-value ≤ .05.
Results
Patient Demographics
Records of 295 female patients (TSR = 271, DTI = 24) were included and analyzed. Demographics and procedure types are displayed in Table 1. Patients did not statistically differ in terms of age (P = .66), BMI (P = .099), race (P = .371), tobacco use (P = .486), history of diabetes mellitus (P = .377), history of coronary artery disease (P = .415), radiotherapy during or after reconstruction (P = .675), neoadjuvant or adjuvant chemotherapy (P = .140), or postoperative follow-up (P = .767). More patients in the TSR group underwent neoadjuvant and/or adjuvant chemotherapy as compared to patients in the DTI group (TSR = 146/271, DTI = 7/24; P = .02).
Table 1.
Patient Characteristics and Outcomes by Procedure Type.
| Overall (N = 295) |
TSR (N = 271, 91.9%) |
DTI (N = 24, 8.1%) |
P-value | |
|---|---|---|---|---|
| Age | 52 (12.5) | 50 (12) | 52 (13) | .660 |
| BMI | 26.6 (6.4) | 26.8 (6.5) | 24.5 (4.5) | .099 |
| Race | ||||
| White | 255 (86.4) | 235 (86.7) | 20 (83.3) | .371 |
| Black | 17 (5.8) | 16 (5.9) | 1 (4.2) | |
| Asian/Pacific Islander | 4 (1.4) | 3 (1.1) | 1 (4.2) | |
| Other | 16 (5.5) | 14 (5.2) | 2 (8.3) | |
| Hispanic | 14 (4.7) | 14 (5.2) | 0 (0) | .617 |
| Smoking | ||||
| Never | 208 (70.5) | 192 (70.8) | 16 (66.7) | .486 |
| Former | 80 (27.1) | 73 (26.9) | 7 (29.2) | |
| Current | 6 (2) | 5 (1.8) | 1 (4.2) | |
| Comorbidities | ||||
| DM | 17 (5.8) | 17 (6.3) | 0 (0) | .377 |
| CAD | 7 (2.4) | 6 (2.2) | 1 (4.2) | .415 |
| Radiotherapy** | 146 (49.5) | 135 (49.8) | 11 (46) | .675 |
| Chemotherapy | ||||
| Neoadjuvant | 65 (22.0) | 61 (22.5) | 4 (16.7) | .185 |
| Adjuvant | 74 (25.0) | 71 (26.2) | 3 (12.5) | |
| Max Breast Resection Weight (g) | 454.8 (345.1) | 468.8 (348.6) | 303.3 (265.2) | .022* |
| Degree Ptosis | ||||
| 1 | 51 (17.3) | 45 (16.6) | 6 (25) | .019* |
| 2 | 117 (39.7) | 107 (39.5) | 10 (41.7) | |
| 3 | 55 (18.6) | 55 (20.3) | 0 (0) | |
| Nipple-Sparing Mastectomy | 91 (30.1) | 80 (87.9) | 11 (12.1) | .171 |
| ADM use | 247 (83.7)) | 228 (84.1) | 19 (79.2) | .772 |
| Implant placement | ||||
| Pre-pectoral | 52 (83.7) | 46 (17.0) | 6 (25) | .339 |
| Subpectoral/ Dual Plane | 240 (81.4) | 223 (82.3) | 17 (70.8) | .170 |
| Post-operative Follow-Up (years) | 3.5 (3.2) | 3.5 (3.2) | 3.7 (3.6) | .768 |
Continuous variables are presented as mean (SD); categorical variables are presented as N (col%). P-values are the results of Mann-Whitney tests (continuous variables) or Fisher's Exact tests (categorical variables).
*Significant at α = .05.
**Received during or after reconstruction.
Abbreviations: BMI, Body Mass Index; DM, Diabetes Mellitus (Type I or Type II); CAD, Coronary Artery Disease; Max, Maximum.
Patients in the TSR group had larger average breast resection weights (468.8 g vs 303.3 g, P = .022) and higher average degree of breast ptosis as compared to patients in the DTI (P = .019). There was no significant difference in nipple-sparing mastectomy (P = .171), ADM use (P = .772), and implant placement location (pre-pectoral, P = .339; subpectoral/dual-plane, P = .170).
Postoperative Complication Rates
Patients with DTI reconstruction had significantly higher rates dehiscence (DTI = 7/24, TSR = 28/271; P = .016) compared to patients with TSR; those who underwent DTI after NSM had significantly higher rates of NAC necrosis compared to TSR (DTI = 4/11, TSR = 4/80; P = .007) (Table 2). There was no significant difference in overall complication rate, MSN, seroma, hematoma, capsular contracture, and infection between the two types of reconstruction (Table 2).
Table 2.
Complications by Procedure Type.
| Overall (N = 295) |
TSR (N = 271) |
DTI (N = 24) |
P-value | |
|---|---|---|---|---|
| Any Complication | 94 (31.9) | 88 (32.5) | 6 (25) | .502 |
| MSN | 34 (11.5) | 29 (10.7) | 5 (20.8) | .173 |
| NAC necrosis† | 8 (8.8) | 4/80 (5) | 4/11 (36.3) | .007 |
| Seroma | 52 (17.6) | 50 (18.5) | 2 (8.3) | .273 |
| Hematoma | 19 (6.4) | 17 (6.3) | 2 (8.3) | .659 |
| Capsular Contracture (I-IV) | 29 (9.8) | 25 (9.2) | 4 (16.7) | .274 |
| Infection | 87 (29.5) | 77 (28.4) | 10 (41.7) | .245 |
| Dehiscence | 35 (11.9) | 28 (10.3) | 7 (29.2) | .016* |
Variables are presented as N (col%). P-values are the results of Fisher's Exact tests (categorical variables).
*Significant at α = .05.
**Significant at α = .01
†Only compared within nipple-sparing mastectomy population, n = 91.
Regardless of procedure, higher BMI (P = .002), higher preoperative grade ptosis (P = .01), and use of adjuvant chemotherapy (P = .010) were associated with a higher risk of any complication (Table 3). In patients with post-operative complications, there was no significant difference in age, tobacco use, history of diabetes mellitus, history of coronary artery disease, ADM use, and implant placement location (Table 3).
Table 3.
Patient Characteristics and Outcomes by Complication Status.
| No complications (N = 199, 67.4%) | Complication (N = 96, 32.5%) | P-value | |
|---|---|---|---|
| Age | 50 (12) | 51 (13) | .623 |
| BMI | 25.7 (5.3) | 28.5 (8.0) | .002** |
| Smoking | |||
| Never | 145 (72.1) | 62 (66.0) | .345 |
| Former | 50 (24.9) | 29 (30.9) | |
| Current | 3 (1.5) | 3 (3.2) | |
| Comorbidities | |||
| DM | 8 (4.0) | 9 (9.6) | .066 |
| CAD | 4 (2.0) | 3 (3.2) | .684 |
| Chemotherapy | |||
| None | 104 (66.2) | 53 (33.8) | .010* |
| Neoadjuvant | 52 (81.25) | 12 (18.75) | |
| Adjuvant | 42 (57.5) | 31 (42.5) | |
| Degree Ptosis† | |||
| 1 | 38 (74.5) | 13 (25.5) | .010* |
| 2 | 86 (73.5) | 31 (26.5) | |
| 3 | 28 (50.9) | 27 (49.1) | |
| ADM use | 170 (84.6) | 75 (80.0) | .309 |
| Implant placement | |||
| Pre-pectoral | 36 (17.9) | 16 (17.0) | .871 |
| Subpectoral/Dual Plane | 162 (80.6) | 78 (83.0) |
Continuous variables are presented as mean (SD); categorical variables presented as N (col%). P-values are the results of Mann-Whitney tests (continuous variables) or Fisher's Exact tests (categorical variables).
*Significant at α = .05.
**Significant at α = .01.
†Missing/no recorded ptosis n = 74 not included in analysis.
Abbreviations: BMI. Body Mass Index; DM, Diabetes Mellitus (Type I or Type II); CAD, Coronary Artery Disease.
For either DTI or TSR, higher grade ptosis was specifically associated with an increased risk of developing MSN (P = .005) (Table 4). Higher grade ptosis was not associated with risk of seroma, hematoma, capsular contracture, infection, dehiscence, or NAC necrosis (Table 4). Further, prior tobacco use was associated with increased risk of infection (P = .036) and dehiscence (P = .025) in both procedures (Table 5). Smoking status was not associated with risk of MSN, NAC necrosis, seroma, hematoma, and capsular contracture (Table 5).
Table 4.
Complications by Grade Ptosis.
| Ptosis Grade 1 N = 51 |
Ptosis Grade 2 N = 117 |
Ptosis Grade 3 N = 55 |
P-value | |
|---|---|---|---|---|
| MSN | 6 (11.8) | 10 (8.5) | 13 (23.6) | .005* |
| NAC necrosis† | 4/23 (17.4) | 2/36 (5.5) | 0/1 (0) | .277 |
| Seroma | 15 (29.4) | 18 (15.3) | 9 (16.4) | .117 |
| Hematoma | 6 (11.8) | 5 (4.3) | 3 (5.5) | .186 |
| Capsular Contracture (I-IV) | 4 (7.8) | 14 (12.0) | 3 (5.5) | .383 |
| Infection | 13 (2.5) | 29 (24.7) | 19 (34.5) | .222 |
| Dehiscence | 5 (9.8) | 17 (14.5) | 6 (10.9) | .796 |
Variables are presented as N (col%). P-values are the results of Fisher's Exact tests (categorical variables).
*Significant at α = .05.
**Missing/no recorded ptosis n = 74.
† Only compared within nipple-sparing mastectomy population with recorded ptosis, n = 60.
Table 5.
Complications by Smoking Status.
| Never Smoker N = 208 |
Former Smoker N = 80 |
Current Smoker N = 6 |
P-value | |
|---|---|---|---|---|
| MSN | 21 (10.1) | 12 (15.0) | 1 (16.7) | .364 |
| NAC necrosis† | 6/73 (8.2) | 2/18 (11.1) | 0 (0) | .658 |
| Seroma | 38 (18.3) | 14 (17.5) | 0 (0) | .752 |
| Hematoma | 14 (6.7) | 4 (5.0) | 1 (16.7) | .396 |
| Capsular Contracture (I-IV) | 24 (11.5) | 4 (5.0) | 1 (16.7) | .144 |
| Infection | 53 (25.5) | 31 (38.8) | 3 (50.0) | .036* |
| Dehiscence | 21 (10.1) | 11 (13.8) | 3 (50.0) | .025* |
Variables are presented as N (col%). P-values are the results of Fisher's Exact tests (categorical variables).
*Significant at α = .05.
†Only compared within nipple-sparing mastectomy population, n = 91.
Neoadjuvant chemotherapy and adjuvant chemotherapy were associated with increased risk of capsular contracture (P = .009). Neoadjuvant chemotherapy was associated with decreased risk of MSN (P = .040) (Table 6). Neoadjuvant or adjuvant chemotherapy was not associated with risk of NAC necrosis, seroma, hematoma, infection, or dehiscence (Table 6).
Table 6.
Complications by Chemotherapy.
| None N = 157 |
Neoadjuvant N = 64 |
Adjuvant N = 74 |
P-value | |
|---|---|---|---|---|
| MSN | 22 (14.0) | 2 (3.1) | 10 (13.5) | .040* |
| NAC necrosis† | 5/51 (9.8) | 0/23 (0) | 2/14 (14.3) | .234 |
| Seroma | 30 (19.1) | 7 (10.9) | 13 (17.6) | .357 |
| Hematoma | 11 (7.0) | 3 (4.7) | 6 (8.1) | .746 |
| Capsular Contracture (I-IV) | 8 (5.1) | 10 (15.6) | 11 (14.9) | .009** |
| Infection | 48 (30.6) | 17 (26.6) | 25 (33.8) | .671 |
| Dehiscence | 21 (13.4) | 6 (9.4) | 9 (12.2) | .838 |
Variables presented as N (col%). P-values are the results of Fisher's Exact tests (categorical variables).
*Significant at α = .05.
**Significant at α = .01.
†Only compared within nipple-sparing mastectomy population with recorded chemotherapy data, n = 88.
Pre-pectoral placement was not significantly associated with risk of NAC necrosis, MSN, seroma, hematoma, capsular contracture, infection, or dehiscence (Table 7).
Table 7.
Complications by Implant Placement.
| Prepectoral
Placement N = 52 |
Subpectoral/
Dual Plane
Placement N = 242 |
P-value | ||
|---|---|---|---|---|
| MSN | 5 (9.6) | 29 (12) | .812 | |
| NAC necrosis† | 1/20 (5) | 7/71 (9.9) | .680 | |
| Seroma | 10 (19.2) | 42 (17.4) | .842 | |
| Hematoma | 3 (5.8) | 16 (6.6) | 1 | |
| Capsular Contracture (I-IV) | 7 (13.5) | 22 (9.1) | .315 | |
| Infection | 20 (38.5) | 67 (27.7) | .132 | |
| Dehiscence | 10 (19.2) | 25 (10.3) | .100 | |
Categorical variables are presented as N (col%). P-values are the results of Fisher's Exact tests (categorical variables).
*Significant at α = .05.
† Only compared within NSM in patients, n = 91.
There was no difference in complications between NSM and SSM (Table 8).
Table 8.
Complications by Nipple Sparing Versus Skin Sparing Mastectomy.
| Nipple Sparing N = 91 | Skin Sparing N = 204 | P-value | |
|---|---|---|---|
| MSN | 8 (8.7) | 26(12.7) | .430 |
| Seroma | 11 (12.1) | 41 (20.1) | .136 |
| Hematoma | 8 (8.8) | 11 (5.4) | .304 |
| Capsular Contracture (I-IV) | 10 (11) | 12 (5.9) | .145 |
| Infection | 25 (27.4) | 63 (30.1) | .782 |
| Dehiscence | 10 (11) | 25 (12.3) | .847 |
Categorical variables are presented as N (col%). P-values are the results of Fisher's Exact tests (categorical variables).
*Significant at α = .05.
Discussion
In line with classical thinking, results from this single-institution study suggest that TSR in general may be the safest choice for patients undergoing post-mastectomy reconstruction in order to reduce the risk of NAC necrosis and wound dehiscence. This study demonstrates higher risk of wound healing complications (ie MSN and NAC necrosis). These findings are particularly relevant in patients who have a high preoperative likelihood for requiring post-mastectomy radiotherapy (PMR) as the presence of open wounds precludes the administration of radiation. 11
Delay of timely administration of adjuvant radiation beyond 8 weeks is associated with poor oncologic outcomes12-14 with studies demonstrated increased recurrence and mortality. 15 Unfortunately, postoperative complications particularly MSN result in increased time to adjuvant therapy. 16 It is thus incumbent on plastic surgeons to be aware of the entire oncologic treatment plan in order to mitigate potential post-surgical complications that could impact cancer therapies.
In contrast to the current study, Srinivasa et al found no difference in any complication between DTI and TSR in their large cohort of 1427 patients (1328 TSR, 99 DTI); however, they did not stratify their results by any complication, major complication, wound infection, major infection, and reconstructive failure. 2 Hoque et al also found no difference in complication rates between DTI and TSR, yet also did not stratify by specific complication. 17 While Han et al stratified their results (233 DTI, 65 TSR) by specific complication and, unlike this study, they found that TSR had a higher rate of hematoma, seroma, and implant failure. 5 However, they also found a trend toward significance (P = .053) with a lower rate of MSN in the TSR group, which was also not observed in our study.
A higher percentage of patients in this study who received neoadjuvant and/or adjuvant chemotherapy underwent TSR over DTI. Chemotherapy, particularly in the neoadjuvant setting has previously been linked to increased wound healing complications.18,19 Many plastic surgeons are weary of adding a heavy implant to already tenuous mastectomy skin flaps. Given the average BMI and ptosis in our patient population is high (BMI 26.6, grade 2 ptosis), thus necessitating a sizable permanent implant, it is unsurprising that most patients in this cohort did not undergo DTI particularly in patients who have or are likely to undergo chemotherapy where additional challenges to proper healing may be more likely. However, a recent study showed that DTI after neoadjuvant chemotherapy did not increase complication rates compared to no chemotherapy and therefore DTI may safely be considered in select patients. 20 Our study similarly did not show neoadjuvant chemotherapy as a variable for increased risk of complications in patients who underwent DTI. However, it is important to note that the total number of DTI patients in this study is substantially smaller than TSR and that most patients in the DTI group had smaller breasts with lesser degrees of ptosis, two factors associated with lower risks of complications.
Interestingly, in our cohort, adjuvant chemotherapy was associated with an increased risk of total complications across both groups, while, neoadjuvant chemotherapy seemed to actually be protective against MSN (P = .04), with only 3% of patients developing MSN compared to patients who received adjuvant (13.5%) or no chemotherapy (14.1%). 21 This is contrary to some schools of thought that chemotherapy can delay wound healing and thereby lead to skin necrosis. However, while chemotherapy has not previously been demonstrated as a protective factor, many studies have shown no association between chemotherapy and wound healing complications. 22 Interestingly, both neoadjuvant and adjuvant chemotherapy were also associated with increased risk of capsular contracture (P = .009). While others have also shown similar associations between neoadjuvant chemotherapy and a higher risk of developing capsular contracture, this has not been previously demonstrated with adjuvant chemotherapy. 21 One potential reason for this association is that it may be an indirect assessment of mastectomy flap thickness, in that patients needing chemotherapy likely have more unfavorable tumor factors, including size. As a result, this may impact the mastectomy flap thickness and ultimately the factors with reference to capsular contracture.
Consistent with the literature,23-26 this study also noted that regardless of the reconstructive modality, higher BMI and preoperative grade ptosis were associated with a higher risk of any complication. Obesity is an independent positive predictor for the development of MSN and infection. In implant based breast reconstruction, MSN and infection in turn are the two major culprits for unplanned reoperations. 27 In fact, risk of reconstructive loss in the obese patient population can be upwards of 25%. 28 Managing a large and pendulous skin envelope after mastectomy, similarly leads to distinct reconstructive challenges.23,29 The poorer baseline skin quality and integrity of the large and pendulous breast is more prone to ischemia and necrosis. 30 Insufficient vascularity becomes particularly relevant in NSM in the context of higher degrees of ptosis. This makes sense as the distance from the blood supply increases the more distal the NAC is. We did not find higher rates of NAC necrosis with increasing degrees of ptosis, although we would expect this as surgeons would instead opt to perform SSM as NSM (without a prior preparatory mastopexy/reduction to address this degree of ptosis) is generally considered to yield aesthetically unfavorable results, particularly with implant-based reconstruction, and thus not usually offered. Patients with recorded grade 3 ptosis had an overall complication rate of 49.1%, with MSN rate of 23.6%, comparable to the higher end of MSN rates recorded in the literature (8%-25%). 31 These rates were significantly higher than patients with grade 2 (26.5% complication, 8.5% MSN) or grade 1 (25.5% complication, 11.8% MSN).
Smoking is a well-known risk factor for surgical site complications including delayed wound healing and tissue necrosis. 32 In line with the literature, for either DTI or TSR, in this study, current or prior tobacco use was associated with increased risk of infection (P = .036) and dehiscence (P = .025). While most plastic surgeons therefore delay reconstruction by at least four weeks after last known nicotine use, our results suggest the increased risks might persist long term. 33 Clinical implications of these findings might include differential patient counseling practices for former smokers regarding higher complications risk profile or implementing novel techniques such as uncoupling the index mastectomy from the reconstruction by a short period to allow the tissues to recover from the initial ischemic insult of the mastectomy prior to placing a foreign body.
Historically, subpectoral placement of tissue expanders and breast implants have been standard of care. 34 However, placing prosthetics in the subpectoral plane has been associated with a variety of complications, including pain, animation deformity, and poor breast projection.35-38 With the advent of ADM, pre-pectoral assisted breast reconstruction has gained popularity with more favorable reported outcomes and comparable complication rates to subpectoral reconstruction.34,37,39 Indeed, results of our study also did not show increased complications with pre-pectoral device. Additionally, by obviating surgical manipulation of the pectoralis major muscle, pre-pectoral reconstruction has been shown to reduce discomfort and improve patient's physical well-being, recovery, and aesthetic outcome without animation deformity.35,39,40
The main limitations in this study are its retrospective nature and the imbalance in sample size between TSR and DTI. However, it is important to note that despite patients in the TSR group having higher degrees of ptosis and having been more likely to have undergone chemotherapy (two factors that have previously been linked to poorer healing), the DTI group, in fact, experienced more complications. Additionally, given that more TSR patients underwent adjuvant or neoadjuvant chemotherapy, this may be a surrogate marker for disease and as a result there may have been a high index of suspicion that these patients may have also needed radiation therapy. Thus, this may have affected the decision for TSR over DTI, biasing the study outcomes in favor of TSR. Additionally, this study was performed at a single academic center study and therefore may have suffered regional or institutional selection bias. Differences in surgical techniques and post-operative clinical management among plastic surgeons precluded true standardization of care, however the total number of plastic surgeons was low (five). Conversely, a true strength of this study is that most mastectomies (201/295) were performed by a single breast surgeon. The remaining surgeries were performed by two other breast surgeons. As most wound healing complications (and sequelae thereof such as infection) including MSN and nipple necrosis are largely a result of the mastectomy technique, consistency of this variable allows for a truer comparison between the reconstructive techniques. Another source of bias is variable losses to follow-up and incomplete data on confounding factors between the two groups. Randomized controlled trials comparing TSR and DTI are therefore necessary.
Conclusions
This single-institution study suggests that TSR may still be preferred in alloplastic reconstruction to minimize the risk of NAC necrosis and wound dehiscence particularly in higher risk patients such as those with obesity and significant ptosis. Pre-pectoral placement did not significantly affect the risk of MSN or NAC necrosis. These results underscore established higher risk conditions for alloplastic reconstruction including higher degrees of ptosis, history of tobacco use, and obesity. Lastly, these results highlight specific risk factors and preoperative considerations for surgeons to be aware of prior to performing implant-based breast reconstruction. Further large-scale studies with more detailed analyses of possible complications are warranted.
Footnotes
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The authors received no financial support for the research, authorship, and/or publication of this article.
Informed Consent: This study was approved by the University of Florida IRB (IRB202101960). All procedures were followed in accordance with the Helsinki Declaration of 1975, as revised in 2013.
ORCID iDs: Kyle M. Ockerman https://orcid.org/0000-0002-6500-6740
Sarah Sorice-Virk https://orcid.org/0000-0002-9563-7738
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