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Chronic postmastectomy pain affects up to 40 percent of patients and leads to diminished quality of life and increased risk of opioid dependence. The cause of this pain is incompletely understood; however, one hypothesis is that direct injury to cutaneous intercostal nerves at the time of mastectomy and/or reconstruction leads to chronic pain. As a result, proximal neurectomy of the involved sensory nerve(s) has been suggested to be effective for these patients. The purpose of this study was to determine whether chronic pain in postmastectomy patients can be diagnosed reliably in an office setting and pain reduced by intercostal sensory neurectomy. The authors performed a retrospective review of seven patients with a history of breast surgery and chronic pain who underwent intercostal neurectomy combined with muscle or dermal wrapping of the proximal end of the resected nerve. All patients were diagnosed by history and physical examination, and suspected nerves were further identified with local anesthetic nerve blocks. An average of 3.14 neurectomies were performed per patient (range, one to six). There was a significant reduction in visual analogue scale pain scores following surgery, from 9 preoperatively to 1 postoperatively (p = 0.02). Eighty-six percent of patients were pain-free or "considerably improved" at their latest follow-up appointment (average, 6.14 months). It is concluded that intercostal sensory nerve injury at the time of mastectomy and/or reconstruction can lead to chronic mastectomy pain, which can be easily diagnosed and effectively treated with intercostal neurectomy.Therapeutic, IV.

OBJECTIVE To determine the impact of gender-affirming mastectomy on depression, anxiety, and body image. BACKGROUND There are many cross-sectional and ad-hoc studies demonstrating the benefits of gender-affirming surgery. There are few prospective investigations of patient-reported outcomes in gender-affirming surgery using validated instruments. METHODS In this prospective study, patients presenting the University of Michigan for gender-affirming Mastectomy were surveyed preoperatively and six-months postoperatively. Primary outcomes were patient-reported measurements of anxiety measured by GAD-7, depression measured by PHQ-9, body image measured by BODY-Q and BIQLI, psychosocial and sexual functioning measured by BREAST-Q, and satisfaction with decision measured by BREAST-Q. Linear regression analysis was used to control for presence of complication and existing history of mental health conditions. RESULTS 70 patients completed the study. The average age of participants was 26.7. The mean PHQ-9 score preoperatively was 7.8 and postoperatively was 5.4 (p=0.001). The mean preoperative and postoperative GAD-7 scores were 7.6 and 4.6 respectively (p

Summary Background Although acellular dermal matrix (ADM) is widely used in expander-implant-based breast reconstructions, previous analyses have been unable to demonstrate improvements in patient-reported outcomes (PROs) with this approach over non-ADM procedures. This study aims to develop a more selective, evidence-based approach to the use of ADM in expander-implant-based breast reconstruction by identifying patient subgroups in which ADM improved clinical outcomes and PROs. Study design The Mastectomy Reconstruction Outcomes Consortium Study prospectively evaluated immediate expander-implant reconstructions at 11 centers from 2012 to 2015. Complications (any/overall and major), and PROs (satisfaction, physical, psychosocial, and sexual well-being) were assessed two years postoperatively using medical records and the BREAST-Q, respectively. Using mixed-models accounting for centers and with interaction terms, we analyzed for differential ADM effects across various clinical subgroups, including age, body mass index, radiation timing, and chemotherapy. Results Expander-implant-based breast reconstruction was performed in 1451 patients, 738 with and 713 without ADM. Major complication risk was higher in ADM users vs. nonusers (22.9% vs. 16.4% and p = 0.04). Major complication risk with ADM increased with higher BMI (BMI=30, OR=1.70; BMI=35, OR=2.29, interaction p = 0.02). No significant ADM effects were observed for breast satisfaction, psychosocial, sexual, and physical well-being within any subgroups. Conclusion In immediate expander-implant-based breast reconstruction, ADM was associated with a greater risk of major complications, particularly in high-BMI patients. We were unable to identify patient subgroups where ADM was associated with significant improvements in PROs. Given these findings and the financial costs of ADM, a more critical approach to the use of ADM in expander-implant reconstruction may be warranted.

BACKGROUND Although the benefits of gender-affirming surgery may be apparent to patients and providers, there remains a paucity of studies assessing the impact of these procedures. As an initial step, preoperative patient-reported outcomes using validated measures of depression, anxiety, and body image were used and compared to cisgender normative data. METHODS Patients presenting for gender-affirming mastectomy were approached and surveyed using validated instruments measuring anxiety, depression, and body image. In addition, clinical data were collected from the medical record. Results were compared to published instrument norms in the general cisgender population. RESULTS One hundred three patients completed the preoperative assessment; 70.3 percent and 66.3 percent of the cohort screened positive for mild to severe depression and anxiety, respectively. Only 25 percent and 29.8 percent of the cohort, respectively, had a previous diagnosis of depression and anxiety. The rates of depression and anxiety were significantly higher than those in cisgender normative data [mean Patient Health Questionnaire score, 2.7 (p < 0.0001); mean Generalized Anxiety Disorder Scale 7 score, 2.66 (p < 0.0001)]. Body Image Quality of Life Index and BREAST-Q scores were also significantly lower than those in cisgender normative data. CONCLUSIONS Patients seeking gender-affirming mastectomy have a significant mental health burden that appears to be underdiagnosed. They further have significant challenges with body image compared with cisgender normative data. These findings signify dramatic mental health disparities in the preoperative transgender population and the need for ongoing prospective research of gender-affirming surgery.

BACKGROUND The objective of this study was to determine whether women with a history of radiation therapy before mastectomy experience a risk for postoperative complications and patient-reported outcomes similar to those of women undergoing postmastectomy radiation therapy in the setting of immediate implant reconstruction. METHODS The cohort included patients undergoing immediate implant reconstruction at 11 centers across North America. Women were categorized into three groups: prior breast conservation therapy, postmastectomy radiation therapy, and no radiation therapy. Mixed effect logistic regressions were used to analyze the effects of radiation therapy status on complication rates and patient-reported outcomes. RESULTS ONE THOUSAND FIVE HUNDRED NINETY-FOUR: patients were analyzed, including 84 women with prior breast conservation therapy, 329 women who underwent postmastectomy radiation therapy, and 1181 women with no history of radiation therapy. Compared with postmastectomy radiation therapy, breast conservation was associated with lower rates of all complications and major complications (OR, 0.65; 95 percent CI, 0.37 to 1.14; p = 0.13; and OR, 0.61; 95 percent CI, 0.33 to 1.13; p = 0.12). These differences were not statistically significant. Rates of reconstructive failure between the two cohorts were comparable. Before reconstruction, satisfaction with breasts was lowest for women with prior breast conservation therapy (p < 0.001). At 2 years postoperatively, satisfaction with breasts was lower for women with postmastectomy radiation therapy compared with breast conservation patients (p = 0.007). CONCLUSIONS Higher postoperative complication rates were observed in women exposed to radiation therapy regardless of timing. Although women with prior breast conservation experienced greater satisfaction with their breasts and fewer complications when compared to women undergoing postmastectomy radiation therapy, there was a similar risk for reconstruction failure. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, II.

Objective In this study, we quantified the global macroeconomic burden of breast cancer to underscore the critical importance of improving access to oncologic surgical care internationally. Summary background data Breast cancer mortality in many low and middle-income countries (LMICs) is dramatically higher than in high-income countries. Prior to identifying solutions, however, it is important to first define the burden of disease. Methods Data from the Institute of Health Metrics and Evaluation (2005-2015) were used to assess epidemiologic trends for 194, middle, and low-income countries. Economic burden defined by Welfare Loss (WL) was calculated by measuring disability-adjusted-life-years lost to breast cancer alongside the dollar equivalent of a value of statistical life year and as a function of each country's gross domestic product (GDP). Results Annual mortality rates among breast cancer patients were significantly greater in LMICs in South Asia (3.06 per 100 women) and Sub-Saharan Africa (2.76 per 100 women), compared with high-income countries like the United States (1.69 per 100 women). From 2005-2015, mortality in South Asia increased by 8.20% and decreased by 6.45% in Sub-Saharan Africa; mortality rates in 2015 were observed as 27.9 per 100,000 in South Asia and 18.61 per 100,000 in Sub-Saharan Africa. Countries in South Asia demonstrated the greatest rise in WL due to breast cancer, from 0.05% to 0.08% of GDP. Conclusions The burden of disease and economic impact of breast cancer is intensifying in LMICs. Global efforts to improve access to surgical care for women with breast cancer could reduce mortality and mitigate the social and financial impact of this disease in LMICs.

Background Previous investigators demonstrated that female patients often prefer female providers. However, these studies have not determined whether there are gender preferences for breast reconstruction surgeons or whether the effects of surgeon gender impacts patient-reported outcomes. Methods Adult women were crowdsourced using Amazon Mechanical Turk to characterize societal preferences for the gender of breast and plastic surgeons in a hypothetical scenario. The authors also used data from the Mastectomy Reconstruction Outcomes Consortium to determine the association between surgeon gender and patient satisfaction after breast reconstruction. The BREAST-Q questionnaire was used to assess patient-reported outcomes at 3 months and 2 years following reconstruction. Regression analyses were performed to investigate the effects of surgeon gender on patient-reported outcomes. Results In total, 1413 surveys were collected. Forty-two percent preferred female plastic surgeons, 5 percent preferred male surgeons, and 53 percent reported no preference. The Mastectomy Reconstruction Outcomes Consortium analysis included 2236 patients of 55 male and nine female plastic surgeons. In this cohort, 1921 patients (82.2 percent) had male surgeons, whereas 415 patients (17.8 percent) had female surgeons. Regression analysis at 2 years revealed no differences in satisfaction with surgeon, outcome, or psychosocial well-being. Only satisfaction with information differed, as patients of female surgeons reported greater satisfaction in this category, with an adjusted mean difference of 2.82 (p = 0.018). Conclusions Although nonpatient women hypothetically prefer female providers, surgeon gender makes little difference in actual patient satisfaction with breast reconstruction. More investigation is needed to determine whether the difference in information delivery is clinically significant and whether it reflects variations in practices between male and female surgeons. Clinical question/level of evidence Therapeutic, III.

Objective The primary aim of this study was to compare patient-reported outcomes (PROs) of women who underwent immediate implant-based breast reconstruction (IBBR) after receiving either: (1) nipple-sparing mastectomy (NSM) or (2) simple mastectomy with subsequent nipple reconstruction (SNR). Background The goal of post-mastectomy breast reconstruction is to restore body image and quality-of-life after mastectomy, but removal of the nipple-areolar complex may have its own negative psychosocial consequences. NSM may have increased in popularity due to its perceived oncologic safety in many women and to reports of superior aesthetic results with this technique. Despite the increased utilization of NSM, few studies have evaluated the impact of NSM on PROs and complications in women undergoing immediate IBBR. Methods We performed a secondary analysis of the Mastectomy Reconstruction Outcomes Consortium study, a multicenter, prospective cohort study that recruited patients between February 2012 and July 2015. The primary aim of this study was to compare PROs as measured by BREAST-Q scores between women who underwent IBBR after NSM versus SNR. The secondary aim was to compare complication rates. Mixed-effects regression models controlled for demographic and clinical covariates. Results Of the 600 women in the study, 286 (47.7%) underwent NSM. After controlling for baseline patient characteristics, we found no significant differences in satisfaction with breast, psychosocial well-being, physical well-being or sexual well-being between women undergoing NSM versus SNR. Mastectomy type was not a significant predictor of complications or reconstructive failure. Conclusions Despite reports of superior aesthetics for NSM over simple mastectomy with nipple reconstruction in immediate IBBR, we found no significant differences at 2 years after reconstruction in patient satisfaction, quality-of-life, or complication rates.

Objective Our objectives were to investigate case-mix adjusted hospital variations in 2-year clinical and patient-reported outcomes following immediate breast reconstruction. Background Over the past few decades, variations in medical practice have been viewed as opportunities to promote best practices and high-value care. Methods The Mastectomy Reconstruction Outcomes Consortium Study is an National Cancer Institute-funded longitudinal, prospective cohort study assessing clinical and patient-reported outcomes of immediate breast reconstruction after mastectomy at 11 leading medical centers. Case-mix adjusted comparisons were performed using generalized linear mixed-effects models to assess variation across the centers in any complication, major complications, satisfaction with outcome, and satisfaction with breast. Results Among 2252 women in the analytic cohort, 1605 (71.3%) underwent implant-based and 647 (28.7%) underwent autologous breast reconstruction. There were significant differences in the sociodemographic and clinical characteristics, and distribution of procedure types at the different Mastectomy Reconstruction Outcomes Consortium Study centers. After case-mix adjustments, hospital variations in the rates of any and major postoperative complications were observed. Medical center odds ratios for major complication ranged from 0.58 to 2.13, compared with the average major complication rate across centers. There were also meaningful differences in satisfaction with outcome (from the lowest to highest of -2.79-2.62) and in satisfaction with breast (-2.82-2.07) compared with the average values. Conclusions Two-year postoperative complications varied widely between hospitals following post-mastectomy breast reconstruction. These variations represent an important opportunity to improve care through dissemination of best practices and highlight the limitations of extrapolating single-institution level data and the ongoing challenges of studying hospital-based outcomes for this patient population.

Background Whether to irradiate the tissue expander before implant exchange or to defer irradiation until after exchange in immediate, two-stage expander/implant reconstruction remains uncertain. The authors evaluated the effects of irradiation timing on complication rates and patient-reported outcomes in patients undergoing immediate expander/implant reconstruction. Methods Immediate expander/implant reconstruction patients undergoing postmastectomy radiation therapy at 11 Mastectomy Reconstruction Outcomes Consortium sites with demographic, clinical, and complication data were analyzed. Patient-reported outcomes were assessed with BREAST-Q, Patient-Reported Outcomes Measurement Information System, and European Organisation for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life Questionnaire surveys preoperatively and 2 years postoperatively. Survey scores and complication rates were analyzed using bivariate comparison and multivariable regressions. Results Of 317 patients who met inclusion criteria, 237 underwent postmastectomy radiation therapy before expander/implant exchange (before-exchange cohort), and 80 did so after exchange (after-exchange cohort). Timing of radiation had no significant effect on risks of overall complications (OR, 1.25; p = 0.46), major complications (OR, 1.18; p = 0.62), or reconstructive failure (OR, 0.72; p = 0.49). Similarly, radiation timing had no significant effect on 2-year patient-reported outcomes measured by the BREAST-Q or the European Organisation for Research and Treatment of Cancer survey. Outcomes measured by the Patient-Reported Outcomes Measurement Information System showed less anxiety, fatigue, and depression in the after-exchange group. Compared with preoperative assessments, 2-year patient-reported outcomes significantly declined in both cohorts for Satisfaction with Breasts, Physical Well-Being, and Sexual Well-Being, but improved for anxiety and depression. Conclusions Radiation timing (before or after exchange) had no significant effect on complication risks or on most patient-reported outcomes in immediate expander/implant reconstruction. Although lower levels of anxiety, depression, and fatigue were observed in the after-exchange group, these differences may not be clinically significant. Clinical question/level of evidence Therapeutic, II.

BACKGROUND The authors' purpose was to evaluate the effects of body mass index, as defined by World Health Organization criteria, on complications and patient-reported outcomes in implant-based and autologous breast reconstruction. METHODS Complications and BREAST-Q patient-reported outcomes were analyzed 2 years after breast reconstruction for women from 11 participating sites. Separate mixed-effects regressions were performed to assess body mass index effects on outcomes. RESULTS A total of 2259 patients (1625 implant-based and 634 autologous) were included. Women with class II/III obesity had higher risks of any complication in both the implant (OR, 1.66; p = 0.03) and autologous (OR, 3.35; p < 0.001) groups, and higher risks of major complications in both the implant (OR, 1.71, p = 0.04) and autologous (OR, 2.72; p = 0.001) groups, compared with underweight/normal weight patients. Both class I (OR, 1.97; p = 0.03) and class II/III (OR, 3.30; p = 0.001) obesity patients experienced higher reconstructive failures in the implant cohort. Class I obesity implant patients reported significantly lower Satisfaction with Breasts scores (mean difference, -5.37; p = 0.007). Body mass index did not significantly affect patient-reported outcomes for autologous reconstruction patients. CONCLUSIONS Obesity was associated with higher risks for complications in both implant-based and autologous breast reconstruction; however, it only significantly affected reconstruction failure and patient-reported outcomes in the implant reconstruction patients. Quality-of-life benefits and surgical risk should be presented to each patient as they relate to her body mass index, to optimize shared decision-making for breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE Risk, I.

Background Survey-based research is essential for evaluating the outcomes of health care in an era of patient-centered care. However, many such studies are hampered by poor response rates in completion of study questionnaires, thus limiting the generalizability of any findings. The objectives of this analysis were to identify independent variables associated with nonresponse to surveys following breast reconstruction to improve future patient-reported outcomes research. Materials and methods The Mastectomy Reconstruction Outcomes Consortium is a prospective cohort study involving 11 leading medical centers from the United States and Canada. Nonresponse rates for surveys assessing satisfaction with breast, satisfaction with care (BREAST-Q), depression (Patient Health Questionnaire-9), and anxiety (Generalized Anxiety Disorder-7) were measured at 1 y and 2 y postoperatively. Clinical complication rates were compared between responders and nonresponders, and multivariable models were used to assess predictors of nonresponse. Results Among 2856 women in the analytic cohort, 1882 (65.9%) underwent implant-based, 817 (28.6%) received autologous, and 157 (5.5%) underwent latissimus dorsi myocutaneous flap breast reconstructions. Nonresponse rates to surveys at 1 y and 2 y were 27.8% and 34.4%, respectively. Race, ethnicity, and annual household income were associated with nonresponse to surveys. Women who underwent implant-based procedures were less likely to complete long-term surveys. Conclusions As survey-based research plays an increasingly prominent role in evaluating the outcomes of breast reconstruction, we found socioeconomic and procedure-related differences in survey response rates. Investigators must consider systematic differences in response rates among particular groups of women on the generalizability and validity of findings and perform rigorous nonresponse bias analyses.

In postmastectomy reconstruction, procedure choice is heavily influenced by the relative risks of the various options. This study sought to evaluate complications in a large, multicenter patient population.Previous studies have reported widely varying complication rates, but have been limited by their single center designs and inadequate controlling for confounders in their analyses.Eleven sites enrolled women undergoing first time, immediate, or delayed reconstruction following mastectomy for cancer treatment or prophylaxis. Procedures included expander/implant, latissimus dorsi (LD), pedicle transverse rectus abdominis musculocutaneous (PTRAM), free TRAM (FTRAM), and deep inferior epigastric perforator (DIEP) techniques. Data were gathered pre- and postoperatively from medical records. Separate logistic regressions were conducted for all complications and major complications (those requiring rehospitalization and/or reoperation) within 1 year. Odds ratios (ORs) were calculated for procedure type, controlling for site, demographic, and clinical variables.Complication rates for 2234 patients were analyzed. Compared with expander/implant reconstructions, LD (OR) 1.95, P = 0.026), PTRAM (OR 1.89, P = 0.025), FTRAM (OR 1.94, P = 0.011), and DIEP (OR 2.22, P0.001) procedures were associated with higher risks of complications. Significantly higher risks were also associated with older age, higher body mass index (BMI), immediate reconstruction, bilateral procedures, and radiation. For major complications, regression showed significantly greater risks for PTRAM (OR 1.86, P = 0.044) and DIEP (OR 1.75, P = 0.004), than expander/implant reconstructions. Failure rates were relatively low, ranging from 0% for PTRAM to 5.9% for expander/implant reconstructions.In this multicenter analysis, procedure choice and other patient variables were significant predictors of 1-year complications in breast reconstruction. These findings should be considered in counseling patients on reconstructive options.

IMPORTANCE: Women undergoing immediate breast reconstruction often require chemotherapy. The effects of chemotherapy on reconstruction are not well described. OBJECTIVE: To evaluate the association of neoadjuvant and adjuvant chemotherapy with complications and patient-reported outcomes (PROs) in immediate reconstruction. DESIGN, SETTING, AND PARTICIPANTS: The Mastectomy Reconstruction Outcomes Consortium Study is a cohort study that prospectively assessed PROs and retrospectively evaluated complications in patients undergoing immediate implant-based or autologous reconstruction at 11 centers from January 1, 2012, to December 31, 2017. Women 18 years or older undergoing immediate reconstruction after mastectomy with 2 years of follow-up were included. Patients were excluded if they had prophylactic mastectomy; delayed reconstruction; mixed-timing reconstruction; mixed reconstruction; a latissimus dorsi, superior gluteal artery perforator, or inferior gluteal artery perforator flap; or both neoadjuvant and adjuvant chemotherapy. Data were analyzed from May 1 to June 30, 2018. MAIN OUTCOMES AND MEASURES: Complications and PROs (satisfaction with breast and physical, psychosocial, and sexual well-being) using the BREAST-Q questionnaire, a validated, condition-specific PRO measure. Baseline patient characteristics were collected. RESULTS: A total of 1881 women were included in the analysis (mean [SD] age, 49.9 [9.9] years). Of these, 1373 (73.0%) underwent implant-based procedures; 508 (27.0%), autologous reconstruction; 200 (10.6%), neoadjuvant chemotherapy; 668 (35.5%), adjuvant chemotherapy; and 1013 (53.9%), no chemotherapy. Patients without chemotherapy were significantly older (mean [SD] age, 51.6 [9.4] years; P

Acellular dermal matrix has gained widespread acceptance in immediate expander/implant reconstruction because of perceived benefits, including improved expansion dynamics and superior aesthetic results. Although previous investigators have evaluated its risks, few studies have assessed the impact of acellular dermal matrix on other outcomes, including patient-reported measures.The Mastectomy Reconstruction Outcomes Consortium Study used a prospective cohort design to evaluate patients undergoing postmastectomy reconstruction from 10 centers and 58 participating surgeons between 2012 and 2015. The analysis focused on women undergoing immediate tissue expander reconstruction following mastectomies for cancer treatment or prophylaxis. Medical records and patient-reported outcome data, using the BREAST-Q and Numeric Pain Rating Scale instruments, were reviewed. Bivariate analyses and mixed-effects regression models were applied.A total of 1297 patients were evaluated, including 655 (50.5 percent) with acellular dermal matrix and 642 (49.5 percent) without acellular dermal matrix. Controlling for demographic and clinical covariates, no significant differences were seen between acellular dermal matrix and non-acellular dermal matrix cohorts in overall complications (OR, 1.21; p = 0.263), major complications (OR, 1.43; p = 0.052), wound infections (OR, 1.49; p = 0.118), or reconstructive failures (OR, 1.55; p = 0.089) at 2 years after reconstruction. There were also no significant differences between the cohorts in the time to expander/implant exchange (p = 0.78). No significant differences were observed in patient-reported outcome scores, including satisfaction with breasts, psychosocial well-being, sexual well-being, physical well-being, and postoperative pain.In this multicenter, prospective analysis, the authors found no significant acellular dermal matrix effects on complications, time to exchange, or patient-reported outcome in immediate expander/implant breast reconstruction. Further studies are needed to develop criteria for more selective use of acellular dermal matrix in these patients.Therapeutic, II.

Assess postoperative morbidity and patient-reported outcomes after unilateral and bilateral breast reconstruction in patients with unilateral breast cancer.Relatively little is known about the morbidity associated with and changes in quality of life experienced by patients who undergo contralateral prophylactic mastectomy (CPM) and breast reconstruction. This information would be valuable for decision making in patients with unilateral breast cancer.Women undergoing mastectomy and breast reconstruction for unilateral breast cancer were recruited for this prospective observational study. Postoperative complications after implant and autologous breast reconstruction in patients undergoing unilateral or bilateral mastectomy were recorded. Preoperative and 1 year patient-reported outcomes were measured. Univariate tests and logistic regression analyses were performed, studying the effects of reconstructive method, laterality, and risk factors on surgical complication rates, patient satisfaction, and anxiety.We identified 1144 women who underwent either unilateral (47.2%) or bilateral (52.8%) mastectomies with reconstruction. Bilateral autologous (odds ratio 1.73, 95% confidence interval 1.07-2.81) and implant reconstructions (odds ratio 1.73, 95% confidence interval 1.22-2.47) were associated with a higher risk of complications compared with unilateral reconstructions. Baseline anxiety was greater in women who chose bilateral compared with unilateral implant reconstructions (P = 0.001). There was no difference in anxiety levels between groups postoperatively. Postoperatively, women who chose CPM with implant reconstructions were more satisfied with their breasts than women with unilateral reconstructions (P = 0.034).Although higher postoperative complications were observed after CPM and reconstruction, these procedures were associated with decreased anxiety levels and improved satisfaction with breasts for women who underwent implant reconstructions.

In women who require postmastectomy radiation therapy, immediate autologous breast reconstruction is often discouraged. The authors prospectively evaluated postoperative morbidity and satisfaction reported by women undergoing delayed or immediate autologous breast reconstruction in the setting of postmastectomy radiation therapy.Patients enrolled in the Mastectomy Reconstruction Outcomes Consortium study, who received postmastectomy radiotherapy and underwent immediate or delayed free abdominally based autologous breast reconstruction, were identified. Postoperative complications at 1 and 2 years after reconstruction were assessed. Patient-reported outcomes were evaluated using the BREAST-Q questionnaire preoperatively and at 1 and 2 years postoperatively. Bivariate analyses and mixed-effects regression models were used to compare outcomes.A total of 175 patients met the authors' inclusion criteria. Immediate reconstructions were performed in 108 patients and delayed reconstructions in 67 patients; 93.5 percent of immediate reconstructions were performed at a single center. Overall complication rates were similar based on reconstructive timing (25.9 percent immediate and 26.9 percent delayed at 1 year; p = 0.54). Patients with delayed reconstruction reported significantly lower prereconstruction scores (p0.0001) for Satisfaction with Breasts and Psychosocial and Sexual Well-being than did patients with immediate reconstruction. At 1 and 2 years postoperatively, both groups reported comparable levels of satisfaction in assessed BREAST-Q domains.From this prospective cohort, immediate autologous breast reconstruction in the setting of postmastectomy radiation therapy appears to be a safe option that may be considered in select patients and centers. Breast aesthetics and quality of life, evaluated from the patient's perspective, were not compromised by flap exposure to radiation therapy.Therapeutic, III.

Background: Patients considering both post-mastectomy radiation (RT) and reconstruction require robust information regarding the expected outcomes of different combinations of approaches in order to make preference-concordant decisions. Methods: In a prospective multicenter cohort study (the Mastectomy Reconstruction Outcomes Consortium, MROC, funded by NCI 1RO1CA152192) of women diagnosed with breast cancer at 11 institutions between 2012-15, we compared responses of 553 radiated and 1461 non-radiated pts who received different approaches to reconstruction. The primary dependent variables of interest were development of any breast complications (e.g. hematoma, wound infection) by one year post-reconstruction, along with satisfaction measured with the validated BREAST-Q instrument. Mixed-effects regression models assessed impact of reconstruction type and RT on the outcomes of interest. Covariate adjustment included reconstruction timing, age, extent of disease, bilateral vs unilateral treatment, chemotherapy receipt, nodal management, BMI, smoking, diabetes, race, ethnicity, education, employment, income, marital status, and hospital site. Results: Median age was 49. Bilateral mastectomy was received by 45.6% of radiated and 53.3% of non-radiated pts (p=0.002). Autologous reconstruction was more commonly received by radiated pts (38.3% vs 25.1%, p Conclusions: In the largest prospective multicenter study of outcomes of breast reconstruction to date, autologous reconstruction appears to yield superior patient-reported outcomes and lower risk of complications than implant-based approaches among patients receiving PMRT. Citation Format: Jagsi R, Momoh AO, Qi J, Hamill JB, Billig J, Kim HM, Pusic AL, Wilkins EG. Impact of radiotherapy on complications and patient-reported satisfaction with breast reconstruction: Findings from the prospective multicenter MROC study [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr S3-07.

Rates of breast reconstruction following mastectomy continue to increase. The objective of this study was to determine the frequency of elective revision surgery and the number of procedures required to achieve a stable breast reconstruction 2 years after mastectomy.Women undergoing first-time breast reconstruction after mastectomy were enrolled and followed for 2 years, with completion of reconstruction occurring in 1996. Patients were classified based on the absence or presence of complications. Comparisons within cohorts were performed to determine factors associated with revisions and total procedures. Mixed-effects regression modeling identified factors associated with elective revisions and total operations.Overall, 1534 patients (76.9 percent) had no complications, among whom 40.2 percent underwent elective revisions. The average number of elective revisions differed by modality (p0.001), with abdominally based free autologous reconstruction patients undergoing the greatest number of elective revisions (mean, 0.7). The mean total number of procedures also differed (p0.001), with tissue expander/implant reconstruction patients undergoing the greatest total number of procedures (mean, 2.4). Complications occurred in 462 patients (23.1 percent), with 67.1 percent of these patients undergoing elective revisions, which was significantly higher than among patients without complications (p0.001). The mean number of procedures again differed by modality (p0.001) and followed similar trends, but with an increased mean number of revisions and procedures overall. Mixed-effects regression modeling demonstrated that patients experiencing complications had increased odds of undergoing elective revision procedures (OR, 3.2; p0.001).Breast reconstruction patients without complications undergo over two procedures on average to achieve satisfactory reconstruction, with 40 percent electing revisions. If a complication occurs, the number of procedures increases.Risk, II.

BACKGROUND: In choosing between implant-based and autologous breast reconstruction, surgeons and patients must weigh relative risks and benefits. However, differences in outcomes across procedure types may vary between unilateral versus bilateral reconstructions. Procedure-related differences in complications and patient-reported outcomes (PROs) were evaluated for unilateral and bilateral reconstruction. METHODS: Complications and PROs were assessed at two years for patients undergoing autologous (TRAM, DIEP, SIEA) or implant-based (TE, DTI) reconstructions. Overall complications and major complications (requiring re-admission and/or re-operation) were recorded, while PROs were measured with BREAST-Q and PROMIS surveys. Stratified regression models compared outcomes between autologous and implant-based reconstructions, separately for unilateral and bilateral cohorts. RESULTS: Among 2125 patients, 917 underwent unilateral (600 implant, 317 autologous) and 1208 underwent bilateral (994 implant, 214 autologous) reconstructions. Controlling for patient characteristics, complication rates were significantly higher in the autologous versus implant-based group with both unilateral (overall: OR 2.50, p

Background. The decision-making process for women considering breast reconstruction following mastectomy is complex. Research suggests that fewer than half of women undergoing mastectomy have adequate knowledge and make treatment decisions that are concordant with their underlying values. This systematic review assesses the feasibility and efficacy of preoperative decision aids (DAs) to improve the patient decision-making process for breast reconstruction. Methods. A systematic review was performed using PubMed, Ovid MEDLINE, EMBASE, CINAHL, and Cochrane Databases published prior to January 4, 2018. Studies that assessed the impact of a DA on patient decision making for breast reconstruction were identified. The effect of preoperative DAs on decisional conflict in randomized controlled trials (RCTs) was measured with inverse variance-weighted mean differences (mean difference [MD] ± 95% confidence interval [CI]). Results. Among 1299 unique articles identified, 1197 were excluded after reviewing titles and abstracts against selection criteria. Among the 17 studies included in this review, 11 assessed the efficacy of DAs for breast reconstruction and 6 additional studies described the development and usability of these DAs. Studies suggest that DAs reduce patient-reported decisional conflict (MD, –4.55 [95% CI, –8.65 to –0.45], P = 0.03 in the fixed-effects model and MD, –4.70 [95% CI, –10.75 to 1.34], P = 0.13 in the random-effects model). Preoperative DAs also improved patient satisfaction with information and perceived involvement in the decision-making process. Conclusions. The existing literature suggests that DAs reduce decisional conflict, improve self-reported satisfaction with information, and improve perceived involvement in the decision-making process for women considering breast reconstruction.

Background Surgical-site infection causes devastating reconstructive failure in implant-based breast reconstructions. Large national database studies offer insights into complication rates, but only capture outcomes within 30 days postoperatively. This study evaluates both early and late surgical-site infection in immediate implant-based reconstruction and identifies predictors. Methods As part of the Mastectomy Reconstruction Outcomes Consortium Study, 1662 implant-based breast reconstructions in 1024 patients were evaluated for early versus late surgical-site infection. Early surgical-site infection was defined as infection occurring within 30 days postoperatively; late surgical-site infection was defined as infection occurring 31 days to 1 year postoperatively. Minor infection required oral antibiotics only, and major infection required hospitalization and/or surgical treatment. Direct-to-implant patients had 1-year follow-up, and tissue expander patients had 1-year post-exchange follow-up. Results Among 1491 tissue expander and 171 direct-to-implant reconstructions, overall surgical-site infection rate for tissue expander was 5.7 percent (85 of 1491) after first-stage, 2.5 percent (31 of 1266) after second-stage, and 9.9 percent (17 of 171) for direct-to-implant reconstruction. Over 47 to 71 percent of surgical-site infection complications were late surgical-site infection. Multivariate analysis identified radiotherapy and increasing body mass index as significant predictors of late surgical-site infection. No significant difference between the direct-to-implant and tissue expander groups in the occurrence of early, late, or overall surgical-site infection was found. Conclusions The majority of surgical-site infection complications in immediate implant-based breast reconstructions occur more than 30 days after both first-stage and second-stage procedures. Radiotherapy and obesity are significantly associated with late-onset surgical-site infection. Current studies limited to early complications do not present a complete assessment of infection associated with implant-based breast reconstructions or their long-term clinical outcomes. Clinical question/level of evidence Risk, II.

Emotional and social adaptation is a central challenge for women with recently diagnosed breast cancer [1]. Prevalence rates for anxiety and depressive disorders among a heterogeneous sample of cancer patients are estimated to range from 10 to 40% [2,3], and women with newly diagnosed breast cancer demonstrate comparable rates of affective distress [4]. As a result, breast reconstruction outcome studies routinely assess psychological variables and their influence on various patient-specific outcomes such as aesthetic satisfaction and functional status. While these studies typically include measures of preoperative depression and anxiety as possible predictors of clinical outcomes, relatively little attention has been paid to the identification of suicidal ideation (SI) in this cohort. This may seem surprising given evidence that depression is highly prevalent among cancer patients and, when increasingly severe, presents a primary risk for SI and intention [5]. While numerous studies describe the incidence of suicide among cancer patients in general [6], and women with breast cancer more specifically [7], there is sparse information on the prevalence of suicidal ideation among these populations. The assessment of SI in breast cancer patients presenting for reconstruction is in line with the American College of Surgeons (ACS) Commission on Cancer guidelines for distress screening of all cancer patients by 2015 [8]. We examined the prevalence of preoperative anxiety and depression among women enrolled in an ongoing prospective study of post-mastectomy breast reconstruction procedure outcomes. The prevalence of moderate-to-severe SI challenged the study team to devise an identification and response system to intervene with potential at-risk patients and triage them to appropriate mental health attention. We describe this system and propose its consideration for future surgical outcome studies where depression and SI are of reasonable concern.

Background Chronic postsurgical pain (CPSP) is a reported risk for women undergoing breast reconstruction, but it remains unclear that such persistent pain is induced by reconstructive surgery. To address this concern, this prospective cohort study examined the prevalence of and risk factors associated with CPSP among women undergoing breast reconstruction. Materials and methods Women (n = 1996) recruited for the Mastectomy Reconstruction Outcomes Consortium (MROC) Study were assessed preoperatively and at two-years postoperatively for relevant medical/.surgical variables, pain experience, body physical well-being, anxiety, depression, and reconstruction procedure type and characteristics. Results Nearly half of the entire sample reported some level of preoperative pain. At two years there were statistically significant but not clinically meaningful increases in both pain intensity and chest/upper body discomfort but a decrease in affective pain rating. Average clinical pain severity was strikingly similar for preoperative and postoperative assessments. Preoperative levels of pain, acute postoperative pain, and (marginally) level of depression held consistent relationship at two-year follow-up with all outcome measures. Autologous flap reconstruction was associated with more severe CPSP compared to TE/I reconstruction. Older age, higher BMI, bilateral reconstruction, and adjuvant radiation and chemotherapy were associated with CPSP and chest/upper body discomfort for at least one outcome measure at two years. Conclusions The substantial rate of preoperative pain and comparable prevalence of preoperative and postoperative pain ratings suggest that persistent pain after breast reconstruction may not necessarily reflect surgery-induced pain. Future research will need to determine those factors that contribute to long-term pain following breast reconstruction.

Previous studies suggest that immediate reconstruction following mastectomy produces superior results over delayed procedures. However, for medical or oncological reasons, some patients may be poor candidates for immediate reconstruction. We compared complications and patient-reported outcomes between immediate and delayed breast reconstructions in a prospective, multicenter study.1957 patients (1806 immediate, 151 delayed) met eligibility criteria. Demographic data, major complications, infections, and reconstructive failure rates were evaluated. Patient-reported outcomes were assessed with BREAST-Q, PROMIS, and EORTC QLQ-BR23 surveys, pre- and two years post-operatively. Subscale scores were compared across cohorts using mixed-effects regression models, controlling for patient characteristics and hospitals.Complete data were available in 1639 immediate and 147 delayed reconstruction patients. There were significant baseline differences between immediate and delayed cohorts in age, BMI, prevalence of diabetes, lymph node management, use of radiation, and chemotherapy. Controlling for clinical covariates, the delayed group had lower odds of any (OR 0.38, p 0.001) and major (OR 0.52, p = 0.016) complications, compared with immediate patients. Furthermore, delayed reconstruction was associated with a significantly lower failure rates (6% vs. 1.3%, p = 0.032). However, multivariate analyses found no significant differences in patient satisfaction or in psychosocial, sexual, or physical well-being at two years.Compared with immediate techniques, delayed reconstruction following mastectomy was associated with lower rates of overall and major complication, while providing equivalent patient satisfaction and quality of life benefits. Although immediate reconstruction is still the preferred choice of most patients and surgeons, delaying reconstruction does not appear to compromise clinical or patient-reported outcomes.

Background Direct-to-implant breast reconstruction offers time-saving advantages over two-stage techniques. However, use of direct-to-implant reconstruction remains limited, in part, because of concerns over complication rates., The authors' aim was to compare 2-year complications and patient-reported outcomes for direct-to-implant versus tissue expander/implant reconstruction. Methods Patients undergoing immediate direct-to-implant or tissue expander/implant reconstruction were enrolled in the Mastectomy Reconstruction Outcomes Consortium, an 11-center prospective cohort study. Complications and patient-reported outcomes (using the BREAST-Q questionnaire) were evaluated. Outcomes were compared using mixed-effects regression models, adjusting for demographic and clinical characteristics. Results Of 1427 patients, 99 underwent direct-to-implant reconstruction and 1328 underwent tissue expander/implant reconstruction. Two years after reconstruction and controlling for covariates, direct-to-implant and tissue expander/implant reconstruction patients did not show statistically significant differences in any complications, including infection. Multivariable analyses found no significant differences between the two groups in patient-reported outcomes, with the exception of sexual well-being, where direct-to-implant patients fared better than the tissue expander/implant cohort (p = 0.047). Conclusions This prospective, multi-institutional study showed no statistically significant differences between direct-to-implant and tissue expander/implant reconstruction, in either complication rates or most patient-reported outcomes at 2 years postoperatively. Direct-to-implant reconstruction appears to be a viable alternative to expander/implant reconstruction. This analysis provides new evidence on which to base reconstructive decisions. Clinical question/level of evidence Therapeutic, II.