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Background: Although studies have compared patient-reported outcomes (PROs) after breast conserving-therapy (BCT) and postmastectomy breast reconstruction (PMBR), they often have been confounded by treatment or other factors that complicate a direct comparison. This study aimed to compare PROs after BCT and PMBR by using propensity score-matching analysis. Methods: Patients who underwent BCT or PMBR between 2010 and 2022 and completed the BREAST-Q were identified. Each BCT patient was matched to a PMBR patient using nearest-neighbor 1:1 matching with replacement for each BREAST-Q time point. Outcomes included all prospectively collected BREAST-Q domains preoperatively, at 6 months, and at 1, 2, and 3 years postoperatively. A 4-point difference was considered clinically meaningful. Results: For this study, 6215 patients (2501 BCT [40.2%] and 3714 PMBR [59.8%] patients) were eligible, and 2616 unique patients were matched. Preoperatively, 463 BCT and 463 PMBR patients were matched for analysis (6 months [443 matched pairs], 1 year [639 matched pairs], 2 years [421 matched pairs], 3 years [254 matched pairs]). At 6 months postoperatively, the BCT patients scored higher on all BREAST-Q domains than the PMBR patients (p < 0.05; differences > 4 points). At 1, 2, and 3 years, the patients who underwent BCT consistently had superior Satisfaction With Breasts, Psychosocial Well-Being, and Sexual Well-Being (p < 0.05), and the differences were clinically meaningful. Conclusion: In this statistically powered study, the BCT patients reported higher quality of life than the PMBR patients in early assessment and also through 3 years of follow-up evaluation. Given the equivalency in survival and recurrence outcomes between BCT and PMBR, patients eligible for either surgery should be counseled regarding the superiority of BCT in terms of PROs. [ABSTRACT FROM AUTHOR]

Background: Mastectomy skin flap necrosis (SFN) is common following nipple-sparing mastectomy (NSM), but studies on its quality-of-life (QOL) impact are limited. We examined patient-reported QOL and satisfaction after NSM with/without SFN utilizing the BREAST-Q patient-reported outcome measure (PROM) survey. Patients and Methods: Patients undergoing NSM between April 2018 and July 2021 at our institution were examined; the BREAST-Q PROM was administered preoperatively, and at 6 months and 1 year postoperatively. SFN extent/severity was documented at 2–3 weeks postoperatively; QOL and satisfaction domains were compared between patients with/without SFN. Results: A total of 573 NSMs in 333 patients were included, and 135 breasts in 82 patients developed SFN (24% superficial, 56% partial thickness, 16% full thickness). Patients with SFN reported significantly lower scores in the satisfaction with breasts (p = 0.032) and psychosocial QOL domains (p = 0.009) at 6 months versus those without SFN, with scores returning to baseline at 1 year in both domains. In the "physical well-being-of-the-chest" domain, there was an overall decline in scores among all patients; however, there were no significant differences at any time point between patients with or without SFN. Sexual well-being scores declined for patients with SFN compared with those without at 6 months and also at 1 year, but this did not reach significance (p = 0.13, p = 0.2, respectively). Conclusions: Patients undergoing NSM who developed SFN reported significantly lower satisfaction and psychosocial well-being scores at 6 months, which returned to baseline by 1 year. Physical well-being of the chest significantly declines after NSM regardless of SFN. Future studies with larger sample sizes and longer follow-up are needed to determine SFN's impact on long-term QOL. [ABSTRACT FROM AUTHOR]

Background: The role that preoperative Satisfaction with Breast plays in a patient's postoperative course after postmastectomy breast reconstruction (PMBR) is not understood. The aim of this study is to understand the impact of the preoperative score on postoperative outcome as an independent variable. Methods: We examined patients who underwent PMBR between 2017 and 2021 and who completed the BREAST-Q Satisfaction with Breasts at 1 year postoperatively. Two multiple linear regression models (Model 1 with the preoperative Satisfaction with Breasts score and Model 2 without the preoperative score), likelihood ratio tests, simple t-statistics, and sample patient dataset to predict the 1 year score were performed. Multiple imputation was used to account for missing preoperative scores. Results: Overall, 2324 patients were included. Model 1 showed that the preoperative score is significantly associated with the postoperative score (β = 0.09, 95% confidence interval 0.04–0.14; p < 0.001). Comparing Model 1 and Model 2 demonstrated that including preoperative Satisfaction with Breasts in a regression significantly improves model fit (test statistic = 10.04; p = 0.0021). Using the absolute value of the t-statistics as a measure of variable importance in linear regression, the importance of the preoperative score was quantified as 3.39—more important than neoadjuvant radiation, mastectomy weight, body mass index, bilateral prophylactic mastectomy, and race, but less than adjuvant radiation, reconstruction type, and psychiatric diagnoses. Conclusion: Preoperative Satisfaction with Breasts scores are an important independent predictor of postoperative satisfaction after PMBR. Just as vital sign and work-up are carefully documented before surgery, preoperative scores should be collected to pre-emptively gauge patients' satisfaction and optimize postoperative outcomes. [ABSTRACT FROM AUTHOR]

Background: Breast cancer-related lymphedema (BRCL) is one of the most common causes of upper extremity (UE) lymphedema in developed nations and substantially impacts health-related quality of life. To advance our understanding of the epidemiology and treatment of BRCL, rigorously developed and validated patient-reported outcome measures (PROMs) are needed. This study aimed to demonstrate the iterative content validity of a modular UE lymphedema-specific PROM called the LYMPH-Q UE module. Methods: A multi-step iterative qualitative approach was used. Semi-structured interview data from in-depth qualitative interviews with adult women (18 years and older) with BCRL were used to develop the first set of the LYMPH-Q UE scales. The content validity of these scales was demonstrated with patient and clinician feedback. Over the course of cognitive debriefing interviews, additional concepts of lymphedema worry and impact on work were identified as missing from the LYMPH-Q UE module. Subsequently, two new qualitative studies (a focus group and in-depth concept elicitation interviews with patients) were conducted, and two new scales were developed to measure lymphedema worry and impact on work life and their content validity was demonstrated. Results: Qualitative data from in-depth and cognitive interviews with 15 (age 40–74 years) and 16 (age 38–74 years) women with BRCL, respectively, and feedback from 12 clinical experts, were used to develop and demonstrate the content validity of six LYMPH-Q UE scales measuring symptoms, function, appearance, psychological, information, and arm sleeve. Additionally, data from in-depth interviews with 12 (age 35–72 years) women with UE lymphedema and four focus groups (n = 16 women; age 35–74 years) was used to develop and assess the content validity of two new LYMPH-Q UE scales measuring lymphedema worry and impact on work life. The content validity of the previously established six scales was also demonstrated in these subsequent qualitative studies. Conclusion: The LYMPH-Q UE is a modular PROM developed using international guidelines for PROM development and can be used in clinical practice, research, and quality improvement to enhance patient-centered shared decision-making. This study's innovative and iterative approach to content validation demonstrates that the LYMPH-Q UE is a comprehensive measure that includes important concepts relevant to patients with UE lymphedema. [ABSTRACT FROM AUTHOR]

Background: Recent data suggest disparities in receipt of regional anesthesia prior to breast reconstruction. We aimed to understand factors associated with block receipt for mastectomy with immediate tissue expander (TE) reconstruction in a high-volume ambulatory surgery practice with standardized regional anesthesia pathways. Patients and Methods: Patients who underwent mastectomy with immediate TE reconstruction from 2017 to 2022 were included. All patients were considered eligible for and were offered preoperative nerve blocks as part of routine anesthesia care. Interpreters were used for non-English speaking patients. Patients who declined a block were compared with those who opted for the procedure. Results: Of 4213 patients who underwent mastectomy with immediate TE reconstruction, 91% accepted and 9% declined a nerve block. On univariate analyses, patients with the lowest rate of block refusal were white, non-Hispanic, English speakers, patients with commercial insurance, and patients undergoing bilateral reconstruction. The rate of block refusal went down from 12 in 2017 to 6% in 2022. Multivariable logistic regression demonstrated that older age (p = 0.011), Hispanic ethnicity (versus non-Hispanic; p = 0.049), Medicaid status (versus commercial insurance; p < 0.001), unilateral surgery (versus bilateral; p = 0.045), and reconstruction in earlier study years (versus 2022; 2017, p < 0.001; 2018, p < 0.001; 2019, p = 0.001; 2020, p = 0.006) were associated with block refusal. Conclusions: An established preoperative regional anesthesia program with blocks offered to all patients undergoing mastectomy with TE reconstruction can result in decreased racial disparities. However, continued differences in age, ethnicity, and insurance status justify future efforts to enhance preoperative educational efforts that address patient hesitancies in these subpopulations. [ABSTRACT FROM AUTHOR]

Background: Prepectoral implant placement for postmastectomy breast reconstruction has increased in recent years. Benefits of prepectoral reconstruction may include lack of animation deformities and reduced postoperative pain, but its complication profile is currently unclear. This study aimed to examine the complication profile of prepectoral tissue expanders (TEs) to determine factors associated with TE loss. Methods: A retrospective review was performed to identify all patients who underwent immediate prepectoral TE reconstruction from January 2018 to June 2021. The decision to use the prepectoral technique was based on mastectomy skin quality and patient comorbidities. Patient demographics, comorbidities, and operative details were evaluated. Outcomes of interest included TE loss, seroma, hematoma, infection/cellulitis, mastectomy skin flap necrosis requiring revision, and TE exposure. Logistic regression analysis was performed to identify factors associated with TE loss. Results: The study identified 1225 TEs. The most frequent complications were seroma (8.7%, n = 106), infection/cellulitis (8.2%, n = 101), and TE loss (4.2%, n = 51). Factors associated with TE loss in the univariate analysis included ethnicity, history of smoking, body mass index, mastectomy weight, and neoadjuvant chemotherapy. In the multivariate regression analysis, only mastectomy weight had a positive association with TE loss (odds ratio, 1.001; p = 0.016). Conclusion: Prepectoral two-stage breast reconstruction can be performed safely with an acceptable early complication profile. The study data suggest that increasing mastectomy weight is the most significant factor associated with TE loss. Further research examining the quality of the soft tissue envelope and assessing patient-reported outcomes would prove beneficial. [ABSTRACT FROM AUTHOR]

Background: Frailty is associated with higher risk of complications following breast reconstruction, but its impact on long-term surgical and patient-reported outcomes has not been investigated. We examined the association of the five-item modified frailty index (MFI) score with long-term surgical and patient-reported outcomes in autologous breast reconstruction. Patients and Methods: We conducted a retrospective cohort study of consecutive patients who underwent mastectomy and autologous breast reconstruction between January 2016 and April 2022. Primary outcome was any flap-related complication. Secondary outcomes were patient-reported outcomes and predictors of complications in the frail cohort. Results: We identified 1640 reconstructions (mean follow-up 24.2 ± 19.2 months). In patients with MFI ≥ 2, the odds of surgical [odds ratio (OR) 2.13, p = 0.023] and medical (OR 17.02, p < 0.001) complications were higher than in nonfrail patients. We found no significant difference in satisfaction with the breast (p = 0.287), psychosocial well-being (p = 0.119), or sexual well-being (p = 0.314) according to MFI score. Chronic obstructive pulmonary disease was an independent predictor of infection (OR 3.70, p = 0.002). Tobacco use (OR 7.13, p = 0.002) and contralateral prophylactic mastectomy (OR 2.36, p = 0.014) were independent predictors of wound dehiscence. Dependent functional status (OR 2.36, p = 0.007) and immediate reconstruction (compared with delayed reconstruction; OR 3.16, p = 0.026) were independent predictors of skin flap necrosis. Dependent functional status was also independently associated with higher odds of reoperation (OR 2.64, p = 0.011). Conclusion: Frailty is associated with higher risk of complications in breast reconstruction, but there is no significant difference in long-term patient-reported outcomes. MFI should be considered in breast reconstruction to improve outcomes in high-risk frail patients. [ABSTRACT FROM AUTHOR]

Background: We sought to predict clinically meaningful changes in physical, sexual, and psychosocial well-being for women undergoing cancer-related mastectomy and breast reconstruction 2 years after surgery using machine learning (ML) algorithms trained on clinical and patient-reported outcomes data. Patients and Methods: We used data from women undergoing mastectomy and reconstruction at 11 study sites in North America to develop three distinct ML models. We used data of ten sites to predict clinically meaningful improvement or worsening by comparing pre-surgical scores with 2 year follow-up data measured by validated Breast-Q domains. We employed ten-fold cross-validation to train and test the algorithms, and then externally validated them using the 11th site's data. We considered area-under-the-receiver-operating-characteristics-curve (AUC) as the primary metric to evaluate performance. Results: Overall, between 1454 and 1538 patients completed 2 year follow-up with data for physical, sexual, and psychosocial well-being. In the hold-out validation set, our ML algorithms were able to predict clinically significant changes in physical well-being (chest and upper body) (worsened: AUC range 0.69–0.70; improved: AUC range 0.81–0.82), sexual well-being (worsened: AUC range 0.76–0.77; improved: AUC range 0.74–0.76), and psychosocial well-being (worsened: AUC range 0.64–0.66; improved: AUC range 0.66–0.66). Baseline patient-reported outcome (PRO) variables showed the largest influence on model predictions. Conclusions: Machine learning can predict long-term individual PROs of patients undergoing postmastectomy breast reconstruction with acceptable accuracy. This may better help patients and clinicians make informed decisions regarding expected long-term effect of treatment, facilitate patient-centered care, and ultimately improve postoperative health-related quality of life. [ABSTRACT FROM AUTHOR]

Purpose of Review: This review aims to summarize the current knowledge regarding the pharmacological interventions studied in both experimental and clinical trials for secondary lymphedema. Recent Findings: Lymphedema is a progressive disease that results in tissue swelling, pain, and functional disability. The most common cause of secondary lymphedema in developed countries is an iatrogenic injury to the lymphatic system during cancer treatment. Despite its high incidence and severe sequelae, lymphedema is usually treated with palliative options such as compression and physical therapy. However, recent studies on the pathophysiology of lymphedema have explored pharmacological treatments in preclinical and early phase clinical trials. Summary: Many potential treatment options for lymphedema have been explored throughout the past two decades including systemic agents and topical approaches to decrease the potential toxicity of systemic treatment. Treatment strategies including lymphangiogenic factors, anti-inflammatory agents, and anti-fibrotic therapies may be used independently or in conjunction with surgical approaches. [ABSTRACT FROM AUTHOR]

Background: The BREAST-Q is an important tool for evaluating patient satisfaction and quality of life in breast-conserving therapy (BCT) patients, but its clinical utility is limited by the lack of guidance on score interpretation. This study determines reference values and the minimal important difference (MID) for the BREAST-Q BCT module. Methods: A retrospective review of BCT patients at Memorial Sloan Kettering Cancer Center from January 2011 to December 2021 was performed. Descriptive statistics were used to summarize median BREAST-Q scores. Distribution-based analyses estimated MIDs based on 0.2 standard deviation of baseline BREAST-Q scores and 0.2 standardized response mean of the difference between baseline and 1-year postoperative BREAST-Q scores. MIDs for different clinical groupings based on body mass index, radiation, and reexcision also were estimated. Results: Overall, 8060 patients were included for determining reference values, and 5673 patients were included for estimating MIDs. Median BREAST-Q scores trended upwards and stabilized by 2 years after surgery for all domains except Physical Well-Being of the Chest, which decreased and stabilized by 2 years. A score interpretation tool, the Real-Time Engagement and Communication Tool, was created based on 25th percentile, median, and 75th percentile scores trajectories. All MID estimates ranged from 3 to 5 points; 4 points was determined to be appropriate for use in clinical practice and research. Conclusions: Reference values and MIDs are crucial to BREAST-Q score interpretation, which can lead to improved clinical evaluation and decision making and improved research methodology. Future research should validate this study's findings in different patient cohorts. [ABSTRACT FROM AUTHOR]

Background: Studies on the impact of secondary lymphedema on patient-reported satisfaction and quality of life following postmastectomy breast reconstruction are limited by their heterogeneity. We aimed to reduce heterogeneity in study sample populations and compare BREAST-Q Reconstruction Module scores of patients with lymphedema matched to patients without lymphedema. Methods: We identified patients who underwent postmastectomy breast reconstruction from 2009 to 2017 and performed a propensity score-matched analysis to compare patient-reported outcomes of patients who developed lymphedema with those who did not. Matched covariates included age, body mass index, race/ethnicity, smoking history, radiation or chemotherapy exposure, postoperative infection, and reconstruction modality and laterality. Outcomes of interest were pre- and postoperative BREAST-Q scores for Satisfaction with Breasts, Physical Well-being of the Chest, Sexual Well-Being, and Psychosocial Well-Being; the minimal clinically important difference (MCID) was four points. Results: Matched cohorts included 322 patients per group. Preoperative BREAST-Q scores did not differ between lymphedema and non-lymphedema matched cohorts. Postoperative BREAST-Q scores were significantly lower in lymphedema patients: Physical Well-Being of the Chest (all time points), Satisfaction with Breast (at 1 and 2 years), Sexual Well-Being (at 2 years), and Psychosocial Well-Being (at 2 and 3 years). All significant differences in average scores were greater than the MCID. Conclusions: Patients with breast cancer-related lymphedema reported significantly lower Physical Well-Being of the Chest, Satisfaction with Breasts, Sexual Well-Being, and Psychosocial Well-Being at various time points. Our findings may prove useful for patient counseling and justify the need for further research on the prevention and treatment of this devastating disease. [ABSTRACT FROM AUTHOR]

Purpose: Longitudinal, routine utilization of patient-reported outcome measures (PROMs) in clinical care has been challenging. The purpose of this study is to describe a quality improvement initiative to improve patient engagement with the BREAST-Q, a gold-standard PROM for breast reconstruction. Methods: In 2011, we implemented the BREAST-Q as part of routine care. In 2018, we began a quality improvement initiative to increase BREAST-Q patient participation. The BREAST-Q was administered at every clinic visit via an institutional patient portal or an in-clinic tablet; digital dashboard technologies were used to improve workflow integration, real-time accountability, and immediate data availability at clinic visits. High clinical staff engagement was encouraged by assigning "BREAST-Q Champions." BREAST-Q completion data and patient characteristics were examined to understand non-response to the assessment. Results: Following quality improvement, the average annual BREAST-Q completion rate increased from 42.8% in 2011–2017 to 87.6% in 2019, the last full year of our study period. High completion rates were maintained January–July 2020; however, a significantly larger proportion of BREAST-Qs were completed at home in 2020 versus the same period in 2019 (49.7 vs. 38.8%, p < 0.001), potentially due to the COVID-19 pandemic. Compared with non-responders, responders were younger (49.7 vs. 52.2 years, p < 0.001), more likely to be white (76.9 vs. 73.6%, p < 0.001), and had private insurance (79.4 vs. 69.8%, p < 0.001). Conclusion: Our quality improvement initiative successfully increased routine completion of the BREAST-Q. Similar implementation techniques may prove beneficial at other institutions interested in incorporating PROMs into routine care. [ABSTRACT FROM AUTHOR]

Background: The BREAST-Q is the most commonly used patient-reported outcome measure (PROM) for breast reconstruction research. However, clinical implementation of this PROM has been impeded by a lack of context for score interpretation. The aim of this study was to define reference values for the BREAST-Q at discrete timepoints following surgery, generating a tool for real-time score interpretation. Methods: BREAST-Q scores were prospectively obtained in women who underwent implant or autologous post-mastectomy breast reconstruction preoperatively and for 2 years following surgery at Memorial Sloan Kettering Cancer Center (MSK). Descriptive statistics were used to create reference values for BREAST-Q satisfaction and quality-of-life subscales. Reference values were externally validated by comparing patient characteristics and BREAST-Q scores between the MSK and the Mastectomy Reconstruction Outcomes Consortium (MROC) study cohorts. Results: Overall, 3268 MSK patients and 2814 MROC patients were included for analysis. When MSK and MROC cohorts were compared for validation, there were some statistical differences in BREAST-Q scores; however, most of these differences did not meet the minimal clinically important difference of 4 points. Reference values were used to create the BREAST-Q Real-time Engagement and Communication Tool (REACT). Conclusions: Using a large cohort of patients, we have defined BREAST-Q reference values for post-mastectomy breast reconstruction patients for use in clinical practice. The BREAST-Q REACT will help breast reconstruction providers gauge patient wellbeing and satisfaction relative to the "average" breast reconstruction patient and determine which patients may benefit from additional intervention. [ABSTRACT FROM AUTHOR]

Background: Comparisons of autologous breast reconstruction (ABR) and implant-based breast reconstruction (IBR) involve unavoidable confounders, which are often adjusted for in post hoc regression analyses. This study compared patient-reported outcomes between ABR patients and IBR patients by using propensity score matching to control for confounding variables upfront. Methods: Propensity score matching analysis (2:1 nearest-neighbor matching with replacement) was performed for patients who underwent ABR or IBR without radiotherapy. Matched covariates included age, body mass index, history of psychiatric diagnosis, race–ethnicity, smoking status, and laterality of reconstruction. Outcomes of interest were BREAST-Q questionnaire scores for breast satisfaction and well-being. Results: Of the 2334 patients identified, 427 were included in the final analysis: 159 who underwent ABR and 268 who underwent IBR. The ABR group matched the IBR group in the selected characteristics. ABR patients did not differ significantly from IBR patients in breast satisfaction or well-being at either 1 or 2 years after reconstructive surgery. Conclusions: This preliminary analysis of immediate breast reconstruction patients not requiring radiation therapy with similar propensities for ABR or IBR suggests comparable levels of breast satisfaction and well-being within 2 years after reconstructive surgery. Further research is needed with larger sample sizes, statistical power, and follow-up to better understand patient reported outcomes in this population, as the current findings differ from studies where patients were not matched on baseline characteristics. [ABSTRACT FROM AUTHOR]

Background: Patients often fear axillary lymph node dissection (ALND) because of its associated complications; however, its effect on quality of life (QOL) is not well described. We aimed to evaluate the effect of ALND on QOL over time and to identify predictors of worse QOL. Patients and Methods: Breast cancer patients undergoing ALND were enrolled in a prospective lymphedema screening study. Arm volumes were measured and QOL questionnaires completed at baseline, postoperatively, and at 6-month intervals. The upper limb lymphedema-27 questionnaire was used to assess the effect of upper extremity symptoms on QOL in three domains (physical, psychological, and social). Predictors of QOL were identified by univariate and multivariable regression analyses. Results: From November 2016 through March 2020, 304 ALND patients were enrolled; 242 patients with at least two measurements and 6 months of follow-up were included. Median age was 48 years, and median follow-up was 1.2 years. The 18-month lymphedema rate was 18%. Overall, QOL scores in all three domains decreased postoperatively and improved over time. On multivariable analysis, after adjusting for baseline scores, symptoms necessitating lymphedema therapy referral (p = 0.006) were associated with worse physical QOL. Younger age (p = 0.005) and lymphedema therapy referral (p = 0.006) were associated with worse psychological QOL. Arm volume was not correlated with QOL. Conclusions: QOL scores initially decreased after ALND but improved by 6 months post-surgery. Decreases in QOL were independent of arm volume. Patients with worse QOL more often sought lymphedema therapy, although the effect of therapy on QOL remains unknown. [ABSTRACT FROM AUTHOR]

Introduction: Breast cancer-related lymphedema occurs in up to 30% of women following axillary lymph node dissection (ALND) and less commonly following sentinel lymph node biopsy. To quantify disability in these patients, patient-reported outcome measures (PROMs) have proven useful; however, given the overlap of symptoms between ALND and lymphedema, examination of their accuracy, sensitivity, and specificity in detecting lymphedema in breast cancer patients undergoing ALND is needed. Methods: The Lymphedema Life Impact Scale (LLIS) and the Upper Limb Lymphedema 27 scale (ULL27) were administered to patients who had undergone ALND at least 2 years prior and either did or did not develop lymphedema. Survey responses and the degree of disability were compared to generate receiver operator characteristic (ROC) curves, and the sensitivity and specificity of PROMs to diagnose lymphedema were analyzed. Results: Both PROMs were highly accurate, sensitive, and specific for detecting lymphedema. The LLIS had an accuracy of 97%, sensitivity of 100%, and specificity of 84.8% at a cutoff of ≥ 5.88 overall percent impairment score (higher scores indicate worse disability). The ULL27 had an accuracy of 93%, sensitivity of 88.6%, and specificity of 90.9% at a cutoff of ≤ 83.3 global score (lower scores indicate worse disability). Conclusions: The LLIS and the ULL27 appear to be highly specific for lymphedema and capable of differentiating it from symptoms resulting from ALND alone. Our findings suggest that use of these questionnaires with a threshold may be effective for diagnosing lymphedema, potentially reducing the need for frequent clinic visits and time-consuming measurements. [ABSTRACT FROM AUTHOR]

Background: The response to the unprecedented opioid crisis in the US has increased focus on multimodal pain regimens and enhanced recovery after surgery (ERAS) pathways to reduce opioid use. This study aimed to define patient and system-level factors related to perioperative consumption of opioids in autologous free-flap breast reconstruction. Methods: We conducted a retrospective study to identify patients who underwent autologous breast reconstruction between 2010 and 2016. A multivariate linear regression model was developed to assess patient and system-level factors influencing opioid consumption. Opioid consumption was then dichotomized as total postoperative opioid consumption above (high) and below (low) the 50th percentile to afford more in-depth interpretation of the regression analysis. Secondary outcome analyses examined postoperative complications and health-related quality-of-life outcomes using the BREAST-Q. Results: Overall, 601 patients were included in the analysis. Unilateral reconstruction, lower body mass index, older age, and administration of ketorolac and liposomal bupivacaine were associated with lower postoperative opioid consumption. In contrast, history of psychiatric diagnoses was associated with higher postoperative opioid consumption. There was no difference in the rates of postoperative complications when comparing the groups, although patients who had lower postoperative opioid consumption had higher BREAST-Q physical well-being scores. Conclusion: System-level components of ERAS pathways may reduce opioid use following autologous breast reconstruction, but surgical and patient factors may increase opioid requirements in certain patients. ERAS programs including liposomal bupivacaine and ketorolac should be established on a system level in conjunction with continued focus on individualized care, particularly for patients at risk for high opioid consumption. [ABSTRACT FROM AUTHOR]

Background: A multiphased mixed-methods study was performed to develop and validate a comprehensive patient-reported outcome measure (PROM) for arm lymphedema in women with breast cancer (i.e., the LYMPH-Q Upper Extremity Module). Methods: Qualitative interviews (January 2017 and June 2018) were performed with 15 women to elicit concepts specific to arm lymphedema after breast cancer treatment. Data were audio-recorded, transcribed, and coded. Scales were refined through cognitive interviews (October and Decemeber 2018) with 16 patients and input from 12 clinical experts. The scales were field-tested (October 2019 and January 2020) with an international sample of 3222 women in the United States and Denmark. Rasch measurement theory (RMT) analysis was used to examine reliability and validity. Results: The qualitative phase resulted in six independently functioning scales that measure arm symptoms, function, appearance, psychological function, and satisfaction with information and with arm sleeves. In the RMT analysis, all items in each scale had ordered thresholds and nonsignificant chi-square p values. For all the scales, the reliability statistics with and without extremes for the Person Separation Index were 0.80 or higher, Cronbach's alpha was 0.89 or higher, and the Intraclass Correlation Coefficients were 0.92 or higher. Lower (worse) scores on the LYMPH-Q Upper Extremity scales were associated with reporting of more severe arm swelling, an arm problem caused by cancer and/or its treatment, and wearing of an arm sleeve in the past 12 months. Conclusions: The LYMPH-Q Upper Extremity Module can be used to measure outcomes that matter to women with upper extremity lymphedema. This new PROM was designed using a modern psychometric approach and, as such, can be used in research and in clinical care. [ABSTRACT FROM AUTHOR]

Lack or dysfunction of the lymphatics leads to secondary lymphedema formation that seriously reduces the function of the affected organs and results in degradation of quality of life. Currently, there is no definitive treatment option for lymphedema. Here, we utilized nucleoside-modified mRNA encapsulated in lipid nanoparticles (LNPs) encoding murine Vascular Endothelial Growth Factor C (VEGFC) to stimulate lymphatic growth and function and reduce experimental lymphedema in mouse models. We demonstrated that administration of a single low-dose of VEGFC mRNA-LNPs induced durable, organ-specific lymphatic growth and formation of a functional lymphatic network. Importantly, VEGFC mRNA-LNP treatment reversed experimental lymphedema by restoring lymphatic function without inducing any obvious adverse events. Collectively, we present a novel application of the nucleoside-modified mRNA-LNP platform, describe a model for identifying the organ-specific physiological and pathophysiological roles of the lymphatics, and propose an efficient and safe treatment option that may serve as a novel therapeutic tool to reduce lymphedema. Dysfunction of the lymphatic system leads to secondary lymphedema and results in degradation of quality of life. Here, the authors show that delivery of nucleoside-modified Vascular Endothelial Growth Factor C (VEGFC) mRNA, encapsulated in lipid nanoparticles, induces organ-specific lymphatic growth and reverses experimental lymphedema. [ABSTRACT FROM AUTHOR]

Background: Obesity is a significant public health concern and clear risk factor for complications following breast reconstruction. To date, few have assessed patient-reported outcomes (PROs) focused on this key determinant. Objective: Our study aimed to investigate the impact of obesity (body mass index ≥ 30) on postoperative satisfaction and physical function utilizing the BREAST-Q in a cohort of autologous breast reconstruction patients. Methods: An Institutional Review Board-approved prospective investigation was conducted to evaluate PROs in patients undergoing autologous breast reconstruction from 2009 to 2017 at a tertiary academic medical center. The BREAST-Q reconstruction module was used to assess outcomes between cohorts preoperatively and at 6 months, 1 year, 2 years, and 3 years after reconstruction. Results: Overall, 404 patients underwent autologous breast reconstruction with abdominal free-tissue transfer (244 non-obese, 160 obese) and completed the BREAST-Q. Although obese patients demonstrated lower satisfaction with breasts preoperatively (p = 0.04), no significant differences were noted postoperatively (p = 0.58). However, physical well-being of the abdomen was lower in the obese cohort compared with their non-obese counterparts at long-term follow-up (3 years; p = 0.04). Conclusion: Obesity significantly impacts autologous breast reconstruction patients. Although obese patients are more likely to present with dissatisfaction with breasts preoperatively, they exhibit comparable PROs overall compared with their non-obese counterparts, despite increased complications. [ABSTRACT FROM AUTHOR]

Background: Many factors influence decisions regarding choice of breast-conserving surgery (BCS) versus mastectomy with reconstruction for early invasive breast cancer. The purpose of this study was to compare patient satisfaction following BCS and mastectomy with implant reconstruction (M-iR) utilizing the BREAST-Q patient-reported outcome measure. Methods: Women with stage I or II breast cancer undergoing BCS or M-iR who completed a BREAST-Q from 2010 to 2016 were identified by retrospective review of a prospective database. Baseline characteristics were compared, and linear mixed models were used to analyze associations with BREAST-Q scores over time. Results: Our study group was composed of 3233 women; 2026 (63%) had BCS, 123 (3.8%) had nipple-sparing mastectomy, and 1084 (34%) had skin-sparing or total mastectomy. Median time from surgery to BREAST-Q was 205 days for BCS and 639 days for M-iR (p < 0.001). Regardless of type of surgery, breast satisfaction scores decreased significantly over time (p < 0.001), whereas psychosocial (p = 0.001) and sexual (p = 0.004) well-being scores increased significantly over time. BCS was associated with significantly higher scores over time compared with M-iR across all subscales (all p < 0.001). Radiation was significantly associated with decreased scores over time across all subscales (all p < 0.05). Conclusions: Breast satisfaction and quality-of-life scores were higher for BCS compared with M-iR in early-stage invasive breast cancer. These findings may help in counseling women who have a choice for surgical treatment. Breast satisfaction scores decreased over time in all women, highlighting the need for further evaluation with longer follow-up. [ABSTRACT FROM AUTHOR]

T cell-mediated responses have been implicated in the development of fibrosis, impaired lymphangiogenesis, and lymphatic dysfunction in secondary lymphedema. Here we show that CD4+ T cells are necessary for lymphedema pathogenesis by utilizing adoptive transfer techniques in CD4 knockout mice that have undergone tail skin and lymphatic excision or popliteal lymph node dissection. We also demonstrate that T cell activation following lymphatic injury occurs in regional skin-draining lymph nodes after interaction with antigenpresenting cells such as dendritic cells. CD4+ T cell activation is associated with differentiation into a mixed T helper type 1 and 2 phenotype, as well as upregulation of adhesion molecules and chemokines that promote migration to the skin. Most importantly, we find that blocking T cell release from lymph nodes using a sphingosine-1-phosphate receptor modulator prevents lymphedema, suggesting that this approach may have clinical utility. [ABSTRACT FROM AUTHOR]

Background: Rates of mastectomy with immediate reconstruction are rising. Skin flap necrosis after this procedure is a recognized complication that can have an impact on cosmetic outcomes and patient satisfaction, and in worst cases can potentially delay adjuvant therapies. Many retrospective studies of this complication have identified variable event rates and inconsistent associated factors. Methods: A prospective study was designed to capture the rate of skin flap necrosis as well as pre-, intra-, and postoperative variables, with follow-up assessment to 8 weeks postoperatively. Uni- and multivariate analyses were performed for factors associated with skin flap necrosis. Results: Of 606 consecutive procedures, 85 (14 %) had some level of skin flap necrosis: 46 mild (8 %), 6 moderate (1 %), 31 severe (5 %), and 2 uncategorized (0.3 %). Univariate analysis for any necrosis showed smoking, history of breast augmentation, nipple-sparing mastectomy, and time from incision to specimen removal to be significant. In multivariate models, nipple-sparing, time from incision to specimen removal, sharp dissection, and previous breast reduction were significant for any necrosis. Univariate analysis of only moderate or severe necrosis showed body mass index, diabetes, nipple-sparing mastectomy, specimen size, and expander size to be significant. Multivariate analysis showed nipple-sparing mastectomy and specimen size to be significant. Nipple-sparing mastectomy was associated with higher rates of necrosis at every level of severity. Conclusions: Rates of skin flap necrosis are likely higher than reported in retrospective series. Modifiable technical variables have limited the impact on rates of necrosis. Patients with multiple risk factors should be counseled about the risks, especially if they are contemplating nipple-sparing mastectomy. [ABSTRACT FROM AUTHOR]

Background: Indications for radiotherapy in breast cancer treatment are expanding. Long-term satisfaction and health-related quality of life (HR-QOL), important outcomes after alloplastic breast reconstruction and radiation, have not been measured in irradiated patients by using a condition-specific, validated patient-reported outcomes instrument. The aim was to evaluate patient satisfaction and HR-QOL in patients with implant breast reconstruction and radiotherapy. Methods: A multicenter cross-sectional survey of patients who underwent implant-based breast reconstruction from three centers in the United States and Canada, with and without radiation, was performed. Satisfaction with breasts, satisfaction with outcome, psychosocial well-being, sexual well-being, and physical well-being outcomes were evaluated using the BREAST-Q (Reconstruction Module). Multivariable analysis was performed to evaluate the effect of radiotherapy on patient satisfaction with breasts with adjustment by patient and treatment characteristics. Results: The response rate was 71 %, with 633 completed questionnaires returned. Mean follow-up was 3.3 years for irradiated patients ( n = 219) and 3.7 years for nonirradiated patients ( n = 414). Patients with radiation had significantly lower satisfaction with breasts (58.3 vs. 64.0; p < 0.01), satisfaction with outcome (66.8 vs. 71.4; p < 0.01), psychosocial well-being (66.7 vs. 70.9; p < 0.01), sexual well-being (47.0 vs. 52.3; p < 0.01), and physical well-being (71.8 vs. 75.1; p < 0.01) compared with nonirradiated patients. Multivariable analysis confirmed the negative effect of radiotherapy on satisfaction with breasts ( β = −2.6; p = 0.03) when adjusted for patient and treatment factors. Conclusions: Radiotherapy has a negative effect on HR-QOL and satisfaction with breasts in patients with implant reconstruction compared with nonirradiated patients. The information provided here can inform decision-making and help set appropriate expectations for patients undergoing implant breast reconstruction and radiation. [ABSTRACT FROM AUTHOR]

Background: Symptomatic capsular contracture occurs in about 10 % of primary breast augmentations and in more than double that rate in reconstruction after mastectomy, especially in the setting of radiation. Mast cells, traditionally associated with immune response and inflammation, secrete profibrotic mediators and may play a role in capsule formation and contracture. We analyzed the mast cell and fibroblast populations in breast capsule tissue from patients who underwent capsular excision. Methods: Capsule tissue was collected from patients who underwent exchange of tissue expanders for permanent implants, revision of reconstruction, or revision augmentation. Breast capsule tissues were prepared for histological analyses of mast cells, fibroblasts, and collagen. Mast cells and fibroblasts were isolated from capsule tissue and screened for mediators and receptor expression. Results: In breast capsule tissue, the average numbers of mast cells and fibroblasts were 9 ± 1/mm and 33 ± 10/mm, respectively. There were significantly more mast cells on the posterior side than on the anterior side of the capsule tissue (12 ± 2 vs. 6 ± 1/mm, p < 0.01). Baker grade IV capsules had an increased number of fibroblasts compared to Baker grade I capsules (93 ± 9 vs. 40 ± 19/mm, p < 0.001). In breast capsule tissue, mast cells contained renin, histamine, and TGF-β, and their respective receptors, ATR, HR, and TGF-βRI were expressed by fibroblasts. Conclusion: These data indicate that within breast capsule tissue mast cells contain mediators that may activate neighboring fibroblasts. Understanding the role of mast cells in pathologic periprosthetic breast capsule formation may lead to novel therapies to prevent and treat capsular contracture. No Level Assigned: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors . [ABSTRACT FROM AUTHOR]

Objective: The performance of a mastectomy for the treatment or prophylaxis of breast cancer may have long-term implications for both physical and mental well-being in women. The development of breast numbness and phantom breast sensations following mastectomy is well-known; however, relatively little is known about physical morbidity following postmastectomy breast reconstruction. The primary objective of this study was to evaluate the level of physical morbidity experienced following three surgical approaches: mastectomy alone, postmastectomy tissue expander/implant reconstruction, and postmastectomy autogenous tissue reconstruction. Methods: We conducted a cross-sectional survey of a sample of women who had undergone mastectomy with or without reconstruction. Chest and upper body morbidity were evaluated using the BREAST-Q. Physical well-being was compared across three types of breast surgery. Results: In total, 308 of 452 women who received a questionnaire booklet returned completed questionnaires. There was an overall difference in physical morbidity attributable to surgical treatment ( P < 0.001). Patients who underwent autogenous tissue reconstruction had the highest (i.e., best) mean physical well-being score. Women who underwent expander/implant reconstruction also had less chronic physical morbidity than women who underwent mastectomy alone ( P < 0.05). Conclusions: Our findings suggest that women who undergo immediate autogenous tissue reconstruction experience significantly less chest and upper body morbidity than those who undergo either mastectomy with implant-based reconstruction or mastectomy alone. This information can be used to facilitate clinical decision-making, to validate individual experiences of breast cancer survivors, and to inform future innovations to decrease the long-term physical morbidity associated with breast cancer surgery. [ABSTRACT FROM AUTHOR]

Background: Free silicone injection for breast augmentation, which became widespread in the 1960s and continues illicitly to this day, has well-known adverse effects. In this retrospective chart review of 14 patients treated for silicone mastitis from 1990 to 2002, we present our experience with the surgical management of patients with silicone mastitis. Methods: All the patients were women, ranging in age from 49 to 76 years old (mean age = 58.8). Patients presented to us a mean of 29.9 years after their free silicone breast injection. Treatment modalities were analyzed, and, specifically, methods of breast reconstruction involving autologous tissue transfers, implants, or a combination were evaluated. Results: The majority of patients (12 of 14) required mastectomies for extensive silicone-infiltrated tissues. The remaining two patients had focal areas of disease and were successfully treated with excision and local breast parenchyma flaps. Autologous reconstruction was performed with a total of 20 flaps, including 12 free transverse rectus abdominis myocutaneous flaps, 4 free superior gluteal artery perforator (SGAP) flaps, and 4 pedicled latissimus dorsi (LD) flaps. Two patients had bilateral implant-based breast reconstruction. Conclusion: A variety of reconstructive options are available for patients presenting with silicone mastitis. Once an appropriate breast cancer workup has been performed, the surgical goal is to excise as much of the silicone-infiltrated tissues as possible before reconstruction. To our knowledge, this is the first reported series that incorporates the use of SGAP and LD flaps as a means of autologous tissue reconstruction for silicone-infiltrated breasts. Level of Evidence IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors . [ABSTRACT FROM AUTHOR]

Purpose: Lymphedema following breast cancer surgery remains a common and feared treatment complication. Accurate information on health-related quality of life (HRQOL) outcomes among patients with lymphedema is critically needed to inform shared medical decision making and evidence-based practice in oncologic breast surgery. Our systematic review aimed to (1) identify studies describing HRQOL outcomes in breast cancer-related lymphedema (BCRL) patients, (2) assess the quality of these studies, and (3) assess the quality and appropriateness of the patient-reported outcome (PRO) instruments used. Methods: Using the PRISMA statement, we performed a systematic review including studies describing HRQOL outcomes among BCRL patients. Studies were classified by levels of evidence and fulfillment of the Efficace criteria. PRO instruments were assessed using the COSMIN criteria. Results: Thirty-nine studies met inclusion criteria, including 8 level I and 14 level II studies. Sixteen of 39 studies were compliant with the Efficace criteria. Seventeen HRQOL instruments were used, two specific to lymphedema patients. Exercise and complex decongestive therapy treatment interventions were associated with improved HRQOL. Conclusions: High-quality data on HRQOL outcomes is required to inform surgical decisions for breast cancer management and survivors. Of the lymphedema-specific PRO instruments, the Upper Limb Lymphedema 27 (ULL-27) was found to have strong psychometric properties. Future studies should strive to use high-quality condition- specific PRO instruments, follow existing guidelines for HRQOL measurement and to consider economic burdens of BCRL. Implications for Cancer Survivors: As lymphedema may develop many years after breast cancer surgery, the ULL-27 may offer greater content validity for use in survivorship research. [ABSTRACT FROM AUTHOR]

Background: Recent reports have demonstrated that lymphedema can occur after even minor pertubation of the axillary region such as sentinel lymph node biopsy (SLNB). The impact of breast reconstruction on the development of lymphedema, however, remains unknown. Therefore, the purpose of this study was to determine the impact of immediate tissue expander breast reconstruction on the risk of developing lymphedema. Materials and Methods: We identified patients who had undergone mastectomy with SLNB or SLNB and axillary lymph node dissection (ALND) with or without breast reconstruction using our prospectively maintained lymphedema and breast reconstruction databases. The development of lymphedema was evaluated prospectively using arm measurements and a validated questionnaire. Associations between variables were examined. Logistic regression was used to examine the association of reconstruction on prevalence of lymphedema while adjusting individually for BMI, age, and weight gain after surgery. Results: Characteristics of patients with or without reconstruction were similar except for age, BMI, and weight gain since surgery. Median follow-up was 5 years. Among patients treated with mastectomy with SLNB or SLNB/ALND, those undergoing reconstruction had a lower rate of measured lymphedema than those who did not (5% vs. 18%, P < .0004). The reconstructed group also had fewer patients with both measured and self-reported lymphedema (3% vs. 12%, P < .002). Differences in the rates of measured lymphedema between groups persisted following univariate logistical regression for differences in age, BMI, and weight gain. Conclusions: Tissue expander breast reconstruction in patients undergoing SLNB or SLNB/ALND does not increase the risk of developing measured or perceived lymphedema. [ABSTRACT FROM AUTHOR]

Limiting surgical morbidity while maintaining staging adequacy is a primary concern in obese patients with uterine malignancy. The goal of this study was to compare the surgical adequacy and postoperative morbidity of three surgical approaches to staging the disease of obese women with uterine cancer. The records of all patients with a body mass index (BMI) of ≥35 undergoing primary surgery for uterine corpus cancer at our institution from January 1993 to May 2006 were reviewed. Patients were assigned to three groups on the basis of planned surgical approach—standard laparotomy, laparoscopy, or laparotomy with panniculectomy. Standard statistical tests appropriate to group size were used to compare the three groups. In all, 206 patients with a BMI of ≥35 were grouped as follows: laparotomy, 154 patients; laparoscopy, 25 patients; and laparotomy with panniculectomy, 27 patients. Median BMI was 41 (range, 35–84). Regional lymph nodes were removed in 45% of the laparotomy patients, 40% of the laparoscopy patients, and 70% of the panniculectomy patients ( P = .04). Compared with laparotomy, both laparoscopy and panniculectomy yielded higher median pelvic and total lymph node counts ( P = .001). Operative time was shortest after standard laparotomy, and blood loss was greatest after panniculectomy. The incidence of all incisional complications was lower for panniculectomy (11%) and laparoscopy (8%) compared with standard laparotomy (35%) ( P = .002). On multivariate analysis, a significantly lower risk of total incisional complications was seen for patients undergoing panniculectomy (risk ratio, .25; 95% confidence interval, .071–.88) and laparoscopy (risk ratio, .19; 95% confidence interval, .04–.94). Both laparoscopic staging and panniculectomy in a standardized fashion were associated with an improved lymph node count and a lower rate of incisional complications than laparotomy alone. Although definitive conclusions are limited by low patient numbers, the substantial decrease in wound complications suggests that these two approaches should be considered for obese patients undergoing uterine cancer staging. [ABSTRACT FROM AUTHOR]

Tumor extirpation around the shoulder can result in large defects requiring coverage of allograft-alloprosthetic constructs and vital neurovascular structures. This study examined a single institution’s experience with the pedicled latissimus dorsi flap in reconstructing large shoulder defects after oncologic resection. Using a prospectively maintained database, 33 consecutive patients were reviewed who had undergone a pedicled latissimus dorsi flap to reconstruct oncologic shoulder defects between 1994 and 2004. Wide excision or radical en-bloc resection of shoulder tissues was performed with defects often extending intra-articularly and to the level of the mid-arm. Patient demographics, comorbid conditions, pathology, adjuvant treatment, defect characteristics, skin paddle dimensions and operative records were evaluated. Outcome variables included major and minor complications, patient survival, and limb viability. Adjuvant therapy included chemotherapy in 18 patients, radiation therapy in 12 patients, and brachytherapy in 2 patients. Defects averaged 280.1 cm2 (range 18–1,225 cm2). Mean skin paddle surface area was 118.9 cm2 (range 21–350 cm2). There were 28 myocutaneous flaps and 5 muscle flaps. Materials for bony reconstruction included 13 allograft and alloprosthetic composites, 6 metallic prostheses, and 3 reconstructions using allograft alone. Two patients experienced partial skin flap necrosis. One patient developed local recurrence. Two patients required combined flaps. Use of the pedicled latissimus dorsi flap in complex shoulder reconstructions provided ample well-vascularized soft tissue, minimized risk of infection, and maximized limb salvage. In our experience, the pedicled latissimus dorsi flap is an excellent choice for reconstruction of defects around the shoulder after tumor extirpation. [ABSTRACT FROM AUTHOR]