External Validation of the Breast Cancer Surgery Risk Calculator (BCSRc): A Predictive Model for Postoperative Complications.

BACKGROUND: The breast cancer surgical risk calculator (BCSRc) is a prognostic tool that determines a breast cancer patient's unique risk of acute complications following each possible surgical intervention. When used in the preoperative setting, it can help to stratify patients with an increased complication risk and enhance the patient-physician informed decision-making process. The objective of this study was to externally validate the four models used in the BCSRc on a large cohort of patients who underwent breast cancer surgery. METHODS: The BCSRc was developed by using a retrospective cohort from the National Surgical Quality Improvement Program database from 2005 to 2018. Four models were built by using logistic regression methods to predict the following composite outcomes: overall, infectious, hematologic, and internal organ complications. This study obtained a new cohort of patients from the National Surgical Quality Improvement Program by utilizing participant user files from 2019 to 2020. The area under the curve, brier score, and Hosmer-Lemeshow goodness of fit test measured model performance, accuracy, and calibration, respectively. RESULTS: A total of 192,095 patients met inclusion criteria in the development of the BCSRc, and the validation cohort included 60,144 women. The area under the curve during external validation for each model was approximately 0.70. Accuracy, or Brier scores, were all between 0.04 and 0.003. Model calibration using the Hosmer-Lemeshow statistic found all p-values > 0.05. All of these model coefficients will be updated on the web-based BCSRc platform: www.breastcalc.org . CONCLUSIONS: The BCSRc continues to show excellent external-validation measures. Collectively, this prognostic tool can enhance the decision-making process, help stratify patients with an increased complication risk, and improve expectant management.

Assessment of Conflicts of Interest in the Transcarotid Artery Revascularization Literature.

INTRODUCTION: To systematically review the accuracy of self-reported conflicts of interest (COIs) among transcarotid artery revascularization (TCAR) studies and evaluate factors associated with increased discrepancies. MATERIALS AND METHODS: A literature search identified all TCAR-related studies with at least one American author published between January 2017 and December 2020. Industry payments from Silk Road Medical, Inc. were collected using the Centers for Medicare and Medicaid Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior (24-mo period). Risk factors for COI discrepancy were evaluated at both the study and author level. RESULTS: A total of 79 studies (472 authors) were identified. Sixty four studies (81%) had at least one author who received payments from Silk Road Medical, Inc. Fifty eight (73%) studies had at least one author who received an undeclared payment. Consulting fees represented the majority of general payment subtype (60%). Authors who accurately disclosed payments received significantly higher median payments compared to authors who did not accurately disclose payments ($37,222 [interquartile range: $28,203-$132,589] versus $1748 [interquartile range $257-$35,041], P < 0.0001). Senior authors were significantly more likely to have a COI discrepancy compared to first authors (P = 0.0219). CONCLUSIONS: The majority of TCAR-related studies did not accurately declare COI. A multivariate analysis demonstrated no effect of sponsorship on study recommendations or impact factor. This study highlights the need for increased efforts in accountability to improve the transparency of industry sponsorship, especially when consulting authors are reporting their results on patient outcomes.

Examining a decade of racial disparity in partial mastectomy and oncoplastic surgery.

BACKGROUND AND OBJECTIVES: Understanding racial disparity is crucial to addressing health equity and access to care. Our study aims to examine racial differences in breast conserving surgery (BCS) utilization rates and determine how these rates have changed over time. METHODS: This retrospective cohort analysis utilized the NSQIP database to identify women diagnosed with breast cancer who underwent BCS procedures between 2008 and 2019. Racial utilization trends were analyzed using a Cochran-Armitage test and Index of Disparity analysis. RESULTS: In the 12-year period, 202 492 women underwent a breast cancer surgery, of which 47% underwent BCS. Within the BCS subgroup, oncoplastic surgery utilization increased from 3% to 10%, leading to a declining proportion of partial mastectomies: 97% to 90.0% (both p < 0.01). The racial index of disparity for overall BCS patients decreased from 7% to 6%, remained unchanged (1%) for partial mastectomies, and significantly decreased in oncoplastics (23%-7.6%). CONCLUSION: BCS represents a mainstay option for early-staged breast cancer interventions, this study demonstrate promising progress in decreasing the index of disparity among races and persistent racial inequalities.

The adoption of oncoplastic surgery: Is there a learning curve?

INTRODUCTION: Oncoplastic surgery (OPS) is a form of breast conservation surgery involving partial mastectomy followed by volume displacement or replacement surgery. As the field of OPS is growing, we sought to determine if there was a learning curve to this surgery. METHODS: A retrospective chart review was conducted of all patients who underwent OPS over a 6-year period with a single surgeon formally trained in both Plastic Surgery and Breast Oncology. Cumulative summation analysis (CUSUM) was performed on mean operative time to generate the learning curve and learning curve phases. Outcomes were compared between phases to determine significance. RESULTS: Mean operative time decreased significantly across the 6-year period, generating three distinct learning curve phases: Learner phase (cases 1-23), Competence phase (24-73), and Mastery phase (74 and greater). The overall positive margin rate was 10.9% and there was no significant difference in rates between phases (p = 0.49). Overall complication rates, reoperation rates, and locoregional recurrence remained the same across all phases (p = 0.16; p = 0.65; p = 0.41). The rate of partial nipple loss decreased between phases (p = 0.02). CONCLUSION: As with many complex operations, there does appear to be a learning curve with OPS, as the operative time and the rates of partial nipple loss decreased over time.

Does Breast-Conserving Surgery with Radiotherapy have a Better Survival than Mastectomy? A Meta-Analysis of More than 1,500,000 Patients.

BACKGROUND: There have been conflicting studies reporting on survival advantages between breast-conserving surgery with radiotherapy (BCS) in comparison with mastectomy. Our aim was to compare the efficacy of BCS and mastectomy in terms of overall survival (OS) comparing all past published studies. METHODS: We performed a comprehensive review of literature through October 2021 in PubMed, Scopus, and EMBASE. The studies included were randomized controlled trials (RCTs) and cohorts that compare BCS versus mastectomy. We excluded studies that included male sex, stage 0, distant metastasis at diagnosis, bilateral synchronous cancer, neoadjuvant radiation/chemotherapy, and articles with incomplete data. We performed a meta-analysis following the random-effect model with the inverse variance method. RESULTS: From 18,997 publications, a total of 30 studies were included in the final analysis: 6 studies were randomized trials, and 24 were retrospective cohorts. A total of 1,802,128 patients with a follow-up ranging from 4 to 20 years were included, and 1,075,563 and 744,565 underwent BCS and mastectomy, respectively. Among the population, BCS is associated with improved OS compared with mastectomy [relative risk (RR) 0.64, 95% confidence interval (CI) 0.55-0.74]. This effect was similar when analysis was performed in cohorts and multi-institutional databases (RR 0.57, 95% CI 0.49-0.67). Furthermore, the benefit of BCS was stronger in patients who had less than 10 years of follow-up (RR 0.54, 95% CI 0.46-0.64). CONCLUSIONS: Patients who underwent BCS had better OS compared with mastectomy. Such results depicting survival advantage, especially using such a large sample of patients, may need to be included in the shared surgical decision making when discussing breast cancer treatment with patients.

Surgical Predictive Model for Breast Cancer Patients Assessing Acute Postoperative Complications: The Breast Cancer Surgery Risk Calculator.

BACKGROUND: Prognostic tools, such as risk calculators, improve the patient-physician informed decision-making process. These tools are limited for breast cancer patients when assessing surgical complication risk preoperatively. OBJECTIVE: In this study, we aimed to assess predictors associated with acute postoperative complications for breast cancer patients and then develop a predictive model that calculates a complication probability using patient risk factors. METHODS: We performed a retrospective cohort study using the National Surgical Quality Improvement Program (NSQIP) database from 2005 to 2017. Women diagnosed with ductal carcinoma in situ or invasive breast cancer who underwent either breast conservation or mastectomy procedures were included in this predictive modeling scheme. Four models were built using logistic regression methods to predict the following composite outcomes: overall, infectious, hematologic, and internal organ complications. Model performance, accuracy and calibration measures during internal/external validation included area under the curve, Brier score, and Hosmer-Lemeshow statistic, respectively. RESULTS: A total of 163,613 women met the inclusion criteria. The area under the curve for each model was as follows: overall, 0.70; infectious, 0.67; hematologic, 0.84; and internal organ, 0.74. Brier scores were all between 0.04 and 0.003. Model calibration using the Hosmer-Lemeshow statistic found all p-values to be > 0.05. Using model coefficients, individualized risk can be calculated on the web-based Breast Cancer Surgery Risk Calculator (BCSRc) platform ( www.breastcalc.org ). CONCLUSION: We developed an internally and externally validated risk calculator that estimates a breast cancer patient's unique risk of acute complications following each surgical intervention. Preoperative use of the BCSRc can potentially help stratify patients with an increased complication risk and improve expectations during the decision-making process.

A comprehensive literature review of patient-reported outcome measures (PROMs) among common breast reconstruction options: What types of breast reconstruction score well?

PURPOSE: Breast cancer continues to be the most prevalent cancer affecting women. Many reconstructive options exist after oncologic resection. Breast reconstruction can have a lasting impact on many areas of the patient's life, and therefore, a high consideration for patient satisfaction is crucial. Patient-reported outcome measures (PROMs) provide an important tool in the evaluation of different surgical methodologies. The aim of this comprehensive systematic review is to look at various surgical modalities in breast reconstruction as they relate to patient satisfaction. METHODS: A PubMed PRISMA search was performed. Criteria for inclusion included nipple-sparing or skin-sparing mastectomy with autologous or implant-based reconstruction, level 2 volume displacement or volume replacement oncoplastic surgery, and measurement of patient-reported outcomes using the BREAST-Q or other validated PROMs. From the data set, weighted proportions were generated and analyzed using the Kruskal-Wallis rank sum test and a post hoc Dunn's test. RESULTS: After obtaining 254 full text copies, 43 articles met inclusion criteria and were included. Analysis of BREAST-Q data showed oncoplastic breast surgery was significantly preferred over mastectomy regardless of the type of reconstruction. Nipple-sparing was significantly preferred over skin-sparing mastectomy, autologous reconstruction was significantly preferred over implant-based reconstruction, and prepectoral implant placement was preferred over subpectoral implant placement. Validated PROMs other than BREAST-Q showed similar trends in all but type of mastectomy. CONCLUSIONS: In this comprehensive systematic review, oncoplastic surgery showed the most favorable PROMs when compared to other reconstructive modalities. Autologous was preferred over implant-based reconstruction, and prepectoral was preferred over subpectoral implant placement.

Analysis of Surgical Trends for Axillary Lymph Node Management in Patients with Ductal Carcinoma In Situ Using the NSQIP Database: Are We Following National Guidelines?

BACKGROUND: For patients with ductal carcinoma in situ (DCIS), multiple national cancer organizations recommend that sentinel lymph node biopsy (SLNB) be offered when treated with mastectomy, but not when treated with breast-conserving surgery (BCS). This study analyzes national surgical trends of SLNB and axillary lymph node dissection (ALND) in DCIS patients undergoing breast surgery with the aim to quantify deviations from national guidelines. METHODS: A retrospective cohort analysis of the American College of Surgeons' National Surgical Quality Improvement Program (ACS NSQIP) database from 2005 to 2017 identified patients with DCIS. Patients were categorized by their primary method of breast surgery, i.e. mastectomy or BCS, then further categorized by their axillary lymph node (ALN) management, i.e. no intervention, SLNB, or ALND. Data analysis was conducted via linear regression and a non-parametric Mann-Kendall test to assess a temporal trend and Sen's slope. RESULTS: Overall, 43,448 patients with DCIS met the inclusion criteria: 20,504 underwent mastectomy and 22,944 underwent BCS. Analysis of DCIS patients from 2005 to 2017 revealed that ALND decreased and SLNB increased in every subgroup, regardless of surgical treatment modality. Evaluation in the mastectomy group increased overall: mastectomy alone increased from 57.1 to 65.8% (p < 0.01) and mastectomy with immediate reconstruction increased from 58.5 to 72.1% (p < 0.01). Increases also occurred in the total BCS population: partial mastectomy increased from 14.0 to 21.1% and oncoplastic surgery increased from 10.5 to 23.0% (both p < 0.01). CONCLUSIONS: Despite national guideline recommendations for the management of ALN surgery in DCIS patients, approximately 20-30% of cases continue to not follow these guidelines. This warrants further education for surgeons and patients.

Surgical trends in breast cancer: a rise in novel operative treatment options over a 12 year analysis.

PURPOSE: Breast cancer surgical techniques are evolving. Few studies have analyzed national trends for the multitude of surgical options that include partial mastectomy (PM), mastectomy without reconstruction (M), mastectomy with reconstruction (M+R), and PM with oncoplastic reconstruction (OS). We hypothesize that the use of M is declining and likely correlates with the rise of surgery with reconstructive options (M+R, OS). METHODS: A retrospective cohort analysis was conducted using the ACS-NSQIP database from 2005 to 2016 and ICD codes for IBC and DCIS. Patients were then grouped together based on current procedural terminology (CPT) codes for PM, M, M+R, and OS. In each group, categories were sorted again based on additional reconstructive procedures. Data analysis was conducted via Pearson's chi-squared test for demographics, linear regression, and a non-parametric Mann- Kendall test to assess a temporal trend. RESULTS: The patient cohort consisted of 256,398 patients from the NSQIP data base; 197,387 meet inclusion criteria diagnosed with IBC or DCIS. Annual breast surgery trends changed as follows: PM 46.3-46.1% (p = 0.21), M 35.8-26.4% (p = 0.001), M+R 15.9-23.0% (p = 0.03), and OS 1.8-4.42% (p = 0.001). Analyzing the patient cohort who underwent breast conservation, categorical analysis showed a decreased use of PM alone (96-91%) with an increased use of OS (4-9%). For the patient cohort undergoing mastectomy, M alone decreased (69-53%); M+R with muscular flap decreased (9-2%); and M+R with implant placement increased (20-40%)-all three trends p < 0.0001. CONCLUSION: The modern era of breast surgery is identified by the increasing use of reconstruction for patients undergoing breast conservation (in the form of OS) and mastectomy (in the form of M+R). Our study provides data showing significant trends that will impact the future of both breast cancer surgery and breast training programs.

Genitourinary vascularized composite allotransplantation: a review of penile transplantation.

PURPOSE OF REVIEW: Vascularized composite allotransplantation (VCA) has developed over the past 20 years, resulting in promising new reconstructive prospects for extensive soft tissue defects. More than 200 VCAs have been performed worldwide, including five genitourinary (GU)VCAs and here we review the most recent literature in this field. RECENT FINDINGS: Developments in GUVCA are continuously evolving to improve patient outcomes and suggest ethical equivalency to solid organ transplant. Recent treatment options have focused on preventing GUVCA complications by acknowledging the immunogenic tissue composition of the penis to treat rejection episodes and implementing stem cell transplant to recognized the GUVCA as self. Utilizing modern, postoperative, treatments can minimize complications and although the ethical dilemma remains, the morality of performing a GUVCA has diminished. The ethical focus relic's on standardization of patient safety. SUMMARY: GUVCA has become an established reconstructive surgical option. The prospect of VCA's future insinuates systemization between multidisciplinary VCA programs and the United Network for Organ Sharing in efforts to endorse ethical standardization. Over the last five years, the unprecedented outcomes have shown purpose to GUVCA that initiates an obligation to help those with severe genitourinary tissue defects. Progress in immunobiology continues to evolve optimal immunosuppression drug regimens and tolerance induction protocols, highlighting potential new immunologic pathways for graft acceptance.

Erratum: 4072 Optimizing ex-vivo perfusion in Vascularized Composite Allotransplantation using Hyperosmolar solution and Electric Stimulation: Preliminary Results - ERRATUM.

[This corrects the article DOI: 10.1017/cts.2020.87.].

The Use of Hemostatic Agents to Decrease Bleeding Complications in Breast Cancer Surgery.

INTRODUCTION: Following breast cancer surgery, patients often require adjuvant radiation and chemotherapy for locoregional and systemic disease control. These procedures may result in postoperative complications, which may delay adjuvant therapy. To potentially decrease these complications, hemostatic agents may be used. This study evaluated the rate of postoperative bleeding complications and duration of Jackson-Pratt (JP) drain use in oncologic breast surgery with and without hemostatic agents. METHODS: After obtaining institutional review board approval, a retrospective chart review was performed. Patients who underwent oncoplastic breast surgery, mastectomy with or without expander/implant-based reconstruction, and subsequent reconstruction with expander to implant exchange were included. Data collected included indication for surgery, type of operation, use of hemostatic agent, specifically fibrin sealant (FS, EVICEL®, Ethicon, USA) or combination powder (CP, HEMOBLAST™ Bellows, biom'up, France), length of follow-up, time to JP drain removal, and post-operative complications (seroma, hematoma, or operating room (OR) takeback). This was a consecutive experience where initially no hemostatic agent was used, followed by use of FS, and then CP. RESULTS: The use of a hemostatic agent resulted in fewer bleeding complications and significantly decreased time until JP drain removal. Although not significant, subgroup analysis demonstrated that this was more pronounced in the CP group. JP drain duration was decreased among all procedures for CP compared to FS. CONCLUSIONS: The use of hemostatic agents in oncologic breast surgery may result in decreased postoperative complications and significantly reduce time to JP drain removal.

Outcomes of Orchiectomy for Gender-affirming Surgery: A National Surgical Quality Improvement Program Study.

OBJECTIVE: To identify perioperative outcomes of transgender orchiectomy (TGO) and to broadly compare outcomes of TGO to cisgender orchiectomy (CGO) for nononcologic indications. METHODS: Using the National Surgical Quality Improvement Program (NSQIP) database from 2010 to 2020, a retrospective study was performed on patients with ICD-9/10 codes for gender dysphoria, testicular torsion, and testicular pain who underwent simple orchiectomy. Demographics and surgical outcomes were summarized. Welch two-sample t test and chi-square test were used for group analysis. A trend analysis was performed for temporal trends of these surgeries. RESULTS: 246 patients underwent TGO and 997 patients underwent CGO (607 testicular torsion, 390 testicular pain). Overall complication rates between TGO and CGO did not differ for testicular torsion (3.7% vs 4.4%, P = .6) or testicular pain (3.7% vs 5.9%, P = .2). No differences in patient characteristics were seen within the TGO group when comparing those who experienced complications to those who didn't. From 2015 to 2020, TGO cases significantly increased by, on average, 9.5 cases per year (95% CI: 6.3-12.7, P = .001), while CGO had showed no significant temporal change. CONCLUSION: Standalone TGO can be performed safely in an outpatient setting with an acceptable complication profile in medically diverse patients.

Legislations Mandating Insurance Coverage Are Highly Effective in Delivering Surgical Care of Transgender Patients.

Although gender-affirming surgery is increasingly performed, few studies have examined any temporal correlation between legislations mandating transgender care and the actuation of such surgical care. Methods: We assembled a retrospective cohort utilizing the National Inpatient Sample database from 2000 to 2018. We stratified utility trends of gender-affirming surgery based on insurance payer types and regions in a crisscrossing effort to detect any temporal or cause-effect relationship between legislations and outcomes. All regions according to the latest National Inpatient Sample categorization were examined based on the nature of their member state's legislations relating to gender-affirming care coverage. Diametrically, opposite regions were selected for further comparisons. Interrupted time series analyses were used to demonstrate any significant uptrend since implementation of relevant legislations. Results: In states with explicit inclusion of gender-affirming care, our interrupted time series analyses showed a significant increase in the number of patients on state-dependent insurance (Medicaid and private insurance) receiving gender-affirming surgery around the time during which state legislations began mandating care (P < 0.01) and thereafter (P < 0.01). This significance was not seen in the same regions among patients under nonstate-dependent payers (Medicare and self-pay), nor was it seen in either payer group in states without explicit inclusion of gender-affirming care. At the federal level, statistical significance was noted among Medicare recipients across all states around the time federal legislations took effect and thereafter. Conclusion: Legislations mandating coverage seem highly effective in actuating surgical care of transgender patients in corresponding jurisdictions, which may provide a roadmap for further care expansion.

How Does Oncoplastic Surgery Compare with Standard Partial Mastectomy? A Systematic Review of Patient-Reported Outcomes.

BACKGROUND: Many breast-conserving surgical options exist for patients with breast cancer. Surgical choices can have lasting effects on a patient's life, so patient satisfaction is important to assess. Patient-reported outcome measures provide important tools when evaluating surgical modalities. This systematic review aimed to evaluate how patients describe breast-conserving surgical choices in standard partial mastectomy and oncoplastic surgery options. METHODS: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses search was performed in PubMed for studies discussing standard partial mastectomy or oncoplastic surgery and measurement of preoperative and postoperative patient-reported outcomes using the BREAST-Q or other validated patient-reported outcome measures. Oncoplastic surgery was categorized as volume displacement or volume replacement. Articles in languages other than English, not involving partial mastectomy or oncoplastic surgery, or not measuring patient-reported outcomes were excluded. Weighted proportions were generated and analyzed with a Welch t test. RESULTS: Of 390 articles, 43 met inclusion criteria, and 8784 patients were included in a pooled database. Although standard partial mastectomy scored well, oncoplastic surgery performed significantly better than partial mastectomy in all postoperative BREAST-Q categories: satisfaction with breasts (74.3 versus 65.7), psychosocial well-being (81.3 versus 78.0), sexual well-being (61.6 versus 54.9), and satisfaction with outcome (85.4 versus 62.2). Level 2 volume displacement surgery had the most favorable scores. CONCLUSIONS: Breast-conserving surgical choices that include a variety of oncoplastic surgery and partial mastectomy methods all score well in patient-reported outcome measures, with oncoplastic surgery significantly preferred over partial mastectomy. Oncoplastic surgery should be considered in all cases, and the appropriate breast-conserving surgical choice should depend on the patient's tumor presentation and anatomy.

Closed Incision Negative Pressure Therapy: Indications and Adherence to Protocol.

BACKGROUND: Complications associated with wound management not only increase the morbidity and mortality of surgical interventions but they also increase the cost and decrease the quality of care. Closed incision negative pressure therapy (CINPT) has been proposed as a superior method of wound care compared to the more traditional wound management methods. Since the Food and Drug Administration indications for using CINPT are broad and generally nonspecific, it is unclear whether patients are appropriately screened for and receive this treatment modality. MATERIAL AND METHODS: To identify common clinical indications for CINPT, we conducted a literature review to define a consensus for CINPT candidates and used the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database to indicate if certain patient demographics impact decision-making. RESULTS: Based on the literature review, encompassing 57 articles, and the National Surgical Quality Improvement Program (NSQIP) database, over 11,000 patients received CINPT. Both the NSQIP data and the literature review commonly reported BMI >30 (47.1% and 39.6%), smoking (22.7% and 29.2%), and diabetes mellitus (22.7% and 47.9) as the most common clinical indications for using CINPT. DISCUSSION: The most common indications for using CINPT according to the literature review and the NSQIP database are BMI > 30, smoking status, and diabetes mellitus. Besides identifying patients who potentially benefit the most from CINPT, the results of this study suggest clinical adherence to the practice guidelines reported in the literature regarding wound management using this treatment modality.