Direct-to-Implant vs Tissue Expander Placement in Immediate Breast Reconstruction: A Prospective Cohort Study.

BACKGROUND: Direct-to-implant (DTI) breast reconstruction after mastectomy has gained increasing popularity. While concerns over ischemic complications related to tension on the mastectomy flap persist, newer techniques and technologies have enhanced safety of this technique. OBJECTIVES: To compare clinical and patient-reported outcomes of DTI and two-stage tissue expander (TE) reconstruction. METHODS: A prospective cohort design was utilized to compare the incidence of reconstructive failure among patients undergoing DTI and TE reconstruction via unadjusted bivariate and adjusted multivariable logistic regression analyses. Secondary clinical outcomes of interest included specific complications requiring intervention (infection, seroma, hematoma, mastectomy flap necrosis, incisional dehiscence, device exposure) and time to final drain removal. Patient-reported outcomes (PROs) via BREAST-Q were also compared. RESULTS: A total of 134 patients (257 breasts) underwent DTI reconstruction and 222 patients (405 breasts) received TEs. DTI patients were significantly younger with lower BMIs, less diabetes, hypertension, and smoking, and smaller breast sizes, and underwent more nipple-sparing mastectomies with prepectoral reconstructions. Rates of any complication (18% DTI vs 24% TE, p=0.047), reconstructive failure (5.1% vs 12%, p=0.004), and seroma (3.9% vs 11%, p<0.001) were significantly lower in the DTI cohort on unadjusted analyses; however, there were no significant differences in adjusted regressions. Patient-reported satisfaction with breasts, psychosocial well-being, and sexual well-being were more substantively improved with DTI reconstruction. CONCLUSIONS: Prepectoral DTI reconstruction is a viable option for post-mastectomy reconstruction in carefully selected patients, with no significant increase in reconstructive failure or other complications.

Cortiva vs AlloDerm in Prepectoral and Partial Submuscular Implant-Based Breast Reconstruction: A Randomized Clinical Trial.

BACKGROUND: Several acellular dermal matrices (ADMs) are utilized for soft tissue support in prosthetic breast reconstruction. Little high-level evidence supports the use of one ADM over another. Therefore, we sought to compare Cortiva 1mm Allograft Dermis to AlloDerm RTU, the most studied ADM in the literature. METHODS: A single-blinded randomized controlled trial comparing Cortiva to AlloDerm in prepectoral and subpectoral immediate prosthetic breast reconstruction was performed at two academic hospitals from March 2017 to December 2021. Reconstructions were direct-to-implant (DTI) or tissue expander (TE). Primary outcome was reconstructive failure, defined as TE explantation prior to planned further reconstruction, or explantation of DTI reconstructions before 3 months postoperatively. Secondary outcomes were additional complications, patient-reported outcomes (PROs), and cost. RESULTS: There were 302 patients included - 151 AlloDerm (280 breasts), 151 Cortiva (277 breasts). Reconstructions in both cohorts were majority TE (62% vs 38% DTI), smooth device (68% vs 32% textured), and prepectoral (80% vs 20% subpectoral). Reconstructive failure was no different between ADMs (AlloDerm 9.3% vs Cortiva 8.3%, p=0.68). There were no additional differences in any complications or PROs between ADMs. Seromas occurred in 7.6% of Cortiva but 12 % of AlloDerm cases, whose odds of seroma formation were two-fold (OR 1.93, 95% CI 1.01-3.67, p=0.047) higher. AlloDerm variable cost was 10-15% more than Cortiva, and there were no additional cost differences. CONCLUSION: When assessing safety, clinical performance, PROs, and cost, Cortiva is non-inferior to AlloDerm in immediate prosthetic breast reconstruction and may be cheaper with lower risk of seroma formation.

A prospective randomized clinical trial to assess antibiotic pocket irrigation on tissue expander breast reconstruction.

Bacterial infection is the most common complication following staged post-mastectomy breast reconstruction initiated with a tissue expander (TE). To limit bacterial infection, antibiotic irrigation of the surgical site is commonly performed despite little high-quality data to support this practice. We performed a prospective randomized control trial to compare the impact of saline irrigation alone to a triple antibiotic irrigation regimen (1 g cefazolin, 80 mg gentamicin, and 50,000 units of bacitracin in 500 mL of saline) for breast implant surgery. The microbiome in breasts with cancer (n = 16) was compared to those without (n = 16), as all patients (n = 16) had unilateral cancers but bilateral mastectomies (n = 32). Biologic and prosthetic specimens procured both at the time of mastectomy and during TE removal months later were analyzed for longitudinal comparison. Outcomes included clinical infection, bacterial abundance, and relative microbiome composition. No patient in either group suffered a reconstructive failure or developed an infection. Triple antibiotic irrigation administered at the time of immediate TE reconstruction did not reduce bacterial abundance or impact microbial diversity relative to saline irrigation at the time of planned exchange. Implanted prosthetic material adopted the microbial composition of the surrounding host tissue. In cancer-naïve breasts, relative to saline, antibiotic irrigation increased bacterial abundance on periprosthetic capsules (P = 0.03) and acellular dermal matrices (P = 0.04) and altered the microbiota on both. These data show that, relative to saline only, the use of triple antibiotic irrigation in TE breast reconstruction does impact the bacterial abundance and diversity of certain biomaterials from cancer-naïve breasts. IMPORTANCE The lifetime risk of breast cancer is ~13% in women and is treated with a mastectomy in ~50% of cases. The majority are reconstructed, usually starting with a tissue expander to help restore the volume for a subsequent permanent breast implant or the women's own tissues. The biopsychosocial benefits of breast reconstruction, though, can be tempered by a high complication rate of at least 7% but over 30% in some women. Bacterial infection is the most common complication, and can lead to treatment delays, patient physical and emotional distress and escalating health care cost. To limit this risk, plastic surgeons have tried a variety of strategies to limit bacterial infection including irrigating the pocket created after removing the breast implant with antibiotic solutions, but good-quality data are scarce. Herein, we study the value of antibiotics in pocket irrigation using a robust randomized clinical trial design and molecular microbiology approaches.

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.

A Novel Biosignature Identifies Patients With DCIS With High Risk of Local Recurrence After Breast Conserving Surgery and Radiation Therapy.

PURPOSE: There is an unmet need to identify women diagnosed with ductal carcinoma in situ (DCIS) with a low risk of in-breast recurrence (IBR) after breast conserving surgery (BCS), which could omit radiation therapy (RT), and also to identify those with elevated IBR risk remaining after BCS plus RT. We evaluated a novel biosignature for a residual risk subtype (RRt) to help identify patients with elevated IBR risk after BCS plus RT. METHODS AND MATERIALS: Women with DCIS treated with BCS with or without RT at centers in the US, Australia, and Sweden (n = 926) were evaluated. Patients were classified into 3 biosignature risk groups using the decision score (DS) and the RRt category: (1) Low Risk (DS ≤2.8 without RRt), (2) Elevated Risk (DS >2.8 without RRt), and (3) Residual Risk (DS >2.8 with RRt). Total and invasive IBR rates were assessed by risk group and treatment. RESULTS: In patients at low risk, there was no significant difference in IBR rates with or without RT (total, P = .8; invasive IBR, P = .7), and there were low overall 10-year rates (total, 5.1%; invasive, 2.7%). In patients with elevated risk, IBR rates were decreased with RT (total: hazard ratio [HR], 0.25; P < .001; invasive: HR, 0.28; P = .005); 10-year rates were 20.6% versus 4.9% (total) and 10.9% versus 3.1% (invasive). In patients with residual risk, although IBR rates decreased with RT after BCS (total: HR, 0.21; P < .001; invasive: HR, 0.29; P = .028), IBR rates remained significantly higher after RT compared with patients with elevated risk (HR, 2.5; 95% CI, 1.2-5.4; P = .018), with 10-year rates of 42.1% versus 14.7% (total) and 18.3% versus 6.5% (invasive). CONCLUSIONS: The novel biosignature identified patients with 3 distinct risk profiles: Low Risk patients with a low recurrence risk with or without adjuvant RT, Elevated Risk patients with excellent outcomes after BCS plus RT, and Residual Risk patients with an elevated recurrence risk remaining after BCS plus RT, warranting potential intensified or alternative treatment approaches.

Factors associated with initiation and continuation of endocrine therapy in women with hormone receptor-positive breast cancer.

BACKGROUND: Despite benefits of endocrine therapy (ET) for patients with hormone-receptor (HR)-positive breast cancer, many patients do not initiate or discontinue ET against recommendations. METHODS: We identified variables associated with ET initiation and continuation, analyzing pooled data from two longitudinal studies at a National Cancer Institute comprehensive cancer center in St. Louis, Missouri. The sample included 533 women with newly diagnosed, non-metastatic, HR-positive breast cancer who completed interviews at enrollment and 6, 12, and 24 months after definitive surgical treatment. Logistic regression models estimated the adjusted odds ratio and 95% confidence interval (aOR [95% CI]) for each of self-reported ET initiation by the 12-month interview and continuation for ≥12 months by the 24-month interview in association with self-reported diabetes, elevated depressed mood, menopausal-symptom severity and obesity, adjusting for race, age, insurance status, chemotherapy, and radiation therapy. RESULTS: Overall, 81.4% (434/533) of patients initiated ET, and 86.5% (371/429) continued ET ≥12 months. Patients with diabetes had lower odds of initiating ET (0.50 [0.27-0.91]). Patients reporting greater menopausal-symptom severity had lower odds of continuing ET (0.72 [0.53-0.99]). CONCLUSION: Efforts to increase ET initiation among patients with diabetes and better manage severe menopausal symptoms among ET users might promote ET continuation. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov : #NCT00929084.

Impact of consensus guidelines for breast-conserving surgery in patients with ductal carcinoma in situ.

BACKGROUND: Consensus guidelines published in 2016 recommended a 2 mm free margin as the standard for negative margins in patients undergoing breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). The goal of the guideline recommendation was standardization of re-excision practices. AIMS: To evaluate the impact of this consensus guideline on our institutional practices. METHODS: We identified all patients at our institution with pure DCIS who were initially treated with BCS from September 2014 to August 2018 using a prospectively-maintained institutional database. A retrospective chart review was performed to determine margin status and re-excision rates during the 2 years before and the 2 years after the guideline was published in order to determine the effect on our re-excision rates. Close margins were defined as <2 mm. RESULTS: In the 2 years before the consensus guideline was published, 184 patients with DCIS underwent BCS. Twenty-six patients had positive margins and 24 underwent re-excision, including three who had completion mastectomy. Of the remaining 159 patients, 76 had ≥2 mm (negative) margins. The remaining 82 patients had close margins and 48 of these patients (58.5%) underwent re-excision, including one who had a completion mastectomy. Excluding the patients with positive margins, our re-excision rate was 30.4% prior to the guideline. In the 2 years after the consensus guideline was published, 192 patients with DCIS underwent initial BCS. Twenty-four patients had positive margins and 22 underwent re-excision, including three who had completion mastectomy. Of the remaining 168 patients, 95 patients had ≥2 mm (negative) margins. The remaining 73 patients had close margins and 45 of those patients (61.6%) underwent re-excision, including six who had completion mastectomy. Excluding the patients with positive margins, our re-excision rate was 26.8% after the guideline. CONCLUSIONS: Our institution's re-excision rate did not change significantly during the 2 years before and after the publication of the consensus guideline on adequate margins for patients undergoing BCT for DCIS. Our overall re-excision rate decreased slightly. However, of the patients who had close margins, a larger proportion underwent re-excision after the guideline was published. The guideline publication appears to have affected our institutional practices slightly, but not dramatically as many of our surgeons' practices were comparable to the guideline recommendations prior to 2016. We continue to use clinical judgment based on patient and tumor characteristics in deciding which patients will benefit from margin re-excision.

The Landmark Series: Breast Conservation Trials (including oncoplastic breast surgery).

Significant progress has been made in the treatment and outcome of breast cancer. Some of the most dramatic strides have been in the surgical management of breast cancer. Breast-conserving therapy (BCT), including wide local excision of the tumor followed by irradiation, has become a standard treatment option for women with early-stage invasive breast cancer. Large cooperative group trials have contributed to the paradigm shift from mastectomy to BCT. This review reports the landmark BCT trials that provided the data for current surgical practices. The review also describes the body of literature contributing to the increasing use of oncoplastic techniques for patients undergoing BCT.

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.

Randomized controlled trial of a breast cancer Survivor Stories intervention for African American women.

RATIONALE: Video-based interventions hold promise for improving quality of life (QoL) among African American breast cancer patients. OBJECTIVE: An interactive, cancer-communication intervention using African American breast cancer survivors' narratives was tested in a randomized controlled trial to determine whether viewing survivor stories improved newly diagnosed African American breast cancer patients' QoL. METHOD: Participants were 228 African American women with non-metastatic breast cancer interviewed five times over two years; 120 controls received standard medical care, and 108 intervention-arm participants also received a tablet-computer with survivor stories three times in 12 months. Growth curve models were used to analyze differences between arms in change in eight RAND 36-Item Health Survey subscales, depressive symptoms, and concerns about recurrence. Additional models explored the effects of intervention usage and other intervention-related variables on QoL among patients in the intervention arm. RESULTS: Models showed no effect of study arm on QoL, depressive symptoms, or concerns about recurrence. Longer use of the intervention was associated with an increase in concerns about recurrence and decline in three QoL subscales: emotional wellbeing, energy/fatigue, and role limitations due to physical health. CONCLUSION: Although no significant impact of the intervention on QoL was observed when comparing the two study arms, in the intervention arm longer intervention use was associated with declines in three QoL subscales and increased concerns about recurrence. Women with improving QoL may have interacted with the tablet less because they felt less in need of information; it is also possible that encouraging patients to compare themselves to survivors who had already recovered from breast cancer led some patients to report lower QoL. Future work is warranted to examine whether adding different stories to this cancer-communication intervention or using stories in conjunction with additional health promotion strategies (e.g., patient navigation) might improve QoL for African American breast cancer patients.

The Landmark Series: Mastectomy Trials (Skin-Sparing and Nipple-Sparing and Reconstruction Landmark Trials).

Despite advances in medical therapy, the foundation of breast cancer treatment is surgery. The landscape of operative intervention for breast cancer has shifted toward less invasive techniques, resulting in improved cosmesis and lower morbidity while maintaining oncologic integrity. In this article, we review the body of literature contributing to landmark advances in mastectomy for the treatment of breast cancer.

Feasibility and Acceptability of an Interactive Cancer-Communication Video Program Using African American Breast Cancer Survivor Stories.

To examine the feasibility and acceptability of an interactive video program of African American breast cancer survivor stories, we explored story reactions among African American women with newly diagnosed breast cancer and associations between patient factors and intervention use. During a randomized controlled trial, patients in the intervention arm completed a baseline/pre-intervention interview, received the video intervention, and completed a post-intervention 1-month follow-up interview. Additional video exposures and post-exposure interviews occurred at 6- and 12-month follow-ups. Multivariable linear mixed-effects models examined interview and clinical data in association with changes in minutes and actions using the program. After Exposure1, 104 of 108 patients allocated to the intervention reported moderate-to-high levels of positive emotional reactions to stories and identification with storytellers. Exposure1 mean usage was high (139 minutes) but declined over time (p <.0001). Patients receiving surgery plus radiation logged about 50 more minutes and actions over 12-month follow-up than patients receiving surgery only (p <.05); patients reporting greater trust in storytellers logged 18.6 fewer actions over time (p =.04). Patients' topical interests evolved, with patients watching more follow-up care and survivorship videos at Exposure3. The intervention was feasible and evaluated favorably. New videos might satisfy patients' changing interests.

Indications for readmission following mastectomy for breast cancer: An assessment of patient and operative factors.

We investigated the impact of patient and operative factors on 30-day hospital readmission following mastectomy for breast cancer. Using the 2011 HCUP California State Inpatient Database, we evaluated readmissions in adult women undergoing mastectomy for invasive, in situ, or history of breast cancer. Clinical data assessment was performed using ICD-9-CM codes and the Elixhauser comorbidity index. Chi-square tests and logistic regression were used to analyze patient and operative factors and associations with 30-day hospital readmission. Of 6214 women undergoing mastectomy, 306 (4.9%) were readmitted within 30 days postoperatively, most commonly for surgical site infection (130, 42.5%) and hematoma (29, 9.5%). 30-day readmission was associated with increasing index length of stay (LOS), comorbidities, and non-private insurance (P < .05). Age, mastectomy type (unilateral vs bilateral, with vs without lymph node assessment), immediate reconstruction, and port placement during the index procedure did not significantly influence the odds of 30-day readmission. Multivariable logistic regression showed increased odds of readmission with index LOS > 2 days (OR 1.81, P < .01), metastatic disease (OR 2.16, P = .01), and Medicare insurance (OR 1.72, P < .01). Index LOS > 2 days, metastatic disease, and Medicare insurance are significant predictors of 30-day readmission following mastectomy for breast cancer. Surgical site infection and wound complications were the most common diagnoses requiring readmission and resulted in over half of readmissions in our study population at 30 days.

Surgical Oncologists and the COVID-19 Pandemic: Guiding Cancer Patients Effectively through Turbulence and Change.

BACKGROUND: The COVID-19 pandemic has posed extraordinary demands from patients, providers, and health care systems. Despite this, surgical oncologists must maintain focus on providing high-quality, empathetic care for the almost 2 million patients nationally who will be diagnosed with operable cancer this year. The focus of hospitals is transitioning from initial COVID-19 preparedness activities to a more sustained approach to cancer care. METHODS: Editorial Board members provided observations of the implications of the pandemic on providing care to surgical oncology patients. RESULTS: Strategies are presented that have allowed institutions to successfully prepare for cancer care during COVID-19, as well as other strategies that will help hospitals and surgical oncologists manage anticipated challenges in the near term. Perspectives are provided on: (1) maintaining a safe environment for surgical oncology care; (2) redirecting the multidisciplinary model to guide surgical decisions; (3) harnessing telemedicine to accommodate requisite physical distancing; (4) understanding interactions between SARS CoV-2 and cancer therapy; (5) considering the ethical impact of professional guidelines for surgery prioritization; and (6) advocating for our patients who require oncologic surgery in the midst of the COVID-19 pandemic. CONCLUSIONS: Until an effective vaccine becomes available for widespread use, it is imperative that surgical oncologists remain focused on providing optimal care for our cancer patients while managing the demands that the COVID-19 pandemic will continue to impose on all of us.