Revisiting Breast Reduction Insurance Coverage: How the Schnur Scale Discriminates Against Women Based on Body Habitus.

INTRODUCTION: The Schnur scale utilizes body surface area (BSA) to determine the amount of breast tissue resection in reduction mammoplasty, resulting in a greater requirement of breast weight removal in patients with larger BSA. We aimed to demonstrate BSA variance among women with similar mastectomy weights and the range of mastectomy weights among women with comparable BSAs. METHODS: A retrospective chart review of patients who underwent mastectomy from October 2021 to June 2022 was performed. Patients were included if they underwent skin-sparing or nipple-sparing mastectomy with a minimum specimen weight of 700g. Patient's BSA, body mass index (BMI), mastectomy weight, and Schnur weight requirement (SWR) were collected. RESULTS: A total of 130 patients (194 breasts) were included. There was significant variance in mean BSA, BMI, SWR, and SWR to mastectomy weight ratio among women with similar mastectomy weights. BSA varied by as much as 0.82 units, BMI varied by as much as 32 kg/m 2, and SWR varied by as much as 1365g within the same mastectomy weight group. There was also significant variance in mastectomy weights among women with comparable BSA, especially in BSA groups>2.20, with the greatest range in mastectomy weights being 1684g. CONCLUSION: Analysis of mastectomy patients showed no predictable relationship between BSA and breast weight. There was significant variance in the BSA of patients with similar breast weights, and conversely in breast weights of patients with comparable BSA. Therefore, strict adherence to the Schnur weight requirement can prevent patients suffering with macromastia from receiving breast reductions.

Conventional versus hypofractionated postmastectomy proton radiotherapy in the USA (MC1631): a randomised phase 2 trial.

BACKGROUND: Proton therapy is under investigation in breast cancer as a strategy to reduce radiation exposure to the heart and lungs. So far, studies investigating proton postmastectomy radiotherapy (PMRT) have used conventional fractionation over 25-28 days, but whether hypofractionated proton PMRT is feasible is unclear. We aimed to compare conventional fractionation and hypofractionation in patients with indications for PMRT, including those with immediate breast reconstruction. METHODS: We did a randomised phase 2 trial (MC1631) at Mayo Clinic in Rochester (MN, USA) and Mayo Clinic in Arizona (Phoenix, AZ, USA) comparing conventional fractionated (50 Gy in 25 fractions of 2 Gy [relative biological effectiveness of 1·1]) and hypofractionated (40·05 Gy in 15 fractions of 2·67 Gy [relative biological effectiveness of 1·1]) proton PMRT. All patients were treated with pencil-beam scanning. Eligibility criteria included age 18 years or older, an Eastern Cooperative Oncology Group performance status of 0-2, and breast cancer resected by mastectomy with or without immediate reconstruction with indications for PMRT. Patients were randomly assigned (1:1) to either conventional fractionation or hypofractionation, with presence of immediate reconstruction (yes vs no) as a stratification factor, using a biased-coin minimisation algorithm. Any patient who received at least one fraction of protocol treatment was evaluable for the primary endpoint and safety analyses. The primary endpoint was 24-month complication rate from the date of first radiotherapy, defined as grade 3 or worse adverse events occurring from 90 days after last radiotherapy or unplanned surgical interventions in patients with immediate reconstruction. The inferiority of hypofractionation would not be ruled out if the upper bound of the one-sided 95% CI for the difference in 24-month complication rate between the two groups was greater than 10%. This trial is registered with ClinicalTrials.gov, NCT02783690, and is closed to accrual. FINDINGS: Between June 2, 2016, and Aug 23, 2018, 88 patients were randomly assigned (44 to each group), of whom 82 received protocol treatment (41 in the conventional fractionation group and 41 in the hypofractionation group; median age of 52 years [IQR 44-64], 79 [96%] patients were White, two [2%] were Black or African American, one [1%] was Asian, and 79 [96%] were not of Hispanic ethnicity). As of data cutoff (Jan 30, 2023), the median follow-up was 39·3 months (IQR 37·5-61·2). The median mean heart dose was 0·54 Gy (IQR 0·30-0·72) for the conventional fractionation group and 0·49 Gy (0·25-0·64) for the hypofractionation group. Within 24 months of first radiotherapy, 14 protocol-defined complications occurred in six (15%) patients in the conventional fractionation group and in eight (20%) patients in the hypofractionation group (absolute difference 4·9% [one-sided 95% CI 18·5], p=0·27). The complications in the conventionally fractionated group were contracture (five [12%] of 41 patients]) and fat necrosis (one [2%] patient) requiring surgical intervention. All eight protocol-defined complications in the hypofractionation group were due to infections, three of which were acute infections that required surgical intervention, and five were late infections, four of which required surgical intervention. All 14 complications were in patients with immediate expander or implant-based reconstruction. INTERPRETATION: After a median follow-up of 39·3 months, non-inferiority of the hypofractionation group could not be established. However, given similar tolerability, hypofractionated proton PMRT appears to be worthy of further study in patients with and without immediate reconstruction. FUNDING: The Department of Radiation Oncology, Mayo Clinic, Rochester, MN, the Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ, USA, and the US National Cancer Institute.

Human Factors Approach to Assess Physician Workload in Elective Plastic Surgery Breast Procedures.

Background: Human factors research involves the study of work system interactions, physician workload, cognitive effort, and performance. This pilot study incorporated a human factor approach and other surgery-based metrics to assess cognitive workload among plastic surgeons during elective plastic surgery breast procedures. Methods: In this prospective study of plastic surgery breast procedures over a 3-month period, surgeon and patient demographics and procedural details were collected. The lead surgeon assessed each procedure using a validated workload questionnaire (National Aeronautics and Space Administration Task Load Index [NASA-TLX]) that included 6 subscales (ie, mental, physical, temporal demand, performance, effort, and frustration), a question on distraction, and their expectation of procedural difficulty. Results: Fifty-seven cases were included in this study. Surgical duration had a positive correlation with increased mental demand (P < .001), physical demand (P < .001), and degree of distractions (P < .001). Free flap reconstruction, breast reduction, and transgender mastectomy had the highest average mental, physical demands, and perceived effort. Bilateral cases had significantly higher workload than unilateral ones (P = .002). NASA-TLX scores between immediate and delayed reconstructions were comparable, but delayed cases had higher degree of distractions (P = .04). There was a strong correlation between degree of distractions and increased mental workload (R = 0.68; P < .001), increased physical demand (P = 0.61; P < .001), and increased temporal demand (R = 0.78; P < .001). More difficult procedures were associated with greater procedural duration than those rated as difficult as expected or less difficult than expected (P = .02). Conclusions: These preliminary data demonstrated multiple factors that may influence and govern perceived physician workload and may provide insight for targeted quality improvement to plan procedures safely and effectively.

Postmastectomy Intensity Modulated Proton Therapy: 5-Year Oncologic and Patient-Reported Outcomes.

PURPOSE: To report oncologic, physician-assessed, and patient-reported outcomes (PROs) for a group of women homogeneously treated with modern, skin-sparing multifield optimized pencil-beam scanning proton (intensity modulated proton therapy [IMPT]) postmastectomy radiation therapy (PMRT). METHODS AND MATERIALS: We reviewed consecutive patients who received unilateral, curative-intent, conventionally fractionated IMPT PMRT between 2015 and 2019. Strict constraints were applied to limit the dose to the skin and other organs at risk. Five-year oncologic outcomes were analyzed. Patient-reported outcomes were evaluated as part of a prospective registry at baseline, completion of PMRT, and 3 and 12 months after PMRT. RESULTS: A total of 127 patients were included. One hundred nine (86%) received chemotherapy, among whom 82 (65%) received neoadjuvant chemotherapy. The median follow-up was 4.1 years. Five-year locoregional control was 98.4% (95% CI, 93.6-99.6), and overall survival was 87.9% (95% CI, 78.7-96.5). Acute grade 2 and 3 dermatitis was seen in 45% and 4% of patients, respectively. Three patients (2%) experienced acute grade 3 infection, all of whom had breast reconstruction. Three late grade 3 adverse events occurred: morphea (n = 1), infection (n = 1), and seroma (n = 1). There were no cardiac or pulmonary adverse events. Among the 73 patients at risk for PMRT-associated reconstruction complications, 7 (10%) experienced reconstruction failure. Ninety-five patients (75%) enrolled in the prospective PRO registry. The only metrics to increase by >1 point were skin color (mean change: 5) and itchiness (2) at treatment completion and tightness/pulling/stretching (2) and skin color (2) at 12 months. There was no significant change in the following PROs: bleeding/leaking fluid, blistering, telangiectasia, lifting, arm extension, or bending/straightening the arm. CONCLUSIONS: With strict dose constraints to skin and organs at risk, postmastectomy IMPT was associated with excellent oncologic outcomes and PROs. Rates of skin, chest wall, and reconstruction complications compared favorably to previous proton and photon series. Postmastectomy IMPT warrants further investigation in a multi-institutional setting with careful attention to planning techniques.

Breast Resection Weight Prediction and Insurance Reimbursement in Reduction Mammaplasty: Which Scale Is Reliable?

BACKGROUND: Many insurance companies in the United States rely on the Schnur sliding scale to predict resection weights to determine medical necessity for breast reduction surgery. Accurate methods to predict resection weights are needed to avoid insurance denials. The authors compared the accuracy of formulas such as the Schnur, Appel, Descamps, and Galveston scales in predicting resection weights, and assessed whether they influence insurance coverage decision. METHODS: A retrospective review of bilateral reduction mammaplasty procedures from June of 2017 to June of 2019 was performed at the Mayo Clinic, Rochester. Oncoplastic reduction operations were excluded. The accuracy of each formula-based estimate was evaluated with linear regression analysis. RESULTS: One hundred fifty-four patients (308 breasts) were reviewed. The Schnur scale had low correlation with actual resection weight ( r2 = 0.381; b1 = 1.153; p < 0.001). The Appel scale was the most accurate ( r2 = 0.642; b1 = 1.01; p < 0.001), followed by the Descamps ( r2 = 0.572, b1 = 0.934, p < 0.001) and Galveston ( r2 = 0.672; b 1 = 0.654; p < 0.001) scales. The Appel, Descamps, and Galveston scales were more accurate for resection weights of 500 g or greater, body mass index greater than 30 kg/m², and patients younger than 50 years. For resection weights of 500 g or greater, the median difference between the estimated and actual resection weight for the Schnur, Appel, Descamps, and Galveston scales was -211.4 ± 272.3, -17.5 ± 272.3, -9.6 ± 229.5, and -99.2 ± 238.5 g, respectively. No scale was accurate for resection weights less than 500 g. Insurance reimbursement was denied in 15.56 percent of patients; of these, 23 percent had resection weights less than 500 g. The Schnur scale overestimated the resection weights in 28.9 percent of patients. CONCLUSIONS: The Schnur scale is a poor predictor of breast resection weight. The Appel scale is the most accurate estimator, especially in the young and obese population with larger resections. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, I.

Postmastectomy Breast Reconstruction is Safe in Patients on Chronic Anticoagulation.

Background Postmastectomy breast reconstruction (PMR) increases patient satisfaction, quality of life, and psychosocial well-being. There is scarce data regarding the safety of PMR in chronic anticoagulated patients. Perioperative complications can reduce patient satisfaction; therefore, it is important to elucidate the safety of PMR in these patients. Methods A retrospective case-control study of patients who underwent PMR with implants and were on chronic anticoagulation was performed at our institution. Inclusion criteria were women ≥ 18 years old. Exclusion criteria included autologous reconstructions, lumpectomy, and oncoplastic procedures. Two controls for every one patient on anticoagulation were matched by age, body mass index, radiotherapy, smoking history, type of reconstruction, time of reconstruction, and laterality. Results From 2009 to 2020, 37 breasts (20 patients) underwent PMR with implant-based reconstruction and were on chronic anticoagulation. A total of 74 breasts (40 patients) who had similar demographic characteristics to the cases were defined as the control group. Mean age for the case group was 53.6 years (standard deviation [SD] = 16.1), mean body mass index was 28.6 kg/m 2 (SD = 5.1), and 2.7% of breasts had radiotherapy before reconstruction and 5.4% after reconstruction. Nine patients were on long-term warfarin, six on apixaban, three on rivaroxaban, one on low-molecular-weight heparin, and one on dabigatran. The indications for anticoagulation were prior thromboembolic events in 50%. Anticoagulated patients had a higher risk of capsular contracture (10.8% vs. 0%, p = 0.005). There were no differences regarding incidence of hematoma (2.7% vs. 1.4%, p = 0.63), thromboembolism (5% vs. 0%, p = 0.16), reconstructive-related complications, or length of hospitalization (1.6 days [SD = 24.2] vs. 1.4 days [SD = 24.2], p = 0.85). Conclusion Postmastectomy implant-based breast reconstruction can be safely performed in patients on chronic anticoagulation with appropriate perioperative management of anticoagulation. This information can be useful for preoperative counseling on these patients.

Defining the Role for Topically Administered Tranexamic Acid in Panniculectomy Surgery.

Background: Abdominal panniculectomy after weight loss is a commonly performed procedure with high patient satisfaction yet continues to have a high post-operative complication profile. Several risk-reducing surgical approaches, such as preservation of Scarpa's fascia, use of tissue adhesives, and progressive tension suture techniques have been described. However, the use of tranexamic acid (TXA) has not been previously reported in panniculectomy surgery. Objectives: To improve the safety and predictability of this procedure, the authors investigate whether the use of topically administered TXA during panniculectomy surgery reduces seroma, hematoma, and drain duration. Methods: Consecutive patients who underwent panniculectomy (January 2010 to January 2022) were retrospectively reviewed. Outcome measures included hematoma requiring surgical evacuation, seroma requiring percutaneous aspiration, and drain duration. Patients with thromboembolic diseases and those taking anticoagulation/antiplatelet medications were excluded. Patients who had received TXA were compared with a historical control group who had not received TXA. Results: A total of 288 consecutive patients were included. Topical TXA was administered in 56 (19.4%) cases. The mean (standard deviation [SD]) follow-up was 43.9 (37.4) months (3.7 years). The median (range) resection weight was 2.6 kg (0.15-19.96 kg). Regarding seroma and hematoma formation, the use of TXA did not reduce the likelihood of developing seroma or hematoma (odds ratio [OR] = 1.7, 95% CI [0.56- 4.8], P = 0.38 and OR = 2.1, 95% CI [0.4-11.8], P = 0.42), respectively. The mean (SD) duration of drains was slightly lower in the TXA group (18.1 [12.1] days vs 19.8 [13.9] days); however, this difference was not statistically significant, albeit clinically significant. Conclusions: As the use of TXA in plastic surgical procedures continues to expand, the utility of TXA in panniculectomy and abdominoplasty has not been elucidated. Although previous studies report hematoma and seroma risk reduction, the use of TXA was not associated with a statistically significant reduction in seroma, hematoma, or drain duration following panniculectomy surgery. Prospective, randomized controlled studies on the use of TXA in body contouring are needed.

Sexual Well-Being After Nipple-Sparing Mastectomy: Does Preservation of the Nipple Matter?

INTRODUCTION: The primary aim of this study was to evaluate patient-reported outcome measures in patients undergoing mastectomy with and without breast reconstruction (immediate or delayed) with and without nipple preservation. METHODS: All female patients undergoing mastectomy between 2011 and 2015 at Mayo Clinic Rochester were identified and were mailed the BREAST-Q survey. Breast satisfaction, psychosocial well-being, and sexual well-being were evaluated and compared by surgery type using Wilcoxon rank-sum tests for univariate analysis and linear regression for multivariable analysis adjusting for potential confounders. RESULTS: Of 1547 patients, 771 completed the BREAST-Q survey (response rate 50%). Of these 771 respondents, 237 (31%) did not have reconstruction, 198 (26%) had nipple-sparing mastectomy with reconstruction (NSM), and 336 (44%) had skin-sparing mastectomy with reconstruction (SSM) ± nipple-areolar complex (NAC) reconstruction (via surgery ± tattoo). Patients with breast reconstruction had consistently higher BREAST-Q scores versus those without. Comparing NSM with all SSMs, there was no difference in satisfaction with breasts (mean 71.8 vs. 70.2, p = 0.21) or psychosocial well-being (mean 81.9 vs. 81.3, p = 0.47); however, sexual well-being was significantly higher in the NSM group on univariate (mean 64.5 vs. 58.0, p = 0.002) and multivariable (ß = -4.69, p = 0.03) analysis. Sexual well-being scores were similar for NSM and the SSM subgroups with any type of NAC reconstruction. CONCLUSIONS: This study demonstrates that NSM positively impacts patient sexual well-being after breast reconstruction compared with SSM, particularly SSM without nipple reconstruction or tattoo. SSM with any type of NAC reconstruction achieved similar satisfaction and sexual well-being to those undergoing NSM.

Implant Malposition in Prepectoral Breast Reconstruction: Experience with Natrelle® Cohesive Implants over 6.5 Years.

Implant malposition has been reported to be a common reason for revision surgery after implant-based breast reconstruction (IBR). With the recent increase in the use of smooth implants due to concerns for breast implant-associated anaplastic large-cell lymphoma with textured implants, we compared and reported the rates of malposition in prepectoral IBR and identified risk factors. A retrospective review of patients who underwent prepectoral IBR with Natrelle® (Allergan, Inc., Irvine, CA) implants at our institution between January 2014 and May 2020 was performed. Clinical characteristics, implant types, and the rate of malposition, defined as implant flipping or rotation, were recorded. Univariate and multivariable time-to-event analyses using the Cox proportional-hazards model were performed to identify predictors of malposition. Three hundred seventy-five patients (660 breasts) were included. Four hundred forty-one (66.8%) breasts had smooth round implants whereas 219 (33.2%) had textured anatomical devices. Malposition requiring either a manual correction or surgical intervention occurred in 26 (5.9%) smooth round implants versus 3 (1.4%) textured anatomical. Multivariable analysis showed that having a smooth round implant (aHR: 7.19, 95% CI: [2.04 - 25.4]) and an increase in implant volume (aHR: 1.003, 95% CI: [1.001 - 1.006]) were associated with having a malposition requiring intervention. Among smooth round implants; INSPIRA® Cohesive implants were more likely to result in a malposition requiring intervention (p<0.0001) compared to other smooth round implants. Overall, malposition requiring intervention occurred in 5.9% of smooth round implants and 1.4% of textured anatomical implants. Statistical analysis demonstrates that smooth round implants and an increase in implant volume both are associated with a malposition requiring intervention.

Immediate Breast Reconstruction Using the Goldilocks Procedure: A Balance between More Surgery and Patient Satisfaction.

BACKGROUND: Since its first description in 2012, the Goldilocks procedure has become an option for immediate breast reconstruction, particularly for obese patients who are poor candidates for traditional implant or autologous reconstruction. In this work, the authors performed a longitudinal study of patients who underwent mastectomy with Goldilocks reconstruction to assess the incidence of additional surgical procedures, and to assess surgical outcomes and patient satisfaction. METHODS: A retrospective review of patients who underwent mastectomy with the Goldilocks procedure only at Mayo Clinic Rochester between January of 2012 and September of 2019 was performed. Demographics, complications, additional breast procedures performed to attain the final results, and patient-reported outcomes using the BREAST-Q were recorded. Univariate and multivariable analyses were performed to identify statistical associations and risk factors. RESULTS: Sixty-three patients (108 breasts) were included. Mean age was 57.8 years. Mean body mass index was 37.6 kg/m2. Median follow-up time after the mastectomy with the Goldilocks procedure was 15 months. The major complication rate within the first 30 days was 9.3 percent. Forty-four breasts (40.7 percent) underwent additional surgery. Dyslipidemia was significantly associated with an increased risk of additional surgery (adjusted hazard ratio, 2.00; p = 0.045). Scores in the four BREAST-Q domains were not statistically different between patients who had additional procedures and those who did not. CONCLUSIONS: Based on the results, the authors recommend a thorough preoperative discussion with patients who are candidates for the Goldilocks procedure to explore all options for reconstruction and their expectations, because it is crucial to reduce the necessity for additional operations in this high-risk population. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Efficacy of Tranexamic Acid in Reducing Seroma and Hematoma Formation Following Reduction Mammaplasty.

BACKGROUND: Tranexamic acid (TXA) has gained increasing recognition as a valuable pharmacologic agent within plastic surgery. OBJECTIVES: The aim of this study was to investigate the value and safety profile of both intravenous and topically administered TXA in the setting of bilateral reduction mammaplasty. METHODS: A retrospective review was performed to identify consecutive patients who underwent bilateral reduction mammaplasty for symptomatic macromastia (January 2016-July 2021). Pertinent preoperative, intraoperative, and postoperative details were collected/reviewed. Primary outcome measures included hematoma requiring surgical evacuation and clinically significant/symptomatic seroma formation mandating percutaneous aspiration. Patients taking anticoagulation/antiplatelet medication or those with a history of thromboembolic diseases were excluded. Patients who had received TXA were compared to a historical control group who did not receive TXA within the same consecutive cohort. RESULTS: A total of 385 consecutive patients (770 breasts) were included. TXA was used in 514 (66.8%) cases (topical, 318 [61.9%]; intravenous, 170 [33.1%]; intravenous and topical, 26 [5.1%]). Neither seroma nor hematoma were impacted/reduced with TXA (P > 0.05). Increased age (hazards ratio, 1.06 per 1-year increase; 95% CI, 1.004-1.118) significantly increased the risk of hematoma (P = 0.032). The use of drains significantly decreased the risk of seroma (P < 0.0001). Increased BMI increased the risk of seroma (hazards ratio, 1.16 per 1-kg/m2 increase; 95% CI, 1.06-1.26; P = 0.0013). The use of TXA did not impact drain duration. CONCLUSIONS: This study, the largest to date on the use of IV and topical TXA, did not find any reduction in risk when using TXA in breast reduction surgery.

Abdominal Panniculectomy: An Analysis of Outcomes in 238 Consecutive Patients over 10 Years.

Panniculectomy is a commonly performed body contouring procedure to address skin laxity and its related complications. This study aimed to assess clinical outcomes of abdominal panniculectomy and identify predictors of complications at a tertiary academic healthcare center. METHODS: A retrospective review of patients who underwent panniculectomy between January 2010 and January 2020 at our institution was performed. Exclusion criteria were a history of prior panniculectomy or abdominoplasty. Patient characteristics and clinical outcomes were collected. Univariate and multivariable analyses were performed to assess the risk factors of complications. RESULTS: The mean age in the included 238 patients was 51.7 ± 12.7 years, and the mean body mass index (BMI) at the time of panniculectomy was 33 ± 7.5 kg/m2. Median resection weight was 2.7 kg (range: 0.15-14.6) and median length of hospital stay was 2 days (range: 0-24). Mean follow-up time was 50 ± 37 months. The rate of major complications was 22.3%. Revision surgery was performed in 3.4% of the cases. Multivariable analyses demonstrated that increase in BMI (P = 0.007) and active smoking (P = 0.026) were significantly associated with increased odds of major complication, and increase in BMI (P = 0.0004), history of venous thromboembolism (P = 0.034) and having a concomitant ventral hernia repair (P = 0.0044) were significantly associated with having a length of hospital stay of 3 days or more. CONCLUSIONS: Panniculectomy is generally safe to perform, with major postoperative complication rate of 22.3% in our series. Increase in BMI and active smoking were significantly associated with having a major complication. Higher BMI, concomitant hernia repair, and a history of venous thromboembolism were associated with length of hospital stay of 3 days or more.

The Goldilocks Procedure with and without Implant-Based Immediate Breast Reconstruction in Obese Patients: The Mayo Clinic Experience.

BACKGROUND: Obesity is a risk factor for complications in breast reconstruction. Thus, implant-based immediate breast reconstruction in obese women may be controversial. The authors analyzed obese patients who underwent skin-sparing mastectomy using Wise-pattern incisions (Goldilocks procedure) and compared outcomes between two groups: Goldilocks with immediate breast reconstruction and Goldilocks only. METHODS: A retrospective review was performed of patients with a body mass index of 30 kg/m2 or higher who underwent the Goldilocks procedure at the Mayo Clinic Health System from 2012 to 2019. Data were extracted from electronic medical records. Minor complications (partial-thickness wound dehiscence or flap necrosis, or tissue expander/implant malposition) and major complications (full-thickness wound dehiscence or flap necrosis, capsular contracture, tissue expander/implant explantation, or unplanned reoperation or readmission) were compared between groups. Patient-reported outcomes using BREAST-Q questionnaires were also assessed. RESULTS: One hundred five patients (181 breasts) were included. Mean ± SEM age and body mass index were 57.1 ± 10.4 years and 37.9 ± 5.8 kg/m2 for the Goldilocks-only group and 51.5 ± 1.1 years and 35.5 ± 0.4 kg/m2 for the Goldilocks with immediate breast reconstruction group, respectively. Median follow-up time was 15.1 months (interquartile range, 10.0 to 28.6 months). Overall, 96 breasts underwent the Goldilocks-only procedure and 85 Goldilocks with immediate breast reconstruction. Multivariable analyses revealed a higher rate of minor complications (adjusted hazard ratio, 2.83; 95 percent CI, 1.22 to 7.02) and major complications (adjusted hazard ratio, 2.26; 95 percent CI, 1.25 to 4.24) in the Goldilocks with immediate breast reconstruction group compared with the Goldilocks-only group, at any given time. Patient satisfaction was not statistically different between groups. CONCLUSIONS: The Goldilocks procedure is a feasible breast reconstructive option in obese patients; however, when it is performed with immediate breast reconstruction, it is associated with higher rates of complications. For patients with a body mass index of 40 kg/m2 or greater, the authors recommend the Goldilocks-only procedure or delayed reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

An 11-year Institutional Review of Nipple-Areolar Complex Tattooing for Breast Reconstruction: Identifying Risk Factors for Development of Tattoo-related Infectious Complications.

BACKGROUND: Nipple-areolar complex (NAC) tattooing remains a simple and safe procedure, which complements breast reconstruction. This study reviews 11 years of NAC tattooing to identify risk factors for tattoo-related complications. METHODS: Patients undergoing NAC tattooing from January 2009 to March 2020 were reviewed. Patient information, reconstructive, and tattoo procedural details were analyzed. Tattoo-related breast infections, defined as breast redness requiring antibiotic therapy within 30 days after tattoo, were captured. Patients with reactive breast redness during the first 2 postprocedural days were excluded. RESULTS: Overall, 539 patients (949 breasts) were included. Implant-based reconstruction (IBR) was performed in 73.6% of breasts (n = 698), whereas 26.4% (n = 251) underwent autologous-based reconstruction (ABR). Acellular-dermal matrix was used in 547 breasts (57.6%). There as a 13.7% (n = 130) of breasts that underwent pretattoo radiation. There was a 65.3% (n = 456) of breasts that underwent subpectoral IBR, whereas 34.7% (n = 242) breasts underwent prepectoral IBR. Tattoo-related infection rate was 2.2% (n = 21 breasts). Mean time to infection was 6.5 ± 5.3 days. There was a 85.7% (n = 18) of infections that occurred in IBR patients, one third occurring in radiated patients. There was a 95.2% (n = 20) of infections that were treated with oral antibiotics only. One explantation was performed after failed intravenous antibiotics. On multivariable analysis, radiation history (odds ratio, 4.1, P = 0.007) and prepectoral IBR (odds ratio, 2.8, P = 0.036) were independent predictors of tattoo-related infection. Among irradiated breasts, breasts with IBR had greater odds of developing tattoo-related infection versus breasts with ABR (P = 0.025). CONCLUSIONS: Although tattoo-related infections were uncommon, previous radiation and prepectoral IBR were both found to be independent predictors of tattoo-related breast infection. There is a role for preprocedural prophylactic antibiotics in these patients to mitigate infectious risk.

Intravenous Tranexamic Acid in Implant-Based Breast Reconstruction Safely Reduces Hematoma without Thromboembolic Events.

BACKGROUND: Antifibrinolytic medications, such as tranexamic acid, have recently garnered increased attention. Despite its ability to mitigate intraoperative blood loss and need for blood transfusion, there remains a paucity of research in breast reconstruction. The authors investigate whether intravenous tranexamic acid safely reduces the risk of hematoma following implant-based breast reconstruction. METHODS: A single-center retrospective cohort study was performed to analyze all consecutive patients undergoing immediate two-stage implant-based breast reconstruction following mastectomy between 2015 and 2016. The incidence of postoperative hematomas and thromboembolic events among all patients was reviewed. The patients in the intervention group received 1000 mg of intravenous tranexamic acid before mastectomy incision and 1000 mg at the conclusion of the procedure. Fisher's exact test and the Mann-Whitney-Wilcoxon test were used. Multivariate logistic regression models were performed to study the impact of intravenous tranexamic acid after adjusting for possible confounders. RESULTS: A total of 868 consecutive breast reconstructions (499 women) were reviewed. Overall, 116 patients (217 breasts) received intravenous tranexamic acid, whereas 383 patients (651 breasts) did not. Patient characteristics and comorbidities were similar between the two the groups. Patients who received tranexamic acid were less likely to develop hematomas [n = 1 (0.46 percent)] than patients who did not [n = 19 (2.9 percent)] after controlling for age, hypertension, and type of reconstruction (prepectoral and subpectoral) (p = 0.018). Adverse effects of intravenous tranexamic acid, including thromboembolic phenomena were not observed. Multivariate analysis demonstrated that age and hypertension independently increase risk for hematoma. CONCLUSIONS: Intravenous tranexamic acid safely reduces risk of hematoma in implant-based breast reconstruction. Further prospective randomized studies are warranted to further corroborate these findings. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Single-Stage Direct-to-Implant Breast Reconstruction: A Comparison Between Subpectoral Versus Prepectoral Implant Placement.

BACKGROUND: Single-stage direct-to-implant (DTI) breast reconstruction can offer several potential benefits. Subpectoral DTI reconstruction can present with animation deformity and pectoralis muscle spasm. To potentially avoid these complications, surgeons have attempted prepectoral placement for DTI; however, the benefits of this approach are mostly unknown. We evaluated the outcomes of DTI between prepectoral and subpectoral placement. METHODS: This was a retrospective review of patients who underwent immediate DTI breast reconstruction (prepectoral vs subpectoral) between 2011 and 2018. Demographics, clinical characteristics, complications, and patient-reported outcomes (BREAST-Q) were compared. RESULTS: Thirty-three patients (55 breasts) underwent prepectoral DTI, and 42 patients (69 breasts) underwent subpectoral DTI. Demographics were similar among groups. The number of breasts with preoperative ptosis lower than grade 2 was not significantly different between groups (29.1% vs 26.1%; P = 0.699). Median follow-up was 20.3 and 21 months in the prepectoral and subpectoral groups, respectively. Average mastectomy weight was 300 g (180-425 g) and 355 g (203-500 g). Average implant size was 410 cc (330-465 cc) and 425 cc (315-534 cc) in the prepectoral and subpectoral groups, respectively. Alloderm was used in all reconstructions. Total numbers of complications were 4 (7.2%) and 8 (11.6%) in the prepectoral and subpectoral groups, respectively (P = 0.227). BREAST-Q demonstrated mean patient satisfaction was high and similar among groups (75 and 73.9, P = 0.211). CONCLUSIONS: Based on these results, we believe prepectoral DTI is safe, reliable, and a promising reconstructive option for selected patients, with equivalent results to other reconstructive options. Our present treatment recommendations are for patients who wish to maintain the same breast size and have minimal or no breast ptosis.

Outcomes of > 1300 Nipple-Sparing Mastectomies with Immediate Reconstruction: The Impact of Expanding Indications on Complications.

BACKGROUND: The enhanced esthetics and demonstrated oncologic safety of nipple-sparing mastectomy (NSM) in selected patients have resulted in increased rates among patients with locally advanced breast cancer and/or additional risk factors (obesity, prior radiation, surgery). Limited data exist on complication and reconstruction success rates in a contemporary patient cohort with expanded indications for NSM. METHODS: With institutional review board (IRB) approval, patients treated from 2009 to 2017 with NSM were identified from our prospective breast surgery registry. Main outcomes were 30-day complications requiring treatment and 1-year reconstruction failure rates. Risk factors were assessed using logistic regression. RESULTS: We evaluated 1301 breasts in 769 women undergoing NSM for cancer (n = 555) or risk reduction (n = 746) with median age of 48 (range 21-77) years. The overall 30-day complication rate was 7.5% (97/1301 breasts) and declined from 14.8% in 2009 to 6.3% in 2017 (p < 0.001), while the proportion of patients with obesity (p = 0.007) and treated with neoadjuvant chemotherapy (p < 0.001) increased. Prior radiation [odds ratio (OR) 2.35, p = 0.04], recent/current smoking (OR 3.37, p < 0.001), and body mass index (BMI) (OR 1.28 per 5-kg/m2 increase, p = 0.03) significantly increased 30-day complication rates. Reconstruction success at 1 year was 96.7%. Prior radiation (OR 5.65, p < 0.001), axillary surgery (OR 2.55, p = 0.006), and postoperative adjuvant radiation (OR 3.22, p = 0.007) significantly affected 1-year reconstruction failure. CONCLUSION: The 30-day complication rates of NSM decreased, despite broadened indications among higher-risk patients over time. These data confirm a team learning curve with NSM and also demonstrate that the nipple-sparing approach is suitable for appropriately selected higher-risk patients for both risk reduction and cancer treatment.

Post-mastectomy intensity modulated proton therapy after immediate breast reconstruction: Initial report of reconstruction outcomes and predictors of complications.

PURPOSE: To report reconstructive outcomes of patients treated with post-mastectomy intensity modulated proton therapy (IMPT) following immediate breast reconstruction (IBR). MATERIALS AND METHODS: Consecutive women with breast cancer who underwent implant-based IBR and post-mastectomy IMPT were included. Clinical characteristics, dosimetry, and acute toxicity were collected prospectively and reconstruction complications retrospectively. RESULTS: Fifty-one women were treated between 2015 and 2017. Forty-two had bilateral reconstruction with unilateral IMPT. The non-irradiated contralateral breasts served as controls. Conventional fractionation (median 50 Gy/25 fractions) was administered in 37 (73%) and hypofractionation (median 40.5 Gy/15 fractions) in 14 (27%) patients. Median mean heart, ipsilateral lung V20Gy, and CTV-IMN V95% were 0.6 Gy, 13.9%, and 97.4%. Maximal acute dermatitis grade was 1 in 32 (63%), 2 in 17 (33%), and 3 in 2 (4%) patients. Surgical site infection (hazard ratio [HR] 13.19, 95% confidence interval [CI] 1.67-104.03, p = 0.0012), and unplanned surgical intervention (HR 9.86, 95% CI 1.24-78.67, p = 0.0068) were more common in irradiated breasts. Eight of 51 irradiated breasts and 2 of 42 non-irradiated breasts had reconstruction failure (HR 3.59, 95% CI 0.78-16.41, p = 0.084). Among irradiated breasts, hypofractionation was significantly associated with reconstruction failure (HR 4.99, 95% CI 1.24-20.05, p = 0.024), as was older patient age (HR 1.14, 95% CI 1.05-1.24, p = 0.002). CONCLUSIONS: IMPT following IBR spared underlying organs and had low rates of acute toxicity. Reconstruction complications are more common in irradiated breasts, and reconstructive outcomes appear comparable with photon literature. Hypofractionation was associated with higher reconstruction failure rates. Further investigation of optimal dose-fractionation after IBR is needed.