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.

Intraoperative Ergonomic Assessment of Exoscopes versus Conventional DIEP Flap.

BACKGROUND: This study compared the ergonomics of surgeons during deep inferior epigastric perforator (DIEP) flap surgery using either baseline equipment (loupes, headlights, and an operating microscope) or an exoscope. Plastic surgeons may be at high risk of musculoskeletal problems. Recent studies indicate that adopting an exoscope may significantly improve surgeon postures and ergonomics. METHODS: Postural exposures, using inertial measurement units at the neck, torso, and shoulders, were calculated in addition to the surgeons' subjective physical and cognitive workload. An ergonomic risk score on a scale of 1 (lowest) to 4 (highest) was calculated for each of the postures observed. Data from 23 bilateral DIEP flap surgeries (10 baseline and 13 exoscope) were collected. RESULTS: The neck and torso risk scores decreased significantly during abdominal flap harvest and chest dissection, while right shoulder risk scores increased during the abdominal flap harvest for exoscope DIEP flap procedures compared with. Exoscope anastomoses demonstrated higher neck, right shoulder, and left shoulder risk scores. The results from the survey for the "surgeon at abdomen" showed that the usage of exoscopes was associated with decreased performance and increased mental demand, temporal demand, and effort. However, the results from the "surgeon at chest" showed that the usage of exoscopes was associated with lower physical demand and fatigue, potentially due to differences in surgeon preference. CONCLUSION: Our study revealed some objective evidence for the ergonomic benefits of exoscope; however, this is dependent on the tasks the surgeon is performing. Additionally, personal preferences may be an important factor to be considered in the ergonomic evaluation of the exoscope.

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.

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.

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.

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.

Two-Staged Implant-Based Breast Reconstruction: A Long-Term Outcome Study in a Young Population.

Background and objectives: Differences in patient anatomy and physiology exist between young and older patients undergoing breast reconstruction after mastectomy. Breast cancer has been described as being more aggressive, more likely to receive radiation, contralateral mastectomy, as well as bilateral reconstruction in young patients. Our purpose is to report long-term experience on two-staged implant-based breast reconstruction (IBR) in young females, with complication sub-analysis based on obesity and adjuvant radiation. Materials and Methods: Retrospective chart review of all consecutive young patients who underwent two-staged IBR at our institution, between 2000 and 2016, was performed. Patients between 15 and 40 years old with least 1-year follow-up were included. Univariate logistic regression models and receiver operating characteristic (ROC) curves were created. Results: Overall 594 breasts met our inclusion criteria. The mean age was 34 years, and the median follow-up was 29.6 months. Final IBR was achieved in 98% of breasts. Overall, 12% of breasts had complications, leading to explantations of 5% of the devices. Adjuvant radiation was followed by higher rates of total device explantations (p = 0.003), while obese patients had higher rates of total complications (p < 0.001). For each point increase in BMI, the odds of developing complications increased 8.1% (p < 0.001); the cutoff BMI to predict higher complications was 24.81 kg/m2. Conclusions: This population demonstrates high successful IBR completion and low explantation rates. These data suggest that obese women and those with planned adjuvant radiation deserve special counseling about their higher risk of complications.

Revisiting an Old Place: Single-Surgeon Experience on Post-Mastectomy Subcutaneous Implant-Based Breast Reconstruction.

Significant advances have been made to the reconstructive tools available to plastic surgeons allowing for the re-exploration of subcutaneous breast reconstruction. The purpose of the current study is to examine the safety, efficacy, and aesthetic results of subcutaneous breast reconstruction by a single-surgeon. A retrospective chart review was performed on all patients undergoing subcutaneous implant-based breast reconstruction between April 2012 and September 2014. All implants were fully wrapped in Alloderm and placed in the subcutaneous (pre-pectoral) plane. Primary outcome was a successful subcutaneous breast reconstruction. All complications were recorded. Aesthetics of the preoperative and postoperative photographs were examined. A total of 135 breasts (79 patients) were reconstructed. Direct-to-implant reconstruction was performed in 8 patients (10%). Successful breast reconstruction was achieved for 130 breasts in 76 patients (96%). Sixty-nine patients (87%) had a course free of any unexpected event or complication. There were no patients with implant extrusion or skin necrosis requiring operative intervention. When comparing pre-mastectomy breasts with post-mastectomy reconstructions, there was an improvement in the overall aesthetic outcome. Subcutaneous post-mastectomy breast reconstruction is safe and effective with comparable complication rates to standard techniques. Yet, this minimally invasive approach does not sacrifice the aesthetic results. Long-term studies will be required to prove the durability of aesthetic results overtime.

Tailoring through Technology: A Retrospective Review of a Single Surgeon's Experience with Implant-Based Breast Reconstruction before and after Implementation of Laser-Assisted Indocyanine Green Angiography.

Reported complication rates of implant-based breast reconstruction in the literature exceed 50%, with mastectomy skin flap necrosis reported to occur in up to 25% of cases. Laser-assisted indocyanine green angiography (LA-ICGA) technology allows the surgeon to optimize preservation of the mastectomy skin flap while avoiding skin necrosis. The purpose of this study was to determine if outcomes of breast reconstruction are beneficially affected by using LA-ICGA. A total 269 consecutive women (467 breast reconstructions) undergoing implant-based breast reconstruction from 2008 to 2013 were examined. The complication rates of those who underwent reconstruction prior to the implementation of LA-ICGA were compared with those who were reconstructed after implementation of LA-ICGA. A total of 254 consecutive breast reconstructions were performed prior to implementation of LA-ICGA, and 213 breasts were reconstructed with the use of LA-ICGA. After implementation of LA-ICGA System, the rate of mastectomy skin flap necrosis decreased by 86% (6.7% versus 0.9%, p = 0.02). The overall complication rate prior to LA-ICGA was 13.8% compared with 6.6% with the use of LA-ICGA (p = 0.01). After LA-ICGA was incorporated, the percentage of patients undergoing single-stage reconstruction increased from 12% to 32% (p = <0.001). Implementation of LA-ICGA provides the surgeon with an objective assessment of mastectomy flap perfusion resulting in a trend toward overall reduction in complications as well as an 86% decrease in the rate of subsequent skin necrosis. The objective assessment of mastectomy flap perfusion allows the surgeon to tailor breast reconstruction intraoperatively, in real-time, adjusting for the individual patient's mastectomy flap perfusion.

Impact of Policy Changes and Program Support on Family Planning Goals among Plastic Surgery Trainees.

Background: In 2020, the American Board of Plastic Surgeons announced an update in the leave policy for plastic surgery trainees, extending personal leave to 12 weeks without delay in graduation. Simultaneously, the Accreditation Council for Graduate Medical Education announced their update in lactation policy. This study sought to understand the influence of the policy change on plastic surgery trainees' goals for family planning and lactation. Methods: An online 32-question survey was developed to evaluate plastic surgery trainees' perceptions of family planning and perceived program support in the United States. The survey was approved by the American Council of Academic Plastic Surgeons Research Committee and sent out to a total of 216 plastic surgery programs. Results: One hundred thirty plastic surgery trainees completed the survey. Most respondents were women, between the ages of 30 and 34 years, and married. Forty-five (34.6%) respondents or their partners had experienced pregnancy or live birth during their training. More than 70% did not feel that they had adequate time for leave. Female trainees faced more barriers than men, including having a partner in training, concern for their pregnancy, and burdening their co-residents during leave. The majority stated that their decision to apply to plastic surgery residency was influenced by program support for family planning compared with policy changes. Conclusions: This survey highlighted that the new policies benefit trainees who consider starting a family during training. Despite this, there are still challenges that need to be addressed to help foster a fair environment for trainees to work and have a family.

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.

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.

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.

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.

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.

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.

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.