Peripheral Nerve Injury After Deoxycholic Acid (ATX-101) Injection in an Experimental Rat Model.

BACKGROUND: Deoxycholic acid (ATX-101) is a drug administered by subcutaneous injection for local fat reduction. However, ATX-101 treatment has been reported to cause marginal mandibular nerve injury with noticeable functional deficits when targeting submental fat. As a cytolytic agent with some selectivity for adipocytes, ATX-101 may damage the lipid-rich myelin surrounding peripheral nerves. OBJECTIVES: This study seeks to characterize the nerve injection injury from ATX-101 in an experimental rat model. METHODS: Using a rat sciatic nerve injection model, intrafascicular and extrafascicular injections of deoxycholic acid (ATX-101) were compared to lidocaine (positive control) and saline (negative control). Nerves were harvested at a 2-week endpoint for histomorphometric analysis. RESULTS: Cross-sectional area of nerve injury was significantly increased by ATX-101 injection at 75±15% with intrafascicular ATX-101 (p<0.001), 41±21% with extrafascicular ATX-101 (p<0.01), and 38±20% with positive control lidocaine (p<0.01) compared to 7±13% with negative control saline. Demyelinating injury was a significant mechanism of injury in the affected nerve fibers compared to uninjured nerve fibers (p<0.04), but there was no difference in axon-to-myelin area ratio between the lidocaine and ATX-101 cohorts. After two weeks, Wallerian degeneration was evident with only small regenerating nerve fibers present in the ATX-101-injured groups compared to saline (2.54±0.26um vs 5.03±0.44um, p<0.001) in average width. CONCLUSIONS: Deoxycholic acid (ATX-101) is capable of extensive nerve injury in rats. The mechanism of action for ATX-101 does not preferentially target myelin more than other common neurotoxic agents. Appropriate knowledge of surgical anatomy and injection technique is necessary for any practitioners providing ATX-101 injections.

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 2-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 by 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 on 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; they also underwent more nipple-sparing mastectomies with prepectoral reconstructions. Rates of any complication (18% DTI vs 24% TE, P = .047), reconstructive failure (5.1% vs 12%, P = .004), and seroma (3.9% vs 11%, P < .001) were significantly lower in the DTI cohort on unadjusted analyses; however, there were no significant differences on 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 postmastectomy reconstruction in carefully selected patients, with no significant increase in reconstructive failure or other complications.

Toward a Consensus Aproach for Assessing Capsular Contracture Severity and Progression: A Systematic Review.

BACKGROUND: Breast implants are the most commonly used medical devices in plastic surgery, and capsular contracture (CC) is one of the most common complications. However, our assessment of CC is based largely on Baker grade, which is problematically subjective and affords only four possible values. METHODS: The authors performed a systematic review concluding in September of 2021 in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. It identified 19 articles that propose approaches to measuring CC. RESULTS: In addition to Baker grade, the authors identified several modalities reported to measure CC. These included magnetic resonance imaging, ultrasonography, sonoelastography, mammacompliance measuring devices, applanation tonometry, histologic evaluation, and serology. Capsule thickness and other measures of CC inconsistently correlated with Baker grade, whereas the presence of synovial metaplasia was consistently associated with Baker grade I and II, but not III and IV capsules. CONCLUSIONS: There remains no particular method to reliably and specifically measure the contracture of capsules that form around breast implants. As such, we would recommend that research investigators use more than one modality to measure CC. Other variables that can impact breast implant stiffness and associated discomfort beyond CC need to be considered when evaluating patient outcomes. Given the value placed on CC outcomes in assessing breast implant safety, and the prevalence of breast implants overall, the need for a more reliable approach to measuring this outcome persists.

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.

Immediate Postmastectomy Implant-Based Breast Reconstruction: An Outpatient Procedure?

BACKGROUND: Coronavirus disease of 2019 (COVID-19) poses unique challenges for breast reconstruction. At the authors' institution, COVID-19 postoperative protocols mandated patients undergoing immediate prosthetic breast reconstruction transition from 23-hour postoperative observation to same-day discharge. The authors sought to compare complications and hospital costs between these groups. METHODS: A retrospective study of consecutive patients who underwent immediate prosthetic breast reconstruction from March of 2019 to April of 2021 at an academic hospital was performed. Before mid-March of 2020, patients were admitted postoperatively for observation; after mid-March of 2020, patients were discharged the same day. Postoperative complications at 48 hours, 30 days, and 90 days and hospital costs were compared. RESULTS: There were 238 patients included (119 outpatient and 119 observation). Across all time points, total complications, major complications, categorical complications (wound healing, seroma, hematoma, infection, implant exposure), and reconstructive failures were low and not statistically different between groups. There were no differences in 30-day hospital readmission/reoperation rates (7.6% outpatient versus 9.2% observation; P = 0.640). No patient or surgical factors predicted major complication or hematoma by 48 hours or infection by 90 days. At 90 days, radiation history ( P = 0.002) and smoking ( P < 0.001) were significant predictors of major complications. Average patient care costs outside of surgery-specific costs were significantly lower for outpatients ($1509 versus $4045; P < 0.001). CONCLUSIONS: Complications after immediate prosthetic breast reconstruction are low. Outpatient surgery is safe, harboring no increased risk of complications. Furthermore, outpatient care is more cost-effective. Therefore, surgeons should consider outpatient management of these patients to minimize COVID-19 exposure and reduce resource consumption, all while maintaining excellent surgical care. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Breast reconstruction is a viable option for older patients.

PURPOSE: Breast cancer is diagnosed at a median age of 62 years in the USA. At the same time, mortality rates for breast cancer continue to decrease, falling by 40% from 1989 to 2016. In the coming decades, the number of elderly patients with breast cancer, potentially seeking reconstruction, is expected to increase. METHODS: A retrospective chart review of 309 patients, aged 60 years or older, undergoing immediate or delayed breast reconstruction, was conducted. Patient characteristics, clinical information and major complications requiring reoperation were evaluated. Multivariate analyses identified factors contributing to complications such as BMI, comorbidities, smoking status, history of previous breast conservation therapy (BCT), total expander volume, radiotherapy, and chemotherapy. RESULTS: 26.7% of patients had at least one complication requiring reoperation, and 6.9% of patients suffered reconstructive failure. Logistic regression analysis of all patients (n = 309) found a statistically significant relationship between major complication and history of ipsilateral BCT (p = 0.026) and adjuvant chemotherapy (p = 0.005). Logistic regression analysis in patients undergoing tissue expander (TE) reconstruction (n = 215) showed that major complications were related to BMI over 35 kg/m2 (p = 0.04), history of ipsilateral BCT (p = 0.048), and adjuvant chemotherapy (p = 0.033). CONCLUSION: Breast reconstruction in women over 60 years old was not independently associated with higher major complication rates in our series.

Impact of Breast Reconstruction Patients on Cosmetic Practice.

Postmastectomy breast reconstruction can often restore a patient's self-image. A notable percentage of women will go on to seek elective aesthetic procedures to further improve their perceived appearance. The purpose of this study was to determine the percentage of primary breast reconstruction patients who go on to receive a cosmetic procedure. We identify factors that may increase the likelihood that a patient subsequently chooses to pursue a cosmetic procedure. METHODS: A retrospective review of primary breast reconstruction patients of the two senior authors was conducted from January 2014 through December 2015. Demographics, types of cosmetic procedures received, and time to first cosmetic procedure were obtained. Time to first cosmetic procedure was assessed from date of mastectomy through December 2017. Logistic regression was performed to identify factors associated with obtaining cosmetic procedures. RESULTS: There were 289 patients in our cohort with ~10% who subsequently sought a cosmetic procedure at our practice. The average time to conversion was ~9 months after mastectomy. The majority (67%) underwent noninvasive procedures only. Patients with lower-staged breast cancers were more likely to undergo a cosmetic procedure (P < 0.042). CONCLUSIONS: At least 10% of patients undergoing primary breast reconstruction over a year period went on to have a cosmetic procedure during the study period. The majority of patients pursued noninvasive cosmetic procedures. Reconstruction of women with higher cancer stages was associated with a lower likelihood of pursuing a cosmetic procedure during the time period studied.

Women in Leadership and Their Influence on the Gender Diversity of Academic Plastic Surgery Programs.

BACKGROUND: Women seldom reach the highest leadership positions in academic plastic surgery. Contributing factors include lack of female role models/mentors and lack of gender diversity. Studies show that female role models and mentors are critical for recruiting and retaining female surgeons and that gender diversity within organizations more strongly influences women's career choices. The authors therefore sought to determine the current gender diversity of academic plastic surgery programs and investigate influences of gender and leadership on program gender composition. METHODS: A cross-sectional study of U.S. plastic surgery residency programs was performed in December of 2018. Genders of the leadership were collected, including medical school dean, department of surgery chair, department/division of plastic surgery chair/chief, plastic surgery program director, plastic surgery faculty, and plastic surgery residents. Gender relationships among these groups were analyzed. RESULTS: Ninety-nine residency programs were identified (79 integrated with or without independent and 20 independent). Women represented a smaller proportion of academic plastic surgeons in more senior positions (38 percent residents, 20 percent faculty, 13 percent program directors, and 8 percent chairs). Plastic surgery chair gender was significantly correlated with program director gender, and plastic surgery faculty gender was significantly associated with plastic surgery resident gender. Although not statistically significant, female plastic surgery chair gender was associated with a 45 percent relative increase in female plastic surgery residents. CONCLUSIONS: Women in leadership and gender diversity influence the composition of academic plastic surgery programs. Gender disparity exists at all levels, worsening up the academic ladder. Recruitment, retention, and promotion of women is critical, as such diversity is required for continued progress in innovation and problem-solving within plastic surgery.

A prospective cohort study to analyze the interaction of tumor-to-breast volume in breast conservation therapy versus mastectomy with reconstruction.

PURPOSE: We explored the impact of the relative volume of a tumor versus the entire breast on outcomes in patients undergoing breast conservation therapy (BCT) versus mastectomy and reconstruction (M + R). We hypothesized that there would be a threshold tumor:breast ratio (TBR) below which patient-reported outcomes (PRO) would favor BCT and above which would favor M + R. METHODS: We conducted a prospective cohort study of patients with ductal carcinoma in situ (DCIS) or invasive breast cancers undergoing BCT or M + R. A prerequisite for inclusion, analysis of tumor and breast volumes was conducted from three-dimensional magnetic resonance imaging reconstructions to calculate the TBR. Three-dimensional photography was utilized to calculate pre- and postoperative volumes and assess symmetry. Oncologic, surgical, and patient-reported outcome data were obtained from relevant BREAST-Q modules administered pre- and postoperatively. RESULTS: The BCT cohort had significantly smaller tumor volumes (p = 0.001) and lower TBRs (p = 0.001) than patients undergoing M + R overall. The M + R group, however, comprised a broader range of TBRs, characterized at lower values by patients opting for contralateral prophylactic mastectomy. Postoperative satisfaction with breasts, psychosocial, and sexual well-being scores were significantly higher in the BCT cohort, while physical well-being significantly favored the M + R cohort 480.2 ± 286.3 and 453.1 ± 392.7 days later, respectively. CONCLUSIONS: Relative to BCT, M + R was used to manage a broad range of TBRs. The relative importance of oncologic and surgical risk reduction, symmetry, and number of procedures can vary considerably and may limit the utility of TBR as a guide for deciding between BCT and M + R. Clinical Trial StatementThis study was registered with clinicaltrials.gov as "A Prospective Trial to Assess Tumor:Breast Ratio and Patient Satisfaction Following Lumpectomy Versus Mastectomy With Reconstruction", Identifier: NCT02216136.

Impact of Residents on Operative Time in Aesthetic Surgery at an Academic Institution.

BACKGROUND: Duration of surgery is a known risk factor for increased complication rates. Longer operations may lead to increased cost to the patient and institution. While previous studies have looked at the safety of aesthetic surgery with resident involvement, little research has examined whether resident involvement increases operative time of aesthetic procedures. OBJECTIVES: We hypothesized that resident involvement would potentially lead to an increase in operative time as attending physicians teach trainees during aesthetic operations. METHODS: A retrospective cohort analysis was performed from aesthetic surgery cases of two surgeons at an academic institution over a 4-year period. Breast augmentation and abdominoplasty with liposuction were examined as index cases for this study. Demographics, operative time, and resident involvement were assessed. Resident involvement was defined as participating in critical portions of the cases including exposure, dissection, and closure. RESULTS: A total of 180 cases fit the inclusion criteria with 105 breast augmentation cases and 75 cases of abdominoplasty with liposuction. Patient demographics were similar for both procedures. Resident involvement did not statistically affect operative duration in breast augmentation (41.8 ± 9.6 min vs 44.7 ± 12.4 min, P = 0.103) or cases for abdominoplasty with liposuction (107.3 ± 20.5 min vs 122.2 ± 36.3 min, P = 0.105). CONCLUSIONS: There was a trend toward longer operative times that did not reach statistical significance with resident involvement in two aesthetic surgery cases at an academic institution. This study adds to the growing literature on the effect resident training has in aesthetic surgery.

A Prospective Evaluation of Three-Dimensional Image Simulation: Patient-Reported Outcomes and Mammometrics in Primary Breast Augmentation.

BACKGROUND: Outcomes in primary breast augmentation depend on careful preoperative planning and clear communication between patient and surgeon. Three-dimensional imaging with computer simulation is an evolving technology with the potential to enhance the preoperative consultation for patients considering primary breast augmentation. The purpose of this study was to prospectively evaluate the impact of three-dimensional imaging with computer simulation on patient-reported and objective, mammometric outcomes in women undergoing primary breast augmentation. METHODS: One hundred patients were enrolled in a prospective trial with randomized and nonrandomized arms. The randomized arm was composed of a control group consisting of patients who underwent tissue-based planning without simulation (n = 13) and an intervention group consisting of patients who were simulated (n = 10). The remainder constituted the nonrandomized group who specifically sought preoperative simulation. Patient-reported outcomes (BREAST-Q) and mammometric data were recorded and compared preoperatively and 6 months postoperatively. RESULTS: Over time, significantly more patients refused randomization and chose simulation (p = 0.03). Breast augmentation led to substantial improvements in satisfaction with breasts, sexual well-being, and outcome. Simulation, however, did not significantly impact patient-reported outcomes or mammometric parameters. No strong correlations were identified between patient-reported outcomes and mammometrics. CONCLUSIONS: Patients are likely to use novel technology such as three-dimensional photography with computer simulation if they perceive it to enhance their understanding of their final outcome. These patients may seek out practices specifically offering such technology. Incorporation of simulation into the preoperative consultation, however, did not lead to clinically meaningful changes in patient-reported outcomes. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Nipple-Sparing Mastectomy Incisions for Cancer Extirpation Prospective Cohort Trial: Perfusion, Complications, and Patient Outcomes.

BACKGROUND: Nipple-sparing mastectomy offers several advantages for women seeking postmastectomy breast reconstruction, but compromised skin and nipple perfusion may lead to skin and nipple necrosis. It is unclear whether the incisional approach contributes to these complications; therefore, the purpose of this study was to compare the impact of incision type on outcomes in patients undergoing nipple-sparing mastectomy. METHODS: This is a prospective cohort study of patients undergoing nipple-sparing mastectomy with prosthetic breast reconstruction through an inframammary fold versus a lateral radial incision. Skin and nipple perfusion as represented by fluorescence intensity, mammometric parameters, patient-reported outcomes, and clinical outcomes were analyzed and compared for the two cohorts, and multivariable logistic regression models were performed to evaluate the effects of covariates on outcomes. RESULTS: Seventy-nine patients were studied: 55 in the inframammary fold cohort and 24 in the lateral radial cohort. The inframammary fold group had significantly less fluorescence intensity to the inferior (21.9 percent versus 36.9 percent; p = 0.001) and lateral portions of breast skin (23.1 percent versus 40.7 percent; p = 0.003) after reconstruction. Decreased fluorescence intensity was associated with smoking, decreased mean arterial pressure, and greater specimen weight. Postreconstruction breast volumes were increased over preoperative volumes in the inframammary fold group (38.3 percent) versus the lateral radial (31.2 percent) group; however, patients with a lateral radial incision had a greater increase in satisfaction with their breasts and psychosocial well-being. CONCLUSIONS: There are significant differences in patient-reported outcomes and final breast volumes based on the incisional approach to nipple-sparing mastectomy. These data can be used to guide providers and counsel patients considering nipple-sparing mastectomy with prosthetic reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.