Scientific Abstract Presentations: Breast Session 8 Saturday, September 28 Sat, Sep 28 8:00-9:30 a.m. PDT

Background Macromastia can be a life-long significant source of both physical and emotional pain. Definitive surgical treatment of macromastia is achieved with the reduction mammoplasty, or breast reduction. In 2020, 97,320 breast reductions were completed for reconstructive and aesthetic patients. Patients undergoing breast reduction require adequate pain control in the perioperative period, often requiring narcotics. Provider over-reliance on narcotics to control pain has long been implicated in the rise of the opioid epidemic. Preoperative regional anesthesia offers another pathway to limit perioperative pain while potentially decreasing the need for narcotic use. The erector spinae plane (ESP) nerve block is a regional anesthetic technique involving the interfacial injection of local anesthetic below the erector spinae muscle at the origin of the dorsal and ventral rami. ESP nerve blocks at the level of T5 have been shown to provide appropriate analgesia over the T1-L3 dermatomes. Alternatively, local anesthetics such as a long-acting bupivacaine solution (LLAB) can be injected superficially at the incision site to provide analgesia. This study investigates the effect that an ESP nerve block has on breast reduction patients' pain and opioid use before, during, and after surgery compared to LLAB injection.

Methods A retrospective chart review was completed of patients undergoing breast reduction at a single tertiary care hospital system from March 1, 2021 through March 1, 2022. Of 98 patients, 51% (n=50) received a perioperative ESP nerve block while 49% (n=48) received only LLAB. Patient opioid usage was determined by review of their operative records and Post Anesthesia Care Unit (PACU) records. All narcotic use in the perioperative period was recorded and standardized to morphine milligram equivalent (MME) units to account for use of varying opioids. Additionally, subjective pain scores (0-10 scale) in the PACU were reviewed and analyzed. These values were compared using two sample z-tests.

Results Patients in the ESP group received significantly less intraoperative narcotics compared to the LLAB group (33.45 MME vs. 89.77 MME, p<0.001), despite no significant difference in preoperative opioids administered (27.75 MME vs. 31.50 MME, p-value = 0.164). There was no significant difference in postoperative opioid requirements in the ESP group compared to LLAB group (22.46 MME vs. 31.38 MME, p=0.058). Average subjective pain scores in the PACU were significantly decreased (4.32 vs. 6.04, p<0.001).

Conclusion: This study provides evidence of the substantial benefits of incorporating an ESP nerve block into the perioperative management of breast reduction surgeries. This regional anesthesia technique led to a significant reduction in the need for intraoperative narcotics. Patients who received the ESP block also reported lower subjective pain scores in the immediate postoperative period, indicating improved pain control. Though there was no significant decrease in postoperative opioid requirements in the ESP group (22.46 MME vs. 31.38 MME, p=0.058), this may be due to a Type II error. Implementing ESP nerve blocks as a standard component of Enhanced Recovery After Surgery (ERAS®) protocols holds the potential to improve the perioperative experience for breast reduction patients, ultimately contributing to improved clinical outcomes and a favorable societal impact.

Background: Enhanced recovery after surgery (ERAS) protocols are evidence-guided protocols that have improved elements of perioperative outcomes.(1,2) ERAS protocols have demonstrated significant success across multiple surgical fields; however, a protocol has only recently been tailored specifically for breast surgeries.(2,3) Implementing ERAS for breast reductions has yet to be evaluated in the veteran population. This study compared outcomes of breast reductions pre and post ERAS implementation at a Veterans Affairs Medical Center (VAMC).

Methods: A retrospective analysis was conducted on patients who underwent reduction mammaplasty with CPT code 19318 over a 5-year period, from November 2018 to January 2024. Patients were stratified into pre and post ERAS implementation cohorts, and post-operative outcomes were compared across the groups. A total of 80 patients were identified; 55 in the pre-ERAS implementation cohort and 25 in the post-ERAS implementation cohort. Patient demographics, perioperative data, post-anesthesia care unit (PACU) times and pain scores, as well as administration of opioids were analyzed in this study.

Results: Patients of the post-ERAS cohort had a significantly decreased average opioid use by dosage per patient in the post-anesthesia care unit (PACU) when compared to the pre-ERAS cohort (p = 0.008). There was a 409% decrease in the need for opioid administration during the overall post-operative period in the post-ERAS cohort when compared to the pre-ERAS cohort (p = 0.009). The post-ERAS cohort also had significantly lower pain scores in the immediate post-operative period (p = 0.073), as well as lower overall pain scores, calculated using the mean difference between peak pain levels in the PACU and at the time of discharge (p = 0.047). In addition to this, the average PACU duration was significantly lower in the post-ERAS cohort when compared to the pre-ERAS cohort (p = 0.048). The post-ERAS cohort also demonstrated a notable decrease in instances of delayed wound healing when compared to the pre-ERAS cohort. Overall, 45-day major complication rates, emergency room visits, and unplanned reoperations did not differ significantly across cohorts.

Conclusion: ERAS should be considered as the standard approach for perioperative care for our veteran population. Notably, reducing opioid use holds particular importance amid the opioid epidemic, which disproportionately affects the veteran population. Since the implementation of the ERAS protocol to breast reduction patients, significant improvements have been observed in the veteran population. There has been a marked reduction in opioid consumption, enhanced postoperative pain management, and a decrease in instances of delayed wound healing. Furthermore, the implementation of the ERAS protocol has enhanced the utilization of operating room (OR) resources, evidenced by the reduced PACU durations and quicker OR turnover rate.

1. Temple-Oberle, et al. Consensus Review of Optimal Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery (ERAS) Society Recommendations. Plast Reconstr Surg. 2017;139(5):1056e-1071e.
2. Arsalani-Zadeh R, et al. Evidence-based review of enhancing postoperative recovery after breast surgery. Br J Surg. 2011;98(2):181-196.
3. Redwood JN, et al.. Adoption of Enhanced Recovery after Surgery Protocols in Breast Reconstruction in Alberta Is High before a Formal Program Implementation. Plast Reconstr Surg Glob Open. 2019;7(5):E2249.

Background: Infection after implant-based breast reconstruction remains challenging. Rates of infection have been reported to be up to 24%. Best clinical practice indicates prophylactic oral antibiotics are ineffective at preventing infection. Absorbable antibiotic beads have been routinely used in other surgical subspecialties such as orthopedic and vascular procedures for continuous local antibiotic delivery to the surgical site when implants are placed. We previously have published that biodegradable calcium sulfate antibiotic beads normalized incidence of infection when used prophylactically for a high-risk patient population. The purpose of this study is to evaluate the effect of prophylactic biodegradable antibiotic beads when used non-selectively for all prepectoral immediate tissue expander (TE) reconstruction.

Methods: A single-center retrospective review was performed for patients who underwent mastectomy and immediate prepectoral TE reconstruction on the same day (2018-2024). Patients were divided into two groups: Group 1 received absorbable antibiotic beads and was compared to Group 2 (control) who did not receive antibiotic beads during prepectoral implant-based reconstruction following mastectomy. For Group 1, absorbable calcium phosphate beads were reconstituted with 1 gram vancomycin and 240 mg gentamicin. Demographic data, body mass index (BMI), diabetes, smoking status, and breast cancer treatment (chemotherapy, radiation) were recorded. Postoperative complications including skin necrosis, surgical site infection, implant loss, time to development of skin necrosis or infection were assessed as outcome variables.

Results: The study included 284 patients (487 TEs) who underwent prepectoral tissue expander breast reconstruction following mastectomy. Group 1 had 28 patients (53 tissue expanders) who received biodegradable antibiotic beads. There were 256 patients (434 tissue expanders) in Group 2. The average age of Group 1 was 49.5 ± 10.5 years old compared to 48.2 ± 10.6 years (p=0.5093). Group 1 had an average BMI of 29.4 ± 8.1 kg/m2 compared to 29.0 ± 6.7 kg/m2 in Group 2 (p=0.7859). Diabetes was present in 10.7% (3/28) in Group 1 compared to 7.4% (19/256) in Group 2 (p=0.4647). Active smoking was present in 10.7% (3/28) in Group 1 compared to 6.3% (16/256) in Group 2 (p=0.4145). There was 25% (7/28) of Group 1 who received neoadjuvant chemotherapy compared to 26.9% (69/256) of Group 2 patients (p=1). Adjuvant radiation was received in 17.8% (5/28) of Group 1 patients compared to 27.3% (70/256) of Group 2 (p=0.3685). Skin necrosis occurred in 5.7% (3/53 TEs) of Group 1 compared to 3.9% (17/434 TEs) in Group 2 (p=0.469). Surgical site infection (SSI) was present in 0% (0/53 TEs) Group 1 compared to 5.5% (24/434 TEs) in Group 2 (p=0.0944). Tissue expander loss occurred in 0% (0/53 TEs) in Group 1 patients compared to 9.4% (41/434 TEs) in Group 2 (p=0.015). The mean follow-up time was 63 days.

Conclusion: Prophylactic biodegradable antibiotic beads used during immediate tissue expander reconstruction decreased implant loss rate. There were no occurrences of surgical site infection in the antibiotic bead group. Antibiotic beads may potentially decrease complications in immediate tissue expander reconstruction when used non-selectively for all patients.

BACKGROUND: Breast cancer is a leading cause of mortality amongst women in sub-Saharan Africa (SSA). As such, optimizing outcomes for treatment and reconstruction is a global health priority. The validated BREAST-Q has been instrumental in improving our understanding of breast related quality of life with surgical treatment and reconstruction. Currently, normative data for interpreting BREAST-Q results is limited to high income countries (HICs). This study seeks to evaluate baseline breast-related quality of life (QOL) in SSA women without breast cancer and compare to previously published normative values to guide future surgical research and targeted treatment paradigms. METHODS: Women in Ghana, Nigeria and Ethiopia aged 18 years and older with no history of breast cancer or breast surgery were recruited from breast cancer clinics at academic institutions to complete the BREAST-Q preoperative mastectomy module. Multivariable regression was performed to identify correlates between sociodemographic variables and BREAST-Q scores. Comparisons were also made between normative data from the SSA populations and those published in other HICs. RESULTS: Normative BREAST-Q scores were obtained from a total of 453 women (169 Ghanaian, 210 Nigerian, and 74 Ethiopian) with mean age of 25.7 ± 7 years and BMI of 26 ± 6 kg/m2. BREAST-Q scores were as follows: satisfaction with breasts, 64 ± 26; psychosocial well-being, 63 ± 23; sexual well-being, 57 ± 26; and physical well-being, 68 ± 16. Significant differences in scores were found between countries in SSA. Compared to scores published in the United States, SSA women scored higher in breast satisfaction (64 vs 58, p < 0.001), and lower in psychosocial (63 vs 71, p < 0.001) and physical well-being (68 vs 93, p < 0.001). CONCLUSION: This study establishes normative values for the BREAST-Q preoperative mastectomy module in a group of women in SSA without breast cancer and found significant variability globally and between countries within the same region. Our findings provide a foundational context to understand the effects of breast cancer and guide future research to enhance counseling, education, and methods for the delivery of wholistic breast cancer care to millions of women in the region.

Introduction: Each year in the United States, over 100,000 women undergo mastectomy with breast reconstruction.1 Approximately 81% of women undergoing reconstruction elect to undergo implant-based reconstruction (IBR).2 Mesh is often employed to support and provide coverage for the implant. There are many mesh options in the market including acellular dermal matrix (ADM), xenograft-based mesh, or synthetic meshes. Studies comparing their safety and costs are limited in their ability to guide surgeons in mesh selection.3-5 We aim to compare complication profiles between various meshes used in breast reconstruction.

Methods: We conducted a retrospective review from December 2021 to September 2023 of patients undergoing IBR. Patients received either ADM in the form of Alloderm or FlexHD, GalaFLEX or Ovitex. The resections were either nipple sparing mastectomy (NSM) or skin sparing mastectomy (SSM). We recorded and analyzed variables such as patient characteristics, complications, complication types, treatment modalities, and implant loss.

Results: Results: There were 164 patients (274 IBR) included in our study period. There were no differences in patient characteristics amongst mesh types. We used GalaFLEX in 55 patients (98 breasts), Ovitex in 52 patients (98 breasts), and ADM in 57 patients (78 breasts). Compared with ADM, GalaFLEX exhibited lower rates of overall complications (p = 0.006), necessity for operating room (OR) procedures (p = 0.008), and implant loss (p = 0.001) compared to other meshes. Outcomes were not different between Ovitex and ADM. In a direct comparison between Ovitex and GalaFLEX, Ovitex exhibited a significantly worse complication profile, with significance in major complications (14% vs 5%, p = 0.033), more OR procedures (12% vs 2%, p = 0.014) and implant loss (12% vs 0%, p = 0.005).

Conclusion: In summary, GalaFLEX stands out with a significantly lower rate of implant loss compared to other meshes. Ovitex, while not differing significantly from ADM, exhibits a markedly worse complication profile when directly compared to GalaFLEX, particularly in OR procedures and implant loss. This information should be taken into account in considering healthcare costs and burden to patients when selecting mesh to use for IBR.

References 1. American Society of Plastic Surgery. 2022 Plastic Surgery Statistics Report. (https://www.plasticsurgery.org/documents/News/Statistics/2022/plastic-surgery-statistics-report-2022.pdf). 2. Saldanha IJ, Broyles JM, Adam GP, et al. Implant-based Breast Reconstruction after Mastectomy for Breast Cancer: A Systematic Review and Meta-analysis. Plast Reconstr Surg Glob Open 2022;10(3):e4179. (In eng). DOI: 10.1097/gox.0000000000004179. 3. Sigalove S, O'Rorke E, Maxwell GP, Gabriel A. Evaluation of the safety of a GalaFLEX-Alloderm construct in prepectoral breast reconstruction. PRS 2022 Oct 1;150:75S-81S. doi: 10.1097/PRS.0000000000009520. Epub 2022 Sept 28. 4. Chu JJ, Nelson JA, Kokosis G, et al. A Cohort Analysis of Early Outcomes After AlloDerm, FlexHD, and SurgiMend Use in Two-Stage Prepectoral Breast Reconstruction. Aesthetic Surgery Journal 2023;43(12):1491-1498. DOI: 10.1093/asj/sjad246. 5. Samuels K, Millet E, Wong L. Efficacy of Acellular Dermal Matrix Type in Treatment of Capsular Contracture in Breast Augmentation: A Systematic Review and Meta-Analysis. Aesthetic Surgery Journal 2023;44(1):26-35. DOI: 10.1093/asj/sjad265.

Purpose Neoadjuvant chemotherapy (NACT) is becoming increasingly used in the treatment of breast cancer and confers several advantages compared to adjuvant chemotherapy (ACT) such as the ability to shrink a tumor prior to surgical excision, therefore increasing the rate of breast conserving therapy (BCT) and improving cosmetic outcomes and quality of life (1). NACT has the potential to adversely affect the immune system and induce a leukopenia state which may leave patients prone to infectious complications during mastectomy and reconstruction. There is a paucity of literature describing the impact of NACT and leukopenia on TE-based reconstructive outcomes. Thus, we performed a retrospective review to investigate the impact of NACT on outcomes for breast cancer patients at UCLA undergoing immediate pre-pectoral TE-based breast reconstruction.

Materials and Methods This was a single-center, retrospective review of all breast cancer patients at UCLA Ronald Reagan Medical Center between January 2018 and September 2022 who underwent breast reconstruction with immediate pre-pectoral TE placement. Patients were divided into NACT, ACT, and no chemotherapy groups as well as leukopenia (WBC ≤ 4500) and no leukopenia (WBC > 4500) at the time of mastectomy and immediate reconstruction. Outcome measures included rates of major complications, explantation with and without replacement, reoperation, infection, hematoma, seroma, necrosis, and rupture. Chi-square (or Fisher's exact) test was used for categorical variables and Kruskal-Wallis test was used for continuous variables.

Results 295 patients were included in our review. There were no statistically significant differences between patients undergoing NACT, ACT, or no chemotherapy with regards to race/ethnicity, BMI, laterality, comorbid diabetes mellitus, tobacco use, postoperative antibiotic usage, use of ADM, expander fill volume, expander manufacturer, implant fill, or implant volume (p>0.05). Patients who underwent NACT experienced fewer major complications compared to patients undergoing ACT or no chemotherapy (14.1% vs 41.8% and 28.5% respectively, p<0.01) and had lower reoperation rates (12.8% vs 39.3% and 26.8% respectively, p<0.01) following TE placement; there were no statistically significant difference between explantation rates (4.7% vs 8.9% and 14.4% respectively, p>0.05), major infection rates (4.6% vs 5.4% and 11.8% respectively, p>0.05), or rates of capsular contracture (9.3% vs 5.4% and 2.6% respectively, p>0.05). There were no statistically significant differences in rates of hematoma, seroma, necrosis, or rupture (p>0.05) between groups. There were no statistically significant differences in outcomes following implant exchange between groups (p>0.05). Compared to patients without leukopenia, patients with leukopenia experienced lower rates of major infections (9.7% vs 0%, p<0.05) but higher rates of hematoma formation (3.8% vs 12.8%, p<0.05) following TE placement, however there were no statistically significant differences in rates of major complications, explantation, reoperation, capsular contracture, seroma, or necrosis (p>0.05).

Conclusion NACT is an important component of modern breast cancer treatment. We found that patients undergoing NACT experienced fewer major complication rates and reoperation rates following TE placement compared to those undergoing ACT or no chemotherapy. Additionally, leukopenia did not pose increased risk of major complications. Therefore, NACT and leukopenia should not be considered contraindications when considering pre-prectoral TE-based breast reconstruction.

References: 1. Oikawa M. The history, present situation, and future directions of neoadjuvant chemotherapy for HER2-negative breast cancer. Chin Clin Oncol. 2020;9(3):29. doi:10.21037/cco-20-12

Background: According to the FDA Adverse Event Reporting System (FAERS), GLP-1 agonists have potential risks of alopecia, aspiration, or suicidal ideation(1). Due to the consequences of delayed gastric emptying and pulmonary aspiration under anesthesia, the American Society of Anesthesiologists suggest holding GLP-1 agonists prior to surgery (2). However, no studies to date have investigated the relationship between GLP-1 agonist use and post-operative wound healing complications in plastic surgery. The purpose of this study is to investigate trends in post-operative complications following mammaplasty reductions in patients on GLP-1 agonists versus in patients who are not.

Methods: Sample population included 321 mammoplasty reduction patients who underwent surgery at Henry Ford Medical Center from 2020-2022. Seven patients were on GLP-1 agonists. Ninety seven patients had postoperative complications, 3 of which were GLP-1 agonist users. Of 314 control patients, 94 had complications, 8 of which had diabetes. Logistic regression analysis was conducted with R (3) to determine if there was an association between GLP-1 agonist use and postoperative wound healing complications. The analysis included variables GLP-1 agonist use and diabetes status. The "logistf" function was used to fit the logistic regression model using Firth's bias reduction method. Likelihood ratio test and Wald tests were included. P-value less than 0.05 was considered statistically significant.

Results: The Likelihood Ratio Test and Wald Test indicated the model as a whole demonstrated statistical significance. The significant likelihood ratio test statistic of 390.833 and p value < 0 indicated that inclusion of variables GLP-1 use and diabetes status were significant predictors that improve the fit of the logistic regression compared to a model without the predictors present. The analysis indicated GLP-1 agonist use to have a 3.91 times higher log-odds of postoperative complications. However, the variables alone are not statistically significant as the individual coefficients had a p-value greater than .05 with wide confidence intervals, possibly attributed to small sample size.

Conclusion: Based on the initial results of this ongoing study, GLP-1 agonist use may potentially impact the likelihood of postoperative wound healing complications. The combination of variables GLP-1 agonist use and diabetes status in the logistic regression model demonstrated statistical significance when predicting wound healing complications. Given the small sample size, the impact of GLP-1 agonists alone on postoperative wound healing requires cautious interpretation. Our study is ongoing, looking at breast reduction patients from 2023 as GLP-1 agonist medications rise in popularity.

1. FDA Adverse Event Reporting System (FAERS). (2023). Retrieved from https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
2. Joshi, G. P., & Abdelmalak, B. B. (2023, June 29). American Society of Anesthesiologists Consensus-based guidance on preoperative management of patients (adults and children) on glucagon-like peptide-1 (GLP-1) receptor agonists. American Society of Anesthesiologists (ASA). https://www.asahq.org/about-asa/newsroom/news-releases/2023/06/american-society-of-anesthesiologists-consensus-based-guidance-on-preoperative
3. Heinze, G., Ploner, M., & Dunkler, D. (2020). logistf: Firth's bias-reduced logistic regression. R package version 1.26.0. URL https://CRAN.R-project.org/package=logistf.

Purpose: The Oppenheimer effect, described in 1948, signaled the beginning of awareness regarding the potential association between implants and tumorigenesis. Subsequent attention arose in the mid-1990s, particularly with the association of breast implants and lymphomas, predominantly breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). To date, many isolated reports have emerged documenting cases of prosthetic implant-associated lymphoid neoplasms beyond BIA-ALCL. This study aims to comprehensively review all implant-related lymphoid neoplasms.

Methods: A scoping review was conducted using PRISMA guidelines. PubMed and Embase were searched to broadly identify a large body of biomedical articles in which both cancers and prostheses/implants/devices were subjects. After preliminary screening, articles pertaining to lymphoid neoplasms at mammary and non-mammary sites were identified. BIA-ALCL was excluded for our review due to the extensive literature currently available on this topic.

Results: Our search yielded 14,613 articles of which 79 articles were included in this review. Following data extraction,108 patients were found to have implant-related lymphomas beyond the scope of BIA-ALCL. The predominant type across all systems is B cell lymphoma (82%), most commonly Diffuse large B cell lymphoma, with notable instances of EBV positivity (40% of all cases). Following mammary lymphoid tumors (30%), bone (27%) and vascular (26%) are the most common locations. Seroma, rupture, and capsular contracture are significantly associated with breast prostheses, while infections, screw loosening, and thrombosis/aneurysm are associated with bone and vascular prostheses, respectively. The time from implantation to diagnosis (latency period) is notably longer in breast implant-related lymphomas compared to lymphomas associated with gluteal implants (p=0.03), a median of 14 versus 5 years respectively. Three lymphoma cases were linked to dermal fillers, and one case was associated with laparoscopic adjustable gastric band. In the majority of cases, the tumors are localized, non-mass forming, and detected in early stages, with favorable treatment outcomes and low recurrence rates following surgical removal. However, exceptions exist, such as Marginal zone lymphoma where 50% spread to infiltrate the bone marrow.

Conclusion: To our knowledge, this is the first scoping review on lymphoid neoplasms associated with prostheses and implants of all types. While implant-associated lymphoid neoplasms beyond BIA-ALCL have been documented in numerous individual case reports, their prevalence has not received widespread recognition to date. Future research should continue to document cases and unravel their underlying mechanisms, clinical courses, and potential treatments. In cases of pathologies associated with implants, especially those that show resistance to treatments, it may be beneficial to consider malignancies as a potential differential diagnosis.

ABSTRACT Introduction The recently mandated US Food and Drug Administration (FDA) patient decision checklists were developed with the goal of improving the informed decision making process for patients considering breast implants. Yet, prior research by our group has demonstrated that these checklists are written at reading levels far in excess of that recommended by the National Institutes of Health and the American Medical Association (1). Patients considering breast implants are required to sign these forms prior to surgery, even if they have little to no comprehension of their contents. This study aims to improve the accessibility, and therefore the utility, of the mandated FDA patient literature for the average breast implant patient using the assistance of artificial intelligence (AI).

Methods Patient decision checklists were obtained from the three most utilized breast implant manufacturers in the United States– Allergan, Mentor, and Sientra. Using these checklists as source material, AI was asked to synthesize a novel patient decision checklist, written at the 6th grade reading level. The generated checklist was then edited by plastic surgeons for both formatting and content. Readability analysis of the mandated checklists and the AI assisted checklist was performed using the Flesch Reading-Ease Score, Flesch-Kincaid Grade Level, Gunning-Fog Index, Coleman-Liau Index, Simplified Measure of Gobbledygook, and Automated Readability Index. Further textual analysis included sentence count, word count, number and percentage of complex words, average number of words per sentence, and average number of syllables per word.

Results The readability of the AI assisted checklist was consistent with a 6th grade reading level. The readability of the Allergan, Mentor, and Sientra patient checklists correlated with a college reading level. Comparison of average Sientra, Mentor, and Allergan grade level indices to that of the Chat-GPT assisted checklist using one-sample two-tailed t testing revealed the FDA mandated documents to be written at significantly higher reading levels than that of the AI-assisted checklist (p<0.0001). Analysis of the FDA-mandated documents and the ChatGPT-assisted checklist similarly revealed significant differences in overall text composition. Average sentence count, word count, complex word count and percentage, average number of words per sentence, and average number of syllables per word were all higher in the FDA-mandated group relative to the ChatGPT-assisted checklist.

Conclusion The currently mandated breast implant patient checklists are written at a college reading level and are inaccessible to the average patient. We propose a new patient decision checklist, generated with the assistance of artificial intelligence, in order to improve healthcare access within plastic surgery. This simplified material can be used as an adjunct to the current checklists in order to improve shared decision making.

References: 1. Boyd LC, Kareh AM, Rodby KA. Navigating Food and Drug Administration Mandated Breast Implant Patient Literature: A Call to Increase Equitable Healthcare Access Within Plastic Surgery. Ann Plast Surg. 2023;91(6):651-655. doi:10.1097/SAP.0000000000003674

Introduction: Abemaciclib, a CDK4/6 inhibitor with the brand name Verzenio, has improved treatment for hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer (1). Its use has increased following FDA approval for use with endocrine therapy in patients with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence (2). Despite its proven efficacy in cancer therapy, the effects of Verzenio on the surgical outcomes of post-mastectomy breast reconstruction are not well understood. This study aims to assess the impact of Verzenio on surgical outcomes in order to inform integrated cancer care strategies.

Methodology: This retrospective cohort study, conducted at a single center from January 2016 to September 2023 with IRB approval, included patients with HR-positive, HER2-negative breast cancer who underwent mastectomy and immediate breast reconstruction with a tissue expander while undergoing treatment with Verzenio. A 2:1 propensity score-matched control group was established. Data analysis focused on demographics, treatment characteristics, and postoperative outcomes, with the primary outcome being the incidence of surgical complications. Statistical analyses were performed using SPSS v26.0.

Results: The study included 135 patients, divided into 43 in the Verzenio group and 92 in the non-Verzenio group. Demographics were comparable between groups. Both cohorts predominantly exhibited invasive ductal carcinoma treated surgically with skin-sparing mastectomy. The Verzenio and non-Verzenio groups had similar incidences of readmission and unplanned surgeries. Notably, the Verzenio group had a higher incidence of mastectomy skin flap necrosis (MSFN). This association persisted in univariable regression analysis (p = 0.008). Further adjustment in multivariable regression analysis, controlling for confounding variables, continued to demonstrate a significant impact of Verzenio on the incidence of MSFN (p = 0.005).

Discussion: Medical treatment options for patients with breast cancer are rapidly evolving with the development of targeted biological therapies. This study demonstrates that Verzenio, despite increasing the risk of MSFN, does not significantly alter the incidence of surgical complications requiring hospital readmission, return to the operating room or reconstructive failure. Understanding how advances in breast cancer treatment impact the process of breast reconstruction is critical to providing individualized, patient centered informed consent.

References: 1. O'Sullivan CC, et al. Ther Adv Med Oncol. 2019;11:1758835919887665. 2. Center for Drug Evaluation and Research (24 March 2023). "FDA D.I.S.C.O. Burst Edition: FDA approval of Verzenio (abemaciclib) with endocrine therapy for patients with HR-positive, HER2-negative, node-positive, early breast cancer". FDA.

Background

Human acellular dermal matrices (ADMs) remain the most used matrices in prosthetic breast reconstruction. Availability and costs may limit their use in prepectoral reconstruction, which requires large amounts of ADM. Thus, alternative matrices are being explored. The purpose of this study is to demonstrate the safety and efficacy of a human-porcine ADM construct through clinical outcomes and histologic evidence of graft integration.

Methods

This is a retrospective study of patients who underwent ADM-assisted, prepectoral, expander/implant breast reconstruction who received both human and porcine dermal matrices in the same breast. Biopsies of both ADMs were obtained at expander/implant exchange and evaluated for cellularization, vascularization, and inflammation. Postoperative complications were retrieved from patient records.

Results

59 patients (116 breast reconstructions) were included in the study. Mean follow-up time was 6.7 (± 0.56) years; minimum follow-up was 5 years. The any-complication rate was 8.6%. This included 8 cases of skin necrosis (6.9%), 2 cases of seroma (1.7%), 2 cases of expander/implant exposure (1.7%), and 3 cases of return to the operating room (2.6%). Of the 8 cases of skin necrosis, 3 were major requiring a return to the operating room. Of these 3 cases of major skin necrosis, 2 also had prosthesis exposure which were salvaged. The 2 cases of seroma were resolved in the office. There were no incidences of surgical-site infection, hematoma, clinically significant capsular contracture (Grade 3 or 4), or expander/implant loss (reconstructive failure). All complications occurred within the first year.

A total of 138 ADM biopsy specimens (66 human and 72 porcine) were obtained from 38 patients at implant exchange. H&E staining of biopsy specimens revealed fibroblast in-growth in 95.5% of the human grafts and 81.9% of the porcine grafts (P = 0.013). There was also a significantly higher presence of capillary in-growth in human versus porcine grafts (72.7% vs 36.1%; P = 0.00002). Intra-graft inflammation was present in 25.8% of human grafts versus 44.4% of porcine grafts (P = 0.022). Despite these differences, there were no cases of graft rejection, capsular contracture, or expander/implant loss. All grafts appeared to be integrated within the host tissue on visual inspection.

Conclusions

Breasts reconstructed with human-porcine ADM constructs had a low rate of postoperative complications, similar to previously reported rates for prepectoral reconstructions with human ADM only (7.6%) or with P4HB-human ADM constructs (6.4%).1 Despite the observed differences in biologic response between the grafts on histologic evaluation, there was no evidence of porcine graft failure or rejection at the time of implant exchange/biopsy. We postulate that the histological differences likely resolved over time, allowing the porcine ADM to integrate within the host tissue without eliciting a clinically significant foreign body response. In summary, our study suggests that porcine derived ADM performs in a similar manner to human derived ADM and may be a feasible alternative to human ADMs in prepectoral breast reconstructions.

1. Sigalove S, O'Rorke E, Maxwell GP, Gabriel A. Evaluation of the Safety of a GalaFLEX-AlloDerm Construct in Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2022;150:75S-81S.