Browsing by Author "Fisher, Carla S."
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Item 177. Prophylactic Absorbable Antibiotic Beads For High Risk Implant-based Reconstruction: A Single Institution Pilot Study(Wolters Kluwer, 2023-05-19) Ahmed, Shahnur; Lee, Jason T. C.; Roth, Dylan D.; Liu, Steven; Fisher, Carla S.; Fan, Betty; Imeokparia, Folasade; Ludwig, Kandice; Lester, Mary E.; Hassanein, Aladdin H.; Surgery, School of MedicinePURPOSE: Infections are problematic in implant-based reconstruction after mastectomies. Infection rates have been reported to be as high as 31%. Strategies to reduce the risk of infection include various antibiotic irrigation solutions, “no-touch” techniques, optimizing sterility, and empiric antibiotic use for skin flora coverage. Absorbable antibiotic beads have been well described for other indications, including orthopedic and pressure sore reconstruction. The purpose of this study is to evaluate the use of prophylactic biodegradable antibiotic beads during pre-pectoral and sub-pectoral implant-based breast reconstruction following mastectomy. METHODS: A single-center retrospective review of patients who underwent implant-based breast reconstruction post-mastectomy between 2019 to 2022. Patients were divided into two groups: Group I were deemed “high risk” by the senior author and received biodegradable antibiotic beads (1 gram vancomycin, 240 mg gentamicin) during tissue expander or implant reconstruction (pre-pectoral or subpectoral) while Group II (control) had no antibiotic beads. Demographic data, diabetes, body mass index (BMI), implant plane (pre-pectoral or sub-pectoral), smoking and use of mesh were recorded. Outcome variables included postoperative cellulitis or infection requiring oral or intravenous antibiotics and tissue expander loss at 90 days. RESULTS: In our study period, 19 patients (36 total implants/expanders) received biodegradable antibiotic beads during implant-based breast reconstruction (Group I). There were 174 patients (290 total expanders) who did not receive antibiotic beads (Group II). Patients in Group I had a history of previous expander/implant infection in 73.6%. Pre-pectoral placement of implants occurred in 84.2% of patients in Group I and 74.1% in Group II. Diabetes was prevalent in 15.8% of Group I compared to 5.7% seen in Group II patients. The mean BMI in Group I was 30.5 kg/m2 compared to 27.8 kg/m2 in Group II (p-value 0.88). Implant infection rate of Group I at 90 days was 8.3% (3/36 total expanders) compared to 8.6% (25/290 total expanders) in Group II. Implant loss in Group I was 5.5% (2/26 total expanders) compared to 7.6% (22/290) in Group II. CONCLUSION: The incidence of infection in high risk patients who have absorbable antibiotic beads placed during the time of reconstruction appears to be normalized to the control group in this pilot study, suggesting that absorbable antibiotic beads may decrease postoperative infection complications. Future studies may further clarify its benefit in selected groups.Item 23rd Annual Meeting of the American Society of Breast Surgeons: Back to In-Person Scientific Exploration(Springer, 2022) Fisher, Carla S.; Teshome, Mediget; Blair, Sarah L.; Surgery, School of MedicineItem ASO Visual Abstract: Breast Cancer Screening, Diagnosis, and Surgery During the Pre- and Peri-pandemic—Experience of Patients in a Statewide Health Information Exchange(Springer, 2023) Milgrom, Zheng Z.; Milgrom, Daniel P.; Han, Yan; Hui, Siu L.; Haggstrom, David A.; Fisher, Carla S.; Mendonca, Eneida A.; Pediatrics, School of MedicineThe COVID-19 pandemic affected delivery of breast cancer care, including screening, diagnosis, and surgery. This study (https://doi.org/10.1245/s10434-023-13119-w) compared patient data from 1 year before the outbreak, during lockdown, and 1 year after lockdown to identify changes in patterns or timeliness of care.Item Breast Cancer Screening, Diagnosis, and Surgery during the Pre- and Peri-pandemic: Experience of Patients in a Statewide Health Information Exchange(Springer Nature, 2023) Milgrom, Zheng Z.; Milgrom, Daniel P.; Han, Yan; Hui, Siu L.; Haggstrom, David A.; Fisher, Carla S.; Mendonca, Eneida A.; Pediatrics, School of MedicineBackground: Measures taken to address the COVID-19 pandemic interrupted routine diagnosis and care for breast cancer. The aim of this study was to characterize the effects of the pandemic on breast cancer care in a statewide cohort. Patients and methods: Using data from a large health information exchange, we retrospectively analyzed the timing of breast cancer screening, and identified a cohort of newly diagnosed patients with any stage of breast cancer to further access the information available about their surgical treatments. We compared data for four subgroups: pre-lockdown (preLD) 25 March to 16 June 2019; lockdown (LD) 23 March to 3 May 2020; reopening (RO) 4 May to 14 June 2020; and post-lockdown (postLD) 22 March to 13 June 2021. Results: During LD and RO, screening mammograms in the cohort decreased by 96.3% and 36.2%, respectively. The overall breast cancer diagnosis and surgery volumes decreased up to 38.7%, and the median time to surgery was prolonged from 1.5 months to 2.4 for LD and 1.8 months for RO. Interestingly, higher mean DCIS diagnosis (5.0 per week vs. 3.1 per week, p < 0.05) and surgery volume (14.8 vs. 10.5, p < 0.05) were found for postLD compared with preLD, while median time to surgery was shorter (1.2 months vs. 1.5 months, p < 0.0001). However, the postLD average weekly screening and diagnostic mammogram did not fully recover to preLD levels (2055.3 vs. 2326.2, p < 0.05; 574.2 vs. 624.1, p < 0.05). Conclusions: Breast cancer diagnosis and treatment patterns were interrupted during the lockdown and still altered 1 year after. Screening in primary care should be expanded to mitigate possible longer-term effects of these interruptions.Item Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108)(American Society of Clinical Oncology, 2022) Khan, Seema A.; Zhao, Fengmin; Goldstein, Lori J.; Cella, David; Basik, Mark; Golshan, Mehra; Julian, Thomas B.; Pockaj, Barbara A.; Lee, Christine A.; Razaq, Wajeeha; Sparano, Joseph A.; Babiera, Gildy V.; Dy, Irene A.; Jain, Sarika; Silverman, Paula; Fisher, Carla S.; Tevaarwerk, Amye J.; Wagner, Lynne I.; Sledge, George W.; Surgery, School of MedicinePurpose: Distant metastases are present in 6% or more of patients with newly diagnosed breast cancer. In this context, locoregional therapy for the intact primary tumor has been hypothesized to improve overall survival (OS), but clinical trials have reported conflicting results. Methods: Women presenting with metastatic breast cancer and an intact primary tumor received systemic therapy for 4-8 months; if no disease progression occurred, they were randomly assigned to locoregional therapy for the primary site (surgery and radiotherapy per standards for nonmetastatic disease) or continuing sysmetic therapy. The primary end point was OS; locoregional control and quality of life were secondary end points. The trial design provided 85% power to detect a 19.3% absolute difference in the 3-year OS rate in randomly assigned patients. The stratified log-rank test and Cox proportional hazards model were used to compare OS between arms. Cumulative incidence of locoregional progression was compared using Gray's test. Quality-of-life assessment used standard instruments. Results: Of 390 participants enrolled, 256 were randomly assigned: 131 to continued systemic therapy and 125 to early locoregional therapy. The 3-year OS was 67.9% without and 68.4% with early locoregional therapy (hazard ratio = 1.11; 90% CI, 0.82 to 1.52; P = .57). The median OS was 53.1 months (95% CI, 47.9 to not estimable) in the systemic therapy arm and 54.9 months (95% CI, 46.7 to not estimable) in the locoregional therapy arm. Locoregional progression was less frequent in those randomly assigned to locoregional therapy (3-year rate: 16.3% v 39.8%; P < .001). Quality-of-life measures were largely similar between arms. Conclusion: Early locoregional therapy for the primary site did not improve survival in patients presenting with metastatic breast cancer. Although it was associated with improved locoregional control, this had no overall impact on quality of life.Item Immediate Lymphatic Reconstruction to Prevent Breast Cancer-Related Lymphedema: A Systematic Review(Liebert, 2022-04) Cook, Julia A.; Sinha, Mithun; Lester, Mary; Fisher, Carla S.; Sen, Chandan K.; Hassanein, Aladdin H.; Medicine, School of MedicineSignificance: Lymphedema is chronic limb swelling from lymphatic dysfunction. The condition affects up to 250 million people worldwide. In breast cancer patients, lymphedema occurs in 30% who undergo axillary lymph node dissection (ALND). Recent Advances: Immediate lymphatic reconstruction (ILR), also termed Lymphatic Microsurgical Preventing Healing Approach (LyMPHA), is a method to decrease the risk of lymphedema by performing prophylactic lymphovenous anastomoses at the time of ALND. The objective of this study is to assess the risk reduction of ILR in preventing lymphedema. Critical Issues: Lymphedema has significant effects on the quality of life and morbidity of patients. Several techniques have been described to manage lymphedema after development, but prophylactic treatment of lymphedema with ILR may decrease risk of development to 6.6%. Future Directions: Long-term studies that demonstrate efficacy of ILR may allow for prophylactic management of lymphedema in the patient undergoing lymph node dissection.Item The Implications of Insurance Status on Presentation, Surgical Management and Mortality among Non-Metastatic Breast Cancer Patients in Indiana(Elsevier, 2018-12) Obeng-Gyasi, Samilia; Timsina, Lava; Miller, Kathy D.; Ludwig, Kandice K.; Fisher, Carla S.; Haggstrom, David A.; Obstetrics and Gynecology, School of MedicineBackground The National Breast and Cervical Cancer Early Detection Program seeks to reduce health care disparities by providing uninsured and underinsured women access to screening mammograms. The objective of this study is to identify the differences in presentation, surgical management, and mortality among nonmetastatic uninsured patients diagnosed through Indiana's Breast and Cervical Cancer Program compared with patients with private and government (Medicare or Medicaid) insurance. Methods Study data were obtained using the Indiana state cancer registry and Indiana's Breast and Cervical Cancer Program. Women aged 50 to 64 with an index diagnosis of stage 0 to III breast cancer from January 1, 2006 to December 31, 2013, were included in the study. Bivariate intergroup analysis was conducted. Kaplan-Meier estimates between insurance types were compared using the log rank test. All-cause mortality was evaluated using a mixed effects model. Results The groups differed significantly for sociodemographic and clinical variables. Uninsured Indiana Breast and Cervical Cancer Program patients presented with later disease stage (P < .001) and had the highest overall mortality (hazard ratio 2.2, P = .003). Surgical management only differed among stage III patients (P = .012). Conclusion To improve insurance-based disparities in Indiana, implementation of the Breast and Cervical Cancer Program in conjunction with expansion of insurance coverage to vulnerable low-income populations need to be optimized.Item Prophylactic Buried Dermal Flap: A Simple Method for Axillary Reconstruction after Lymph Node Dissection(Wolters Kluwer, 2024-09-12) Fallah, Kasra N.; Ahmed, Shahnur; Venardi, Andrew S.; Hulsman, Luci A.; Fisher, Carla S.; Ludwig, Kandice K.; Lester, Mary E.; Hassanein, Aladdin H.; Surgery, School of MedicineBreast cancer-related lymphedema is characterized by progressive limb enlargement and occurs in up to 30% of breast cancer patients following axillary lymph node dissection (ALND). Immediate lymphatic reconstruction (ILR) is a preventative technique used to reduce lymphedema rates by performing lymphovenous anastomoses of disrupted afferent lymphatics. This study presents a novel method of axillary reconstruction following ALND using a buried dermal flap that provides local tissue with intact subdermal lymphatics to the axillary dead space. A single-center retrospective review was performed to assess breast cancer patients who underwent modified radical mastectomy without reconstruction between 2018 and 2023. Groups were divided into those who had ILR alone (group 1) and those who had buried dermal flap with attempted ILR (group 2). There were 31 patients included in this study: 18 patients in group 1 and 13 patients in group 2. Patient demographics, comorbidities, and breast cancer history were similar between the groups. There was no significant difference in the mean number of lymphovenous anastomoses performed (1.6 versus 1.7, P = 0.84). Mean operative time of 224.4 ± 51.9 minutes in group 1 was similar to 223.4 ± 30.4 minutes in group 2 (P = 0.95). We introduce a novel method of axillary reconstruction following ALND using a buried dermal flap that is inset into the axillary dissection space and over the area of ILR. We propose that it is an efficient accessory procedure to augment ILR by providing supplementary intact lymphatic channels to the area of lymphatic injury, while obliterating the axillary dead space.Item Regenerative tissue filler for breast conserving surgery and other soft tissue restoration and reconstruction needs(Springer Nature, 2021-02-01) Puls, Theodore J.; Fisher, Carla S.; Cox, Abigail; Plantenga, Jeannie M.; McBride, Emma L.; Anderson, Jennifer L.; Goergen, Craig J.; Bible, Melissa; Moller, Tracy; Voytik‑Harbin, Sherry L.; Surgery, School of MedicineComplete removal of cancerous tissue and preservation of breast cosmesis with a single breast conserving surgery (BCS) is essential for surgeons. New and better options would allow them to more consistently achieve this goal and expand the number of women that receive this preferred therapy, while minimizing the need for re-excision and revision procedures or more aggressive surgical approaches (i.e., mastectomy). We have developed and evaluated a regenerative tissue filler that is applied as a liquid to defects during BCS prior to transitioning to a fibrillar collagen scaffold with soft tissue consistency. Using a porcine simulated BCS model, the collagen filler was shown to induce a regenerative healing response, characterized by rapid cellularization, vascularization, and progressive breast tissue neogenesis, including adipose tissue and mammary glands and ducts. Unlike conventional biomaterials, no foreign body response or inflammatory-mediated “active” biodegradation was observed. The collagen filler also did not compromise simulated surgical re-excision, radiography, or ultrasonography procedures, features that are important for clinical translation. When post-BCS radiation was applied, the collagen filler and its associated tissue response were largely similar to non-irradiated conditions; however, as expected, healing was modestly slower. This in situ scaffold-forming collagen is easy to apply, conforms to patient-specific defects, and regenerates complex soft tissues in the absence of inflammation. It has significant translational potential as the first regenerative tissue filler for BCS as well as other soft tissue restoration and reconstruction needs.