2:00 PM
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A Multi-Decade, Multi-institutional Propensity Score Matched Analysis of Recurrence-Free Survival and Mortality in Post-mastectomy Patients with and without Immediate Breast Reconstruction
Introduction: Post-mastectomy reconstruction has become the standard of care for breast cancer patients due to its positive impact on patient-reported quality of life, body image, psychological well-being, and physical comfort.1 Previous studies have reported disparities in healthcare outcomes among various racial and sociodemographic groups, which may be attributed to variances in medical service accessibility, physician education patterns, and patient awareness of reconstructive options.1,2 The effect of breast reconstruction on cancer-recurrence and fatalities remains ambiguous. Therefore, our objective was to examine how patient-specific factors and reconstruction status influence recurrence-free survival and mortality rates.
Method: Retrospective review identified post-mastectomy patients at NYP-Cornell and Columbia between 1979 and 2019. Patients were propensity score matched (1:1 nearest neighbor) based on age, race, marital status, smoking history, cancer staging, ER/PR/HER2 status, as well as treatment course (i.e., radiation, chemotherapy, immunotherapy, and hormone therapy). Cox proportional hazards model and log rank test were used for recurrence-free survival analysis. Logistic regression was used to evaluate predictors of mortality.
Results: We found 2385 pairs of matched patients who did and did not undergo post-mastectomy breast reconstruction. Reconstruction was correlated with a significantly lower risk of recurrence (OR 0.58, p < 0.05) and mortality (OR 0.38, p < 0.05) compared to mastectomy without reconstruction. For patients who had relapsed disease, completion of the reconstruction sequence was correlated with an earlier detection of cancer recurrence (p < 0.05). Stratified analysis of the reconstruction group alone did not reveal significant effects of median household income, insurance status, or surgical technique (i.e., implant vs. autologous) on survival or recurrence. Propensity score matching of pedicle and free flap patients (211 pairs) found no difference in the timeline of recurrence, but a significant mortality benefit for patients who undergo free flap reconstruction (OR 0.27, p < 0.05).
Conclusion: Patients who complete breast reconstruction may have better access to follow-up care, medical imaging and screening, and more opportunities for physician interface, which can lead to the earlier detection and treatment of cancer recurrence. However, patients who do not undergo reconstruction may have higher mortality rates due to factors such as delayed detection and treatment. This study may underscore the need for continued surveillance of patients who undergo mastectomy without reconstruction.
References
1. Butler PD, Morris MP, Momoh AO. Persistent Disparities in Postmastectomy Breast Reconstruction and Strategies for Mitigation. Ann Surg Oncol. 2021 Oct;28(11):6099-6108. doi: 10.1245/s10434-021-10487-z. Epub 2021 Jul 21. PMID: 34287788.
2. Fu RH, Baser O, Li L, Kurlansky P, Means J, Rohde CH. The Effect of the Breast Cancer Provider Discussion Law on Breast Reconstruction Rates in New York State. Plast Reconstr Surg. 2019 Sep;144(3):560-568. doi: 10.1097/PRS.0000000000005904. PMID: 31461002.
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2:05 PM
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The presence of staphylococcus and pseudomonas in the breast microbiome of post-mastectomy expander infection patients and the impact of prophylactic antibiotics
Introduction:
Post-mastectomy implant infections have been cited ranging from 2-28%, with Staphylococcus and Pseudomonas as the usual culprits.¹⁻³ Individuals each have a unique microbiome, or composition of internal microorganisms, that impacts their response to the external environment,⁴ but its role in breast infections is unknown. Often by the time of operative washout, clinical culture data is negative due to antibiotics. However, microbiome analysis of the breast would still show a signal and potentially before fulminant clinical infection. In a pilot study using 16s rRNA sequencing, we explore the breast microbiome in post-mastectomy tissue expander infection patients and the implications of prophylactic antibiotics.
Methods:
We designed a two-arm randomized-controlled trial for mastectomy patients undergoing two-stage implant-based reconstruction. Patients were randomized to 7 days of prophylactic post-operative antibiotics (Cohort A), versus only 24 hours of Cefazolin (Cohort B) at the time of surgery. Post-operatively the peri-prosthetic space was sampled via expander aspiration or drain output at 3 weeks. Microbial analysis was performed with 16S rRNA microbiome sequencing. The relative abundance percentages of pseudomonas and staphylococcus in each sample were recorded. Culture data was collected at the time of operative explantation.
Results:
Of the 39 enrolled patients, 19 patients (32 breasts) were in Cohort A and 20 (32 breasts) were in Cohort B. Expander removal due to infection was required in 7 breasts (22%) of Cohort A, compared to 5 breasts (15.6%) of cohort B (p=0.200). Of the 12 tissue expanders that were removed, 10 were the cancerous breast, while 2 were prophylactic. Negative cultures at the time of explant were seen in 3 of Cohort A (42%) compared to 1 (20%) in Cohort B (p=0.408). Of those that had positive cultures, Staphylococcus was present in 7(88%) compared with Pseudomonas in 2 (12%). The main cultured organism at time of explant was already abundantly present on the prior aspirate microbiome data in 50% of Cohort A compared to 100% of Cohort B explants (p=0.079). Mean time from mastectomy to second aspiration was 22.3 vs 21.2 days (p=0.860). Mean relative abundance of staphylococcus at this visit was 16.1% in Cohort A compared to 37.1% in Cohort B (p=0.356). Pseudomonas was 29.3% in A vs 17.3% in B (p=0.852). Time from mastectomy to explant was 92 days (cohort A) vs 63 days (Cohort B) p=0.426. Mean time from last aspiration to explantation was 70 days in Cohort A, compared to 42 days in Cohort B (p=0.432).
Conclusion
Prophylactic oral antibiotics did not significantly alter infection rates in post-mastectomy patients, however infections in this cohort had more negative operative cultures, delayed time to explantation, and lower correlation with aspirate microbiome data. Larger cohort samples are necessary to continue studying these variations but this may reflect changes to the balance of the microbiome seen with prolonged antibiotics, and provides novel insight into the larger impact of antibiotics in effacing potential markers for implant infections.
References
1. Yamin F, Nouri A, McAuliffe P, et al. Routine Postoperative Antibiotics After Tissue Expander Placement Postmastectomy Does Not Improve Outcome. Ann Plast Surg. 07 01 2021;87(1s Suppl 1):S28-S30. doi:10.1097/SAP.0000000000002826
2. Phillips BT, Fourman MS, Bishawi M, et al. Are Prophylactic Postoperative Antibiotics Necessary for Immediate Breast Reconstruction? Results of a Prospective Randomized Clinical Trial. J Am Coll Surg. 06 2016;222(6):1116-24. doi:10.1016/j.jamcollsurg.2016.02.018
3. Banuelos J, Abu-Ghname A, Asaad M, Vyas K, Sohail MR, Sharaf B. Microbiology of Implant-Based Breast Reconstruction Infections: A Systematic Review. Ann Plast Surg. Aug 2020;85(2):194-201. doi:10.1097/SAP.0000000000001974
4. Meng S, Chen B, Yang J, et al. Study of Microbiomes in Aseptically Collected Samples of Human Breast Tissue Using Needle Biopsy and the Potential Role of. Front Oncol. 2018;8:318. doi:10.3389/fonc.2018.00318
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2:10 PM
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Immediate Discharge Following Mastectomy and Immediate Tissue Expander Reconstruction
Purpose:
Patients who undergo mastectomy with immediate tissue expander (TE) reconstruction are typically observed overnight for immediate post-operative complications and patient comfort.1 Changes within the US healthcare system including differential resource allocation, staffing shortages, and hampered bed utilization catalyzed necessary changes in patient management.2 Within, we compare the short-term outcomes of patients receiving same day mastectomy and tissue expander reconstruction for those discharged on postoperative day one versus those discharged immediately following surgery to explore the safety, efficacy, and potential impact on hospital processes.
Materials and Methods:
Institutional Board Review approval was obtained and a retrospective review of patients undergoing mastectomy with immediate TE reconstruction from March 2019 to March 2021 was performed. Patients were stratified into two cohorts; the first cohort was observed overnight (OBS) and underwent surgery from March 2019 to March 2020. Patients in cohort two were treated as outpatient surgery and discharged the same day (DC) of their surgery, and this occurred from April 2020 to March 2021. Both cohorts underwent the same enhanced recovery after surgery protocol.
Basic demographic information, and immediate post-operative complication rates were collected. Primary outcomes included rates of seroma, hematoma, infection, dehiscence, mastectomy flap necrosis and TE exposure, rupture, and leak. Secondary outcomes included ED visit, readmission rates, need for unplanned re-operation, and need for additional pain medications. Outcomes were tracked for 7 days following surgery. Statistical analysis was performed using chi-squared tests, Fisher exact tests, and two-sample t-tests and significance determined by a p<0.05.
Results:
In total, 153 patients underwent 256 mastectomies with immediate TE reconstruction. All patients were female and mean age was 48 years old. The DC cohort contained 71 patients (125 mastectomies) and there were 82 Patients (131 mastectomies) within the OBS cohort. No differences were observed between groups for medical comorbidities, neoadjuvant chemotherapy/radiation, indication for mastectomy, mastectomy type, location of TE, or antibiotic on discharge.
On average the DC cohort had a lower BMI than the OBS group (mean ± SD; DC 26.8 kg/m2 ± 5.3 kg/m2, OBS 28.7 kg/m2 ± 6.1 kg/m2, p = 0.05), the DC cohort had higher rates of adjuvant chemotherapy (DC 40.1%, OBS 23.2%, p=0.02), and were more likely to undergo bilateral TE reconstruction (DC 76%, OBS 60%, p=0.03) than the OBS group. No differences were observed between cohorts in complication rates regarding primary or secondary outcomes.
Conclusions:
These findings indicate that it is safe and effective within the immediate 7-day post-operative period to immediately discharge patients undergoing mastectomy with immediate TE reconstruction. There were no differences regarding rates of complications between the DC and OBS group. Patients may experience enhanced satisfaction with immediate recovery within their own homes and with their support groups.3 Additionally, alteration of patient management practices can have a profound impact on the operational flow within hospitals. A reduction in bed and staff utilization provides space for growth.
- Perez-Alvarez IM, Bartholomew AJ, King CA, et al. Breast Surgery in the Time of Global Pandemic: Benefits of Same-Day Surgery for Breast Cancer Patients Undergoing Mastectomy with Immediate Reconstruction during COVID-19. Plast Reconstr Surg. Oct 2020;146(4):522e-523e. doi:10.1097/prs.0000000000007269
- Impact of the COVID-19 Pandemic on the Hospital and Outpatient Clinician Workforce. . Assistant Secretary for Planning and Evaluation Office of Health Policy; 2022. Accessed May 3, 2022.
- Ludwig K, Wexelman B, Chen S, et al. Home Recovery After Mastectomy: Review of Literature and Strategies for Implementation American Society of Breast Surgeons Working Group. Ann Surg Oncol. Sep 2022;29(9):5799-5808. doi:10.1245/s10434-022-11799-4
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2:15 PM
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National Trends and Impact of Preoperative CT-Angiography on Autologous Breast Reconstruction
Purpose: Prior studies investigating the impact of preoperative CT-angiography (pCTA) on outcomes for autologous breast reconstruction (ABR) have had conflicting results. Prior studies have largely been limited to single-center studies with limited sample size, which have contributed to the conflicting data. Larger, nationwide studies are needed to better understand the trends and outcomes associated with pCTA for ABRs.
Methods and Materials: Using ICD/CPT codes, we identified patients who underwent ABR with and without pCTA between 2010-2021 in a national administrative claims database. Costs, length of hospital stay (LOS), and trends in usage of pCTA were evaluated. 90-day outcomes were assessed, including wound complications, infection, flap failure, and hematoma/seroma.
Results: Of 15,997 ABR patients, 10,337 (64.6%) did not undergo pCTA and 5,660 (35.4%) underwent pCTA. Annual rate of pCTAs gradually increased from 29% in 2010 to 44% in 2021. Patients with pCTA observed higher median hospital costs and prolonged LOS. No difference in 90-day outcomes was observed in patients undergoing ABR with or without pCTA after adjusting for age, geographic region of residence, insurance plan, BMI and other co-morbidities in multivariable regression analysis.
Conclusion: The use of pCTA for ABRs has been gradually rising nationwide and is associated with higher costs and prolonged LOS. However, there appears to be no difference in 90-day outcomes for patients undergoing ABR with or without pCTA. Use of pCTA should be carefully considered to avoid unnecessary expense and risks for ABR patients.
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2:20 PM
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The Safety of Combining Breast Reconstruction and Risk Reducing Gynecologic Surgeries: An Analysis of cases from the National Surgical Quality Improvement Program
Introduction: Patient's undergoing breast reconstruction may opt for extirpative gynecologic surgery for risk reducing purposes. The potential benefits of this include reduction of number of general anesthetic periods and total amount of time for recovery from repeated procedures as well as increased cost effectiveness. One prior concern raised is the potentially increased risk of complications from combining surgeries. Prior studies have had relatively small case numbers and mixed results with some finding no significant increase in complications while others have found increased complication rates. Large database studies are lacking with those that have been performed focusing specifically on oncologic breast surgery. In this study, we aim to examine the risks and benefits of breast reconstruction performed with or without concurrent gynecologic procedures.
Methods: The National Surgical Quality Improvement Program database was queried for breast reconstruction CPT codes from 2010 to 2020. Abstracted cases were then stratified by those that were performed with or without concurrent risk reducing gynecologic procedures. Operative times between these groups were compared with T-Test analysis and complication rates were examined and compared using the Fisher exact test. All statistics were performed in SPSS.
Results: 60,029 cases were extracted for 7 plastic surgery CPT codes. Operative times differed significantly between cases with and without concurrent plastic surgery and gynecologic procedures with the combined cases taking significantly longer. Complications of superficial infection, dehiscence, pneumonia, bleeds requiring transfusion, deep vein thrombosis, and pulmonary embolism did not differ significantly between the groups with the exception of bleeds in the context of periprosthetic capsulectomy.
Conclusion: Combining plastic and gynecologic surgeries is safe with no greater complication rates associated. While performing these procedures concurrently does significantly increase operative time, the time required to perform these procedures on separate occasions is likely much greater. While it can be difficult to coordinate teams to perform these procedures concurrently, these patients gain the benefit of completing surgical treatment more expeditiously.
References
1. Schrauder MG, Brunel-Geuder L, Häberle L, Wunderle M, Hoyer J, Csorba R, Reis A, Schulz-Wendtland R, Beckmann MW, Lux MP. Cost effectiveness of bilateral risk-reducing mastectomy and salpingo-oophorectomy. Eur J Med Res. 2019 Sep 14;24(1):32. doi: 10.1186/s40001-019-0391-8. PMID: 31521205; PMCID: PMC6744699.
2. Del Corral GA, Wes AM, Fischer JP, Serletti JM, Wu LC. Outcomes and Cost Analysis in High-Risk Patients Undergoing Simultaneous Free Flap Breast Reconstruction and Gynecologic Procedures. Ann Plast Surg. 2015 Nov;75(5):534-8. doi: 10.1097/SAP.0000000000000156. PMID: 24691318.
3. Tevis SE, Steiman JG, Neuman HB, Greenberg CC, Wilke LG. Postoperative complications in combined gynecologic, plastic, and breast surgery: An analysis from National Surgical Quality Improvement Program. Breast J. 2019 Nov;25(6):1111-1116. doi: 10.1111/tbj.13429. Epub 2019 Jul 6. PMID: 31280491; PMCID: PMC7192577.
4. Jayaraman AP, Boyd T, Hampton SN, Haddock NT, Teotia SS. The Impact of Combined Risk-Reducing Gynecological Surgeries on Outcomes in DIEP Flap and Tissue-Expander Breast Reconstruction. Plast Surg (Oakv). 2020 May;28(2):112-116. doi: 10.1177/2292550320925905. Epub 2020 May 22. PMID: 32596186; PMCID: PMC7298572.
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2:25 PM
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The Effect of Perioperative Exercise on Post-operative Outcomes After Breast Surgery: A Review of the Current Literature
Background:
Perioperative exercise after oncologic breast surgery confers several benefits including decreased pain intensity 1 and improved quality of life (QOL) 2, but the evidence for optimal timing and types of physical activity permitted following surgery is limited. Furthermore, understanding the impact of perioperative physical activity on post-surgical complications like seroma and hematoma helps to ensure the best possible patient outcomes. This review seeks to test the hypothesis that early exercise after breast surgery improves patient reported outcomes but increases rates of post-operative complications.
Methods:
A comprehensive literature review on PubMed identified articles related to the effects of exercise on post breast oncologic surgery recovery. Inclusion criteria were as follows: peer reviewed publications from 2011 to 2022, effects of exercise after breast surgery as the primary outcome, patient-reported and objective outcomes were included, studies were excluded if the main outcome was not exercise effect on patient outcomes. The data recorded included the number of patients in each study, experimental groups, exercise regimen, primary and secondary outcomes, the number of days to exercise after surgery, complications, quality of life measurements, study protocol, study results, and inclusion and exclusion criteria.
Results:
Out of 377 studies identified, 16 studies were included in the final analysis after applying selection criteria. All were level 1, randomized controlled trials. Four studies started exercise on postoperative day 1 (POD1). Single studies started exercise on POD 7-10, 3 weeks, 1-3 months and 5-6 months. The remaining studies used chemotherapy sessions (CS) as a timeline for exercise: 3 started within 6 months of CS, one during chemotherapy, one 3 days after the second CS, and one within 1-2 weeks of the first CS. Exercise regimens included shoulder and upper limb exercises, physiotherapy, walking, resistance training, aerobics, Pilates, yoga, and water exercises. Five studies found significant improvement in functional capacity, three studies showed improvement in pain, ten studies showed improvement in QOL measures. Only one study examined exercise's effect on seroma and hematoma development and found no significant difference in short-term or long-term complications.1
Conclusions:
Perioperative exercise improves patient quality of life, post-operative pain, and functional capacity, although there is wide variability in the timing to start exercise after breast surgery. Effects of exercise on complications like seroma and hematoma were seldom studied, however the study reviewed in this paper suggests that it is safe to begin range of motion exercising on POD1. Further research is needed to better understand the effects of the timing of exercise on post-surgical complications and to define best practices.
References:
Klein, Ifat, et al. "A Pilot Study Evaluating the Effect of Early Physical Therapy on Pain and Disabilities after Breast Cancer Surgery: Prospective Randomized Control Trail." The Breast, vol. 59, 2021, pp. 286–293., https://doi.org/10.1016/j.breast.2021.07.013.
Tehreem, Fatima, et al. "Effectiveness of Preoperative Stretchings on Postoperative Shoulder Function in Patients Undergoing Mastectomy." Journal of the Pakistan Medical Association, vol. 72, no. 4, 2022, pp. 625–628., https://doi.org/10.47391/jpma.0475.
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2:30 PM
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Comparing the use of acellular dermal matrix with surgical mesh in immediate prepectoral breast reconstruction
Introduction
Acellular dermal matrices (ADMs) have been routinely used in breast reconstruction for soft tissue reinforcement. However, the risk profile, including seromas, infection, and red breast syndrome, as well as cost has made surgeons look for other options. We aimed to determine if surgical mesh is a comparable alternative to ADM in breast reconstruction.
Methods
A retrospective cohort study was performed to assess consecutive patients who underwent immediate pre-pectoral implant-based breast reconstruction with either ADM (AlloDerm) or surgical mesh (GalaFLEX) implant wrap between 2021 and 2022. Patients were asked to complete the BREAST-Q questionnaire to evaluate satisfaction and quality of life. Descriptive statistics were conducted for sociodemographic and oncologic risk factors and complications of the surgery. Multivariable logistic regression analyses were also performed. A loose age-matched subsample was created for sub-analysis.
Results
66 patients (123 breasts) were included in this study. 88 breasts had ADM used and 35 breasts had GalaFLEX. The average age in the study was 52±13years, and the average BMI was 26.6±5.7kg/m2. The overall complication rate was 28.5%. Patients who had GalaFLEX did not have higher odds of developing complications compared to ADM (OR 1.49 [0.60 – 3.71], p = 0.39). The BREAST-Q scores were similar between the two groups: satisfaction with breasts (p = 0.86), psychosocial wellbeing (p = 0.11), sexual wellbeing (p = 0.38), and physical wellbeing of the chest (p = 0.59).
Conclusions
Given its lower cost and comparable surgical and patient reported outcomes, GalaFLEX is a safe and reliable option for immediate breast reconstruction.
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2:35 PM
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Breast Session 8 - Discussion 1
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2:45 PM
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Surgimend vs. Alloderm in Immediate Implant Based Prepectoral Breast Reconstruction: A Single Surgeon’s Experience
Purpose:
Breast cancer is the second most common cancer among women in the United States, with 254,744 new cases in women each year [1], many of whom undergo mastectomies as a result. Currently, the most common method of breast reconstruction is implants. Many plastic surgeons use Acellular Dermal Matrices (ADM) during implant-based breast reconstruction. This allows for the stabilization and definition of the borders of the breast implant under the pectoralis major. Its use has also allowed for direct implant and nipple-sparing mastectomies with reconstruction. More recently, the use of ADMs has transformed the dominant breast reconstruction technique from subpectoral to prepectoral [2], providing patients with better post-operative pain control, lower analgesic requirements, and less animation deformity.
The most common ADM is Alloderm (LifeCell Corp., Branchburg, N.J.), which is derived from human cadaveric dermis. Many studies have examined the complications and the benefits of Alloderm use in breast reconstruction. Fewer studies have looked at the other ADMs and even fewer have compared different ADMs. We wanted to compare the outcomes of Alloderm with Surgimend, especially given the price difference between the two ADMs (Surgimend $22/cm2 vs. Alloderm $30/cm2) [3].
Given the increasing trend towards prepectoral breast reconstruction, our study attempts to retrospectively examine and compare the outcomes and complications of Alloderm and Surgimend in prepectoral breast reconstruction from a single surgeon who transitioned from Alloderm to Surgimend. Factors compared included infection, seroma/hematoma, nipple or skin necrosis, and any other post-operative complications.
Methods:
Electronic medical records of patients aged 18–85 years old who underwent unilateral or bilateral, immediate prepectoral implant-based breast reconstruction from June 2020 through July 2022 at our institution were retrospectively reviewed. Patients with subpectoral implant placement, delayed reconstruction, or patients who had their reconstruction done by another surgeon were excluded from the study. Data on patient demographics such as age, BMI, comorbidities, and substance use were recorded. The study also noted whether patients received pre- or postoperative chemotherapy or radiotherapy. Postoperative complications consisted of seroma, hematoma, infection, skin/nipple necrosis, capsular contracture, infection, and implant failure. Infection was divided into minor and major infection, in which major infections resulted in hospitalization or explantation. T-test and Chi-square test of independence were used to determine significance.
Results:
A total of 131 reconstructions (75 patients) were included (44.27% Alloderm and 55.73% Surgimend). Characteristics of both groups were similar, though patients in the Alloderm group were more likely to have hyperlipidemia (22.41% Alloderm vs. 8.22% Surgimend, p=0.022). For Alloderm vs. Surgimend, the rate of hematoma (3.45% vs. 2.74%, p=0.81), seroma (15.52% vs. 26.03%, p=0.14), skin/nipple necrosis (6.90% vs. 12.33%, p=0.30), explantation (18.97% vs. 15.07%, p=0.55), infection (18.97% vs. 15.07%, p=0.55), capsular contracture (6.90% vs. 4.11%, p=0.43), and failed reconstruction (6.90% vs. 4.11%, p=0.48) were not statistically significant.
Conclusions:
Our study found that in prepectoral implant-based reconstruction, there are no differences in surgical complications between Alloderm and Surgimend, demonstrating that the outcomes associated with the use of Surgimend is equivalent to the use of Alloderm in pre-pectoral immediate breast implant-based reconstruction.
References
1. U.S. Cancer Statistics Working Group. U.S. Cancer Statistics Data Visualizations Tool, based on 2020 submission data (1999-2018): U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; www.cdc.gov/cancer/dataviz, released in June 2021.
2. Gui GaT, F. J. . 'Meshed Enhanced Hammock' or 'Tent': A New Patient Centred Pre-Pectoral One-Stage Immediate Breast Reconstruction Technique for Varying Ptosis. Annals of Plastic and Reconstructive Surgery. 2019;3(1):4.
3. Butterfield JL. 440 Consecutive immediate, implant-based, single-surgeon breast reconstructions in 281 patients: a comparison of early outcomes and costs between SurgiMend fetal bovine and AlloDerm human cadaveric acellular dermal matrices. Plast Reconstr Surg. 2013;131(5):940-951.
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2:50 PM
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The Korean Breast Implant Registry (K-BIR) : Small but Essential Step for Patient Safety
Background: With the first Korean case of breast implant-associated anaplastic large cell lymphoma(BIA-ALCL) reported in 2019, the Korean Breast Implant Registry(K-BIR) was initiated as a pilot registry in April 2020, a cooperative effort of the Korean Society of Plastic and Reconstructive Surgeons, and the Korean Ministry of Food and Drug Safety. After modification based on feedback from participating surgeons, a trial version was launched in January 2022. This is an analysis of the findings and lessons learned during the 2022 trial K-BIR.
Methods: The pilot K-BIR dataset was modified using the modified Delphi process with the participation of the Korean Academic Association of Aesthetic and Reconstructive Breast Surgery, and implemented into a new electronic data collection form. This included patient data(age, gender, height, weight, chemotherapy, radiotherapy), surgical details(operation date, incision, procedure type, reason for revision, plane, fat graft, simultaneous mastopexy, mastectomy, flap reconstruction, use of synthetic mesh, acellular dermal matrix, drain, antibiotics, funnel, nipple shield, irrigation of pocket, change of surgical gloves), and implant characteristics(typed in or scanned via barcode). The data collection system was linked with a digital implant catalogue that enabled the barcode to automatically fill in the implant characteristics. The trial K-BIR was initiated in January, 2022, opened to 21 experienced breast plastic surgeons. As an opt-in registry, the surgeon was required to receive informed consent regarding collection of personal data.
Results: From January to November, 2022, a total of 1,059 data collection forms (966 individual patients, 1,470 breasts) were registered in the K-BIR. The mean age of the patients was 44.95 years. 32%(339 cases) of the 1,059 cases were aesthetic, and 68%(720 cases) were reconstructive. 90.3%(956) were primary cases, and 9.6%(103) were revision operations. 10.3% were revisions of aesthetic, and 9.4% were revisions of reconstructive procedures. 92.2% of the registered implants had a smooth surface, 7.8% surface of unknown properties.
Revision procedures were performed due to complications in 62.1% of cases, pure patient demand in 26.2%, and both combined in 8.7%. Aesthetic revisions were due to complications in 57.1%, purely patient demands in 40%, and combined in 2.9%, whereas reconstructive revisions were 64.7%, 19.1%, and 11.8%, respectively. The most common complication in aesthetic procedures was implant rupture(30.2%), and capsular contracture(39.7%) in reconstructive procedures.
Feedback from participating surgeons revealed that the smaller dataset, digital interface and digital implant catalogue was time-saving, but the process of explaining the whole concept, and receiving patient consent was the largest burden.
Conclusions: The K-BIR is the first nationwide registry for specific medical devices in Korea, and the first BIR initiated in Asia. However, the trial run has augmented the limitations exposed during the pilot registry. Considering the annual estimate of breast augmentation procedures is over 50,000 nationally, a trial run open to all surgeons is necessary to assess the actual capture rate. The legislative background for an opt-out registry, a confidential personal data protection system, incentives for participation, and permanent maintenance personnel with stable funding are goals that must be achieved for the K-BIR to become a consistent, high-quality registry.
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2:55 PM
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Staging Wise Pattern Oncoplastic Reduction / Mastopexy Provides Superior Control of the Skin Pocket Compared to Vertical Pattern Prior to Nipple Sparing Mastectomy
Introduction: Nipple sparing mastectomy (NSM) is an oncologically safe procedure that compared to skin sparing techniques can enhance the reconstructive patient's body image and health-related quality of life. However, for patients who present with large, ptotic breasts, control of the nipple position and skin envelope is unpredictable. Mastopexy and reduction mammoplasty techniques have long been a powerful tool to preserve perfusion of the nipple whilst achieving satisfactory NAC position over a lifted or reduced breast. Oncoplastic reduction/mastopexy performed prior to NSM has the potential to increase control of the skin envelope, nipple position, and reduce complications for patients with significant macromastia or ptosis. There is limited insight into the advantages of one technique over another in the reconstructive patient. To discern whether Wise or vertical pattern reduction/mastopexy provides superior control over the mastectomy skin, we examined the rate of revision of patients treated with these techniques prior to undergoing NSM with more than 4 years of follow up.
Methods: An IRB approved retrospective review was performed on all patients who underwent staged reduction/mastopexy prior to NSM and reconstruction from 2013-2023 at a single institution by two surgeons. Patients were queried for demographic factors, operative factors, outcomes, and revisions, specifically to that of the skin envelope.
Results: 67 patients (123 breasts) underwent reduction/mastopexy with an average of 4.25±0.8 years of follow up. Wise pattern (N=34) and vertical pattern (N=33) patients were well matched by demographic factors, however, the average BMI of all patients was 31±6. Both groups presented with similar grades of ptosis and asymmetry, but Wise pattern patients had higher rates of symptomatic macromastia (23 (68%) vs. 12 (36%), p=0.01). Indication did not differ significantly between either group. Superior/superiomedial dermoglandular pedicles were consistently used in both cohorts (32 (97%) vs. 28 (82%), p=0.10). Cohorts were well matched by treatment factors including lymphatic surgeries, radiation, and reconstructive plane with most undergoing prosthetic prepectoral reconstruction (18 (55%) vs. 18 (53%), p=1). Time between stages was also similar (83±59 vs. 79±61 days, p=0.84). The overall complication rate of 37% (13 (39%) vs. 12 (35%), p=0.79) did not differ significantly by staging pattern. Most complications were minor with delayed wound healing (4 (12%) vs. 4 (12%), p=1) occurring most frequently. There were no instances of complete nipple loss or reconstructive failure. Vertical staging pattern was correlated with an overall higher revision rate to the skin pocket (7 (21%) vs. 22 (67%), p<0.05); in particular, correction of relative pseudoptosis with excision of excess inferior pole skin (2 (6%) vs. 16 (48%), p<0.05). Nipple malposition was not common in either group, but statistically higher among the vertical cohort (1 (3%) vs. 4 (12%), p=0.04).
Conclusions: When performed prior to NSM, Wise pattern reduction/mastopexy techniques afford the surgeon superior control of the mastectomy skin with an acceptable risk profile. While vertical staging patterns may be favored by patients that desire a lower scar burden, over the long term they are associated with significantly more revisions in the reconstructive context.
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3:00 PM
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A Paired Analysis of Outcomes in Therapeutic versus Prophylactic Breasts Following Bilateral Mastectomy with Deep Inferior Epigastric Perforator (DIEP) Flap Reconstruction
Background: There is an increasing trend in patients electing for bilateral mastectomy when diagnosed with unilateral breast cancer.1 Although there is no increase in patient survival, women often are still satisfied with their decision to undergo contralateral prophylactic mastectomy. Patients that elect for contralateral prophylactic mastectomy and the incidence of breast reconstruction are closely related. Earlier literature investigating the complications of prophylactic contralateral mastectomy with reconstruction has been contradictory and focused mainly on implant-based reconstruction.2,3 Patients with unilateral cancer that undergo bilateral mastectomy with autologous reconstruction deserve clearer answers about reconstructive outcomes that are not convoluted with implant-based results. The purpose of our study is to compare outcomes in the therapeutic versus prophylactic breast following bilateral mastectomy with DIEP flap reconstruction.
Methods: A single-institution retrospective review was conducted of women undergoing autologous breast reconstruction following bilateral mastectomy for treatment of a unilateral breast cancer between January 2019 and March 2022. Patient demographics, medical history, and postoperative complications were collected. 263 patients (526 breasts) met inclusion criteria. A paired analysis was performed using repeated measures logistic regression.
Results: 263 patients with unilateral breast cancer underwent bilateral mastectomy with DIEP flap reconstruction. 55.1% of patients underwent radiation, 54.8% of patients received chemotherapy and 80.6% of patients had delayed reconstruction. 33% of patients had surgical complications and 19.8% of patients developed complications on the prophylactic side. Paired analysis comparing reconstruction of the therapeutic versus prophylactic mastectomy side revealed no difference in overall complications (p=0.68); however, when stratified by type of complication, the therapeutic side experienced a higher rate of fat necrosis (p= .0463). Mean follow up was 311.9 days.
Conclusion: This is the largest paired analysis of surgical outcomes between therapeutic and prophylactic breasts following bilateral autologous DIEP flap reconstruction. Patients may often assume that the prophylactic side will have less reconstructive complications than the therapeutic side; however, our analysis shows similar rates of overall complications. Patients should be counseled of the risk associated with reconstruction on the prophylactic side, with nearly 1 in 5 patients experiencing a complication. Our study additionally found a higher incidence of fat necrosis in the therapeutic mastectomy reconstruction. This may lead to increased medical interventions and anxiety for a patient during breast cancer surveillance. Our study provides clarity on reconstructive outcomes for patients with unilateral breast cancer undergoing bilateral mastectomy with autologous reconstruction.
1. Panchal H, Matros E. Current Trends in Postmastectomy Breast Reconstruction. Plast Reconstr Surg. 2017;140:7S-13S. doi:10.1097/PRS.0000000000003941
2. Crosby MA, Garvey PB, Selber JC, et al. Reconstructive Outcomes in Patients Undergoing Contralateral Prophylactic Mastectomy. Plast Reconstr Surg. 2011;128(5):1025-1033. doi:10.1097/PRS.0b013e31822b6682
3. Nealon KP, Sobti N, Gadd M, Specht M, Liao EC. Assessing the additional surgical risk of contralateral prophylactic mastectomy and immediate breast implant reconstruction. Breast Cancer Res Treat. 2020;179(2):255-265. doi:10.1007/s10549-019-05460-0
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3:05 PM
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A National Claims Database Case-Matched Cohort Comparison of Breast Implant Illness Symptoms in Women With and Without Breast Implants
Purpose: Patients and physicians describe a variety of systemic symptoms that may be reported by women with breast implants as breast implant illness (BII). Currently BII does not have an international classification of diseases designation to aid in recording and analysis of patient outcomes for these non-specific symptoms. The Food and Drug Administration's review of the medical device report (MDR) database yielded 7,467 cases of women with breast implants reporting systemic symptoms (August, 2022). There were ten symptom types that were found in the majority of these cases including fatigue, joint pain, brain fog, anxiety, hair loss, depression, autoimmune diseases, rash, headache and inflammation with 40% of these patients reporting device explantation after experiencing these symptoms. We performed a national insurance claims database review to determine if women with breast implants were more likely to seek medical care for these symptom categories than women without breast implants.
Methods: A national claims database (Pearldiver) query was performed to define a group of women that had breast implants for augmentation or breast reconstruction after mastectomy from 2010-2022 and an age and Charlson Comorbidity Index (CCI) matched control group without breast implants. The proportion of patients seeking medical care for the symptoms listed above were recorded for each cohort and subsequent analysis on any relationship of age, geographic region and medical comorbidities on symptom reporting was analyzed as well as the proportion of patients explanted during the study time period.
Results: 36,680 women with breast implants were identified with 5,757 after augmentation, 21,272 direct to implant at the time of mastectomy and 14,261 staged expander to breast implant reconstruction. 102,934 case-matched women were identified without breast implants. 59.9% of women with breast implants reported one of the listed symptoms compared to 50.1% of women without breast implants (p<0.001) with significantly more women with implants carrying diagnoses for fatigue, joint pain, anxiety, hair loss and rash than those without (p<0.001). Depression and brain fog were more commonly reported by patients without breast implants (p<0.001) (Table 1). 18,959 or 24.5% of patients with breast implants reporting any symptoms underwent explantation during the study period. Logistic regression demonstrated having breast implants increased the likelihood of carrying a diagnosis for any of these symptoms (OR 1.49 CI 1.46-1.53) and patients carrying a diagnosis of anxiety (OR 1.09 CI 1.04-1.114), hair loss (OR 1.16 CI 1.03-1.29) or depression (OR 1.12 CI 1.06-1.19) were significantly more likely to undergo explantation while patients with a diagnosis of fatigue were less likely (OR 0.93 CI 0.88-0.97) while other symptoms did not contribute to explant.
Summary: Women with breast implants were more likely to carry medical diagnoses for systemic symptoms identified by the MDR in the majority of cases of BII when compared to age and CII-matched controls without implants. Patients with diagnoses of anxiety, depression or hair loss were more likely to undergo explantation within this cohort. Multi-center studies are required to understand the associations between non-specific medical diagnoses and having breast implants.
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3:10 PM
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Evaluating the Association Between Flap Monitoring and DIEP Flap Outcomes in Postmastectomy Patients at Mayo Clinic, Florida
Introduction: The use of the deep inferior epigastric artery perforator (DIEP) flap is the current gold standard for autologous breast reconstruction. Clinical flap monitoring is the most cost-effective method for postsurgical monitoring, yet the evidence is still needed to recommend it. Routine doppler assessments can aid in detecting vascular compromise, but their utility has remained controversial. Despite the evolution and improvement of free flap procedures to achieve high success rates, the necessity of flap monitoring has yet to be widely studied. This study analyzes the association between postoperative flap monitoring and reconstructive DIEP flap outcomes in patients who underwent a mastectomy at Mayo Clinic, Florida.
Methods: Using the EPIC system, we conducted a chart review of patients who underwent unilateral or bilateral DIEP flap procedures between July 2018 and November 2022. Patients who underwent bilateral DIEP flap reconstruction were counted as separate cases per side. We collected patient demographics (age, BMI, smoking status, significant past medical history), diagnosis at admission, surgical interventions, postoperative adverse events, length of stay, and monitoring device use (pencil doppler, Vioptix, and implantable Cook-Swartz Doppler) and flap survival at discharge. We used a statistical analysis tool (Rstudio v2022.12.0+353) to perform a chi-square on the categorical variables of interest; furthermore, we adjusted the p-value using FDR.
Results: A total of 167 DIEP flaps were assessed in our study, of which 48.5% were monitored clinically and 51.5% were monitored using a device. The mean age of participants was 53.7 (SD 10.2), 82.0% were white, 81.4% were "not Hispanic or Latino," 53.3% were obese (BMI ≥ 30), 7.8% were diabetic, and 68.3% had never smoked. The mean length of stay was 3.84 (SD 1.27), with 81.4% of patients having a length of stay lower than 4 days; moreover, the mean number of comorbidities was 1.65 (SD 1.51). Skin-sparing mastectomies preceded 68.3% of the DIEP flaps, and 68.3% were immediate reconstructions. The mean number of perforator arteries used in each DIEP flap was 2.03 (SD 0.83), and the mean flap weight was 738 (SD 200). In addition, 7.8% of the flaps had at least 1 postoperative complication during hospitalization, including drain obstruction, hematoma, seroma, and venous and arterial obstruction; moreover, 99.4% of flaps survived at discharge. Ninety-six (57.5%) of the procedure were non-buried, and 71 (42.5%) were buried. The pencil doppler was the most common flap monitoring tool, used in 67 cases (77.9%). The flaps were clinically monitored in 86.4% of the buried procedures and 13.6% of the non-buried procedures. There was no statistically significant association between the use of devices for flap monitoring and flap survival (p = 0.99) or the need for surgical re-exploration during hospitalization (p = 0.99).
Conclusion: Our data indicate no association between the use of devices for flap monitoring and DIEP flap survival in postmastectomy patients. A cost/analysis is deemed necessary to determine the economic impact of using devices to monitor DIEP flaps.
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Francisco Avila, MD
Abstract Co-Author
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Sahar Borna, MD
Abstract Co-Author
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Gioacchino De Sario Velasquez, MD
Abstract Presenter
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Antonio Forte, MD, PhD, MS
Abstract Co-Author
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John Garcia, MD
Abstract Co-Author
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Olivia Ho, MD MMSc MPH FRCSC FACS
Abstract Co-Author
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Karla Maita, MD
Abstract Co-Author
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Brian Rinker, MD
Abstract Co-Author
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Ricardo Torres-Guzman, MD
Abstract Co-Author
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3:15 PM
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Temporal Trends in Free Flap Breast Reconstruction from 2005 to 2020, a Longitudinal ACS-NSQIP Study of 11,500 Cases
Purpose
Free flap breast reconstruction (FFBR) is an established option in the armamentarium of reconstructive microsurgeons. Over the years, improving patient optimization has been an important focus in the attempt to create better outcomes. However, actual trends in FFBR patient demographics, comorbidities, and outcomes over time, has not been well described. Therefore, the purpose of this study is to investigate these temporal trends in demographics, comorbidities, and short-term outcomes of patients undergoing FFBR, in order to determine how the typical FFBR patient and their outcomes have evolved.
Methods
The 2005-2020 American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database was queried for all cases of FFBR using Current Procedural Terminology (CPT) code 19364. Data was stratified by year, with 2005-2012 being grouped together to maintain adequate sample size. Data regarding patient demographics, medical comorbidities, and episode of care characteristics including length of stay, operative time, and 30-day readmission were recorded. Chi-square tests and analysis of variance were used to identify any significant difference in variables over time.
Results
Overall, 11,500 cases met inclusion criteria. From 2005-2012 (n=408) to 2020 (n=1,707), ranges for average age were (50.1-51.0) and average BMI were (29.4-29.9). Clinically significant changes were seen in functional status (2012: 95.6%, 2020: 99.8%, p <0.05), smoking status (2012: 7.6%, 2020 5%, p <0.05) and hospital length of stay (2012: 5.5 days, 2020: 3.6 days, p <0.05). There was not a clinically significant change in age, BMI, BMI >40, and other medical comorbidities. Across 2005-2020, most comorbid conditions only affected a very minor (<1-2%) of cases for that year. The vast majority (>99%) of cases were discharged home with a low (<7.0%) rate of readmission.
Conclusions
Contemporary FFBR remains a safe and viable reconstructive option. Although it was expected that improving approaches to preoperative patient optimization would have yielded more significant differences in rates of objective patient health measures over time, this was not completely observed. However, the downward trend of current smoking status is of relevance given the known detrimental effects on surgical outcomes. In general, the average patient undergoing FFBR is healthy and is likely to have an acceptable short-term outcome, with a shorter total hospital length of stay compared to prior. Therefore, more focused studies examining patient temporal trends within certain races, age groups, or from breast cancer programs offering high-risk management may yield more significant differences. Overall, FFBR in a healthy patient remains an excellent reconstructive choice for women battling breast cancer.
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3:20 PM
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Breast Session 8 - Discussion 2
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