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Inflammatory breast cancer (IBC) exhibits dermal lymphatic involvement at presentation, and thus, the standard surgical approach is a nonskin-sparing modified radical mastectomy (MRM) without breast reconstruction (BR). In this study, we evaluated immediate and delayed BR receipt and its outcomes in IBC. Using an IRB-approved database, we retrospectively evaluated stage III IBC patients who received trimodality therapy (preoperative systemic therapy, followed by MRM and postmastectomy chest wall/regional nodal radiation). Patients with an insufficient response to preoperative systemic therapy and/or who required preoperative radiotherapy were excluded. BR receipt, timing, and morbidity were evaluated. Among 240 stage III IBC patients diagnosed between 1997 and 2016, 40 (17%) underwent BR. Thirteen (33%) had immediate, and 27 (67%) had delayed BR. Four patients had complications (1 [8%] immediate BR and 3 [11%] delayed BR); only 1 BR (delayed) was unsuccessful. From the MRM date, the median time to recurrence was 35 months (<1-212) and median overall survival was 87 months (<1-212). In this cohort of stage III IBC patients, only 11% pursued delayed BR following trimodality therapy, possibly attributable to the observed high recurrence rates hindering BR. Further studies addressing BR outcomes in IBC are needed for better counseling patients regarding their reconstructive options.
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Neoplasias de la Mama , Neoplasias Inflamatorias de la Mama , Mamoplastia , Neoplasias de la Mama/cirugía , Femenino , Humanos , Neoplasias Inflamatorias de la Mama/cirugía , Mastectomía , Recurrencia Local de Neoplasia , Estudios RetrospectivosRESUMEN
PURPOSE: External beam radiation in the mantle field has been a mainstay of therapy for Hodgkin's lymphoma for decades. The incidence of breast cancer in patients treated with mantle radiation is known to be elevated. Few studies have examined outcomes of breast reconstruction in this high-risk group. The current study presents the largest series of immediate breast reconstruction in this population and aims to evaluate reconstructive outcomes and examine differences between implant-based and autologous reconstructions. METHODS: A retrospective review of records from a 10-year period at 2 institutions was undertaken. Patients treated with mantle radiation for Hodgkin's lymphoma who subsequently underwent mastectomy with immediate reconstruction were identified. Patient demographics, clinical characteristics, and outcomes including complications and operative revisions were gathered. Univariate and multivariate analyses were conducted to assess differences between implant-based and autologous reconstructions. RESULTS: A total of 97 breast reconstructions were performed in 52 patients. Seventy-nine reconstructions were implant-based, and 18 were autologous. Patients with implant-based reconstructions were older than autologous reconstructions (47 ± 8.8 years vs 42 ± 6.5 years, P < 0.05). Both groups had long-term follow-up; however, the mean follow-up duration was shorter in the implant-based compared with the autologous group (5 years vs 8.3 years; P < 0.05). Otherwise, the groups were similar with respect to BMI, medical comorbidities, oncologic diagnosis, and therapy. The interval between mantle radiation and reconstruction was comparable for implant-based and autologous groups (23.4 ± 9 years vs 21.3 ± 6.1 years, P = 0.6). The overall complication rate of breast reconstruction was not statistically different between the implant-based and autologous groups (35% vs 16%, P = 0.16). Three implant-based reconstructions (3.7%) required explantation. There were no complete flap losses in the autologous group. An associated 6-fold higher rate of unplanned revisions was observed with the autologous reconstruction group compared with the implant-based reconstruction group (odds ratio, 6.09; 95% confidence interval, 1.14-32.48; P = 0.035). CONCLUSIONS: In this study, long-term follow-up suggests immediate breast reconstruction in patients with prior mantle radiation can be achieved safely with an acceptable complication profile utilizing either implant-based or autologous techniques. Autologous breast reconstruction is linked with a higher rate of revisions compared with implant-based breast reconstruction in this study population.
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Implantes de Mama , Neoplasias de la Mama , Enfermedad de Hodgkin , Mamoplastia , Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Enfermedad de Hodgkin/radioterapia , Enfermedad de Hodgkin/cirugía , Humanos , Mastectomía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: The purpose of this study was to explore national patterns in the uptake of breast reconstruction and nipple-sparing mastectomy (NSM). METHODS: We used the National Cancer Database to identify all women who underwent mastectomy for stage 0-III breast cancer between 2005-2015. Multivariable logistic regression was used to determine factors associated with receipt of reconstruction, with subset analyses performed to determine trends and predictors of NSM in those who underwent mastectomy with reconstruction. RESULTS: Our cohort consisted of 395,815 women, 238,568 (60.3%) who underwent mastectomy alone and 157,247 (39.7%) who underwent mastectomy followed by reconstruction. The use of breast reconstruction increased from 22.3% of mastectomy cases in 2005 to 49.7% of mastectomy cases in 2015 (odds ratio [OR] 9.7, 95% confidence interval [CI] 7.3-12.8). Among those receiving reconstruction, the use of NSM increased from 1.7% in 2005 to 14.3% in 2015 (OR 9.4, 95% CI 7.1-12.5), with increased utilization among those with early-stage and locally advanced disease, such that by 2015, NSM was performed in 15.3% of mastectomies with reconstruction for DCIS, 14.3% of mastectomies with reconstruction for stage I-II breast cancer, and 10.7% of mastectomies with reconstruction for stage III breast cancer. Factors strongly predicting receipt of NSM included age < 45 years, smaller clinical tumor size, clinically node negative disease, use of neoadjuvant therapy, and facility type. CONCLUSIONS: There has been a dramatic increase in the use of breast reconstruction and NSM between 2005-2015. Further prospective studies evaluating oncologic outcomes of NSM in locally advanced breast cancer are warranted.
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Neoplasias de la Mama/cirugía , Carcinoma Ductal de Mama/cirugía , Carcinoma Lobular/cirugía , Mamoplastia/tendencias , Mastectomía/tendencias , Pezones/cirugía , Tratamientos Conservadores del Órgano/tendencias , Anciano , Neoplasias de la Mama/patología , Carcinoma Ductal de Mama/patología , Carcinoma Lobular/patología , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Invasividad Neoplásica , PronósticoRESUMEN
BACKGROUND: Bilateral breast reconstruction in the setting of unilateral postmastectomy radiation therapy (PMRT) remains one of the most difficult reconstructive challenges due to significant radiation-induced asymmetry from capsular contracture and superior migration of the irradiated reconstructed breast. We describe a novel and straightforward intraoperative technique for creating compensatory asymmetry to maximize postradiation symmetry in immediate bilateral tissue expander (TE) and acellular dermal matrix (ADM) reconstruction requiring unilateral PMRT. METHODS: A cohort of 25 bilateral TE/ADM breast reconstructions with planned unilateral PMRT was performed using this approach, and outcomes were reviewed. On the PMRT side, the ADM edge was inset to a lower inframammary fold (IMF) position resulting in a near "bottoming-out" effect. On the non-PMRT side, the ADM was inset using a triple point stitch onto the IMF in a higher chest wall location. The planned PMRT side TE was overexpanded and second-stage exchanges were performed 6+ months post-PMRT. RESULTS: Post-PMRT results showed improved symmetry as the PMRT side migrated superiorly to match the contralateral non-irradiated side. Minimal pocket or IMF adjustments were required during second-stage procedures, with just 6 patients (24%) requiring minor lowering and 1 patient (4%) requiring elevation of the PMRT side IMF. Thus, most (72%) patients undergoing bilateral mastectomy and unilateral PMRT did not require any IMF modifications during the second-stage procedure. CONCLUSIONS: A differential ADM inset and TE pocket creation for bilateral TE/ADM breast reconstructions with planned unilateral PMRT can minimize the typical adverse aesthetic effects of PMRT on reconstruction results and maximize symmetry.
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Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Estética , Mamoplastia/métodos , Mastectomía/métodos , Cicatrización de Heridas/fisiología , Adulto , Implantes de Mama , Neoplasias de la Mama/patología , Estudios de Cohortes , Femenino , Humanos , Persona de Mediana Edad , Radioterapia Adyuvante , Estudios Retrospectivos , Medición de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Surgical management of breast cancer in pregnancy (BCP) requires balancing benefits of therapy with potential risks to the developing fetus. Minimal data describe outcomes after mastectomy with immediate breast reconstruction (IR) in pregnant patients. METHODS: Retrospective review was performed of patients who underwent IR after mastectomy within a BCP cohort. Parameters included intra- and post-operative complications, short-term maternal/fetal outcomes, surgery duration, and delayed reconstruction in non-IR cohort. RESULTS: Of 82 patients with BCP, 29 (35%) had mastectomy during pregnancy: 10 (34%) had IR, 19(66%) did not. All IR utilized tissue expander (TE) placement. Mean gestational age (GA) at IR was 16.2 weeks. Mean surgery duration was 198 min with IR versus 157 min without IR. Those with IR delivered at, or close to, term infants of normal birthweight. No fetal or major obstetrical complications were seen. Post-mastectomy radiation (PMRT) was provided after pregnancy in 2 (20%) patients in the IR cohort and 12 (63%) in the non-IR cohort. All patients in the IR cohort successfully transitioned to permanent implant. CONCLUSIONS: This report represents one of the largest series describing IR during BCP. IR after mastectomy increased surgery duration, but was not associated with adverse obstetrical or fetal outcomes. IR with TE may preserve reconstructive options when PMRT is indicated. J. Surg. Oncol. 2016;114:140-143. © 2016 Wiley Periodicals, Inc.
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Neoplasias de la Mama/cirugía , Mamoplastia , Mastectomía , Complicaciones Neoplásicas del Embarazo/cirugía , Adulto , Implantes de Mama , Neoplasias de la Mama/radioterapia , Estudios de Cohortes , Femenino , Edad Gestacional , Humanos , Complicaciones Posoperatorias , Embarazo , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Unlike conventional reconstruction, facial transplantation seeks to correct severe deformities in a single operation. We report on three patients who received full-face transplants at our institution in 2011 in operations that aimed for functional restoration by coaptation of all main available motor and sensory nerves. We enumerate the technical challenges and postoperative complications and their management, including single episodes of acute rejection in two patients. At 6 months of follow-up, all facial allografts were surviving, facial appearance and function were improved, and glucocorticoids were successfully withdrawn in all patients.
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Traumatismos Faciales/cirugía , Trasplante Facial , Procedimientos de Cirugía Plástica , Adulto , Transfusión de Eritrocitos , Trasplante Facial/métodos , Femenino , Estudios de Seguimiento , Rechazo de Injerto , Humanos , Masculino , Persona de Mediana Edad , Procedimientos de Cirugía Plástica/métodos , Infección de la Herida Quirúrgica , Trasplante HomólogoRESUMEN
BACKGROUND: Prosthetic reconstruction of the breast, as a 2-staged procedure using tissue expanders followed by placement of permanent implants, offers favorable aesthetic results with minimal additional surgical intervention. However, the current outpatient process to fill saline expanders can be lengthy and onerous, involving months of office visits and discomfort from the bolus saline expansions. We present a new technology (AeroForm Tissue Expansion System), which has the potential to improve the process of breast tissue expansion by providing a method for low-volume incremental filling, eliminating the need for injections and directly involving the patient by allowing her some control over the expansion process. METHODS: The described study is a 2:1 randomized controlled trial of the investigational CO2 expansion system and saline expanders. Of the 82 women receiving expanders, 58 (39 bilateral and 19 unilateral; bilateral rate, 67%) were implanted with CO2 tissue expanders and 24 subjects (15 bilateral and 9 unilateral; bilateral rate, 63%) were implanted with saline expanders. RESULTS: Preliminary validated expansion results were available for 55 women. Available mean time for active expansion in the CO2 group was 18.2 (9.2) days (median, 14.0; range, 5-39; number of expanders, 53), which was less than the mean time for active expansion in the saline group: 57.4 (33.6) days (median, 55; range, 5-137; number of expanders, 33). Available mean time from implant placement to exchange for a permanent prosthesis in the CO2 group was shorter [106.3 (42.9) days; median, 99; range, 42-237; number of expanders, 53] than for the women in the control group [151.7 (62.6) days; median, 140; range, 69-433; number of expanders, 33]. After 2 events--underexpansion (n=1) and erosion (n=1)--in the CO2 group, the internal membrane was redesigned and the expander bulk was decreased to minimize the risk of underexpansion and erosion in subsequent patients. CONCLUSIONS: Preliminary evidence indicates that the CO2-based tissue expansion system performs the same function as saline expansion devices without significantly altering the risk to the patient and that the device has the potential to make the expansion process faster and more convenient for both the patient and the physician.
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Implantación de Mama/métodos , Dispositivos de Expansión Tisular , Expansión de Tejido/instrumentación , Adolescente , Adulto , Anciano , Implantes de Mama , Dióxido de Carbono , Femenino , Humanos , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Estudios Prospectivos , Cloruro de Sodio , Expansión de Tejido/métodos , Adulto JovenRESUMEN
Background: Nipple-sparing mastectomy (NSM) preserves the natural nipple-areola complex and entire native breast skin, with the goal of better cosmetic outcomes in breast reconstruction. In bilateral TE/implant-based reconstruction requiring unilateral postmastectomy radiotherapy (PMRT), progressive radiation-induced fibrosis can lead to increasing nipple asymmetry with cosmetic dissatisfaction. Thus, PMRT may ultimately negate the intended positive cosmetic value of NSM compared with skin-sparing mastectomy (SSM). This study compares (1) surgical complications, (2) patient satisfaction, and (3) aesthetic outcomes between NSM versus SSM in bilateral implant-based reconstruction with unilateral PMRT. Methods: This retrospective matched cohort study included consecutive NSM patients with bilateral TE/implant breast reconstruction + unilateral PMRT matched 1:2 to SSM group. Patients completed PMRT and TE exchange to implants. Demographics, oncologic stage, comorbidities, and complications were collected. Patient satisfaction was evaluated by BREAST-Q. Aesthetic outcomes were assessed by blinded reviewers with a five-point Likert scale. Results: Among 58 patients who underwent bilateral TE/implant reconstruction with unilateral PMRT, 17 NSM patients were matched to 41 SSM patients by age, body mass index, and comorbidities. No significant differences existed in overall surgical complications and individual BREAST-Q questionnaire scores between cohorts. However, aesthetic outcomes scores were higher in SSM compared with NSM. Conclusions: Although NSM is generally associated with superior cosmetic outcomes compared with SSM, it has far less impact in bilateral implant-based breast reconstruction with unilateral PMRT due to the negative postradiotherapy effect on nipple symmetry.
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Importance: Postmastectomy radiation therapy (PMRT) improves local-regional disease control and patient survival. Hypofractionation (HF) regimens have comparable efficacy and complication rates with improved quality of life compared with conventional fractionation (CF) schedules. However, the use of HF after mastectomy in patients undergoing breast reconstruction has not been prospectively examined. Objective: To compare HF and CF PMRT outcomes after implant-based reconstruction. Design, Setting, and Participants: This randomized clinical trial assessed patients 18 years or older undergoing mastectomy and immediate expander or implant reconstruction for breast cancer (Tis, TX, or T1-3) and unilateral PMRT from March 8, 2018, to November 3, 2021 (median [range] follow-up, 40.4 [15.4-63.0] months), at 16 US cancer centers or hospitals. Analyses were conducted between September and December 2023. Interventions: Patients were randomized 1:1 to HF or CF PMRT. Chest wall doses were 4256 cGy for 16 fractions for HF and 5000 cGy for 25 fractions for CF. Chest wall toxic effects were defined as a grade 3 or higher adverse event. Main Outcomes and Measures: The primary outcome was the change in physical well-being (PWB) domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life assessment tool at 6 months after starting PMRT, controlling for age. Secondary outcomes included toxic effects and cancer recurrence. Results: Of 400 women (201 in the CF arm and 199 in the HF arm; median [range] age, 47 [23-79] years), 330 patients had PWB scores at baseline and at 6 months. There was no difference in the change in PWB between the study arms (estimate, 0.13; 95% CI, -0.86 to 1.11; P = .80), but there was a significant interaction between age group and study arm (P = .03 for interaction). Patients younger than 45 years had higher 6-month absolute PWB scores if treated with HF rather than CF regimens (23.6 [95% CI, 22.7-24.6] vs 22.0 [95% CI, 20.7-23.3]; P = .047) and reported being less bothered by adverse effects (mean [SD], 3.0 [0.9] in the HF arm and 2.6 [1.2] in the CF arm; P = .02) or nausea (mean [SD], 3.8 [0.4] in the HF arm and 3.6 [0.8] in the CF arm; P = .04). In the as-treated cohort, there were 23 distant (11 in the HF arm and 12 in the CF arm) and 2 local-regional (1 in the HF arm and 1 in the CF arm) recurrences. Chest wall toxic effects occurred in 39 patients (20 in the HF arm and 19 in the CF arm) at a median (IQR) of 7.2 (1.8-12.9) months. Fractionation was not associated with chest wall toxic effects on multivariate analysis (HF arm: hazard ratio, 1.02; 95% CI, 0.52-2.00; P = .95). Fewer patients undergoing HF vs CF regimens had a treatment break (5 [2.7%] vs 15 [7.7%]; P = .03) or required unpaid time off from work (17 [8.5%] vs 34 [16.9%]; P = .02). Conclusions and Relevance: In this randomized clinical trial, the HF regimen did not significantly improve change in PWB compared with the CF regimen. These data add to the increasing experience with HF PMRT in patients with implant-based reconstruction. Trial Registration: ClinicalTrials.gov Identifier: NCT03422003.
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BACKGROUND: Acellular dermal matrix (ADM) use in implant-based breast reconstruction has been associated with higher rates of postoperative seroma and infection. This follow-up study was performed to determine whether specific modifications in technique are associated with a reduction in the rate of complications. METHODS: The authors performed a retrospective analysis of immediate ADM-assisted implant-based breast reconstructions performed by the lead author (Y.C.) during an 18-month period after instituting specific modifications to prevent seroma. These included draining both the submastectomy and sub-ADM planes, lowering the threshold for drain removal, and addition of postoperative soft compression dressings and surgical bras. A total of 179 implant-based reconstructions were evaluated for rates of complications, including infection, hematoma, seroma, and skin flap necrosis. These were compared to results of a series of 150 similar procedures performed by the lead author before institution of the procedural modifications described. RESULTS: Seroma rate decreased from 18.6% to 4.7% (P = 0.0022), and major infection rate decreased from 7% to 1.9% (0.0250). CONCLUSIONS: Although implant-based breast reconstruction using ADM has been associated with increased seroma and possible infection rates, the use of specific clinical practices designed to prevent seroma has minimized our rate of these postoperative complications.
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Dermis Acelular , Implantación de Mama/métodos , Mamoplastia/métodos , Seroma/prevención & control , Infección de la Herida Quirúrgica/prevención & control , Expansión de Tejido/métodos , Adulto , Implantación de Mama/efectos adversos , Implantes de Mama/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Mamoplastia/efectos adversos , Persona de Mediana Edad , Cuidados Posoperatorios/métodos , Estudios Retrospectivos , Seroma/etiología , Colgajos Quirúrgicos , Infección de la Herida Quirúrgica/etiología , Resultado del TratamientoRESUMEN
BACKGROUND: This study compares complication rates between transverse rectus abdominis myocutaneous (TRAM) flaps based on previously irradiated versus nonirradiated superior pedicles to assess the impact of prior ipsilateral chest wall radiation on pedicled TRAM flap breast reconstruction. METHODS: A retrospective study of 302 consecutive TRAM flap reconstructions was performed; 76 TRAM flaps based on a previously irradiated superior epigastric pedicle were compared to 226 TRAM flaps based on a nonirradiated pedicle in medical comorbidities, oncologic data, and complications. RESULTS: Patients having undergone previous chest wall irradiation had a higher cancer stage, but demographic data were otherwise similar within the groups. Previous chest wall irradiation did not result in increased rate of flap loss, infection, and fat necrosis. However, there was a trend toward higher revision rate in the previously irradiated TRAM group. CONCLUSIONS: Previous radiation to the superior epigastric pedicle is not associated with a significant increase in flap complications and should be considered a viable modality for pedicled TRAM flap breast reconstruction.
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Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Mamoplastia/métodos , Colgajos Quirúrgicos , Pared Torácica/diagnóstico por imagen , Adulto , Necrosis Grasa/epidemiología , Femenino , Humanos , Persona de Mediana Edad , Radiografía , Reoperación , Estudios RetrospectivosRESUMEN
BACKGROUND: With advances in oncologic treatment, cosmesis after mastectomy has assumed a pivotal role in patient and provider decision making. Multiple studies have confirmed the safety of both chemotherapy before breast surgery and immediate reconstruction. Little has been written about the effect of neoadjuvant chemotherapy on decisions about reconstruction. METHODS: The authors identified 665 patients with stage I through III breast cancer who received chemotherapy and underwent mastectomy at Dana-Farber/Brigham & Women's Cancer Center from 1997 to 2007. By using multivariate logistic regression, reconstruction rates were compared between patients who received neoadjuvant chemotherapy (n = 180) and patients who underwent mastectomy before chemotherapy (n = 485). The rate of postoperative complications after mastectomy was determined for patients who received neoadjuvant chemotherapy compared with those who did not. RESULTS: Reconstruction was performed immediately in 44% of patients who did not receive neoadjuvant chemotherapy but in only 23% of those who did. Twenty-one percent of neoadjuvant chemotherapy recipients and 14% of adjuvant-only chemotherapy recipients underwent delayed reconstruction. After controlling for age, receipt of radiotherapy, and disease stage, neoadjuvant recipients were less likely to undergo immediate reconstruction (odds ratio [OR], 0.57; 95% confidence interval [CI], 0.37, 0.87) but were no more likely to undergo delayed reconstruction (OR, 1.29; 95% CI, 0.75, 2.20). Surgical complications occurred in 30% of neoadjuvant chemotherapy recipients and in 31% of adjuvant chemotherapy recipients. CONCLUSIONS: The current results suggest that patients who receive neoadjuvant chemotherapy are less likely to undergo immediate reconstruction and are no more likely to undergo delayed reconstruction than patients who undergo surgery before they receive chemotherapy.
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Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/cirugía , Mamoplastia , Terapia Neoadyuvante , Adulto , Anciano , Anciano de 80 o más Años , Antineoplásicos/uso terapéutico , Neoplasias de la Mama/patología , Quimioterapia Adyuvante , Femenino , Humanos , Mamoplastia/efectos adversos , Mastectomía , Persona de Mediana Edad , Estadificación de Neoplasias , Complicaciones Posoperatorias , Resultado del TratamientoRESUMEN
BACKGROUND: Implant-based breast reconstruction accounts for the vast majority of breast reconstruction procedures and is commonly performed with human acellular dermal matrix. There is no consensus as to the optimal human acellular dermal matrix preparation, and high-quality evidence concerning comparative effectiveness is lacking. This study is the first prospective, multicenter, randomized controlled clinical trial to compare human acellular dermal matrix-related complications of the two most commonly used human acellular dermal matrices in implant-based breast reconstruction. The authors hypothesize that there will be no difference in infection, seroma, and reconstructive failure between FlexHD Pliable and AlloDerm RTU. METHODS: The authors conducted a Level 1 prospective, randomized, controlled, multicenter clinical trial to assess complications associated with the use of two human acellular dermal matrices in immediate postmastectomy implant-based breast reconstruction across seven clinical sites. Group A patients received FlexHD Pliable (113 patients with 187 breast reconstructions), and group B patients received AlloDerm RTU (117 patients with 197 breast reconstructions). RESULTS: There was no significant difference with respect to patient demographics, indications, comorbidities, and reconstruction approach between groups. Mean follow-up time was 10.7 ± 3.2 months. There was no statistical difference in the overall matrix-related complications between groups A and B (4.3 percent versus 7.1 percent, p = 0.233). Obesity (OR, 1.14; 95 percent CI, 1.05 to 1.24; p = 0.001) and prepectoral placement of matrix (OR, 4.53; 95 percent CI, 1.82 to 11.3; p = 0.001) were independently associated with greater risks of overall matrix-related complications. CONCLUSION: This work supports the use of human acellular dermal matrices in implant-based breast reconstruction and demonstrates no significant difference in matrix-related complication rates between FlexHD Pliable and AlloDerm RTU. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
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Dermis Acelular/efectos adversos , Implantación de Mama/efectos adversos , Complicaciones Posoperatorias/epidemiología , Expansión de Tejido/efectos adversos , Adulto , Implantación de Mama/instrumentación , Implantación de Mama/métodos , Implantes de Mama/efectos adversos , Neoplasias de la Mama/cirugía , Colágeno/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Mastectomía/efectos adversos , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Expansión de Tejido/métodos , Resultado del TratamientoRESUMEN
INTRODUCTION: The emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients' own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions. METHODS AND ANALYSIS: International, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm). ETHICS AND DISSEMINATION: This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator's site by the Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' (2020-00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles. TRIAL REGISTRATION NUMBER: NCT04293146.
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Implantación de Mama , Implantes de Mama , Neoplasias de la Mama , Mamoplastia , Neoplasias de la Mama/cirugía , Femenino , Humanos , Mastectomía , Pezones/cirugíaRESUMEN
Galactorrhea and galactocele formation are rare complications of augmentation mammoplasty. A number of case reports have been published in the literature; however, the etiology remains unclear. A case is presented of a unilateral galactocele associated with transient hyperprolactinemia after augmentation mammoplasty.
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Quiste Mamario/etiología , Implantación de Mama/efectos adversos , Hiperprolactinemia/etiología , Leche Humana , Adulto , Femenino , HumanosRESUMEN
BACKGROUND: In choosing between implant-based and autologous breast reconstruction, surgeons and patients must weigh relative risks and benefits. However, differences in outcomes across procedure types may vary between unilateral versus bilateral reconstructions. Procedure-related differences in complications and patient-reported outcomes were evaluated for unilateral and bilateral reconstruction. METHODS: Complications and patient-reported outcomes (BREAST-Q and Patient-Reported Outcomes measurement Information System surveys) were assessed at 2 years for patients undergoing autologous or implant-based reconstructions. Stratified regression models compared outcomes between autologous and implant-based reconstructions, separately for unilateral and bilateral cohorts. RESULTS: Among 2125 patients, 917 underwent unilateral (600 implant and 317 autologous) and 1208 underwent bilateral (994 implant and 214 autologous) reconstructions. Complication rates were significantly higher in the autologous versus implant-based group for both unilateral (overall: OR, 2.50, p < 0.001; major: OR, 2.19, p = 0.001) and bilateral (overall: OR, 2.13, p < 0.001; major: OR, 1.69, p = 0.014) cohorts. In unilateral reconstruction, the autologous group demonstrated significantly better patient-reported outcomes versus implant-based group in satisfaction with breast (mean difference, 9.85; p < 0.001), psychosocial well-being (mean difference, 4.84; p = 0.006), and sexual well-being (mean difference, 11.42; p < 0.001). In bilateral reconstruction, the autologous group demonstrated significantly higher patient-reported outcomes only for satisfaction with breast (mean difference, 5.13; p = 0.001). CONCLUSIONS: Although autologous reconstruction is associated with significantly better patient-reported outcomes compared to implant-based techniques in unilateral reconstruction, procedure choice has far less impact in bilateral reconstruction. Autologous procedures have higher complications rates in both unilateral and bilateral settings. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
Asunto(s)
Mamoplastia/métodos , Colgajos Quirúrgicos , Autoinjertos , Implantes de Mama/efectos adversos , Implantes de Mama/psicología , Neoplasias de la Mama/psicología , Neoplasias de la Mama/cirugía , Toma de Decisiones Clínicas , Femenino , Humanos , Mamoplastia/efectos adversos , Mamoplastia/psicología , Mastectomía/efectos adversos , Mastectomía/métodos , Mastectomía/psicología , Persona de Mediana Edad , Pezones/cirugía , Tratamientos Conservadores del Órgano/métodos , Tratamientos Conservadores del Órgano/psicología , Medición de Resultados Informados por el Paciente , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Resultado del Tratamiento , Estados UnidosRESUMEN
PURPOSE: Postmastectomy radiation therapy (PMRT) delivered to an immediate reconstruction increases the risk of surgical complications. Although acellular dermal matrix (ADM) has been used with immediate tissue expander (TE) reconstruction to improve cosmetic outcomes and minimize capsular contracture, there is a paucity of data on this approach in the setting of PMRT. METHODS AND MATERIALS: Thirty-two patients with stage I to III breast cancer were treated with mastectomy, immediate TE-ADM reconstruction, and PMRT between 2009 and 2012 in a prospective single-arm study. The primary objective was the "success" rate, determined by the number of patients at 2 years after PMRT having an intact final reconstruction, no major complications, and a cosmetic outcome rated by a physician as excellent or good. RESULTS: The median follow-up was 24 months. Final reconstruction status was known in 31 of 32 patients (96.9%; 1 patient left the country) and completed in 29 of 31 patients (93.5%; implant, n = 26; flap, n = 1; both, n = 2; none, n = 2). At 2 years, 6 patients were unevaluable (metastatic disease, n = 3; withdrawn consent, n = 1; left the country, n = 2). Of 26 evaluable patients, the success rate was 65.4% (17 of 26). Lack of success was the result of "fair" cosmesis (n = 2), infection (n = 2), severe capsular contracture (n = 1), major revision (n = 2), and no final reconstruction (n = 2). Most patients had good-to-excellent 2-year overall cosmesis based on patient perception (15; 62.5%) and physician evaluation (19; 79.2%). CONCLUSIONS: To the best of our knowledge, this is the first dedicated prospective trial evaluating long-term cosmetic and complication outcomes in patients treated with immediate TE-ADM reconstruction followed by PMRT. Most patients (65.4%) met the success criteria in this prospective single-arm series. The great majority (93.5%) achieved final reconstruction; most had good-to-excellent overall cosmetic outcomes (79.2%). The results with longer follow-up will be of interest, and further investigation of strategies to optimize reconstruction with PMRT are warranted.
Asunto(s)
Dermis Acelular/metabolismo , Mastectomía/métodos , Radioterapia Adyuvante/efectos adversos , Adulto , Femenino , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Radioterapia Adyuvante/métodos , Dispositivos de Expansión Tisular , Adulto JovenRESUMEN
BACKGROUND: Abdominal flap reconstruction is the most popular form of autologous breast reconstruction. The current study compared complications and patient-reported outcomes after pedicled transverse rectus abdominis myocutaneous (TRAM), free TRAM, deep inferior epigastric perforator (DIEP), and superficial inferior epigastric artery (SIEA) flaps. METHODS: Patients undergoing abdominally based breast reconstruction at 11 centers were prospectively evaluated for abdominal donor-site and breast complications. Patient-reported outcomes were measured by the BREAST-Q and Patient-Reported Outcomes Measurement Information System surveys. Mixed-effects regression models were used to assess the effects of procedure type on outcomes. RESULTS: Seven hundred twenty patients had 1-year follow-up and 587 had 2-year follow-up. Two years after reconstruction, SIEA compared with DIEP flaps were associated with a higher rate of donor-site complications (OR, 2.7; p = 0.001); however, SIEA flaps were associated with higher BREAST-Q abdominal physical well-being scores compared with DIEP flaps at 1 year (mean difference, 4.72, on a scale from 0 to 100; p = 0.053). This difference was not significant at 2 years. Abdominal physical well-being scores at 2 years postoperatively were lower in the pedicled TRAM flap group by 7.2 points (p = 0.006) compared with DIEP flaps and by 7.8 points (p = 0.03) compared with SIEA flaps, and in the free TRAM flap group, scores were lower by 4.9 points (p = 0.04) compared with DIEP flaps. Bilateral reconstruction had significantly lower abdominal physical well-being scores compared with unilateral reconstruction. CONCLUSIONS: Although all abdominally based flaps are viable breast reconstruction options, DIEP and SIEA flaps are associated with higher abdominal physical well-being than pedicled and free TRAM flaps. Although SIEA flaps offer the advantage of not violating the fascia, higher rates of donor-site complications may diminish patient satisfaction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
Asunto(s)
Neoplasias de la Mama/cirugía , Mamoplastia/efectos adversos , Colgajo Miocutáneo/trasplante , Medición de Resultados Informados por el Paciente , Colgajo Perforante/trasplante , Complicaciones Posoperatorias/epidemiología , Adulto , Arterias Epigástricas/trasplante , Fasciotomía/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Mamoplastia/métodos , Mastectomía/efectos adversos , Persona de Mediana Edad , Colgajo Miocutáneo/irrigación sanguínea , Satisfacción del Paciente , Colgajo Perforante/irrigación sanguínea , Complicaciones Posoperatorias/etiología , Recto del Abdomen/irrigación sanguínea , Recto del Abdomen/trasplante , Sitio Donante de Trasplante/irrigación sanguínea , Sitio Donante de Trasplante/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND: Surgical-site infection causes devastating reconstructive failure in implant-based breast reconstructions. Large national database studies offer insights into complication rates, but only capture outcomes within 30 days postoperatively. This study evaluates both early and late surgical-site infection in immediate implant-based reconstruction and identifies predictors. METHODS: As part of the Mastectomy Reconstruction Outcomes Consortium Study, 1662 implant-based breast reconstructions in 1024 patients were evaluated for early versus late surgical-site infection. Early surgical-site infection was defined as infection occurring within 30 days postoperatively; late surgical-site infection was defined as infection occurring 31 days to 1 year postoperatively. Minor infection required oral antibiotics only, and major infection required hospitalization and/or surgical treatment. Direct-to-implant patients had 1-year follow-up, and tissue expander patients had 1-year post-exchange follow-up. RESULTS: Among 1491 tissue expander and 171 direct-to-implant reconstructions, overall surgical-site infection rate for tissue expander was 5.7 percent (85 of 1491) after first-stage, 2.5 percent (31 of 1266) after second-stage, and 9.9 percent (17 of 171) for direct-to-implant reconstruction. Over 47 to 71 percent of surgical-site infection complications were late surgical-site infection. Multivariate analysis identified radiotherapy and increasing body mass index as significant predictors of late surgical-site infection. No significant difference between the direct-to-implant and tissue expander groups in the occurrence of early, late, or overall surgical-site infection was found. CONCLUSIONS: The majority of surgical-site infection complications in immediate implant-based breast reconstructions occur more than 30 days after both first-stage and second-stage procedures. Radiotherapy and obesity are significantly associated with late-onset surgical-site infection. Current studies limited to early complications do not present a complete assessment of infection associated with implant-based breast reconstructions or their long-term clinical outcomes. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.
Asunto(s)
Implantación de Mama , Mastectomía , Infección de la Herida Quirúrgica/etiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Implantación de Mama/métodos , Femenino , Estudios de Seguimiento , Humanos , Modelos Logísticos , Persona de Mediana Edad , Factores de Riesgo , Infección de la Herida Quirúrgica/epidemiología , Factores de Tiempo , Adulto JovenRESUMEN
BACKGROUND: Implant-based breast reconstruction is the most common reconstructive technique in the United States. Despite its popularity, saline-based tissue expansion still has its limitations, including lengthy expansion times, large uncomfortable bolus dosing, and frequent percutaneous injections/expansion visits. Ideally, a novel technology would eliminate frequent, percutaneous saline injections and allow patients to perform expansion at home, reducing the disruptive experience of current tissue expansion. METHODS: Within the past 6 years, the AeroForm tissue expander system has used remotely activated carbon dioxide release as the fill medium instead of saline, eliminating many limitations of traditional tissue expanders. In this article, the authors first review the relevant literature concerning carbon dioxide-based tissue expansion in animal and human models. The authors then analyze the similarities and differences between two groundbreaking human trials (i.e., Patient Activated Controlled Expansion and AirXpanders Patient Activated Controlled Tissue Expander) with carbon dioxide-based expanders and discuss the risks and benefits associated with this new technology. RESULTS: At their site, the authors have enrolled 34 patients using 36 experimental devices in total, and have found significantly shorter expansion and overall reconstruction times in the patient-controlled tissue expander group. CONCLUSIONS: The authors believe that carbon dioxide-based devices may play a significant role in the future of implant-based breast reconstruction, and may be widely applicable to other areas of plastic surgery that also involve tissue expansion.