Post-mastectomy Breast Reconstruction With Gas vs Saline Tissue Expanders: Does the Fill Type Matter?

The most common reconstruction technique following mastectomy is a 2-stage technique that involves tissue expansion followed by definitive implant-based reconstruction (IBR). Tissue expanders (TEs) have classically used saline for initial fill; however, TEs with an initial gas fill (GTE)-including the CO2-based AeroForm (AirXpanders, San Francisco, CA) TE and TEs initially filled with atmospheric air-have been increasingly used in the past decade. We aimed to compare the outcomes in breast reconstruction for tissue expanders initially filled with saline vs gas. PubMed was queried for studies comparing gas- and saline-filled tissue expanders (STEs) used in IBR. A meta-analysis was performed on major postoperative outcomes and the required expansion and definitive reconstruction time. Eleven studies were selected and included in the analysis. No significant differences existed between tissue expansion with GTEs vs STEs for 11 of the 13 postoperative outcomes investigated. Out of the complications investigated, only the risk of infection/cellulitis/abscess formation was significantly lower in the GTE cohort (odds ratio 0.62; 95% CI, 0.47 to 0.82; P = .0009). The time to definitive reconstruction was also significantly lower in the GTE cohort (mean difference [MD], 45.85 days; 95% CI, -57.80 to -33.90; P < .00001). The total time to full expansion approached significance in the GTE cohort (MD, -20.33 days; 95% CI, -41.71 to 1.04; P = .06). A cost analysis considering TE cost and infection risk determined that GTE use saved a predicted $2055.34 in overall healthcare costs. Surgical outcomes for both fill types were predominantly similar; however, GTEs were associated with a significantly decreased risk of postoperative infection compared to saline-filled TEs. GTEs could also reduce healthcare expenditures and require less time until definitive reconstruction after placement.

A Case for the Use of the 5-Item Modified Frailty Index in Preoperative Risk Assessment for Tissue Expander Placement in Breast Reconstruction.

BACKGROUND: Preoperative risk assessment is essential in determining which surgical candidates will have the most to gain from an operation. The 5-item modified frailty index (mFI-5) has been validated as an effective way to determine this risk. This study sought to evaluate the performance of the mFI-5 as a predictor of postoperative complications after tissue expander placement. METHODS: Patients who underwent placement of a tissue expander were identified using the 2012 to 2018 American College of Surgeons National Surgical Quality Improvement Project database. Univariate and multivariate regression analysis models were used to assess how mFI-5, the components of the mFI-5 (functional status, diabetes, chronic obstructive pulmonary disease, chronic heart failure, and hypertension), and other factors commonly used to risk stratify (age, body mass index [BMI], American Society of Anesthesiologists (ASA) classification, and history of smoking) were associated with complications. RESULTS: In 44,728 tissue expander placement cases, the overall complication rate was 10.5% (n = 4674). The mFI-5 score was significantly higher in the group that experienced complications (0.08 vs 0.06, P < 0.001). Compared with the mFI-5 individual components and other common variables used preoperatively to risk stratify patients, univariate analysis demonstrated that mFI-5 had the largest effect size (odds ratio [OR], 5.46; confidence interval [CI], 4.29-6.94; P < 0.001). After controlling for age, BMI, ASA classification, and history of smoking, the mFI-5 still remained the predictor of complications with the largest effect size (OR, 2.25; CI, 1.70-2.97; P < 0.001). In assessing specific complications, the mFI-5 is the independent predictor with the largest significant effect size for surgical dehiscence (OR, 12.76; CI, 5.58-28.18; P < 0.001), surgical site infection (OR, 6.68; CI, 4.53-9.78; P < 0.001), reoperation (OR, 5.23; CI, 3.90-6.99; P < 0.001), and readmission (OR, 4.59; CI, 3.25-6.45; P < 0.001) when compared with age, BMI, ASA class, and/or history of smoking alone. CONCLUSIONS: The mFI-5 can be used as an effective preoperative predictor of postoperative complications in patients undergoing tissue expander placement. Not only does it have the largest effect size compared with other historical perioperative risk factors, it is more predictive than each of its individual components.

The Use of Absorbable Mesh in Implant-Based Breast Reconstruction: A 7-Year Review.

BACKGROUND: Breast reconstruction is most frequently performed using implants or expanders. Adjunctive materials such as acellular dermal matrix and synthetic meshes are used to support the implant or expander. A paucity of large studies exist on the use of synthetic mesh for breast reconstruction. METHODS: A retrospective chart review of all patients over the past 7 years who had implant reconstruction with synthetic absorbable mesh at the Massachusetts General Hospital was performed. Data were collected on demographic and surgical outcomes. Statistical analysis was performed. RESULTS: A total of 227 patients (376 mastectomies) were treated with direct-to-implant subpectoral reconstruction with absorbable mesh from 2011 to 2017. The infection rate was 2.1 percent. The rate of capsular contracture was 4.8 percent. Patients who had radiation therapy either preoperatively or postoperatively had a higher rate of complications, including capsular contracture. Cost savings for using mesh instead of acellular dermal matrix surpassed $1.2 million. CONCLUSION: Synthetic absorbable mesh is a safe alternative to acellular dermal matrix in prosthetic breast reconstruction and provides stable results along with significant cost savings. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Breast Tissue Expander With Radiofrequency Identification Port: Assessment of MRI Issues.

OBJECTIVE. Breast tissue expanders with magnetic ports are MRI unsafe, preventing patients from benefiting from the diagnostic capabilities of MRI. A tissue expander was recently developed with a radiofrequency identification (RFID) port used for needle location and expansion that may be acceptable for a patient undergoing MRI. The purpose of this investigation was to evaluate MRI issues using standardized techniques and well-accepted methods for this tissue expander with RFID port. MATERIALS AND METHODS. The breast tissue expander with RFID port (Motiva Flora Tissue Expander, Establishment Labs) was assessed for magnetic field interactions (translational attraction and torque, 3 T), MRI-related heating (1.5 T/64 MHz and 3 T/128 MHz), artifacts (3 T), and functional changes associated with different MRI conditions (1.5 T/64 MHz and 3 T/128 MHz). RESULTS. Magnetic field interactions were minor (deflection angle of 2° and no torque) and thus will not pose a risk. At 1.5 T/64 MHz and 3 T/128 MHz, the highest temperature elevations (1.7°C and 1.9°C, respectively) were physiologically inconsequential. The tissue expander with RFID port exhibited relatively small artifacts on MRI. Exposures of the tissue expander with RFID port to different MRI conditions did not impact the ability to localize the RFID port or to read the electronic serial number. CONCLUSION. The findings indicated that this tissue expander with RFID port is "MR Conditional" for a patient referred for MRI at 1.5 T or 3 T. Importantly, the relatively small artifact associated with this implant offers potential advantages for patients undergoing MRI compared with tissue expanders that have magnetic ports that create substantial signal losses and distortions on MR images.

Quantitative assessment and risk factors for nipple-areolar complex malposition after nipple-sparing mastectomy.

PURPOSE: Nipple sparing mastectomy (NSM) for breast cancer preserves the nipple-areola complex (NAC) and has limited the extent of the scar, giving good cosmetic results. However, NAC malposition may occur. The aim of this study is to evaluate NAC malposition after NSM and to determine factors associated with malposition in two-stage reconstruction. METHODS: The subjects were 46 patients who underwent unilateral NSM, without contralateral mastopexy or reduction surgery, in two-stage reconstruction using an expander with implant or flap replacement. Vertical and horizontal NAC malposition and predictors of malposition were evaluated before and more than 1 year after reconstruction surgery. RESULTS: The total amount of saline injected into the expander and aging were significant predictors of increased superior malposition of NAC before and more than 1 year after reconstruction or implant surgery. In contrast, the amount of saline injected into the expander until 2 weeks after expander insertion was a significant predictor of decreased superior NAC malposition. BMI was also a statistically significant predictor of decreased superior NAC malposition, but this result was likely to have been due to the measurement method. Autologous reconstruction was a significant negative predictor of superior malposition at more than 1 year after surgery. Superior NAC malposition resulting from full expansion of the expander improved by a mean vertical angle of 4.5° after autologous reconstruction, but hardly improved after implant use. In autologous reconstruction, NAC tended to move slightly to the lateral side after autologous reconstruction, compared to implant use. CONCLUSIONS: Until 2 weeks after expander insertion, as much saline as possible should be injected to prevent superior NAC malposition. At full expansion, superior malposition of vertical angle > 4.5° may require repositioning surgery.

Evaluating Mastectomy Skin Flap Necrosis in the Extended Breast Reconstruction Risk Assessment Score for 1-Year Prediction of Prosthetic Reconstruction Outcomes.

BACKGROUND: Rates of mastectomy for breast cancer treatment and immediate reconstruction continue to rise. With increasing scrutiny on outcomes and patient satisfaction, there is an impetus for providers to be more deliberate in appropriate patient selection for breast reconstruction. The Breast Reconstruction Risk Assessment (BRA) Score was developed for prediction of complications after primary prosthetic breast reconstruction, focusing on calculating risk estimations for a variety of complications based on individual patient demographic and perioperative characteristics. In this study, we evaluated mastectomy skin flap necrosis (MSFN) as a function of patient characteristics to validate the BRA Score. STUDY DESIGN: We examined our prospective intra-institutional database of prosthetic breast reconstructions from 2004 to 2015. The end point of interest was 1-year occurrence of MSFN after stage I tissue expander placement. RESULTS: Nine hundred and three patients were included; 50% underwent bilateral reconstruction. Median follow-up was 23 months. Mean 1-year complication rates were as follows: MSFN 12.4%, seroma 3.0%, infection 6.9%, dehiscence/exposure 7.1%, and explantation 13.2%. Statistically significantly higher rates of MSFN were found in older patients, smokers, patients with postoperative infections, patients with hypertension, and patients who used aspirin. Neoadjuvant or adjuvant chemotherapy and radiation, diabetes, and seroma formation did not have a statistically significant impact on necrosis rates. CONCLUSIONS: The BRA Score was expanded to estimate complication risk after tissue expander placement up to 1 year postoperatively. The risk of MSFN as calculated by the BRA Score: Extended Length is consistent with published studies demonstrating increased risk with specific comorbidities, and further validates expansion of the BRA score risk calculator.

Comparison of two cadaveric acellular dermal matrices for immediate breast reconstruction: A prospective randomized trial.

AlloDerm RTU® and AlloMaxTM are two acellular dermal matrices (ADMs) used in implant-based breast reconstruction. In this study, we examined whether different processing methods for the ADMs lead to a disparity in histologic, clinical, and financial outcomes after breast reconstruction. Thirty patients undergoing implant-based breast reconstruction were randomized into AlloMax or AlloDerm arms (n = 15, each). ADM was placed at the time of immediate reconstruction. Patients were evaluated for complications on postoperative days 7, 14, and 30. During implant exchange, ADM biopsies were taken and compared histologically for vascular and cellular infiltration. Patient satisfaction was evaluated using the BRECON-31 questionnaire 1 year after implant exchange. A cost analysis was performed comparing the two ADMs. Patient demographics and complication rates were similar between the two groups (p > 0.05). Histologically, vessel density and fibroblast/inflammatory cell infiltrate were greater on the dermal side than on the implant side (p < 0.01) in both ADMs, suggesting greater vascular and cellular in-growth from the dermal side. Vessel density in the middle portion of the Allomax biopsies was significantly higher than the same site in the Alloderm biopsies (p < 0.05). The extent of fibroblast/inflammatory cell infiltration was similar in both arms (p > 0.05). The BRECON-31 satisfaction questionnaire yielded similar responses across all metrics between the two study arms. The negotiated price was slightly different when comparing the two ADMs, with no significant difference in ADM reimbursement. In this study, AlloDerm RTU and AlloMax were successfully used for implant-based breast reconstruction with comparable outcomes.

Risk factors for complications following immediate tissue expander based breast reconstruction in Taiwanese population.

BACKGROUND/PURPOSE: Breast cancer patients in Asia show considerable disparities from Caucasian patients, such as younger age of onset and lower rates of smoking, obesity, and diabetes. Findings of prior studies regarding risk factors associated with complications in tissue expander may not hold for Asian populations, since most of these studies involved Caucasian patients. In this study, we surveyed risk factors in the Taiwanese population, providing additional evidence about the important differences and discuss the implications for clinical practice. METHODS: Patients who underwent immediate, two-stage, tissue expander breast reconstruction from December 2008 to August 2014 in the National Taiwan University Hospital, Taipei, Taiwan were included. Follow-up observations of all patients were conducted until December 2014. Complications occurring during the tissue expander stage were evaluated. Multivariate regression modeling was used to identify risk factors for complications. RESULTS: A total of 246 consecutive, immediate, smooth round tissue expander placements were performed for breast reconstruction. The most common complication was skin necrosis (4.9%), followed by wound dehiscence (4.1%). In the multivariate model, body mass index (BMI) ≥ 24 kg/m2 was the only risk factor that reached statistical significance (odds ratio: 2.41, 95% confidence interval: 1.17-4.96). CONCLUSION: We provided evidence that racial disparities have an impact on the risk factors for complications associated with tissue expander breast reconstruction. BMI≥24 kg/m2 was the only risk factor significantly associated with complications. Clinically, BMI≥24 kg/m2, rather than the standard definition of obesity (BMI > 30 kg/m2), may be a more suitable cutoff point for risk in patients of Asian ethnicity.

Avaliação volumétrica das mamas em pacientes submetidas à lipoenxertia com uso de expansão pré-operatória (BRAVA®): experiência da Santa Casa de São Paulo / Volumetric assessment of breasts in patients undergoing fat grafting with pre-operative expansion (BRAVA®): experience of Santa Casa de São Paulo

Introdução: O enxerto autólogo de tecido adiposo exibe qualidades desejáveis para utilização como material de preenchimento. Contudo, a grande barreira para o seu maior desenvolvimento foram os resultados pouco previsíveis e o alto índice de absorção da gordura enxertada ao longo do tempo. O objetivo é realizar avaliação volumétrica das mamas de pacientes submetidas à lipoenxertia com uso de expansão pré-operatória (BRAVA®). Métodos: Foram operadas 19 pacientes no período entre março de 2012 e junho de 2015 na disciplina de Cirurgia Plástica da Santa Casa de São Paulo. Os parâmetros avaliados por ressonância nuclear magnética (pré e 6 meses pós-operatório) foram: Volume Aumentado=Volume Pós-operatório - Volume Pré operatório; Percentual de Aumento=Volume Aumentado/ Volume Pré operatório x100; Percentual de Integração=Volume Aumentado/Volume Enxertado x 100. Resultados: O volume médio das mamas no pré-operatório foi de 294,73 ml e de 458,42 ml no pós-operatório. O volume médio de enxerto foi de 274,4 ml (150-350 ml). Em relação aos parâmetros avaliados, o volume médio de aumento foi de 168,42 ml (90-270 ml), o percentual médio de aumento foi de 58,98% (23-90%) e o percentual médio de integração foi de 62,36% (30-80%). Conclusão: A utilização da expansão externa (BRAVA®) na mama mostrou-se um método efetivo nas taxas de integração do enxerto de gordura, bem como no aumento global do volume mamário.

Introduction: Autologous fat graft possesses the desired qualities of a filling material. However, the largest barriers to its further development are unpredictable results and high rate of absorption of the grafted fat over time. The objective is to perform a volumetric assessment of the breasts in patients undergoing fat grafting using pre-operative external expansion (BRAVA®). Methods: Nineteen patients were operated between March 2012 and June 2015 in the Service of Plastic Surgery, Santa Casa de São Paulo. The parameters evaluated using nuclear magnetic resonance (pre-operatively and 6 months post-operatively) were the following: augmented volume=postoperative volume - pre-operative volume; percentage of augmentation=augmented volume/pre-operative volume x 100; percentage of integration=augmented volume/volume grafted x 100. Results: The average volume of the breasts in the pre- and post-operative periods were 294.73 ml and 458.42 ml, respectively. The average graft volume was 274.4 ml (150-350 ml). The following parameters were assessed: average volume augmentation, 168.42 ml (90-270 ml); average percentage of augmentation, 58.98% (23-90%); and average percentage of integration, 62.36% (30-80%). Conclusion: The use of external expansion (BRAVA®) in breasts was effective in increasing the rates of integration of the fat grafts and the overall augmentation in breast volumes.

The cost of major complications associated with immediate two-stage expander/implant-based breast reconstruction.

Previous studies assessing the costs associated with two stage expander/implant (E/I) reconstruction rarely include the cost of complications. The purpose of this study is to analyze the complication costs associated with a single institution experience with immediate E/I reconstruction. All immediate two stage E/I reconstructions at a single institution between March 2005-April 2011 were reviewed. The reconstruction database was retrospectively queried for reconstructive details, complications, and cost. Statistical analyses were performed to determine which complications significantly increased reconstructive cost. 327 E/I reconstructions in 195 patients were analyzed. The major complications analyzed included haematoma requiring evacuation (1.2% of reconstructions), major infection (6.1% of reconstructions), E/I exposure (3.1% of reconstructions), and E/I rupture (2.4% of reconstructions); 2.1% of patients experienced reconstructive failure. The mean reconstructive cost was $22,323 ± 9,072. Costs were increased $12,554 by E/I infection (p < 0.001) and $17,153 by prosthetic exposure (p < 0.001). Pre- or postoperative radiation or chemotherapy did not significantly affect reconstructive costs. Unplanned readmissions or unplanned visits to the operative room significantly increased total reconstructive costs (p < 0.001 and p < 0.001, respectively). In conclusion, prosthetic infection and prosthetic exposure significantly increased costs associated with immediate two-stage E/I reconstruction, as did unplanned readmissions and unplanned visits to the operative room. In the current state of the US healthcare system, it is becoming more important for surgeons to be conscious of the economic burden associated with poor reconstructive outcomes.

In vitro assessment of MRI issues at 3-Tesla for a breast tissue expander with a remote port.

OBJECTIVES: A patient with a breast tissue expander may require a diagnostic assessment using magnetic resonance imaging (MRI). To ensure patient safety, this type of implant must undergo in vitro MRI testing using proper techniques. Therefore, this investigation evaluated MRI issues (i.e., magnetic field interactions, heating, and artifacts) at 3-Tesla for a breast tissue expander with a remote port. METHODS: A breast tissue expander with a remote port (Integra Breast Tissue Expander, Model 3612-06 with Standard Remote Port, PMT Corporation, Chanhassen, MN) underwent evaluation for magnetic field interactions (translational attraction and torque), MRI-related heating, and artifacts using standardized techniques. Heating was evaluated by placing the implant in a gelled-saline-filled phantom and MRI was performed using a transmit/receive RF body coil at an MR system reported, whole body averaged specific absorption rate of 2.9-W/kg. Artifacts were characterized using T1-weighted and GRE pulse sequences. RESULTS: Magnetic field interactions were not substantial and, thus, will not pose a hazard to a patient in a 3-Tesla or less MRI environment. The highest temperature rise was 1.7°C, which is physiologically inconsequential. Artifacts were large in relation to the remote port and metal connector of the implant but will only present problems if the MR imaging area of interest is where these components are located. CONCLUSIONS: A patient with this breast tissue expander with a remote port may safely undergo MRI at 3-Tesla or less under the conditions used for this investigation. These findings are the first reported at 3-Tesla for a tissue expander.

Incidence of pneumothorax during tissue expander-implant reconstruction and algorithm for intraoperative management.

BACKGROUND: Iatrogenic pneumothorax is a serious intraoperative complication of immediate breast reconstruction with tissue expanders. However, there is paucity of literature regarding incidence or management of intraoperative pneumothorax in the breast reconstruction patient population. METHODS: We performed a retrospective chart review on prospectively collected data from all patients undergoing immediate breast reconstruction with tissue expanders from 1992 to 2012 to determine institutional incidence. We also searched the Nationwide Inpatient Sample database from 1998 to 2008 to determine national incidence. RESULTS: A total of 9653 tissue expanders were placed in 6955 patients at the Memorial Sloan Kettering Cancer Center between 1992 and 2012. There were 3 cases of pneumothorax during immediate breast reconstruction with tissue expanders. The incidence of pneumothorax is 0.03% per expander and 0.04% per patient. From the national database, there were 153 cases of pneumothorax during immediate breast reconstruction with tissue expanders in 27,612 patients. The overall national incidence of pneumothorax is 0.55% per patient. CONCLUSIONS: Our algorithm for management includes a thoracic surgery consultation intraoperatively. A chest tube should be placed at a site distal to the pleurotomy. The site of injury should be repaired primarily or patched as necessary. If the patient remains stable, it is safe to proceed with placement of the tissue expander.

Cost comparison of immediate one-stage and tissue-expander breast reconstructions after mastectomy in commercially insured patients.

OBJECTIVE: Growing acceptance of nipple-sparing mastectomy and rising rates of prophylactic mastectomy due to genetic findings make immediate one-stage implant breast reconstruction an attractive option for many American women facing post-mastectomy breast reconstruction. We compared medical services utilization and cost of immediate one-stage reconstruction with that of the more common tissue-expander (TE) breast reconstruction. DESIGN: Retrospective administrative claims database analysis. METHODS: We obtained commercial insurance claims on patients in the U.S. who had undergone one-stage or TE post-mastectomy implant breast reconstructions in 2008, and we compared 18-month results in terms of the frequency and cost of return visits for additional procedures and/or for the treatment of complications. Return visits were categorized as planned, planned with revision, or unplanned. RESULTS: Among 1,316 immediate implant breast reconstructions, 95 (7%) were one-stage procedures and 1,221 (93%) were TE reconstructions. The data showed a modest, nonsignificant trend toward fewer return visits after one-stage reconstruction versus TE reconstruction (191 vs. 242 visits per 100 patients, respectively; relative risk [RR]: 0.95). Patients with TE reconstructions returned more often for planned returns and planned returns with revisions. Patients with one-stage reconstructions returned more often for unplanned events. The total costs over 18 months were $34,839 and $39,062 for one-stage and TE reconstructions, respectively, for a difference of -$4,223 (P = 0.38). The initial reconstruction, including the mastectomy, accounted for 64% of the 18-month costs with one-stage reconstructions and for 54% of the 18-month costs for TE reconstructions. CONCLUSION: Costs and utilization trended lower over 18 months for one-stage versus TE reconstructions following post-mastectomy breast reconstructions but did not achieve statistical significance.

Skin expansion. Long term follow up of complications and costs of care.

To find out our rate of complications after tissue expansion, and the cost of treatment in terms of use of hospital resources and length of sick leave, we analysed our experience of 181 expansion treatments in 97 patients undertaken between 1986 and 1991. There were 60 women and 37 men, with a mean age of 22 (range 1-74). Twenty patients had more than one period of treatment (range 2-8). The most common conditions treated were naevi (n = 75); scars (trauma--n = 33, burns--n = 17, and operations--n = 16); and breasts that required reconstruction (n = 15). Of the 181 expansions there were 29 failures (16%), and 117 complete successes (64%); fifteen of the latter developed minor complications (8%), 35 were partly successful (20%). There were 77 complications in 71 treatments (38%), and 45 expanders (25%) had to be removed prematurely because of complications. The most common complications were skin penetration (n = 15), minor infection (n = 13), and breakdown of the surgical wound (n = 13). The median (range) inpatient hospital stay was 8 days (2-39); number of visits to the outpatient clinic for filling 7 days (0-20); and total treatment time/patient 82 (19-286). We conclude that skin expansion is a useful technique, but that there is room for improvement in reducing the rate of complications and the amount of time that patients spend being treated.