A study on the therapeutic effects of biplane skin dilator implantation in auricular reconstruction.

This study aimed to compare the therapeutic effects of biplane skin dilator implantation with those of conventional skin dilator implantation in auricular reconstruction. A total of 137 patients with microtia who met the inclusion criteria from January 2020 to April 2021 were retrospectively selected. Sixty-three patients comprised the control group and were implanted with a skin expander using the conventional method. Seventy-four patients comprised the experimental group and were implanted with a skin expander using the biplane method. Non-parametric tests were used to compare the down-moving distance of the skin dilator between the experimental group and the control group. There was a statistically significant difference in the down-moving distance of the skin dilator between the experimental group and the control group (P < 0.05). The chi-square test showed no significant difference in postoperative complications between the experimental group and the control group (P > 0.05). Moreover, there was no significant difference in the satisfaction rate of patients and their families between the experimental group and the control group (P > 0.05). In this study, the treatment effect of biplane skin dilator implantation was better than that of conventional skin dilator implantation.

The Impact of the COVID-19 Pandemic on Breast Reconstruction Practices in the United States.

BACKGROUND/AIM: We employed a survey to the American Society of Plastic Surgeons (ASPS) to investigate the management of breast reconstruction across the US during the COVID-19 pandemic. PATIENTS AND METHODS: An electronic survey on breast reconstruction practice demographics, COVID-19-related restrictions on breast reconstruction, and pertinent dates of restrictions was employed. RESULTS: A total of 228 responses were obtained. Demographics were balanced for geography with most respondents located in either urban or suburban settings (91.2%). The majority proceeded with mastectomy/reconstruction as originally planned (39.0%), followed by hormonal/chemotherapy only (22.6%). The most common reconstructive option was tissue expander/implant-based reconstruction (47.7%). Most institutions implemented restrictions between March 11-20th (59%). Almost all respondents (91.8%) reported mandatory pre-operative SARS-Cov-2 testing once cases resumed. CONCLUSION: COVID-19 has forced the breast surgical team to adapt to new conditions to the detriment of women with breast cancer requiring reconstruction. Varying restrictions have limited access to breast reconstruction, carrying consequences yet to be determined.

Postmastectomy Breast Reconstruction: Exploring Plastic Surgeon Practice Patterns and Perspectives.

BACKGROUND: Within the multidisciplinary management of breast cancer, variations exist in the reconstructive options offered and care provided. The authors evaluated plastic surgeon perspectives on important issues related to breast cancer management and reconstruction and provide some insight into factors that influence these perspectives. METHODS: Women diagnosed with early-stage breast cancer (stages 0 to II) between July of 2013 and September of 2014 were identified through the Georgia and Los Angeles Surveillance, Epidemiology, and End Results registries. These women were surveyed and identified their treating plastic surgeons. Surveys were sent to the identified plastic surgeons to collect data on specific reconstruction practices. RESULTS: Responses from 134 plastic surgeons (74.4 percent response rate) were received. Immediate reconstruction (79.7 percent) was the most common approach to timing, and expander/implant reconstruction (72.6 percent) was the most common technique reported. Nearly one-third of respondents (32.1 percent) reported that reimbursement influenced the proportion of autologous reconstructions performed. Most (82.8 percent) reported that discussions about contralateral prophylactic mastectomy were initiated by patients. Most surgeons (81.3 to 84.3 percent) felt that good symmetry is achieved with unilateral autologous reconstruction with contralateral symmetry procedures in patients with small or large breasts; a less pronounced majority (62.7 percent) favored unilateral implant reconstructions in patients with large breasts. In patients requiring postmastectomy radiation therapy, one-fourth of the surgeons (27.6 percent) reported that they seldom recommend delayed reconstruction, and 64.9 percent reported recommending immediate expander/implant reconstruction. CONCLUSIONS: Reconstructive practices in a modern cohort of plastic surgeons suggest that immediate and implant reconstructions are performed preferentially. Respondents perceived a number of factors, including surgeon training, time spent in the operating room, and insurance reimbursement, to negatively influence the performance of autologous reconstruction.

Elective Revisions after Breast Reconstruction: Results from the Mastectomy Reconstruction Outcomes Consortium.

BACKGROUND: Rates of breast reconstruction following mastectomy continue to increase. The objective of this study was to determine the frequency of elective revision surgery and the number of procedures required to achieve a stable breast reconstruction 2 years after mastectomy. METHODS: Women undergoing first-time breast reconstruction after mastectomy were enrolled and followed for 2 years, with completion of reconstruction occurring in 1996. Patients were classified based on the absence or presence of complications. Comparisons within cohorts were performed to determine factors associated with revisions and total procedures. Mixed-effects regression modeling identified factors associated with elective revisions and total operations. RESULTS: Overall, 1534 patients (76.9 percent) had no complications, among whom 40.2 percent underwent elective revisions. The average number of elective revisions differed by modality (p < 0.001), with abdominally based free autologous reconstruction patients undergoing the greatest number of elective revisions (mean, 0.7). The mean total number of procedures also differed (p < 0.001), with tissue expander/implant reconstruction patients undergoing the greatest total number of procedures (mean, 2.4). Complications occurred in 462 patients (23.1 percent), with 67.1 percent of these patients undergoing elective revisions, which was significantly higher than among patients without complications (p < 0.001). The mean number of procedures again differed by modality (p < 0.001) and followed similar trends, but with an increased mean number of revisions and procedures overall. Mixed-effects regression modeling demonstrated that patients experiencing complications had increased odds of undergoing elective revision procedures (OR, 3.2; p < 0.001). CONCLUSIONS: Breast reconstruction patients without complications undergo over two procedures on average to achieve satisfactory reconstruction, with 40 percent electing revisions. If a complication occurs, the number of procedures increases. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Complication Profiles by Mastectomy Indication in Tissue Expander Breast Reconstruction.

BACKGROUND: Two-stage implant breast reconstruction is the most commonly performed breast reconstruction procedure. Limited data exist regarding reconstruction complication rates examined by mastectomy indication. METHODS: Patients who underwent two-stage implant breast reconstruction at Yale New Haven Hospital from 2011 to 2017 were included in the study. Perioperative complications were compared. Chi-square analysis, t tests, and Fisher's exact tests were used to determine significant associations. A binary logistic regression was used to determine variables with a significant impact on the likelihood of mastectomy flap necrosis. RESULTS: Between 2011 and 2017, complete perioperative records were available for 141 patients who underwent 226 mastectomies followed by two-stage tissue expander/permanent implant reconstruction. Of the 226 mastectomies, 134 were therapeutic and 92 were prophylactic. On regression analysis, there were no significant differences in demographics, comorbidities, or mastectomy and reconstructive details between the two breast groups except for there being more modified radical mastectomies in therapeutic breasts (p = 0.003). When comparing complications, there was a significantly higher risk of mastectomy flap necrosis in the therapeutic group (p = 0.017). Therapeutic mastectomies had a 9.5 times higher risk of mastectomy flap necrosis than prophylactic mastectomies when adjusted for confounding variables. There were no significant differences in other reconstructive complications between the two groups. CONCLUSIONS: Patients undergoing therapeutic mastectomies have a significantly higher risk of mastectomy flap necrosis than those undergoing prophylactic mastectomies. Although the underlying cause still needs to be determined, differences in technique may be related to mastectomy flap necrosis. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Impact of Contralateral Symmetry Procedures on Long-Term Patient-Reported Outcomes following Unilateral Prosthetic Breast Reconstruction.

BACKGROUND: One aim of unilateral postmastectomy breast reconstruction (BR) is to restore symmetry with the contralateral breast. As such, unilateral prosthetic reconstruction often requires a contralateral symmetry procedure (CSP). There is sparse literature on the impact of CSPs on long-term patient-reported outcomes (PROs) such as satisfaction and health-related quality of life (HRQoL). This study aims to describe PROs following CSPs, using a validated PRO tool, BREAST-Q. The hypothesis is that CSPs are associated with greater patient-reported satisfaction and HRQoL. METHODS: This study is a single institutional analysis of prospectively collected BREAST-Q scores of patients who underwent unilateral prosthetic BR during 2011 to 2015. Women 18 years and older with BREAST-Q scores measured ≥ 9months after BR with or without CSP(s) at the time of expander replacement were included. Patients were classified into four subcohorts: augmentation, mastopexy, reduction, and no symmetry procedure (controls). Sociodemographic, clinical characteristics, and BREAST-Q scores were analyzed. Multivariable linear regression was performed. RESULTS: Of 553 patients, 67 (12%) underwent contralateral augmentation, 68 (12%) mastopexy, 93(17%) reduction, and 325 (59%) were controls. Mean follow-up time was 52 months. Satisfaction with breast and outcomes were higher in the augmentation compared with the control groups (p = 0.01). On multivariable analysis, augmentation remained an independent predictor of satisfaction with breast (p = 0.04). Physical well-being scores were lower for contralateral mastopexy and reduction compared with the controls with a trend toward statistical significance on multivariable models. Psychological and sexual well-being was similar across groups. CONCLUSION: Prosthetic reconstruction with contralateral breast augmentation was associated with greater satisfaction with breast and reconstructive outcome. In contrast, breast reduction and mastopexy procedures demonstrated equivalent satisfaction with breasts compared with controls but may be associated with lower physical well-being. Such information can be used to improve the shared decision-making process for women who choose unilateral prosthetic BR.

The Influence of Physician Payments on the Method of Breast Reconstruction: A National Claims Analysis.

BACKGROUND: Flap-based breast reconstruction demands greater operative labor and offers superior patient-reported outcomes compared with implants. However, use of implants continues to outpace flaps, with some suggesting inadequate remuneration as one barrier. This study aims to characterize market variation in the ratio of implants to flaps and assess correlation with physician payments. METHODS: Using the Blue Health Intelligence database from 2009 to 2013, patients were identified who underwent tissue expander (i.e., implant) or free-flap breast reconstruction. The implant-to-flap ratio and physician payments were assessed using quadratic modeling. Matched bootstrapped samples from the early and late periods generated probability distributions, approximating the odds of surgeons switching reconstructive method. RESULTS: A total of 21,259 episodes of breast reconstruction occurred in 122 U.S. markets. The distribution of implant-to-flap ratio varied by market, ranging from the fifth percentile at 1.63 to the ninety-fifth percentile at 43.7 (median, 6.19). Modeling the implant-to-flap ratio versus implant payment showed a more elastic quadratic equation compared with the function for flap-to-implant ratio versus flap payment. Probability modeling demonstrated that switching the reconstructive method from implants to flaps with a 0.75 probability required a $1610 payment increase, whereas switching from flaps to implants at the same certainty occurred at a loss of $960. CONCLUSIONS: There was a correlation between the ratio of flaps to implants and physician reimbursement by market. Switching from implants to flaps required large surgeon payment increases. Despite a relative value unit schedule over twice as high for flaps, current flap reimbursements do not appear commensurate with physician effort.

Sientra AlloX2 Short-Term Case Study, Surgical Pearls, and Roundtable Discussion.

BACKGROUND: The AlloX2 Breast Tissue Expander (Sientra, Santa Barbara, Calif.) is a unique device that contains a second port to allow for transdermal communication with the pocket around the implant. The injection dome of this expander contains two ports; one is used for traditional saline injection, and a new second port facilitates fluid drainage from the periprosthetic space through an integral drain. The AlloX2 allows for the treatment of seromas and diagnostic fluid sampling to identify bacteria and hone antibiotic treatment in the setting of periprosthetic infection. This device has a significant advantage over traditional expanders, given that seromas and infections are the most common complications in implant-based breast reconstruction, with or without the use of soft-tissue support matrix. METHODS: This article provides short-term case studies and surgical pearls from 3 surgeons who utilize the AlloX2 in primary breast reconstruction patients. Three surgeons implanted 40 primary reconstruction patients with AlloX2. Follow-up was approximately 6 months, per the standard of care. All patients implanted with AlloX2 underwent immediate reconstruction, with the exception of 1 delayed reconstruction. RESULTS: The most common complications the patients experienced were seromas. In most cases, the surgeons successfully used the second port to drain periprosthetic fluid. CONCLUSIONS: The AlloX2 has been successful in treating seromas and should be considered a tool for noninvasive treatment of common complications of implant-based breast reconstruction. Three surgeons with varied backgrounds and techniques provide their surgical and postoperative management experiences and recommendations.

Trends in Physician Payments for Breast Reconstruction.

BACKGROUND: Prosthetic breast reconstruction rates have risen in the United States, whereas autologous techniques have stagnated. Meanwhile, single-institution data demonstrate that physician payments for prosthetic reconstruction are rising, while payments for autologous techniques are unchanged. This study aims to assess payment trends and variation for tissue expander and free flap breast reconstruction. METHODS: The Blue Health Intelligence database was queried from 2009 to 2013, identifying women with claims for breast reconstruction. Trends in the incidence of surgery and physician reimbursement were characterized by method and year using regression models. RESULTS: There were 21,259 episodes of breast reconstruction, with a significant rise in tissue expander cases (incidence rate ratio, 1.09; p < 0.001) and an unchanged incidence of free flap cases (incidence rate ratio, 1.02; p = 0.222). Bilateral tissue expander cases reimbursed 1.32 times more than unilateral tissue expanders, whereas bilateral free flaps reimbursed 1.61 times more than unilateral variants. The total growth in adjusted tissue expander mean payments was 6.5 percent (from $2232 to $2378) compared with -1.8 percent (from $3858 to $3788) for free flaps. Linear modeling showed significant increases for tissue expander reimbursements only. Surgeon payments varied more for free flaps (the 25th to 75th percentile interquartile range was $2243 for free flaps versus $987 for tissue expanders). CONCLUSIONS: The incidence of tissue expander cases and reimbursements rose over a period where the incidence of free flap cases and reimbursements plateaued. Reasons for stagnation in free flaps are unclear; however, the opportunity cost of performing this procedure may incentivize the alternative technique. Greater payment variation in autologous reconstruction suggests the opportunity for negotiation with payers.

The Use of Soft Tissue Expanders Prior to Total Ankle Arthroplasty.

Soft tissue coverage and tension-free closure can often be challenging in patients with ankle arthropathy being considered for total ankle arthroplasty. We present 2 patients with severe posttraumatic ankle arthropathy who underwent placement of a soft tissue expander to assist with soft tissue coverage prior to total ankle arthroplasty. LEVELS OF EVIDENCE: Level IV.

Reconstrucción mamaria posmastectomía con colgajo miocutáneo de dorsal ancho y expansión tisular / Posmastectomy breast reconstruction with latissimus dorsi myocutaneous flap and tissue expander

Introducción: El colgajo miocutáneo de dorsal ancho es una excelente opción para reconstruir la mama mutilada por enfermedad oncológica, pero tiene limitaciones en cuanto al volumen del implante a utilizar que garantice el cierre directo de la zona a tratar. De ahí que se consideró realizar este estudio utilizando el colgajo dorsal con un expansor mamario en el primer tiempo quirúrgico y luego la colocación del implante definitivo. Objetivo: caracterizar la experiencia de la reconstrucción mamaria con colgajo miocutáneo de músculo dorsal ancho y expansión tisular. Métodos: se realizó un estudio descriptivo longitudinal prospectivo de aquellas pacientes consultadas en el servicio de reconstructiva del Instituto Nacional de Oncología y Radiobiología (INOR) de La Habana, por presentar mastectomía por cáncer de mama. Se reconstruyeron a 20 pacientes, utilizando el colgajo miocutáneo de dorsal ancho con la utilización de expansor mamario. Luego de terminada la infiltración del expansor se esperaron 2 meses y se realizó el cambio del expansor por el implante definitivo y la remodelación de la mama contralateral. Resultados: el promedio de edad en el estudio fue de 43 años y el mayor porciento de casos se presentó entre las edades de 40 a 50 años. El tratamiento de la mama contralateral varió según las características de la misma y los deseos de la paciente. Se observaron complicaciones inmediatas como necrosis parcial del colgajo y complicaciones mediatas y tardías como extrusión y rotura del expansor. Se lograron resultados estéticos buenos y la mayoría de las pacientes manifestaron estar satisfechas con el proceder y con los resultados obtenidos. Conclusiones: todas las mujeres pudieron ser reconstruidas con adecuados resultados estéticos y algunas se favorecieron con mayor volumen de sus mamas(AU)

Introduction: the latissimus dorsi myocutaneous flap is an excellent option to reconstruct the breast mutilated for oncologic disease, but it has limitations regarding the volume of the implant to be used that guarantees the direct closure of the area to be treated. Hence, we considered to perform this study using the dorsal flap with a breast expander in the first time and then in a second time the placement of the definitive implant. Objective: to characterize the experience of breast reconstruction with myocutaneous flap of broad dorsal muscle and tissue expansion. Method: aprospective, longitudinal, descriptive study was carried out on patients consulted at the Reconstructive Service of National Institute for Oncology and Radiobiology (INOR) of Havana, for mastectomy due to breast cancer. 20 patients were reconstructed using the latissimus dorsi myocutaneous flap and a breast expander. After expiratory infiltration of the expander, we waited two months, and the expander change was made, using the definitive implant and remodeling of the contralateral breast. Results: the mean age in the study was 43 years and the highest percentage of cases were at ages 40-50 years. Treatment of the contralateral breast varied according to their characteristics and the patients' desires. Immediate complications were observed, such as partial necrosis of the flap and mediating and late complications such as extrusion and rupture of the expander. Good aesthetic results were achieved and most patients stated that they were satisfied with the procedure and the outcomes obtained. Conclusions: all women could be reconstructed with adequate esthetic outcomes and some were favored with greater volume of their breasts(AU)

Breast reconstruction after mastectomy: A ten-year analysis of trends and immediate postoperative outcomes.

The landscape of breast reconstruction has changed significantly. This study assesses trends in type of reconstruction performed after mastectomy and impact on immediate postoperative complications. METHODS: Data for 67,450 patients undergoing mastectomy for breast cancer were analyzed using the National Surgical Quality Improvement Program (NSQIP) database for years 2005-2014. Primary outcomes were wound, nonwound related infections, and bleeding complications. Data were analyzed by univariate and multivariate analysis. RESULTS: The percentage of patients that underwent reconstruction after breast cancer increased from 26.94% in 2005 to 43.30% in 2014 (p < 0.01). There was increased wound (5.59%), bleeding (6.82%), and infection (1.80%) complications after flap-based reconstruction (p < 0.01). There was no difference in wound, infection, and bleeding complications between immediate implant reconstruction and tissue expander (TE) at 4.38 vs. 3.89% (p = 0.18), 0.82 vs. 0.7%, p = 0.46), and 0.76 vs. 0.64% (p = 0.45), respectively. Several independent factors were associated with increased wound complications in patients undergoing all or any forms of reconstruction after mastectomy such as being overweight (OR 1.38, CI 1.23-1.55), obese (OR 2.11, CI 1.89-2.35), morbidly obese (OR 3.84, CI 3.34-4.43), ASA Class III (OR 1.35, CI 1.08-1.69), ASA Class IV (OR 1.49, 1.06-2.10), diabetic (OR 1.28 , CI 1.14-1.43), and smokers (OR 1.76, CI 1.59-1.94). TRAM flap was associated with increased risk of wound complication (OR 1.87, CI 1.28-2.75). CONCLUSION: More women are undergoing reconstruction as utilization of TE increases drastically. Immediate implant placement has only seen moderate increase likely due to surgeon preference.

Ectopic implantation of an avulsed scalp with a tissue expander on a forearm for combined total scalp avulsion and spine injuries: A case report.

Total scalp avulsion with severe cervical spine injury is a contraindication for emergency replantation of the scalp to its anatomical site. We describe a case involving the ectopic implantation of an avulsed scalp on the forearm. A 41-year-old woman presented with severe total scalp avulsion and tears in the intervertebral discs at the C4/5 and C5/6 levels. The avulsed scalp was ectopically implanted on the left forearm with a tissue expander to provide support. Two-stage replantation of the scalp at its anatomical site was performed 19 and 40 days later. Replantation was successful, and the avulsed tissue exhibited excellent viability. In conclusion, this case shows that the ectopic implantation of the avulsed scalp on the forearm may be an option for total scalp avulsion with cervical spine injury.

Penile Improvement Protocol in Postoperative Management of Patients Undergoing Metoidioplasty.

OBJECTIVE: To introduce a postoperative protocol to optimize the final size of the penis in patients undergoing metoidioplasty. PATIENTS AND METHODS: Fourteen patients with the mean age of 29.3 years (8-40 ± 11.7), ten female transsexuals (46 xx karyotype) and four with 5-alpha-reductase deficiency syndrome (5ARDS) who had undergone extensive metoidioplasty entered a penile improvement protocol (PIP) between 2007 and 2015 at a specialized clinic in a general hospital in Tehran, Iran. Subjects were thoroughly instructed, rehearsed on the protocol and closely followed for 24 weeks. Written informed consent was obtained from all participants. We adapted a popular device, the so-called penile traction device, to accommodate the size of the neo-penis. RESULTS: All patients achieved an increase in their penile length with a mean of 28.42 mm (21-47 ± 6.86). Two subjects developed penile bruises and edema during the protocol implementation. No significant procedural complications were detected in the remaining 12 participants. CONCLUSIONS: PIP can be an effective step in increasing the size of the neo-penis in patients who have undergone metoidioplasty. We suggest this procedure to be seriously considered in postoperative management of well-informed and motivated patients to improve the final penile length and function in this population. Larger studies are needed to further validate this protocol. LEVEL OF EVIDENCE II: This journal requires that the authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A Randomized Controlled Trial Comparing Endoscopic-Assisted Versus Open Neck Tissue Expander Placement in Reconstruction of Post-Burn Facial Scar Deformities.

BACKGROUND: Tissue expansion has evolved reconstruction surgery by providing a great source of additional tissue for large skin defects. Nevertheless, wide application of tissue expander reconstruction is challenging due to high complication rates and uncertainty about final outcomes. Recently, endoscopy has shown promise in reconstructive surgeries using tissue expander placement. AIMS: This study aimed to compare outcomes between open and endoscopic-assisted neck tissue expander placement in reconstruction of post-burn facial scar deformities. METHODS: Through a randomized clinical trial, 63 patients with facial burn scars were assigned to an open group or endoscopic group for placement of 81 tissue expanders. The complication rate, operative time, length of hospital stay, and time to full expansion were compared between the two groups. RESULTS: Thirty-one patients were assigned to the open group and 32 patients to the endoscopic group. The average operative time was significantly reduced in the endoscopic group compared with the open group (42.2 ± 3.6, 56.5 ± 4.5 min, p < 0.05). The complication rate was significantly lower in the endoscopic group than the open group (6 vs. 16, p < 0.05). Hospital stay was also significantly diminished from 26.3 ± 7.7 h in open group to 7.4 ± 4.5 h in endoscopic group (p < 0.0001). There was a significant reduction in time to full expansion in the endoscopic group as compared with the open group (93.5 ± 10.2 vs. 112.1 ± 14.2 days, p = 0.002). CONCLUSION: Endoscopic neck tissue expander placement significantly reduced operative time, the postoperative complication rate, length of hospital stay, and time to achieve full expansion and allowed early initiation of expansion and remote placement of the port in relation to the expander pocket. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Results from the ASPIRE study for breast reconstruction utilizing the AeroForm™ patient controlled carbon dioxide-inflated tissue expanders.

BACKGROUND: Therapeutic or prophylactic mastectomy is often indicated for women with breast cancer, or for those at a high risk of developing cancer due to familial history or genetic mutations. Favorable aesthetic and psychological results make prosthetic reconstruction of the breast with placement of tissue expanders followed by permanent implant a popular choice for women diagnosed with breast cancer. This study describes the results of the ASPIRE trial, the objective of which was to provide supportive data to demonstrate the performance and safety of the AeroForm™ System in a population with broader selection criteria than previous studies. Results of the earlier PACE clinical studies (PACE 1 and 2) demonstrated that the AeroForm™ System could be used safely and effectively to achieve the desired expansion necessary for successful breast reconstruction. In the current ASPIRE trial described in the paper, performance of the device was evaluated by successful tissue expansion and exchange to breast implant(s) unless precluded by a non-device related event. Safety data was evaluated based on reported adverse events. METHODS: A prospective, single center, open-label study in which subjects who met the inclusion criteria and agreed to participate were enrolled and implanted with the AeroForm expander either at the time of mastectomy (immediate) or sometime after mastectomy (delayed). In the event of a bilateral procedure, the expander was implanted in each side. Subjects were followed until the explant of the tissue expander(s) and exchange for silicone or saline breast implant(s). RESULTS: Thirty-four expanders were placed in 21 subjects in the clinical trial; the average age of subjects was 49.7 ± 8.6 years with average BMI of 26.1 ± 4.7. Bilateral procedures accounted for 62% of the total and 88% of the reconstructions were completed with a latissimus dorsi flap (anterior approach) per the investigators standard procedure. Four (12%) of the cases (12%) were completed in two subjects using an inferior dermal flap. Overall success rate was 94% (32/34 breasts) with no device related reconstruction failures. Two subjects failed reconstruction, one due to infection and one due to wound healing issues, both requiring unilateral expander removal and revision surgery. However, successful second stage reconstruction was completed in both subjects in a delayed procedure. CONCLUSION: The ASPIRE trial reports confirmatory data in a more inclusive patient population than the previous PACE 1 and 2 trials, indicating that the AeroForm Expander, provides a time-saving, needle-free, safe and effective method of tissue expansion for breast reconstruction. There were no device related complications that precluded the subjects from achieving the study goal of a permanent implant exchange. Reported complications are similar to those reported in the literature for tissue expansion procedures. Further development may enable a single dose controller to operate both expanders in a bilateral patient and increase the size range offered with this promising technology.

Does acellular dermal matrix really improve aesthetic outcome in tissue expander/implant-based breast reconstruction?

BACKGROUND: The expectation for improved results by women undergoing postmastectomy reconstruction has steadily risen. A majority of these operations are tissue expander/implant-based breast reconstructions. Acellular dermal matrix (ADM) offers numerous advantages in these procedures. Thus far, the evidence to justify improved aesthetic outcome has solely been based on surgeon opinion. The purpose of this study was to assess aesthetic outcome following ADM use in tissue expander/implant-based breast reconstruction by a panel of blinded plastic surgeons. METHODS: Mean aesthetic results of patients who underwent tissue expander/implant-based breast reconstruction with (n = 18) or without ADM (n = 20) were assessed with objective grading of preoperative and postoperative photographs by five independent blinded plastic surgeons. Absolute observed agreement as well as weighted Fleiss Kappa (κ) test statistics were calculated to assess inter-rater variability. RESULTS: When ADM was incorporated, the overall aesthetic score was improved by an average of 12.1 %. In addition, subscale analyses revealed improvements in breast contour (35.2 %), implant placement (20.7 %), lower pole projection (16.7 %), and inframammary fold definition (13.8 %). Contour (p = 0.039), implant placement (p = 0.021), and overall aesthetic score (p = 0.022) reached statistical significance. Inter-rater reliability showed mostly moderate agreement. CONCLUSIONS: Mean aesthetic scores were higher in the ADM-assisted breast reconstruction cohort including the total aesthetic score which was statistically significant. Aesthetic outcome alone may justify the added expense of incorporating biologic mesh. Moreover, ADM has other benefits which may render it cost-effective. Larger prospective studies are needed to provide plastic surgeons with more definitive guidelines for ADM use. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Disparities associated with breast reconstruction in Japan.

BACKGROUND: With increasing rates of postmastectomy breast reconstruction, it has been suggested that there is an insufficient supply of services that meet patient demands. This study aimed to identify potential disparities in, and variables associated with, postmastectomy reconstruction in Japan. METHODS: Using 20,257 Japanese breast cancer discharge data from 2010, the authors identified 1616 breast cancer patients, with tumor-node-metastasis classification of malignant tumors T1~4 and N0M0, between 20 and 59 years of age. Factors influencing the use of immediate breast reconstruction of either autogenous tissue or tissue expander placement were analyzed using multinomial logistic regression comparing no reconstruction to either autogenous tissue or tissue expander placement. RESULTS: The immediate breast reconstruction rate was 11.2 percent among the study patients. The rate of autogenous method use was 49 percent and the rate of tissue expander use was 51 percent. Tissue expander placement was performed primarily in patients who resided in cities (OR, 2.4; 95 percent confidence interval, 1.5 to 4.1) and was performed at city hospitals. Patients who lived in rural areas primarily underwent autogenous tissue reconstruction, traveled to city hospitals to undergo surgery (OR, 2.0; 95 percent confidence interval, 1.0 to 4.0), and had normal body mass index (OR, 1.9; 95 percent confidence interval, 1.1 to 3.1). CONCLUSIONS: The authors identified potential disparities associated with breast reconstruction. These disparities might be due to limited surgery methods and might have excluded some patients because of their age, physical, and economic status. Uneven distribution of plastic surgeons might have required patients to travel for breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Breast reconstruction modality outcome study: a comparison of expander/implants and free flaps in select patients.

BACKGROUND: Choosing a breast reconstructive modality after mastectomy is a critical step involving complex decisions. The authors provide outcomes data comparing two common reconstructive modalities to assist patients and surgeons in preoperative counseling and discussions. METHODS: A prospectively maintained database was queried identifying select patients undergoing expander/implant and abdominally based free flaps for breast reconstruction between 2005 and 2008. Variables evaluated included comorbidities, operations, time to reconstruction, complications, overall outcome, clinic visits, revisions, and costs. RESULTS: One hundred forty-two patients received free flaps and 60 received expander/implants. Expander/implant patients required more procedures (p < 0.001) but had shorter overall hospital lengths of stay (p < 0.001). The two cohorts experienced a similar rate of revision (p = 0.17). Free flap patients elected to undergo nipple-areola reconstruction more frequently (p = 0.01) and were able to sooner (p < 0.0001). Patients undergoing expander/implant reconstruction had a higher rate of failure (7.3 versus 1.3 percent, p = 0.008). Free flap patients achieved a stable reconstruction significantly faster (p = 0.0005), with fewer visits (p = 0.02). Cost analysis demonstrated total cost trended toward significantly lower in the free flap cohort (p = 0.15). Reconstructive modality was the only independent factor associated with time to stable reconstruction and reconstructive failure (p < 0.001 and p = 0.05, respectively). CONCLUSIONS: The authors' analysis revealed that free flap reconstructions required fewer procedures, had lower rates of complications and failures, had fewer clinic visits, and achieved a final, complete reconstruction faster than expander/implant reconstructions. Although autologous reconstruction is still not ideal for every patient, these findings can be used to enhance preoperative discussions when choosing a reconstructive modality. CLINICAL QUESTION/LEVEL OF EVIDENCE: : Therapeutic, III.