Fat Grafting With Expanded Adipose-Derived Stromal Cells for Breast Augmentation: A Randomized Controlled Trial.

BACKGROUND: The main challenge with fat grafting is loss of some of the graft to postsurgery resorption. Previous studies suggest that adipose-derived stromal cells (ASCs) can improve the volume retention of fat grafts but there is a lack of randomized trials to support the use of ASCs in clinical practice. OBJECTIVES: This trial aimed to investigate whether ASCs improve fat graft volume retention in patients undergoing breast augmentation with lipofilling. METHODS: This was a double-blind, randomized controlled trial of breast augmentation with ASC-enriched fat grafting. Healthy women aged 30 to 45 years were enrolled. First, the participants underwent liposuction to obtain fat for culture expansion of ASCs. Then, the participants were randomly assigned to undergo a 300- to 350-mL breast augmentation with ASC-enriched fat grafting (10 × 106 ASCs/mL fat graft) to 1 of their breasts and placebo-enriched fat grafting of identical volume to the contralateral breast. The primary outcome was fat graft volume retention after a 1-year follow-up measured with MRI. The trial is registered at www.clinicaltrialsregister.eu (EudraCT-2014-000510-59). RESULTS: Ten participants were included in the trial; all completed the treatment and follow-up. No serious adverse events occurred. Fat graft volume retention after 1 year was 54.0% (95% CI, 30.4%-77.6%) in the breasts treated with ASC-enriched fat grafting (n = 10) and 55.9% (95% CI, 28.9%-82.9%) in the contralateral breasts treated with placebo-enriched fat grafting (n = 10) (P = 0.566). CONCLUSIONS: The findings of this trial do not support that ASC-enriched fat grafting is superior to standard fat grafting for breast augmentation.

Risk factors for local atypical fibroxanthoma recurrence and progression to pleomorphic dermal sarcoma: A meta-analysis of individualized participant data.

BACKGROUND: Risk factors for local atypical fibroxanthoma (AFX) recurrence and progression to pleomorphic dermal sarcoma (PDS) have not previously been identified. OBJECTIVE: To identify risk factors and provide follow-up suggestions for local AFX recurrence and progression to PDS. METHODS AND MATERIALS: A literature search was performed in the PubMed, EMBASE, and Cochrane databases. The PRISMA and MOOSE guidelines were followed. The risks of local AFX recurrence and progression to PDS were presented as Kaplan-Meier plots and risk factors were presented as hazard ratios (HRs) calculated with univariate and multivariate Cox regression. RESULTS: Five hundred and ninety-eight patients with AFX from 14 studies were included. Age >74 years and male sex significantly increased the risk of local recurrence (HR: 7.31 [95% confidence interval [CI]: 1.78-30.0], p < 0.01 and HR: 2.89 [95% CI: 1.04-8.01], p < 0.05, respectively). There was no difference when comparing wide local excision and Mohs' micrographic surgery (p = 0.89). The risks of local AFX recurrence and progression to PDS after 2 years were <1%. CONCLUSION: A more intensive follow-up regimen could be considered in patients >74 years old and males due to the higher risk of local AFX recurrence.

Hematoma and deep surgical site infection following primary breast augmentation: A retrospective review of 1128 patients.

BACKGROUND: Breast augmentation is one of the most frequently performed cosmetic surgery worldwide. Some of the most severe short-term complications after breast augmentation are hematoma and deep surgical site infection. However, these complications are relatively rare; therefore, large patient populations are required to perform statistical analyses. In this study, we provide a detailed analysis of the complications after primary breast augmentation with an emphasis on deep surgical site infection and hematoma. METHOD: We retrospectively reviewed the medical records of women who underwent primary breast augmentation without the use of pocket irrigation between 2012 and 2019 in a single private clinic. A cumulative hazard function and a multivariate analysis on the risk of hematoma were performed. RESULTS: We included 1128 patients in the study. Thirty patients (2.7%) developed postoperative hematoma after a median time of 14 h (IQR 5 h-9 days). Six patients (0.5%) contracted a deep surgical site infection after a median time of 14 days (range 4-41 days). Age, BMI, implant volume, or implant placement was not significantly associated with hematoma. CONCLUSION: Our findings support that the risk of hematoma after primary breast augmentation is highest within the first 24 h after the surgery. This time period should be considered when planning postoperative care for these patients. We did not find an increased rate of deep surgical site infection compared with studies of breast augmentations with pocket irrigation. Further studies and meta-analyses are needed to explore the effect of pocket irrigation and other risk factors.

Breast Augmentation with Microtextured Anatomical Implants in 653 Women: Indications and Risk of Rotation.

BACKGROUND: Anatomical implants provide a wide range of options in terms of implant dimensions for breast augmentation. Nevertheless, many surgeons choose not to use anatomical implants due to the risk of rotation malposition and because their advantages over round implants are not clearly defined. METHODS: A retrospective review of medical records was performed on all women who underwent breast augmentation or implant exchange with microtextured anatomical implants from 2012 to 2019 in a single private clinic. The authors focused on the outcomes of a subgroup of women with glandular ptosis and nipple placement below the inframammary fold who underwent breast augmentation with anatomical implants. Furthermore, the incidence and risk factors for implant rotation were analyzed. RESULTS: In total, 653 women underwent primary breast augmentation (n = 529) or implant exchange (n = 124) with anatomical implants. The median follow-up period was 2.7 years (interquartile range, 1.6 to 3.9 years). The incidence of implant rotation was 14 (2.6 percent) in the primary augmentation group and four (3.2 percent) in the implant exchange group. Implant rotation was not associated with type of surgery (p = 0.76), implant projection (p = 0.23), or implant height (p = 0.48). The authors successfully used anatomical implants to elevate the nipple in 92.9 percent of the women with glandular ptosis without using a mastopexy. CONCLUSIONS: The study results indicate that the rotation risk with microtextured implants is similar to that with macrotextured implants. Furthermore, the authors found that high-projection anatomical implants can be used as an alternative to augmentation-mastopexy in women with glandular ptosis. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

New Validated Method for Measuring Fat Graft Retention in the Breast with MRI.

In this study, we present a new method for measuring fat graft volume retention in the breast based on magnetic resonance imaging scans and a validation study to assess its accuracy and precision. The method was validated by 4 observers using the magnetic resonance imaging scans of 14 patients undergoing breast augmentation with fat grafting. The method was translated into software and was used to measure the change in breast volume from a preoperative scan to a postoperative scan recorded within 3 hours after the surgery, which was compared with the injected fat graft volume. The new method measured the injected fat graft volumes with an average systematic overestimation of 6.3% (SD, 10.5). The median interobserver variation was <7%. We propose that this new method can be a good alternative to previous techniques for clinical research purposes. The software can be made available upon request free of charge for use on the MeVisLab platform.

Breast Reduction with Deskinning of a Superomedial Pedicle: A Retrospective Cohort Study.

BACKGROUND: In most breast reduction techniques, the pedicle of the nipple-areola complex (NAC) is de-epithelialized to preserve the subdermal plexus, thereby decreasing the risk of NAC necrosis. However, deskinning the pedicle is faster and makes it more pliable, which potentially improves the aesthetic outcome. There is no scientific evidence regarding the beneficial effects of de-epithelialization. In this study, we present data from patients undergoing breast reduction with deskinning of a superomedial pedicle. METHODS: In the period June 2013 to March 2019, a single surgeon performed all breast reductions using a superomedial glandular pedicle. The patients were included retrospectively and data were collected by reviewing the medical records. The NAC necrosis rate was compared with data from the literature through a systematic review. RESULTS: The cohort consisted of 142 consecutive patients. The median resection weight was 287 g (interquartile range (IQR), 197-399) per breast. No complete NAC necroses occurred during the follow-up period, but two patients (1.4%) developed partial NAC necrosis. In the literature, the rate of NAC necrosis (complete or partial) was 1.5% of patients undergoing breast reduction with de-epithelialization. CONCLUSION: The rate of NAC necrosis after breast reduction with deskinning of the pedicle was comparable with breast reductions with de-epithelialization that has been reported in the literature. Our findings support that the pedicle in breast reduction surgery can be deskinned safely in patients with low resection weights.

Complications after Breast Augmentation with Fat Grafting: A Systematic Review.

BACKGROUND: Breast augmentation with fat grafting is used as an alternative to breast implants. However, a systematic evaluation of the complication rates after fat grafting using only studies with consecutive patients has not previously been performed. In this study, the authors compiled studies reporting complication rates and radiologic changes in consecutive patients undergoing cosmetic breast augmentation with fat grafting. METHODS: Studies reporting on consecutive patients undergoing breast augmentation with fat grafting were included. Complication rates, radiologic changes, Breast Imaging Reporting and Data System assessments, and the number of patients undergoing revision surgery were extracted. Mean complication rates and radiologic changes were calculated with meta-analytical methods. RESULTS: Twenty-two studies with 2073 patients were included. The rates of major complications were low (hematoma, 0.5 percent; infection, 0.6 percent; and seroma, 0.1 percent). None of these patients needed revision surgery. The most frequent minor complication was palpable cysts in 2.0 percent of the patients; 67 percent of these were treated with aspiration. The radiologic changes in the patients after fat grafting were as follows: oil cysts, 6.5 percent; calcifications, 4.5 percent; and fat necrosis, 1.2 percent. The risk of being referred for additional radiologic imaging (e.g., to exclude malignant changes) was 16.4 percent, and the risk of being referred for biopsy was 3.2 percent. CONCLUSIONS: The complication rates after breast augmentation with fat grafting are low and support fat grafting as an alternative to breast augmentation with implants. The rates of radiologic changes are high after fat grafting, but the changes do not seem to have any therapeutic consequences for the patients.

Cell-Enriched Fat Grafting Improves Graft Retention in a Porcine Model: A Dose-Response Study of Adipose-Derived Stem Cells versus Stromal Vascular Fraction.

BACKGROUND: Cell-enrichment of fat grafts has produced encouraging results, but the optimal concentrations and types of added cells are unknown. The authors investigated the effects of enrichment with various concentrations of ex vivo-expanded adipose-derived stem/stromal cells and stromal vascular fraction on graft retention in a porcine model. METHODS: Adipose-derived stem/stromal cells were culture-expanded, and six fat grafts (30 ml) were prepared for each minipig (n = 13). The authors investigated grafts enriched with 2.5 × 10 to 20 × 10 adipose-derived stem cells/ml and stromal vascular fraction and nonenriched control grafts. Each pig served as its own control. Magnetic resonance imaging was performed immediately after grafting and 120 days postoperatively before the pigs were euthanized, and histologic samples were collected. RESULTS: The authors recorded an enhanced relative graft retention rate of 41 percent in a pool of all cell-enriched grafts compared to the nonenriched control (13.0 percent versus 9.2 percent; p = 0.0045). A comparison of all individual groups showed significantly higher graft retention in the 10 × 10-adipose-derived stem/stromal cells per milliliter group compared with the control group (p = 0.022). No significant differences were observed between the cell-enriched groups (p = 0.66). All fat grafts showed a significantly better resemblance to normal fat tissue in the periphery than in the center (p < 0.009), but no differences in overall graft morphology were observed between groups (p > 0.17). CONCLUSIONS: Cell-enriched fat grafting improved graft retention and was feasible in this porcine model. No significant differences in graft retention were observed among the various adipose-derived stem/stromal cell concentrations or between adipose-derived stem/stromal cell and stromal vascular fraction enrichment. Future studies using this model can help improve understanding of the role of adipose-derived stem/stromal cells in cell-enriched fat grafting.

The current gold standard breast volumetry technique seems to overestimate fat graft volume retention in the breast: A validation study.

BACKGROUND: MRI is generally considered as the gold standard for measuring breast volume because of its high accuracy of the modality. Many techniques used to measure total breast volume have been validated, but none of these techniques have been validated for their ability to measure the volume retention of fat grafts in the breast. In this study, the authors investigated the accuracy of the most common MRI technique used to measure fat graft retention in the breast by measuring the volume changes after breast augmentation. METHODS: Patients undergoing breast augmentation with either breast implants or fat grafting underwent MRI scans before and after surgery. Blinded observers measured the change in breast volume from the MRI scans. The difference between the measured change in breast volume and the volume of the breast augmentation was used to determine the accuracy of the MRI technique. RESULTS: Twenty-eight patients with a total of 56 breasts were included. In total, 168 measurements of change in breast volume were performed by the observers. The MRI measurements of change in breast volume overestimated the true volumes of the breast augmentations by an average of 50.8%, and only 8 of the 168 individual measurements had measurement errors below 50 mL. CONCLUSION: The MRI technique, which is considered as the gold standard for the quantification of fat graft volume retention, was associated with a significant measurement error. These findings have potential implications for the interpretation of previously published results of studies based on this technique.

Efficacy of breast reconstruction with fat grafting: A systematic review and meta-analysis.

BACKGROUND: Breast reconstruction with fat grafting is a new alternative to prosthetic implants and flaps for women with breast cancer. In this study, we investigate the efficacy of fat grafting for breast reconstruction in a meta-analysis. METHODS: The study followed the PRISMA and MOOSE guidelines for systematic reviews and meta-analyses. Studies were included if the patients underwent complete breast reconstruction with fat grafting as the only treatment modality. The number of fat grafting treatments needed to complete a breast reconstruction was modeled in a meta-analysis for five treatment categories: modified radical mastectomy, skin-sparing mastectomy, and breast-conserving surgery; the two mastectomy groups were subdivided into nonirradiated and irradiated. RESULTS: Twenty-one studies were included in the meta-analysis. The studies comprised 1011 breast reconstructions in 834 patients. The estimated numbers of treatments to complete a reconstruction were 2.84-4.66 in the mastectomy groups and 1.72 in the breast-conserving surgery group. The number of fat grafting sessions needed to complete a breast reconstruction was significantly higher for the irradiated patients than for the nonirradiated patients (p < 0.05). There was no significant difference in the number of fat grafting sessions needed to complete a breast reconstruction after a modified radical mastectomy versus a skin-sparing mastectomy. CONCLUSIONS: This study provides an evidence-based foundation for several practical issues related to breast reconstruction with fat grafting. The analysis showed that radiotherapy is the most important factor associated with the number of treatment sessions needed to complete a breast reconstruction and with the rate of complications.

A Novel Porcine Model for Future Studies of Cell-enriched Fat Grafting.

BACKGROUND: Cell-enriched fat grafting has shown promising results for improving graft survival, although many questions remain unanswered. A large animal model is crucial for bridging the gap between rodent studies and human trials. We present a step-by-step approach in using the Göttingen minipig as a model for future studies of cell-enriched large volume fat grafting. METHODS: Fat grafting was performed as bolus injections and structural fat grafting. Graft retention was assessed by magnetic resonance imaging after 120 days. The stromal vascular fraction (SVF) was isolated from excised fat and liposuctioned fat from different anatomical sites and analyzed. Porcine adipose-derived stem/stromal cells (ASCs) were cultured in different growth supplements, and population doubling time, maximum cell yield, expression of surface markers, and differentiation potential were investigated. RESULTS: Structural fat grafting in the breast and subcutaneous bolus grafting in the abdomen revealed average graft retention of 53.55% and 15.28%, respectively, which are similar to human reports. Liposuction yielded fewer SVF cells than fat excision, and abdominal fat had the most SVF cells/g fat with SVF yields similar to humans. Additionally, we demonstrated that porcine ASCs can be readily isolated and expanded in culture in allogeneic porcine platelet lysate and fetal bovine serum and that the use of 10% porcine platelet lysate or 20% fetal bovine serum resulted in population doubling time, maximum cell yield, surface marker profile, and trilineage differentiation that were comparable with humans. CONCLUSIONS: The Göttingen minipig is a feasible and cost-effective, large animal model for future translational studies of cell-enriched fat grafting.