Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer: A Randomized Clinical Trial.

Importance: There is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment. Objective: To investigate quality of life (QoL) among patients undergoing a new breast reconstruction technique, autologous fat transfer (AFT), compared with that among patients undergoing implant-based reconstruction (IBR). Design, Setting, and Participants: The BREAST trial was a randomized clinical trial conducted between November 2, 2015, and October 31, 2021, performed in 7 hospitals across the Netherlands. Follow-up was 12 months. Referrals could be obtained from general practitioners and all departments from participating or nonparticipating hospitals. The patients with breast cancer who had undergone mastectomy and were seeking breast reconstruction were screened for eligibility (radiotherapy history and physique) by participating plastic surgeons. Patients receiving postmastectomy radiotherapy were excluded. Interventions: Breast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio. Main Outcomes and Measures: The statistical analysis was performed per protocol. The predefined primary outcome was QoL at 12 months after final surgery. This was measured by the BREAST-Q questionnaire, a validated breast reconstruction surgery questionnaire. Questions on the BREAST-Q questionnaire are scored from 0 to 100, with a higher score indicating greater satisfaction or better QoL (depending on the scale). Secondary outcomes were breast volume and the safety and efficacy of the techniques. Results: A total of 193 female patients (mean [SD] age, 49.2 [10.6] years) 18 years or older who desired breast reconstruction were included, of whom 91 patients in the AFT group (mean [SD] age, 49.3 [10.3] years) and 80 in the IBR group (mean age, 49.1 [11.0] years) received the allocated intervention. In total, 64 women in the AFT group and 68 women in the IBR group completed follow-up. In the IBR group, 18 patients dropped out mainly due to their aversion to implant use while in the AFT group 6 patients ended their treatment prematurely because of the burden (that is, the treatment being too heavy or tiring). The BREAST-Q scores were higher in the AFT group in all 5 domains and significantly higher in 3: satisfaction with breasts (difference, 9.9; P = .002), physical well-being: chest (difference; 7.6; P = .007), and satisfaction with outcome (difference, 7.6; P = .04). Linear mixed-effects regression analysis showed that QoL change over time was dependent on the treatment group in favor of AFT. The mean (SD) breast volume achieved differed between the groups (AFT: 300.3 [111.4] mL; IBR: 384.1 [86.6] mL). No differences in oncological serious adverse events were found. Conclusions and Relevance: This randomized clinical trial found higher QoL and an increase in QoL scores over time in the AFT group compared with the IBR group. No evidence was found that AFT was unsafe. This is encouraging news since it provides a third, less invasive reconstruction option for patients with breast cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02339779.

BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial.

INTRODUCTION: Pioneers have shown that it is possible to reconstruct a full breast using just autologous fat harvested by liposuction or autologous fat transfer (AFT). This study describes the first multicentre randomised study protocol to thoroughly investigate the effectiveness of AFT to reconstruct full breasts following mastectomy procedures (primarily and delayed). METHODS AND ANALYSIS: This study is designed as a multicentre, randomised controlled clinical superiority trial with a 1:1 allocation ratio. A total of 196 patients (98 patients per treatment arm) are aimed to be included. Patients who wish to undergo breast reconstruction with either one of the two techniques are randomly allocated into the AFT group (intervention) or the tissue-expander/prosthesis group (control). The primary outcome measure for the quality of life is measured by the validated BREAST-Q questionnaire. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethics committee of Maastricht University Medical Centre/Maastricht University; the trial has been registered at ClinicalTrials.gov. The results of this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peer-reviewed journals. TRIAL STATUS: Enrolment into the trial has started in October 2015. Data collection and data analysis are expected to be completed in December 2021. TRIAL REGISTRATION NUMBER: NCT02339779.

Autologous fat transfer to treat fibrosis and scar-related conditions: A systematic review and meta-analysis.

BACKGROUND: Autologous fat transfer (AFT), also known as lipofilling, has been demonstrated to be more than just a filler. Through both mechanical dissection and local tissue remodelling mediated by stem cells, it is thought to improve scar quality, function and even pain. This paper aims to investigate the evidence regarding its safety and effectiveness for treating fibrosis and scar-related conditions. METHODS: A literature search was performed in PubMed, Embase and the Cochrane Library to identify relevant studies. Extensive data extraction and standardization allowed conducting a meta-analysis. RESULTS: Forty-five studies (3033 patients) provided sufficient data for meta-analysis. The AFT treatment resulted in significant increase in satisfaction scores of both patient and surgeon (p  = â€¯0.001). Furthermore, a significant overall scar improvement was also found in the evaluation using the Patient and Observer Scar Assessment Scale, with the most notable effect in the scar stiffness (p<0.001) and pliability (p  = â€¯0.004). In patients with severe pain, AFT resulted in a significant pain reduction of 3.7 points on the Visual Analogue Scale (p<0.001). Last, but not the least, the evidence suggests a significant recovery of radiotherapy-induced tissue damage (p  = â€¯0.003) and function (p  = â€¯0.012). On average, 1.4 procedures were required to achieve the desired result. Minor complications occurred in 4.8% of the procedures. CONCLUSIONS: AFT is a promising treatment for fibrosis and scar-related conditions. Future research should focus on determining the long-term effects of AFT on fibrosis, pain and function. In addition, it would be crucial to quantify the mechanical and regenerative properties of fat as well as the effect of added supplements or stem cells.

Efficacy of autologous fat transfer for the correction of contour deformities in the breast: A systematic review and meta-analysis.

BACKGROUND: Autologous fat transfer (AFT), also known as fat grafting or lipofilling, has already become a part of clinical practice for treating contour deformities of the breast, even though evidence regarding its efficacy is still lacking. This is the first meta-analysis on this subject, aimed to facilitate intuitive interpretation of the available data by clinicians, guideline committees and policy makers. METHODS: A literature search was performed on 1 September 2017 in PubMed, EMBASE and the Cochrane Library to identify all relevant studies. A rigorous data extraction and standardisation process allowed pooling of clinical outcome data into a meta-analysis. RESULTS: Eighty-nine studies consisting of 5350 unique patients were included. The mean follow-up was 1.9 years. Meta-analysis revealed a very high overall patient and surgeon satisfaction rate of 94.3% and 95.7%, respectively, which was also confirmed by high satisfaction scores and Breast-Q scores. Overall, only 1.5 sessions were needed to achieve the desired result. Though evidence on the long-term volume retention is lacking, based on the current data it was calculated to be 52.4% at one year. Only 5.0% of procedures resulted in clinical complications and 8.6% of breasts required biopsy due to abnormal clinical or radiological findings. CONCLUSIONS: AFT seems to be an effective procedure in breast reconstruction, reflected by the high patient and surgeon satisfaction and low incidence of clinical and radiological complications. Future research should focus on evaluating the technical and patient factors influencing the rate of fat resorption as well as its oncological safety.

Efficacy and Safety of Autologous Fat Transfer in Facial Reconstructive Surgery: A Systematic Review and Meta-analysis.

IMPORTANCE: The use of autologous fat transfer (AFT) or lipofilling for correcting contour deformities is seen as one of the major breakthroughs in reconstructive plastic surgery. Its applications in facial reconstructive surgery have been of particular interest owing to the prospect of achieving autologous reconstruction by a minimally invasive approach. However, its unpredictability and variable degree of resorption have limited its utility and much skepticism still exists regarding its efficacy. Furthermore, more than 2 decades of clinical research have produced a highly fragmented body of evidence that has not been able to provide definite answers. OBJECTIVE: To investigate the safety and efficacy of AFT in facial reconstruction through a systematic review and meta-analysis. DATA SOURCES: A literature search was performed in PubMed, Embase, and the Cochrane Library from inception to October 11, 2017. STUDY SELECTION: All published studies investigating the efficacy and safety of AFT in facial reconstructive surgery. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers performed data extraction systematically, adhering to the PRISMA guidelines. Summary measures were pooled in a random-effects model meta-analysis. MAIN OUTCOMES AND MEASURES: The patient and surgeon satisfaction, graft survival, number of AFT sessions, and the incidence of AFT-related complications were the main outcomes of interest in this meta-analysis. RESULTS: This systematic review resulted in the inclusion 52 relevant studies consisting of 1568 unique patients. These included 4 randomized clinical trials, 11 cohort studies, and 37 case series. The overall follow-up averaged 1.3 years after AFT. Meta-analysis revealed a very high overall patient satisfaction rate of 91.1% (95% CI, 85.1%-94.8%) and overall surgeon satisfaction rate of 88.6% (95% CI, 83.4%-92.4%). The number of AFT sessions required to achieve the desired result was 1.5 (95% CI, 1.3-1.7) and 50% to 60% of the injected volume was retained at 1 year. Only 4.8% (95% CI, 3.3%-6.9%) of procedures resulted in clinical complications. CONCLUSIONS AND RELEVANCE: To our knowledge, this study provides the first overview of the current knowledge about AFT in facial reconstructive surgery. Our results confirm that AFT is an effective technique for treating soft-tissue deformities in the head and neck, with low rate of minor complications. LEVEL OF EVIDENCE: NA.

Autologous Fat Transfer for Facial Rejuvenation: A Systematic Review on Technique, Efficacy, and Satisfaction.

BACKGROUND: Parallel to the steady decline in surgical aesthetic procedures to the face, dermal fillers seem to have gained a more prominent place in facial rejuvenation over the last couple of years. As a dermal, facial filler, autologous fat transfer (AFT) seems to have real potential because of the biocompatibility of adipose tissue besides being a procedure with few and primarily minor complications. This systematic review aims to evaluate the available evidence regarding the safety and effectiveness of AFT for facial rejuvenation. METHOD: A systematic review after the Preferred-Reporting-Items-for-Systematic-Reviews-and-Meta-Analysis (PRISMA) statement was conducted. MEDLINE, Embase, and Cochrane Library were searched up to December 2016, with no language restrictions imposed. Case series, cohort studies, and randomized controlled trials (RCTs) reporting on relevant outcomes were included. RESULTS: Eighteen clinical articles were included, reporting on 3,073 patients in total over a mean follow-up period of 13.9 months. Meta-analysis showed an overall complication rate of 6% (95% CI 3.0-14.0), with hematoma/ecchymosis (5%), fat necrosis/oil cysts (2%), and irregular fat distribution and scars (both 2%) being among the most reported. No major complications were reported, and the overall patient satisfaction rate was 81%. CONCLUSION: Although the evidence in this systematic review is still limited and plagued by heterogeneity between studies, AFT seems to be a promising method in facial rejuvenation with fewer complications than other fillers and high patient satisfaction rates. Further large-cohort, preferably multicenter, RCTs should substantiate these results through quantifiable volumetric assessment tools and validated patient questionnaires, while adhering to predetermined nomenclature in terms of complications.