Background: Autologous Fat Transfer (AFT) has emerged as a promising technique for total breast reconstruction post-mastectomy, particularly in patients unsuitable for other reconstruction methods. Evaluating its efficacy, safety, and impact on quality of life is essential. Objective: To assess the efficacy and safety outcomes of AFT as total breast reconstruction in women post-mastectomy, based on 12-month follow-up data from the BREAST-II trial. Methods: This multicentre, nonrandomised clinical trial included women aged ≥18 years with a history of or planned mastectomy across eight Dutch hospitals. Participants underwent multiple AFT sessions combined with external expansion using the EVE-bra device, with a maximum of five sessions over 12 months. Primary outcome was quality of life measured by BREAST-Q and BODY-Q questionnaires. Secondary outcomes included safety (serious adverse events SAEs), operating time, hospital stay, and number of sessions. Results: A total of 229 women were included. At 12 months post-AFT, significant improvements were observed in psychosocial well-being (+5.72 ±16.79), sexual well-being (+8.05 ±19.61), physical well-being of the chest (+5.97 ±20.44), and chest satisfaction (+17.22 ±27.27) (all p<0.001). BODY-Q scores showed significant increases in satisfaction with abdomen, back, body, hips/outer thighs, inner thighs, and scars (all p<0.001). Among 805 AFT sessions, 52 (S)AEs occurred (6.46% complication rate). Hospital stays were less than one day per session. Conclusions: AFT is an effective and safe total breast reconstruction technique post-mastectomy, significantly improving quality of life with low complication rates. These findings support AFT as a valuable addition to breast reconstruction options. Trial registration: AFT: Introduction of a Full Breast Reconstructive Method (BREAST-II) ClinicalTrials.gov ID: NCT04261829 Study Details | AFT: Introduction of a Full Breast Reconstructive Method | ClinicalTrials.gov
Venne et al. (Thu,) studied this question.