Evaluation of the BREAST-II Trial for Total Breast Reconstruction Solely Using Autologous Fat Transfer: 1-Year Follow-Up.

Abstract

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. 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. 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. 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. 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. AFT: Introduction of a Full Breast Reconstructive Method (BREAST-II). NCT04261829. Introduction of a Full Breast Reconstructive Method | ClinicalTrials.gov.