Value of ultrasound-guided vacuum-assisted excision in the treatment of non-malignant breast nodules diagnosed as BI-RADS 4A or higher by ultrasound.

Background: In clinical practice, decision-making for Breast Imaging Reporting and Data System (BI-RADS) category 4A breast nodules poses significant challenges. Although 2-10% of such nodules are malignant, the majority are benign or high-risk lesions. Conventional management strategies-ranging from short-term imaging follow-up to open surgical excision (SE)-are associated with limitations: the former increases psychological burden and risk of loss to follow-up, while the latter entails trauma, cost, and aesthetic concerns. Ultrasound-guided vacuum-assisted excision (VAE), as a minimally invasive technique, enables both diagnosis and treatment. Compared with core needle biopsy (CNB), VAE achieves more complete removal; compared with open surgery, it is less traumatic, allows faster recovery, and yields better cosmetic outcomes. Nevertheless, the precise clinical value of VAE in managing nodules initially assessed as BI-RADS 4A or higher but pathologically confirmed as non-malignant remains inadequately defined. In particular, robust evidence regarding its complete excision rate, long-term local recurrence rate, and risk of malignant transformation is lacking, contributing to variability in clinical practice. This study aimed to evaluate the efficacy of ultrasound-guided VAE in treating non-malignant breast nodules diagnosed as BI-RADS 4A or higher by ultrasound, and to assess the rates of recurrence and malignant transformation post-VAE. Methods: A retrospective analysis was conducted on 262 patients diagnosed with non-malignant breast nodules classified as BI-RADS 4A or higher by ultrasound who underwent VAE between January 2014 and December 2022. Post-VAE follow-up was performed to observe the rates of nodule recurrence and malignant transformation. Results: Among the 262 patients, 10 experienced recurrence post-VAE, resulting in a local recurrence rate of 3.8%. Of these, 3 cases were benign phyllodes tumors, and 7 were intraductal papillomas. One patient developed malignant transformation post-VAE, yielding a malignant transformation rate of 0.4%. The patient underwent VAE surgery and the pathological findings suggested breast adenosis. The overall rate of recurrence and malignant transformation was 4.2%. No statistically significant differences were observed between the recurrence/malignant transformation group and the non-recurrence/non-malignant transformation group in terms of age, distance of the nodule from the nipple or BI-RADS classification (P<0.05). Conclusions: VAE is an effective treatment for non-malignant breast nodules diagnosed as BI-RADS 4A or higher by ultrasound, with a low rate of recurrence and malignant transformation, indicating a certain level of safety. However, we recommend regular follow-up after VAE, with follow-up conducted every two years, and any suspicious lesions detected during follow-up should be actively diagnosed and treated.