Clinical practice guidelines for ultrasound-guided vacuum-assisted breast biopsy: Chinese Society of Breast Surgery (CSBrS) practice guidelines 2021



## Level of evidence and recommendation strength
Level of evidence standard [bib_ref] Clinical practice guidelines for sentinel lymph node biopsy in patients with early-stage..., Ye [/bib_ref] Recommendation strength standard [bib_ref] Clinical practice guidelines for sentinel lymph node biopsy in patients with early-stage..., Ye [/bib_ref] Recommendation strength review committee There were 82 voting committee members for this guideline: 66 from breast surgery departments (80.5%), six from medical oncology departments (7.3%), four from medical imaging departments (4.9%), two from pathology departments (2.4%), two from radiotherapy departments (2.4%), and two epidemiologists (2.4%).

## Target audience
Clinicians specializing in breast diseases in China.II A

## Recommendations

# Discussion
The expert group believes that ultrasound guided VABB is safe, fast, effective, economical, without radioactivity, and permits monitoring the location of the biopsy needle in real time. [bib_ref] Expert consensus and operation guidelines for ultrasound-guided vacuum-assisted breast biopsy surgery (2017)..., Fan [/bib_ref] [bib_ref] Image-guided breast biopsy and localisation: recommendations for information to women and referring..., Bick [/bib_ref] The VABB technique was approved by the US Food and Drug Administration (FDA) in April 1995. In 1999, the American Medical Association announced that image-guided VABB is a reliable diagnostic technique that replaces surgical biopsy. In 1999, the technique was approved by the China Food and Drug Administration for clinical use in China. In 2004, the US FDA approved VABB for "total excision of abnormalities found in imaging," that is, the technique can be applied to remove benign breast lesions.After VABB was introduced in China, because of the high cost, it was mainly used for treatment purposes and was extensively recognized by breast surgeons and patients. With the continuous upgrading of this technique, its applications are increasingly extensive, and it is currently used for diagnosis and treatment in breast surgery.
According to previous reports, VABB is superior to core needle biopsy (CNB) in terms of the specificity of the histopathological diagnosis of lesion biopsy for diagnosis. The underestimation rates of VABB and CNB for ductal carcinoma in situ in a previous study were 9% and 38%, respectively, and the underestimation rates of these techniques for high-risk lesions were 11% and 25%, respectively. [bib_ref] Core Needle and Open Surgical Biopsy for Diagnosis of Breast Lesions: An..., Dahabreh [/bib_ref] According to the recommendations of the expert group, the indication of VABB for diagnostic purposes is ultrasound diagnosis of breast imaging reporting and data system (BI-RADS) classification IV lesions, [bib_ref] The evolving role of vacuum assisted biopsy of the breast: a progression..., Bennett [/bib_ref] especially for lesions with small volumes (largest diameter <1.0 cm). VABB is also preferred for biopsy of lesions adjacent to the chest wall or a prosthesis. [bib_ref] Clinicopathological analysis of ultrasound-guided vacuum-assisted breast biopsy for the diagnosis and treatment..., Park [/bib_ref] [bib_ref] Core Needle and Open Surgical Biopsy for Diagnosis of Breast Lesions: An..., Dahabreh [/bib_ref] For lesions with inconsistent results by imaging evaluation and CNB, VABB can be performed again to enhance the diagnostic accuracy. [bib_ref] The evolving role of vacuum assisted biopsy of the breast: a progression..., Bennett [/bib_ref] For VABB used for diagnosis, the expert group recommends that a clip can be placed simultaneously to enhance the accuracy of lesion resection in subsequent open surgery, reduce the rate of secondary resection of the incision margins in breast-conserving surgery, and reduce recurrence. For patients receiving neoadjuvant treatment, positioning a clip can avoid difficulty in confirming the location of the original lesion after complete clinical remission, which can facilitate subsequent surgery. [bib_ref] Image-guided breast biopsy and localisation: recommendations for information to women and referring..., Bick [/bib_ref] [bib_ref] A clinical feasibility trial for identification of exceptional responders in whom breast..., Kuerer [/bib_ref] Chinese Medical Journal 2021;134 [bib_ref] Analysis of the efficacy and accuracy of two vacuum-assisted breast biopsy devices:..., Bozzini [/bib_ref] www.cmj.org VABB for treatment is indicated for BI-RADS classification III lesions with surgical indications. For BI-RADS classification III lesions measuring 2.0 cm, the complete resection rate of VABB is nearly 100%, while for lesions measuring >2.0 cm, the probability of residual lesions is positively correlated with the tumor size. [bib_ref] The evolving role of vacuum assisted biopsy of the breast: a progression..., Bennett [/bib_ref] [bib_ref] Clinicopathological analysis of ultrasound-guided vacuum-assisted breast biopsy for the diagnosis and treatment..., Park [/bib_ref] [bib_ref] Analysis of the efficacy and accuracy of two vacuum-assisted breast biopsy devices:..., Bozzini [/bib_ref] The expert group has not yet discussed VABB for treating gynecomastia, accessory breast, breast abscess, and early breast cancer because of the lack of evidence from prospective randomized controlled trials.
Hematoma is a common complication after VABB, and small-volume hematomas do not require treatment. The expert group considers that surgery is necessary for hemostasis or debridement if a patient is suspected of having active bleeding or has a huge hematoma causing severe pain. [bib_ref] Feasibility and safety of imageguided vacuum-assisted breast biopsy: a PRISMA-compliant systematic review..., Fang [/bib_ref] High-risk breast lesions are composed of a group of heterogeneous lesions (atypical ductal hyperplasia, lobular neoplasia, flat epithelial atypia, radial scars, papillary lesions, phyllodes tumors, and others). The highest risk of these lesions for malignancy is 35% after total resection.

## Conflicts of interest
The expert committee for these guidelines declares no conflict of interest. These guidelines are a reference for breast disease specialists in clinical practice. However, the guidelines are not to be used as the basis for medical evaluation, and do not play an arbitrating role in the handling of any medical disputes. The guidelines are not a reference for patients or non-breast specialists. The Chinese Society of Breast Surgery assumes no responsibility for results involving the inappropriate application of these guidelines and reserves the right to interpret and revise the guidelines.
List of compiling committee members (In alphabetical order by surname followed by first name): Zhong-Wei Cao, De-Dian Chen, Yuan-Jia Cheng, Xue-Ning Duan,