Elite VABB 13G: A new ultrasound-guided wireless biopsy system for breast lesions. Technical characteristics and comparison with respect to traditional core-biopsy 14-16g systems

Abstract

The typification of breast lumps with fine-needle biopsies is often affected by inconclusive results that extend diagnostic time. Many breast centers have progressively substituted cytology with micro-histology. The aim of this study is to assess the performance of a 13G-needle biopsy using cable-free vacuum-assisted breast biopsy (VABB) technology. Two of our operators carried out 200 micro-histological biopsies using the Elite 13G-needle VABB and 1314 14-16G-needle core biopsies (CBs) on BI-RADS 3, 4, and 5 lesions. Thirty-one of the procedures were repeated following CB, eighteen following cytological biopsy, and three after undergoing both procedures. The VABB Elite procedure showed high diagnostic performance with an accuracy of 94.00%, a sensitivity of 92.30%, and a specificity of 100%, while the diagnostic underestimation was 11.00%, all significantly comparable to of the CB procedure. The VABB Elite 13G system has been shown to be a simple, rapid, reliable, and well-tolerated biopsy procedure, without any significant complications and with a diagnostic performance comparable to traditional CB procedures. The histological class change in an extremely high number of samples would suggest the use of this procedure as a second-line biopsy for suspect cases or those with indeterminate cyto-histological results.