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.

Highlights

  • Cytological and histological needle biopsies represent a fundamental step in breast diagnosis.Since the early 1990s, fine-needle aspiration cytology (FNAC) has become the most widespread method thanks to its simplicity, rapid execution, low cost, high sensitivity, and it being the best choice in anticoagulated patients [1,2,3]

  • Over the years, this procedure has shown some limitations connected with a number of false negatives (FNs), inadequate biopsies, operator-sensitive results, limited information regarding the tumor histology [4,5,6,7,8,9,10,11,12,13] above all in large lesions, in the diagnosis of microcalcifications, differentiation between invasive and in situ cancer, as well as between benign and malignant papillary lesions

  • All the Elite vacuum-assisted breast biopsy (VABB) biopsies concerned lesions classified by ultrasound as doubtful, suspected, or suggested malignancy (BI-RADS classes 3, 4, or 5, respectively)

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Summary

Introduction

Cytological and histological needle biopsies represent a fundamental step in breast diagnosis.Since the early 1990s, fine-needle aspiration cytology (FNAC) has become the most widespread method thanks to its simplicity, rapid execution, low cost, high sensitivity, and it being the best choice in anticoagulated patients [1,2,3]. Over the years, this procedure has shown some limitations connected with a number of false negatives (FNs), inadequate biopsies, operator-sensitive results, limited information regarding the tumor histology [4,5,6,7,8,9,10,11,12,13] above all in large lesions, in the diagnosis of microcalcifications, differentiation between invasive and in situ cancer, as well as between benign and malignant papillary lesions. The large number of FNs, the inadequate samples, operator-sensitive results, and the limited information obtained on the histology of the cancer using cytology [1,2,3,4,5,6,7,8,9,10,11] have, over the years, brought about a progressive substitution of FNAC with micro-histological sampling. The evidence present in literature continues to recommend FNAC as the most sensitive screening for breast cancer metastases in the axillary region [14,15,16]

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