A systematic review on the use of the breast lesion excision system in breast disease

Abstract

Purpose To outline the current status of and provide insight into possible future research on the breast lesion excision system (BLES) as a diagnostic and therapeutic device. Methods A systematic search of the literature was performed using PubMed, Embase, and the Cochrane databases to identify relevant studies published between January 2002 and April 2018. Studies were considered eligible for inclusion if they evaluated the diagnostic or therapeutic accuracy or safety of BLES. Results Ultimately, 17 articles were included. The reported underestimation rates of atypical ductal hyperplasia and ductal carcinoma in situ (DCIS) ranged from 0 to 14.3% and from 0 to 22.2%, respectively. Complete excision rates for invasive ductal carcinoma and DCIS ranged from 5.3 to 76.3%. Bleeding was the most frequently reported complication (0–11.8%). Device-related complications may arise, with an empty basket being the most common (0.6–3.6%). Thermal damage of the specimen, caused by the use of a radiofrequency cutting wire, was reported in eight of the included studies. Most thermal artifacts were reported as superficial and small (0.1–1.9 mm). Conclusions The BLES, an automated, image-guided, single-pass biopsy system for breast lesions using radiofrequency is designed to excise and retrieve an intact tissue specimen. It is an efficient and safe breast biopsy method with acceptable complication rates, which may be used as an alternative to vacuum-assisted biopsies. The variable rate of complete excision raises questions about the possibility to use BLES as a therapeutic device for the excision of small lesions. Further research should focus on this aspect of BLES.

Comparison of vacuum-assisted excision (VAE) and breast lesion excision system (BLES) in the treatment of intraductal papillomas

“…Previous studies report device-related complications comparable to ours using BLES, of which empty basket is the most common [22]. Thermal artifact is another device-related problem with BLES but it is unlikely to affect the histopathological analysis [22]. These device-related complications do not occur in VAE procedures.…”

Minimally Invasive Excision of Breast Masses under Ultrasound Guidance: A Single Center’s Five-Year Experience on the Breast Lesion Excision System

“…There was only one case where an empty basket was retrieved. According to the relevant literature, the relative frequency of such an event is 0.6–3.6% [ 12 ]. Such cases are usually due to the failure of the basket to deploy or to the presence of a very tight entry point or access path.…”

“…In this study, this rate was found to be 40%, although the number of malignant cases was too low to reach a solid conclusion regarding this parameter. The large variation in the literature regarding the rate of complete excision raises some questions about the use of BLES as a therapeutic device [ 12 , 14 ]. However, it is not uncommon for patients to undergo more than one surgical procedure before achieving tumor-free margin even in surgery [ 15 ].…”

Image-guided breast biopsy and localisation: recommendations for information to women and referring physicians by the European Society of Breast Imaging

“…In the last decade, percutaneous image-guided systems aiming to completely remove small breast lesions have been developed [49][50][51], for instance using radiofrequency to excise intact lesions in a basket preserving the tissue structure [52][53][54][55]. These devices have the potential to provide highly accurate tissue diagnosis and offer an alternative option for percutaneous lesion removal.…”