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Review
. 2019 May 2;10(1):49.
doi: 10.1186/s13244-019-0737-3.

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

Wendelien B G Sanderink  1 , Babette I Laarhuis  1 , Luc J A Strobbe  2 , Ioannis Sechopoulos  1 , Peter Bult  3 , Nico Karssemeijer  1 , Ritse M Mann  4
Affiliations
Review

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

Wendelien B G Sanderink et al. Insights Imaging. .

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.

Keywords: Biopsy; Breast; Breast cancer; Minimally invasive surgical procedures; Vacuum.

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Conflict of interest statement

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

The authors of this manuscript declare relationships with the following companies, whose products or services may be related to the subject matter of the article. In an associated clinical study, Medtronic the producer of the BLES needles has provided a research grant and non-financial support (BLES device and needles).

The authors of this manuscript declare relationships with the following companies outside the submitted work:

WS, BL, LS, and PB declare that they have no competing interests. IS has received research grants and research support from Siemens Healthineers and Canon Medical Systems and is a scientific advisor of Fischer Medical. NK is a shareholder of Matakina Technology Limited Consultant, QView Medical, ScreenPoint, and Medical BV, and is director of ScreenPoint Medical.

RM has received research grants and research support from Siemens Healthineers, Bayer Medical, Seno Medical, Elswood, Identification Solutions, and Micrima, and is a scientific advisor of Screenpoint Medical, Transonic Imaging.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
BLES probe
Fig. 2
Fig. 2
Specimen obtained with the BLES probe
Fig. 3
Fig. 3
Flowchart of systematic review
Fig. 4
Fig. 4
QUADAS-2 graph demonstrates the risk of bias and the applicability of assessment results
See this image and copyright information in PMC

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