Margin-free excision of small solid breast carcinomas using the Intact Breast Lesion Excision System®: is it feasible?

BACKGROUND: The Breast Lesion Excision System® (BLES®) is a stereotactic vacuum-assisted breast biopsy device that utilizes radiofrequency in order to excise non-palpable mammographic lesions for pathologic diagnosis. The purpose of this study was to evaluate the efficacy of BLES® in performing complete, margin-free excisions of small solid carcinomas. METHODS: Our retrospective study of prospectively enrolled patients included 50 cases of non-palpable, BIRADS ≥ 4, solid by means of mammography and sonography, lesions. All these patients underwent a BLES® breast biopsy procedure from June 2010 to June 2014 and had a malignant diagnosis. According to each patient's pathologic diagnosis, appropriate surgical treatment was recommended. Postoperatively, surgical specimens were histologically analyzed, aiming to determine whether residual malignant disease was present in the specimen cavity formatted by BLES®. RESULTS: Ductal carcinoma in situ (DCIS) was diagnosed in 5 patients and invasive carcinoma (IC) in 45 patients, at primary BLES® pathology report. Tumor-free resection margins (< 0.5 and < 1 mm) were accomplished in only 8/24 subcentimeter cases (33.3%). Absence of residual disease upon surgical excision was confirmed in 23/24 subcentimeter cases (95.8%) and 2/26 of the cases measuring > 1 cm (7.69%). Statistical analysis revealed that mammographic size was the only significant prognostic factor for complete excision (i.e., with no residual disease in the biopsy cavity) of a malignant lesion. CONCLUSIONS: Our results indicate that it is possible, when using the BLES® device, to completely excise small (≤ 10 mm) breast carcinomas that appear radiologically as solid lesions. This subset of patients should be investigated regarding the therapeutic potential of this method.

Thermal damage of the specimen during breast biopsy with the use of the Breast Lesion Excision System: does it affect diagnosis?

BACKGROUND: Stereotactic vacuum assisted breast biopsy (VABB) procedures remain of key importance in the diagnostic evaluation of suspicious non-palpable mammographic lesions. The Breast Lesion Excision System(®) (BLES) is an image-guided percutaneous biopsy method that utilizes radiofrequency (RF) in order to retrieve an intact-tissue biopsy specimen. The purpose of this study is to determine the effects of RF application on the tissue specimen and the possible interference with the histopathologic results. METHODS: In this study we included 265 patients with suspicious non-palpable mammographic lesions who underwent 273 stereotactic VABB procedures using the BLES. All biopsies were performed by the same surgical-radiology team under local anesthesia. The specimen thermal damage was classified according to the pathology report in 3 categories: Severe (extensive thermal damage or inability to diagnose), medium (ability to diagnose but either circumferential damage >1.5 mm or diffuse areas of thermal damage) and mild (circumferential thermal damage <1.5 mm but >0.5 mm). RESULTS: Radiofrequency-associated thermal damage of the specimen was observed in 14 cases (5.13 %), and was classified as severe in 5, medium in 5, and mild in 4 specimens. Within the group of RF damaged specimens, we found a significant (p < 0.05) positive correlation between fat cell content and classification of thermal damage. CONCLUSIONS: Although thermal damage is of concern during BLES breast biopsy, the incidence is low, and the outcome of the histopathologic assessment is not affected even in severely damaged specimens. Increased thermal damage seems to correlate with higher fat cell content of the specimen.

Complications of percutaneous stereotactic vacuum assisted breast biopsy system utilizing radio frequency.

OBJECTIVE: The Breast Lesion Excision System (BLES) is a novel, automatic breast biopsy device that utilizes radiofrequency to excise suspicious non-palpable mammographic lesions. The purpose of the present prospective study is to report and evaluate the complications of this new technique. MATERIALS AND METHODS: In a two year period, we used the BLES device in 132 consecutive patients (134 procedures) with non-palpable mammographic lesions. The inclusion criteria consisted of suspicious microcalcifications, solid lesions and asymmetric density. In order to retrieve an intact biopsy specimen, we used the 12mm, 15mm or 20mm tissue basket under local anesthesia, depending on the size of the lesion. Complications were recorded and classified as immediate if occurring during or shortly after the procedure, or late, if occurring in the post-procedure days. RESULTS: The procedure was considered successful in all cases, with mammographic confirmation of appropriate excision of the targeted lesion. Although, in a single case the basket initially failed to deploy. Immediate complications were encountered in 11 patients, with minor hemorrhage being the most common (n=6). 17 patients suffered late complications, in seven of whom delayed wound healing was observed. Overall, 27 patients suffered Grade 1 complications (20.14%), one patient experienced a Grade 2 complication while no patients encountered Grade 3-5 complications. CONCLUSIONS: According to our experience, the BLES device is an efficient and safe breast biopsy method, with low complication rates, which are minor in their majority. It appears to be a very promising alternative to other, minimally invasive, breast biopsy techniques.