Predictive factors for breast lesion excision system (BLES) accuracy and safety in stereotactic biopsy of suspicious calcifications.

AIM: To retrospectively assess the effectiveness and safety of BLES stereotactic biopsy of suspicious calcifications and investigate possible predictive factors for underestimation. METHODS AND MATERIALS: Between January 2014 and January 2016, 400 biopsies of suspicious calcifications were performed in our Department using the BLES stereotactic device. The mean age of our population was 58.5 years (range 39-78 years). The final surgical results were used as gold standard. The effectiveness of the method was statistically evaluated. Mammographic size, grade, molecular type, and presence of comedo type/necrosis were assessed as predictive factors. RESULTS: 90/400 (22.5%) cases were cancers (20% invasive cancers, 80% non-invasive cancers). 38/400 cases were atypical lesions (9.5%). No underestimation was found in atypical lesions that underwent surgery (29/38 cases). Downgrade was achieved in 45.5% of cases (with complete removal in 34.4%), concordance in 43.3%, and upgrade was found in 15.5% of the cases; the initial mammographic size and the grade of the cancers were found to be statistically significant predictive factors. The total complication rate was 8.75%. CONCLUSIONS: Breast lesion excision system is a highly accurate and safe stereotactic biopsy technique of suspicious calcifications with low underestimations and high downgrade/removal rates with the potential to alter the final surgical decision in selected cases.

Performance of breast lesion excision system (BLES) in complete removal of papillomas presented mammographically as groups of calcifications.

OBJECTIVES: To retrospectively assess the stereotactic one-pass BLES performance in excision of small groups of calcifications seen on mammogram that proved to be papillomas. METHODS: Between January 2014 and January 2016, 37/400 cases (9.2%) of stereotactic BLES biopsies performed in our department due to suspicious calcifications proved to be papillomas. Lesions with atypia underwent surgical removal and lesions with no atypia were followed up for 2 years. BLES and surgical histology results, radiological removal and 2-years stability were statistically analysed to assess BLES performance in biopsy and excision of papillomas. RESULTS: The mean mammographic size of papillomas was 6.54 mm (st dev = 3.85, range 2 mm-17 mm) and within the size excised by the BLES needle (20 mm). 4/37 cases (10.8%) showed atypia. BLES excision was achieved in 29/37 cases (78.4%); radiological removal based on post BLES mammogram was achieved in 25/29 cases (86.2%). In the remaining 8/37 cases the papillomas were seen at the ink of the specimens' margins; 3/8 cases showed residual calcifications on post-BLES mammogram. The BLES histology result of removal and the mammographic size of the papillomas were found to be statistically significant predictive factors of excision (p < 0,001, Fisher's exact test, Mann Whitney test). Follow up mammograms showed no change for a period of 2 years. CONCLUSION: BLES is a safe and accurate technique to biopsy papillomas with high success rates of excision which could potentially minimize the need of subsequent radiological or surgical excision.

Role of one-pass breast lesion excision system in complete excision of high-risk breast lesions with atypia expressed as clusters of microcalcifications.

PURPOSE: To assess the role of the breast lesion excision system (BLES) in complete removal of clusters of microcalcifications found on mammogram proved histologically to be high-risk lesions with cell atypia. METHODS AND MATERIALS: Three hundred ninety-four consecutive women (mean age 58.5 years, range 39-78 years) with 400 clusters of suspicious microcalcifications underwent stereotactic biopsy using the intact BLES device between January 2014 and January 2016. All cases proved histologically to be high-risk lesions were subsequently assessed for complete removal. The underestimation rate was also assessed. RESULTS: Thirty-eight out of 400 (9.5%) lesions were high-risk lesions with atypia with mean size 7.63 mm (st. dev. = 4.03 mm) which was within the size that the BLES needle can excise (20 mm). Four (10.5%) papillomas with atypia, 14 (36.8%) cases with flat epithelial atypia (FEA), 10 (26.3%) cases with lobular intraepithelial neoplasia (LIN-LIN 1, LIN 2), 8 (21.2%) with atypical ductal hyperplasia (ADH) and 2 (5.3%) cases with mucocele-like lesions (MLL) with atypia were found. Twenty-nine out of 38 lesions had subsequent surgery. Complete excision was achieved in 23/29 lesions (79.3%). No underestimation was found. Two-year mammographic stability was found in all lesions. Non-parametric statistical analysis showed no other significant predictive factor for complete excision apart from the distance of the lesions from the specimen margins (p = 0.031 Mann-Whitney test). CONCLUSION: One-pass BLES intact biopsy technique is a safe method of complete removal of high-risk atypical lesions with high accuracy rates for certain histologies and could be potentially used as an alternative excision method to diagnostic surgery in selected cases. KEY POINTS: • Breast lesion excision system (BLES) is an image-guided biopsy technique that uses radiofrequency to remove an intact piece of tissue including the target breast neoplasm. • Breast lesion excision system (BLES) under stereotactic guidance is able to accurately biopsy high-risk breast lesions expressed mammographically as clusters of suspicious microcalcifications. • BLES under stereotactic guidance is an accurate technique for en bloc excision of selected cases of small clusters of suspicious microcalcifications proved to be high-risk lesions with histopathologically disease-free margins of excision.

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.

The value of stereotactic vacuum assisted breast biopsy in the investigation of microcalcifications. A six-year experience with 853 patients.

PURPOSE: Vacuum Assisted Breast Biopsy (VABB) is a minimal invasive technique, in the diagnostic approach for non palpable lesions. The aim of this study was to evaluate the efficacy and accuracy of VABB in the investigation of breast microcalcifications, a significant mammographic sign of early breast cancer. The rate of histological underestimation and the false negative rate were assessed based on the follow up data and the histological examination of the surgical specimens. METHODS: From January 2005 to November 2011, 853 women with mammographically detected microcalcifications, classified as BI-RADS 3-5, were referred to our Breast Unit for evaluation. During this 6-year period, 825 vacuum-assisted breast biopsies were performed, while 28 women (3.3%) were not submitted to VABB due to superficial location of microcalcifications. RESULTS: VABB histology revealed 594 benign (69.6%), 66 high risk (7.7%) and 164 malignant (19.2%) lesions. Twenty- nine cases were classified as non diagnostic, as in one case (0.1%) the sample of the biopsy was maladjusted and not suitable to undergo histopathological examination due to mechanical alterations and in 28 (3.3%) cases microcalcifications were located in proximity to the skin and open surgical excision was performed. The overall documented underestimation rate was 4.6%, the false negative rate was 2.4%. The sensitivity of the method was 98.2%, specificity 100%, positive predictive value 100% and negative predictive value 97.6%. CONCLUSIONS: VABB is a safe and accurate method for the evaluation of suspicious microcalcifications and diagnosis of early breast cancer.

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.

The current status of positron emission mammography in breast cancer diagnosis.

Mammography is currently the standard breast cancer screening procedure, even though it is constrained by low specificity in the detection of malignancy and low sensitivity in women with dense breast tissue. Modern imaging modalities, such as magnetic resonance imaging (MRI), have been developed in an effort to replace or complement mammography, because the early detection of breast cancer is critical for efficient treatment and long-term survival of patients. Nuclear medicine imaging technology has been introduced in the field of oncology with the development of positron emission tomography (PET), positron emission tomography/computed tomography (PET/CT) and, ultimately, positron emission mammography (PEM). PET offers the advantage of precise diagnosis, by measuring metabolism with the use of a radiotracer and identifying changes at the cellular level. PET/CT imaging allows for a more accurate assessment by merging the anatomic localization to the functional image. However, both techniques have not yet been established as diagnostic tools in early breast cancer detection, primarily because of low sensitivity, especially for sub-centimeter and low-grade tumors. PEM, a breast-specific device with increased spatial resolution, has been developed in order to overcome these limitations. It has demonstrated higher detectability than PET/CT and comparable or better sensitivity than MRI. The ability to target the lesions visible in PEM with PEM-guided breast biopsy systems adds to its usability in the early diagnosis of breast cancer. The results from recent studies summarized in this review indicate that PEM may prove to be a useful first-line diagnostic tool, although further evaluation and improvement are required.

Downgrading BIRADS 3 to BIRADS 2 category using a computer-aided microcalcification analysis and risk assessment system for early breast cancer.

This paper explores the potential of a computer-aided diagnosis system to discriminate the real benign microcalcifications among a specific subset of 109 patients with BIRADS 3 mammograms who had undergone biopsy, thus making it possible to downgrade them to BIRADS 2 category. The system detected and quantified critical features of microcalcifications and classified them on a risk percentage scale for malignancy. The system successfully detected all cancers. Nevertheless, it suggested biopsy for 11/15 atypical lesions. Finally, the system characterized as definitely benign (BIRADS 2) 29/88 benign lesions, previously assigned to BIRADS 3, and thus achieved a reduction of 33% in unnecessary biopsies.

Hematoma after vacuum-assisted breast biopsy: are interleukins predictors?

BACKGROUND: Hematoma is the main complication of vacuum-assisted breast biopsy (VABB). This study aims to evaluate the associations between interleukin (IL)-1alpha, IL-1beta and IL-6 and hematoma progression. METHODS: This study included 36 women who underwent VABB (11G). After VABB, mammograms were obtained from these patients and the maximum diameter of the hematomas was measured. The hematoma progression / occurrence of organized hematomas was followed up for the subsequent 30 days. Venous samples were collected peripherally at 3 time points: prior, at the end, and 1 h after the end of the VABB procedure. Enzyme-linked immunosorbent assays were used for the determination of serum IL-1alpha, IL-1beta and IL-6 levels. RESULTS: 2/36 hematomas were eventually organized within the follow-up period. In these cases, IL-6 had been significantly higher 1 h after the end of VABB (5.70 +/- 0.18 vs. 1.73 +/- 1.01 pg/ml; p = 0.019, Mann-Whitney-Wilcoxon test for independent samples). No statistically significant associations existed concerning IL-1alpha and IL-1beta. The association between the size of a hematoma on the mammogram and the subsequent organization did not reach statistical significance. CONCLUSIONS: Elevated IL-6 at 1 h after the end of VABB might point to subsequent organization of the hematoma and the need for appropriate action.

Diagnosing papillary lesions using vacuum-assisted breast biopsy: should conservative or surgical management follow?

BACKGROUND: This study evaluates the underestimation rate of papilloma lesions diagnosed with vacuum-assisted breast biopsy (VABB), taking into consideration the greater volume excised. PATIENTS AND METHODS: 56 women with a diagnosis of a papilloma lesion after VABB (Mammotest; Fischer Imaging, Denver, CO, USA) were evaluated. At least 24 cores were excised in all cases (mean 74, range 24-96 cores) and a preoperative diagnosis was established. Subsequently, open surgery using hook-wire localization followed. A second, postoperative diagnosis was independently and blindly made. The association between the pathological types and Breast Imaging Report and Data System (BI-RADS) classification, as well as the discrepancy between preoperative and postoperative diagnoses, was evaluated. RESULTS: The underestimation rate of papillary lesions was 3.6%. When the papillary lesions did not coexist preoperatively with any other precursor breast lesions, the underestimation rate was 0%. The underestimation rate did not differ with age, BI-RADS category or type of lesion. CONCLUSION: Conservative management of patients with a papillary lesion diagnosis may follow when the extended VABB protocol is adopted and a great tissue volume is excised. However, when diagnosing a coexisting papillary lesion with a precursor breast lesion, open surgery should follow, given the high probability of a postoperative cancer diagnosis.

Vacuum-assisted breast biopsy in nonpalpable solid breast lesions without microcalcifications: the Greek experience.

PURPOSE: To present the initial Greek experience with vacuumassisted breast biopsy (VABB) in the diagnosis of nonpalpable solid mammographic lesions without microcalcifications. MATERIALS AND METHODS: We performed 83 VABB procedures (using a Fischer table and 11-guage Mammotome probes) in an 18- month period on women with nonpalpable solid breast tumors. We performed VABB procedures on women with breast imaging reporting and data system (BI-RADS) categories 3 and 4. VABB procedures excised more than 24 cores. RESULTS: Eighty-three women with nonpalpable lesions identified on mammography were evaluated; 42.2% were BI-RADS category 3, and 57.8% were BI-RADS 4. Of all solid tumors excised, 83.1% were benign, 3.6% were precursor lesions, and 13.3% of the lesions were malignant. No underestimation occurred. Clinically important hematoma developed in 4.8% of cases. CONCLUSION: VABB is an effective method for the diagnosis of nonpalpable solid lesions because of the lack of underestimation, although it is technically more difficult to focus on lesions without microcalcifications than those with microcalcifications on the Fischer table.

Pain during vacuum-assisted breast biopsy: are there any predictors?

INTRODUCTION: To assess the putative predictors that may be implicated in the pain experienced during stereotactic vacuum-assisted breast biopsy (VABB). MATERIALS AND METHODS: One hundred and thirty-five consecutive women with microcalcifications underwent VABB on the Fischer's table. The visual analogue scale was used to measure the degree of the "average pain" (AP). RESULTS: At the univariable analysis, the AP was positively associated with the duration of the procedure, the diagnosis of malignant/preinvasive lesions and the volume of blood lost. Although menopausal status was not associated with the AP, within the premenopausal subpopulation, luteal phase was associated with higher VAS score. These findings also persisted at the multivariable ordinal logistic regression model. However, the mean experienced pain was associated neither with the volume of tissue excised nor with the hematoma formation, nor with patients' age. CONCLUSION: The aforementioned factors were independent positive predictors of the mean experienced pain during VABB.

Vacuum-assisted breast biopsy in close proximity to the skin: a case report.

INTRODUCTION: Vacuum-assisted breast biopsy is a minimally invasive technique used increasingly for the assessment of mammographically detected, non-palpable breast lesions. The effectiveness of vacuum-assisted breast biopsy has been demonstrated on lesions both with and without microcalcifications. Given that the position of the lesion represents a major factor in stereotactic vacuum-assisted breast biopsy, targeting lesions in close proximity to the skin (superficial lesions) has been described as a problematic issue. CASE PRESENTATION: A 53-year-old woman presented with a newly developed, non-palpable lesion in her left breast. The lesion consisted of widely spread microcalcifications located approximately 5 mm from the skin. The lesion was isoechoic on ultrasound examination. Vacuum-assisted breast biopsy was scheduled (on the Fischer's table, using 11-gauge probes, under local anaesthesia). The vacuum-assisted breast biopsy probe was inserted antidiametrically into the breast, the probe reached the lesion and effort was made to excise the microcalcifications. As only a small proportion of the microcalcifications were excised an accurate diagnosis could not be expected. However, with the probe having entered the breast antidiametrically, the probe tip underlying the skin could be palpated. Following the palpation of the tip, the exact point was marked by a pen, the probe was removed and the patient was transferred to the surgery room to have the remaining lesion removed by a spindle-form excision under local anaesthesia. The mammogram of the removed specimen confirmed the total excision of the suspicious microcalcifications. CONCLUSION: Isoechoic superficial lesions can be localized with a hook-wire and open breast biopsy under general or local anaesthesia can be performed. However, vacuum-assisted breast biopsy might offer an alternative solution and serve as an alternative approach to localize the lesion. The clinical significance of the present exploratory effort remains to be assessed in the future.