Breast Lesion Excision System Research Articles

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

Background The purpose of this study was to investigate the feasibility of the percutaneous radiofrequency (RF) excision system (BLES) as a primary method of diagnosis and removal of small breast masses. Methods Ninety-six lesions in 95 patients with 50.5 ± 8.4 years of age were treated in a five-year period by a single operator. Inclusion criteria were as follows: size (<20 mm), depth (>10 mm), and indeterminate or suspicious radiological features (74 BI-RADS 3 and 22 BI-RADS 4). The procedure was performed under ultrasound (US) guidance using 6 G retriever probes with 12-, 15-, and 20-mm baskets. Results Lesions were between 5 and 20 (12.3 ± 3.8) mm in length. They were removed at the first attempt in all but one case. The technical success rate was 98.95%, and the diagnostic success rate was 100%. Ninety-one lesions were histologically benign and five were neoplastic. Two lesions that were previously classified as BI-RADS 3 were diagnosed as neoplasia (atypical lobular hyperplasia), and nineteen lesions that were previously classified as BI-RADS 4a were diagnosed as benign. The complete excision rate (presence of tumor-free negative surgical margin) was 40% in neoplastic lesions. There were no major complications. The minor complication rate was 1.58%. No recurrence was observed during 18 months of follow-up. Conclusion BLES delivers surgical quality specimens for confident histopathological examination and is a safe alternative to surgical resection in lesions with suitable size.

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

PurposeThis study aims to compare the feasibility of VAE and BLES in the treatment of intraductal papillomas. Material and methodsPatients with a suspected intraductal papilloma who underwent a BLES or a VAE procedure were included in this retrospective study. The BLES procedures were performed between November 2011 and June 2016 and the VAE procedures between May 2018 and September 2020 at the Department of Radiology of Helsinki University Hospital (HUH). The procedures were performed with an intent of complete removal of the lesions. ResultsIn total, 72 patients underwent 78 BLES procedures and 95 patients underwent 99 VAE procedures. Altogether 52 (60%) papillomas with or without atypia were completely removed with VAE, whereas 24 (46%) were completely removed with BLES, p = 0.115. The median radiological size of the high-risk lesions completely removed with BLES was 6 mm (4–12 mm), whereas with VAE it was 8 mm (3–22 mm), p = 0.016. Surgery was omitted in 90 (94.7%) non-malignant breast lesions treated with VAE and in 66 (90.4%) treated with BLES, p = 0.368. ConclusionBoth VAE and BLES were feasible in the treatment of intraductal papillomas. In most non-malignant lesions surgery was avoided, but VAE was feasible in larger lesions than BLES. However, follow-up ultrasound was needed more often after VAE. The histopathologic assessment is more reliable after BLES, as the lesion is removed as a single sample.

Criteria for Excision of Suspicious Calcifications Using the Breast Lesion Excision System (BLES)

Background: The aim of the study was to retrospectively evaluate possible imaging and histopathology criteria that can be used in a clinical basis to assess the success of excision of suspicious calcifications using the breast lesion excision system (BLES).Methods: We investigated 400 BLES stereotactic biopsies of suspicious calcifications with the mean size of 15.38 mm (st. dev.= 13.579 mm, range 3-78 mm) using a 20 mm probe performed in our department between January 2014 and 2016. The mean age of our population was 58.5 years old (range 39-78 years). The pathology results of BLES specimens were compared with the final surgical results to assess excision success rates. Possible imaging and histopathology criteria for removal were statistically analyzed (mammographic size, disease free margins, grade, comedo phenotype, molecular type).Results: The results showed that 90/400 (22.5%) biopsies were cancers (80% DCIS) and 38/400 were lesions with cell atypia (9.5%) of which 29/38 had subsequent surgery and were included in the study. Excision was achieved in 31/90 cancers (34.4%) and in 23/29 lesions with cell atypia (76.3%). The imaging and histopathology criteria for BLES excision that could be potentially clinically assessed were the initial mammographic size (p&lt;0.001), the distance of the lesion from the specimen margins (p&lt;0.001), the presence of comedo necrosis (p=0.014) and the grade of the cancers (p=0.021). The underestimation rate was 15.5%. Conclusion: the mammographic size, grade, comedo presence and disease-free margins, were the main criteria for BLES success rate of excision of suspicious calcifications.

127 Poster - Breast Lesion Excision System as a treatment method for small invasive breast cancers

127 Poster - Breast Lesion Excision System as a treatment method for small invasive breast cancers

140 Poster - Evaluation of the breast lesion excision system, a percutaneous, vacuum assisted, intact-specimen, breast biopsy device

140 Poster - Evaluation of the breast lesion excision system, a percutaneous, vacuum assisted, intact-specimen, breast biopsy device

Minimally invasive breast cancer excision using the breast lesion excision system under ultrasound guidance

PurposeTo assess the feasibility of completely excising small breast cancers using the automated, image-guided, single-pass radiofrequency-based breast lesion excision system (BLES) under ultrasound (US) guidance.MethodsFrom February 2018 to July 2019, 22 patients diagnosed with invasive carcinomas ≤ 15 mm at US and mammography were enrolled in this prospective, multi-center, ethics board-approved study. Patients underwent breast MRI to verify lesion size. BLES-based excision and surgery were performed during the same procedure. Histopathology findings from the BLES procedure and surgery were compared, and total excision findings were assessed.ResultsOf the 22 patients, ten were excluded due to the lesion being > 15 mm and/or being multifocal at MRI, and one due to scheduling issues. The remaining 11 patients underwent BLES excision. Mean diameter of excised lesions at MRI was 11.8 mm (range 8.0–13.9 mm). BLES revealed ten (90.9%) invasive carcinomas of no special type, and one (9.1%) invasive lobular carcinoma. Histopathological results were identical for the needle biopsy, BLES, and surgical specimens for all lesions. None of the BLES excisions were adequate. Margins were usually compromised on both sides of the specimen, indicating that the excised volume was too small. Margin assessment was good for all BLES specimens. One technical complication occurred (retrieval of an empty BLES basket, specimen retrieved during subsequent surgery).ConclusionsBLES allows accurate diagnosis of small invasive breast carcinomas. However, BLES cannot be considered as a therapeutic device for small invasive breast carcinomas due to not achieving adequate excision.

The learning curve of breast lesion excision system: Balancing patient's safety and surgical training.

The learning curve of breast lesion excision system: Balancing patient's safety and surgical training.

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

To retrospectively assess the effectiveness and safety of BLES stereotactic biopsy of suspicious calcifications and investigate possible predictive factors for underestimation. 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 58.5years (range 39-78years). 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. 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%. 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

ObjectivesTo retrospectively assess the stereotactic one-pass BLES performance in excision of small groups of calcifications seen on mammogram that proved to be papillomas. MethodsBetween 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. ResultsThe 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. ConclusionBLES 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.

Comparison of two minimally invasive biopsy techniques - Breast Lesion Excision System and vacuum-assisted biopsy - for diagnosing and treating breast lesions.

The vacuum-assisted biopsy (VAB) and the Breast Lesion Excision System (BLES) are minimally invasive biopsy techniques, both used as diagnostic and therapeutic tools. The aim of the study is to compare these two methods and assess them in the context of discomfort, early and late complications and their diagnostic and therapeutic potential. The study involved 173 patients who underwent a VAB or a BLES breast biopsy in the period between 2009 and 2016. Approximately 3 months after the biopsy, the patients completed a questionnaire in which they assessed the procedure for discomfort associated with the procedure and the final cosmetic outcome. The cosmetic effect of the biopsy was also assessed by a surgeon. The BLES and the VAB breast biopsies did not differ in terms of pain, duration, and discomfort of the procedure, breast bruising, breast tenderness about 24 h after the procedure or pain lasting over 3 months after the biopsy. Subsequently, the biopsies were evaluated in terms of the cosmetic effect assessed by the patient and by a surgeon and no differences were observed. There were no significant differences between the VAB and the BLES breast biopsies in the course of the procedure, early and late complications and cosmetic effect. Since the BLES breast biopsy makes it possible to evaluate the margins, it is a good alternative to the open breast biopsy.

A comparison of the excision methods in breast lesions of classic wire localisation and the advanced breast biopsy system of breast lesion excision system

A comparison of the excision methods in breast lesions of classic wire localisation and the advanced breast biopsy system of breast lesion excision system

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

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. Three hundred ninety-four consecutive women (mean age 58.5years, range 39-78years) 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. Thirty-eight out of 400 (9.5%) lesions were high-risk lesions with atypia with mean size 7.63mm (st. dev. = 4.03mm) which was within the size that the BLES needle can excise (20mm). 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). 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. • 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.

524 (PB-157) - A systematic review on the use of the Breast Lesion Excision System in breast disease

524 (PB-157) - A systematic review on the use of the Breast Lesion Excision System in breast disease

Breast Lesion Excision System in the diagnosis and treatment of intraductal papillomas – A feasibility study

ObjectivesThis study aims to evaluate the feasibility of Breast Lesion Excision System (BLES) in the treatment of intraductal papillomas. Material and methodsAll patients with a needle biopsy –based suspicion of an intraductal papilloma who consequently underwent a BLES procedure at Helsinki University Hospital between 2011 and 2016 were included in this retrospective study. The purpose of the BLES procedure was either to excise the entire lesion or in few cases to achieve better sampling. ResultsIn total, 74 patients underwent 80 BLES procedures. Pathological diagnosis after the BLES biopsy confirmed an intraductal papilloma without atypia in 43 lesions, whereas 10 lesions were upgraded to high-risk lesions (HRL) with either atypical ductal hyperplasia or lobular carcinoma in situ. Five cases were upgraded to malignancy, two were invasive ductal carcinomas and three were ductal carcinoma in situ. Additionally, 18 lesions were diagnosed as other benign lesions. Four procedures failed. Complete excision with BLES was achieved in 19 out of 43 intraductal papillomas, 6 out of 10 HRL and two out of five malignant lesions. No major complications occurred. The BLES procedure was adequate in the management of the 71 breast lesions. ConclusionThe BLES procedure is an acceptable method for the management of small benign and high-risk breast lesions such as intraductal papillomas in selected patients. Thus, a great amount of diagnostic surgical biopsies can be avoided.

The Intact® breast lesion excision system as a therapeutic device for selected benign breast lesions.

The aim of this paper is to evaluate our Unit's initial experience using the Intact breast lesion excision system as a therapeutic excision option for benign or borderline breast lesions, which otherwise would entail open operative excision. The study includes the first 111 patients who underwent therapeutic excision with the intact radiofrequency system between December 2012 and May 2016 performed at the Meirav Center for Breast Health, at the Chaim Sheba Medical Center, Ramat Gan Israel. The indications for the procedure included those patients who have benign, or atypical high risk lesions following a previous core needle biospy (CNB) who would have normally undergone conventional excision biopsy. After reviewing each case separately, we found that the use of the BLES system as a treatment device permitted the avoidance of operations that would have been otherwise indicated, in 98 cases of the total 111 in the cohort (88.3%). Thirteen cases eventually had to undergo surgical excision. In eight cases pathology was upgraded from the initial CNB to invasive or noninvasive carcinoma. Although the INTACT sysytem is most commonly used as an alternative biopsy technique for its diagnostic capabilities, this study assessed its clinical role as a definitive therapeutic excisional modality in selected cases of benign breast disease. It proved valuable in the majority of cases with avoidance of surgery where it was traditionally indicated, (98/111, 88.3%) and as definitive fibroadenoma management in a further 28 patients.

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

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. 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®. 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<1mm) 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>1cm (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. Our results indicate that it is possible, when using the BLES® device, to completely excise small (≤10mm) breast carcinomas that appear radiologically as solid lesions. This subset of patients should be investigated regarding the therapeutic potential of this method.

The breast lesion excision system (BLES) under stereotactic guidance cannot be used as a therapeutic tool in the excision of small areas of microcalcifications in the breast

ObjectiveThe breast lesion excision system (BLES) is a new, automatic percutaneous breast biopsy device that excises single large specimens using radiofrequency cutting. The aim of this study was to determine whether BLES, under stereotactic guidance, can be used as a therapeutic tool in the assessment of small areas of microcalcifications in the breast by providing samples with clear margins. Material and methodsIn this retrospective study, 149 patients with suspicious (BIRADS 4 or 5) small areas of microcalcifications underwent stereotactic-guided BLES. Of these, 34 patients (22.8%) with microcalcifications that had a diameter smaller than the basket size (≤15mm) underwent both BLES and subsequent surgery. Histopathology findings from BLES and subsequent surgery were compared. Identical, underestimation and total excision findings were assessed. ResultsBLES revealed fourteen (41.1%) high-risk lesions, ten (29.4%) ductal carcinomas in situ, and ten (29.4%) invasive cancers. Identical results between BLES and surgery were seen in 17/34 (50%) lesions. Surgery confirmed total excision of BLES in 15/34 (44.1%) lesions. Underestimation was seen in 2/34 (5.8%) lesions. ConclusionBLES allows accurate diagnosis of small areas of microcalcifications, with few underestimates. BLES is a diagnostic, but cannot be considered to be a therapeutic tool in the case of suspicious microcalcifications because total excision was seen in only 44.1% of these lesions. Studies are needed to address the therapeutic benefit of this procedure in solid lesions.

Evaluation of percutaneous vacuum assisted intact specimen breast biopsy device for ultrasound visualized breast lesions: Upstage rates and long term follow-up for high risk lesions and DCIS

ObjectivePercutaneous core biopsy of ultrasound visualized breast lesions is standard for diagnosis. Large gauge vacuum-assisted core needles have improved accuracy; but a significant underestimation of malignancy remains. The IntactR device was assessed for upstaging and subsequent malignancy at the biopsy site. Methods469 consecutive ultrasound visualized breast lesions, < 2.0 cm in size, BIRADS 4 or 5, biopsied with IntactR Breast Lesion Excision System, between July 2007 and August 2014, were reviewed. All non-concordant lesions (0.8%), DCIS (1.7%) and invasive cancers (9.8%) were surgically excised. Excision was recommended for all high risk lesions (13.0%). The upstage rate to DCIS or invasive cancer was determined. All patients were followed for a median of 66 months (24–96 months) with serial imaging and exams to determine the incidence of re-biopsy, or malignancy at the original biopsy site. Results23 of 61 high risk lesions (37.5%) were not excised, but observed for a median of 66 months. None required re-biopsy. One atypical lesion was upstaged to DCIS on excision. No patient was diagnosed with malignancy at or near the original biopsy site during follow-up. Overall upstage rate was 1.2%. ConclusionsPercutaneous biopsy of ultrasound visualized lesions was performed accurately using IntactR. Upstaging was much lower with IntactR than with large-gauge core needles. High risk lesions, diagnosed with IntactR, have a very low upstage rate at surgical excision. It may be possible to observe these lesions without surgery when they present as ultrasound findings and undergo IntactR biopsy.

Use of the handheld ultrasound-guided basket Intact Breast Lesion Excision System for the excision of breast cancers from patients suitable for primary endocrine therapy: Is this technically feasible?

Introduction: The handheld Intact Breast Lesion Excision System (Intact) allows radiological excision of an entire breast lesion under ultrasound (USS) guidance for diagnosis and margin assessment. Its use excising benign breast lesions is established, and we have presented data demonstrating it as a reliable and effective tool in this context. The treatment of patients with primary endocrine therapy (PET) is the cause for debate, in particular whether denying surgical excision adversely affects outcome. The aim of the current study was to determine the feasibility of Intact excision of breast cancers from these patients.

Handheld ultrasound-guided 20 mm basket Intact breast lesion excision system biopsy for excision of benign breast lesions

In selected patients, our Unit has recently moved from handheld ultrasound-guided vacuum-assisted core biopsy (VACB) piecemeal acquisition of tissue to the handheld Intact Breast Lesion Excision System (Intact). Intact removes a single piece of tissue, potentially allowing radiologists to excise the entire lesion as well as allowing pathologists to visualise lesion architecture more easily and to calculate margins. We evaluated our early experience of excising benign or likely benign breast lesions using the 20 mm Intact.