Abstract P6-02-04: Breast Lesion Excision System — Intact®(B.L.E.S): A Novel Stereotactic Method of Biopsy Utilizing Radiofrequency for Suspicious Non-Palpable Mammographic Lesions

Abstract

AIM: The Breast Lesion Excision System by Intact®(B.L.E.S) is a novel stereotactic, vacuum-assisted breast biopsy device that utilizes radiofrequency in order to completely excise any suspicious (BIRAD ≥4) non palpable mammographic lesion. The purpose of this clinical study is to evaluate the efficiency and success rate of the B.L.E.S system in the accurate diagnosis of any suspicious non-palpable mammographic lesions. MATERIAL AND METHODS: This study included 105 patients with suspicious non palpable mammographic lesions that visited the Breast Unit of the First Propaedeutic Surgical Clinic at Ippocration hospital from January 2008 to April 2010. The mammographic findings included suspicious microcalcifications, solid lesion and radial scars, all classified as BIRAD ≥4. The method was performed by the same surgical-radiologist team utilizing the Fisher's stereotactic table which includes a breast compression plate, incorporated digital mammography device, a robotic arm that carries the biopsy needle and a vacuum apparatus. The system is controlled by a central computer that performs the stereotactic localization. We utilize the 15mm or the 20mm tissue basket depending on the size of the lesion, trying to completely excise it with healthy margins, if possible. The procedure is performed under local anaesthesia (20ml of 2% Lydokaine) and is completed with a single needle pass. A 5-6 mm skin incision is performed and a retrieval basket is deployed to circumscribe the lesion, while radiofrequency is used to ablate the surrounding breast tissue. The basket containing the captured specimen is removed through the incision and the wound is dressed with steril strip. We routinely perform mammography on the specimen to insure the success of the biopsy and we place a titanium clip in the biopsy cavity to mark the area. RESULTS: One hundred and five patients with non palpable mammographic lesions underwent biopsy with the BLES — Intact® system. All lesions were excised completely, but not all with healthy margins especially in cases of DCIS with intraductal component. The histological findings included: Fibroadenoma: 38 (36.1 %), Invasive Ductal Breast Cancer with associated DCIS 14 (13.3 %), papilloma: 11 (10.4 %), Fibrocystic changes 11 (10.4 %), Papillary Apocrine Metaplasis 7 (6.6 %), Stromal Fibrosis: 7 (6.6%), mammary duct ectasia: 6 (5.71%), DCIS :5 (4.7%), Liponecrosis: 2 (1.9 %), Intramamary lymph node: 2 (1.9%), Invasive Ductal Carcinoma: 1 (0.95%), Invasive Ductal Carcinoma with associated lobular in situ (LCIS): 1 (0.95%). CONCLUSION: Suspicious non palpable mammographic lesions can be safely removed for histologic diagnosis utilizing the BLES — Intact® system. The method has the unique advantage of completely removing the lesion without cutting through it. This way the specimen retains its original architectural structure intact, which means even more accurate histologic diagnosis and thus lower underestimation rates. Furthermore, the BLES system alliviates all concern for possible tumor dissemination through the needle tract since it comes in no contact with the tumor and can remove the lesion with healthy margins. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-02-04.

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

“…However, there were 8 upgrades to carcinoma and DCIS in patients deemed suitable for definitive BLES excision. Most studies have suggested that the incidence of pathological underestimation of lesions (most notably ADH) with the BLES system is particularly low (ranging from 0%‐9%) because of the single large specimen provided by the device . Complete excision of ADH lesions is common with the BLES system as noted in our small series with one case where there was marginal involvement of ADH treated conservatively because of patient high risk of anesthesia.…”

“…However, there were 8 because of the single large specimen provided by the device. 9,11,[13][14][15] Complete excision of ADH lesions is common with the BLES system as noted in our small series with one case where there was marginal involvement of ADH treated conservatively because of patient high risk of anesthesia. Moreover, the underestimation for DCIS or IDC in our study with the BLES device is in keeping with previously reported ranges in the literature which vary from 3% to 20% overall.…”

“…An alternative to VACNB is the Intact ® breast lesion excision system (BLES Intact Medical, Framingham, MA). This is an automated single‐pass biopsy instrument utilizing radiofrequency (RF) under stereotactic OR US guidance designed to provide excision of breast tissue as a single intact specimen and potentially producing a sample of sufficient size with preserved architecture for diagnosis and possible margin evaluation . The BLES technique also may have a selected therapeutic role for definitive specimen excision of benign or borderline lesions and the avoidance of a traditional surgical excision .…”

“…This is an automated single-pass biopsy instrument utilizing radiofrequency (RF) under stereotactic OR US guidance designed to provide excision of breast tissue as a single intact specimen and potentially producing a sample of sufficient size with preserved architecture for diagnosis and possible margin evaluation. 8,9 The BLES technique also may have a selected therapeutic role for definitive specimen excision of benign or borderline lesions and the avoidance of a traditional surgical excision. [10][11][12] Preliminary work has shown promising results, with DCIS underestimation rates using the device ranging between 3%-21% 8,12,13 and complete excision rates for malignant lesions of between 39%-66% overall.…”