Breast Lesion Excision System-Intact (BLES): A Stereotactic Method of Biopsy of Suspicius Non-Palpable Mammographic Lesions.

Transcription

1 Breast Lesion Excision System-Intact (BLES): A Stereotactic Method of Biopsy of Suspicius Non-Palpable Mammographic Lesions. Poster No.: C-1595 Congress: ECR 2014 Type: Authors: Scientific Exhibit I. Georgiou 1, M. Milatou 2, O. Aggelatou 2 ; 1 ATHENS/GR, 2 ATHENS/GR Keywords: DOI: Diagnostic procedure, Percutaneous, Breast, Neoplasia /ecr2014/C-1595 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. Page 1 of 17

2 Aims and objectives Image-guided percutaneous biopsy is the recommended diagnostic stereotactic procedure to excise suspicious non palpable mammographic lesions (BIRADS #4). Percutaneous biopsy has provided a simple, relatively inexpensive, and cosmetically agreeable alternative to open surgical biopsy for the assessment of suspicious breast lesions. Percutaneous biopsy also affords prompt diagnoses and for many women obviates the need for surgery. The Breast Lesion Excision System (BLES) is an automated, vacuum-assisted breast biopsy device. (fig. 1) The BLES biopsy procedures are done with a single pass. Upon entry into the breast, radiofrequency is used to ablate breast tissue. (fig. 2) At the lesion site, the retrieval basket is deployed to circumscribe the lesion. Once captured, the specimen-containing basket and wand are removed from the incision site which is generally 6-8 mm. Image guidance for the BLES device can be either sonographic or stereotactic. The breast lesion excision system (BLES) has the unique feature of using radiofrequency cautery to excise a small but whole sample in one piece with intact architecture and clear margins, as a swift local anesthetic outpatient procedure. The purpose of this study is to evaluate the efficiency and accuracy of complete excision of BLES system and the underestimation rate compared to surgical excision. Page 2 of 17

3 Images for this section: Fig. 1: The BLES Biopsy System Page 3 of 17

4 Fig. 2: The lightweight hand-held piece of the BLES system with the incerted wand Page 4 of 17

5 Methods and materials The study was conducted between November 2012 and June 2013 on 78 patients with suspicious non palpable mammographic lesions, classified as BIRADS#4 that visited the Breast Imaging Department of Athens'OncologicHospitaland underwent biopsy with the BLES system. The findings included microcalcifications, solid lesions and radial scars. The goals for the biopsies were to retrieve representative diagnostic specimens and not necessarily remove the entire mammographic finding. The method was performed by board-certified radiologists utilizing the Siemens stereotactic table which includes a breast compression plate, incorporated digital mammography device, a robotic arm that carries the biopsy needle and a vacuum apparatus. (fig. 3) 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 anesthesia (20ml of 2% Lydokaine) and is completed with a single needle pass. A 5-6mm skin incision is performed and a retrieval basket is deployed to circumscribe the lesion, while radiofrequency is used to ablate the surrounding breast tissue. (fig. 4) The basket containing the captured specimen is removed through the incision (fig. 5) and the wound is dressed with sterile strip. We routinely perform mammography on the specimen to insure the success of the biopsy (fig. 6,7) and we place a titanium clip in the biopsy cavity to mark the area. (fig. 8) Biopsy samples were analyzed by pathologists at participating clinical sites. Primary pathology diagnoses included benign lesion, atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), ductal carcinoma in situ (DCIS), invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC), lobular carcinoma in situ (LCIS), and other cancer. Benign diagnoses were not further classified. Women with percutaneous diagnoses of ADH or DCIS were offered surgical biopsy. Diagnosis obtained from biopsy specimen was compared with the final diagnosis on surgical excision. BLES can be used in most patients and in many breast lesions, but there are a number of clear controindications. Patients fitted with a cardiac pacemaker or other radiofrequency devices are not suitable as the RF waves can potentially interfere with or damage these devices. It is not recommended for patients who are pregnant. Due to the RF wave emanating from the metallic prongs during the biopsy, and the risk of a thermal burn and possibly skin necrosis, careful attention has to be paid to the location of the lesion in relation to the skin surface and chest wall prior to performing a BLES procedure. Page 5 of 17

6 Images for this section: Fig. 3: The BLES System incerted on stereotactic table. Page 6 of 17

7 Fig. 4: The biopsy procedure operated by the BLES System last 10 sec. Page 7 of 17

8 Fig. 5: The prongs pass radiofrequency waves into surrounding tissue in order to excise and allow haemostasis. Fig. 6: The histologic specimen Page 8 of 17

9 Fig. 7: The mammography of the specimen Page 9 of 17

10 Fig. 8: A titanium clip placed in the biopsy cavity Page 10 of 17

11 Results Seventy eight 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: 13 (16.6%) cell atypia, 18 (23%) fibroadenoma, 20 (25.6%) sclerotic adenosis, 16 (20.5%) fibrocystic changes, 8 (10.3%) non invasive carcinoma and 3 (4.0%) invasive carcinoma. Seven of 13 patients with severe cell atypia had open surgical excision and none showed underestimation. All patients with non invasive and invasive carcinoma underwent surgical excision. An invasive carcinoma was found in 2 cases (25% underestimation). A complete removal of the lesion by BLES, with healthy margins was found in 3 cases (37.5%). (fig. 9,10,11) Page 11 of 17

12 Images for this section: Fig. 9: Non palpable mammographic lesions underwent biopsy with the BLES System Page 12 of 17

13 Fig. 10: A haematoxylin and eosin stained slide showing a ductal hyperplasia with atypia Page 13 of 17

14 Fig. 11: A haematoxylin and eosin stained slide showing a lobular hyperplasia with atypia Page 14 of 17

15 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 removing the lesion without cutting through it so the specimen retains its original architectural structure intact, which means even more accurate histologic diagnosis and thus lower underestimation rates. The high rate of complete removal of the lesion with healthy margins offers an interesting perspective of avoiding subsequent excisional surgery for small lesions and alleviates all concern for possible tumor dissemination through the needle tract. Page 15 of 17

16 Personal information I. Georgiou, M. Milatou, R. Aggelatou Diagnostic Breast Imaging Department Oncologic Hospital of Athens"St. Savvas", Athens Greece. Page 16 of 17

17 References 1. WA Al-Harethee, I Papanagiotou, P Grigoropoulos, GM Filippakis, and G. Zografos (2010) Breast Lesion Excision System - Intact (B.L.E.S): A Novel Stereotactic Method of Biopsy Utilizing Radiofrequency for Suspicious Non- Palpable Mammographic Lesions. Cancer Research; Volume 70, Issue 24, Supplement Steven D. Allen, Ashish Nerurkar, Guidabaldo U. Querci Della Rovere (2011) The breast lesion excision system (BLES): a novel technique in the diagnostic and therapeutic management of small indeterminate breast lesions? European Society of Radiology. 3. Sie A. et al. (2006) Multicenter evaluation of the breast lesion excision system, a percutaneous, vacuum-assisted, intact-specimen breast biopsy device. Cancer 1;107(5): Devalia H, Alomran F, Parker R, Ward R, Allen SD, Querci Della Rovere GU (2008) BLES biopsy reduces the need for surgical excision and is associated with high patient satisfaction. Poster presentation ASBGI Br J Surg 95: Devalia H, Alomran F, Parker R, Ward R, Allen SD, Querci Della Rovere GU (2008) BLES biopsy reduces the need for surgical excision and is associated with high patient satisfaction. Poster presentation ASBGI Br J Surg 95:101. Page 17 of 17