title: 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.
abstract: OBJECTIVE
  Percutaneous 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 IntactRdevice was assessed for upstaging and subsequent malignancy at the biopsy site.
  
  
  METHODS
  469 consecutive ultrasound visualized breast lesions, < 2.0 cm in size, BIRADS 4 or 5, biopsied with IntactRBreast 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.
  
  
  RESULTS
  23 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%.
  
  
  CONCLUSIONS
  Percutaneous biopsy of ultrasound visualized lesions was performed accurately using IntactR. Upstaging was much lower with IntactRthan 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 IntactRbiopsy.
authors.affiliation: Case Western Reserve University School of Medicine, Department of Surgery, 11100 Euclid Avenue, Cleveland, Ohio 44106, USA. Electronic address: cathygraham57@gmail.com.
authors.forename: Cathy L
authors.initials: CL
authors.lastname: Graham
mesh_terms: D000328:Adult; D062005:Biopsy, Large-Core Needle / Q000295:instrumentation* / Q000379:methods; D001940:Breast / Q000473:pathology; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000473:pathology; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000175:diagnosis* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D009367:Neoplasm Staging / Q000295:instrumentation* / Q000379:methods; D011446:Prospective Studies; D012189:Retrospective Studies; D016217:Ultrasonography, Mammary; D014618:Vacuum
keywords: Atypical hyperplasia; Breast cancer; DCIS; High risk lesion; Intact specimen; Lobular neoplasia; Ultrasound guided breast biopsy; Upstage rate