title: Multicenter evaluation of the breast lesion excision system, a percutaneous, vacuum-assisted, intact-specimen breast biopsy device.
abstract: BACKGROUND
  Percutaneous, vacuum-assisted, large-gauge core needle biopsy (VACNB) provides an alternative to open surgical biopsy as an initial diagnostic tool for breast lesions, yet rates of underestimating malignant diagnoses remain sufficiently high to warrant surgical biopsy in some cases. The current study was performed to determine if the Breast Lesion Excision System (BLES) provides a feasible alternative to VACNB.
  
  
  METHODS
  A retrospective review was conducted of 742 consecutive mammographic lesions with microcalcifications classified as Breast Imaging Reporting and Data System (BIRADS) IV or V that had stereotactic percutaneous biopsy using BLES. Initial diagnoses obtained from the histopathologic examination of tissues retrieved at biopsy were compared with the histopathologic examination of tissues received from surgical excision or lumpectomy. Underestimation rates for atypical ductal hyperplasia (ADH) and ductal carcinoma in situ (DCIS) were recorded if open surgical biopsy revealed DCIS or invasive cancer, and invasive cancer, respectively.
  
  
  RESULTS
  Of the 742 breast lesions, 34 displayed ADH upon biopsy with the BLES device. Two patients did not receive open surgical biopsy. Of the 32 patients who had open surgical excision, 3 (9.4%) had DCIS or invasive cancer. There were 119 diagnoses of DCIS upon biopsy with the BLES device. Four patients did not receive open surgical biopsy. Of the 115 patients who had open surgical excision, 6 (5.2%) had invasive cancer.
  
  
  CONCLUSIONS
  Breast biopsy can be performed accurately using the BLES device. Compared with VACNB, it does not alter the need for surgical excision in women diagnosed with ADH or DCIS at core biopsy.
authors.affiliation: Long Beach Memorial Breast Center, Long Beach, California 90086, USA. asie@memorialcare.org
authors.forename: Angela
authors.initials: A
authors.lastname: Sie
authors.forename: David C
authors.initials: DC
authors.lastname: Bryan
authors.forename: Victor
authors.initials: V
authors.lastname: Gaines
authors.forename: Larry K
authors.initials: LK
authors.lastname: Killebrew
authors.forename: Christine H
authors.initials: CH
authors.lastname: Kim
authors.forename: Carrie C
authors.initials: CC
authors.lastname: Morrison
authors.forename: William R
authors.initials: WR
authors.lastname: Poller
authors.forename: Ada P
authors.initials: AP
authors.lastname: Romilly
authors.forename: Kathy
authors.initials: K
authors.lastname: Schilling
authors.forename: Janet H
authors.initials: JH
authors.lastname: Sung
mesh_terms: D001707:Biopsy, Needle / Q000295:instrumentation / Q000379:methods*; D001940:Breast / Q000473:pathology; D001941:Breast Diseases / Q000175:diagnosis; D001943:Breast Neoplasms / Q000175:diagnosis*; D018270:Carcinoma, Ductal, Breast / Q000175:diagnosis*; D002285:Carcinoma, Intraductal, Noninfiltrating; D005188:False Negative Reactions; D005260:Female; D006801:Humans; D006965:Hyperplasia; D012189:Retrospective Studies; D014618:Vacuum