title: Two-year follow-up of stereotactically guided 9-G breast biopsy: a multicenter evaluation of a self-contained vacuum-assisted device.
abstract: OBJECTIVE
  To evaluate the performance of a self-contained, battery-driven, vacuum-assisted breast biopsy (VABB) system for the sampling of clustered breast microcalcifications and masses under stereotactic guidance.
  
  
  METHODS
  A total of 144 patients (median age: 56 years; range: 21-87 years) in four European breast centers underwent percutaneous 9-gauge (G), stereotactic-guided VABB. The median lesion size was 11 mm (range 2-60 mm). Patients were biopsied in the prone (n=125) or upright position (n=19). All patients were followed up for at least 24 months.
  
  
  RESULTS
  The stereotactic procedure was successful in 142 (98.6%) of 144 cases, with two cases cancelled due to either severe patient motion (one case) or failure to detect faint calcifications (one case). A median of 12 specimens per procedure was obtained. In 39 cases (27.5%), the suspicious lesion could no longer be detected mammographically after the biopsy procedure. The histological diagnosis was malignancy in 45 (31.7%) cases. One case of atypical ductal hyperplasia diagnosed preoperatively was upgraded to ductal carcinoma in situ (DCIS) at operation, giving an overall sensitivity of 97.7% for the vacuum-assisted biopsy procedure. In two cases where DCIS was diagnosed at vacuum-assisted biopsy, the malignant tissue was apparently completely removed and could no longer be found at operation. No serious complications occurred. During the follow-up period, no breast cancers appeared at the location of biopsy. Six patients dropped out during the follow-up period.
  
  
  CONCLUSIONS
  The self-contained, vacuum-assisted biopsy device is well suited for stereotactically guided breast biopsies, having demonstrated excellent sensitivity and specificity in the preoperative workup of mammographically detected breast lesions after 2 years of follow-up.
authors.affiliation: Institute of Diagnostic and Interventional Radiology, University Hospital Jena, Erlanger Allee 101, D-07740 Jena, Germany. stefan.pfleiderer@med.uni-jena.de
authors.forename: Stefan O R
authors.initials: SO
authors.lastname: Pfleiderer
authors.forename: Harry
authors.initials: H
authors.lastname: Brunzlow
authors.forename: Ruediger
authors.initials: R
authors.lastname: Schulz-Wendtland
authors.forename: Martti
authors.initials: M
authors.lastname: Pamilo
authors.forename: Tibor
authors.initials: T
authors.lastname: Vag
authors.forename: Oumar
authors.initials: O
authors.lastname: Camara
authors.forename: Mirjam
authors.initials: M
authors.lastname: Facius
authors.forename: Ingo B
authors.initials: IB
authors.lastname: Runnebaum
authors.forename: Peter B
authors.initials: PB
authors.lastname: Dean
authors.forename: Werner A
authors.initials: WA
authors.lastname: Kaiser
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001707:Biopsy, Needle / Q000295:instrumentation* / Q000379:methods; D001940:Breast / Q000473:pathology*; D001941:Breast Diseases / Q000000981:diagnostic imaging / Q000473:pathology*; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000473:pathology*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D021621:Imaging, Three-Dimensional / Q000295:instrumentation*; D008327:Mammography / Q000295:instrumentation; D008875:Middle Aged; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013238:Stereotaxic Techniques / Q000295:instrumentation*