Two-year follow-up of stereotactically guided 9-G breast biopsy: a multicenter evaluation of a self-contained vacuum-assisted device.

Purpose: 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 and Materials: 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.
Conclusion: 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.