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.

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 Intact device 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 Intact Breast 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 Intact. Upstaging was much lower with Intact than with large-gauge core needles. High risk lesions, diagnosed with Intact, 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 Intact biopsy.