Abstract

Evaluation of feasibility and clinical performance of a tomosynthesis-guided vacuum-assisted breast biopsy (TVAB) system compared to Stereotaxy (SVAB). All biopsies were performed on consecutive patients: 148 TVAB biopsies and 86 biopsies on different patients using SVAB. Evaluation criteria for each biopsy were technical feasibility, histopathology, procedure time, and complications. All 148 TVAB biopsies were technically successful, and gained the targeted groups of microcalcifications (100%). In 1 of 86 SVAB procedures, it was not possible to gain the targeted microcalcifications (1%), in 3 of 86 the needle had to be adjusted (4%). All TVAB biopsies were performed without clinically relevant complications. Distortions were biopsied exclusively by TVAB, mean size 0.9cm, p < 0.0001. Of the 24 distortions, 13 were cancer, 11 Radial Scars/ CSL. The mean procedure time for TVAB was 15.4minutes (range 7-28min), for SVAB 23minutes (range 11-46min), p < 0.0001. TVAB is able to biopsy small architectural distortions with high accuracy. TVAB is easily feasible and appears to have the same degree of clinical performance for diagnosing microcalcifications. The increased number of biopsied distortions by TVAB is presumably due to increased use of tomosynthesis and its diagnostic potential. • TVAB is easily feasible. • TVAB is able to target architectural distortions with high accuracy. • TVAB diagnoses microcalcifications with the same clinical performance as SVAB.

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