Analysis of Efficacy and Accuracy of 2 Vacuum-Assisted Breast Biopsy Devices: Mammotome and Elite

Vacuum-assisted breast biopsy has gained a pivotal role in breast cancer management. Diagnostic performances of Mammotome have been extensively studied, while further evidences for Elite are needed. We evaluated and compared performances of Mammotome and Elite on a series of 195 patients. Our study did not show remarkable differences in diagnostic accuracy between the 2 systems.Background: Ultrasound-guided vacuum-assisted breast biopsy (US-VABB) has recently replaced surgical biopsy as a result of its high diagnostic accuracy and low patient discomfort, and at present it relies mainly on 2 devices, Mammotome and, more recently, Mammotome Elite (Elite). Our purpose was to compare the efficacy of these 2 bioptical devices. Patients and Methods: We performed US-VABB on 195 patients with Mammotome 8G or 11G in 130 patients and Elite 13G in 65 patients. Of these 195 patients, 95 were submitted to surgery for lumpectomy or mastectomy in case of malignant lesions or of lesions of uncertain malignant potential (B5 and B3), while the remaining 100 were strictly monitored clinically and radiologically for 12 to 24 months. Results: Both the devices showed high absolute sensitivity (96.2% for Mammotome and 83.3% for Elite), complete sensitivity (98.1% for Mammotome and 90.0% for Elite), specificity (92.3% for Mammotome and 94.3% for Elite), and diagnostic accuracy (99.1% for Mammotome and 95% for Elite), thus fulfilling criteria suggested by the European guidelines. Total underestimation rate seemed to be higher in the Elite cohort (14.2%) than in the Mammotome cohort (3.4%) (P = .02). However, none of the patients with a benign diagnosis (B2) presented any event during the follow-up period. Conclusion: US-VABB is an accurate method for sampling breast lesions. Our study did not show large, statistically significant differences in diagnostic accuracy between the Elite and Mammotome systems, except for a slight increase in diagnostic underestimation of benign pathologies when using the Elite.