Anna Bozzini1, Enrico Cassano1, Dario Raciti1, Davide Disalvatore2, Oriana Pala3, Andrea Vingiani4, Giuseppe Renne5. 1. Breast Imaging Unit, European Institute of Oncology, Milan, Italy. 2. IFOM, The FIRC Institute for Molecular Oncology Foundation, Milan, Italy. 3. Division of Pathology, European Institute of Oncology, Milan, Italy. 4. Division of Pathology, European Institute of Oncology, Milan, Italy. Electronic address: andrea.vingiani@ieo.it. 5. Division of Uropathology and Intraoperative Consultation, European Institute of Oncology, Milan, Italy.
Abstract
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.
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.