Abstract
BackgroundMinimally invasive breast biopsy technology is now considered a standard of care for the diagnostic evaluation of suspicious breast lesions. The aim of the current study was to present a comprehensive evaluation of the 8-gauge vacuum-assisted Mammotome® system for ultrasound-guided diagnostic biopsy and selective excision of breast lesions.MethodsA retrospective analysis was conducted of a series of 304 consecutive 8-gauge Mammotome® procedures that were performed under ultrasound guidance by a single surgeon from March 2004 to December 2006. Multiple variables, including patient demographics, characteristics of the breast lesion (based on ultrasound and mammography), procedural and histopathology variables, and interval follow-up variables (based on ultrasound and mammography), were evaluated.ResultsAmong 304 procedures, 235 (77%) were performed with the presumption of complete excision of the ultrasound lesion during Mammotome® core acquisition, while 69 (23%) were performed with only partial excision of the ultrasound lesion during Mammotome® core acquisition (diagnostic tissue sampling only). 100% of all ultrasound lesions were accurately diagnosed, demonstrating no apparent false-negative results among the 256 patients that were compliant with follow-up at a median interval follow-up duration of 11 months (range 1 to 37). Likewise, 89% of all appropriately selected ultrasound lesions were completely excised, as demonstrated on interval follow-up ultrasound at a median time of 6 months (range, 3 to 16). There were no independent predictors of successful complete excision of any given appropriately selected ultrasound lesion by the ultrasound-guided 8-gauge Mammotome® biopsy technique.ConclusionThe 8-gauge vacuum-assisted Mammotome® system is highly accurate for ultrasound-guided diagnostic biopsy of suspicious breast lesions and is highly successful for complete excision of appropriately selected presumed benign breast lesions. This particular technology should be routinely offered to all appropriately selected patients that are evaluated by physicians involved in breast-specific health care.
Highlights
Invasive breast biopsy technology is considered a standard of care for the diagnostic evaluation of suspicious breast lesions
We present a comprehensive evaluation of the 8-gauge vacuum-assisted Mammotome® breast biopsy system for ultrasound-guided diagnostic biopsy and selective excision of 304 breast lesions
Patients in which the ultrasound lesion appeared to be completely excised during Mammotome® core acquisition were generally younger, had a predilection toward breast imaging reporting and data system (BI-RADS) category 3 and 4 classification of the breast lesion, and had a significantly smaller original breast lesion size based on the preMammotome® procedure ultrasound findings
Summary
Invasive breast biopsy technology is considered a standard of care for the diagnostic evaluation of suspicious breast lesions [1] In this regard, an innovative vacuum-assisted breast biopsy technology was first commercially introduced in 1995 by Biopsys Medical, Inc. in Irvine, California [2] and was later acquired in 1997 and successfully marketed by Ethicon Endo-Surgery, Inc. in Cincinnati, Ohio [3]. Multiple reports have been published using this technology for ultrasound-guided applications [6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33] The majority of these reports have evaluated the 11-gauge Mammotome® breast biopsy device [6-12,15,1722,24-26,28-30]. We present a comprehensive evaluation of the 8-gauge vacuum-assisted Mammotome® breast biopsy system for ultrasound-guided diagnostic biopsy and selective excision of 304 breast lesions
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