A comprehensive evaluation of the 8-gauge vacuum-assisted Mammotome® system for ultrasound-guided diagnostic biopsy and selective excision of breast lesions

BACKGROUND Minimally 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(R) system for ultrasound-guided diagnostic biopsy and selective excision of breast lesions. METHODS A retrospective analysis was conducted of a series of 304 consecutive 8-gauge Mammotome(R) 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. RESULTS Among 304 procedures, 235 (77%) were performed with the presumption of complete excision of the ultrasound lesion during Mammotome(R) core acquisition, while 69 (23%) were performed with only partial excision of the ultrasound lesion during Mammotome(R) 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(R) biopsy technique. CONCLUSION The 8-gauge vacuum-assisted Mammotome(R) 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.