Clinical experience with the new manual and automated large core biopsy systems based on a rotational cutting on a helix

1550 Background: Survival from breast cancer has increased significantly in recent years mainly as a result from better imaging techniques, earlier detection and improved tissue sampling. Newer technologies should improve existing biopsies because major drawbacks, including tumor cell displacement, preclude women and physicians to biopsy suspect lesions. A new large core biopsy device with a direct frontal approach, lesser side effects, less sampling needs, lower costs and improved yields has been evaluated in clinical practice. Methods: The results of 70 subsequent transdermal biopsies with rotational cutting on a helix are evaluated with regard to quality of the sample, patient satisfaction and completeness of diagnosis. The patients with a suspect lesion in the breast are selected in an oncological practice. Malignancy was verified by subsequent excision of the lesion. Attention was given to tumor cell displacement. Benign disease was verified by the subsequent clinical course. Results: In 69 patients at least one high quality sample with an average length of 1.8 cm and 0.3 cm diameter could be obtained. One patient refused the procedure. The average number of biopsy cores needed to obtain a reliable diagnosis was 1.5 (mininum 1 - maximum 5). No complication was noted with regard to pain, hemorrhagy, infection or other wound problems. 64 patients quoted the procedure as relative pain free. In 69 patients the diagnosis was complete with regard to the diagnosis of malignancy or benign disease. No destruction, biopsy artefacts or cell displacement was noted on histopathology. In all diagnoses with malignancy the grade of the tumor could be reliably given as well as steroid receptor content and HER2 immunohistochemistry. FISH-HER2 tests were possible in all HER2 positive tumors. Automated biopsies with vacuumassistance had slightly larger samples compared to the manual technique. Conclusions: The new large core biopsy technique with a rotational cutting on a helix performs well in clinical practice. All developmental goals with regard to quality of sample, patient satisfaction and cost price per biopsy have been met. Large core biopsies are now available for a larger population of women at risk for breast cancer with less risk of complication. No significant financial relationships to disclose.