Efficacy and safety of direct and frontal macrobiopsies in breast cancer.

Recent innovations in tissue acquisition from the human breast have led to the development of unique direct frontal systems. We intend to evaluate efficacy and safety in a multicenter clinical study. Efficacy was considered optimal if the diagnosis by transcutaneous biopsy was identical to the surgical specimen in case of malignancy or in line with clinical follow-up when benign. One hundred and seventy-three women (aged 22-95 years) with a suspect lesion in the breast were eligible for transdermal biopsy. One hundred and seventeen biopsies were performed with the Spirotome and 56 with the Coramate under radiological or ultrasound guidance. Sample quality was evaluated by comparing the pathology results of the samples with definitive pathology at subsequent surgery or follow-up in case of benign lesions. An average of 1.66 biopsies per procedure were obtained. All patients had sufficient sample size (up to 5 mm diameter/20 mm length) to make a reliable diagnosis. The average length was 1.39 cm and the average diameter 3.72 mm. There were three false-negative diagnoses, leaving a correct diagnosis in 170 patients. None of the patients suffered from a serious complication, and the procedure was generally well tolerated. The new direct frontal transdermal tissue acquisition approach gives adequate diagnostic results through high-quality tissue samples. No major patient discomfort was noted.