Multicenter clinical experience with the new direct frontal 360 degree vacuum assisted large core biopsy device (Coramate®) (n=109)

Abstract

Ziele: Recent innovations in large core biopsies for the human breast led to the development of unique direct frontal and 360 degree vacuum aspiration systems (Coramate®). Preclinical and single center clinical trials proved the usefulness of this method. Now the multicenter clinical experience is described. Methode: Between 10/06–3/07 175 women with a suspect lesion were eligible for biopsy. Anticoagulant medication was allowed. No prior sedation was given. The lesion was detected by clinical examination, mammography, ultrasound, and/or MRI (BI-RADS 4). Emphasis was made for those conditions where the classical large core biopsy was difficult or impossible. The performance of the sampling method, the comfort of the patient, and sample quality was examined. The accuracy of diagnosis is evaluated by comparing the pathology results of the samples and definitive pathology at subsequent surgery or follow-up of the patient in case of benign lesions. Both manual and computerized systems were used throughout the study. Ergebnis: An average of 1,73 biopsies per procedure was obtained. The average diameter 4,07mm with a length of 1,28cm. All patients had sufficient sample size to make a diagnosis. None of the patients suffered from a serious complication and the procedure was in general extremely well tolerated. Hematoma was seen in only 4 patients that could be treated with conservative measures. Postprocedure esthetic results were excellent. Correct diagnosis was made in 174 patients. One patient had a minimal invasive cancer on definite pathology after resection while the sample contained only DCIS. Follow-up 6 month. Schlussfolgerung: The direct frontal approach with 360 degree vacuum aspiration is a new technology (Coramate®) that gives excellent diagnostic results without major patient discomfort and with high quality tissue samples. The system is particularly useful in various difficult situations at low costs.