Stereotactic vacuum-assisted breast biopsy in 2874 patients: a multicenter study

Abstract

Background: Vacuum-assisted breast biopsy (VAB) can replace surgical biopsy for the diagnosis of breast carcinoma. The authors evaluated the accuracy and clinical utility of VAB in a multicenter setting using a strict quality assurance protocol.

Methods: In the current study, VABs were performed successfully for 2874 patients at 5 sites. Benign lesions were verified by follow-up. Surgery was recommended for malignant and borderline lesions. VAB was performed on patients with lesions rated as highly suspicious (6%), intermediate to suspicious (85%), or probably benign (9%). Fifty-eight percent of the lesions were < 10 mm and 70% had microcalcifications.

Results: The authors identified 7% of patients with invasive carcinomas, 15% with ductal carcinomas in situ (DCIS), 5% with atypical ductal hyperplasias (ADH), and 0.6% with lobular carcinomas in situ. The results of the VAB necessitated an upgrade of 24% of patients with ADH to DCIS or DCIS and invasive carcinoma. Twelve percent of patients with DCIS proved to have invasive carcinoma. Seventy-three percent of the patients had benign lesions. Only 1 false-negative result was encountered (negative predictive value, 99.95%). Minor side effects were reported to occur in 1.4% of patients and 0.1% of patients required a subsequent intervention. Scarring relevant for mammography was rare among patients (i.e., 0.3% of patients had relevant scarring).

Conclusions: Quality-assured VAB was found to be highly reliable. VAB effectively identified patients with benign lesions and assisted therapeutic decisions. Most important, only a single case of malignancy was missed. A close interdisciplinary approach assured optimal results.