Authors' objectives: This study aims to inform on and describe the background and the current evidence on the use of image-guided vacuum-assisted breast biopsy (IGVB) for diagnostic sampling of suspicious, image-detected, non-palpable breast lesions or abnormalities.

Authors' recommendations: Facilities currently performing stereotactic core needle biopsy (CNB) may consider IGVB under stereotactic guidance as an alternative for the diagnostic sampling of selected suspicious image-detected, non-palpable breast lesions or abnormalities. The choice of the technique to use depends on the lesion and breast characteristics, as well as on the equipment availability, the expertise of the physician performing the biopsy, and cost considerations. Selective application of 11-gauge IGVB may be considered for calcifications and lesions not amenable to stereotactic 14-gauge CNB. Currently it is still unclear whether the benefits of stereotactic 11-gauge IGVB outweigh its additional costs when compared to stereotactic 14-gauge CNB. Based on the results of two systematic reviews, stereotactic 11-gauge IGVB appears to diminish the shortcomings of the stereotactic 14-gauge CNB by reducing histologic underestimation and the need for repeat biopsy. However, the question on whether the miss-rate of cancer is lower when using stereotactic 11-gauge IGVB has yet to be answered. The histologic underestimation and the need for repeat biopsy have not been completely eradicated by using stereotactic 11-gauge IGVB. False positive interpretations still occur with stereotactic IGVB and all cases should be subject to multidisciplinary review before definitive treatment. Potential candidates should be informed about the procedure and its risks. An advantage of using IGVB under ultrasound guidance over ultrasound-guided CNB has yet to be established. Currently, the experience with IGVB under MRI guidance is still limited. Further research is necessary to evaluate the utility and cost-effectiveness of these methods. As for screening programs, quality control and quality assurance programs should be instituted for all IGVB techniques. While FDA and Health Canada have approved several IGVB systems for diagnosis, none has been approved for treatment of breast cancer. Coverage for this procedure varies in North America. This TechNote response is limited since it reports the results from two systematic reviews and recently published primary research studies (which may address some of the outstanding issues outlined below) are not included. Further research is needed to define the definitive role of IGVB as a diagnostic sampling method. Consensus is needed on the adequate patient selection criteria and techniques to reduce the false positive and false negative rates as much as possible, as well on follow-up strategies. Further work should include evaluation of IGVB in direct comparison with CNB (using stereotactic, ultrasound, or MRI guidance) with respect to safety, diagnostic accuracy and cost effectiveness, and the evaluation of these methods with respect to optimisation of choice for different breast lesions. Long-term follow-up studies are also needed.

Authors' methods: Overview

Project Status: Completed

Year Published: 2005

URL for published report: https://www.ihe.ca/advanced-search?type=1020

URL for additional information: http://www.health.alberta.ca/initiatives/health-evidence-reviews-list.html

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Institute of Health Economics

Contact Address: 1200, 10405 Jasper Avenue, Edmonton, Alberta, Canada, T5J 3N4. Tel: +1 780 448 4881; Fax: +1 780 448 0018;

Contact Name: djuzwishin@ihe.ca

Contact Email: djuzwishin@ihe.ca

Copyright: <p>Alberta Heritage Foundation for Medical Research (AHFMR)</p>