Image-guided vacuum-assisted excision biopsy of benign breast lesions

# Guidance
Current evidence on the safety and efficacy of image-guided vacuum-assisted excision biopsy of benign breast lesions appears adequate to support the use of this procedure, provided that the normal arrangements are in place for consent, audit and clinical governance.
Clinicians wishing to perform this procedure should undergo training as recommended by the Royal College of Radiologists in 'Ultrasound training recommendations for medical and surgical specialties'.# The procedure

# Indications
Image-guided vacuum-assisted core biopsy has been regularly used for gathering samples of tissue in women with breast lesions suspicious of breast cancer, or when histological evidence of a benign lesion is required. This procedure can also be used to remove benign breast lesions such as fibroadenomas. This can reduce the need for open surgical biopsy or excision.
Diagnosis of benign breast disease is usually done by clinical examination, imaging and fine needle biopsy; this is known as the triple test. Women who have negative results for malignancy in all three tests may choose to have benign lumps removed.

# Outline of the procedure
The procedure involves the use of a needle probe device with vacuum suction to remove breast tissue under imaging guidance (commonly ultrasound). The aim of the procedure is to continue using the biopsy device until the lesion visible on imaging has been removed. A small incision is made in the breast and an 8- or 11-gauge probe is inserted through the lesion. Small amounts of tissue are aspirated and the probe is withdrawn further into the lesion and the process repeated. When the device has been removed the site of incision is compressed for a short time. The procedure takes between 13 and 60 minutes, depending on the size of lesion being removed. The procedure can be performed on an outpatient basis under local anaesthesia.

# Efficacy
Complete removal was achieved in between 22% (21/95) and 98% (121/124) of lesions. The success rate may depend on the gauge of the probe used and the size of the lesion to be removed (these are often dependent variables). The accuracy of determining complete removal may depend on the quality of the imaging technique used.
In one case series, 23% (3/13) of patients with incompletely excised lesions after vacuum-assisted biopsy had subsequent open surgery excision. For more details, refer to the Sources of evidence.

# Safety
The most frequent complication of this procedure was haematoma. This complication was recorded in 13% (24/186) of patients in one case series, but none of these haematomas were classified as serious. In another study of 20 patients, no clinically problematic haematomas were reported.
In one large case series, 39% (73/186) of patients complained of mild postoperative pain, and 4% (8/186) of moderate pain. No patients reported severe pain.
Bleeding during the procedure occurred in 4% (2/56) of patients in one case series, and in 2% (3/186) in another. However, all three latter cases resolved with little or no intervention. For more details, refer to the Sources of evidence.
The Specialist Advisors noted that complications include haemorrhage, haematoma formation, vasovagal episodes and failure to excise the correct area. In addition, wound infection is a possible problem.

# Other comments
It was noted that, despite prior biopsy, patients may occasionally be found to have a malignant cancer.
It was noted that benign lesions such as fibroadenomas may sometimes recur after this procedure.# Further information
The NHS Breast Screening Programme has produced guidelines entitled 'Clinical guidelines for breast cancer screening assessment'.
Andrew DillonChief ExecutiveFebruary 2006

# Sources of evidence
The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.
'Interventional procedure overview of image-guided vacuum-assisted excision biopsy of benign breast lesions', February 2005.

# Information for patients
NICE has produced information on this procedure for patients and carers. It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedure guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
We have produced a summary of this guidance for patients and carers. Information about the evidence it is based on is also available.
Changes since publication
January 2012: minor maintenance.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2006. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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