Guidance

Breast screening: how to record vacuum-assisted excisions

Published 4 October 2018

The NHS Breast Screening Programme (BSP) Clinical guidelines for breast cancer screening assessment outlines the requirements for the management of B3 lesions.

This includes the use of vacuum-assisted excision (VAE) as an alternative to diagnostic surgery. The background to this guidance is available from Clinical Radiology.

The facility to record VAE procedures on the National Breast Screening System (NBSS) was introduced with NBSS release 914 in September 2018. Staff working within breast screening services should also refer to NBSS training articles developed by Hitachi (TA018, TA019 and TA020) which are available from the Hitachi helpdesk or the NBSS intranet.

1. Vacuum-assisted biopsy and excision

1.1 Vacuum-assisted biopsy (VAB)

VAB is a safe and minimally invasive procedure in which a small sample of breast tissue is removed for examination.

The vacuum draws tissue into the centre of the needle and a rotating cutting device takes the samples. The purpose of the biopsy is always diagnostic. The aim of VAB is to obtain enough tissue to make a diagnosis, not to remove the abnormality. It is reported similarly to a wide bore needle (WBN) biopsy. The outcome of the VAB is recorded on the NBSS histology VAB form.

1.2 Vacuum-assisted excision (VAE)

Like VAB, VAE also involves removing a sample of breast tissue for examination. The aim of VAE is to replace the diagnostic surgical biopsy.

VAE will not be the first diagnostic procedure a woman has. The aim is to take enough breast tissue to ensure representative sampling. In doing so, small lesions (typically 15mm or smaller) may be fully excised.

VAE will often be the last intervention required for lesions of uncertain malignant potential and will avoid the need for many women to have further surgery. The outcome of the VAE is recorded on a new NBSS VAE lesion form, which is very similar to the surgery form. For reporting purposes, it is treated like a surgical biopsy.

2. Information for administrative staff

A normal breast is made up of ducts (tiny tubes) that end in lobules (groups of tiny sacs). When women breastfeed, the milk travels along the ducts from the lobules to the nipple. The breast ducts and lobules are lined by 2 layers of cells. These are called epithelial cells.

2.1 Important terms

B3 outcome

A B3 outcome is defined as a ‘lesion of uncertain malignant potential’. This includes a range of abnormalities. In general, they are one or both of the following:

1. Lesions known to be associated with malignancy (but are not themselves malignant).

2. Lesions known to be variable in pattern in different areas and the part sampled may be benign but there may be an area of greater concern nearby.

Breast atypia

Breast atypia (in the context of B3) refers to epithelial atypia. The cells in the ducts or lobules look unusual but are not unusual enough to describe as malignant. Under the microscope there is usually a greater growth of cells.

Atypia can be associated with malignancy. Studies have shown that when atypia is associated with another B3 lesion (such as a papilloma or radial scar) there is a much higher chance of malignancy compared to lesions where atypia is not present. This is why we report atypia.

2.2 Diagnosis

Women with an initial B3 outcome (whether this was from a WBN biopsy or VAB) will have a repeat procedure in order to obtain a definitive diagnosis from the examination of more tissue. The multidisciplinary team (MDT) will decide if this should be a surgical open biopsy or a VAE. It is essential for the screening office to know which procedure has been undertaken so it is accurately recorded on NBSS.

Clinicians undertaking either VAB or VAE procedures must clearly input on NBSS which procedure has been completed.

Pathologists will not report VAE procedures with a biopsy ‘B’ code. Instead, the pathology report should clearly state whether the specimen is benign or malignant. This should then be entered on NBSS as E2 (benign) or E5 (malignant) by screening office staff. If there is any uncertainty, screening office staff should go back to the reporting pathologist to confirm. The VAE lesion pathology entry on NBSS is very similar to the surgery form currently used. For a VAE procedure, the specimen type selected on NBSS should always be LB (Localisation Biopsy).

There are 2 additional codes on NBSS, which are equivalent to those already used for surgery. E0 is to be used for VAE specimens taken which cannot be reported and E1 is to be used for VAE specimens which are reported as normal.

The table below outlines the benign conditions likely to be diagnosed, all of which are to be coded as E2 (benign) on NBSS when diagnosed from a VAE procedure:

NBSS code	Description	Notes
BBP	Borderline Phyllodes Tumour	New code for Surgery/VAE
BCC	Columnar cell change
BCF	Benign Phyllodes	New code for Surgery/VAE
BCR	Complex sclerosing lesion/radial scar
BDE	Periductal mastitis/duct ectasia
BFA	Fibroadenoma
BFC	Fibrocystic change
BML	Mucocoele-like lesion	New code for Surgery/VAE
BPM	Multiple papillomas
BPS	Solitary papilloma
BSA	Sclerosing adenosis
BSC	Solitary cyst
BST	New code for Surgery/VAE	New code for Surgery/VAE
BXX	Other

For benign lesions, the ‘Epithelial Proliferation’ field is mandatory. A new code of EAF has been added within this field to denote the presence of atypia:

NBSS code	Description	Notes
ENP	Not present
EPW	Present without atypia
EAD	Present with atypia (ductal)
EAF	Present with atypia (FEA)	New code for WBN/VAE/Surgery
EAL	Present with atypia (lobular)

Lobular neoplasia (sometimes called lobular in situ neoplasia) is the term used for the range of abnormalities from atypical lobular hyperplasia (ALH) to lobular carcinoma in situ (LCIS). These are characterised by the amount of disease present, which usually requires more tissue than is present in a WBN or a VAB. If diagnosed on a WBN or a VAB, lobular neoplasia should be entered on NBSS as a B3 lesion. A B3 code should also be entered if the pathologist has reported either ALH or LCIS on a WBN or VAB.

If the woman proceeds to surgery and a diagnosis of LCIS is confirmed, the surgery is coded as H5 (malignant). If the woman has a VAE procedure and LCIS is confirmed, the E5 (malignant) code is used.

Just like with a WBN or VAB, a VAE procedure can remove the whole lesion. If a VAE procedure removes a cancerous lesion, resulting in a benign or normal opinion on any subsequent surgical treatment, the surgery can be marked as a ‘cancer on KC62’ on NBSS.

A multidisciplinary meeting (MDM) record needs to be entered on NBSS before the episode can be closed.

For detailed guidance on recording VAE on NBSS please refer to TA018 ‘How to record details for Vacuum Assisted Excision (VAE )’, which is available from the Hitachi helpdesk. The guidance follows the complete pathway for inputting VAE data. For experienced users of the NBSS system, a summary of changes for VAE are provided on page 5 and 6 of this training article.

3. Information for staff undertaking VAE

All services should follow the management of B3 guidance included in the appendices of Clinical guidelines for breast cancer screening assessment. This includes a second line vacuum assisted excision (VAE) for most B3 lesions rather than surgical open biopsy ^{[footnote 1]}. Referral pathways should be established with neighbouring services if services are not able to offer this in-house. This should be discussed with the screening quality assurance service (SQAS) and commissioners.

A distinct VAE needle biopsy type procedure is available on NBSS. The content is the same as the WBN (wide bore needle) record. The clinician performing the procedure is responsible for selecting the correct procedure type and completing the necessary information on NBSS. Refer to the Hitachi training article TA018, ‘How to record details for Vacuum Assisted Excision (VAE)’, for details on how this NBSS data entry is made.

If a WBN or fine needle aspiration (FNA) of lymph nodes is performed at the same assessment visit as the VAE, this should be recorded on a separate WBN or FNA NBSS record.

The multidisciplinary team (MDT) must make it clear which procedure is being requested and make sure it is accurately recorded on the MDT meeting record.

The request should be clearly labelled to show whether the specimen is a VAB or VAE sample as this will determine the reporting style used by the pathologist and whether they provide a ‘B’ code. The NBSS ‘Path Lab’ form has been updated to include a specific category for VAE procedures.

If a woman had an initial core biopsy (WBN or VAB) and it was non diagnostic and a second vacuum biopsy was performed, this is still a VAB, not a VAE even if a 7 or 8 gauge needle is used. A VAE procedure should only be recorded for B3 lesions diagnosed on a previous VAB or WBN who are being assessed with second line VAE. Some women will have an initial core biopsy/VAB followed by VAE and then surgery (as outlined in the flow diagrams below).

The VAE specimens will have E codes recorded on NBSS. Pathologists will not provide E codes. This will be entered by the screening office staff, depending on whether the pathologist has reported the specimen as benign or malignant. The E codes are similar to the surgical H codes. All benign lesions would be classified as E2 benign. All cancers would be classified as E5 malignant (as outlined in the flow diagrams below).

Patient pathway with second line VAE after B3 outcome

Patient pathway with second line VAB / WBN after initial B1 outcome. VAE is the third line procedure.

An educational pack is available which contains patient information leaflets, consent forms and post biopsy care leaflets from many different centres from the UK. These resources may be helpful to patients to explain vacuum-assisted biopsy and excision procedures.

4. Information for pathology staff

The Royal College of Pathologists guidance (2017) states ‘It is planned that in future it will not be necessary to insert a B category on the NBSS for a vacuum-assisted excision’ and ‘A B category is not necessary for vacuum-assisted excision of a lesion that has already been diagnosed on a previous biopsy’. NHS BSP clinical guidelines outline the requirements for the management of B3 lesions. This includes the use of VAE as an alternative to diagnostic surgery ^{[footnote 1]}. Updates have been made to NBSS to reflect these changes.

Before reporting a specimen, it is essential the pathologist knows if it was obtained via a VAB or VAE procedure. This should be clearly stated by the clinician sampling the lesion. It should also be clearly documented in the MDT meeting record.

4.1 Reporting VAB specimens

A ‘B’ code is required for these specimens and should be reported using the same codes as needle core biopsies (B1-B5). The B code should be recorded on the pathology report

4.2 Reporting VAE specimens

These are entered on NBSS as a separate specimen type. A ‘B’ code is not appropriate on the pathology report for VAE specimens. On NBSS, an ‘E’ code will be entered by the screening office with 2 main options – E2 for benign pathology and E5 for malignant pathology. This is similar to the H2 for benign pathology and H5 for malignant pathology coding on surgical specimens.

Pathologists should record clearly on the report if the diagnosis is benign or malignant, but do not need to provide an ‘E’ code on the pathology report.

There are also NBSS codes for use by the screening office if the specimen cannot be reported (E0) or where the specimen is reported as containing normal breast tissue only (E1).

Screening office staff are advised to interpret the following diagnoses as benign and to enter an E2 diagnosis on NBSS for them:

NBSS Code	Description	Notes
BBP	Borderline Phyllodes Tumour	New code for surgery/VAE
BCC	Columnar cell change
BCF	Benign Phyllodes	New code for surgery/VAE
BCR	Complex sclerosing lesion/radial scar
BDE	Periductal mastitis/duct ectasia
BFA	Fibroadenoma
BFC	Fibrocystic change
BML	Mucocoele-like lesion	New code for surgery/VAE
BPM	Multiple papillomas
BPS	Solitary papilloma
BSA	Sclerosing adenosis
BSC	Solitary cyst
BST	Stromal lesion of uncertain significance	New code for surgery/VAE
BXX	Other

A clear comment regarding the presence or absence of epithelial proliferation needs to be made by the reporting pathology as it forms a separate mandatory data entry.

NBSS Code	Description	Notes
ENP	Not present
EPW	Present without atypia
EAD	Present with atypia (ductal)
EAF	Present with atypia (FEA)	New code for WBN/VAE/surgery
EAL	Present with atypia (lobular)

For example, flat epithelial atypia or atypical ductal hyperplasia are E2 but the codes would be EAF or EAD, respectively, on VAE.

If diagnosed on a WBN or VAB, lobular neoplasia is the most appropriate term (not atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS)) and this should be classified as a B3 lesion.

In a surgical excision or a VAE the pathologist should be clear in distinguishing between ALH and LCIS. If the woman goes on to have surgery and LCIS is seen, the specimen should be classified as malignant and will be coded as H5 on NBSS. If the woman has a VAE procedure and LCIS is confirmed, the specimen should be classified as malignant and will be coded as E5 on NBSS. ALH diagnosed by a VAE is coded as E2, with a further subcategory of EAL.

Screening office staff have been advised to query cases with the reporting pathologists if any of the above is unclear.

The wide bore needle (BQA) data available from NBSS can be produced for all biopsy tests or all clients which select the most significant biopsy outcome for the woman. The statistics will be presented in:

• Table B: this presents the non-operative results from WBN and/or VAB and cross-matches with the outcome achieved on VAE
• Table C: this presents the non-operative results from WBN and/or VAB and cross-matches with the outcome achieved on surgery
• Table D: WBN / VAB to VAE or surgery (combines outcomes from Tables B and C)
• Table F: this presents the non-operative results from VAE and cross-matches with the outcome achieved at surgery

5. Impact on data

For most processes and statistical reports, NBSS treats VAE procedures as wide bore needle procedures. The exception to this is the BQA Wide Bore Needle QA KC62 Cohort Report [STA01A] statistical report.

Please refer to the Hitachi training article, ‘TA019 – How the NBSS Statistics Reports treat a VAE’, which details the implications for the following NBSS statistical reports:

• STA12: KC62
• STA02a: breast screening feedback reports (BSF)
• STA17: workload analysis report
• STA01a: wide bore needle report (BQA)

6. References

1. Pinder SE, Shaaban A, Deb R, Desai A, Gandhi A, Lee AHS, Pain S, Wilkinson L, Sharma N. NHS Breast Screening multidisciplinary working group guidelines for the diagnosis and management of breast lesions of uncertain malignant potential on core biopsy (B3 lesions) ↩ ↩²