Guidelines from the European Society of Breast Imaging for diagnostic interventional breast procedures

Abstract

The aim of the breast team is to obtain a definitive, nonoperative diagnosis of all potential breast abnormalities in a timely and cost-effective way. Percutaneous needle biopsy with its high sensitivity and specificity should now be standard practice, removing the need for open surgical biopsy or frozen section. For patients with cancer, needle biopsy provides a cost-effective and rapid way of providing not only a definitive diagnosis but prognostic information, allowing prompt discussion of treatment options, be they surgical or medical. Early removal of uncertainty also allows better psychosocial adjustment to the disease. Patients with benign conditions found either by themselves or as a result of population or opportunistic screening can be promptly reassured and discharged, removing the health care and psychological costs of surgical biopsy or repeated follow-up. Radiologists involved in breast imaging should ensure that they have the necessary skills to carry out core biopsy and/or fine-needle aspiration (FNA) under all forms of image guidance. This paper provides guidelines on best practice for diagnostic interventional breast procedures and standards, against which all practitioners should audit themselves, from the European Society of Breast Imaging.

Full text

Eur Radiol
DOI 10.1007/s00330-006-0408-x
NEWS FROM EUSOBI
Matthew Wallis
Anne Tarvidon
Thomas Helbich
Ingrid Schreer
# Springer-Verlag 2006
Guidelines from the European Society
of Breast Imaging for diagnostic interventional
breast procedures
Abstract The aim of the breast team
is to obtain a definitive, nonoperative
diagnosis of all potential breast ab-
normalities in a timely and cost-
effective way. Percutaneous needle
biopsy with its high sensitivity and
specificity should now be standard
practice, removing the need for open
surgical biopsy or frozen section. For
patients with cancer, needle biopsy
provides a cost-effective and rapid
way of providing not only a definitive
diagnosis but prognostic information,
allowing prompt discussion of treat-
ment options, be they surgical or
medical. Early removal of uncertainty
also allows better psychosocial ad-
justment to the disease. Patients with
benign conditions found either by
themselves or as a result of population
or opportunistic screening can be
promptly reassured and discharged,
removing the health care and psycho-
logical costs of surgical biopsy or
repeated follow-up. Radiologists in-
volved in breast imaging should
ensure that they have the necessary
skills to carry out core biopsy and/or
fine-needle aspiration (FNA) under all
forms of image guidance. This paper
provides guidelines on best practice
for diagnostic interventional breast
procedures and standards, against
which all practitioners should audit
themselves, from the European
Society of Breast Imaging.
Keywords Breast cancer
.
Diagnostic imaging
.
Needle biopsy
.
Guidelines
Introduction
The aim of the breast team is to obtain a definitive,
nonoperative diagnosis of all potential breast abnormalities
in a timely and most cost-effective way. Women with no
significant breast problems should be reassured as quickly
as possible, and women with cancer should be diagnosed
without delay.
The highest levels of diagnostic accuracy in the
nonoperative diagnosis of breast disease are achieved by
using a triple approach [1], which combines the results of
clinical examination and imaging with fine-needle aspira-
On behalf of EUSOBI Committee (see:
http://www.eusobi.org).
M. Wallis (*)
Warwickshire, Solihull & Coventry
Breast Screening Service,
University Hospital,
Clifford Bridge Road,
Coventry CV2 2DX, UK
e-mail: Matthew.wallis@uhcw.nhs.uk
Tel.: +44-2476967169
Fax: +44-2476967180
A. Tarvidon
Department of Radiology,
Institut Curie,
26, rue d’Ulm,
75248 Paris, France
e-mail: anne.tardivon@curie.net
Tel.: +33-1-44324200
Fax: +33-1-44324015
T. Helbich
Department of Radiology,
Medical University Vienna-AKH Wien,
Waehringerguertel 18–20 1090,
Vienna, Austria
e-mail: thomas.helbich@meduniwien.
ac.at
Tel.: +43-1-404004819
Fax: +43-1-404004898
I. Schreer
Mammazentrum Klinik fuer
Gynaekologie und Geburtshilfe,
Universitätsklinikum Schleswig-
Holstein Campus Kiel,
Michaelisstr. 16,
24105 Kiel, Germany
e-mail: ischreer@email.uni-kiel.de
Tel.: +49-431-5972100
Fax: +49-431-5973617

tion cytology (FNAC) and/or core biopsy (both wide bore
and vacuum-assisted) of significant breast abnormalities [2,
3]. When the results of all three modalities agree, the level
of diagnostic accuracy exceeds 99% [4]. It is of interest to
note that similar levels of accuracy have been obtained in
the case of impalpable lesions, in which clinical examina-
tion is noncontributory [5].
Percutaneous needle biopsy with its high sensitivity and
specificity should now be standard practice, removing the
need for open surgical biopsy or frozen section [6–9]. For
patients with cancer, needle biopsy provides a cost-
effective and rapid way of providing not only a definitive
diagnosis but prognostic information, allowing prompt
discussion of treatment options, be they surgical or
medical. Early removal of uncertainty also allows better
psychosocial adjustment to the disease. It is not the goal of
percutaneous biopsy to completely excise cancer.
Benign conditions found either by the patient themselves
or as a result of population or opportunistic screening can
be promptly reassured and discharged, removing the health
care and psychological costs of surgical biopsy [10, 11].
The role of needle biopsy verses short-term follow up in the
management of probably benign lesions is less clear cut.
The American literature, where annual examinations are
routine, suggests that there is no difference in the levels of
stress or intention to reattend [12, 13]. On the other hand, in
the UK NHS Breast Screening Programme, early recall is
considered more stressful both in the short- and long-term
than needle biopsy [14, 15]. Early follow-up is said to be
cheaper, but this might depend on individual health care
economies and clinic organisation [16, 17]. The two
options should be discussed with the patient, and if the
triple approach confirms benignity, then the lesion can be
reclassified as benign and the patient discharged. Radi-
ologists involved in breast imaging should ensure that they
have the necessary skills to carry out core biopsy and/or
FNAC under stereotactic, ultrasound (US) and magnetic
resonance imaging (MRI) control.
The aim of this paper is to provide guidelines for
diagnostic interventional breast procedures by the European
Society of Breast Imaging.
Standards and objectives
Tables 1 and 2 provide a list of both outcome and process
standards for interventional breast biopsy against which all
individual practitioners and their multidisciplinary teams
should audit them selves.
Standard 1
This standard applies to all carcinomas (invasive and in
situ) and applies to diagnoses made by FNAC and/or core
biopsy vacuum-assisted biopsy. Only definitive diagnoses
of malignancy should be included. Open surgical biopsy is
not included.
Table 1 Quality indicators (standards) for breast interventional procedures
Objective Criteria Acceptable
standard
Desirable
target
1 To ensure that the majority of cancers, both palpable and
impalpable, receive a nonoperative tissue diagnosis
of cancer
The percentage of women who have a
nonoperative diagnosis of cancer by cytology
or needle histology
>70% >80%
2 To minimise the number of visits necessary to achieve
a definitive diagnosis
The number of visits for interventional
procedures
No more
than 2
No more
than 1
3 To minimise the number of unnecessary operative
procedures
Ratio of benign:malignant biopsies ≤1:1 ≤0.5:1
4 To achieve optimum aspiration technique and minimise
the number of repeat needle biopsy procedures
Inadequate rate of NAC (all) <25% <15%
5 To maximise the nonoperative diagnosis rate and minimise
the number of repeat needle biopsy procedures
Inadequate rate of FNAC from cancer <10% <5%
6 To maximise the nonoperative diagnosis rate and minimise
the number of repeat needle biopsy procedures
Miss rate on core breast biopsy from cancer <5% <2%
7 To minimise understaging of invasive breast cancer Percent of noninvasive core breast
biopsies that are invasive at final surgery
<15% <5%
8 To minimise understaging of breast cancer Percent of high-risk core breast biopsies
that are malignant at surgery
<25% <10%
NAC needle aspiration cytology, FNAC fine-needle aspiration cytology

Standard 2
There is a risk that, in an attempt to drive up the
nonoperative diagnostic rate, repeated attendances for
needle biopsy during a single clinical episode are likely
to be associated with unnecessary anxiety. A definitive
diagnosis should be achieved in the minimum number of
visits wherever possible.
To date, these standards and objectives have been laid
down for screening programmes [18, 19] and, to a lesser
extent, for referral (symptomatic) practice [20], but we
have pulled them together and updated them. Each
objective defines the purpose of the standard and has an
accompanying criteria, which defines how the standard
should be measured. The acceptable standard is a minimum
that all teams should achieve. The desirable target is
aspirational. We are aware that long-established teams and
countries with population screening can comfortably attain
these targets and, indeed, have national targets set at higher
levels [18], but this only comes with considerable expe-
rience and the repeated use of audit [21]. We are confident
that in a few years, we will be able to revisit and reset both
the acceptable standard and the desirable target.
Before interventional procedures
All patients should undergo a thorough workup including
clinical examination and imaging prior to FNAC and/or
core biopsy. The imaging characteristics of suspicious
lesions are demonstrated using special views, including
fine-focus magnification views for microcalcifications and
spot compression views and US examination for mass
lesions, focal asymmetry or architectural distortion. Imag-
ing features of mammographically and/or US-detected
abnormalities are assessed to determine the probability of
malignancy, and this should be indicated in the radiological
report. The radiologist must be certain that the abnormality
seen on US is the same as the abnormality seen on
mammography and, where relevant, that this corresponds
to the palpable lesion. There should be written local
protocols clearly defining the indications for FNAC,
automated core biopsy and other needle biopsy techniques
[2]. The procedure should be explained to the patient, with
a brief explanation of risks and benefits. It should be
standard practice to provide the patient with written
information about complications.
Teaching and experience
Training standards have been set out by the European
Association of Radiology in the European Training Charter
for Clinical Radiology (http://www.ear-online.org)[22].
We suggest that a minimum of 20 interventional proce-
dures are undertaken under supervision (with histological
verification) before commencing independent practice and
then a minimum of 25 per year to maintain competence
[23, 24].
Choice of sampling technique
Current evidence suggests that, firstly, vacuum-assisted
core biopsy (VACB) properly carried out provides better
sensitivity and specificity than either 14-gauge core biopsy
or FNAC for microcalcifications and architectural distor-
tion. Secondly 14-gauge core biopsy provides better
sensitivity and specificity than FNAC for other types of
lesions [8, 9, 25, 26]. Core biopsy also facilitates definitive
diagnosis of benign lesions [10, 11]. This has to be
balanced against the cost and the fact that unless one uses
imprint cytology [27, 28] or fast-track biopsy techniques
[29] it is not possible to provide an answer immediately.
Finally, core biopsy provides information on invasion,
grade, hormone receptor status and other immunological
and genetic markers. These can be used to assist in
management decisions and aid in monitoring of the effects
of neoadjuvant treatment [30]. In expert hands, remarkable
results can be obtained on cytological specimens [31, 32].
FNAC may be preferred in some centres for sampling
mass lesions and obvious carcinoma, but only where a
satisfactory standard of excellence of both sampling and
cytology interpretation has been achieved [8, 9, 33–35].
The main advantages of FNAC are cost [20, 33, 36] as one
only requires 18- to 23-gauge disposable needles attached
to a plastic syringe. Additional equipment includes glass
slides with alcohol fixative for unsmeared tissue samples
[37]. Another advantage is the ability to provide immediate
reporting, either on adequacy by a technician or a full
diagnosis when a cytopathologist is available [25, 33, 38,
39]. While this is considered to be very beneficial for
women with benign disease, it is less clear cut for patients
with malignancy who need longer to come to terms with
their diagnosis. The combination of the two techniques has
been shown to be beneficial [40], particularly for cancer, as
Table 2 Quality indicators (standards) for breast interventional procedures (population screening)
Objective Criteria Acceptable standard Desirable target
9 To minimise the number of un-
necessary operative procedures
The rate of benign biopsies
(when population screening)
Prevalent screen <3.6 per 1,000;
incident screen <2.0 per 1,000
Prevalent screen <1.8 per 1,000;
incident screen <1.0 per 1,000

FNAC allows for rapid diagnosis, which is subsequently
confirmed by histology (core biopsy). This avoids the risk
of a false positive diagnosis and obtains prognostic
information for treatment decisions.
Needle size is important, with clear evidence that, when
comparing 14-, 16- and 18-gauge needles, accuracy rises
with needles of increasing size [41]. Long-throw needles
used with a fully automated biopsy gun produce the best
specimens [42–44]. Current best practice is to use a long-
throw (2-cm) 14-gauge needle with biopsy gun (integral or
separate).
VACB (from 8 to 11 gauge) can be used with either
standard upright or prone stereotactic apparatus and under
US guidance. Published evidence shows that the use of
VACB is associated with higher rates of calcium retrieval
and lower rates of underdiagnosis of both ductal carcinoma
in situ (DCIS) and invasive tumour [25, 45, 46]. Where
available, VACB may be considered the sampling method
of choice for:
– Indeterminate cluster of microcalcifications
– Obviously malignant cluster of microcalcifications, to
increase to the chance of detection of invasive foci
– Discordant results after 14-gauge core biopsy
– Architectural distortion
– Diagnostic excision of papillary lesions diagnosed at
core biopsy
Guidance
High proportions of mammographically detected lesions
are impalpable and require image guidance for FNAC or
core biopsy sampling. In addition, image guidance,
particularly US, can have advantages over freehand
procedures when sampling palpable lesions to ensure
accurate and safe sampling [47, 48]. The choice of
radiological guidance must be the method that (a) allows
the best visualisation of the lesion, (b) offers the best
chance of successful and adequate lesion sampling and (c)
is the simplest and cheapest.
If a diagnostic MRI of the breast identifies a suspicious
lesion, every effort should be made to reidentify the lesion
on conventional modalities such as mammography or US
[49]. If a lesion can be clearly identified on mammography
or US, biopsy should be performed using one of these
guiding modalities. However, second-look US fails to
identify a sonographic correlate in up to 77% of MRI-
detected lesions referred for biopsy [50, 51]. Where
possible, MRI procedure should be undertaken with the
same sequences used for the diagnostic study and, if time
permits, in the second week of the menstrual cycle [52].
A clip should be placed at the end of the procedure to
allow for mammographic marking if subsequent surgical
intervention is indicated. Two orthogonal mammographic
views are required to document the position of the clip.
Complications
Complications from both FNAC and core biopsy are rare.
However, the following have been reported:
– Pain
– Haematoma
– Fainting
– Pneumothorax [54]
– Infection [55]
– Seeding of tumour [56, 57, 60] (this does not appear to
be of clinical significance)
– Removal of lesion by the core. (It is not the objective of
the diagnostic biopsy to remove the lesion in its
entirety; however, this will happen in the case of small
lesions, and it is good practice to take a stereo film at 0°
to check how much remains and, if needed, deploy a
marker clip.)
– Dislocation of clip placement [53, 58]
Adequacy of sampling
FNAC sample
An adequate FNAC sample should contain at least five
clusters of epithelial cells, each of which should contain
five or more cells [2].
Core biopsy
Generally, it is not appropriate to be dogmatic about the
number of specimens taken when undertaking core biopsy,
particularly when using US. The important thing is to
achieve the targets set out above. Liberman [59, 60]
suggests that a minimum of five passes are required. With
experience, mass lesions can be diagnosed with a couple of
passes [61]. However, it is necessary to obtain a
representative sample adapted to lesion size and tissue
consistency and document this. There should be radiolog-
ical and pathological correlation before discussing the
result with the patient. There are two specific lesion types
in which more definitive evidence based guidance can be
provided: microcalcification and architectural distortion.
Microcalcifications
Representative microcalcification must be demonstrated in
the core specimens on specimen radiography [45]. Iden-
tification of microcalcification on histology alone is not a
reliable indicator of adequate sampling (histological
microcalcification is a common incidental finding and
can be present when there is no calcification visible on
mammography) [62]. The literature is divided on how to

ensure optimal diagnostic accuracy: the minimalist ap-
proach of counting calcification on the specimen radio-
graphs verses counting the number of cores or the volume
removed. Bagnall [63] recommends that at least three
flecks of calcification be seen in at least two cores. Ideally,
five flecks or more should be seen in three cores. This
requirement is obviously lessened in lesions with fewer
than ten flecks of calcification. In these circumstances, a
comparison before and after the procedure (scouts 0°) to
evaluate the percentage of microcalcifications retrieved by
the biopsies is indicated. Biopsies that retrieve more than
50% of the cluster can be considered as representative of
the lesion [64]. On the other hand, Lomschitz [65]
considers that when using 11-gauge VACB, 12 specimens
(harvested by two rotations) gives maximum diagnostic
yield.
If sampling is not adequate and/or in discordant
radiohistological results, the procedure should be repeated
or localisation surgical biopsy performed [46]. Surgical
biopsy is not required when histology shows a definitively
benign cause for calcifications in core specimens con-
firmed by specimen radiography to contain calcifications
clearly representative of those considered suspicious on
mammography.
Specificity and absolute sensitivity for sampling micro-
calcifications is significantly higher with the use of larger-
bore biopsy devices, such as VACB, and such devices may
be considered where there is diagnostic uncertainty [66,
67]. Surgical open biopsy is normally required to exclude
frank malignant change in the adjacent tissues when
histology shows indeterminate changes (e.g. hyperplasia
with atypia) [45, 63], as even with large volume sampling,
underestimation of disease will take place, i.e. hyperplasia
on core is a harbinger of noninvasive disease, and some
noninvasive core biopsies will turn out to be invasive on
surgical treatment.
It is not the goal of percutaneous biopsy to completely
excise cancer [64].
Architectural distortion
Management of architectural distortion is still controver-
sial, as 20–50% of cases of architectural distortion are due
to malignancy [68]. Traditional teaching is that all these
lesions should be removed. However, data from several
published series now show that image-guided core biopsy
is accurate in distinguishing malignant lesions from benign
causes, e.g. radial scar, providing targeting is accurate and
sufficient material is obtained [69–72]. A recent series has
shown that the most accurate results are obtained by taking
more than 12 11-gauge samples using a VACB device [73].
Recommendations for the management of architectural
distortion depends on the local availability of vacuum-
assisted mammotomy. If VACB is not available, it is
recommended that conventional core biopsy is performed
as the initial diagnostic procedure on all distortions not due
to surgical scarring [26]. If this shows malignant change,
therapeutic surgery should be performed (a minimum of
three cores targeted to sample different areas of the imaging
abnormality). For all other diagnoses, diagnostic surgical
open biopsy should be performed.
If VACB is available, it is recommended that initial
diagnosis is carried out using conventional automated core
biopsy. Again, a malignant result should be managed by
therapeutic surgery. However if a result is benign or shows
radial scar with no evidence of epithelial atypia, a choice of
either open surgical excision or excision with VAB may be
offered. VAB can be performed under US or stereotactic X-
ray guidance, and a minimum of 12 11-gauge cores should
be obtained. Where VAB is chosen and histology again
shows either benign changes or radial scar with no
evidence of epithelial atypia, then further excision is not
required.
In all cases, management should be discussed prospec-
tively by the multidisciplinary team. If there is doubt
regarding concordance of the imaging/histology findings,
diagnostic surgical excision should be recommended.
Staging of the axilla
Sentinel lymph node biopsy (SLNB) has become rapidly
accepted as an alternative to axillary sampling or clearance
[74, 75]. Seven-year follow-up from Veronesi et al.
suggests that this is a safe procedure [76]. Variable surgical
and pathological practice indicates that there are still
outstanding questions [75, 77]. Axillary node US with
either FNAC or core biopsy can identify between 30% and
40% axillas with macroscopic disease [ 78– 82] and
according to Deurloo can reduce the number of SLNBs
by up to 14% [80].
Documentation
Images should be taken to document accurate needle
placement. A written report to both the referring team and
the reporting pathologist should include:
– Nature of lesion biopsied
– Radiological opinion and classification
– Details of procedure undertaken (including needle
calibre)
– Adequacy of targeting
– Quantity of material sampled
– Presence or absence of microcalcification on specimen
radiographs
– Changes (or not) of the lesion after biopsy (e.g. mass
decreasing in size)
– Placement of a clip marker and description of its
position

– Pathology centre where the specimen is being processed
– Complications (if any)
After interventional procedures
Communication and discussion of result
Clinical examination, together with the result of imaging,
must be considered with the results of needle biopsy to
ensure clinico-radio-pathological concordance before man-
agement decisions are made. It is good practice that this
occurs in a multidisciplinary fashion, preferably as part of a
regular multidisciplinary meeting where full notes are
taken or a written report is produced.
Audit
In addition to routine quality control tests, to ensure
equipment safety and performance during imaging and
interventional procedures, outcome data on the procedures
should be collected. This data should be prospectively
collected and summarised for each facility and physician
who performs the procedures and by the reporting pathol-
ogist. In addition to data required to monitor performance
against the standards outlined in the early part of the
document, the number of complications, and the number of
lesions requiring repeat biopsy and the reason should be
recorded. A number of accreditation schemes are available
[20, 81, 82].
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