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366 Original Article

Interdisciplinary Consensus Recommendations for the


use of Vacuum-Assisted Breast Biopsy under
Sonographic Guidance: First update 2012
Konsensusempfehlung zu Anwendung und Indikationen der Vakuumbiopsie der
Brust unter Ultraschallsicht: erste Aktualisierung 2012

Authors M. Hahn1, U. Krainick-Strobel2, T. Toellner3, J. Gissler4, S. Kluge4, E. Krapfl5, U. Peisker6, V. Duda7, F. Degenhardt8,
H. P. Sinn9, D. Wallwiener1, I. V. Gruber1

In cooperation with the Minimally Invasive Breast Intervention Study Group (AG MiMi) of the German Society of Senology
(DGS) and the Study Group for Breast Ultrasonography of the German Society for Ultrasound in Medicine (DEGUM).

Affiliations Affiliation addresses are listed at the end of the article.

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Key words Zusammenfassung Abstract
● breast
"
! !
● vacuum-assisted biopsy
"
Ziel: Die Vakuumbiopsie der Brust unter sonografi- Purpose: The vacuum biopsy of the breast under
● ultrasound
"
scher Bildgebung (VB) wurde flächendeckend in sonographic guidance (VB) was introduced in Ger-
● consensus recommendations
"
Deutschland ab dem Jahr 2000 eingesetzt. Die erste many in the year 2000 and the first consensus re-
Konsensusempfehlung von Krainick-Strobel et al. commendations were published by Krainick-Stro-
erschien 2005. Seitdem ist die Literatur zu diesem bel et al. in 2005. Since then, many clinical studies
Thema deutlich erweitert worden. Ziel dieser Pub- on this technique have been published. The pur-
likation ist die Aktualisierung der Konsensusemp- pose of this publication is to update the consensus
fehlung von 2005 unter Beachtung der neuesten recommendations from 2005 regarding the latest
Literatur. literature.
Material und Methoden: Nach Durchsicht der Lite- Materials and Methods: The consensus state-
ratur fand die Konsensusfindung im Rahmen von ments were the result of two preliminary meet-
2 Arbeitstreffen von Mitgliedern der Arbeitsge- ings after the review of the latest literature by
meinschaft Minimalinvasive Mammainterventio- members of the Minimally Invasive Breast Inter-
nen der Deutschen Gesellschaft für Senologie statt. vention Study Group from the German Society of
Der fertige Konsensustext wurde allen Mitgliedern Senology. The final consensus text was review by
der Arbeitsgruppe vorgelegt. Die unter Ergebnisse all members of the working group. The state-
genannten Punkte wurden einstimmig (Konsensus ments listed under results obtained complete ac-
100 %) verabschiedet. ceptance (consensus 100 %).
Ergebnisse: Diese Konsensusempfehlung be- Results: The consensus recommendations de-
schreibt die Indikationen, die Anforderungen an scribe the indications, investigator qualifications,
den Untersucher, die technischen Voraussetzun- technical requirements, documentation, quality
received 19.1.2012 gen, die Dokumentation, die Qualitätssicherung assurance and follow-up intervals regarding the
accepted 27.3.2012 und die Kontrollintervalle unter Beachtung der latest literature.
aktuellen Datenlage. Conclusion: The VB is a safe method for extracting
Bibliography
Schlussfolgerung: Die VB stellt eine sichere Metho- breast tissue for histological workup. The tech-
DOI http://dx.doi.org/
10.1055/s-0032-1312831 de zur Histologiegewinnung bei Brusttumoren dar. nique allows the resection of breast tissue up
Published online: June 21, 2012 Sie ermöglicht die Resektion von Gewebsvolumina to 8 cm3. Besides the diagnostic indications, the
Ultraschall in Med 2012; 33: bis 8 cm3. Neben den diagnostischen Indikationen method qualifies for a therapeutic resection of
366–371 © Georg Thieme eignet sich die Methode auch zur therapeutischen symptomatic benign lesions (e. g. fibroadenomas).
Verlag KG Stuttgart · New York · Exstirpation von symptomatischen, benignen Be- The technique should be used in specialized breast
ISSN 0172-4614
funden (z. B. Fibroadenome). Die Technik sollte in centers working in a multidisciplinary setup. This
Correspondence spezialisierten, interdisziplinär arbeitenden Brust- paper is an expert’s recommendation for the use
PD Dr. Markus Hahn zentren durchgeführt werden. Diese Empfehlung of VB under sonographic guidance. It is not formu-
Universitäts-Frauenklinik ist als Expertenempfehlung zu verstehen und er- lated as a nationwide guideline.
Tübingen hebt nicht den Anspruch einer Leitlinie.
Calwerstr. 7
72076 Tübingen
Germany
Tel.: ++ 49/70 71/2 98 22 11
markus.hahn@med.uni-
tuebingen.de

Hahn M et al. Interdisciplinary Consensus Recommendations … Ultraschall in Med 2012; 33: 366–371
Original Article 367

Introduction cision of approximately 8 cm3 of tissue [4, 5] (a therapeutic VB is


! not suitable for malignancies). The quantity of tissue obtained by
Ultrasound-guided vacuum biopsy (VB) of the breast [1] was first VB is comparable to that obtained by open biopsy. Thus, the diag-
performed in Germany in January 2000 and has since been estab- nostic reliability of VB is nearly equivalent to that of open biopsy. A
lished as a valuable diagnostic tool to obtain tissue through a large number of studies have documented their equivalence with
minimally invasive approach. respect to false-negative rates [6 – 13].
In 2005 Krainick-Strobel et al. [2] published the first consensus The following indications may be derived from the above.
recommendations for the use of vacuum-assisted breast biopsies
under sonographic guidance. Numerous studies published after- Indications for diagnostic representative VB
wards have confirmed the diagnostic safety and benefits of the 1. After core needle biopsy (CNB) following a benign histological
method. Therefore, in 2010 the AG MiMi Study Group (Minimal- report, yet persistent suspicion of carcinoma (BIRADS IV/V, mis-
ly Invasive Breast Interventions Study Group) decided to revise match between diagnostic imaging studies and histology)
the consensus recommendations on the basis of recently pub- In the case of mismatch between imaging reports and histolo-
lished data. gical findings after CNB, the decision to perform ultrasound-
The stage 3 guidelines for the early detection of breast cancer in guided VB should be made at the interdisciplinary tumor con-
Germany [3] specify that at least 95 % of abnormal lesions must ference, as described in the Guidelines for Early Recognition of
be confirmed by histological investigation for histological confir- Breast Cancer [3]. Due to the larger volume of resected tissue
mation of the diagnosis prior to the formulation of the therapy in VB as compared to CNB, a representative biopsy can be vis-
plan in cases of suspected breast carcinoma At least 70 % of these ualized and documented on ultrasound [14 – 19].
procedures should be obtained by a minimally invasive approach 2. Suspicious findings (BIRADS IV/V) that cannot be clarified with

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[3]. Open biopsies for the confirmation of the diagnosis should be sufficient reliability by core needle biopsy
performed only when a minimally invasive investigation is not This mainly concerns lesions that are too small for a represent-
possible for technical reasons or is rejected by the patient. In ative biopsy by means of CNB. The investigator should ensure
this setting, ultrasound-guided VB is an important complemen- that the biopsy site could be found again, especially after com-
tary technique. It is used especially when large quantities of tis- plete excision of a lesion. In the case of doubt, a marking clip
sue are needed for an exact histological diagnosis. should be used [13, 20 – 22].
The aim of this consensus paper is to summarize the current in-
dications that have been accepted in the consensus, name the Indications for diagnostic-therapeutic VB
prerequisites for performing ultrasound-guided VB, and docu- 1. Symptomatic lesions not suspicious for carcinoma, with the aim
ment the development of this method since 2005. of complete image-guided excision (e. g. fibroadenoma, recur-
rent cysts)
Ultrasound-guided VB is a suitable method for complete exci-
Method sion of benign symptomatic lesions. In these cases it serves as
! an alternative to open biopsy. The lesion to be excised may ex-
Achieving a consensus ceed a maximum diameter of 2 cm only in exceptional cases.
This update of the consensus recommendations of 2005 is the re- Complete resection rates of 95 to 100 % have been reported
sult of preliminary meetings after a review of the recent literature for lesions of this size [4, 23 – 30].
(Raunheim on 4/30/2010 and 5/1/2010, and Hamburg on 6/30/ 2. Intraductal/intracystic growths with the aim of complete im-
2010). The consensus text was presented to all members of the age-guided resection
work group for final correction. Reports that were published while Intraductal and intracystic lesions are suitable for needle biop-
the consensus recommendations were being prepared were inclu- sy only to a limited extent, as the altered surrounding struc-
ded in the list of references if their contents were considered tures after biopsy make it difficult to find the lesion again.
meaningful. The update was presented at the German Senology Complete excision by VB permits reliable histological diagno-
Congress in 2011 in Dresden (on 6/24/2011). Important points of sis. Simultaneously, accompanying clinical symptoms such as
criticism that did not concur with the achieved consensus are secretion or pain can be eliminated [31 – 37].
mentioned in the discussion section. Recommendations that were
not accepted unanimously are specified in the results section. All Potential indications without unanimous consensus
other recommendations were accepted unanimously. Unanimous consensus has not been achieved in the study group
This update refers to the published consensus recommendations for the following indications. Currently these are not regarded as
of 2005 [2]. It should be noted that this is a consensus that is generally valid indications and must be specifically discussed at
based on joint expert recommendations and has not been formu- an interdisciplinary case conference.
lated as a guideline.
Dealing with B3 lesions after CNB
B3 lesions include radial scars, flat epithelial atypia, atypical duc-
Results tal hyperplasia, lobular intraepithelial neoplasia, and complex
! papillary lesions. The published literature reports underestima-
Indications and differentiation between diagnostic and tion rates of up to 25 % after CNB for these histological lesions.
therapeutic procedures Therefore, they are defined as lesions with an uncertain malig-
The decision to perform VB is made when the clinician aims to ob- nancy potential and are usually followed by an open diagnostic
tain larger quantities of tissue than those obtained by needle biop- biopsy. The reliability of histological diagnosis after large-lumen
sy, provided such quantities are required for a reliable histological VB (8 gauge) is nearly equivalent to that of open biopsy with im-
diagnosis. For therapeutic purposes, one can achieve complete ex- age-guided complete resection [38]. Thus, VB is a minimally inva-

Hahn M et al. Interdisciplinary Consensus Recommendations … Ultraschall in Med 2012; 33: 366–371
368 Original Article

sive percutaneous biopsy method that permits exact planning of Selection of needle size
initial therapy and may avoid unnecessary secondary or tertiary The needle size should be selected according to the indication and
interventions. size of the lesion. As sonographic VB is primarily employed for the
The decision whether an additional open biopsy should be per- resection of large lesions, preference should be given to a large
formed on a B3 lesion should be made at the interdisciplinary con- needle (11 gauge or larger). The use of smaller needles may be
ference. The existing body of data does not provide sufficient evi- meaningful in lesions located close to the nipple, the pectoral mus-
dence as to whether radial scars and ADH are suitable for excision cle, or the skin [5, 45 – 47].
by VB alone [38 – 40]. Therefore, they should be removed by open
excisional biopsy. Number of tissue specimens
During diagnostic interventions using an 11-gauge VB needle, a
Postoperative organized hematomas minimum of 10 specimens should be removed. With an 8-
Postoperative organized hematomas may be painful and cosme- gauge needle, at least six specimens should be removed. When
tically unpleasant on the one hand, and may limit the evaluation using needles of other sizes, equivalent minimum quantities of
of imaging procedures on the other. Some users have reported tissue should be removed [48]. If fewer tissue samples are ob-
successful removal of hematomas by VB. tained, the reasons should be documented (e. g. hemorrhage,
pain, etc.).
Microcalcifications
A representative VB of suspicious microcalcifications under ul- Local anesthesia
trasound guidance can be performed provided that the clinician Interventions should be performed under adequate local anes-
is aware of the location of the microcalcifications on mammo- thesia, taking surgical and cosmetic aspects into account. Exces-

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graphy and correlations of these have been found on ultrasound sive use of local anesthesia may hinder sonographic imaging.
investigation [41, 42]. As stereotactic VB is able to clearly de-
monstrate microcalcifications on mammography, it is the meth- Dressing
od of choice for this indication. At specialized centers and in After the procedure the biopsy cavity should be compressed by
individual cases, suspicious microcalcifications may also be con- manual compression until complete hemostasis has been achieved.
firmed by ultrasound-guided VB. In line with the consensus An elastic pressure dressing will assist hemostasis and should be
recommendations for stereotactic VB, one should perform a left in place for 24 hours. After hemostasis has been achieved, the
radiographic investigation of the sample and a post-interven- wound should be closed adequately (e. g. sterile Steri-Strips, tissue
tional mammography to demonstrate representative extraction adhesive).
of microcalcifications.
Special cases not mentioned above should be discussed at an in- Written documentation
terdisciplinary case presentation. The following should be documented in writing:
▶ Site of lesion (side, clock position, distance from lesion to nip-
Implementation and documentation ple, distance from lesion to skin)
Imaging ▶ Size of the lesion on two planes and with three diameters
The images needed prior to the intervention (mammography/so- ▶ Type of intervention (diagnostic or therapeutic)
nography) must fulfill the standards of the current S3 guidelines ▶ Needle size
[3], and the physician performing the biopsy should be provided ▶ Number of specimens removed
with images of appropriate quality. The lesion must be classified ▶ Complications
according to BIRADS [43] or the DEGUM criteria; the latter are And the success of biopsy according to the following classifica-
analogous to the BIRADS criteria [44]. tion:
▶ Complete excision
Mammography ▶ Representative biopsy
In addition to medical history-taking and a clinical investigation, ▶ Non-representative biopsy
a complete imaging investigation in keeping with current stand- ▶ Uncertain representative biopsy
ards (and in accordance with the patient’s age) should have been The final assessment as to whether the histological outcome cor-
completed prior to establishment of the indication for VB. relates with the imaging study is made upon receipt of the histo-
A recent two-plane bilateral mammography no more than six logical report. The final assessment must include recommenda-
months old should be available for patients > 40 years. For some tions concerning further measures and follow-up intervals.
women under 40 years of age, a one or two-plane unilateral or
bilateral mammography may be indicated. Patient information and consultation
▶ Before the VB is performed, the patient should be informed in
Ultrasound detail about the advantages and disadvantages of the method
Before VB, imaging must be performed on two planes, and the le- as compared to other procedures.
sion metrics (length, width and depth) and site (side, clock posi- ▶ Rules of behavior for the period prior to VB, especially discon-
tion, and distance from nipple to lesion) are to be documented on tinuation of anticoagulant medication
the image. During the entire procedure the movement of the nee- ▶ Behavior after VB: The patient should be asked to avoid stren-
dle should be monitored on ultrasound. Special attention should uous physical work, unnecessary manipulation of the breast,
be given to the position of the needle with reference to the skin and taking full baths.
and the chest wall. After the intervention, the biopsy cavity ▶ Special features of diagnostic imaging investigations during
should be documented on two planes, demonstrating any resi- controls, especially scars on ultrasound and also on mammo-
dual lesion or hematoma. graphy

Hahn M et al. Interdisciplinary Consensus Recommendations … Ultraschall in Med 2012; 33: 366–371
Original Article 369

Analogous to other minimally invasive interventions, the patient Pathomorphological findings should be assigned to one of 5 cate-
should also be informed about gories (B1–B5). The respective B classification should be men-
▶ Infection, wound healing disorder tioned in the report along with the final assessment.
▶ Bleeding, hematoma
▶ Allergic reactions to local anesthesia Follow-up intervals
▶ Trauma to adjacent tissues and organs (skin, breast wall, pleura, The recommendations for follow-up intervals refer to a biopsy
lungs, and heart), pneumothorax that is considered representative or a complete excision.
▶ Surgical revision A clinical and sonographic follow-up investigation should be con-
▶ Cosmetic impairment ducted no later than 12 months after the procedure.
▶ Pain An ipsilateral mammography should be performed after 12 to
▶ False-negative diagnosis in case of diagnostic VB 24 months, depending on the patient’s age and the density of
▶ Residual lesions in case of therapeutic VB the breast.
In addition to routine reporting of the breast, the biopsy cavity,
Technical requirements and personnel resources any residues, scars, or recurrent lesions should be assessed on so-
Ultrasound system nography.
The ultrasound device must fulfill the equipment requirements
specified in § 135 paragraph 2 SGB V. An updated version of these Quality assurance of the result
requirements may be viewed on the homepage of the DEGUM Any mismatch between the outcome of imaging investigations
(www.degum.de). and histological findings should be followed by an interdisciplin-
ary conference of the concerned specialties, which then issues re-

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VB systems commendations concerning the subsequent procedure. A proto-
Several different VB systems from different manufacturers are on col of these recommendations should be prepared, and should be
the market. A common feature of all of these devices is that the tis- included in the written documentation.
sue to be excised is aspirated by vacuum into a sample window in
the needle and then removed by means of a rotation knife. The VB Benefits of the method
device must be able to produce tissue specimens through a large VB is a minimally invasive intervention of the breast and is super-
lumen and without fragmentation of the specimen. Several needle ior to open biopsy in regards to cosmetic outcome, the duration of
sizes must be available in order to ensure that the investigator is the procedure, and postoperative internal scars. Comparative stud-
able to adapt the procedure to the size of the lesion. ies concerning complication rates, postoperative pain, and periods
of absence from work have not been published thus far.
Investigator’s qualifications Several authors report that 92 – 95 % of patients would prefer a VB
The investigator’s qualifications for breast sonography should com- again if a subsequent procedure would be required [4, 30, 49, 50].
ply with DEGUM level II for breast sonography (www.degum.de). In VB complications, such as infection requiring treatment, bleeding
other words, the investigator should be a specialist and should have or hematoma, are extremely rare.
more than 2 years of experience performing breast sonography. He The entire procedure takes a maximum of half an hour [23, 49,
should provide evidence of having conducted a minimum of 600 51, 52] and the patient may be discharged from the hospital im-
breast sonographies, of which at least 200 cases were pathological. mediately after the intervention. This represents a significant
The investigator should also provide evidence of at least 50 docu- time and cost savings compared to open biopsy [52, 53].
mented ultrasound-guided interventional procedures. VB costs much less than open biopsy. A number of European cost
Attending a special VB course is recommended (which can be analyses have reported a savings of approximately 82 % compar-
found, for instance, at www.senologie.org, www.degum.de). The ed with open biopsy [9, 53].
first 10 examinations should be conducted under the supervision
of an investigator with experience performing VB.
Discussion
Quality management !
Pathology quality assurance The update of the consensus recommendations of 2005 reveals
Frozen-section investigation of the VB specimens should be a- two advancements:
voided. At the initial consensus the VB was evaluated and discussed in
The tissue specimens should be fixed in neutral buffered forma- comparison with CNB. Now it is increasingly regarded as a com-
lin, and the number of specimens sent to the laboratory should be plement to the spectrum of minimally invasive procedures and
documented. A minimum fixation time of 6 hours is recommen- therefore as an alternative to open biopsy, especially when the
ded to preserve antigenicity of immunohistological studies. latter is performed with diagnostic intent.
For pathological examination, specimens are processed in 6 – 8 With regard to its therapeutic application for the purpose of ex-
section levels. The number of section levels may vary according to tirpation, there is currently unanimous agreement among spe-
needle size and the suspected diagnosis indicated by the imaging cialist about B2 lesions (fibroadenoma, symptomatic cysts).
procedure, as well as lesion size and the number of specimens to Depending on the histological type of lesion [54], open follow-up
be investigated. resection after complete image-guided extirpation of B3 lesions is
In case of any mismatch between the suspected diagnosis based currently not considered mandatory in the published literature.
on imaging investigations and the histological outcome, all speci- The decision as to whether one may dispense with a follow-up re-
mens should be processed completely. section must be made in an interdisciplinary conference [55].

Hahn M et al. Interdisciplinary Consensus Recommendations … Ultraschall in Med 2012; 33: 366–371
370 Original Article

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Hahn M et al. Interdisciplinary Consensus Recommendations … Ultraschall in Med 2012; 33: 366–371