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Published online before print July 23, 2004, 10.1148/radiol.2323031224
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(Radiology 2004;232:897-903.)
© RSNA, 2004

Breast Imaging

Stereotactic 11-gauge Vacuum-assisted Breast Biopsy: Influence of Number of Specimens on Diagnostic Accuracy1

Friedrich M. Lomoschitz, MD, Thomas H. Helbich, MD, Margarete Rudas, MD, Georg Pfarl, MD, Ken F. Linnau, MD, Alfred Stadler, MD and Roger J. Jackman, MD

1 From the Departments of Radiology (F.M.L., T.H.H., G.P., K.F.L., A.S.) and Pathology (M.R.), University of Vienna Medical School, AKH Wien, Waehringer Guertel 18–20, A-1090 Vienna, Austria; Ludwig Boltzmann Institute for Clinical and Experimental Radiology Research, Vienna, Austria (F.M.L., T.H.H., G.P., K.F.L., A.S.); and Department of Radiology, Palo Alto Medical Clinic, Palo Alto, Calif (R.J.J.). From the 2000 RSNA scientific assembly. Received August 1, 2003; revision requested October 15; final revision received December 5; accepted January 13, 2004. Address correspondence to F.M.L. (e-mail: friedrich .lomoschitz@univie.ac.at).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 REFERENCES
 
PURPOSE: To determine whether number of specimens obtained at stereotactic 11-gauge vacuum-assisted breast biopsy with the patient prone influences diagnostic accuracy and to determine whether this number varies depending on mammographic appearance of lesions as masses or microcalcifications.

MATERIALS AND METHODS: Biopsy was prospectively performed in 100 patients (median age, 55 years; range, 31–81 years) with 100 lesions that were mammographically evident as masses (n = 50) and microcalcifications (n = 50) with standardized protocol to acquire 20 specimens per lesion in three 360° probe rotations at one skin entry site. Specimens were histologically evaluated sequentially, and findings were compared with results of surgical excision or of mammographic follow-up for at least 24 months. Differences in diagnostic yield after each probe rotation and differences in diagnostic yield between masses and microcalcifications were determined with {chi}2 test.

RESULTS: Up to 12 specimens harvested within two 360° probe rotations were necessary to yield correct diagnosis in 96% of patients with masses and 92% of patients with microcalcifications. Diagnostic yield was not improved with more than 12 specimens for masses or microcalcifications. In two (4%) of 47 patients with lesions that were eventually diagnosed as cancer, results at stereotactic biopsy indicated they were benign. Underestimation of diagnosis of lesions as atypical ductal hyperplasia and ductal carcinoma in situ occurred in two (50%) of four and two (17%) of 12 lesions, respectively. With 20 specimens harvested during three probe rotations, there was no statistically significant difference in diagnostic yield between patients with masses and those with microcalcifications (P = .68).

CONCLUSION: At 11-gauge vacuum-assisted biopsy, highest diagnostic yield was achieved with 12 specimens per lesion, independent of mammographic appearance of the lesion. Even with standardized retrieval of 20 specimens per lesion, underestimation of disease still occurs.

© RSNA, 2004

Index terms: Breast, biopsy, 00.1261 • Breast neoplasms, 00.32


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
 REFERENCES
 
In recent years, stereotactic 11-gauge vacuum-assisted breast biopsy (VABB) has been established as a reliable and cost-effective method for diagnosis of mammographically evident breast disorders (1–4). With a single probe insertion, 11-gauge VABB allows more and larger samples to be obtained in a shorter period of time compared with those obtained at large-core breast biopsy (3,5). In the early 1990s, several investigators emphasized the need for multiple passes with 14-gauge large-core biopsy devices and reported the optimum number of samples to be obtained for these systems (6–8). However, there is still an ongoing debate about the optimum number of specimens that should be obtained with 11-gauge VABB (1).

Some authors recommend that 15 specimens should be obtained at stereotactic 11-gauge VABB (3), but this has not been universal practice (4,9–33). The number of specimens for 11-gauge VABB in recently published articles about this datum in series of patients varied from one to 110 specimens per lesion, with a mean number between nine and 18 specimens per lesion. This wide range might, at least partially, be related to operator preference, mammographic appearance, and individual patient conditions. Guidelines, however, might help reduce the degree of variability. The purpose of this study, therefore, was to determine whether the number of specimens obtained with stereotactic 11-gauge VABB with the patient prone influences diagnostic accuracy and to determine whether this number varies depending on the mammographic appearance of the lesions as masses or microcalcifications.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 REFERENCES
 
Patients
This study was prospectively designed to evaluate histologic biopsy results in 100 consecutive women (median age, 55 years; range, 31–81 years) with solitary nonpalpable breast lesions who were referred for 11-gauge VABB between February 1999 and July 2000 and to accumulate an equal number of breast lesions mammographically found as masses (n = 50) and as microcalcifications (n = 50). At the time our study protocol was formulated in 1998, there was no clear-cut requirement in our institution for ethics committee approval. We did follow the principles of the Declaration of Helsinki, however, and written informed consent was obtained from the patients. Currently, there is such a requirement for ethics committee approval. Thus, our study was so submitted, and the ethics committee stated that the study would have been approved without restrictions and that the committee had no objection to publication of the study.

The definition of masses and microcalcifications, which formed the basis of the two study groups, was based on previously published criteria (4). Written informed consent and blood coagulation study results were obtained in every patient before biopsy. Masses included definite masses (n = 41), asymmetric densities (n = 5), and areas of architectural distortion (n = 4). In six of the 41 definite masses, associated nondominant calcifications were present. Among the 50 lesions in which microcalcifications were the leading mammographic appearance, nine lesions were associated with equivocal asymmetric densities or architectural distortions. All lesions were evaluated for greatest mammographic diameter and were categorized according to the Breast Imaging Reporting and Data System (BI-RADS) (34) by two readers (F.M.L., T.H.H.) in consensus.

Biopsy Procedure
Among 100 patients, 88 (88%) underwent biopsy performed by one of two attending radiologists who specialized in breast imaging. One attending radiologist had 27 years of experience, and the other (T.H.H.) had 8 years of experience. The other 12 (12%) patients underwent biopsy performed by one of two residents under the supervision of one of the two attending breast imaging radiologists. Biopsy was performed with patients lying prone on a dedicated table (Mammotest; Fischer Imaging, Denver, Colo) by using a stereotactic 11-gauge vacuum-assisted biopsy device (Mammotome; Biopsys Medical/Ethicon Endo-Surgery, Cincinnati, Ohio).

The setup, the targeting of the lesion, and the prepuncture application of local anesthetic were performed as previously described. Initial deep injection of anesthetic was performed sparingly in soft-tissue-density lesions to avoid obscuring or displacing the lesion (2,3). In all lesions, biopsy was performed at one skin entry site with a standardized protocol (2,3,5). The pattern of obtaining biopsy samples depended on the morphologic characteristics of the lesion. For masses and clusters of microcalcifications, the needle was inserted toward the center of the lesion. For microcalcifications that spanned a larger area, the region most suspected of being cancerous was targeted for needle biopsy (2).

The tissue-harvesting protocol was prospectively designed to obtain 20 specimens in every lesion in a standardized way. The probe was always inserted with the aperture at the 12-o’clock position. To sample contiguously, the sampling chamber was moved in 2-hour (60°) increments, that is, from 12- to 2- to 4-o’clock positions, and so on, during the first needle rotation and from 1- to 3- to 5-o’clock positions, and so on, during the second needle rotation (total, 360° per rotation). Six specimens were obtained per needle rotation (5). During the third and final needle rotation, specimens were obtained contiguously, and the probe was moved in 1.5-hour (45°) increments. In addition, eight specimens were obtained (2,3). In all 100 patients, stereotactic images were obtained immediately after biopsy (35). The specimens were placed separately on a dedicated plate in chronologic order, and radiography of the specimens was performed (12).

Specimens were then placed in eight chronologically numbered formalin-filled containers (with the first six specimens in individual containers, specimens seven to 12 in container 7, and specimens 13–20 in container 8) and were sequentially evaluated histologically (36). Thus, the histologic results of evaluation of the last two containers revealed the added diagnostic information from the second and third needle rotations, respectively.

Histologic Analysis
A pathologist whose subspecialty was breast pathology (M.R., 11 years of experience) prospectively performed histologic analysis. Lesions were categorized as cancer (invasive carcinoma or ductal carcinoma in situ [DCIS]), high risk (atypical ductal hyperplasia [ADH] was the only high-risk lesion found), or benign (ie, neither cancer nor high risk). The histologic findings for the eight sequential containers were tabulated and compared with the final histologic diagnosis, which was determined with complete assessment of all 20 biopsy specimens. A diagnosis was considered to have been made when the diagnosis in the respective specimen matched the final diagnosis. For example, if fibrosis was seen in the first specimen and fibroadenoma was seen in the fourth specimen, and the final diagnosis was fibroadenoma, then the fourth specimen was considered to be diagnostic. If intraductal carcinoma was found in the third specimen, and an infiltrating component was present in the group of specimens 7–12, then the group of specimens 7–12 was considered to be diagnostic. The 11-gauge VABB results were considered discordant if the histologic findings did not provide sufficient explanation for the imaging features (22).

Data Collection and Analysis
Medical records and histologic findings were evaluated by one reader (F.M.L.) to determine surgical outcomes. Surgery was performed in all patients with lesions for which results were malignant at biopsy. Additional reasons for subsequent surgery included the presence of high-risk lesions, the radiologist’s recommendation to perform repeat biopsy in case of imaging finding–histologic finding discordance, and the preferences of the patient or referring surgeon (1,14,31). When surgery was performed, the final histologic diagnosis at 11-gauge VABB and at surgery was then compared in consensus by two radiologists (F.M.L., T.H.H.) and one pathologist (M.R.) to evaluate agreement. A pathologically proved cancer was a lesion that yielded cancer at stereotactic biopsy, surgery, or both.

Histologic inaccuracy of 11-gauge VABB was evaluated in four ways. First, the rate of missed cancers was calculated as the number of benign lesions at 11-gauge VABB that were later found to be cancer at surgery divided by the total number of cancers found (either at initial 11-gauge VABB or at surgery) (33,37). The underestimation rate for lesions diagnosed as ADH was calculated by dividing the number of ADH lesions observed at 11-gauge VABB that were later diagnosed as cancer at surgery by the total number of ADH lesions for which surgery was performed (14,31). The underestimation rate for lesions diagnosed as DCIS was calculated by dividing the number of DCIS lesions observed at 11-gauge VABB that were later diagnosed as invasive carcinoma at surgery by the total number of DCIS lesions for which surgery was performed (24). Finally, a diagnosis of a benign lesion was considered as underestimated until the container with the most specific histologic diagnosis was interpreted. Lack of any of those four histologic inaccuracies was considered to be histologic concordance. In addition, radiographs of specimens of lesions that appeared as microcalcifications were evaluated for the presence of retrieved calcifications, and postbiopsy mammograms were checked to determine whether the entire lesion had been removed.

In patients with benign lesions in whom surgery was not performed, clinical and mammographic follow-up was performed for at least 24 months (range, 24–42 months; mean, 33 months), as recommended by several groups (38–40). For lesions with a specific diagnosis (eg, fibroadenoma or lymph node), routine mammographic follow-up was recommended. For lesions with a nonspecific diagnosis (eg, fibrocystic changes), unilateral mammographic follow-up was recommended at 6 months, and bilateral follow-up was recommended at 12 months (40). If a histologic result concordant with the mammographic appearance was identified at histologic examination and stability was documented with follow-up for at least 24 months, the patient was advised to resume routine annual screening. If the histologic result at biopsy was discordant with mammographic findings, surgery was performed. A benign diagnosis at 11-gauge VABB was considered accurate if findings at subsequent surgery failed to show cancer or if findings at mammographic follow-up were stable for at least 24 months.

Statistical Analysis
Data were entered into a computerized spreadsheet (Excel; Microsoft, Redmond, Wash). Statistical calculations were made with software (SAS; SAS Institute, Cary, NC). Descriptive statistical analysis included the calculation of means, medians, and standard deviations of the obtained data. Differences in diagnostic yield after each probe rotation and differences in diagnostic yield for lesions that appeared as masses and those that appeared as microcalcifications were determined with the {chi}2 test. For all analyses, results were considered statistically significant if the P value was .05 or less.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 REFERENCES
 
Final Diagnoses
Patient and lesion variables are summarized in Table 1. Histologic analysis of 11-gauge VABB specimens of 100 lesions revealed carcinoma in 43 (43%), ADH in four (4%), and benign entities in 53 (53%). Surgery was performed in all patients with carcinoma (n = 43), all patients with ADH (n = 4), and in 17 (32%) of 53 patients with benign lesions. In three of 17 patients with lesions for which results at 11-gauge VABB were benign, surgery was recommended because of imaging finding–histologic finding discordance. Histologic analysis of the surgical specimen revealed carcinoma in two lesions and fibrocystic changes in one lesion. In the remaining 14 of 17 patients with lesions for which results at 11-gauge VABB were benign, surgery was performed because of the preference of the patient or the referring surgeon. In the remaining 36 (36%) patients with lesions with a benign diagnosis at 11-gauge VABB, no malignancies were identified at clinical and mammographic follow-up for at least 24 months. Correlation of histologic results obtained at 11-gauge VABB with histologic results at surgical biopsy or follow-up examination is summarized in Table 2.


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  		TABLE 1. Patient Age and Mammographic Features for Stereotactic 11-gauge VABB in 100 Lesions

 

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  		TABLE 2. Correlation of Histologic Results at Stereotactic 11-gauge VABB with Results at Surgical Biopsy or Follow-up Examination

 
VABB Diagnoses
The Figure shows the diagnostic yield for the four measures of histologic accuracy from the progressive number of tissue specimens for lesions that appeared as masses and microcalcifications. Overall, biopsy yielded the correct diagnosis in the first specimen in 48 (48%) of 100 lesions. The diagnostic yield after two probe rotations with 12 specimens resulted in the correct diagnosis in 94 (94%) of 100 lesions. With comparison of the diagnostic yield between the first completed probe rotation and that of the second completed probe rotation, no statistically significant differences were revealed for lesions that appeared as masses (P = .36) or for those that appeared as microcalcifications (P = .52). The additional eight specimens from the third probe rotation did not improve the diagnostic yield in any of the 100 lesions. In this study, with 20 specimens harvested during three probe rotations, there was no statistically significant difference in diagnostic yield between specimens of lesions that appeared as masses and those that appeared as microcalcifications (P = .68) (Figure).



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  		Bar graph illustrates diagnostic yield for four measures of histologic accuracy from progressive number of stereotactic 11-gauge VABB tissue specimens obtained with patients lying prone. Graph shows comparison of mammographic appearance in 50 lesions that appeared as masses (white bars) and 50 that appeared as microcalcifications (gray bars). Specimens 1-6, 7-12, and 13-20 represent the first, second, and third 360° probe rotations, respectively, with individual histopathologic assessment of specimens 1-6 and pooled histopathologic assessment of specimens 7-12 and 13-20. For lesions that appeared as masses and microcalcifications, the increase in diagnostic yield was for up to 12 specimens per lesion but not for more than 12 specimens per lesion. Comparison of diagnostic yield for lesions with appearances as masses and microcalcifications revealed a statistically significant difference with two specimens (P = .04) but no statistically significant difference with one (P = .17) or more than two specimens (specimen 3 [P = .18], 4 [P = .08], 5 [P = .1], 6 [P = .5], 7-12 [P = .68], and 13-20 [P = .68]).

 
In six (6%) lesions, 11-gauge VABB did not yield the correct diagnosis (Table 2). Underestimation occurred in the diagnosis of four, two with a diagnosis of ADH and two with that of DCIS, of those six lesions. Two diagnoses of cancer were missed. Two (50%) of four lesions classified as ADH were diagnosed as DCIS and infiltrating ductal carcinoma at surgical excision. In those two lesions, a histologic diagnosis of ADH was made at stereotactic biopsy from the first and fourth specimens. In both cases of underestimation of the diagnosis of ADH, lesions were areas of heterogeneous microcalcifications and were categorized as BI-RADS 4 lesions. The underestimation rate for diagnosis of DCIS was 17%, which revealed an infiltrating component at surgery in two of 12 carcinomas classified as DCIS at biopsy. In both lesions, a histologic diagnosis of DCIS was determined from the first retrieved specimen. No infiltrating component was present in the additionally harvested 19 specimens in either lesion at 11-gauge VABB. The mammographic appearance was a small spiculated mass and an area of heterogeneous microcalcifications, respectively. Both lesions classified as underestimates of the diagnosis of DCIS were categorized as BI-RADS 5 lesions.

A diagnosis of cancer was missed in two (4%) of the total 47 cancers in the study. In both lesions, subsequent surgery was immediately recommended because of imaging finding–histologic finding discordance. One of the lesions was mammographically characterized as a spiculated mass that was 7 mm in diameter and was categorized as a BI-RADS 5 lesion. Histologic results at 11-gauge VABB included a description of parenchymal tissue, and results at surgery revealed infiltrating ductal carcinoma. The other lesion was mammographically characterized as an area of heterogeneous microcalcifications associated with an asymmetric density that spanned an area of 30 mm and was categorized as a BI-RADS 4 lesion. Histologic results at biopsy revealed fibrocystic changes without microcalcifications. Results at open breast surgery revealed infiltrating lobular carcinoma, and the infiltrating component was 12 mm. After removal of 20 specimens, radiography was performed and did not reveal retrieval of calcifications in this lesion. No other lesion revealed mammographic finding–pathologic finding discrepancy at imaging finding–histologic finding correlation.

Overall, there were two (4%) of 50 lesions with microcalcifications for which radiographs of specimens had been obtained that were negative for calcifications. One, as stated previously, represented a missed cancer. The other lesion was a cluster of microcalcifications that was 6 mm in diameter and was categorized as a BI-RADS 3 lesion. Although the radiograph of the specimen did not reveal calcifications, histologic work-up indicated calcifications in association with fibrocystic changes in the first specimen, and the final histologic results of analysis of biopsy specimens indicated fibrocystic changes. Repeat stereotactic biopsy was recommended, but open surgery was performed at the discretion of the referring surgeon. Results of histologic analysis of the surgical specimen confirmed the diagnosis of fibrocystic changes. The entire lesion was removed in 12 (12%) patients. All 12 lesions were smaller than 1 cm, and a clip was placed when images obtained after stereotactic biopsy revealed that the entire lesion was removed.


   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
REFERENCES
 
The results of this prospective study show that the number of specimens obtained at stereotactic 11-gauge VABB with the patient prone influences diagnostic accuracy. Contiguous sampling of 12 specimens within two 360° probe rotations per lesion at one skin entry site with pooled histopathologic assessment of the six specimens from the second probe rotation yielded the highest diagnostic accuracy, independent of the mammographic appearance of the lesion. However, missed diagnoses of cancer, underestimations of the diagnosis of ADH and DCIS, and missed retrieval of calcifications could not be avoided, even with 20 specimens obtained within three 360° probe rotations at one skin entry site for every lesion.

Table 3 includes authors of articles about stereotactic 11-gauge VABB performed with the patient prone, with inclusion of at least 50 study lesions, mean or median number and range of tissue samples, and at least one of four measures of inaccuracy (ie, number of missed diagnoses of cancer, number of underestimated diagnoses of ADH and of DCIS, and radiographs of specimens that were negative for calcifications).


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  		TABLE 3. Stereotactic 11-gauge VABB: Lesions, Specimens, and Measures of Inaccuracy

 
The underestimation rate for diagnosis of ADH at 11-gauge VABB varied from 7% to 35% in recent articles (Table 3) and was 50% (two of four lesions) in our study. The data suggest that lesions diagnosed as ADH at 11-gauge VABB will continue to necessitate surgical excision (1,14,20,21). The underestimation rate for the diagnosis of DCIS at 11-gauge VABB was 5%–18% in recent articles (Table 3) and was 17% (two of 12 lesions) in our study. In a multi-institutional study, Jackman et al (24) reported an underestimation rate of 11.2% (107 of 953 lesions) for diagnosis of DCIS with 14- and 11-gauge VABB. In their study, with 14-gauge automated large-core biopsy and 14- and 11-gauge VABB, the underestimation rate decreased from 17.5% (88 of 502 lesions) with 10 or fewer specimens to 11.5% (92 of 799 lesions) with more than 10 specimens per lesion (P < .02) (24). Liberman et al (12) reported that retrieval of all, as opposed to some, calcifications resulted in significantly lower frequencies of underestimation of the diagnosis of ADH and DCIS with 11-gauge VABB. This lends further support to the assumption that a higher number of specimens might lower underestimation rates for diagnosis of ADH and DCIS. On the other hand, in the same study, underestimation of the diagnosis of DCIS could not be avoided in a lesion that appeared as microcalcifications that spanned an area of several centimeters, even with acquisition of more than 40 specimens (12). In our study, obtaining more than 12 specimens within two probe rotations at one skin entry site did not influence the underestimation rate for diagnosis of either ADH or DCIS.

The missed rate for diagnosis of cancer at 11-gauge VABB was 0%–3% in recent articles (Table 3) (30,32,33) and was 4% (two of 47 total cancer lesions) in our study. In both cases in which diagnosis of cancer was missed in our study, surgery was recommended immediately because of radiographic finding–histologic finding discordance. One of these lesions showed heterogeneous microcalcifications at mammography, but a review of radiographs of the specimen revealed no calcification retrieval. Failure to retrieve calcifications in lesions that appeared as microcalcifications at 11-gauge VABB was 0%–5% in recent articles (Table 3) and was 4% (two of 50 lesions) in our study. Failure to identify calcifications on radiographs of specimens is considered a nondiagnostic result at stereotactic biopsy (12,41). Liberman et al (41) found that the likelihood of obtaining a specific histologic diagnosis at stereotactic biopsy was significantly higher if calcifications were present on radiographs of the specimen (81% vs 38%, P < .001).

Findings in our study indicated no statistically significant difference in the number of specimens necessary to achieve the highest diagnostic yield, depending on the mammographic appearance of the lesion (P = .08–.68), with the exception of one specimen harvested during the first probe rotation (specimen 2, P = .04). For lesions that appeared as both masses and microcalcifications, obtaining up to 12 specimens during two probe rotations (with pooled histopathologic assessment of the six specimens from the second probe rotation) improved the diagnostic yield, but obtaining more than 12 specimens did not cause further improvement. Lesions that appeared as masses were more likely than those that appeared as microcalcifications to be diagnosed within the first 360° probe rotation, compared with those diagnosed with the second and third 360° probe rotations; this might be explained by the influence of different tissue patterns on the performance of breast biopsy (36).

There were limitations in our study. Different radiologists with different levels of experience performed 11-gauge VABB. Although this condition may be seen as a limitation, it reflects routine clinical practice. In both cases with false-negative results, a resident who had at that time performed fewer than 15 previous 11-gauge VABB procedures performed the biopsies with the supervision of an experienced radiologist. Therefore, the error cannot be blamed on only lack of experience (33,42). One case in which the diagnosis of cancer was missed, a lesion that appeared as microcalcifications for which radiography of the specimen revealed no calcification retrieval, was discussed previously. The other lesion in which a diagnosis of cancer was missed at 11-gauge VABB was a small spiculated mass in a dense breast and was difficult to localize on stereotactic images. Because of the reported problems and the coherent imaging finding–histologic finding discordance, subsequent open surgery was performed in both lesions. In consistency with our results, it seems that it does not matter how many specimens are obtained if targeting is inaccurate.

Another limitation of our study may have been the set pattern of acquisition of 20 specimens per lesion in three 360° probe rotations at one skin entry site. We are aware that the number of specimens required to yield a diagnosis might be influenced or even reduced with rotation of the aperture to face the lesion at the beginning of the procedure and with acquisition of more samples from one location than from another. However, since different radiologists were to perform biopsy, the procedure of tissue harvesting was prospectively standardized (2,3,5), and overall, 20 specimens were harvested in every lesion. In addition, we did not test the potential value of acquisition of additional specimens either from retargeting of the lesion after acquisition of the initial 12 or 20 tissue samples or from use of multiple skin entry sites to more thoroughly sample large lesions. Moreover, histopathologic assessment had to be based on individual examination of six distinct specimens harvested within the first probe rotation (specimens 1–6), whereas specimens from the second (specimens 7–12) and third (specimens 13–20) probe rotations were assessed as pools of specimens. Again, we want to emphasize that we are not advocating that everyone should use a "cookbook" approach to 11-gauge VABB with a single probe insertion and three 360° probe rotations to collect 20 specimens but that we present our data to see what accuracy can be accomplished with the previously described set pattern of tissue acquisition.

The relatively high number of biopsies performed in patients with BI-RADS 3 lesions might also be seen as a limitation. Despite numerous publications that describe the ability to define lesions as BI-RADS 3 with a less than 2% chance of malignancy and the logic of following up rather than performing a biopsy in patients with such lesions, there is still a lack of acceptance of that approach by many referring surgeons and patients at our institution (1,43).

In conclusion, diagnostic accuracy of 11-gauge VABB increased with the increase of harvested specimens; the highest diagnostic yield was achieved with 12 specimens per lesion obtained within two 360° probe rotations at one skin entry site, with pooled histopathologic assessment of the six specimens from the second probe rotation. With a set pattern of specimen acquisition of 20 specimens per lesion in three 360° probe rotations at one skin entry site, however, missed diagnoses of cancer, underestimations of diagnosis, and missed retrieval of calcifications could not be avoided. In our series, there was no significant difference between masses and microcalcifications with regard to the number of specimens necessary to achieve the highest diagnostic yield at 11-gauge VABB with retrieval of 12 specimens during two 360° probe rotations and 20 specimens during three 360° probe rotations.


   ACKNOWLEDGMENTS
 
The authors thank Elfriede Sturm and her team for technical support. The authors also acknowledge the expert help of Rainer Alexandrowitsch with the statistical analysis.


   FOOTNOTES
 
R.J.J. is a consultant to Ethicon Endo-Surgery and was formerly a consultant to and a shareholder in Biopsys Medical.

Abbreviations: ADH = atypical ductal hyperplasia, BI-RADS = Breast Imaging Reporting and Data System, DCIS = ductal carcinoma in situ, VABB = vacuum-assisted breast biopsy

Author contributions: Guarantors of integrity of entire study, F.M.L., T.H.H.; study concepts and design, F.M.L., T.H.H., R.J.J.; literature research, F.M.L., R.J.J.; clinical studies, F.M.L., T.H.H., M.R., K.F.L.; data acquisition and analysis/interpretation, all authors; statistical analysis, A.S.; manuscript preparation, F.M.L., T.H.H., R.J.J.; manuscript definition of intellectual content, editing, revision/review, and final version approval, all authors


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 REFERENCES
 

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