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Frequency of Discordant Lesions and False-negative Cancers at Stereotactic Vacuum-assisted Biopsy

Posted Jul 31, 2016 Updated Apr 10, 2023
By Samantha L. Heller PhD MD , Sonam Jaglan MD , James S. Babb PhD , Amy Melsaether MD , Hildegard B. Toth MD , Linda Moy MD
8 min read

Rationale and Objectives

This study aimed to determine frequency of discordant lesions and discordant false-negative cancers at stereotactic vacuum-assisted biopsy (SVAB).

Materials and Methods

Institutional database was searched for discordant SVAB results between January 1, 2005 and December 31, 2012, in this retrospective institutional review board-approved Health Insurance Portability and Accountability Act-compliant study. Patient age, indication for initial mammogram, breast density, lesion size, Breast Imaging Reporting and Data System categorization, operator experience, biopsy needle gauge, biopsy histology, and final surgical histology of discordant lesions were collected and entered into a Microsoft Excel spreadsheet. Discordant rate and false-negative rates were calculated. Fisher exact test was used to assess prevalence of discordance using 11-Gauge needles versus 9-Gauge needles. Patient age, lesion Breast Imaging Reporting and Data System, operator days of experience, mammographic density, and lesion size were evaluated for association with false-negative discordant lesions using an exact Mann-Whitney U test.

Results

A total of 1861 SVABs were performed, 224 (12%) with an 11-Gauge VAB device and 1637 (88%) with a 9G Suros or Eviva device. Majority (1409 of 1861; 76%) of SVABs targeted calcifications. Twenty-three of 1861 (1.2%) discordant lesions were identified in 23 women. Seven of 23 (30%) discordant lesions were found to be cancers after final surgical pathology. Needle gauge was not associated with discordance. Operator experience was not associated with false-negative discordance.

Conclusions

A relatively low discordance rate (1.2%) was observed. However, a high percentage (30%; range in literature 11.7%–53.8%) of our discordant lesions were false negatives. This study emphasizes the need for careful radiological-pathologic review after SVAB and for repeat biopsy or surgical excision in the setting of discordance.

Introduction

The majority of the literature reviewing stereotactic vacuum-assisted biopsy (SVAB) and addressing discordance arises from the late 1990s and early 2000s when SVAB was an emerging technology. Early studies served to validate the efficacy of SVAB and demonstrated that SVAB was statistically less likely to lead to radiological-pathologic discordance and undersampling compared to stereotactic core biopsy . SVAB has now become a standard tool for tissue sampling of breast lesions, particularly lesions without a sonographic correlate, most frequently calcifications.

Recognition and documentation of discordance by the radiologist after tissue sampling is a key element of SVAB and is mandated by the American College of Radiology . Discordance suggests a lesion has not been sampled adequately and therefore raises the possibility of a missed cancer.

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Materials and Methods

Data Collection

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Stereotactic Vacuum Biopsy Techniques

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Determination of Discordance

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Statistical Analysis

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Results

Stereotactic Vacuum Biopsy Pathology Results

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Characteristics of Women with Discordant Lesions

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Characteristics of Discordant Lesions

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Reasons for Discordance

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Benign and High-risk Discordant Lesions

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Figure 1, 55-year-old woman with right breast 7-o'clock focal asymmetry initially seen on screening mammogram. The focal asymmetry persisted on (a) diagnostic mediolateral oblique spot compression views and (b) diagnostic craniocaudal spot compression views ( white arrows ). Targeted ultrasound was negative and stereotactic vacuum-assisted biopsy (SVAB) (9G) recommended and performed. Postbiopsy lateral (c) and craniocaudal (d) mammograms for marker placement demonstrate the biopsy marker clip in appropriate position ( white arrows ). Biopsy pathology was benign nondiagnostic fibrofatty tissue, termed discordant by the radiologist who performed the biopsy. Wire localization and surgical excision was therefore recommended. Postlocalization mammographic specimen radiograph (e) shows the wire in good position in relation to the biopsy clip ( white arrow ). Final surgical pathology was benign fibrocystic change. The biopsy site was identified on the surgical specimen.

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False-negative Discordant Lesions

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Table 1

Characteristics of False-negative Discordant Lesions

Lesion Type Description BI-RADS Biopsy Pathology Needle Gauge Needle Position Residual Calcs Final Pathology Calcs Pleomorphic 4c FCC 9G Correct A few HNG DCIS Calcs Pleomorphic 4c FCC 9G Correct, scant calcs Yes LNG DCIS Calcs Pleomorphic 5 FCC 9G Correct Yes IDC/HNG DCIS Calcs Amorphous 4b FCC 11G Incorrect Yes IDC/ING DCIS Calcs Pleomorphic 4c FCC 9G Incorrect Yes HNG DCIS Calcs Pleomorphic 5 FCC 9G Correct Yes IDC/HNG DCIS AD NA 5 FCC 9G Correct NA ING DCIS

AD, architectural distortion; BI-RADS, Breast Imaging Reporting and Data System; calcs, calcifications; DCIS, ductal carcinoma in situ; FCC, fibrocystic change; HNG, high nuclear grade; IDC, invasive ductal carcinoma; ING, intermediate nuclear grade; LNG, low nuclear grade; NA, not applicable.

Figure 2, 59-year-old woman with grouped pleomorphic calcifications in the right breast initially seen on screening mammogram and demonstrated here on magnification (a) craniocaudal and (b) lateral views at diagnostic work-up ( white arrows ). (c) Stereotactic vacuum-assisted biopsy (SVAB) (9G) was performed on the calcifications. Needle position was appropriate with multiple calcifications seen on presampling image ( white arrows ). (d) Although calcifications were seen on the specimen radiograph ( white arrows ), relative number is scant compared to calcifications on diagnostic mammogram and at SVAB. Residual calcifications were also noted on postbiopsy mammogram ( not pictured ). SVAB yielded fibrocystic changes with benign calcifications. Pathology was thought to be discordant with imaging by the radiologist who performed the biopsy, and surgical excision was recommended and performed with final surgical pathology showing low nuclear grade ductal carcinoma in situ with associated calcifications.

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Impact of Needle Gauge

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Impact of Operator Experience

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Discussion

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Table 2

Studies Evaluating Discordance After Stereotactic Vacuum-assisted Biopsy

Study Sample Size (Lesions) Calcification Cases Needle Gauge Discordant Cases False-negative Discordant Cases (Cancers) Liberman et al. 741 523/741 (71%) 14G SVAB, 11G SVAB 19/741 (2.5%) 2/17 (11.7%) (only 17/19 lesions had repeat biopsy) Pfarl et al. 318 166/318 (52%) 11G SVAB 13/318 (4%) 7/13 (53.8%) Ciatto et al. \* 1388 1223/1388 (88%) 11G SVAB 4.4% (N/D not available; false negatives given for all lesions and modalities)

4/1391 (0.29%) (inadequacy rate VAB11G-includes two US cases) 50/151 (33%) (all lesions and modalities combined) Jackman et al. 1280 766/1280 (60%) 11G SVAB, 14G SVAB 16/1280 (1.3%) (nine with repeat biopsy; six stable imaging follow-up, mean 90 months; one lost to follow-up) 2/9 (22%) Venkataraman et al. 912 858/912 (94%) 11G SVAB, 8G SVAB 21/471 (4.4%) (471 = total benign lesions after initial biopsy) 3/21 (14%) Present study 1861 1409/1861 (76%) 11G SVAB, 9G SVAB 23/1861 (1.2%) 7/23 (30%)

N/D, numerator/denominator; SVAB, stereotactic vacuum assisted biopsy; US, ultrasound.

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Limitations

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Conclusion

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References

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Academic Radiology, Volume 23, Issue 8
Journals General Radiology
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