Multicenter evaluation of the breast lesion excision system, a percutaneous, vacuum‐assisted, intact‐specimen breast biopsy device

Sie, Angela; Bryan, David C.; Gaines, Victor D.; Killebrew, Larry K.; Kim, Christine H.; Morrison, Carrie C.; Poller, William R.; Romilly, A. Pat; Schilling, Kathy; Sung, Janet

doi:10.1002/cncr.22090

Cited by 67 publications

(62 citation statements)

References 20 publications

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“…Invasive carcinoma was found in surgery (e) in diagnosis as well as better calcification retrieval, a lower rate of underestimation, and a lower re-biopsy rate [1,2,7]. One has to be aware that despite this technical improvement with VB, the underestimation rate is still 10-50% for ADH and 4-28.6% for DCIS [7,17]. This underlines that false negative biopsies occur even when using this technique, as shown in our and other studies.…”

Section: Discussionsupporting

confidence: 71%

False-negative results after stereotactically guided vacuum biopsy

Peter¹,

Grünhagen²,

Wenke³

et al. 2007

Eur Radiol

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The purpose of this study was to determine the false negative rate of stereotactically guided vacuum biopsy (VB). Data of patients with benign lesions in VB were evaluated retrospectively during a median follow-up period of 21 months. A total of 404 VB were considered benign and representative and were recommended for follow-up. Of these 404 lesions, 195 were completely removed radiologically. Follow-up data were available for 354/404 patients (87.6%), with intervals ranging from 3 to 66 months (median 21, mean 22.4). Reintervention or surgery was necessary in 13/354 (3.7%) cases. Of these cases, 5/354 (1.4%) turned out to be false negatives. Four of these cases showed large areas of microcalcifications or several clusters, and only partial removal was possible due to the size of the lesions. Although VB is an accurate procedure for diagnosing nonpalpable breast lesions with a low cancer miss rate, we consider the exclusion of malignancy in cases of disseminated microcalcifications or several clusters as a limitation. The radiologic-pathologic correlation in these cases is a challenge, particularly in terms of the residuals. Strict follow-up of benign lesions is essential to avoid delayed cancer diagnosis.

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Section: Discussionsupporting

confidence: 71%

False-negative results after stereotactically guided vacuum biopsy

Peter¹,

Grünhagen²,

Wenke³

et al. 2007

Eur Radiol

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“…It has been well validated as a safe and efficacious biopsy procedure [6,7]. It however has the unique feature of using radiofrequency cautery to excise a small but whole sample in one piece with intact architecture and clear margins, as a swift local anaesthetic outpatient procedure.…”

Section: Introductionmentioning

confidence: 99%

The breast lesion excision system (BLES): a novel technique in the diagnostic and therapeutic management of small indeterminate breast lesions?

2011

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“…However, this criterion is questionable in microcalcification cases since microcalcifications due to DCIS may remain stable in 25% of cases [15], and, conversely, microcalcifications due to benign disease may grow. Consequently, ADH and DCIS underestimation rates are generally used to measure the accuracy of VAB procedures, to compare different device sizes [9,16,17], or, recently, to evaluate new VAB devices, such as the breast lesion excision system [10]. Our underestimation rates of 27% for ADH and 8% for DCIS must be confirmed in a study including more patients with surgical verification.…”

Section: Resultsmentioning

confidence: 99%

“…This study was thus designed to evaluate the feasibility, safety, and accuracy of VAB using a Vacora® device. Like numerous other studies [9][10][11], we have used the underestimation rates of ADH and DCIS to determine the accuracy of this percuraneous breast biopsy device.…”

mentioning

confidence: 99%

Stereotactic vacuum biopsy of calcifications with a handheld portable biopsy system: a validation study

et al. 2008

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To prospectively evaluate a compact portable 10-gauge handheld battery-operated biopsy system for stereotactic biopsy of microcalcifications. The ethics committee of the hospital approved this prospective multicentric study, and informed consent was obtained. Biopsy under stereotactic guidance was performed in 215 patients for 219 lesions consisting of microcalcifications without mass. The feasibility and the tolerance of the procedure were evaluated. The mean weight of the specimen was calculated. In patients with surgical diagnoses, the underestimation rate in biopsy diagnoses of atypical ductal hyperplasia and ductal carcinoma in situ were evaluated. The sampled specimens were separated according to the presence of calcifications on magnified specimen radiographs and to the probe the rotation number in order to evaluate the contribution of each rotation and the contribution of the specimen with and without calcifications on the radiographs. The macrobiopsy was feasible in 98.5% of the patients and was well tolerated in 82% of patients. It identified 4.6% invasive carcinomas, 18.5% ductal carcinomas in situ, 14.8% atypical ductal hyperplasias, 22.2% benign proliferative mastopathies and 39.8% benign non-proliferative mastopathies. The underestimation rate was 26.6% when an atypical ductal hyperplasia was diagnosed at biopsy, and 7.7% when a ductal carcinoma in situ was diagnosed. In the 77 patients with surgical correlation, the accurate diagnosis was obtained in specimens sampled during the first, second, and third in 69%, 9%, and 4% of the biopsies, respectively, and the analysis of specimens without microcalcification had an added value in 8% of patients. The compact portable battery-operated biopsy system can be used successfully for stereotactic biopsy of microcalcifications and constitutes a valid alternative to current systems.

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Multicenter evaluation of the breast lesion excision system, a percutaneous, vacuum‐assisted, intact‐specimen breast biopsy device

Cited by 67 publications

References 20 publications

False-negative results after stereotactically guided vacuum biopsy

False-negative results after stereotactically guided vacuum biopsy

The breast lesion excision system (BLES): a novel technique in the diagnostic and therapeutic management of small indeterminate breast lesions?

Stereotactic vacuum biopsy of calcifications with a handheld portable biopsy system: a validation study

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