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1
Ceclines, Av. Libertador, Edificio Siclar, PB, Urb. La Florida 1050, Caracas,
Venezuela.
2
Breast Imaging Section, Department of Radiology, Memorial Sloan-Kettering
Cancer Center, 1275 York Ave., New York, NY 10021.
Received April 26, 2001;
accepted after revision June 8, 2001.
Presented at the annual meeting of the American Roentgen Ray Society,
Seattle, April—May 2001.
Abstract
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MATERIALS AND METHODS. Eighty-eight lesions in 83 women underwent sonographically guided 11-gauge directional vacuum-assisted breast biopsy during a 26-month period. Biopsies were performed using high-resolution sonography equipment with a 7.5-MHz transducer, obtaining a median of 17 specimens per lesion. Imaging studies, medical records, and histologic findings were reviewed.
RESULTS. Median patient age was 48 years (range, 25-78 years). Median lesion size was 1.2 cm (range, 0.4-2.5 cm). Twenty-four (27.3%) of 88 lesions were palpable. The median time required to perform biopsy was 17 min (range, 10-40 min). Complete removal of the lesion seen at sonography occurred in 78 (88.6%) of 88 lesions and was significantly more frequent in lesions measuring 1.5 cm or less than in larger lesions (68/71 = 95.8% vs 10/17 = 58.8%,p < 0.0003). A surgical procedure was spared in 79 (95.2%) of 83 women. In 36 lesions with imaging and clinical follow-up after sonographically guided biopsy with benign findings (range, 4-24 months; median, 11.3 months), we found no evidence of cancer or scarring in the breast.
CONCLUSION. In our small series, sonographically guided directional vacuum-assisted biopsy was a fast and accurate method for breast diagnosis. This technique resulted in complete removal of 95.8% of lesions shown at sonography measuring 1.5 cm or less and spared a surgical procedure in 95.2% of women. Further work is necessary to refine indications, evaluate cost-effectiveness, and assess long-term outcome.
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Most published experience with sonographically guided core biopsy used 14-gauge automated core biopsy needles [1,2,3,4,5,6,7]. In a pioneering study, Parker et al. [1] reported 100% concordance between the results of sonographically guided 14-gauge automated core biopsy and surgery in 49 lesions that had subsequent excision, including 34 cancers; in the remaining 132 lesions yielding benign core biopsy findings, no cancers were found at follow-up (range, 12-36 months). The average procedure time was 20 min, and there were no complications. Other investigators found that use of sonographically guided 14-gauge automated core biopsy increased the positive predictive value of needle localization and surgical biopsy (by selectively removing lesions with benign findings from the pool of lesions that undergo surgical excision) [3] and yielded substantial cost savings compared with surgical or stereotactic biopsy [4].
An 11-gauge directional vacuum-assisted device is now available for performing sonographically guided breast biopsy, but few data address its usefulness [8,9,10,11]. This study was undertaken to evaluate the safety and efficacy of sonographically guided 11-gauge directional vacuum-assisted breast biopsy.
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The choice of the tissue-acquisition device for sonographically guided biopsy was made by the radiologist performing the biopsy. The 11-gauge directional vacuum-assisted biopsy probe (Mammotome; Biopsys/Ethicon Endo-Surgery, Cincinnati, OH) with an articulated arm was selectively used for sonographically guided biopsy of the following lesions: solid lesions that were suspicious (Breast Imaging Reporting and Data System [BI-RADS] [12], category 4) and measured 2 cm or less, to potentially enable complete removal of the lesion found at imaging and clip placement if necessary; solid lesions that were highly suggestive of malignancy (BI-RADS, category 5) and measured 1 cm or less, to facilitate biopsy of small lesions that can be difficult to sample with a 14-gauge automated needle and to enable clip placement; complex lesions, intraductal lesions, subtle lesions, and cysts with mural thickening, intramural nodules, or thick septations, regardless of size, to provide a larger volume of tissue to the pathologist for analysis; lesions suspected of having specific complex histologies such as radial scar or papilloma; other lesions for which it was desired to remove a large volume of tissue (e.g., to remove a palpable lump), to place a localizing clip, or not to fire the needle within the breast; and occasional lesions with probably benign (BI-RADS, category 3) or benign (BI-RADS, category 2) findings measuring 2 cm or less, for which biopsy was requested by the patient and her referring physician.
During the study period, sonographically guided 14-gauge automated core biopsy was performed for 168 lesions that did not fulfill the preceding criteria. Stereotactic biopsy was an additional option for masses that were mammographically evident; the choice between stereotactic or sonographic guidance was based on lesion visibility and accessibility, equipment availability, and preferences of the radiologist and of the woman undergoing biopsy. Informed consent was obtained for all biopsy procedures.
Sonographically Guided Biopsy Technique
The technique of sonographically guided 11-gauge vacuum-assisted biopsy is
shown in Figure
1A,1B,1C,1D.
Sonographically guided 11-gauge directional vacuum-assisted biopsies were
performed with patients in the supine or supine oblique position, using
high-resolution sonography equipment (Flexus SSD 1100; Aloka, Tokyo, Japan)
with a 7.5-MHz linear array transducer. A localizing clip (MicroMark;
Biopsys/Ethicon Endo-Surgery) was placed if the entire lesion seen at
sonography was removed. The median number of specimens obtained per lesion was
17 (range, 8-40); the larger number of specimens was obtained if complete
removal of the lesion seen at imaging or the palpable lump was desired.
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Follow-Up Protocol
Pathologic findings at sonographically guided biopsy were correlated with
the imaging findings, and specific follow-up recommendations were made to the
referring clinician as per the following protocol: repeated biopsy
(sonographically guided or surgical) was suggested if inadequate tissue was
obtained or if there was discordance between imaging and pathologic findings.
Diagnostic surgical biopsy was suggested for women in whom sonographically
guided biopsy revealed certain specific lesions including atypical ductal
hyperplasia, possible phyllodes tumor, radial scar, papilloma with atypia, or
if the pathologist suggested surgical excision
[13,
14]. For patients with lobular
neoplasia, surgical excision was suggested as per previously defined criteria
[15] or if the lesion found at
imaging had not been completely removed. If sonographically guided biopsy
revealed carcinoma, the patient was referred for definitive surgery. If
sonographically guided biopsy revealed benign findings concordant with the
imaging characteristics for which excision was not deemed necessary, the
patient was advised to return for imaging follow-up in 6 months.
Data Analysis
Imaging studies, medical records, and histologic findings were reviewed. A
woman was considered to have been spared a surgical procedure if
sonographically guided biopsy yielded benign findings concordant with imaging
features for which imaging follow-up was suggested or if the biopsy yielded
carcinoma referred for definitive treatment. A woman was considered not to
have been spared a surgical procedure if she was referred for diagnostic
surgical biopsy after sonographically guided biopsy
[4,
16,17,18].
The time to perform sonographically guided biopsy procedure was calculated
from the time of acquisition of the prebiopsy sonogram to the time of
positioning a sterile bandage on the skin.
Data were entered into spreadsheet software (Excel; Microsoft, Redmond, WA) for analysis. Statistical analysis was performed with Fisher's exact test, using statistics software (Epi Info; Centers for Disease Control and Prevention, Atlanta, GA).
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The median time to perform sonographically guided biopsy was 17 min (range, 10-40 min). A complication was encountered in one (1.2%) of 83 patients. In this woman with breast augmentation prostheses, postprocedural bleeding did not resolve with compression and required surgical intervention; histologic analysis of material obtained at 11-gauge vacuum-assisted biopsy yielded nodular fibrosis with vascular congestion. No other complications were encountered.
Complete removal of the lesion seen at sonography (i.e., the imaging finding) occurred in 78 (88.6%) of 88 lesions that had sonographically guided 11-gauge vacuum-assisted biopsy. Complete removal of the lesion seen at sonography was significantly more frequent in lesions measuring 1 cm or less than in larger lesions (34/35 = 97.1% vs 44/53 = 83.0%, p < 0.05) and in lesions measuring 1.5 cm or less than in larger lesions (68/71 = 95.8% vs 10/17 = 58.8%, p < 0.0003). Among 24 palpable lumps (range, 0.7-2.5 cm; median, 1.5 cm), sonographically guided 11-gauge vacuum-assisted biopsy resulted in complete removal of the palpable finding in all lumps. A localizing clip was placed in 40 (45.5%) of 88 lesions.
Sonographically guided 11-gauge vacuum-assisted biopsy yielded carcinoma in 14 (15.9%) of 88 lesions (Table 1). Subsequent surgery performed for all 14 cancers showed reactive changes consistent with the recent biopsy in all 14 cases, but no hematomas larger than 1 cm were encountered. In 10 of these 14 cancers, the lesion seen at sonography was completely removed at vacuum-assisted biopsy (Fig. 2A,2B,2C). Surgery revealed residual cancer in five (50%) of 10 cancers in which the lesion seen at sonography was removed, including four lesions yielding infiltrating ductal carcinoma at sonographically guided biopsy and surgery and one lesion in which sonographically guided biopsy showed infiltrating ductal carcinoma but surgery yielded ductal carcinoma in situ. In four of these 14 cancers, the lesion seen at sonography was not completely removed at sonographically guided biopsy; surgical histology confirmed sonographically guided—biopsy histology in all four.
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Surgical biopsy was recommended after sonographically guided biopsy in three (3.4%) of 88 lesions. In two of these lesions, the lesion seen at sonography was completely removed at sonographically guided vacuum-assisted biopsy. Histologic findings at sonographically guided biopsy in these two lesions were phyllodes tumor in one and atypical ductal hyperplasia in the other. In both, surgery revealed reactive changes consistent with the recent biopsy, but no residual lesion was identified. In the third lesion, the histologic finding at sonographically guided biopsy was fibroepithelial tumor, either cellular fibroadenoma or phyllodes tumor; surgical excision revealed a cellular fibroadenoma.
Sonographically guided 11-gauge vacuum-assisted biopsy yielded benign findings concordant with the imaging features for which surgical excision was not warranted in 71 lesions (80.7%). Imaging and clinical follow-up data are available in 42 of these benign lesions (59.2%; range, 4-24 months; median follow-up, 11.1 months); among these lesions, there was no evidence of cancer or scarring in the breast at mammography or physical examination.
Sonographically guided 11-gauge vacuum-assisted biopsy spared a surgical procedure in 79 (95.2%) of 83 women, including 65 women in whom sonographically guided biopsy yielded benign findings and 14 women in whom sonographically guided biopsy yielded carcinoma. Sonographically guided 11-gauge vacuum-assisted biopsy did not spare a surgical procedure in four (4.8%) of 83 women, including the three women who were referred for diagnostic surgical biopsy after sonographically guided biopsy and the one woman who developed a hematoma requiring surgical drainage.
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Few data address sonographically guided 11-gauge vacuum-assisted biopsy [8, 10]. Simon et al. [8] reported their experience with sonographically guided 11-gauge directional vacuum-assisted biopsy of 71 lesions, using an articulated arm. In that study, sonographically guided biopsy accurately diagnosed 18 (94.7%) of 19 malignant lesions; in one lesion in which technical problems were encountered during the biopsy procedure, sonographically guided biopsy yielded benign findings, but carcinoma was found at subsequent surgical excision. Repeated biopsy was recommended in two (2.8%) of 71 lesions. Follow-up data from subsequent surgery (n = 24) or mammography (n = 8; range, 6-12 months; median follow-up, 9 months) were available only in 32 (45%) of 71 lesions, a limitation of that study.
Duchesne et al. [10] reported results of 61 sonographically guided biopsies with the hand-held 11-gauge vacuum-assisted biopsy device. Complete excision of the sonographic lesion was observed in 55% of all cases, including 77% of lesions measuring 4-10 mm and 43% of lesions measuring 10-15 mm. Carcinoma was found in 10% of lesions, with no change in diagnosis after surgery. Parker et al. [11] reported a multiinstitutional study of 124 lesions that underwent sonographically guided biopsy with the handheld 11-gauge vacuum-assisted device. The average lesion size was 9.1 mm, average number of specimens per lesion was 9.1, and average weight of each specimen was 77.7 mg. Among those 124 lesions, which included 20 cancers, there were no histologic underestimates, no cases of epithelial displacement, and no repeated biopsies. Long-term follow-up data on benign lesions were not available.
In our study, sonographically guided 11-gauge vacuum-assisted biopsy spared a surgical procedure in 79 (95.2%) of 83 women. There were no cases of insufficient samples or histologic underestimates. The 3.4% frequency of recommending repeated biopsy after sonographically guided 11-gauge vacuum-assisted biopsy in our study is lower than the 9-10% rebiopsy rate reported after sonographic 14-gauge automated core biopsy in prior published reports [4, 7]. No scarring was identified at subsequent mammography or physical examination. We found no false-negative results, but follow-up data are limited. Our findings, like the preliminary results of others [8, 10, 11], suggest that sonographically guided 11-gauge vacuum-assisted biopsy may provide an accurate alternative to other percutaneous biopsy methods for diagnosis of breast masses.
Complete removal of the lesion found at imaging (an uncommon event at 14-gauge automated core biopsy) occurred in 88.6% of our lesions that had sonographically guided 11-gauge vacuum-assisted biopsy, including 97.1% of lesions measuring 1 cm or less and 95.8% of lesions measuring 1.5 cm or less. These results are comparable to those of Parker et al. [11], who reported complete removal of the lesions found at imaging in 110 (88.7%) of 124 lesions that underwent sonographically guided 11-gauge vacuum-assisted biopsy. Although the goal of percutaneous biopsy is diagnosis, not treatment, complete lesion removal may have diagnostic advantages, such as lower rebiopsy rate (due to lower frequencies of histologic underestimation, imaging—histologic discordance, and interval growth on follow-up). For women with small but symptomatic lesions, sonographically guided 11-gauge vacuum-assisted biopsy may also result in relief of symptoms of palpable lump or nipple discharge [9].
Our data underscore the fact that complete removal of the lesion found at imaging does not ensure complete excision of the histologic process. Of cancers in which the lesion seen at sonography was removed, surgery revealed residual carcinoma in 50%. This finding is consistent with prior work of Liberman et al. [31], who found that of cancers in which the mammographic lesion was completely removed at stereotactic 11-gauge vacuum-assisted biopsy, surgery revealed residual carcinoma in 73%. The vacuum-assisted technique is used for diagnosis but does not provide definitive excision of carcinoma.
We encountered a complication (hematoma requiring surgical drainage) in one (1.1%) of 88 cases. Simon et al. [8] reported bleeding of more than 10 min in five (7%) of 71 sonographically guided 11-gauge vacuum-assisted biopsies and a vasovagal reaction in one (1%) of 71 biopsies. Duchesne et al. [10] noted an immediate complication rate of 10% in their study of 61 patients, including four skin defects and two cases of arterial bleeding. Parker et al. [11] reported minor complications in two (1.6%) of 124 lesions, including one skin defect and one hematoma that resolved with compression. These rates are higher than the reported complication rates of 0-0.2% in prior studies of patients who underwent sonographically guided 14-gauge automated core biopsy [1, 2, 7] and may, in part, reflect the learning curve for this new procedure.
In an era of limited health care resources, use of more expensive equipment when less expensive equipment is available should be justified in terms of some benefit (improved outcome, more wide applicability) that outweighs the additional cost. The disposable costs of the 11-gauge vacuum-assisted devices are greater than those of the 14-gauge automated needles in Venezuela, as in the United States. We suggest that the ability to remove a larger volume of tissue (or completely remove the lesion found at imaging), to relieve symptoms, and to place a localizing clip may provide benefits that justify the additional cost in selected cases. Furthermore, in our practice in Venezuela, complete lesion removal substantially increases the likelihood of sparing the patient a surgical procedure. Our surgeons are far more likely to recommend surgical excision in spite of a benign percutaneous biopsy diagnosis if the lesion is still evident at imaging studies than if all imaging evidence of the lesion has been removed.
In conclusion, data from our small series suggest that sonographically guided 11-gauge directional vacuum-assisted biopsy is a fast and accurate method for breast diagnosis. This technique resulted in complete removal of 95.8% of lesions found at sonography measuring 1.5 cm or less and spared a surgical procedure in 95.2% of women. The complication rate may be slightly higher than that for 14-gauge automated core biopsy but may improve with experience. Limitations of our study include the selected group of cases reported and incomplete follow-up data. Further work is necessary to assess long-term outcome of sonographically guided 11-gauge directional vacuum-assisted biopsy, to evaluate its cost-effectiveness, and to determine which women would benefit most from use of vacuum-assisted biopsy rather than from the use of automated core biopsy for tissue acquisition during sonographically guided biopsy of the breast.
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