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Sonographically Guided Directional Vacuum-Assisted Breast Biopsy Using a Handheld Device

¹ The Sally Jobe Breast Centre, 8200 E. Belleview Ave., Ste. 102, Greenwood Village, CO 80111.
² Wellspring Breast Center, Community General Hospital, POB South, 4900 Broad Rd., Syracuse, NY 13215.
³ Van Dyke Haebler Center for Women's Imaging, 2025 E. Newport Ave., Milwaukee, WI 53211.
⁴ Women's Center Boca Raton at Community Hospital, 690 Meadows Rd., Boca Raton, FL 33486.
⁵ South Carolina Comprehensive Breast Center, One Richland Medical Park Dr. # 120, Columbia, SC 29203.
⁶ Hopital St. Sacrement, Clinique Radiologique Audet, 1000 Chemin Ste-Foy, Ste. 208, Quebec, P. Q. G1S 2L6 Canada.
⁷ Tristan Associates, 4518 Union Deposit Rd., Harrisburg, PA 17111.
⁸ University of California-Davis, and Highland Hospital, Surgery Department, 1411 E. 31st St., Oakland, CA 94602.

Received October 13, 2000; accepted after revision January 30, 2001.

 
Address correspondence to S. H. Parker.

Abstract

Top Abstract Introduction Subjects and Methods Results Discussion References

 
OBJECTIVE. The goal of this study was to show that one can safely remove all sonographic evidence of masses in the breast less than or equal to 1.5 cm in greatest dimension using the 11-gauge handheld Mammotome, thereby reducing the possibility of a false-negative diagnosis and other shortcomings of the automated core biopsy device.

SUBJECTS AND METHODS. Over a 12-week period (May 3-July 31, 2000), 124 sonographically guided breast biopsies were performed in 113 patients, using a new handheld directional vacuum-assisted biopsy device. All lesions that were less than or equal to 1.5 cm were biopsied using a handheld Mammotome; an attempt was made to continue the biopsy until no sonographic evidence of the lesion remained.

RESULTS. Of these 124 lesions, 14 had infiltrating ductal carcinomas, four had infiltrating ductal carcinomas with associated ductal carcinoma in situ, one had infiltrating lobular carcinoma, one had ductal carcinoma in situ, three had atypical ductal hyperplasias, one had atypical lobular hyperplasia, and one had phyllodes tumor. Only one infiltrating ductal carcinoma was entirely removed histologically at Mammotome biopsy. There were no underestimates of disease. No cases of epithelial displacement were observed in any of the surgical excisions of malignancies. The remaining 99 lesions were benign.

CONCLUSION. The handheld Mammotome diminishes the shortcomings of the automated core biopsy device. It reduces the possibility of false-negatives and underestimation of disease. It eliminates the need for multiple insertions and reduces the likelihood of epithelial displacement. As a result, we now use this device for all sonographically guided biopsies of breast masses smaller than 1.5 cm and recommend that others consider it for such use.

Introduction

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Sonographically guided, percutaneous, large-core breast biopsy has been performed successfully for more than a decade [1]. It is efficacious, cost effective, and generally accepted as an alternative to open surgical biopsy. Although the method usually provides a reliable diagnosis, the technique has shortcomings.

The possibility of false-negative diagnoses is the most obvious shortcoming of core biopsy of the breast. Percutaneous large-core breast biopsy carries with it an overall false-negative rate of 2.9-10.9% [2,3,4,5,6]. Although most of false-negatives can be traced to the biopsy of microcalcifications, there remains a 1.4% false-negative rate for masses, which are typically biopsied using sonographic guidance (Burbank F, personal communication, February 1996). This false-negative rate was calculated from long-term follow-up of 6152 lesions who underwent 14-gauge automated core biopsies [6]. In addition, in both short-term (6 months-2 years) and long-term (>2 years) follow-up of that series, all of the false-negative findings arose from biopsies of small masses (<1.5 cm) [6]. False-negatives can theoretically occur also with core biopsy of an ill-defined mass composed largely of fibrosis surrounding a small infiltrating carcinoma.

The Mammotome Hand-Held (Ethicon Endo-Surgery, Cincinnati, OH) (Fig. 1) is a new instrument for sonographically guided breast biopsy. This device should bring to sonographically guided breast biopsy advantages similar to those that the Mammotome has already been recognized as bringing to stereotactic guidance. The goal of this study was to show that one can safely remove all sonographic evidence of masses less than or equal to 1.5 cm in greatest dimension using the handheld Mammotome, thereby reducing the possibility of a false-negative diagnosis, the most worrisome shortcoming of the automated core biopsy device.

View larger version (107K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 1. —Photograph of Mammotome (Ethicon Endo-Surgery, Cincinnati, OH) with handle in one hand and sonographic transducer in other hand.

Subjects and Methods

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Over a 12-week period (May 3-July 31, 2000), 124 sonographically guided breast biopsies were performed in 113 patients, using the 11-gauge handheld Mammotome. The biopsies were guided with high-resolution near-field sonography units with 7.5-, 10-, or 13-mHz transducers (Logic 400 & Logic 500, General Electric, Milwaukee, WI; HDI 5000, ATL, Bothell, WA; Performa, Acoustic Imaging, Tempe, AZ; Sonoline Elegra, Siemens, Issaquah, WA). The biopsies were performed at eight locations (in seven states and Quebec, Canada). All lesions less than or equal to 1.5 cm were biopsied using the handheld Mammotome, with an attempt made to continue the biopsy until there was no sonographic evidence of the lesion (Fig. 2A,2B,2C). The greatest dimension of the lesion and the number of samples obtained were recorded.

View larger version (161K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 2A. —29-year-old woman with palpable finding who underwent sonographically guided biopsy performed using handheld Mammotome (Ethicon Endo-Surgery, Cincinnati, OH). Mammogram shows 10.6-mm mass (arrows) in 4-o'clock position of left breast.

View larger version (142K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 2B. —29-year-old woman with palpable finding who underwent sonographically guided biopsy performed using handheld Mammotome (Ethicon Endo-Surgery, Cincinnati, OH). Sonogram shows handheld Mammotome probe (arrows) positioned just posterior to lesion.

View larger version (172K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 2C. —29-year-old woman with palpable finding who underwent sonographically guided biopsy performed using handheld Mammotome (Ethicon Endo-Surgery, Cincinnati, OH). Postbiopsy sonogram reveals no imaging evidence of lesion remaining. Final histology revealed benign fibrocystic change.

A marking clip (MicroMark; Ethicon Endo-Surgery) was placed at the biopsy site at the conclusion of each biopsy. A mammogram and a sonogram were obtained after each biopsy to record the measurement and resultant percentage of any portion of the lesion that remained. The distance from the clip to the original lesion site was measured. Complications from the biopsy (significant bleeding, infection, hematoma, skin defect) were recorded.

The pathologist was asked to record the weight of the biopsy material for each biopsy. A record was made of the number of repeated biopsies (percutaneous or surgical) that were performed as a result of imaging-pathology discordance (i.e., when the histology did not make sense in light of the imaging findings). Surgical lumpectomies after the diagnosis of high-risk lesions (atypical ductal hyperplasia, atypical lobular hyperplasia, and lobular carcinoma in situ) were not recorded as repeated biopsies. After all lumpectomies, the pathologist recorded the type of any malignancy remaining and reported any evidence of epithelial displacement. The final histology was compared with the histology from the Mammotome biopsy to determine whether there was an underestimation of disease. Any histologic underestimation (e.g., atypical ductal hyperplasia upgraded to ductal carcinoma in situ) was recorded.

Results

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Sonographically guided breast biopsy using the handheld Mammotome was performed on a total of 124 lesions. Lesions were categorized using the Breast Imaging Reporting and Data System (BI-RADS) [7] Eleven lesions were classified as BI-RADS category 5, 59 lesions were classified as BI-RADS category 4, and 54 lesions were classified as BI-RADS category 3. These sonographically determined BI-RADS designations were derived from the work of Stavros et al. [8]. Histologically, 25 lesions were classified as malignant, high risk (atypical ductal hyperplasia, atypical lobular hyperplasia, or lobular carcinoma in situ), or phyllodes tumor. We found 14 infiltrating ductal carcinomas, four infiltrating ductal carcinomas with associated ductal carcinoma in situ, one infiltrating lobular carcinoma, one ductal carcinoma in situ, three atypical ductal hyperplasias, one atypical lobular hyperplasia, and one phyllodes tumor with benign features. All 11 lesions classified as BI-RADS category 5 were malignant. Of the BI-RADS category 4 lesions, 13 were noted to be malignant, high risk, or phyllodes (13/59 [22%]). Of the BI-RADS category 3 lesions, one was noted to be malignant (1/54 [1.8%]). Histologically, 99 lesions were classified as benign. There were 38 fibroadenomas, 41 regions of fibrocystic change, 14 papillomas, two scars or fat necroses, one hamartoma, one intramammary lymph node, and two cases of mastitis. Of the 53 benign BI-RADS category 3 lesions, 26 were fibroadenomas, 16 were regions of fibrocystic change, 10 were papillomas, and one was an intramammary lymph node.

The average lesion size was 9.1 mm, and the average number of samples obtained per lesion was 9.1. The average total tissue weight obtained per biopsy was 707 mg. The average weight per individual 11-gauge Mammotome sample was 77.7 mg. The average distance of the biopsy marking clip from the original center of the lesion as measured on the postbiopsy mammogram was 1.4 mm. The greatest distance of a marking clip from the center of the original lesion was 1.5 cm. Sonography and mammography performed after biopsy revealed that 110 of the 124 lesions (88%) had no imaging evidence of the original lesion remaining. Among the other 14 lesions, 10 still had sonographic evidence of the lesion remaining after biopsy and four still had some mammographic density remaining after biopsy but no sonographic evidence of the lesion. In 18 patients, the lesion was not seen well or at all on the original mammogram and therefore the judgment as to whether any evidence of the original lesion remained was based solely on sonography.

Two minor complications were seen: one hematoma and one skin defect (a Mammotome sample of skin was obtained during biopsy). The hematoma measured 1.7 x 1.2 cm and required no further intervention beyond applying pressure to the biopsy site. No residua of this hematoma were noted 8 months later. The skin defect, which was 5 mm in size, occurred during the biopsy of a superficial lesion and required no further intervention. It was noted to be healing well at 5 days. The patient ultimately had a mastectomy as treatment for ipsilateral breast cancer.

No repeated biopsies were required because of insufficient tissue or inconclusive results. One Mammotome biopsy was performed as a repeated biopsy on a BI-RADS category 4 lesion, 7 mm in size, after a 14-gauge core biopsy with benign findings. This was done because of uncertainty as to the accuracy of the nonspecific 14-gauge core diagnosis of fibrocystic change. The Mammotome biopsy revealed a tubular carcinoma. We found no underestimates of disease ("upgrade" discrepancies) and three "downgrade" discrepancies. One patient with infiltrating ductal carcinoma diagnosed at mammotomy was shown to have only atypical duct hyperplasia in the lumpectomy specimen. No residual infiltrating ductal carcinoma was observed. This was the only infiltrating carcinoma of the 18 infiltrating carcinomas in this series (5.5%) that was entirely removed by the Mammotome. One patient with atypical ductal hyperplasia and one patient with atypical lobular hyperplasia had only lobular hyperplasia remaining in the surgical excisional specimen.

The only other discrepancy in diagnosis was in a patient with infiltrating lobular carcinoma at Mammotome biopsy with infiltrating ductal carcinoma observed in addition to the infiltrating lobular carcinoma in the surgical specimen. All other lesions that were surgically excised had complete histologic agreement with the original percutaneous biopsy. No cases of epithelial displacement were observed in any of the surgical excisions, despite an active search for such by the pathologist.

Discussion

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Small lesions, especially those smaller than 1 cm, are the most difficult to accurately target when performing sonographically guided automated core biopsy because of the possibility of the needle traversing near, but not through, the lesion. This is especially true in small, deep lesions in a large breast. There are occasions when, even with five or more core passes, one is uncertain if tissue from the lesion has definitely been obtained. This then leaves doubt about any non-specific benign diagnosis, such as fibrocystic change, resulting from that biopsy. In fact, this happened in the case of one patient in this series, whose cancer was missed on a previous 14-gauge core biopsy. With complete removal of the sonographic evidence of the small mass, there is a reduced chance of sampling error and consequent false-negative diagnosis. Thus, when performing an excisional Mammotome biopsy of a BI-RADS category 4 or 5 small mass, any resultant benign diagnosis can intuitively be relied on more confidently, obviating a rebiopsy in the face of discordant imaging and histologic results.

In addition, when one biopsies a small mass with the handheld Mammotome, the imaging evidence of the lesion is no longer present; therefore, it is unlikely that the lesion "proven" benign at biopsy will grow to a size that would confuse the original diagnosis. For example, if a 15-mm lesion is biopsied using standard automated core biopsy technique and the resultant histology is fibroadenoma, the radiologist's confidence in this specific benign diagnosis is high. However, if at 6-month follow-up the lesion measures 19 mm, that confidence is diminished somewhat and questions arise as a result. Is it safe to continue to follow up this lesion? Should it be rebiopsied with the core technique? Should it be surgically excised? By performing an excisional mammotomy initially, one can mitigate this dilemma and its corresponding questions.

On the basis of our study, one can reasonably expect to reduce the likelihood of a false-negative result using this technique because the Mammotome biopsy of masses 1.5 cm in size or smaller resulted in no remaining imaging evidence of the lesion almost 90% of the time. Even in those instances where not all of the lesion was successfully removed, at least some of the lesion was removed in all cases. Therefore, it is clear that the lesion is much less likely to be missed entirely as can happen with the automated core biopsy of small masses.

Other, less substantial, shortcomings occur with the use of the standard automated core biopsy device. A 14-gauge core biopsy can result in an underestimate of the malignancy present [2,3,4,5,6, 9,10,11]. That is, a diagnosis of atypical ductal hyperplasia is upgraded to ductal carcinoma in situ or infiltrating ductal carcinoma in up to 50% of cases, and ductal carcinoma in situ is upgraded to infiltrating ductal carcinoma in up to 20% of cases. The Mammotome technique has been shown to result in fewer underestimates [11, 12]. In our study, there were no underestimates of disease. Granted, most cases involving underestimation of disease occur in stereotactic biopsy of calcifications, in which the odds of a diagnosis of atypical ductal hyperplasia or ductal carcinoma in situ are much greater. However, these diagnoses (atypical ductal hyperplasia, ductal carcinoma in situ) do occur occasionally with sonographically guided biopsy of breast masses (five in this series).

Another shortcoming of the standard automated core biopsy is that it must be inserted and reinserted multiple times to acquire the recommended minimum of five cores to sample a mass [13]. Because the Mammotome uses a vacuum to pull the tissue into the probe and to extract the tissue from the breast without removing the probe, the handheld 11-gauge Mammotome also eliminates this drawback of multiple insertions. Finally, the standard automated core biopsy needle device has been shown to cause more epithelial displacement than the directional, vacuum-assisted devices [14]. In this study, no instances of epithelial displacement were observed.

The complications experienced in this series (<2%) were fewer than the 8% of complications reported by Simon et al. [15] in a series of 64 sonographically guided Mammotome biopsies using the standard Mammotome attached to an articulated arm. In that series, there was no attempt to remove the visualized evidence of the lesion, but rather to sample it. Simon et al. found no false-negatives. However, because it was a sampling procedure rather than an excision, imaging follow-up to confirm a benign diagnosis was necessary. Simon et al. performed 6-month follow-up imaging on all patients with nonspecific benign diagnoses (e.g., fibrocystic change) and routine annual mammography on patients with specific benign diagnoses (for example, fibroadenoma). Because we perform an "excisional" Mammotome biopsy, we perform only routine annual mammography as follow-up. Others may wish to continue to perform 6-month follow-up even after an excisional Mammotome biopsy. It is doubtful that the differences in technique between our study and that of Simon et al. had anything to do with the difference in complications.

Subjectively, we believe that there were far fewer "dry taps" (a Mammotome sampling sequence where no sample is retrieved) with the handheld Mammotome compared with the standard Mammotome used with sonographic guidance and held in place by an articulating arm. This difference in frequency of dry taps may be attributed to the automated vacuumcontrol module that accompanies the handheld Mammotome. With this module, the vacuum is automatically activated to retain the sample within the inner cutter when it is withdrawn into the sample collection chamber. In addition, any blood is automatically suctioned into the forward vacuum line when the Mammotome is not actively engaged in biopsy. This prevents blood products from occluding the vacuum holes opposite the sample aperture at the terminus of the probe. We think that the samples obtained with the handheld Mammotome were larger and more consistent than those obtained with the standard Mammotome, but this subjective conclusion is at variance with the objective specimen weights obtained. Although the samples were 450% larger than standard 14-gauge automated core samples (77 mg vs 17 mg), they were somewhat smaller than what has been reported for traditional 11-gauge Mammotome samples (77 mg vs 95 mg) [16, 17].

Some may question the high number of BI-RADS category 3 lesions that were biopsied. The positive biopsy rate (malignancies and high-risk lesions) with these lesions included in the calculation is 20% (25/124). If the BI-RADS category 3 lesions had not been biopsied, the positive biopsy rate (malignancies and high-risk lesions) would have been 34% (24/70), but one 9-mm grade III infiltrating ductal carcinoma would have been missed. It is our opinion that many women with a known mass (e.g, women with lesions designated as BI-RADS category 3 who underwent biopsy in this series) prefer to have an immediate biopsy or Mammotome removal of that mass rather than undergo 6-month imaging followup, in spite of reassurance that there is less than a 2% chance of malignancy (a rate confirmed in our study). If one considers the patient's mental state as well as her physical state (practicing the art of medicine in addition to the science), it is clear to us that many women with BI-RADS category 3 masses will desire and should be allowed to undergo immediate biopsy. If, on the other hand, one wants to achieve a higher positive biopsy rate, one can deny biopsy to women in this category.

In conclusion, we believe that the handheld Mammotome diminishes the shortcomings of the automated core biopsy device. It reduces the small but real false-negative rate by removing all of the imaged lesion in most cases. In those instances in which all of the visualized lesion has not been removed, closer attention to imaging follow-up might be appropriate. Some physicians may prefer to subject all patients who have a benign diagnosis to a 6-month follow-up imaging study until more data are available.

The handheld Mammotome reduces the underestimation of disease. It eliminates the need for multiple insertions, and it reduces the likelihood of epithelial displacement. As a result, we now use the handheld Mammotome for all sonographically guided biopsies of breast masses smaller than 1.5 cm and recommend that others consider it for such use.

References

Top Abstract Introduction Subjects and Methods Results Discussion References

 

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