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1 All authors: Department of Diagnostic Radiology, Yale University School of Medicine, 333 Cedar St., P. O. Box 208042, New Haven, CT 06520.
Received June 20, 2002;
accepted after revision July 31, 2002.
Presented at the annual meeting of the American Roentgen Ray Society,
Atlanta, April-May 2002.
Abstract
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MATERIALS AND METHODS. We retrospectively reviewed all sonographically guided core biopsies performed between January 1997 and August 2001. Before February 2000, biopsies were performed using the 14-gauge automated gun and after that time, with either the 14-gauge automated gun or the 11-gauge vacuum-assisted device. During the study period, 181 biopsies were performed with the 14-gauge automated gun and 100 with the 11-gauge vacuum-assisted device.
RESULTS. The histologic results of the core biopsies were similar for the group who underwent biopsy with the 14-gauge automated gun and the group who underwent biopsy with the 11-gauge vacuum-assisted device: malignant, 19% versus 19%; benign, 78% versus 79%; and high-risk lesion or other, 3% versus 2%, respectively (p > 0.7). Complications were rare and similar for both methods: 2% for the 14-gauge automated gun and 3% for the 11-gauge vacuum-assisted device (p = 0.46). A second biopsy was recommended immediately after the first in 14% of the patients who underwent biopsy with the 14-gauge automated gun versus 17% of those who underwent biopsy with the 11-gauge vacuum-assisted device (p = 0.47). Recommendation for delayed rebiopsy due to interval change occurred in 2.5% of the patients who underwent biopsy with the 14-gauge automated gun method and 3% of those who underwent biopsy with the 11-gauge vacuum-assisted device (p = 0.94).
CONCLUSION. No significant differences were found in the outcomes of sonographically guided core biopsies performed with the automated gun compared with those performed with the vacuum-assisted device in terms of missed cancers, underestimation, complications, or the need (immediate or delayed) for a second biopsy.
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Like stereotactic core breast biopsy, sonographically guided biopsy has been performed for many years using needle and automated gun methods using needles of varying sizes up to 14-gauge. More recently, the vacuum-assisted method has become available for sonographically guided biopsies in the form of a handheld device (Mammotome; Biopsys/Ethicon-Endosurgery, Cincinnati, OH) with 8- and 11-gauge probes available. Vacuum-assisted devices provide larger core samples than automated guns and enable more contiguous sampling, potentially allowing more complete sampling of lesions and lowering the chance of sampling error [5,6,7]. For stereotactic biopsies, vacuum-assisted methods have been shown to have several advantages over the automated methods, including increased ease of sampling calcification lesions, the need for fewer repeated biopsies, and fewer cases of underestimation of cancer [8,9,10,11,12,13,14,15].
The benefits of the vacuum-assisted technique over the automated method for sonographically guided core biopsies have not yet, to our knowledge, been studied. The vacuum-assisted device has been suggested to likely have similar advantages for sonographically guided biopsy as it has for stereotactic core biopsy [4]. However, the types of lesions for which sonographically guided biopsy is usually performed differ, both in imaging features and in histologic diagnoses, from those for which stereotactic biopsy is performed. Although vacuum-assisted methods may facilitate more thorough sampling and even the removal of some lesions, the need for such extensive sampling has not, to our knowledge, been shown.
The purpose of this study was to compare the outcome for sonographically guided core biopsies performed with the automated method with those performed with the vacuum-assisted method. To determine whether outcomes of core biopsies performed by the two methods differ, we compared the histologic entities found; the rate of missed cancers; the rate of cancer under-estimation; complication rates; and the need for a second biopsy, both immediate and delayed.
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From January 1997 to February 2000, 123 core biopsies in 120 patients were performed using the 14-gauge automated gun. From February 2000 to August 2001, 58 biopsies in 57 patients were performed using the 14-gauge automated gun, and 100 biopsies in 94 patients were performed using the 11-gauge vacuum-assisted device. Thus, a total of 181 biopsies in 177 patients were performed with the 14-gauge automated gun, and 100 in 94 patients were performed with the 11-gauge vacuum-assisted device.
The technique used to perform sonographically guided core biopsy with either the automated gun or vacuum-assisted device has been previously described [1, 4, 5]. All biopsies were performed with the patient in a supine or supine—oblique position. Imaging guidance for the biopsy was performed on a sonography unit (model HDI 3000 or 5000; Phillips—Advanced Technology Laboratories, Bothell, WA) with a high-resolution linear array transducer (12.5 MHz). The mean number of core samples obtained with the 14-gauge automated gun was 4.7 (range, 1-17). For the biopsies performed with the 11-gauge vacuum-assisted device, the mean number of core samples was 5.8 (range, 1-12). After each biopsy, a pathology report from the core biopsy sample was reviewed by the responsible radiologist before management recommendations were made. Complications relating to the core biopsy were recorded on a datasheet at the time of the procedure.
The pathology reports from the core biopsies were reviewed to determine the histologic entities found. Malignant entities included invasive carcinoma and ductal carcinoma in situ. High-risk lesions (i.e., lesions for which a second biopsy is generally recommended) included atypical hyperplasia, radial scar, phyllodes tumor, and other unusual histologic entities. Benign lesions included specific diagnoses, such as fibroadenoma and papilloma, and nonspecific processes, such as fibrosis and fibrocystic change.
The recommendations for subsequent management made at the time of core biopsy were reviewed. If a second biopsy or surgery was recommended immediately after the first biopsy, the reasons for the recommendation were determined. For patients undergoing a second biopsy, the histologic findings of the core sample from the second biopsy or of the surgical specimen were reviewed and correlated with the original core biopsy results. Cases were considered an underestimation if either atypical hyperplasia diagnosed at core biopsy was found to be carcinoma at surgery or ductal carcinoma in situ diagnosed at core biopsy was upgraded to invasive carcinoma at surgery. Cases were considered false-negative if carcinoma was found at surgery after core biopsy had shown benign results.
The usual follow-up protocol was a 6-month interval for benign nonspecific results and a 1-year interval for benign specific results. For cases undergoing imaging follow-up, subsequent mammography and sonography reports were reviewed. We identified cases for which a second biopsy was recommended after a delay since the first biopsy, and the time interval (from core biopsy) and reason for the repeated biopsy recommendation were assessed. The histologic findings of the specimens obtained at the second biopsies that were performed after a delay were compared with the original core biopsy results. Follow-up information was available for 118 (63%) of 186 cases: 67% (81/121) of the lesions biopsied with the 14-gauge automated gun and 58% (37/64) of the lesions biopsied with the 11-gauge vacuum-assisted device. In 64 cases (37 lesions biopsied with the 14-gauge automated gun and 27 lesions biopsied with the 11-gauge vacuum-assisted device), no follow-up information was available. In four cases (all biopsied with the 14-gauge automated gun), the follow-up information was not yet due; these cases were excluded from the follow-up analysis.
The group biopsied with the 14-gauge automated gun was compared with the group biopsied with the 11-gauge vacuum-assisted device for each of the parameters examined: histologic entities found on core biopsy, complications, management recommendations, need for a second biopsy, reasons for the second biopsy, number of missed cancers, rate of histologic underestimation, and rate of second biopsy performed after a delay and outcome of these cases.
Statistical associations were determined with chi-square analyses (Excel; Microsoft, Redmond, WA), with statistically significant differences assumed when p was less than 0.05.
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When cases diagnosed as malignant were excluded, an additional 14% (25/181) of lesions biopsied with the 14-gauge automated gun and an additional 17% (17/100) of the lesions biopsied with 11-gauge vacuum-assisted device were recommended for a second biopsy. These rebiopsy rates are not significantly different (p = 0.47). The reasons for the second biopsy are detailed in Table 2. The most common reason in both groups for a second biopsy was imaging—histologic discordance, 56% and 65%, respectively (p = 0.57, not significant). Diagnosis of high-risk or borderline lesions was not common. Atypical hyperplasia was found in only two cases, both sampled with the 14-gauge automated gun. Radial scars were found in only three cases, one diagnosed with the 14-gauge automated gun and two with the 11-gauge vacuum-assisted device. Insufficient sampling occurred in only three biopsies (2%) performed with the 14-gauge automated gun and one biopsy (1%) with the 11-gauge vacuum-assisted device (p = 0.50, not significant).
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Most of the lesions with nonmalignant results at the first biopsy that underwent a second biopsy underwent a surgical biopsy (35/37, 95%), but two (5%) underwent a second sonographically guided core biopsy. The comparison of the results from the initial core biopsy samples and those from the surgical specimens are shown in Table 3. Of the two cases of atypical ductal hyperplasia diagnosed at core biopsy with the 14-gauge automated gun, both were benign on surgical excision.
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Surgery was performed in all 54 lesions with malignant findings. Histologic underestimation occurred in only one case of ductal carcinoma in situ (1/3, 33%) diagnosed on core biopsy. In this case, the lesion was a 9-mm hypoechoic mass with microlobulated margins; five specimens from this mass had been obtained with the 11-gauge vacuum-assisted device. At surgery, invasive disease was found. The underestimation rates were similarly low in the two groups: 0% for the 14-gauge automated gun and 1% for the 11-gauge vacuum-assisted device (p = 0.17, not significant).
A second biopsy performed immediately after the first revealed false-negative results in only one (0.5%) of the lesions biopsied with the 14-gauge automated gun and one (1%) of the lesions biopsied with the 11-gauge vacuum-assisted device (p = 0.67, not significant). Both cases yielded nonspecific benign diagnoses on core biopsy and were recognized because of discordance. During the biopsy performed with the 14-gauge automated gun, three samples of a 5-mm intracystic mass were obtained. Surgical biopsy results showed ductal carcinoma in situ. The lesion sampled with the 11-gauge vacuum-assisted device method was a 17-mm irregular hypoechoic mass in which "multiple" samples (the exact number was not recorded) were obtained. Surgical biopsy results showed invasive ductal carcinoma.
The complication rate was low and similar in the two groups: 2% (3/181) for the 14-gauge automated gun and 3% (3/100) for the 11-gauge vacuum-assisted device (p = 0.46, not significant). Bleeding during and after the procedure occurred in the three lesions biopsied with the 14-gauge automated gun. In one of these three lesions, the procedure had to be terminated because of bleeding after only one core sample had been obtained. This sample was considered insufficient for accurate diagnosis, and a second biopsy was required. The three complications in the 11-gauge vacuum-assisted biopsy group were hematomas occurring immediately after the procedure. All the hematomas were conservatively treated, and none required surgical intervention.
For cases not undergoing a second biopsy immediately after the first, follow-up imaging information was available in 118 cases: 67% (81/121) of the 14-gauge automated gun group and 58% (37/64) of the 11-gauge vacuum-assisted device group. For the 14-gauge automated gun group, the mean follow-up time was 19 months (range, 3-53 months). For the 11-gauge vacuum-assisted device group, the mean follow-up time was 13 months (range, 1-25 months). No suspicious interval changes were noted in 115 lesions (97%; 79 biopsied with the 14-gauge automated gun and 36 with the 11-gauge vacuum-assisted device). Recommendations for a second biopsy after a delay since the first because of interval change occurred at similar rates in the two groups: two (2.5%) of 81 of the lesions biopsied with the 14-gauge automated gun and one (3%) of the 37 lesions biopsied with the 11-gauge vacuum-assisted device (p = 0.94, not significant). Of the 14-gauge automated gun method, one had been diagnosed as fibroadenoma and one as benign nonspecific on core biopsy. Interval growth at 15 and 18 months, respectively, prompted surgery confirming a fibroadenoma in one and a second sonographically guided core biopsy confirming benign nonspecific results in the other. In a lesion biopsied with the 11-gauge vacuum-assisted device, surgery was performed because of interval growth at 5 months; in this case, surgery also confirmed the original core biopsy result of fibroadenoma. No delayed false-negative cases have been identified to date.
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The results of this study support this hypothesis. No significant differences were found in the outcome for lesions biopsied with the vacuum-assisted device compared with those biopsied with the automated method. Thus, the advantages found with the use of the vacuum-assisted device in stereotactic core biopsies are not similarly found with sonographically guided core biopsies. For the reasons outlined earlier, these findings are not surprising.
The optimal amount of core tissue for sonographically guided core biopsy has not been well established. Liberman et al. [16] showed that in stereotactic core biopsy the number of core samples obtained with the 14-gauge automated gun differed for mass lesions than for calcifications. Although five core samples were adequate to accurately diagnose 99% of the masses, calcification lesions often required more samples for diagnosis. The number of core samples necessary for sonographically guided core biopsy would be expected to be not greater than that found necessary for stereotactic biopsy of masses. In fact, the real-time visualization of needle position afforded with sonographically guided biopsy may decrease the number of core samples necessary to accurately diagnose many cases. The increased amount of tissue obtained by the vacuum-assisted device, therefore, may not provide any additional diagnostic benefit over automated methods. This assumption is concordant with the findings of this study, which showed the outcomes of biopsies performed using the automated method were similar to those of biopsies performed using the vacuum-assisted device.
The use of the vacuum-assisted device might be expected to reduce the number of insufficient samples. However, insufficient sampling was an unusual occurrence at sonographically guided core biopsy. Only four biopsies failed to provide sufficient tissue for diagnosis; three (2%) were performed with the 14-gauge automated gun and one (1%), with the 11-gauge vacuum-assisted device. The difference between the two methods was not statistically significant. Therefore, although the vacuum-assisted device is capable of yielding more tissue in a shorter amount of time than the 14-gauge automated gun, the results show that the use of the vacuum-assisted device is not usually necessary for diagnosis.
Uncommon high-risk lesions diagnosed by core biopsy, including atypical hyperplasia, radial scars, lobular carcinoma in situ, papillary lesions, and others, often lead to a recommendation for surgical excision. The use of the vacuum-assisted device may increase the level of confidence in excluding malignancy in these cases; however, a second biopsy will likely be recommended regardless of the biopsy method. High-risk lesions, furthermore, were not found in many sonographically guided core biopsy cases. The rates of high-risk lesions were similarly low in the two groups: 3% of the lesions biopsied with the 14-gauge automated gun and 2% of those biopsied with the 11-gauge vacuum-assisted device. Therefore, high-risk lesions did not contribute significantly to the overall rebiopsy rate. In our series, only two cases of atypical hyperplasia, three radial scars, one papillary lesion, and one phyllodes tumor that underwent a second biopsy were found.
Discordance of imaging features and histologic findings is a major concern in determining case management after core biopsy and was the main reason a second biopsy was recommended for both groups of lesions, those biopsied with the 14-gauge automated gun and those biopsied with the 11-gauge vacuum-assisted device. This issue is an important one because the two missed cancer cases were immediately recognized because of the imaging—histologic discordance. However, many other lesions had findings that were also considered discordant and were subjected to a second biopsy. Benign entities such as fibrocystic disease, for example, may produce sufficiently suspicious sonographic findings to be considered discordant. Our results showed that the use of the vacuum-assisted device did not decrease the rate of imaging—histologic discordance. Because this factor was a major one in contributing to the rate of rebiopsy, efforts to decrease discordance warrant further investigation.
Because a larger amount of tissue can be obtained at core biopsy with the vacuum-assisted device, complete percutaneous removal of lesions has been attempted. This practice may avoid the possibility of underestimation of cancer and the possibility of delayed repeated biopsy because of interval growth [4]. Our study has shown that underestimation is not common with sonographically guided core biopsies, likely because of the types of lesions (primarily masses) sampled with this method. Atypical hyperplasia and ductal carcinoma in situ were infrequently found, and underestimation occurred in only one case. Likewise, delayed repeated biopsy due to suspicious interval growth of lesions after the first core biopsy was also found to be infrequent. A delayed recommendation for a second biopsy due to interval change occurred in only three cases: two lesions (1%) biopsied with the 14-gauge automated gun and one lesion (1%) biopsied with the 11-gauge vacuum-assisted device. Therefore, suspicious growth of lesions after the first core biopsy is not a common problem, and delayed repeated biopsies are infrequent.
The complication rate of core biopsy performed with an automated gun is low. Major complications have been reported in only 0.2% [17]. These complications include hematomas requiring surgical drainage and infections requiring antibiotics. However, minor complications, including bruising and pain, are more common, reported in 33-69% of patients [18, 19]. Only a few reports about the complications associated with vacuum-assisted biopsy have been published. Simon et al. [3] found a complication rate of 8% in 71 cases, which included five cases of bleeding more than 10 min (7%) and one vasovagal response (1%) [3]. Parker et al. [1] reported a complication rate of only 2% in 124 cases, which included one hematoma and one skin defect. Our low complication rate of 3% is similar to that reported by Parker et al. We found no significant differences in bleeding or hematoma formation between the automated and vacuum methods.
The vacuum-assisted method of biopsy may have some practical benefits for biopsy of lesions under sonographic guidance as compared with the automated method. As stated earlier, the vacuum feature may help decrease or control bleeding in some patients. The probe is manually inserted rather than "fired" into the breast tissue. Manual insertion may be preferable for biopsy of deep lesions because it could potentially decrease the chance of perforation of the chest wall. Therefore, although not necessary for diagnostic reasons, some radiologists may prefer the vacuum-assisted method over the automated gun method in certain cases.
Limitations of this study include the possible selection bias in choice of biopsy method for individual cases. The radiologists' personal preferences and differences in breast tissue and lesions determined the choice of one biopsy method over another. However, because the histologic profile of the two groups was almost identical, it seems unlikely that a significant selection bias occurred. Second, a learning curve for biopsy with the handheld vacuum-assisted device may exist. This bias would not be present for the biopsies performed with the 14-gauge automated gun, because this method had already been used for several years at the time of the study. Such a learning curve might affect the accuracy of biopsy and the level of comfort in accepting concordance with the histologic results. In fact, the single case of false-negative core biopsy diagnosis in the 11-gauge vacuum-assisted device group occurred early in our experience. Another potential limitation is the short follow-up, particularly for biopsies performed with the 11-gauge vacuum-assisted device. Given that the vacuum-assisted method is a more recently acquired technique, the follow-up time for the lesions biopsied with the 11-gauge vacuum-assisted device (13 months) was shorter than that for the lesions biopsied with the 14-gauge automated gun (19 months). However, given the small number of cases that required delayed rebiopsy due to interval change in the lesions biopsied with 14-gauge automated gun (two cases), it is unlikely that a significantly different rate of delayed rebiopsy will be found with longer follow-up of the lesions biopsied with the 11-gauge vacuum-assisted device.
The current goal of core biopsy remains to establish a definitive diagnosis, either benign or malignant, in the most efficient and cost-effective manner. Factors such as the repeated biopsy rate, underestimation of cancer, and false-negative results all contribute to this outcome. The results of this study show that the use of the vacuum-assisted biopsy device for sonographically guided core biopsy offers no significant advantages in terms of such factors over automated gun methods. These findings should aid radiologists in choosing the optimal biopsy method for patients.
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