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1
Manhattan Radiology, 1133 College Ave., Ste. E, Manhattan, KS 66502.
2
Department of Radiology, Hutchinson Clinic, 2100 N. Waldron Dr., Hutchinson,
KS 67502.
3
Department of Radiology, Irwin Army Hospital, 600 Caisson Hill Rd., Ft. Riley,
KS 66442.
4
Surgical Associates, 1133 College Ave., Ste. A, Manhattan, KS 66502.
5
Department of Radiology, General Leonard Wood Hospital, Ft. Leonard Wood, MO
65473.
Received August 2, 1999;
accepted after revision December 17, 1999.
Address correspondence to G. J. Welle.
Abstract
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MATERIALS AND METHODS. We retrospectively reviewed the results of 225 stereotactic core breast biopsies performed during a 42-month period. The biopsies were performed using a reclining mammography chair and add-on stereotactic equipment. Procedures were performed with the patient in the right or left lateral decubitus position or upright. Patients with benign biopsy results were followed up mammographically at 6 months initially, then yearly.
RESULTS. Of the 225 lesions biopsied stereotactically, 205 lesions (91%) were biopsied with the patient in the decubitus (right or left) position and 20 (9%) biopsied with the patient upright. Pathology results were classified as abnormal in 45 lesions (20%) and normal in 180 lesions (80%). All but one of the abnormal lesions were followed up with surgical excision. One hundred thirty-four of the 180 benign lesions have been followed up with at least one 6-month mammogram (follow-up range, 6-40 months), and none of the lesions has been subsequently proven malignant.
CONCLUSION. Stereotactic core biopsy can be performed effectively and accurately using standard add-on equipment when it is performed with the patient in the decubitus position. This approach obviates the use of dedicated prone stereotactic equipment.
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We implemented a protocol for stereotactic core breast biopsy using an add-on unit in 1995, which included the use of a dedicated reclinable mammography chair (Model MBC000; Hausted, Medina, OH). We have found that we can successfully perform core biopsies using add-on equipment, primarily as a result of implementing a decubitus positioning technique. The traditional upright position can also be used, but we prefer and recommend using the recumbent method when possible. Use of this protocol substantially reduces the problems (patient motion and vasovagal reactions) of add-on units [1].
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In this protocol, lesions were characterized primarily as either a mass or calcifications, and all lesions were measured (in millimeters) by their greatest dimension. A median of six (range, three to 12) tissue cores were obtained for biopsy of a mass, and a median of 11 (range, nine to 16) tissue cores were obtained for biopsy of microcalcifications.
The most common approach was that with the patient in the lateral decubitus position, using straight lateromedial compression (Fig. 1). In this position the needle or Mammotome probe traverses the breast in a lateromedial orientation. The second most common approach was a medial approach with the patient lying in a lateral decubitus position although in this position mediolateral compression is used and the needle or probe traversed the breast in a mediolateral orientation (Fig. 2). Note that the breast being biopsied by this approach is dependent. A few biopsies were performed in a craniocaudal or caudocranial orientation (Fig. 3). The patient may lie in a decubitus position and the craniocaudal or caudocranial approach can be used, depending on the position of the lesion. Some of the craniocaudal biopsy procedures were performed in the traditional upright position (not shown). The upright position was used only when lesions were not well seen with the patient in the decubitus position. We frequently obtain a direct lateromedial view as part of the prebiopsy diagnostic workup to facilitate positioning.
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Procedure times were recorded as minutes in compression. Adverse reactions and complications were also recorded. Postprocedural specimen radiographs were obtained for biopsy of microcalcifications, although no specimen radiographs were obtained for biopsy of masses. Most biopsies were performed using local anesthetic only. IV or oral sedation was used selectively.
Biopsy specimens that yielded fibrocystic change (without evidence of atypia) fibroadenoma, or other benign breast disorders were categorized as benign. Lesions consisting of atypical ductal hyperplasia, ductal carcinoma in situ, or infiltrating breast cancer were considered abnormal and in need of further surgical follow-up. All patients with a benign biopsy result were instructed to undergo unilateral followup mammography in 6 months to document stability of the lesion and to reestablish a baseline.
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Of the 225 lesions biopsied stereotactically, 205 lesions (91%) were biopsied with the patient in the decubitus position, either right or left, and 20 (9%) were biopsied with the patient upright. One hundred sixty-eight (75%) were biopsied from a lateral approach with the patient decubitus (Fig. 1), 34 (15%) were approached medially with the patient in a decubitus position (Fig. 2), 20 (9%) were approached craniocaudally with the patient upright, and two were approached caudocranially with the patient decubitus (1%).
Of the 225 lesions biopsied, 45 were classified as abnormal and 44 have been surgically followed up. One patient with atypical ductal hyperplasia has had no surgical follow-up (despite recommendations for surgical biopsy), although the hyperplasia remains mammographically stable at 12 months. One hundred eighty of the lesions were classified as benign (Table 1). Of these, 134 (74%) have been followed up with at least one mammogram obtained at 6 months or later. Fifty-two (39%) of the 134 patients have undergone one examination 6-12 months after biopsy, 51 have had between 12 months and 24 months of follow-up, and 31 have had at least 24 or more months of follow-up mammography. None of the 134 lesions has subsequently proven to be malignant.
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Five lesions were recommended for needle localization because of persistent concern (incongruence) after receiving benign biopsy results or concern at the 6-month follow-up examination, but none of these have subsequently been proven malignant. The remaining patients in the benign category are scheduled for follow-up mammography, although there have been a small number (approximately 10 patients) lost to follow-up.
Six patients were referred for needle-localization breast biopsy after inadequate or incomplete stereotactic core breast biopsy. Five had microcalcifications that were inadequately biopsied (not seen on specimen radiography or in pathology specimen). Four of the five calcified lesions were encountered with the 14-gauge core needle biopsy and only one lesion was inadequately biopsied with the 11-gauge Mammotome. All five of these calcified lesions were diagnosed as benign at follow-up needle-localization breast biopsy. One mass, which was subsequently shown to be malignant, was not well seen stereotactically and was referred for needle-localization breast biopsy. It was located far posterior and no tissue had been removed at the initial stereotactic procedure.
The 45 abnormal pathology results were divided into initial and final pathology (Table 2) and these were also subdivided into one of three categories: atypical ductal hyperplasia, ductal carcinoma in situ, or infiltrating ductal carcinoma. At initial pathology, 13 lesions were classified as atypical ductal hyperplasia, seven as ductal carcinoma in situ, and 25 as infiltrating ductal carcinoma. On the basis of final pathology results, eight were classified as atypical ductal hyperplasia, five as ductal carcinoma in situ, and 31 as infiltrating ductal carcinoma. Three of the cases of atypical ductal hyperplasia were upgraded to infiltrating ductal carcinoma, and one case of atypical ductal carcinoma was upgraded to ductal carcinoma in situ. Three of the ductal carcinoma in situ lesions were also upgraded to infiltrating ductal carcinoma. Since we began using the 11-gauge Mammotome probe, our incidence of histopathologic under-sampling has been significantly reduced and, thus far, none of our abnormal results with the Mammotome probe (seven cases) have been upgraded.
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Procedures took 20-50 min (average, 25 min). Procedures performed with the digital mammographic equipment and the Mammotome were approximately 10 min shorter in procedure time, on average. Six adverse reactions were recorded. One consisted of a small hematoma. Another patient experienced some delayed minor bleeding from the incision site, and four patients suffered vasovagal reactions. All the vasovagal reactions occurred with the patients in the upright position.
Two cases of malignancy were discovered on stereotactic core breast biopsy but not on subsequent needle-localization biopsy in one patient or on mastectomy in the other patient. The malignant tissue was missed on the follow-up needle-localization breast biopsy. In the patient who underwent mastectomy, it was presumed that the lesion was completely removed during the stereotactic biopsy. Note that the final pathology (Table 2) in this case was classified as infiltrating ductal carcinoma specimen. There are two other cases in our series that deserve special mention. One case was initially recommended for needle-localization breast biopsy because of an equivocal increase in lesion density, although the patient refused biopsy. The lesion was subsequently shown to be stable and the patient is now undergoing routine mammographic follow-up (stable at 24 months). One patient with atypical ductal hyperplasia has also undergone no surgical follow-up, but the hyperplasia remains mammographically stable at approximately 12 months after biopsy.
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Most stereotactic core biopsies are performed using dedicated prone equipment. The add-on stereotactic units have not received widespread acceptance because of the relatively high frequency of vasovagal reactions that occur when the patient is upright and the biopsy is being performed in view of the patient. The actual frequency with which vasovagal reactions occur is somewhat variable and not well documented in the literature. The lack of published data on this subject probably is a result of a general reluctance to publish adverse results. Although we still occasionally use the traditional upright position, it is our least desirable position (20 of 225 biopsies performed upright). With newer equipment and an experienced technologist, most (if not all) procedures performed with the patient upright can be converted to a decubitus position. Most of the 20 procedures performed with the patient upright were performed early in our series when the technologists were less experienced with decubitus positioning. We now rarely perform biopsies with the patient upright. Vasovagal reactions are eliminated with the patient lying in a lateral decubitus position.
The second major reported problem with the upright unit is patient motion. The patient tends to pull back and out of the compression device during the upright procedure (particularly during rotation of the tube head) and move within the compression device. This movement is essentially eliminated in the decubitus position. In our study a retrospective review of the stereotactic images was not performed and a qualitative assessment of motion (or lack of motion) was made at the time of the procedure only.
With patients in the decubitus position, patient comfort also seems to usually be satisfactory. In fact, two patients in our series have undergone biopsies in both the lateral decubitus and traditional prone positions and both patients preferred the decubitus position. Although specific reasons for this preference were not given, both patients stated they would rather lie on their sides. Our patients were routinely asked about their comfort level during the biopsy procedure. Twenty-nine percent of our patients reported mild discomfort of numbness in the dependent arm, although this side effect seems to have little or no significance in procedure outcome. Back and neck pain are relative disadvantages with the prone system that have not been addressed. In our experience these particular patient disorders or complaints appear to be less of an issue in the decubitus position, presumably because the patient does not have her neck turned toward the side. In the decubitus position, patients are not able to easily see the incision, bleeding, or needle entry site. They can see blood in the suction tubing from the Mammotome, but this has not been a source of complaint or problem. An additional difference between the prone and decubitus techniques is that the operator stands behind the patient (Fig. 1) instead of sitting below the patient.
Performing stereotactic core breast biopsies successfully requires maintaining technical proficiency; therefore, a certain minimum number of procedures must be performed. The precise number required is to some degree arbitrary and probably varies from one operator to another. The American College of Radiology has attempted to address this issue in its accreditation program. One could argue that performing two biopsies per week would suffice in maintaining technical proficiency, yet this same number of procedures would be inadequate in terms of appropriate equipment use (i.e., too few procedures to financially justify dedicated prone equipment).
Use of the regular mammography unit with an add-on device offers the advantages of lower cost (approximately half the cost of a dedicated unit) [6] and of less space requirement than a dedicated prone unit, and the unit can be used to perform routine mammography when biopsy procedures are not being performed. Equipment use is improved significantly by performing both screening mammography and stereotactic core breast biopsies on the same unit. For example, at one of our facilities gross monthly billing for biopsies alone averages about $8000 per month. The same mammography unit also generates about 300 screening examinations per month, resulting in an additional $21,000 in gross charges. These charges are for the technical component billing only. The cost of biopsy supplies, technician-related expenses, and reimbursement for biopsies would be about the same for prone or add-on systems.
Most of the biopsies in our experience are performed using a lateral approach because this is the easiest approach to positioning the patient and because most lesions are located in the mid or lateral aspect of the breast. With the older mammography equipment (GE 600-T), we performed a limited number of biopsies of medial breast lesions with a lateral arm, although we no longer use this method. For medial breast lesions we now use a direct medial approach (Fig. 2) using mediolateral compression with the needle traversing the breast parallel to the X-ray beam, or we use either a craniocaudal or caudocranial approach (Fig. 3).
The medial approach is also fairly easy to use, although the opposite breast may need to be held or taped out of the operative area, especially in patients with large pendulous breasts. One group of researchers [4] recently described the importance of using the shortest skin-to-lesion distance. The necessity and absolute benefit of using the shortest skin-to-lesion distance have not been, to our knowledge, thoroughly investigated with stereotactic core breast biopsy procedures. The need to use the shortest skin-to-lesion distance seems to be less of an issue with the stereotactic core breast biopsy procedure than with traditional needle-localization biopsy because the former technique is less invasive, disrupts less breast tissue, and is much less traumatic. Additionally, needle-tract seeding does not appear to be a significant issue thus far, although little has been written regarding this matter [7]. The necessity of excising the needle track seems to be controversial. Positioning flexibility provided by the newer mammography units appears to facilitate use of the shortest skin-to-lesion distance if necessary.
Although we have not compared the weight of tissue samples obtained using the Mammotome in the vertical orientation with those from the horizontal position, our limited and anecdotal experience would also suggest that the vacuum-assisted device (Mammotome) seems to function equally well when mounted on the add-on unit in the vertical or horizontal orientation.
Cost savings vary considerably depending on the environment in which the stereotactic core breast biopsies are performed. Many dedicated prone systems are underused, standing idle when no biopsies are being performed. Our data obtained appear to be similar to data obtained in other stereotactic breast biopsy study protocols [2, 7]. Sampling errors, particularly with the 14-gauge automated core-cutting needles, are significant. As anticipated, the use of the Mammotome has, in our limited experience, resulted in a significantly reduced rate of underestimation of atypical ductal hyperplasia and ductal carcinoma in situ.
The cancer detection rate for patients undergoing stereotactic core breast biopsy in our study (positive predictive value of abnormal mammograms yielding abnormal histology is 20%) is somewhat low. However, in our facilities, many of the highly suspicious lesions are referred for surgical excision, sonographically guided core biopsy, or needle-localization biopsy without stereotactic breast biopsy being performed. There is a tendency for surgical referral for stereotactic breast biopsy when the prebiopsy suspicion is low. Not surprisingly, the positive yield has significantly increased in the excisional biopsy and needle-localization breast biopsy procedure rate.
Of the 180 benign lesions, 134 (74%) have been examined with at least one follow-up mammography. None of these lesions have been subsequently proven to contain malignancy and, thus far, all 134 lesions appear to be stable or, in some cases, smaller. The negative predictive value and the sensitivity of the procedure, thus far, are 100%. The specificity is 94% and the positive predictive value is 80%. The positive predictive value is reduced by the cases of atypical ductal hyperplasia that subsequently were proven benign. The Mammotome also appears to improve positive predictive value by reducing sampling errors.
Another group of researchers [4] questioned the need for a dedicated mammography chair. The procedure can be performed using a standard gurney or cart; however, the mammography chair is relatively lightweight and versatile. The reclining mammography chair is useful in needle-localization breast biopsies and occasionally is helpful in performing mammography on debilitated patients. The cost of the chair is $3500-$5000. The mammography chair and add-on biopsy equipment are easily stored in a corner when not in use.
Our results indicate that stereotactic core breast biopsies can be performed effectively using add-on stereotactic equipment when coupled with a dedicated reclinable mammography chair and decubitus positioning of the patient. The newer mammography units, which are equipped with the vacuum-assisted needle biopsy device, are particularly effective and the results achieved in this series are similar to the results achieved by others using prone positioning. Use of this technique alleviates purchase of dedicated prone equipment and reduces the number of patients who require open breast biopsy.
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