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MRI-Guided 9-Gauge Vacuum-Assisted Breast Biopsy: Initial Clinical Experience

Department of Radiology, Memorial Sloan-Kettering Cancer Center, 1275 York Ave., New York, NY 10021.

Received August 12, 2004; accepted after revision October 4, 2004.

 
Address correspondence to L. Liberman (libermal{at}mskcc.org).

Presented at the 2004 annual meeting of the American Roentgen Ray Society, Miami, FL.

Abstract

Top Abstract Introduction Materials and Methods Results Discussion References

 
OBJECTIVE. The objective of this study was to evaluate our initial clinical experience with MRI-guided vacuum-assisted breast biopsy as an alternative to surgical excision.

MATERIALS AND METHODS. A retrospective review revealed 112 consecutive nonpalpable, mammographically occult MRI-detected breast lesions scheduled for MRI-guided vacuum-assisted biopsy. Biopsy was performed with a 9-gauge vacuum-assisted biopsy probe (Suros Surgical Systems) followed by clip placement (Artemis Medical). Medical records and histologic findings were reviewed.

RESULTS. Among 112 lesions, biopsy was cancelled because of nonvisualization of the lesion in 14 (12%). Of the remaining 98 lesions, tissue was successfully acquired in 95 (97%). The median number of specimens obtained was 12 (range, 6-20). The median time to perform MRI-guided biopsy was 33 min for one lesion and 56 min for two lesions. Histology in 95 lesions was benign and concordant in 52 (55%), cancer in 24 (25%), high-risk in 10 (11%), and discordant in nine (9%). MRI-guided biopsy histologies in 24 cancers were ductal carcinoma in situ in 13 (54%) and infiltrating carcinoma in 11 (46%). Seven additional cancers were found at surgery in four discordant lesions and in three high-risk lesions. The clip successfully deployed in 86 (95%) of 91 lesions. Six complications (three hematomas, two instances in which the biopsy probe pierced the skin on the far side of the breast, and one vasovagal reaction) resolved without sequelae.

CONCLUSION. MRI-guided vacuum-assisted biopsy is a fast and safe alternative to surgical biopsy for MRI-detected breast lesions. Imaging-histologic correlation is necessary to ensure lesion sampling.

Introduction

Top Abstract Introduction Materials and Methods Results Discussion References

 
Breast MRI can identify cancers that cannot be found by mammography or physical examination. In women at high risk for developing breast cancer, MRI identifies an otherwise unsuspected cancer in 4% (range, 2-8%) [1, 2]. In women with cancer in one breast, MRI identifies additional sites of cancer in the contralateral breast in 6% (range, 3-9%) [3] and in the ipsilateral breast in 16% (range, 6-34%) [4]. Although MRI is highly sensitive to breast-cancer detection, it has lower specificity [5]. For women to benefit from breast MRI, methods for biopsy of MRI-detected lesions are essential.

MRI-guided breast biopsy can be performed with MRI-guided needle localization for surgical excision [6, 7] or with MRI-guided percutaneous biopsy using fine needles [8], automated core needles [9, 10], or vacuum-assisted biopsy probes [11-17]. Needle biopsy methods have advantages over surgical biopsy: They are fast, safe, nondeforming, and less expensive. Compared with other needle biopsy techniques, vacuum-assisted biopsy removes a larger volume of tissue, provides better characterization of high-risk lesions such as atypical ductal hyperplasia (ADH) and ductal carcinoma in situ (DCIS), and facilitates placement of a localizing clip [18].

A 9-gauge probe is commercially available in the United States for performing MRI-guided vacuum-assisted biopsy. This technique has been validated in a study of women who had MRI-guided vacuum-assisted biopsy and immediate surgical excision [14] and has been described in small clinical series [16, 17] (Table 1). We report our initial clinical experience with 106 women scheduled for MRI-guided 9-gauge vacuum-assisted biopsy as an alternative to surgical excision for MRI-detected lesions interpreted as suspicious or highly suggestive of malignancy.

Materials and Methods

Top Abstract Introduction Materials and Methods Results Discussion References

 
MRI Indications and Evaluation
During this period at our institution, breast MRI was primarily used for the following indications: high-risk screening (e.g., in women with genetic predisposition, strong family history of breast cancer, prior breast cancer, biopsy-proven diagnosis of atypical hyperplasia or lobular carcinoma in situ, or prior mantle irradiation for Hodgkin's disease), extent of disease assessment in the ipsilateral or contralateral breast in a woman with proven breast cancer, follow-up after previous breast MRI, or problem solving.

View larger version (118K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 1A —46-year-old woman with prior left mastectomy who had suspicious right breast mass on MRI examination performed for high-risk screening. MRI-guided biopsy device is inserted into breast to acquire tissue specimens.

View larger version (90K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 1B —46-year-old woman with prior left mastectomy who had suspicious right breast mass on MRI examination performed for high-risk screening. Small skin nick is present after MRI-guided vacuum-assisted biopsy (arrow), which is managed with sterile strips and a sterile gauze bandage.

Biopsy Radiologists
Biopsies were performed with a 9-gauge MRI-compatible vacuum-assisted biopsy device (Automated Tissue Excision and Collection, Suros Surgical Systems) [14] (Figs. 1A, and 1B). Biopsies were performed by one of nine radiologists specializing in breast imaging. All nine radiologists had prior experience in breast MRI and percutaneous breast biopsy under stereotactic and sonographic guidance. Three of the radiologists had performed a median of five (range, 1-22) MRI-guided vacuum-assisted biopsies before this study; six had not previously performed the procedure but had observed or assisted one or more of the experienced radiologists.

Pretreatment, Positioning, and Biopsy
At our institution, after informed consent is obtained for the biopsy the morning of the procedure, the patient is offered oral lorazepam (Ativan, Wyeth-Ayerst Laboratories) 1.0 mg orally. The patient is positioned prone in the 1.5 T magnet (Signa, GE Healthcare). A dedicated breast surface coil and breast biopsy device are used, either the Biopsy Breast Array Coil (model BBC, MRI Devices) or the Open Breast Coil (model OBC-63, MRI Devices) with a grid-localizing system (Biopsy Positioning Device, model MRBI-160, MRI Devices). A vitamin E marker is taped on the skin of the breast over the expected lesion site, and its position is marked on a transparency diagram.

The MRI biopsy technique has been previously described [14, 15] (Figs. 2A, 2B, 2C, 2D, 2E, and 2F). Attaching a syringe of anesthesia to the side port of the biopsy device enables approximately 1 mL of anesthesia to be automatically injected with each specimen that is obtained. After tissue acquisition is complete, the biopsy device is removed, the obturator reinserted, and postexamination MRI is performed to determine if the appropriate area underwent biopsy. A second injection of IV gadolinium may be given if desired to assist in visualization of the target lesion. The biopsy site is marked with a titanium clip in a resorbable collagen pledget (MammoMark Biopsy Site Marker, Artemis Medical). "Postclip" sagittal MRI may be performed to assess clip deployment. After biopsy, the breast is compressed with ice, sterile strips are applied, a two-view mammogram is obtained to assess clip deployment, and a sterile gauze bandage is applied. The patient is given postbiopsy instructions verbally and in writing and is told when she will be contacted with biopsy results.

View larger version (90K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 2A —59-year-old woman with recently diagnosed contralateral (left) breast invasive lobular cancer, who had suspicious right breast mass on MRI examination to assess for other sites of cancer in ipsilateral and contralateral breasts. Axial localizing image from MRI performed on day of biopsy. Vitamin E marker (arrow) has been placed on skin overlying lesion site, based on review of prior diagnostic MRI. Coil (Biopsy Breast Array Coil, MRI Devices) has breast support that displaces contralateral breast posteriorly, enabling access to medial or lateral skin surface with patient prone. Coil is also useful for patients with thin breasts; placing grids medially and laterally enables grid on far side to function as "reverse compression paddle," enabling biopsy device to displace tissue into opening of the grid on far side without piercing skin on far side.

View larger version (125K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 2B —59-year-old woman with recently diagnosed contralateral (left) breast invasive lobular cancer, who had suspicious right breast mass on MRI examination to assess for other sites of cancer in ipsilateral and contralateral breasts. Sagittal T1-weighted contrast-enhanced scout images show irregularly marginated, irregularly shaped, rim-enhancing mass measuring 0.7 cm in right breast 12 o'clock axis, corresponding to lesion identified on diagnostic MRI examination. This could not be seen with mammography or directed sonography.

View larger version (51K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 2C —59-year-old woman with recently diagnosed contralateral (left) breast invasive lobular cancer, who had suspicious right breast mass on MRI examination to assess for other sites of cancer in ipsilateral and contralateral breasts. Sagittal T1-weighted contrast-enhanced images show how radiologist determines skin-entry site and depth of insertion of needle. Image on left is same contrast-enhanced sagittal T1-weighted scout image showing the lesion in B, with cursor (x) placed over lesion. Image on far right shows vitamin E marker, with different cursor (o) placed over it. Image in center is skin surface, which is identified by indentations from grid lines, evident as low signal-intensity lines like a tic-tac-toe board. By correlating location of cursors over lesion and vitamin E marker on middle image, skin-entry site of needle (i.e., appropriate square and location within square of grid) is determined. Depth of needle insertion is equal to distance between skin (sagittal slice with low signal intensity lines) and lesion; this is determined by multiplying number of sagittal slices between skin and lesion by slice thickness (3 mm).

View larger version (149K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 2D —59-year-old woman with recently diagnosed contralateral (left) breast invasive lobular cancer, who had suspicious right breast mass on MRI examination to assess for other sites of cancer in ipsilateral and contralateral breasts. Sagittal T1-weighted contrast-enhanced image of low signal intensity obturator in region of high signal intensity lesion.

View larger version (145K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 2E —59-year-old woman with recently diagnosed contralateral (left) breast invasive lobular cancer, who had suspicious right breast mass on MRI examination to assess for other sites of cancer in ipsilateral and contralateral breasts. Sagittal T1-weighted contrast-enhanced image of biopsy cavity, evident as low signal air, after tissue acquisition. Enhancing lesion has undergone biopsy. Clip is obscured by air at biopsy site.

View larger version (85K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 2F —59-year-old woman with recently diagnosed contralateral (left) breast invasive lobular cancer, who had suspicious right breast mass on MRI examination to assess for other sites of cancer in ipsilateral and contralateral breasts. Mediolateral oblique mammogram view after biopsy confirms that clip (arrow) has deployed within breast.

Data Collection and Analysis
In a protocol approved by the institutional review board, data collected included indication for breast MRI, patient age, menopausal status, imaging findings including MRI lesion size and type, biopsy parameters, histologic results, and complications. MRI examinations before, during, and after biopsy and postbiopsy mammograms were reviewed. Each MRI lesion was described by one of nine radiologists before biopsy as mass, nonmass, or focus of enhancement and further categorized per the Breast Imaging Reporting and Data System Breast MRI lexicon [19]. The time of the biopsy in minutes was determined by calculating the interval between the beginning of the MRI localizing sequence and the end of the final MRI sequence obtained.

Data were entered in a computerized spreadsheet (Excel, Microsoft). Tests for statistical significance were performed with computerized statistical software (Epi Info, Centers for Disease Control) using the chi-square and Fisher's exact tests, with p < 0.05 considered significant. The 95% confidence intervals were calculated using the Geigy scientific tables [20].

Results

Top Abstract Introduction Materials and Methods Results Discussion References

 
Patients and Lesions
A retrospective review revealed 112 nonpalpable, mammographically occult, MRI-detected breast lesions scheduled for MRI-guided vacuum-assisted biopsy as an alternative to surgical biopsy in a 14-month period. These 112 lesions were detected in 106 women with a median age of 49 years (range, 19-78 years). Lesions referred for biopsy were solitary in 101 women, synchronous unilateral in two women, synchronous bilateral in two women, and metachronous (solitary one year and synchronous bilateral the following year) in one woman. Sonography, performed in 49 lesions, showed no sonographic correlate.

Fifty-eight (52%) of 112 lesions occurred in postmenopausal women and 54 (48%) of lesions occurred in premenopausal women. The MRI lesion type was a mass in 61 (54%) of 112 lesions, nonmass in 48 (43%), and focus in three (3%). The median MRI lesion size was 1.0 cm (range, 0.4-8.5 cm). Indication for MRI was high-risk screening in 52 (46%) of 112 lesions, extent of disease assessment in 26 (23%), problem solving in 24 (21%), and follow-up in 10 (9%).

Nonvisualized Lesions
In 14 (12%) of 112 lesions, MRI-guided biopsy was cancelled because no suspicious lesion was identified on the day of biopsy. Among these 14 nonvisualized lesions, eight (57%) occurred in premenopausal women and six (43%) in postmenopausal women; the indication for MRI was high-risk screening in eight (57%), extent of disease assessment in three (21%), follow-up in two (14%), and problem solving in one (7%). Nonvisualization occurred in one (33%) of three foci, in eight (13%) of 61 masses, and in five (10%) of 48 nonmass lesions. The median MRI size of nonvisualized lesions was 1.0 cm (range, 0.4-5.5 cm).

Among 14 lesions for which biopsy was canceled due to nonvisualization of the lesion, follow-up MRI examinations were performed in 13 (93%). The median interval between scheduled biopsy and follow-up MRI was 5 months (range, 1-12 months). Among the 13 nonvisualized lesions that had follow-up MRI, 7 (54%) were not evident on MRI follow-up, and 6 (46%) reappeared on MRI follow-up but were smaller than the original lesion scheduled for biopsy and were referred for repeat MRI examination in 6 months.

Technical Success
MRI-guided vacuum-assisted biopsy was attempted in the remaining 98 lesions. In three (3%) of the 98, MRI-guided vacuum-assisted biopsy was aborted due to technical reasons (thin breast and posterior lesion) in one, patient anxiety in one, and vasovagal reaction in one. MRI-guided vacuum-assisted biopsy resulted in acquisition of tissue (technical success) in the remaining 95 (97%; 95% confidence intervals, 91-99%) of 98 cases in which it was attempted. The clip was successfully deployed in 86 of 91 attempted lesions (95%; 95% confidence intervals, 88-98%). Reasons for nondeployment of the clip included superficial location (n = 2), technical failure (n = 2), and bleeding (n =1).

Biopsies Performed
In the 95 lesions that completed MRI-guided vacuum-assisted biopsy, the median number of specimens obtained was 12 (range, 6-20). The median time to perform MRI-guided vacuum-assisted biopsy was 33 min (range, 17-60 min) for one lesion and 56 min (range, 54-74 min) for two lesions. Histologic findings in these 95 lesions were benign and concordant in 52 (55%), cancer in 24 (25%), high-risk in 10 (11%), and discordant in nine (9%) (Table 2).

Benign Lesions
Dominant histologic findings in 52 lesions yielding benign, concordant results at MRI-guided vacuum-assisted biopsy were fibrocystic change (n = 18); fibrosis (n = 11); duct hyperplasia (n = 7); fibroadenoma or fibroadenomatoid change (n = 6); sclerosing adenosis (n = 3); biopsy site changes (n = 2); and single cases of benign breast tissue, benign lymph node, columnar alteration, duct ectasia, and pseudoangiomatous stromal hyperplasia.

Cancers
Vacuum-assisted biopsy findings in 24 cancers were DCIS in 13 (54%) and infiltrating carcinoma in 11 (46%). Histology of 11 invasive cancers was infiltrating ductal in nine, infiltrating lobular in one, and mixed infiltrating ductal and lobular in one. Among 13 DCIS lesions diagnosed at vacuum-assisted biopsy, there was one (8%) histologic underestimate (Fig. 3).

View larger version (139K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 3 —53-year-old asymptomatic woman with prior right mastectomy. Sagittal fat-suppressed T1-weighted MRI of left breast shows 6 cm area of nonmass, segmental, clumped enhancement (arrows) with wash-out kinetics. MRI-guided vacuum-assisted biopsy yielded ductal carcinoma in situ (DCIS). At mastectomy, surgical histopathology yielded DCIS, cribriform, and micropapillary type, with intermediate nuclear grade and moderate necrosis and 0.2 cm infiltrating ductal carcinoma. Sentinel lymph-node biopsy performed at time of mastectomy was negative. This case, in which biopsy sampled small part of a large lesion, was the only DCIS underestimate encountered in our series of MRI-guided 9-gauge vacuum-assisted biopsy.

High-Risk Lesions
Vacuum-assisted biopsy findings in 10 high-risk lesions were ADH (n = 4; two of the four yielded DCIS at surgery), lobular carcinoma in situ (LCIS) (n = 3; two of which were excised, yielding LCIS in both), papilloma (n = 1; in a woman with known Paget's disease who had DCIS located 0.7 cm anterior to the papilloma at surgery), atypical lobular hyperplasia (n = 1; yielding ADH, LCIS, and papilloma at surgery), and radial scar (n = 1; yielding radial scar at surgery).

Discordant Lesions
Among nine lesions yielding discordant results (Table 3), MRI examination immediately after biopsy suggested that the lesion was sampled in five and possibly missed in four. Subsequent surgical biopsy, performed in eight discordant lesions, showed cancer in four (50%), two of which were DCIS and two of which were invasive ductal cancers (Figs. 4A, 4B, 4C, and 4D). Among the four discordant lesions that yielded cancer, MRI scans immediately after completion of tissue acquisition suggested that the lesion had been sampled in two and possibly missed in two. In eight (89%) of nine discordant lesions and in all four discordant lesions that yielded cancer at surgery, the radiologist performing the biopsy had previously performed six or fewer MRI-guided vacuum-assisted biopsy procedures.

View larger version (132K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 4A —54-year-old woman with history of left breast cancer with normal mammogram and no palpable lumps, in whom MRI detected spiculated right breast mass with no sonographic correlate. Sagittal fat-suppressed T1-weighted contrast-enhanced scout image from MRI-guided biopsy shows 0.9 cm mass with spiculated borders, irregular shape, and heterogeneous enhancement in right retroareolar region (arrow).

View larger version (115K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 4B —54-year-old woman with history of left breast cancer with normal mammogram and no palpable lumps, in whom MRI detected spiculated right breast mass with no sonographic correlate. Sagittal fat-suppressed T1-weighted, contrast-enhanced image shows low-signal artifact from obturator in area of mass (arrow). Mass is less well seen due to washout of contrast and bright signal from mild hematoma. Appearance of this region did not change after biopsy.

View larger version (128K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 4C —54-year-old woman with history of left breast cancer with normal mammogram and no palpable lumps, in whom MRI detected spiculated right breast mass with no sonographic correlate. Sagittal fat-suppressed T1-weighted, contrast-enhanced image after tissue acquisition shows biopsy cavity evident as hyperintense hematoma (arrow) deep (medial) to area of lesion. Histologic analysis yielded nodular stromal fibrosis, which was considered discordant with imaging findings.

View larger version (141K): [in this window] [in a new window] [as a PowerPoint slide]   Fig. 4D —54-year-old woman with history of left breast cancer with normal mammogram and no palpable lumps, in whom MRI detected spiculated right breast mass with no sonographic correlate. Sagittal, T1-weighted, contrast-enhanced MRI on date of MRI-guided needle localization shows persistence of right retroareolar spiculated mass (arrow). MRI-guided needle localization yielded 0.5 cm infiltrating ductal carcinoma and ductal carcinoma in situ.

Final Diagnosis of Cancer
Among 95 lesions, the final diagnosis, based on review of available vacuum-assisted biopsy and surgical histology, was cancer in 31 (33%; 95% confidence intervals, 23-43%). In these 31 cancers, MRI-guided vacuum-assisted biopsy histology yielded cancer in 24, discordant results in four, ADH in two, and papilloma in one. Final histology of these 31 cancers was DCIS in 17 (55%) and infiltrating carcinoma in 14 (45%).

Complete Removal of the MRI Target
Among 95 MRI-detected lesions that had biopsy, images obtained immediately after biopsy suggested that the MRI target was completely excised in 28 (29%) (Table 4). The likelihood of complete removal of the MRI target was significantly higher in lesions smaller than 1 cm than in lesions 1 cm or larger (20 of 28 = 71% versus eight of 28 = 29%, p = 0.003). Among eight cancers diagnosed at MRI-guided vacuum-assisted biopsy in which the MRI target was considered to have been completely excised, residual cancer was found at surgery in five (63%).

Complications
Among the 98 lesions in which MRI-guided vacuum-assisted biopsy was attempted, complications were encountered in six (6%; 95% confidence intervals, 2-13%). These complications included three hematomas that required more than 20 min of compression, two instances in which the biopsy probe pierced the skin on the far side of the breast, and one case in which the procedure was aborted due to vasovagal reaction (n = 1). In the two cases in which the biopsy probe pierced the skin on the opposite side of the breast, the lesions were slightly medial in relatively thin breasts and were approached from the lateral skin surface. The skin nicks were cleansed and sterile strips applied, and they healed without sequelae.

Follow-up MRI After Benign Biopsy
Among 52 lesions yielding benign results concordant with imaging features, MRI follow-up was available in 41 (81%) at a median interval of 7 months (range, 1-14 months) after biopsy. No evidence of cancer was identified in 29 (94%) of 31 follow-up MRI examinations. In one woman who had follow-up MRI 6 months after biopsy, there was interval increase in regional clumped enhancement; MRI-guided needle localization yielded benign findings, including pseudoangiomatous stromal hyperplasia, similar to histologic findings at vacuum-assisted biopsy. In another woman who had follow-up MRI performed 11 months after biopsy, the nonmass lesion that had undergone MRI-guided biopsy yielding benign fibrosis had been excised, and a localizing clip was in place; 3 cm posterior to the biopsy site, a new enhancing mass was present. Mammography showed interval development of pleomorphic microcalcifications in the region of the new enhancing mass at MRI. MRI-guided needle localization yielded invasive ductal carcinoma measuring 1 cm and DCIS; sentinel nodes were free of tumor.

Sparing Diagnostic Surgical Biopsy
A diagnostic surgical biopsy was spared in 74 (78%) of 95 lesions in which tissue was acquired, due to benign and concordant histology in 50 (53%) and diagnosis of cancer in 24 (25%). A diagnostic surgical biopsy was not spared in 21 (22%) of 95 lesions, due to high-risk lesions in 10 (11%), discordance in nine (9%), and interval change on follow-up leading to biopsy in two (2%).

Discussion

Top Abstract Introduction Materials and Methods Results Discussion References

 
Pioneering work in MRI-guided vacuum-assisted biopsy was performed in Europe using an 11-gauge probe [11]. In a multiinstitutional study of 413 lesions [13], MRI-guided biopsy was canceled due to nonvisualization of the lesion in 52 (13%). Among 361 lesions that were identified on the day of the biopsy, tissue was acquired in 341 (94%). Histologic findings in 341 lesions were carcinoma in 84 (25%), ADH in 17 (5%), benign and concordant in 233 (68%), and insufficient or discordant in seven (2%). Complications, encountered in 16 of 341 (5%) lesions, were bleeding in 11 (3%), requiring surgical drainage in two and treatment for superinfection in one; and vasovagal reaction in five (1%). The time required to perform the biopsy was approximately 70 min for one lesion and 90 min for two lesions.

In a prior validation study of MRI-guided 9-gauge vacuum-assisted biopsy in the United States, 20 women with 27 lesions had 9-gauge MRI-guided vacuum-assisted biopsy, clip placement, and immediate surgical excision [14]. Vacuum-assisted biopsy was successfully accomplished in 19 (95%) of 20 women. Among 27 lesions that had biopsy, histology was benign at vacuum-assisted biopsy and at surgery in 19 (70%), cancer at vacuum-assisted biopsy in six (22%), ADH at vacuum-assisted biopsy and DCIS at surgery in one (4%), and benign at vacuum-assisted biopsy with surgery showing microscopic DCIS that was occult at MRI in one (4%). The localizing clip, attempted in 26 lesions, was successfully placed in 25 (96%). The median time to perform biopsy of a single lesion was 35 min. One complication occurred, which was a hematoma that resolved with compression.

We report our experience with MRI-guided vacuum-assisted biopsy as an alternative to surgical excision. Of 112 lesions referred for MRI-guided biopsy, biopsy was cancelled due to lesion nonvisualization in 12%. This 12% nonvisualization rate is comparable with the previously reported 13% nonvisualization rate at MRI-guided vacuum-assisted biopsy [13] and higher than the previously reported 4% nonvisualization rate at MRI-guided needle localization and surgical biopsy [7]. Most nonvisualized lesions in our study were detected at high-risk screening in premenopausal women. Scheduling screening MRI at midcycle (i.e., week 2 or 3) may minimize the likelihood of such hormonal "false-positives" [22]. In postmenopausal women with nonvisualized lesions, differences in positioning, contrast agent injection, or compression may play a role [23]. For nonvisualized lesions, we generally obtain a delayed MRI scan after contrast enhancement; if nonvisualization persists, contrast may be reinjected and MRI performed again. If the lesion still does not appear, biopsy is cancelled, and short-term follow-up MRI is recommended.

Published data emphasize the importance of short-term follow-up for these nonvisualized lesions. Hefler et al. [24] reported no enhancement in the lesions on the day of scheduled MRI-guided vacuum-assisted biopsy in 37 (13%) of 291 scheduled biopsies. Two were identified on nonenhanced images and had biopsy, yielding invasive ductal carcinoma in one and benign findings in one. Six lesions were lost to follow-up. Of the 29 lesions that had short-term follow-up MRI without compression 4-24 hr after the aborted biopsy, 25 lesions did not reappear and presumably represented hormonally induced enhancement. Four lesions reappeared; biopsy yielded invasive cancer in two (ductal in one and lobular in one) and benign findings in two. Hence, cancer was identified in two (7%) of 29 lesions that were not visible on the day of scheduled MRI-guided biopsy. The authors suggest prompt follow-up MRI without breast compression for nonvisualized lesions that had enhanced on the original breast MRI.

Among 98 lesions in which biopsy was attempted in our study, tissue was retrieved in 95 (97%). This 97% technical success rate is within the 96-100% range of technical success rates reported in prior studies of MRI-guided vacuum-assisted biopsy with this device [14-17] (Table 1) and comparable with the 98% technical success rate reported for stereotactic biopsy by Jackman and Marzoni [25]. The single case in our study aborted for technical reasons was the second lesion in this series and may reflect our learning curve. The 1% (1 of 98) frequency of vasovagal reactions in our study is comparable to the 1% (5 of 341) frequency of vasovagal reactions reported in the European multiinstitutional study [13]. Vasovagal reactions and patient anxiety may be minimized by sharing with the patient what she can expect from the biopsy procedure and by administration of anti-anxiolytic medication before the procedure.

MRI-guided vacuum-assisted biopsy can be performed quickly. The median time of 33 min required to perform biopsy of one lesion in this study is within the 30-38 min range reported in prior studies of MRI-guided vacuum-assisted biopsy with the same device, and approximately half as long as the 70 min reported in the European multiinstitutional study of 11-gauge biopsy [13]. The faster time for the 9-gauge as opposed to the 11-gauge device in part reflects the difference in design of the biopsy probe: the 9-gauge device enables rapid acquisition of multiple specimens, deferring specimen collection until after all specimens have been acquired. Tissue acquisition time during 9-gauge MRI-guided vacuum-assisted biopsy is usually less than 2 min [14]. Most of the time for MRI-guided biopsy is due to imaging, which generally includes a precontrast 3-plane MRI localizer and a minimum of four contrast-enhanced fat-suppressed sagittal T1-weighted MRI scans; the imaging time on the magnet is comparable to that required for diagnostic breast MRI.

MRI-guided vacuum-assisted biopsy yielded cancer in 24 (25%) of 95 lesions. This 25% positive predictive value (PPV) is within the 22-37% range of PPVs noted in prior studies of MRI-guided vacuum-assisted biopsy [14-16] (Table 1). Our 25% PPV is also within the 0-47% range of PPVs noted in prior reports of mammographically-guided needle localization and surgical biopsy [26], within the 21-63% range of PPVs reported for stereotactic 11-gauge vacuum-assisted biopsy [27, 28], and exceeds the 14-19% range of PPVs reported for sonographically-guided vacuum-assisted biopsy [29-31]. The 25% PPV of MRI-guided vacuum-assisted biopsy reflects the restriction of breast MRI to specific clinical scenarios, primarily to women with a high risk for breast cancer due to recent diagnosis of breast cancer, specific risk factors, or problematic mammograms.

A diagnostic surgical biopsy was spared in 78% of lesions, within the 76-85% range of sparing a surgical procedure due to percutaneous biopsy under stereotactic or sonographic guidance [18]. The most common reason for not sparing surgery was high-risk histology, present in 11% of lesions. The 11% prevalence of high-risk lesions at MRI-guided vacuum-assisted biopsy is not surprising. High-risk lesions have been reported in up to 29% of MRI-guided needle localization procedures [32]. Although the need for surgical excision of some high-risk lesions (such as ADH) is well established, the need to excise other high-risk lesions such as LCIS, papilloma, and radial scar remains controversial [33]. We found cancer at surgery in three of nine (33%) high-risk lesions diagnosed at MRI-guided vacuum-assisted biopsy, including two ADH lesions and one papilloma. Further data, particularly in high-risk women undergoing 9-gauge MRI-guided vacuum-assisted biopsy, are essential.

Imaging-histologic discordance was encountered in 9% of lesions; in half of the discordant lesions that had subsequent excision, surgery yielded cancer. In biopsies performed under stereotactic or sonographic guidance, discordance is encountered in 0-6% of lesions; among discordant lesions, surgery yields cancer in 0-64% [34]. In our study, most lesions yielding discordant results and all discordant lesions yielding cancer at surgery had biopsy by radiologists who had previously performed six or fewer MRI-guided vacuum-assisted biopsy procedures. These data suggest that the learning curve impacts outcome at MRI-guided vacuum-assisted biopsy, as has been shown for stereotactic biopsy [28]. Imaging-histologic correlation, essential in all methods of biopsy, is more challenging in MRI-guided biopsy due to the paucity of data addressing the PPV of MRI features. In our practice, imaging-histologic correlation is based on experience with MRI patterns of benign and malignant lesions in the literature and in our practice, and assessment of sampling of the MRI target lesion. Careful review of MRI obtained immediately after biopsy (with reinjection of contrast agent, if necessary) is performed to determine if the target lesion has been appropriately sampled. Postbiopsy MRI on a subsequent date may also provide important information, particularly in instances of possible discordance.

Complete removal of the MRI target occurred in 29% of lesions in our study and was significantly more likely in lesions smaller than 1 cm. In a prior study, Heywang-Kobrunner et al. [11] report complete removal of the MRI target at vacuum-assisted biopsy in 57% of lesions; all MRI targets removed were smaller than 1 cm. Among eight cancers in our study in which the MRI target was completely removed, 63% had residual cancer at surgery; in the series from Heywang-Kobrunner et al., of six cancers in which the MRI target was removed, surgery revealed residual cancer in two (33%). Complete removal of the imaging target has been reported in up to 58% of stereotactic 11-gauge vacuum-assisted biopsies [35] and in 88-89% of sonographically-guided 11-gauge vacuum-assisted biopsies [29, 30]; among cancers in which the imaging target is removed at sonographic or stereotactic biopsy, surgery reveals residual cancer in 50-79% [29, 35]. We found that complete removal of the MRI target, like complete removal of the mammographic or sonographic target, does not ensure complete excision of the pathologic process.

A limitation of our study is incomplete follow-up. Among 52 lesions yielding results considered benign and concordant, follow-up MRI examinations were performed in 81%. Mammographic and clinical follow-up are inadequate proof of lesion sampling for lesions identified by MRI only. A review of MRI scans performed immediately after tissue acquisition is helpful, but their accuracy in confirming lesion sampling has not yet been established. In light of the high-risk status of the patients, limited data regarding imaging-histologic correlation of MRI-detected lesions, and the lack of existing technology to confirm MRI lesion sampling by specimen imaging, follow-up MRI may be prudent after MRI-guided vacuum-assisted biopsy. The optimal timing of the follow-up MRI after MRI-guided vacuum-assisted biopsy has not been determined. Furthermore, compliance with recommended mammographic imaging follow-up after stereotactic biopsy is suboptimal [36]; adherence to recommendations for follow-up MRI after MRI-guided biopsy may be worse, because MRI is expensive, not universally available, and variably reimbursed by insurance.

In summary, we found that MRI-guided vacuum-assisted biopsy was a fast and safe alternative to surgical excision for diagnosis of MRI-detected lesions. In our study, the technical success rate was 97%; vacuum-assisted biopsy histology yielded cancer in 25% and spared the need for diagnostic surgical biopsy in 78%. Imaging-histologic correlation and evaluation of MRI immediately after biopsy are essential to evaluate whether the target lesion has been appropriately sampled. Further research is necessary, including studies of imaging-histologic correlation of MRI-detected lesions and follow-up after MRI-guided biopsy, to minimize benign biopsies and maximize the benefits of MRI in detecting early breast cancer.

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