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The Usefulness of US-guided Vacuum-Assisted Breast Biopsy for Probably Benign Lesions

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INTRODUCTION

With the advent of screening mammography or ul- trasonography, the incidence of breast mass is in- creased. Seltzer(1) has reported that women who pres- ent with a mass might be offered open biopsy in up to 42% of surgical practices, although many of these women have benign results. Recently, an increased awareness of breast cancer screening has not only increased the early detection of breast cancer, but has also increased breast biopsy for nonpalpable lesions, with approximately 70∼80% of them being confirmed as benign(2). Short-term follow-up is commonly rec- ommended for the management of probably benign lesions(3), but many women prefer to undergo biopsy for a tissue-based diagnosis to allay their anxiety. A- mong the image-guided breast biopsy techniques, core

Correspondence to: Shin-Ho Kook, Department of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine 108, Pyeong-dong, Jongno-gu, Seoul 110-746, Korea. (Tel) 02- 2001-1031, 2420, (Fax) 02-2001-2354, (E-mail) shinho.kook@

samsung.com, [email protected]

Received August 11, 2004, Accepted December 9, 2004

The Usefulness of US-guided Vacuum-Assisted Breast Biopsy for Probably Benign Lesions

1Department of Surgery, 2Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

Eun-Kyu Lee, M.D.1, Shin-Ho Kook, M.D.2, Hyon-Joo Kwag, M.D.2, Eun-Chol Chung, M.D.2, Hae-Won Park, M.D.2, Yong-Lai Park, M.D.1 and Won-Kil Pae, M.D.1,

유방 양성종양에서 초음파 유도하 진공보 조 유방생검술의 유용성

이은규1․국신호2․곽현주2․정은철2 박해원2․박용래1․배원길1

Purpose: We wished to determine the usefulness of ultra- sound-guided vacuum-assisted biopsy (mammotome) for the removal of the breast lesions that had displayed benign evidence on sonography.

Methods: During an 11 month period, vacuum-assisted breast biopsy was performed for 186 probably benign lesions on sonography using 11-gauge (127 cases) and 8-gauge (59 cases) devices. The age of the patients ranged from 19 to 65 years, and the size of the lesions ranged from 0.4 to 3 cm. We retrospectively analyzed the clinical findings and medical history of the patients who underwent vacuum- assisted breast biopsy, and we then evaluated the compli- cations, the histopathologic results, and the follow-up US findings.

Results: Of the 186 cases, the lesions were palpated in 95 cases (51%), and lesions were detected in women during a screening examination in 40 cases (36%), and lesions were detected in women having a history of benign breast biopsy or having a cancer operation in the remaining 18 cases (10%). Severe bleeding during or after the procedures was noted in 4 cases (2.2%). The lesions were patho- logically proved as benign in 185 cases and malignant in 1 case. With vacuum-assisted breast biopsy, high-risk benign disease was found in 7 cases, but none of the lesions was pathologically upgraded on the subsequent open surgical biopsy. On the 3-month follow-up US, variable sized hematomas were observed in 6 of 24 cases (25%). We

performed incidental treatment on four of the vacuum- assisted breast biopsy patients for nipple discharge that was caused by intraductal papilloma.

Conclusion: US-guided vacuum-assisted breast biopsy is a minimally invasive, fast and convenient biopsy technique. In addition, it is safe and accurate to use for the histological diagnosis because it would remove all the sonographically demonstrated evidence of a probable benign lesion. This technique can potentially be a useful alternative to some forms of surgical biopsy for the properly selected patients.

(J Korean Surg Soc 2005;68:90-95)

Key Words: Breast benign lesion, Ultrasound, Vacuum-as- sisted breast biopsy, mammotome

중심 단어: 유방 양성종양, 초음파, 진공보조 유방생 검술, 맘모톰

ꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏ

성균관대학교 의과대학 강북삼성병원 외과1, 방사선과2

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replace surgical biopsy for benign lesions, although at false negative diagnosis and histopathologic under- estimation of the malignancy were considered as the obvious shortcomings(4-7).

Ultrasound (US)-guided hand-held vacuum-assisted breast biopsy has recently been introduced as a mini- mally invasive, fast and convenient biopsy technique.

The vacuum-assisted breast biopsy has shown an im- proved diagnostic accuracy over a larger volume of tissue samples than core biopsy; it does not deform the breast, and causes only minimal to no scarring (8-10). Moreover, removal of all imaging evidence of lesions with vacuum-assisted breast biopsy has sever- al reported advantages. It can decrease the false neg- ative diagnoses and the histologic underestimation.

And it can also reduce the imaging-histologic discor- dance and rebiopsy rate by eliminating sampling error and improving lesion characterization(11-14).

The purpose of this study is to determine the use- fulness of US-guided vacuum-assisted breast biopsy for the removal of all sonographic evidence of prob- ably benign lesions (BI-RADS category 3).

MATERIALS AND METHODS

We performed 186 cases of US-guided vacuum- assisted breast biopsy on 185 patients from April 2002 to February 2003 in the Kangbuk Samsung Hospital in Korea. One patient underwent vacuum-assisted breast biopsy two times for different lesions in both breasts with a 1-week interval.

We retrospectively analyzed the clinical findings and histories of the mammotome biopsy patients, and we evaluated the post-biopsy complications by re- viewing the chart or by direct contact on the phone.

And we also reviewed the pathologic results, and follow- up US findings.

The patients' age range was from 19 to 65 years old (mean; 42 years). The size of the lesions ranged from 0.4 to 3 cm (0.4∼1 cm in 70 cases, 1∼2 cm in 97 cases, and 2∼3 cm in 19 cases).

All the patients who visited our breast clinic were referred from the breast surgeons to the radiologist.

Indication criteria for vacuum-assisted breast biopsy are as follows; among the patients who were assessed as having “probably benign lesions” (BI-RADS cat- egory 3) on sonographically(15), those who wanted to remove their breast lesions instead of interval follow- up or surgical biopsy, except whose lesions were located on subareolar region or larger than 3 cm and except who had hemostatic disorders.

We used an US-guided hand-held mammotome unit (Biopsys/Ethicon Endo-surgery inc., Johnson & Johnson Co., Cincinnati, OH, USA) and high- resolution near- field US units with 13-MHz transducers (HDI 5,000, ATL, Bothell, WA, USA).

In preparation for the procedure, the patient was positioned as comfortably as possible. After preparing and dressing the operating area, 6∼9 cc of 2% lido- caine was infiltrated around the lesion, especially be- neath the lesion area to float the lesion away from the chest wall, thereby allowing the easy separation of tissues during the insertion of the device. Vacuum-

Fig. 1. Complete removal of the lesion using 11-gauge Mammotome device. (A) Ultrasonography of a 29-year-old woman with a palpable mass shows a 1.2 cm-sized, well-defined oval-shaped, hypoechoic lesion in the 12 o'clock direction of the left breast (arrows), assessed as a probably benign lesion, (B) From the bottom of the lesion, the lesion was completely removed and was confirmed as fibroadenoma. (C) Arrows reveal that the sonographic evidence of lesion has vanished at the biopsy site after removal of the device.

B C

A

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devices for the 59 lesions that were larger than 1.5 cm in size, and with 11-gauge for the remaining 127 le- sions. The lesions in the subareolar area were ex- cluded to prevent the nipple retraction. Five to 47 samples were obtained according to the lesion size. In cases of prepectoral or superficial lesions, more care was taken not to cut the skin or muscle. For the superficial lesions, we used a side-to-side or upside- down cutting motion to remove the mass.

Tissue sampling was continued till the sonographic evidence of the lesion was removed (Fig. 1). We did not use marking clips. Manual compression on the biopsy site was done for 10 minutes. An elastic ban- dage over gauze packing was applied on the small bandage, and then applied sandbag under the lesion area in a prone position for an additional 10 minutes.

Complications, including significant bleeding, skin defect, hematoma from the biopsy and infection (in case of redness with a heating sense at the biopsy site) were recorded.

The patients with a pathologic diagnosis of high- risk lesions, such as atypical ductal hyperplasia, or phyllodes tumor, underwent open surgery and the pathologic results were compared. Follow-up US after mammotome biopsy was done in 52 cases (11-gauge in 33 cases, 8-gauge in 19 cases) to check for hema- toma and residual lesion during the study period with a 1-week to 6-month interval. During our early ex- perience with vacuum-assisted breast biopsy, three cases (11-gauge in 1 case, 8-gauge in 2 cases) were followed after 1-week. After this, follow-up studies were done with a 3-month (24 cases; 11-gauge in 14 cases, 8-gauge in 10 cases) and 6-month interval (25 cases; 11-gauge in 18 cases, 8-gauge in 7 cases).

RESULTS

Among 186 lesions, 95 (51.1%) were palpable. A- mong 95 palpable lesions, 19 were growing, and 18 were accompanied with pain. About one-third of the cases (67/186, 36%) were detected in women during a screening examination, and 9 of these cases were newly developed lesions during hormone replacement therapy. About 10 percent of lesions (18/186) were detected in women with a history of benign breast biopsy or surgery for breast cancer. There were four

cases (2.2%) of sonographically visualized intraductal lesions with nipple discharge. Multiple lesions were shown in about 20% (38/186)(Table 1).

For the vacuum-assisted breast biopsy, we per- formed the procedure without difficulty in all site except for the subareolar area, including three cases with deep retroareolar locations.

All cases except one were confirmed as benign. The only case of malignancy was a medullary carcinoma.

Among 185 benign lesions, fibroadenoma (86 cases) and fibrocystic change (55 cases) were the most com- mon pathology. There were seven cases of high- risk lesions (5 cases of atypical ductal hyperplasia and 2 cases of phyllodes tumor). The rest of the lesions were as follows; 8 adenosis, 6 intraductal papilloma, 5 stromal fibrosis, 4 sclerosing adenosis, 4 pseudoangio- matous hyperplasia, 2 hamartoma, 2 tubular adeno- ma, 1 lactating adenoma, and 5 other benign lesions.

No repeated biopsies were required because of insuf- ficient or inadequate tissue sampling, or inconclusive pathologic results. Seven patients with high-risk le- sions had undergone definitive surgery, and the path- ologic results of the surgery showed complete histol- ogic agreement with the original mammotome biopsy results.

Among 186 cases, we successfully removed 184 lesions on the US image, but we failed in two cases due to severe bleeding during the procedure.

The complications of mammotome biopsy are sum- marized in Table 2. Severe bleeding during the pro-

Table 1. Clinical findings of the lesions with mammotome biopsy ꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚ

Clinical findings No. of Cases (n=186) % ꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏ

Palpable mass 95 51.1

growing 19

pain 18

Screening detected mass 67 36

HRT* 9

pain 4

History of Bx or Op. 18 9.7

Nipple discharge 4 2.2

Atypia on fine needle aspiration 3 1.6 Multiple lesions on sonography 38 20.4 ꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏ

* = hormone replacement therapy; = history of benign breast biopsy or cancer operation.

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cedure was recorded in two cases (1.1%) with using 8-gauge devices, one tumor was 2.2 cm and the other was 3.0 cm in size, and both were confirmed as fibroadenomas. Rebleeding after 10 minutes of man- ual compression occurred in 2 cases (1.1%), but both of these patients were also under medication for se- vere hypertension. No further intervention was need- ed beyond applying manual pressure to the biopsy site. Ecchymosis that lasted more than 1 week oc- curred in 41 cases (22%), and most of these (93%) had an 8-gauge device used for the biopsy procedure. He- matoma drainage through the mammotome puncture site was performed in one case (0.5%) by the surgeon at the outpatient clinic 1 week after the initial pro- cedure. No residual hematoma was found in this case at the 6-month follow-up sonography. In two cases (1.1%), the patients complained of the reappearance of palpable masses that were similar to the previously removed lumps at 1 month after the biopsy. Those lesions had decreased in size and then softened up by the next 3-month follow-up. Analgesics or antibiotics were usually not necessary. Only 2.7% of patients took the analgesics one time on the first day after the procedure. There were no cases of skin defects or infection.

Follow-up US after mammotome biopsy was done one time in 52 cases (11-gauge in 33 cases, 8-gauge in 19 cases) during the study period. Variable sized (0.2∼0.8 cm) hematomas were observed on the 3- month follow-up images with the 8-gauge device in 50% (5 of 10 cases) and with the 11-gauge device in 7% (1 of 14 cases). None of the cases revealed hema- toma at the biopsy site on the US imaging that fol-

lowed after 6 months. Residual tumor was detected in one case (2%) among the 49 cases of 3- or 6-month follow-up, and it was the 2nd vacuum-assisted breast biopsy case of this study.

We performed vacuum-assisted breast biopsy on four cases of intraductal papilloma with nipple dis- charge. These patients were followed-up for 3-month (2 cases) and 6-month (2 cases) periods after biopsy, and no patient reported a recurrence of nipple dis- charge.

DISCUSSION

Generally, US-guided core biopsy of the breast has been accepted as an efficacious and cost-effective al- ternative procedure to open surgical biopsy. How- ever, the rate of false-negative diagnoses in core biop- sies has been reported to be from 2.9 up to 10.9%.(4,5) The vacuum-assisted breast biospy is a recently introduced instrument that offers a minimally inva- sive alternative to surgical biopsy for the diagnosis of breast disease. US-guided vacuum-assisted breast bi- opsy has advantages that the tissue specimens ob- tained are superior in volume and quality to those obtained with core devices(7,16-18). The improved quality of biopsy specimens decreases the rate of histologic underestimation and allows greater histo- pathologic concordance with subsequent excisional bi- opsy specimens(5-7,8,19).

The incidence of complications of stereotactic mam- motome biopsy has been reported to be as low (2∼

8%) as automated core biopsy(16,17). Simon et al(17) have reported at high incidence (17%) of immediate post-biopsy bleeding, despite the use of lidocaine that contained epinephrine. In our study, although we did not use epinephrine, our incidence of post-biopsy bleeding was only 2.2% (severe bleeding during bi- opsy in 2 cases and post-biopsy bleeding in 2 cases).

We used the 8-gauge devices for lesions larger than 1.5 cm, and we noted that bleeding was definitely more frequent with 8-gauge devices than for 11-gauge ones. We thought that both the removed tissue vol- ume and the tumor angiogenesis might have affected the bleeding.

Generally, the most common reasons for rebiopsy after sonographically guided 14-gauge automated core biopsy were the presence of high-risk lesion, discor- Table 2. Complications of mammotome biopsy

ꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚ Complications No. of cases (n= 186) % ꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏ

Severe bleeding during the procedure 2 1.1

Delayed bleeding* 2 1.1

Hematoma drainage 1 0.5

Ecchymosis 41 22.0

Lump in biopsy site 2 1.1

Medication for pain 5 2.7

Infection or skin defect 0 0

ꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏ

* = rebleeding after 10 minutes manual compression; = lasting more than 1 week.

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ꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏꠏ dance between imaging and histologic findings, and

an inadequate tissue sample. The most common rea- son we did rebiopsy was a diagnosis of atypical duc- tal hyperplasia, and this accounted for 16∼56% of rebiopsy procedures. A phyllodes tumor on core biop- sy might also be accepted as a reason for rebiopsy(20, 21). Philpotts et al.(20) have reported a significantly lower rebiopsy rate after stereotactic 11-gauge direc- tional vacuum-assisted biopsy (9%) than after 14- gauge automated core biopsy (15%). Parker et al(16) studied the safe removal of all sonographic evidence of masses less than 1.5 cm in size using the vacuum- assisted breast biospy device, and they reported that there were no cases of underestimation of the disease;

there were, no “upgrade” or “downgrade” discrepan- cies. In our study, no repeated biopsies were required because of either insufficient tissue or inconclusive results. Rebiopsy was only performed in seven cases in our study for lesions of atypical ductal hyperplasia and phyllodes tumors, but there was no upgrade on the pathologic results compared with the vacuum- as- sisted breast biopsy.

Dennis et al(22) reported on the incidental treat- ment of nipple discharge caused by benign intraductal papilloma using diagnostic vacuum-assisted breast biopsy. We also had the same results in four cases.

There are variable opinions about the excisional mammotome biopsy of probably benign lesions. Kim et al(23) suggested that removal of breast mass with mammotome should be limited for benign breast le- sions. If the lesion is most likely benign, percutane- ous biopsy devices could be an useful alternative to open surgical biopsy in the management of breast le- sions, especially for those lesions detected upon screening examinations. Complete removal of the tar- get lesion may not only improve the diagnostic under- estimation, but it also gives more confidence to obvi- ate a rebiopsy in the face of discordant imaging and histologic results when compared with any resultant benign diagnosis. Moreover, it may diminish the like- lihood of subsequent growth on follow-up, which occurs in 7∼9% of lesions yielding a benign result (24,25). In our study, the incidence of residual mass on follow-up imaging was very low, about 2%.

Parker et al(16) reported that women with probably benign masses prefer and should be allowed to un- dergo immediate biopsy, in consideration of not only

their physical state, but also their mental status. We certainly share that opinion. Before performing the excisional vacuum-assisted breast biopsy, we consid- ered the risks for cancer, the feasibility of follow-up, the degree of anxiety, and the patient's economic status. When the patient has a family history of breast cancer, a history of previous benign biopsy or surgery for breast cancer, or if the patient reports hormonal replacement therapy, or actively attends the screening program, their anxiety level is very high and they often prefer an immediate biopsy rather than under- going a 6-month imaging follow-up. The media and Internet both have great power to introduce new medical techniques to the public, and this increases the desire for patients to have that new modality they have seen used on their breast lesions. Thus, the de- sirable indications for vacuum-assisted breast biopsy should be discussed and a multi-institutional consen- sus should be reached a guidance for the proper use of this benign biopsy procedure.

In conclusion, US-guided vacuum-assisted breast bi- opsy is a safe and accurate technique for histologic diagnosis through the removal of all the sonographic evidence of probably benign lesions. Care must be taken so as not to increase the rate of useless benign biopsy with this technique. Vacuum-assisted breast biopsy would be an useful alternative to the surgical biopsy for properly selected patients to achieve an accurate tissue diagnosis with good cosmetic results, as well as alleviating patient anxiety resulting from short-term follow-up for benign pathology.

REFERENCES

1) Seltzer MH. The significance of breast complaints as corre- lated with age and breast cancer. Am J Surg 1992;58:413-7.

2) Homer MJ, Smith TJ, Safaii H. Prebiopsy needle localization;

methods, problems, and expected results. Radiol Clin North Am 1992;30:139-53.

3) Brenner RJ, Sickles EA. Surveillance mammography and ste- reotactic core breast biopsy for probably benign lesions: a cost comparison analysis. Acad Radiol 1997;4:419-25.

4) Elvecrog EL, Lechner MC, Nelson MT. Non-palpable breast lesions: correlation of stereotactic large-core needle biopsy and surgical biopsy results. Radiology 1993;188:453-5.

5) Parker SH, Burbank F, Jackman RJ, Aucreman CJ, Cardenosa G, Cink TM, et al. Percutaneous large-core breast biopsy: a multi-institutional study. Radiology 1994;193:359-64.

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수치

Fig.  1.  Complete  removal  of  the  lesion  using  11-gauge  Mammotome  device.  (A)  Ultrasonography  of  a  29-year-old  woman  with  a  palpable  mass  shows  a  1.2  cm-sized,  well-defined  oval-shaped,  hypoechoic  lesion  in  the  12  o'clock  dir
Table  1.  Clinical  findings  of  the  lesions  with  mammotome  biopsy ꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚꠚ

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