Ultrasound-guided, vacuum-assisted excision in the diagnosis and treatment of clinically benign breast lesions

INTRODUCTION

Ultrasound-guided, vacuum-assisted biopsy has a definitive role in the diagnosis of breast lesions. Its role in the treatment of benign breast lesions like fibroadenomas has not been established.

PATIENTS AND METHODS

This is a retrospective review of patients undergoing ultrasound-guided, vacuum-assisted biopsy for clinically benign breast lesions. The procedures were performed in all cases by two consultant radiologists with special interest in breast radiology between February 2002 and January 2004. Patients were followed up in the clinic 6 weeks after the procedure.

RESULTS

Seventy-six patients had ultrasound-guided, vacuum-assisted excision of clinically benign breast lesions during this 2-year period. Mean age of the patients was 31 years. Altogether, 86 procedures were performed. Six patients with larger lesions (> 2 cm) had two procedures on separate sitting and 4 patients had separate lesions excised on a later date. Fifty-six patients were identified to have fibroadenomas and had complete excisions as evidenced on scan. Three out of nine patients identified with equivocal disease on fine needle aspiration cytology (FNAC) were found to have cancer following ultrasound-guided, vacuum-assisted excision. One patient who was diagnosed with cancer on FNAC, proved to be fibroadenoma on final histopathology. Four patients developed haematomas following ultrasound-guided, vacuum-assisted excision and all were managed conservatively.

CONCLUSIONS

Our study shows that ultrasound-guided, vacuum-assisted excision can play an efficient role in the diagnosis of benign breast lesions and is a safe and successful alternative in treatment of fibroadenomas.     

Cryoablation treatment of benign breast lesions with 12-month follow-up

OBJECTIVE: Eighty percent of all breast biopsies reveal benign findings. The most common benign tumor is a fibroadenoma. Despite their benign nature, many women eventually choose to have their bothersome lumps surgically removed. We report the use of cryoablation to treat these benign breast lesions with minimum 12-month follow-up. METHODS: After receiving Institutional Review Board approval, a prospective nonrandomized trial was initiated in June 2000. Ultrasound-guided cryoablation of core biopsy-proven benign fibroadenomas, other benign breast nodules, or nodular fibrocystic change was performed on 78 lesions in 63 patients. Eighty-five percent of lesions treated were benign fibroadenomas. The cryoablation procedure consisted of a double freeze-thaw cycle that lasted between 6 and 30 minutes and was performed most often in an office setting. Each patient was serially evaluated for treatment efficacy, complications, and patient satisfaction. RESULTS: Sixty-four of 78 lesions (mean size 2.0 cm [range 0.8 to 4.2]) were followed-up for at least 12 months after cryoablation per protocol, which included 53 fibroadenomas. At 1 year, ultrasound tumor volume resorption was 88.3% overall (87.3% for fibroadenomas), and 73% of the entire group became nonpalpable to both clinician and patient (75% for fibroadenomas). Two of the fibroadenoma patients had their palpable residual nodule excised, both revealing necrotic debris and no viable tumor in the treated volume. Serial mammograms showed resorption of the lesion leaving minimal residual density without calcifications. Cosmesis was excellent with only a small scar remaining at the probe insertion site. There was no report of visual or palpable volumetric deficit. Patient satisfaction was good to excellent in 92% of cases. CONCLUSIONS: Cryoablation was successful in treating core biopsy-proven benign breast lesions in 63 patients. At 12 months, we found gradual resorption of treated tissue with no cosmetic deficit. Ultrasound-guided cryoablation is an effective and safe treatment for benign breast lesions, as seen at 12-month follow-up, and offers an office-based, minimally invasive alternative to surgical excision.     

超声引导下Mammotome微创旋切系统在乳腺肿瘤诊治中的应用

目的：探讨B超引导下Mammotome微创旋切系统对乳腺病灶的诊断价值，并探索其用于乳腺纤维腺瘤微创手术的可行性。方法：对289例430处乳腺病灶进行B超引导下Mammotome微创旋切术，通过病理检查与随访评价其对乳腺病灶的诊治效果。结果：Mammotome微创手术操作成功率达100％。皮肤伤口微小，仅3-5mm。无严重并发症。临床及超声诊断为乳腺纤维腺瘤者均在超声实时监控下完全予以切除。92例144处术后6个月。5年获得随访，其中89例141处经临床B超随访复查均未见“复发”迹象，肿瘤被完全切除率为97．9％（141／144）。对可疑病灶及Ⅲ期乳腺癌均取材满意，并能作出明确诊断。结论：B超引导下的Mammotome微创旋切系统对乳腺不同病灶均能作出明确诊断；对小纤维腺瘤成功进行微创切除术，创伤和皮肤伤口小，效果满意，对其他良性小病灶也可避免不必要的手术活检。     

Long-term outcome of benign fibroadenomas treated by ultrasound-guided percutaneous excision

Abstract:  Surgical as well as conservative treatment has been described for fibroadenomas. Both have disadvantages. A minimally invasive treatment, ultrasound-guided, vacuum-assisted percutaneous excision has been shown to facilitate the removal of all imaged evidence of benign breast lesions, including fibroadenomas up to 3 cm in diameter. This study is performed to assess the long-term outcome of ultrasound-guided percutaneous excision as a minimally invasive treatment for fibroadenomas. A retrospective review of 69 consecutive fibroadenomas treated with ultrasound-guided percutaneous excision between May, 2001 and December, 2005 was carried out. All these lesions underwent percutaneous excision of all imaged lesion evidence. Clinical and sonographic follow-up was recommended for all patients every 6 months. Initial size, location, and patient age were recorded for each treated lesion. Of 69 lesions treated, 52 were available for follow-up. The median follow-up period was 22 months, with a range of 7 to 59 months. At 6 months, there were no fibroadenoma recurrences. Follow-up sonography demonstrated recurrences in 13 lesions distributed across eight patients. The overall recurrence rate was 15% (8/52) with an actuarial recurrence rate of 33% at 59 months. All of the recurrences were in lesions which were larger than 2 cm in size at initial presentation. Our data suggest that the mechanism of recurrence is the regrowth of retained lesion fragments too small to be detected by ultrasound—not the incomplete excision of all imaged lesion evidence. Despite successful percutaneous excision, fibroadenomas do recur. Lesions smaller than 2 cm in size, so treated, do not need additional therapy or surveillance. Fibroadenomas larger than 2 cm are prone to recurrence and require additional treatment.     

Management of fibroadenoma of the breast.

Fibroadenoma is a common cause of discrete breast lumps in young women. There is agreement that fibroadenomas can be diagnosed preoperatively with a high degree of confidence and that some of the lesions thus diagnosed will resolve, possibly obviating the need for excision. There is, however, wide disagreement over the proportion of fibroadenomas that resolve spontaneously and therefore the benefit that accrues from an expectant policy. The aim of this study was to audit the management of fibroadenomas on one unit and clarify their natural history over a 5-year period. A cohort of 70 women with 87 fibroadenomas diagnosed using a triple assessment of clinical examination, cytology and imaging (sonomammography) have been followed for a minimum of 5 years. In all, 53 of the 'fibroadenomas' have been excised. In four cases the histology revealed benign disease other than fibroadenoma; there were no neoplasms. The sensitivity of cytology and sonomammography for the diagnosis of fibroadenoma were 84% and 98% respectively. Thirty-four fibroadenomas have not been excised. Of 25 fibroadenomas that have been reassessed after at least 5 years of follow-up, 13 (52%) have reduced in size, 4 (16%) are unchanged in size and 8 (32%) have grown. No patient has developed a carcinoma at the site of the presumed fibroadenoma. This study confirms that an expectant management policy of fibroadenomas has not resulted in misdiagnosis of carcinomas. Further, since a significant proportion of fibroadenomas remain static or reduce in size over a 5-year period many women can avoid excision.     

Office-based cryoablation of breast fibroadenomas: 12-month followup

BACKGROUND: Fibroadenomas comprise between 30% and 50% of all breast biopsies. Despite their benign nature, many women have their fibroadenomas surgically removed. We previously reported on a minimally invasive therapy using cryoablation to treat fibroadenomas. We now report on 12-month followup using this technique. STUDY DESIGN: A prospective, nonrandomized trial was initiated in June 2000 with IRB approval. The Visica Treatment System was used to cryoablate 70 biopsy-proved fibroadenomas in 57 patients using a freeze-thaw-freeze cycle lasting 6 to 30 minutes. Each patient was serially evaluated for safety, efficacy, and satisfaction. RESULTS: Fifty-seven fibroadenomas (mean 2.1 cm, range 0.8 to 4.2 cm) in 47 patients were followed for 12 months. At 1 year, with 89% median tumor volume reduction measured by ultrasonography, 75% of fibroadenomas were nonpalpable. There were no adverse events and only minor complications. Two patients (4%) had their lesions excised after 12 months; pathology revealed no viable fibroadenoma. Serial mammograms showed resorption of the fibroadenoma leaving minimal residual density without calcifications. Cosmesis was excellent with no volume deficit, as no tissue is removed. Ninety-one percent of patients were satisfied at 12 months. CONCLUSIONS: Cryoablation is safe and effective in treating breast fibroadenomas. It offers a nonsurgical, office-based treatment that is well tolerated by patients and accurately monitored with ultrasonographic guidance. At 12 months we found progressive tumor volume reduction and reduced palpability, with no volume deficit, excellent cosmesis, and satisfied patients. Ultrasonography-guided cryoablation is a preferred option for treatment of breast fibroadenomas without open surgery.     

Percutaneous excisional biopsy of impalpable breast lesions under ultrasound visualization

Within the last ten years, the development of innovative minimally invasive breast biopsy technologies has made a significant impact on the diagnostic evaluation of impalpable breast lesions. The Mammotome minimally invasive biopsy system is a diagnostic tool used under stereotactic or ultrasound guidance. The minimally invasive biopsies for 143 impalpable breast lesions in 86 patients were performed using the B-ultrasound-guided 8-gauge vacuum-assisted Mammotome system at Jinan Military General Hospital. One hundred and forty-three breast lesions in 86 patients were excised completely using this method. The average biopsy procedure time was 17 min (range, 3–45 min). Clinically, suspicious lesions were satisfactorily confirmed by this system. One hundred and twenty-one lesions were diagnosed as fibroadenoma, nineteen lesions as breast adenosis, one lesion as invasive breast cancer, and two lesions as ductal carcinoma in situ. Skin ecchymosis was found in two patients. One hundred and thirty-two impalpable lesions were completely excised, as demonstrated by the follow-up ultrasound examination. The results suggest that the B-ultrasound-guided Mammotome system may be an efficient tool for the diagnosis and treatment of impalpable breast lesions.     

Fine needle aspiration biopsy in the diagnosis and management of fibroadenoma of the breast

Cytological and histological biopsies were obtained on 75 breast lumps clinically diagnosed as fibroadenomas. Of these, 95 per cent of lesions were benign. In 51 (68 per cent) confirmed as fibroadenomas histologically, cytology was benign in 78 per cent, but inadequate for diagnosis in 16 per cent. The remaining 24 lesions included three breast cancers and one lymph node with Hodgkin's disease. In this group cytology was inadequate for diagnosis in 54 per cent, including one breast cancer. No lesion with benign cytology was subsequently shown to be malignant. The study supports the view that clinical diagnosis and cytology are accurate in the diagnosis of benign breast disease of this type. Breast cancer may rarely present with the clinical features of a fibroadenoma and too few lesions have been studied to assess fully the performance of cytological biopsy in detecting these small mobile lesions. A non-excisional policy should therefore include prolonged follow-up and repeat biopsy.     

An evaluation of a 10-gauge vacuum-assisted system for ultrasound-guided excision of clinically benign breast lesions

The aim of this study was to evaluate a 10-gauge vacuum-assisted system for the excision of clinically benign breast lesions.The minimal excision of 245 lesions in 162 patients was performed with VACORA vacuum-assisted system under the guidance of ultrasound between July 2007 and April 2008. The lesions were category 3 lesions as determined by ultrasound imaging according to Breast Imaging Reporting and Data System (BI-RADS) (n = 208) or had been confirmed as benign by a previous core-needle biopsy (n = 37).As many as 244 lesions were demonstrated to be benign and one case was demonstrated to be malignant by pathology after resection. In the 244 benign lesions, 220 lesions were excised completely as demonstrated by the follow-up ultrasound examination. The malignant lesion was managed with surgical excision.The 10-gauge vacuum-assisted system is highly successful for the excision of benign breast lesions; it is an alternative tool for minimal treatment of benign breast lesions.     

手持式Mammotome系统在乳腺微创外科中的应用

目的 探讨B超引导下Mammotome系统对乳腺实质病灶的诊治价值及操作技巧。方法对81例87处乳腺病灶行B超引导下Mammotome微创旋切术，评价其对乳腺病灶的诊治效果。结果所有病灶均成功切除。87处乳腺病灶中，70处为纤维腺瘤，6处为腺瘤样增生，8处乳腺增生，1处为重度不典型增生，1处为乳头状增生活跃，1处为乳腺癌。结论手持式Mammotome微创旋切系统可有效治疗乳腺纤维瘤；能明确诊断可疑病灶，降低良性病变手术率。若为恶性可确定癌组织生物学特性并据此进行新辅助治疗。     

Progressive adoption of cryoablative therapy for breast fibroadenoma in community practice

BACKGROUND: Cryoablation is a recent technological advance and has been used for the percutaneous treatment of breast fibroadenomas. Herein, we provide a retrospective summary of the early experience from a nationwide group. METHODS: We organized a national registry to document the community practice and adoption of an office-based system of cryoablation for breast fibroadenoma. Data were abstracted during the first 6 weeks after the procedure to assess acute outcome and potential complications. At 6-and 12-month follow-up intervals, additional data were collected regarding fibroadenoma resolution, cosmesis, and patient satisfaction. RESULTS: Fifty-three sites ablated 310 fibroadenomas. Early follow-up data on 256 lesions showed that the procedure was well tolerated with infrequent minor complications immediately after the procedure. At 6 and 12 months postprocedure, the remaining fibroadenoma volume progressively involuted. At both intervals, cosmesis was excellent, and patient satisfaction was rated high. CONCLUSIONS: An early community experience with office-based cryoablation of breast fibroadenomas is encouraging and comparable to the initial experience of high-volume tertiary centers. More follow-up is necessary to determine long-term results and residual mammographic changes.     

Ultrasound-guided, vacuum-assisted, percutaneous excision of breast lesions: an accurate technique in the diagnosis of atypical ductal hyperplasia

BACKGROUND: In October 2002, ultrasound-guided, vacuum-assisted, percutaneous excision was shown to facilitate the complete removal of benign breast lesions up to 3 cm in diameter. This study was performed to ascertain the overall accuracy of ultrasound-guided, vacuum-assisted, percutaneous excision as evidenced by the frequency of atypical ductal hyperplasia (ADH) underestimation. STUDY DESIGN: A retrospective review was conducted of 542 consecutive ultrasound-guided, vacuum-assisted breast biopsies performed between February 2000 and September 2004. Before July 2002, no attempt was made to completely remove all imaged lesion evidence. After July 2002, all patients underwent complete percutaneous excision of all imaged lesion evidence. Pathology review revealed 52 lesions that demonstrated ADH and no evidence of malignancy. Each patient with this diagnosis was offered surgical excision. Pathologic reports for each group were compared with the subsequent open surgical specimens. RESULTS: Of 542 consecutively diagnosed lesions, 52 displayed ADH with no evidence of malignancy (10%). Five patients refused operation. Of the 47 patients who underwent open excision, 6 (13%) were found to have malignancies. The rate of ADH underestimation was 6 of 18 (33%) in incisional biopsies and 0 of 29 performed with complete imaged lesion evidence (p=0.002). The rate of ADH underestimation in women who underwent ultrasound-guided, vacuum-assisted, percutaneous excision was zero, a result equivalent to open surgical biopsy. CONCLUSIONS: ADH is a more common finding in sonographic lesions than has been previously reported. Complete ultrasound-guided, vacuum-assisted, percutaneous excision is more accurate than nonexcisional ultrasound-guided biopsy. Patients so diagnosed have very low underestimation rates and may not require open surgical reexcision.     

EnCor真空辅助旋切系统在多发性乳腺肿物微创切除术中的应用

目的探讨超声引导下EnCor真空辅助旋切系统治疗乳腺多发性肿物（单侧乳腺肿物≥3个）的价值。方法2009年3月～2010年1月,对700例多发性乳腺肿物在超声引导下进行EnCor切除术（美国SenoRx公司EnCor旋切系统）,术中旋切刀刀槽位于肿物下方或侧方进行扇形或大角度旋切,切除组织收纳于标本收集盒中送冰冻病理检查。结果全部乳腺肿物均采用EnCor旋切,均使用1把旋切活检针成功完成单侧乳腺肿物切除。术后病理：纤维腺瘤319例,纤维囊性乳腺病241例,瘤样增生96例,导管内乳头状瘤44例。术后并发症：皮下瘀斑24例,血肿形成11例,乳头溢血1例。679例随访3～12个月,平均6个月,均未发现病灶残留、复发,且无切口瘢痕形成,乳房外形正常,皮肤触觉无异常。结论超声引导下EnCor旋切术可完整切除乳腺多发性病灶,具有微创、美容、操作简单、安全等优点。     

Long‐term results after excision of breast mass using a vacuum‐assisted biopsy device

Background: The excision of breast lesions using an ultrasound‐guided vacuum‐assisted biopsy device (VABD) is a widely used technique for the diagnosis and treatment of breast disease, but the results of long‐term follow‐up after VABD excision of benign breast tumours have not been reported. The purpose of this study was to evaluate the results of long‐term follow‐up after complete excision of benign breast tumours using an ultrasound‐guided VABD. Methods: This is a retrospective clinical study. Between January 2001 and December 2004, patients who had undergone VABD excision of benign breast tumours and been followed up by clinical examination and ultrasonography for 2 years or more were included. Results: One hundred eighty‐four cases representing 153 patients were studied. The median follow‐up period was 33 months (range, 24–67 months). All lesions were histologically benign. The mean size of the lesions was 1.09 ± 0.57 cm (range, 0.3–3.03 cm). Within 2 years after VABD excision, residual lesions were detected in 10% of patients sonographically, but after 2 years or more, residual masses were found in 6.5% of patients. Scar changes also decreased from 36.0% to 15.8% during the period of follow‐up. Finally, the benign breast tumours were completely excised without residual masses in 93.5% of the participant patients. Residual masses developed in two fibroadenoma cases (1.08%); one was re‐excised and the other was followed serially. Conclusion: Ultrasound‐guided VABD excision is a minimally invasive technique for the complete removal of benign breast tumours. The results of this long‐term follow‐up of VABD excisions are comparable to conventional methods.     

Intraoperative ultrasound-guided breast biopsy

BACKGROUND: Biopsy of nonpalpable lesions has increased during the last decade. Commonly these lesions are excised using preoperative wire localization. We describe a technique of intraoperative ultrasound-guided breast biopsy that allows easier excision and aids in obtaining surgical margins in breast cancer. METHODS: Intraoperative ultrasound was performed on 81 lesions. Ultrasound was used in an attempt to approximate a 1 cm margin on malignant lesions. RESULTS: All attempts to localize lesions with ultrasound in surgery were successful (81 of 81). Ultrasound-guided surgery was accurate in predicting margins in 24 of 25 malignant lesions. No complications resulted. CONCLUSION: Ultrasound proved to be an effective technique for localizing and excising breast lesions. Benefits may include improving patient comfort, avoiding complications of needle localization breast biopsy, and simplifying the scheduling of surgical procedures. Additionally, this procedure may be used to obtain adequate surgical margins and thus reduce the recurrence rate of breast cancer.     

超声引导下负压吸引旋切术治疗乳腺肿瘤

目的探讨超声引导下负压吸引旋切术治疗乳腺肿瘤的治疗效果。方法回顾性分析2010年9月-2011年4月在我院接受超声引导下乳腺肿瘤旋切术的26例患者（38个病灶）的临床资料及术后病理检查与随访情况。结果采用EnCor真空辅助旋切系统全部切除38个病灶,术后肿瘤无残留、复发,无明显血肿、感染,穿刺点无明显瘢痕。结论超声引导下乳腺旋切术是诊断和治疗乳腺肿瘤、特别是不易触及的乳腺小病灶的有效方法。     

Core needle biopsy as a diagnostic tool to differentiate phyllodes tumor from fibroadenoma

HYPOTHESIS: Core needle biopsy is a useful diagnostic tool in differentiating phyllodes tumor from fibroadenoma. DESIGN: The radiology database was queried for patients who underwent core needle biopsies of fibroepithelial lesions that raised the possibility of phyllodes tumor. These diagnoses were then compared with the final pathological diagnoses after surgical excision. SETTING: The data were gathered from the Comprehensive Breast Center, Columbia Presbyterian Medical Center, a tertiary care, university-based medical center. RESULTS: From August 21, 1998, to December 14, 2001, 57 core needle biopsies were identified in which the specimen raised the possibility of phyllodes tumor. The median age of the patients was 42 years (range, 16-77 years). The median diameter of all lesions was 1.1 cm (range, 0.6-3.6 cm). Of the 57 specimens, 25 had core biopsies in which the pathological findings favored a diagnosis of fibroadenoma over phyllodes tumor. Twenty-three had initial core biopsies favoring phyllodes tumor. Nine of the core biopsies were equivocal. Of the 25 patients with specimens favoring fibroadenoma, excisional biopsy confirmed the diagnosis of fibroadenoma in 23, and phyllodes tumor was found in 2. The negative predictive value was 93%. Of the 23 core biopsies favoring phyllodes tumor, 19 were confirmed on excisional biopsy, while 4 were fibroadenoma. The positive predictive value was 83%. In the equivocal core biopsies, 5 were fibroadenoma and 4 were phyllodes tumor on final pathological analysis. None of the lesions studied were determined to be malignant on final analysis. CONCLUSIONS: Core needle biopsy can significantly reduce the need for operative management of fibroepithelial lesions. A core needle biopsy with results favoring fibroadenoma should allow the breast physician to treat the lesion as a fibroadenoma, with observation and close follow-up or with enucleation. Core needle histologic examination of phyllodes tumor allows the physician to preoperatively plan the definitive management at one surgical procedure, reducing the need for reoperations.     

Mammotome乳腺肿块微创切除术的初步应用

目的探讨Mammotome真空微创穿刺活检系统在乳腺肿块进行微创切除活检术的应用价值。方法在超声图像的监控下,利用Mammotome系统特殊的真空抽吸系统和旋切系统对54例102个乳腺肿块进行肿块活检并将肿块切除。记录术后情况,对病例进行随访。结果54例102个乳腺肿块被准确地完全切除,切除组织量大,足够用于病理诊断,92个肿块为纤维腺瘤或纤维腺病伴腺瘤形成,10个肿块为纤维腺病。术后4例并发血肿。切口小而隐蔽,乳房无变形。短期随访47例无残留和复发。结论使用Mammotome微创切除术能够安全、准确地对2 cm以下的乳腺肿块进行切除活检,创伤小、并发症少,是治疗良性乳腺肿块尤其是无体征的乳腺肿块的一项理想的微创技术。     

Intermediate and long‐term outcomes of fibroadenoma excision in adolescent and young adult patients

Fibroadenomas are benign breast masses that often occur in adolescence and young adulthood. Primary management options include observation or surgical excision, but little is known about long‐term outcomes after fibroadenoma excision in adolescents. In the present study, we reviewed the medical records of females aged 13‐35 years who underwent fibroadenoma excision at our institution from 1986 through 2010. Patients were included if they had excision of at least 1 fibroadenoma (confirmed by histopathology) smaller than 5 cm in maximal diameter. We collected information pertaining to clinical presentation, management, and outcomes. In addition, an investigator‐designed long‐term outcome survey was sent to 138 eligible participants to assess patient satisfaction, as well as the recurrence of fibroadenoma, and the need or desire for further surgical intervention. Most patients (126 of 138) underwent 1 operation for fibroadenoma excision. Three women underwent immediate breast reconstruction at fibroadenoma excision. Fifty‐seven patients completed the investigator‐designed survey (response rate, 41.3%) with a median follow‐up time of 13.5 (range, 2.0‐26.7) years. Nine of 55 patients (16.4%) reported postoperative breast asymmetry and the desire to pursue reconstructive surgery. Three survey responders reported breast pain. Fourteen of 56 women (25.0%) reported the diagnosis of 1 or more additional fibroadenomas after the initial excision; another 7 reported recurrence of the mass at the site of excision. Most survey participants were satisfied with the aesthetic outcome of their fibroadenoma excision; however, a small proportion believed that they would benefit from reconstructive breast surgery. The recurrence and development of additional fibroadenomas should be addressed by providers during counseling for treatment options and postoperative follow‐up.     

Evaluation of percutaneous vacuum assisted intact specimen breast biopsy device for ultrasound visualized breast lesions: Upstage rates and long term follow-up for high risk lesions and DCIS

ObjectivePercutaneous core biopsy of ultrasound visualized breast lesions is standard for diagnosis. Large gauge vacuum-assisted core needles have improved accuracy; but a significant underestimation of malignancy remains. The Intact^R device was assessed for upstaging and subsequent malignancy at the biopsy site.Methods469 consecutive ultrasound visualized breast lesions, < 2.0 cm in size, BIRADS 4 or 5, biopsied with Intact^R Breast Lesion Excision System, between July 2007 and August 2014, were reviewed. All non-concordant lesions (0.8%), DCIS (1.7%) and invasive cancers (9.8%) were surgically excised. Excision was recommended for all high risk lesions (13.0%). The upstage rate to DCIS or invasive cancer was determined. All patients were followed for a median of 66 months (24–96 months) with serial imaging and exams to determine the incidence of re-biopsy, or malignancy at the original biopsy site.Results23 of 61 high risk lesions (37.5%) were not excised, but observed for a median of 66 months. None required re-biopsy. One atypical lesion was upstaged to DCIS on excision. No patient was diagnosed with malignancy at or near the original biopsy site during follow-up. Overall upstage rate was 1.2%.ConclusionsPercutaneous biopsy of ultrasound visualized lesions was performed accurately using Intact^R. Upstaging was much lower with Intact^R than with large-gauge core needles. High risk lesions, diagnosed with Intact^R, have a very low upstage rate at surgical excision. It may be possible to observe these lesions without surgery when they present as ultrasound findings and undergo Intact^R biopsy.