Vacuum-assisted Breast Biopsy System Research Articles

Pathological characteristics of breast nodules after large-volume fat grafting for breast augmentation.

The complications of large-volume fat grafting (LVFG) for breast augmentation remain unpredictable and include palpable breast nodules, oil cysts, and calcifications. This study was aimed to provide an optimal treatment option for breast nodules after LVFG and evaluate their pathological characteristics. We effectively performed complete resection of breast nodules in 29 patients after LVFG using a minimal skin incision with the vacuum-assisted breast biopsy (VABB) system under ultrasound guidance. And we further carried on histologic examination of excised nodules and evaluated their pathological characteristics. The breast nodules were excised thoroughly with cosmetic effect satisfactorily. Interestingly, subsequent histologic examination showed that type I and VI collagens were strongly expressed in the fibrotic area and type IV collagen were positively expressed around the blood vessel. Furthermore, we found that the type VI collagen+ area appeared around mac2+ macrophages and α-SMA+ myofibroblasts. The VABB system may be the optimal treatment option for breast nodules after LVFG. And type VI collagens may serve as a biomarker of grafted adipose tissue fibrosis. The relationship between macrophages, fibroblasts, and collagen formation may be therapeutic targets for regulating fibrosis.

Clinical performance and patient outcomes in upright Digital Breast Tomosynthesis-guided Vacuum-Assisted Breast Biopsy and Prone stereotactic system: A review

Clinical performance and patient outcomes in upright Digital Breast Tomosynthesis-guided Vacuum-Assisted Breast Biopsy and Prone stereotactic system: A review

Does Mammotome biopsy affect surgery option and margin status of breast conserving surgery in breast cancer?

The Mammotome, an image-guided, usually ultrasound-guided vacuum-assisted breast biopsy (US-VABB) system, has been widely used in the early diagnosis of breast disease and the complete excision of benign lesions. However, in some malignant lesions underestimated by U.S., whether Mammotome biopsy would affect the surgery option, especially the margin status in breast-conserving surgery (BCS), has never been studied. Between 2015 and 2019, 198 patients with 200 lesions who have been diagnosed with breast cancer by Mammotome elsewhere received surgery by pathological confirmation in our center. The clinicopathological characteristics, surgery options, therapies, and the details of the specimen, such as margin status of BCS, tumor residual after VABB, and hematoma were reviewed. Among 200 lesions, 90% were evaluated below US-BIRADS 4b before Mammotome biopsy and 94.5% with a tumor size ≤3 cm. 131 patients received mastectomy (66.2%) and 67 received BCS (33.8%). Hematoma and tumor residual were observed in 37.5% and 71.5% of all lesions, respectively. There is a higher incidence of hematoma in the mastectomy group than in the BCS group (44.4% vs. 23.9%, P=0.005). In BCS group, the positive margin was found in 7 patients at first examination including four focals with re-excision, two extensive with mastectomy and one focal but refusing further surgery. The ultimate success rate of BCS was 95.5%. Margin positivity correlated with tumor residual (P=0.044) but not with hematoma. Mammotome biopsy might lead to hematoma and tumor residual; however, it is not the determinant factor for a surgery option, and BCS is feasible through a complete excision of tumor residual to acquire negative margin.

Vacuum-Assisted Breast Biopsy System: No Innovation Without Evaluation.

BackgroundVacuum-assisted breast biopsy (VABB) has recently been gaining more popularity as a modality to reach the final diagnosis, especially in indeterminate breast lesions, resulting in a decreased number of surgical interventions and unnecessary follow-ups.ObjectiveWhile our primary aim was to look into the outcomes of the VABB technique, our secondary aim was to assess the impact of the method on changes in patients’ management.Patients and methodsThis study was a retrospective database analysis of vacuum-assisted biopsies (VABs) carried out at our breast unit during the period between January 2011 and January 2018. All our cases were image-guided; the caliber of vacuum-assisted needles used was 8 gauge (G) and 11 G. Patient demographics, lesion characteristics, and outcomes were retrieved from patients’ notes and the hospital database.ResultsA total of 122 female patients were included in the analysis, out of whom 41.8% (51 patients) were screen-detected, and 58.1% (71 patients) were symptomatic presentations. The mean lesion size on imaging was 14.8 mm (SD: 12.6); 50% (61 patients) had stereotactic vacuum-assisted breast biopsy (SVAB), and 50% (61 patients) had ultrasound-guided vacuum-assisted breast biopsy (US-VAB). Post-procedure histology was upgraded in 19.6% (24 patients), downgraded in 18.8% (23 patients), and remained unchanged in 61.4% (75 patients).ConclusionVABB is a safe and efficient procedure for the diagnosis and management of indeterminate and suspicious breast lesions. It provides an adequate amount of tissue, which can help in upgrading or downgrading histopathologically diagnosed patients, thereby decreasing the need for surgery.

The Vacuum-Assisted Breast Biopsy System is an Effective Strategy for the Treatment of Gynecomastia.

Gynecomastia is the most common benign disease in males with an increasing prevalence in recent years. It may cause local pain and psychological disorders. The vacuum-assisted breast biopsy system has been reported to be a novel surgical approach for the treatment of gynecomastia. However, there are little detailed reports comparing the curative effect between traditional surgery and vacuum-assisted breast biopsy for gynecomastia. Besides, there was little study which compared the application of two different systems for the treatment of gynecomastia. Our study aimed to investigate the effectiveness of vacuum-assisted breast biopsy systems for patients with gynecomastia. We retrospectively reviewed 83 patients with gynecomastia between January 2015 and December 2019. Open surgery was performed in 56 patients, and vacuum-assisted breast biopsy was performed in 27 patients. The characteristics of patients as well as the curative effects between the two groups were analyzed. The two vacuum-assisted breast biopsy systems (Mammotome and Encor) were performed for the patients with gynecomastia. The efficacy, safety, complications, and patient satisfactions were recorded during postoperative follow-up periods. Compared with the open surgery group, the vacuum-assisted breast biopsy group had significantly smaller scar sizes left after the operation (5.5 ± 1.3cm vs 0.8 ± 0.2cm, p < 0.001), and shorter hospital stay time (5.5 ± 2.4 ds vs 3.1 ± 1.6 ds, p < 0.001). Patients in vacuum-assisted breast biopsy group had a better cosmetic outcome than those in open surgery group. There were no statistically significant differences between the two vacuum-assisted breast biopsy systems according to the mean age, the mean operation time, sites, or grade. In addition, no serious complications were observed in vacuum-assisted breast biopsy group. All the patients recovered well and were satisfied with the cosmetic outcomes. The vacuum-assisted breast biopsy system can be used as a feasible and minimally invasive approach for the treatment of gynecomastia. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Invited Discussion on: The Vacuum-Assisted Breast Biopsy System is an Effective Treatment Strategy for Breast Lumps After Augmentation with Autologous Fat Grafting

Invited Discussion on: The Vacuum-Assisted Breast Biopsy System is an Effective Treatment Strategy for Breast Lumps After Augmentation with Autologous Fat Grafting

The Vacuum-Assisted Breast Biopsy System is an Effective Treatment Strategy for Breast Lumps After Augmentation with Autologous Fat Grafting.

With the extensive application of autologous fat grafting (AFG) to the breasts, postoperative complications such as breast lumps attract high attention. Breast lumps greatly reduce patient satisfaction and bring mental stress. However, there are few detailed reports about minimally invasive treatment strategies for breast lumps after AFG. Our study aimed to investigate the effectiveness of the vacuum-assisted breast biopsy (VABB) system for patients with lumps after AFG. We retrospectively reviewed 37 patients with breast lumps between April 2015 and January 2019. The characteristics of patients and breast lumps were analyzed. Breast lumps were classified into four types, including cystic, solid, complex and calcification. The vacuum-assisted breast biopsy (Mammotome and Encor) was performed for the patients with lumps after AFG. The efficacy, safety, complications and patient satisfactions were recorded during postoperative follow-up periods. Under the guidance of ultrasound, the breast lumps could be thoroughly and accurately excised by the vacuum-assisted biopsy system. No patient experienced breast infections or major complications requiring treatment. Hematoma was observed in only 2 patients and gradually resolved without any special management. With a median follow-up of 29months, no recurrence was observed. Furthermore, there were no statistical differences in duration of the procedures and complications between the two VABB systems. All the patients recovered well and were satisfied with the cosmetic outcome. The vacuum-assisted breast biopsy system can be used as an effective and minimally invasive approach for the surgical management of lumps after AFG. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Surgical drainage of lactational breast abscess with ultrasound-guided Encor vacuum-assisted breast biopsy system.

Lactational breast abscess is a serious complication of mastitis and commonly diagnosed in breast‐feeding women. The traditional drainage of breast abscess was often performed with incisive technique which may result in prolonged healing time, regular dressings, dressing pain, interfering with breastfeeding and unsatisfactory cosmetic outcome. As minimal invasive alternatives to incisive drainage, needle aspiration or percutaneous catheter placement cannot completely replace incisive drainage for the inability to treat large, multiloculated or chronic abscess. Vacuum‐assisted breast biopsy system (VABB) has been successfully applied in the treatment of benign breast diseases with satisfactory cosmetic outcomes. Among VABB devices, EnCor system has some distinctive features that make it an appropriate candidate for the treatment of lactational breast abscesses. In this study, for the first time, we investigated the feasibility, efficacy, and cosmetic results of surgical drainage of lactational breast abscess with US‐guided Encor VABB system. Our data suggests this procedure could serve as a promising alternative for women with lactational breast abscess who require incisive intervention with high cure rate, relatively short healing time, low recurrence rate, few complications, satisfactory cosmetics outcome and without interfering with breastfeeding.

Differentiating vacuum-assisted breast biopsy from core needle biopsy: Is it necessary?

Needle biopsy has replaced excisional biopsy as a definitive diagnostic technique for breast tumours, although excisional biopsy is still used for complete tumour removal for therapeutic and/or diagnostic purposes. Many vacuum-assisted breast biopsy (VAB) systems have been made available by several manufacturers since the release of the Mammotome (MMT) by Johnson & Johnson in 1995. Several recent discussions have been conducted to identify whether core needle biopsy (CNB) or VAB, is more appropriate. However, currently available VAB systems differ from the conventional system (i.e. articulate arm type 11-gauge(G) MMT), and the characteristics of both CNB and VAB have been improved. In CNB, a 14-G needle is frequently used to obtain a larger sample. By contrast, VAB is considered easier to perform because it uses a thinner needle and a lighter, non-tethered system. When differentiating CNB from VAB, the type of VAB should also be defined. In this review, we discuss the characteristics of ultrasonography-guided VAB and CNB with a focus on practical issues such as the number of samples and volume of tissue obtained during ultrasonography-guided needle biopsy.

Ultrasound-guided mammotome for diagnosis and minimally invasive excision of mammary clustered calcifications.

e13034 Background: To validate the ultrasound-guided vacuum-assisted breast biopsy system (Mammotome) for diagnosis and minimally invasive excision of calcification in breast. Methods: In 20 patients, breast calcification lesions diagnosed by mammography were excised by ultrasound-guided Mammotome system with 8-gauge probe. The samples were taken mammography and followed by pathological examination. Results: All lesions were removed accurately and thoroughly with satisfactory cosmetic outcomes. No clinically significant hematoma developed. Each mass was resected through 9.15±2.70 cores on average over a mean of 11.65±3.88 minutes. Two cases of them were histologically diagnosed as ductal carcinoma in situ and 8 cases were fibroadenoma and 10 cases were adenosis. Conclusions: Ultrasound-guided Mammotome system can profit to diagnose and treat breast calcification lesions which is ultrasound positive. Ultrasound detection rate of microcalcifications is up to the instrument resolution and the operator's experience and patience.

Histological underestimation of a 9-gauge stereotactic vacuum-assisted breast biopsy system compared with surgical excision at a tertiary hospital in South Africa

Background: Breast cancer is a major cause of morbidity and mortality worldwide. Certain lesions encountered on mammography require histological assessment of biopsy samples to identify benign versus malignant disease. Stereotactic vacuum-assisted breast biopsy (SVAB) is a useful technique, especially for non-palpable microcalcific lesions, and was introduced at our institution in 2011.Objectives: To determine whether the histological underestimation from 9-gauge SVABs performed at our institution is within acceptable limits.Method: In this cross-sectional study, 9-gauge stereotactic biopsy histology results and breast imaging and reporting data system (BI-RADS) findings of 158 lesions (from 153 patients) were analysed and the histological findings compared with surgical excision histology results (54 lesions) to determine histological underestimation (upgrade rates).Results: One out of eight cases of ductal carcinoma in situ (DCIS) was underestimated, yielding a DCIS underestimation rate of 12.5%.Conclusion: The DCIS underestimation obtained from the present study in our institution was on a par with other authors’ findings and was therefore within acceptable limits. Atypical ductal hyperplasia underestimation could not be reliably obtained with the small study population.Keywords: Stereotactic vacuum assisted breast biopsy; histological underestimation; histological upgrade

Feasibility and Safety of Ultrasound-Guided Vacuum-Assisted Breast Biopsy System for Intraductal Papilloma

Purpose: We aimed to evaluate the feasibility and safety of ultrasound-guided vacuum-assisted breast biopsy system for the treatment of intraductal papilloma (IDP). A vacuum-assisted breast biopsy system mammotome® was recently introduced for simultaneous biopsy and excision of benign breast masses. Mammotome excision has the advantages of safety and less scar formation compared to open biopsy. Wide excision is a standard treatment for IDP of the breast. Methods: We retrospectively reviewed the clinical data by using the electric medical records of 752 cases of breast masses that were treated via Mammotome excision performed by a single surgeon between January 2007 and December 2012. Among these patients, 26 patients were diagnosed with benign IDP as indicated in the final pathologic reports. Results: The median follow-up period was 56.2 months (range, 29–92 months). Two patients were diagnosed with another IDP during the follow-up period. However, no recurrence was detected at the previous excision site, but new primary lesions were confirmed at another quadrant. Conclusion: We suggest that ultrasound-guided vacuum-assisted breast biopsy system may be feasible and safe for the treatment of IDP. Keywords: Biopsy; Breast; Excision; Intraductal papilloma

Cumulative Sum Analysis for Learning Curve for Breast Mass Excision Using an Ultrasound-Guided Vacuum-Assisted Biopsy System

Purpose: The aim of the study was to evaluate the existence of a learning curve for procedures using ultrasound-guided vacuum-assisted breast biopsy (VAB) system in terms of the cumulative sum (CUSUM). Methods: Data from a series of 54 consecutive patients who had undergone ultrasound-guided VAB were reviewed in the study. Patients’ characteristics, operative times, and complication rates were analyzed. The total operation time was analyzed by using the CUSUM method. Results: CUSUM analysis revealed three phases of the learning curve: phase 1 (the initial 15 cases), phase 2 (intermediate 23 cases), and phase 3 (subsequent cases). Operative times, including preparation time, procedure time, and total operation time, in phase 1 were significantly longer than those in phases 2 and 3. Surgical complications were the most frequent in the initial phase (26.7%); however, complication rates were not significantly different among the three groups. Conclusion: The current study showed the three different phases of the learning curve for ultrasound-guided VAB using CUSUM analysis. CUSUM analysis can be used to determine appropriate competency of various procedures in patients with breast diseases.

Tomosynthesis-guided vacuum-assisted breast biopsy: A feasibility study.

Evaluation of feasibility and clinical performance of a tomosynthesis-guided vacuum-assisted breast biopsy (TVAB) system compared to Stereotaxy (SVAB). All biopsies were performed on consecutive patients: 148 TVAB biopsies and 86 biopsies on different patients using SVAB. Evaluation criteria for each biopsy were technical feasibility, histopathology, procedure time, and complications. All 148 TVAB biopsies were technically successful, and gained the targeted groups of microcalcifications (100%). In 1 of 86 SVAB procedures, it was not possible to gain the targeted microcalcifications (1%), in 3 of 86 the needle had to be adjusted (4%). All TVAB biopsies were performed without clinically relevant complications. Distortions were biopsied exclusively by TVAB, mean size 0.9cm, p < 0.0001. Of the 24 distortions, 13 were cancer, 11 Radial Scars/ CSL. The mean procedure time for TVAB was 15.4minutes (range 7-28min), for SVAB 23minutes (range 11-46min), p < 0.0001. TVAB is able to biopsy small architectural distortions with high accuracy. TVAB is easily feasible and appears to have the same degree of clinical performance for diagnosing microcalcifications. The increased number of biopsied distortions by TVAB is presumably due to increased use of tomosynthesis and its diagnostic potential. • TVAB is easily feasible. • TVAB is able to target architectural distortions with high accuracy. • TVAB diagnoses microcalcifications with the same clinical performance as SVAB.

P148 Feasibility of ultrasound-guided vacuum-assisted breast biopsy system for intraductal papilloma

P148 Feasibility of ultrasound-guided vacuum-assisted breast biopsy system for intraductal papilloma

Learning curve for breast mass excision using a vacuum-assisted biopsy system

Background: Vacuum-assisted breast biopsy system (VAB) is an alternative modality to core needle biopsy for the diagnosis of breast lesions. Material and methods: Fifty-four patients who underwent ultrasound-guided VAB procedures were analyzed. Patients were categorized into two groups: The first 20 consecutive patients as group A and the next 34 consecutive patients as group B. Results: Fifty-two patients underwent excision, and two underwent biopsy only. Moving average curves showed a plateau phase for performing VAB procedures after the 20th patient. Total operation times of group B were significantly shorter than those of group A (p < 0.001). Complication rates in group B tended to be lower, and VAB probe position of group B tended to be better than that of group A, but these differences were not statistically significant. Conclusion: Our data suggest the existence of a learning curve for ultrasound-guided VAB procedures. VAB procedures can be performed safely, even during the early learning period.

Evaluation of two different vacuum-assisted breast biopsy systems: Mammotome® system 11G/8G vs. ATEC® system 12G/9G

Breast cancer screening programs have been established worldwide and early detection of breast cancer has increased steadily. The most common way to confirm dignity of non-palpable and sonographically-occult suspicious findings on mammography is the stereotactically-guided vacuum-assisted breast biopsy To compare two stereotactically guided vacuum-assisted breast biopsy systems measuring time effectiveness and quality of harvested material in clinical practice. One hundred and forty-six patients presenting with suspicious microcalcifications on mammography were included in the study. Biopsies were carried out with either the Mammotome(®) system (11-gauge and 8-gauge) or the ATEC(®) system (12-gauge and 9-gauge). Lesions with a diameter <15 mm on mammography were biopsied with 11-gauge or 12-gauge devices whereas lesions >15 mm were targeted with 8-gauge and 9-gauge. Mammotome(®) system 8-gauge device was used in 34 patients, the 11-gauge system in 37 patients. The ATEC(®) system 9-gauge system was used in 37 patients and 12-gauge in 38 patients. Time was taken, focusing on preparing the system, time of collecting the samples, preparing the samples, and cleaning the site. During the biopsies 24 samples were taken. The histologic quality of the tissue samples was judged by a pathologist in a blinded fashion according to a specimen grading classification concerning tissue fragmentation, artefacts, and the adequacy of the tissue for diagnosis. The median overall time for the Mammotome(®) system was 879 s (11-gauge) and 934 s (8-gauge) and for the ATEC(®) system 671 s (12-gauge) and 673 s (9-gauge). The ATEC(®) system displays a significantly shorter overall time for small and large biopsy devices (U-test, P < 0.001). Concerning the mean time difference of the overall time comparing small and large systems the ATEC(®) system was 267.6 s faster using the small and 244.8 s faster using the large system. Comparing the histologic quality of tissue samples the Mammotome(®) system shows significantly higher values for the large and the small system (Chi-square test, P < 0.001). Both biopsy systems meet all requirements for daily practice and confirm the diagnosis of suspicious microcalcifications. The ATEC(®) system was observed to be faster but this difference of about 250 s might not be relevant in daily practice. The Mammotome(®) system provides a better histologic quality of tissue samples.

66 Health-related Quality of Life After Stereotactic Vacuum Assisted Breast Biopsy System Utilizing Radio Frequency – Breast Lesion Excision System (BLES)

66 Health-related Quality of Life After Stereotactic Vacuum Assisted Breast Biopsy System Utilizing Radio Frequency – Breast Lesion Excision System (BLES)

Complications of percutaneous stereotactic vacuum assisted breast biopsy system utilizing radio frequency

ObjectiveThe Breast Lesion Excision System (BLES) is a novel, automatic breast biopsy device that utilizes radiofrequency to excise suspicious non-palpable mammographic lesions. The purpose of the present prospective study is to report and evaluate the complications of this new technique. Materials and methodsIn a two year period, we used the BLES device in 132 consecutive patients (134 procedures) with non-palpable mammographic lesions. The inclusion criteria consisted of suspicious microcalcifications, solid lesions and asymmetric density. In order to retrieve an intact biopsy specimen, we used the 12mm, 15mm or 20mm tissue basket under local anesthesia, depending on the size of the lesion. Complications were recorded and classified as immediate if occurring during or shortly after the procedure, or late, if occurring in the post-procedure days. ResultsThe procedure was considered successful in all cases, with mammographic confirmation of appropriate excision of the targeted lesion. Although, in a single case the basket initially failed to deploy. Immediate complications were encountered in 11 patients, with minor hemorrhage being the most common (n=6). 17 patients suffered late complications, in seven of whom delayed wound healing was observed. Overall, 27 patients suffered Grade 1 complications (20.14%), one patient experienced a Grade 2 complication while no patients encountered Grade 3–5 complications. ConclusionsAccording to our experience, the BLES device is an efficient and safe breast biopsy method, with low complication rates, which are minor in their majority. It appears to be a very promising alternative to other, minimally invasive, breast biopsy techniques.

Therapeutic Application of Ultrasound-Guided 8-Gauge Mammotome System in Presumed Benign Breast Lesions

The stereotactic or ultrasound-guided vacuum-assisted breast biopsy (Mammotome, MMT) system is a minimally invasive surgical technique. Increasingly, it is used to remove benign breast lesions as management. To evaluate the therapeutic value of 8-gauge ultrasound-guided MMT system (UMS) in presumed benign breast lesions, a retrospective analysis was performed on a series of 2,167 consecutive 8-gauge UMS procedures. The parameters used in this analysis included lesion size, location, breast imaging reporting and data system for ultrasound category, histopathologic diagnosis, and others. A total of 1,119 women whose mean ages were 36.6 years (range: 12-71, SD: 9.6) underwent 2,167 consecutive 8-gauge UMS procedures. Among the patients, 298 cases (26.63%) did not have palpable mass, 430 (38.43%) had multiple lesions, and 237 (21.18%) had bilateral ones. The average size of excised lesions was 15.8 mm (range: 5-55, SD: 6.7) in the largest dimension, including 294 lesions < 10 mm (13.57%); 1,359 lesions, 10-19 mm (62.71%); 420 lesions, 20-29 mm (19.38%), and 94 lesions ≥ 30 mm (4.34%). Predominant lesions (81.59%) were solid on ultrasound image and nearly half (48.59%) of them were localized in the upper outer quadrant. Histopathologic diagnosis revealed that the overwhelming majority of specimens (96.61%) were benign, most of which manifested as fibroadenoma and fibrocystic changes, while high-risk lesions were revealed in 31 (2.29%) cases and malignancies in 15 (1.11%). Average time for procedure was 8.6 minutes (range: 3.5-38, SD: 5.4) and mean number of cores removed in the procedure was 9.3 (range: 2-42, SD: 3.7). Complete excision was achieved predominantly (99.82%). Complications (59, 5.27%) in which hematoma (41, 3.66%) was the majority were acceptable. In conclusion, the 8-gauge UMS procedure is a safe and potent therapeutic management with satisfactory cosmetic outcome for benign and high-risk breast lesions, especially for bilateral, multiple, and nonpalpable ones. It is a reliable biopsy tool for suspected lesions as well. Eradication and maximal cosmesis can be achieved with few complications if the targeted lesion is limited to 30 mm.