Vacuum-assisted Biopsy Research Articles

Identification of a localization wire tip in an occult breast lesion using a handheld magnetometer.

The Sentimag hand-held probe detects the magnetic response from iron oxide particles trapped in a sentinel node. To investigate if an electromagnetic probe can be helpful in the identification of a hook wire tip located in an occult breast lesion. Forty-two patients undergoing lumpectomy without axillary procedure were enrolled. In all cases, suspicious non-palpable microcalcifications without mass were found, and a vacuum-assisted stereotactic biopsy was performed. On the day of surgery, a traditional localization wire (LW) was placed under imaging guidance. The Sentimag magnetometer was used to precisely detect the wire tip through the skin. Then, the skin incision was made and Sentimag was used again to guide the surgeon to the lumpectomy bed. The accuracy of excision was assessed with intra-operative specimen 3D tomosynthesis. Median lesion size was 16 mm (range: 4-38 mm) and median depth was 33 mm (range: 14-78 mm). In all cases, the wire tip was successfully identified. Neither wire displacement nor transection occurred. Intraoperative radiography demonstrated doubtful margin requiring selective cavity shaving in 6 patients (14%). The need for cavity shaving was significantly influenced by the lesion size and histology: median size 30 mm (range: 24-38 mm) compared to 15 mm (range: 4-28 mm) and histology of ductal carcinoma in situ (DCIS) compared to atypical ductal hyperplasia (ADH) and lobular neoplasia (LN). Tumors requiring cavity shaving tended to be deeper - they had a median depth of 43 mm (range: 17-78 mm) compared to 32 mm (range: 14-76 mm) in patients who did not need cavity shaving, but this parameter was statistically significant. Intraoperative identification of the wire tip using Sentimag is a simple technique facilitating targeted excision without excessive removal of breast tissue. Since it is not associated with additional costs, it may be worth considering, particularly in developing countries.

Wireless ultrasound-guided vacuum-assisted breast biopsy: Experience in clinical practice at European Institute of Oncology.

In the last few years, ultrasound-guided vacuum-assisted breast biopsy (US-VABB) has replaced surgical biopsy due to higher diagnostic accuracy and lower patient discomfort, and, at present, an even greater possibility is represented by the new wireless ultrasound-guided VAB device (Wi-UVAB). The purpose of our study is to determine the diagnostic accuracy of this new device in a sizeable representative number of patients. From January 2014 to June 2018, 168 biopsies were performed in our institution using the new Wi-UVAB device. We analyzed sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of biopsies obtained with the new device using surgical results as reference point, following patients for at least one year. In our cohort, we obtained a complete sensitivity of 97.5%, an absolute sensitivity of 94.3%, a complete specificity of 98%, and an absolute specificity of 98%. The positive predictive value of the procedure was 97.5% while the negative predictive value was 98%. The diagnostic accuracy was 98%. The Wi-UVAB is a safe procedure with high diagnostic accuracy, comparable to that of the traditional vacuum-assisted breast biopsy and even higher than that of core needle biopsy (CNB). Moreover, the Wi-UVAB is easy to use and shows low costs as core needle biopsy (CNB).

The influence of preoperative biopsy on the surgical method in breast cancer patients: a single-center experience of 3,966 cases in China.

The National Surgical Adjuvant Breast and Bowel Project (NSABP) B32 trial reported that the detection rate of sentinel lymph nodes by core needle biopsy (CNB) is higher than that by segmental resection. However, there are few reports regarding the detection rate of sentinel lymph nodes by vacuum-assisted breast biopsy (VABB). Therefore, we analyzed the impact of preoperative biopsy methods on the surgical modes of 3,966 patients with breast cancer in our center. In total, 3,966 female breast cancer patients [clinical tumor node metastasis (TNM) stage I-III] were enrolled in this study. Preoperative pathological diagnosis methods included fine needle aspiration (FNA) biopsy, CNB, excision biopsy, and VABB. According to the time of diagnosis. The data were analysis by chi square test, variance analysis and the Kaplan-Meier time series in SPSS 22.0. There was a decrease in the number of patients that underwent excision biopsy (7.3% to 2.7%) and intraoperative freezing (89.4% to 28.9%) over time, while CNB exhibited an increasing trend (1.6% to 55.3%). The positive rates of VABB, CNB, excision biopsy, and FNA were 99.5%, 97.1%, 97.9%, and 82.2%, respectively, and the false negative rates were 0%, 1.8%, 0.34%, and 8.9%, respectively. The overall breast-conserving rate was 36.7%, while the breast-conserving rate for VABB was 57.1%. The axillary sentinel lymph node biopsy rate of cN0 patients was 48.3%, and the intraoperative frozen group (36.7%) and excision biopsy group (39.5%) were lower than the CNB (57.1%) and VABB (77.9%) groups. Until December 2019, there were 350 cases with tumor recurrence or metastasis. The methods of biopsy were not correlated to the cumulative survival time. Changes to the diagnosis and treatment of breast cancer has a profound impact on the method of tumor biopsy. VABB biopsy offers advantages such as accurate diagnosis, a greater volume of tissue taken at one time, minimally invasive and repeatable, and does not affect the surgical approach and prognosis of patients. It will gradually become the primary method of preoperative pathological evaluation of breast cancer.

Complete Removal of the Lesion as a Guidance in the Management of Patients with Breast Ductal Carcinoma In Situ.

Simple SummaryA diagnosis of ductal carcinoma in situ, made on biopsy, is often followed by surgery or radiotherapy because of the risk of an upgrading disease upon subsequent surgical specimens, finding invasive carcinoma. In order to select which patients can be spared overtreatments and alternatively followed with active surveillance, we retrospectively reviewed 2173 vacuum assisted breast biopsies. Our goal was to demonstrate if complete removal of the lesion by biopsy, documented by mammograms, can be a valid criterion to select the patients that can be spared further treatments. The results of our study demonstrate a significant lower upgrading rate of disease when the lesion is completely removed. Thus, performing a mammogram to document the absence of residual lesion following vacuum-assisted breast biopsy (VABB) allows us to reduce overtreatments and to select which patients can be followed with an active surveillance, sparing unjustified public health costs.Background: Considering highly selected patients with ductal carcinoma in situ (DCIS), active surveillance is a valid alternative to surgery. Our study aimed to show the reliability of post-biopsy complete lesion removal, documented by mammogram, as additional criterion to select these patients. Methods: A total of 2173 vacuum-assisted breast biopsies (VABBs) documented as DCIS were reviewed. Surgery was performed in all cases. We retrospectively collected the reports of post-VABB complete lesion removal and the histological results of the biopsy and surgery. We calculated the rate of upgrade of DCIS identified on VABB upon excision for patients with post-biopsy complete lesion removal and for those showing residual lesion. Results: We observed 2173 cases of DCIS: 408 classified as low-grade, 1262 as intermediate-grade, and 503 as high-grade. The overall upgrading rate to invasive carcinoma was 15.2% (330/2173). The upgrade rate was 8.2% in patients showing mammographically documented complete removal of the lesion and 19% in patients without complete removal. Conclusion: The absence of mammographically documented residual lesion following VABB was found to be associated with a lower upgrading rate of DCIS to invasive carcinoma on surgical excision and should be considered when deciding the proper management DCIS diagnosis.

Abstract PS7-52: The upgrade risk to (pre-)invasive breast cancer for B3 lesions diagnosed on core needle or vacuum assisted biopsy. A Belgian retrospective study

Abstract Introduction: Flat epithelial atypia (FEA), classical lobular neoplasia (LN), papillary lesions (PL), radial scars (RS) and atypical ductal hyperplasia (ADH) are lesions of uncertain malignant potential in the breast, which are described as B3 lesions in the B classification system of the European Working Group for Breast Cancer Screening Pathology. Current standard for management of B3 lesions on core needle biopsy (CNB) or vacuum assisted biopsy (VAB), is wide local excision (WE). However, recent consensus-based guidelines no longer recommend WE for all such lesions, but propose surveillance following CNB or VAB to be sufficient in some cases. In the absence of a Belgian guideline on the treatment of B3 lesions, this study was conducted to identify which B3 lesions have the lowest likelihood for breast malignancy and could therefore be spared from WE. Methods: Using data from the Belgian Cancer Registry (BCR), all patients with a new diagnosis of a B3 lesion on CNB or VAB between 2013-2016 and who had a histological follow up with VAB or WE after CNB or WE after VAB were included. Histological follow-up was retrieved from BCR and limited to 12 months following diagnosis. Histology was compared between the first- and follow-up investigation to determine the upgrade risk to ductal carcinoma in situ (DCIS) or invasive breast cancer (IC) according to the type of B3 lesion. Patients with synchronous (pre-) invasive lesions were excluded. Results: Between 2013-2016 there were 812 B3 lesions available for upgrade analysis after initial diagnosis. After CNB 551 lesions had WE or VAB as follow up and after VAB 261 lesions had WE. After primary diagnosis on CNB, the total upgrade risk was 19,0%. There was histological agreement in 57,9% and no B3 lesion or upgrade was reported in 21,8%. Per B3 lesion subtype the upgrade risk to DCIS - IC after diagnosis on CNB was: ADH 17,1%-12,4%, FEA 21,1% - 18,4%, LN 18,9% -21,6%, RS 14,3% - 11,4%, and PL 7,2% - 3,2%. After initial diagnosis on VAB the total upgrade risk was 14,9%. There was histological agreement in 52,9% and no B3 lesion or upgrade was found in 31,4%. Per B3 subtype the upgrade risk to DCIS - IC after diagnosis on VAB was: ADH 17,3%- 2,7%, FEA 11,7%- 5,9%, LN 0,0% - 4,3%, PL 10,4% - 2,1%. We found no upgrade for RS. (Table 1). Conclusions: In a series of B3 lesions with a histological follow-up, we notice that overall upgrade risk is higher for lesions detected on CNB than on VAB: 19,0% vs. 14,9%. The majority of lesions showed histological agreement between initial B3 diagnosis and histological follow-up: 57,9% after CNB and 53,5% after VAB. More investigation is needed to make a proper risk assessment as to which B3 lesions can be followed with regular surveillance. Also, further prospective research is needed to get a better understanding of associated risk factors for upgrade, upgrade risk and lifetime risk of developing breast cancer after diagnosis of a B3 lesion. Table 1: Upgrade risk per B3 subtype after diagnosis on CNB or VABSubtypeNumberCNB followed by VAB or WEDCISICTotal Upgrade riskCNBNumberVAB followed by WEDCISICUpgrade riskVAB followed by WEADH10517,1%12,4%29,5%11017,3%2,7%20,0%FEA3821,1%18,4%39,5%5111,7%5,9%17,6%LN3718,9%21,6%40,5%460%4,3%4,3%PL3367,2%3,2%10,4%4810,4%2,1%12,5%RS3514,3%11,4%25,7%60%0%0%Total551261Upgrade105/55119,0%39/26114,9%B3 lesion319/55157,9%138/26152,9%No B3 lesion120/55121,8%82/26131,4%Result not available7/5511,3%2/2610,8% Citation Format: Nynke Willers, Patrick Neven, Giuseppe Floris, Cecile Colpaert, Eva Oldenburger, Sileny Han, Chantal Van Ongeval, Ann Smeets, Francois Duhoux, Hans Wildiers, Petra Denolf, Isabel De Brabander, Nancy Van Damme, Harlinde De Schutter. The upgrade risk to (pre-)invasive breast cancer for B3 lesions diagnosed on core needle or vacuum assisted biopsy. A Belgian retrospective study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS7-52.

Abstract PS2-42: Identify breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment - an international, multicenter analysis

Abstract Purpose: Neoadjuvant systemic treatment elicits a pathologic complete response (pCR) in an average of 35% of women with breast cancer. In such cases, breast surgery may be considered overtreatment. However, imaging and vacuum-assisted biopsy (VAB) alone showed high rates of missed cancer compared to standard breast surgery. We therefore evaluated multivariate algorithms using patient, tumor, and VAB variables to accurately identify patients with breast pCR. Methods: We developed and tested three multivariate approaches: elastic net regression, Support Vector Machines (SVM), and a deep neural network. We analyzed 452 patients, randomly partitioned into training and test samples (2:1 ratio), who participated in three prospective studies assessing the feasibility of VAB to accurately detect residual disease after neoadjuvant systemic treatment (NST). The studies were conducted at 23 sites in the United States, Germany, and South Korea. The trials enrolled women who presented with clinical stage I-III breast cancer of any biological subtype and a partial or complete response to NST confirmed by ultrasonography, mammography, or magnetic resonance imaging; all patients underwent guideline-adherent surgery. We compared the performance of the multivariate algorithms to the histopathologic evaluation of disease response in the surgical specimen (reference standard) - false-negative rate (FNR, missed residual cancer) and specificity (identification of breast pCR) were the main outcome measures. The best performing algorithm on the test set with respect to sensitivity and specificity was validated using data of an independent fourth trial. We compared the performance of the multivariate approaches to the performance of imaging and/or VAB. Results: In the test set (n=152), elastic net regression, SVM and the neural network revealed an FNR of 1.2% (1 of 85 patients with missed residual disease). Specificity of the elastic net regression was 46.3% (31 of 67 women with surgically confirmed breast pCR identified), of the SVM 62.7% (42 of 67) and of the neural network 67.2% (45 of 67). All multivariate algorithms performed better than imaging or VAB: FNR 25.9% (22 of 85) and 16.5% (14 of 85), respectively. Subsequent external validation (n=50) of the neural network algorithm showed a false-negative rate of 0% (0 of 27) and a specificity of 65.2% (15 of 23). The area under the ROC curve for the deep neural network was 0.97 (95% CI, 0.94 to 1.00). Analyzing the coefficients of the elastic net regression (regularized beta; ß) showed that the lesion diameter on imaging after NST (ß = 0.31) and VAB results (ß = 0.49) were the most important variables in the prediction of residual tumor. Other variables were also important: age (ß = 0.18), in-situ in the initial diagnostic (not VAB) biopsy (ß = 0.11), difficulties during the pathologic evaluation of the VAB specimen (ß = 0.11); needle size 7G (ß = -0.06, as opposed to 8G, 9G, 10G), multicentricity on imaging after NST (ß = 0.06), hormone-receptor positivity (ß = 0.01), and a clip marker positioned within the (former) lesion (ß = -0.01, as opposed to a clip marker positioned <5mm or >5mm from the lesion Conclusion: A multivariate algorithm can accurately select breast cancer patients without residual disease after neoadjuvant treatment. This finding may pave the way to study omission of breast surgery in these patients in the future. Performance of multivariate algorithms compared to imaging and vacuum-assisted biopsyFalse-negative rate - value (95% CI)Specificity - value (95% CI)Negative predictive value - value (95% CI)Positive predictive value - value (95% CI)Test set (n=152)Imaging25.9% (17.0-36.5%)61.2% (48.5-72.9%)65.1% (52.0-76.7%)70.8% (60.2-79.9%)VAB16.5% (9.3-26.1%)89.6% (79.7-95.7%)81.1% (70.3-89.3%)91.0% (82.4-96.3%)Imaging + VAB5.9% (1.9-13.2%)52.2% (39.7-64.6)87.5% (73.2-95.8%)71.4% (62.1-79.6%)Elastic net regression1.2% (0.0-6.4%)46.3% (34.0-58.9%)96.9% (83.8-99.9%)70.0% (61.0%-78.0%)Support Vector Machine1.2% (0.0-6.4%)62.7% (50.0 - 74.2%)97.7% (87.7-99.9%)77.1% (68.0-84.6%)Deep Neural Network1.2% (0.0-6.4%)67.2% (54.6-78.2%)97.8% (88.5-99.9%)79.3% (70.3-86.5%)Validation set (n=50)Deep Neural Network0.0% (0.0-12.8%)65.2% (42.7-83.6%)100% (78.2-100%)77.1% (59.9-89.6%) Citation Format: André Pfob, Chris Sidey-Gibbons, Han-Byoel Lee, Marios Konstantinos Tasoulis, Vivian Koelbel, Michael Golatta, Gaiane M. Rauch, Benjamin D. Smith, Vicente Valero, Fiona MacNeill, Wonshik Han, Walter Paul Weber, Geraldine Rauch, Henry Kuerer, Joerg Heil. Identify breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment - an international, multicenter analysis [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS2-42.

Abstract SP058: Exceptional responders to neoadjuvant chemotherapy - Pro

Abstract Increasing use of neoadjuvant systemic treatment (NST) and improved efficacy of treatment regimens have led to increasing numbers of patients without any detectable residual cancer upon surgery (pathologic complete response, pCR, ypT0, ypN0). For these exceptional responders to NST, invasive surgery may cause more harm than benefit and thus should be tailored to this response. For nodal disease, axillary lymph node dissection (ALND) used to be the standard of care for all patients but ALND causes relevant morbidity (i.g. lymphedema, pain, restricted mobility). Sentinel lymph node biopsy (SLNB) causes less morbidity but its use for patients receiving NST has been controversial. Based on rates of missed cancer (false-negative rate, FNR) compared to ALND, several current national guidelines recommend use of SLNB for patients undergoing NST with initial nodal negative disease (FNR about 7%; Shirzadi et al 2019, J Res Med Sci) and use of targeted axillary dissection (TAD; removal of clipped nodes plus SLNB) for patients with initial nodal positive disease converting to nodal negative disease after NST (FNR about 2%; Caudle et al 2016, J Clin Onc). However, while already implemented in clinical practice recurrence and survival data are still lacking for SLNB/TAD after NST. For the primary tumor in the breast, breast conserving surgery (BCS) is the current standard of care. The use of NST instead of adjuvant treatment has allowed for more patients to be treated with BCS instead of mastectomy with equal survival (EBCTCG 2018, Lancet Onc). Although BCS is a low morbidity procedure compared to other oncologic surgeries, also BCS causes morbidity relevant to patients: (1) About 30% of patients undergoing BCS and SLNB report moderate, persistent pain two years after surgery (Gärtner et al 2009, JAMA); (2) the reduction in patient-reported quality of life up to 8 years after surgery is comparable between patients undergoing BCS or mastectomy (Flanagan et al 2019, Ann Surg Onc). In the light of increasing ypT0 rates, current research evaluates alternative diagnostic procedures than BCS to identify these exceptional responders to NST who achieve ypT0. Imaging (ultrasound, mammography, MRI, PET-CT) is insufficiently accurate to reliably exclude residual disease (FNR about 20% for US and mammography) and/ or specificity is suboptimal (MRI, PET-CT) (Fowler et al 2017, Radiology). Vacuum-assisted biopsies (VAB) showed promising results in some pilot trials (FNR about 5%; Heil et al 2016, Eur J Cancer and Kuerer et al 2018, Ann Surg) which could however not be confirmed in larger multicenter trials (FNR about 18%; Heil, Pfob et al 2020, Ann Surg). Recent exploratory analyses using machine learning algorithms to combine VAB with patient and tumor data could decrease the FNR to ~3% while maintaining good specificity (Pfob et al 2020, ASCO meeting). However, we do not know yet to which extend these FNR would influence local recurrence or survival rates when omitting breast surgery for these exceptional responders to NST. In summary, several less invasive and therefore less morbidity causing procedures are currently evaluated to identify exceptional responders to NST to spare them surgery-associated morbidity in the axilla and breast. TAD to identify ypN0 patients showed an FNR <2% in prospective trials and survival outcome analyses in these cohorts are underway. VAB combined with patient and tumor data to identify ypT0 patients showed promising results (FNR around 3%) in exploratory analyses but needs further prospective validation before trials with oncological endpoints should be considered. The topic is worth to be studied further to decrease potentially unnecessary treatment burden for patients, providers, and health care systems. Citation Format: J Heil. Exceptional responders to neoadjuvant chemotherapy - Pro [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr SP058.

Development of a novel framework to evaluate the localization accuracy of tomosynthesis-guided breast biopsy units.

To develop a scheme to quantitatively assess localization accuracy of tomosynthesis-guided vacuum-assisted breast biopsy apparatus. A phantom containing a metallic pellet on a flexible plastic shaft was constructed and was tested in cranio-caudal (CC) and lateral (LAT) arm biopsy geometries following the standard clinical breast biopsy workflow. Three points were manually digitized on tomosynthesis images including: the center of the target, and the tip of the needle in pre- and postfire positions. The needle trajectory was determined and four error metrics were defined: (1) stroke length error (difference between the nominal and measured stroke lengths); (2) Euclidian distance between the target and center of trough (i.e., aperture); (3) longitudinal distance between target and center of trough; and (4) lateral distance between target and needle. The proposed methodology was also evaluated on a breast gel phantom and the complete biopsy procedure, including vacuum-assisted biopsy was performed. Three biopsy geometries were investigated: (i) LAT arm on a prone table unit (Hologic, Affirm Prone), (ii) CC- and (iii) LAT arm in an upright unit (Hologic Affirm Upright). Both biopsy units passed the vendor-provided daily localization accuracy test, with <1mm nominal error in each dimension. The aforementioned error metrics (1) to (4) were (0.6, 1.8, 0.4, 1.7) mm, (0.4, 4.2, 4.1, 1.1) mm, and (0.3, 2.4, 0.7, 2.3) mm, respectively, for geometry-I, -II, and -III. The gel phantom was tested on the upright unit with lateral arm and the error metrics (1) to (4) were 0.4, 2.5, 0.8, and 2.4mm respectively. A framework was developed to evaluate the tomosynthesis-guided breast biopsy localization error, allowing quantitative comparisons between different systems and biopsy configurations. The proposed framework can also be extended to the stereotactic breast biopsy units. We suggest that a quantitative tolerance level for localization accuracy of breast biopsy units be established.

Ultrasound-Guided Vacuum-assisted Biopsy Versus Surgical Resection in Patients With Breast Desmoid Tumor

BackgroundRecent studies suggest that desmoid tumors can be managed more conservatively rather than undergoing wide surgical resection (SR). Ultrasound-guided vacuum-assisted biopsy (UGVAB) is a minimally invasive technique. This retrospective study aimed to compare the outcome in patients with breast desmoid tumor (BDT) who received UGVAB alone versus SR. Materials and methodsThe pathology database was searched for patients diagnosed with BDT ≤ 3 cm from 2007 to 2019. All patients underwent breast ultrasound examination and were then performed UGVAB alone or local SR. The Kaplan–Meier method with a log-rank test was used as a univariate analysis to compare the relapse-free survival (RFS) rates between UGVAB and SR groups. Cox regression analysis was used for multivariate analysis. ResultsA total of 39 patients were included. The median follow-up was 41 mo (range, 5-110 mo). The incidence of tumor recurrence was 23.1% (9/39). The 3-y cumulative RFS was 83.1% and 95.8% in the UGVAB and SR group, respectively, which was not significantly different between the two groups (P = 0.131, log-rank test). Multivariate analysis also revealed that treatment strategy (UGVAB versus SR) was not associated with an increased risk of relapse events (P = 0.274). ConclusionsSmall desmoid tumors (≤3 cm) after UGVAB alone did not have a significantly compromised RFS compared with those who underwent SR. UGVAB may be an alternative and relatively conservative method for the diagnosis and local control of BDT with a smaller size. A prospective, randomized study with large sample size is needed to confirm this observation.

Long-term MRI-guided vacuum-assisted breast biopsy results of 600 single-center procedures.

The objective of this study is to report on the performance of the MRI-guided VABB in our center and to look at the long-term outcome of biopsies with benign histology over a period of 19 years. In a single-center retrospective review study, data of 600 VABB procedures performed between September 1999 and March 2017 were evaluated. We collected patient demographics, histopathological diagnosis at MRI-VABB, and basic lesion characteristics (size, location). Data from the Belgian Cancer Registry was cross-referenced with our database to find out which patients with benign MRI-VABB results developed a malignant lesion over time. These 600 VABB procedures were performed in 558 women with a mean patient age of 51.8 years (range 18-82 years). Our technical success rate was 99.3%. We found 27.67% B5 lesions, 9.82% B3 lesions, and 0.17% B4 lesions. Of 362 benign MRI-guided VABBs, follow-up data was available for a mean follow-up period of 7.6 years (0.8-18.3). Only one (0.3%) biopsy was a false negative lesion after MRI-guided VABB during follow-up. Short-term FU-MRI provided no increase in detection rate. The accuracy of MRI-guided VABB is high with a very low false negative rate of 0.3% on long-term follow-up. The value of short-term FU-MRI for every case after MRI-guided VABB may be questioned. • MRI-guided vacuum-assisted breast biopsies yield a large portion of clinically relevant lesions (9.82% B3, 0.17% B4, and 27.67% B5 lesions). • The false negative biopsy rate of MRI-guided VABB in this study with a mean follow-up time of 7.6 years was only 0.3%. • Performing a short-term follow-up MRI after a benign MRI-guided VABB concordant to the MRI appearance may be questioned.

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.

A difficult-to-diagnose fibromatosis-like metaplastic carcinoma of the breast: a case report

BackgroundFibromatosis-like metaplastic carcinoma (FLMCa), classified as a metaplastic carcinoma of the breast, is a very rare type of metaplastic carcinoma. We report a case of FLMCa that was difficult to diagnose.Case presentationThe patient was a 56-year-old postmenopausal woman who presented with a left-sided breast mass. A 1.3-cm irregular mass was found in the lower outer quadrant of the left breast on breast ultrasonography. She underwent core needle biopsy and vacuum-assisted biopsy, but the pathological findings only revealed inflammatory cell infiltration and a high level of fibrosis, with no malignant findings. At 3 months follow-up, she underwent a repeat breast ultrasonography, which revealed an increase in the size of the mass to 1.8 cm, and a repeat core needle biopsy, which showed a few spindle cells and squamous cells positive for cytokeratin (CK)5/6 and AE1/AE3, leading to the suspicion of FLMCa. Since the amount of tissue was insufficient to establish a definitive diagnosis, she underwent a lumpectomy. We found low-grade and slightly atypical spindle cells and partly atypical spindle cell carcinoma and squamous cell carcinoma. CK5/6 and α-SMA were positive, thus confirming FLMCa. Because the margins on the edge of the nipple side and anterior side were “ink on tumor”, she underwent a mastectomy and sentinel lymph node biopsy. After the surgery, she received adjuvant chemotherapy. At 3 years and 8 months of follow-up, no recurrent or metastatic lesions were identified in her body.ConclusionsFLMCa should be considered in the differential diagnosis when collagenous fibers are proliferating and malignancy is clinically suspected. Immunohistochemical analysis may be helpful in confirming this diagnosis.

Diagnostic accuracy of tomosynthesis-guided vacuum assisted breast biopsy of ultrasound occult lesions

This study aims to evaluate the diagnostic accuracy of digital breast tomosynthesis-guided vacuum assisted breast biopsy (DBT-VABB) of screening detected suspicious mammographic abnormalities comprising of calcifications, asymmetric densities, architectural distortions and spiculated masses. In this institutionally approved study, a total of 170 (n = 170) DBT-VABB were performed, 153 (90%) were for calcifications, 8 (4.7%) for spiculated mass, 5 (2.9%) for asymmetric density and 4 (2.4%) for architectural distortion. All these lesions were not detected on the corresponding ultrasound. Histopathology results revealed 140 (82.4%) benign, 9 (5.3%) borderline and 21 (12.4%) malignant lesions. The total upgrade rate at surgery was 40% for atypical ductal hyperplasia and 5.9% for ductal carcinoma in-situ. 3.6% discordant benign lesions showed no upgrade. DBT-VABB showed 100% specificity, 91.3% sensitivity and 100% positive predictive value (PPV) for detecting malignant lesions. The negative predictive value (NPV) was 80%. 2 (1.2%) patients had mild complications and 1 (0.6%) had severe pain. Our study showed that DBT-VABB was a safe and reliable method, with high sensitivity, specificity, PPV and NPV in the diagnosis of non-palpable benign and malignant breast lesions. Our data also confirmed the accuracy of DBT-VABB in detecting malignant lesions and we suggest further surgical excision in borderline lesions for a more accurate diagnostic evaluation.

Vacuum-assisted breast biopsy of microcalcifications on the stereotactic prone table and comparison of the histopathologic diagnosis with mammographic features

Aim: Breast cancer is one of the most important causes of mortality and morbidity in women. With the widespread use of screening mammography, the detection of non-palpable suspected cancerous lesions is increasing. Therefore, the use of vacuum-assisted breast biopsy in the management of breast lesions continues to increase. The aim of this study was to evaluate the histopathological results of suspicious microcalcifications which were diagnosed by vacuum-assisted needle biopsy on a stereotactic prone table and to compare the mammographic features of the microcalcifications with the histopathological results. Materials and Methods: The study included a total of 119 patients with a median age of 51 years (range, 33-77 years) who underwent stereotactic biopsy on a prone table because of suspicious microcalcifications between March 2010 and July 2014. Retrospective evaluation was made of the preoperative mammographic features, and the BI-RADS (Breast imaging-reporting and data system) scores of the microcalcifications and the vacuum biopsy and / or excisional histopathological results. Results: Stereotactic vacuum-assisted breast biopsy revealed that 52.1% of the lesions were benign and 47.9% were malignant. After vacuum-assisted stereotactic biopsy 61 patients underwent surgery. In 10 of these (16.3%) the final excisional histopathological diagnosis was benign, and in 51 (83.7%) malignancy was determined. Conclusion: Vacuum-assisted breast biopsy on a stereotactic prone table is a successful technique with a low failure rate for microcalcifications that are non-palpable and have no ultrasonographic findings.

VAB and MRI Following Percutaneous Ultra-Sound Guided Cryoablation for Primary Early-Stage Breast Cancer: A Pilot Study in Japan

Objective: This study aimed to evaluate the feasibility, safety, and cosmetic outcomes of percutaneous cryoablation (PCA) of breast intraductal carcinoma (IDC) lesions, as well as post-cryoablation magnetic resonance imaging (MRI) as a follow-up tool for detection of residual malignancies and local recurrences. Methods: Eight female patients underwent percutaneous ultrasound-guided cryoablation of breast IDC tumors under local anesthesia without subsequent resection. All patients received radiation- and endocrine therapies (RT, ET). The patients were followed using vacuum-assisted biopsy (VAB), mammography (MG), magnetic resonance imaging (MRI), and Moire Topography for cosmetic outcomes. VAB was performed 6 months following cryoablation treatment for cases 1 and 2 (after starting radiation- and endocrine-therapies) or one month after PCA (cases 3, 4, 5, 6 and 7), prior to RT and ET. One patient declined VAB. Results: Mean age of the patients was 61.9 years, SD 7.7, ages range 53 - 72 years. Mean tumor size was 10.3 mm, SD 2.74, ranged 6.8 - 14.5 mm, median follow-up time was 28 months (range 13 - 34 months). No residual or recurrent malignancies were detected. One minor adverse event was observed: A skin redness in the ablated area; MRI at one-month post-cryotherapy showed various degrees of thermal burns in all patients in the pectoralis major muscle, which were not symptomatic and were resolved by 6 months following PCA. Decrease of fat necrosis areas in the vicinity of ablated ex-tumor was traced with MRI (mean size 54.9 mm, mean decrease after 2 years was 58%) and validated with VAB. Conclusions: Percutaneous cryoablation of early-stage low-risk breast cancer tumors smaller than 15 mm potentially presents a potential substitute for lumpectomy, offering encouraging short- to mid-term oncology results with good cosmesis outcomes. Patients would be able to benefit from local anesthesia in an outpatient setting and a shorter recovery period.

Ultrasound-Guided Laser Ablation After Excisional Vacuum-Assisted Breast Biopsy for Small Malignant Breast Lesions: Preliminary Results.

Background:The purpose of this preliminary study is to evaluate the feasibility of the excisional ultrasound (US) guided vacuum-assisted breast biopsy (VAE), followed by US-guided Laser Interstitial Thermal Therapy (LITT) in the treatment of unifocal ductal breast carcinomas ≤ 1 cm and estimate the ablation rate analyzing the final histopathological results after subsequent surgical excision.Methods:In a single session 11 female patients with unifocal less than a centimeter breast cancer underwent 2 different minimally invasive percutaneous US-guided techniques: a VAE breast biopsy with an 8 G needle to remove the lesion and, immediately after, a LITT ablation in the biopsy site. Four weeks later, all patients underwent radiological follow-up. Afterward, a systematic surgery was performed, the ablation rate was calculated, and iconographic and histological features were correlated.Results:Average maximum diameter of the lesions was 7.6 mm (5-10 mm). No patient reported pain or discomfort during procedure. 1/11 patient (9.1%) reported an early minor complication (a small superficial skin burn). After surgical excision, the histopathological evaluation reported in 10/11 cases (90.9%) complete ablation of the target lesion. In only one case (9.1%) residual cancer was detected. The necrotic-hemorrhagic cavities showed a mean maximum diameter of 27.3 mm (20-35 mm).Conclusions:Laser ablation performed after excisional biopsy could be considered a valid alternative to surgical excision for the treatment of lesions ≤ 1 cm, if carried out by expert radiologists. The association of these minimally invasive percutaneous methods has proven to be reliable, fast, and safe with an ablation rate of 90.9% and excellent aesthetic results. RM and CESM are potentially able to quantifying treatment results and to follow-up the ablation effects.

Evaluating the usefulness of breast strain elastography for intraductal lesions

PurposeStrain elastography for imaging lesion stiffness is being used as a diagnostic aid in the malignant/benign discrimination of breast diseases. While acquiring elastography in addition to B-mode images has been reported to help avoid performing unnecessary biopsies, intraductal lesions are difficult to discriminate whether they are malignant or benign using elastography. An objective evaluation of strain in lesions was performed in this study by measuring the elasticity index (E-index) and elasticity ratio (E-ratio) of lesions as semi-quantitative numerical indicators of the color distribution of strain. We examined whether ductal carcinoma in situ (DCIS) and intraductal papilloma could be distinguished using these semi-quantitative numerical indicators.MethodsIn this study, 170 ultrasonographically detected mass lesions in 162 cases (106 malignant lesions and 64 benign lesions)—in which tissue biopsy by core needle biopsy and vacuum-assisted biopsy, or surgically performed histopathological diagnosis, was performed—were selected as subjects from among 1978 consecutive cases (from January 2014 to December 2016) in which strain elastography images were acquired, in addition to standard B-mode breast ultrasonography, by measuring the E-index and E-ratio.ResultsThe cut-off values for E-index and E-ratio in the malignant/benign discrimination of breast lesions were determined to be optimal values at 3.5 and 4.2, respectively, based on receiver operating characteristic (ROC) curve analysis. E-index sensitivity, specificity, accuracy, and AUC value (area under the curve) were 85%, 86%, 85%, and 0.860, respectively, while those for E-ratio were 78%, 74%, 74%, and 0.780, respectively. E-index yielded superior results in all aspects of sensitivity, specificity, accuracy, and AUC values, compared to those of E-ratio. The mean E-index values for malignant tumors and benign tumors were 4.46 and 2.63, respectively, indicating a significant difference (P < 0.001). E-index values of 24 DCIS lesions and 25 intraductal papillomas were 3.88 and 3.35, respectively, which showed a considerably close value, while the false-negative rate for DCIS was 29.2%, and the false-positive rate for intraductal papilloma was as high as 32.0%.ConclusionE-index in strain elastography yielded better results than E-ratio in the malignant/benign discrimination of breast diseases. On the other hand, E-index has a high false-negative rate and false-positive rate for intraductal lesions, a factor which should be taken into account when making ultrasound diagnoses.

Unusual Presentation of a Post-procedural Breast Hematoma: A Case Report

Hematoma is the most frequent complication after Vacuum-Assisted Breast Biopsy (VABB) in 13% of cases. A direct communication channel with patients eases the diagnosis of VABB complications and ensures treatment at an early stage, as outpatients, in most cases. In 2020, due to the COVID-19 pandemic, we observed a reduction of self-reported postoperative complication leading to delay in the identification of harmful complications, therefore leading to need for more invasive treatment. A 50-year-old patient was admitted to the Emergency Department for dry cough, fever, chest discomfort, dyspnea, and slight confusion four days after VABB. Due to the reported symptoms, the patient was sent to our COVID-19 Emergency Department. The COVID-19 swab was negative. Ultrasound revealed a large hematoma at the biopsy site, with active bleeding. Open evacuation with accurate hemostasis was planned with rapid and complete resolution of the clinical symptoms. After surgery, the patient reported that she intentionally avoided admittance in the hospital due to the risk of COVID-19 infection. The patient was discharged in the first postoperative day and maintained in quarantine for 14 days. In the COVID-19 era due to the risk of hospital cross-infections, reduction of patient-doctor communication could lead to misdiagnosis, delay in recognition of procedural complications thus leading to requirement for invasive treatment, hospitalization, while also further multiplying the risk of COVID-19 infection.

Detection rate of breast malignancy of needle localization biopsy of breast microcalcification.

Objective:The current study aimed to retrospectively assess the cancer detection rate of needle localization biopsy of breast microcalcifications undetectable on sonography.Materials and Methods:Patients who underwent mammography-guided needle localization biopsy of breast microcalcifications undetectable on sonography from January 2005 to December 2017 were included in the study. Patients with incomplete medical records were excluded from the study. Patient mammograms were categorized using the Breast Imaging-Reporting and Data System (BI-RADS) assessment criteria. The percentages of benign and malignant lesions were determined by pathological examination of surgically recovered specimens. Correlation between preoperative imaging assessment and final diagnosis was investigated, and the complications associated with the procedures were recorded.Results:A total of 301 needle-localized biopsies were performed under mammographic guidance. The mean age of the patients was 58.18 ± 7.73 years. The overall ductal carcinoma in situ (DCIS) and cancer detection rate was 23.3%. The proportion of patients with BI-RADS 0 category and undergoing second mammography was higher in the DCIS and cancer group. A total of 227 patients did not undergo second mammography. Of these patients, 70 demonstrated BI-RADS 4 category, 34 were diagnosed with DCIS, and 5 were diagnosed with breast cancer during subsequent follow-up.Conclusion:Needle-localized excision of microcalcifications undetectable on sonography has high detection rate for early stage of breast cancer with low risk of associated complications. Regular mammography is a satisfactory follow-up tool for female patients with microcalcifications in the breasts. Additional studies should be performed to compare between needle-localized excision and vacuum-assisted breast biopsy.

Effect of digital breast tomosynthesis on stereotactic vacuum-assisted breast biopsy

Effect of digital breast tomosynthesis on stereotactic vacuum-assisted breast biopsy