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

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. KEY POINTS: • 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.

Clinical performance of Siemens digital breast tomosynthesis versus standard supplementary mammography for the assessment of screen-detected soft-tissue abnormalities: a multi-reader study.

AIM: To compare the diagnostic accuracy of standard screening images plus single-view digital breast tomosynthesis (DBT), using Siemens DBT equipment, with standard screening images plus supplementary mammographic views in non-calcific, screen-detected mammographic abnormalities. MATERIALS AND METHODS: Participants were unselected women aged 50-69 years recalled within a population-based European breast screening programme for assessment of soft-tissue mammographic abnormalities. Supplementary mammographic views (SMVs) and DBT were performed in all cases. A range of equipment was used for screening and supplementary mammography, but all DBT examinations were performed using the Siemens Mammomat Inspiration. A retrospective multi-reader study including 238 cases for whom either histology or at least 2 years' follow-up was available was performed with eight suitably accredited UK breast screening personnel reading all cases under both conditions, with temporal separation. Readers were blinded to case outcomes and findings from other examinations. Diagnostic accuracy using receiver operating characteristic (ROC) analysis was compared between screening plus SMV images and screening plus DBT images. The study was powered to detect a 3% inferiority margin in diagnostic accuracy between methods. RESULTS: The final sample with complete data available for analysis included 195 benign cases (1,560 reads) and 35 malignant cases (280 reads). The DBT method yielded a slightly higher area under the curve (AUC) value than the SMV method (0.870 versus 0.857), but the difference was not statistically significant (p=0.4890), indicating that the methods have equivalent accuracy. CONCLUSION: Siemens DBT demonstrates equivalent diagnostic accuracy according to ROC curve analysis when used in place of SMVs in screen-detected soft-tissue mammographic abnormalities.

Conclusions for mammography screening after 25-year follow-up of the Canadian National Breast Cancer Screening Study (CNBSS).

UNLABELLED: Twenty-five-year follow-up data of the Canadian National Breast Cancer Screening Study (CNBSS) indicated no mortality reduction. What conclusions should be drawn? After conducting a systematic literature search and narrative analysis, we wish to recapitulate important details of this study, which may have been neglected: Sixty-eight percent of all included cancers were palpable, a situation that does not allow testing the value of early detection. Randomisation was performed at the sites after palpation, while blinding was not guaranteed. In the first round, this "randomisation" assigned 19/24 late stage cancers to the mammography group and only five to the control group, supporting the suspicion of severe errors in the randomisation process. The responsible physicist rated mammography quality as "far below state of the art of that time". Radiological advisors resigned during the study due to unacceptable image quality, training, and medical quality assurance. Each described problem may strongly influence the results between study and control groups. Twenty-five years of follow-up cannot heal these fundamental problems. This study is inappropriate for evidence-based conclusions. The technology and quality assurance of the diagnostic chain is shown to be contrary to today's screening programmes, and the results of the CNBSS are not applicable to them. KEY POINTS: • The evidence base of the Canadian study (CNBSS) has to be questioned.• Severe flaws in the randomization process and test methods occurred. • Problems were criticized during and after conclusion of the trial by experts.• The results are not applicable to quality-assured screening programs. • The evidence base of this study must be re-analyzed.

[Mammography screening in Germany. Current results and future challenges]. / Mammographiescreening in Deutschland. Aktuelle Ergebnisse und zukünftige Herausforderungen.

The concept of mammography screening is based on the expectation that early diagnosis in a preclinical tumor stage enables less invasive treatment with a better prognosis than detection in advanced tumor stages. Mammography screening was implemented in European countries after results from large randomized controlled trials showed that regular screening led to a significant reduction in breast cancer mortality by 25-30 %. Recently, a major review of breast cancer screening services in Europe concluded that the benefits of screening clearly outweighed the disadvantages. In comparison to other European screening nations the German mammography screening program is relatively new. The challenge to prove the effectiveness by reduction in mortality still has to be solved. Continuous evaluation and optimization concerning the quality of structure, processes and results already confirm the high quality of the nationwide German screening services.

[Changes in therapy for breast cancer patients as a result of mammography screening. An analysis of Bavarian cancer registry data from 2000 to 2008]. / Veränderungen der Therapie des Mammakarzinoms in Bayern seit Einführung des Mammografie-Screenings. Eine Analyse bayerischer Krebsregisterdaten der Jahre 2000 bis 2008.

PURPOSE: A quality controlled mammography screening programme was initiated at the end of 2003 in Bavaria, a region with 12.5 million inhabitants, and transferred over to the national screening programme at the end of 2006. The purpose of this study was to evaluate immediate population-based consequences of mammography screening on breast cancer therapy. METHODS: Data from 75 475 breast cancer cases, diagnosed between 2000 and 2008 and registered in one of the 6 Bavarian clinical cancer registries were analysed. 51.4% of these patients were between 50 and 69 years of age and therefore the target population for screening. Trends of prognostic factors and standard therapies were calculated for 3 age groups (≤49 years, 50-69 years, ≥70 years) by means of annual percentages as well as 95%-confidence intervals for the percent difference between 2000 and 2008 (year of diagnosis). For interpretation of therapy trends, logistic regression models were calculated. RESULTS: Therapy trends showed that the increasingly favourable stage distribution may have resulted in the reduction of more radical surgical methods such as mastectomy (2000: 32.6%; 2008: 19.6%) or axillary dissection (89.0% vs. 37.0%), especially for women aged 50-69. An increase of radiation therapies (59.7% vs. 66.6%) can be explained to some extent by the increase in breast conserving surgeries. The shift to more favourable prognostic factors led, in accordance with the guidelines, to an increase of the proportion of singular endocrine therapies (28.5% vs. 40.7%), a decrease of chemotherapies (20.4% vs. 13.1%) and therefore to more gentle systemic therapies overall. These trends strengthened in the years following the introduction of screening, with a simultaneous rise of screening participants in the target population. CONCLUSION: The introduction of mammography screening in Bavaria has already shown the expected trend towards more favourable prognostic factors. Among other things, this could be a reason for the increasing use of more gentle therapies. Whether the screening in Bavaria leads to a mortality reduction, has to be analysed on the basis of an initial comparison of participation status followed by the trends in mortality thereafter.

[Diagnostic image quality of mammograms in german outpatient medical care]. / Die diagnostische Bildqualität von Mammografien in der vertragsärztlichen Versorgung Deutschlands.

PURPOSE: A total of 79115 mammograms from statutory health insurance (SHI) physicians within German outpatient care were evaluated with respect to the diagnostic image quality. MATERIALS AND METHODS: Mammograms were randomly selected between 2006 and 2008 by the regional Associations of Statutory Health Insurance Physicians and submitted to regional boards of experts for external evaluation. The mammogram quality was evaluated using a 3-point scale (adequate, borderline, failure) and documented using a nationally standardized protocol. RESULTS: 87.6% of the mammograms were classified as adequate, 11.0% as borderline and 1.4% as failure. Mediolateral oblique mammograms (mlo) had worse ratings than craniocaudal mammograms (cc). Main reasons for classifying the mammograms as borderline or failure were "inframammary fold not adequately visualized" (mlo), "pectoral muscle not in the correct angle or not to the level with the nipple" (mlo), "the nipple not in profile" (mlo, cc) and "breast not completely or not adequately visualized" (cc). CONCLUSION: The results show a good overall quality of mammograms in German outpatient medical care. Failures can be associated predominantly with incorrect positioning of the breast. More precisely defined quality criteria using objective measures are recommended, especially for craniocaudal mammograms (cc).

[Mammography screening. Concept, quality assurance and interdisciplinary cooperation]. / Mammographie-Screening. Konzept, Qualitätssicherung und interdisziplinäre Zusammenarbeit.

In 2005/2006 the German National Mammography Screening Program was initiated and has now become established. The objective is to reduce breast cancer mortality and the early diagnosis and therapy of small cancers. The program follows the European guidelines and is controlled by over 30 parameters of quality. All trained members of the team document each step of the screening chain electronically. Histological assessment (HA) is recommended in up to 2% of examinations, 90% of HAs are performed by core needle biopsy (CNB) or by stereotactic vacuum-assisted biopsy (VABB). Open diagnostic biopsies are performed in <10% of all HAs and therapy is successful in some of the B3 lesions. Mammograms are interpreted by two independent readers. Recommendations of the regular interdisciplinary conferences, preoperative and postoperative, follow the European guidelines. About 45% of all breast cancers detected by screening are in-situ or less than 10 mm in size. The 17% alterations diagnosed by needle biopsy are B3 or B4 lesions and impose high demands on the pathologists and the interdisciplinary team. Due to the many early and discrete lesions counterchecking of representative biopsies is crucial. Problems may be caused by sampling error or partial volume effects. Interdisciplinary conferences and knowledge of the limitations of each discipline and method are needed to optimize diagnostic and therapeutic decisions.

[Guideline for the Early Detection of Breast Cancer in Germany 2008. Recommendations from the short version]. / Stufe-3-Leitlinie Brustkrebs-Früherkennung in Deutschland 2008 : Auszug aus der Kurzfassung: Handlungsempfehlungen.

The updated 2008 German Guideline for Early Detection of Breast Cancer provides evidence-based and consensus-based recommendations of the knowledge gained by the German Society for Surgery and the German Society of Plastic, Aesthetic, and Reconstructive Surgeons together with 29 professional societies, associations, and nonmedical organizations. The guideline is meant to assist physicians, healthy women, and patients in medical decisions with recommendations regarding the diagnostic chain in early detection of breast cancer. In addition to these recommendations, the guideline also includes descriptions of quality assurance for resources, procedures, outcomes, and evaluation using a set of quality indicators. It updates the previous version from 2003. The guideline's recommendations are presented. They are described in detail in the full publication (in German) Geburtsh Frauenh 2008; 68:251-261. The long version of the Guideline, methods report, and evidence report are available on the internet at www.awmf-leitlinien.de (reg. no. 077/001) with free access.

[Experiences of the Bavarian mammography screening program]. / Erfahrungen aus dem Bayerischen Mammographie-Screening-Programm.

The Bavarian Mammography Screening Program started in April 2003. A detailed analysis of the consistency of diagnosis in the evaluation of vacuum-assisted stereotactic or core needle breast biopsies is presented. A total of 32 pathologists participated in a blinded evaluation of the biopsies. Each case was evaluated independently by two participating pathologists. A total of 1,357 cases were reviewed. The histopathological reports of the biopsies made by the two consulting pathologists were compared. The concordance rate of the first and second consulting pathologist was 93% for the B-classification. In general, the level of diagnostic agreement was very high for well defined, benign and malignant lesions. Some of the discrepancies resulted from the incorrect application of the B-classification. Discrepancies in the reports were also due to divergent interpretation of benign and "borderline" lesions. The protocol for the blinded evaluation of breast biopsies in two rounds assured a high level of quality. In conclusion, prerequisites for the success of a mammography screening program are interdisciplinary consensus conferences and audit rounds involving pathologists.

MR-guided intervention in women with a family history of breast cancer.

OBJECTIVE: A study was undertaken to assess the clinical value of magnetic resonance (MR) imaging-guided interventions in women with a family history, but no personal history of breast cancer. METHODS AND PATIENTS: Retrospective review was performed on 63 consecutive women who had a family history, but no personal history of breast cancer. A total of 97 lesions were referred for an MR-guided intervention. Standardized MR examinations (1.0 T, T1-weighted 3D FLASH, 0.15 mmolGd-DTPA/kg body weight, prone position) were performed using a dedicated system which allows vacuum assisted breast biopsy or wire localization. RESULTS: Histologic findings in 87 procedures revealed 9 (10%) invasive carcinomas, 12 (14%) ductal carcinomas in situ, 2 atypical ductal hyperplasias (2.5%) and 2 atypical lobular hyperplasias (2.5%). Sixty-two (71%) benign histologic results are verified by an MR-guided intervention, retrospective correlation of imaging and histology and by subsequent follow-up. In ten lesions the indication dropped since the enhancing lesion was no longer visible. Absent enhancement was confirmed by short-term re-imaging of the noncompressed breast and by follow-up. CONCLUSION: Malignancy was found in 24%, high-risk lesions in 5% of successfully performed MR-guided biopsy procedures. A 57% of MR-detected malignancies were ductal carcinoma in situ. In 10% of the lesions the intervention was not performed, since no enhancing lesion could be reproduced at the date of anticipated intervention. Such problems may be avoided if the initial MRI is performed in the appropriate phase of the menstrual cycle and without hormonal replacement therapy.

[Bavarian mammography screening program]. / Bayerisches Mammographiescreening (BMS).

In Bavaria since the 1st April 2003 we have been conducting a high quality mammography-screening carried out in individual practises (BMS). We have used the European and the S 3 guidelines. The best diagnosis is an early diagnosis of the breast carcinoma to save human life. Because of this and the high mortality rate due to this disease it is essential to have a mammogram screening program. There is no single one ideal way of constructing a screening program, it is always based on compromise within the particular health care-systems. Arising problems cannot be avoided, it is only possible when all parties work closely together that the BMS works properly.

[Clip marker placement following MR-guided vacuum biopsy of the breast]. / Clipmarkierung nach MRT-gesteuerter Vakuumbiopsie der Mamma.

PURPOSE: The purpose of our study was to determine the placement accuracy, usefulness as a guide for wire localization, and long-term stability of tissue marker clips following MR-guided vacuum-assisted biopsy (VB) of breast lesions. METHODS: During a 2-year period, MR-guided VB with an 11-gauge device was performed in 79 lesions. In 26 lesions a marker clip was placed at the biopsy site. RESULTS: In 18 cases, the clip was shown to be closely adjacent to the lesion on post-interventional MR images. In seven cases in which minor bleeding occurred, the clip dislocated (< or =15 mm) in the direction of the needle pathway. In one case dislocation in the dorsal direction (< or =5 mm) was observed. In eight cases with a malignant or borderline histology according to the VB, the marker clips served as targets for mammographically guided wire localization. In all of those patients, histology results derived from open surgery confirmed those of VB. Eighteen patients with benign findings according to the VB were followed up 6 months later. Among these cases we found a significant displacement of the marker clip in one case (3 cm). The clip generally caused a round artifact (diameter of 9+/-2 mm). In two cases it was not possible to determine whether the lesion had been removed completely or was just behind the artifact caused by the clip. CONCLUSION: Based on our results, clip marker placement following MR-guided vacuum biopsy should be called into question due to the possibility of masking the lesion by a metallic artifact and because of possible dislocation.

Success of sentinel lymph node mapping after breast cancer ablation with focused microwave phased array thermotherapy.

BACKGROUND: Breast cancer tumor ablation as part of a multimodality approach in the treatment of breast cancer is the subject of recent interest. This study was conducted to determine if the ability to perform sentinel node biopsy was impaired after thermal-induced ablation of breast cancer. METHODS: We studied patients who had sentinel node biopsy after preoperative focused microwave phased array for breast cancer ablation. RESULTS: Twenty-one patients with T1-T2 breast cancer and clinically negative axilla underwent wide local excision and sentinel node biopsy guided by blue dye and sulfur colloid. Surgery was done an average of 17 days after microwave ablation. Fifteen of 22 patients (68%) had histologic evidence of tumor necrosis. Sentinel lymph node mapping was successful in 19 of 21 patients (91%). Axillary metastases were detected in 42% of cases. CONCLUSIONS: This study documents successful sentinel lymph node mapping for patients treated with antecedent local tumor ablation using focused microwave phased array ablation.

Interdisciplinary consensus on the use and technique of vacuum-assisted stereotactic breast biopsy.

PURPOSE: Quality assurance of stereotactic vacuum-assisted breast biopsy (VB). METHOD: A consensus was achieved based on the existing literature and the experience of VB users (Ethicon Endosurgery, Norderstedt). RESULTS: The imaging work-up must be completed according to existing standards before an indication for stereotactic VB is established. Indications include microcalcifications and small non-palpable masses; for the time being lesions very close to the skin and architectural distortions (radial scar) are considered less suitable. Acquisition of >20 cores (11 Gauge) should be routinely attempted (goals: as complete a removal of small lesions as possible, thereby increasing diagnostic confidence and reducing so-called 'underestimates'). The pre/post-fire and post-biopsy stereotactic images and a post-biopsy orthogonal mammogram must be documented. All cases with no or uncertain histopathological correlation require discussion in a regular interdisciplinary conference and a documented consensus concerning further work-up or therapy. Standardised documentation of the primary findings and follow-up mammography after approximately 6 months is requested. CONCLUSION: This consensus includes protocols for the establishment of an indication, performance indicators, interdisciplinary interpretation and therapeutic recommendation, documentation and follow-up. It does not replace official recommendations for percutaneous biopsy.

Follow-up of breast lesions detected by MRI not biopsied due to absent enhancement of contrast medium.

Our objective was to follow-up patients in whom scheduled MR-guided vacuum biopsies for suspicious lesions were aborted due to absent enhancement of contrast medium. Thirty-seven of 291 scheduled MR-guided vacuum biopsies were aborted. Six cases were lost to follow-up. Two could be unequivocally identified and were nevertheless biopsied. In 25 of 29 patients absent enhancement was confirmed on subsequent studies without compression. Varying hormonal or inflammatory changes between initial MRI and MR-guided vacuum biopsy most probably explain the findings. Enhancement re-appeared on short-term follow-up <6 months without compression in 4 of the 29 patients. Too strong compression during MR-guided vacuum biopsy explains the absence of enhancement in these patients. Of note, on histology, three of these cases proved malignant. We conclude that short-term follow-up without compression is necessary and recommended for all lesions not visible during scheduled MR-guided vacuum biopsy.

The clinical value of preoperative wire localization of breast lesions by magnetic resonance imaging--a multicenter study.

To evaluate the clinical value of MRI guided preoperative wire localization of clinically and mammographically occult lesions of the breast. In a multicenter study, we evaluated 132 preoperative MRI guided localizations. Median lesion size evaluated by MRI prior to wire localization was 9mm. MRI guided localization was successfully performed in 96.2% of cases. Median wire deviation from the lesion was 0 (0-10) mm. Moderate bleeding with no further treatment required occurred in three patients. We conclude that MRI guided preoperative wire localization is a safe and accurate procedure in cases of clinically and mammographically occult lesions of the breast.

European quadricentric evaluation of a breast MR biopsy and localization device: technical improvements based on phase-I evaluation.

Our purpose was to report about technical success, problems and solutions, as experienced in a first multicentre study on MR-guided localisation or vacuum biopsy of breast lesions. The study was carried out at four European sites using a dedicated prototype breast biopsy device. Experiences with 49 scheduled localisation procedures and 188 vacuum biopsies are reported. Apart from 35 dropped indications, one localisation procedure and 9 vacuum biopsies were not possible (3 times space problems due to obesity, 2 times too strong compression, 3 times impaired access from medially, 2 times impaired access due to a metal bar). Problems due to too strong compression were recognised by repeat MR without compression. During the procedure problems leading to an uncertain result occurred in eight vacuum biopsies, two related to the procedure: one limited access, and one strong post-biopsy enhancement. Improvements after phase-I study concerned removal of the metal bar, development of an improved medial access, of a profile imitating the biopsy gun, optimisation of compression plates and improved software support. The partners agreed that the improvements answered all important technical problems.

Multicenter study for the evaluation of a dedicated biopsy device for MR-guided vacuum biopsy of the breast.

The purpose of this multicenter study was to determine the accuracy and clinical value of a dedicated breast biopsy system which allows for MR-guided vacuum biopsy (VB) of contrast-enhancing lesions. In five European centers, MR-guided 11-gauge VB was performed on 341 lesions. In 7 cases VB was unsuccessful. This was immediately realized on postinterventional images or direct follow-up combined with histopathology-imaging correlation; thus, a false-negative diagnosis was avoided. Histology of 334 successful biopsies yielded 84 (25%) malignancies, 17 (5%) atypical ductal hyperplasias, and 233 (70%) benign entities. Verification of malignant or borderline lesions included reexcision of the biopsy cavity. Benign histologic biopsy results were verified by retrospective correlation with the pre- and postinterventional MRI and by subsequent follow-up. Our results indicate that MR-guided VB, in combination with the dedicated biopsy coil, offers the possibility to accurately diagnose even very small lesions that can only be visualized or localized by MRI.

MR-guided interventional breast procedures considering vacuum biopsy in particular.

Histologic work-up of just MR-detected breast lesions has become essential with increasing use of contrast-enhanced MR imaging. In the present article an overview is given about the different MR-guided breast interventions, performed since 1990. Presently, for reasons of costs and image quality closed magnets are most widely used. The following approaches have been described: MR-guided freehand localization in supine position, stereotaxic localization in supine position and most frequently used localization in the prone position by means of a compression device that immobilises the breast to prevent tissue shift during intervention. Only limited experience exists with interventions on open magnets. MR-guided wire localization is a well-established procedure. Recently, percutaneous vacuum biopsy of enhancing breast lesions has become possible under MR guidance. The new system allows accurate and safe access to lesions in any location of the breast and direct check-up of representative excision by visualisation of the cavity. Thus reliable histologic evaluation of lesions smaller than 10 mm is possible with this approach.