Search

Objectives: We evaluated whether lesion-to-fat ratio measured by shear wave elastography in patients with Breast Imaging Reporting and Data System (BI-RADS) 3 or 4 lesions has the potential to further refine the assessment of B-mode ultrasound alone in breast cancer diagnostics., Methods: This was a secondary analysis of an international diagnostic multicenter trial (NCT02638935). Data from 1288 women with breast lesions categorized as BI-RADS 3 and 4a-c by conventional B-mode ultrasound were analyzed, whereby the focus was placed on differentiating lesions categorized as BI-RADS 3 and BI-RADS 4a. All women underwent shear wave elastography and histopathologic evaluation functioning as reference standard. Reduction of benign biopsies as well as the number of missed malignancies after reclassification using lesion-to-fat ratio measured by shear wave elastography were evaluated., Results: Breast cancer was diagnosed in 368 (28.6%) of 1288 lesions. The assessment with conventional B-mode ultrasound resulted in 53.8% (495 of 1288) pathologically benign lesions categorized as BI-RADS 4 and therefore false positives as well as in 1.39% (6 of 431) undetected malignancies categorized as BI-RADS 3. Additional lesion-to-fat ratio in BI-RADS 4a lesions with a cutoff value of 1.85 resulted in 30.11% biopsies of benign lesions which correspond to a reduction of 44.04% of false positives., Conclusions: Adding lesion-to-fat ratio measured by shear wave elastography to conventional B-mode ultrasound in BI-RADS 4a breast lesions could help reduce the number of benign biopsies by 44.04%. At the same time, however, 1.98% of malignancies were missed, which would still be in line with American College of Radiology BI-RADS 3 definition of <2% of undetected malignancies., (© 2023 The Authors. Journal of Ultrasound in Medicine published by Wiley Periodicals LLC on behalf of American Institute of Ultrasound in Medicine.)

Purpose:  In this prospective, multicenter trial we evaluated whether additional shear wave elastography (SWE) for patients with BI-RADS 3 or 4 lesions on breast ultrasound could further refine the assessment with B-mode breast ultrasound for breast cancer diagnosis., Materials and Methods:  We analyzed prospective, multicenter, international data from 1288 women with breast lesions rated by conventional 2 D B-mode ultrasound as BI-RADS 3 to 4c and undergoing 2D-SWE. After reclassification with SWE the proportion of undetected malignancies should be < 2 %. All patients underwent histopathologic evaluation (reference standard)., Results:  Histopathologic evaluation showed malignancy in 368 of 1288 lesions (28.6 %). The assessment with B-mode breast ultrasound resulted in 1.39 % (6 of 431) undetected malignancies (malignant lesions in BI-RADS 3) and 53.80 % (495 of 920) unnecessary biopsies (biopsies in benign lesions). Re-classifying BI-RADS 4a patients with a SWE cutoff of 2.55 m/s resulted in 1.98 % (11 of 556) undetected malignancies and a reduction of 24.24 % (375 vs. 495) of unnecessary biopsies., Conclusion:  A SWE value below 2.55 m/s for BI-RADS 4a lesions could be used to downstage these lesions to follow-up, and therefore reduce the number of unnecessary biopsies by 24.24 %. However, this would come at the expense of some additionally missed cancers compared to B-mode breast ultrasound (rate of undetected malignancies 1.98 %, 11 of 556, versus 1.39 %, 6 of 431) which would, however, still be in line with the ACR BI-RADS 3 definition (< 2 % of undetected malignancies)., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: Breast ultrasound identifies additional carcinomas not detected in mammography but has a higher rate of false-positive findings. We evaluated whether use of intelligent multi-modal shear wave elastography (SWE) can reduce the number of unnecessary biopsies without impairing the breast cancer detection rate., Methods: We trained, tested, and validated machine learning algorithms using SWE, clinical, and patient information to classify breast masses. We used data from 857 women who underwent B-mode breast ultrasound, SWE, and subsequent histopathologic evaluation at 12 study sites in seven countries from 2016 to 2019. Algorithms were trained and tested on data from 11 of the 12 sites and externally validated using the additional site's data. We compared findings to the histopathologic evaluation and compared the diagnostic performance between B-mode breast ultrasound, traditional SWE, and intelligent multi-modal SWE., Results: In the external validation set (n = 285), intelligent multi-modal SWE showed a sensitivity of 100% (95% CI, 97.1-100%, 126 of 126), a specificity of 50.3% (95% CI, 42.3-58.3%, 80 of 159), and an area under the curve of 0.93 (95% CI, 0.90-0.96). Diagnostic performance was significantly higher compared to traditional SWE and B-mode breast ultrasound (P < 0.001). Unlike traditional SWE, positive-predictive values of intelligent multi-modal SWE were significantly higher compared to B-mode breast ultrasound. Unnecessary biopsies were reduced by 50.3% (79 versus 159, P < 0.001) without missing cancer compared to B-mode ultrasound., Conclusion: The majority of unnecessary breast biopsies might be safely avoided by using intelligent multi-modal SWE. These results may be helpful to reduce diagnostic burden for patients, providers, and healthcare systems., Competing Interests: Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

For many years, breast ultrasound has been used in addition to mammography as an important method for clarifying breast findings. However, differences in the interpretation of findings continue to be problematic 1 2. These differences decrease the diagnostic accuracy of ultrasound after detection of a finding and complicate interdisciplinary communication and the comparison of scientific studies 3. In 1999, the American College of Radiology (ACR) created a working group (International Expert Working Group) that developed a classification system for ultrasound examinations based on the established BI-RADS classification of mammographic findings under consideration of literature data 4. Due to differences in content, the German Society for Ultrasound in Medicine (DEGUM) published its own BI-RADS-analogue criteria catalog in 2006 3. In addition to the persistence of differences in content, there is also an issue with formal licensing with the current 5th edition of the ACR BI-RADS catalog, even though the content is recognized by the DEGUM as another system for describing and documenting findings. The goal of the Best Practice Guideline of the Breast Ultrasound Working Group of the DEGUM is to provide colleagues specialized in senology with a current catalog of ultrasound criteria and assessment categories as well as best practice recommendations for the various ultrasound modalities., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Objectives: AI-based algorithms for medical image analysis showed comparable performance to human image readers. However, in practice, diagnoses are made using multiple imaging modalities alongside other data sources. We determined the importance of this multi-modal information and compared the diagnostic performance of routine breast cancer diagnosis to breast ultrasound interpretations by humans or AI-based algorithms., Methods: Patients were recruited as part of a multicenter trial (NCT02638935). The trial enrolled 1288 women undergoing routine breast cancer diagnosis (multi-modal imaging, demographic, and clinical information). Three physicians specialized in ultrasound diagnosis performed a second read of all ultrasound images. We used data from 11 of 12 study sites to develop two machine learning (ML) algorithms using unimodal information (ultrasound features generated by the ultrasound experts) to classify breast masses which were validated on the remaining study site. The same ML algorithms were subsequently developed and validated on multi-modal information (clinical and demographic information plus ultrasound features). We assessed performance using area under the curve (AUC)., Results: Of 1288 breast masses, 368 (28.6%) were histopathologically malignant. In the external validation set (n = 373), the performance of the two unimodal ultrasound ML algorithms (AUC 0.83 and 0.82) was commensurate with performance of the human ultrasound experts (AUC 0.82 to 0.84; p for all comparisons > 0.05). The multi-modal ultrasound ML algorithms performed significantly better (AUC 0.90 and 0.89) but were statistically inferior to routine breast cancer diagnosis (AUC 0.95, p for all comparisons ≤ 0.05)., Conclusions: The performance of humans and AI-based algorithms improves with multi-modal information., Key Points: • The performance of humans and AI-based algorithms improves with multi-modal information. • Multimodal AI-based algorithms do not necessarily outperform expert humans. • Unimodal AI-based algorithms do not represent optimal performance to classify breast masses., (© 2022. The Author(s).)

Background: Shear wave elastography (SWE) and strain elastography (SE) have shown promising potential in breast cancer diagnostics by evaluating the stiffness of a lesion. Combining these two techniques could further improve the diagnostic performance. We aimed to exploratorily define the cut-offs at which adding combined SWE and SE to B-mode breast ultrasound could help reclassify Breast Imaging Reporting and Data System (BI-RADS) 3-4 lesions to reduce the number of unnecessary breast biopsies., Methods: We report the secondary results of a prospective, multicentre, international trial (NCT02638935). The trial enrolled 1288 women with BI-RADS 3 to 4c breast masses on conventional B-mode breast ultrasound. All patients underwent SWE and SE (index test) and histopathologic evaluation (reference standard). Reduction of unnecessary biopsies (biopsies in benign lesions) and missed malignancies after recategorising with SWE and SE were the outcome measures., Results: On performing histopathologic evaluation, 368 of 1288 breast masses were malignant. Following the routine B-mode breast ultrasound assessment, 53.80% (495 of 920 patients) underwent an unnecessary biopsy. After recategorising BI-RADS 4a lesions (SWE cut-off ≥3.70 m/s, SE cut-off ≥1.0), 34.78% (320 of 920 patients) underwent an unnecessary biopsy corresponding to a 35.35% (320 versus 495) reduction of unnecessary biopsies. Malignancies in the new BI-RADS 3 cohort were missed in 1.96% (12 of 612 patients)., Conclusion: Adding combined SWE and SE to routine B-mode breast ultrasound to recategorise BI-RADS 4a patients could help reduce the number of unnecessary biopsies in breast diagnostics by about 35% while keeping the rate of undetected malignancies below the 2% ACR BI-RADS 3 definition., Competing Interests: Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Aim: This research compares postoperative complication rates with Strattice™, SERAGYN ® BR, and TiLOOP ® Bra interposition devices for subpectoral implant placement after skin or nipple sparing mastectomy., Patients and Methods: 188 breast reconstructions in 157 patients after primary (n=96), secondary (n=71), or prophylactic (n=21) surgery were analyzed regarding major and minor complications., Results: With acellular dermal matrix (ADM) Strattice™, 27.5% major and 27.5% minor complications occurred. Implant loss rates were 27.3% in primary and 30.8% in secondary reconstructions. With SERAGYN ® BR, 11.1% major and 13,0% minor complications occurred. Implant losses (6.1%) occurred exclusively in primary reconstructions. With TiLOOP ® Bra, 14.9% major and 9.6% minor complications occurred. Implant loss rates were 7.7% in primary and 7.1% in secondary reconstructions., Conclusion: ADM was associated with high complication rates in primary and secondary reconstructions. Low complication rates were seen with mesh interposition devices in primary, secondary, and prophylactic reconstructions., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Aim: Quality of life and patient satisfaction after subpectoral breast reconstruction with meshes or acellular dermal matrices (ADM) and implants were assessed using the BreastQ questionnaire to investigate a potential influence of the materials on these parameters., Patients and Methods: The BreastQ questionnaire was completed by 121 patients, who had received material-assisted, heterologous, subpectoral breast reconstruction between 2010 and 2018., Results: Answers were similar independent of the reconstruction materials used. After prophylactic mastectomy, the physical wellbeing (chest) improved significantly with all materials (p=0.04). Postoperative radiotherapy significantly reduced satisfaction with outcome (p=0.005). Patients under 50 years old had significantly better postoperative sexual wellbeing than older patients (p=0.03)., Conclusion: No influence was detected of the materials on the postoperative quality of life and patient satisfaction. An overall better quality of life was reported by younger and normal-weight patients with prophylactic or nipple-sparing mastectomy without radiotherapy., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: Synthetic meshes (SMs) and acellular dermal matrices (ADMs) are used in reconstructive breast surgery. In the absence of prospective comparative studies, the identification of differences relies on retrospective analyses., Patients and Methods: Our analysis focused on the impact of pre- and postoperative radiotherapy (RTX) and material-related differences. The analysis included 281 breast cancer patients (362 breasts) after nipple- and skin-sparing mastectomy with subpectoral implant insertion., Results: Overall, the implant loss rate was 23.1% using porcine ADM, 7% using partially resorbable SM (prSM), and 5.6% using non-resorbable SM (nrSM). After RTX, the implant loss rate was 56.3% with ADM, 13% with prSM and 13.2% with nrSM. The ADM group showed a significant effect of RTX on the postoperative seroma rate, wound infections, and implant loss rate. When prSM was used, RTX showed no significant effect. When using the nrSM, RTX significantly influenced complication rates regarding wound infections and implant loss., Conclusion: In material-assisted breast reconstructions with pre- or post-operative RTX, there is a significantly higher implant loss rate when using porcine ADM compared to SM., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: This trial intended to identify patient- and therapy-specific risk factors influencing the genesis of seroma and the extent of its formation., Patients and Methods: Within a prospective randomized controlled trial, 70 patients (n=35 TissuGlu ® ; n=35 drain) underwent a mastectomy with or without sentinel lymphonodectomy. Specific seroma-associated risk factors were recorded. Regular outpatient aftercare was performed during a 90-day postoperative follow-up., Results: A statistically significant increase in the postoperative seroma rate was demonstrated for those with pre-adiposity compared to normal body weight (p=0.016), as well as for the state of health evaluated by the score of American Society of Anesthesiologists (ASA) (ASA III compared to I; p=0.046), the presence of diabetes mellitus (p<0.001) and the reduction of the length of the surgical procedure (p=0.044)., Conclusion: A high body mass index, a poor state of health (ASA score), and diabetes mellitus, as well as a shorter duration of surgery, favor the incidence of postoperative seroma., (Copyright © 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Purpose: Postoperative seromas are a problem in the surgical treatment of breast cancer. The aim of the study was to evaluate whether the lysine-urethane-based tissue adhesive TissuGlu ® without drainage is equal/ non-inferior to standard mastecomy with drainage., Methods: The study was designed as a prospective, randomized, multicentre non-inferiority study comparing the use of TissuGlu ® without drainage with standard wound care with a drain insertion in ablative breast procedures. The number of clinical interventions, quality of life and wound complications were followed-up for 90 days in both groups., Results: Although the statistical power was not reached, twice as many clinical interventions were performed in the TissuGlu ® group than in the drainage group, especially aspirations of clinically relevant seromas (p = 0.014). The TissuGlu ® group produced overall less wound fluid, but developed a clinically relevant seroma (100% vs. 63%) which made an intervention necessary. Less hospitalisation time was observed in the TissuGlu ® group, but the complication rate was higher. There was no significant difference in regards to postoperative pain. In summary the non-inferiority of TissuGlu ® compared to standard drainage couldn't be reached., Discussion: The present evaluation shows no advantage of the tissue adhesive TissuGlu ® in terms of seroma formation and frequency of intervention compared to a standard drainage for mastectomies, but the shorter inpatient stay certainly has a positive effect on the quality of life.

Introduction: Implant-based or expander-supported breast reconstruction is an established surgical method after mastectomies due to cancer or to prophylactic reasons. Patient reported outcome (PRO) and cosmetic outcome after breast reconstruction with a synthetic surgical mesh was investigated in a prospective, single-arm, multi-center study., Material and Methods: Primary or secondary implant-based breast reconstruction with support of TiLOOP® Bra was performed in 269 patients during the PRO-BRA study. PRO 12 months after breast reconstruction was evaluated using Breast-Q questionnaire. Cosmetic outcome was evaluated by two independent experts by means of pictures taken preoperatively and at the follow-up visits., Results: Breast-Q and 12 months FU were completed by 210 women. Patients without adverse event had a significantly higher Breast-Q score for "sexual well-being" (p = 0.001); "psychosocial well-being" was negatively influenced by prior therapies (p < 0.01), and older patients had significantly lower scores at 12 months FU compared to pre-OP for "satisfaction with breasts" (p < 0.01) while the opposite was true for younger patients. Unilateral surgery resulted in reduced "satisfaction with breast" at 12 months FU (p < 0.01). Radiotherapy negatively influenced "satisfaction with breast", "sexual well-being" and "physical well-being chest". The cosmetic evaluation showed a significant difference (p < 0.001) in the evaluation by the patients and experts with the patients' assessment being worse compared to experts' assessment., Conclusion: Our study showed that two years after implant-based breast reconstruction with support of TiLOOP® Bra PRO is influenced by different factors. This information can be used to improve the decision-making process for women who chose implant-based breast reconstruction., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background/aim: The influence of a polyurethane-based tissue adhesive (TissuGlu®) on common complications following breast surgery was investigated., Patients and Methods: Within a Randomized-Controlled-Trial 70 women (n=35 TissuGlu®, n=35 drain) underwent a mastectomy with or without sentinel lymph node excision (SLNE), followed by a 90-day postoperative follow-up., Results: Postoperative interventions: Non-inferiority of the application of TissuGlu® was seen. Pain-Level/ Hospitalization: A statistically significant pain reduction from day four onwards (p<0.001) and a shorter hospitalization period (p<0.001) was observed. In contrast, the TissuGlu® group showed increased mean puncture incidence (p=0.013), and increased puncture volume (p=0.021)., Conclusion: Application of the polyurethane-based tissue adhesive TissuGlu® after mastectomy, with or without SLNE, showed potential for improvement of the clinical outcome. In contrast, high intervention rates and increased puncture volume, caused by recurring seromas following application of the surgical adhesive TissuGlu®, have a negative impact on the patient-specific convalescence., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background/aim: The study aimed at investigating the correlation between ductoscopic and histopathological findings and clarify whether the former allow for accurate prediction of malignancy., Patients and Methods: The prospective national multi-center study covered a sample of 224 patients with pathologic nipple discharge. A total of 214 patients underwent ductoscopy with subsequent extirpation of the mammary duct. The ductoscopic findings were categorized according to shape, number, color and surface structure of lesions and vascularity and compared to the histological results and analyses., Results: Ductoscopy revealed lesions in 134 of 214 patients (62.2%). The criteria "multiple versus solitary lesion" differed significantly between malignant and benign lesions. All other criteria were not statistically significant. Malignant tumors were more frequently presented as multiple lesions, benign lesions or masses as solitary lesions (80% vs. 24.8%; p=0.018)., Conclusion: The ductoscopic criterion "solitary vs. multiple lesion" appears to have a low diagnostic prediction of malignancy or benignity., (Copyright© 2020, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

This year's annual AWOgyn meeting focused on studies of reconstructive breast surgery. As the majority of breast reconstructions are implant-based, most studies also focused on implant-based reconstruction. Since 2011, the guidelines have recommended using interposed mesh materials as support. The basic idea behind every type of material is to provide coverage and stabilization for the implant by constructing an "internal bra" which will create the appropriate implant shape and maintain the position, stability and flexibility of the implant. The Working Group for Reconstructive Surgery in Oncology-Gynecology (AWOgyn) has undertaken to analyze different materials with regard to indications, success rates and side effects as documented in registers, clinical assessments and study protocols. This has increased application safety and is expected to improve it even further in future. Prospective studies are being carried out to investigate issues such as the optimal material, optimal implant site and best cosmetic results. The first results for porcine and human acellular matrices and for partially resorbable titanium-coated synthetic polypropylene meshes are now available. In 2019, the AWOgyn working group will be launching further studies to evaluate a perforated acellular dermal matrix (Fortiva ® ), a titanium-coated implant pocket (TiLOOP ® Bra Pocket) and a fully resorbable synthetic mesh (TIGR ® mesh).

Purpose:  The aim of the present study was to determine the accuracy of breast cancer measurement with 2 D shear wave elastography (2 D SWE), B-mode ultrasound, and mammography by comparing these methods with the actual histopathological tumor size., Materials and Methods:  135 patients with proven malignant breast lesions at two centers were included in a prospective study. The maximum lesion diameter was measured by 2 D SWE, B-mode ultrasound, and mammography. After surgery, the histopathological tumor size was measured by a pathologist., Results:  The mean difference in tumor size on 2 D SWE, B-mode ultrasound, and mammography on the one hand, and the actual tumor size on the other, was -0.03 cm, 0.16 cm and 0.10 cm, respectively. Lesion size on histopathological investigation was overestimated by 2 D SWE (p = 0.004) and underestimated by B-mode imaging (p < 0.001). All three imaging methods underestimated the size of invasive lobular cancers and lesions > 15 mm; 2 D SWE was most accurate in this regard., Conclusion:  2 D SWE predicted lesion size more precisely than B-mode ultrasound or mammography. In cases of invasive lobular carcinoma, all three imaging methods underestimated lesion size, with 2 D SWE coming closest to the actual tumor size., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (© Georg Thieme Verlag KG Stuttgart · New York.)

With improvements in breast imaging, mammography, ultrasound and minimally invasive interventions, the detection of early breast cancer, non-invasive cancers, lesions of uncertain malignant potential, and benign lesions has increased. However, with the improved diagnostic capabilities comes a substantial risk of false-positive benign lesions and vice versa false-negative malignant lesions. A statement is provided on the manifestation, imaging, and diagnostic verification of isolated benign breast tumours that have a frequent manifestation, in addition to general therapy management recommendations. Histological evaluation of benign breast tumours is the most reliable diagnostic method. According to the S3 guideline and information gained from analysis of the literature, preference is to be given to core biopsy for each type of tumour as the preferred diagnostic method. An indication for open biopsy is also to be established should the tumour increase in size in the follow-up interval, after recurring discrepancies in the vacuum biopsy results, or at the request of the patient. As an alternative, minimally invasive procedures such as therapeutic vacuum biopsy, cryoablation or high-intensity focused ultrasound are also becoming possible alternatives in definitive surgical management. The newer minimally invasive methods show an adequate degree of accuracy and hardly any restrictions in terms of post-interventional cosmetics so that current requirements of extensive breast imaging can be thoroughly met.

Objective: Synthetic meshes and acellular dermal matrices are increasingly used in implant-based breast reconstruction. The objective of this study was to determine the incidence and severity of complications following the implantation of the partially absorbable bi-component soft mesh SERAGYN® BR and assess risk factors for adverse operative outcomes., Methods: A retrospective clinical study was performed: The SERAGYN® BR soft mesh was utilized in 148 operations (skin-sparing mastectomy, nipple-sparing mastectomy, breast-conserving surgery, and secondary reconstruction after mastectomy) in four different institutions in Germany from June 2012 to February 2014. We analyzed whether the results were affected by tumor morphology (e.g., grading), patient characteristics and comorbidities, previous surgery or therapies, and use of alloplastic materials., Results: The SERAGYN® BR soft mesh was successfully implanted in 131 of 148 operations. The rate of reconstructive failure was 11.5%. The most common complication was seroma (25.7%), followed by hematoma and skin infection (each 14.2%). Wound-healing issues were detected in 13.5% cases, secondary wound infections in 10.8%. 83.8% of operations had no severe complications. Independent predictors for reconstructive failure were wound-healing issues, nipple- or skin necrosis, wound- or skin infections, a high volume of excised tissue, hematomas, seromas, and sentinel lymph node excisions. A higher body mass index was correlated with a higher rate of infection., Conclusion: SERAGYN® BR mesh can be used successfully in breast reconstructive surgery. Rates of major complications or reconstructive failure are comparable to the use of other synthetic or biological meshes.

Background/aim: Using drains after breast surgery is a preventive, but invasive measure to reduce seroma formation. A polyurethane-based tissue adhesive (TissuGlu®) might facilitate drainage-free wound healing after mastectomy in a non-invasive manner., Patients and Methods: Retrospectively, data from 84 patients (42 receiving TissuGlu®, 42 receiving a drainage) who underwent mastectomy, were collected (90 days postoperative follow-up). Study endpoints were defined as the number of fluid-related postoperative clinical interventions, cumulative volume of postoperative wound fluid, duration of hospitalization and postoperative complications., Results: In the entirety of postoperative interventions, no significant difference could be demonstrated (p=0.298). The drainage arm showed significantly less seroma aspirations (p=0.024) and complications (p=0.012). A significantly reduced length of hospitalization (p<0.001) and less cumulative wound secretion volume (p<0.001) appeared in the TissuGlu® group., Conclusion: The polyurethane-based tissue adhesive is a less invasive alternative to drain use in mastectomy., (Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: Retrospective analysis of breast cancer imaging methods is a common tool for evaluating the effectiveness of ultrasound and mammography regarding ductal carcinoma in situ (DCIS). No large number subpopulation of pure DCIS has been reported. It is however known that mammography and ultrasound underestimate tumor dimension with increasing tumor size. We aimed to quantify this discrepancy., Materials and Methods: This retrospective analysis reviewed the ultrasound and mammography data from 173 patients with DCIS at the University of Cologne - Department of Gynecology and Obstetrics between the years 2007 and 2010. Of these 173 patients, 34 fulfilled the DCIS analysis requirements and were evaluated in this study., Results: Overall, ultrasound underestimated tumor size 79.4% of the time, while overestimating only 20.6% of the time. Mammography underestimated tumor size in 50%, overestimated in 38.2%, correctly estimating in 11.8%. Over and underestimation distributions differed drastically above and a cut-off point of ≤2 cm actual tumor size, with a significant shift toward severe underestimation by both methods above a tumor size of 2 cm. DCIS misestimation was defined as the absolute value of the difference between actual tumor size and pre-surgical measurement by an imaging method. Mean DCIS size misestimation (actual tumor size ≤2 cm) was 3 mm for ultrasound and 6.2 mm for mammography., Conclusion: We support previous findings that ultrasound and mammography lose accuracy with increasing tumor size. Nonetheless, ultrasound may be more useful in estimation of DCIS size for tumors ≤2 cm than previously expected., (Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: Acellular dermal matrix is increasingly used as caudolateral coverage for breast implants in immediate breast reconstruction after skin-sparing mastectomy or in the correction of implant-associated breast deformities. Matrices of human, bovine, and porcine origin are available. The purpose of this retrospective multicenter study was to report experiences with porcine acellular dermal matrices, as only limited data can be found in the literature., Methods: In the hospital databases of five institutions, 127 patients were identified who underwent breast reconstructions in 156 breasts using an acellular porcine dermal matrix. Medical records were reviewed. Patients were divided into three groups: immediate expander-implant or direct to implant reconstructions (n = 98), delayed expander-implant reconstructions (n = 14), and revision surgery for implant-associated breast deformities (n = 44)., Results: With a mean follow-up of 19.6 months, total major complication rate was 7.1 %: implant loss (3.2 %), skin flap necrosis (2.6 %), delayed skin healing (2.6 %), hematoma (1.9 %), seroma (1.3 %), infection (0.6 %), and capsular contracture (0.6 %). Total minor complication rate was 22.9 %, with seroma being the most frequent complication (19.2 %). In the group of immediate breast reconstructions, 20.4 % of the breasts had received radiotherapy in the past. These patients exhibited a significantly higher rate of seroma than patients without prior radiotherapy (35.0 vs. 14.9 %, p = 0.031)., Conclusions: Complication rates using porcine acellular dermal matrix in breast reconstruction are comparable to complication rates reported in studies using human acellular dermal matrices. Thus, porcine acellular dermal matrices can safely be applied in breast reconstructive surgery.

Objective: The objective of this study was to evaluate the safety and efficacy of SprayShield™ Adhesion Barrier in preventing and/or reducing postoperative adhesion during gynecological surgery., Design: This was a prospective, controlled, blinded, and randomized study. Patient blinding was performed intraoperatively. Subjects were randomly assigned to the SprayShield™ or the control group in a 2:1 ratio., Setting: The study was conducted at the Clinic of Gynaecology and Obstetrics, at the University Hospital for Gynecology in Germany., Patients: Fifteen patients participated in this study; nine patients were assigned to the SprayShield™ and six patients to the control group., Interventions: During first operation (FLL) in the SprayShield™ group, the agent was applied to all myomectomy suture lines. Patients in the control group did not receive any anti-adhesion treatment, only good surgical practice. A second-look laparoscopy (SLL) was performed 8-12 weeks after myomectomy to evaluate adhesion formation., Main Outcome Measures: Main outcome measures were incidence, severity, and extent of uterine adhesions., Results: No significant differences were found between the two study groups., Conclusions: SprayShield™ is easy to use. No serious adverse event related to SprayShield™ was observed. Efficacy data are inconclusive regarding the performance of SprayShield™. Further studies are needed to better understand this performance.

Purpose: The aim of this study was to evaluate the quality standard of the nationwide breast ultrasound training program of the German Society of Ultrasound in Medicine (DEGUM) through objective parameters., Materials and Methods: 10 quality criteria, based on the recommendations of The National Association of Statutory Health Insurance Physicians (KBV), were defined for this study. All training units of the DEGUM received a questionnaire. The questionnaires and training material were analyzed., Results: All units met the required criteria pertaining to the trainer's qualification, duration per training course and the maximum number of participants per ultrasound machine. Only 1 course did not fulfill the required 50 % practical training time. The requirements to participate in the graduate course (200 self-made and documented cases) were not clearly conceived and a defined training log could be improved., Conclusion: DEGUM breast ultrasound training offers trainees a high level of education based on the requirements of the KBV. Despite the high quality of training, the content of course announcements could be improved and an official and structured educational index could be meaningful., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: According to the literature, ductoscopy is gaining increasing importance in the diagnosis of intraductal anomalies in cases of pathologic nipple discharge. In a multicenter study, the impact of this method was assessed in comparison with that of standard diagnostics., Patients and Methods: Between 09/2006 and 05/2009, a total of 214 patients from 7 German breast centers were included. All patients underwent elective ductoscopy and subsequent ductal excision because of pathologic nipple discharge. Ductoscopy was compared with the following standard diagnostics: breast sonography, mammography, magnetic resonance imaging (MRI), galactography, cytologic nipple swab, and ductal lavage cytology. The histological and imaging results were compared and contrasted to the results obtained from the nipple swab and cytologic assessment., Results: Sonography had the highest (82.9%) sensitivity, followed by MRI (82.5%), galactography (81.3%), ductoscopy (71.2%), lavage cytology (57.8%), mammography (57.1%), and nipple swab (22.8%). Nipple swabs had the highest (85.5%) specificity, followed by lavage cytology (85.2%), ductoscopy (49.4%), galactography (44.4%), mammography (33.3%), sonography (17.9%), and MRI (11.8%)., Conclusion: Currently, ductoscopy provides a direct intraoperative visualization of intraductal lesions. Sensitivity and specificity are similar to those of standard diagnostics. The technique supports selective duct excision, in contrast to the unselective technique according to Urban. Therefore, ductoscopy extends the interventional/diagnostic armamentarium., (© 2014 S. Karger GmbH, Freiburg.)

Purpose: To determine the benefit of ShearWave™ Elastography (SWE™) in the ultrasound characterization of BI-RADS® 3 breast lesions in a diagnostic population., Materials and Methods: 303 BI-RADS® 3 lesions (mean size: 13.2 mm, SD: 7.5 mm) from the multicenter BE1 prospective study population were analyzed: 201 (66%) had cytology or core biopsy, and the remaining 102 had a minimum follow-up of one year; 8 (2.6%) were malignant. 7 SWE features were evaluated with regard to their ability to downgrade benign BI-RADS® 3 masses. The performance of each SWE feature was assessed by evaluating the number of lesions correctly reclassified and the impact on cancer rates within the new BI-RADS® 3' lesion group., Results: No malignancies were found with an E-color "black to dark blue", which allowed the downgrading of 110/303 benign masses (p < 0.0001), with a non-significant increase in BI-RADS® 3' malignancy rate from 2.6% to 4.1%. E-max ≤ 20 kPa (2.6 m/s) was able to downgrade 48/303 (p < 0.0001) lesions with a lower increase in BI-RADS® 3' malignancy rate (3.1%). No other SWE features were useful for reclassifying benign BI-RADS® 3 lesions., Conclusion: Applying simple reclassification rules, SWE assessment of the maximum stiffness of lesions allowed the downgrading of a sub-group of benign BI-RADS® 3 lesions. This was accompanied by a non-significant increase in the malignancy rate in the new BI-RADS® 3 class., (© Georg Thieme Verlag KG Stuttgart · New York.)

The clinical part of these Guidelines and Recommendations produced under the auspices of the European Federation of Societies for Ultrasound in Medicine and Biology EFSUMB assesses the clinically used applications of all forms of elastography, stressing the evidence from meta-analyses and giving practical advice for their uses and interpretation. Diffuse liver disease forms the largest section, reflecting the wide experience with transient and shear wave elastography . Then follow the breast, thyroid, gastro-intestinal tract, endoscopic elastography, the prostate and the musculo-skeletal system using strain and shear wave elastography as appropriate. The document is intended to form a reference and to guide clinical users in a practical way., (© Georg Thieme Verlag KG Stuttgart · New York.)

The technical part of these Guidelines and Recommendations, produced under the auspices of EFSUMB, provides an introduction to the physical principles and technology on which all forms of current commercially available ultrasound elastography are based. A difference in shear modulus is the common underlying physical mechanism that provides tissue contrast in all elastograms. The relationship between the alternative technologies is considered in terms of the method used to take advantage of this. The practical advantages and disadvantages associated with each of the techniques are described, and guidance is provided on optimisation of scanning technique, image display, image interpretation and some of the known image artefacts., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: To study T1 baseline signal intensity (SI) and contrast material enhancement kinetics of normal breast parenchyma by using dynamic contrast-enhanced (DCE) magnetic resonance (MR) mammography and to determine the influence of anthropometric measures and menopausal status on the variability of these features., Materials and Methods: Institutional review board approval and written informed consent were obtained. Between June 2008 and September 2011, 345 women (age range, 26-81 years; mean age, 51.3 years ± 11.6 [standard deviation]) underwent DCE MR mammography, with T1-weighted three-dimensional MR images (repetition time msec/echo time msec, 8.86/4.51; flip angle, 25°) acquired with a 1.5-T whole-body MR unit before and 1, 2, 3, 4, and 5 minutes after a gadobutrol bolus injection of 0.1 mmol per kilogram of body weight. Regions of interest were traced manually, and T1 SI of parenchyma was recorded. The influence of different predictors of T1 baseline SI and contrast enhancement was studied by using random-effects models., Results: T1 baseline SI varied considerably between women, with a mean of 167.7 ± 49.2 (71.4-424.7 [range]) and 175.9 ± 48.9 (51.8-458.3) in the right and the left breast, respectively (P < .01). T1 baseline SI increased linearly with age (P < .0001) and body weight (P < .0001). After contrast material delivery, relative percentage of enhancement was 8.1%, 13.8%, 18.2%, 22.1%, and 24.6% at 1, 2, 3, 4, and 5 minutes, respectively, but varied considerably between women. Contrast enhancement was 9.3% in the lowest quintile and 47.4% in the highest. Contrast enhancement increased with body weight (P < .01) but decreased in postmenopausal women (P < .01). Women with higher baseline T1 SI tended to have a higher contrast enhancement slope., Conclusion: Anthropometric measures and menopausal status contribute to a large variability in contrast enhancement of normal breast parenchyma. This might influence the interpretation of contrast enhancement kinetics of breast lesions and current strategies for determining contrast medium dose for breast MR imaging., (RSNA, 2012)

Background: This study aims to assess the role of ductoscopy for detecting intraductal anomalies in patients with nipple discharge in comparison to conventional tests and to find an effective combination of both approaches., Materials and Methods: Prior to duct excision, ductoscopy was performed in 97 women. Histologic and all other diagnostic results were compared. Sensitivity, specificity, and efficiency were calculated for all methods. These parameters were also calculated for all possible test combinations in 12 patients who had completed all tests., Results: Breast sonography reached the highest sensitivity (64.1%) and efficiency (64%); mammography had the highest specificity (100%). The sensitivity of ductoscopy was 53.2%, its specificity 60%, and its efficiency 55.1%. Among combinations of all methods, the combination ductoscopy + galactography was the most sensitive (80%). Mammography, magnetic resonance imaging, and ductoscopy were each 100% specific. Ductoscopy was the most efficient (75%) single method., Conclusion: Ductoscopy is a valuable test for diagnosing intraductal lesions in patients with nipple discharge. It is more efficient than conventional tests in patients undergoing all tests., (Copyright © 2013 S. Karger AG, Basel.)

Objectives: To investigate effects of menopausal status, oral contraceptives (OC), and postmenopausal hormone therapy (HT) on normal breast parenchymal contrast enhancement (CE) and non-mass-like enhancing areas in magnetic resonance mammography (MRM)., Methods: A total of 459 female volunteers (mean age 49.1 ± 12.5 years) underwent T1-weighted 3D MRM 1-5 min after bolus injection of gadobutrol. Quantitative analysis was performed in normal breast parenchyma by manually tracing regions of interest and calculating percentage CE. Semiquantitative analysis was performed in non-mass-like enhancing areas, and signal intensity changes were characterised by five predefined kinetic curve types. The influence of OC (n = 69) and HT (n = 24) on CE was studied using random effects models., Results: Breast parenchymal enhancement was significantly higher in premenopausal than in postmenopausal women (P < 0.001). CE decreased significantly with the use of OC (P = 0.01), while HT had negligible effects (P = 0.52). Prevalence of kinetic curve types of non-mass-like enhancement differed strongly between pre- and postmenopausal women (P < 0.0001), but was similar in OC users and non-OC users (P = 0.61) as well as HT users and non-HT users (P = 0.77)., Conclusions: Normal breast parenchymal enhancement and non-mass-like enhancing areas were strongly affected by menopausal status, while they were not affected by HT use and only moderately by OC use., Key Points: Breast parenchymal enhancement at MR mammography is stronger in premenopausal than postmenopausal women. The prevalence of strong enhancing non-mass-like areas is greater before menopause. Such enhancing non-mass-like areas may impair lesion detection in premenopausal women. Breast parenchymal enhancement is only marginally affected by hormone use. Discontinuation of hormone use before MR mammography may be unnecessary.

Purpose: This retrospective study aimed to assess the diagnostic value of mammography, breast ultrasonography, and palpation in diagnosing fibroadenomas, making consistent use of the BI-RADS classification. The impact of breast density, patient age, and the size and palpability of the mass will be evaluated., Patients and Methods: Between January 2000 and December 2009, a total of 339 fibroadenomas suitable for inclusion in this study were diagnosed and histologically verified at our institution. Based on their BI-RADS or BI-RADS analog classification, all lesions were categorized as benign or malignant. These results were compared to the corresponding histopathological findings. Specificities were calculated for each of the abovementioned parameters. Chi-square test results with p-values < 0.05 were considered significant. Congruence between mammography and ultrasonography was assessed based on Cohen's kappa., Results: Palpation had a specificity of 100 %, mammography 83.9 %, and ultrasonography 88.2 %. Considering the parameters under investigation, ultrasonography is superior to mammography. The specificity of the ultrasonographic assessment "benign" vs. "malignant" varied with patient age and palpability of the lesion (p = 0.001 and p = 0.025). Mammography and ultrasonography were most congruent for lesions rated ACR 1 - 2 and for lesions > 1.9 cm (κ = 0.464, κ = 0.444)., Conclusion: For diagnosing fibroadenomas, ultrasonography is more specific than mammography when all examined variables are taken into account. Ultrasonography should therefore be favored, especially in younger patients. One needs to be aware of the effects of palpability and patient age on the ultrasonographic differentiation "malignant" vs. "benign". In some cases, mammography should be considered as an adjunct., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: To determine whether adding shear-wave (SW) elastographic features could improve accuracy of ultrasonographic (US) assessment of breast masses., Materials and Methods: From September 2008 to September 2010, 958 women consented to repeat standard breast US supplemented by quantitative SW elastographic examination in this prospective multicenter institutional review board-approved, HIPAA-compliant protocol. B-mode Breast Imaging Reporting and Data System (BI-RADS) features and assessments were recorded. SW elastographic evaluation (mean, maximum, and minimum elasticity of stiffest portion of mass and surrounding tissue; lesion-to-fat elasticity ratio; ratio of SW elastographic-to-B-mode lesion diameter or area; SW elastographic lesion shape and homogeneity) was performed. Qualitative color SW elastographic stiffness was assessed independently. Nine hundred thirty-nine masses were analyzable; 102 BI-RADS category 2 masses were assumed to be benign; reference standard was available for 837 category 3 or higher lesions. Considering BI-RADS category 4a or higher as test positive for malignancy, effect of SW elastographic features on area under the receiver operating characteristic curve (AUC), sensitivity, and specificity after reclassifying category 3 and 4a masses was determined., Results: Median participant age was 50 years; 289 of 939 (30.8%) masses were malignant (median mass size, 12 mm). B-mode BI-RADS AUC was 0.950; eight of 303 (2.6%) BI-RADS category 3 masses, 18 of 193 (9.3%) category 4a lesions, 41 of 97 (42%) category 4b lesions, 42 of 57 (74%) category 4c lesions, and 180 of 187 (96.3%) category 5 lesions were malignant. By using visual color stiffness to selectively upgrade category 3 and lack of stiffness to downgrade category 4a masses, specificity improved from 61.1% (397 of 650) to 78.5% (510 of 650) (P<.001); AUC increased to 0.962 (P=.005). Oval shape on SW elastographic images and quantitative maximum elasticity of 80 kPa (5.2 m/sec) or less improved specificity (69.4% [451 of 650] and 77.4% [503 of 650], P<.001 for both), without significant improvement in sensitivity or AUC., Conclusion: Adding SW elastographic features to BI-RADS feature analysis improved specificity of breast US mass assessment without loss of sensitivity., (© RSNA, 2012)

Background and Objective. The aim of this study was to assess the subjective outcome following laparoscopic sacropexy. Methods. We performed a retrospective cohort study among women treated for descensus with laparoscopic sacropexy between January 2000 and December 2007. 310 patients received questionnaires during followup assessing major pre- and postoperative symptoms and overall satisfaction. Results. 214 (69%) patients responded to the questionnaire. Mean followup was 24.5 months. The number of patients with back or lower abdominal pain, foreign body sensation in the vagina and prolapse-related symptoms, urinary symptoms, vaginal and bladder infections, and the need for pessary usage decreased significantly postsurgically. Bowel symptoms increased slightly but not significantly. Two years after surgery, nearly 2 thirds of the women were satisfied or very satisfied with the outcome. Conclusion. Laparoscopic sacropexy is an effective treatment of descensus, with favorable or satisfactory subjective outcomes.

Background: The objective was the investigation of a possible predictive quantitative impact of initial tumor sphericity, measured by 3D sonography, on response to pre-operative chemotherapy., Patients and Methods: This 3D ultrasound study was conducted on 41 consecutive primary breast cancer patients who received pre-operative epirubicin and paclitaxel chemotherapy; the tumors were measured by 3D sonography and by pathology after chemotherapy. Sphericity was defined as the ratio of the smallest to the largest extent by 3D sonography., Results: A predictive impact of initial tumor sphericity on response to pre-operative chemotherapy was quantitatively identified for the first time. Sphericity was a significant predictor of pathological complete remission with a rank difference of 0.34 or about 1/3 i.e., spherical tumors were more likely to show successful remission., Conclusion: Tumor sphericity as defined from 3D sonography could be predictive of response to pre-operative chemotherapy regimens; prospective investigation is suggested.

Purpose: Rational therapy planning should aim to minimize the rate of axillary lymph node dissection (ALND) in patients without metastatic disease. By the same token, the frequency of sentinel lymph node biopsies (SLNB) should not be unnecessarily high in patients with axillary node disease. Preoperative axillary ultrasonography is a generally available noninvasive technique for assessing nodal status., Materials and Methods: Based on retrospective data, we analyzed the sensitivity, specificity, positive and negative predictive value, and efficiency of preoperative ultrasonography US. A total of 429 axillary ultrasonographic examinations were included, and the management decisions were based on the ultrasonographic findings. Patients with suspicious US results were scheduled for ALND, while patients with unremarkable findings underwent SLNB., Results: Axillary metastases were found in 146 of 429 (34 %) cases. In 75 of 429 (17 %) axillary examinations, ultrasonography revealed suspicious findings. In these cases, we proceeded with ALND, thereby reducing the number of SLNB by 17 %. 219 of 429 cases were classified correctly as not having metastasis, thus lowering the rate of ALND, which is associated with higher postoperative morbidity, by 51 %. Preoperative ultrasonography had a sensitivity of 53.6 %, specificity of 75.5 %, and a positive predictive value of 77.3 %. The negative predictive value was 51.3 % and the efficiency was 68.5 %., Conclusion: Ultrasonography is a moderately sensitive, but quite specific, preoperative method for assessing the axillary lymph nodes., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: This prospective study evaluates whether sonoelastography can improve B-mode ultrasonographic sizing of breast tumors. Precise measuring is important for effective therapy planning for breast cancer patients., Materials and Methods: The size of 100 surgically excised breast lesions (92 patients: 77 malignant, 23 benign) was compared to preoperative measurements. Lesions were imaged with both ultrasonographic techniques in identical planes. The largest sizes measured with each modality were compared to the largest histopathological measurements. The interobserver variability was also computed from measurements made by two examiners assessing identical planes., Results: Both ultrasonographic measuring techniques underestimate lesion size. The sonoelastography measurements were within ± 5 mm of the histological size in 70.1 % of malignant lesions, and the B-mode measurements in 57.1 % of cases. Sonoelastography leads to more accurate measurements of 13.0 % of cases (statistically not significant). A total of 22 lesions were also imaged by a second examiner. Sonoelastography had 27.3 % less interobserver variability (examiners agreed in 36.4 % of sonoelastography and in 9.1 % of B-mode results)., Conclusion: In this study there is no significant advantage of sonoelastography, although a tendency is apparent. The low interobserver variability also favors sonoelastography for preoperative diagnostics, since it may be less dependent on the observer than conventional B-mode imaging. The results of this prospective study require validation in a prospective multicenter study with larger case numbers., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: This prospective study aimed to compare sonoelastography, B-mode ultrasonography, and mammography in terms of their ability to distinguish benign from malignant breast lesions. We also assessed how the diagnostic value of sonoelastography differs between palpable and clinically occult lesions., Materials and Methods: Evaluation revealed a total of 97 lesions (66 benign; 31 malignant) without histological confirmation at the time of the initial examination. The sensitivity, specificity, positive (PPV) and negative predictive value (NPV) as well as efficiency were calculated. These parameters were separately assessed for palpable lesions and for non-palpable lesions. We subsequently compared these results., Results: Sonography had a sensitivity of 97% and a specificity of 82% (PPV: 71 %, NPV: 98%, efficiency: 87%). For mammography, the respective figures were 84% and 89% (PPV: 79%, NPV: 92%, efficiency: 88%). Sonoelastography had a sensitivity of 71% and a specificity of 48% (PPV: 39%, NPV: 78%, efficiency: 56%). The combination of sonography and sonoelastography yielded a sensitivity of 100% and a specificity of 38% (PPV: 43%, NPV: 100%, efficiency: 58%). The sensitivity and specificity were not statistically different between the groups of palpable and non-palpable lesions., Conclusion: Sonoelastography is easily performed and not very time-consuming. Used by itself, the method is not more efficacious than alternative techniques. When used in conjunction with B-mode ultrasonography, the latter's sensitivity was increased, albeit at the expense of specificity., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Mesh reconstruction, especially in combination with vacuum-assisted closure, might improve healing and reduce the surgical morbidity of extensive inguinofemoral lymphadenectomy or extensive local resection in progressive cancer of the vulva., Cases: Radical vulvectomy combined with inguinofemoral lymphadenectomy was performed in 2 patients (P1, P2). The inguinofemoral wound bed was stabilized by polypropylene mesh implantation and sealed with vacuum closure system. In 1 patient with local recurrence of vulvar cancer (P3), local excision and stabilization of the wound were performed by mesh implantation., Conclusions: Mesh implantation fulfills 2 purposes: (1) it protects exposed vessels and the wound can be vacuum sealed; and (2) it stabilizes the surgical bed, permitting the required radical excision locally and inside the vascular compartment.

Background: In order to elucidate criteria for distinguishing benign from malignant lesions, this study correlated the ductoscopy-based macroscopic description of intraductal lesions with histopathologic results., Materials and Methods: Aiming to use diagnostic criteria consistent with previous publications, we analyzed the literature and established a uniform set of diagnostic descriptors. Based on these criteria, we subsequently analyzed and catalogued video and photographic material from 68 patients with nipple discharge, who had undergone ductoscopy followed by open surgery. For all breast lesions, the factors lesion type, number of lesions, lesion color, surface characteristics, and presence of blood or atypical vessels were reported. Based on the frequency distribution and the odds ratio, we were able to evaluate the differential diagnostic value of ductoscopic criteria in comparison with the respective histopathologic results., Results: Among the ductoscopic criteria, a fissured surface, hemorrhage or atypical vessels, and a polypoid appearance were important predictors for malignant lesions. In contrast, a smooth surface, the absence of hemorrhage and atypical vessels and a level appearance of the lesions predicted benign lesions., Conclusions: For predicting the benign versus malignant character of ductoscopic lesions, the following criteria should be used: presence or absence of blood and atypical vessels, surface type, and level versus polypoid appearance.

Purpose: According to the current interdisciplinary S 3 guideline for breast cancer diagnostics, treatment, and follow-up (1st update 2008), palpation is one of the diagnostic mainstays for follow-up examinations after mastectomy. Although recommended in the manuscript, regular ultrasonographic examinations are neither explicitly mentioned in the statement nor in the follow-up plan. In ambiguous cases, MRI can serve as a supplementary diagnostic method. In order to evaluate the value of palpation and ultrasonography for diagnosing recurrent disease after mastectomy, we analyzed the sensitivity of each method individually and the sensitivity of both methods combined., Materials and Methods: Over a 12-year time span, histological data from 57 patients suspected to have recurrent disease after mastectomy (benign lesions: n = 15, 26.3% malignant lesions: n = 42, 73.7%) were collected. Prior to biopsy, the benign versus malignant character of all lesions was assessed by palpation and ultrasonography (BI-RADS). Sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv), and efficacy were calculated using a contingency table., Results: Palpation had a sensitivity of 85.7 % and a specificity of 6.7% the respective figures for ultrasonography were 90.5% and 46.7%. The sensitivity of palpation and ultrasonography combined was 100%, i. e. 14.3% higher than the sensitivity of palpation alone. Five cases of recurrent disease which remained undetected by palpation were only recognized by ultrasonography., Conclusion: In agreement with several other studies, the results of our retrospective study show that ultrasonography is superior to palpation for diagnosing recurrent disease after mastectomy. Prospective multicenter studies are needed to evaluate ultrasonographic follow-up before an amendment of the current S 3 guidelines can be recommended with a high degree of evidence., (Georg Thieme Verlag KG Stuttgart, New York.)

Background: To investigate the diagnostic reliability of selective microdochectomy after direct ductoscopic wire marking of suspect lesions in patients with pathological nipple discharge., Methods: Selective microdochectomy due to pathological discharge was performed in 33 patients with mean age of 51.7 years. Ductoscopes of 0.9 and 1.1 mm in diameter with a channel for wire marking were used. Only patients without sonographic or mammographic correlation for the discharge were included. The pathologic mammary duct was wire marked and extirpated under direct visual guidance via the ductoscope. The histological results were compared with cytology, galactography and ductoscopy., Results: In 24 out of 33 cases (72%) an intraductal, epithelial proliferation was found histologically. The following sensitivities for intraductal, epithelial proliferations could be determined: cytology 4%, galactography 74%, and ductoscopy 78%., Conclusion: The method allows selective microdochectomy of the pathological duct and the intraductal proliferation under visual guidance. The resection volume can be reduced in contrast to the unselective ductectomy after injection of methylene blue.

Objective: Laparoscopic supracervical hysterectomy (LASH) was analyzed with regard to surgical indications and outcomes., Methods: This is a retrospective analysis of the first 1,000 consecutive laparoscopic supracervical hysterectomies performed by one gynecologist from September 1, 2002 to April 30, 2006. The objective of the study was to find out to what extent the indication and the outcome of surgery changed with the increase in experience of the surgeon and whether a learning curve could be established based on the results. The demographic patient data, indication for surgery, patient history with regard to previous surgery, duration of surgery, intraoperative complications, uterus weight, and length of in-patient stay were collected from the medical records., Results: The main indication in 80.4% of cases was uterus myomatosis. The median duration of surgery was 70.9+/-26.3 minutes (95% CI, 69.2 to 72.5) with an average uterus weight of 212.5+/-177.0g (95% CI, 201 to 223.6). This was reduced from 85.4+/-25.9 minutes (95% CI, 78.5 to 92.3) in 2002 to 72.4+/-30.1 minutes (95% CI, 66.7 to 78.2) in 2006, in conjunction with an increase in average uterus weight from 192.3+/-145.4g (95% CI, 153.8 to 230.9) to 228.7+/-160.3g (95% CI, 198.1 to 259.3). Overall, one intraoperative lesion of the bladder (0.1%) occurred, and in 4 cases the surgeon had to convert to laparotomy instead, due to the size and immobility of the uterus. Sixty-eight patients had a uterus weight of more than 500 g. In 67% of the cases, surgery was performed on patients with at least one previous laparotomy, and 51.4% of the patients required further interventions., Conclusion: An experienced surgeon can rapidly learn the technique of laparoscopic supracervical hysterectomy and can safely perform it. In patients with symptomatic uterine myomatosis, previous laparotomy and/or with a uterine weight of more than 500g, laparoscopic supracervical hysterectomy is a useful alternative to total hysterectomy. There are few complications if preservation of the cervix is not contraindicated.

Hypogonadotropic hypogonadism is defined as a medical condition with low or undetectable gonadotropin secretion, associated with a complete arrest of follicular growth and very low estradiol. The main cause can be traced back to an irregular or absent hypothalamic GnRH secretion, whereas only a minority suffers from a pituitary disorder. The choice of treatment to reverse this situation is a pulsatile GnRH application or a direct ovarian stimulation using gonadotropin injections. The goal is to achieve a proper ovarian function in these cases for a short time to allow ovulation and chance of pregnancy. Since the pulsatile GnRH treatment lost its former importance, several gonadotropins are in use to stimulate follicular growth, such as urine-derived human menopausal gonadotropin, highly purified follicle stimulating hormone (FSH) or recombinant FSH, all with different success. The introduction of recombinant luteinizing hormone (LH) and FSH provided an opportunity to investigate the distinct influences of LH and FSH alone and in combination on follicular growth in monofollicular ovulation induction cycles, and additionally on oocyte maturation, fertilization competence of the oocyte and embryo quality in downregulated IVF patients. Whereas FSH was known to be indispensable for normal follicular growth, the role of LH remained questionable. Downregulated IVF patients with this short-term gonadotropin depletion displayed no advance in stimulation success with the use of recombinant LH. Patients with hypogonadotropic hypogonadism undergoing monofollicular stimulation for ovulation induction showed clearly a specific role and need for both hormones in normal follicular growth. Therefore, a combined stimulation with FSH and LH seems to be the best treatment choice. In the first half of the stimulation cycle the FSH dosage should exceed that of LH by 2:1, with an inverse ratio for the second half.

Background: In consideration of increasing incidence by introduction of screening mammography, the prevalence of distant metastases and necessity of staging procedures in early breast cancer should be proved., Patients and Methods: A retrospective review was undertaken of 466 patients with newly diagnosed breast cancer in the period from 2003 to 2006., Results: Distant metastases were found in 22 (4.8%) patients at the time of primary diagnosis of breast cancer. None of these patients had a tumour < or =1 cm and the percentage of metastatic disease increased with local extension (pT1 1.4%; pT2 7.9%; pT3 14.3%; pT4 23.1%; p<0.001) and nodal status (pN0 1.7%; pN1 3.8%; pN2 21.7%; pN3 17.6%; p<0.001), Conclusion: Indication for bone scan, liver ultrasound and chest x-ray should be limited to patients with tumours >2 cm, or tumours >1 cm with lymph node involvement (N1-3).

Asparagus spears collected from a total of six commercial plantings in Austria during the main harvest periods in May and June of 2003 and 2004 were examined for endophytic colonization byFusarium spp., particularlyF. proliferatum. Potentially toxigenic fungi such asF. proliferatum were isolated and identified by morphological characteristics using light microscopy. Fumonisin B1 inF. proliferatum-infected asparagus spears was detected with IAS-HPLC-FLD or HPLC-MS/MS. The identity of endophytic fungi colonizing of a total of 816 individual spears was determined. The incidence of infection byF. proliferatum and otherFusarium spp. was highly dependent on location and sampling date. The dominantFusarium species among the endophytic microflora wasF. oxysporum. Other frequently isolated species includedF. proliferatum, F. sambucinum, F. culmorum, F. avenaceum andF. equiseti. The incidence ofF. proliferatum-infected asparagus spears was less than 10% at four of the six sampling locations. At the two remaining locations, 20-47% of the spears examined were infected withF. proliferatum. Further exploration of FB1 generation in asparagus is required because the low levels of FB1 (10-50 (μg/kg) detected in harvested spears in 2003 and 2004 cannot be explained by the results of this study.

Several large, well-controlled clinical trials have now established that the aromatase inhibitors (AIs), including letrozole, anastrozole, and exemestane, are more effective than tamoxifen when used as adjuvant endocrine therapy in postmenopausal women with breast cancer. Yet, it is an open question as to how these drugs should be best integrated into the adjuvant treatment regimen. Both letrozole and anastrozole have shown efficacy over tamoxifen when used as initial adjuvant therapy (initiated just following surgery for breast cancer), while exemestane and anastrozole have been used as switching adjuvant therapy, i.e., following 2-3 years of initial adjuvant tamoxifen therapy, with proven efficacy over continued tamoxifen. Studies demonstrate that recurrence risk peaks in the early period after surgery, and that distant metastases in particular, accounting for most of the early recurrences, have worse survival rates when compared with other types of recurrences. Treatments that reduce recurrences, especially distant metastases, in this early period are therefore likely to improve overall survival (OS) and reduce mortality from breast cancer. In this review, we discuss early recurrence risk among postmenopausal women with successfully treated early breast cancer, the efficacy of the different AIs in reducing early recurrences and distant metastases when incorporated into adjuvant therapy, and the evidence for increased OS when AIs are used as initial or switch adjuvant therapy.

Background: Endoscopy of the female breast, known as ductoscopy, is increasingly gaining acceptance as a diagnostic procedure worldwide. Recent technical development of ductoscopes and micro-instruments is shifting research interest from diagnostic to interventional ductoscopy. We describe novel technical aspects and the resulting possible future perspective of ductoscopy., Methods: This study comprised the analysis and review of new technical developments from research at the Technical University Munich, Germany, and others, as well as a review of the MEDLINE and COCHRANE databases for the keyword ductoscopy., Results: Diagnostic ductoscopy is performed by many breast physicians worldwide. Interventional ductoscopy, however, depends on an additional working channel and a variety of micro-instruments of 0.4-0.8 mm for procedures inside the breast duct. They are at present not available in the U.S. but are used in Germany and several other countries. Autofluorescence ductoscopy is a new imaging technique used on an experimental base for clinical evaluation to identify intraductal lesions. Laser ductoscopy for removal of intraductal papillomas and 3-dimensional intraductal tracking systems are future projects., Conclusion: Technical innovation and further miniaturization of instruments is supporting a change from diagnostic to interventional ductoscopy. A therapeutic intraductal approach as well as autofluorescence endoscopy could potentially eliminate unnecessary biopsies and offer better identification of intraductal lesions.

Background: This is a retrospective cohort study on the safety and efficacy profiles of weekly docetaxel at varying doses in patients with pretreated metastatic breast cancer., Patients and Methods: Twenty-five anthracycline-pretreated patients received docetaxel administered on a weekly basis, as a one-hour infusion, at various dosage levels (25, 30, 35, 40 mg/m2) depending on their baseline Karnofsky index. Each 8-week cycle consisted of 6 weeks of drug infusion, followed by a 2-week rest period., Results: Of the 25 patients investigated, none achieved complete response (CR), while 9 patients showed partial response (PR), which corresponds to an overall response rate of 36%. Five patients (20%) maintained stable disease (SD), whereas 11 patients (44%) suffered tumor progression (PD) during treatment. Clinical response (defined as PR+SD) was achieved in 14 patients (56%). Median time to progression was 231 days (95% CI, 187-275). The baseline Karnofsky index was 87% +/- 9% (range: 70-100). Patients pretreated with anthracyclines only tended to have a better response than anthracycline/paclitaxel-pretreated patients (n = 6, p = 0.054). Higher dosages were associated with neurotoxicity, skin/nail toxicity, leukopenia, nausea/vomiting, fatigue/asthenia, peripheral edema, but not with diarrhea and alopecia. The cumulative dose per patient was largest for a weekly docetaxel dosage of 35 mg/m2 and almost as large for 30 mg/m2., Conclusion: Balancing toxicity vs. efficacy/cumulative dosage delivered, our results support weekly administration of docetaxel at dosages of 30-35 mg/m2 in metastatic breast cancer. Response in patients pretreated with anthracyclines and taxanes may be poorer than in those pretreated with anthracyclines only.

Purpose: According to the S-3 guidelines for the diagnosis and treatment of breast cancer, only palpation and mammography are mandatory follow-up examinations. Ultrasonography is only mentioned as an optional technique. Aiming to elucidate the diagnostic yield for detecting recurrent disease after breast-preserving therapy (BPT) and radiation treatment, we analysed the sensitivity of palpation, mammography, ultrasonography, and combinations of these methods., Materials and Methods: Over a period of 12 years, 27 suspicious lesions in patients status post BPT and radiation therapy were biopsied (histologic results: 16 benign lesions: 59.3 %, 11 malignant lesions: 40.7 %). Prior to biopsy, the benign or malignant character of each lesion was predicted by palpation, mammography and ultrasonography (BIRADS). Sensitivity, specifity, positive predictive value (ppv), negative predictive value (npv), and efficiency were calculated from a contingency table., Results: For lesions status post BPT and radiation treatment, palpation had a sensitivity of 72.7 % and was 25 % specific. For mammography, the respective values were 36.4 % and 87.5 %, and for ultrasonography 90.9 % and 68.8 %. Palpation and mammography combined were 81.8 % sensitive and had a specificity of 6.2 %. The computed sensitivity for the 3 methods applied together was 100 %. Adding ultrasonography to palpation and mammography therefore increases sensitivity by 18.2 %., Conclusion: For diagnosing recurrent disease in patients status post BPT and radiation therapy, ultrasonography is superior to palpation and/or mammography and should become an obligatory follow-up tool. The role of mammographic follow-up appears overrated and the role of ultrasonographic assessment underrated. The S-3 guidelines will need to be changed accordingly.