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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

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.

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, 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 co-morbidities, 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. Citation Format: Machleidt A, Schmidt-Feuerheerd N, Blohmer J-U, Ohlinger R, Küper J, von Waldenfels G, Dittmer S, Paepke S, Klein E. Reconstructive breast surgery with partially absorbable bi-component Seragyn® BR soft mesh: An outcome analysis [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-16-16.

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.

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.

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

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.

This yearʼs 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).

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

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. 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. 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. 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.

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.

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.

Einleitung: Der Einsatz von azellularer Dermis und Netzinterponaten in der plastisch-rekonstruktiven Mammachirurgie wird bei bisher exzellenten Erfahrungen durch die Leitlinien der Arbeitsgemeinschaft Gynakologische Onkologie gleichrangig zu Rekonstruktionen mit korpereigenem Gewebe empfohlen. Seit 8/2010 steht ein teilresorbierbares Zweikomponentennetz zur Verfugung, dessen Grundfaden als Tragergerust aus resorbierbarem Polyglykolsaure-Caprolacton (PGA-CL) besteht und nach Resorption Polypropyleneinzelfilamente als Dauerimplantat zurucklasst. Die Materialeigenschaften des Netzes sprechen fur einen Einsatz in der plastisch-rekonstruktiven Mammachirurgie bei Implantateinlage. Material und Methoden: Von 3/11 – 6/12 fuhrten wir bei 28 Patientinnen (Alter im Median: 47 Jahre) subkutane Mastektomien mit Einlage des teilresorbierbaren Zweikomponentennetzes (n = 34) als sofortrekonstruktive Methode durch. Ergebnisse: Die Brustdrusenabladate wiesen ein Durchschnittsgewicht von 329 g (120 – 580 g) auf, die Implantate ein Durchschnittsvolumen von 335 cm³ (125 – 515 cm³). Die Implantateinlage erfolgte vornehmlich als subpectorale Implantateinlage; in 7 Fallen wurde das Implantat ausschlieslich netzbedeckt. Wir verzeichneten keine Netzarosion, 4 Wundinfektionen, von denen 2 operativ korrigiert werden mussten und weitere 3 ungeplante Folgeoperationen mit zweimaliger Entfernung der gesamten Rekonstruktion. Als Hauptrisikofaktoren fur Fruhkomplikationen wurden Voroperationen, Bestrahlung und ein periareolarer operativer Zugang identifiziert. Die mittlere Drainagedauer betrug 8 Tage. Diskussion: Der Einsatz grosporiger, teilresorbierbarer Implantate fuhrt durch die Materialkombination und -konstruktion, die Reduktion des Fremdkorperanteils und die gesteigerten Weichheit nach Resorption zu Formstabilitat und Geschmeidigkeit der Rekonstruktion. Die bisher geringe Fallzahl und die kurze Nachbeobachtungszeit limitieren die Gultigkeit der Aussagen. Initiiert wurde eine prospektive multizentrische Untersuchung, die Erfahrungen anhand von 100 Patientinnen zusammenfuhren soll. Darauf aufbauend wird ein Vergleich der zur Verfugung stehenden Gewebeinterponate gefuhrt werden.

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.

Previous studies have already shown a survival benefit in sub groups of metastatic breast cancer treated with bisphosphonates. Zoledronate given monthly to patients with metastatic disease to the bones showed a reduction in mortality of 32% [1]. Conceivable mechanisms include changes in the microenvironment of tumor cells, induction of apoptotic pathways, reduction of angiogenesis and cell adhesion [2-7]. Moreover, zoledronate interferes with the interaction between tumor cells and the bone marrow microenvironment. Bone metabolism is reduced, and proliferation requirements are disrupted in a major target location of metastatic disease. All these effects seem to be independent of the estrogen receptor status or grading of the primary breast tumor. There is accumulating evidence that adjuvant treatment with zoledronate improves progression and recurrent free survival in estrogen receptor positive breast cancer independent of the menopausal status. Although the use of zoledronic acid in the adjuvant setting is still off label, it has become a major corner stone in everyday clinical practice. Moreover, also in the special situation of triple negative or estrogen receptor negative breast cancer with a high risk of recurrence, zoledronate is increasingly used both within clinical trials and in individual cases.

PURPOSE: Aim of the study was to investigate the diagnostic reliability of selective microdochectomy after direct ductoscopic wire marking of suspect lesions in patients with pathological nipple discharge. MATERIAL AND METHODS: Selective microdochectomy due to pathological discharge was performed in 45 patients with a mean age of 52 years (range 21-71). Ductoscopes with diameters of 0.9 and 1.1 mm and 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 32 of 45 cases (71 %) an intraductal, epithelial proliferation was found histologically. The following sensitivities for intraductal, epithelial proliferations could be determined: cytology 12 %, galactography 70 %, and ductoscopy 79 %. CONCLUSION: The method allows selective microdochectomy of the pathological duct and intraductal proliferation to be performed under visual guidance. The resection volume can be reduced in contrast to unselective ductectomy after injection of methylene blue.