Evolution of Fetal Growth in Symptomatic Sars-Cov-2 Pregnancies.

INTRODUCTION: SARS-CoV-2 is a viral disease with potentially devastating effects. Observational studies of pregnant women infected with SARS-CoV-2 report an increased risk for FGR. This study utilizes data from a prospective SARS-CoV-2 registry in pregnancy, investigating the progression of fetuses to fetal growth restriction (FGR) at birth following maternal SARS-CoV-2 and evaluating the hypothesis of whether the percentage of SGA at birth is increased after maternal SARS-CoV-2 taking into account the time interval between infection and birth. MATERIALS & METHODS: CRONOS is a prospective German registry enrolling pregnant women with confirmed SARS-CoV-2 infection during their pregnancy. SARS-CoV-2 symptoms, pregnancy- and delivery-specific information were recorded. The data evaluated in this study range from March 2020 until August 2021. Women with SARS-CoV-2 were divided into three groups according to the time of infection/symptoms to delivery: Group I<2 weeks, Group II 2-4 weeks, and Group III>4 weeks. FGR was defined as estimated and/or birth weight<10% ile, appropriate for gestational age (AGA) was within 10 and 90%ile, and large for gestational age (LGA) was defined as fetal or neonatal weight>90%ile. RESULTS: Data for a total of 2,650 SARS-CoV-2-positive pregnant women were available. The analysis was restricted to symptomatic cases that delivered after 24+0 weeks of gestation. Excluding those cases with missing values for estimated fetal weight at time of infection and/or birth weight centile, 900 datasets remained for analyses. Group I consisted of 551 women, Group II of 112 women, and Group III of 237 women. The percentage of changes from AGA to FGR did not differ between groups. However, there was a significantly higher rate of large for gestational age (LGA) newborns at the time of birth compared to the time of SARS-CoV-2 infection in Group III (p=0.0024), respectively. CONCLUSION: FGR rates did not differ between symptomatic COVID infections occurring within 2 weeks and>4 weeks before birth. On the contrary, it presented a significant increase in LGA pregnancies in Group III. However, in this study population, an increase in the percentage of LGA may be attributed to pandemic measures and a reduction in daily activity.

Best Practice Guideline - DEGUM Recommendations on Breast Ultrasound. / Best Practice Guideline ­ Empfehlungen der DEGUM zur Durchführung und Beurteilung der Mammasonografie.

Alongside mammography, breast ultrasound is an important and well-established method in assessment of breast lesions. With the "Best Practice Guideline", the DEGUM Breast Ultrasound (in German, "Mammasonografie") working group, intends to describe the additional and optional application modalities for the diagnostic confirmation of breast findings and to express DEGUM recommendations in this Part II, in addition to the current dignity criteria and assessment categories published in Part I, in order to facilitate the differential diagnosis of ambiguous lesions.The present "Best Practice Guideline" has set itself the goal of meeting the requirements for quality assurance and ensuring quality-controlled performance of breast ultrasound. The most important aspects of quality assurance are explained in this Part II of the Best Practice Guideline.

Correlation analysis of resected breast tissue and implant volume after mastectomy and its association with breast density.

BACKGROUND: The current methods for calculating the ideal implant volume for breast reconstruction are based on pre- or intraoperative volume measurements of the existing breast volume and do not take into account the individual breast density of the woman. This study aims is to identify objective parameters that can help to improve the optimal implant selection. MATERIALS AND METHODS: This retrospective analysis includes 198 breast cancer patients who underwent mastectomy. Breast densities (ACR) measured in mammography and MRI were compared with the removed breast tissue weight and volume of the implants used. In addition, the resected weight was compared directly with the implant volume to calculate a mathematical function. RESULTS: There was no significant correlation between the ACR values and the resected weights [correlation coefficient: mammography:- 0.117 (p = 0.176), MRI - 0.033 (p = 0.756)]. A negative correlation between the implant volumes and both imaging methods could be demonstrated [correlation coefficient: mammography - 0.268; p = 0.002; MRI was - 0.200 (p = 0.055)]. A highly significant correlation between the resected weights and the implant volumes (correlation coefficient 0.744; p < 0.001) was observed. This correlation corresponds to a power function (y = 34.71 x0.39), in which any resected weight can be used for the variable x to calculate the implant volume. CONCLUSION: We were able to show that there is a significant correlation between the resected breast tissue and the implant volume. With our novel potency function, the appropriate implant volume can be calculated for any resected weight making it easier for the surgeon to choose a fitting implant in a simple and more objective manner.

Platelet-rich plasma (PRP) in oncological patients: long-term oncological outcome analysis of the treatment of subcutaneous venous access device scars in 89 breast cancer patients.

PURPOSE: Platelet-rich plasma (PRP) is widely used product, and meta-analyses showed this product to be beneficial when applied to a wound area. This study group has already demonstrated increased patient satisfaction and lower complication rates in breast cancer patients who received PRP after removal of their subcutaneous venous access device. This work is a follow-up analysis focusing on oncologic safety. Currently, there is no long-term data on the use of PRP products in cancer patients available yet. METHODS: Between the years 2012-2016, venous access device removal was supported with the application of Arthrex ACP® (Autologous Conditioned Plasma)-a PRP product to improve the wound-healing process. All surgeries were performed in the breast cancer center of the municipal hospital of Cologne, Holweide, Germany. 35 patients received an application of Arthrex ACP® after port removal compared to the control group of 54 patients. Endpoints were local recurrence-free, distant recurrence-free as well as overall survival. RESULTS: Median follow-up was 45 months. No (0) adverse events were shown for cancer recurrence within the subcutaneous venous access device scar area. Thus, there seems to be no local oncogenic potential of the PRP product. All other endpoints as well as any-cause death numerically favor PRP use. CONCLUSION: PRP products such as Arthrex ACP® seem to be oncological inert when applied after removal of subcutaneous access devices. This is the first study providing long-term data about overall survival, distant recurrence-free and local recurrence-free survival after applying PRP in high-risk cancer patients.

A biomechanical analysis of different meshes for reconstructions of the pelvic floor in the porcine model.

PURPOSE: Many different surgical approaches have been established for the repair of a pelvic organ prolapse. Especially in laparoscopic surgery, it is important to generate easy surgical techniques with similar stability. This study shall simplify the choice of mesh by evaluating three polypropylene meshes regarding their biomechanical properties. METHODS: Biomechanical testing was performed in the porcine model. The meshes are fixated on porcine fresh cadaver cervices after subtotal hysterectomy. The apical part of the mesh is fixated with parallel screw clamps at the testing frame. Forty-one trials were performed overall, subdivided into four subgroups. The groups differ in mesh type and fixation method. Maximum load, displacement at failure and stiffness parameters were evaluated with an Instron 5565® test frame. RESULTS: SERATEX® E11 PA (E11) showed the highest values for maximum load (199 ± 29N), failure displacement (71 ± 12 mm) and stiffness (3.93 ± 0.59 N/mm). There was no significant difference in all three evaluated parameters between SERATEX® B3 PA (B3) and SERATEX® SlimSling® with bilateral fixation (SSB). SERATEX® SlimSling® with unilateral fixation (SSU) had the lowest stiffness (0.91 ± 0.19 N/mm) and maximum load (30 ± 2 N) but no significant difference in displacement at failure. CONCLUSION: All meshes achieved a good tensile strength, but the results of maximum load show that the E11 is superior to the other meshes. Through a bilateral fixation of SERATEX® SlimSling®, a simple operating method is generated without a loss of stability.

Tacks vs. sutures: a biomechanical analysis of sacral bony fixation methods for laparoscopic apical fixations in the porcine model.

PURPOSE: There is a novel surgical procedure, called cervicosacropexy (CESA) and vaginosacropexy (VASA) to treat pelvic organ prolapse and a concomitant urgency and mixed urinary incontinence. As there is little experience with the tapes so far and literature is scanty, the aim of this study was to investigate biomechanical properties for the fixation of the PVDF-tapes with three different fixation methods in context of apical fixations. METHODS: Evaluation was performed on porcine, fresh cadaver sacral spines. A total of 40 trials, divided into 4 subgroups, was performed on the anterior longitudinal ligament. Recorded biomechanical properties were displacement at failure, maximum load and stiffness in terms of the primary endpoints. The failure mode was a secondary endpoint. Group 4 was a reference group to compare single sutures on porcine tissue with those on human tissue. Biomechanical parameters for single sutures on the human anterior longitudinal ligament were evaluated in a previous work by Hachenberg et al. RESULTS: The maximum load for group 1 (two single sutures) was 65 ± 12 N, for group 2 (three titanium tacks arranged in a row) it was 25 ± 10 N and for group 3 (three titanium tacks arranged in a triangle) it was 38 ± 12 N. There was a significant difference between all three groups. The most common failure mode was a "mesh failure" in 9/10 trials for groups 1-3. CONCLUSION: The PVDF-tape fixation with two single sutures endures 2.6 times more load than titanium tacks arranged in a row and 1.7 times more load than titanium tacks arranged in a triangle. The presacral fixation with titanium tacks reduced surgical time compared to the fixation with sutures, nevertheless sutures represent the significantly stronger and cheaper fixation method.

Best Practice Guideline - DEGUM Recommendations on Breast Ultrasound. / Best Practice Guideline ­ Empfehlungen der DEGUM zur Durchführung und Beurteilung der Mammasonografie ­ TEIL I ­ Untersuchungstechnik, Ultraschall-DEGUM-Kriterien und deren Dokumentation.

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.

Intraoperative central nipple biopsy in nipple-sparing mastectomy- A retrospective analysis of 211 patients.

Subcutaneous nipple sparing mastectomies (NSM) are an important tool in modern oncoplastic surgery. Especially when an immediate implant-based reconstruction (IBR) is desired, clean margins are of the utmost importance. Central nipple biopsies during surgery serve two main purposes. Most importantly, it is hypothesized that intraoperative pathological evaluation of this biopsy may increase clean margin resection rates. In addition, a general recurrence risk reduction may occur due to the elimination of glandular and ductal components within the nipple. This analysis is a single center, multi-surgeon, retrospective, head to head analysis. Starting in March 2015, intraoperative central nipple biopsy in NSMs with IBR was introduced at the Municipal Breast Cancer Centre Cologne, Holweide, Germany. This trial retrospectively evaluates global complication rates, clean margin status and local recurrence rates for cohort 1 (NSM/no nipple biopsy, n = 103) vs. cohort 2 (NSM with nipple biopsy, n = 108) Median follow-up was 15 months. All implant-based reconstruction procedures used an epipectoral implant pocket. Cohorts were comparable. Global complication rates slightly favored the nipple biopsy cohort with respects to implant loss rate. An involved central nipple biopsy was found in 4.6% (n = 5/108) of the performed NSM procedures leading to the immediate removal of the nipple areola complex. All positive retro-areolar biopsies correlated with a positive nipple biopsy. However, in n = 1 case we found DCIS discontinual proliferation with an involved nipple biopsy, without a correlating positive retro-areolar biopsy (ie, 1 false-negative case was prevented). For the 15 month follow-up, there was no case of local recurrence within nipple areola complex for both cohorts. With this retrospective head to head analysis of 211 patients, it was shown that the central nipple biopsy correlates well with the retro-areolar biopsy. There may be a reduction in false negative rates. The procedure is safe to use and should be offered to NSM patients.

The impact of EndoPredict ® on decision making with increasing oncological work experience: can overtreatment be avoided?

BACKGROUND: Estimating distant recurrence risk in women with estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer is still challenging. EndoPredict® is a gene expression-based test predicting the likelihood of recurrent disease. We analyzed the difference in oncological decision making with and without the knowledge of gene expression tests. PATIENTS AND METHODS: This is a retrospective analysis including patients diagnosed with hormone-receptor positive, Her2 negative breast cancer between 2011 and 2015 at the Municipal Breast Cancer Centre Cologne, Germany. All patients received an evaluation by EndoPredict®. An oncological tumor board (TB) with knowledge of these results served as a baseline (control group). This baseline was compared to the treatment decision (adjuvant chemotherapy yes vs. no) made by oncologists with different experience levels (less than 5 years, between 5 and 15 years, and more than 15 years) who were not provided the EndoPredict® scores. All clinicians had access to clinical as well to histopathological data. RESULTS: There was no significant difference between control group and the oncologists with different experience levels concerning a chemotherapy indication. A trend could be shown in the subgroup of nodal negative patients between the treatment recommendation and physicians with more than 15 years of experience (p = 0.088). A further trend could be demonstrated in the subgroup of patients with a low Ki67 index (≤ 14%) (p = 0.063) between physician with 5-10 years of clinical experience and official treatment recommendation. CONCLUSION: It seems that inexperienced physicians may profit from the use of EndoPredict® to avoid an overtreatment. In nodal negative patients and patients with a low Ki67 index, undertreatment can be avoided with the use of EndoPredict® (borderline significance). Further prospective studies with larger study cohorts are needed to further validate this tool.

The Use of Acellular Dermal Matrices (ADM) in Breast Reconstruction: A Review.

The use of acellular dermal matrices (ADM), sometimes referred to as extracellular matrix (ECM), has become an interesting aspect of breast reconstruction. A great deal of literature is available, totaling over 7000 ADM-based reconstructions. Most often, ADMs are used in a skin sparing mastectomy (SSM) scenario, although heterologous breast augmentation with a sub-pectoral fixation may also require an ADM application. Their use has become an attractive, but expensive option. Available data shows head to head comparisons between individual ADMs to be mostly retrospective in nature with only a few prospective trials available. Points of interest include postoperative hematoma, postoperative skin irritation, infection, red breast syndrome, and revision surgery. This work will, therefore, highlight the individual properties of ADMs used in breast reconstruction and compare the available data on complication rates and costs for these devices.

The number of removed lymph nodes by inguinofemoral lymphadenectomy: impact on recurrence rates in patients with vulva carcinoma.

OBJECTIVE: Inguinal lymph node (LN) metastasis is a crucial prognostic factor in vulva carcinoma. The aim of this study was to determine the prognostic value of the number of resected LNs in patients with vulvar carcinoma on recurrence rates. METHODS: This retrospective study includes patients with vulvar squamous cell carcinoma who underwent inguinofemoral lymphadenectomy (IFL) between 1998 and 2011. Dissected groins were stratified by the number of removed lymph nodes (<6 LNs versus ≥6 LNs) or inguinal LN metastasis (pN- versus pN+) and analyzed according to groin, local and distance recurrence rates. RESULTS: In total 45 patients were identified and 79 groins were eligible for this analysis. 11 patients underwent ipsilateral IFL and 34 bilateral IFL. The median age was 58 years (range 31-80). The median tumor size was 2 cm (range 0.1-7.9). A median of 8 (range 0-19) LNs were resected per groin. Overall in 11 groins LN metastases were found. Groin recurrences occurred in four patients, local recurrence in six patients and distant metastasis in one patient. We did not observe any significant improvement in groin recurrence rates, local recurrence rates and distant recurrence rates if more than six LNs were removed per groin. Notably, patients with LN metastasis did not show higher recurrence rates compared to unaffected LNs. CONCLUSION: In this cohort we demonstrated that resection of more than six LNs per groin does not improve the recurrence rates in patients with carcinoma of the vulva. Further prospective studies with more individuals are needed to evaluate the role of resected LNs in vulvar carcinoma.

A Retrospective Multicenter Analysis of Diagon/Gel® 4Two Implant in 209 Cases of Reconstructive Breast Surgery.

BACKGROUND/AIM: Breast cancer was the most common cancer in women in 2020. Breast reconstruction is an elementary component of modern breast surgery. This is especially important after oncological treatments. This is a retrospective multicenter study comparing Diagon\Gel® 4Two implants with different implants chosen by the treating surgeon. Diagon\Gel® 4Two (Polytech Health & Aesthetics, Germany) are anatomical silicone implants. PATIENTS AND METHODS: A total of 209 patients underwent surgery. All patients were treated in the period from 2001 to 2019. All procedures were subcutaneous mastectomies. The surgical techniques used were either skin-sparing mastectomies or nipple-sparing mastectomies. Surgery was performed with Diagon/Gel® 4Two implant or treatment of choice implant by the treating physician. Endpoints were major and minor complication rates. The average follow-up time was 5 years. In total, 110 subjects were asked about their satisfaction with the treatment. RESULTS: A total of 155 procedures were performed in the Diagon/Gel® 4Two implant group. One hundred and sixty procedures were done in the comparison group. Concerning either minor or major complications, there were no significant differences between both groups. The postoperative patient survey showed high satisfaction scores for both. There was significantly higher patient satisfaction among the study participants in the Diagon/Gel® 4Two implant group compared to the comparison group (p<0.01). CONCLUSION: The Diagon/Gel® 4Two implants are safe alternatives in direct comparison to previously used breast implants. Our study even demonstrated a slight superiority concerning patient satisfaction. Based on this study, further implants can be compared concerning both the direct perioperative complication rate and patient satisfaction.

Sonographic Assessment of Breast Implants Using Strain Elastography and Shear Wave Elastography in an Animal Model.

BACKGROUND/AIM: To date, magnetic resonance imaging (MRI) remains the gold standard for diagnosing breast implant rupture. As MRI is an expensive procedure with limited availability, the improvement of sonographic assessment is desirable. A potentially useful tool in this regard is elastography. To evaluate the diagnostic benefits of strain elastography and shear wave elastography under standardized conditions we developed an animal model. MATERIALS AND METHODS: An animal model was created by preparing an implant site in a chicken breast, imitating tissue layers covering a breast implant after mastectomy. Different broken and intact implants were inserted. Thereby, measurements were performed using strain elastography and shear wave elastography. For strain elastography, the resulting images were investigated on repeated patterns. The data generated by shear wave elastography were analyzed for significant differences between the ruptured and intact implants. RESULTS: The animal model using chicken breast generated realistic images and measurements comparable to those of a human breast. Hence, ruptured and intact implants could be compared under standardized conditions. Statistical analysis showed no significant difference between intact and ruptured implants with respect to the data generated by shear wave elastography. Qualitative analysis using strain wave elastography showed different patterns between intact and ruptured implants in the animal model. Intact implants showed a characteristic sonographic image of three layers in certain levels. CONCLUSION: Shear wave elastography does not seem to produce reliable data for the evaluation of breast implants, whereas qualitative analysis using strain elastography might be a useful tool to improve diagnostic accuracy.

Cyclic long-term loading of a bilateral fixed-angle plate in comparison with tension band wiring with K-wires or cannulated screws in transverse patella fractures.

PURPOSE: A bilateral fixed-angle plate was biomechanically compared to the two currently preferred methods of osteosynthesis for transverse patella fractures. It was hypothesized that the new angle-stable implant would provide a secure and sustainable fracture fixation, superior to the established standard techniques. METHODS: Twenty-one identical patellae made of polyurethane foam (Sawbones(®)), osteotomized to create a transverse two-part fracture, were fixed with modified anterior tension wiring, cannulated lag screws with anterior tension wiring or bilateral polyaxial 2.7-mm fixed-angle plates. The testing protocol consisted of 10,000 repetitive cycles using a non-destructive physiological load between 100 and 300 N at a simulated knee flexion of 60°. RESULTS: All 21 Sawbone(®)-patellae sustained repetitive loading up to 10,000 cycles without failing. The anterior tension wire group displayed significant displacement of the fracture gap (0.7 ± 0.2 mm) during cyclic loading, while both lag screws with tension wiring and bilateral fixed-angle plates showed no fracture gap widening at all (p < 0.01). CONCLUSION: The bilateral fixed-angle plate and cannulated lag screws with anterior tension wiring preserved a constantly reduced fracture gap over 10,000 tensile cycles in contrast to modified anterior tension wiring, which exhibited significant widening of the gap after initial loading. Results of in vitro testing indicate that bilateral fixed-angle plates provide sustainable fixation stability offering a promising new option in the treatment for transverse patella fractures.

The use of biodegradable sutures for the fixation of tibial eminence fractures in children: a comparison using PDS II, Vicryl and FiberWire.

BACKGROUND: Arthroscopic suture fixation of tibial eminence fractures using FiberWire is a favorable therapeutic option. The application of biodegradable material may be of advantage especially during childhood. The aim of this study was to evaluate the biomechanical properties using the biodegradable suture materials PDS II and Vicryl compared with FiberWire. METHODS: Bone mineral density was evaluated by pqCT in 18 human knee specimens and 3 similar groups were formed. A standardized anterior tibial eminence fracture was created and suture fixation was performed using each suture material (PDS II, Vicryl, FiberWire) in 6 specimens. Cyclic testing and destructive loading to failure was conducted. RESULTS: Both testing modalities showed PDS II to be inferior to the other evaluated suture materials. Although significantly higher failure loads were seen with FiberWire sutures, Vicryl yielded comparable stiffness in load-to-failure testing. No significant differences between Vicryl and FiberWire could be observed under nondestructive cyclic conditions. CONCLUSIONS: Even though FiberWire yields a superior ultimate failure load, Vicryl presented comparable results under cyclic conditions. CLINICAL RELEVANCE: For tibial eminence fractures in children, Vicryl should be considered as an alternative biodegradable suture material. The use of PDS II cannot be advocated.

Biomechanical stability of different suture fixation techniques for tibial eminence fractures.

PURPOSE: Displaced tibial eminence fractures require surgical fixation in order to obtain a stable knee joint. Suture fixation with FiberWire(®) seems to be the most favorable therapeutic option. Biomechanical studies show failure of this technique most commonly due to a suture cutout with subsequent fracture of the tibial eminence fragment. The goal of this study is to compare the biomechanical properties of three different techniques of suture fixation using FiberWire(®). METHODS: Bone mineral density was evaluated in 18 human knee specimens by pqCT, and three similar groups were formed. A standardized anterior tibial eminence fracture was created, and suture fixation was performed using one of three different techniques in 6 specimens each. Cyclic and destructive testing was conducted. RESULTS: Significant differences between the three techniques could be shown neither in the cycles needed to achieve a steady state nor in a failure load or initial stiffness. Almost all specimens failed by suture cutout. CONCLUSION: The presented modification of the existing technique for suture fixation of tibial eminence fractures did not lead to an increased initial stability nor did it lower the rate of suture cutout. All tested suture techniques showed comparable initial stiffness and failure load.

Initial stability of two different adhesives compared to suture repair for acute Achilles tendon rupture--a biomechanical evaluation.

PURPOSE: Treatment of acute subcutaneous Achilles tendon rupture remains challenging. Whereas the results of conservative and operative treatment are inconsistent, early mobilisation treatment seems to be beneficial. Besides suture repair, operative treatment using adhesives reveals promising results. Our hypothesis was that a gluing technique provides initial stability comparable to sutures. METHODS: In a biomechanical study, 18 fresh frozen sheep Achilles tendons were used to compare the biomechanical properties of suture repair using PDS® II and Bunnell's technique to tendon gluing using BioGlue® and Tissucol®. Load to failure testing was performed. RESULTS: Ultimate failure loads of sutures (146.2 ± 30.8 N) are significantly superior to the techniques using BioGlue® (38.4 ± 18.3 N; p <0.0001) or Tissucol® (4.7 ± 2.5 N; p <0.0001). Interestingly, no significant differences in stiffness were found between the application of BioGlue® and PDS® II. CONCLUSIONS: Suture repair provides significantly superior biomechanical properties compared to the use of both tested adhesives BioGlue® and Tissucol®. Based on the presented data we recommend the use of suture material for open Achilles tendon repair.

Angle stable locking nails versus conventionally locked intramedullary nails in proximal tibial shaft fractures: a biomechanical study.

INTRODUCTION: A tibial nail with fixed-angle locking screws intends to combine the advantages of angular stability and intramedullary stabilization in extraarticular proximal tibial fractures. The goal of this study is to analyze if the angle stable tibial nail (ASN) is biomechanically more stable than an established conventional standard nail (CN). METHODS: Two types of nails were compared on a series of ten matched pairs of human tibiae. After setting a proximal tibial defect fracture, the intramedullary stabilized tibiae were axially loaded starting from 100 N increasing in steps of 100 N after every 200 cycles until failure was reached. Failure was defined as deformation of the fracture gap, fracturing of the bone or the implant. RESULTS: The two types of nails showed no significant difference in terms of maximum tolerated load, maximum cycles repeated or axial deformation of the bone-implant construct. The mean load at failure was 1,365 N for the CN and 1,195 N for the ASN. The mean axial deformation for conventional (19 mm) and angle stable nail (21 mm) did not differ significantly. Slightly less nail or screw loosening was noticed with the fixed-angle nail. CONCLUSION: No significant difference in stability between the two compared implants could be demonstrated. A trend could be shown indicating that the rate of nail loosening in the proximal osteotomized part of the bone was lower for the angle stable nail. This trend, however, could not be substantiated statistically.

Improving Breast Conserving Surgery Using the Faxitron® OR Specimen Radiography System - A Complication Analysis, Cost Evaluation and Literature Review.

BACKGROUND/AIM: The combination of pre-surgical clip placement and hook-wire guided surgery is considered the gold standard for adequately locating non-palpable lesions during breast conserving surgery. After surgical removal of the segment, radiography is required to confirm clip removal, increasing surgical time, post-surgical complication rates, and cost. PATIENTS AND METHODS: We performed a retrospective analysis, using the Faxitron® in-theater specimen radiography system, of the following primary endpoints: surgical time and complication rates. The secondary endpoints were cost effectiveness and clip-location rates. The Control cohort included breast conserving surgery patients prior to May 2019 (n=150) and the Validation cohort included breast conserving surgery patients after May 2019 (n=53). RESULTS: The analysis showed an improvement in surgical time when using the Faxitron® system, which is directly linked to a benefit in cost effectiveness. A numerical benefit in complication rates was also shown. A subgroup analysis showed a significant advantage in surgical time for breast conserving surgery plus sentinel node biopsy and open breast biopsies. CONCLUSION: Use of the Faxitron® system significantly reduces surgical time, which increases cost efficiency while maintaining a low complication rate.

Impact of demographic and perioperative risk factors on complication rates in skin-sparing/nipple-sparing mastectomy with implant-based reconstruction using titanized polypropylene mesh (TiLOOP® Bra).

BACKGROUND: Skin/nipple-sparing mastectomies (SSM/NSSM) have been reported to have acceptable complication rates and good aesthetic outcomes with high patient satisfaction. However, in this relatively young and rapidly expanding field of reconstructive plastic surgery, differences in perioperative management are noted between breast centers. Prospective studies of complication rates using a titanized polypropylene mesh (TiLOOP® Bra) are currently lacking. METHODS: A prospective subgroup analysis was performed based on the data set of the prospective, single-arm, multicenter observational study (PRO-BRA). Early complication rates after skin/nipple-sparing mastectomy with implant-based immediate or secondary reconstruction using a titanized polypropylene mesh (TiLOOP® Bra) subpectorally were investigated in relation to demographic factors, as well as intra-and postoperative management. The subgroup consists of 258 patients. Complications were categorised into necrosis, infection, postoperative bleeding or hematoma, seroma, wound healing delays and R1-situations. RESULTS: Early complication rates of SSM/NSSM using titanium-based meshes are comparable to complication-rates using ADM's. Logistic regression shows significantly higher risk for wound healing delays, necrosis and seroma with increasing BMI, abladat- and implant-weight (OR 1,17 -1,66, p-value < 0,001). Smokers have significantly higher necrosis rates (20.7%) compared to non-smokers (5.5%) (p-value = 0.002). Discharge with drainage results in a trend toward higher rates of wound healing complications. CONCLUSION: The use of TiLOOP® Bra meshes was shown to have acceptable complication rates. Complication rates depend on certain demographic and intraoperative risk factors and should be considered in indications and information of patients.