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"text": "\n183892\nMinimally Invasive Lower Leg Fasciotomy for Chronic Exertional Compartment Syndrome-How Safe Is It? A Cadaveric Study.\n\nGrechenig, P\n\nValsamis, EM\n\nMüller, T\n\nGänsslen, A\n\nHohenberger, G\n\nBeiträge in Fachzeitschriften\nISI:000576913400001\n33062761.0\n10.1177/2325967120956924\nPMC7536378\nChronic exertional compartment syndrome (CECS) is a recognized clinical diagnosis in running athletes and military recruits. Minimally invasive fasciotomy techniques have become increasingly popular, but with varied results and small case numbers. Although decompression of the anterior and peroneal compartments has demonstrated a low rate of iatrogenic injury, little is known about the safety of decompressing the deep posterior compartment.\n To evaluate the risk of iatrogenic injury when using minimally invasive techniques to decompress the anterior, peroneal, and deep posterior compartments of the lower leg.\n Descriptive laboratory study.\n A total of 60 lower extremities from 30 adult cadavers were subject to fasciotomy of the anterior, peroneal, and deep posterior compartments using a minimally invasive technique. Two common variations in surgical technique were employed to decompress each compartment. Anatomical dissection was subsequently carried out to identify incomplete division of the fascia, muscle injury, neurovascular injury, and the anatomical relationship of key neurovascular structures to the incisions.\n Release of the anterior and peroneal compartments was successful in all but 2 specimens. There was no injury to the superficial peroneal nerve or any vessel in any specimen. A transverse incision crossing the anterior intermuscular septum resulted in muscle injury in 20% of the cases. Release of the deep posterior compartment was successful in all but 1 specimen when a longitudinal skin incision was used, without injury to neurovascular structures. Compared with a longitudinal incision, a transverse skin incision resulted in fewer complete releases of the deep posterior compartment and a significantly higher rate of injury to the saphenous nerve (16.7%; P = .052) and long saphenous vein (23.3%; P = .011).\n Minimally invasive fasciotomy of the anterior, peroneal, and deep posterior compartments using longitudinal incisions had a low rate of iatrogenic injury in a cadaveric model. Complete compartment release was achieved in 97% to 100% of specimens when employing this technique.\n Minimally invasive fasciotomy techniques for CECS have become increasingly popular with purported low recurrence rates, improved cosmesis, and faster return to sport. It is important to determine whether this technique is safe, particularly given the variable rates of neurovascular injury reported in the literature.\n © The Author(s) 2020.\n\nHohenberger, Gloria\n\n\n"
},
{
"text": "\n103355\nHLA genotyping in the international Type 1 Diabetes Genetics Consortium.\n\nMychaleckyj, JC\n\nNoble, JA\n\nMoonsamy, PV\n\nCarlson, JA\n\nVarney, MD\n\nPost, J\n\nHelmberg, W\n\nPierce, JJ\n\nBonella, P\n\nFear, AL\n\nLavant, E\n\nLouey, A\n\nBoyle, S\n\nLane, JA\n\nSali, P\n\nKim, S\n\nRappner, R\n\nWilliams, DT\n\nPerdue, LH\n\nReboussin, DM\n\nTait, BD\n\nAkolkar, B\n\nHilner, JE\n\nSteffes, MW\n\nErlich, HA\n\nT1DGC\n\nBeiträge in Fachzeitschriften\nISI:000280707300006\n20595243.0\n10.1177/1740774510373494\nPMC2917849\nBackground Although human leukocyte antigen (HLA) DQ and DR loci appear to confer the strongest genetic risk for type 1 diabetes, more detailed information is required for other loci within the HLA region to understand causality and stratify additional risk factors. The Type 1 Diabetes Genetics Consortium (T1DGC) study design included high-resolution genotyping of HLA-A, B, C, DRB1, DQ, and DP loci in all affected sibling pair and trio families, and cases and controls, recruited from four networks worldwide, for analysis with clinical phenotypes and immunological markers. Purpose In this article, we present the operational strategy of training, classification, reporting, and quality control of HLA genotyping in four laboratories on three continents over nearly 5 years. Methods Methods to standardize HLA genotyping at eight loci included: central training and initial certification testing; the use of uniform reagents, protocols, instrumentation, and software versions; an automated data transfer; and the use of standardized nomenclature and allele databases. We implemented a rigorous and consistent quality control process, reinforced by repeated workshops, yearly meetings, and telephone conferences. Results A total of 15, 46 samples have been HLA genotyped at eight loci to four-digit resolution; an additional 6797 samples have been HLA genotyped at two loci. The genotyping repeat rate decreased significantly over time, with an estimated unresolved Mendelian inconsistency rate of 0.21%. Annual quality control exercises tested 2192 genotypes (4384 alleles) and achieved 99.82% intra-laboratory and 99.68% inter-laboratory concordances. Limitations The chosen genotyping platform was unable to distinguish many allele combinations, which would require further multiple stepwise testing to resolve. For these combinations, a standard allele assignment was agreed upon, allowing further analysis if required. Conclusions High-resolution HLA genotyping can be performed in multiple laboratories using standard equipment, reagents, protocols, software, and communication to produce consistent and reproducible data with minimal systematic error. Many of the strategies used in this study are generally applicable to other large multi-center studies. Clinical Trials 2010; 7: S75-S87. http://ctj.sagepub.com.\n\nHelmberg, Wolfgang\n\n\n"
},
{
"text": "\n129893\nA diagnostic score for the prediction of spontaneous resolution of acute hepatitis C virus infection.\n\nBeinhardt, S\n\nPayer, BA\n\nDatz, C\n\nStrasser, M\n\nMaieron, A\n\nDorn, L\n\nGrilnberger-Franz, E\n\nDulic-Lakovic, E\n\nStauber, R\n\nLaferl, H\n\nAberle, JH\n\nHolzmann, H\n\nKrall, C\n\nVogel, W\n\nFerenci, P\n\nHofer, H\n\nBeiträge in Fachzeitschriften\nISI:000325754200011\n23850880.0\n10.1016/j.jhep.2013.06.028\nNone\nIL28B polymorphisms, jaundice, decline in HCV-RNA, IP-10, and gender have been proposed to be indicative of spontaneous clearance of acute hepatitis C virus infection. The aim of this study was to define a score enabling the discrimination of patients with spontaneous clearance of HCV from those with development of viral persistence and need for early antiviral treatment.\n 136 patients (74 male; 35 ± 15 years) were analyzed. From variables predictive of spontaneous clearance, calculated by univariate analysis, three scores were built. Analogous cut-offs were evaluated by computing area under the receiver operating characteristic curves. Candidate variables and cut-offs were: (I) presence of IL28B C/C (p=0.027), (II) age (p=0.031; cut-off: 35 years), (III) peak-bilirubin (p=0.018; cut-off: 6 mg/dl), (IV) HCV-RNA decline within 4 weeks (p<0.001;cut-off: >2.5 log), (V) serum IP-10 (p=0.003; cut-off: 546 pg/ml), (VI) presence of CD4(+) Th1 cells (p=0.024). Each variable was allocated to 0 or 1 point, an HCV-RNA decline of ≥ 1 log 10 but <2.5 log 10 to 1 point, a decline of ≥ 2.5 log 10 to 2 points. Three scores were evaluated (Score 1: I-IV; Score 2: I-V; Score 3: I-VI).\n A cut-off of ≥ 3 points out of 5 in Score 1 (AUROC: 0.82; DeLong 95% CI: 0.76-0.93) predicted spontaneous clearance with a sensitivity of 71% (95% CI: 0.53-0.86) and specificity of 87% (95% CI: 0.73-0.95). PPV and NPV were 79% and 82%. Corresponding findings for Score 2 including IP-10 (AUROC: 0.93; DeLong 95% CI: 0.86-0.93) at a cut-off of ≥ 4 were: sensitivity 81%, specificity 95% (PPV: 100%; NPV: 77%). A cut-off of ≥ 5 in Score 3 (AUROC: 0.98; DeLong 95% CI: 0.95-1.0) predicted spontaneous resolution with a sensitivity of 75% and specificity of 100% (PPV: 100%; NPV: 88%).\n The scores enable a reliable discrimination between AHC-patients with high potential for spontaneous clearance from candidates for early therapeutic intervention due to marginal chance of spontaneous resolution.\n Copyright © 2013 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.\n\nStauber, Rudolf\n\n\n"
},
{
"text": "\n158632\nSampling Modification Effects in the Subgingival Microbiome Profile of Healthy Children.\n\nSantigli, E\n\nTrajanoski, S\n\nEberhard, K\n\nKlug, B\n\nBeiträge in Fachzeitschriften\nISI:000392130200001\n28149291.0\n10.3389/fmicb.2016.02142\nPMC5241288\nBackground: Oral microbiota are considered major players in the development of periodontal diseases. Thorough knowledge of intact subgingival microbiomes is required to elucidate microbial shifts from health to disease. Aims: This comparative study investigated the subgingival microbiome of healthy children, possible inter- and intra-individual effects of modified sampling, and basic comparability of subgingival microprints. Methods: In five 10-year-old children, biofilm was collected from the upper first premolars and first molars using sterilized, UV-treated paper-points inserted into the subgingival sulcus at eight sites. After supragingival cleaning using an electric toothbrush and water, sampling was performed, firstly, excluding (Mode A) and, secondly, including (Mode B) cleansing with sterile cotton pellets. DNA was extracted from the pooled samples, and primers targeting 16S rRNA hypervariable regions V5 and V6 were used for 454-pyrosequencing. Wilcoxon signed rank test and t-test were applied to compare sampling modes. Principal coordinate analysis (PCoA) and average agglomerative hierarchical clustering were calculated with unweighted UniFrac distance matrices. Sample grouping was tested with permutational MANOVA (Adonis). Results: Data filtering and quality control yielded 67, 18 sequences with an average sequence length of 243bp (SD 6.52; range 231-255). Actinobacteria (2.8-24.6%), Bacteroidetes (9.2-25.1%), Proteobacteria (4.9-50.6%), Firmicutes (16.5-57.4%), and Fusobacteria (2.2-17.1%) were the five major phyla found in all samples. Differences in microbial abundances between sampling modes were not evident. High sampling numbers are needed to achieve significance for rare bacterial phyla. Samples taken from one individual using different sampling modes were more similar to each other than to other individuals' samples. PCoA and hierarchical clustering showed a grouping of the paired samples. Permutational MANOVA did not reveal sample grouping by sampling modes (p = 0.914 by R2 = 0.09). Conclusion: A slight modification of sampling mode has minor effects corresponding to a natural variability in the microbiome profiles of healthy children. The inter-individual variability in subgingival microprints is greater than intra-individual differences. Statistical analyses of microbial populations should consider this baseline variability and move beyond mere quantification with input from visual analytics. Comparative results are difficult to summarize as methods for studying huge datasets are still evolving. Advanced approaches are needed for sample size calculations in clinical settings.\n\nEberhard, Katharina\n\nKlug, Barbara\n\nSantigli, Elisabeth\n\nTrajanoski, Slave\n\n\n"
},
{
"text": "\n159126\nRetrospective 25-year follow-up of treatment outcomes in Angle Class III patients : Success versus failure.\n\nWendl, B\n\nKamenica, A\n\nDroschl, H\n\nJakse, N\n\nWeiland, F\n\nWendl, T\n\nWendl, M\n\nBeiträge in Fachzeitschriften\nISI:000396154300004\n28204847.0\n10.1007/s00056-016-0075-8\nPMC5343075\nDespite recommendations for early treatment of hereditary Angle Class III syndrome, late pubertal growth may cause a relapse requiring surgical intervention. This study was performed to identify predictors of successful Class III treatment.\n Thirty-eight Class III patients treated with a chincup were retrospectively analyzed. Data were collected from the data archive, cephalograms, and casts, including pretreatment (T0) and posttreatment (T1) data, as well as long-term follow-up data collected approximately 25 years after treatment (T2). Each patient was assigned to a success or a failure group. Data were analyzed based on time (T0, T1, T2), deviations from normal (Class I), and prognathism types (true mandibular prognathism, maxillary retrognathism, combined pro- and retrognathism).\n Compared to Class I normal values, the data obtained in both groups yielded 11 significant parameters. The success group showed values closer to normal at all times (T0, T1, T2) and vertical parameters decreased from T0 to T2. The failure group showed higher values for vertical and horizontal mandibular growth, as well as dentally more protrusion of the lower anterior teeth and more negative overjet at all times. In adittion, total gonial and upper gonial angle were higher at T0 and T1. A prognostic score-yet to be evaluated in clinical practice-was developed from the results. The failure group showed greater amounts of horizontal development during the years between T1 and T2. Treatment of true mandibular prognathism achieved better outcomes in female patients. Cases of maxillary retrognathism were treated very successfully without gender difference. Failure was clearly more prevalent, again without gender difference, among the patients with combined mandibular prognathism and maxillary retrognathism. Crossbite situations were observed in 44% of cases at T0. Even though this finding had been resolved by T1, it relapsed in 16% of the cases by T2.\n The failure rate increased in cases of combined mandibular prognathism and maxillary retrognathism. Precisely in these combined Class III situations, it should be useful to apply the diagnostic and prognostic parameters identified in the present study and to provide the patients with specific information about the increased risk of failure.\n\nJakse, Norbert\n\nWeiland, Frank\n\nWendl, Brigitte\n\n\n"
},
{
"text": "\n169196\nAutomatic evaluation of tumor budding in immunohistochemically stained colorectal carcinomas and correlation to clinical outcome.\n\nWeis, CA\n\nKather, JN\n\nMelchers, S\n\nAl-Ahmdi, H\n\nPollheimer, MJ\n\nLangner, C\n\nGaiser, T\n\nBeiträge in Fachzeitschriften\nISI:000442949400002\n30153844.0\n10.1186/s13000-018-0739-3\nPMC6114534\nTumor budding, meaning a detachment of tumor cells at the invasion front of colorectal carcinoma (CRC) into single cells or clusters (<=5 tumor cells), has been shown to correlate to an inferior clinical outcome by several independent studies. Therefore, it has been discussed as a complementary prognostic factor to the TNM staging system, and it is already included in national guidelines as an additional prognostic parameter. However, its application by manual evaluation in routine pathology is hampered due to the use of several slightly different assessment systems, a time-consuming manual counting process and a high inter-observer variability. Hence, we established and validated an automatic image processing approach to reliably quantify tumor budding in immunohistochemically (IHC) stained sections of CRC samples.\n This approach combines classical segmentation methods (like morphological operations) and machine learning techniques (k-means and hierarchical clustering, convolutional neural networks) to reliably detect tumor buds in colorectal carcinoma samples immunohistochemically stained for pan-cytokeratin. As a possible application, we tested it on whole-slide images as well as on tissue microarrays (TMA) from a clinically well-annotated CRC cohort.\n Our automatic tumor budding evaluation tool detected the absolute number of tumor buds per image with a very good correlation to the manually segmented ground truth (R2 value of 0.86). Furthermore the automatic evaluation of whole-slide images from 20 CRC-patients, we found that neither the detected number of tumor buds at the invasion front nor the number in hotspots was associated with the nodal status. However, the number of spatial clusters of tumor buds (budding hotspots) significantly correlated to the nodal status (p-value = 0.003 for N0 vs. N1/N2). TMAs were not feasible for tumor budding evaluation, as the spatial relationship of tumor buds (especially hotspots) was not preserved.\n Automatic image processing is a feasible and valid assessment tool for tumor budding in CRC on whole-slide images. Interestingly, only the spatial clustering of the tumor buds in hotspots (and especially the number of hotspots) and not the absolute number of tumor buds showed a clinically relevant correlation with patient outcome in our data.\n\nLangner, Cord\n\nPollheimer, Marion\n\n\n"
},
{
"text": "\n181370\nImage-guided breast biopsy and localisation: recommendations for information to women and referring physicians by the European Society of Breast Imaging.\n\nBick, U\n\nTrimboli, RM\n\nAthanasiou, A\n\nBalleyguier, C\n\nBaltzer, PAT\n\nBernathova, M\n\nBorbély, K\n\nBrkljacic, B\n\nCarbonaro, LA\n\nClauser, P\n\nCassano, E\n\nColin, C\n\nEsen, G\n\nEvans, A\n\nFallenberg, EM\n\nFuchsjaeger, MH\n\nGilbert, FJ\n\nHelbich, TH\n\nHeywang-Köbrunner, SH\n\nHerranz, M\n\nKinkel, K\n\nKilburn-Toppin, F\n\nKuhl, CK\n\nLesaru, M\n\nLobbes, MBI\n\nMann, RM\n\nMartincich, L\n\nPanizza, P\n\nPediconi, F\n\nPijnappel, RM\n\nPinker, K\n\nSchiaffino, S\n\nSella, T\n\nThomassin-Naggara, I\n\nTardivon, A\n\nOngeval, CV\n\nWallis, MG\n\nZackrisson, S\n\nForrai, G\n\nHerrero, JC\n\nSardanelli, F\n\nEuropean Society of Breast Imaging (EUSOBI), with language review by Europa Donna–The European Breast Cancer Coalition\n\nBeiträge in Fachzeitschriften\nISI:000513864300001\n32025985.0\n10.1186/s13244-019-0803-x\nPMC7002629\nWe summarise here the information to be provided to women and referring physicians about percutaneous breast biopsy and lesion localisation under imaging guidance. After explaining why a preoperative diagnosis with a percutaneous biopsy is preferred to surgical biopsy, we illustrate the criteria used by radiologists for choosing the most appropriate combination of device type for sampling and imaging technique for guidance. Then, we describe the commonly used devices, from fine-needle sampling to tissue biopsy with larger needles, namely core needle biopsy and vacuum-assisted biopsy, and how mammography, digital breast tomosynthesis, ultrasound, or magnetic resonance imaging work for targeting the lesion for sampling or localisation. The differences among the techniques available for localisation (carbon marking, metallic wire, radiotracer injection, radioactive seed, and magnetic seed localisation) are illustrated. Type and rate of possible complications are described and the issue of concomitant antiplatelet or anticoagulant therapy is also addressed. The importance of pathological-radiological correlation is highlighted: when evaluating the results of any needle sampling, the radiologist must check the concordance between the cytology/pathology report of the sample and the radiological appearance of the biopsied lesion. We recommend that special attention is paid to a proper and tactful approach when communicating to the woman the need for tissue sampling as well as the possibility of cancer diagnosis, repeat tissue sampling, and or even surgery when tissue sampling shows a lesion with uncertain malignant potential (also referred to as "high-risk" or B3 lesions). Finally, seven frequently asked questions are answered.\n\nFuchsjäger, Michael\n\n\n"
},
{
"text": "\n187056\nCardiometabolic risk factors and early indicators of vascular dysfunction: a cross-sectional cohort study in South African adolescents.\n\nLetswalo, BP\n\nSchmid-Zalaudek, K\n\nBrix, B\n\nMatjuda, EN\n\nKlosz, F\n\nObernhumer, N\n\nGaisl, M\n\nEngwa, GA\n\nSewani-Rusike, C\n\nFredriksen, PM\n\nNkeh-Chungag, B\n\nGoswami, N\n\nBeiträge in Fachzeitschriften\nISI:000631525800028\n33737426.0\n10.1136/bmjopen-2020-042955\nPMC7978086\nPrevalence of child and adolescents' overweight and obesity in low- and middle-income countries has increased dramatically. Simultaneously, the incidence of pre-hypertension/hypertension is also increasing in children, which, in turn, predisposes these children to the risk of cardiovascular disease (CVD) in later life. The present study assessed cardiometabolic risk factors and early indicators of vascular dysfunction in adolescents from a low socio-economic rural area in South Africa.\n Cross-sectional cohort study.\n The study was conducted in public schools in Mthatha, OR Tambo district municipality, Eastern Cape Province, South Africa.\n A total of 244 adolescents (188 females) of African ancestry aged 13-16 years were enrolled.\n Anthropometric and haemodynamic measures and pulse wave velocity (PWV) were related to overweight/obesity and hypertension. Blood markers of cardiometabolic syndrome were assessed as well as vascular function (via PWV).\n One-third (33.0%) of the adolescents exceeded the age and sex-specific body mass index percentiles for overweight (≥85th) or obesity (>95th) with a prevalence of 61.1% pre-hypertensives in this group. Overweight/obesity and hypertension were associated with higher triglycerides (lean:overweight: 0.79<1.01 mmol/L; normotensive:hypertensive: 0.82<0.89 mmol/L). Fasting glucose was higher in hypertensive as compared to normotensive adolescents (4.85>4.69 mmol/L, p<0.05). PWV was elevated in 25.9% of the children and significantly correlated with asymmetric dimethylarginine and systolic blood pressure (p<0.001).\n Overweight/obesity and hypertension show a high prevalence in rural South African youth. Almost half of the studied adolescents are at risk for developing CVD. The high association between cardiometabolic risk factors and PWV further suggests that hypertension in adolescents may promote the progression of CVD in adulthood. Early detection of those at risk and the implementation of preventive strategies in underprivileged young people is urgently needed to stop the progression of vascular damage and manifestation of CVD in rural African children.\n © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.\n\nBrix, Bianca\n\nGaisl, Michael\n\nGoswami, Nandu\n\nObernhumer, Natalie Bernadette\n\nSchmid-Zalaudek, Karin\n\n\n"
},
{
"text": "\n187184\nAutomatic reconstruction of the left atrium activation from sparse intracardiac contact recordings by inverse estimate of fibre structure and anisotropic conduction in a patient-specific model.\n\nLubrecht, JM\n\nGrandits, T\n\nGharaviri, A\n\nSchotten, U\n\nPock, T\n\nPlank, G\n\nKrause, R\n\nAuricchio, A\n\nConte, G\n\nPezzuto, S\n\nBeiträge in Fachzeitschriften\nISI:000637048300017\n33751078.0\n10.1093/europace/euaa392\nNone\nElectric conduction in the atria is direction-dependent, being faster in fibre direction, and possibly heterogeneous due to structural remodelling. Intracardiac recordings of atrial activation may convey such information, but only with high-quality data. The aim of this study was to apply a patient-specific approach to enable such assessment even when data are scarce, noisy, and incomplete.\n Contact intracardiac recordings in the left atrium from nine patients who underwent ablation therapy were collected before pulmonary veins isolation and retrospectively included in the study. The Personalized Inverse Eikonal Model from cardiac Electro-Anatomical Maps (PIEMAP), previously developed, has been used to reconstruct the conductivity tensor from sparse recordings of the activation. Regional fibre direction and conduction velocity were estimated from the fitted conductivity tensor and extensively cross-validated by clustered and sparse data removal. Electrical conductivity was successfully reconstructed in all patients. Cross-validation with respect to the measurements was excellent in seven patients (Pearson correlation r > 0.93) and modest in two patients (r = 0.62 and r = 0.74). Bland-Altman analysis showed a neglectable bias with respect to the measurements and the limit-of-agreement at -22.2 and 23.0 ms. Conduction velocity in the fibre direction was 82 ± 25 cm/s, whereas cross-fibre velocity was 46 ± 7 cm/s. Anisotropic ratio was 1.91±0.16. No significant inter-patient variability was observed. Personalized Inverse Eikonal model from cardiac Electro-Anatomical Maps correctly predicted activation times in late regions in all patients (r = 0.88) and was robust to a sparser dataset (r = 0.95).\n Personalized Inverse Eikonal model from cardiac Electro-Anatomical Maps offers a novel approach to extrapolate the activation in unmapped regions and to assess conduction properties of the atria. It could be seamlessly integrated into existing electro-anatomic mapping systems. Personalized Inverse Eikonal model from cardiac Electro-Anatomical Maps also enables personalization of cardiac electrophysiology models.\n Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.\n\nPlank, Gernot\n\n\n"
},
{
"text": "\n4594\nSerological and molecular response on combined antiviral treatment in children with chronic hepatitis B after pediatric malignancy.\n\nLackner, H\n\nMoser, A\n\nBenesch, M\n\nDeutsch, J\n\nKessler, HH\n\nKerbl, R\n\nSchwinger, W\n\nDornbusch, HJ\n\nSovinz, P\n\nUrban, C\n\nBeiträge in Fachzeitschriften\nISI:000179936400010\n12467780.0\n10.1016/s1386-6532(02)00189-0\nNone\nChronic hepatitis B is a serious long-term problem for children surviving malignancy. The annual rate of spontaneous clearance of hepatitis B e antigen (HBeAg) is only 3% in these patients, and the response to monotherapy with interferon (IFN)-alpha is also low.\n To monitor the serological and molecular response on combined antiviral treatment in children with chronic hepatitis B after pediatric malignancy.\n Twelve patients with a history of childhood malignancy and chronic hepatitis B were treated with prednisone for 4 weeks (0.6 mg/kg body weight per day orally for 3 weeks followed by 0.3 mg/kg body weight per day for 1 week) followed by IFN-alpha-2a (5 megaunits/m(2) body surface area, three times a week, subcutaneously) at least for 1 year. After 1 year of IFN-alpha monotherapy, treatment was discontinued in patients with HBeAg seroconversion as well as patients without HBeAg seroconversion and a decrease of serum hepatitis B virus (HBV) DNA level less than 0.5 logs of the basal level. Patients who had a decrease of the serum HBV DNA of more than 0.5 logs of the basal level underwent treatment continuation with IFN-alpha combined with famciclovir (FAM) (20 mg/kg body weight per day orally) for another year.\n After 1 year of IFN-alpha monotherapy, a decrease of the serum HBV DNA level to less than 0.5 logs was found in eight of 12 patients. Two of them additionally developed HBeAg seroconversion after 3 and 12 months. The remaining six patients received antiviral treatment with IFN-alpha combined with FAM for another year. Two of them showed HBeAg seroconversion after 21 and 24 months from study entry. HBeAg seroconversion was only observed in patients who had a decrease of serum HBV DNA to levels below 1 x 10(6) copies/ml. Treatment-induced toxicity was moderate and reversible in all patients.\n Combination treatment of chronic hepatitis B with prednisone, IFN-alpha, and FAM seems to be a safe and effective treatment option for children surviving pediatric malignancy.\n\nBenesch, Martin\n\nDornbusch, Hans Jürgen\n\nKerbl, Reinhold\n\nKessler, Harald\n\nLackner, Herwig\n\nRitter-Sovinz, Petra\n\nSchwinger, Wolfgang\n\nUrban, Ernst-Christian\n\n\n"
},
{
"text": "\n60985\nComparing polymethylmethacrylate implant with collagen implant in deep sclerectomy: a randomized controlled trial.\n\nMansouri, K\n\nShaarawy, T\n\nWedrich, A\n\nMermoud, A\n\nBeiträge in Fachzeitschriften\nISI:000238243200015\n16778652.0\n10.1097/01.ijg.0000212211.33265.6d\nNone\nPurpose: To compare the intraocular pressure (IOP) lowering effect and safety of a new rigid, nonabsorbable polymethylmethacrylate implant (PMMA) with the commercially available cylindrical collagen implant used in deep sclerectomy procedure. Intervention: Nonpenetrating deep sclerectomy was performed on all patients. Patients were randomly assigned to receive either a PMMA implant or a collagen implant. Methods: The trial involved 60 patients (60 eyes) with medically uncontrolled primary and secondary open-angle glaucoma who were randomized to receive either a PMMA implant (30 eyes) or the collagen implant (30 eyes). The patients were examined before and after the operation I day before surgery and at day 1; weeks 1, 2 and 3; and months 1, 2, 3, 6, 9, 12, 18, 24, and 30. At each visit, the following examinations were performed: slit lamp examination, tonometry, visual acuity, and fundoscopy. Results: The mean follow-up period was 20.4 (SD 12.4) months (PMMA) and 15.1 (SD 7.7) months (collagen) (P = NS). The mean preoperative IOP was 21.4 (SD 7.1) mm Hg (PMMA) and 21.0 mm Hg (SD 5.4) (collagen). The mean postoperative IOP was 7.4 (SD 4.5) mm Hg (PMMA) and 5.4 (SD 4.4) mm Hg (collagen) at day 1 (P = NS), 15.7 (SD 5.0) mm Hg (PMMA) and 14.7 (SD 5.0) mm Hg (collagen) at month 1 (P = NS), and 13.8 (SD 4.8) mm Hg (PMMA) and 13.3 (SD 2.4) mm Hg (collagen) at month 12 (P = NS). Seven patients had perforations of the trabeculo-Descemet membrane and were excluded from the analysis. At the last follow-up visit, 42% of PMMA patients and 44% of collagen patients achieved an IOP of 21 mm Hg or less without medication (P = NS). The number of medications was reduced from 2.4 (SD 1.0) to 0.6 (SD 0.6) (P < 0.001) in the PMMA group, and from 2.4 (SD 1.1) to 0.7 (SD 0.8) (P < 0.001) in the collagen group. There were no significant differences between the 2 groups in postoperative and transient complications. Conclusions: The new PMMA implant offered success and complication rates equal to those of the collagen implant. The new PMMA implant could serve as a low-cost alternative to the collagen implant and render the use of deep sclerectomy with an implant affordable for settings with limited financial resources.\n\nWedrich, Andreas\n\n\n"
},
{
"text": "\n82074\nEffect on hearing of ganciclovir therapy for asymptomatic congenital cytomegalovirus infection: four to 10 year follow up.\n\nLackner, A\n\nAcham, A\n\nAlborno, T\n\nMoser, M\n\nEngele, H\n\nRaggam, RB\n\nHalwachs-Baumann, G\n\nKapitan, M\n\nWalch, C\n\nBeiträge in Fachzeitschriften\nISI:000265303800006\n18588736.0\n10.1017/S0022215108003162\nNone\nBACKGROUND: Congenital cytomegalovirus infection is the leading identified nongenetic cause of congenital sensorineural hearing loss. Most of the infections are asymptomatic but may be detected from umbilical cord vein and/or newborn serum positivity for human cytomegalovirus immunoglobulin M, and from urine positivity (on polymerase chain reaction) for human cytomegalovirus deoxyribonucleic acid in the newborn period. Children infected by cytomegalovirus may later develop sensorineural hearing loss. In symptomatically infected infants, ganciclovir therapy administered in the neonatal period prevents hearing deterioration. However, preventative therapy of asymptomatic congenital cytomegalovirus disease with ganciclovir is controversial, as side effects such as severe neutropenia may occur during treatment. METHODS: The study population consisted of 23 asymptomatic children with congenital cytomegalovirus infection. Twelve children were treated just after diagnosis of cytomegalovirus infection in the newborn period, with ganciclovir 10 mg/kg bodyweight for 21 days. The other 11 children were observed without therapy. Over a four to 10 year follow-up period, we evaluated all the children's hearing status using pure tone audiometry. RESULTS: All 23 children had normal sensorineural hearing at one year follow up. Five of the 23 children (21.7 per cent) were lost to follow up over the four to 11 year follow-up period. Of the remaining 18 children, sensorineural hearing loss occurred in two (11.1 per cent). Neither child had been treated with ganciclovir in the newborn period. An eight-year-old boy showed bilateral high frequency loss and a 10-year-old girl showed severe unilateral sensorineural hearing loss. In the ganciclovir-treated group (nine children), none showed sensorineural hearing loss. During ganciclovir therapy, moderate neutropenia occurred as a side effect in two out of 12 (16.6 per cent) treated children. Speech and general development were normal in all children. CONCLUSION: Asymptomatic congenital cytomegalovirus infection is likely to be a leading cause of sensorineural hearing loss in young children. Intravenous ganciclovir therapy seems to offer a medical option to prevent subsequent sensorineural hearing loss. Further studies including a greater number of children are needed. Cytomegalovirus screening models are mandatory if medical therapy is to be implemented in time.\n\nRaggam, Reinhard Bernd\n\nWalch, Christian\n\n\n"
},
{
"text": "\n117731\nThe Austrian tonsil study 2010--part 1: statistical overview.\n\nSarny, S\n\nOssimitz, G\n\nHabermann, W\n\nStammberger, H\n\nBeiträge in Fachzeitschriften\nISI:000298822700008\n22231963.0\n10.1055/s-0031-1291310\nNone\nBackground: Tonsillectomy (TE), tonsillotomy (TO) and adenoidectomy (AE) are surgeries performed routinely by otorhinolaryngologists. There were 5 cases of fatal postoperative bleeding in Austria during the years 2006 and 2007, all in children under 6 years of age. The intensive discussion following these sad events resulted in a Consensus Paper of the Austrian Society of ORL, H&NS with the Austrian Society of Pediatrics with modified recommendations towards indications and surgical techniques in different age groups; in addition, the prospective study presented here was initiated. In Austria for the first time a full census could be performed assessing all TE, TO and AE with standardized definitions. Material and Methods: Within the study period of 9 months' from October 1, 2009, to June 30, 2010, data on patients' characteristics, indication for surgery, surgical technique and postoperative haemorrhage were prospectively collected. Postoperative haemorrhage was defined as any bleeding after extubation regardless of whether or not a surgical intervention was required. Postoperative bleeding events were categorised into 7 grades depending on severity. Results: More than one million data of 9 405 patients from 32 ENT-departments in Austria were collected and analysed. One third were children younger than 6 years (n=3474; 37%) and one third were adults (n=3507, 37%). ATE AE was performed in 48.8% (n=4594), an AE in 37.1% (n=3492) and a TO in 14.0% (n=1319). For the indication "recurrent tonsillitis and tonsilar hypertrophy" 70% of children had a TO but 95% of adults had a TE (p <0.001). Adults with OSAS had a TE whereas in children aged younger than 6 with the same indication a TO was preferably performed in 90% (p <0.001). For TO the Colorado-needle and the Coblation technique were most commonly used. The Adenotome by La Force and the Adenoid curette by Beckmann, with or without endoscopic control, were most frequently used for AE. Conclusions: For the first time a prospective full survey could be performed in one country assessing all tonsil and adenoid surgeries along standardized criteria. The study gives an overview about the types of surgery, the indications, the operation techniques and the frequency of postoperative haemorrhage. The latter, because of its clinical importance, is dealt with and described in detail in the second part of this publication.\n\nHabermann, Walter\n\nSarny, Stephanie\n\n\n"
},
{
"text": "\n130170\nThe discriminatory capacity of BMD measurements by DXA and dual X-ray and laser (DXL) at the calcaneus including clinical risk factors for detecting patients with vertebral fractures.\n\nMuschitz, C\n\nDimai, HP\n\nKocijan, R\n\nKaider, A\n\nZendeli, A\n\nKühne, F\n\nTrubrich, A\n\nLung, S\n\nWaneck, R\n\nResch, H\n\nBeiträge in Fachzeitschriften\nISI:000321655500005\n23344258.0\n10.1007/s00198-013-2266-0\nNone\nOsteoporotic fracture risk depends on bone mineral density (BMD) and clinical risk factors (CRF). Five hundred and eighty-eight untreated female and male outpatient subjects were evaluated, 160 with vertebral fractures. BMD was measured both by using calcaneal dual X-ray and laser (DXL) and dual-energy X-ray absorptiometry (DXA), and CRF were evaluated. Detection frequencies for different BMD methods with or without CRF are presented. Osteoporotic fracture risk depends on bone mineral density and clinical risk factors. DXA of the spine/hip is considered a gold standard for BMD assessment, but due to degenerative conditions, particularly among the older population, assessment of BMD at the lumbar spine has been shown to be of limited significance. Portable calcaneal dual X-ray technology and laser can be an easily obtainable alternative. Vertebral fractures were evaluated in a baseline analysis of 588 females and males (median age 64.4, range 17.6-93.1 years), comparing BMD measurements by using DXL and DXA and CRF with/without BMD. One hundred and sixty subjects had radiological verified vertebral fractures. Area under receiver-operating characteristic curves (AUROCC) and univariate and multiple logistic regressions were calculated. AUROCC for detection of vertebral fractures was comparable for DXL at calcaneus and DXA at femoral neck (DXL 0.665 and DXA 0.670). Odds ratio for prevalent vertebral fracture was generally weak for DXA femoral neck (0.613) and DXL (0.521). Univariate logistic regression among CRF without BMD revealed age, prevalent fragility fracture, and body mass index significantly associated with prevalent vertebral fracture (AUROCC = 0.805). Combining BMD and CRF, a prognostic improvement in case of DXA at femoral neck (AUROCC 0.869, p = 0.02), DXL at calcaneus (AUROCC 0.869, p = 0.059), and DXA at total hip (AUROCC 0.861, p = 0.06) was observed. DXL was similarly sensitive compared with DXA for identification of subjects with vertebral fragility fractures, and combination of CRF with BMD by DXL or DXA further increased the discriminatory capacity for detection of patients susceptible to vertebral fracture.\n\nDimai, Hans\n\n\n"
},
{
"text": "\n160393\nInfants Requiring Maintenance Dialysis: Outcomes of Hemodialysis and Peritoneal Dialysis.\n\nVidal, E\n\nvan Stralen, KJ\n\nChesnaye, NC\n\nBonthuis, M\n\nHolmberg, C\n\nZurowska, A\n\nTrivelli, A\n\nDa Silva, JEE\n\nHerthelius, M\n\nAdams, B\n\nBjerre, A\n\nJankauskiene, A\n\nMiteva, P\n\nEmirova, K\n\nBayazit, AK\n\nMache, CJ\n\nSánchez-Moreno, A\n\nHarambat, J\n\nGroothoff, JW\n\nJager, KJ\n\nSchaefer, F\n\nVerrina, E\n\nESPN/ERA-EDTA Registry\n\nBeiträge in Fachzeitschriften\nISI:000399484200010\n27955924.0\n10.1053/j.ajkd.2016.09.024\nNone\nThe impact of different dialysis modalities on clinical outcomes has not been explored in young infants with chronic kidney failure.\n Cohort study.\n Data were extracted from the ESPN/ERA-EDTA Registry. This analysis included 1, 63 infants 12 months or younger who initiated dialysis therapy in 1991 to 2013.\n Type of dialysis modality.\n Differences between infants treated with peritoneal dialysis (PD) or hemodialysis (HD) in patient survival, technique survival, and access to kidney transplantation were examined using Cox regression analysis while adjusting for age at dialysis therapy initiation, sex, underlying kidney disease, and country of residence.\n 917 infants initiated dialysis therapy on PD, and 146, on HD. Median age at dialysis therapy initiation was 4.5 (IQR, 0.7-7.9) months, and median body weight was 5.7 (IQR, 3.7-7.5) kg. Although the groups were homogeneous regarding age and sex, infants treated with PD more often had congenital anomalies of the kidney and urinary tract (CAKUT; 48% vs 27%), whereas those on HD therapy more frequently had metabolic disorders (12% vs 4%). Risk factors for death were younger age at dialysis therapy initiation (HR per each 1-month later initiation, 0.95; 95% CI, 0.90-0.97) and non-CAKUT cause of chronic kidney failure (HR, 1.49; 95% CI, 1.08-2.04). Mortality risk and likelihood of transplantation were equal in PD and HD patients, whereas HD patients had a higher risk for changing dialysis treatment (adjusted HR, 1.64; 95% CI, 1.17-2.31).\n Inability to control for unmeasured confounders not included in the Registry database and missing data (ie, comorbid conditions). Low statistical power because of relatively small number of participants.\n Despite a widespread preconception that HD should be reserved for cases in which PD is not feasible, in Europe, we found 1 in 8 infants in need of maintenance dialysis to be initiated on HD therapy. Patient characteristics at dialysis therapy initiation, prospective survival, and time to transplantation were very similar for infants initiated on PD or HD therapy.\n Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.\n\nMache, Christoph\n\n\n"
},
{
"text": "\n168784\nBentall procedure: quarter century of clinical experiences of a single surgeon.\n\nBenke, K\n\nÁgg, B\n\nSzabó, L\n\nSzilveszter, B\n\nOdler, B\n\nPólos, M\n\nCao, C\n\nMaurovich-Horvat, P\n\nRadovits, T\n\nMerkely, B\n\nSzabolcs, Z\n\nBeiträge in Fachzeitschriften\nISI:000368494700001\n26801237.0\n10.1186/s13019-016-0418-y\nPMC4724135\nWe retrospectively analyzed 25 years of experiences with the button Bentall procedure in patients with aortic root pathologies. Even though this procedure has become widespread, there are only a few very long term follow-ups available in the clinical literature, especially regarding single surgeon results.\n Between 1988 and 2013, a total of 147 patients underwent the Bentall procedure by the same surgeon. Among them there were 62 patients with Marfan syndrome. At the time of the surgery the mean age was 46.5 ± 17.6 years. The impact of surgical experience on long-term survival was evaluated using a cumulative sum analysis chart.\n The Kaplan-Meier estimated overall survival rates for the 147 patients were 91.8 ± 2.3 %, 84.3 ± 3.1 %, 76.3 ± 4.9 % and 59.5 ± 10.7 % at 1, , 0 and 20 years, respectively. Multivariate Cox regression analysis identified EuroSCORE II over 3 % (OR 4.245, 95 % CI, 1.739-10.364, p = 0.002), acute indication (OR 2.942, 95 % CI, 1.158-7.480, p = 0.023), use of deep hypothermic circulatory arrest (OR 3.267, 95 % CI, 1.283-8.323, p = 0.013), chronic kidney disease (OR 6.865, 95 % CI, 1.339-35.189, p = 0.021) and early complication (OR 3.134, 95 % CI, 1.246-7.883, p = 0.015) as significant risk factors for the late overall death. The survival rate for freedom from early complication was 94.3 ± 2.2 %, 88.0 ± 3.3 %, 82.9 ± 4.7 % and 69.2 ± 8.4 % at 1, , 0 and 20 years. The main pathological findings of the aortic wall were cystic medial degeneration in 75 %, fibrosis in 6 %, atherosclerosis in 13 % and no pathological alteration in 6 % of the samples. The overall survival rate was significantly lower in patients operated in first 15 years compared to patients operated in the last decade (log-rank p = 0.011).\n According to our long-term follow-up the Bentall operation provides an appropriate functional result by resolving the lesions of the ascending aorta. Based on our results, 25-30 operations done is necessary to gain such a level of confidence and experience to aquire better results on long-term survival. In addition, we discussed that there were no co-morbidities affecting on the survival of Marfan patients and prophylactic aortic root replacement ensures a longer survival among patients with Marfan syndrome.\n\nOdler, Balazs\n\n\n"
},
{
"text": "\n175197\nComparison of four DLL3 antibodies performance in high grade neuroendocrine lung tumor samples and cell cultures.\n\nBrcic, L\n\nKuchler, C\n\nEidenhammer, S\n\nPabst, D\n\nQuehenberger, F\n\nGazdar, AF\n\nPopper, H\n\nBeiträge in Fachzeitschriften\nISI:000468470400002\n31109352.0\n10.1186/s13000-019-0827-z\nPMC6528329\nSmall cell lung cancer (SCLC) is usually diagnosed in the advanced stage. It has a very poor prognosis, with no advancements in therapy in the last few decades. A recent phase 1 clinical study, using an antibody-drug conjugate directed against DLL3, showed promising results. A prerequisite for this therapy is an immunohistochemical test for DLL3 expression. The antibody used in the clinical trial was bound to a specific platform, which is not available in all pathology laboratories. In this study, the expression of DLL3 was analyzed using different DLL3 antibodies in high-grade neuroendocrine tumors of the lung and cell cultures. Additionally, correlation of DLL3 expression with Rb1 loss and TP53 mutation was evaluated.\n The study cohort consisted of surgically resected cases, 24 SCLC and 29 large cell neuroendocrine carcinoma (LCNEC), from which tissue microarrays (TMAs) were constructed. The validation cohort included 46 SCLC samples, mostly small biopsies. Additionally, well-characterized SCLC cell lines were used. Immunohistochemical analysis was performed using four different DLL3 antibodies, as well as TP53 and Rb1 antibodies. Expression was evaluated microscopically and manually scored.\n The comparison of all DLL3 antibodies showed poor results for the overall agreement, as well as positive and negative agreement. Differences were observed regardless of the applied cut-off values and the tumor type. The antibody used in the clinical trial was the only which always positively stained the tumor cells obtained from cell cultures with known DLL3 expression and was negative on cells that did not express DLL3. There was no correlation between p53 and DLL3 expression in SCLC and LCNEC. RB1 loss in SCLC showed statistical significant correlation with the DLL3 positivity (p = 0.037), while no correlation was found in LCNEC.\n The DLL3 antibody used in the clinical trial demonstrated superiority in the detection of DLL3 expression. Cell cultures, which can be used for DLL3 antibodies as positive and negative probes, were established. Evidence of DLL3 expression in high proportions of patients with LCNEC might provide basis for studies of new therapy options in this group of patients.\n\nBrcic, Luka\n\nEidenhammer, Sylvia\n\nPabst, Daniela\n\nPopper, Helmuth\n\nQuehenberger, Franz\n\n\n"
},
{
"text": "\n182809\nQuantification of fat in the posterior sacroiliac joint region applying a semi-automated segmentation method.\n\nPoilliot, A\n\nTannock, M\n\nZhang, M\n\nZwirner, J\n\nHammer, N\n\nBeiträge in Fachzeitschriften\nISI:000546180100007\n32088491.0\n10.1016/j.cmpb.2020.105386\nNone\nFat within the posterior sacroiliac joint region (PSIJ) is thought to compensate for the incongruent surfaces of the sacrum and ilium posteriorly. Knowledge on the presence of fat in the SIJ could provide useful information about joint physiology and clinical kinematic implications of its presence. This study aimed at quantifying fat within the PSIJ, using a semi-automated method, and to compare the results to a manual segmentation method based on data from frozen cadaveric sections and computed tomography (CT). The results may provide a quicker and more objective method for fat volume quantification.\n Seventy-eight cadaveric hemipelves were used. Frozen sections were obtained and photographed and CT data obtained from subsamples. A MATLAB routine was deployed to assess fat in the serial sections and CT scans, using masks derived from color thresholds and Hounsfield units, respectively. Regions of interest were created to isolate the PSIJ region before fat volume was computed. A Friedman test was used for the comparison between all masks and the manual method, a Kruskall-Wallis test for comparing the CT results with all masks and the manual method and Bland-Altman plots were used to express the result differences of these methods.\n PSIJ fat volume averaged 3.9 ± 2.2, 4.9 ± 2.5, 3.7 ± 2.3 and 7.2 ± 7.3 cm3 for masks 1 (fat mask), 2 (no-fat mask), 3 ('control' fat mask) and CT, respectively. All masks and the CT fat volume were significantly different to the manual segmentation method (p<0.01). Mask 2 differed significantly from masks 1 and 3 (both p<0.01). Bland-Altman plots yielded differences in the measurements between the various methods.\n Manual segmentation of PSIJ fat volume may result in a relative underestimation of the total fat compared to semi-automated or CT-based methods, as fat might not be sufficiently distinguished from surrounding structures. However, the CT-based method resulted in vastly higher variation in the results and warrants further study. The semi-automated approach to quantify fat based on color thresholds presented here is more investigator-independent, time efficient and applicable to CT scans, which provides opportunity to use this technique on various tissue types in vivo.\n Copyright © 2020. Published by Elsevier B.V.\n\nHammer, Niels\n\n\n"
},
{
"text": "\n184530\nVariable fixation promotes callus formation: an experimental study on transverse tibial osteotomies stabilized with locking plates.\n\nPlecko, M\n\nKlein, K\n\nPlanzer, K\n\nWähnert, D\n\nBehm, P\n\nFerguson, SJ\n\nBrianza, S\n\nStadelmann, VA\n\nvon Rechenberg, B\n\nBeiträge in Fachzeitschriften\nISI:000597941200005\n33272239.0\n10.1186/s12891-020-03781-6\nPMC7713143\nA new locking screw technology, named variable fixation, has been developed aiming at promoting bone callus formation providing initial rigid fixation followed by progressive fracture gap dynamisation. In this study, we compared bone callus formation in osteotomies stabilized with standard locking fixation against that of osteotomies stabilized with variable fixation in an established tibia ovine model.\n A 3 mm tibial transverse osteotomy gap was stabilized in three groups of six female sheep each with a locking plate and either 1) standard fixation in both segments (group LS) or 2) variable fixation in the proximal and standard fixation in the distal bone segment (group VFLS3) or 3) variable fixation in both segments (group VFLS6). The implantation site and fracture healing were compared between groups by means of radiologic, micro tomographic, biomechanical, and histological investigations.\n Compared to LS callus, VFLS3 callus was 40% larger and about 3% denser, while VFLS6 callus was 93% larger and its density about 7.2% lower. VFLS3 showed 65% and VFLS6 163% larger amount of callus at the cis-cortex. There wasn't a significant difference in the amount of callus at the cis and trans-cortex in groups featuring variable fixation only. Investigated biomechanical variables were not significantly different among groups and histology showed comparable good healing in all groups. Tissues adjacent to the implants did not show any alteration of the normal structure in all groups.\n Variable fixation promoted the formation of a larger amount of bone callus, equally distributed at the cis and trans cortices. The histological and biomechanical properties of the variable fixation callus were equivalent to those of the standard fixation callus. The magnitude of variable fixation had a biological effect on the formation of bone callus. At the implantation site, the usage of variable fixation did not raise additional concerns with respect to standard fixation. The formation of a larger amount of mature callus suggests that fractures treated with variable fixation might have a higher probability to bridge the fracture gap. The conditions where its usage can be most beneficial for patients needs to be clinically defined.\n\nPlecko, Michael\n\n\n"
},
{
"text": "\n184591\nSafety and efficacy of the endothelin receptor antagonist macitentan in pediatric pulmonary hypertension.\n\nSchweintzger, S\n\nKoestenberger, M\n\nSchlagenhauf, A\n\nGrangl, G\n\nBurmas, A\n\nKurath-Koller, S\n\nPocivalnik, M\n\nSallmon, H\n\nBaumgartner, D\n\nHansmann, G\n\nGamillscheg, A\n\nBeiträge in Fachzeitschriften\nISI:000582467900041\n33224780.0\n10.21037/cdt.2020.04.01\nPMC7666951\nMacitentan, a dual endothelin receptor antagonist (ERA), was approved in 2014 for the treatment of adults with idiopathic pulmonary arterial hypertension (PAH). Once-per-day dosing and low potential hepatic toxicity make macitentan an appealing therapeutic option for children with PAH, but reports on its use in pediatric patients are still lacking.\n Prospective observational study of 18 children [10 male; median age: 8.5, minimum (min.): 0.6, maximum (max.): 16.8 years] with pulmonary hypertension (PH). Four of these 18 patients were treatment-naïve and started on a de novo macitentan therapy. The remaining 14/18 children were already on a PH-targeted pharmacotherapy (sildenafil or bosentan as monotherapy or in combination). Nine children who were on bosentan were switched to macitentan. We analyzed the 6-minute walking distance (6MWD), NYHA functional class (FC)/modified ROSS score, invasive hemodynamics, echocardiographic variables and the biomarker N-terminal pro-brain natriuretic peptide (NT-proBNP).\n The median follow up was 6 months (min.: 0.5, max.: 30). Macitentan treatment was associated with improvement of invasive hemodynamics, e.g., the ratio of mean pulmonary arterial pressure/mean systemic arterial pressure decreased from a median of 62% (min.: 30%, max.: 87%) to 49% (min.: 30%, max.: 69%), P<0.05; pulmonary vascular resistance index (PVRi) decreased from a median of 7.6 (min.: 3.3, max.: 11.5) to 4.8 Wood units × m2 body surface area (min.: 2.5, max.: 10), P<0.05. The tricuspid annular plane systolic excursion (TAPSE) increased from a median of 1.4 (min.: 0.8, max.: 2.8) to 1.9 (min.: 0.8, max.: 2.7) cm, (P<0.05). NT-proBNP values decreased from a median of 272 (min.: 27, max.: 2, 10) to 229 (min.: 23, max.: 814) pg/mL under macitentan therapy (P<0.05). The 6MWD and NYHA FC/modified ROSS score did not change significantly.\n This is the first prospective study of macitentan pharmacotherapy in infants and children with PH <12 years of age. Except in one patient, macitentan treatment was well tolerated and was associated with improvements in invasive hemodynamics, longitudinal systolic RV function (TAPSE) and serum NT-proBNP values.\n 2020 Cardiovascular Diagnosis and Therapy. All rights reserved.\n\nBaumgartner, Daniela\n\nBurmas, Ante\n\nGamillscheg, Andreas\n\nGrangl, Gernot\n\nKoestenberger, Martin\n\nKurath-Koller, Stefan\n\nPocivalnik, Mirjam\n\nSchlagenhauf, Axel\n\nSchweintzger, Sabrina\n\n\n"
}
]
}