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Hafizi, Redona ; Imeri, Faik ; Stepanovska Tanturovska, Bisera ; Manaila, Roxana ; Schwalm, Stephanie ; Trautmann, Sandra ; Wenger, Roland H. ; Pfeilschifter, Josef ; Huwiler, Andrea
Erythropoietin (Epo) is a crucial hormone regulating red blood cell number and consequently the hematocrit. Epo is mainly produced in the kidney by interstitial fibroblast-like cells. Previously, we have shown that in cultures of the immortalized mouse renal fibroblast-like cell line FAIK F3-5, sphingosine 1-phosphate (S1P), by activating S1P1 and S1P3 receptors, can stabilize hypoxia-inducible factor (HIF)-2α and upregulate Epo mRNA and protein synthesis. In this study, we have addressed the role of intracellular iS1P derived from sphingosine kinases (Sphk) 1 and 2 on Epo synthesis in F3-5 cells and in mouse primary cultures of renal fibroblasts. We show that stable knockdown of Sphk2 in F3-5 cells increases HIF-2α protein and Epo mRNA and protein levels, while Sphk1 knockdown leads to a reduction of hypoxia-stimulated HIF-2α and Epo protein. A similar effect was obtained using primary cultures of renal fibroblasts isolated from wildtype mice, Sphk1−/−, or Sphk2−/− mice. Furthermore, selective Sphk2 inhibitors mimicked the effect of genetic Sphk2 depletion and also upregulated HIF-2α and Epo protein levels. The combined blockade of Sphk1 and Sphk2, using Sphk2−/− renal fibroblasts treated with the Sphk1 inhibitor PF543, resulted in reduced HIF-2α and Epo compared to the untreated Sphk2−/− cells. Exogenous sphingosine (Sph) enhanced HIF-2α and Epo, and this was abolished by the combined treatment with the selective S1P1 and S1P3 antagonists NIBR-0213 and TY52156, suggesting that Sph was taken up by cells and converted to iS1P and exported to then act in an autocrine manner through S1P1 and S1P3. The upregulation of HIF-2α and Epo synthesis by Sphk2 knockdown was confirmed in the human hepatoma cell line Hep3B, which is well-established to upregulate Epo production under hypoxia. In summary, these data show that sphingolipids have diverse effects on Epo synthesis. While accumulation of intracellular Sph reduces Epo synthesis, iS1P will be exported to act through S1P1+3 to enhance Epo synthesis. Furthermore, these data suggest that selective inhibition of Sphk2 is an attractive new option to enhance Epo synthesis and thereby to reduce anemia development in chronic kidney disease.
Janning, Melanie ; Süptitz, Juliane ; Albers-Leischner, Corinna ; Delpy, Pierre ; Tufman, Amanda L. H. ; Velthaus-Rusik, Janna-Lisa ; Reck, Martin ; Jung, Andreas ; Kauffmann-Guerrero, Diego ; Bonzheim, Irina ; Brändlein, Stephanie ; Hummel, Horst-Dieter ; Wiesweg, Marcel ; Schildhaus, Hans-Ulrich ; Stratmann, Jan Alexander ; Sebastian, Martin ; Alt, Jürgen ; Buth, Juliane ; Esposito, Irene ; Berger, Johannes ; Tögel, Lars ; Saalfeld, Felix ; Wermke, Martin ; Merkelbach-Bruse, Sabine ; Hillmer, Axel Maximilian ; Klauschen, Frederick ; Bokemeyer, Carsten ; Büttner, Reinhard ; Wolf, Jürgen ; Loges, Sonja
Background: Atypical EGFR mutations occur in 10%-30% of non-small-cell lung cancer (NSCLC) patients with EGFR mutations and their sensitivity to classical epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKI) is highly heterogeneous. Patients harboring one group of uncommon, recurrent EGFR mutations (G719X, S768I, L861Q) respond to EGFR-TKI. Exon 20 insertions are mostly insensitive to EGFR-TKI but display sensitivity to exon 20 inhibitors. Clinical outcome data of patients with very rare point and compound mutations upon systemic treatments are still sparse to date.
Patients and methods: In this retrospective, multicenter study of the national Network Genomic Medicine (nNGM) in Germany, 856 NSCLC cases with atypical EGFR mutations including co-occurring mutations were reported from 12 centers. Clinical follow-up data after treatment with different EGFR-TKIs, chemotherapy and immune checkpoint inhibitors were available from 260 patients. Response to treatment was analyzed in three major groups: (i) uncommon mutations (G719X, S7681, L861Q and combinations), (ii) exon 20 insertions and (iii) very rare EGFR mutations (very rare single point mutations, compound mutations, exon 18 deletions, exon 19 insertions).
Results: Our study comprises the largest thus far reported real-world cohort of very rare EGFR single point and compound mutations treated with different systemic treatments. We validated higher efficacy of EGFR-TKI in comparison to chemotherapy in group 1 (uncommon), while most exon 20 insertions (group 2) were not EGFR-TKI responsive. In addition, we found TKI sensitivity of very rare point mutations (group 3) and of complex EGFR mutations containing exon 19 deletions or L858R mutations independent of the combination partner. Notably, treatment responses in group 3 (very rare) were highly heterogeneous. Co-occurring TP53 mutations exerted a non-significant trend for a detrimental effect on outcome in EGFR-TKI-treated patients in groups 2 and 3 but not in group 1.
Conclusions: Based on our findings, we propose a novel nNGM classification of atypical EGFR mutations.
Maier, Hannes ; Lenarz, Thomas ; Agha-Mir-Salim, Parwis ; Agterberg, Martijn J. H. ; Anagiotos, Andreas ; Arndt, Susan ; Ball, Geoffrey R. ; Bance, Manohar ; Barbara, Maurizio ; Baumann, Uwe ; Baumgartner, Wolfgang ; Bernardeschi, Daniele ; Beutner, Dirk ; Bosman, Arjan ; Briggs, Robert ; Busch, Susan ; Caversaccio, Marco ; Dahm, Markus ; Dalhoff, Ernst ; Devèze, Arnaud ; Ebrahimi-Madiseh, Azadeh ; Fraysse, Bernard ; Frenzel, Henning ; Gavilán, Javier ; Ghoncheh, Mohammad ; Håkansson, Bo E. V. ; Hodgetts, William ; Hol, Myrthe Karianne Sophie ; Holland, Julian ; Holmberg, Marcus ; Huber, Alexander ; Jenkins, Herman ; Katiri, Roulla ; Kheirkhah, Kiana ; Koitschev, Assen ; Kompis, Martin ; Lanting, Cris ; Lassaletta, Luis ; Lerut, Bob ; Leuwer, Rudolf ; Linder, Thomas ; Löwenheim, Hubert Martin ; Lustig, Lawrence ; Mandavia, Rishi ; Manrique, Manuel ; Jorge Humberto, Martins ; Mertens, Griet ; Mlynski, Robert Arndt ; Mojallal, Hamidreza ; Monini, Simonetta ; Monksfield, Peter ; Müller, Alexander ; Mylanus, Emmanuel ; Nakajima, Hideko Heidi ; Neudert, Marcus ; Offeciers, Erwin ; Pfiffner, Flurin ; Pietsch, Markus ; Plontke, Stefan K.-R. ; Prenzler, Nils Kristian ; Profant, Milan ; Rahne, Torsten ; Rajan, Gunesh ; Ratuszniak, Anna ; Raufer, Stefan ; Ray, Jaydip ; Reinfeldt, Sabine ; Röösli, Christof ; Rosenbom, Tove ; Salcher, Rolf Benedikt ; Schönermark, Matthias ; Schwab, Burkard ; Skarżyński, Henryk ; Skarżyński, Piotr H. ; Snapp, Hillary ; Sprinzl, Georg ; Spearman, Michael ; Stenfelt, Stefan ; Stieger, Christof ; Tringali, Stephane ; Truy, Eric ; Tysome, James ; Van de Heyning, Paul ; Verhaert, Nicolas ; Wesarg, Thomas ; Westerkull, Patrik ; Wollenberg, Barbara ; Zahnert, Thomas ; Zarowski, Andrzej ; Snik, Ad
Nowadays, several options are available to treat patients with conductive or mixed hearing loss. Whenever surgical intervention is not possible or contra-indicated, and amplification by a conventional hearing device (e.g., behind-the-ear device) is not feasible, then implantable hearing devices are an indispensable next option. Implantable bone-conduction devices and middle-ear implants have advantages but also limitations concerning complexity/invasiveness of the surgery, medical complications, and effectiveness. To counsel the patient, the clinician should have a good overview of the options with regard to safety and reliability as well as unequivocal technical performance data. The present consensus document is the outcome of an extensive iterative process including ENT specialists, audiologists, health-policy scientists, and representatives/technicians of the main companies in this field. This document should provide a first framework for procedures and technical characterization to enhance effective communication between these stakeholders, improving health care.
Gelhard, Sarah ; Kestner, Roxane-Isabelle ; Armbrust, Moritz ; Steinmetz, Helmuth ; Förch, Christian ; Bohmann, Ferdinand
(1) Intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) in patients with acute ischemic stroke is limited because of several contraindications. In routine clinical practice, patients with a recent stroke are typically not treated with rt-PA in case of a recurrent ischemic event. The same applies to its use in the context of pulmonary artery embolism and myocardial infarction with a recent stroke. In this translational study, we evaluated whether rt-PA treatment after experimental ischemic stroke with or without additional hyperglycemia increases the risk for hemorrhagic transformation (HT) and worsens functional outcome regarding the old infarct area. (2) In total, 72 male C57BL/6N mice were used. Ischemic stroke (index stroke) was induced by transient middle cerebral artery occlusion (tMCAO). Mice received either rt-PA or saline 24 h or 14 days after index stroke to determine whether a recent ischemic stroke predisposes to HT. In addition to otherwise healthy mice, hyperglycemic mice were analyzed to evaluate diabetes as a second risk factor for HT. Mice designated to develop hyperglycemia were pre-treated with streptozotocin. (3) The neurological outcome in rt-PA and saline-treated normoglycemic mice did not differ significantly, either at 24 h or at 14 days. In contrast, hyperglycemic mice treated with rt-PA had a significantly worse neurological outcome (at 24 h, p = 0.02; at 14 days, p = 0.03). At 24 h after rt-PA or saline treatment, HT scores differed significantly (p = 0.02) with the highest scores within hyperglycemic mice treated with rt-PA, where notably only small petechial hemorrhages could be detected. (4) Thrombolysis after recent ischemic stroke does not increase the risk for HT or worsen the functional outcome in otherwise healthy mice. However, hyperglycemia as a second risk factor leads to neurological deterioration after rt-PA treatment, which cannot be explained by an increase of HT alone. Direct neurotoxic effects of rt-PA may play a role.
Eickholz, Peter ; Asendorf, Anne ; Schröder, Mario Pascal ; Schacher, Beate ; Oremek, Gerhard ; Schubert, Ralf ; Wohlfeil, Martin ; Zuhr, Otto
Background: Assessment of the effect of subgingival instrumentation (SI) on systemic inflammation in periodontitis grades B (BP) and C (CP). Methods: In this prospective cohort study, eight BP and 46 CP patients received SI. Data were collected prior to and 12 weeks after SI. Blood was sampled prior to, one day, 6, and 12 weeks after SI. Neutrophil elastase (NE), C-reactive protein (CRP), leukocyte count, lipopolysaccharide binding protein, interleukin 6 (IL-6) and IL-8 were assessed. Results: Both groups showed significant clinical improvement. NE was lower in BP than CP at baseline and 1 day after SI, while CRP was lower in BP than CP at baseline (p < 0.05). NE and CRP had a peak 1 day after SI (p < 0.05). Between-subjects effects due to CP (p = 0.042) and PISA (p = 0.005) occurred. Within-subjects NE change was confirmed and modulated by grade (p = 0.017), smoking (p = 0.029), number of teeth (p = 0.033), and PISA (p = 0.002). For CRP between-subjects effects due to BMI (p = 0.008) were seen. Within-subjects PISA modulated the change of CRP over time (p = 0.017). Conclusions: In untreated CP, NE and CRP were higher than in BP. SI results in better PPD and PISA reduction in BP than CP. Trial registration: Deutsches Register Klinischer Studien DRKS00026952 28 October 2021 registered retrospectively.
Hintergrund: Ein adäquates Gerinnungsmanagement ist für antikoagulierte Patient*innen von zentraler Bedeutung. Gleichzeitig stellt dies sowohl für die Hausarztpraxis als auch für die Patient*innen eine große Herausforderung dar. Orale Antikoagulantien (OAK) werden zur Primär- und Sekundärprophylaxe von thromboembolischen Erkrankungen eingesetzt. Häufigste Nebenwirkungen sind Blutungskomplikationen, von einer harmlosen Bagatellblutung bis hin zur gefürchteten vital bedrohlichen intrazerebralen Blutung reichend. Zur Optimierung des Gerinnungsmanagements in der hausärztlichen Versorgung und Reduktion gerinnungsassoziierter Komplikationen bei Betroffenen wurde im Rahmen der PICANT-Studie (Primary Care Management for Optimized Antithrombotic Treatment) ein hausarztpraxisbasiertes Case Management mit einem engmaschigen Monitoring von Patient*innen durch das Praxisteam – bestehend aus Medizinischer Fachangestellten (MFA) und Hausärzt*innen – untersucht. Die stärke Einbindung der MFA in die Betreuung von Patient*innen mit einer Langzeitindikation für eine gerinnungshemmende Medikation stellt eine Weiterentwicklung des Gerinnungsmanagements in der hausärztlichen Versorgung dar. Diese Arbeit beschreibt die Sichtweise und Erfahrungen von MFA in ihrer neuen Rolle als Case Manager*innen (CM) für ein hausärztliches Gerinnungsmanagement. Zudem soll durch die zusätzliche Befragung beteiligter Hausärzt*innen und Patient*innen die Rolle der MFA aus den drei unterschiedlichen Perspektiven beleuchtet und miteinander verglichen werden. Durch die Erfahrungsberichte von MFA, Hausärzt*innen und Patient*innen zum hausarztpraxisbasiertem Case Management soll diese Arbeit einen wertvollen Beitrag zu den Diskussionen um neue Versorgungs- und Delegationskonzepte im Gerinnungsmanagement leisten.
Methoden: Im Anschluss an die cluster-randomisierte PICANT-Studie wurden leitfadengestützte Telefoninterviews mit 15 MFA, 15 Hausärzt*innen und 25 Patient*innen der Interventionsgruppe geführt. Nach Datenerhebung und wörtlicher Transkription erfolgte die Auswertung nach der Methode der inhaltlich strukturierenden Inhaltsanalyse nach Kuckartz mithilfe der Auswertungssoftware MAXQDA 12.
Ergebnisse: Die Mehrheit der MFA empfand die Erweiterung ihres Verantwortungsbereiches und die damit einhergehende stärkere Einbindung in die Patientenbetreuung als persönliche Bereicherung. Sie gaben an, dass sie neben vertieften Kenntnissen zum Gerinnungsmanagement v.a. auch an Selbstsicherheit im Umgang mit antikoagulierten Patient*innen dazugewinnen konnten. In der Rolle der CM betrachteten sie sich als federführende Studienorganisatorinnen, Vertrauenspersonen für Erkrankte, kompetente Ansprechpartnerinnen und Vermittlerinnen zwischen Hausärzt*innen und Patient*innen. Auch die beteiligten Hausärzt*innen sahen die MFA als treibende Kräfte der Studienorganisation und erkannten, dass sie einen Wissenszuwachs erzielen und damit die Rolle einer kompetenten Ansprechpartnerin für Patient*innen einnehmen konnten. Demgegenüber waren die MFA aus Patientensicht vorwiegend für die Studienorganisation verantwortlich und wurden eher weniger als kompetente Ansprechpartnerinnen bei Fragen zum Gerinnungsmanagement gesehen.
Schlussfolgerung: Unter den Befragten zeigte sich ein unterschiedliches Rollenverständnis. Während MFA bereit waren, ihren Kompetenzbereich zu erweitern und eine Aufwertung ihrer beruflichen Funktion beschrieben, wurden die neuen Rollen von der Ärzteschaft und den Patient*innen nur bedingt wahrgenommen. Insbesondere für den Großteil der Erkrankten blieb der Hausarzt / die Hausärztin die einzige Anlaufstelle bei wichtigen medizinischen Themen. Damit besteht weiterer Forschungsbedarf hinsichtlich teambasierter Interventionen, einschließlich der Frage, wie der Kompetenzgewinn der MFA und die damit verbundene Aufwertung ihrer beruflichen Rolle noch stärker ins Bewusstsein der Ärzteschaft und Patient*innen gelangen kann. Schließlich erfordert die erfolgreiche Implementierung eines Case Managements mit stärkerem Einbezug von MFA die Umgestaltung vorhandener Handlungs- und Rollenmuster und die enge Zusammenarbeit aller Beteiligten.
Mühlenfeld, Nils ; Schindler, Cora ; Sterz, Jasmina ; Thönissen, Philipp Nikolaus ; Störmann, Philipp ; Marzi, Ingo ; Verboket, René
Strzelczyk, Adam ; Lagae, Lieven ; Kurlemann, Gerhard ; Flege, Silke Christiane ; Bast, Thomas ; Polster, Tilman ; Pringsheim, Milka ; Spiczak Brzezinski, Sarah von ; Hipp, Petra ; Schubert-Bast, Susanne
Hintergrund: Das Dravet-Syndrom (DS) ist ein seltenes, in der frühen Kindheit beginnendes, therapierefraktäres Epilepsiesyndrom, das mit einer hohen Morbidität und Mortalität verbunden ist.
Fragestellung: Ziele der Querschnittsstudie „Dravet syndrome caregiver survey“ (DISCUSS) sind die Identifizierung und Beschreibung der Faktoren, die einen Einfluss auf die Krankheitslast von Patienten mit DS und ihre Betreuer haben können. Die Ergebnisse der deutschen Kohorte werden vorgestellt.
Material und Methoden: Die Datenerhebung erfolgte durch eine anonyme Befragung von Eltern. Die Ergebnisse wurden für die verschiedenen Altersgruppen statistisch ausgewertet.
Ergebnisse: Der Fragebogen wurde von 68 Eltern der DS-Patienten mit einem durchschnittlichen Alter von 10 Jahren (Median: 9, Spanne: 1–26) ausgefüllt. Nur 3 Patienten (4,4 %) waren in den letzten 3 Monaten anfallsfrei. Insgesamt hatten 97 % der Patienten, die älter als 5 Jahre waren (n = 45), mindestens eine Komorbidität. Die zum Befragungszeitpunkt am häufigsten eingenommenen Antiepileptika waren Valproat, Kaliumbromid, Stiripentol, Clobazam und Topiramat. In der Vergangenheit wurden Natriumkanalblocker, Phenobarbital und Levetiracetam eingesetzt, aktuell fanden diese Antiepileptika nur selten Verwendung. Die Lebensqualität der Patienten war niedriger als die der Allgemeinbevölkerung. Die Erkrankung eines Familienmitglieds mit DS beeinflusst Eltern und Geschwister in hohem Maße.
Diskussion: Trotz individueller Kombinationstherapien sind die meisten Patienten mit DS nicht anfallsfrei. Insgesamt hat sich der Einsatz von beim DS wenig wirksamer Medikamente und der kontraindizierten Natriumkanalblocker zugunsten von wirksameren Medikamenten verschoben. Neue Therapie- und Versorgungskonzepte sind notwendig, um die Versorgung der Patienten mit DS zu verbessern und Eltern und Geschwister zu entlasten.
Myocardial fibrosis and inflammation by CMR predict cardiovascular outcome in people living with HIV
(2021)
Leuw, Philipp de ; Arendt, Christophe ; Haberl, Annette E. ; Froadinadl, Daniel ; Kann, Gerrit ; Wolf, Timo ; Stephan, Christoph ; Schüttfort, Gundolf ; Vasquez, Moises ; Arcari, Luca ; Zhou, Hui ; Zainal, Hafisyatul ; Gawor, Monika ; Vidalakis, Eleftherios ; Kolentinis, Michael ; Albrecht, Moritz Hans Ernst ; Escher, Felicitas ; Vogl, Thomas J. ; Zeiher, Andreas M. ; Nagel, Eike ; Puntmann, Valentina O.
Objectives_: The goal of this study was to examine prognostic relationships between cardiac imaging measures and cardiovascular outcome in people living with human immunodeficiency virus (HIV) (PLWH) on highly active antiretroviral therapy (HAART).
Background: PLWH have a higher prevalence of cardiovascular disease and heart failure (HF) compared with the noninfected population. The pathophysiological drivers of myocardial dysfunction and worse cardiovascular outcome in HIV remain poorly understood.
Methods: This prospective observational longitudinal study included consecutive PLWH on long-term HAART undergoing cardiac magnetic resonance (CMR) examination for assessment of myocardial volumes and function, T1 and T2 mapping, perfusion, and scar. Time-to-event analysis was performed from the index CMR examination to the first single event per patient. The primary endpoint was an adjudicated adverse cardiovascular event (cardiovascular mortality, nonfatal acute coronary syndrome, an appropriate device discharge, or a documented HF hospitalization).
Results: A total of 156 participants (62% male; age [median, interquartile range]: 50 years [42 to 57 years]) were included. During a median follow-up of 13 months (9 to 19 months), 24 events were observed (4 HF deaths, 1 sudden cardiac death, 2 nonfatal acute myocardial infarction, 1 appropriate device discharge, and 16 HF hospitalizations). Patients with events had higher native T1 (median [interquartile range]: 1,149 ms [1,115 to 1,163 ms] vs. 1,110 ms [1,075 to 1,138 ms]); native T2 (40 ms [38 to 41 ms] vs. 37 ms [36 to 39 ms]); left ventricular (LV) mass index (65 g/m2 [49 to 77 g/m2] vs. 57 g/m2 [49 to 64 g/m2]), and N-terminal pro–B-type natriuretic peptide (109 pg/l [25 to 337 pg/l] vs. 48 pg/l [23 to 82 pg/l]) (all p < 0.05). In multivariable analyses, native T1 was independently predictive of adverse events (chi-square test, 15.9; p < 0.001; native T1 [10 ms] hazard ratio [95% confidence interval]: 1.20 [1.08 to 1.33]; p = 0.001), followed by a model that also included LV mass (chi-square test, 17.1; p < 0.001). Traditional cardiovascular risk scores were not predictive of the adverse events.
Conclusions: Our findings reveal important prognostic associations of diffuse myocardial fibrosis and LV remodeling in PLWH. These results may support development of personalized approaches to screening and early intervention to reduce the burden of HF in PLWH (International T1 Multicenter Outcome Study; NCT03749343).
Worm, Margitta ; Zidane, Miriam Theresa Charlotte ; Eisert, Lisa ; Fischer-Betz, Rebecca ; Foeldvari, Ivan ; Günther, Claudia ; Iking-Konert, Christof ; Kreuter, Alexander ; Müller-Ladner, Ulf ; Nast, Alexander ; Ochsendorf, Falk ; Schneider, Matthias ; Sticherling, Michael ; Tenbrock, Klaus ; Wenzel, Jörg ; Kuhn, Annegret