466 results on '"Helios Klinikum [Erfurt]"'
Search Results
2. Children of Mentally Ill Parents-Network - CHIMPS-NET (CHIMPS-NET)
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Universitätsklinikum Hamburg-Eppendorf, Charite University, Berlin, Germany, University Medical Center Rostock, Immanuel Klinik Rüdersdorf, Evangelisches Klinikum Bethel, Universitätsklinikum Köln, University of Göttingen, Ruhr University of Bochum, University Hospital Tuebingen, University Hospital Freiburg, Josefinum Augsburg, University Hospital Augsburg, Klinikum der Universität München, University Hospital, Saarland, University of Magdeburg, Helios Kliniken Schwerin, Universitätsklinikum Marburg, Universitätsklinikum Koblenz - Landau, Pfalzklinikum, Helios Klinikum Erfurt, Bezirkskrankenhaus Günzburg, DAK Gesundheit, Techniker Krankenkasse, BARMER, BKK Mobil Oil, KKH Kaufmännische Krankenkasse, IKK Classic Krankenkasse, AOK Hessen, University of Ulm, University Hospital Heidelberg, aQua-Institut, Leibniz Universität, Center for Health Economics Research Hannover, AFET Bundesverband für Erziehungshilfe e.V., Dachverband Gemeindepsychiatrie, AOK Baden-Württemberg, LWL Klinik Gütersloh, Staedtisches Klinikum Karlsruhe, and Silke Wiegand-Grefe, Prof. Dr., Prof. Dr.
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- 2022
3. Clinical Implementation and Evaluation for the Family-oriented Care CHIMPS-NET (Ci-Chimps)
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Evangelisches Klinikum Bethel, Charite University, Berlin, Germany, Universitätsklinikum Leipzig, University Hospital, Saarland, Immanuel Klinik Rüdersdorf, LWL Klinik Gütersloh, University Hospital, Aachen, University of Ulm, Universitätsklinikum Köln, University Hospital Freiburg, University Hospital Augsburg, University Medical Center Rostock, University Hospital Tuebingen, Helios Kliniken Schwerin, University of Magdeburg, Universitätsklinikum Koblenz - Landau, Helios Klinikum Erfurt, and Goethe University
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- 2021
4. Diversion-p64 : results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device
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Joachim Klisch, Christian L. Roth, Frédéric Clarençon, Stefanita Dima, Xavier Barreau, Massimo Dall’Olio, Hans Henkes, Ana-Paula Narata, Peter Keston, Stanimir Sirakov, Luc Stockx, Alain Bonafe, Tony Goddard, Marcin Miś, Francis Turjman, Nunzio Paolo Nuzzi, Laurent Spelle, Marta Aguilar Pérez, Alexander Sirakov, Cezary Wałęsa, Ansgar Berlis, Sergey Yakovlev, Christian Loehr, Pedro Lylyk, Christina Wendl, Peter Schramm, A. V. Petrov, Carlos Bleise, Tine Willems, A. Clifton, Laurent Pierot, Gregory Gascou, Neuroradiologie [Hôpital Gui de Chauliac], Hôpital Gui de Chauliac [Montpellier], La Sagrada Familia Clinic/Clínica La Sagrada Familia [Buenos Aires, Argentina] (LSFC), St. Ivan Rilski University Hospital, Ziekenhuis Oost-Limburg (ZOL), Service de neuroradiologie [Lyon], Hôpital neurologique et neurochirurgical Pierre Wertheimer [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Almazov National Medical Research Centre (St. Petersburg), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Groupe hospitalier Pellegrin, Klinikum Vest GmbH, Klinikum Augsburg, Hôpital Maison Blanche, Centre Hospitalier Universitaire de Reims (CHU Reims), Wroclaw Medical University [Wrocław, Pologne], Leeds Teaching Hospitals NHS Trust, St George’s University Hospitals, Helios Klinikum [Erfurt], Service de Neuroradiologie [CHU de Bicêtre], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Faculté de Médecine Paris-Saclay, AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)-Université Paris-Saclay, Service de Neuroradiologie [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), NHS Lothian, Istituto Clinico Humanitas [Milan] (IRCCS Milan), Humanitas University [Milan] (Hunimed), University Hospital Regensburg, and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
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Adult ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,[SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,Aneurysm ,[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system ,Occlusion ,medicine ,Medicine and Health Sciences ,Humans ,Prospective Studies ,ddc:610 ,Prospective cohort study ,Stroke ,Aged ,Retrospective Studies ,medicine.diagnostic_test ,business.industry ,Incidence (epidemiology) ,Mortality rate ,Endovascular Procedures ,Stent ,flow diverter ,Intracranial Aneurysm ,General Medicine ,Middle Aged ,medicine.disease ,Embolization, Therapeutic ,3. Good health ,Surgery ,Cerebral Angiography ,Treatment Outcome ,Angiography ,aneurysm ,Female ,Stents ,stent ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Follow-Up Studies - Abstract
BackgroundThe use of flow diversion to treat intracranial aneurysms has increased in recent years.ObjectiveTo assess the safety and angiographic efficacy of the p64 flow modulation device.MethodsDiversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3–6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography.ResultsA total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10).ConclusionsDiversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity.
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- 2022
5. MTOR inhibitors reduce enteropathy, intestinal bleeding and colectomy rate in patients with juvenile polyposis of infancy with PTEN-BMPR1A deletion
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Henry Taylor, Marta C. Cohen, Stephan Buderus, Charis Eng, Isabel Rojas, Kevin Sweet, Peter Dale, Natalia Nedelkopoulou, Victor L. Fox, Claudia Phen, Inés Loverdos, Holm H. Uhlig, Tim G. J. de Meij, Jürgen Heise, Isabel Spier, Dilay Yerlioglu, Stefan Aretz, Emmanuel Mas, Veronica Busoni, Mike Thomson, Antje Ballauff, Imperial College London, Istanbul University, University of Texas Southwestern Medical Center [Dallas], Helios Klinikum Krefeld - Helios Klinikum Krefeld, Sheffield Children's NHS Foundation Trust, University Hospital Bonn, University of Barcelona, Italian Hospital of Buenos Aires, Helios Klinikum [Erfurt], Royal Gwent Hospital, Vrije Universiteit Amsterdam [Amsterdam] (VU), Ohio State University [Columbus] (OSU), Boston Children's Hospital, Harvard Medical School [Boston] (HMS), Institut de Recherche en Santé Digestive (IRSD ), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Case Western Reserve University [Cleveland], Cleveland Clinic, Gemeinnützige Gesellschaft der Franziskanerinnen zu Olpe mbH (GFO), University of Oxford [Oxford], NIHR Oxford Biomedical Research Centre, Pediatric surgery, Amsterdam Gastroenterology Endocrinology Metabolism, and Amsterdam Reproduction & Development (AR&D)
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AcademicSubjects/SCI01140 ,03 medical and health sciences ,0302 clinical medicine ,Neoplastic Syndromes, Hereditary ,Genetics ,medicine ,[SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO] ,PTEN ,Humans ,Enteropathy ,Juvenile polyposis syndrome ,[SDV.BBM]Life Sciences [q-bio]/Biochemistry, Molecular Biology ,Molecular Biology ,Genetics (clinical) ,PI3K/AKT/mTOR pathway ,Bone Morphogenetic Protein Receptors, Type I ,Colectomy ,030304 developmental biology ,0303 health sciences ,Everolimus ,biology ,Intestinal Polyposis ,TOR Serine-Threonine Kinases ,PTEN Phosphohydrolase ,General Medicine ,MTOR Inhibitors ,medicine.disease ,BMPR1A ,3. Good health ,030220 oncology & carcinogenesis ,Sirolimus ,biology.protein ,Cancer research ,General Article ,Haploinsufficiency ,Gastrointestinal Hemorrhage ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology ,medicine.drug - Abstract
Ultra-rare genetic disorders can provide proof of concept for efficacy of targeted therapeutics and reveal pathogenic mechanisms relevant to more common conditions. Juvenile polyposis of infancy (JPI) is caused by microdeletions in chromosome 10 that result in haploinsufficiency of two tumor suppressor genes: phosphatase and tensin homolog deleted on chromosome 10 (PTEN) and bone morphogenetic protein receptor type IA (BMPR1A). Loss of PTEN and BMPR1A results in a much more severe phenotype than deletion of either gene alone, with infantile onset pan-enteric polyposis and a high mortality rate. No effective pharmacological therapy exists. A multi-center cohort analysis was performed to characterize phenotype and investigate the therapeutic effect of mammalian target of rapamycin (mTOR) inhibition (adverse events, disease progression, time to colectomy and mortality) in patients with JPI. Among 25 JPI patients identified (mean age of onset 13 months), seven received mTOR inhibitors (everolimus, n = 2; or sirolimus, n = 5). Treatment with an mTOR inhibitor reduced the risk of colectomy (hazard ratio = 0.27, 95% confidence interval = 0.07–0.954, P = 0.042) and resulted in significant improvements in the serum albumin level (mean increase = 16.3 g/l, P = 0.0003) and hemoglobin (mean increase = 2.68 g/dl, P = 0.0077). Long-term mTOR inhibitor treatment was well tolerated over an accumulated follow-up time of 29.8 patient years. No serious adverse events were reported. Early therapy with mTOR inhibitors offers effective, pathway-specific and personalized treatment for patients with JPI. Inhibition of the phosphoinositol-3-kinase–AKT–mTOR pathway mitigates the detrimental synergistic effects of combined PTEN–BMPR1A deletion. This is the first effective pharmacological treatment identified for a hamartomatous polyposis syndrome., Graphical Abstract Graphical Abstract
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- 2021
6. Hematopoietic cell transplantation and cellular therapy survey of the EBMT: monitoring of activities and trends over 30 years
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Régis Peffault de Latour, Harry Dolstra, Ibrahim Yakoub-Agha, Nicolaus Kröger, Jakob Passweg, Bertram Glass, Arjan C. Lankester, Grzegorz W. Basak, Marrow Transplantation, Raffaella Greco, Mohamad Mohty, John A. Snowden, Rafael de la Cámara, Selim Corbacioglu, Helen Baldomero, Rafael F. Duarte, Christian Chabannon, University Hospital Basel [Basel], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Medical University of Warsaw - Poland, University of Regensburg, Radboud University Medical Center [Nijmegen], Helios Klinikum [Erfurt], IRCCS Ospedale San Raffaele [Milan, Italy], Leiden University Medical Center (LUMC), Universiteit Leiden, Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institute for Translational Research in Inflammation - U 1286 (INFINITE (Ex-Liric)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), University Hospital Hamburg-Eppendorf, Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg] (UKE), Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Laboratoire d'Hématologie et d'Immunologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), and Gestionnaire, Hal Sorbonne Université
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Oncology ,medicine.medical_specialty ,Myeloid ,medicine.medical_treatment ,Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2] ,[SDV]Life Sciences [q-bio] ,Hematopoietic stem cell transplantation ,Article ,Cell therapy ,03 medical and health sciences ,0302 clinical medicine ,Unrelated Donor ,Internal medicine ,hemic and lymphatic diseases ,Surveys and Questionnaires ,medicine ,Humans ,Transplantation, Homologous ,Leukaemia ,Aged ,Transplantation ,Haematological cancer ,Hematopoietic cell ,Marrow transplantation ,business.industry ,Hematopoietic Stem Cell Transplantation ,Hematology ,3. Good health ,[SDV] Life Sciences [q-bio] ,Europe ,medicine.anatomical_structure ,surgical procedures, operative ,030220 oncology & carcinogenesis ,Cord blood ,business ,Unrelated Donors ,030215 immunology - Abstract
Numbers of Hematopoietic cell transplantation (HCT) in Europe and collaborating countries continues to rise with 48,512 HCT in 43,581 patients, comprising of 19,798 (41%) allogeneic and 28,714 (59%) autologous, reported by 700 centers in 51 countries during 2019. Main indications were myeloid malignancies 10,764 (25%), lymphoid malignancies 27,895 (64%), and nonmalignant disorders 3173 (7%). A marked growth in CAR-T cellular therapies from 151 in 2017 to 1134 patients in 2019 is observed. This year’s analyses focus on changes over 30 years. Since the first survey in 1990 where 143 centers reported 4234 HCT, the number has increased to 700 centers and 48,512 HCT. Transplants were reported in 20 countries in 1990, and 51, 30 years later. More than 800,000 HCT in 715,000 patients were reported overall. Next to the massive expansion of HCT technology, most notable developments include the success of unrelated donor and haploidentical HCT, an increase followed by decrease in the number of cord blood transplants, use of reduced intensity HCT in older patients, and the phenomenal rise in cellular therapy. This annual report of the European Society for Blood and Marrow Transplantation (EBMT) reflects current activity and highlights important trends vital for health care planning.
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- 2020
7. COVID-19 pandemic and cardiac imaging: EACVI recommendations on precautions, indications, prioritization, and protection for patients and healthcare personnel
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Leyla Elif Sade, Kristina H. Haugaa, Marc R. Dweck, Alessia Gimelli, Mark Westwood, Bernhard Gerber, Tara Bharucha, Thor Edvardsen, Jeanette Schulz-Menger, Pál Maurovich-Horvat, Denisa Muraru, Julien Magne, Giovanni Di Salvo, Bogdan A. Popescu, Erwan Donal, Gianluca Pontone, Steffen E. Petersen, Matteo Cameli, Gerald Maurer, Helge Skulstad, Maurizio Galderisi, Bernard Cosyns, Ana G. Almeida, Oslo University Hospital [Oslo], University of Oslo (UiO), Vrije Universiteit Brussel (VUB), Université de Médecine Carol Davila, University of Naples Federico II = Università degli studi di Napoli Federico II, Università degli Studi di Padova = University of Padua (Unipd), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), William Harvey Research Institute, Barts and the London Medical School, Barts Health NHS Trust [London, UK], Fondazione Toscana Gabriele Monasterio, Università degli Studi di Milano-Bicocca = University of Milano-Bicocca (UNIMIB), Universidade de Lisboa = University of Lisbon (ULISBOA), Humboldt University Of Berlin, German Center for Cardiovascular Research (DZHK), Berlin Institute of Health (BIH), Helios Klinikum [Erfurt], Centre for Cardiovascular Science [Edinburgh] (BHF), University of Edinburgh, Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Université Catholique de Louvain = Catholic University of Louvain (UCL), Semmelweis University [Budapest], NHS Foundation Trust [London], The Royal Marsden, Service de cardiologie [CHU Limoges], CHU Limoges, Neuroépidémiologie Tropicale (NET), CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Medizinische Universität Wien = Medical University of Vienna, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service de pathologie cardiovasculaire, Repositório da Universidade de Lisboa, Clinical sciences, Cardio-vascular diseases, Cardiology, Università degli studi di Napoli Federico II, Universita degli Studi di Padova, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Università degli Studi di Milano-Bicocca [Milano] (UNIMIB), Universidade de Lisboa (ULISBOA), Humboldt-Universität zu Berlin, University of Turin, Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM)-CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM), Jonchère, Laurent, Skulstad, H, Cosyns, B, Popescu, B, Galderisi, M, Salvo, G, Donal, E, Petersen, S, Gimelli, A, Haugaa, K, Muraru, D, Almeida, A, Schulz-Menger, J, Dweck, M, Pontone, G, Sade, L, Gerber, B, Maurovich-Horvat, P, Bharucha, T, Cameli, M, Magne, J, Westwood, M, Maurer, G, and Edvardsen, T
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Heart diseases ,Infectious Disease Transmission ,Review ,030204 cardiovascular system & hematology ,Transesophageal ,Patient-to-Professional ,covid19 ,Health personnel ,0302 clinical medicine ,Health care ,Pandemic ,Medicine ,Prenatal ,Heart Diseases/diagnostic imaging ,Viral ,Pandemics/prevention & control ,Cardiac imaging ,ComputingMilieux_MISCELLANEOUS ,Ultrasonography ,General Medicine ,3. Good health ,Heart Disease ,Radiology Nuclear Medicine and imaging ,Echocardiography ,[SDV.IB]Life Sciences [q-bio]/Bioengineering ,Medical emergency ,Covid-19 ,Ultrasonography, Prenatal/methods ,Cardiology and Cardiovascular Medicine ,ECHOCARDIOGRAPHY ,Coronavirus Infections ,Human ,Prioritization ,Infectious Disease Transmission, Patient-to-Professional ,Coronavirus disease 2019 (COVID-19) ,Heart Diseases ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Pneumonia, Viral ,Diagnostic imaging procedures ,Echocardiography/methods ,Pneumonia, Viral/diagnostic imaging ,Ultrasonography, Prenatal ,03 medical and health sciences ,Echocardiography, Transesophageal/methods ,Betacoronavirus ,Infectious Disease Transmission, Patient-to-Professional/prevention & control ,Humans ,Radiology, Nuclear Medicine and imaging ,Pandemics ,[SDV.IB] Life Sciences [q-bio]/Bioengineering ,Coronavirus pandemic ,Betacoronavirus/isolation & purification ,Betacoronaviru ,Coronavirus Infection ,business.industry ,SARS-CoV-2 ,COVID-19 ,Echocardiography, Transesophageal ,MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE ,Pneumonia ,medicine.disease ,business ,Coronavirus Infections/diagnostic imaging - Abstract
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020., The coronavirus disease 2019 (COVID-19) pandemic has created new and unpredictable challenges for modern medicine and healthcare systems. Preliminary reports have demonstrated that older age, previous cardiovascular disease, diabetes, and hypertension are risk factors for increased mortality. Data on the cardiac affinity of the virus and its potential to harm the cardiovascular system and the mechanisms by which this occurs are sparse. A systemic infection generally increases demand on the heart, and can exacerbate underlying cardiac conditions. When the lungs are heavily involved, as seen in COVID-19 patients, this may have a major impact on cardiac function, particularly that of the right ventricle. Finally, COVID-19 may have direct effects on the heart, as may some drugs being used in its treatment.
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- 2020
8. Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of 3 Prospective, Multicenter Series: 2-Year Follow-Up
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Werner Weber, Laurent Spelle, Francis Turjman, Joachim Klisch, Anne-Christine Januel, Xavier Barreau, Laurent Pierot, Joachim Berkefeld, Andrew J. Molyneux, Hubert Desal, Thomas Liebig, Luc Stockx, Jacques Moret, James V. Byrne, Denis Herbreteau, Jean-Yves Gauvrit, Stéphane Velasco, Jens Fiehler, Vincent Costalat, István Szikora, Markus Holtmannspötter, Hôpital Maison Blanche, Centre Hospitalier Universitaire de Reims (CHU Reims), Service de Neuroradiologie [CHU de Bicêtre], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU de Bordeaux Pellegrin [Bordeaux], National Institute of Clinical Neurosciences [Budapest] (NICN), Service de neuroradiologie [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Département de Neuroradiologie [Centre Hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Rigshospitalet [Copenhagen], Copenhagen University Hospital, Neuroradiologie Diagnostique et Thérapeutique [Toulouse], Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], Département de Neuroradiologie[Montpellier], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [Montpellier]-Université de Montpellier (UM), Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg] (UKE), Helios Klinikum [Erfurt], Service de Neuroradiologie [Rennes], CHU Pontchaillou [Rennes], Universitätsklinikum Knappschaftskrankenhaus [Bochum], Département de Neuroradiologie [CHU Nantes], Centre hospitalier universitaire de Nantes (CHU Nantes), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Ludwig Maximilian University [Munich] (LMU), Ziekenhuis Oost-Limburg (ZOL), Klinikum der Johann Wolfgang Goethe-Universität, Nuffield Department of Clinical Neurosciences [Oxford], University of Oxford [Oxford], and Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)
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Neuros/1 ,Male ,Neuros/4 ,Flow disruption ,030218 nuclear medicine & medical imaging ,0302 clinical medicine ,Occlusion ,Prospective Studies ,MESH: Treatment Outcome ,MESH: Aged ,education.field_of_study ,MESH: Middle Aged ,Endovascular Procedures ,WEB device ,MESH: Follow-Up Studies ,Middle Aged ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,Embolization, Therapeutic ,3. Good health ,Europe ,Research—Human—Clinical Studies ,medicine.anatomical_structure ,Treatment Outcome ,Middle cerebral artery ,cardiovascular system ,Female ,[SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,Internal carotid artery ,Aneurysms ,Artery ,Adult ,medicine.medical_specialty ,MESH: Endovascular Procedures ,AcademicSubjects/MED00930 ,Population ,MESH: Intracranial Aneurysm ,03 medical and health sciences ,Aneurysm ,medicine.artery ,medicine ,Basilar artery ,Neurosurgery 20/20: Concise, Clear Content ,Humans ,Endovascular treatment ,cardiovascular diseases ,education ,Adverse effect ,Aged ,ComputingMethodologies_COMPUTERGRAPHICS ,MESH: Humans ,business.industry ,Intracranial Aneurysm ,MESH: Adult ,medicine.disease ,MESH: Prospective Studies ,MESH: Male ,Surgery ,Editor's Choice ,MESH: Embolization, Therapeutic ,Neurology (clinical) ,MESH: Europe ,business ,MESH: Female ,030217 neurology & neurosurgery ,Follow-Up Studies - Abstract
BACKGROUND Woven EndoBridge (WEB; Sequent Medical) treatment is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown high safety with good efficacy at short term confirmed by trials conducted in United States (WEB-Intrasaccular Therapy) and in Europe (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy [WEBCAST], French Observatory, and WEBCAST-2). OBJECTIVE To report the 2-yr clinical and anatomical results of WEB treatment in the combined population of 3 European trials. METHODS In a French Observatory, 2-yr clinical and anatomical data were collected. In WEBCAST and WEBCAST-2, 2-yr follow-up was optional, and data were collected when follow-up was performed. Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS The population for safety was 138/168 patients (82.1%), including 89 females (64.5%), with mean age of 55.5 ± 10.2 yr. The population for efficacy was 121/169 aneurysms (71.6%). Aneurysm locations were middle cerebral artery in 65/121 aneurysms (53.7%), anterior-communicating artery in 25/121 (20.7%), basilar artery in 17/121 (14.0%), and internal carotid artery terminus in 14/121 (11.6%). No clinically relevant adverse events occurred between years 1 and 2. At 2 yr, complete occlusion was observed in 62/121 (51.2%) aneurysms, neck remnant in 36/121 (29.8%) aneurysms, and aneurysm remnant in 23/121 (19.0%) aneurysms. The global retreatment rate at 2 yr was 9.3%. CONCLUSION This analysis confirms the high safety profile of WEB treatment at 2 yr. Aneurysm occlusion is generally stable at 2 yr, and the retreatment rate between 1 yr and 2 yr is low (2.0%)., Graphical Abstract Graphical Abstract
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- 2021
9. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series
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István Szikora, Hubert Desal, Joachim Klisch, James V. Byrne, Thomas Liebig, Stéphane Velasco, Jens Fiehler, Vincent Costalat, Anne-Christine Januel, Laurent Pierot, Werner Weber, Luc Stockx, Joachim Berkefeld, Francis Turjman, Denis Herbreteau, Jean-Yves Gauvrit, Jacques Moret, Laurent Spelle, Xavier Barreau, Markus Holtmannspötter, Andrew J. Molyneux, Hôpital Maison Blanche, Centre Hospitalier Universitaire de Reims (CHU Reims), Mécanismes Adaptatifs et Evolution (MECADEV), Muséum national d'Histoire naturelle (MNHN)-Centre National de la Recherche Scientifique (CNRS), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), CHU de Bordeaux Pellegrin [Bordeaux], National Institute of Clinical Neurosciences [Budapest] (NICN), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Rigshospitalet [Copenhagen], Copenhagen University Hospital, CHU Toulouse [Toulouse], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génomique Fonctionnelle (IGF), Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS), Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg] (UKE), Helios Klinikum [Erfurt], Vision, Action et Gestion d'informations en Santé (VisAGeS), SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE (IRISA-D5), Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Université de Bretagne Sud (UBS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National de Recherche en Informatique et en Automatique (Inria)-École normale supérieure - Rennes (ENS Rennes)-Centre National de la Recherche Scientifique (CNRS)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-CentraleSupélec-IMT Atlantique Bretagne-Pays de la Loire (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université de Bretagne Sud (UBS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Inria Rennes – Bretagne Atlantique, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de radiologie et imagerie médicale [Rennes] = Radiology [Rennes], CHU Pontchaillou [Rennes], Universitätsklinikum Knappschaftskrankenhaus [Bochum], Centre hospitalier universitaire de Nantes (CHU Nantes), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Universitätsklinikum Köln (Uniklinik Köln), Ziekenhuis Oost-Limburg (ZOL), Universitätsklinikum Frankfurt, University of Oxford [Oxford], Sequent, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Inria Rennes – Bretagne Atlantique, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE (IRISA-D5), Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-IMT Atlantique (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-IMT Atlantique (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT), Universitätsklinikum Knappschaftskrankenhaus = University Hospital Knappschaftskrankenhaus [Bochum], University of Oxford, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-IMT Atlantique Bretagne-Pays de la Loire (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Université de Rennes 1 (UR1), and Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-IMT Atlantique Bretagne-Pays de la Loire (IMT Atlantique)
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Adult ,Male ,medicine.medical_specialty ,[SDV]Life Sciences [q-bio] ,Population ,Self Expandable Metallic Stents ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,Aneurysm ,medicine.artery ,Occlusion ,medicine ,Humans ,Prospective Studies ,cardiovascular diseases ,education ,Prospective cohort study ,Aged ,education.field_of_study ,business.industry ,Endovascular Procedures ,Intracranial Aneurysm ,General Medicine ,Middle Aged ,medicine.disease ,Embolization, Therapeutic ,3. Good health ,Surgery ,Clinical trial ,Hemorrhagic Stroke ,Anterior communicating artery ,Treatment Outcome ,Middle cerebral artery ,cardiovascular system ,Female ,France ,Neurology (clinical) ,Radiology ,Internal carotid artery ,business ,030217 neurology & neurosurgery - Abstract
BackgroundFlow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy.PurposeTo report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2.MethodsWEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.ResultsThe cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%.ConclusionsThis series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment.Clinical trial registrationFrench Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).
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- 2018
10. Best practices for the management of local-regional recurrent chordoma: a position paper by the chordoma global consensus group
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Vittoria Colia, Bernd Kasper, R. Imai, Michael Baumann, Stéphanie Bolle, R. Capanna, Riccardo Casadei, Paolo G. Casali, Claire Alapetite, P. A. Gardner, C. L. A. Vleggeert-Lankamp, C. Heery, Elena Tamborini, Anant Desai, Stefano Radaelli, Alessandro Gronchi, Nadia Hindi, Akira Kawai, Daniel Vanel, C. Sen, Francesco Doglietto, Nicolas Penel, Ziya L. Gokaslan, S. Froelich, Katherine Anne Thornton, Carlo Morosi, Hans Gelderblom, Francis J. Hornicek, O. J. Norum, M. Uhl, Palma Dileo, Sandip Pravin Patel, Piero Fossati, J. Martin Broto, Peter Hohenberger, Rick L. Haas, Andreas Leithner, Toru Akiyama, F. Ricchini, Robin L. Jones, Valter Torri, Josh Sommer, Peter Pal Varga, Y. Yamada, Per-Ulf Tunn, J.-Y. Blay, Augusto Caraceni, Piotr Rutkowski, Jürgen Debus, Lee Jeys, Adrienne M. Flanagan, Diego Mazzatenta, I. Logowska, Marco Krengli, Damien C. Weber, Thomas F. DeLaney, Susanne Scheipl, P. Picci, Beate Timmermann, Piero Nicolai, S. Pilotti, P. Bruzzi, Silvia Stacchiotti, Stefano Boriani, S. Dijkstra, Fondazione IRCCS Istituto Nazionale Tumori - National Cancer Institute [Milan], European Institute of Oncology [Milan] (ESMO), Saitama University, Institut Curie [Paris], University of Dresden Medical School, Centre Léon Bérard [Lyon], Institut Gustave Roussy (IGR), University of Pisa - Università di Pisa, University Medical Center Heidelberg, Massachusetts General Hospital [Boston], Queen Elizabeth Hospital, University College London Hospitals (UCLH), Universiteit Leiden [Leiden], University of Brescia, Cancer Research UK London Research Institute, Hôpital Lariboisière, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), University of Pittsburgh School of Medicine, Pennsylvania Commonwealth System of Higher Education (PCSHE), Providence University, Netherlands Cancer Institute (NKI), Antoni van Leeuwenhoek Hospital, National Cancer Institute [Bethesda] (NCI-NIH), National Institutes of Health [Bethesda] (NIH), Hospital Universitario Virgen del Rocío [Sevilla], University of Heidelberg, Medical Faculty, Harvard Medical School [Boston] (HMS), Chiba University Hospital, Queens Elizabeth Hospital [Birmingham], Royal Marsden NHS Foundation Trust, National Cancer Center Research Institute [Tokyo], Università del Piemonte Orientale - Dipartimento DISIT Italy, Medical University Graz, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology (MCMCC), MD Anderson Cancer Center [Houston], The University of Texas Health Science Center at Houston (UTHealth), Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), University Hospital Graz, New York University Langone Medical Center (NYU Langone Medical Center), NYU System (NYU), University of Duisbourg-Essen, Helios Klinikum [Erfurt], Memorial Sloane Kettering Cancer Center [New York], SwissFEL, Paul Scherrer Institut, Leiden University Medical Center (LUMC), Universiteit Leiden, CHU Lille, Université de Lille, METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694, European Institute of Oncology [Milan] [ESMO], Institut Gustave Roussy [IGR], University College London Hospitals [UCLH], Netherlands Cancer Institute [NKI], National Cancer Institute [Bethesda] [NCI-NIH], Harvard Medical School [Boston] [HMS], Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology [MCMCC], Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS], New York University Langone Medical Center [NYU Langone Medical Center], Leiden University Medical Center [LUMC], Stacchiotti, S., Gronchi, A., Fossati, P., Akiyama, T., Alapetite, C., Baumann, M., Blay, J. Y., Bolle, S., Boriani, S., Bruzzi, P., Capanna, R., Caraceni, A., Casadei, R., Colia, V., Debus, J., Delaney, T., Desai, A., Dileo, P., Dijkstra, S., Doglietto, F., Flanagan, A., Froelich, S., Gardner, P. A., Gelderblom, H., Gokaslan, Z. L., Haas, R., Heery, C., Hindi, N., Hohenberger, P., Hornicek, F., Imai, R., Jeys, L., Jones, R. L., Kasper, B., Kawai, A., Krengli, M., Leithner, A., Logowska, I., Martin Broto, J., Mazzatenta, D., Morosi, C., Nicolai, P., Norum, O. J., Patel, S., Penel, N., Picci, P., Pilotti, S., Radaelli, S., Ricchini, F., Rutkowski, P., Scheipl, S., Sen, C., Tamborini, E., Thornton, K. A., B., Timmermann, Torri, V., Tunn, P. U., Uhl, M., Yamada, Y., Weber, D. C., Vanel, D., Varga, P. P., Vleggeert-Lankamp, C. L. A., Casali, P. G., and Sommer, J.
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sarcoma ,[SDV]Life Sciences [q-bio] ,Medizin ,chemotherapy ,Patient advocacy ,surgery ,0302 clinical medicine ,Neoplasm Recurrence ,Medicine ,chordoma ,relapse ,radiotherapy ,Relapse ,Sarcoma ,Hematology ,3. Good health ,Oncology ,030220 oncology & carcinogenesis ,Practice Guidelines as Topic ,chordoma, consensus, recurrence ,Sacral Chordoma ,musculoskeletal diseases ,medicine.medical_specialty ,recurrence ,Best practice ,MEDLINE ,Reviews ,610 Medicine & health ,03 medical and health sciences ,Chordoma ,Humans ,Chemotherapy ,Medical physics ,Radiotherapy ,business.industry ,medicine.disease ,Cervical spine ,consensus ,Family medicine ,Position paper ,Surgery ,Neoplasm Recurrence, Local ,business ,030217 neurology & neurosurgery - Abstract
Chordomas are rare, malignant bone tumors of the skull-base and axial skeleton. Until recently, there was no consensus among experts regarding appropriate clinical management of chordoma, resulting in inconsistent care and suboptimal outcomes for many patients. To address this shortcoming, the European Society of Medical Oncology (ESMO) and the Chordoma Foundation, the global chordoma patient advocacy group, convened a multi-disciplinary group of chordoma specialists to define by consensus evidence-based best practices for the optimal approach to chordoma. In January 2015, the first recommendations of this group were published, covering the management of primary and metastatic chordomas. Additional evidence and further discussion were needed to develop recommendations about the management of local-regional failures. Thus, ESMO and CF convened a second consensus group meeting in November 2015 to address the treatment of locally relapsed chordoma. This meeting involved over 60 specialists from Europe, the United States and Japan with expertise in treatment of patients with chordoma. The consensus achieved during that meeting is the subject of the present publication and complements the recommendations of the first position paper.
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- 2017
11. Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence
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Frank Van der Aa, Alfredo L. Milani, Jean Nicolas Cornu, Heinz Koelbl, John Heesakkers, Mohamed Abdel-Fattah, Xavier Deffieux, Manfred P. Wirth, Salvador Arlandis, Stefano Salvatore, Ricarda M. Bauer, Christopher R. Chapple, Fiona C. Burkhard, Alfons Gunnemann, Gert Naumann, David Castro-Diaz, Walter Artibani, Sheila MacNeil, Maria Gyhagen, Jan Deprest, Francesco Montorsi, Linda Cardozo, Jan-Paul W. R. Roovers, Tufan Tarcan, Karl-Dietrich Sievert, Francisco Cruz, Sheffield Teaching Hospitals National Health Service Foundation Trust, Instituto de Inovação e Investigação em Saúde (I3S), University of Porto, Portugal, Molecular Neurobiology Group, IBMC - Institute for Molecular & Cell Biology, University of Porto, 4150-180 Porto, Portugal., service de gynécologie hôpital Antoine Béclère Paris, Reinier de Graaf Hospital, Hospital La Fe [Valencia, Spain], Azienda ospedaliera universitaria integrata di Verona [Italy], University Hospital of the Ludwig-Maximilians University, University of Bern [Bern, Switzerland] (University Hospital Bern ), King's College Hospital (KCH), Hospital Universitario De Canarias, Service d'urologie [Rouen], Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU), Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), University Hospitals Leuven [Leuven], Georg-August-University [Göttingen], Södra Älvsborgs Hospital [Borås], University College of Borås, Radboudumc Nijmegen [The Netherlands], Medizinische Universität Wien = Medical University of Vienna, University of Sheffield [Sheffield], Helios Klinikum [Erfurt], Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA), Vita-Salute San Raffaele University and Center for Translational Genomics and Bioinformatics, Paracelsus Medizinische Privatuniversität = Paracelsus Medical University (PMU), Marmara University [Kadıköy - İstanbul], Department of urology, Università Vita-Salute San Raffaele, Universitätsklinikum Carl Gustav Carus, University of Aberdeen, Chapple, Christopher R., Cruz, Francisco, Deffieux, Xavier, Milani, Alfredo L., Arlandis, Salvador, Artibani, Walter, Bauer, Ricarda M., Burkhard, Fiona, Cardozo, Linda, Castro-Diaz, David, Cornu, Jean Nicola, Deprest, Jan, Gunnemann, Alfon, Gyhagen, Maria, Heesakkers, John, Koelbl, Heinz, Macneil, Sheila, Naumann, Gert, Roovers, Jan-Paul W. R., Salvatore, Stefano, Sievert, Karl-Dietrich, Tarcan, Tufan, Van der Aa, Frank, Montorsi, Francesco, Wirth, Manfred, and Abdel-Fattah, Mohamed
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Male ,Stress incontinence ,Time Factors ,Urinary Incontinence, Stress ,030232 urology & nephrology ,Urinary incontinence ,Urologic Surgical Procedure ,[SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology ,Abdominal wall ,0302 clinical medicine ,Urinary Incontinence, Stre ,Societies, Medical ,030219 obstetrics & reproductive medicine ,Chronic pain ,3. Good health ,Europe ,medicine.anatomical_structure ,Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10] ,Treatment Outcome ,Consensus statement ,Vagina ,Urologic Surgical Procedures ,Female ,medicine.symptom ,Polypropylene ,Human ,medicine.medical_specialty ,Consensus ,Urologic Surgical Procedures, Male ,Time Factor ,Urology ,Consensu ,Polypropylenes ,Prosthesis Design ,Pelvic Organ Prolapse ,Sling (weapon) ,03 medical and health sciences ,medicine ,Humans ,Suburethral Sling ,Mesh ,Suburethral Slings ,Stress urinary incontinence ,business.industry ,Surgical Mesh ,medicine.disease ,Surgery ,Pelvic organ prolapse ,Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10] ,Surgical mesh ,Gynecology ,business - Abstract
Context: Surgical nonautologous meshes have been used for several decades to repair abdominal wall herniae. Implantable materials have been adopted for the treatment of female and male stress urinary incontinence (SUI) and female pelvic organ prolapse (POP). Objective: A consensus review of existing data based on published meta-analyses and reviews. Evidence acquisition: This document summarises the deliberations of a consensus group meeting convened by the European Association of Urology (EAU) and the European Urogynecological Association, to explore the current evidence relating to the use of polypropylene (PP) materials used for the treatment of SUI and POP, with reference to the 2016 EAU guidelines (European Association of Urology 2016), the European Commission's SCENIHR report on the use of surgical meshes (SCENIHR 2015), other available high-quality evidence, guidelines, and national recommendations. Evidence synthesis: Current data suggest that the use of nonautologous durable materials in surgery has well-established benefits but significant risks, which are specific to the condition and location they are used for. Various graft-related complications have been described-such as infection, chronic pain including dyspareunia, exposure in the vagina, shrinkage, erosion into other organs of xenografts, synthetic PP tapes (used in SUI), and meshes (used in POP)-which differ from the complications seen with abdominal herniae. Conclusions: When considering surgery for SUI, it is essential to evaluate the available options, which may include synthetic midurethral slings (MUSs) using PP tapes, bulking agents, colposuspension, and autologous sling surgery. The use of synthetic MUSs for surgical treatment of SUI in both male and female patients has good efficacy and acceptable morbidity. Synthetic mesh for POP should be used only in complex cases with recurrent prolapse in the same compartment and restricted to those surgeons with appropriate training who are working in multidisciplinary referral centres. Patient summary: Synthetic slings can be safely used in the surgical treatment of stress incontinence in both male and female patients. Patients need to be aware of the alternative therapy and potential risks and complications of this therapy. Synthetic mesh for treating prolapse should be used only in complex cases with recurrent prolapse in specialist referral centres. (C) 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved
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- 2017
12. Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST study
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Werner Weber, Jacques Moret, Denis Herbreteau, Markus Holtmannspötter, James V. Byrne, Thomas Liebig, Laurent Pierot, István Szikora, Andrew J. Molyneux, Christophe Cognard, Joachim Klisch, Alain Bonafe, Anne-Christine Januel, Vincent Costalat, Laurent Spelle, Vojtech Sychra, Christoph Strasilla, Université de Reims Champagne-Ardenne (URCA), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université de Montpellier (UM), Hôpital Beaujon, Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), National Institute of Clinical Neurosciences [Budapest] (NICN), Helios Klinikum [Erfurt], CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Rigshospitalet [Copenhagen], Copenhagen University Hospital, Universitätsklinikum Knappschaftskrankenhaus [Bochum], CHU Toulouse [Toulouse], Universitätsklinikum Köln (Uniklinik Köln), Neuroradiologie Diagnostique et Thérapeutique [Toulouse], Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Hôpital Purpan [Toulouse], Institut des Neurosciences de Montpellier - Déficits sensoriels et moteurs (INM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), University of Oxford [Oxford], Hôpital Beaujon-Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)
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Male ,endovascular treatment ,MCA = middle cerebral artery ,ICA = internal carotid artery ,CCT = Cerecyte Coil Trial ,flow-diverter device ,030218 nuclear medicine & medical imaging ,0302 clinical medicine ,Postoperative Complications ,DSA = digital subtraction angiography ,Aneurysm treatment ,Modified Rankin Scale ,Cause of Death ,Prospective Studies ,BA = basilar artery ,medicine.diagnostic_test ,intracranial aneurysms ,Endovascular Procedures ,General Medicine ,Prostheses and Implants ,Middle Aged ,Combined Modality Therapy ,Embolization, Therapeutic ,3. Good health ,WEB ,Outcome and Process Assessment, Health Care ,Treatment Outcome ,ACoA = anterior communicating artery ,Diffusion Chambers, Culture ,Female ,Stents ,[SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,Radiology ,Patient Safety ,Core laboratory ,Adult ,medicine.medical_specialty ,[SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery ,vascular disorders ,03 medical and health sciences ,Text mining ,Aneurysm ,Thromboembolism ,WEBCAST = WEB Clinical Assessment of Intrasaccular Aneurysm Therapy ,Complete occlusion ,medicine ,Alloys ,Humans ,Adverse effect ,ITT = intention to treat ,Aged ,business.industry ,Angiography, Digital Subtraction ,Intracranial Aneurysm ,Digital subtraction angiography ,medicine.disease ,Surgery ,business ,mRS = modified Rankin Scale ,030217 neurology & neurosurgery ,Platelet Aggregation Inhibitors ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology ,Follow-Up Studies - Abstract
OBJECT WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide-neck bifurcation aneurysms. METHODS Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicentergood clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. RESULTS Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting in a permanent deficit (modified Rankin Scale [mRS] Score 1) in 1 patient (2.0%). Intraoperative rupture was not observed. Morbidity (mRS score > 2) and mortality were 2.0% (1 of 51 patients, related to rupture status on entry to study) and 0.0% at 1 month, respectively. Success was achieved at 6 months in 85.4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. CONCLUSIONS The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results.
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- 2016
13. WEB-DL endovascular treatment of wide-neck bifurcation aneurysms: short- and midterm results in a European study
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Vojtech Sychra, F. D. Paola, Joachim Klisch, Boris Lubicz, Marco Leonardi, Laurent Pierot, Thomas Liebig, Benjamin Mine, Werner Weber, Nunzio Paolo Nuzzi, E. Calgliari, Markus Holtmannspötter, Jean-Yves Gauvrit, Edoardo Boccardi, István Szikora, Department of Neuroradiology (B.L., B.M.), Erasme University Hospital, Brussels, Belgium., Texas Children's Hospital [Houston, USA], Service de radiologie et imagerie médicale [Rennes] = Radiology [Rennes], CHU Pontchaillou [Rennes], Vision, Action et Gestion d'informations en Santé (VisAGeS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Inria Rennes – Bretagne Atlantique, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE (IRISA-D5), Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), CentraleSupélec-Télécom Bretagne-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de Recherche en Informatique et en Automatique (Inria)-École normale supérieure - Rennes (ENS Rennes)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Télécom Bretagne-Université de Rennes 1 (UR1), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École normale supérieure - Rennes (ENS Rennes)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA), Neuroradiology, National Institute of Neurosciences, Budapest, Hungary, Department of Life, Health and Environmental Sciences, L'Aquila University, L'Aquila, Italy, Molecular Medicine, National Heart and Lung Institute, Imperial College London., United Kingdom, Radiodiagnostic and Interventional Radiology Institute, University of Eastern Piedmont, Novara, Italy., Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Università degli studi di Bari Aldo Moro (UNIBA), Division of Interventional Neuroradiology (M.H.), Københavns Universitet, Copenhagen, Denmark, Neuroradiology, Ospedale dell'Angelo, Mestre, Italy, Institute of Diagnostic und Interventional Radiology and Neuroradiology (J.K., V.S., C.S.), Helios Klinikum, Erfurt, Germany, and Departments of Neuroradiology (C.A.T., H.U., S.M.) and Neurology (M.R.), University Hospital Freiburg, Freiburg, Germany, Erasme University Hospital, Department of Diagnostic and Interventional Neuroradiology, Route de Lennik, 808, 1070 Brussels, Belgium, Hôpital Maison Blanche, Centre Hospitalier Universitaire de Reims (CHU Reims), Neuroadiology, Knappschaftskrankenhaus, Recklinghausen, Germany, Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), Università degli Studi dell'Aquila = University of L'Aquila (UNIVAQ), Imperial College London, Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro (UNIBA), Gauvrit, Jean-Yves, Lubicz B, Klisch J, Gauvrit JY, Szikora I, Leonardi M, Liebig T, Nuzzi NP, Boccardi E, Paola FD, Holtmannspötter M, Weber W, Calgliari E, Sychra V, Mine B, and Pierot L.
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FLOW-DISRUPTION ,medicine.medical_specialty ,[SDV]Life Sciences [q-bio] ,education ,MULTICENTER ,INTRACRANIAL ANEURYSMS ,Aneurysm ,Text mining ,medicine.artery ,Occlusion ,medicine ,Radiology, Nuclear Medicine and imaging ,[SDV.NEU] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,cardiovascular diseases ,Endovascular treatment ,COILING ,[SDV.IB] Life Sciences [q-bio]/Bioengineering ,business.industry ,Retrospective cohort study ,Sciences bio-médicales et agricoles ,medicine.disease ,3. Good health ,Surgery ,[SDV] Life Sciences [q-bio] ,Anterior communicating artery ,Middle cerebral artery ,cardiovascular system ,TRIAL ,[SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,[SDV.IB]Life Sciences [q-bio]/Bioengineering ,Neurology (clinical) ,Radiology ,Internal carotid artery ,FOLLOW-UP ,business - Abstract
BACKGROUND AND PURPOSE:Flow disruption with the WEB-DL device has been used safely for the treatment of wide-neck bifurcation aneurysms, but the stability of aneurysm occlusion after this treatment is unknown. This retrospective multicenter European study analyzed short- and midterm data in patients treated with WEB-DL.MATERIALS AND METHODS:Twelve European neurointerventional centers participated in the study. Clinical data and pre- and postoperative short- and midterm images were collected. An experienced interventional neuroradiologist independently analyzed the images. Aneurysm occlusion was classified into 4 grades: complete occlusion, opacification of the proximal recess of the device, neck remnant, and aneurysm remnant.RESULTS:Forty-five patients (34 women and 11 men) 35-74 years of age (mean, 56.3 ± 9.6 years) with 45 aneurysms treated with the WEB device were included. Aneurysm locations were the middle cerebral artery in 26 patients, the posterior circulation in 13 patients, the anterior communicating artery in 5 patients, and the internal carotid artery terminus in 1 patient. Forty-two aneurysms were unruptured. Good clinical outcome (mRS < 2) was observed in 93.3% of patients at the last follow-up. Adequate occlusion (complete occlusion, opacification of the proximal recess, or neck remnant) was observed in 30/37 patients (81.1%) in short-term follow-up (median, 6 months) and in 26/29 patients (89.7%) in midterm follow-up (median, 13 months). Worsening of the aneurysm occlusion was observed in 2/28 patients (7.1%) at midterm follow-up.CONCLUSIONS:The results suggest that the WEB endovascular treatment of wide-neck bifurcation aneurysms offers stable occlusion in a class of aneurysms that are historically unstable. Additionally, our data show that opacification of the WEB recess can be delineated from true neck or aneurysm remnants., JOURNAL ARTICLE, SCOPUS: ar.j, info:eu-repo/semantics/published
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- 2014
14. Different Patterns of Autoantibody Secretion by Peripheral Blood Mononuclear Cells in Autoimmune Nodopathies.
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Rohrbacher S, Seefried S, Hartmannsberger B, Annabelle R, Appeltshauser L, Arlt FA, Brämer D, Dresel C, Dorst J, Elmas Z, Franke C, Geis C, Högen T, Krause S, Marziniak M, Mäurer M, Prüss H, Schoeberl F, Schrank B, Steen C, Teichtinger H, Thieme A, Wessely L, Zernecke A, Sommer C, and Doppler K
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- Humans, Female, Male, Adult, Middle Aged, Nerve Growth Factors immunology, Young Adult, Contactin 1 immunology, Aged, Autoimmune Diseases of the Nervous System immunology, Autoimmune Diseases of the Nervous System drug therapy, Immunoglobulin G blood, Immunoglobulin G immunology, Adolescent, Cell Adhesion Molecules immunology, Autoantibodies blood, Autoantibodies immunology, Leukocytes, Mononuclear immunology, Rituximab pharmacology
- Abstract
Background and Objectives: Autoimmune nodopathies with antibodies against the paranodal proteins show a distinct phenotype of a severe sensorimotor neuropathy. In some patients, complete remission can be achieved after treatment with rituximab whereas others show a chronic course. For optimal planning of treatment, predicting the course of disease and therapeutic response is crucial., Methods: We stimulated peripheral blood mononuclear cells in vitro to find out whether secretion of specific autoantibodies may be a predictor of the course of disease and response to rituximab., Results: Three patterns could be identified: In most patients with anti-Neurofascin-155-, anti-Contactin-1-, and anti-Caspr1-IgG4 autoantibodies, in vitro production of autoantibodies was detected, indicating autoantigen-specific memory B cells and short-lived plasma cells/plasmablasts as the major source of autoantibodies. These patients generally showed a good response to rituximab. In a subgroup of patients with anti-Neurofascin-155-IgG4 autoantibodies and insufficient response to rituximab, no in vitro autoantibody production was found despite high serum titers, indicating autoantibody secretion by long-lived plasma cells outside the peripheral blood. In the patients with anti-pan-Neurofascin autoantibodies-all with a monophasic course of disease-no in vitro autoantibody production could be measured, suggesting a lack of autoantigen-specific memory B cells. In some of them, autoantibody production by unstimulated cells was detectable, presumably corresponding to high amounts of autoantigen-specific plasmablasts-well in line with a severe but monophasic course of disease., Discussion: Our data suggest that different B-cell responses may occur in autoimmune nodopathies and may serve as markers of courses of disease and response to rituximab.
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- 2024
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15. Shortened progression free and overall survival to immune-checkpoint inhibitors in BRAF-, RAS- and NF1- ("Triple") wild type melanomas.
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Jansen P, Galetzka W, Lodde GC, Standl F, Zaremba A, Herbst R, Terheyden P, Utikal J, Pföhler C, Ulrich J, Kreuter A, Mohr P, Gutzmer R, Meier F, Dippel E, Weichenthal M, Placke JM, Landsberg J, Möller I, Sucker A, Paschen A, Hadaschik E, Zimmer L, Livingstone E, Schadendorf D, Ugurel S, Stang A, and Griewank KG
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- Humans, Male, Female, Middle Aged, Aged, Adult, Skin Neoplasms genetics, Skin Neoplasms drug therapy, Skin Neoplasms mortality, Skin Neoplasms pathology, Skin Neoplasms immunology, Neurofibromin 1 genetics, Prospective Studies, Progression-Free Survival, Aged, 80 and over, Programmed Cell Death 1 Receptor antagonists & inhibitors, Telomerase genetics, GTP Phosphohydrolases genetics, Promoter Regions, Genetic, Membrane Proteins, Melanoma drug therapy, Melanoma genetics, Melanoma mortality, Melanoma pathology, Melanoma immunology, Immune Checkpoint Inhibitors therapeutic use, Proto-Oncogene Proteins B-raf genetics, Mutation
- Abstract
Background: Melanomas lacking mutations in BRAF, NRAS and NF1 are frequently referred to as "triple wild-type" (tWT) melanomas. They constitute 5-10 % of all melanomas and remain poorly characterized regarding clinical characteristics and response to therapy. This study investigates the largest multicenter collection of tWT-melanomas to date., Methods: Targeted next-generation sequencing of the TERT promoter and 29 melanoma-associated genes were performed on 3109 melanoma tissue samples of the prospective multicenter study ADOREG/TRIM of the DeCOG revealing 292 patients suffering from tWT-melanomas. Clinical characteristics and mutational patterns were analyzed. As subgroup analysis, we analyzed 141 tWT-melanoma patients receiving either anti-CTLA4 plus anti-PD1 or anti PD1 monotherapy as first line therapy in AJCC stage IV., Results: 184 patients with cutaneous melanomas, 56 patients with mucosal melanomas, 34 patients with acral melanomas and 18 patients with melanomas of unknown origin (MUP) were included. A TERT promoter mutation could be identified in 33.2 % of all melanomas and 70.5 % of all tWT-melanomas harbored less than three mutations per sample. For the 141 patients with stage IV disease, mPFS independent of melanoma type was 6.2 months (95 % CI: 4-9) and mOS was 24.8 months (95 % CI: 14.2-53.4) after first line anti-CTLA4 plus anti-PD1 therapy. After first-line anti-PD1 monotherapy, mPFS was 4 months (95 %CI: 2.9-8.5) and mOS was 29.18 months (95 % CI: 17.5-46.2)., Conclusions: While known prognostic factors such as TERT promoter mutations and TMB were equally distributed among patients who received either anti-CTLA4 plus anti-PD1 combination therapy or anti-PD1 monotherapy as first line therapy, we did not find a prolonged mPFS or mOS in either of those. For both therapy concepts, mPFS and mOS were considerably shorter than reported for melanomas with known oncogene mutations., Competing Interests: Declaration of Competing Interest All other authors declare no conflicts of interest for the submitted work., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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16. Mortality and postinterventional complications after ablative treatment of liver malignancies: A cohort study of 4374 patients.
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March C, Thormann M, Hass P, Georgiades M, Sensse M, Herrmann T, Omari J, Pech M, and Damm R
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Purpose: Ablative therapies for primary and secondary liver malignancies are increasingly adopted in current guidelines. Nevertheless, surgical resection remains the gold standard in most curative therapy settings. Extensive studies on mortality and morbidity after ablative treatment of the liver are missing. We investigated complications and mortality after ablative treatment in a large, unselected study cohort., Materials and Methods: Standardized patient and treatment data in 4374 percutaneous and angiographic ablative procedures of the liver from the DRG-based hospital reimbursement system (diagnosis-related groups) of an academic hospital in Germany were retrospectively evaluated. We analyzed descriptive patient data, length of stay (LOS), pre-existing medical conditions, previous gastrointestinal surgeries, severe complications, and occurrence of death., Results: Treatment of secondary liver malignancies constituted over two-thirds of all procedures (71%, n = 3053). The mean LOS was 4.1 ± 3.5 days. Severe complications were documented in 1.4% and in-house death in 0.2% of cases, significantly more often after treatment with chemoembolization of primary liver malignancies (p = 0.003; p = 0.0001). Previous partial liver resection, partial bowel resection, and chronic renal failure were independent risk factors for the occurrence of severe complications., Conclusion: Severe complications and in-hospital death are rare in the treatment of primary and secondary liver malignancies with percutaneous and angiographic procedures. They are a viable alternative or addition to a surgical approach in treating liver lesions., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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17. Anatomic locations of ureterovascular fistulae: a review of 532 patients in the literature and a new series of 8 patients.
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Shamseldin M, Heers H, Steiner T, and Puls R
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Introduction: Ureterovascular fistula (UVF) is a rare but potentially life-threatening condition. Since its primary description by Moschkowitz in 1908, many case reports, studies and reviews have been written about this condition with the suggestive symptoms and risk factors repeatedly discussed. This study will be focusing on the different locations of 532 out of 605 fistulae published from 1908 up to 2022 besides eight new patients of our own., Material and Methods: A systematic review of the literature started using PubMed database searching for "ureteroarterial fistula", "arteriovascular fistula" and "uretero vascular fistula" was performed yielding 122, 62 and 188 results respectively. Those studies and the cited literature in each study were examined to include studies, which did not appear in the primary search. A total of 605 patients in 315 publications were gathered. Only studies mentioning new patients, a clear indication of the location of the UVF, the presence/absence of urinary diversion (UD) as well as the type of UD if present were included. Ten duplicates as well as studies lacking information regarding the UVF and/or the UD (seven publications with 63 patients) were excluded, with 298 publications including 532 external patients remaining. Eight internal cases were included with a total of 540 cases., Results: From the 540 included cases, 384 patients (71.1%) had no UD compared to 156 patients (28.9%) with UD. Due to the anatomical ureteral course, the common iliac artery (CIA) was the most common vascular component of UVF, irrespective of the presence or absence of UD. Any dispute to whether the crossing point is the common or the external iliac artery (EIA) was settled for the CIA. Further common vascular components besides CIA include the aorta, EIA, internal iliac artery (IIA) including its branches and vascular bypasses including the anastomosis sites. Other unusual arterial localizations were stated under the "others" category., Conclusion: Identifying the location of the bleeding artery in UVF is critical and represents the most important step for successful management. We present the largest summary of described locations up to date including our own., (© 2024. The Author(s).)
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- 2024
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18. Flow diversion with hydrophilic polymer coating with prasugrel as single antiplatelet therapy in the treatment of acutely ruptured intracranial aneurysms: a multicenter case series, complication and occlusion rates.
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Khanafer A, Lobsien D, Sirakov A, Almohammad M, Schüngel MS, Pielenz D, Borgmann T, Hajiyev K, Bäzner H, Ganslandt O, Hennersdorf F, Cohen JE, Felber S, Schob S, Kemmling A, Sirakov S, Forsting M, Klisch J, and Henkes H
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Background: This study reports a multicenter experience of using hydrophilic polymer-coated (HPC) flow diverters with prasugrel single antiplatelet therapy to treat ruptured aneurysms with subarachnoid hemorrhage (SAH)., Methods: Patients treated for intracranial aneurysms within 30 days after SAH with a p64/p48 MW HPC flow diverter were prospectively identified. Clinical presentation and outcomes, periprocedural and postprocedural complications, and degree of occlusion at follow-up were evaluated., Results: A total of 84 patients were treated in 88 sessions (54.5% women; mean age 53.3 years). Four patients (4.7%) experienced flow diverter-dependent complications. No cases of aneurysm re-rupture or hemorrhagic complications related to antiplatelet therapy were recorded. Immediate complete occlusion was achieved in 27.4% of cases (23/84). The rate of complete occlusion among survivors was 83% in early follow-up, 90.2% in mid-term follow-up, and 92.3% in the latest possible follow-up., Conclusion: p64/p48 MW HPC flow diverters with prasugrel single antiplatelet therapy were associated with safety from aneurysm re-rupture and high occlusion rates at medium- and long-term follow-up in managing ruptured aneurysms. Adequate management of single antiplatelet therapy with prasugrel is crucial, particularly with higher doses than usual, to avoid both ischemic and hemorrhagic complications., Competing Interests: Competing interests: HH: Consulting and proctoring for Wallaby Phenox GmbH, co-owner of CONTARA GmbH., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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19. [Robotic vs. laparoscopic right hemicolectomy-An analysis of costs].
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Wittmann M, Vladimirov M, Renz M, Thumfart L, Giulini L, and Dubecz A
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- Humans, Male, Aged, Female, Retrospective Studies, Germany, Middle Aged, Costs and Cost Analysis, Colonic Neoplasms surgery, Colonic Neoplasms economics, Aged, 80 and over, Postoperative Complications economics, Postoperative Complications epidemiology, Postoperative Complications etiology, Colectomy economics, Colectomy methods, Colectomy adverse effects, Laparoscopy economics, Laparoscopy adverse effects, Laparoscopy methods, Robotic Surgical Procedures economics, Robotic Surgical Procedures adverse effects, Robotic Surgical Procedures methods
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The use of robotic surgical methods for performing right-sided hemicolectomy has been somewhat controversial, primarily due to concerns related to costs. The purpose of this study is to document the initial robotic right hemicolectomies conducted at our institution and to compare them with a laparoscopic reference group. A significant focus of this study is the detailed analysis of the costs associated with both techniques within the German healthcare system.Surgical and cost-related data for 34 cases each for robotic and laparoscopic right-sided hemicolectomy performed at Nürnberg Hospital were compared. This comparison was conducted through a retrospective single-center case-matched analysis. Cost analysis was carried out following the current guidelines provided by the Institute for the Hospital Remuneration System (InEK) of Germany.The average age of the patient cohort was 70 years, with a male patient proportion of 57.4%. Analysis of perioperative parameters indicated similar outcomes for both surgical techniques. Regarding the incidence of complications of Clavien-Dindo stages III-V (8.8% vs. 17.6%; p = 0.48), a positive trend towards robotic surgery was observed. The cost analysis showed nearly identical total costs for the selected cases in both groups (mean €13,423 vs. €13,424; p = 1.00), with the most significant cost difference noted in surgical (operative) costs (€5,779 vs. €3,521; p < 0.01). The lower costs for laparoscopic cases were primarily due to the reduced material costs (mean €2,657 vs. €702; p < 0.05).In conclusion, both surgical approaches are clinically equivalent, with only minor differences in the total case costs., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2024
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20. Safety and efficacy of the latest generation biodegradable polymer-coated ultrathin sirolimus-eluting stent in the treatment of coronary artery disease in a European all-comer population with or without high bleeding risk: The Cruz HBR Registry.
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Leistner DM, Rampat R, Haude M, Schmitz T, Allali A, Möllmann H, Stähli BE, Rudolph TK, Lauten A, Koning R, Bogaerts K, Sudhir K, and Naber C
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- Humans, Male, Female, Prospective Studies, Aged, Middle Aged, Treatment Outcome, Europe epidemiology, Absorbable Implants, Prosthesis Design, Risk Factors, Drug-Eluting Stents adverse effects, Sirolimus administration & dosage, Sirolimus therapeutic use, Registries, Coronary Artery Disease surgery, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention methods, Polymers, Hemorrhage chemically induced, Hemorrhage epidemiology
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Background: The latest generation ultrathin Supraflex Cruz (Sahajanand Medical Technologies Limited, Surat, India) sirolimus-eluting stent (SES) has shown early healing properties and represents an attractive percutaneous coronary intervention (PCI) device in a high bleeding risk (HBR) population. The aim of this Cruz HBR registry was to assess safety and efficacy of the Supraflex Cruz SES in a large cohort of all-comer patients, of whom about one third were patients at HBR., Methods: Patients undergoing PCI were enrolled in this prospective, multi-centre, open label registry and stratified into non-HBR and HBR groups. The primary endpoint was a device-oriented composite endpoint (DOCE), a composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel and clinically driven target lesion revascularization within 12 months after PCI. The predefined aims were to show non-inferiority of the non-HBR group to the Supraflex arm of the TALENT Trial, and of the HBR group to polymer-free biolimus-coated stent arm of LEADERS FREE Trial., Results: A total of 1203 patients were enrolled across 26 European centers, including a significant proportion (38.7%; N.=466) of HBR patients. A total of 1745 lesions were treated in 1203 patients and 2235 stents were implanted. The DOCE occurred within the total cohort in 5.8% of patients with a significant difference between HBR patients and non-HBR patients (8.1% vs. 4.4%; P<0.001). All-cause mortality at 12 months was significantly (P<0.0001) different among HBR (9.0%) and non-HBR patients (1.7%), respectively. At 12 months, the overall incidence of definite and probable stent thrombosis was 1.0%. Major bleeding occurred in 5.9% patients of the HBR group. These results met the non-inferiority criteria with respect to the TALENT trial for the non-HBR group (P<0.0001), and the LEADERS FREE trial for the HBR group (P<0.0001)., Conclusions: The Cruz HBR registry confirms that PCI with the Supraflex Cruz SES is associated with a favorable clinical outcome in an all-comer population, including complex patients with HBR.
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- 2024
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21. Treatment of newly diagnosed moderate or severe chronic graft-versus-host disease with prednisone and everolimus (PredEver first): a prospective multicenter phase IIA study.
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Ayuk F, Wagner-Drouet EM, Wolff D, von Huenerbein N, von Pein UM, Klyuchnikov E, von Harsdorf S, Koenecke C, Sayer H, and Kröger N
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- Humans, Middle Aged, Adult, Male, Female, Prospective Studies, Chronic Disease, Aged, Young Adult, Immunosuppressive Agents therapeutic use, Adolescent, Bronchiolitis Obliterans Syndrome, Graft vs Host Disease drug therapy, Everolimus therapeutic use, Everolimus administration & dosage, Prednisone therapeutic use, Prednisone administration & dosage
- Abstract
Although most patients with chronic graft-versus-host disease (cGVHD) show initial response to first-line therapy, long-term clinically meaningful success of first-line treatment remains rare. In a prospective multicentre phase II trial in 6 German centers, patients with newly diagnosed moderate or severe cGVHD received prednisone and everolimus for 12 months followed by a 1-year follow-up period. Primary endpoint was treatment success (TS) at 6 months defined as patient being alive, achieving PR or CR of cGVHD, having no relapse of underlying disease and requiring no secondary treatment for cGVHD. Of the 34 patients evaluable for efficacy, 19 (56%) had TS at 6 months with 22 and 52% of the patients in a CR and PR respectively. Overall 30 patients (88%) had a CR or PR as best response, nearly all responses (29/30) occurring within the first 6 weeks of treatment. The cumulative incidence of treatment failure at 1 year was 63%, corresponding to 37% TS. Predefined safety endpoint (thrombotic microangiopathy, pneumonitis, and avascular necrosis) were not observed in any patient. Addition of everolimus to prednisolone is well tolerated and may improve long-term treatment success. Larger studies are necessary to ascertain the possible role of everolimus in first-line treatment of cGVHD., (© 2024. The Author(s).)
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- 2024
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22. [The WHO grades of hearing loss : A consensus on the German version].
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Holube I, Dziemba O, Fedtke T, Hoth S, Michel O, Neumann K, Rahne T, Veraguth D, von Gablenz P, Wesarg T, and Baljić I
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- Humans, Germany, Practice Guidelines as Topic, Hearing Loss diagnosis, World Health Organization
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- 2024
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23. Cleaning validation for blister packaging machines in hospital-supplying pharmacies.
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Fenske D, Zerrenner L, and Zergiebel S
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Objective: To ensure quality-assured care for patients, validation of a cleaning process for blister machines is essential. Due to the high operating costs of maintaining high-performance liquid chromatography (HPLC) which is mainly used for this type of analysis, a new, quick and cost-effective analysis method using UV-Vis spectroscopy has been developed., Method: Marker substances (metamizole (dipyrone) and paracetamol tablets) were packed in blisters. Afterwards test tablets were packaged before and after cleaning the blister machine and examined for contamination using UV-Vis spectroscopy., Results: UV-Vis spectroscopy has been shown to be superior to HPLC analysis for cleaning validation of blister machines, as it is much faster and cheaper, requires less equipment and personnel effort, while maintaining the same reliability and sensitivity., Conclusion: Unit-dose blistering is becoming increasingly popular in the daily routine of hospital pharmacies worldwide due to a variety of advantages. Therefore, cleaning validation of blistering machines has become a mandatory duty of care. The UV-Vis spectroscopic method presented here is the first innovative method suitable for the cleaning validation of blister machines to date., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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24. CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms.
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Spelle L, Costalat V, Caroff J, Wodarg F, Fischer S, Herbreteau D, Möhlenbruch MA, Januel AC, Papagiannaki C, Klisch J, Numminen J, Rautio R, Berlis A, Mihalea C, Chalumeau V, Downer J, Cortese J, Ikka L, Gallas S, Bester M, Liebig T, Velasco S, Grimaldi L, Byrne J, Szikora I, Pierot L, and Cognard C
- Abstract
Background: The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017″ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year., Objective: To evaluate angiographic stability at 1 year., Methods: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design., Results: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms CONCLUSION: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB., Competing Interests: Competing interests: JCa acts as associate editor for Journal of NeuroInterventional Surgery, Neuroradiology, and Journal of Neuroradiology; MAM acts as associate editor for Neuroradiology. RR acts as associate editor for Journal of Neuroradiology., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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25. Optic nerve and chiasm hemangioblastomas in von Hippel-Lindau disease: report of 12 cases and review of the literature.
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Vergauwen E, Klingler JH, Krüger MT, Steiert C, Kuijpers R, Rosahl S, Vanbinst AM, Andreescu CE, and Gläsker S
- Abstract
Introduction: Optic nerve and chiasm hemangioblastomas are rare tumors, occurring sporadically or in the context of von Hippel-Lindau (VHL) disease. They have only been portrayed in isolated case reports and small cohorts. Their natural history and therapeutic strategies are only scarcely described. To better characterize these rare tumors, we retrospectively analyzed an optic nerve and chiasm hemangioblastoma series of 12 VHL patients. By combining our own experience to a review of all known cases in literature, we intended to create treatment recommendations for optic nerve and chiasm hemangioblastomas in VHL patients., Methods: We reviewed two electronic databases in the hospitals of our senior authors, searching for VHL patients with optic nerve or chiasm hemangioblastomas. Clinical data were summarized. Tumor size and growth rate were measured on contrast enhanced MRI. Comparable data were collected by literature review of all available cases in VHL patients (Pubmed, Trip, Google and Google Scholar)., Results: Of 269 VHL patients, 12 had optic nerve or chiasm hemangioblastomas. In 10 of 12 patients, tumors were diagnosed upon annual ophthalmoscopic/MRI screening. Of 8 patients who were asymptomatic at diagnosis, 7 showed absent or very slow annual progression, without developing significant vision impairment. One patient developed moderate vision impairment. Two symptomatic patients suffered from rapid tumor growth and progressive vision impairment. Both underwent late-stage surgery, resulting in incomplete resection and progressive vision impairment. One patient presented with acute vision field loss. A watchful-waiting approach was adopted because the hemangioblastoma was ineligible for vision-sparing surgery. One patient developed progressive vision impairment after watchful waiting. In the literature we found 45 patient cases with 48 hemangioblastomas., Discussion: When optic nerve and chiasm hemangioblastomas are diagnosed, we suggest annual MRI follow-up as long as patients do not develop vision impairment. If tumors grow fast, threaten the contralateral eye, or if patients develop progressive vision deficiency; surgical resection must be considered because neurological impairment is irreversible, and resection of large tumors carries a higher risk of further visual decline., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Vergauwen, Klingler, Krüger, Steiert, Kuijpers, Rosahl, Vanbinst, Andreescu and Gläsker.)
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- 2024
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26. [Speech discrimination with separated signal sources and sound localization with speech stimuli : Learning effects and reproducibility].
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Buth S, Baljić I, Mewes A, and Hey M
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- Humans, Reproducibility of Results, Female, Adult, Male, Young Adult, Sensitivity and Specificity, Speech Reception Threshold Test methods, Acoustic Stimulation methods, Speech Discrimination Tests methods, Sound Localization physiology, Speech Perception physiology, Noise
- Abstract
Background: Binaural hearing enables better speech comprehension in noisy environments and is necessary for acoustic spatial orientation. This study investigates speech discrimination in noise with separated signal sources and measures sound localization. The aim was to study characteristics and reproducibility of two selected measurement techniques which seem to be suitable for description of the aforementioned aspects of binaural hearing., Materials and Methods: Speech reception thresholds (SRT) in noise and test-retest reliability were collected from 55 normal-hearing adults for a spatial setup of loudspeakers with angles of ± 45° and ± 90° using the Oldenburg sentence test. The investigations of sound localization were conducted in a semicircle and fullcircle setup (7 and 12 equidistant loudspeakers)., Results: SRT (S
-45 N45 : -14.1 dB SNR; S45 N-45 : -16.4 dB SNR; S0 N90 : -13.1 dB SNR; S0 N-90 : -13.4 dB SNR) and test-retest reliability (4 to 6 dB SNR) were collected for speech intelligibility in noise with separated signals. The procedural learning effect for this setup could only be mitigated with 120 training sentences. Significantly smaller SRT values, resulting in better speech discrimination, were found for the test situation of the right compared to the left ear. RMS values could be gathered for sound localization in the semicircle (1,9°) as well as in the fullcircle setup (11,1°). Better results were obtained in the retest of the fullcircle setup., Conclusion: When using the Oldenburg sentence test in noise with spatially separated signals, it is mandatory to perform a training session of 120 sentences in order to minimize the procedural learning effect. Ear-specific SRT values for speech discrimination in noise with separated signal sources are required, which is probably due to the right-ear advantage. A training is recommended for sound localization in the fullcircle setup., (© 2024. The Author(s).)- Published
- 2024
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27. The History of Endovascular Stroke Treatment: From Local Intraarterial Fibrinolysis to Stent Retriever Thrombectomy.
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Buecke P, Cohen J, Klisch J, Felber S, Bäzner H, and Henkes H
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- Humans, History, 20th Century, History, 21st Century, Thrombectomy history, Thrombectomy methods, Stents, Stroke diagnostic imaging, Stroke surgery, Thrombolytic Therapy methods, Thrombolytic Therapy history, Endovascular Procedures methods
- Abstract
Competing Interests: HH is co-inventor of the Solitaire Stent and the pRESET stent retriever, co-founder and shareholder of phenox GmbH and Femtos GmbH. The other authors declare that they have no conclicts of interest regarding the content of this manuscript.
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- 2024
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28. Early versus late response to PD-1-based immunotherapy in metastatic melanoma.
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Lodde GC, Zhao F, Herbst R, Terheyden P, Utikal J, Pföhler C, Ulrich J, Kreuter A, Mohr P, Gutzmer R, Meier F, Dippel E, Weichenthal M, Jansen P, Kowall B, Galetzka W, Hörst F, Kleesiek J, Hellwig B, Rahnenführer J, Rajcsanyi L, Peters T, Hinney A, Placke JM, Sucker A, Paschen A, Becker JC, Livingstone E, Zimmer L, Tasdogan A, Roesch A, Hadaschik E, Schadendorf D, Griewank K, and Ugurel S
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- Humans, Male, Female, Middle Aged, Aged, Prospective Studies, Skin Neoplasms immunology, Skin Neoplasms pathology, Skin Neoplasms mortality, Skin Neoplasms drug therapy, Skin Neoplasms therapy, Immunotherapy methods, Time Factors, Adult, Melanoma drug therapy, Melanoma immunology, Melanoma mortality, Melanoma therapy, Melanoma secondary, Melanoma pathology, Immune Checkpoint Inhibitors therapeutic use, Immune Checkpoint Inhibitors adverse effects, Programmed Cell Death 1 Receptor antagonists & inhibitors
- Abstract
Background: Immune checkpoint inhibition (ICI) currently is the most effective treatment to induce durable responses in metastatic melanoma. The aims of this study are the characterization of patients with early, late and non-response to ICI and analysis of survival outcomes in a real-world patient cohort., Methods: Patients who received PD-1-based immunotherapy for non-resectable stage-IV melanoma in any therapy line were selected from the prospective multicenter real-world DeCOG study ADOREG-TRIM (NCT05750511). Patients showing complete (CR) or partial (PR) response already during the first 3 months of treatment (Early Responders, EarlyR) were compared to patients showing CR/PR at a later time (Late Responders, LateR), a stable disease (SD) and to patients showing progressive disease (Non-Responders, NonR)., Results: Of 522 patients, 8.2 % were EarlyR (n = 43), 19.0 % were LateR (n = 99), 37.0 % had a SD (n = 193) and 35.8 % were NonR (n = 187). EarlyR, LateR and SD patients had comparable baseline characteristics. Multivariate logbinomial regression analyses adjusted for age and sex revealed positive tumor PD-L1 (RR=1.99, 95 %-CI=1.14-3.46, p = 0.015), and normal serum CRP (RR=1.59, 95 %-CI=0.93-2.70, p = 0.036) as independently associated with the achievement of an early response compared to NonR. The median progression-free and overall survival was 46.0 months (95 % CI 19.1; NR) and 47.8 months (95 %-CI 36.9; NR) for EarlyR, NR (95 %-CI NR; NR) for LateR, 8.1 months (7.0; 10.4) and 35.4 months (29.2; NR) for SD, and 2.0 months (95 %-CI 1.9; 2.1) and 6.1 months (95 %-CI 4.6; 8.8) for NonR patients., Conclusion: Less than 10 % of metastatic melanoma patients achieved an early response during the first 3 months of PD-1-based immunotherapy. Early responders were not superior to late responders in terms of response durability and survival., Competing Interests: Declaration of Competing Interest GCL received travel support from Sun Pharma, Pierre Fabre, research funding from Novartis. RH is employee of Helios Kliniken GmbH. PT has received honoraria from Bristol-Myers Squibb, Novartis, Merck Sharp & Dohme, Pierre Fabre, CureVac, Merck Serono, Sanofi, Roche, Kyowa Kirin and Biofrontera; and travel support from Bristol-Myers Squibb and Pierre Fabre. JU received honoraria (speaker honoraria or honoraria as a consultant) and travel support from Bristol-Myers Squibb, Kyowa Kirin, Merck Sharp & Dohme, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi/Regeneron, Sunpharma outside the submitted work. CP received honoraria (speaker honoraria or honoraria as a consultant) and travel support from Novartis, BMS, MSD, Merck Serono, MSD, Celgene, AbbVie, Sunpharma, Pierre Fabre, UCB, Nutricia Milupa, Janssen and LEO, outside the submitted work. JU is on the advisory board or has received honoraria and travel support from Amgen, Bristol Myers Squibb, GSK, Immunocore, LeoPharma, Merck Sharp and Dohme, Novartis, Pierre Fabre, Roche, Sanofi outside the submitted work. AK served as a speaker and/or consultant and/or advisory board for MSD, AbbVie, Boehringer Ingelheim, Janssen, and Sanofi. PM declares research support from Bristol Myers Squibb, Merck Sharp & Dohme and Novartis; speakers and advisory board honoraria from Bristol Myers Squibb, Beiersdorf, Merck Sharp & Dohme, Pierre Fabre, Sun Pharma, Immunocore, Sanofi and Novartis, and travel support from Bristol Myers Squibb, Merck Sharp & Dohme, Sanofi, Sun Pharma, and Pierre Fabre, outside the submitted work. RG received honoraria as speaker from BMS, MSD, Novartis, Amgen, Merck Serono, Almirall Hermal, SUN, Sanofi/Regeneron, Pierre-Fabre, as advisory board member from BMS, Novartis, Almirall Hermal, MSD, Amgen, SUN, Sanofi/Regeneron, Pierre-Fabre, 4SC, MerckSerono, Pfizer, Immunocore, Delcath, for meeting support from SUN, Pierre-Fabre, Boehringer Ingelheim and for research projects (to institution) from Amgen, Merck-Serono, SUN Pharma, Sanofi/Regeneron, Kyowa-Kirin, Almirall-Hermal. FM has received travel support or/and speaker’s fees or/and advisor’s honoraria by Novartis, Roche, BMS, MSD, Pierre Fabre, Sanofi and Immunocore and research funding from Novartis and Roche. MW received grants from Bristol-Myers Squibb and Merck Sharp & Dohme, consulting fees from Merck Sharp & Dohme, Immunocore and Novartis, lecture honoraria from Bristol-Myers Squibb and Merck Sharp & Dohme and Pierre-Fabre, and advisory board honoraria from Merck Sharp & Dohme. AP reports grants from Bristol Myers Squibb (BMS) and Merck Sharp & Dohme (MSD) outside the submitted work. JCB is receiving speaker’s bureau honoraria from Amgen, Pfizer, Recordati and Sanofi, and is a paid consultant/advisory board member/DSMB member for Almirall, Boehringer Ingelheim, InProTher, ICON, MerckSerono, Pfizer, 4SC, and Sanofi/Regeneron. His group received research grants from Bristol-Myers Squibb, Merck Serono, HTG, IQVIA, and Alcedis. EL served as consultant and/or has received honoraria from Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre-Fabre, Sanofi, Sunpharma, Takeda and travel support from Bristol-Myers Squibb, Pierre- Fabre, Sunpharma and Novartis, outside the submitted work. LZ served as consultant and has received honoraria from BMS, MSD, Novartis, Pierre Fabre, Sanofi, and Sunpharma and travel support from MSD, BMS, Pierre Fabre, Sanofi, Sunpharma and Novartis, outside the submitted work. DS reports partial financial support from Bristol Myers Squibb for the conduct of this study and drug supply (nivolumab and ipilimumab) support; grants (or contracts) from Amgen, Array/Pfizer, Bristol-Myers Squibb, MSD, Novartis and Roche; consulting fees from 4SC, Amgen, Array Biopharma, AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Haystick, Immunocore, InFlarX, Innocent, LabCorp, Merck Serono, MSD, Nektar, NeraCare, Novartis, OncoSec, Pfizer, Philogen, Pierre Fabre, Replimune, Roche, Sandoz, Sanofi/Regeneron, Sun Pharma; honoraria from Bristol-Myers Squibb, MSD/Merck, Merck Serono, Novartis, Roche, Sanofi and Sun Pharma; support for attendings meetings or travel support from Bristol-Myers Squibb, MSD, Merck Serono, Novartis, Pierre Fabre and Sanofi; participation on drug safety monitoring or advisory boards for 4SC, Amgen, Array Biopharma, AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Immunocore, InFlarX, Merck Serono, MSD, Nektar, NeraCare, Novartis, OncoSec, Pfizer, Philogen, Pierre Fabre, Replimune, Roche, Sandoz, Sanofi/Regeneron and SunPharma; leadership roles for DeCOG, German Cancer Society, Hiege-Stiftung, Deutsche Hautkrebsstiftung, NVKH e.V. and EuMelaReg. SU declares research support from Bristol Myers Squibb and Merck Serono; speakers and advisory board honoraria from Bristol Myers Squibb, Merck Sharp & Dohme, Merck Serono, and Novartis; and meeting and travel support from Almirall, Bristol-Myers Squibb, IGEA Clinical Biophysics, Merck Sharp & Dohme, Novartis, Pierre Fabre, and Sun Pharma. All other authors declared no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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29. Prognostic Implications of Residual Tricuspid Regurgitation Grading After Transcatheter Tricuspid Valve Repair.
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Dreyfus J, Taramasso M, Kresoja KP, Omran H, Iliadis C, Russo G, Weber M, Nombela-Franco L, Estevez Loureiro R, Hausleiter J, Latib A, Stolz L, Praz F, Windecker S, Zamorano JL, von Bardeleben RS, Tang GHL, Hahn R, Lubos E, Webb J, Schofer J, Fam N, Lauten A, Pedrazzini G, Rodés-Cabau J, Nejjari M, Badano L, Alessandrini H, Himbert D, Sievert H, Piayda K, Donal E, Modine T, Nickenig G, Pfister R, Rudolph V, Bernick J, Wells GA, Bax J, Lurz P, Enriquez-Sarano M, Maisano F, and Messika-Zeitoun D
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- Humans, Male, Female, Aged, Treatment Outcome, Time Factors, Risk Factors, Aged, 80 and over, Middle Aged, Risk Assessment, Registries, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Insufficiency mortality, Severity of Illness Index, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Tricuspid Valve physiopathology, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality, Cardiac Catheterization instrumentation, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality
- Abstract
Background: The safety profile of transcatheter tricuspid valve (TTV) repair techniques is well established, but residual tricuspid regurgitation (TR) remains a concern., Objectives: The authors sought to assess the impact of residual TR severity post-TTV repair on survival., Methods: We evaluated the survival rate at 2 years of 613 patients with severe isolated functional TR who underwent TTV repair in TRIGISTRY according to the severity of residual TR at discharge using a 3-grade (mild, moderate, and severe) or 4-grade scheme (mild, mild to moderate, moderate to severe, and severe)., Results: Residual TR was none/mild in 33%, moderate in 52%, and severe in 15%. The 2-year adjusted survival rates significantly differed between the 3 groups (85%, 70%, and 44%, respectively; restricted mean survival time [RMST]: P = 0.0001). When the 319 patients with moderate residual TR were subdivided into mild to moderate (n = 201, 33%) and moderate to severe (n = 118, 19%), the adjusted survival rate was also significantly different between groups (85%, 80%, 55%, and 44%, respectively; RMST: P = 0.001). Survival was significantly lower in patients with moderate to severe residual TR compared to patients with mild to moderate residual TR (P = 0.006). No difference in survival rates was observed between patients with no/mild and mild to moderate residual TR (P = 0.67) or between patients with moderate to severe and severe residual TR (P = 0.96)., Conclusions: The moderate residual TR group was heterogeneous and encompassed patients with markedly different clinical outcomes. Refining TR grade classification with a more granular 4-grade scheme improved outcome prediction. Our results highlight the importance of achieving a mild to moderate or lower residual TR grade during TTV repair, which could define a successful intervention., Competing Interests: Funding Support and Author Disclosures Dr Dreyfus has received speaker or proctoring fees from Abbott. Dr Kresoja has received consulting fees from Edwards Lifesciences. Dr Taramasso has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Boston Scientific, Shenqi Medical, PiCardia, CoreMedic, VentriMend, MEDIRA, CoreQuest, and HiD Imaging. Dr Iliadis has received consulting fees from Abbott Vascular and Edwards Lifesciences. Dr Nombela-Franco has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, and Products and Features. Dr Estevez-Loureiro has received speaker fees from Abbott Vascular, Edwards Lifesciences, Boston Scientific, and Venus Medtech. Dr Hausleiter has received grants and consulting fees from Edwards Lifesciences. Dr Stolz has received consulting or speaker fees from Edwards Lifesciences. Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an Advisory Board member and/or member of the Steering/Executive Group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and has served as a member of the Steering/Executive Committee Group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Zamorano has received consulting or speaker fees from Novartis, Bayer, and Pfizer. Dr von Bardeleben has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Philips, and Siemens. Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, Advisory Board member, TAVR Publications Committee Member, APOLLO Trial Screening Committee Member, and IMPACT MR Steering Committee member for Medtronic; has received speaker honoraria and has served as a physician proctor, consultant, Advisory Board member, and TRILUMINATE Trial Anatomic Eligibility and Publications Committee member for Abbott Structural Heart; has served as an Advisory Board member for Boston Scientific and JenaValve; has served as a consultant and Physician Screening Committee Member for Shockwave Medical; has served as a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Hahn has received speaker fees from Boston Scientific, Edwards Lifesciences, and Philips Healthcare. Dr Webb has received consulting fees from Edwards Lifesciences; and has received research funding from Medtronic, Abbott, Boston Scientific, and Edwards Lifesciences. Dr Lauten has received speaker fees from Boehringer Ingelheim, Medtronic, Amgen, Bayer, Novartis, Sanofi, Chiesi, and AstraZeneca; and is a shareholder of the Devie Medical Drug Eluting Valve for Endocarditis Treatment. Dr Rodés-Cabau has received consulting or speaker fees from Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr Nejjari has received consulting or speaker fees from Abbott Vascular, Medtronic, Edwards Lifesciences, Boston Scientific, and Robocath. Dr Badano has received consulting or speaker fees from Edwards Lifesciences, GE Healthcare, and Philips Medical Systems. Dr Himbert has received proctoring fees from Edwards Lifesciences and Abbott Vascular. Dr Modine has received speaker or consulting fees from Abbott, Edwards Lifesciences, Medtronic, Microport, and GE. Dr Rudolph has received consulting or speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Bax has received lecture fees from Abbott and Edwards Lifesciences. Dr Lurz has received consulting fees from Abbott Medical, Innoventric, and Edwards Lifesciences. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, Terumo, Venus, and 3mensio; has received consulting fees and personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, Mtex, Venus, and Squadra; has received royalty income/IP rights from Edwards Lifesciences; and is a shareholder (including share options) in Cardiogard, Cardiovalve, Magenta, SwissVortex, Transseptalsolutions, and 4Tech. Dr Messika-Zeitoun has received research grants from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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30. Clinical and genetic characteristics of BAP1 -mutated non-uveal and uveal melanoma.
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Matull J, Placke JM, Lodde G, Zaremba A, Utikal J, Terheyden P, Pföhler C, Herbst R, Kreuter A, Welzel J, Kretz J, Möller I, Sucker A, Paschen A, Livingstone E, Zimmer L, Hadaschik E, Ugurel S, Schadendorf D, Thielmann CM, and Griewank KG
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- Humans, Male, Female, Middle Aged, Aged, Retrospective Studies, Adult, Aged, 80 and over, Prognosis, Ubiquitin Thiolesterase genetics, Melanoma genetics, Melanoma mortality, Melanoma therapy, Uveal Neoplasms genetics, Uveal Neoplasms mortality, Uveal Neoplasms therapy, Tumor Suppressor Proteins genetics, Mutation
- Abstract
Background: Screening for gene mutations has become routine clinical practice across numerous tumor entities, including melanoma. BAP1 gene mutations have been identified in various tumor types and acknowledged as a critical event in metastatic uveal melanoma, but their role in non-uveal melanoma remains inadequately characterized., Methods: A retrospective analysis of all melanomas sequenced in our department from 2014-2022 (n=2650) was conducted to identify BAP1 mutated samples. Assessment of clinical and genetic characteristics was performed as well as correlations with treatment outcome., Results: BAP1 mutations were identified in 129 cases and distributed across the entire gene without any apparent hot spots. Inactivating BAP1 mutations were more prevalent in uveal (55%) compared to non-uveal (17%) melanomas. Non-uveal BAP1 mutated melanomas frequently exhibited UV-signature mutations and had a significantly higher mutation load than uveal melanomas. GNAQ and GNA11 mutations were common in uveal melanomas, while MAP-Kinase mutations were frequent in non-uveal melanomas with NF1 , BRAF V600 and NRAS Q61 mutations occurring in decreasing frequency, consistent with a strong UV association. Survival outcomes did not differ among non-uveal melanoma patients based on whether they received targeted or immune checkpoint therapy, or if their tumors harbored inactivating BAP1 mutations., Conclusion: In contrast to uveal melanomas, where BAP1 mutations serve as a significant prognostic indicator of an unfavorable outcome, BAP1 mutations in non-uveal melanomas are primarily considered passenger mutations and do not appear to be relevant from a prognostic or therapeutic perspective., Competing Interests: JM: Declares travel support from Bristol Myers Squibb, Novartis and Sun Pharmaceutical Industries, outside the submitted work. J-MP: served as consultant and/or has received honoraria from Bristol-Myers Squibb, Novartis, Sanofi and received travel support from Bristol-Myers Squibb, Novartis, Pierre Fabre and Therakos, outside the submitted work. GL: Declares travel support from Sun Pharma, outside the submitted work. AZ: Declares travel support from Novartis, Sanofi Grenzyme, and Bristol-Myers Squibb, outside the submitted work. JU: Is on the advisory board or has received honoraria and travel support from Amgen, Bristol Myers Squibb, GSK, Immunocore, LeoPharma, Merck Sharp and Dohme, Novartis, Pierre Fabre, Roche, Sanofi outside the submitted work. PT: served as consultant and/or received honoraria form Almirall, Bristol Myers Squibb, Biofrontera, Curevac, Kyowa Kirin, Merck, Merck Sharp & Dohme, Novartis, Pierre-Fabre, Roche, Sanofi, 4SC, and travel support from Bristol Myers Squibb outside the submitted work. CP: Received honoraria speaker honoraria and advisory-board honoraria and travel support from BMS, MSD, Novartis, Merck Serono, Pierre Fabre, Sunpharma, AbbVie, LEO, and Kyona Kirin, outside the submitted work. RH: Is an employee of Helios Kliniken Erfurt GmbH. JW: Received honoraria and travel support from Almirall, Bristol Myers Squibb, Novartis, Pierre Fabre and Merck Sharp & Dohme, outside the submitted work. EL: Served as consultant and/or has received honoraria from Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre-Fabre, Sanofi, Sunpharma, Takeda and travel support from Bristol-Myers Squibb, Pierre Fabre, Sunpharma and Novartis, outside the submitted work. LZ: Served as consultant and/or has received honoraria from Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre-Fabre, Sunpharma and Sanofi; Research funding to institution: Novartis; travel support from Merck Sharp & Dohme, Bristol- Myers Squibb, Amgen, Pierre-Fabre, Sunpharma and Novartis, outside the submitted work. SU: Research support from Bristol Myers Squibb and Merck Serono; speakers and advisory board honoraria from Bristol Myers Squibb, Merck Sharp & Dohme, Merck Serono, and Novartis; meeting and travel support from Almirall, Bristol-Myers Squibb, IGEA Clinical Biophysics, Merck Sharp & Dohme, Novartis, Pierre Fabre, and Sun Pharma, outside the submitted work. DS: Reports personal fees and non-financial support from Roche/Genentech, grants, personal fees, non-financial support and other from BMS, personal fees from Merck Sharp & Dohme, personal fees and non-financial support from Merck Serono, grant, personal fees and non-financial support from Amgen, personal fees from Immunocore, personal fees from Incyte, personal fees from 4SC, personal fees from Pierre Fabre, personal fees and non-financial support from Sanofi/Regeneron, personal fees from Array BioPharma, personal fees from Pfizer, personal fees from Philogen, personal fees from Regeneron, personal fees from Nektar, personal fees from Sandoz, grants, personal fees and non-financial support from Novartis, personal fees and non-financial support from SunPharma, Replimune, Helsinn, OncoSec and InFlaRx outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Matull, Placke, Lodde, Zaremba, Utikal, Terheyden, Pföhler, Herbst, Kreuter, Welzel, Kretz, Möller, Sucker, Paschen, Livingstone, Zimmer, Hadaschik, Ugurel, Schadendorf, Thielmann and Griewank.)
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- 2024
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31. Automated Non-Sterile Pharmacy Compounding: A Multi-Site Study in European Hospital and Community Pharmacies with Pediatric Immediate Release Propranolol Hydrochloride Tablets.
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Sandler Topelius N, Shokraneh F, Bahman M, Lahtinen J, Hassinen N, Airaksinen S, Verma S, Hrizanovska L, Lass J, Paaver U, Tähnas J, Kern C, Lagarce F, Fenske D, Malik J, Scherliess H, Cruz SP, Paulsson M, Dekker J, Kammonen K, Rautamo M, Lück H, Pierrot A, Stareprawo S, Tubic-Grozdanis M, Zibolka S, Lösch U, Jeske M, Griesser U, Hummer K, Thalmeier A, Harjans A, Kruse A, Heimke-Brinck R, Khoukh K, and Bruno F
- Abstract
Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, quality control, contamination, and scalability. However, the emergence of cutting-edge technologies has paved a way for a new era for pharmacy compounding, promising to redefine the way medications are prepared and delivered as pharmacy-tailored personalized medicines. In this multi-site study, more than 30 hospitals and community pharmacies from eight countries in Europe utilized a novel automated dosing approach inspired by 3D printing for the compounding of non-sterile propranolol hydrochloride tablets. CuraBlend
® excipient base, a GMP-manufactured excipient base (pharma-ink) intended for automated compounding applications, was used. A standardized study protocol to test the automated dosing of tablets with variable weights was performed in all participating pharmacies in four different iterative phases. Integrated quality control was performed with an in-process scale and NIR spectroscopy supported by HPLC content uniformity measurements. In total, 6088 propranolol tablets were produced at different locations during this study. It was shown that the dosing accuracy of the process increased from about 90% to 100% from Phase 1 to Phase 4 by making improvements to the formulation and the hardware solutions. The results indicate that through this automated and quality controlled compounding approach, extemporaneous pharmacy manufacturing can take a giant leap forward towards automation and digital manufacture of dosage forms in hospital pharmacies and compounding pharmacies.- Published
- 2024
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32. Interdisciplinary Management of Skull Base Tumors.
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Gerlach R, Modesti CL, and Rampinelli V
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- Humans, Endoscopy, Patient Care Team, Skull Base surgery, Natural Orifice Endoscopic Surgery methods, Interdisciplinary Communication, Skull Base Neoplasms surgery, Skull Base Neoplasms pathology
- Abstract
Objective: Endoscopic endonasal skull base surgery has gained acceptance worldwide. Comparative analysis has demonstrated that endoscopic skull base surgery may have advantages for many pathologies of the anterior skull base, e. g., sinonasal malignant tumors; pathologies of the central skull base, e. g., pituitary adenomas, craniopharyngiomas; well-selected cases of planum sphenoidale and tuberculum sellae meningiomas; or for clival lesions, e. g., chordomas, chondrosarcomas, or selected meningiomas. Over the past three decades, interdisciplinary surgical teams, consisting of otolaryngologists and neurosurgeons, have provided detailed anatomical knowledge, suggested new approaches or modifications of established surgical techniques, and offered continued surgical education., Method: A review of pertinent literature was conducted with an emphasis on interdisciplinary endoscopic surgery of skull base lesions., Results: Based on the authors̓ surgical experience in two different interdisciplinary endoscopic skull base centers, the authors classify approaches for endoscopic endonasal skull base surgery, describe indications, and key anatomic landmarks for common pathologies, and highlight surgical techniques to avoid complications., Conclusion: Interdisciplinary endonasal endoscopic surgery combines surgical expertise, improves resection rates for many pathologies, and minimizes morbidity by reducing the incidence of surgical complications., Competing Interests: Die Autoren geben an, dass kein Interessenkonflikt besteht., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
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- 2024
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33. National and International Comparisons of Gynecological Research in Germany Based on a Bibliometric Analysis of Publications.
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Häussler B, Schmalfeldt B, Häussler S, Köninger A, Loos S, Naumann G, Scharl A, Thaler CJ, Weiss M, and Albrecht M
- Abstract
Background: Recent years have seen a considerable shift from male doctors to female doctors in the field of gynecology. Female doctors are traditionally more involved with planning and maintaining their family. For gynecology, this could be associated with a risk that research activities will decrease, particularly if results are published in scientific journals., Methods: In view of this shift, a comparative observational study was carried for 2022 in which 1306 publications were matched to 1786 female and male doctors reported on the websites of the 44 locations of university gynecology departments in Germany. In addition, the volume of publications issued between 2014 and 2022 was compared for Germany, France, the United Kingdom, and the United States. In Germany, the volume of publications in Gynecology was additionally compared with the publication outputs of the specialties Urology and Trauma Surgery., Results: Since 2014, the increase in the numbers of publications in the field of Gynecology in Germany was lower (225%) than that of the countries with which it was compared (238%/252%/260% for F/UK/USA). When Gynecology was compared with other medical specialties in Germany, the number of publications in Urology were found to have increased at a lower rate (196%) while the number of publications in the field of Trauma Surgery increased by more (286%) than that of Gynecology. At the start of 2023, the percentage of women who were working as doctors at the lowest hierarchical level (junior doctor) was 81%. The publication output per capita of female doctors working at lower levels in the medical hierarchy, i.e., working as junior doctors and senior physicians, was between 40% and 80% lower than that of male doctors working at the same level. However, female directors published as much as male directors did. In the lower hierarchy levels, men were up to 14% more likely to be without an academic title. Predictors for more extensive publication activities by young female and male doctors include the extent and quality of publications by doctors in senior positions, the presence of a comprehensive cancer center or an institute for human genetics at the location where the young doctors were working, and joint publications with foreign authors., Conclusion: For the German Society of Gynecology and Obstetrics, the results suggest a number of approaches to promote young researchers. The support provided to young female doctors is especially important as this should help to retain them as junior researchers over the long term., Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
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- 2024
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34. Oncological and functional outcome after laryngectomy for laryngeal and hypopharyngeal cancer: a population-based analysis in Germany from 2001 to 2020.
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Kouka M, Beckmann L, Bitter T, Kaftan H, Böger D, Büntzel J, Müller A, Hoffmann K, Podzimek J, Pietschmann K, Ernst T, and Guntinas-Lichius O
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- Male, Humans, Middle Aged, Female, Laryngectomy, Retrospective Studies, Treatment Outcome, Hypopharyngeal Neoplasms surgery, Laryngeal Neoplasms surgery, Larynx surgery
- Abstract
Prognostic factors for overall survival (OS), percutaneous endoscopic gastrostomy (PEG) dependency, and long-term speech rehabilitation via voice prosthesis (VP) after laryngectomy for laryngeal or hypopharyngeal cancer were investigated in a retrospective population-based study in Thuringia, Germany. A total of 617 patients (68.7% larynx; hypopharynx; 31.3%; 93.7% men; median age 62 years; 66.0% stage IV) from 2001 to 2020 were included. Kaplan-Meier and Cox multivariable regression analyses were performed. 23.7% of patients received a PEG. 74.7% received a VP. Median OS was 131 months. Independent factors for lower OS were stage IV (compared to stage II; hazard ratio [HR] = 3.455; confidence interval [CI] 1.395-8.556) and laryngectomy for a recurrent disease (HR = 1.550; CI 1.078-2.228). Median time to PEG removal was 7 months. Prior partial surgery before laryngectomy showed a tendency for independent association for later PEG removal (HR = 1.959; CI 0.921-4.167). Postoperative aspiration needing treatment was an independent risk factor (HR = 2.679; CI 1.001-7.167) for later definitive VP removal. Laryngectomy continuously plays an important role in a curative daily routine treatment setting of advanced laryngeal or hypopharyngeal cancer in Germany. Long-term dependency on nutrition via PEG is an important issue, whereas use of VP is a stable long-term measure for voice rehabilitation., (© 2024. The Author(s).)
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- 2024
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35. The impact of mental health on health-related quality of life in patients with NF2-related Schwannomatosis.
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Freier A, Lawson McLean AC, Loeschner D, Rosahl SK, and Kruse J
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- Humans, Quality of Life psychology, Mental Health, Neurofibromatoses, Neurofibromatosis 2 genetics, Neurilemmoma, Skin Neoplasms
- Abstract
NF2-related schwannomatosis (NF2-SWN) is a rare genetic disorder and is associated with progressive morbidities. This study aimed to investigate the relationship between NF2-SWN disease severity, health-related Quality of Life (QoL), and mental health aspects of patients. Standardised questionnaires assessing mental health problems (symptoms of depression, anxiety, and somatic burden), psychological factors (resilience, loneliness, and personality functioning), and health-related QoL were administered to 97 patients with NF2-SWN. The results of these questionnaires were compared with physician-rated disease severity. Questionnaires were completed by 77 patients. Physician-rated disease severity scores were available for 55 patients. NF2-SWN patients showed a high prevalence of clinically relevant symptoms of depression (30%), anxiety (16%), and somatic burden (32%). Almost all variables showed moderate to high correlations with NF2-SWN-related QoL. NF2-SWN-related QoL was associated with physician-reported disease severity (r = 0.614). In the stepwise hierarchical linear regression analysis, a significant model with four predictors (disease severity type, depression symptoms, personality functioning, and gender) explained 64% of the variance in NF2-SWN-related QoL. Our results showed a strong association between NF2-SWN-related QoL and depression symptoms. Moreover, personality functioning is an important influencing factor, representing a modifiable construct that can be targeted by prevention programs or psychotherapy., (© 2024. The Author(s).)
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- 2024
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36. Introduction of Unit-Dose Care in the 1,125 Bed Teaching Hospital: Practical Experience and Time Saving on Wards.
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Herrmann S, Giesel-Gerstmeier J, Steiner T, Lendholt F, and Fenske D
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Purpose: The shortage of nursing staff as well as the slow progress in the German health care system's digitalisation has gained much attention due to COVID-19. Patient-specific medication management using the unit-dose dispensing system (UDDS) has the potential for a lasting and positive influence on both digitalisation and the relief of nursing staff., Methods: Nursing staff UDDS-acceptance was determined via a validated online survey. For the evaluation of stock keeping on the wards, the delivery quantities were determined for a comparative period before and after the introduction of the UDDS. The time required for on-ward medication-related processes on ward before and after the introduction of UDDS was recorded based on a survey form and the nursing relief in full-time equivalent (FTE) was calculated using the data obtained., Results: We show that nurses appreciate the UDDS and confirm a significant reduction in drug stocks on the wards. The UDDS reduces the time needed to dispense medications from 4.52 ± 0.35 min to 1.67 ± 0.15 min/day/patient. In relation to the entire medication process, this corresponds to a reduction of 50% per day and per patient. Based on 40,000 patients/year and a supply of 1,125 beds with unit-dose blisters, 7.36 FTE nursing staff can be relieved per year. In contrast, 6.5 FTE in the hospital pharmacy are required for supplying the hospitals., Conclusion: UDDS is well accepted by nurses, reduces stock levels on ward, and fulfils criteria as a nursing-relief measure., Competing Interests: The authors report no conflicts of interest in this work., (© 2024 Herrmann et al.)
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- 2024
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37. Comparison of Vaginal Pessaries to Standard Care or Pelvic Floor Muscle Training for Treating Postpartum Urinary Incontinence: a Pragmatic Randomized Controlled Trial.
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Lange S, Lange R, Tabibi E, Hitschold T, Müller VI, and Naumann G
- Abstract
Introduction: To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that are accessible to most patients and practitioners in a generalizable cohort., Materials and Methods: A multicenter, open-label, parallel group, pragmatic randomized controlled clinical trial comparing standard care, PFMT, and vaginal cube pessary for postpartum urinary incontinence was conducted in six outpatient clinics. Sample size was based on large treatment effects (Cramers' V > 0.35) with a power of 80% and an alpha of 0.05 for a 3 × 3 contingency table, 44 patients needed to be included in the trial. Outcomes were analyzed according to the intention-to-treat principle. Group comparisons were made using analysis of variance (ANOVA), Kruskal-Wallis, and chi-square test as appropriate. P < 0.05 was considered statistically significant., Results: Of the 516 women screened, 111 presented with postpartum UI. Of these, 52 were randomized to one of three treatment groups: standard care (n = 17), pelvic floor muscle training (n = 17), or vaginal cube pessary (n = 18). After 12 weeks of treatment, treatment success, as measured by patient satisfaction, was significantly higher in the vaginal pessary group (77.8%, n = 14/18), compared to the standard care group (41.2%, n = 7/17), and the PFMT (23.5%, n = 4/17; χ
2 2,n = 52 = 14.55; p = 0.006, Cramer-V = 0.374). No adverse events were reported. SUI and MUI accounted for 88.4% of postpartum UI., Conclusion: Vaginal pessaries were superior to standard care or PFMT to satisfyingly reduce postpartum UI symptoms. No complications were found., Competing Interests: Conflict of Interest Sören Lange: None. Elham Tabibi: None. Rainer Lange: Shareholder of coma-urogyn GmbH, received payment for research from Coloplast. Thomas Hitschold: None. Veronika I. Müller: None. Gert Naumann: Received payment for research and travel expenses/honoraria from Promedon., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)- Published
- 2024
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38. Efficacy and safety of treating acute haemoptysis using glue embolization: A retrospective observational study and comparison to the literature.
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Shamseldin M, Kluge J, Bauer JU, and Puls R
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- Humans, Male, Middle Aged, Prospective Studies, Angiography, Ethiodized Oil, Retrospective Studies, Treatment Outcome, Hemoptysis diagnostic imaging, Hemoptysis therapy, Hemoptysis etiology, Embolization, Therapeutic methods
- Abstract
Introduction: A retrospective observational study of the short-term efficacy and safety of using glue embolization, namely n-butyl-2-cyanoacrylate (NBCA), in bronchial artery embolization (BAE) and comparison with the literature. The main aim of the study is to display the safety of this embolic material through standardization of interventional procedure for consideration of NBCA as a possible primary embolic agent in cases of BAE., Methods: A total of 35 BAE was performed in 31 patients with acute haemoptysis after failure of bronchoscopic therapy using NBCA. The mean age was 56 years with 22 male patients. Pre-interventional bronchoscopy and computed tomographic angiography were performed. In 35 cases, embolization was performed exclusively with NBCA. One patient in combination with coils and one with particles and coils. The 1:4 NBCA-to-Lipiodol mixture was most commonly used. Post-interventional bronchoscopy was performed after 24 h., Results: Technical success was possible in all cases. Clinical success was achieved in 94.3%. There was a mortality rate of 6.5% within 48 h. No other embolization related major complications were noticed. A minor complication of temporary ischaemia of the bronchial mucosa. No reperfusion of the embolized vessel, however with rebleeding in four patients from different primarily not embolized bronchial arteries., Conclusion: Despite previous concerns about its safety based on previous reports and in line with recent studies, we conclude that NBCA is a safe and effective embolic agent to perform BAE in cases of acute haemoptysis if performed according to a clear standard operating procedure as described with a possible superiority over embolic agents. Further blinded prospective comparative studies are necessary., (© 2023 The Authors. Journal of Medical Imaging and Radiation Oncology published by John Wiley & Sons Australia, Ltd on behalf of Royal Australian and New Zealand College of Radiologists.)
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- 2024
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39. Cardio-Hepatic Interaction in Cardiac Amyloidosis.
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Ihne-Schubert SM, Goetze O, Gerstendörfer F, Sahiti F, Schade I, Papagianni A, Morbach C, Frantz S, Einsele H, Knop S, Sommer C, Müllhaupt B, Schubert T, Störk S, and Geier A
- Abstract
Background: Congestion is associated with poor prognosis in cardiac amyloidosis (CA). The cardio-hepatic interaction and the prognostic impact of secondary liver affection by cardiac congestion in CA are poorly understood and require further characterisation. Methods: Participants of the amyloidosis cohort study AmyKoS at the Interdisciplinary Amyloidosis Centre of Northern Bavaria with proven transthyretin (ATTR-CA) and light chain CA (AL-CA) underwent serial work-up including laboratory tests, echocardiography, and in-depth hepatic assessment by vibration-controlled transient elastography (VCTE) and
13 C-methacetin breath test. Results: In total, 74 patients with AL-CA (n = 17), ATTR-CA (n = 26) and the controls (n = 31) were analysed. ATTR-CA patients showed decreased microsomal liver function expressed by maximal percentage of dose rate (PDRpeak ) related to hepatic congestion. Reduced PDRpeak in AL-CA could result from altered pharmacokinetics due to changed hepatic blood flow. Liver stiffness as a combined surrogate of chronic liver damage and congestion was identified as a predictor of all-cause mortality. Statistical modelling of the cardio-hepatic interaction revealed septum thickness, NT-proBNP and PDRpeak as predictors of liver stiffness in both CA subtypes; dilatation of liver veins and the fibrosis score FIB-4 were only significant for ATTR-CA. Conclusions: Non-invasive methods allow us to characterise CA-associated hepatic pathophysiology. Liver stiffness might be promising for risk stratification in CA.- Published
- 2024
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40. Minimal Residual Disease Status Predicts Outcome in Patients With Previously Untreated Follicular Lymphoma: A Prospective Analysis of the Phase III GALLIUM Study.
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Pott C, Jurinovic V, Trotman J, Kehden B, Unterhalt M, Herold M, Jagt RV, Janssens A, Kneba M, Mayer J, Young M, Schmidt C, Knapp A, Nielsen T, Brown H, Spielewoy N, Harbron C, Bottos A, Mundt K, Marcus R, Hiddemann W, and Hoster E
- Subjects
- Humans, Antineoplastic Combined Chemotherapy Protocols adverse effects, Bendamustine Hydrochloride, Cyclophosphamide, Doxorubicin, Neoplasm, Residual drug therapy, Prednisone, Rituximab, Vincristine, Gallium therapeutic use, Lymphoma, Follicular
- Abstract
Purpose: We report an analysis of minimal residual/detectable disease (MRD) as a predictor of outcome in previously untreated patients with follicular lymphoma (FL) from the randomized, multicenter GALLIUM (ClinicalTrials.gov identifier: NCT01332968) trial., Patients and Methods: Patients received induction with obinutuzumab (G) or rituximab (R) plus bendamustine, or cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or cyclophosphamide, vincristine, prednisone (CVP) chemotherapy, followed by maintenance with the same antibody in responders. MRD status was assessed at predefined time points (mid-induction [MI], end of induction [EOI], and at 4-6 monthly intervals during maintenance and follow-up). Patients with evaluable biomarker data at diagnosis were included in the survival analysis., Results: MRD positivity was associated with inferior progression-free survival (PFS) at MI (hazard ratio [HR], 3.03 [95% CI, 2.07 to 4.45]; P < .0001) and EOI (HR, 2.25 [95% CI, 1.53 to 3.32]; P < .0001). MRD response was higher after G- versus R-chemotherapy at MI (94.2% v 88.9%; P = .013) and at EOI (93.1% v 86.7%; P = .0077). Late responders (MI-positive/EOI-negative) had a significantly poorer PFS than early responders (MI-negative/EOI-negative; HR, 3.11 [95% CI, 1.75 to 5.52]; P = .00011). The smallest proportion of MRD positivity was observed in patients receiving bendamustine at MI (4.8% v 16.0% in those receiving CHOP; P < .0001). G appeared to compensate for less effective chemotherapy regimens, with similar MRD response rates observed across the G-chemo groups. During the maintenance period, more patients treated with R than with G were MRD-positive (R-CHOP, 20.7% v G-CHOP, 7.0%; R-CVP, 21.7% v G-CVP, 9.4%). Throughout maintenance, MRD positivity was associated with clinical relapse., Conclusion: MRD status can determine outcome after induction and during maintenance, and MRD negativity is a prerequisite for long-term disease control in FL. The higher MRD responses after G- versus R-based treatment confirm more effective tumor cell clearance.
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- 2024
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41. Thrombectomy With the pRESET vs Solitaire Stent Retrievers as First-Line Large Vessel Occlusion Stroke Treatment: A Randomized Clinical Trial.
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Nogueira RG, Lobsien D, Klisch J, Pielenz D, Lobsien E, Sauvageau E, Aghaebrahim N, Möhlenbruch M, Vollherbst D, Ulfert C, Bozorgchami H, Clark W, Priest R, Samaniego EA, Ortega-Gutierrez S, Ghannam M, Lopes D, Billingsley J, Keigher K, Haussen DC, Al-Bayati AR, Siddiqui A, Levy E, Chen M, Munich S, Schramm P, Boppel T, Narayanan S, Gross BA, Roth C, Boeckh-Behrens T, Hassan A, Fifi J, Budzik RF, Tarpley J, Starke RM, Raz E, Brogan G, Liebeskind DS, and Hanel RA
- Subjects
- Aged, Aged, 80 and over, Female, Humans, Male, Cerebral Infarction complications, Prospective Studies, Stents, Thrombectomy methods, Treatment Outcome, Middle Aged, Brain Ischemia complications, Ischemic Stroke complications, Stroke surgery, Stroke complications
- Abstract
Importance: Stent retriever-based thrombectomy is highly beneficial in large vessel occlusion (LVO) strokes. Many stent retriever designs are currently available, but comparison of these technologies in well-conducted studies is lacking., Objective: To determine whether thrombectomy for LVO stroke with the pRESET stent retriever is noninferior to treatment with the Solitaire stent retriever., Design, Setting, and Participants: This study was a multicenter, prospective, randomized, controlled, open-label, adaptive, noninferiority trial with blinded primary end point evaluation. Between October 2019 and February 2022, multicenter participation occurred across 19 research hospitals and/or universities in the US and 5 in Germany. Patients with LVO stroke were enrolled and included up to 8 hours after symptom onset., Interventions: Patients underwent 1:1 randomization to thrombectomy with the pRESET or Solitaire stent retriever., Main Outcomes and Measures: The primary outcome was the difference in the rate of 90-day functional independence across the 2 devices, using a -12.5% noninferiority margin for the lower bound of the 1-sided 95% CI of the difference between pRESET and Solitaire retrievers., Results: Of 340 randomized patients, 170 (50.0%) were female, and the median (IQR) age was 73.0 (64.0-82.0) years. The study procedure was completed in 322 of the 340 randomized patients. The primary end point of 90-day functional independence was achieved by 95 patients (54.9%; 95% CI, 48.7-61.1) in the pRESET group and in 96 (57.5%; 95% CI, 51.2-63.8) in the Solitaire group (absolute difference, -2.57%; 95% CI, -11.42 to 6.28). As the lower bound of the 95% CI was greater than -12.5%, the pRESET retriever was deemed noninferior to the Solitaire retriever. The noninferiority of pRESET over Solitaire was also observed in the secondary clinical end point (90-day shift in modified Rankin Scale score) and in both angiographic end points (Expanded Treatment in Cerebral Infarction [eTICI] score of 2b50 or greater within 3 passes: 146 of 173 [84.4%] vs 149 of 167 [89.2%]; absolute difference, -4.83%; 95% CI, -10.84 to 1.19; eTICI of 2c or greater following the first pass: 76 of 173 [43.7%] vs 74 of 167 [44.3%]; absolute difference, -0.63%; 95% CI, -9.48 to 8.21). Symptomatic intracranial hemorrhage occurred in 0 patients in the pRESET group and 2 (1.2%) in the Solitaire group. Mortality occurred in 25 (14.5%) in the pRESET group and in 24 (14.4%) in the Solitaire group at 90 days. Findings of the per-protocol and as-treated analyses were in concordance with findings of the intention-to-treat analysis., Conclusions and Relevance: In this study, among patients with LVO stroke, thrombectomy with the pRESET stent retriever was noninferior to thrombectomy with the Solitaire stent retriever. Findings suggest that pRESET offers a safe and effective option for flow restoration and disability reduction in patients with LVO stroke.
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- 2024
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42. The pEGASUS-HPC stent system for stent-assisted coiling of cerebral aneurysms: a multicenter case series.
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Lobsien D, Holtmannspoetter M, Eff F, Berlis A, Maurer CJ, Behme D, Diamandis E, Gawlitza M, Fiorella D, Princiotta C, Cirillo L, Dall'Olio M, Keston P, Klisch J, and Nania A
- Abstract
Background: Stent-assisted coiling (SAC) is a well-established method for treatment of wide-necked intracranial aneurysms. In this multicenter, retrospective case series we evaluated SAC with a new low-profile, laser-cut stent with an antithrombogenic hydrophilic polymer coating (pEGASUS-HPC) for the treatment of intracranial aneurysms., Methods: Patients treated with pEGASUS-HPC SAC for one or more intracranial aneurysms were retrospectively included. Clinical, imaging, and procedural parameters as well as clinical and imaging follow-up data were recorded., Results: We treated 53 aneurysms in 52 patients in six neurovascular centers between August 2021 and November 2022. Thirty-seven patients (69.8%) were female. Mean age was 57 (±11.7) years. Twenty-nine patients were treated electively, 23 in the acute phase (22 with aneurysmal subarachnoid hemorrhage (SAH), and 1 with a partially thrombosed aneurysm causing ischemic events). One intraprocedural thromboembolic event and three postprocedural ischemic complications occurred in two (8.7 %) of the SAH patients and in one of the elective patients (3.45%). Overall aneurysm occlusion was Raymond Roy (RR) I in 36 (69.2%), RR II in 9, and RR III in 9 cases. Follow-up imaging was available for 23 patients after an average of 147.7 (±59.6) days demonstrating RR I occlusion in 22 (95.5%) and RR II in 1 patient., Conclusion: SAC with the pEGASUS-HPC stent system demonstrates rates of periprocedural safety and effectiveness that are comparable with previously reported series for stent-assisted coil embolization., Competing Interests: Competing interests: All authors: phenox GmbH organized online meetings of the centers during the initiation of the work. DL: phenox – travel expenses, speaker honoraria (money paid to institution). MH: Balt, Medtronic, Microvention, Cerenovus, Stryker, Rapid Medical, phenox – consulting fees; Penumbra – speaker honoraria; Medtronic – steering committee “Inspire” Study. FE: did not disclose competing interests. AB: none. CJM: none. DB: phenox, Acandis, Stryker, Vesalio – consulting fees; Acandis – speaker honoraria; Acandis – travel expenses. ED: none. DF: Medtronic, Cerenovous, Microvention, Penumbra, Stryker, Balt USA, Seimens, Mentice, Neurogami, Rapid.AI, Rapid Medical, Q’apel Medical, Arsenal Medical, phenox, Scientia, NVMed, Perfuze, Vesalio – consulting fees; Medtronic, Cerenovous, Microvention, Penumbra, Stryker, Balt USA, Q’apel Medical – speaker honoraria; Medtronic, Cerenovous, Microvention, Penumbra, Stryker, Balt USA, Seimens, Mentice, Neurogami, Rapid.AI, Rapid Medical, Q’apel Medical, Arsenal Medical, phenox, Scientia, NVMed, Perfuze, Vesalio – travel expenses; Scientia, MENTICE, Neurogami, NVMed, Perfuze – leadership role; Scientia, Perfuze, NVMED, Mentice, Neurogami – stock options. MG: phenox, Microvention, Balt – consulting; phenox – speaker honoraria. CP: none. LC: none. MD: none. PK: Medtronic, Stryker, Microvention – consulting fees; Stryker, Oxford Heartbeat – grants. JK: phenox – travel expenses, speaker honoraria; phenox, Microvention – consulting fees (money paid to institution). AN: none., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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43. [Urinary incontinence after radical prostatectomy for prostate cancer-data from 17,149 patients from 125 certified centers].
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Kowalski C, Sibert NT, Hammerer P, Wesselmann S, Feick G, Carl EG, Klotz T, Apel H, Dieng S, Nyarangi-Dix J, Knoll T, Reike MJ, Duwe G, Bartolf E, Steiner T, Borowitz R, Lümmen G, Seitz AK, Pfitzenmaier J, Aziz A, Brock M, Berger FP, Kaftan BT, Grube C, Häfner T, Hamza A, Schmelz H, Haas J, Lenart S, Lafita A, Sippel C, Winter A, Kedia G, Hadaschik B, Varga Z, Buse S, Richter M, Distler F, Simon J, Wiegel T, Baltes S, Janitzky A, Sommer JP, Hijazi S, Fülkell P, Harke NN, Bolenz C, Khalil C, Breidenbach C, Tennstedt P, and Burchardt M
- Subjects
- Male, Humans, Prostatectomy adverse effects, Urinary Incontinence epidemiology, Erectile Dysfunction epidemiology, Prostatic Neoplasms surgery
- Abstract
Background: In addition to erectile dysfunction, urinary incontinence is the most common functional limitation after radical prostatectomy (RPE) for prostate cancer (PCa). The German S3 guideline recommends informing patients about possible effects of the therapy options, including incontinence. However, only little data on continence from routine care in German-speaking countries after RPE are currently available, which makes it difficult to inform patients., Objective: The aim of this work is to present data on the frequency and severity of urinary incontinence after RPE from routine care., Materials and Methods: Information from the PCO (Prostate Cancer Outcomes) study is used, which was collected between 2016 and 2022 in 125 German Cancer Society (DKG)-certified prostate cancer centers in 17,149 patients using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). Changes in the "incontinence" score before (T0) and 12 months after RPE (T1) and the proportion of patients who used pads, stratified by age and risk group, are reported., Results: The average score for urinary incontinence (value range: 0-worst possible to 100-best possible) was 93 points at T0 and 73 points 12 months later. At T0, 97% of the patients did not use a pad, compared to 56% at T1. 43% of the patients who did not use a pad before surgery used at least one pad a day 12 months later, while 13% use two or more. The proportion of patients using pads differs by age and risk classification., Conclusion: The results provide a comprehensive insight into functional outcome 12 months after RPE and can be taken into account when informing patients., (© 2023. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2024
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44. Weaning and extubation failure in myasthenic crisis: a multicenter analysis.
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Neumann B, Angstwurm K, Dohmen C, Mergenthaler P, Kohler S, Schönenberger S, Lee DH, Gerner ST, Huttner HB, Thieme A, Steinbrecher A, Dunkel J, Roth C, Schneider H, Reichmann H, Fuhrer H, Kleiter I, Schneider-Gold C, Alberty A, Zinke J, Schroeter M, Linker R, Meisel A, Bösel J, and Stetefeld HR
- Subjects
- Humans, Retrospective Studies, Airway Extubation adverse effects, Immunoglobulins, Intravenous, Respiration, Artificial, Ventilator Weaning adverse effects, Myasthenia Gravis therapy, Myasthenia Gravis complications
- Abstract
Myasthenic crisis (MC) requiring mechanical ventilation is a serious complication of myasthenia gravis (MG). Here we analyze the frequency and risk factors of weaning- and extubation failure as well as its impact on the clinical course in a large cohort. We performed a retrospective chart review on patients treated for MC in 12 German neurological departments between 2006 and 2015. Weaning failure (WF) was defined as negative spontaneous breathing trial, primary tracheostomy, or extubation failure (EF) (reintubation or death). WF occurred in 138 episodes (64.2%). Older Age (p = 0.039), multiple comorbidities (≥ 3) (p = 0.007, OR = 4.04), late-onset MG (p = 0.004, OR = 2.84), complications like atelectasis (p = 0.008, OR = 3.40), pneumonia (p < 0.0001, OR = 3.45), cardio-pulmonary resuscitation (p = 0.005, OR = 5.00) and sepsis (p = 0.02, OR = 2.57) were associated with WF. WF occurred often in patients treated with intravenous immungloblins (IVIG) (p = 0.002, OR = 2.53), whereas WF was less often under first-line therapy with plasma exchange or immunoadsorption (p = 0.07, OR = 0.57). EF was observed in 58 of 135 episodes (43.0%) after first extubation attempt and was related with prolonged mechanical ventilation, intensive care unit stay and hospital stay (p ≤ 0.0001 for all). Extubation success was most likely in a time window for extubation between day 7 and 12 after intubation (p = 0.06, OR = 2.12). We conclude that WF and EF occur very often in MC and are associated with poor outcome. Older age, multiple comorbidities and development of cardiac and pulmonary complications are associated with a higher risk of WF and EF. Our data suggest that WF occurs less frequently under first-line plasma exchange/immunoadsorption compared with first-line use of IVIG., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)
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- 2024
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45. Multicenter study of the safety and effectiveness of intracranial aneurysm treatment with the p64MW-HPC flow modulation device.
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Ernst M, Jamous A, Bartl M, Riedel CH, Holtmannspötter M, Voit-Höhne H, Grieb D, Schlunz-Hendann M, Fiebig T, Fiorella D, Klisch J, and Lobsien D
- Abstract
Background and Purpose: The new p64 flow diverter with hydrophilic polymer coating (HPC) was designed to reduce thrombogenicity. To date, it is unclear how antithrombogenic surface modifications affect neoendothelialization and thrombus formation in patients with unruptured intracranial aneurysms. The purpose of this study was to evaluate the safety and effectiveness of the p64MW-HPC in the treatment of unruptured aneurysms of small to giant size and of both the anterior and posterior circulation., Materials and Methods: Between March 2020 and October 2022 all patients with unruptured intracranial aneurysms treated with the p64MW-HPC were included at five neurovascular centers. Demographic data, aneurysm characteristics, antiplatelet therapy, procedural complications, and clinical and angiographic outcomes were recorded., Results: A total of 100 patients with 100 unruptured intracranial aneurysms met the inclusion criteria. Eighty-three aneurysms were classified as saccular, 12 aneurysms were fusiform, 4 aneurysms dissecting, and 1 aneurysm was blister-like. Dual antiplatelet therapy with Clopidogrel and Aspirin was given in 68 cases, and with Ticagrelor and Aspirin in 24 cases. Technical issues with deployment were encountered in 14 cases (torsion ( n = 3), foreshortening ( n = 8), and incomplete opening ( n = 3)). Ischemic stroke occurred in a total of seven cases. In one patient a wire perforation and subsequent severe ICH occurred. Complete aneurysm occlusion at angiographic follow-up (mean time = 7 months) was seen in 73% and adequate occlusion in 93%., Conclusion: This study is the largest multicenter study to date documenting the safety and effectiveness of the new antithrombogenic p64MW-HPC in the treatment of unruptured intracranial aneurysms of the anterior and posterior circulation., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DF: Medtronic—Consulting, Proctoring, Cerenovous—Consulting, Microvention—Consulting, Proctoring, Research Support, Penumbra—Research Support, Stryker—Consulting, Research Support, Balt USA—Consulting, Research Support, Siemens—Research Support, MENTICE-Vascular Simulations—Consultant, Neurogami—Stock Holder, Consultant, Marblehead—Consultant, Stock Holder, RAPID.AI—Consultant, RAPID Medical—Consultant, Qapel Medical—Honorarium, Consultant, Arsenal Medical—Consultant, Phenox Medical—Consultant, Scientia Medical—SAB, Consultant, Stock Holder, NVMed—SAB, Stockholder, Perfuze—SAB, Consultant, Vesalio—Consultant. JK: Phenox—Consulting. MH: speaker, consultant, and proctoring honoraria for Microvention, Phenox, Stryker, Cerenovus, Medtronic, Balt.
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- 2023
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46. [Exposures to fruit plants in Germany from 2010-2019 : Analysis of the Erfurt joint poison information center database].
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Wendt S, Prasa D, Lübbert C, Begemann K, and Franke H
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- Child, Humans, Child, Preschool, Fruit, Retrospective Studies, Germany epidemiology, Poison Control Centers, Information Centers, Poisons, Poisoning epidemiology
- Abstract
Background: Inquiries about fruit plants are a frequent reason for consultation with poison information centers, although it should be emphasized that there are no large systematic studies on toxicity based on exposure data. The aim of this work is to determine the risk of poisoning by fruit plants in Germany., Methods: Retrospective study of data from the Erfurt Joint Poison Information Center on poisoning inquiries regarding fruit plants (2010-2019) with a detailed presentation of interim results, a tabular handout, plant photos as identification aids, and trend analyses., Results: From 16,088 plant exposures with 16,700 plants, 214 different fruit plant species were identified. Forty-five fruit plant species (21%) turned out to be relevant (≥ 30 inquiries) and of these, 6 (2.8%) turned out to be highly relevant (≥ 300 inquiries). All relevant plants were assigned a defined risk category (RC): RC 0 (2; 4.4%), RC 1 (26; 57.8%), RC 2 (12; 26.7%), and RC 3 (5; 11.1%). Regarding the inquiries, 6% (459/7607) were related to RC 0; 47.9% (3645/7607) to RC 1; 39.3% to RC 2 (2986/7607); and 6.8% (517/7607) to RC 3. Of the inquiries, 69.5% (5284/7607) were related to young children (1 to < 6 years). Exposure outcomes for all age groups were asymptomatic in 82%, mild in 14.7%, moderate in 3%, and severe in 0.3%, with severe poisoning caused by seven plant species. Interventions were initiated in 66.8% (5079) of the inquiries. Inquiries were most frequently related to Taxus baccata, Ligustrum vulgare, Physalis alkekengi, Prunus laurocerasus, Convallaria majalis, Mahonia spec., Sambucus spec., Lonicera spec., Sorbus aucuparia, Thuja spec., Hedera helix, and Cotoneaster spec., Discussion: Poisoning by fruit plants in Germany is rare. However, there is a great need for information and education., (© 2023. The Author(s).)
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- 2023
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47. One Hundred Years of the Tracer Principle.
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Hoberück S, Zöphel K, Pomper MG, Rowe SP, and Gafita A
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- 2023
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48. [Skull base surgery in the German DRG system-New categorization of important procedures].
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Sommer F, Hoffmann TK, Jäckel M, Gerlach R, Schwager K, Deitmer T, and Betz CS
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- Humans, Neurosurgical Procedures, Nose, Skull Base surgery, Diagnosis-Related Groups, Surgeons
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Surgery of the skull base includes interventions between the nose or paranasal sinuses (anterior skull base) or ear/temporal bone (lateral skull base) and the intracranial space. As interventions at the anterior skull base almost exclusively involve complex pathologies in a demanding anatomical region, in many cases two experienced surgeons from different disciplines are required who should be experienced in operating together. The technical and time requirements are also considerable in many cases; however, for many procedures there are no specific skull base operational and procedural keys (OPS) codes that take the considerable personnel and structural effort into account. A change in the diagnosis-related groups (DRG) system, implemented since the beginning of 2023, now adjusts the remuneration of the abovementioned effort for malignant pathologies of the anterior and lateral skull base. The reallocation of procedures 5‑015.0/1/3/4 and 5‑016.0/2/4/6 results in a significant upgrade of anterior and lateral skull base surgery. Since the beginning of 2023 skull base surgery will no longer be charged under DRG D25C with a (former) relative weight of 1.893, but with DRG D25B with a current relative weight of 3.753 when a code of the aforementioned groups is used. Nevertheless, further adjustments are necessary, for example, in the available reconstructive steps in order to provide the Institute for the Remuneration System in Hospitals (InEK) with the most differentiated data possible on the procedural effort of the intervention and to achieve a more balanced distribution of the reimbursements of skull base surgery in the long term., (© 2023. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2023
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49. Nivolumab Switch Maintenance Therapy After Tyrosine Kinase Inhibitor Induction in Metastatic Renal Cell Carcinoma: A Randomized Clinical Trial by the Interdisciplinary Working Group on Renal Tumors of the German Cancer Society (NIVOSWITCH; AIO-NZK-0116ass).
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Grünwald V, Ivanyi P, Zschäbitz S, Wirth M, Staib P, Schostak M, Dargatz P, Müller L, Metz M, Bergmann L, Steiner T, Welslau M, Lorch A, Rafiyan R, Hellmis E, Darr C, Schütt P, Meiler J, Kretz T, Loidl W, Flörcken A, Mänz M, Hinke A, Hartmann A, and Grüllich C
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- Aged, Female, Humans, Male, Nivolumab adverse effects, Protein Kinase Inhibitors adverse effects, Tyrosine Kinase Inhibitors, Adult, Middle Aged, Carcinoma, Renal Cell pathology, Kidney Neoplasms pathology
- Abstract
Background: The role of immune checkpoint inhibitor (ICI) maintenance therapy in metastatic renal cell carcinoma (mRCC) is undefined., Objective: To determine whether switch maintenance therapy with nivolumab improves clinical outcomes in patients with mRCC with tyrosine kinase inhibitor (TKI) sensitivity., Design, Setting, and Participants: This open-label phase 2 trial randomized patients with a partial response or stable disease after 10-12-wk TKI induction therapy to either TKI or nivolumab maintenance. Key inclusion criteria were measurable disease, clear cell histology, Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2, and adequate organ function., Intervention: Intravenous nivolumab 8 × 240 mg every 2 wk, followed by 480 mg every 4 wk or sunitinib 50 mg (4-2 regimen) or pazopanib 800 mg once daily orally., Outcome Measurements and Statistical Analyses: The primary endpoint was overall survival (OS). Secondary endpoints were the objective response rate (ORR; Response Evaluation Criteria in Solid Tumors v1.1), progression-free survival (PFS), safety (Common Terminology Criteria for Adverse Events v4.03), and patient-reported outcomes (Functional Assessment of Cancer Therapy Kidney Symptom Index). The Kaplan-Meier method, two-sided log-rank tests, and Cox regression models were used for statistical analysis., Results and Limitations: Maintenance therapy was nivolumab for 25 patients (51.0%) and TKI for 24 (48.9%). The median age was 65 yr (range 35-79). Nine patients (18.4%) were female, 31 (63.3%) had ECOG PS of 0, and 15 (30.6%) had favorable risk. OS data are immature (17 deaths, 34.7%). The ORR was 20.0% (n = 5) for nivolumab and 52.2% (n = 12) for TKI. PFS was worse with nivolumab (hazard ratio 2.57, 95% confidence interval 1.36-4.89; p = 0.003). Grade ≥3 adverse events occurred in 14 patients (56.0%) with nivolumab and 17 (70.8%) with TKI. A major limitation is early termination of our study., Conclusions: TKI treatment achieved superior ORR and PFS in comparison to nivolumab maintenance therapy. Our data do not indicate a role for nivolumab switch maintenance in mRCC., Patient Summary: Patients with metastatic kidney cancer who experienced a tumor response or disease stabilization after a short period of targeted treatment with a tyrosine kinase inhibitor did not benefit from a switch to the immunotherapy drug nivolumab. Patients who continued their original treatment achieved better responses and a longer time without disease progression. This trial is registered on EudraCT as 2016-002170-13 and on ClinicalTrials.gov as NCT02959554., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
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- 2023
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50. Safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide necked bifurcation aneurysms: final 5 year results of the pivotal WEB Intra-saccular Therapy study (WEB-IT).
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Fiorella D, Molyneux A, Coon A, Szikora I, Saatci I, Baltacioglu F, Aziz-Sultan MA, Hoit D, Delgado Almandoz JE, Elijovich L, Cekirge HS, Byrne J, Klisch J, and Arthur AS
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- Humans, Treatment Outcome, Prospective Studies, Retrospective Studies, Intracranial Aneurysm diagnostic imaging, Intracranial Aneurysm surgery, Embolization, Therapeutic methods, Endovascular Procedures methods
- Abstract
Introduction: The US Woven EndoBridge Intra-saccular Therapy (WEB-IT) study is a pivotal, prospective, single arm, investigational device exemption study to evaluate the safety and effectiveness of the WEB device for the treatment of wide neck bifurcation aneurysms (WNBAs). We present complete 5 year data for the cohort of 150 patients., Methods: 150 patients with WNBAs were enrolled at 21 US and six international centers. Imaging from the index procedure, 6 month, 1 year, 3 year, and 5 year follow-up were reviewed by a core laboratory. Adverse events were reviewed and adjudicated by a clinical events adjudicator., Results: 83 patients had 5 year follow-up imaging and 123 had clinical follow-up. No ruptured (0/9) or unruptured aneurysm (0/141) rebled or bled during follow-up. No new device or procedure related adverse events or serious adverse events were reported after 1 year. At 5 years, using the LOCF method, complete occlusion was observed in 58.1% and adequate occlusion in 87.2% of patients. For patients with both 1 year and 5 year occlusion statuses available, 76.8% (63/82) of aneurysms remained stable or improved with no retreatment. After 1 year, 18 aneurysms were retreated, 11 of which were adequately occluded at 1 year, and 15 of which were retreated in the absence of any deterioration in occlusion grade., Conclusions: Five year follow-up data from the WEB-IT study demonstrated that the WEB device was safe and effective when used in the treatment of WNBAs. Aneurysm occlusion rates achieved at 1 year follow-up were durable, with rates of progressive thrombosis far exceeding rates of recurrence over time., Competing Interests: Competing interests: The US WEB IT trial was supported by Terumo/Microvention USA., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2023
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