Late outcomes after acute pulmonary embolism: rationale and design of FOCUS, a prospective observational multicenter cohort study.

Autor: Konstantinides SV; Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131, Mainz, Germany. stavros.konstantinides@unimedizin-mainz.de.; Department of Cardiology, Democritus University of Thrace, Xanthi, Greece. stavros.konstantinides@unimedizin-mainz.de., Barco S; Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131, Mainz, Germany., Rosenkranz S; Department of Cardiology, Heart Center at the University Hospital Cologne, and Cologne Cardiovascular Research Center, Cologne, Germany., Lankeit M; Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131, Mainz, Germany., Held M; Abteilung für Innere Medizin, Missionsärztliche Klinik Würzburg, Würzburg, Germany., Gerhardt F; Department of Cardiology, Heart Center at the University Hospital Cologne, and Cologne Cardiovascular Research Center, Cologne, Germany., Bruch L; Klinik für Innere Medizin und Kardiologie, Unfallkrankenhaus Berlin, Berlin, Germany., Ewert R; Clinic for Internal Medicine, Greifswald University Hospital, Greifswald, Germany., Faehling M; Klinik für Kardiologie, Angiologie und Pneumologie, Klinikum Esslingen, Esslingen am Neckar, Germany., Freise J; Klinik für Pneumologie, Medizinische Hochschule Hannover, Hanover, Germany., Ghofrani HA; Universitätsklinikum Gießen und Marburg, Marburg, Germany., Grünig E; Thoraxklinik at Heidelberg University Hospital, Heidelberg, Germany., Halank M; Medizinische Klinik und Poliklinik I, Universitätsklinikum an der TU Dresden, Dresden, Germany., Heydenreich N; Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131, Mainz, Germany., Hoeper MM; Klinik für Pneumologie, Medizinische Hochschule Hannover, Hanover, Germany., Leuchte HH; Fachklinik für Innere Medizin, Krankenhaus Neuwittelsbach, Munich, Germany., Mayer E; Department of Thoracic Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany., Meyer FJ; Lungenzentrum München, Klinik für Pneumologie und Pneumologische Onkologie, Klinikum Bogenhausen, Munich, Germany., Neurohr C; Medizinische Klinik und Poliklinik, LMU Klinikum der Universität München, Munich, Germany., Opitz C; Klinik für Innere Medizin, DRK Kliniken Berlin Westend, Berlin, Germany., Pinto A; Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131, Mainz, Germany.; Preventive Cardiology and Preventive Medicine, Center for Cardiology, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.; German Center for Cardiovascular Research (DZHK), Partner Site RheinMain, Mainz, Germany., Seyfarth HJ; Department of Pneumology, Universitätsklinikum Leipzig AöR, Leipzig, Germany., Wachter R; Klinik für Kardiologie und Pneumologie, Universitätsmedizin Göttingen, Göttingen, Germany., Zäpf B; Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131, Mainz, Germany.; Preventive Cardiology and Preventive Medicine, Center for Cardiology, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.; German Center for Cardiovascular Research (DZHK), Partner Site RheinMain, Mainz, Germany., Wilkens H; Saarland University Medical Center, Homburg, Germany., Binder H; Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University, Mainz, Germany., Wild PS; Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131, Mainz, Germany.; Preventive Cardiology and Preventive Medicine, Center for Cardiology, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.; German Center for Cardiovascular Research (DZHK), Partner Site RheinMain, Mainz, Germany.
Jazyk: angličtina
Zdroj: Journal of thrombosis and thrombolysis [J Thromb Thrombolysis] 2016 Nov; Vol. 42 (4), pp. 600-9.
DOI: 10.1007/s11239-016-1415-7
Abstrakt: Acute pulmonary embolism (PE) is a frequent cause of death and serious disability. The risk of PE-associated mortality and morbidity extends far beyond the acute phase of the disease. In earlier follow-up studies, as many as 30 % of the patients died during a follow-up period of up to 3 years, and up to 50 % of patients continued to complain of dyspnea and/or poor physical performance 6 months to 3 years after the index event. The most feared 'late sequela' of PE is chronic thromboembolic pulmonary hypertension (CTEPH), the true incidence of which remains obscure due to the large margin of error in the rates reported by mostly small, single-center studies. Moreover, the functional and hemodynamic changes corresponding to early, possibly reversible stages of CTEPH, have not been systematically investigated. The ongoing Follow-Up after acute pulmonary embolism (FOCUS) study will prospectively enroll and systematically follow, over a 2-year period and with a standardized comprehensive program of clinical, echocardiographic, functional and laboratory testing, a large multicenter prospective cohort of 1000 unselected patients (all-comers) with acute symptomatic PE. FOCUS will possess adequate power to provide answers to relevant remaining questions regarding the patients' long-term morbidity and mortality, and the temporal pattern of post-PE abnormalities. It will hopefully provide evidence for future guideline recommendations regarding the selection of patients for long-term follow-up after PE, the modalities which this follow-up should include, and the findings that should be interpreted as indicating progressive functional and hemodynamic post-PE impairment, or the development of CTEPH.
Databáze: MEDLINE
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