title: Late outcomes after acute pulmonary embolism: rationale and design of FOCUS, a prospective observational multicenter cohort study.
abstract: 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.
authors: 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.
authors: Stavros V
authors: SV
authors: Konstantinides
authors: Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131, Mainz, Germany.
authors: Stefano
authors: S
authors: Barco
authors: Department of Cardiology, Heart Center at the University Hospital Cologne, and Cologne Cardiovascular Research Center, Cologne, Germany.
authors: Stephan
authors: S
authors: Rosenkranz
authors: Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131, Mainz, Germany.
authors: Mareike
authors: M
authors: Lankeit
authors: Abteilung für Innere Medizin, Missionsärztliche Klinik Würzburg, Würzburg, Germany.
authors: Matthias
authors: M
authors: Held
authors: Department of Cardiology, Heart Center at the University Hospital Cologne, and Cologne Cardiovascular Research Center, Cologne, Germany.
authors: Felix
authors: F
authors: Gerhardt
authors: Klinik für Innere Medizin und Kardiologie, Unfallkrankenhaus Berlin, Berlin, Germany.
authors: Leonard
authors: L
authors: Bruch
authors: Clinic for Internal Medicine, Greifswald University Hospital, Greifswald, Germany.
authors: Ralf
authors: R
authors: Ewert
authors: Klinik für Kardiologie, Angiologie und Pneumologie, Klinikum Esslingen, Esslingen am Neckar, Germany.
authors: Martin
authors: M
authors: Faehling
authors: Klinik für Pneumologie, Medizinische Hochschule Hannover, Hanover, Germany.
authors: Julia
authors: J
authors: Freise
authors: Universitätsklinikum Gießen und Marburg, Marburg, Germany.
authors: Hossein-Ardeschir
authors: HA
authors: Ghofrani
authors: Thoraxklinik at Heidelberg University Hospital, Heidelberg, Germany.
authors: Ekkehard
authors: E
authors: Grünig
authors: Medizinische Klinik und Poliklinik I, Universitätsklinikum an der TU Dresden, Dresden, Germany.
authors: Michael
authors: M
authors: Halank
authors: Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, Building 403, 55131, Mainz, Germany.
authors: Nadine
authors: N
authors: Heydenreich
authors: Klinik für Pneumologie, Medizinische Hochschule Hannover, Hanover, Germany.
authors: Marius M
authors: MM
authors: Hoeper
authors: Fachklinik für Innere Medizin, Krankenhaus Neuwittelsbach, Munich, Germany.
authors: Hanno H
authors: HH
authors: Leuchte
authors: Department of Thoracic Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.
authors: Eckhard
authors: E
authors: Mayer
authors: Lungenzentrum München, Klinik für Pneumologie und Pneumologische Onkologie, Klinikum Bogenhausen, Munich, Germany.
authors: F Joachim
authors: FJ
authors: Meyer
authors: Medizinische Klinik und Poliklinik, LMU Klinikum der Universität München, Munich, Germany.
authors: Claus
authors: C
authors: Neurohr
authors: Klinik für Innere Medizin, DRK Kliniken Berlin Westend, Berlin, Germany.
authors: Christian
authors: C
authors: Opitz
authors: 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.
authors: Antonio
authors: A
authors: Pinto
authors: Department of Pneumology, Universitätsklinikum Leipzig AöR, Leipzig, Germany.
authors: Hans-Jürgen
authors: HJ
authors: Seyfarth
authors: Klinik für Kardiologie und Pneumologie, Universitätsmedizin Göttingen, Göttingen, Germany.
authors: Rolf
authors: R
authors: Wachter
authors: 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.
authors: Bianca
authors: B
authors: Zäpf
authors: Saarland University Medical Center, Homburg, Germany.
authors: Heinrike
authors: H
authors: Wilkens
authors: Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
authors: Harald
authors: H
authors: Binder
authors: 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.
authors: Philipp S
authors: PS
authors: Wild
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D000208:Acute Disease; D000359:Aftercare; D018572:Disease-Free Survival; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000401:mortality / Q000628:therapy; D015996:Survival Rate
keywords: Chronic thromboembolic pulmonary hypertension; Cohort study; Follow-up; Functional impairment; Pulmonary embolism; Quality of life