Luca Valerio1, Stefano Barco2, Marius Jankowski1, Stephan Rosenkranz3, Mareike Lankeit1, Matthias Held4, Felix Gerhardt3, Leonhard Bruch5, Ralf Ewert6, Martin Faehling7, Julia Freise8, Hossein-Ardeschir Ghofrani9, Ekkehard Grünig10, Michael Halank11, Marius M Hoeper8, Frederikus A Klok12, Hanno H Leuchte13, Eckhard Mayer14, F Joachim Meyer15, Claus Neurohr16, Christian Opitz17, Kai-Helge Schmidt18, Hans-Jürgen Seyfarth19, Franziska Trudzinski20, Rolf Wachter21, Heinrike Wilkens22, Philipp S Wild23, Stavros V Konstantinides24. 1. Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany. 2. Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany; Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland. 3. Department of Cardiology, Heart Center at the University Hospital Cologne, and Cologne Cardiovascular Research Center, Cologne, Germany. 4. Abteilung für Innere Medizin, Missionsärztliche Klinik Würzburg, Würzburg, Germany. 5. Klinik für Innere Medizin und Kardiologie, Unfallkrankenhaus Berlin, Berlin, Germany. 6. Department for Internal Medicine, Greifswald University Hospital, Greifswald, Germany. 7. Klinik für Kardiologie, Angiologie und Pneumologie, Klinikum Esslingen, Esslingen am Neckar, Germany. 8. Klinik für Pneumologie, Medizinische Hochschule Hannover, Member of the German Center for Lung Research (DZL), Hannover, Germany. 9. Lung Center at the University of Giessen and Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany; Department of Medicine, Imperial College London, London, England. 10. Center for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Heidelberg, Germany. 11. Medizinische Klinik und Poliklinik I, Universitätsklinikum an der TU Dresden, Dresden, Germany. 12. Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands. 13. Department of Internal Medicine II, Neuwittelsbach Academic Hospital, Ludwig Maximilians University, Member of the DZL, Munich, Germany. 14. Department of Thoracic Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany. 15. Lungenzentrum München, Klinik für Pneumologie und Pneumologische Onkologie, Klinikum Bogenhausen, Munich, Germany. 16. Medizinische Klinik und Poliklinik, LMU Klinikum der Universität München, Munich, Germany. 17. Klinik für Innere Medizin, DRK Kliniken Berlin Westend, Berlin, Germany. 18. Center for Cardiology, Cardiology 1, University Medical Center of the Johannes Gutenberg University, Mainz, Germany. 19. Department of Pneumology, Universitätsklinikum Leipzig AöR, Leipzig, Germany. 20. Saarland University Medical Center, Homburg, Germany; Pneumology and Critical Care Medicine at University Hospital Heidelberg, Translational Lung Research Center Heidelberg (TLRC), Member of German Center for Lung Research (DZL), Heidelberg, Germany. 21. Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig AöR, Leipzig, Germany. 22. Saarland University Medical Center, Homburg, Germany. 23. Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, 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. 24. Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University, Mainz, Germany; Department of Cardiology, Democritus University of Thrace, Alexandroupolis, Greece. Electronic address: stavros.konstantinides@unimedizin-mainz.de.
Abstract
BACKGROUND: Few data are available on the long-term course and predictors of quality of life (QoL) following acute pulmonary embolism (PE). RESEARCH QUESTION: What are the kinetics and determinants of disease-specific and generic health-related QoL 3 and 12 months following an acute PE? STUDY DESIGN AND METHODS: The Follow-up after Acute Pulmonary Embolism (FOCUS) study prospectively followed up consecutive adult patients with objectively diagnosed PE. Patients were considered for study who completed the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire at predefined visits 3 and 12 months following PE. The course of disease-specific QoL as assessed using the PEmb-QoL and the impact of baseline characteristics using multivariable mixed effects linear regression were studied; also assessed was the course of generic QoL as evaluated by using the EuroQoL Group 5-Dimension 5-Level utility index and the EuroQoL Visual Analog Scale. RESULTS: In 620 patients (44% women; median age, 62 years), overall disease-specific QoL improved from 3 to 12 months, with a decrease in the median PEmb-QoL score from 19.4% to 13.0% and a mean individual change of -4.3% (95% CI, -3.2 to -5.5). Female sex, cardiopulmonary disease, and higher BMI were associated with worse QoL at both 3 and 12 months. Over time, the association with BMI became weaker, whereas older age and previous VTE were associated with worsening QoL. Generic QoL also improved: the mean ± SD EuroQoL Group 5-Dimension 5-Level utility index increased from 0.85 ± 0.22 to 0.87 ± 0.20 and the visual analog scale from 72.9 ± 18.8 to 74.4 ± 19.1. INTERPRETATION: In a large cohort of survivors of acute PE, the change of QoL was quantified between months 3 and 12 following diagnosis, and factors independently associated with lower QoL and slower recovery of QoL were identified. This information may facilitate the planning and interpretation of clinical trials assessing QoL and help guide patient management. CLINICAL TRIAL REGISTRATION: German Clinical Trials Registry (Deutsches Register Klinischer Studien: www.drks.de); No.: DRKS00005939.
BACKGROUND: Few data are available on the long-term course and predictors of quality of life (QoL) following acute pulmonary embolism (PE). RESEARCH QUESTION: What are the kinetics and determinants of disease-specific and generic health-related QoL 3 and 12 months following an acute PE? STUDY DESIGN AND METHODS: The Follow-up after Acute Pulmonary Embolism (FOCUS) study prospectively followed up consecutive adult patients with objectively diagnosed PE. Patients were considered for study who completed the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire at predefined visits 3 and 12 months following PE. The course of disease-specific QoL as assessed using the PEmb-QoL and the impact of baseline characteristics using multivariable mixed effects linear regression were studied; also assessed was the course of generic QoL as evaluated by using the EuroQoL Group 5-Dimension 5-Level utility index and the EuroQoL Visual Analog Scale. RESULTS: In 620 patients (44% women; median age, 62 years), overall disease-specific QoL improved from 3 to 12 months, with a decrease in the median PEmb-QoL score from 19.4% to 13.0% and a mean individual change of -4.3% (95% CI, -3.2 to -5.5). Female sex, cardiopulmonary disease, and higher BMI were associated with worse QoL at both 3 and 12 months. Over time, the association with BMI became weaker, whereas older age and previous VTE were associated with worsening QoL. Generic QoL also improved: the mean ± SD EuroQoL Group 5-Dimension 5-Level utility index increased from 0.85 ± 0.22 to 0.87 ± 0.20 and the visual analog scale from 72.9 ± 18.8 to 74.4 ± 19.1. INTERPRETATION: In a large cohort of survivors of acute PE, the change of QoL was quantified between months 3 and 12 following diagnosis, and factors independently associated with lower QoL and slower recovery of QoL were identified. This information may facilitate the planning and interpretation of clinical trials assessing QoL and help guide patient management. CLINICAL TRIAL REGISTRATION: German Clinical Trials Registry (Deutsches Register Klinischer Studien: www.drks.de); No.: DRKS00005939.
Authors: Luca Valerio; Anna C Mavromanoli; Stefano Barco; Christina Abele; Dorothea Becker; Leonhard Bruch; Ralf Ewert; Martin Faehling; David Fistera; Felix Gerhardt; Hossein Ardeschir Ghofrani; Aleksandar Grgic; Ekkehard Grünig; Michael Halank; Matthias Held; Lukas Hobohm; Marius M Hoeper; Frederikus A Klok; Mareike Lankeit; Hanno H Leuchte; Nadine Martin; Eckhard Mayer; F Joachim Meyer; Claus Neurohr; Christian Opitz; Kai Helge Schmidt; Hans Jürgen Seyfarth; Rolf Wachter; Heinrike Wilkens; Philipp S Wild; Stavros V Konstantinides; Stephan Rosenkranz Journal: Eur Heart J Date: 2022-09-21 Impact factor: 35.855