Chronic thromboembolic pulmonary hypertension and impairment after pulmonary embolism: the FOCUS study
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 Leuchte, Nadine Martin, Eckhard Mayer, F. Joachim Meyer, Claus Neurohr, Christian Opitz, Kai Helge Schmidt, H.-J. Seyfarth, Rolf Wachter, Heinrike Wilkens, Philipp S. Wild, Stavros Konstantinides, Stephan Rosenkranz, FOCUS Investigators, Christina Abele, Stefano Barco, Dorothea Becker, Brunhilde Fischer, Lukas Hobohm, Anja Käberich, Karsten Keller, Frederikus A. Klok, Nadine Martin, Anna C. Mavromanoli, Stavros Konstantinides, Mareike Lankeit, Silke Otto, Kurt Quitzau, Kathrin Rost, Kai‐Helge Schmidt, Doris Schöneberger, Luca Valerio, Philipp S. Wild, Leonhard Bruch, Stefanie Geistert, K. Schüler, Ralf Ewert, Claudia Pohl, Jeannette Pieper, Martin Faehling, Birgit Blaich, Annika Landmesser, Stephan Rosenkranz, Felix Gerhardt, Jasmin Rudolph, Sibel Gün, Hossein-Ardeschir Ghofrani, Ute George, Ekkehard Grünig, Benjamin Egenlauf, Amina Salkić, Eva-Maria Heier, Michael Halank, Kristin Tausche, Tina Rink, Diana Jäkel, Matthias Held, Barbara Schröder, Marius M. Hoeper, Julia Freise, Susanne Tayler, Hanno Leuchte, Annika Horn, F. Joachim Meyer, Dagmar Emge-Rossa, Karine Thabaret, Claus Neurohr, Juergen Barton, Christian Opitz, Ines Bressem, Hans‐Jürgen Seyfarth, Patricia Berger, A. Hennig, Rolf Wachter, Kristian Hellenkamp, Carmen Sentler, Martina Schulte, Heinrike Wilkens, Franziska Trudzinski, Ines Holtz
Abstract
AIMS: To systematically assess late outcomes of acute pulmonary embolism (PE) and to investigate the clinical implications of post-PE impairment (PPEI) fulfilling prospectively defined criteria. METHODS AND RESULTS: A prospective multicentre observational cohort study was conducted in 17 large-volume centres across Germany. Adult consecutive patients with confirmed acute symptomatic PE were followed with a standardized assessment plan and pre-defined visits at 3, 12, and 24 months. The co-primary outcomes were (i) diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH), and (ii) PPEI, a combination of persistent or worsening clinical, functional, biochemical, and imaging parameters during follow-up. A total of 1017 patients (45% women, median age 64 years) were included in the primary analysis. They were followed for a median duration of 732 days after PE diagnosis. The CTEPH was diagnosed in 16 (1.6%) patients, after a median of 129 days; the estimated 2-year cumulative incidence was 2.3% (1.2-4.4%). Overall, 880 patients were evaluable for PPEI; the 2-year cumulative incidence was 16.0% (95% confidence interval 12.8-20.8%). The PPEI helped to identify 15 of the 16 patients diagnosed with CTEPH during follow-up (hazard ratio for CTEPH vs. no CTEPH 393; 95% confidence interval 73-2119). Patients with PPEI had a higher risk of re-hospitalization and death as well as worse quality of life compared with those without PPEI. CONCLUSION: In this prospective study, the cumulative 2-year incidence of CTEPH was 2.3%, but PPEI diagnosed by standardized criteria was frequent. Our findings support systematic follow-up of patients after acute PE and may help to optimize guideline recommendations and algorithms for post-PE care.