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Valerio, Luca; Mavromanoli, Anna C.; Barco, Stefano; Abele, Christina; Becker, Dorothea; Bruch, Leonhard; Ewert, Ralf; Faehling, Martin; Fistera, David; Gerhardt, Felix; Ghofrani, Hossein-Ardeschir; Grgic, Aleksandar; Gruenig, Ekkehard; Halank, Michael; Held, Matthias; Hobohm, Lukas; Hoeper, Marius M.; Klok, Frederikus A.; Lankeit, Mareike; Leuchte, Hanno H.; Martin, Nadine; Mayer, Eckhard; Meyer, F. Joachim; Neurohr, Claus; Opitz, Christian; Schmidt, Kai-Helge; Seyfarth, Hans-Jürgen; Wachter, Rolf; Wilkens, Heinrike; Wild, Philipp S.; Konstantinides, Stavros V. und Rosenkranz, Stephan (2022): Chronic thromboembolic pulmonary hypertension and impairment after pulmonary embolism: the FOCUS study. In: European Heart Journal, Bd. 43, Nr. 36: S. 3387-3398

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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.

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