Abstract

Abstract Background Up to one-third of patients report persisting hemodynamic abnormalities and functional limitation over long-term follow-up after acute pulmonary embolism (PE). Purpose We tested whether a validated algorithm designed to rule-out chronic thromboembolic pulmonary hypertension (CTEPH) after acute PE can be used for identifying patients at lower risk of presenting with persisting symptoms and echocardiographic abnormalities. Methods The multicentre Follow-up of Acute Pulmonary Embolism (FOCUS) cohort study prospectively enrolled 1,100 consecutive patients diagnosed with acute symptomatic PE; two-year follow-up is ongoing. We focused on the scheduled visits for 3- and 12-month follow-up. The rule-out criteria are based on: the absence of ECG signs of right ventricular dysfunction and normal NT-proBNP/BNP values. Echocardiographic abnormalities were defined according to the presence of abnormal parameters indicating an intermediate/high probability of pulmonary hypertension as recommended by the 2015 ESC/ERS Society Guidelines on Pulmonary Hypertension. The presence of functional limitation was defined based on a World Health Organization classification grade ≥3, a Borg dyspnoea index ≥4, or a 6-minute walking distance <300 m. Results We included 323 patients (mean age 61 years, 58% men), of whom 255 have meanwhile completed a one-year follow-up. At 3- and 12-month follow-up, 194 (60%) and 155 (61%) of patients exhibited no abnormal echocardiographic findings or natriuretic peptide levels. The percentage of patients with echocardiographic abnormalities was 20.4% and 18.0%, respectively. The negative predictive value of the score for ruling out the combination of functional limitation and intermediate/high probability of pulmonary hypertension as recommended by the 2015 ESC/ERS Guidelines on Pulmonary Hypertension was 0.96 (95% CI 0.92–0.98) at 3 and 0.97 (0.92–0.99) at 12 months. The corresponding positive predictive values were 0.10 (0.06–0.17) and 0.09 (0.05–0.17), respectively. Conclusions The CTEPH rule-out criteria are capable of excluding functional limitation and evidence of (chronic) pulmonary hypertension 3 and 12 months after the diagnosis of acute PE. Acknowledgement/Funding The sponsor (University Medical Center of the Johannes Gutenberg University, Mainz) has obtained grants from Bayer Vital GmbH and Bayer Pharma AG

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