Recommandations formalisées d’experts pour la prise en charge des pneumothorax spontanés primaires

International audienceIntroduction: Primary spontaneous pneumothorax (PSP) is the presence of air in the pleural space, occurring in the absence of trauma and known lung disease. Standardized expert guidelines on PSP are needed due to the variety of diagnostic methods, therapeutic strategies and medical and surgical disciplines involved in its management. Methods: Literature review, analysis of literature according to the GRADE (Grading of Recommendation Assessment, Development and Evaluation) methodology; proposals for guidelines rated by experts, patients, and organizers to reach a consensus. Only expert opinions with strong agreement were selected. Results: A large PSP is defined as presence of a visible rim along the entire axillary line between the lung margin and the chest wall and superior or equal to 2 cm at the hilum level on frontal chest x-ray. The therapeutic strategy depends on the clinical presentation: emergency needle aspiration for tension PSP; in the absence of signs of severity: conservative management (small PSP), needle aspiration or chest tube drainage (large PSP). Outpatient treatment is possible if a dedicated outpatient care system is previously organized. Indications, surgical procedures and perioperative analgesia are detailed. Associated measures, including smoking cessation, are described. Conclusion: These guidelines are a step towards PSP treatment and follow-up strategy optimization in France.Introduction : Le pneumothorax spontané primaire (PSP) est un épanchement gazeux dans la cavité pleurale, survenant hors traumatisme et pathologie respiratoire connue. Des recommandations formalisées d'experts sur le sujet sont justifiées par les pluralités de moyens diagnostiques, stratégies thérapeutiques et disciplines médicochirurgicales intervenant dans leur prise en charge. Méthodes : Revue bibliographique, analyse de la littérature selon méthodologie GRADE (Grading of Recommendation Assessment, Development and Evaluation) ; propositions de recommandations cotées par experts, patients et organisateurs pour obtenir un consensus. Seuls les avis d'experts avec accord fort ont été retenus. Résultats : Un décollement sur toute la hauteur de la ligne axillaire et supérieur ou égal à 2 cm au niveau du hile à la radiographie thoracique de face définit la grande abondance. La stratégie thérapeutique dépend de la présentation clinique : exsufflation en urgence pour PSP suffocant ; en l'absence de signe de gravité : prise en charge conservatrice (faible abondance), exsufflation ou drainage (grande abondance). Le traitement ambulatoire est possible si organisation en amont de la filière. Les indications, procédures chirurgicales et l'analgésie périopératoire sont détaillées. Les mesures associées, notamment le sevrage tabagique, sont décrites. Conclusion : Ces recommandations sont une étape de l'optimisation des stratégies de traitement et de suivi des PSP en France

Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry

Objective: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice. Methods: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping riociguat treatment. Primary safety outcomes were adverse events (AEs) and serious adverse events (SAEs) coded using Medical Dictionary for Regulatory Activities preferred terms and System Organ Classes version 21.0, collected during routine clinic visits and collated via case report forms. Results: In total, 956 patients with CTEPH were included in the analysis. The most common AEs in these patients were peripheral edema/edema (11.7%), dizziness (7.5%), right ventricular (RV)/cardiac failure (7.7%), and pneumonia (5.0%). The most common SAEs were RV/cardiac failure (7.4%), pneumonia (4.1%), dyspnea (3.6%), and syncope (2.5%). Exposure-adjusted rates of hemoptysis/pulmonary hemorrhage and hypotension were low and comparable to those in the long-term extension study of riociguat (Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase–Stimulator Trial [CHEST-2]). Conclusion: Data from EXPERT show that in patients with CTEPH, the safety of riociguat in routine practice was consistent with the known safety profile of the drug, and no new safety concerns were identified