Chronic thromboembolic pulmonary hypertension (CTEPH) is potentially curable by pulmonary endarterectomy (PEA), although a substantial proportion of patients develop residual pulmonary hypertension despite successful surgery. Currently, postoperative haemodynamic assessment relies on intermittent right heart catheterization, which does not provide information on the temporal evolution of pulmonary artery pressures during recovery.
The CTEPH-CardioMEMS study is a prospective, single-centre observational study evaluating the feasibility and clinical utility of continuous haemodynamic monitoring using the CardioMEMS™ system implanted intraoperatively during PEA. The primary objective is to characterize the postoperative trajectory of mean pulmonary artery pressure (mPAP), determine the time to haemodynamic stabilization, and explore the relationship between continuous pressure monitoring and clinical, echocardiographic, invasive haemodynamic and functional recovery.
Age ≥18 years. 2. Confirmed diagnosis of CTEPH according to current international guidelines. 3. Multidisciplinary indication for pulmonary endarterectomy. 4. Considered suitable for intraoperative CardioMEMS™ implantation. 5. Ability to comply with remote monitoring and scheduled follow-up. 6. Written informed consent.
Age <18 years.
Inability or unwillingness to provide written informed consent.
Contraindication to CardioMEMS™ implantation according to the manufacturer's instructions for use or investigator judgement.
Life expectancy <1 year due to a non-cardiopulmonary comorbidity.
Hospital Universitario 12 de Octubre
Lead sponsor
Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre
Collaborator
Complutense
Collaborator
Universidad Complutense de Madrid
Collaborator