Continuous Remote Haemodynamic Monitoring With CardioMEMS™ Following Pulmonary Endarterectomy in Chronic Thromboembolic Pulmonary Hypertension:

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. Chronic thromboembolic pulmonary hypertension (CTEPH) is a potentially curable form of pulmonary hypertension caused by persistent organized thromboembolic obstruction of the pulmonary arteries together with secondary pulmonary microvascular remodeling. Pulmonary endarterectomy (PEA) is the treatment of choice for operable disease and results in normalization of pulmonary haemodynamics in many patients. However, a substantial proportion of patients develop persistent or residual pulmonary hypertension after surgery, which is associated with persistent symptoms, right ventricular dysfunction, need for additional balloon pulmonary angioplasty or pulmonary hypertension-targeted therapy, and worse long-term outcomes. Current postoperative follow-up combines clinical evaluation, laboratory biomarkers, transthoracic echocardiography, pulmonary function tests, cardiopulmonary exercise testing (CPET), and right heart catheterization (RHC). Although RHC remains the reference standard for haemodynamic assessment, it provides only isolated measurements and cannot characterize the dynamic haemodynamic changes occurring during the early postoperative period. Consequently, the temporal pattern of pulmonary artery pressure recovery following PEA remains largely unknown. The CardioMEMS™ HF System is a wireless implantable pulmonary artery pressure sensor that enables continuous remote monitoring of pulmonary artery pressures through daily measurements. Although its safety and clinical benefit have been demonstrated in patients with heart failure, experience in patients with CTEPH is currently lacking. In this study, the device will be implanted intraoperatively under direct surgical visualization during PEA, avoiding the need for an additional percutaneous implantation procedure.\*\* The CTEPH-CardioMEMS study is a prospective, single-centre, exploratory observational study designed to characterize the postoperative trajectory of mean pulmonary artery pressure after PEA. The primary endpoint is the time from surgery to haemodynamic stabilization, defined according to a pre-specified longitudinal criterion based on daily CardioMEMS™ measurements. Secondary objectives include evaluating the relationship between continuous haemodynamic data and clinical status, laboratory findings, right ventricular remodeling assessed by echocardiography, invasive haemodynamics obtained by RHC, functional capacity assessed by CPET, quality of life, need for pulmonary hypertension-specific therapy, balloon pulmonary angioplasty, and clinical outcomes. Given its pilot nature, the study incorporates a risk-enrichment strategy aimed at preferentially including patients considered to be at increased risk of residual pulmonary hypertension, while maintaining consecutive screening of all patients discussed by the multidisciplinary CTEPH team. The study is intended to provide the first comprehensive description of continuous haemodynamic recovery after PEA, assess the feasibility and safety of CardioMEMS™ monitoring in this population, and generate data to support future multicentre confirmatory studies