Résumé
Abstract Aims The aim of this study was to analyse the feasibility, safety, and clinical benefit of the CardioMEMS HF System in different healthcare systems outside the United States of America. Methods and results Prospective, open-label registry of NYHA class III patients with at least one heart failure hospitalization (HFH) within 12 months before enrolment, regardless of left ventricular ejection fraction. The primary safety endpoints assess the freedom from device/system-related complications (DSRC) and freedom from pressure sensor failure (PSF) at 2 years post-implant. The primary efficacy endpoint was the rate of HFH one year before and one year after implantation. Three hundred and four patients from 37 centres in 6 countries underwent a CardioMEMS implant procedure, which was successful in 98.3% of the cases. At 2 years, there were no DSRCs and only 1 PSF. There were 517 HFH in the year before implant compared with 144 HFH in the year post-implant (risk reduction: 69% (RR: 0.31 95% CI [0.25–0.37]; P < 0.0001). Pulmonary artery (PA) pressures were significantly lowered (mean PA pressure reduction: −3.07 ± 5.91 mmHg, P < 0.0001) with a significant improvement in functional class and quality of life (mean EQ-5D-5L visual analogue score increase 8.1 ± 22.7, P < 0.0001). Conclusion The results of the COAST study demonstrate that the CardioMEMS HF System is a reliable device, with no device-related complications and very few pressure sensor failures. Its use is associated with a substantial HFH risk reduction, with a significant reduction in PA pressures, an improvement in NYHA classification, and an improvement in quality of life. Clinical registration number ClinicalTrials.gov Identifier: NCT02954341.