Key result
CardioMEMS linked to ~69% fewer HF hospitalizations in NYHA class III patients, without device complications.
Why the study?
The study was conducted to analyze the feasibility, safety, and clinical benefit of the CardioMEMS HF System in different healthcare systems outside the United States.
Does the CardioMEMS HF System reduce heart failure hospitalizations and demonstrate safety in NYHA class III patients outside the USA?
Does the CardioMEMS HF System reduce heart failure hospitalizations and demonstrate safety in NYHA class III patients outside the USA?
The CardioMEMS HF System is safe and associated with a 69% reduction in heart failure hospitalizations in a real-world, non-US cohort of NYHA class III patients.
May be considered in NYHA class III HF outside the US; extends RCT evidence to real-world post-market cohorts.[[1]](https://academic.oup.
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.
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Groote et al. (2026) studied this question. The CardioMEMS HF System reduced heart failure hospitalizations by 69% (RR 0.31) at one year post-implant in NYHA class III patients, with zero device-related complications at two years.
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