Effect of Pulmonary Artery Pressure-Guided Management on Outcomes of Patients with Heart Failure Outside Clinical Trials: A Systematic Review and Meta-Analysis of Real-World Evidence with the CardioMEMS Heart Failure System

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AIMS: Pulmonary artery pressure (PAP)-guided heart failure (HF) management using the CardioMEMS HF System improves patient outcomes in randomized controlled trials (RCTs). Our aim was to systematically assess its impact on outcomes of HF patients receiving the device in a non-RCT setting. METHODS AND RESULTS: PubMed, ClinicalTrials.gov and Cochrane Clinical Trial Collection were searched on 8 January 2025. Studies were eligible if they included: (i) pre/post-comparison of outcomes in patients receiving CardioMEMS; (ii) adult patients diagnosed with HF; (iii) follow-up ≥6 months, and (iv) report of the primary outcome, i.e. HF hospitalization (HFH) rates. Other outcomes were changes in PAP, New York Heart Association (NYHA) class and quality of life. Quantitative analysis was performed by generating forest plots and calculating pooled means, mean differences and incidence rate ratio (IRR) by random-effect models, as appropriate. Eight studies with a total of 3306 patients were included. Four studies were single-arm, open-label, industry-funded studies and four real-world practice studies. Four studies were performed in the US and four in Europe. Significant decreases in systolic PAP (-7.8 mmHg [-10.1 mmHg; -5.6 mmHg]), mean PAP (-5.2 mmHg [-6.7 mmHg; -3.8 mmHg]) and diastolic PAP (-4.4 mmHg [-5.5 mmHg; -3.3 mmHg]) were demonstrated. One year after CardioMEMS implantation, 56% [43%; 67%] of patients were NYHA class I/II with EQ-5D-5L visual analogue scale scores being significantly improved from baseline (7.2 [3.5; 10.9]). PAP-guided HF management was associated with a significant, 61% decrease in HFHs at 1 year (IRR 0.39 [0.31; 0.47]). CONCLUSIONS: Heart failure management with CardioMEMS leads to lower PAP, improved functional status and quality of life, and decrease of HFHs at 1 year in patients receiving the device in a real-life, non-RCT setting. SYSTEMATIC REVIEW REGISTRATION: PROSPERO database registration number CRD42025635206.

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