Key result
CardioMEMS PAP guidance is linked to ~62% fewer HF hospitalizations versus the pre-implant period.
Why the study?
Benefits of pulmonary artery pressure-guided HF management with CardioMEMS had not been replicated in health systems outside the United States.
Does pulmonary artery pressure-guided heart failure management using the CardioMEMS sensor improve safety and reduce heart failure hospitalizations in NYHA class III patients?
Observational (n=234)
Yes
Does pulmonary artery pressure-guided heart failure management using the CardioMEMS sensor improve safety and reduce heart failure hospitalizations in NYHA class III patients?
Pulmonary artery pressure-guided heart failure management using the CardioMEMS system is safe, feasible, and associated with reduced heart failure hospitalizations and improved quality of life in European health systems.
Answers are grounded in this paper and cite their sources.
Supports reduced HF hospitalizations in European real-world use; extends prior data but leaves open need for randomized confirmation.
AIMS: Heart failure (HF) leads to repeat hospitalisations and reduces the duration and quality of life. Pulmonary artery pressure (PAP)-guided HF management using the CardioMEMS™ HF system was shown to be safe and reduce HF hospitalisation (HFH) rates in New York Heart Association (NYHA) class III patients. However, these findings have not been replicated in health systems outside the United States. Therefore, the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) evaluated the safety, feasibility, and performance of this device in Germany, The Netherlands, and Ireland. METHODS AND RESULTS: A total of 234 NYHA class III patients (68 ± 11 years, 22% female, ≥1 HFH in the preceding year) from 31 centres were implanted with a CardioMEMS sensor and underwent PAP-guided HF management. One-year rates of freedom from device- or system-related complications and from sensor failure (co-primary outcomes) were 98.3% [95% confidence interval (CI) 95.8-100.0] and 99.6% (95% CI 97.6-100.0), respectively. Survival rate was 86.2%. For the 12 months post- vs. pre-implant, HFHs decreased by 62% (0.60 vs. 1.55 events/patient-year; hazard ratio 0.38, 95% CI 0.31-0.48; P < 0.0001). After 12 months, mean PAP decreased by 5.1 ± 7.4 mmHg, Kansas City Cardiomyopathy Questionnaire (KCCQ) overall/clinical summary scores increased from 47.0 ± 24.0/51.2 ± 24.8 to 60.5 ± 24.3/62.4 ± 24.1 (P < 0.0001), and the 9-item Patient Health Questionnaire sum score improved from 8.7 ± 5.9 to 6.3 ± 5.1 (P < 0.0001). CONCLUSION: Haemodynamic-guided HF management proved feasible and safe in the health systems of Germany, The Netherlands, and Ireland. Physician-directed treatment modifications based on remotely obtained PAP values were associated with fewer HFH, sustainable PAP decreases, marked KCCQ improvements, and remission of depressive symptoms.
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Angermann et al. (2020) conducted an observational in Symptomatic Heart Failure (n=234). Pulmonary artery pressure (PAP)-guided HF management using the CardioMEMS HF system vs. 12 months pre-implant period was evaluated on Freedom from device- or system-related complications and from sensor failure (co-primary outcomes) (95% CI 95.8-100.0). Pulmonary artery pressure-guided HF management using the CardioMEMS system was safe and reduced HF hospitalisations by 62% compared to the pre-implant period (HR 0.38; 95% CI 0.31-0.48; P<0.0001).
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