Article Impact Level: HIGH Data Quality: STRONG Summary of The Lancet, S0140673623009236. https://doi.org/10.1016/S0140-6736(23)00923-6 Dr. Jasper Brugts et al.
Points
- The MONITOR-HF trial in the Netherlands assessed the impact of hemodynamic monitoring on patients with chronic heart failure.
- Three hundred forty-eight (348) patients were randomly assigned to either receive hemodynamic monitoring (CardioMEMS-HF system) or standard care.
- The hemodynamic monitoring group showed a significant improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at 12 months compared to the standard care group.
- The responder analysis revealed higher odds of improvement and lower odds of deterioration in the hemodynamic monitoring group.
- The hemodynamic monitoring system demonstrated a low rate of device-related or system-related complications and sensor failure, indicating its safety and reliability.
Summary
This research paper presents the findings of the MONITOR-HF trial, a randomized trial conducted in the Netherlands to evaluate the impact of hemodynamic monitoring of pulmonary artery pressure on patients with chronic heart failure. The study, which included 348 patients, assigned 176 patients to the CardioMEMS-HF group and 172 patients to the control group. The median age of the participants was 69 years, and the median ejection fraction was 30%.
The trial’s primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at 12 months. The analysis revealed a statistically significant difference between the two groups, with a mean change of 7.13 (95% CI 1.51–12.75; p=0.013) in favor of the CardioMEMS-HF group. In the responder analysis, the odds ratio (OR) of an improvement of at least 5 points in the KCCQ overall summary score was 1.69 (95% CI 1.01–2.83; p=0.046) for the CardioMEMS-HF group compared to the standard care group. Furthermore, the OR of a deterioration of at least 5 points was 0.45 (95% CI 0.26–0.77; p=0.0035) in favor of the CardioMEMS-HF group.
The study also assessed the safety and reliability of the hemodynamic monitoring system. The freedom of device-related or system-related complications was reported to be 97.7%, indicating a low rate of such issues. Additionally, the sensor failure rate was 98.8%, demonstrating the robustness of the monitoring system.
Overall, the findings of this trial demonstrate that hemodynamic monitoring of pulmonary artery pressure significantly improved the quality of life and reduced heart failure hospitalizations in patients with moderate-to-severe heart failure who were treated according to current guidelines. These results provide valuable evidence supporting the use of remote monitoring technology and have potential implications for guideline recommendations and the implementation of pulmonary artery pressure monitoring in clinical practice.
Link to the article: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00923-6/fulltext
References Brugts, J. J., Radhoe, S. P., Clephas, P. R. D., Aydin, D., Van Gent, M. W. F., Szymanski, M. K., Rienstra, M., Van Den Heuvel, M. H., Da Fonseca, C. A., Linssen, G. C. M., Borleffs, C. J. W., Boersma, E., Asselbergs, F. W., Mosterd, A., Brunner-La Rocca, H.-P., De Boer, R. A., Emans, M. E., Beeres, S. L. M. A., Heerebeek, L., … Manintveld, O. C. (2023). Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (Monitor-hf): A randomised clinical trial. The Lancet, S0140673623009236. https://doi.org/10.1016/S0140-6736(23)00923-6
