New data presented from an investigator-sponsored European trial found managing indicated heart failure patients with Abbott’s CardioMEMS HF system resulted in a significant improvement in patient-reported quality-of-life scores as early as three months after use with the remote monitoring sensor.
The MONITOR-HF trial also resulted in a significant 44% reduction in heart failure-related hospitalisations among chronic heart failure patients who used guideline-directed medical therapy (GDMT). GDMT refers to the European and US guidelines for heart failure management that uses a combination of up to four heart medications. MONITOR-HF is the third randomised, controlled clinical trial globally to show a significant health benefit and quality-of-life improvement for heart failure patients using the CardioMEMS HF System.
The MONITOR-HF results were announced as a late-breaking presentation at the European Society of Cardiology’s annual meeting of the Heart Failure Association (20 May, Prague, Czech Republic) and simultaneously published in The Lancet. The trial was funded by the Dutch Ministry of Health with clinical research organisation costs paid by Abbott.
The MONITOR-HF trial met its primary endpoint and found that heart failure participants who received a CardioMEMS sensor reported a clinically meaningful improvement in their quality-of-life as quantified by a seven-point mean increase on the Kansas City Cardiomyopathy Questionnaire’s (KCCQ) score compared to patients in the control group, who did not receive the pressure sensor and whose scores decreased.
In heart failure, the KCCQ is a clinical standard assessment that has been recommended to capture and measure patient-reported quality of care. The questionnaire asks patients how difficult it is to complete common activities such as walking a short distance, doing household chores and socialising with family and friends.
Andrew Flett (University Hospital Southampton, Southampton, UK), said: “The results from the MONITOR-HF trial mirror what we have seen in practice with quick and sustained improvements in quality-of-life for patients with heart failure.
“When you balance the patient benefits from these latest findings, with how considerably Abbott’s CardioMEMS sensor can cut heart failure-related hospitalisations and free-up vital NHS resources, it solidifies exactly why this should be standard of care for at-risk heart failure patients across the UK. “
The CardioMEMS sensor is a paperclip-sized device that, once placed in the pulmonary artery during a minimally invasive procedure, monitors for pressure changes that indicate worsening heart failure.
“Heart Failure is a global health problem with a devastating impact on patient lives and high rate of morbidity and mortality,” said Philip B. Adamson, chief medical officer of Abbott’s heart failure business. “These results demonstrate once again that a proactive, remote-centred approach using pressure monitoring with CardioMEMS leads to better health outcomes and higher patient satisfaction across multiple health indicators than medication alone.”