Abbott’s CardioMEMS Sensor Shows Improved QOL, Reduction of HF Hospitalizations in Dutch Study

June 2, 2023—Abbott recently announced the presentation of data from an investigator-sponsored European MONITOR-HF trial demonstrating that managing indicated heart failure (HF) patients with the company’s CardioMEMS HF system resulted in a significant improvement in patient-reported quality-of-life scores as early as 3 months after use with the remote monitoring sensor. MONITOR-HF also showed a significant 44% reduction in HF-related hospitalizations among chronic HF patients who used guideline-directed medical therapy (GDMT).

MONITOR-HF was designed and run by the Erasmus University Medical Center in Rotterdam, the Netherlands. Jasper J. Brugts, MD, Associate Professor at Erasmus Medical Center, is the trial’s Principal Investigator. The trial was funded by the Dutch Ministry of Health with clinical research organization costs paid by Abbott.

Abbott noted that MONITOR-HF is the third randomized controlled clinical trial globally to show a significant health benefit and quality-of-life improvement for HF patients using the CardioMEMS HF system.

The MONITOR-HF results were delivered as a late-breaking presentation at the European Society of Cardiology’s Heart Failure 2023 conference held May 20-23 in Prague, Czechia. Simultaneously, the study was published online by Dr. Brugts et al in The Lancet.

According to the company, the MONITOR-HF trial met its primary endpoint and found that HF 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 score compared to patients in the control group who did not receive the pressure sensor and whose scores decreased.

“The Dutch health care system is known for its structured approach to HF management at outpatient clinics with general access to GDMTs,” commented Dr. Brugts in Abbott’s press release. “This approach raises the bar, making the MONITOR-HF results even more meaningful given that patients who were already receiving a high standard of care reported significant improvements in their quality of life while using the CardioMEMS monitoring system.”

Abbott advised that the MONITOR-HF is a prospective, randomized study with 348 patients enrolled in 25 centers in the Netherlands, representing one-third of the country’s hospitals. Patients had New York Heart Association class III HF with a previous HF-related admission or an urgent care visit requiring intravenous diuretics within the past year. Patients were randomly assigned to either hemodynamic monitoring using the Abbott CardioMEMS or the standard of care for HF management using GDMT.

In the Netherlands, all participating sites had dedicated outpatient clinics where patients were seen at 3 months, 6 months, and every 6 months thereafter. Patients implanted with the Abbott CardioMEMS device were managed for at least 1 year, and risk for complications remained low at 2.3%, which is consistent with previous investigations.

The CardioMEMS sensor first received approval from the FDA in 2014 and European CE Mark approval in 2016. The paperclip-sized CardioMEMS sensor is placed in the pulmonary artery during a minimally invasive procedure. The device monitors for pressure changes that indicate worsening HF and wirelessly transmits daily readings to a patient’s clinical team, noted the company.