Meta-Analysis Reinforces Role of Remote Monitoring Technology to Improve Survival in HF Patients

March 21, 2023—Abbott announced new data that showed monitoring patients remotely with hemodynamic pressure sensing technology, such as with the company’s CardioMEMS HF system, can significantly improve survival in heart failure (HF) patients with reduced ejection fraction (HFrEF). The analysis gives doctors specific insight into how remotely monitoring patients with technology like CardioMEMS can provide an early warning against worsening HF and significantly reduce mortality risk by 25% at 2 years in HFrEF patients.

The meta-analysis of three randomized, controlled trials (CHAMPION, GUIDE-HF, and LAPTOP-HF) was presented at THT 2023, the second annual Technology and Heart Failure Therapeutics conference organized by the Cardiovascular Research Foundation and held March 20-23 in Boston, Massachusetts.

According to the company, the data reinforce that remote monitoring technology like CardioMEMS—in addition to providing an early warning system against worsening HF—can help doctors more proactively make changes to a patient’s treatment plan before the disease advances, often resulting in repeat hospitalizations. Because a patient’s risk of mortality significantly rises with each HF-related hospitalization, it is critical that treatment plans aim to manage the disease and keep patients out of the hospital, noted Abbott’s press release.

JoAnn Lindenfeld, MD, Professor of Medicine at Vanderbilt University Medical Center in Nashville, Tennessee, is an investigator for the meta-analysis.

“The incidence of HF is a growing epidemic that affects more than 6.2 million Americans—and nearly half of those hospitalized for HF die within a year of their first admission,” commented Dr. Lindenfeld in Abbott’s press release. “This analysis confirms that remote pressure monitoring is a life-extending option that reduces hospitalizations and should be considered for those with this type of weak heart.”

In the analysis, data from the CHAMPION, GUIDE-HF, and LAPTOP-HF trials were combined to assess the mortality and HF hospitalizations of 1,350 HFrEF patients. Among the three randomized trials, more than 650 patients underwent hemodynamic monitoring and 684 received the control. HF hospitalizations were analyzed during a 12-month follow-up period and all-cause mortality was evaluated across 24 months.

The meta-analysis validated that hemodynamic monitoring can slow the progression of HF in HFrEF patients by significantly decreasing HF-related hospitalizations and improving survival, stated Abbott.

According to Abbott, the CardioMEMS sensor provides an early warning system enabling doctors to protect against worsening HF. The paperclip-sized device is placed in the pulmonary artery during a minimally invasive procedure. It monitors for pressure changes that indicate worsening HF and wirelessly transmits daily readings to a patient’s clinical team to manage the patient's condition from virtually anywhere.

The CardioMEMS HF system is approved for use in patients with New York Heart Association (NYHA) class II or III HF who either have been hospitalized for HF in the previous year or for patients who undergo a blood test showing elevated levels of natriuretic peptides.

The CardioMEMS sensor first received FDA approval in 2014 for use in NYHA class III HF patients with a HF hospitalization within the previous year. In February 2022, Abbott announced that the FDA has approved an expanded indication for the company’s CardioMEMS HF system to support the treatment of patients with class II HF and for patients with elevated levels of natriuretic peptides. The expanded indication was supported by clinical data from the GUIDE-HF trial.