Noninvasive Device Dramatically Cuts Heart Failure Hospitalizations and Deaths in HFpEF Patients

A new study, presented at the American College of Cardiology's Annual Scientific Session (ACC.26), reveals a significant breakthrough in managing heart failure with preserved ejection fraction (HFpEF). Treatment management guided by a noninvasive device that monitors fluid accumulation in the lungs significantly reduced hospitalizations and deaths among patients with HFpEF.

Patients receiving treatment guided by the device experienced a 74% reduction in heart failure hospitalizations and a 74% reduction in heart failure-related deaths over more than three years of follow-up.

Researchers attributed these remarkable outcomes to an improved ability to detect fluid buildup early and adjust medications based on the level of lung congestion. Clinicians in the guided group adjusted medications over twice as frequently and at an earlier stage of lung congestion compared to standard care.

Michael Kleiner-Shochat, MD, a professor and head of the heart failure clinic at Hillel Yaffe Institute of Cardiology in Hadera, Israel, and the study's first author, emphasized the device's impact:

"The device allows for early intervention in heart failure treatment before symptoms manifest, which can lead to more effective responses."

Understanding Heart Failure and the CardioSet Monitor

Heart failure occurs when the heart muscle is either too weak to pump effectively or too stiff to fill properly. This leads to reduced blood circulation and fluid accumulation (congestion) in the lungs. Worsening lung congestion is a primary cause of heart failure hospitalizations and is typically managed with diuretics to remove excess fluid.

The CardioSet Edema Guard Monitor, which tracks lung congestion, had previously demonstrated improved outcomes in patients with heart failure with reduced ejection fraction (HFrEF). The current study highlights even more pronounced benefits for HFpEF patients.

How the CardioSet Edema Guard Monitor Works

The device operates by measuring impedance, where lung resistance to electrical current decreases as fluid accumulates. The CardioSet device employs multiple electrodes to calculate and eliminate noise signals from the chest wall, allowing for accurate lung impedance assessment even with minor changes in fluid accumulation.

The Study: Design and Methodology

Researchers enrolled 150 HFpEF patients in the trial. Half were randomized to receive lung-impedance guided care during monthly outpatient visits, while the other half received standard care. Both groups shared similar baseline characteristics and visit frequency.

Pulmonary congestion was measured for all patients, but only physicians in the lung-impedance guided group were informed of the results, enabling them to adjust treatments according to study protocols. Patients were followed for a median of 38.4 months.

Significant Reductions in Hospitalizations

The study's primary endpoint was recurrent heart failure hospitalization.

• The lung-impedance guided group reported 19 events.
• The standard care group reported 93 events.

This represents a 74% reduction in heart failure hospitalizations in the guided arm. Furthermore, the average time to first heart failure hospitalization was 602 days for the guided group versus a mere 83 days for standard care.

Improved Mortality Rates

Mortality rates also showed significant improvement in the lung-impedance guided group over the three-year follow-up:

• These patients demonstrated a 60% lower rate of all-cause death.
• They also showed a 74% lower rate of heart failure-related death.

No device-related adverse events were reported during the study.

Why the Pronounced Benefits in HFpEF?

The study noted that the benefits observed in this trial surpassed those reported in a previous trial involving HFrEF patients. Potential reasons cited included clinicians' increased comfort with aggressive diuretic use based on monitoring signals and possible physiological differences in how HFpEF patients respond to diuretics compared to HFrEF patients.

Future Directions and Study Context

The trial was conducted at a single center. Researchers suggested that multi-site studies across different countries would be beneficial to confirm the feasibility and effectiveness of lung-impedance guided heart failure treatment in diverse settings. The study was funded internally by Hillel Yaffe Medical Center without external support.