Noninvasive Monitoring Device Enables Earlier Intervention in Heart Failure

Missed early decompensation drives repeat admissions, higher mortality, and medication complexity for outpatient teams. Researchers now report that guiding therapy with a noninvasive lung-congestion monitor reduced clinical events in patients with preserved ejection fraction. The approach was evaluated in a long-term, prospective study and presented at a major cardiology meeting.

The CardioSet Edema Guard Monitor (CardioSet Medical) is a noninvasive system that quantifies pulmonary congestion by measuring changes in lung impedance. As fluid accumulates, electrical resistance in the lungs decreases. The device applies a multi-electrode configuration that calculates and subtracts chest-wall signal “noise,” enabling more accurate tracking of small changes in lung fluid status.

In a single-center randomized study, 150 patients with HFpEF were assigned to lung-impedance–guided care or standard care during monthly outpatient visits. CardioSet measurements were obtained at each visit for all participants, but treating physicians saw the readings only in the guided arm and adjusted therapy per protocol. Baseline characteristics and visit frequency were similar between groups, and patients were followed for a median of 38.4 months.

Recurrent heart failure hospitalization was the primary endpoint. Investigators recorded 19 events in the lung-impedance–guided group versus 93 with standard care, a 74% reduction. Time to first hospitalization averaged 602 days with guided care compared with 83 days with standard management. All-cause mortality was 60% lower and heart failure mortality 74% lower with guided care over three years, with no device-related adverse events. Clinicians using the device modified medications more than twice as often and at earlier stages of congestion.

The device had previously improved outcomes in patients with reduced ejection fraction (HFrEF), and the new findings indicate greater benefit in HFpEF. Investigators suggested this may reflect a stronger diuretic response in HFpEF and greater clinician confidence from prior trials. The study, presented at the American College of Cardiology’s Annual Scientific Session (ACC.26) in New Orleans, was limited to a single center; a multinational, multicenter trial was identified as a next step.

“This device offers a way to change the treatment of patients with heart failure in order to start treatment early—before the patient starts to experience symptoms. The secret of success is to enable us to intervene at the preclinical stage when the reaction to treatment is more powerful,” said Michael Kleiner-Shochat, MD, professor and head of the heart failure clinic at Hillel Yaffe Institute of Cardiology in Hadera, Israel.

“It’s a simple, scalable device that could be used at each point of care—in clinics and, in the future, in the patient’s home—and you can get indications about the patient’s lung fluid status very quickly,” said Kleiner-Shochat, who is also the founder of CardioSet Medical and a member of its Board of Directors.

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American College of Cardiology