TOPLINE:

In patients hospitalized with acute decompensated heart failure (HF), the preCARDIA system, which included a next‑generation lower‑profile device, was feasible and safe; it reduced right and left heart filling pressures and increased urine output.

METHODOLOGY:

• Prior work has shown that preCARDIA is safe and feasible for intermittently occluding the superior vena cava to lower cardiac filling pressures in acute decompensated HF. Researchers reported findings from the prospective multicenter study which also evaluated a next-generation device with a reduced-profile sheath and updates to tubing and software.
• Between July 2019 and November 2024, researchers enrolled 60 adults with acute decompensated HF and elevated filling pressures, all of whom had New York Heart Association functional class III-IV and systolic HF, and at least two symptoms of venous congestion. The mean age was 65 years, and 68% were men.
• Across phases, 30 patients received the first‑generation device and 30 received the next‑generation. A catheter was placed via the internal jugular vein to intermittently occlude the superior vena cava for up to 24 hours while standard diuretics were continued.
• The primary endpoint was freedom from device- or procedure-related major adverse events. Secondary endpoints included technical success, changes in right atrial and wedge pressures, and urine output.
• Hemodynamics were assessed at baseline, end of support, and 3 hours post‑removal of the device. Symptoms and patient‑reported outcomes were assessed at 24 hours post‑removal.

TAKEAWAY:

• Freedom from device- or procedure-related major adverse events was achieved in 98% of patients, with successful device deployment and removal in all patients.
• In patients with 24 hours of support, mean right atrial pressure declined by 35% (P < .0001) and pulmonary capillary wedge pressure declined by 18% (P < .0001), with reductions persisting 3 hours after removal of the device.
• Mean total urine output rose from 2.3 L before using the device to 5.4 L during support (P < .001) and 3.5 L afterward (P = .002). Net fluid output also improved during support and afterward (P < .05 for both).
• Levels of brain natriuretic peptide decreased at 24 hours post-device use (P = .0031). No device- or procedure-related deaths, myocardial infarctions, hemorrhagic strokes, neurologic events, or major thromboembolic events were reported.

IN PRACTICE:

“Existing approaches with diuretic escalation to treat ADHF [acute decompensated HF] have failed to show significant benefit and are associated with important side effects like acute and chronic kidney injury,” the researchers of the study reported.

“The findings from [this] study demonstrate the feasibility and safety of the preCARDIA device in the treatment of patients with ADHF,” they added.

SOURCE:

This study was led by Rayan Yousefzai, MD, of Houston Methodist Hospital in Houston. It was published online on December 13, 2025, in JACC: Heart Failure.

LIMITATIONS:

This study had a single-arm design and a small sample size and lacked randomization. Doctors adjusted diuretics at their discretion, which may have limited generalizability of the findings. The follow-up duration was short; thus, the durability of the treatment effects could not be assessed.

DISCLOSURES:

This study received funding from preCARDIA Inc and Johnson & Johnson MedTech-Heart Recovery. Three authors reported being employees of Johnson & Johnson MedTech, Abiomed, and one author of Edwards LifeSciences. Several authors reported receiving consulting fees, research support, grants from, serving on various boards of, and/or holding stocks and having other financial ties with multiple pharmaceutical, biotechnology, and healthcare companies including Abbott, Novo Nordisk, and BridgeBio.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.