Cardiosense Presents New Clinical Analysis of SEISMIC-HF I Data on AI-Enabled Volume Assessment in Heart Failure at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 Scientific Symposium

CHICAGO--(BUSINESS WIRE)--Cardiosense, a digital health company pioneering AI-enabled solutions for cardiac disease management, today announced a new subgroup analysis of clinical data from the SEISMIC-HF I study at the Cardiovascular Research Foundation's 2025 annual Transcatheter Cardiovascular Therapeutics^® (TCT^®) scientific symposium. The analysis examined the prescribed medications for symptomatic patients hospitalized with acute decompensated heart failure (ADHF), highlighting the potential that noninvasive pulmonary capillary wedge pressure (PCWP) assessment could have in guiding individualized therapy adjustment in the hospital setting.

Anjan Tibrewala, MD, of Northwestern Medicine's Bluhm Cardiovascular Institute, presented the analysis as a moderated abstract titled, “Low Filling Pressures in Patients with Acute Exacerbation of Heart Failure with Reduced Ejection Fraction (HFrEF) as Identified with a Novel Sensor: A Sub-Analysis of the SEISMIC-HF I Study” (abstract TCT-558). Key findings suggest that a noninvasive method for volume assessment could potentially reduce excessive diuretic use and help providers optimize guideline-directed medical therapy (GDMT). The analysis in 76 patients with HFrEF hospitalized with ADHF showed:

• 29 patients (26%) with a catheterization-measured PCWP ≤15 mmHg, suggesting that low filling pressures occur frequently and the reflex treatment of increased diuretic use in the setting of physical exam findings of congestion may not be appropriate
• Among those 29 patients with low-to-normal PCWP, 19 (66%) were receiving diuretic therapy and only 10 (34%) were on quadruple guideline-directed medical therapy (GDMT)

“Managing volume status is one of the most challenging and consequential aspects of care in heart disease, even in the hospital where volume can only be accurately assessed invasively in the cath lab or intensive care unit today,” said John Martin, MD, MBA, EVP and Chief Medical Officer of Cardiosense. “Our SEISMIC-HF I analysis at TCT this year underscores the need for more accessible, noninvasive methods of volume assessment to help guide clinical decision making. We have the potential to aid providers in better optimizing medical therapy with our noninvasive wearable CardioTag™ device and PCWP_AI algorithm.”

This subgroup analysis follows results from the SEISMIC-HF I study showing that the noninvasive CardioTag device and AI algorithm can estimate PCWP with accuracy on par with implantable sensors, recently published in the Journal of the American College of Cardiology: Heart Failure.

About Cardiosense

Cardiosense is a digital health company pioneering AI-enabled solutions for precision cardiac care. Its platform leverages advanced biosensors and predictive analytics to enable early detection of cardiac disease and intervention, with the goal of leveraging personalized therapy to reduce hospitalizations, improve outcomes, and lower healthcare costs. Headquartered in Chicago, Cardiosense has advanced its platform with regulatory clearance and peer-reviewed clinical validation to shape the future of heart health. For more information, visit www.cardiosense.com and follow Cardiosense on LinkedIn and X.

The CardioTag device has been cleared to market as a class II medical device.

PCWP Analysis Software is an investigational device pending FDA approval.