Ventric Health's Vivio® System Demonstrates High Scalability and Operational Feasibility for Population-Level Heart Failure Screening in New Peer-Reviewed Study

The paper, titled "Noninvasive left ventricular end-diastolic pressure assessment using a novel workflow and device in primary care settings to enhance heart failure diagnosis," underscores the clinical utility and operational feasibility of using the Vivio System within a dedicated, high-throughput "heart health clinic" to capture hidden cardiovascular disease in at-risk populations.

Key Findings: High Screening Yield and Operational Efficiency

The study, authored by Faisal Amlani et al., evaluated a streamlined, 15-minute screening workflow across 25 primary care sites. Dedicated medical assistant "superusers" administered the non-invasive tests independent of either a standard problem-focused visit or an Annual Wellness Visit (AWV).

Key results from the 1,238 high-risk patients evaluated include:

• High Diagnostic Success: The Vivio System achieved a 92.2% conclusive diagnostic rate (1,141 patients), proving its robustness in fast-paced, outpatient environments.
• Substantial Disease Detection: Elevated left ventricular end-diastolic pressure (LVEDP > 18 mmHg)—a critical objective marker of cardiogenic congestion—was identified in 40.1% of screened patients.
• Uncovering Asymptomatic Heart Failure: Among the patients with elevated LVEDP who completed the integrated digital Kansas City Cardiomyopathy Questionnaire (KCCQ-12), 42.3% were classified as asymptomatic Stage B heart failure (KCCQ score = 100). The remaining 59.8% were classified as symptomatic Stage C heart failure and of these 12.7% were classified as New York Heart Association (NYHA) Class II-III/IV functional status.
• No Selection Bias: The workflow successfully identified elevated LVEDP without introducing demographic or clinical bias related to age or body mass index (BMI).

Reshaping Primary Care Heart Failure Paradigms

Traditionally, identifying elevated filling pressures required invasive left-heart catheterization or specialized, low-sensitivity imaging techniques. The Vivio System replaces these methods with a non-invasive, five-minute test that analyzes cardiac pressure and volume waveforms in any outpatient setting.

"These findings demonstrate that the Vivio-facilitated screening workflow can be seamlessly integrated into scalable, population-level care models," said Thomas Cheek, MD, Chief Medical Officer at Ventric Health. "By enabling medical assistants to drive the acquisition protocol independently, health systems can efficiently identify asymptomatic Stage B patients before irreversible cardiac structural changes occur."

This study adds to Vivio's rapidly expanding body of clinical evidence, which includes a 2026 multicenter JAHA validation study, a 2025 Heart Failure Society of America (HFSA) abstract on pre-symptomatic Stage A detection, and a JACC: Advances study evaluating primary care screening paradigms. By demonstrating that numbers and detection rates remain highly consistent across diverse care centers and workflows, this publication proves that Vivio is uniquely positioned to standardize proactive heart failure screening nationwide.

About the Vivio® System

The Vivio System identifies elevated left ventricular end-diastolic pressure (LVEDP) non-invasively using an advanced, physics-based analysis of cardiac pressure and volume waveforms. Performed at the point of care in under five minutes, the test requires no imaging, specialist referrals, or invasive procedures. Vivio pairs objective, physiologic data with the digital Kansas City Cardiomyopathy Questionnaire (KCCQ-12) to provide clinicians with a definitive diagnosis of heart failure which in turn allows them to immediately begin guideline-directed medical therapy (GDMT) including prescribing SGLT-2i and other medications that significantly improve the trajectory of heart failure. Learn more at www.ventrichealth.com/vivio-system.

About Ventric Health

Ventric Health is a pioneering medical technology company dedicated to enabling the early detection of heart failure at the point of care. The Vivio® System is trusted by leading health systems, Medicare Accountable Care Organizations (ACOs), and primary care groups across the United States to capture hidden cardiovascular risk. Ventric Health is headquartered in Pasadena, California. Learn more at www.ventrichealth.com.

SOURCE Ventric Health