Ventric Health, a medical technology company focused on early heart failure detection in primary care, announced the publication of its FDA validation study results in the Journal of the American Heart Association. The study confirmed that the Vivio System can non-invasively measure left ventricular end-diastolic pressure, the gold standard for diagnosing heart failure, with high accuracy. “The Vivio System can accurately detect elevated LVEDP and has the potential to significantly improve early detection of HF in the outpatient setting,” said the study authors.
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The FDA-approved Vivio System allows clinicians to measure LVEDP in a five-minute test during a single office visit, supporting early intervention before patient quality of life declines. The study involved 728 patients across eight U.S. sites and found that the system achieved 80 percent sensitivity and 83 percent specificity for heart failure detection. The Vivio System outperformed conventional methods, demonstrating six times higher sensitivity than echocardiography and twice that of B-type natriuretic peptide tests. The algorithm was trained and validated using precise LVEDP measurements obtained from an indwelling Millar Mikro-Cath catheter in the left ventricle.
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Authors highlighted that integrating Vivio into routine care could shift heart failure management from reactive to proactive, particularly for patients with comorbidities such as diabetes or chronic kidney disease. Earlier identification may allow timely initiation of guideline-directed medical therapy, improving outcomes and reducing hospitalizations. Additional studies of over 2,000 patients published in JACC: Advances demonstrated the system’s ability to identify previously undiagnosed HF patients at risk for hospitalization and reduced health status. Another study with 1,179 patients presented at the Heart Failure Society of America meeting showed that 71 percent of asymptomatic high-risk patients identified with elevated LVEDP using Vivio also reported concerning symptoms, leading to reclassification from Stage A to Stage C heart failure.
Elevated cardiac filling pressures are among the earliest indicators of heart failure and often occur before symptoms or structural changes in the heart, yet direct LVEDP measurement has traditionally required invasive procedures, limiting its use in broader clinical practice.
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