Ventric Health has announced publication of outcomes from the US Food and Drug Administration (FDA) validation study demonstrating the accuracy of the novel Vivio system in non-invasively detecting heart failure using left ventricular end-diastolic pressure (LV-EDP). The manuscript was published online in the Journal of the American Heart Association (JAHA).
The study included 728 patients recruited at eight US sites and demonstrated that the Vivio system achieved 80% sensitivity and 83% specificity in non-invasively detecting heart failure using LV-EDP.
The system demonstrated six times greater sensitivity than echocardiography and twice the sensitivity of B-type natriuretic peptide (BNP) blood tests, two commonly used and guideline-accepted, non-invasive heart failure measurement methods. In the study, the Vivio system algorithm was trained with and tested against LV-EDP data obtained from simultaneous recordings using an indwelling Millar Mikro-Cath catheter in the left ventricle.
The authors concluded: “The Vivio system can accurately detect elevated LVEDP and has the potential to significantly improve early detection of HF in the outpatient setting.”
They added: “Integrating the Vivio system into routine care pathways may shift heart failure diagnosis from reactive to proactive management, particularly for individuals with comorbidities such as diabetes mellitus or chronic kidney disease. By identifying patients before heart failure decompensation occurs the Vivio system may support earlier initiation of guideline-directed medical therapy (GDMT), which can improve outcomes and reduce hospitalisations.”
A recent study of more than 2,000 patients published in JACC: Advances showed that the Vivio system accurately identified previously undiagnosed heart failure patients who could benefit from further treatment to improve or manage their condition. Almost one-quarter of the patients identified by the Vivio System as having elevated LV-EDP reported substantial symptoms and impaired health status associated with higher risks of hospitalisation and death.
Additionally, a study of 1,179 patients presented at the Heart Failure Society of America (HFSA) annual scientific meeting (26 – 29 September, Minneapolis, USA) found that 71% of previously asymptomatic patients with a high risk for developing heart failure (stage A heart failure patients) who tested positive for elevated LV-EDP using the Vivio system also reported concerning symptoms on the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) that led to their reclassification as stage C heart failure patients.
