New Study Demonstrates Vivio System From Ventric Health Enables Early Detection of Heart Failure and Effective Triage of Symptomatic Patients in Primary Care Setting

PASADENA, Calif.--(BUSINESS WIRE)--Ventric Health, a medtech innovator enabling early detection of heart failure (HF) in a primary care setting, today announced publication of a study showing that the company’s Vivio System used with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in primary care practices accurately identified previously undiagnosed HF patients who could benefit from further treatment to improve or manage their condition. The article appears in the current issue of JACC: Advances.

“In an average of five minutes and in one visit, PCPs can now accurately diagnose and assess the burden of heart failure in high risk patients,” said Thomas Cheek, Chief Medical Officer for Ventric Health.

Share

Today, most patients are first diagnosed with HF in the emergency room (ER) or hospital, often with significant symptoms, disease progression and quality of life impact.¹ The gold standard measure to diagnose their HF – elevated left ventricular end-diastolic pressure, or filling pressure (LVEDP) – has historically been obtained in an invasive, in-hospital catheterization procedure, limiting its accessibility.

The FDA-cleared Vivio System empowers earlier HF detection by enabling LVEDP measurement non-invasively in a five-minute test performed in a single primary care office visit, with the goal of earlier intervention before a patient’s quality of life deteriorates.

The study authors stated, “Combining the KCCQ with non-invasive LVEDP assessment (using the Vivio System) is a promising strategy to identify a significant number of patients who may benefit from further HF evaluation and treatment, potentially improving their health status and reducing clinical events.”

In the study, the Vivio System was used to non-invasively screen 2,040 patients over the age of 65 having diabetes or chronic kidney disease (CKD) for elevated LVEDP. The 38.5% of those patients who exhibited elevated LVEDP were then given the KCCQ questionnaire to assess their HF symptom burden and quality of life. Almost one-quarter of the patients with elevated LVEDP reported substantial symptoms and impaired health status consistent with NYHA functional class II-IV. This health status is associated with higher risks of HF hospitalization and death, and these patients are commonly prescribed medication or referred to a cardiologist for further assessment or treatment to manage their condition, at their primary care physician’s discretion.

Interestingly, a higher proportion of women were identified with newly-diagnosed HF than men, reinforcing previously published research suggesting delayed HF diagnoses in women.

“In an average of five minutes and in one visit, PCPs can now accurately diagnose and assess the burden of heart failure in high risk patients with our Vivio System working in concert with the KCCQ,” said Thomas Cheek, Chief Medical Officer for Ventric Health. "We are proud of the role our technology is playing in practices across the country to make early heart failure diagnosis more accessible, leading to improved patient outcomes and greater clinician satisfaction. Through earlier disease identification, we are helping the healthcare system better control the high and growing costs of heart failure.”

ABOUT THE VIVIO SYSTEM

The Vivio System screens for elevated left ventricular end-diastolic pressure, or filling pressure (LVEDP) – the gold standard measure for HF – quickly and non-invasively using a blood pressure cuff, single-lead Bluetooth-enabled ECG, and proprietary algorithm. It is designed to assess patients at high risk of HF – those over the age of 65 with diabetes and/or CKD – in a primary care setting. The technology has demonstrated greater sensitivity than other non-invasive methods used to measure LVEDP today, including blood tests and echocardiograms. As a non-invasive test, the Vivio System does not present the risks or costs of LVEDP measurement using invasive cardiac catheterization.

More than 15,000 Vivio System tests have been performed to-date. Practices using the Vivio System have reported an increase in first-time HF diagnosis at primary care; decreased patient mortality, hospitalization and ER visits; and improved patient medication compliance and quality of life.²

The Vivio System screening fits into a typical primary care office visit, with results immediately available and actionable in the same visit, so a physician can quickly intervene with medication, a cardiology referral, or other necessary HF management strategy at their discretion.

ABOUT VENTRIC HEALTH

Ventric Health is on a mission to empower earlier diagnosis of heart failure, enabling earlier intervention and better patient cardiac health. Its Vivio System helps non-invasively diagnose HF within a primary care environment, moving screening to a more accessible and less expensive point of care, and away from the ER and in-patient hospital setting. By doing this, the company intends to enable value-based care organizations and healthcare teams to lower costs and improve patient lives. To learn more, visit https://www.ventrichealth.com/.

References:

1. Hayhoe B, Kim D, Aylin PP, Majeed FA, Cowie MR, Bottle A. Adherence to guidelines in management of symptoms suggestive of heart failure in primary care. Heart. 2018;105(9):678-685. doi:https://doi.org/10.1136/heartjnl-2018-313971.
2. Data on file. Ventric Health.