Heart failure affects 6.5 million people in the USImmediately Another 550,000 new diagnoses are added every year. Hospital admissions for heart failure are the leading cause of admissions overall for people aged 65 and older hundreds of billions in terms of costs.
Sean Brady, CEO and co-founder of Ventric Health, is doing his part to reverse this problem. He heads the team behind a new FDA-approved heart device designed to help manage the challenges surrounding heart failure. Advanced algorithms for non-invasive diagnosis are intended as an alternative to conventional methods, enabling home and outpatient treatments that previously could only be performed in the hospital.
And a new study of the device that Brady presented at the 2023 American Heart Association Scientific Symposium shows promising results.
We interviewed Brady to discuss how this technology works, the results of the study, and how a hybrid care-at-home model can help overcome social determinants of health barriers and promote value-based healthcare outcomes.
Q. Please describe your new FDA-approved cardiac device for heart failure and discuss how it works.
A. We designed the Vivio system to reduce the impact of heart failure and slow its progression, helping value-based healthcare organizations improve clinical and health outcomes. It is the first medical device to enable non-invasive diagnosis of heart failure in a clinical or home care setting.
Heart failure is defined as the inability of the heart to pump enough blood to meet the body’s needs, or only at the expense of increased filling pressure, also known as elevated left ventricular end-diastolic pressure (LVEDP). The device is simple to use, yet advanced in function and usage advanced algorithms to detect elevated LVEDP non-invasively.
We use our algorithms and data-driven approach to deploy Vivio in healthcare, reducing the impact of cardiovascular disease and empowering healthcare teams to simultaneously reduce costs and improve patients’ lives.
Doctors can now perform an evaluative test in the clinic or at home in less than five minutes to help diagnose heart failure. Healthcare providers can access the Vivio application on any mobile tablet, place an ECG patch and arm cuff on the patient and connect effortlessly via Bluetooth.
The Vivio test collects cardiac data non-invasively in less than two minutes and analyzes the cardiac data in less than 60 seconds. The doctor receives the test results in real time.
Q. Your efforts are focused on advanced algorithms for non-invasive diagnosis, enabling home and outpatient treatments that previously could only be performed in the hospital. Please provide some more information.
A. Diagnosing heart failure can be time-consuming and difficult for patients and caregivers. Standard non-invasive procedures such as an echocardiogram require specialized equipment and technicians to perform an examination that can take 30 minutes or more, often requiring an additional appointment.
LVEDP is the gold standard for diagnosing heart failure, but relies on invasive catheterization, which requires specialized equipment and technicians, and inpatient procedures, and poses risks to the patient such as bleeding, artery damage, heart attack and a stroke.
Vivio, on the other hand, is designed for mobility and ease of use, making it an attractive alternative to traditional methods such as catheterization or echocardiograms. Its adaptability across different healthcare environments and the ability to deliver results in real-time increase clinical workflow efficiency while enabling patient-centered care.
Q. What were the results of the research you did on the device results you presented at the 2023 American Heart Association Scientific Symposium?
A. Vivio is the direct result of groundbreaking research in leading university laboratories – providing deep, unusual data about the human heart that is being used for the first time. In November 2023, Ventric Health presented at the American Heart Association Scientific Symposium, highlighting a pivotal study demonstrating the validation of a non-invasive brachial cuff ECG system for estimating elevated left ventricular end-diastolic pressure (LVEDP).
The The Vivio system used in the study consists of a custom blood pressure cuff, a single-lead Bluetooth ECG, and an algorithm to identify patients with elevated LVEDP (>18 mmHg non-invasive).
The catheter laboratory-based study enrolled 728 patients at seven sites.
Measurements from a high-fidelity Millar catheter were compared with paired recordings from the Vivio system. Data from the study met efficacy endpoints, with the hold-out validation dataset having a sensitivity of 0.80 (95% CI: 0.64 – 0.91) and a specificity of 0.83 (95% CI: 0.75 – 0.90) showed.
These results highlight the enormous potential of this new technology to significantly improve physicians’ ability to diagnose heart failure in the outpatient clinic or home setting. We are pleased with the outcome of this work and look forward to making a positive impact on access in the communities that need it most by advancing healthcare equity.
Q. How can this technology and a hybrid home care model helps overcome the social determinants of health barriers?
A. Vivio’s mobility and simplicity help overcome SDOH barriers to diagnosis, such as transportation restrictions, by allowing trained physicians to test for elevated LVEDP at home or in the clinic. Doctors can perform the test in less than five minutes and receive real-time generated results that can help diagnose heart failure.
The ability to receive real-time results in any healthcare setting ensures that patients and physicians can discuss the consequences of heart failure immediately after a diagnosis. This can significantly change the timeline for treatment and result in meaningful discussions between doctors and patients.
Patients can ask questions about a diagnosis and do not have to wait for further interpretation of the results. This can be a positive impact on healthcare literacy and better understanding of recent diagnoses.
Q. You are introducing the device and home care enable lower healthcare costs and improve patient experience – critical to value-based healthcare goals. How does technology achieve these goals?
A. Up to 50% of patients with heart failure are undiagnosed, and The diagnosis can be delayed for up to 30 months after the first onset of symptoms. Early diagnosis is critical for treating and managing heart failure in the most vulnerable populations, namely people aged 65 years or older.
Due to the delay in diagnosis, clinical research has shown this 65% of Medicare patients who are first diagnosed with heart failure in the emergency department or in an inpatient setting, and this number is increasing 75% for patients with a lower socio-economic status.
Furthermore, the economic impact of heart failure is high, making early detection and diagnosis even more important. Heart failure yes good for 70 billion dollars of U.S. healthcare spending by 2030. Vivio represents a step forward in enabling the diagnosis of this costly and fatal condition within Medicare populations.
Although the progression of heart failure cannot be reversed, lifestyle changes and early treatment, if diagnosed early, can improve quality of life and reduce inpatient rates. In fact, we conducted a recent survey of patients that found that all respondents could easily have the Vivio test performed by doctors, and 95% preferred to receive an echocardiogram.
Shifting the point of diagnosis upstream from traditional clinical settings to more accessible locations such as homes and clinical care facilities can significantly improve outcomes by facilitating earlier detection. This advancement not only supports physicians in their practice, but does so without increasing their workload.
Today’s landscape, where many physicians are shying away from primary care due to staffing issues, the complexity of dealing with insurers, and the demands of extensive documentation, requires solutions that can be smoothly integrated into existing medical workflows. This integration enables a more proactive approach to healthcare management rather than a reactive approach following hospital admissions.
By changing the diagnosis timeline, at-risk organizations can reduce costs while improving outcomes through earlier lifestyle and treatment interventions.
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