Noninvasive LVEDP Screening: Finding Heart Failure Before Symptoms Appear

Heart failure in primary care is frequently invisible until it isn't. Symptoms like fatigue and shortness of breath get attributed to aging or existing comorbidities. By the time a patient receives a formal diagnosis, functional status is often already compromised — and the window for the most effective early intervention has passed.

A study of 2,040 outpatients across three primary care sites tested whether noninvasive screening could surface this population earlier. The screening tool — the Vivio System, an FDA-cleared device that uses a modified pneumatic brachial cuff and single-lead ECG to estimate left ventricular end-diastolic pressure — takes 40 seconds and identifies elevated LVEDP above 18 mmHg with 80% sensitivity and 83% specificity.

What the screening found

Among the 2,040 patients screened (mean age 74, all with diabetes, CKD stage 3+, or clinical suspicion of heart failure), 785 — 38.5% — had elevated filling pressure. Women were disproportionately represented at 62.2% of positive screens, reinforcing existing research on delayed heart failure diagnosis in women and potentially explaining lower rates of guideline-directed medical therapy in this group.

Of the 653 patients who completed the KCCQ-12 health status questionnaire after screening positive, 31.4% scored a perfect 100 — no symptoms at all. These are Stage B patients: structural or hemodynamic evidence of disease, fully asymptomatic, and almost certainly undiagnosed. Another 26.5% scored below 80, consistent with NYHA Class II–IV, and 12.1% scored below 60, indicating significant functional impairment that had gone unaddressed.

The clinical opportunity in that 31.4%

Stage B is where prevention has the strongest evidence base. SGLT2 inhibitors, GLP-1 receptor agonists, and mineralocorticoid receptor antagonists each have trial data supporting their use before symptoms develop — but only if the patient is identified. Without screening, Stage B patients are invisible to the care system until they become Stage C, at which point the intervention shifts from prevention to management.

“Nearly 40% of high-risk outpatients in a primary care setting are living with elevated filling pressure. The hemodynamic marker often precedes symptoms by months to years — a window for intervention that closes once the patient becomes symptomatic.”

The interaction between elevated LVEDP and comorbidities matters, too. Patients with diabetes and CKD showed high screening yield, highlighting the need for integrated cardio-renal-metabolic monitoring rather than siloed disease management. SYNC-PREVENT™ pairs in-office LVEDP screening with continuous physiological surveillance for patients who screen positive — tracking the hemodynamic drift and volume trends that indicate whether a Stage B patient is holding steady or beginning the transition toward symptomatic heart failure.