A physician assessing a patient for heart failure symptoms during a clinical heart health exam.

Treating Heart Failure After a Positive Vivio® Test

A clear, evidence-aligned pathway to diagnose, stage, and treat heart failure starting at the earliest stages of disease.

Why This Matters

Why early heart failure is often missed.

Heart failure is a hemodynamic disease that often develops before structural changes are visible. Traditional imaging tools may not detect disease early enough to intervene effectively.

  • A normal echocardiogram does not rule out HFpEF.
    •  Standard resting echocardiography identifies only 34–60% of patients with HFpEF that was confirmed by invasive LVEDP testing.1
  • Most HFpEF patients have normal or only mildly abnormal echo findings.
    •  Up to 68% of patients with confirmed HFpEF are classified as having normal or Grade 1 diastolic dysfunction on echocardiography, even when filling pressures are confirmed as elevated.2
  • “Normal diastolic function” on echo often overlooks elevated filling pressures.
    • Among HFpEF patients labeled as normal or mild diastolic dysfunction by echo, over 60% have elevated left-sided filling pressures when measured directly by catheterization highlighting false negatives from echo.2

This creates a critical gap precisely when early intervention can prevent progression.

Vivio helps close that gap by identifying elevated filling pressures earlier, when treatment has the greatest impact.

Validated hemodynamic insights with 80% sensitivity and 83% specificity support earlier, more confident clinical decisions.

Clipboard with heart checklist

How Vivio compares to other diagnostic modalities.

Diagnosing HFpEF remains challenging because accurately identifying elevated filling pressures is difficult without invasive testing.

While cardiac catheterization is the gold standard, non-invasive tools are more commonly used in clinical practice. However, no single non-invasive test has historically demonstrated both high sensitivity and high specificity.

Vivio changes that.

  • Vivio detects elevated filling pressures with 80% sensitivity and 83% specificity validated head-to-head against invasive hemodynamic measurement, the gold standard physiologic evidence for heart failure diagnosis.3,4
  • Non-invasive alternatives including echocardiography and BNP have well-documented limitations in reliably detecting elevated filling pressures and neither achieves both sensitivity and specificity above 70%.5

This balanced performance enables clinicians to detect heart failure earlier and with greater confidence, supporting more timely and appropriate treatment decisions.

Vivio LVEDP

  • Echocardiogram
    E/e’>13
    (estimated filling pressure ratio)

  • NTproBNP>275 pg/mL
    Blood biomarker released when the heart is under mechanical stress

  • Echocardiogram
    GLS <16%
    Global Longitudinal Strain
    (measure of the heart’s overall squeeze efficiency)

Clinical Framework

Vivio’s pathway to heart failure management.

Our workflow translates recommendations from the American College of Cardiology and the American Heart Association into a practical approach for identifying risk, confirming physiologic evidence, initiating Guideline-Directed Medical Therapy (GDMT) and monitoring patients over time. By aligning evaluation, diagnosis and management with established heart failure staging and treatment principles, clinicians can support earlier intervention, more consistent care decisions, and improved longitudinal outcomes.

A positive Vivio test is not the end of diagnosis. It’s the beginning of a structured, evidence-aligned care pathway.

Browse through each of the five pillars below.

Identify

Risk and Stage A/B HF

Identify adults at risk for heart failure (Stage A or B) who lack a prior HF diagnosis.

  • Patients with cardiometabolic risk factors or structural risk exposures (e.g., hypertension, diabetes, obesity, CKD, OSA, cardiotoxic therapy)
  • Individuals with symptoms or clinical changes warranting evaluation for possible HF

Assess

Objective Evidence + Symptom Burden

Assess for physiologic evidence of HF and patient-reported functional status.

  • Obtain objective physiologic assessment to evaluate filling pressures and cardiac function (e.g., Vivio assessment)
  • Use validated patient-reported tools (e.g., KCCQ) to quantify symptom burden and functional limitation
  • Review comorbidities, prior testing, and clinical trajectory to establish baseline status

Diagnose

Guideline-Concordant HF Classification

Establish HF diagnosis when objective evidence of cardiac dysfunction is present in the context of symptoms or structural abnormalities.

  • Diagnose HF when physiologic findings consistent with HF are accompanied by symptoms or functional limitation
  • Consider preclinical or asymptomatic structural/physiologic abnormalities as Stage B HF
  • Document diagnostic reasoning and staging to guide therapy selection and follow-up

Manage

Initiate/Optimize Guideline-Directed Therapy

Initiate or optimize guideline-directed medical therapy (GDMT) and address modifiable drivers of disease progression.

  • Initiate or titrate GDMT consistent with HF phenotype and comorbidities
  • Refer to cardiology when diagnostic uncertainty, disease progression, or therapy escalation is present
  • Identify and treat contributors to HF progression, including hypertension, CKD, sleep apnea, obesity, inactivity, and substance exposure

Optimize

Longitudinal Monitoring and Risk Reduction

Reassess symptoms, physiologic status, and therapy response over time.

  • Perform periodic reassessment for patients with HF risk, Stage B disease, or prior abnormal findings
  • Evaluate for new or worsening symptoms at each clinical encounter
  • Use objective reassessment to guide GDMT titration, diuretic strategy, and referral decisions
  • Aim to prevent decompensation and reduce hospitalization risk through proactive monitoring

Improving Care Decisions

Pairing Vivio with patient-reported outcomes.

Combining Vivio hemodynamic data with KCCQ symptom assessment enables:

  • More precise staging of disease
  • Better-informed treatment decisions
  • Improved identification of patients needing escalation

This dual approach supports proactive, personalized care planning. See how Vivio incorporates the KCCQ, Kansas City Cardiomyopathy Questionnaire, directly into clinical workflows. Download our Pathway to Success Guide to learn more.

From Result to Action

What your Vivio test means.

Treatment decisions should align with both hemodynamic findings and symptom burden. Click on each stage below to explore recommendations and considerations for patient care.

Stage B Heart Failure

Clinical Profile: Elevated filling pressures without symptom burden

Recommended Approach:

  • Initiate cardioprotective therapy as appropriate
  • Optimize management of comorbid conditions (T2DM, CKD, hypertension)
  • Reinforce lifestyle modification and risk factor reduction

Follow-Up Strategy:

  • Reassess annually with Vivio or sooner if symptoms develop
  • Maintain proactive surveillance and risk reduction

Additional Considerations:

  • Optional echocardiography within 12 months
  • Consider sleep apnea evaluation

Stage C Heart Failure (NYHA Class I)

Clinical Profile: Elevated filling pressures with mild symptoms

Recommended Approach:

  • Initiate GDMT without delay:
    • SGLT2 inhibitor
    • ARNI (preferred) or ACEi/ARB
    • Mineralocorticoid receptor antagonist (MRA)
    • Reinforce lifestyle modification

Care Support:

  • Refer to pharmacy or disease management programs
  • Address hypertension, CKD, obesity, and physical activity

Follow-Up Strategy:

  • Optimize GDMT to target doses within 3–6 months
  • Reassess annually or with symptom changes

Additional Considerations:

  • Selective echocardiography based on clinical suspicion
  • Consider cardiology referral if symptoms progress

Stage C Heart Failure (NYHA Class II)

Clinical Profile: Elevated filling pressures with moderate symptoms

Recommended Approach:

  • Initiate or optimize GDMT
  • Consider loop diuretics for volume management
  • Educate patients on daily weights and sodium awareness

Care Support:

  • Collaborate with cardiology, pharmacy, or disease management programs
  • Consider echocardiography within 3–6 months

Follow-Up Strategy:

  • Achieve maximally tolerated GDMT within 3–6 months
  • Maintain close clinical monitoring and reassessment

Additional Considerations:

  • Sleep apnea evaluation
  • Cardiac rehabilitation when appropriate

Stage C/D Heart Failure (NYHA Class III–IV)

Clinical Profile: Elevated filling pressures with significant symptom burden

Recommended Approach:

  • Refer to cardiology for evaluation (ideally within 2 weeks)
  • Initiate or optimize GDMT immediately
  • Stabilize volume status with diuretics

Care Coordination:

  • Align treatment plan with cardiology
  • Initiate beta-blocker therapy based on LVEF
  • Evaluate for advanced therapies

Follow-Up Strategy:

  • Ongoing multidisciplinary management
  • Frequent reassessment and therapy adjustment

Guideline-aligned Care

Built on evidence-based heart failure management.

Treatment recommendations following a positive Vivio test align with established clinical guidelines.

Core GDMT pillars:

  • SGLT2 inhibitors
  • ARNI (preferred) or ACE inhibitors /ARBs, ACE Inhibitors and/or ARNIs
  • Mineralocorticoid receptor antagonists

Download our Pathway to Success Guide

Resulting benefits:

Early initiation and optimization of these therapies can:

• Slow disease progression
• Reduce hospitalization risk
• Improve long-term outcomes

Primary care clinicians play a critical role in early-stage management before advanced disease develops.

When to Refer

Do all patients need an echo or cardiology referral?

Not necessarily. Early-stage patients can often be effectively managed in primary care using guideline-directed therapy.

Echocardiography:

  • Recommended for patients with advanced symptoms (NYHA Class III/IV)
  • Limited sensitivity in early-stage heart failure
  • May not detect elevated filling pressures in early disease

Cardiology:

Most appropriate when:

  • Symptoms progress despite therapy
  • Advanced heart failure is suspected
  • Additional diagnostic clarification is needed

Clinical Resources

Download practical tools to support heart failure management.

GDMT Reference Table | HFrEF

Treatment considerations tailored to reduced EF (HFrEF) patients.

GDMT Reference Table | HFpEF

Treatment considerations tailored to preserved EF (HFpEF) patients.

Pathway to Success Guide

See the structure behind our evidence-aligned care pathway.

Bring Clarity to Heart Failure Management

Vivio enables earlier detection, clearer staging and more confident treatment decisions helping clinicians intervene when it matters most.

Hands holding a tablet displaying the Vivio System's intuitive patient ID entry screen, ready for a clinical heart failure diagnostic test.