Clinical Evidence

With 400+ peer-reviewed publications, HeartFlow is committed to ongoing clinical research as we work to transform the diagnosis and management of coronary artery disease worldwide.

Significant research involving the HeartFlow FFRCT Analysis has focused on four key areas:


Clinical Validity
and Accuracy
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Clinical Efficacy
and Utility
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Long Term
Patient Safety
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Cost Savings
 
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Clinical Validity and Accuracy

The HeartFlow Analysis combines anatomic and physiologic information in a single non-invasive cardiac test that provides clinicians with higher diagnostic performance and accuracy than other non-invasive tests.1

Diagnostic accuracy:
  • 87% (PACIFIC, JACC 2019)
  • 86% (NXT, JACC 2014)

P-values reflect comparison to the HeartFlow FFRCT Analysis

Clinical Efficacy and Utility

Real-world and clinical use of the HeartFlow Analysis has been shown to be safe, improve cath lab efficiency and help physicians risk stratify patients. Substantial evidence demonstrates that clinicians use the HeartFlow Analysis to:

  1. Safely impact clinical decision making
  2. Conservatively treat patients with a negative HeartFlow Analysis
  3. Reduce unnecessary ICAs with no reduction in revascularization rates
  4. Increase cath lab efficiency
  5. Identify long-term patient cardiovascular risk

Long Term Patient Safety

Multiple clinical trials demonstrate that physicians can efficiently determine the most appropriate treatment pathway for each patient by utilizing the HeartFlow Analysis.

There are numerous studies providing long-term follow-up (1-5 years) of over 6,000 patients demonstrating that clinicians can safely and confidently utilize the HeartFlow Analysis in their clinical decision making.

Long Term Outcomes Findings

Patients with a stenosis between 30 and 90% but a negative HeartFlow Analysis (FFRCT > 0.80) have a favorable long-term prognosis with very low rates of adverse cardiac event rates or unplanned revascularization, rates similar to patients without stenosis.7

Among patients with a positive HeartFlow Analysis (FFRCT ≤ 0.80), those who undergo revascularization have lower event rates than patients who do not undergo revascularization.7

Cost Savings

A patient pathway driven by coronary CTA and appropriate use of the HeartFlow Analysis improves care while providing significant per-patient cost savings.4


For more information about our ongoing research, visit our Clinical Research page.

Clinical Research

REFERENCES

1 Driessen, et al. J Am Coll Cardiol 2019.

2 Ihdayhid, et al. Radiology 2019.

3 Fairbairn, et al. Euro Heart J 2018.

4 Douglas, et al. J Am Coll Cardiol 2016.

5 Fairbairn, et al. Euro Heart J 2018. Patel, et al, J Am Coll Cardiol Img 2019.

6 Patel, et al, J Am Coll Cardiol Img 2019.

7 Nørgaard, et al. J Am Coll Cardiol 2018.


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