Technology from HeartFlow Provides Insights to Help Identify Coronary
Plaques at Risk of Rupturing
Hemodynamic Assessment Could Improve Prediction of
Acute Coronary Syndrome Risk
PARIS - May 19, 2016 - First-in-human data presented at EuroPCR 2016 demonstrate
that hemodynamic data from HeartFlow, Inc., may help predict which coronary plaques
have the potential to rupture. The results were part of a study designed to determine
whether use of HeartFlow technology could predict risk of developing acute coronary
syndrome (ACS), a condition associated with sudden, reduced blood flow to the heart.
The study was led by Professor Bon-Kwon Koo, M.D., Ph.D., FACC, of Seoul National
University Hospital.
The EMERALD (Exploring the MEchanism of the plaque Rupture in Acute coronary
syndrome using coronary CT angiography and computationaL fluid Dynamics) study
evaluated 71 patients who experienced ACS and who had received a coronary CT
angiography (cCTA) between one month and two years previously.
HeartFlow’s hemodynamic assessment, consisting of FFRCT, and more importantly the
change in FFRCT across the plaque, was a better predictor of which plaques would
rupture and lead to ACS than percent diameter stenosis or adverse plaque
characteristics (APCs). APCs are features identifiable with cCTA related to plaque
composition and disease burden that increase the risk of rupture, as observed in prior
clinical studies.
A total of 226 coronary plaques from the cCTAs were assessed - 151 that had not
ruptured (non-culprit lesions) and 75 that had ruptured and caused ACS (culprit lesions
as identified by invasive angiography). In addition, combining HeartFlow’s
hemodynamic assessment and APCs increased the discrimination of lesions at risk for
causing ACS more than 10 percent over lesion severity alone.
“When evaluating a patient for risk of ACS, we need to look at not only the burden and
composition of the plaque, but also the hemodynamic forces - or stress - placed upon
the lesion,” Koo said. “The EMERALD study has demonstrated that by applying this
important measurement we may have the potential to greatly improve prediction of the
lesions that cause ACS, which could help us optimize treatment strategies for these
high-risk patients.”
ACS is a life-threatening condition that hospitalizes approximately 1.4 million Americans
each year, of which 810,000 are for myocardial infarction.1 Studies have shown that
plaque rupture causes approximately 75 percent of fatal myocardial infarctions.1 In the
United States alone, an ACS occurs every 25 seconds and someone dies from an ACS-
related event every minute.2
“EMERALD is an exciting study, which demonstrates that HeartFlow technology may
have prognostic applicability beyond aiding in the improved diagnosis of ischemia,” said
John H. Stevens, M.D., chairman and CEO of HeartFlow. “The findings provide
important clinical insights to help identify at-risk ACS patients and has the potential to
save many lives.”
HeartFlow’s initial product, the HeartFlow FFRCT Analysis, is the only non-invasive
technology to provide insight into both the extent of coronary artery disease and the
impact that disease has on blood flow to the heart, enabling clinicians to select an
appropriate treatment. This product is cleared for use in the United States, is also
available in Canada, Europe and Japan, and has demonstrated its utility in reducing
invasive and costly procedures to diagnose patients suspected of having coronary
artery disease. The hemodynamic factors tested in the EMERALD study include those
in the HeartFlow FFRCT Analysis, which involves the creation of a patient-specific
anatomic model from medical imaging data and the application of Computational Fluid
Dynamics.
About EMERALD
EMERALD is a physician-initiated multicenter, international study conducted at 11
centers in four countries in Europe and Asia. The study evaluated patients who
presented with ACS between 2010 and 2014, and underwent a cCTA prior to the ACS
event. The goal of the study was to determine whether the evaluation of hemodynamic
forces, in combination with adverse plaque characteristics, could improve overall
identification of patients at risk for ACS.
About HeartFlow, Inc.
HeartFlow, Inc. is a personalized medical technology company seeking to transform the
way cardiovascular disease is diagnosed and treated. The company’s HeartFlow FFRCT
Analysis is the first available non-invasive solution that enables a physician to more
accurately evaluate whether a patient has significant coronary artery disease (CAD)
based on both anatomy and physiology. The solution, which produces a model of the
patient’s coronary arteries, is well positioned to become an integral part of the standard
of care for patients who are at risk for CAD because of its potential to improve clinical
outcomes, improve the patient experience and reduce the cost of care. The HeartFlow
Analysis is available in the United States, Canada, Europe and Japan. For more
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1. Kumar A, Cannon CP. Acute coronary syndromes: diagnosis and management, part I. Mayo Clin Proc.
2. Wachira JK, Stys TP. Cardiovascular disease and bridging the diagnostic gap. S D Med. 2013;66:366-369.
Media Contacts:
Chris Ernst
HeartFlow, Inc.
415-710-9445
Diana Soltesz
Nobles Global Communications
818-618-5634
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