HeartFlow Analysis Demonstrates Highest Diagnostic Performance for Detecting
Heart Disease Compared to Other Non-Invasive Tests
des Better Functional Evaluation of Heart Disease Compared to Other Non-Invasive Tests
Two New Studies Reinforce Value of the HeartFlow Analysis in Providing Functional
Evaluation of Coronary Blockages and Enabling Clinicians to Make Treatment
Paris, France - May 22, 2018 - HeartFlow, Inc. today announced new data from the PACIFIC
trial showed that the HeartFlow Analysis had the highest diagnostic performance for detecting
coronary artery disease (CAD), the most common form of heart disease, when compared to
other commonly used non-invasive cardiac tests. Additionally, data from the SYNTAX III
Revolution trial demonstrated the utility of the HeartFlow Analysis combined with coronary
computed tomography angiography (CTA) in helping clinicians make revascularization
treatment decisions (stenting or coronary bypass surgery) for patients with multi-vessel disease.
The non-invasive HeartFlow Analysis is a personalized cardiac test that aids clinicians in
identifying the right treatment pathway for each patient. The results of both trials were presented
during the EuroPCR Conference in Paris, France.
The PACIFIC trial included 208 patients who each underwent a coronary computed tomography
angiography (CTA), SPECT, PET and routine three-vessel invasive fractional flow reserve
(FFR) measurements. The HeartFlow Analyses were retrospectively obtained from the coronary
CTA images. On a per vessel basis, HeartFlow demonstrated significantly greater diagnostic
performance (0.94 as measured by area under the receiver operating characteristic curve)
compared to coronary CTA (0.83, p<0.001), SPECT (0.70, p<0.001) and PET (0.87, p<0.001).
The results of this head-to-head study were presented by Dr. Roel Driessen of the VU
University Medical Center. Paul Knaapen, M.D., Ph.D. was the principal investigator of the
PACIFIC trial.
In the SYNTAX III trial, two heart teams, each comprised of an interventional cardiologist,
cardiac surgeon and radiologist, made treatment recommendations based on either data from a
coronary CTA plus HeartFlow Analysis or an invasive coronary angiogram. The study, which
included more than 200 patients, showed almost perfect agreement in the treatment
recommendations of the heart team using coronary CTA plus HeartFlow Analysis and heart
team using invasive angiography. SYNTAX III also demonstrated that the HeartFlow Analysis
provided supplemental information to a coronary CTA, allowing physicians to understand the
functional significance of each lesion, and in some cases, changing the treatment
recommendation. The data were presented today by Professor Patrick W. Serruys, M.D., Ph.D.,
FACC, FESC, chairman of the SYNTAX III trial.
“The new data presented at EuroPCR show that the HeartFlow Analysis can hold great clinical
value in real-world practice for the non-invasive evaluation of coronary artery disease as it
provides both anatomic and functional evaluation of coronary lesions,” said Campbell Rogers,
MD, FACC, chief medical officer, HeartFlow. “A HeartFlow-guided pathway provides physicians
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with functional information that was previously only available via invasive measures, and can
reduce the need for patients to undergo additional tests. Additionally, by having non-invasive
data available to them, physicians can develop a treatment plan ahead of time for a more
efficient procedure.”
About the HeartFlow FFRct Analysis
Clinicians diagnosing someone with suspected CAD want to know as definitively as possible if
the individual has a significant blockage in their coronary arteries. They also want to know the
impact of that blockage on blood flow so they can best determine which treatment pathway is
appropriate (e.g., medical management, stenting or coronary artery bypass grafting).
Data from a patient’s non-invasive coronary CTA are securely uploaded from the hospital’s
system to the cloud. HeartFlow leverages deep learning to create a personalized, digital 3D
model of the patient’s coronary arteries. The HeartFlow Analysis then uses powerful computer
algorithms to solve millions of complex equations to simulate blood flow and assess the impact
of blockages on coronary blood flow. The HeartFlow Analysis is provided via a secure online
interface to offer actionable information to enable clinicians to determine the optimal course of
treatment. To date, clinicians around the world have used the HeartFlow Analysis for more than
20,000 patients to aid in the diagnosis of heart disease.
This technology has been demonstrated to reduce unnecessary and invasive diagnostic
coronary angiography procedures, which can be associated with bleeding, stroke, major blood
vessel damage and other serious complications. It also significantly reduces healthcare costs
for hospitals.i
About HeartFlow, Inc.
HeartFlow, Inc. is a medical technology company transforming the way heart disease is
diagnosed and treated. Our non-invasive HeartFlow FFRct Analysis leverages deep learning to
create a personalized 3D model of the heart. By using this model, clinicians can better evaluate
the impact a blockage has on blood flow and determine the best treatment for patients. Our
technology is reflective of our Silicon Valley roots and incorporates decades of scientific
evidence with the latest advances in artificial intelligence. The HeartFlow FFRct Analysis is
commercially available in the United States, Canada, Europe and Japan. For more information,
visit www.heartflow.com.
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Media Contact:
Jennie Kim
i Douglas PS, DeBruyne B, Pontone G., Patel MR, et al. One-year outcomes of FFRCT-guided care in patients with
suspected coronary disease: The PLATFORM Study. J Am Coll Cardiol. 2016;68(5),435-45.
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