Use of HeartFlow Planner Leads to Change in Treatment Strategy in Nearly Half of Patients with Coronary Heart Disease

HeartFlow,
Inc., today announced new data demonstrating that the use of the
investigational HeartFlow Planner, a real-time, non-invasive interactive
planning tool, led to a change in treatment strategy in 45% of patients
with coronary artery disease (CAD) and reduced the need for invasive
physiology. The data from the BOWIE (Benefits
of Obtaining information for planning With
noninvasive FFRCT prior to Invasive Evaluation)
study were presented by Eric Van Belle, M.D., Ph.D., Professor of
Cardiology, Head of the Lille Heart & Lung Institute, and principal
investigator for BOWIE, as a late-breaking trial at the EuroPCR
Conference in Paris, France.

“The BOWIE results highlight the potential benefit of using a real-time
interactive tool prior to a revascularization procedure as it can help
inform the treatment plan, optimize completeness of revascularization,
and streamline resource utilization in the cath lab,” said Campbell
Rogers, M.D., Chief Medical Officer, HeartFlow.

BOWIE is a retrospective study that included 101 patients. Three
interventional cardiologists independently reviewed the diagnostic
angiogram for each patient and provided a treatment recommendation. The
same three interventional cardiologists then reviewed each patients’
HeartFlow Analysis and used the HeartFlow Planner to virtually explore
different treatment scenarios and provide a treatment recommendation.
The study compared the differences in recommended treatment plans.

For example, in one case, the interventionalists initially recommended
that a lesion be treated with a 38mm stent based on the diagnostic
angiogram. After reviewing different treatment options with the
HeartFlow Planner, the interventionalists changed the recommendation to
treat the lesion with a 15mm stent as the reduced stent length
demonstrated a similar physiologic effect.

The HeartFlow Planner is an interactive tool that enables interventional
cardiologists and heart teams to modify vessels virtually, and thereby
determine the optimal treatment strategy prior to an invasive procedure.
Every HeartFlow Analysis case is accompanied by enough data to allow
HeartFlow Planner to modify vessel narrowings and arrive at a
personalized ideal anatomical model, and to allow additional
computations based on altered flow rates resulting from modified
vessels. With HeartFlow Planner, an interventional cardiologist or heart
team can explore the treatment area and view the modified vessel and
resulting FFRct changes in real time. This tool allows non-invasive
study of treatment scenarios to identify which intervention is optimal.
The HeartFlow Planner is currently not available for commercial use and
is under review with the U.S. Food and Drug Administration (FDA).

About the HeartFlow FFRct Analysis

Data from a patient’s non-invasive coronary CTA are securely uploaded
from the hospital’s system to HeartFlow’s software application running
in the AWS cloud. HeartFlow leverages deep learning and highly trained
analysts 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.

The HeartFlow Analysis offers the highest per-vessel diagnostic
performance available from a non-invasive test.¹ To date,
clinicians around the world have used the HeartFlow Analysis for more
than 30,000 patients to aid in the diagnosis of heart disease.

About HeartFlow, Inc.

HeartFlow, Inc. is a medical technology company uniquely positioned at
the intersection of advanced artificial intelligence and healthcare to
transform how 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.

¹ Driessen, R., et al. Comparison of Coronary Computed
Tomography Angiography, Fractional Flow Reserve, and Perfusion Imaging
for Ischemia Diagnosis. J Am Coll Cardiol. 2019;73(2),161-73.

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