[January 15, 2019]

New JACC Publication Reinforces Value of a Coronary CTA + HeartFlow Analysis-Guided Pathway for Diagnosing Heart Disease

HeartFlow, Inc. today announced the publication of the PACIFIC substudy showing that the HeartFlow FFRct Analysis demonstrates the highest diagnostic performance for detecting coronary artery disease (CAD) compared to other non-invasive tests. The HeartFlow Analysis is a non-invasive, personalized cardiac test that starts with a standard coronary computed tomography angiogram (CTA). The publication, titled "Comparison of Coronary Computed Tomography Angiography, Fractional Flow Reserve, and Perfusion Imaging for Ischemia Diagnosis," was published online by the Journal of the American College of Cardiology (JACC) on January 14, and will be in print in the January 22, 2019 issue of JACC.

The PACIFIC study included 208 patients who each underwent a coronary CTA, SPECT, PET and three-vessel invasive fractional flow reserve (FFR) measurements. The HeartFlow Analyses were retrospectively obtained using data 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 HeartFlow Analsis demonstrated a diagnostic accuracy of 87%, sensitivity (or ability to correctly identify those with disease) of 90% and specificity (or ability to correctly identify those without disease) of 86% on a per vessel basis.¹ The data were previously presented at the EuroPCR conference in May 2018.

"These findings should give physicians confidence in the diagnostic performance of the HeartFlow Analysis as it can identify disease that other non-invasive tests, such as SPECT, may overlook, and help better identify patients who require invasive treatment," said Campbell Rogers, MD, FACC, Chief Medical Officer, HeartFlow. "The practical applicability of the PACIFIC study is profound. More and more centers around the world are incorporating a coronary CTA and HeartFlow Analysis-guided pathway into their clinical workflow as physicians appreciate having highly accurate and actionable information to ensure their patients receive the best possible care."

The HeartFlow Analysis leverages artificial intelligence and highly trained analysts to create a digital 3D model of the patient's arteries using image data taken from a standard CTA. It then applies advanced algorithms to solve millions of complex equations to assess the impact any blockages have on blood flow to the heart. 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 technology has been demonstrated to reduce unnecessary 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.²

To date, clinicians around the world have used the HeartFlow Analysis for more than 25,000 patients to aid in the diagnosis of heart disease.

About HeartFlow, Inc.

HeartFlow, Inc. is a medical technology company redefining 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.

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.

² 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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