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Heart disease is still the number one cause of death globally1. Many diagnostic tests currently considered the standard of care for detecting heart disease simply do not provide enough information. The result: unhealthy people are sent home, while others unnecessarily go to the cath lab. We think we can help provide a better way.
Among the existing noninvasive tests available for detecting coronary artery disease (CAD) are stress testing – including exercise treadmill tests, SPECT, and stress echo – as well as a coronary computed tomography (CT). A number of recent studies have shown that a coronary CT-first pathway has benefits over the traditional stress testing approach2. Coupling the HeartFlow Analysis with a coronary CT adds the ability to understand whether a specific lesion is restricting blood flow, information that was previously only available invasively.
However, coronary CT has been difficult to order in certain circumstances, preventing some patients with suspected CAD from experiencing the benefits of HeartFlow. Fortunately, this scenario is changing rapidly.
Radiology Benefits Management companies, such as AIM and eviCore, have reduced the pre-authorization requirements for ordering a coronary CT. Now, ordering a coronary CT, and HeartFlow Analysis, if needed, can be as easy as ordering a stress test.
CT technology has advanced dramatically in recent years. Newer CT scanners rapidly acquire coronary images and are ideally suited for coronary applications.
For coronary CT to be a front line test, it needs to work in a wide range of patients. Coronary CT has traditionally been limited to low- to intermediate- risk patients, as a result of its very high sensitivity. However, SYNTAX III demonstrates that coronary CT can be used in high-risk patients.
The SYNTAX III trial enrolled patients with multivessel disease whose doctors were deciding on the best treatment: stenting or coronary bypass surgery. For each patient, two heart teams decided independently on the best treatment for the patient. One heart team looked only at coronary CT and the HeartFlow Analysis, while another looked only at invasive angiography data. The study, which included more than 200 patients, showed almost perfect agreement in the treatment recommendations of the heart teams using coronary CT and heart teams using invasive angiography. SYNTAX III also demonstrated that the HeartFlow Analysis provided supplemental information to a coronary CT, allowing physicians to understand the functional significance of each lesion – in some cases changing the treatment recommendation3.
Dr. Jonathan Leipsic, FRCPC, FSCCT
Past President SCCT
“With a quality CT image, you are provided with tremendous information regarding anatomy, plaque morphology and extent of the disease. You get a broad overview. With stress tests, you get no sense of the extent of atherosclerosis and with some can completely miss triple vessel disease. Yet, with CT, you are still missing key information in approximately 30-40% of patients. The missing link is the impact on blood flow, and this is exactly where the HeartFlow FFRCT Analysis comes in. With it, I get a complete picture; the 3D model is color-coded making it clear where I need to focus my evaluation. Ultimately, CT plus FFRCT is going to change how we diagnose and manage patients with CAD. I’m incredibly excited.”
Looking to the UK provides an example of how this shift to a CT-first strategy can happen systematically. The UK’s National Institute of Health and Care Excellence (NICE) issued a clinical guidance that recommended patients with suspected chest pain get a coronary CT first, rather than stress testing. In this Clinical Guidance, the NICE found that CT is the most costeffective front line test for patients with stable chest pain. NICE also issued a medical technology guidance recommending the HeartFlow Analysis when more information is needed after a coronary CT. Finally, the NHS selected the HeartFlow Analysis for the highly competitive Innovation Technology Payment program, whereby funding is made available to hospitals to pay for the HeartFlow Analysis. Taken together, these three steps position and enable the CT-HeartFlow Analysis pathway as the preferred approach in the UK.
1 World Health Organization (2017, January 12). Top 10 Causes of Death. http://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death.
2 Lu MT, et al. Noninvasive FFR Derived From Coronary CT Angiography: Management and Outcomes in the PROMISE Trial. JACC Cardiovasc Imaging 2017
[Epub ahead of print Apr 7]; Newby, David, et al. Scottish Computed Tomography of the HEART – SCOT HEART Trial. American College of Cardiology 2017
[Updated: April 2017].
3 Serruys, PW, SYNTAX III Revolution Trial. Presented at EuroPCR 2018.
The information provided by the HeartFlow FFRCT Analysis, RoadMap Analysis, and Plaque Analysis from the HeartFlow ONE platform and the HeartFlow Planner is intended to be used in conjunction with the patient's clinical history, symptoms and other diagnostic tests, as well as the clinician's professional judgment. The HeartFlow FFRCT Analysis, RoadMap Analysis, Plaque Analysis and HeartFlow Planner may not be appropriate for all patients. See their respective indications for use for more information. The HeartFlow FFRCT Analysis has received FDA Clearance, is CE-Marked, and is commercially available in the United States, Europe, Japan and Canada. The RoadMap Analysis and Plaque Analysis have received FDA Clearance and are commercially available in the United States. The HeartFlow Planner has received FDA Clearance and is commercially available in the United States.
© 2023 HeartFlow, Inc. | HeartFlow and the HeartFlow logo are registered trademarks of HeartFlow, Inc. Additionally, RoadMap is claimed as a trademark of HeartFlow, Inc. www.heartflow.com | 331 E Evelyn Ave, Mountain View, CA 94041
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If you would like to request to have the HeartFlow Analysis available at a location near you, please submit your information below with details of the institution. We will share this information with the institution, but it will not guarantee HeartFlow will become available.
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HeartFlow FFRCT 分析は、有資格の臨床医による臨床的に安定した症状のある冠状動脈疾患患者への使用を目的とした個別化された心臓検査です。 HeartFlow Analysis によって提供される情報は、資格のある臨床医が患者の病歴、症状、その他の診断検査、および臨床医の専門的判断と組み合わせて使用することを目的としています。
ハートフロー分析に関する追加の適応情報については、次のサイトをご覧ください。www.heartflow.com/indications.
さらに質問がある場合は、このメッセージを閉じてフォームに記入するか、サポート チームにお電話ください。: 877.478.3569.
The HeartFlow FFRCT Analysis is a personalized cardiac test indicated for use in clinically stable symptomatic patients with coronary artery disease by qualified clinicians. The information provided by the HeartFlow Analysis is intended to be used by qualified clinicians in conjunction with the patient’s history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgement.
For additional indication information about the HeartFlow Analysis, please visit www.heartflow.com/indications.
If you have additional questions, close out of this message to complete our form or call our support team: 877.478.3569.Please apply for research grants through our online submission form.
Executive Vice President and Chief Medical Officer
Campbell brings a wealth of experience to HeartFlow, where he serves as the Chief Medical Officer. Prior to joining HeartFlow, he was the Chief Scientific Officer and Global Head of Research and Development at Cordis Corporation, Johnson & Johnson, where he was responsible for leading investments and research in cardiovascular devices. Prior to Cordis, he was Associate Professor of Medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology, and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital. He served as Principal Investigator for numerous interventional cardiology device, diagnostic, and pharmacology trials, is the author of numerous journal articles, chapters, and books in the area of coronary artery and other cardiovascular diseases, and was the recipient of research grant awards from the NIH and AHA.
He received his A.B. from Harvard College and his M.D. from Harvard Medical School.
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