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November Edition 2020

Transforming the diagnosis and management of coronary artery disease worldwide: HeartFlow


Every year in the U.S., approximately 735,000 Americans suffer from a heart attack. Further, the Centers for Disease Control and Prevention report that heart disease is the leading cause of death among men and women in the U.S. These findings underscore the importance of proper cardiac care. Proper cardiac care can also include certain medications prescribed by your doctor. For example, medications are available for lowering blood pressure or cholesterol levels when lifestyle changes alone are not enough. Proper cardiac care is important for maintaining a healthy heart and reducing your risk of developing heart disease or suffering a heart attack. A cardiologist can help you maintain better heart health. At the intersection of health and technology, HeartFlow leverages advanced technology and applies it to transforming cardiovascular care. The HeartFlow FFR Analysis combines artificial intelligence with trained analysts to provide a personalized, color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow. At the intersection of health and technology, HeartFlow leverages advanced technology and applies it to healthcare. With the HeartFlow FFRCT Analysis, HeartFlow is driving towards a new standard of care for the diagnosis and management of coronary artery disease – the number one killer worldwide.

The HeartFlow Analysis starts when a patient undergoes a standard coronary Computed Tomography (CT) scan at a hospital or imaging center. The CT images are securely uploaded to cloud. Next, HeartFlow use advanced algorithms incorporating artificial intelligence to build a personalized, digital model of that patient’s coronary arteries. Once this patient-specific model is completed, the HeartFlow process applies physiologic principles and computational fluid dynamics to compute the blood flow and FFRCT values at every point in the model. The completed HeartFlow Analysis is a color-coded, digital 3D-model of the heart, reflecting the impact that blockages have on blood flow. This model can be viewed both on web browser and on mobile. The entire process for receiving a HeartFlow Analysis is conducted non-invasively, fits in with your current workflow and leverages the convenience of cloud computing for easy, and secure, data exchange. What makes deep learning so powerful is the fact that as the algorithms are trained on more data, the performance of future product improves. Today deep learning algorithms have been trained using tens of thousands of CT images for better results.

HeartFlow® Planner

HeartFlow Planner is the planning tool that interventional cardiologists have been missing. By virtually modeling clinical scenarios vessel-by vessel, explore treatment strategies for patients with CAD before each procedure, review cases with colleagues, and ensure everyone has a clear picture of the initial treatment plan. The modeled stenosis marker, indicated by a white ring, identifies an area of >30% narrowing in the anatomic model. FFRCT pins provide specific values and can be viewed at any point along the vessel. When selected, a stenosis marker will show a dotted line that indicates the area of the model affected by the narrowing. The range tool’s end dots can be used to adjust the desired length of the region to modify. Once the range tool is adjusted, you can open the lumen to display the impact of your selected strategy on the modeled vessel. Then revert the changes to explore other scenarios.

CAD and Symptoms

Coronary Artery Disease (CAD) is the most common type of heart disease, affecting nearly half the adult population. CAD develops when the coronary arteries become narrowed or blocked and cannot deliver enough oxygen-rich blood to the heart. This is usually caused by atherosclerosis, the buildup of plaque in the arteries that supply blood flow to the heart. Atherosclerosis can cause chest pains or other symptoms and increase the risk of heart attack.

Matters of the Heart

Despite many recent advances in cardiovascular diagnosis and treatment, misdiagnosis is still a common concern for patients at risk of heart disease, the leading cause of death in the United States. A complex web of symptoms, circumstances and comorbidities means that it’s not always easy for physicians to correctly identify conditions on the first visit. The information provided by the HeartFlow Analysis 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. Patient symptoms must be documented in the patient’s medical record. While no diagnostic test is perfect, the HeartFlow Analysis has demonstrated higher diagnostic performance compared to other non-invasive cardiac tests1.

Misdiagnosis is a Top Concern of Cardiac Patients

HeartFlow’s recent consumer survey points to how fears can cause people to avoid treatment. The survey found reluctance among respondents to talk to their doctors about heart disease. Despite 42 percent of Americans knowing they have a family history of heart disease and another 77 percent admitting to worrying about their heart health, most (67 percent) have never sought diagnosis or treatment. The top concern of survey respondents regarding cardiac care is a misdiagnosis or a missed diagnosis. In fact, more than 1/3 of respondents admitted they have avoided the doctor for fear of what they will find out. This anxiety is understandable, given that other diagnostic tests are less accurate and often miss disease1. The good news is that new medical technologies are drastically improving the accuracy of diagnosing coronary artery disease. Tools like the HeartFlow Analysis are helping to improve outcomes1, which in turn can help reduce fears and uncertainty in patients. Dennis and David are just two examples of how things can go right, before it’s too late.

Simplifying Your Path to Better Care

The HeartFlow Analysis is a non-invasive personalized cardiac test that shows how each blockage impacts blood flow to your heart. The company is committed to ensuring that the HeartFlow Analysis is affordable to everyone who needs the test. However, your insurance coverage, specific plan benefits and the type of facility you visit will determine if you owe anything for the test. For a majority of patients, the HeartFlow Analysis will be billed through your insurance and provider; the HeartFlow Analysis is covered by Medicare and most commercial insurers. If you are a patient who is part of the HeartFlow Access Program, you may be responsible for paying HeartFlow directly for a portion of the test’s cost. You may or may not be responsible for costs related to the HeartFlow Analysis depending on your insurance plan. HeartFlow’s Patient Support Advisors can help you find out if your health insurance plan covers the test and how much your out-of-pocket cost may be. They can also advise you if you qualify for any income-based payment programs. You also have the option to pay cash but will need to elect this option before the test is complete.

After the HeartFlow Analysis is completed, HeartFlow will send the claim to your insurance company and notify you that the claim was submitted. Your insurance company will review the claim and send an Explanation of Benefits (EOB) to you. Please note that the EOB is not a bill. It is an informational summary of the claim. You will receive a bill from HeartFlow if there is any amount owed after your insurance company has processed your claim. HeartFlow will submit any payment appeals on your behalf to ensure you owe the least amount necessary, but this final amount will vary based on your coverage. The billing process takes time. You may not receive an EOB or a bill until several weeks or months after the HeartFlow Analysis is completed.

Take Control of Your Health

Meanwhile, a better understanding of the advances in heart health technologies available could help to alleviate patient fears. For example, artificial intelligence (AI) and deep learning are driving innovation in non-invasive testing modalities and remote monitoring tools. AI can help physicians make informed diagnoses and treatment decisions, while remote monitoring and telemedicine allow physicians to review patient data and perform virtual consultations without requiring an office visit. Some people are eager to adopt new technologies in their everyday lives, but does that mean that they’re willing to embrace new technology when it comes to their healthcare? HeartFlow’s survey suggests that consumers are becoming more comfortable with new technologies, with 78 percent of respondents indicating they trust artificial intelligence technology, for example, to assist doctors with their tasks. Additionally, 78 percent think a combination of technology and human analysis results in the most accurate diagnosis, over either alone.

Dana G. Mead, Jr., President, Chief Executive Officer and Member of the Board of Directors

“Getting the correct diagnosis for your symptoms is crucial in determining the appropriate treatment.”