Coronary artery disease (CAD) is a leading killer of men and women worldwide. CAD develops when the coronary arteries, which supply blood to the heart, narrow, reducing blood flow and causing chest pain (angina), heart attack (myocardial infarction) and even death. Some people are unaware that they have CAD, and sudden death is their first symptom.

Randy Rochman, an avid runner and otherwise healthy individual, was almost one of them. Fortunately, a first-of-its-kind, non-invasive test, called the HeartFlow® FFRct Analysis, found evidence of CAD, which limited blood flow to his heart and had been missed by conventional tests. Once the blockage in his coronary arteries was discovered, Randy was sent for urgent bypass surgery, which saved his life. 

 

Millions of patients need two questions answered

 

Physicians 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 is most appropriate for that person – whether medical management, a stent or coronary artery bypass graft (CABG) surgery.

Typically, people with suspected CAD are sent for a stress test or electrocardiogram, which are inaccurate more than 50 percent of the time and often inconclusive, requiring that the patient undergo additional tests such as coronary angiography, an invasive procedure done in a cardiac catheterization lab. However, coronary angiography puts the patient at risk for bleeding, stroke, major blood vessel damage and other serious complications. Moreover, it is often unnecessary.

A study that included data from over 1,100 U.S. hospitals found that more than half of the 385,000 patients with suspected CAD who underwent an invasive coronary angiography in fact had no need for intervention since no blockage of blood flow in their coronary arteries was found during the procedure.[i]  

HeartFlow, Inc. developed the HeartFlow FFRct Analysis as a non-invasive approach to diagnosing patients with suspected CAD. The HeartFlow FFRct Analysis was based on decades of research conducted by scientists and physicians at Stanford University in California. The technology uses a super-computing computational fluid dynamics algorithm to calculate data points throughout the coronary arteries. The HeartFlow FFRct Analysis is the first and only non-invasive technology to provide insight into both the extent of CAD and the impact of the disease on blood flow to the heart.

 

Assessing impact of blockages on coronary blood flow

 

The process starts with data from a patient’s non-invasive coronary computed tomography (CT) scan. Those data are securely uploaded from the hospital’s system to the cloud. HeartFlow then creates a personalized, digital 3D model of the patient’s coronary arteries using an advanced form of artificial intelligence called deep learning. HeartFlow uses powerful computer algorithms to solve millions of complex equations to simulate blood flow in the model and assess the impact of blockages on coronary blood flow. The HeartFlow FFRct Analysis is provided via a secure web interface to the patient’s physician, who uses the information to design a definitive, personalized treatment plan for the patient.

 

Helping patients avoid unnecessary procedures

 

A mounting body of published literature has shown that the HeartFlow FFRct Analysis reduces unnecessary invasive diagnostic coronary angiography procedures and may significantly reduce healthcare costs for hospitals.[ii] This technology also enhances the patient experience, making it an integral diagnostic test in assessing patients with suspected CAD.

The HeartFlow FFRct Analysis has been evaluated in four large, prospective clinical trials enrolling a total of more than 1,100 patients at major medical centers worldwide. The PLATFORM (Prospective LongitudinAl Trial of FFRCT: Outcome and Resource IMpacts) trial demonstrated that a HeartFlow-guided patient evaluation strategy effectively identified which patients do and do not need invasive treatment. When compared to usual care, a HeartFlow-guided strategy reduced by 83 percent the number of patients who underwent a planned invasive coronary angiography only to find they in fact had no obstructive disease and, therefore, no need for invasive intervention.

Despite the difference in the number of patients who required invasive coronary angiography, the rate of revascularization procedures, such as coronary stenting or bypass surgery, was similar. A health economic analysis performed as part of the PLATFORM study found the HeartFlow FFRct Analysis reduced healthcare systems’ costs by 26 percent, saving thousands of dollars per patient. Results from the PLATFORM trial were published in the European Heart Journalii and the Journal of the American College of Cardiology.[iii]

Based on these positive data, healthcare professionals, professional organizations and commercial health plans have all taken notice of HeartFlow’s technology. In the U.K., the National Institute for Health and Care Excellence (NICE) of the National Health Service recommends the HeartFlow FFRct Analysis to help determine the cause of stable chest pain.

After reviewing the data, NICE concluded that the HeartFlow FFRct Analysis is safe, has a high level of diagnostic accuracy, and may avoid the need for invasive coronary angiography. NICE further concluded that, compared to all other tests, use of the HeartFlow FFRct Analysis is the most cost-effective solution because it avoids unnecessary invasive tests and treatment.

In the United States, the American College of Cardiology (ACC) and the American Heart Association (AHA) have released updated Appropriate Use Criteria for Coronary Revascularization in Patients with Stable Ischemic Heart Disease. These criteria include the use of the HeartFlow FFRct Analysis in determining the appropriateness of revascularization in many clinical scenarios.

 

To date, more than 13,000 patients have benefitted from the HeartFlow FFRct Analysis, which is available in hospitals and medical centers in the U.K., the United States and Japan. For more information about the HeartFlow FFRct Analysis, visit www.heartflow.com or email info@heartflow.com.

 

[i] Patel et al. Am Heart J. 2014;167:846-852.e2.

[ii] 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.

[iii] Hlatky et al. J Am Coll Cardiol. 2015.