Using data from a standard CT scan, the non-invasive HeartFlow Analysis creates a personalized 3D model of the coronary arteries and analyzes the impact that blockages have on blood flow.
Today’s non-invasive diagnostic tests provide little explanation of chest pain, leading many patients to unnecessary invasive testing.
In fact, more than half of patients who undergo these invasive tests have no significant blockage.
Enables clinicians to identify significant coronary artery disease and determine the optimal treatment pathway.
For decades, invasive coronary angiograms have been the gold standard for determining whether a patient has blockage in the coronary arteries and the extent of the blockage. Angiograms involve inserting a long flexible catheter into the bloodstream, usually by way of the femoral artery in the thigh, to deliver contrast agent so the arteries can be seen on an X-ray. Coronary arteries are quite small and moving because the heart is beating, so getting a clear image is technically quite difficult. Still, about 1 million patients have invasive coronary angiography in the United States each year.
The diagnostic angiogram is a fork in the road. It allows the cardiologist to determine if a patient has nonobstructive coronary artery disease (no visible blockages present) or obstructive disease. The former typically leads to medical therapy while the latter may lead to angioplasty and stents or to a coronary bypass graft.
HeartFlow recently launched the second generation of its HeartFlow FFRCT Analysis. This technology is based on 15 years of scientific research conducted by Charles Taylor and Christopher Zarins at Stanford University. FFR in FFRCT stands for fractional flow reserve, and the CT refers to the fact that it is derived from a CT scan. The fractional flow reserve traditionally has been done during the invasive angiogram. It’s a measurement of the functional consequences of a partial obstruction — basically the impact the blockage has on the blood flow to the heart. If a partially blocked coronary artery is not functionally impairing the heart’s need for oxygen, it can be safely treated with medication and lifestyle modification.
HeartFlow uses advanced algorithms and pure science to balance the risks and benefits of the various coronary tests. By using the enormous amount of data that can be obtained from a CT angiogram, certified analysts, and a well-honed proprietary algorithm containing millions of mathematical calculations based on the physics of fluid dynamics, an accurate and clinically relevant Heart Flow’s FFRCT can be calculated.
Long-term results from HeartFlow’s fourth clinical trial, PLATFORM, were presented at the American College of Cardiology annual meeting in April. PLATFORM was a European, multicenter, controlled, prospective, pragmatic, comparative effectiveness trial utilizing a consecutive cohort design. It compared standard diagnostic strategies to a FFRCT-guided strategy in 584 patients with stable chest pain.
Coronary computed tomographic angiography (CCTA) provides anatomic detail of lumen stenosis and information on plaque burden, plaque extent and plaque characteristics. CCTA does not, however, provide insight into the hemodynamic significance of a stenosis, which is essential to allow appropriate revascularization decision-making.
This could reduce downstream invasive coronary angiography and nonbeneficial coronary revascularization, particularly with intermediate coronary stenosis. Invasive fractional flow reserve (FFR) is the gold standard for the determination of lesion-specific ischemia and the need for revascularization.
Advances in computational technology now permit calculation of FFR using resting CCTA image data, without the need for additional radiation or medication. Early data demonstrate improved accuracy and a discriminatory ability of FFR computed tomography to identify ischemia-producing lesions compared with CCTA alone.
This new, combined anatomic-functional assessment has the potential to simplify the noninvasive diagnosis of coronary artery disease with a single study to identify patients with ischemia-causing stenosis who may benefit from revascularization.