Public Release: 

UH Case Medical Center first to offer novel HeartFlow FFR(CT) technology

Highly accurate, non-invasive test will change management of coronary artery disease

University Hospitals Case Medical Center

CLEVELAND - Medical tests are stressful. Invasive tests, stress tests and unnecessary surgeries are too, not to mention the costs associated with all of them, but the alternative of undiagnosed heart problems are not. They can be fatal.

UH Case Medical Center is now offering a new, non-invasive test for coronary artery disease designed to help physicians develop the right treatment plan for each patient. Developed by HeartFlow Inc., FFRCT is the first and only non-invasive imaging technology specifically designed to offer insight on both the extent of the blockage, as well as whether it is impacting blood flow to the heart.

UH Case Medical Center's Daniel Simon, MD, and Hiram Bezerra, MD, PhD, were the first to use the FFRCT test in the United States on Jan. 16.

Most other diagnostic tests are designed to provide information to clinicians regarding a patient's overall risk of having coronary artery disease, but they cannot help the clinician determine the extent to which a specific blockage is impeding blood flow to the heart.

HeartFlow's FFRCT technology is designed to address this unmet need.

The FFRCT platform was developed by marrying non-invasive 3D imaging with computational fluid dynamics technology to produce detailed models of a patient's cardiovascular anatomy. For every patient, FFRCT performs millions of complex equations simulating blood flow in the coronary arteries to provide mathematically computed fractional flow reserve (FFRCT) values from images derived using non-invasive computed tomography (CT) angiography. Fractional flow reserve values demonstrate blood pressure differences around a lesion to determine whether it is likely to reduce blood flow to the heart. These simulated values help physicians determine the right course of action for each patient.

"FFRCT represents a tremendous advancement in the diagnosis of coronary artery disease," said Dr. Simon, president, Harrington Heart & Vascular Institute at UH Case Medical Center, and Herman K. Hellerstein Chair and professor of medicine at Case Western Reserve University School of Medicine. "Historically, we have been faced with either using tests we knew were not always accurate or putting a patient through an invasive procedure just to determine whether they needed another invasive procedure. For the first time, we have access to a diagnostic that is both non-invasive and highly accurate in showing us the extent of a lesion, as well as how it can hinder blood flow through the vessel. I believe FFRCT has the potential to completely change the way we manage coronary artery disease globally."

Clinical data from the landmark HeartFlow NXT study demonstrated superior discriminatory ability to identify lesions that have the potential to impede blood flow when compared to coronary CT angiography alone. In the study, published in the Journal of the American College of Cardiology in 2014, FFRCT had higher diagnostic accuracy (86 percent) than coronary CT angiography (65 percent). This difference is primarily due to a significantly increased specificity with FFRCT (86 percent) compared to coronary CT angiography (60 percent).1 Invasive angiography performed with 71 percent accuracy in the study.2

With the improved data, patients will not have to undergo unnecessary procedures or further invasive or time-consuming testing associated with coronary artery disease.

"We believe FFRCT technology has the potential to transform the way coronary artery disease is managed," said John H. Stevens, MD, chairman and CEO of HeartFlow. "Research on this technology began more than 20 years ago and we have continued to refine it over time to ensure we were able to provide precision, safety and efficiency. It is incredibly gratifying to finally give clinicians in the United States the chance to use our technology to help treat their patients."

Coronary artery disease develops when the arteries leading to the heart become diseased or damaged, often because of the build up of plaque in the vessel walls. The plaque - or lesions - can cut off vital blood flow to the heart, causing chest pain, heart attacks and death. Coronary artery disease affects an estimated 16.3 million adults and is one of the most costly medical conditions to the United States health care system.

Non-invasive tests are widely used to diagnose coronary artery disease, but studies have shown a need to improve their accuracy. A study conducted by Duke University investigators and published in the New England Journal of Medicine found that fewer than 38 percent of patients who underwent elective invasive cardiac catheterization and angiography were found to have obstructive coronary artery lesions, even though non-invasive testing had been performed on 84 percent of those patients.3

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About HeartFlow Inc.

HeartFlow Inc. is a personalized medical technology company dedicated to transforming the way cardiovascular disease is managed. Committed to improving outcomes, reducing costs and creating a better patient experience, HeartFlow's goal is to provide healthcare professionals with actionable knowledge about each patient by combining best-in-class, non-invasive healthcare imaging with advanced, computational fluid dynamics technology and the insights of big data. HeartFlow's non-invasive FFRCT technology helps physicians diagnose coronary artery disease and provides them with information they need to manage each patient. For more information visit http://www.heartflow.com.

About University Hospitals

University Hospitals, the second largest employer in Northeast Ohio with 25,000 employees, serves the needs of patients through an integrated network of 15 hospitals, 28 outpatient health centers and primary care physician offices in 15 counties. At the core of our $3.5 billion health system is University Hospitals Case Medical Center, ranked among America's 50 best hospitals by U.S. News & World Report in all 12 methodology-ranked specialties. The primary affiliate of Case Western Reserve University School of Medicine, UH Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation, including cancer, pediatrics, women's health, orthopaedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and genetics. Its main campus includes UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University. For more information, go to http://www.uhhospitals.org.

  1. Nostrokergaard, B. et al. J Am Coll Cardiol 2014;63:1145-55

  2. Nostrokergaard, B., Transcatheter Cardiovascular Therapeutics presentation, October 2013

  3. Patel, M. et al. N Engl J Med 2010;362:886-95

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