HeartFlow, Inc. the Institute’s first company-in-residence and graduate, is changing the way that patients with suspected coronary artery disease (CAD) are managed. Affecting 16.8 million Americans, CAD develops when the coronary arteries are narrowed, reducing blood flow to the heart and causing chest pain, heart attack, or worse, death.
The tests commonly used to diagnose CAD, including stress tests and electrocardiograms, 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, coronary angiography has been shown to be unnecessary more than 60 percent of the time. Invasive procedures may cause additional risks and may worry the patient and burden the healthcare system.
HeartFlow has developed an innovative technology, the HeartFlow FFRct Analysis, which 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. It helps cardiologists design a definitive, personalized treatment plan for each patient.
With HeartFlow’s approach, data from a patient’s non-invasive coronary CT angiogram are securely uploaded from the hospital’s system to the cloud. HeartFlow leverages deep learning to create a personalized, digital 3D model of the patient’s coronary arteries, and then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and assess the impact of blockages on coronary blood flow. The HeartFlow FFRct Analysis results are provided to the patient’s clinician via a secure web interface to offer actionable information on the optimal course of treatment.
Making substantial strides since graduating from the Institute
HeartFlow has made major advances since graduating from the Institute in 2010. It has raised more than $225 million in funding and has gained tremendous momentum with the adoption of its technology, The HeartFlow FFRct Analysis is commercially available in the United States, Europe and Japan, and more than 13,000 patients have benefitted from this technology. The company is continuously making iterations and providing numerous releases to improve the product and reduce the turnaround time so physicians can have the information as expediently as possible.
The effort has paid off for HeartFlow: Several large trials have clinically validated the technology, and a wealth of evidence-based data supports its clinical and economic benefits. In one large multicenter clinical study, use of the HeartFlow FFRct Analysis resulted in cancellation of a planned invasive coronary angiography in 60 percent of patients. A health economic analysis performed as part of that study found the HeartFlow test reduced the healthcare system’s costs by 26 percent, saving thousands of dollars per patient.
Based on this peer-reviewed data, a number of commercial payers have issued positive coverage decisions for the HeartFlow FFRct Analysis, including Aetna, which covers more than 23 million lives, Anthem which covers 37 million, and seven Blue Cross Blue Shield plans throughout the U.S. To date nearly 80 million Americans will have access to the HeartFlow technology. Evidence Street, which provides healthcare technology evaluations for the Blue Cross Blue Shield Association, a national federation of 36 independent Blue Cross and Blue Shield companies that collectively provide healthcare coverage for 105 million Americans, issued a review supporting the HeartFlow FFRct Analysis and indicating an expected improvement in net health outcomes. The National Institute for Health and Care Excellence (NICE) of the U.K.’s National Health Service, which covers 59 million lives, issued positive guidance, recommending the HeartFlow FFRct Analysis to help determine the cause of stable chest pain.
Additionally, the American Medical Association (AMA) issued a set of first-in-class Category III Current Procedural Terminology (CPT®) codes for the HeartFlow FFRct Analysis. Beginning in January 2018, hospitals and clinics utilizing this technology will be able to generate claims with both Medicare and commercial payers when the test is ordered for patients with suspected CAD.
The company has also forged partnerships with the largest manufacturers of computed tomography (CT) scanners, including GE and Siemens, with the goal of increasing the clinical availability and adoption of the HeartFlow FFRct Analysis. Recently announced was a collaboration agreement with Philips to co-promote HeartFlow to its Interventional Cardiology customers.
Saving patients’ lives
While it’s important to focus on metrics, HeartFlow is equally focused on the real reason for its technology – saving patient’s lives.
Its technology has proven to be critical in cases where traditional diagnostic tests missed coronary artery blockage, placing the patient at great risk of a heart attack or even sudden death.
Take Stephen Burke, an avid marathon runner, with no symptoms of CAD. As part of an executive health program, he underwent a 30-minute treadmill test and was sent to a cardiologist for a second opinion. After a CT scan showed significant calcium in one of his coronary arteries, the physician recommended the HeartFlow FFRct Analysis, which found evidence of triple vessel coronary artery disease – resulting in emergency quadruple bypass surgery that saved his life.
With those positive patient outcomes spurring them on, HeartFlow is looking to the future. The opportunity to expand the use of its technology is significant, and the company plans to enter other markets and launch additional products and features. The company intends to stay independent with the goal of going public at the opportune time.
The Institute has had a positive impact on HeartFlow’s success to date.
“The Fogarty Institute provided HeartFlow with an opportunity to share our technology with physicians at Palo Alto Medical Foundation who offered valuable insight,” said John Stevens, M.D., CEO of HeartFlow. “We found the Institute’s collaborative environment, in which we could brainstorm with other like-minded professionals in a thoughtful and productive manner, to be very helpful. It’s unusual to find an atmosphere where you can experience such a solid community and constructive sounding board.”