Highmark Health, Allegheny Health Network (AHN), and HeartFlow announced today that they are partnering to evaluate a novel non-invasive diagnostic technology that offers physicians insight into both the extent of a patient's coronary arterial blockage and the impact the blockage has on blood flow.

The partnership is part of Highmark Health’s VITAL (Verification of Innovation by Testing, Analysis and Learning) Innovation Program.

The HeartFlow Analysis uses images derived from a standard, non-invasive coronary CT angiogram (cCTA); the U.S. Food & Drug Administration (FDA)-cleared product creates a personalized, digital 3D model of each patient’s coronary arteries.

Powerful computer algorithms then solve millions of complex equations to assess the impact of blockages on blood flow. This information aids physicians to determine the appropriate course of action for each patient.

"Traditionally, our options for diagnosing coronary artery disease included either a non-invasive stress test or an invasive heart catheterization." said Moneal Shah, MD, a cardiologist at AHN and the lead investigator of this program.

"With the technology from HeartFlow, we are essentially combining the information provided by a heart catheterization and a stress test through a simple non-invasive test. This is the first non-invasive technology to do this and has the potential to reduce the need for invasive testing."

Coronary artery disease, also called coronary heart disease, is the leading cause of death for both men and women in the United States.

Coronary artery disease develops when the arteries leading to the heart narrow, often because of the buildup of plaque in the vessel walls. The coronary narrowing can reduce blood flow to the heart, causing chest pain, heart attacks and death. In the United States, an estimated 16.3 million adults suffer from coronary artery disease and it is the leading cause of death worldwide, killing approximately 3.8 million men and 3.4 million women each year.

AHN cardiologists already have reported that the HeartFlow Analysis has provided more definitive clinical information that led to an improved treatment strategy for several patients. Recently, a 78-year-old male dealing with chest pain for more than a year had two normal stress tests, but his symptoms persisted.

Physician review of the coronary CT and HeartFlow analysis indicated the patient had extensive disease that would require a revascularization with two stents. Meanwhile, a 58-year-old female patient with a history of hypertension had an abnormal stress test but was able to avoid an invasive angiography when physician review of the HeartFlow Analysis indicated that her disease was not severe and medical management would be the optimal treatment.

"These examples illustrate how this innovative technology can potentially assist cardiologists to improve their diagnostic skills so that the right care can be prescribed to the right patient," said Srinivas Murali, MD, Director of AHN’s Cardiovascular Institute.

Through the VITAL program, payers are able to understand the full impact of new technologies on their members without changing insurance medical policy prematurely. Additionally, providers gain early access to novel technologies and a first-hand understanding of their impact on patients. In this way, technology vendors have the opportunity to prove the benefits of their new innovations to patients, providers and payers.

"VITAL’s mission is to leverage Highmark Health’s position as one of the largest integrated health care delivery and financing systems in the nation in order to accelerate the pace with which novel technologies and services are made available to the public," stated David Holmberg, President and CEO, Highmark Health.

"Our members and patients will be afforded access to safe new technologies that increase the quality of care and create positive patient outcomes without undue financial burden."