HeartFlow touts registry study, large hospital trial data

HeartFlow this week released data from two studies of its HeartFlow fractional flow reserve FFRct analysis system, touting that the system allows for the more effective differentiation of patients who need coronary stenting or bypass surgery and those who can be managed on medications alone.

HeartFlow’s FFRct technology works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing the changes in flow across coronary lesions.

Results from the Advance registry study were published in the European Heart Journal and results from the Aarhus University Hospital experience were published in Journal of the American College of Cardiology, and both were presented during the European Society of Cardiology Conference, HeartFlow said.

Redwood City, Calif.-based HeartFlow said that in both studies, the HeartFlow analysis allowed for more efficient separation of patients who required invasive management and those who did not through the identification of patients at very low risk of adverse events under medical therapy, and those whose risk was reduced by invasive management.

The Advance registry included data from more than 5,000 patients in the US, Japan, Europe and Canada, while the Aarhus University Hospital experience included data from 3,600 patients in Denmark followed for an average of two years, HeartFlow said.

Results from the Advance registry showed that the use of the HeartFlow analysis resulted in reconsiderations and changes to management plans for approximately 67% of patients, the company said. This allows certain patients scheduled to receive a coronary stent or bypass operation to safely avoid the procedure and be treated with medications alone, the company added.

Data from the Aarhus University Hospital Experience indicated that use of the HeartFlow analysis allowed physicians to effectively differentiate higher risk patients who needed additional testing, stenting or bypass surgery from those who only required medications.

“The HeartFlow Analysis is a tool that helps me more effectively develop treatment plans with greater confidence for my CAD patients. Being able to use a non-invasive cardiac test to clearly differentiate which of my patients need invasive procedures or are most at-risk for adverse events is instrumental in my ability to provide them with the best care,” cardiologist and Advance registry paper first author Timothy Fairbairn of the Liverpool Heart and Chest Hospital said in a press release.

“These studies confirm the role of the HeartFlow Analysis in identifying disease that other tests may miss, and in providing reassurance to patients and doctors that some blockages are not in need of invasive management,” HeartFlow chief medical officer Dr. Campbell Rogers said in a prepared statement.

In June, Heartflow said that it won reimbursement coverage from insurer UnitedHealthcare, which will now cover its HeartFlow FFRct fractional flow reserve analysis for its 45 million members.