May 19, 2021
REDWOOD CITY, Calif. – May 19, 2021 — HeartFlow, Inc., a leader in revolutionizing precision heartcare, today announced new data demonstrating the accuracy of the HeartFlow Planner in providing modeled post-percutaneous coronary intervention (PCI) fractional flow reserve derived from computed tomography (FFRCT) values, which are an important measure for understanding the effectiveness of a PCI procedure, such as a stent implantation. The results from the Precise PCI Plan (P3) trial were presented as a late-breaking trial during the virtual EuroPCR conference.
“The ability to non-invasively model different treatment strategies and preview the post-procedural impact of a PCI can help interventional cardiologists understand in advance how to achieve complete functional revascularization, which has been associated with improved clinical outcomes,” said Jeroen Sonck, MD, Co-Director, Cardiovascular Center, OLV Aalst and principal investigator of the P3 trial. “Based on the accuracy demonstrated in the P3 trial, we found the HeartFlow Planner is a useful tool for facilitating complete revascularization in patients with coronary artery disease.”
The HeartFlow Planner is a real-time, non-invasive interactive planning tool that enables heart teams to modify vessels virtually and determine the optimal treatment strategy prior to an invasive procedure. The P3 trial is a multi-center, investigator-initiated, prospective study which included 120 patients who were scheduled to undergo a PCI procedure. All patients underwent a coronary computed tomography angiogram (CTA) and received a HeartFlow FFRCT Analysis, and then underwent PCI guided by optical coherence tomography (OCT) and motorized invasive FFR pullbacks both pre- and post-PCI.
The primary objective of the P3 trial was to assess the level of agreement between the post-PCI FFR invasive measurements and the non-invasive values provided by the HeartFlow Planner. The agreement between the mean values provided by the HeartFlow Planner (0.86) and invasive FFR (0.88) was excellent, meeting the primary endpoint.
“Invasive FFR measurements, whether pre- or post-PCI, are the gold standard for evaluating physiology in coronary arteries. The validation of accuracy of the HeartFlow Planner against the gold standard should give physicians a high degree of confidence as they incorporate this information in procedural planning,” said Campbell Rogers, MD, FACC, Chief Medical Officer, HeartFlow. “The P3 trial is a reflection of HeartFlow’s commitment to providing compelling clinical data to help physicians optimize therapy for their patients with coronary artery disease. We also believe the HeartFlow Planner may prove important in enabling provider-patient communication regarding planned or completed treatments.”
Starting with a standard coronary CTA, the HeartFlow Analysis leverages deep learning and highly trained analysts to create a digital, personalized 3D model of the heart. The HeartFlow Analysis then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and provides FFRCT values along the coronary arteries. This information helps physicians evaluate the impact a blockage may be having on blood flow and determine the optimal course of treatment for each patient. A positive FFRCT value (≤0.80) indicates that a coronary blockage may be impeding blood flow to the heart muscle to a degree which may warrant invasive management.
Data demonstrating the safety, efficacy and cost-effectiveness of the HeartFlow Analysis have been published in more than 425 peer-reviewed publications, including long-term data out to five years. The HeartFlow Analysis offers the highest diagnostic performance available from a non-invasive test.1 To date, clinicians around the world have used the HeartFlow Analysis for more than 75,000 patients to aid in the diagnosis of heart disease.
With HeartFlow Planner, an interventional cardiologist or heart team can virtually explore the treatment area and view the modified vessel and resulting FFRCT changes in real time. This tool allows non-invasive modeling of different treatment scenarios to identify which intervention is optimal.
HeartFlow, Inc. is a leader in revolutionizing precision heartcare, uniquely combining human ingenuity with advanced technology. Our non-invasive HeartFlow FFRCT Analysis leverages artificial intelligence to create a personalized 3D model of the heart. By using this model, clinicians can better evaluate the impact a blockage has on blood flow and determine the best treatment for patients. Our technology is reflective of our Silicon Valley roots and incorporates decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRCT Analysis is commercially available in the United States, Canada, Europe and Japan. For more information, visit www.heartflow.com.