Balancing Enthusiasm for New Technologies With the Need for Trial Data, With David Rizik, MD, and Michael Morris, MD

On February 11, 2026, cardiologists from Banner Health gave a live demonstration of the Heartflow PCI Navigator, an investigational, AI-driven device that analyzes CT scan data to generate 3D models of patients’ venous systems to help clinicians determine optimal stent placement.1

First debuted at the Transcatheter Cardiovascular Therapeutics (TCT) conference from October 25-28, 2025, the Navigator more specifically generates models of the patient’s anatomy, plaque composition, and lesion-specific physiology, giving clinicians access to all necessary data before entering the catheterization lab for stenting procedures. The current presentation, delivered at the inaugural Scottsdale Interventional Forum (SCI) in Phoenix, Arizona, was many clinicians’ first example of the technology.1

However, despite the promise of this new technology, it is still very much in the investigative phase. The first in-human trials of the Heartflow PCI Navigator have yet to take place. To discuss the dichotomy between enthusiasm for new technology and the necessary steps to clear it for clinical use, as well as how clinicians can balance this frustrating reality, the HCPLive editorial team spoke with David Rizik, MD, an interventional cardiologist at Banner University Health and co-leader of the session, and Michael Morris, MD, a diagnostic radiologist at Banner University Health and the other session co-leader.

“The frustrating thing is that we always want to have the outcomes data at the same time as we get the new information, but there’s a delay,” Morris told HCPLive. “Right now, we’re at the early aspect of the process, where we just now have it available, and we have thought leaders who are enlightening us as to how best these tools can be used in terms of enhancing the clinical pathway.”

The Heartflow PCI Navigator was developed as a result of the PLAN CALCIUM study, a retrospective cohort analysis which was presented alongside the Navigator at TCT 2025. A total of 85,306 patients were included in the analysis, of whom 4936 were receiving CCTA and 80,370 were not.2

Investigators established a composite endpoint of all-cause mortality, heart failure, and AMI at 1 and 5 years of follow-up; by the end of the trial, 9.6% of patients receiving CCTA exhibited this endpoint versus 13% of those not receiving CCTA at 1 year. Additionally, at the 5-year mark, 16.1% of recipients and 23.7% of non-recipients exhibited the composite endpoint.2

Heartflow has also announced that it is actively recruiting patients into the NAVIGATE-PCI registry, which will assess the Navigator’s effect on procedural safety and efficacy, strategy and patient outcomes, and physician confidence compared to standard treatments. The registry aims to enroll >2500 patients; currently, it is targeting roughly 30 sites across the US.3

Until this study – and its subsequent clinical trials – are complete, clinicians remain limited to traditional stent treatment. Rizik and Morris acknowledge that this is a point of frustration, given the hypothetically superior outcomes that the Heartflow PCI Navigator can provide for patients. However, they urge patience, as the actual practical efficacy – and potential limitations – of the technology are still unknown.

“A very wise cardiologist once said, no matter how enthusiastic you are, you put your prejudices aside, and you do the studies,” Rizik told HCPLive.

Editor’s Note: Rizik reports disclosures with Abbott Vascular, Biotronik, Cordis, Trireme, and Boston Scientific. Morris reports no relevant disclosures.

References

1. Banner Health. Banner Health pioneers advanced treatment for complex coronary disease. February 11, 2026. Accessed February 12, 2026. https://www.bannerhealth.com/newsroom/press-releases/complex-coronary-disease

2. Patel A, Sandoval Y, Mullen S, et al. TCT-417 coronary CT angiography and AI-enabled coronary plaque analysis to inform PCI and lesion preparation: The plan calcium study. JACC. 2025;86(17). doi:10.1016/j.jacc.2025.09.534

3. Heartflow. New Heartflow PCI Navigator to Equip Interventional Cardiologists with Pre-procedural Insights to Enable PCI Planning. October 22, 2025. Accessed February 12, 2026. https://ir.heartflow.com/news-releases/news-release-details/new-heartflow-pci-navigator-equip-interventional-cardiologists