Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography

Abstract

Background: Low fractional flow reserve (FFR) values after percutaneous coronary intervention (PCI) carry a worse prognosis than high post-PCI FFR values. Therefore, the ability to predict post-PCI FFR might play an important role in procedural planning. Post-PCI FFR values can now be computed from pre-PCI coronary computed tomography angiography (CTA) using the fractional flow reserve derived from coronary computed tomography angiography revascularization planner (FFRCT Planner).

Objectives: The aim of this study was to validate the accuracy of the FFRCT Planner.

Methods: In this multicenter, investigator-initiated, prospective study, patients with chronic coronary syndromes and significant lesions based on invasive FFR ≤0.80 were recruited. The FFRCT Planner was applied to the fractional flow reserve derived from coronary computed tomography angiography (FFRCT) model, simulating PCI. The primary objective was the agreement between the predicted post-PCI FFR by the FFRCT Planner and measured post-PCI FFR. Accuracy of the FFRCT Planner's luminal dimensions was assessed by using post-PCI optical coherence tomography as the reference.

Results: Overall, 259 patients were screened, with 120 patients (123 vessels) included in the final analysis. The mean patient age was 64 ± 9 years, and 24% had diabetes. Measured FFR post-PCI was 0.88 ± 0.06, and the FFRCT Planner FFR was 0.86 ± 0.06 (mean difference: 0.02 ± 0.07 FFR unit; limits of agreement: -0.12 to 0.15). Optical coherence tomography minimal stent area was 5.60 ± 2.01 mm2, and FFRCT Planner minimal stent area was 5.0 ± 2.2 mm2 (mean difference: 0.66 ± 1.21 mm2; limits of agreement: -1.7 to 3.0). The accuracy and precision of the FFRCT Planner remained high in cases with focal and diffuse disease and with low and high calcium burden.

Conclusions: The FFRCT-based technology was accurate and precise for predicting FFR after PCI. (Precise Percutaneous Coronary Intervention Plan Study [P3]; NCT03782688).

Keywords: FFR(CT) Planner; coronary computed tomography angiography; fractional flow reserve; invasive coronary angiography; optical coherence tomography; percutaneous coronary intervention.

Conflict of interest statement

Funding Support and Author Disclosures The study was sponsored by the Cardiac Research Institute Aalst with unrestricted grants from HeartFlow and Cardiopath. Drs Sonck and Munhoz have received research grants provided by the Cardiopath PhD program. Dr De Bruyne has received consultancy fees from Boston Scientific and Abbott Vascular; research grants from Coroventis Research, Pie Medical Imaging, CathWorks, Boston Scientific, Siemens, HeartFlow, and Abbott Vascular; and owns equity in Siemens, GE, Philips, HeartFlow, Edwards LifeSciences, Bayer, Sanofi, and Celyad. Dr Collet has received research grants from Biosensor, Coroventis Research, Medis Medical Imaging, Pie Medical Imaging, CathWorks, Boston Scientific, Siemens, HeartFlow, and Abbott Vascular; and consultancy fees from HeartFlow, OpSens, Abbott Vascular, and Philips Volcano. Dr Ko has received consulting fees from Canon Medical, Abbott, and Medtronic. Dr Mizukami has received consulting fees from Zeon Medical and HeartFlow; and speaker fees from Abbott Vascular. Dr Heggermont reports that Cardiac Research Institute Aalst receives consultancy fees on his behalf from Boston Scientific, Abbott Vascular, MicroPort, Medtronic, Biotronik, and AstraZeneca. Dr Updegrove and Ms Collinsworth are employees of HeartFlow. Dr Leipsic is a consultant and reports holding stock options in Circle CVI and HeartFlow; and has received a research grant from GE and modest speaker fees from GE and Philips. Drs Norgaard and Møller Jensen have received unrestricted institutional research grants from Siemens and HeartFlow. Dr Otake has received research grants from Abbott Vascular; and speaker fees from HeartFlow and Abbott Vascular. Dr Ihdayhid has received consulting fees from Canon, Artrya Medical, and Boston Scientific. Dr Koo has received institutional research grants from HeartFlow. Dr Andreini has received research grants from GE Healthcare and Bracco. Dr Barbato has received speaker fees from Boston Scientific, Abbott Vascular, and GE. Dr Maeng has received advisory board and lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Boston Scientific, and Novo Nordics; and research grants from Bayer and Philips Healthcare. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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