Heart Flow Planner preprocedural planning to enable Interventionalists
® Heart. Flow Planner: pre-procedural planning to enable Interventionalists to determine optimal treatment
Charles A. Taylor, Ph. D. Heart. Flow, Inc. DISCLOSURE Chief Technology Officer, Founder and Board Member Stanford University Adjunct Professor of Bioengineering Technical University of Eindhoven Part-time Professor of Biomedical Engineering
Typical non-invasive cardiac testing Symptomatic patient with suspected CAD 1. 2. Patel, et al. N Engl J Med 2010. Patel, et al. AHJ 2014. Danad, et al. JAMA Cardiology 2017. Arbab-Zadeh, Heart Int 2012. Yokota, et al. Neth Heart J 2018. Nakanishi, et al. J. Nuc Cardiol 2018. DOC 56816634
Negative SPECT, Severe Proximal LAD lesion and low FFR LAD FFR = 0. 43 SPECT read by core lab as negative c. CTA read by core lab as having a severe proximal LAD lesion DOC 56816634
Paradigm Shift: Heart. Flow® FFRCT Analysis Anatomical Information + Functional Insight = Heart. Flow Model Coronary CTA + the Heart. Flow Analysis is the only non-invasive cardiac pathway to provide both anatomical and lesion-specific functional information in a single patient encounter Patient management guided by lesion-specific physiology led to a 28% reduction in MI in a meta-analysis of multiple invasive FFR studies 1 1. Zimmerman, et al. Euro Heart J 2019. DOC 56816634 5
FFRCT uses A. I. Deep Learning methods for image analysis Deep learning algorithm used to create anatomic model Image data from CTA Trained analysts inspect & correct Supercomputers apply CFD to create physiologic model Approved model delivered Virtuous cycle where human corrections are used in subsequent releases to train the algorithm, the algorithm improves and fewer corrections are needed DOC 56816634
FFRCT Image segmentation methods validated with OCT data and robust even in patients with high calcium scores Ag =3865 Uzu et. al. Euro. Intervention. 2019; 14: e 1609 -e 1618. Nørgaard B et al, JACC Imaging 2015 DOC 56816634
Better diagnostic performance against FFR than any other non-invasive test PACIFIC Heart. Flow FFRCT 0. 94 PET 0. 87 (p < 0. 001) Coronary CTA 0. 83 (p < 0. 001) Diagnostic accuracy: • 87% (PACIFIC, JACC 2019) • 86% (NXT, JACC 2014) SPECT 0. 70 (p < 0. 001) P-values reflect comparison to the Heart. Flow FFR C T Analysis DOC 56816634 Driessen, et al. J Am Coll Cardiol 2019. Nørgaard, et al. J Am Coll Cardiol 2014. 8
A better noninvasive cardiac testing pathway: Coronary CTA + Heart. Flow FFRCT Reduce overutilization of Invasive Testing by reducing false positives 1 Identify Functional Disease Other Tests Miss 2 by reducing false negatives Sensitivity vs. Invasive FFR (per vessel) Rate of Negative Coronary Angiograms 100% 86% 100% 73% the sensitivity of all other tests. ↓ 83% reduction in unnecessary invasive testing 50% ↑ ~2 x 50% 45% 48% SPECT Stress Echo 12% 0% 0% Usual Care FFRCT Guided 1. Douglas, et al. Eur Heart J 2015. 2. Nørgaard, et al. Euro J Radiol 2015. Incl. Jung, et al. Euro Heart J 2008. Melikian, et al. JACC Cardiovasc Interv 2010. Koo, et al. JACC 2011. Min, et al. J Am Med Assoc 2012. Nørgaard, et al. JACC 2014. Danad, et al. JAMA Cardiol 2017. Driessen, et al. JACC 2019. FFRCT DOC 56816634 9
FFRCT is not a replacement for invasive physiology, but rather a means to identify enriched patient population that may benefit from further invasive assessment DOC 56816634 “Coronary Computed Tomography Angiography With Selective Noninvasive Fractional Flow Reserve, ” BCBSA Evidence Street Review, June 2017.
FFRCT improved patient referral to ICA ADVANCE 72. 3% of patients who had a positive Heart. Flow Analysis (FFRCT≤ 0. 80) and were undergoing ICA were revascularized Fairbairn, T. A. , et al. Euro Heart J 2018 | Douglas, P. S. et al. J Am Coll Cardiol. 2016 All MACE included above (Death, MI, Hospital Admission for ACS and Unplanned Revascularization) DOC 56816634 11
Patients have better outcomes with higher Post-PCI FFR Survival curves % Adverse Events at 6 Months FFR Post-PCI Fewer Adverse Events & 40% Reduction in Post-PCI MACE 1. Pijls NHP et al. Circulation 2002; 105: 2950 -2954. 2. Johnson N et al. Prognostic Value of FFR: Linking Physiologic Severity to Clinical Outcomes. J Am Coll Cardiol 2014; 64: 1641 -1654. DOC 56816634
Heart. Flow Planner Enables the Interventionalist to evaluate alternate treatment strategies to optimize coronary blood flow before they enter the catheterization lab • • • Noninvasive interactive tool that leverages the information within the Heart. Flow Analysis Explore different clinical scenarios by virtually modifying the vessel Assess the FFRCT value(s) resulting from each scenario *Investigational Device. Not for clinical use. DOC 56816634
Core Components 1 Heart. Flow Analysis Interactive Mobile Platform 2 ● IOS, interactive viewer ● Cath-lab specific features (e. g. projection angles) Heart. Flow Planner 3 Ideal Geometry ● Contains a second anatomic model representing the “ideal” vessel *Not for clinical use. Real-time FFRCT calculation 4 ● Modified vessel combined with updated physiology ● Updated FFRCT values calculated based on these inputs in seconds DOC 56816634 *Investigational Device. Not for clinical use.
Case Report Ihdayhid AR et al. JACC Int 2017 DOC 56816634 *Investigational Device. Not for clinical use.
Recent paper – Revascularization of Serial Lesions “A novel noninvasive FFRCT-based PCI planner tool more accurately predicts the true FFR contribution of each stenosis in serial coronary artery disease” DOC 56816634 *Investigational Device. Not for clinical use. 16
Precise PCI Plan (P 3) Trial A prospective multicenter clinical trial assessing the accuracy of FFR CT and Heart. Flow Planner before and after PCI as compared to measured FFR in patients with suspected CAD in whom PCI is intended. • • P. I. : Jeroen Sonck, M. D. , OLV Aalst Chairman: Bernard De. Bruyne, M. D. , Ph. D. To enroll 120 patients at 5 centers Determine the agreement between Heart. Flow Planner & m. FFR in predicting the functional status of coronary vessel(s) after PCI. – Pre and Post-PCI Angiography, motorized FFR pullback traces, OCT data – Prospective, blinded comparison between Heart. Flow CT-derived anatomy, FFRCT and measurements (OCT, QCA, FFR) DOC 56816634 *Investigational Device. Not for clinical use.
DECISION Trial A multicenter randomized trial of FFRCT-guided selective angiography and FFRCTguided revascularization compared with routine angiography and FFR/i. FR-guided revascularization in patients with suspected CAD in whom angiography is intended. CTA +/- FFRCT ~5000 troponin negative symptomatic pts in whom angiography is planned for suspected CAD (n=2500) R 1: 1 Plaque rupture, LM Stenosis ≥ 30%, or FFRCT ≤ 0. 80 OR Typical angina & FFRCT 0. 81 -0. 85 Angiography, and as appropriate, PCI informed by invasive physiology Yes Invasive assessment, and as appropriate, PCI informed by Heart. Flow Planner No (n=2500) PI: Gregg W. Stone AROs: CRF and DCRI; Sponsor: Heart. Flow Defer Cath DOC 56816634 *Investigational Device. Not for clinical use.
Future of FFRCT in the Cath. Lab Pre-procedural planning may improve patient outcomes, reduce procedure time, minimize contrast and radiation and lower costs DOC 56816634 *Investigational Device. Not for clinical use.
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