Quantitative Flow Ratio QFR Computed FFR based on

Quantitative Flow Ratio (QFR) Computed FFR based on two angiographic projectio Hector M. Garcia-Garcia MD, MSc, Ph. D, FESC, FACC Director, Angio and IVUS/NIRS corelab Chairman, Clinical Event Committee Confidential 2016

Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company None

Functional Assessment of Coronary Stenosis Using Angiography: will you treat it? diameter stenosis (DS): 53% Anatomy: DS = 53% vs. Physiology: FFR = 0. 85 Quantitative Coronary Angiography (QCA)

Functional Assessment of Coronary Stenosis Using Angiography: Background Traditional Methods Issues • Invasive – need a wire • Need for adenosine: • Discomfort; Arrythmia • Time consuming • Pullback device not available • For bifurcations, wire in both main vessel and sidebranch • Expensive for patient/hospital • Worldwide acceptance 7 -10% Echavarria-Pinto M, Garcia-Garcia HM et al. Interventional Cardiology. Oct 2015 , Vol. 7, No. 5, 483 Gonzalvez PA, Garcia-Garcia HM et al. JACC: Cardiovascular Imaging. Vol. 8, No. 11, Nov 2015, 1322.

Functional Assessment of Coronary Stenosis Using Angiography: Background Traditional Methods Computer Tomography Methods Echavarria-Pinto M, Garcia-Garcia HM et al. Interventional Cardiology. Oct 2015 , Vol. 7, No. 5, 483 Gonzalvez PA, Garcia-Garcia HM et al. JACC: Cardiovascular Imaging. Vol. 8, No. 11, Nov 2015, 1322.

Quantitative Flow Ratio - QFR: One-stop shop?

Quantitative Flow Ratio Relies on 3 D QCA 3 D vessel modelling is the backbone for the PCI procedure: • Allows the calculation of the functional significance parameter QFR • Optimal viewing angle for PCI • Precise stent sizing • Co-registration with OCT or IVUS

Quantitative Flow Ratio - QFR (Quantitative Flow Ratio = Medis’ QCA derived FFR) 3 D model reconstructed from 2 angiographic projections with angles ≥ 25º apart, acquired by monoplane or biplane systems. Patient-specific volumetric flow rate (at hyperaemia) calculated using the combination of contrast bolus front frame count and 3 D QCA; In-procedure time: < 5 min Based on Euro. PCR presentation by Aarhus University Hospital, Skejby, Denmark QFR = 0. 87 FFR = 0. 85

Quantitative Flow Ratio Study Results – FAVOR I

Quantitative Flow Ratio Study Results FFRQCA versus FFR FN FP Difference: 0. 00 ± 0. 06 (p = 0. 541) Tu et al. JACC Cardiovasc Interv 2014, 7: 768 -777

Quantitative Flow Ratio Study Results – FAVOR II Pilot

Functional Assessment of Coronary Stenosis Using Angiography: Background 1. f. QFR: a fixed empiric hyperemic flow velocity (HFV) of 0. 35 m/s that was derived from previous FFR studies was used for computation. 2. c. QFR: frame count (FC) analysis was performed, without pharmacologically induced hyperemia, to derived the HFV. 3. a. QFR: FC analysis was performed during hyperemia, induced by intravenous administration of adenosine or adenosine triphosphate. The “real” HFVs were derived and the software calculated 2 new QFR pullbacks. Flow velocity is segment length in 3 D QCA divided by dye flow time from FC. Tu S et al. JACC: Cardiovascular Interventions. Vol 9, Issue 19, 10 Oct 2016, 2024– 2035

Functional Assessment of Coronary Stenosis Using Angiography: Background Tu S et al. JACC: Cardiovascular Interventions. Vol 9, Issue 19, 10 Oct 2016, 2024– 2035

QFR analysis in a dedicated offline software (Medis Suite XA) Certified QFR analysis team Vessel QFR = 0. 54 Lesion QFR = 0. 56 Note: The wire based FFR is 0. 57

Functional Assessment of Coronary Stenosis Using Angiography: Background (A) Per patient (73). (B) Per vessel (84). Tu S et al. JACC: Cardiovascular Interventions. Vol 9, Issue 19, 10 Oct 2016, 2024– 2035

Conclusions from Authors • Fast computation of FFR from coronary angiography (QFR), acquired with or without pharmacological hyperemia-induction, is feasible. • Contrast-flow QFR (c. QFR) based on conventional diagnostic coronary angiography provides results similar to QFR based on hyperemic conditions, and is superior to fixed-flow QFR. • The favorable results of c. QFR bears the potential of a wider adoption of FFR-based lesion assessment, as c. QFR might reduce procedure time, risk, and costs (no need to use pressure wire, and no need to induce maximal hyperemia). • The use of QFR is not without a stiff learning curve, which requires that users be certified by the offline software provider (Medis) before being able to start. • Current indications: Patients with stable angina; • Under investigations: MI, bifurcation lesions, lengthy diffuse disease, etc.

QFR Ongoing Studies FAVOR II study Q 2 FR trial FDA IDE submission ALL AMI trial