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Departman
Tarih
The Role of Angiography Based Mapping
Techniques
Dr.Gürsel Ateş
FFR – Gold Standard Physiological Index
 FFR is supported by European (class I, level of evidence: A ) and U.S. guidelines
(class Ⅱa, level of evidence: A ) for assessing intermediate coronary lesions and
guiding revascularization decisions.1,2)
TCT 2019
But still…global adoption of FFR remains low.
ESC CONGRESS2013
Wakayama Medical University
1) 2018 ESC/EACTS Guidelines on myocardial revascularization 2) 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention
3D Reconstruction
+ QFR = 0.87
QFR
Theoretical fluid dynamics
QUANTITATIVE FLOW RATIO (QFR): AN ESTIMATE OF FFR
Data Transmission System
StandardAngiogram
Two image runs with angle
difference ≥25°
AngioPlus
System
Without InducingHyperemia
Tu S et al. JACC CV Interv. 2014;7:768-77; Tu S et al. JACC CV Interv.2016;9:2024-35
• Could reduce time and
costs of assessment
• Good correlationwith FFR
• Lack of clinical evidence
• Practical to perform
(no adenosine)
• Robust randomized
evidence
• Non-inferior to FFR
• Two-decade clinical
experience
• Robust randomized
evidence
• Proven clinical benefit
FFR iFR QFR
KEY POINTS
CORRELATION AND AGREEMENT OF QFR VS FFR
Difference: 0.003±0.069 0.001±0.059 -0.001±0.065
Fixed-flow Contrast-flow Adenosine-flow
Tu S et al J Am Coll Cardiol Intv 2016;9:2024–35
Patients
(vessels)
FFR FFR<0.80 SD AUC
WIFI II 170(240) 0.85 (IQR:0.77-0.91) 36 % 0.08 0.86 (95% CI: 0.81-0.91)
FAVOR Pilot 73 (84) 0.84±0.08 32 % 0.06 0.92 (95% CI: 0.85-0.97)
FAVOR II E/J 272(317) 0.85 (IQR:0.77-0.89) 33 % 0.06 0.92 (95% CI: 0.89-0.96)
FAVOR II China 304(328) 0.85 (IQR:0.77-0.90) 36 % 0.06 0.96 (95% CI: 0.94-0.98)
Pooled 819 (969) 0.85 (IQR: 0.77-0.90) 35 % 0.07 0.92 (95% CI: 0.90-0.94)
DIAGNOSTIC PERFORMANCE OF QFR
IPD Meta-Analysis of FAVOR I, FAVOR II Europe Japan, FAVOR II China, and WIFI II
Holm NR et al. Presented at CIT 2018
3D 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
Relies on 3D QCA
Quantitative Flow Ratio - QFR
(Quantitative Flow Ratio = Medis’ QCA derived FFR)
Based on EuroPCR presentation by
Aarhus University Hospital, Skejby, Denmark
QFR = 0.87
FFR = 0.85
3D 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 3D QCA;
In-procedure time: < 5 min
Difference: 0.00 ± 0.06 (p = 0.541)
FFRQCA versus FFR
Tu et al. JACC Cardiovasc Interv 2014, 7:768-777
Quantitative Flow Ratio
Study Results
FN
FP
Computational
Model based on
CCTA
3-D anatomic model from CCTA
No additional
imaging No
additional
medications
Blood Flow Solution
Blood flow equations
solved on
supercomputer
Physiologic models
-Myocardial demand
-Morphometry-based boundary
condition
-Effect of adenosine on
microcirculation
CT-derived computed
FFR (FFRCT)
FFRCT = 0.72
(can select
any point on
model)
Koo BK. EuroPCR
2011
Patient-specific non-invasive FFR using
CT & CFD
Seoul National
1
Diagnostic performance of FFRCT
Patient
No
Sensitivity Specificity PPV NPV Accuracy
DISCOVE
R- FLOW
103 93% 82% 85% 91% 87%
DeFACTO 252 90% 54% 67% 84% 73%
NXT 251 86% 79% 65% 92% 81%
Total:
606
90% 72% 72% 89% 80%
Seoul National
1
Diagnostic performance of coronary
diagnostic tests vs. FFR
Stress
Echo
SPEC
T cCT
A
FFRC
T
Norgaard et. al. J Eur Radiology 2015. Seoul National
8
FFRCT Image segmentation methods validated with OCT data and robust
even in patients with high calcium scores
Uzu et.al. EuroIntervention. 2019;14:e1609-e1618. Nørgaard B et al, JACC Imaging 2015
Ag =3865
DOC 56816634
15
FFRCT improved patient referral to ICA
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)
72.3% of patients
who had a positive
HeartFlow Analysis
(FFRCT≤0.80) and were
undergoing ICA
were revascularized
Revascularization
Patients with
suspected CAD
Invasive coronary
angiography (ICA)
No obstructive
disease found
Usual care path
Patients with
suspected CAD
Invasive coronary
angiography (ICA)
No obstructive
disease found
Revascularization
No need for ICA
CTA/FFRCT-Guided Cohort
Usual Care Cohort
CTA /
FFRCT
Obstructive Disease
Obstructive Disease
T H E P L A T F O R M T R I A L
ADVANCE
DOC 56816634
ESC CONGRESS2013
TCT 2019
ESC CONGRESS2013
Wakayama Medical University
FFRCT – Non-invasive Physiological Index
Anatomical + Functional
Off-site supercomputing
 Non-invasive
 Gatekeeper
1) Koo et al. J Am Coll Cardiol 2011;58:1989–97 2) Min et al. JAMA 2012;308:1237-1245,
ESC CONGRESS2013
ESC CONGRESS2013
Wakayama Medical University
QFR – Less-invasive Physiological Index
Angiography-based technique
Without pressure wire
Without adenosine/ATP
Diagnostic angiography
+ TIMI frame count
1) Tu S. et al: JACC Cardiovasc Interv 2016; 9: 2024–35. 2)Xu B. et al: JACC 2017; 9: 3077–87.
TCT 2019
ESC CONGRESS2013
Results – Correlation
CVIT 2018 ESC CONGRESS2013
TCT 2019
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
QFR
R = 0.78
1.0
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
FFR FFR
FFR
CT
R = 0.63
N=11
False-negative
Tanigaki et al. J Am Coll Cardiol Intv2019; 12: 2050.
N=23
False-positive
N=97
True-negative
N=102
True-positive
N=19
False-negative
N=38
False-positive
N=89
True-negative
N=87
True-positive
QFR was highly correlated with FFR, while FFRCT was moderately correlated withFFR.
ESC CONGRESS2013
Percentage
(%)
Sensitivity
100
90
80
70
60
50
40
30
20
10
0
QFR
FFRCT
85%
76%
90%
82%
Specificity
82%
70%
Accuracy
Results – QFR vs. FFRCT with FFR as reference
CVIT 2018 ESC CONGRESS2013
TCT 2019
* p < 0.01
*
Tanigaki et al. J Am Coll Cardiol Intv2019; 12: 2050.
ESC CONGRESS2013
AUC comparisons
QFR – QCA: 0.15 (p<0.001)
FFRCT –CCTA: 0.12 (p<0.001)
QFR – FFRCT: 0.11 (p<0.001)
AUC
QFR 0.93
FFRCT 0.82
3D-QCA-derived %DS 0.78
CCTA-derived %DS 0.70
100
90
80
70
60
50
40
30
20
10
0
0 10 20 80 90 100
30 40 50 60 70
100-Specificity
Sensitivity
Results – Comparison of FFR < 0.80 predictors
CVIT 2018 ESC CONGRESS2013
TCT 2019
QFR
FFRCT
3D-QCA-derived %DS
CCTA-derived %DS
Tanigaki et al. J Am Coll Cardiol Intv2019; 12: 2050.
ESC CONGRESS2013
Target vessel: RCA - CCTA, FFRCT , Angiography &QFR
CVIT 2018 ESC CONGRESS2013
TCT 2019
FFRCT: 0.83 FFR: 0.82 QFR: 0.83
70-90% stenosis
FFRCT
CCTA CAG QFR
%DS=58%
ESC CONGRESS2013
Target vessel: LAD - CCTA, FFRCT , Angiography &QFR
CVIT 2018 ESC CONGRESS2013
TCT 2019
FFRCT: 0.73 FFR: 0.73 QFR: 0.74
50-70% stenosis
CCTA FFRCT CAG QFR
ESC CONGRESS2013
Target vessel: RCA - CCTA, FFRCT , Angiography &QFR
CVIT 2018 ESC CONGRESS2013
TCT 2019
FFRCT: 0.75 FFR: 0.92 QFR: 0.86
30-49% stenosis
CCTA CAG QFR
FFRCT
0.76
0.99
Introducing FFR | SIZE* (FFRangio Stent SizingTool)
 The Need:
 Stent size decisions are often based on visual
assessment alone, which could lead to misestimation
and complications:
 Intimal hyperplasia, coronary rupture
 Restenosis and stent thrombosis
 Additional unnecessary stent insertions
* FFR-SIZE not FDA approved.
Angiogram Visual Assessment
Prox
Ramus
70%
distal
Ramus
80%
 Physician Estimation:
 Proximal Stent:
 diameter 3 mm
 length 15 mm
 Distal Stent:
 diameter 2.75 mm
 length 20 mm
FFRangio
 FFRangio Estimation:
 Proximal Stent:
 diameter 2.4 mm
 length 15 mm
 Distal Stent:
 diameter 2 mm
 length 25 mm
Clinical Case #1 – Stent Diameter Overestimation
Post PCI Results (2 stents)
“new” mid lesion
2 stents were inserted based on the physician's assessment only, leading
to overdilation and creating a “new” lesion, so a 3rd stent needed to be
inserted
 3rd Stent FFRangio Estimation:
 Stent Diameter : 3 mm
 Stent Length : 12 mm
 3rd Stent Physician Estimation:
 Stent Diameter : 3 mm
 Stent Length : 12 mm
“new” mid
lesion
Post PCI Final Results (3 stents)
Mid LAD
80%
 Physician Estimation:
 Stent Size:
 diameter 3 mm
 length 18 mm
 FFRangio Estimation:
 Stent Size:
 diameter 3 mm
 length 26 mm
Angiogram Visual Assessment FFRangio
Clinical Case #2 – Stent Length Underestimation
Post PCI Results
Residual
lesion
The stent inserted was based on the physician's assessment, and since its
length was underestimated, a second stent needed to be inserted
 2nd Stent PhysicianEstimation:
 Stent Size
 diameter : 3 mm
 length : 8 mm
Residual
lesion
 FFRangio Estimation:
 Stent Size
 diameter : 3 mm
 length : 8 mm
Post PCI Final Result (2 stent)
A second stent was inserted:
HeartFlow Planner
• Noninvasive interactive tool that leverages the information within the
HeartFlow Analysis
• Explore different clinical scenarios by virtually modifying the vessel
• Assess the FFRCT value(s) resulting from each scenario
Enables the Interventionalist to evaluate alternate treatment strategies to optimize coronary
blood flow before they enter the catheterization lab
DOC 56816634
Core Components
HeartFlowAnalysis
1 Interactive Mobile Platform
● IOS, interactive viewer
● Cath-lab specific features (e.g. projection
angles)
2
IdealGeometry
3
● Contains a second anatomic
model representing the
“ideal” vessel
Real-time FFRCT
calculation
4
● Modified vessel combined with
updated physiology
● Updated FFRCT values calculated
based on these inputs in seconds
HeartFlow Planner
*Not for clinical use. DOC 56816634
*Investigational Device. Not for clinical use.
Bhavik N. Modi. Circulation: Cardiovascular Interventions. Predicting
the Physiological Effect of Revascularization in Serially Diseased
Coronary Arteries, Volume: 12, Issue: 2, DOI:
(10.1161/CIRCINTERVENTIONS.118.007577)
© 2019 The Authors. Circulation: Cardiovascular Interventions is
published on behalf of the American Heart Association, Inc., by
Wolters Kluwer Health, Inc. This is an open access article under
the terms of the Creative Commons Attribution License, which
permits use, distribution, and reproduction in any medium, provided
that the original work is properly cited.
Bhavik N. Modi. Circulation: Cardiovascular Interventions. Predicting
the Physiological Effect of Revascularization in Serially Diseased
Coronary Arteries, Volume: 12, Issue: 2, DOI:
(10.1161/CIRCINTERVENTIONS.118.007577)
© 2019 The Authors. Circulation: Cardiovascular Interventions is
published on behalf of the American Heart Association, Inc., by
Wolters Kluwer Health, Inc. This is an open access article under
the terms of the Creative Commons Attribution License, which
permits use, distribution, and reproduction in any medium, provided
that the original work is properly cited.
40
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.
Case Report
Ihdayhid AR et al. JACC Int 2017 DOC 56816634
*Investigational Device. Not for clinical use.
Lesions in ostial
LCX and mid LCX
PCI Planner
predicted only mid-
LCX lesion required
stenting
Confirmed by FFR
during the actual
case
Kim KH et al.
JACC Intv 2014;7:72-8
FFRCT Planner Application: VirtualStenting
Kim KH et al. JACC Intv 2014;7:72-8
FFRCT Planner Superior to FFR? Case report #1
Operator did not cover LAD ostial lesion – confirmed by IVUS. FFR0.74.
PCI Planner predicted FFR 0.76 if the ostium
was untreated vs. 0.81 if ostium was stented
Precise PCI Plan (P3) Trial
A prospective multicenter clinical trial assessing the accuracy of
FFRCT and HeartFlow 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 DeBruyne, M.D., Ph.D.
To enroll 120 patients at 5 centers
Determine the agreement between HeartFlow Planner
& mFFR 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 HeartFlow CT-
derived anatomy, FFRCT and measurements (OCT, QCA,
FFR)
DOC 56816634
*Investigational Device. Not for clinical use.
DECISION Trial
PI:GreggW. Stone
AROs:CRF and DCRI;Sponsor: HeartFlow
~5000 troponin negative
symptomatic pts in whom
angiography is planned for
suspected CAD
R
Angiography, and as
appropriate, PCI
informed by invasive
physiology
(n=2500)
CTA +/- FFRCT
(n=2500)
1:1
A multicenter randomized trial of FFRCT-guided selective
angiography and FFRCT-guided revascularization compared with
routine angiography and FFR/iFR-guided revascularization in
patients with suspected CAD in whom angiography is intended.
Plaque rupture, LM
Stenosis ≥30%, or
FFRCT ≤0.80
OR
Typical angina &
FFRCT 0.81-0.85
Invasive assessment, and as
appropriate, PCI informed by
HeartFlow Planner
Yes
No
Defer Cath
DOC 56816634
*Investigational Device. Not for clinical use.
Implications for Clinical Practice – QFR & FFRCT
 FFRCT is used mainly in the outpatient setting and reduces the number of
unnecessary diagnostic angiography.
 FFRCT might play the role of a gatekeeper to the pathway of coronary angiography.
 QFR is obtained during coronary angiography and helps decision making in
revascularization by identifying functionally significant lesions.
 QFR might reduce procedure time, risk, and costs because there is no need to use
pressure wire and to induce maximal hyperemia.
Conclusion
 Both QFR and FFRCT possessed the ability to accurately evaluate the functional
severity of coronary stenosis.

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ga30102020son.pptx

  • 1. Departman Tarih The Role of Angiography Based Mapping Techniques Dr.Gürsel Ateş
  • 2. FFR – Gold Standard Physiological Index  FFR is supported by European (class I, level of evidence: A ) and U.S. guidelines (class Ⅱa, level of evidence: A ) for assessing intermediate coronary lesions and guiding revascularization decisions.1,2) TCT 2019 But still…global adoption of FFR remains low. ESC CONGRESS2013 Wakayama Medical University 1) 2018 ESC/EACTS Guidelines on myocardial revascularization 2) 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention
  • 3. 3D Reconstruction + QFR = 0.87 QFR Theoretical fluid dynamics QUANTITATIVE FLOW RATIO (QFR): AN ESTIMATE OF FFR Data Transmission System StandardAngiogram Two image runs with angle difference ≥25° AngioPlus System Without InducingHyperemia Tu S et al. JACC CV Interv. 2014;7:768-77; Tu S et al. JACC CV Interv.2016;9:2024-35
  • 4. • Could reduce time and costs of assessment • Good correlationwith FFR • Lack of clinical evidence • Practical to perform (no adenosine) • Robust randomized evidence • Non-inferior to FFR • Two-decade clinical experience • Robust randomized evidence • Proven clinical benefit FFR iFR QFR KEY POINTS
  • 5. CORRELATION AND AGREEMENT OF QFR VS FFR Difference: 0.003±0.069 0.001±0.059 -0.001±0.065 Fixed-flow Contrast-flow Adenosine-flow Tu S et al J Am Coll Cardiol Intv 2016;9:2024–35
  • 6. Patients (vessels) FFR FFR<0.80 SD AUC WIFI II 170(240) 0.85 (IQR:0.77-0.91) 36 % 0.08 0.86 (95% CI: 0.81-0.91) FAVOR Pilot 73 (84) 0.84±0.08 32 % 0.06 0.92 (95% CI: 0.85-0.97) FAVOR II E/J 272(317) 0.85 (IQR:0.77-0.89) 33 % 0.06 0.92 (95% CI: 0.89-0.96) FAVOR II China 304(328) 0.85 (IQR:0.77-0.90) 36 % 0.06 0.96 (95% CI: 0.94-0.98) Pooled 819 (969) 0.85 (IQR: 0.77-0.90) 35 % 0.07 0.92 (95% CI: 0.90-0.94) DIAGNOSTIC PERFORMANCE OF QFR IPD Meta-Analysis of FAVOR I, FAVOR II Europe Japan, FAVOR II China, and WIFI II Holm NR et al. Presented at CIT 2018
  • 7. 3D 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 Relies on 3D QCA
  • 8. Quantitative Flow Ratio - QFR (Quantitative Flow Ratio = Medis’ QCA derived FFR) Based on EuroPCR presentation by Aarhus University Hospital, Skejby, Denmark QFR = 0.87 FFR = 0.85 3D 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 3D QCA; In-procedure time: < 5 min
  • 9. Difference: 0.00 ± 0.06 (p = 0.541) FFRQCA versus FFR Tu et al. JACC Cardiovasc Interv 2014, 7:768-777 Quantitative Flow Ratio Study Results FN FP
  • 10. Computational Model based on CCTA 3-D anatomic model from CCTA No additional imaging No additional medications Blood Flow Solution Blood flow equations solved on supercomputer Physiologic models -Myocardial demand -Morphometry-based boundary condition -Effect of adenosine on microcirculation CT-derived computed FFR (FFRCT) FFRCT = 0.72 (can select any point on model) Koo BK. EuroPCR 2011 Patient-specific non-invasive FFR using CT & CFD Seoul National 1
  • 11. Diagnostic performance of FFRCT Patient No Sensitivity Specificity PPV NPV Accuracy DISCOVE R- FLOW 103 93% 82% 85% 91% 87% DeFACTO 252 90% 54% 67% 84% 73% NXT 251 86% 79% 65% 92% 81% Total: 606 90% 72% 72% 89% 80% Seoul National 1
  • 12. Diagnostic performance of coronary diagnostic tests vs. FFR Stress Echo SPEC T cCT A FFRC T Norgaard et. al. J Eur Radiology 2015. Seoul National 8
  • 13. FFRCT Image segmentation methods validated with OCT data and robust even in patients with high calcium scores Uzu et.al. EuroIntervention. 2019;14:e1609-e1618. Nørgaard B et al, JACC Imaging 2015 Ag =3865 DOC 56816634
  • 14. 15 FFRCT improved patient referral to ICA 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) 72.3% of patients who had a positive HeartFlow Analysis (FFRCT≤0.80) and were undergoing ICA were revascularized Revascularization Patients with suspected CAD Invasive coronary angiography (ICA) No obstructive disease found Usual care path Patients with suspected CAD Invasive coronary angiography (ICA) No obstructive disease found Revascularization No need for ICA CTA/FFRCT-Guided Cohort Usual Care Cohort CTA / FFRCT Obstructive Disease Obstructive Disease T H E P L A T F O R M T R I A L ADVANCE DOC 56816634
  • 15. ESC CONGRESS2013 TCT 2019 ESC CONGRESS2013 Wakayama Medical University FFRCT – Non-invasive Physiological Index Anatomical + Functional Off-site supercomputing  Non-invasive  Gatekeeper 1) Koo et al. J Am Coll Cardiol 2011;58:1989–97 2) Min et al. JAMA 2012;308:1237-1245,
  • 16. ESC CONGRESS2013 ESC CONGRESS2013 Wakayama Medical University QFR – Less-invasive Physiological Index Angiography-based technique Without pressure wire Without adenosine/ATP Diagnostic angiography + TIMI frame count 1) Tu S. et al: JACC Cardiovasc Interv 2016; 9: 2024–35. 2)Xu B. et al: JACC 2017; 9: 3077–87. TCT 2019
  • 17. ESC CONGRESS2013 Results – Correlation CVIT 2018 ESC CONGRESS2013 TCT 2019 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 QFR R = 0.78 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 FFR FFR FFR CT R = 0.63 N=11 False-negative Tanigaki et al. J Am Coll Cardiol Intv2019; 12: 2050. N=23 False-positive N=97 True-negative N=102 True-positive N=19 False-negative N=38 False-positive N=89 True-negative N=87 True-positive QFR was highly correlated with FFR, while FFRCT was moderately correlated withFFR.
  • 18. ESC CONGRESS2013 Percentage (%) Sensitivity 100 90 80 70 60 50 40 30 20 10 0 QFR FFRCT 85% 76% 90% 82% Specificity 82% 70% Accuracy Results – QFR vs. FFRCT with FFR as reference CVIT 2018 ESC CONGRESS2013 TCT 2019 * p < 0.01 * Tanigaki et al. J Am Coll Cardiol Intv2019; 12: 2050.
  • 19. ESC CONGRESS2013 AUC comparisons QFR – QCA: 0.15 (p<0.001) FFRCT –CCTA: 0.12 (p<0.001) QFR – FFRCT: 0.11 (p<0.001) AUC QFR 0.93 FFRCT 0.82 3D-QCA-derived %DS 0.78 CCTA-derived %DS 0.70 100 90 80 70 60 50 40 30 20 10 0 0 10 20 80 90 100 30 40 50 60 70 100-Specificity Sensitivity Results – Comparison of FFR < 0.80 predictors CVIT 2018 ESC CONGRESS2013 TCT 2019 QFR FFRCT 3D-QCA-derived %DS CCTA-derived %DS Tanigaki et al. J Am Coll Cardiol Intv2019; 12: 2050.
  • 20. ESC CONGRESS2013 Target vessel: RCA - CCTA, FFRCT , Angiography &QFR CVIT 2018 ESC CONGRESS2013 TCT 2019 FFRCT: 0.83 FFR: 0.82 QFR: 0.83 70-90% stenosis FFRCT CCTA CAG QFR %DS=58%
  • 21. ESC CONGRESS2013 Target vessel: LAD - CCTA, FFRCT , Angiography &QFR CVIT 2018 ESC CONGRESS2013 TCT 2019 FFRCT: 0.73 FFR: 0.73 QFR: 0.74 50-70% stenosis CCTA FFRCT CAG QFR
  • 22. ESC CONGRESS2013 Target vessel: RCA - CCTA, FFRCT , Angiography &QFR CVIT 2018 ESC CONGRESS2013 TCT 2019 FFRCT: 0.75 FFR: 0.92 QFR: 0.86 30-49% stenosis CCTA CAG QFR FFRCT 0.76 0.99
  • 23. Introducing FFR | SIZE* (FFRangio Stent SizingTool)  The Need:  Stent size decisions are often based on visual assessment alone, which could lead to misestimation and complications:  Intimal hyperplasia, coronary rupture  Restenosis and stent thrombosis  Additional unnecessary stent insertions * FFR-SIZE not FDA approved.
  • 24. Angiogram Visual Assessment Prox Ramus 70% distal Ramus 80%  Physician Estimation:  Proximal Stent:  diameter 3 mm  length 15 mm  Distal Stent:  diameter 2.75 mm  length 20 mm FFRangio  FFRangio Estimation:  Proximal Stent:  diameter 2.4 mm  length 15 mm  Distal Stent:  diameter 2 mm  length 25 mm Clinical Case #1 – Stent Diameter Overestimation
  • 25. Post PCI Results (2 stents) “new” mid lesion 2 stents were inserted based on the physician's assessment only, leading to overdilation and creating a “new” lesion, so a 3rd stent needed to be inserted  3rd Stent FFRangio Estimation:  Stent Diameter : 3 mm  Stent Length : 12 mm  3rd Stent Physician Estimation:  Stent Diameter : 3 mm  Stent Length : 12 mm “new” mid lesion
  • 26. Post PCI Final Results (3 stents)
  • 27. Mid LAD 80%  Physician Estimation:  Stent Size:  diameter 3 mm  length 18 mm  FFRangio Estimation:  Stent Size:  diameter 3 mm  length 26 mm Angiogram Visual Assessment FFRangio Clinical Case #2 – Stent Length Underestimation
  • 28. Post PCI Results Residual lesion The stent inserted was based on the physician's assessment, and since its length was underestimated, a second stent needed to be inserted  2nd Stent PhysicianEstimation:  Stent Size  diameter : 3 mm  length : 8 mm Residual lesion  FFRangio Estimation:  Stent Size  diameter : 3 mm  length : 8 mm
  • 29. Post PCI Final Result (2 stent) A second stent was inserted:
  • 30. HeartFlow Planner • Noninvasive interactive tool that leverages the information within the HeartFlow Analysis • Explore different clinical scenarios by virtually modifying the vessel • Assess the FFRCT value(s) resulting from each scenario Enables the Interventionalist to evaluate alternate treatment strategies to optimize coronary blood flow before they enter the catheterization lab DOC 56816634
  • 31. Core Components HeartFlowAnalysis 1 Interactive Mobile Platform ● IOS, interactive viewer ● Cath-lab specific features (e.g. projection angles) 2 IdealGeometry 3 ● Contains a second anatomic model representing the “ideal” vessel Real-time FFRCT calculation 4 ● Modified vessel combined with updated physiology ● Updated FFRCT values calculated based on these inputs in seconds HeartFlow Planner *Not for clinical use. DOC 56816634 *Investigational Device. Not for clinical use.
  • 32. Bhavik N. Modi. Circulation: Cardiovascular Interventions. Predicting the Physiological Effect of Revascularization in Serially Diseased Coronary Arteries, Volume: 12, Issue: 2, DOI: (10.1161/CIRCINTERVENTIONS.118.007577) © 2019 The Authors. Circulation: Cardiovascular Interventions is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited.
  • 33. Bhavik N. Modi. Circulation: Cardiovascular Interventions. Predicting the Physiological Effect of Revascularization in Serially Diseased Coronary Arteries, Volume: 12, Issue: 2, DOI: (10.1161/CIRCINTERVENTIONS.118.007577) © 2019 The Authors. Circulation: Cardiovascular Interventions is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited.
  • 34. 40 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.
  • 35. Case Report Ihdayhid AR et al. JACC Int 2017 DOC 56816634 *Investigational Device. Not for clinical use.
  • 36. Lesions in ostial LCX and mid LCX PCI Planner predicted only mid- LCX lesion required stenting Confirmed by FFR during the actual case Kim KH et al. JACC Intv 2014;7:72-8 FFRCT Planner Application: VirtualStenting
  • 37. Kim KH et al. JACC Intv 2014;7:72-8 FFRCT Planner Superior to FFR? Case report #1 Operator did not cover LAD ostial lesion – confirmed by IVUS. FFR0.74. PCI Planner predicted FFR 0.76 if the ostium was untreated vs. 0.81 if ostium was stented
  • 38. Precise PCI Plan (P3) Trial A prospective multicenter clinical trial assessing the accuracy of FFRCT and HeartFlow 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 DeBruyne, M.D., Ph.D. To enroll 120 patients at 5 centers Determine the agreement between HeartFlow Planner & mFFR 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 HeartFlow CT- derived anatomy, FFRCT and measurements (OCT, QCA, FFR) DOC 56816634 *Investigational Device. Not for clinical use.
  • 39. DECISION Trial PI:GreggW. Stone AROs:CRF and DCRI;Sponsor: HeartFlow ~5000 troponin negative symptomatic pts in whom angiography is planned for suspected CAD R Angiography, and as appropriate, PCI informed by invasive physiology (n=2500) CTA +/- FFRCT (n=2500) 1:1 A multicenter randomized trial of FFRCT-guided selective angiography and FFRCT-guided revascularization compared with routine angiography and FFR/iFR-guided revascularization in patients with suspected CAD in whom angiography is intended. Plaque rupture, LM Stenosis ≥30%, or FFRCT ≤0.80 OR Typical angina & FFRCT 0.81-0.85 Invasive assessment, and as appropriate, PCI informed by HeartFlow Planner Yes No Defer Cath DOC 56816634 *Investigational Device. Not for clinical use.
  • 40. Implications for Clinical Practice – QFR & FFRCT  FFRCT is used mainly in the outpatient setting and reduces the number of unnecessary diagnostic angiography.  FFRCT might play the role of a gatekeeper to the pathway of coronary angiography.  QFR is obtained during coronary angiography and helps decision making in revascularization by identifying functionally significant lesions.  QFR might reduce procedure time, risk, and costs because there is no need to use pressure wire and to induce maximal hyperemia.
  • 41. Conclusion  Both QFR and FFRCT possessed the ability to accurately evaluate the functional severity of coronary stenosis.