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FFRangio
Image-Based Fractional Flow Reserve
During Coronary Angiography
Stephane Fournier, MD
Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
19.09.2017
Cardiovascular
Center
Aalst
• Nothing to disclose
Cardiovascular
Center
Aalst
Disclosures
Toth et al, Eur Heart J. 2014 Oct 21;35(40):2831-8
The relationship between
angiographic evaluation and
hemodynamic assessment is
weak.
Discordance between methods is
observed in more than one-third of
the lesions.
Cardiovascular
Center
Aalst
Background (1)
Tonino et al, N Engl J Med. 2009 Jan 15;360(3):213-24.
Routine FFR measurement
in patients undergoing PCI
significantly reduces the
rate of MACE
Cardiovascular
Center
Aalst
Background (2)
Adapted from Rigamonti et al,
EuroIntervention. 2017 May 15;13(Z):Z75-Z79
Cardiovascular
Center
Aalst
Background (2)
0.00%
2.00%
4.00%
6.00%
8.00%
10.00%
12.00%
2010 2011 2012 2013 2014 2015
(FFR / PCI) / year in
Switzerland
(FFR / PCI) / year in Europe
Barbato et al,
EuroIntervention. 2017 May 15;13(Z):Z8-Z10
10%
15%
• FFR is underutilized
• Interrupted workflow - more time, resources, expense
• Technical considerations - balancing, drift, pullbacks, etc.
• Pharmacologic vasodilation – patient adverse events, time
Background (3)
Cardiovascular
Center
Aalst
FFRangio: Real time functional angiography
Cardiovascular
Center
Aalst
Background (4)
Routine angiograms
1
3D full tree & flow
analysis
2
FFRangio
color coded map
3
Cardiovascular
Center
Aalst
Background (5)
184 patients
with CAD,
203 lesions
1
Blinded
FFRangio, off
site by core
lab
3
FFR in every
lesion
2
FFR
Validationstudy
On-linestudy
The same set of algorithms were used in both studies
53 patients
with CAD,
60 lesions
1
FFR in every
lesion
2
FFR
Blinded
FFRangio,
during
procedure
3
Cardiovascular
Center
Aalst
Methods
J Am Coll Cardiol. 2016 Nov 15;68(20):2235-2237
Circ Cardiovasc Interv. 2017 Sep;10(9)
Submitted
Age, mean ± SD 65.9 ± 9.5 61.8 ± 10.6
Male gender 67% 79%
BMI 26.8 ± 3.3 26.8 ± 3.3
Family history of CAD, % 33% 38%
Hypertension, % 67% 58%
Hypercholesterolemia, % 89% 77%
Diabetes, % 32% 32%
Smoking (current), % 17% 15%
Smoking (prior), % 23% 32%
Prior MI, % 19% 21%
Prior PCI, % 36% 40%
Cardiovascular
Center
Aalst
Results (1)
Validation study On-line study
Cardiovascular
Center
Aalst
Stable angina, % 71% 32%
Unstable angina % 18% 36%
NSTEMI, % 11% 21%
Radial access, % 74% 94%
Vessel
LAD / Diagonal
LCX / Marginal
RCA
58% / 1%
15% / 4%
19%
70% / 5%
13% / 5%
7%
FFR
Range
Mean
<0.80
0.70-0.90
0.75-0.85
0.50-0.97
0.85
35.9%
67%
35%
0.52-0.97
0.82
37.0%
78%
38%
Validation study On-line study
Results (2)
Key Results
Correlation: 0.90
BA limits: -0.096 ; +0.112
Sensitivity: 88%
Specificity: 95%
Accuracy: 93%
Cardiovascular
Center
Aalst
Results : Validation Study
Correlation: 0.9
95% CI: 0.95 – 0.97
Intra-operator variability:
Cardiovascular
Center
Aalst
Results : Validation Study
Cardiovascular
Center
Aalst
Results : On-line Study
Key Results
Correlation: 0.91
BA limits: -0.065 ; +0.070
Sensitivity: 86%
Specificty: 100%
Accuracy: 96%
Estimation of Diameter Stenosis:
Visual Estimation 2D-QCA FFRangio 3D-QCA
Min 20 23 22
Max 95 70 68
Avg 59.8±14.8 45.0±10.27 40.3±11.16
Cardiovascular
Center
Aalst
Results : AUC
Dist-RCA : FFR=0.84Mid-LAD : FFR=0.72 Intermediate : FFR=0.68
Cardiovascular
Center
Aalst
Example : a patient with 3VD
Cardiovascular
Center
Aalst
Example : a patient with 3VD
Cardiovascular
Center
Aalst
Example : a patient with 3VD
Dist-RCA : FFR=0.84
Mid-LAD : FFR=0.72
Intermediate : FFR=0.68
Cardiovascular
Center
Aalst
Dist-RCA : FFR=0.85
Mid-LAD : FFR=0.76
Intermediate : FFR=0.66
FFR : Angio FFR :
PCI
PCI
No PCI
PCI
PCI
No PCI
Example : a patient with 3VD
Cardiovascular
Center
Aalst
Conclusion
• Results of these first
clinical experiences are
encouraging
 Accuracy
 Reproducibility
 Operator independency
• May foster the rate of
FFR-based decisions
• Pivotal study starting
FFRangio = “co-registration” of anatomy and function

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05 FFR Fournier aimradial2017 - FFR Angio

  • 1. FFRangio Image-Based Fractional Flow Reserve During Coronary Angiography Stephane Fournier, MD Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium 19.09.2017 Cardiovascular Center Aalst
  • 2. • Nothing to disclose Cardiovascular Center Aalst Disclosures
  • 3. Toth et al, Eur Heart J. 2014 Oct 21;35(40):2831-8 The relationship between angiographic evaluation and hemodynamic assessment is weak. Discordance between methods is observed in more than one-third of the lesions. Cardiovascular Center Aalst Background (1)
  • 4. Tonino et al, N Engl J Med. 2009 Jan 15;360(3):213-24. Routine FFR measurement in patients undergoing PCI significantly reduces the rate of MACE Cardiovascular Center Aalst Background (2)
  • 5. Adapted from Rigamonti et al, EuroIntervention. 2017 May 15;13(Z):Z75-Z79 Cardiovascular Center Aalst Background (2) 0.00% 2.00% 4.00% 6.00% 8.00% 10.00% 12.00% 2010 2011 2012 2013 2014 2015 (FFR / PCI) / year in Switzerland (FFR / PCI) / year in Europe Barbato et al, EuroIntervention. 2017 May 15;13(Z):Z8-Z10 10% 15%
  • 6. • FFR is underutilized • Interrupted workflow - more time, resources, expense • Technical considerations - balancing, drift, pullbacks, etc. • Pharmacologic vasodilation – patient adverse events, time Background (3) Cardiovascular Center Aalst
  • 7. FFRangio: Real time functional angiography Cardiovascular Center Aalst Background (4)
  • 8. Routine angiograms 1 3D full tree & flow analysis 2 FFRangio color coded map 3 Cardiovascular Center Aalst Background (5)
  • 9. 184 patients with CAD, 203 lesions 1 Blinded FFRangio, off site by core lab 3 FFR in every lesion 2 FFR Validationstudy On-linestudy The same set of algorithms were used in both studies 53 patients with CAD, 60 lesions 1 FFR in every lesion 2 FFR Blinded FFRangio, during procedure 3 Cardiovascular Center Aalst Methods J Am Coll Cardiol. 2016 Nov 15;68(20):2235-2237 Circ Cardiovasc Interv. 2017 Sep;10(9) Submitted
  • 10. Age, mean ± SD 65.9 ± 9.5 61.8 ± 10.6 Male gender 67% 79% BMI 26.8 ± 3.3 26.8 ± 3.3 Family history of CAD, % 33% 38% Hypertension, % 67% 58% Hypercholesterolemia, % 89% 77% Diabetes, % 32% 32% Smoking (current), % 17% 15% Smoking (prior), % 23% 32% Prior MI, % 19% 21% Prior PCI, % 36% 40% Cardiovascular Center Aalst Results (1) Validation study On-line study
  • 11. Cardiovascular Center Aalst Stable angina, % 71% 32% Unstable angina % 18% 36% NSTEMI, % 11% 21% Radial access, % 74% 94% Vessel LAD / Diagonal LCX / Marginal RCA 58% / 1% 15% / 4% 19% 70% / 5% 13% / 5% 7% FFR Range Mean <0.80 0.70-0.90 0.75-0.85 0.50-0.97 0.85 35.9% 67% 35% 0.52-0.97 0.82 37.0% 78% 38% Validation study On-line study Results (2)
  • 12. Key Results Correlation: 0.90 BA limits: -0.096 ; +0.112 Sensitivity: 88% Specificity: 95% Accuracy: 93% Cardiovascular Center Aalst Results : Validation Study
  • 13. Correlation: 0.9 95% CI: 0.95 – 0.97 Intra-operator variability: Cardiovascular Center Aalst Results : Validation Study
  • 14. Cardiovascular Center Aalst Results : On-line Study Key Results Correlation: 0.91 BA limits: -0.065 ; +0.070 Sensitivity: 86% Specificty: 100% Accuracy: 96%
  • 15. Estimation of Diameter Stenosis: Visual Estimation 2D-QCA FFRangio 3D-QCA Min 20 23 22 Max 95 70 68 Avg 59.8±14.8 45.0±10.27 40.3±11.16 Cardiovascular Center Aalst Results : AUC
  • 16. Dist-RCA : FFR=0.84Mid-LAD : FFR=0.72 Intermediate : FFR=0.68 Cardiovascular Center Aalst Example : a patient with 3VD
  • 19. Dist-RCA : FFR=0.84 Mid-LAD : FFR=0.72 Intermediate : FFR=0.68 Cardiovascular Center Aalst Dist-RCA : FFR=0.85 Mid-LAD : FFR=0.76 Intermediate : FFR=0.66 FFR : Angio FFR : PCI PCI No PCI PCI PCI No PCI Example : a patient with 3VD
  • 20. Cardiovascular Center Aalst Conclusion • Results of these first clinical experiences are encouraging  Accuracy  Reproducibility  Operator independency • May foster the rate of FFR-based decisions • Pivotal study starting FFRangio = “co-registration” of anatomy and function