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Will CT-FFr Replace the Diagnostic Angiogram in the Next 5 Years?
Sharon L. Roble, MD, FACC
DISCLOSURES
I have no disclosures relevant to today’s talk
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Stress Testing Leads toInappropriate Invasive Procedures
3--Patel et al, NEJM 2010; Patel et al, AHJ 2014.
Data includes nearly 400,000 patients at over 650 US hospitals
Findings DuringInvasive Coronary Angiograms
Over half of patientswho undergo an additional
invasive test
have no disease
Because standard non-invasive stress testing is low yield
and could have avoided ICAif better non-invasive testing
was available
Non-obstructive CAD
Obstructive CAD 55%
ANATOMY
Identify obstructive CAD
FUNCTION
Identify lesion-specific ischemia that may benefit from PCI
Invasive
Noninvasive
Diagnosing Anatomic and Functionally-Significant CAD
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HeartFlow: Advancing Cardiovascular Disease Diagnosis and Treatment
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Development of image-based modeling for coronary blood flow begun in 1995
Founded HeartFlow in 2007, Silicon Valley CA
HeartFlow: Advancing Cardiovascular Disease Diagnosis and Treatment
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>110 peer-reviewed publications
>100 Issued US and worldwide patents
FDA Clearance– De Novo 510(k) clearance
received November 2014
– CE Mark in July 2011
– Commercially available in the US and Europe
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FFRCT Provides Non-Invasive, Lesion-Specific Functional Information
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Exercise StressStress EchoSPECTCMR
Non-Invasive Lesion-Specific Assessment
Invasive FFR
FFRCT
HeartFlow FFRCT Process
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A standard cardiac CT scan is performed and the data is uploaded to HeartFlow.
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HeartFlow FFRCT Process
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HeartFlow Analysts use proprietary software to create a personalized, digital 3D model of the coronary arteries.
A standard cardiac CT scan is performed and the data is uploaded to HeartFlow.
*Image not representative of actual product.
HeartFlow FFRCT Process
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HeartFlow Analysts use proprietary software to create a personalized, digital 3D model of the coronary arteries.
Powerful computer algorithms solve millions of complex equations to assess the impact that blockages have on blood flow.
A standard cardiac CT scan is performed and the data is uploaded to HeartFlow.
*Image not representative of actual product.
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HeartFlow FFRCT Process
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HeartFlow Analysts use proprietary software to create a personalized, digital 3D model of the coronary arteries.
Powerful computer algorithms solve millions of complex equations to assess the impact that blockages have on blood flow.
Physicians interrogate the model and interpret the FFRCT results to determine, vessel-by-vessel, if sufficient blood is reaching the heart.
A standard cardiac CT scan is performed and the data is uploaded to HeartFlow.
Case 1:
48 y.o. M with HTN presented to ER with chest pain and underwent stress echo
Stress echo: Hypertensive response to exercise, patient experienced worsening chest pain and echo showed no wall motion abnormalities; however, EF did not augment with exercise
What would you do next? CCTA with FFR Invasive coronary angiography
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Case 1
FFRCT 0.87
Case 1 Continued
FFRCT 0.87
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Case 1
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High Accuracy of FFRCT Compared to Gold Standard
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DISCOVER-FLOW
Completed 2011
N=103 patientsDeFACTO• Completed 2012
• N=252 patients NXT• Completed 2013
• N=254 patients
NXT Per-Vessel
Performance
• Specificity: 86%• Sensitivity: 84%• Accuracy: 86%
Data supported 2014 FDA Clearance
Koo et al, JACC 2011.
Min et al, JAMA 2012.
Norgaard et al, JACC 2014.
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Performance of Coronary Diagnostic Tests for Functional Disease
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CT
Nørgaard et al, Eur Radiol 2015
More information neededN=38
Initial Decision – CT Angio only
Optimal Medical Therapy (OMT)N=67
Intervention (PCI or CABG)N=95
More information neededN=0
Final Decision – Post FFRCT
Optimal Medical Therapy (OMT)N=113 (68.7% increase)
Intervention (PCI or CABG)N=87 (8.4% decrease)
Change in disease management pathway for
36% of patients
Change in vessel assigned to PCI for
an additional 8% of patients
44% of patientshad decisions altered
after physicians incorporated FFRCT
n=200
Results of the FFRCT RIPCORD Trial
18Curzen et al. JACC CV Imaging 2016
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PLATFORM Trial
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Prospective clinical utility trial
comparing two distinct patient management
strategies.
vs.
FFRCT-Guided Strategy
Usual Care
Douglas, et al. EHJ 2015.
Hlatky, et al. JACC 2015.
Usual Care FFRCT-Guided
27%
Non-obstructive CADObstructive CAD
27%
73% 12%
61%
ICACanceled
83% reduction
Dramatic Reduction in Invasive Catheterization (ICA) with No Obstructive Disease
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Douglas, et al. EHJ 2015.
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PLATFORM: The HeartFlow Analysis did not Change Overall Revascularization Rates
17 September 2016
100.0%
32.6%
23.5%
9.1%
39.4%31.6%
26.4%
5.2%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Invasive Angiography Revascularization (all)¹ Stent placement (PCI) CABG
Standard pathway HeartFlow Analysis
HeartFlow Analysis aids in identifying the appropriate patients in need of revascularization
HeartFlow Analysis aids in identifying the appropriate patients in need of revascularization
Diagnostic Catheterization and Revascularization Rates1
¹ Total revascularization includes stent placements (PCI) and Coronary Artery Bypass Graft surgery
Source: Douglas, P. e.a. (2015). “Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial for FFRCT: outcome and resource impacts study” European Heart Journal
Case 2 64 y.o. M with abnormal pre-op ECG referred for
coronary CTA with FFRct
Started on high-intensity statin therapy and aspirin
Underwent repeat CTA with FFRct after six months of medical therapy
0.82
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#2
0.82
0.68
0.89
0.78
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Case 3
64 y.o. M with seasonal allergies, awoke 2 days in a row with chest congestion and inability to “fill his lungs with air”
Evaluation by PCP, referred for treadmill ECG which was abnormal
What would you do next? Coronary CTA with FFR Invasive coronary angiography
LAD
LCxRCA
0.79
0.75
0.52
0.750.79
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Will CT-FFr Replace the Diagnostic Angiogram in the Next 5 Years?
CT-FFR provides both anatomic and functional data
Early studies suggest that CT-FFR may play a useful role in reducing rates of invasive coronary angiography
Unlikely to have a significant impact on rates of revascularization
Long-term studies are ongoing
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Thank you
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