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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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