ct scanning ffr-ct handouts - bryan health · t h e p l a t f o r m t r i a l ccm-100-051-f 0.77...

8/31/2016

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September 2016

Non-Invasive FFRCT

Optimizing Outcomes with Physiology-Guided Coronary Revascularization

Clyde R. Meckel, MDBryan Heart

CCM-100-051-F

62%

38%

Non-obstructive CAD Obstructive CAD

Positive stress tests lead to large numbers of unnecessary invasive angiograms

Patel et al, NEJM 2010.

Nearly 2/3rd of patients

without known CAD who went to elective

diagnostic angiogram were found to have no

obstructive disease

Data from an

analysis of

approximately

400,000 patients at

over 650 US

hospitals

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Vavalle et al, JAMA Cardiology 2016.

This was true for patients with both typical and atypical angina.

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A recent study of over 15,000 patients found thatPatients with a negative stress test were the most likely to have obstructive CADPatients with a positive stress test were the least likely to have obstructive CAD

0%

10%

20%

30%

40%

50%

60%

70%

80%

Non-obstructive/ No CAD

Obstructive CAD

Stress Tests w/ Atypical Angina

0%

10%

20%

30%

40%

50%

60%

70%

80%

NegativeResult

PositiveResult

No Test NegativeResult

PositiveResult

No Test

Stress Tests w/ Typical Angina

Negative stress tests often miss serious CAD

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FFR is a Better Measurement:Accepted Gold Standard for Identifying CAD

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But not clinically adopted

InvasiveTime consumingExpensive

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ANATOMYIdentify Obstructive CAD

Identifying Anatomically & Functionally Significant CAD

FUNCTIONIdentify ischemia that may

benefit from PCI

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NON-INVASIVE

• SPECT• Stress Echocardiography

• Exercise Stress Test• CMR

INVASIVE

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The HeartFlow FFRCT AnalysisAdvances Current Standards

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Coronary Anatomy

Lesion Specific IschemiaFFRCT

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HeartFlow Clinical Data

31 August 2016 Confidential Information

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• Compare accuracy to FFR

• 103 patients

DISCOVER-FLOW (2011)

• Compare accuracy to FFR and coronary angiography

• 254 patients

NXT (2013)

• Compare accuracy to FFR and cCTA

• 252 patients

DeFACTO (2012)

CCM-100-051-FCT

Nørgaard et al, Eur Radiol 2015

Performance of Coronary Diagnostic Tests for Functional Disease

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The HeartFlow Analysis

Model of coronary

arteries

FFRCT values indicate

functional

significance of CAD

Confidential Information

Summary: The Left Anterior Descending System has an FFRCT <_ 0.80.

MAY BE FUNCTIONALLY SIGNIFICANT 1,2,3

CORONARY ARTERIES & SYSTEMS FFRCT

Left Main Artery 0.98

Left Anterior Descending System 0.61

Left Circumflex System 0.93

Right Coronary Artery System 0.87

FFRCT

0.00 1.000.20 0.40 0.60 0.80

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HeartFlow FFRCT Process

A standard CT scan is performed and the data is uploaded to HeartFlow.

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With cloud-based automation and human oversight, HeartFlow creates a personalized, digital 3D model of the arteries.


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Powerful computer algorithms solve millions of complex equations to assess the impact that blockages have on blood flow.


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Powerful computer algorithms solve millions of complex equations to assess the impact that blockages have on blood flow.

Physicians interrogate and interpret results to aid in determining, vessel-by-vessel, if sufficient blood is reaching the heart.


CCM-100-051-F

70 y.o. woman with chest pain during exertionHigh cholesterol

Case Example: Using FFRCT to Aid in Choosing a Treatment Path

Medical treatment or intervention for this patient?

Stenoses seen on cCTA

LAD

LAD

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No functionally significant lesions presentMedical management

Case Example: Using FFRCT to Aid in Choosing a Treatment Path

LAD

LAD

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PLATFORM TRIAL

PI: Pam Douglas, Duke

HECON PI: Mark Hlatky,

Stanford

Prospective clinical utility trial

comparing two distinct patient management strategies.

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HeartFlow FFRCT Clinical Trial Data are Substantial

vs.FFRCT Guided

StrategyUsual Care

• Primary Endpoint:Patients with a planned ICA– Are patients evaluated

using a CTA/FFRCT

guided strategy less likely to undergo ICAs that show no obstructive CAD?

62%

Health

Costs

Experience

T H E P L A T F O R M T R I A L

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Usual Care CTA/FFRCT Guided

27%

Non-obstructive CADObstructive CAD

27%

73% 12%

61%

ICACanceled

83% reduction

Invasive Catheterization (ICA) with No Obstructive Disease

16Douglas, et al. Presented at ACC 2016.

No adverse clinical

events after 12 months in 117 patients with cancelled ICA

Health

Costs

Experience


CCM-100-051-FCTA/FFRCT CohortUsual Care Cohort

ICAs Performed RevascularizationsPerformed

MACE RateFunctional Information

Available Prior to Revasc.

No Difference in Revascularization or MACE Rates Patients with a Planned ICA

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0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

39%

PCIPCI

31.6%28.5%CABG

96%

51%

CABG

100%

1.0%1.1%

Douglas, et al. Presented at ACC 2016.

Health

Costs

Experience

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0.77

0.79

0.81

0.83

0.85

0.87

0.89

0.91

Baseline 90 Day Follow-Up

EQ-5D: Non-Invasive Test

Usual Care HeartFlow Guided

Quality of Life Improvements to 90 Days

HeartFlow showed significantly greater improvement

in Quality of Life than evaluation with usual non-invasive testing.

Significant improvements from baseline for all groups.

p=0.002

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0.77

0.79

0.81

0.83

0.85

0.87

0.89

0.91

Baseline 90 Day Follow-Up

EQ-5D: Planned ICA

Usual Care HeartFlow Guided

Health

Costs

Experience

Hlatky, et al. JACC 2015.


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Significant Savings to the Healthcare System

Costs Over 1 Year –

Patients with Planned ICA

*p<0.0001

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$12,145

$9,036

$0

$2,000

$4,000

$6,000

$8,000

$10,000

$12,000

$14,000

26%Savings*

FFRCT

GuidedUsualCare

Cost savings of 26%

to the health system

after accounting for the $1,500 cost of the HeartFlow Analysis.

Douglas, et al. Presented at ACC 2016.

Health

Costs

Experience

ct scanning ffr-ct handouts - bryan health · t h e p l a t f o r m t r i a l ccm-100-051-f 0.77...

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