The 80 Lead ECG Body Surface Map:Can We Detect More STEMI Than

with a 12 Lead ECG?

The 80 Lead ECG Body Surface Map:Can We Detect More STEMI Than

with a 12 Lead ECG?

James Hoekstra MD

Professor and Chairman

Department of Emergency Medicine

James Hoekstra MD

Professor and Chairman

Department of Emergency Medicine

Affiliation/Financial Interest – Corporate Organizations, Manufacturers, Providers

Consultant Heartscape Technologies, Sanofi, Schering Plough

Grants/Research Support Heartscape Technologies

Stock Shareholder None

Other Financial or Material Support None

Speaker’s Bureau BMS, Sanofi, Schering Plough, Genentech

Employee None

James Hoekstra, MD

Disclosure Statement

Initial Chest Pain AssessmentInitial Chest Pain Assessment

Risk determined in the ED by:

• Assessment of anginal symptoms

• Physical examination

• CAD risk factors

• Cocaine/methamphetamine use

• Electrocardiogram

• Markers of Infarction/Ischemia

Risk determined in the ED by:

• Assessment of anginal symptoms

• Physical examination

• CAD risk factors

• Cocaine/methamphetamine use

• Electrocardiogram

• Markers of Infarction/Ischemia

“Limitations” of the 12-Lead ECG“Limitations” of the 12-Lead ECG

• Posterior MI

• Right Sided MI

• High Lateral MI

• Inferior MI

• LBBB and STEMI

• In an all-comers CP population, 98% of ECGs are nondiagnostic

• Posterior MI

• Right Sided MI

• High Lateral MI

• Inferior MI

• LBBB and STEMI

• In an all-comers CP population, 98% of ECGs are nondiagnostic

TRITON subset analysis evaluated occurrence of occult STEMI

TRITON subset analysis evaluated occurrence of occult STEMI

• TRITON–TIMI 38 evaluated prasugrel vs. clopidogrel in 13,608 patients undergoing PCI

– Follow up duration: 6-15 months

• Post-hoc analysis: 1,198 patients with isolated anterior precordial ST segment depression (>1 mm) on 12-lead ECG

– STEMI defined as TFG 0/1 and positive troponin

• TRITON–TIMI 38 evaluated prasugrel vs. clopidogrel in 13,608 patients undergoing PCI

– Follow up duration: 6-15 months

• Post-hoc analysis: 1,198 patients with isolated anterior precordial ST segment depression (>1 mm) on 12-lead ECG

– STEMI defined as TFG 0/1 and positive troponin

Gibson CM. Circulation. Vol 118, Suppl. 2, 2008, presented at AHA, Nov, 2008.Gibson CM. Circulation. Vol 118, Suppl. 2, 2008, presented at AHA, Nov, 2008.

95% of occult STEMI were missed in TRITON–subset analysis

95% of occult STEMI were missed in TRITON–subset analysis

• 26.2% (314/1198) of patients with isolated anterior precordial ST segment depression >1mm had a “STEMI”, TFG 0/11

• 4.5% (14/314) of “STEMIs” were interpreted as STEMI by investigators1

• Median time to PCI for patients with STEMI was 29.4 hours1

• No patient with an occluded artery had an ECG to PCI time < 6 hours

• 26.2% (314/1198) of patients with isolated anterior precordial ST segment depression >1mm had a “STEMI”, TFG 0/11

• 4.5% (14/314) of “STEMIs” were interpreted as STEMI by investigators1

• Median time to PCI for patients with STEMI was 29.4 hours1

• No patient with an occluded artery had an ECG to PCI time < 6 hours

1.Gibson CM. Circulation. Vol 118, Suppl. 2, 2008.

1198 patients with isolated anterior precordial ST segment depression1

CULPRIT ARTERY IN “STEMI”* PATIENTSCULPRIT ARTERY IN “STEMI”* PATIENTS

48.4%

33.8%

17.8%

0%

10%

20%

30%

40%

50%

60%

LCx LAD RCA

Patie

nts

n=106 n=56n=152

* TFG 0/1 in culprit artery Positive cardiac biomarkers

Occult STEMI patients had higher 30-day rates of Death/MI

Occult STEMI patients had higher 30-day rates of Death/MI

1.Gibson CM. Circulation. Vol 118, Suppl. 2, 2008.

Occult STEMI in TRITON subset analysis1

Increased death/MI in patients with occult STEMI1

The 80-Lead ECG and Body Surface MappingThe 80-Lead ECG and Body Surface Mapping

• More leads investigate more areas of the heart

• Mapping allows computer generated pictures of ischemic areas

• Computerized readings allow for more accurate interpretation

• More leads investigate more areas of the heart

• Mapping allows computer generated pictures of ischemic areas

• Computerized readings allow for more accurate interpretation

The PRIME ECG® Technology

• Easily-applied, self-adhesive plastic strips containing 80 data collection points

• Strips allow analysis of the heart’s electrical activity with 360 degrees of spatial resolution

• Data from the 80 leads are processed into 3-D color maps for easy visualization

Single-patient Disposable Vest

Placement of the 80 Leads Provides a Comprehensive View of the Heart

Placement of the 80 Leads Provides a Comprehensive View of the Heart

• 64 anterior and 16 posterior leads

• Conventional V leads 1-6 are marked

• 64 anterior and 16 posterior leads

• Conventional V leads 1-6 are marked

PRIME ECG® Allows You to Investigate Data from All 80 Leads

PRIME ECG® Allows You to Investigate Data from All 80 Leads

• View a single 10-second recording for leads of interest

• View a single 10-second recording for leads of interest

PRIME ECG® Provides a 3-D, Color-coded, Anatomically-referenced Visualization of the Injury

ST-segment elevation and depression are translated into colors:

Red = ST elevation

Blue = ST depression

Green = No deflection

3-D Color Representation of the 80-Lead ECG

• Data from the 80 leads are processed by an interactive algorithm that suggests findings and can provide important details necessary to achieve a timely and accurate diagnosis

• Represents an extension of conventional ECG technology, resulting in a fast learning curve with minimal training time

Interactive Algorithm Suggests Diagnosis

Pop-up Displays Underlying ECG Trace and Value

PosteriorAnterior

Algorithm Result on

Presentation

PRIME ECG® Detected More Acute MIs Without Loss of Specificity

PRIME ECG® Detected More Acute MIs Without Loss of Specificity

25%

34%

10%

20%

30%

40%

12-Lead PRIME

45%

64%

30%

40%

50%

60%

70%

12-Lead PRIME

In a meta-analytic composite of three separate studies, PRIME showed relative improvement of 53% and absolute improvement of 23% over the 12-lead

McClelland, n=103 (2) Owens, n=294 (3)

• Pretest probability of MI: 51%• 12-Lead sensitivity: 45%• PRIME sensitivity: 64%• Relative improvement: 42%• Absolute improvement: 19%

• Pretest probability of MI: 62%• 12-Lead sensitivity: 57%• PRIME sensitivity: 80%• Relative improvement: 42%• Absolute improvement: 24%

(1) Ornato JP, et al. Amer J Cardiol. 2002;39(5):332A (2) McClelland AJ, et al. Amer J Cardiol. 2003;92:252-257(3) Owens CG, et al. J Electrocardiol. 2004;37:223-232

57%

80%

40%

50%

60%

70%

80%

90%

12-Lead PRIME

Ornato, n=481 (1)

• Pretest probability of MI: 22%• 12-Lead sensitivity: 25%• PRIME sensitivity: 34%• Relative improvement: 33%• Absolute improvement: 8%

The OCCULT MI Trial DesignThe OCCULT MI Trial Design

• Multicenter prospective observational trial of 80-lead mapping ECG versus 12 lead ECG

• 12 academic EDs, 1830 patients

• Moderate-to-high risk chest pain

• Clinicians blinded to result of 80L, treatment by standard of care

• Outcomes: Door to Sheath Time and MACE in patients with STEMI by 80-lead-only versus STEMI by 12 lead ECG

• Multicenter prospective observational trial of 80-lead mapping ECG versus 12 lead ECG

• 12 academic EDs, 1830 patients

• Moderate-to-high risk chest pain

• Clinicians blinded to result of 80L, treatment by standard of care

• Outcomes: Door to Sheath Time and MACE in patients with STEMI by 80-lead-only versus STEMI by 12 lead ECG

OCCULT MI 12-lead STEMI Population

1,830 patients enrolled

91 diagnosed as STEMI by site final diagnosis 1,739 not diagnosed as STEMI

84 underwentcardiac catheterization

and had DTST available

7 did not undergo cardiac catheterization: 2 patients were DNR and aggressive medical measures were withheld 1 refused cardiac catheterization 1 deemed not to be a candidate for cardiac catheterization 1 patient had GI bleed and was monitored in the CCU 1 patient expired prior to cardiac catheterization 1 patient treated conservatively due to normal echocardiogram

OCCULT MI 80L-only STEMI Population

1,830 patients enrolled

316 Troponin positive 1500 Troponin negative+14 missing

75 site-determined STEMI 241 not site-determined STEMI

210 with evaluable 80-lead PRIME ECG 27 with inevaluable 80-lead PRIME ECG+4 missing

25 PRIME-only STEMI 14 with DTST data available 11 did not undergo cardiac catheterization

185 NOT PRIME only STEMI

Tn positive defined as peak level over site normal range, precathTn positive defined as peak level over site normal range, precath

OCCULT MI Outcomes: Cath Strategy% Angiography

Door to Sheath Time

OCCULT MI Outcomes: Cath Strategy% Angiography

Door to Sheath Time

0

20

40

60

80

100

% Angiography

12L

80L

0

200

400

600

800

1000

1200

Door To Sheath Time

12L

80L

%% MinMin

5454

10021002

p<0.0001p<0.0001

92%92%

56%56%

12L n=8480L, n=1412L n=8480L, n=14

(median, minutes)(median, minutes)

% Revascularization: 89% vs 78%, p=0.48% Revascularization: 89% vs 78%, p=0.48

OCCULT MI: Clinical OutcomesOCCULT MI: Clinical Outcomes

0

2

4

6

8

10

12

14

% Death/MI

12L, n=88

80L, n=248.0 %8.0 %

12.5 %12.5 %

%%

Peak TnI: 19.7 versus 10.3 ng/dl, p=0.37Peak TnI: 19.7 versus 10.3 ng/dl, p=0.37

p=0.45p=0.45

OCCULT MI ConclusionsOCCULT MI Conclusions• 80 lead map ECG identifies 27.5%

higher number of STEMI patients than 12 lead ECG

• 80 lead-only STEMI patients received conservative and significantly delayed catheterization strategy

• 80 lead-only STEMI patients have clinical and angiographic outcomes similar to 12 lead STEMI

• The 80 lead ECG identifies a patient population which may benefit from more aggressive care

• 80 lead map ECG identifies 27.5% higher number of STEMI patients than 12 lead ECG

• 80 lead-only STEMI patients received conservative and significantly delayed catheterization strategy

• 80 lead-only STEMI patients have clinical and angiographic outcomes similar to 12 lead STEMI

• The 80 lead ECG identifies a patient population which may benefit from more aggressive care

Who is Eligible for PRIME ECG?Who is Eligible for PRIME ECG?

• High risk patients, ongoing pain

• Abnormal, but nondiagnostic ECG

• ST Depression (25% missed STEMI)

• LBBB

• Known CAD, PCI, High TIMI Score

• Elevated Tn

• High risk patients, ongoing pain

• Abnormal, but nondiagnostic ECG

• ST Depression (25% missed STEMI)

• LBBB

• Known CAD, PCI, High TIMI Score

• Elevated Tn

SummarySummary

 • The 80-lead technology increases the sensitivity

and specificity of the ECG for MI

• The PRIME system allows for ease of ECG acquisition in clinical care

• OCCULT MI trial confirms that PRIME can identify a high risk patient that may benefit from more aggressive therapy.

 • The 80-lead technology increases the sensitivity

and specificity of the ECG for MI

• The PRIME system allows for ease of ECG acquisition in clinical care

• OCCULT MI trial confirms that PRIME can identify a high risk patient that may benefit from more aggressive therapy.