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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.

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Presentation on theme: "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."— Presentation transcript:

1 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

2 Affiliation/Financial Interest – Corporate Organizations, Manufacturers, Providers ConsultantHeartscape Technologies, Sanofi, Schering Plough Grants/Research SupportHeartscape Technologies Stock ShareholderNone Other Financial or Material SupportNone Speaker’s BureauBMS, Sanofi, Schering Plough, Genentech EmployeeNone James Hoekstra, MD Disclosure Statement

3 Initial 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

4 “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

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

6 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/ % (14/314) of “STEMIs” were interpreted as STEMI by investigators 1 Median time to PCI for patients with STEMI was 29.4 hours 1 No patient with an occluded artery had an ECG to PCI time < 6 hours 1.Gibson CM. Circulation. Vol 118, Suppl. 2, patients with isolated anterior precordial ST segment depression 1

7 CULPRIT ARTERY IN “STEMI”* PATIENTS n=106 n=56 n=152 * TFG 0/1 in culprit artery Positive cardiac biomarkers

8 Occult STEMI patients had higher 30-day rates of Death/MI 1.Gibson CM. Circulation. Vol 118, Suppl. 2, Occult STEMI in TRITON subset analysis 1 Increased death/MI in patients with occult STEMI 1

9 The 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

10 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

11 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

12 PRIME ECG ® Allows You to Investigate Data from All 80 Leads View a single 10-second recording for leads of interest

13 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

14 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 Posterior Anterior Algorithm Result on Presentation

15 PRIME ECG ® Detected More Acute MIs Without Loss of Specificity 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: (3) Owens CG, et al. J Electrocardiol. 2004;37: Ornato, n=481 (1) Pretest probability of MI: 22% 12-Lead sensitivity: 25% PRIME sensitivity: 34% Relative improvement: 33% Absolute improvement: 8%

16 The 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

17 OCCULT MI 12-lead STEMI Population 1,830 patients enrolled 91 diagnosed as STEMI by site final diagnosis1,739 not diagnosed as STEMI 84 underwent cardiac 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

18 OCCULT MI 80L-only STEMI Population 1,830 patients enrolled 316 Troponin positive1500 Troponin negative +14 missing 75 site-determined STEMI241 not site-determined STEMI 210 with evaluable 80-lead PRIME ECG27 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, precath Tn positive defined as peak level over site normal range, precath

19 OCCULT MI Outcomes: Cath Strategy % Angiography Door to Sheath Time % % Min p< % 56% 12L n=84 80L, n=14 12L n=84 80L, n=14 (median, minutes) % Revascularization: 89% vs 78%, p=0.48

20 OCCULT MI: Clinical Outcomes 8.0 % 12.5 % % % Peak TnI: 19.7 versus 10.3 ng/dl, p=0.37 p=0.45

21 OCCULT 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

22 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

23 Summary 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.


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