Transcript No Slide Title - Clinical Trial Results

MAXIMIZING THE UTILITY
OF THE PRIME ECG
James Hoekstra, MD
Professor and Chairman
Department of Emergency Medicine
Wake Forest University
SO HOW DO YOU READ THIS
DAMN THING ANYWAY??
• Patient Selection
• Evaluating the PRIME ECG results
PRIME ECG Patient Selection
• The PRIME ECG does not replace the
screening ECG
– Too time intensive
– Too expensive
• PRIME sensitivity and specificity was
determined from high risk subsets of
patients
• Low risk chest pain patients will
result in high false positive rates, just
like the 12 lead ECG
PRIME ECG Patient Selection
• High Risk Patients
• High index of suspicion for evolving
STEMI: Serial PRIME
• ST Depression
• Abnormal but nonspecific ECG, BBB,
LVH
• Troponin Positive (after TnI or TnT
comes back)
• TIMI 2+
PRIME ECG Patient Selection
• Should not be used to screen for
“safe to go home” screening
scenarios
• Should not be used in “observation
unit” patients (TIMI 0-1)
• Should be used in “admissions,” in
serial fashion, especially if high risk
Reading the PRIME ECG
• Regimented Reading
– Assure a quality recording
– Stepwise approach to reading
• Match the ECG to the Patient
– Like the 12 Lead ECG, when in
doubt, go back to the clinical scenario
Reading the PRIME ECG
• Regimented Reading Approach
– Low Quality Screen
– Assisted Beat Markings
– 80 Lead Screen
– 4 MAP View
– STO Filter View
– Computerized Reading
PRIME ECG Case Study:
54 yo Male with Chest Pain
• Arrives in the ED with chest pain that
had been constant since 11 AM.
• Pain is described as intense, midline
substernal, radiating to the left arm,
associated with shortness of breath
and nausea. It began with light
walking. It feels like his prior MI pain
• Pain 8/10 on arrival, in mild distress
54 year old Male with CP (PMH)
• PMH: CAD, MI
• Prior stent placed for MI
• SH: Smoker
• FH: Noncontributory
• Meds: ASA. Noncompliant with
other medications
54 year old Male with Chest Pain (ECG)
• Normal Sinus Rhythm at 72 bpm
• ST depression anteriorly
• Tall R waves anteriorly
54 year old Male with CP (Ancillary)
• Chest Xray: Normal
• Initial Cardiac Markers:
– CK 37, MB ,1.0
– TnI < 0.05
– Renal Function Normal
– Hb 14
– TIMI 5
PRIME ECG Applied
628
54 year old Male with CP (PRIME)
Low
Qual
• STEP 1: LOW QUALITY REVIEW
54 year old Male with CP (PRIME)
Rate,
Axis,
Intervals
Low
Quality
Lead
80 Lead
Toggle
• STEP 1: LOW QUALITY REVIEW
54 year old Male with CP (PRIME)
Hit Analyze
Button
If OK,
Accept
• STEP 2: ACCEPT BEAT MARKINGS
54 year old Male with CP (PRIME)
STO Takeoff
End of T
Start
of QRS
• STEP 2: ACCEPT BEAT MARKINGS
54 year old Male with CP (PRIME)
80 Lead
View
Button
Step 3: Scroll Through the 80 Leads
54 year old Male with CP (PRIME)
4 View
Torso
View
Isolate
PQRST
Max ST
Deviation
• Step 4: MAP 4 View (Torso)
54 year old Male with CP (PRIME)
STO
• Step 5: ST0 Filter
54 year old Male with CP (PRIME)
Rotate
• Step 5: Rotate Filter
54 year old Male with CP (PRIME)
• Step 6: Read the Analysis: Post MI
54 year old Male with CP (ED Course)
• Cardiology consulted for possible
acute posterior MI
• Cardiologist saw pt in the ER
• Pain reduced, workup complete,
decision is made to admit to CCU for
medical management pre-cath (treat
as NSTE ACS)
54 year old Male with CP (CCU Course)
• Second set of markers elevated with
CKMB 37, TnI 6.6
• Pain continues, 2-3/10, despite
maximal medical management
• Patient taken to cath lab for urgent
PCI
54 year old Male with CP (Cath Results)
• 99% thrombotic lesion of the proximal
first obtuse marginal off the
circumflex
• Remainder of circumflex without
stenoses
• LAD and RCA with mild lumenal
irregularities, none more than 20%
obstructive
• LVEF 50%
54 year old Male with CP (Course)
• Patient underwent PCI with taxus
stent of the proximal obtuse marginal
99% lesion with good result.
• Discharged home on hospital day 5
• Final diagnosis: Acute Posterior MI
PRIME ECG Case Study:
53 yo Male with Chest Pain
• Arrives in the ED with chest pain that
had been stuttering for the past 12
hours
• Pain is described as dull, substernal,
associated with shortness of breath
and nausea
• Pain 2/10 on arrival, in no distress
53 year old Male with CP (PMH)
• PMH: HTN, CVA, Seizures, CAD,
Ashma
• EF 40% secondary to past MIs
(anatomy unclear due to cath at
outside hospital)
• SH: Smoker 1 ppd X 30 years
• FH: Noncontributory
• Meds: ASA, Lipitor, Lisinopril,
Lamictal, Albuterol, Lopressor,
Neurontin
53 year old Male with Chest Pain (ECG)
• Normal Sinus Rhythm at 79 bpm
• Diffuse nonspecific ST/T wave changes anteriorly
• Early R wave progression anteriorly
53 year old Male with CP (Ancillary)
• Chest Xray: Mild cardiomegaly, no
CHF
• Initial Cardiac Markers:
– CK 221, MB 5.3
– TnI < 0.05
– Renal Function Normal
– Hb 14
Pain Returns
PRIME Obtained
332
53 year old Male with CP (ED Course)
• Cardiology consulted for acute
anterior MI
• Cath Lab Activated
• Cardiologist at Bedside, agrees with
PRIME interpretation
• Angiogram performed
53 year old Male with CP (Cath Results)
•LAD with 95% mid lesion
•Critical stenosis of first diagonal branch
•85% circumflex 2nd OM lesion
•70% circumflex 3rd OM lesion
•75% lesion of PDA off the RCA
•Apical hypokinesis and LVEF 40%
53 year old Male with CP (Course)
• Cardiothoracic Surgery consulted for
CABG due to triple vessel disease
• Felt not to be surgical candidate due
to prior CVA
• Day 2 underwent stenting of LAD 95%
lesion, without complication
• Peak Troponin 0.10
• Discharged home on hospital day 5
• Diagnosis: Unstable Angina
PRIME ECG Case Study:
62 yo Male with Chest Pain
• Arrives in the ED by EMS with chest
pain that has been intermittent for 2
days, and constant for the last 2
hours.
• Pain is described as substernal,
radiating to the left arm, associated
with shortness of breath and nausea.
He has been taking NTG without relief
• Pain 8/10 on arrival, in moderate
distress
62 year old Male with CP (PMH)
• PMH: CAD, MI, DM, HTN, CHF,
Neuropathy
• PSH: CABG, Pacemaker
• SH: Nonsmoker
• FH: MI
• Meds: ASA, Clopidogrel,
Glucophage, Lantis, Lopressor,
Lisinipril, Lasix, Lipitor, Neurontin
62 year old Male with Chest Pain (ECG)
• Normal Sinus Rhythm at 72 bpm
• Bifascicular Block RBBB and LAHB
• Diffuse ST depression over anterior leads
PRIME Obtained
290
62 year old Male with CP (ED Course)
• Cardiology consulted for possible
acute posterior MI
• Cardiologist at bedside. Agrees with
PRIME Reading
• Patient offered PCI, but initially not
willing to undergo cath. Agreed later
after second set of TnI elevated at 6.1
62 year old Male with CP (Cath Results)
• LAD, RCA, and circumflex all
occluded from the native circulation.
• LIMA graft to LAD patent, distal LAD
80% stenosis
• Saphenous graft to the RCA patent
without stenoses
• Saphenous graft to the circumflex
occluded at the distal anastomosis
• LVEF 30%
62 year old Male with CP (Course)
• Patient underwent PCI with taxus
stent of the distal saphenous graft to
the circumflex, with good results.
• Patient admitted to the CCU post
procedure
• Peak CKMB >80, Peak TnI >30
• Discharged home on hospital day 5
• Final diagnosis: Acute Posterior MI
OCCULT – MI TRIAL
• Mitchell Krucoff, MD and James Hoekstra, MD Co-chair
• Heartscape - Sponsor
• Steering Committee
• DCRI - Prime ECG Core Laboratory
• PERFUSE Angiographic Core Lab
• Cardiovascular Clinical Studies -CRO
OCCULT – MI Trial Sites
Occult-MI study
1400 patients
10 + sites
Bay State
Medical Center
William Beaumont ColumbiaPresbyterian
Cleveland Clinic
UC-Davis
University of
Cincinnati
Thomas Jefferson
Wake-Forest
Duke
Medical University
of South Carolina *
Tallahassee Heart &
Vascular Institute *
Tampa General
Inclusion Criteria
•
•
•
•
Able to consent
>39 years old
Has access to a working telephone and the ability to hear by phone
Non-trauma associated ACS symptoms beginning 12 hours or less
before presentation
• Chest pain and at least one of the following: (i) ECG abnormality;
(ii) known CAD; (iii) at least 3 coronary risk factors for CAD
(including: family history, current or treated hypertension,
hypercholesterolemia or treatment for it, diabetes mellitus and/or
subject is a current smoker).
Exclusion Criteria
• Symptoms > 12 hours
• Prior 12-lead STEMI within the past 48 hours
• Hemodynamic instability
• Cardiogenic shock
• Pulmonary edema (Killips class 3: overt failure with 1/3
of lung fields)
• Recent trauma.
Methods: Data Capture
• Prospective, cohort study of PRIME ECG
• Participants blinded to PRIME result
• Brief medical history (vital signs, height, weight, cardiopulmonary exam,
concomitant medications)
• 12-L and PRIME SERIAL recordings – near simultaneous at enrollment,
simultaneous at change of symptoms or at least one additional recording
within 3 hours; with pain assessment at time of each recording
• Clinical labs including cardiac markers – must include troponin [ I or T ]
• TIMI risk assessment
• Interventional therapies
• Angiographic films
• Results of: stress MPI, echocardiography, and SPECT scan during index
ED visit / hospitalization
• 30 day f/u for MACE
Primary Endpoint
DTST for Prime-only STEMI subjects vs. STEMI
subjects.
DTST will be measured in minutes, from the time stamped on the ED intake sheet
to the time of sheath insertion in the cardiac catheterization laboratory.
Secondary Endpoints
• 10+ endpoints of clinical and economic factors
• Sub-group analyses between Prime-only STEMI, STEMI, nonSTEMI
• Clinical factors analyzed will include: 30-day MACE rates, AMI
detection, ACS detection, angiographic determination of arterial
stenosis/occlusion, revascularization rates, medical therapy
regimens
PRIME ECG Case: OCCULT MI
• 6/10 Pain
• ECG with ST depression only in
anterior and lateral leads
• Posterior leads OK
• PRIME ECG applied
001-046
PRIME ECG Case Resolution
• Door to cath time 486 minutes
• TnI 186X ULN
• Final Dx NSTEMI
PRIME ECG Case: OCCULT MI
ECG with nonspecific findings
TIMI 2
Pain 2/10 on arrival, PRIME Applied
003-0148
PRIME ECG Case Resolution
• PRIME reading lateral ischemia
• No cath
• Troponin 210X ULN
• Final Dx NSTEMI
PRIME ECG Case: OCCULT MI
•
•
•
•
Pain 2/10 on arrival
ECG shows lateral ST depression
PRIME Applied
Serial Studies done 30 minutes apart
as pain continued
004-0124 (2)
PRIME ECG Case Resolution
• Rx as Unstable Angina
• Cath at 6022 min
• TnI 11X ULN
• Dx: NSTEMI
QUESTIONS??