Level One STEMI Treatment Protocol Myron E Bloom MD MMM Medical Director Rural Healthcare Quality Ne

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Level One STEMI Treatment ProtocolMyron E
Bloom MD MMMMedical DirectorRural Healthcare
Quality Network TIME COUNTS
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ACC / AHA 2004 recommendation30 minutes to
Thrombolytic if patient can not get PCI within
90 minutes of first Emergency Room Door (now
1st medical contact)

• Because Time is Muscle
• A ONE SIZE FITS ALL TYPE OF STATEMENT

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So how are we doing presently?

• In the US
• 37 of all STEMI patients are not reperfused (39
  PPCI 23 lytic)
• Average D-N time is 33 minutes but only
• 1/3rd of STEMI PPCI under 90 minutes and
• lt5 of transfer in PPCI under 90 minutes
• NRMI 5 database median time of 143 minutes!
• Time is muscle, especially first 2-3 hours !
• Average time from onset to arrival is 3 hrs like
  it was 10 years ago
• And most downstream heart muscle is dead by 4-5
  hr
• MUST EDUCATE THE PUBLIC

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Will show evidence that

• PCI is safer and offers better outcome than
  lytics
• 2-3 per 100 STEMI mortality benefit with less
• re-thrombosis or bleeding
• Time delay to thrombolytic /or PCI deleteriously
  affects outcome
• Strategy expedites treatment optimizes outcome
• Clinical factors time of Sx onset, age, STEMI
  location
• Predetermined time of transport and protocol
• Standardized Recipe for STEMI
• Transfer immediately for PPCI or after lytics

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Long-term Outcome of Primary PercutaneousCoronary
Intervention vs Pre-hospital and In-Hospital
Thrombolysis for Patients With ST-Elevation
Myocardial Infarction JAMA, October 11, 2006

• 26,205 consecutive STEMI patients in Sweden 1999
  to 2004
• 30 day mortality
• PPCI Pre H T In H T
• 4.9 7.6 11.4
• 1 year mortality
• 7.6 10.3 15.9
• Primary PCI was also associated with shorter
  hospital stay and less re-infarction than either
  PHT or IHT.

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One year mortality Percutaneous Coronary
Intervention vs Pre-hospital and In-Hospital
Thrombolysis
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Door-to-Balloon Time With Primary Percutaneous
Coronary Intervention for Acute Myocardial
Infarction Impacts Late Cardiac Mortality in
High-Risk Patients and Patients Presenting Early
After the Onset of SymptomsJournal of the
American College of Cardiology Vol. 47, No. 2,
2006

• In-hospital outcomes by Door-to-Balloon Time
• lt90 90-120 120-180 gt180
  p Value
• Mortality () 4.9 6.1 8.0 12.2
  0.0001
• Reinfarction () 2.9 2.4 2.9 2.2
  0.84
• Stroke () 0.8 1.0 1.1 1.9 0.31
• (384) (493) (750) (673)
• 2,322 consecutive patients with STEMI from 1984
  through 2003 treated with primary PCI without
  previous thrombolytic therapy.

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EFFECT OF DOOR-TO-BALLOON TIME ON MORTALITY IN
PATIENTS WITH ST- SEGMENT ELEVATION MYOCARDIAL
INFARCTION J Am Coll Card June 2006
29,222 patients presenting within 6 hrs of
STEMI symptom onset who had PCI at 395 hospitals.

• Median D2B of 102 min inpatient mortality of
  4.55.
• Longer D2B times associated with increasing
  mortality, regardless of the interval from
  symptom onset to presentation, or presence of
  high-risk features.
• from 3.0 with D2B of 90 minutes or less,
• to 7.4 with intervals greater than 150 minutes.
• The odds ratio for inpatient mortality was 1.08
  for every 30-minute increase in D2B time.

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PCI v. Fibrinolytic therapy in AMI Is timing
(almost) everything? Am J Cardiol. 2003 92
824826

• No mortality advantage for primary PCI versus
  fibrinolytic therapy when door-to-balloon time
  exceeded door-to-needle time by 62 minutes.

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Delays in reperfusion for STEMI Circulation.
2006 114 20192025

• In single variable analysis of 192,000 cases
  from 1994 to 2003, the survival advantage of PCI
  was lost after
• By AGE under 65 at 71 min of delay and if
  over 65 at 155 min
• or
• By Type anterior MI at 115 min of delay and
  nonanterior MI 112 minutes.

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Delays in reperfusion for STEMI Circulation.
2006 114 20192025

• 3 variables age, type of STEMI, and time since
  Sx onset
• The survival advantage of PCI is lost when DB-DN
  time exceeds
• Patients under 65 under 2 hrs after 2 hrs of
  Sx
• Anterior MI _at_ 40 min. _at_ 43 min.
• Nonanterior MI _at_ 58 min. _at_ 103 min
• Patients over 65 under 2 hrs after 2 hrs of
  Sx
• Anterior MI _at_ 107 min _at_ 148 min.
• Nonanterior MI _at_168 min. _at_ 179 min.

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DB-DN time when mortality benefit is lostmaximum
delay between D12B and D12N times
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So what happens when you call?"We found that
delays to reperfusion occurred while waiting to
talk to the cardiologist,

• "Also, the recommendations for a specific
  patient often depended on who the cardiologist
  was, and the time of day and day of the week.
• Quotes by Minneapolis Heart Institute
  Cardiologists

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What to do? Develop a Strategy

• Two Cardiology Centers of Excellence published
  their strategies in the same issue of Circulation
  (August 2007)
• Mayo Clinic - PPCI or Lytic
• Based on time to presentation
• AN Minnesota Heart Institute PPCI or Lytic
  PCI
• Based on time to cath lab

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The Mayo Clinic STEMI ProtocolAugust 2007 issue
of Circulation

• 258 presented directly to Mayo for Primary PCI
• median D2B 71 min.
• 236 rural transfers from up to 150 miles
• 105 Sx gt3 hours transferred for Primary PCI
  median D2B 116 min.
• 131 Sx lt3 hours full-dose fibrinolytic
• median D2N 25min (70lt30m)
• In-hospital mortality said to be similar - ?
• Mayo PPCI 6.6 (95 CI, 3.9 to 10.3),
  
  
  Transfer PPCI 5.7 (95 CI, 2.1 to
  12.0), Thrombolytic 3.1 (95 CI, 0.8 to
  7.6).

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• Minnesota Heart Institute
• Predicted minimum expected time to PCI
• given realities of packaging the patient and
  transport and allowing 30 min. for PCI
• Zone One within 60 miles 60 minutes
• expected arrival PCI 90 minutes
• no lytic!
• Zone Two - beyond 60 miles 60 minutes
• expected arrival PCI gt 90 minutes
• lytic facilitation if no contraindication!

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MHI Bail Out Protocol for all patients D2PCI
expected delay gt120 min

• ½ dose Lytic for all patients (both Zone 1 and
  Zone 2)
• Clopidogrel 600 mg PO and Heparin
• (beta blockers and nitroglycerin but no
  IIb/IIIa)
• Rationale experience from Zone 2 PCI after
  lytic
• 208 patients w/ ½ dose, patency rates of 75
• TIMI 2 21, TIMI 3 49
• 22 patients w/ full dose, patency rates of 73
• TIMI 2 41, TIMI 3 32

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MHI Level One Program Report Card 3/03-11/06
1345 consecutive STEMI patients

• 1048 were transferred Median D2B time
• No lytic zone 1 lt60 mi 95 min
• partial lytic zone 2 lt210 mi 120 min
• IN HOSPITAL MORTALITY 4.2
• 30 DAY MORTALITY 4.9
• ONE YEAR CARDIOVASCULAR 5.6
• OVER ALL ONE YEAR MORTALITY 7.2
• unselected high-risk patient population with
  12.3 in cardiogenic shock, 10.8 cardiac arrest
  and 14.6 over 80 years age

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So what about a facilitated PCI approach with
2b3a or 2b3a lytic?
The FINESSE study will answer important
questions regarding the efficacy and safety of
"upstream" medical therapy followed by planned
intervention for patients with ST-elevation MI
Facilitated Intervention with Enhanced
Reperfusion Speed to Stop Events Enrollment
halted at 2452 randomized in December
2006 Reported at ESC 2007
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FINESSE trial
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At cath the combination was associated with an
increase in TIMI 2-3 flow and ST-segment
resolution (61 vs 25 26) but No differences
between treatment arms in all-cause mortality,
readmission for heart failure, ventricular
fibrillation, or cardiogenic shock. ie. NO
BENEFIT to either upstream strategy But there
were differences in safety Non-intracranial
bleeding was significantly higher in the
combination facilitated PCI strategy compared to
primary PCI with in lab abciximab. Major and
minor bleeding was statistically higher in the
combination strategy compared to the upstream
abciximab-only and in the upstream abciximab-only
compared to abciximab during PCI.
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ESC September 2007

• The future of facilitated PCI following acute
  ST elevation MI now seems doomed to history
  following the outcome of the long awaited FINESSE
  study.
• "There may still be a role in extreme cases
  where there are long delays, but the broad
  approach of offering thrombolytic therapy prior
  to PCI is now dead..."
• Stephen Ellis MD (Cleveland Clinic)
• Or is it?
• CARESS trial ½ dose rPA, Abcx PCI
• Transfer AMI trial TNK, /-Abcx PCI
• Or other regimens
• BRAVE-3
• Vienna Registry

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CARESS Study

• Randomized 600 high risk STEMI
• (gt15mm STE, new LBBB, Killip gt2 HF,lt35 EF,
  prior MI)
• to drip and ship or drip and keep
• All pts got 2x 5u reteplase, UFH (3000 then
  7u/k/h), and abcx bolus drip
• Immediate transfer for PCI
• Or
• Admit ICU and urgent transfer for rescue PCI if
  persistent gt50 STE _at_ 90 min or hemodynamic
  compromise

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30 day CARESS OUTCOMES
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BRAVE-3 Bavarian Reperfusion Alternatives
Evaluation-3

• to investigate the added value of abciximab in
  STEMI patients undergoing PCI who had been
  pretreated with a 600-mg loading dose of
  clopidogrel
• At 30 days, the mortality rate was 3.2 in
  abciximab-treated patients and 2.5 in
  placebo-treated patients (P 0.53).
• The composite of death, MI, stroke, or urgent
  revascularization occurred in 5.0 of
  abciximab-treated patients and 3.8 of
  placebo-treated patients (P 0.39).
• Thrombocytopenia occurred significantly more
  often in abciximab-treated patients (1.5 vs 0,
  P 0.03).
• Patients with STEMI undergoing PCI benefit from
  treatment with either clopidogrel or abciximab,
  but not from their combined use.

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VIENNA STEMI registry Primary PCI vs
Fibrinolytic Therapy in STEMI

• One-year outcomes were available for 1035
  patients
• median time from onset of symptoms until
  treatment
• 617 Primary PCI 277 Fibrinolytic 141 No
  reperfusion
• 205 minutes 120 minutes
• One-year mortality rates
• 11.8 PPCI 11.9 Lytic 24.8
• If treated in lt2 hours from symptoms until
  treatment
• 10 PPCI 5.7 Lytic
• If treated in gt2 hours from symptoms until
  treatment
• 12 PPCI 18.2 Lytic

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Planned immediate transfer after
lyticTRANSFER-AMI 30 day End Points Both
groups got TNK, ASA, LMWH or UFH andIIb IIIa
clopidogrel at the clinician's discretion
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TRANSFER-AMI30-Day Bleeding End Points40
reduction in adverse outcomes with no excess
bleeding
best strategy is to get that patient transferred
to undergo angioplasty within six hours rather
than our usual strategy of watchful waiting
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Failure to reperfuse

• Now defined using ECG as
• Less than 50 reduction in STE at 90 minutes
  after lytic in the single lead that showed the
  greatest elevation
• for those who successfully reperfused
• routine diagnostic cath PCI by 6 - 24 hours
  after the bad humors of lytics have abated

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Goal Timely safe Reperfusion

• ACC / AHA Thrombolytic within 30 min if patient
  can not get PCI within 90 min of first ER door
• (PCI is preferred)
• Design a protocol to achieve this goal
• Predetermined minimum transport times
• by ground and air to predict potential of
• PCI within 90 /- 30 minutes

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To benefit more from Primary PCI than IV Lytic
given the advantage of PPCI may be lost when
DB-DN time exceeds the time shown in the center
columns, the time conditions to be met are
displayed in the columns on the right
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Expedite Reperfusion Minutes
is Muscle

• Symptoms to Test Time
• Expedite Transport, Triage and ECG
• Educate the public
• Pre-hospital assessment tool, ECG and ED Cardiac
  Alert
• Expedite ECG Set standard for door to ECG time
• Test to Treatment Time
• Empower the emergency room provider to make
  initial treatment decision for STEMI your
  patient until arrives there
• Standardized Protocols based on
• Predetermined expected transport times for PCI
• Then Immediate transfer to cath lab facility

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ST-Elevation Myocardial Infarction or New Left
Bundle Branch Block

• 1st Dispatch transport team helicopter or
  ground ACLS.
• One Decision fibrinolytic if expected D2B time
  not lt 120 min.
• ie. Arrival 1st ER to delivery at cath lab lt
  90 minutes total time
• Monitor, oxygen, IV line, and draw routine labs
• Aspirin and Plavix (clopidogrel)
• Nitroglycerin as needed PO IV for chest pain
  and hypertension
• Heparin loading dose infusion (or enoxaparin or
  fondaparinux)
• Beta-blocker intravenously then PO - cautiously
• Morphine sulfate (fentanyl) as needed for pain
• Portable Chest X-ray
• Second IV (saline lock) and hands-free
  defibrillation pads
• Consider anxiolytic for transport

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Journal of the American College of Cardiology
Circulation January 15, 2008

• A new recommendation for a loading dose of 600 mg
  of Plavix before or when PCI is performed.
• For those treated within 12 to 24 hours of
  fibrinolytic therapy, a loading dose of 300 mg
  may be considered.
• A new recommendation that a reperfusion strategy
  using full-dose fibrinolytic therapy followed by
  immediate PCI should be avoided
• Other facilitated regimens might be considered in
  high-risk patients with a low risk of bleeding
  when PCI is not available within 90 minutes.

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Plavix at PCI risk _at_ CABG

• CURE study clopidogrel within 5 days of
  coronary artery bypass graft, had a trend toward
  more major bleeding complications
• 9.6 versus 6.3 P of 0.06 NS
• 3.3 increased rate of bleeding x the lt3 rate
  of emergent CABG 9.9/10,000
• 1 in a thousand harmed for 999 potentially
  helped
• Emergency Medicine always has to deal with
  probabilities

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Mean reduction in door-to-balloon times by
strategy N Engl J Med 2006

• ED activate the cath lab 8.2 min
• Single call to activate cath lab 13.8 min
• Activates cath lab while patient en route 15.4
  min
• Staff arrive at cath lab within 20 minutes 19.3
  min
• Having an attending cardiologist on site 14.6 min
• Real-time feedback to ED and cath lab use 8.6 min

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Questions for Your Facility

• Have you implemented a Cardiac Alert protocol
  to facilitate your evaluation and initial
  treatment of potential ACS patients by maximizing
  your available resources?
• What percentage of your chest pain (and chest
  pain equivalent) patients have an ECG performed
  and evaluated within 10 minutes of arrival? How
  can this be improved?
• Have you established a minimum default treatment
  recipe for all ACS patients with a customizable
  preprinted order set with prompts to ensure that
  all pertinent issues are addressed?

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Questions for Transfer System

• What is the probable minimum time from arrival to
  departure at your facility for a STEMI patient?
  Do you monitor this? What delays can be
  identified and avoided?
• What ACLS providers provide cardiac
  transportation for your patients and how long
  does it take to assemble a team and for their
  arrival at your door?
• What is the minimum transfer time to each
  potential cardiac catheterization capable
  receiving facility by ground and/ or by air?
• What is the likely minimum total time from
  arrival at your facility to arrival at the
  receiving facility a composite of your time
  spent in diagnosis and stabilization, waiting for
  departure and in transport to the referral
  hospital?

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Questions for Cardiology Centers

• To whom do you refer acute coronary syndrome
  STEMI patients? Which physicians and what
  institutions? How meaningful and timely is the
  feedback received on cases transferred?
• How is the referral made? Whom do you call and
  how many calls are required? How can the referral
  / transfer process be streamlined and simplified?
• What is the expected cath lab arrival to balloon
  inflation time for your transferred patients?
  What is their average time currently and what are
  the percentages under 90 120 minutes? How does
  it change by time of day, day of week, and
  practitioner?

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Patient Characteristics for choosing initial
reperfusion strategy

• How much time has elapsed since the onset of
  symptoms to presentation for care?
• What is the ECG suggested infarct location?
• What is the patients age?
• What is the patients coronary and renal history?
  
• Does the patient have contraindications to
  thrombolytic therapy?