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Reperfusion Strategies for ST
elevation MI.

Tom P Stys, FACC, MD

Medical Director

Sanford Cardiology

ACS and Rural Hospitals


4897 community hospitals in the United States
1


2900 are located in urban areas
1


1997 are located in rural areas
1


Although primary PCI is often the preferred strategy for STEMI, only about 25% of US
hospitals are capable of performing PCI
2


Non

PCI
-
capable institutions are often located in rural areas and face challenges
related to their distance from PCI centers


Almost 60% of US adults live in an area where a non

PCI
-
capable institution is their
closest hospital
2



Guideline
-
based multidisciplinary care and coordinated transfer protocols are
important for best outcomes






1.
American Hospital Association Statistics. Available at:
www.aha.org/aha/resource
-
center/Statistics
-
and
-
Studies/fast
-
facts.html
. Accessed May 23, 2010.

2.
Nallamothu BK, et al.
Circulation
. 2006;113(9):1189
-
1195.

STEMI Chain of Survival

Time to Treatment Is Critical in STEMI

Onset of
symptoms of
STEMI

9
-
1
-
1

EMS

dispatch

EMS on
-
scene


Encourage 12
-
lead ECGs


Consider prehospital fibrinolytic if
capable and EMS
-
to
-
needle within
30 min

Total ischemic time: within 120 min

EMS Transport

GOALS

PCI

capable

Not PCI

capable

Golden hr = 1st 60 min

Patient

Prehospital fibrinolysis

EMS
-
to
-
needle

within 30 min

EMS transport

EMS
-
to
-
balloon within 90 min

Patient self
-
transport


Hospital door
-
to
-
balloon

within 90 min

Dispatch

1 min

5

min

8

min

0.4 million
discharges per
year

for STEMI

in US



Time to reperfusion is a critical determinant of the extent of


myocardial damage and clinical outcomes in patients with STEMI



Key factors in STEMI care are rapid, accurate diagnosis and


keeping the encounter time to reperfusion as short as possible

The Thrombus in STEMI

STEMI is generally caused by a

completely occlusive fibrin
-
rich

thrombus in a coronary artery

Results from stabilization by fibrin
mesh of a platelet aggregate at site
of plaque rupture

*RBC = red blood cell.

GP IIb
-
IIIa inhibitors are not indicated for STEMI.

Van de Werf F.
Thromb Haemost
. 1997;78(1):210
-
213; White HD.
Am J Cardiol
. 1997;80(4A):2B
-
10B;

Davies MJ.
Heart
. 2000;83(3):361
-
366.

Achieve Coronary Patency



Initial Reperfusion Therapy


-

Defined as the initial strategy employed to restore blood flow
to the occluded coronary artery



3 Major Options:



Pharmacological Reperfusion



PCI



Acute Surgical Reperfusion


Class I

All patients should undergo rapid evaluation for reperfusion
therapy & have a reperfusion strategy implemented promptly after
contact with the medical system


Antman et al. JACC 2004;44:680.


Goals When
Considering

a Reperfusion Strategy




Decrease amount of myocardial necrosis



Preserve LV function



Prevent major adverse cardiac events



Treat life threatening complications

Importance of Early

Reperfusion Therapy in STEMI

Outcomes Dependent Upon:



Time to treatment
-
TIME IS STILL MUSCLE



Early and full restoration in coronary blood

flow



Sustained restoration of flow

Reperfusion Recommendations

-

STEMI patients presenting to a hospital with PCI
capability should be treated
with primary PCI
within 90 minutes
of first medical contact.

I

III

IIa

IIb


STEMI patients presenting to a hospital without
PCI capability and who cannot be transferred to
a PCI center for intervention within 90 minutes
of first medical contact should be treated with
fibrinolytic therapy within 30 minutes
of
hospital presentation, unless contraindicated.

I

III

IIa

IIb

ACC/AHA 2007 STEMI Focused Update

Circulation
2007; on line, December 10.

Risk Stratification

Based on initial

Evaluation, ECG, and

Cardiac markers

STEMI

Patient?

YES

NO

-

Assess for reperfusion

-

Select & implement
reperfusion therapy

-

Directed medical
therapy


UA or NSTEMI

-

Evaluate for Invasive vs.
conservative treatment

-

Directed medical
therapy

Choices:

Reperfusion Strategies for STEMI


Plan A: percutaneous coronary intervention
(primary PCI)

-
Mechanical means of restoring blood
flow



Balloon angioplasty



Stents

-

More effective

-

Lower bleeding risk

-

Available at only 25% of U.S. hospitals



Treatment delays

Plan B: thrombolytics (fibrinolytics
)

-

Pharmacologic means of restoring
blood flow



Clot
-
busting” drugs

-

Less effective

-

Greater bleeding risk

-

Widely available at U.S. hospitals

STEMI cardiac care



Determine preferred reperfusion strategy


Fibrinolysis

preferred if:


<
3 hours from onset


PCI not available/delayed


door to balloon > 90min


door to balloon minus door
to needle > 1hr


Door to needle goal <30min


No contraindications



PCI

preferred if:


PCI available


Door to balloon < 90min


Door to balloon minus door to
needle < 1hr


Fibrinolysis contraindications


Late Presentation > 3 hr


High risk STEMI


Killup 3 or higher


STEMI dx in doubt


STEMI cardiac
care




Assessment

-

Time since onset of symptoms

90 min for PCI / 12 hours for fibrinolysis

-

Is this high risk STEMI?

-

KILLIP classification

-

If higher risk may manage with more
invasive rx

-

Determine if fibrinolysis candidate

-

Meets criteria with no contraindications

-

Determine if PCI candidate

-

Based on availability and time to balloon rx


Acute Phase Risk Stratification:

Importance of LV dysfunction

Killip Classification

% patients

Mortality (%)

I No CHF

30
-
50

5

II Rales, S3, Pulmonary venous hypertension

33

15
-
20

III Pulmonary edema

15

40

IV Cardiogeni
c shock

10

80
-
100



Continuing Medical Implementation …..
.bridging the care gap

Fibrinolysis indications



ST segment elevation >1mm in two contiguous


leads



New LBBB




Symptoms consistent with ischemia



Symptom onset less than 12 hrs prior to

presentation


Absolute contraindications for fibrinolysis therapy in
patients with acute STEMI





Any prior ICH



Known structural cerebral vascular lesion (e.g., AVM)



Known malignant intracranial neoplasm (primary or

metastatic)



Ischemic stroke within 3 months EXCEPT acute ischemic

stroke within 3 hours



Suspected aortic dissection



Active bleeding or bleeding diathesis (excluding menses)



Significant closed
-
head or facial trauma within 3 months

CONTRAINDICATIONS

It is estimated that 20
-
30% of
patients ineligible for
thrombolytic therapy…




Which Lytic Agent?

EFFICACY



Benefit first demonstrated w/
streptokinase

(GISSI
-
2

and ISIS
-
2 trials). ISIS
-
2 showed combination of

ASA and streptokinase reduced mortality from

10.2% (placebo) to 7.2%.



GUSTO
-
I:
alteplase

superior to streptokinase

(although more expensive)



ASSENT
-
2 and GUSTO
-
III: newer agents like

tenecteplase
,
reteplase
,
lanoteplase

as effective as

alteplase but have significantly lower incidence of

noncerebral bleeding complications and need for

transfusion.


Comparison of Approved Fibrinolytic Agents






Streptokinase



Alteplase




Reteplase



Tenecteplase



Dose




1.5
MU over


Up to 100mg in


10U x 2


30
-
50mg






30
-
60
min


90 min (wt
-
based) each over 2 min


based on weight


Bolus Admin
.


No



No



Yes


Yes


Antigenic





Yes




No





No




No


Allergic React



Yes No


No





No


Systemic





Marked


Mild




Moderate


Minimal


Fibrinogen Depletion



~90
-
min patency 50


75
75
?




7
5


rates (%)


TIMI grade 3 flow, % 32


54


60




63

Adapted from Table 15, pg 53.Accessed on August 6, 2004

http://www.acc.org/clinical/guidelines/stemi/index.pdf.

Assessment of response …



Relief of symptoms



Maintenance or restoration of hemodynamic

and/or electrical stability



Reduction of at least 50% of initial ST segment

injury pattern on a follow
-
up EKG 60
-
90 min

after initiation of therapy



Serial measurements of cardiac biomarkers

Long
-
term survival…



Long
-
term benefit primarily seen in patients

who achieved TIMI 3 flow w/ lytic

administration. Vessel opening (TIMI 2 or 3)

reported in 60
-
87% of patients receiving

lytics,

but normalization (TIMI 3) in only 50
-
60% of

arteries. Only
TIMI 3

flow associated with

improved LV function and survival.

***Note: TIMI 3 flow is achieved in ~90% of patients treated with primary PCI.

Time from Symptom Onset to Treatment

Predicts 1
-
year Mortality after Primary PCI

The relative risk of 1
-
year mortality increases by

7.5% for each 30
-
minute delay

De Luca et al,

Circulation 2004
;109:1223
-
1225


2009 ACC/AHA STEMI/PCI Guidelines Focused Updates

Triage and Transfer for PCI (for STEMI)

New Recommendation

B



It is reasonable to transfer high
-


risk patients who receive

fibrinolytic therapy as primary

reperfusion therapy at a non


PCI
-
capable facility to a PCI
-

capable facility as soon as

possible where PCI can be

performed either when needed

or as a pharmacoinvasive

strategy

EFFECT OF DOOR
-
TO
-
BALLOON TIME ON
MORTALITY IN PATIENTS WITH STEMI

8

7

6

5

4

3

2

1

0


90

>90
-

120

>120
-

150

>150

In
-
hospital Mortality, %


90

>90
-

120

>120
-

150

>150

Door
-
to
-
Balloon Time (min)

In
-
hospital mortality and door
-
to
-
balloon time;
P

for trend <.001.

Reproduced with permission from McNamara RL
, et al.
J Am Coll Cardiol.
2006;47(11):2180
-
2186.

Estimated in
-
hospital mortality by door
-
to
-
balloon times


Time (min)

Adjusted mortality*

15

2.9 (2.8

3.1)

30

3.0 (2.9

3.2)

60

3.5 (3.4

3.6)

90

4.3 (4.2
-

4.4)

120

5.6 (5.4

5.7)

180

8.4 (8.2

8.7)

240

10.3 (10.0

10.7)

*Adjusted for age, sex, race, findings on presentation, medical
history, procedural characteristics, angiographic findings, and
hospital factors

No “floor” to the
mortality reduction
that can be achieved
by reducing time to
treatment

Any delay in D2B time associated with
increased in
-
hospital mortality

Rathore SS, et al.
BMJ

2009; 339:b1807
.

Yale University School of Medicine; ACC
-
NCDR

D2B: PCI Engineering

1.
ED physician activates cath lab

a.
Via Field Interpretation

b.
Via Referral Interpretation

c.
Via ED Interpretation

2.

One call activates the cath lab

3.

Cath lab team ready in 20
-
30 minutes

4.

Prompt data feedback

5.

Senior management commitment

6.

Team
-
based approach


PCI after thrombolytics???

This issue remains unresolved…

3 possible scenarios…

*Facilitated PCI

lytic drug given prior to planned PCI in

attempt to achieve an open infarct
-
related artery

before arrival of cath lab

*Adjunctive PCI

PCI performed within hours after

thrombolysis

*Early elective PCI

PCI performed within a few days

after thrombolysis

Comparing outcomes: PCI vs Lytics


The Golden Rule: Once a STEMI

is Identified
it
Must

Trigger a Clear
Response
Downstream!

Rapid
Recognition

of STEMI on ECG will only improve
the process IF
Recognition

leads to a concrete action
occurring downstream


Recognition allows early Reperfusion… but does not
guarantee it!

STEMI


Door
-
to
-
Balloon and Door
-
to
-
Needle Times

Cumulative 12
-
Month Data from ACTION Registry

ACTION DATA: January 1, 2007


December 31. 2007 (n=19,523)

DTB = 1st door to balloon for primary PCI

DTN = Door to needle for lytics

ACTION Median Door
-
to
-
Balloon Times

For Transfer In & Non
-
Transfer In Patients

123

236

62

103

Q1 07

120

223

60

102

Q2 07

116

215

57

Q3 07

113

212

57

95

Q4 07

Time (min)

50

220

210

60

70

80

90

110

100

120

130

140

150

160

170

200

180

190

240

230

96

40

30

20

250

10

0

79

78

75

74

169

158

151

156

Transfer in DTB Times

Non
-
Transfer in DTB Times


Today: The 5 Essential Elements

of STEMI System Optimization

R1

Relationships

R2

Recognition

R3

Reperfusion

R4

Real
-
time data collection

R5

Reassessment & refinement

Date
Day of
Week
HAR/
Account
Number
ST Elevation
Transfer
In
Cardiologist
Emergency
Room Doctor
Interventionalist
Admit Time to
1st EKG
EKG to Time
CCL Notified
CCL Notified
to Pt. Arrival
in CCL
CCL Arrival to
Arterial
Access
Arterial
Access to
Inflation
Total Time
(Admit Time
to Inflation)
5/15/2007
Tuesday
4117288
Yes
No
T. Stys
McSherry
T. Stys
2
10
4
6
22
Emergency Department to Cath Lab
Individual Incident Graph
10
4
6
2
0
10
20
30
40
50
60
70
80
90
100
110
120
130
140
150
4117288
Patient Account Number
Time (Measured in Minutes)
Admit Time to 1st EKG
EKG to Time CCL Notified
CCL Notified to Pt. Arrival in CCL
CCL Arrival to Arterial Access
Arterial Access to Inflation
*Cardiologist Examined Patient
Admit Time: 1423
*
What we should do about STEMI Cardiogenic Shock



Emergency angiography and revascularisation: Primary PCI preferably

-

All patients <75 years

-

Selected patients
≥75 years



On
-
table echo to rule out mechanical defects



Stabilise the patient in the lab before revascularisation

-

IABP

-

Pressors if required (Norepinephrine/dopamine)

-

Anaesthetic support



Consider calling the surgeon for true surgical disease



PCI culprit artery. Other vessels if shock persists



Use abciximab for PCI



Consider percutaneous LVAD if shock persists with IABP + multi
-
vessel

revascularisation

Motor


Blood outlet

Blood Inlet

Cardiogenic Shock: Impella



Axial flow pump



Much simpler to use



Increases cardiac output & unloads LV



LP 2.5

-

12 F percutaneous approach; Maximum 2.5 L flow



LP 5.0

-

21 F surgical cut down; Maximum 5L flow



Cost: 3
-
5K

Pressure Lumen

STEMI 2012: “60 is the New 90”




<30 Minutes
: First Medical Contact (Recognition) to

Thrombolytic administration




<90 Minutes
: First Medical Contact to on
-
site PCI (AHA/ACC

recs) ?????




<90 Minutes

: First Medical Contact followed by
inter
-
facility

transfer

to a PCI
-
capable facility




***BUT realistically <60 Minutes should be the goal for

Contact/Recognition to Reperfusion @ a STEMI Receiving

Facility (PCI Center)!








CARESS
-
in
-
AMI: Primary Outcome

Barriers to Timely Reperfusion



The patient

-

Failure to promptly recognize

symptoms

-

Hesitation to seek medical attention



Time to transport

-

Mandated delivery to the closest

hospital, regardless of PCI

capabilities

-

Long transport in rural areas



Decision process on arrival

-

Clot
-
busting drugs vs. PCI

-

Off hours

-

Transfer to PCI facility



Time to implement treatment
strategy

-

Procedural factors

-

Team assembly


1970


Cardiology invented EMS


Emergency!

Gage &
DeSoto

2010


EMS transforming Cardiology

Thank

You!