0

1

2

3

0

1

2

3

GUSTO I90-93

GUSTO I90-93

2.82.8

Med

ian

Tim

e (h

rs)

Bet

wee

n S

ymp

tom

On

set

and

Tre

atm

ent

Med

ian

Tim

e (h

rs)

Bet

wee

n S

ymp

tom

On

set

and

Tre

atm

ent

GUSTO III95-97

GUSTO III95-97

InTIME II97-99

InTIME II97-99

ASSENT 300-01

ASSENT 300-01

ASSENT II97-98

ASSENT II97-98

GUSTO V99-01

GUSTO V99-01

2.82.82.72.7 2.72.72.72.7

2.92.9

Gibson CM, Circulation 2001;104:2632-2634Gibson CM, Circulation 2001;104:2632-2634

1.0

1.5

2.0

2.5

3.0

Tim

e (

ho

urs

)

All patients

Men

Women

All patients 2.2 2.2 2.2 2.1 2.0 2.0 2.0 2.0 2.0 1.8 1.8 1.8 1.8 1.7 1.7 1.7 1.6

Men 2.0 2.0 2.0 2.0 1.9 1.8 1.8 1.8 1.8 1.7 1.7 1.7 1.7 1.6 1.6 1.6 1.5

Women 2.6 2.6 2.6 2.5 2.3 2.2 2.2 2.2 2.1 2.1 2.0 2.0 2.0 2.0 2.0 1.9 1.8

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

National Registry of Myocardial Infarction,1990-2006National Registry of Myocardial Infarction,1990-2006

Trends in symptom onset-to-door time among STEMI patients, stratified by sex

Gibson CM, ACC 2008

The AngelMed Guardian SystemThe AngelMed Guardian System

• AnAn Implantable DeviceImplantable Device ( (IMDIMD) ) - - Implantable cardiac Implantable cardiac event recorder with ST-segment measurement and event recorder with ST-segment measurement and alarm. Records electrogram and will issue an alarm alarm. Records electrogram and will issue an alarm for acute ST shift changesfor acute ST shift changes

• A A ProgrammerProgrammer to program the IMD and retrieve to program the IMD and retrieve and process the data captured by the IMD.and process the data captured by the IMD.

• An An External DeviceExternal Device ( (EXDEXD)) that provides an additional that provides an additional (audio) alarm and telemetry up to 6 feet between the (audio) alarm and telemetry up to 6 feet between the implant and the EXD. The EXD has an alert silence implant and the EXD. The EXD has an alert silence button, labeled LEDs to indicate the type of alarm and button, labeled LEDs to indicate the type of alarm and printed patient instructions.printed patient instructions.

Patient B9 Acute ST Elevation Event September 2007Patient B9 Acute ST Elevation Event September 2007

2nd Em. Alarm

Emergency Alarm at 12:20 pm 9/17/07

Arrival at hospital ~1 hour later

Start of Arterial Occlusion

Patient B9 – ST Elevation 1st Emergency AlarmPatient B9 – ST Elevation 1st Emergency Alarm

Patient arrives at the hospital

Patient B9 – ST Elevation Emergency Patient B9 – ST Elevation Emergency AlarmsAlarms

1st Em. Alarm 2nd Em. Alarm (in hospital)

Patient put on Heparin and ClopidogrelPatient put on Heparin and Clopidogrel

Ruptured Plaque Site in Pt. B9 CircumflexRuptured Plaque Site in Pt. B9 Circumflex

March 1, 2007 Sept 18, 2007

Gersh, B. J. et al. JAMA 2005;293:979-986.

Relationship Between Duration of Symptoms of Acute MI Before Relationship Between Duration of Symptoms of Acute MI Before Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial

SalvageSalvage

Relationship Between Duration of Symptoms of Acute MI Before Relationship Between Duration of Symptoms of Acute MI Before Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial

SalvageSalvage

Time is Muscle: Delays in Symptom to Door Time are Time is Muscle: Delays in Symptom to Door Time are Associated with Poorer Flow in the Muscle Independent Associated with Poorer Flow in the Muscle Independent

of Flow in Arteryof Flow in Artery

Time is Muscle: Delays in Symptom to Door Time are Time is Muscle: Delays in Symptom to Door Time are Associated with Poorer Flow in the Muscle Independent Associated with Poorer Flow in the Muscle Independent

of Flow in Arteryof Flow in Artery

16% rise in risk of a closed muscle for every hour of delay in STEMI (p=0.0005) Gibson, JACC 200416% rise in risk of a closed muscle for every hour of delay in STEMI (p=0.0005) Gibson, JACC 2004

Normal LargeCapillary Lumen

Clinical Picture: Clinical Picture: Open ArteryOpen Artery

Closed MuscleClosed MuscleBlistering of CapillariesBlistering of Capillaries

& Endothelium& Endothelium

“Blistered” / Swollen Endothelium /wall of the capillary

Normal non-infarcted

wall without edema

Infarcted wall with edema (white

areas)

Interstitial Edema Interstitial Edema

EHJ (2004) 25, 794–803EHJ (2004) 25, 794–803

Gibson CM 2008

Symptom – balloon inflation (min)Symptom – balloon inflation (min)

On

e-ye

ar m

ort

alit

y, %

On

e-ye

ar m

ort

alit

y, %

6 RCTs of Primary PCI by Zwolle Group 1994 – 20016 RCTs of Primary PCI by Zwolle Group 1994 – 2001N = 1791N = 1791

RR = 1.08 for each 30 min delayRR = 1.08 for each 30 min delay((PP = 0.04) = 0.04)

PP < 0.0001 < 0.000112

10

8

6

4

2

00 60 120 180 240 300 360

Symptom Onset-Balloon Time and Symptom Onset-Balloon Time and Mortality in Primary PCI for STEMIMortality in Primary PCI for STEMI

DeLuca, Suryapranata, Circ 109:1223, 2004DeLuca, Suryapranata, Circ 109:1223, 2004

The relative risk of 1-year mortality increases by7.5% for each 30-minute delay

20

30

40

50

60

70

Tim

e (

min

ute

s)

Door-to-needle time 59 55 55 48 43 40 38 35 35 34 34 33 32 32 30 30 29

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

Trend in door-to-needle time among reperfusion-eligibleSTEMI patients receiving fibrinolytic therapy

Gibson CM, ACC 2008

National Registry of Myocardial Infarction, 1990-2006National Registry of Myocardial Infarction, 1990-2006

5.0

5.5

6.0

6.5

7.0

7.5

8.0

Mo

rta

lity

(%

)

In-hospital mortality 7.0 7.5 7.0 7.1 7.0 7.0 6.6 6.2 5.8 5.8 5.4 5.3 6.0

1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

National Registry of Myocardial Infarction, 1994-2006National Registry of Myocardial Infarction, 1994-2006

Trend in in-hospital mortality among reperfusion-eligible STEMI patientstreated with fibrinolytic therapy

Gibson CM, ACC 2008

50

100

150

200

250

Tim

e (

min

ute

s)

All patients

Transfers

Non-transfers

All patients 120 117 116 111 113 110 107 106 108 105 101 94 87

Transfers 226 208 196 190 192 185 186 186 176 168 152 146 139

Non-transfers 111 109 110 105 108 105 102 101 103 99 94 86 79

1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

National Registry of Myocardial Infarction, 1994-2006National Registry of Myocardial Infarction, 1994-2006

Trends in door-to-balloon time among reperfusion-eligible STEMI patientstreated with primary PCI, stratified by transfer status

Gibson CM, ACC 2008

0

1

2

3

4

5

6

7

8

9

10

Mo

rta

lity

(%

)

All patients

Transfers

Non-transfers

All patients 8.6 7.4 6.7 5.4 5.2 5.3 4.9 4.5 4.1 3.9 3.4 3.2 3.3

Transfers 8.7 9.1 9.4 6.3 7.2 7.5 6.3 6.3 4.4 5.1 4.0 3.0 3.9

Non-transfers 8.6 7.0 6.2 5.3 4.9 4.9 4.7 4.3 4.1 3.7 3.3 3.2 3.1

1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

National Registry of Myocardial Infarction, 1994-2006National Registry of Myocardial Infarction, 1994-2006

Trends in in-hospital mortality among reperfusion-eligible STEMI patients treatedwith primary PCI, stratified by transfer status

Gibson CM, ACC 2008