myocardial infarction angioplasty the middlesbrough experience rob wright james cook university...
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Myocardial Infarction AngioplastyThe Middlesbrough Experience
Rob Wright
James Cook University Hospital
Acknowledgements
Mark de Belder Jim Hall Alun Harcombe Andrew Sutton Bob Morley and the Audit Team Cath Lab Team CCU
SCH Original AMI PCI Protocol Contraindication to thrombolysis Presentation in, or early shock
(if within 12 hours of onset of symptoms) Rescue at 2 hours post onset of thrombolysis Re-infarction
Age not a contra-indication but comorbidity is
James Cook & Referring HospitalsThrombolysis 2002-2003
Bishop Auckland 92Darlington Memorial 99Friarage Northallerton 47Hartlepool 98James Cook 159North Durham 161North Tees 129Scarborough 96West Cumberland 98
South Cleveland HospitalInfarct Angioplasty 1998 - 2002
AMI cases Primary non-shock
Shock Rescue ReMI
1998 152 22 13 64 53
1999 151 20 22 78 31
2000 148 20 15 50 63
2001 171 25 16 73 57
2002 144 27 12 52 53
Mortality 9.6% 50% 9.5% 4.3%
MERLIN Sutton AGC JACC 2004;44:287-96
What to do when thrombolysis fails 307 patients with ECG failure to reperfuse Randomised to immediate angiogram or
usual care
A randomised trial of rescue angioplasty versus a conservative approach for failed fibrinolysis
in ST elevation myocardial infarction:Middlesbrough Early Revascularisation to Limit INfarction
(MERLIN) trial
AGC Sutton MA MB MRCP, PG Campbell MB MRCP, R Graham MB MRCP, DJA Price MB MRCP, JC Gray1 BSc PhD, ED Grech MD MRCP FACC,
JA Hall MA MD FRCP, AA Harcombe MD MRCP, RA Wright MD FRCP, RH Smith2 Bsc MB FRCP, JJ Murphy3 MB BS DM FRCP,
A Shyam-Sundar2 MB BS MD DM FRCP, MJ Stewart MD FRCP, A Davies BSc MB BS FRCP, NJ Linker BSc MD FRCP FESC,
MA de Belder MA MD FRCP
The James Cook University Hospital, Middlesbrough, UK.1University of Newcastle-upon-Tyne, UK.
2University Hospital of North Tees, Stockton-on-Tees, UK.3Darlington Memorial Hospital, Darlington, UK .
No conflicts of interest
METHODS
Inclusion Criteria• Patients with STEMI and evidence of failure to respond to the
administration of fibrinolytic therapy • Presentation to hospital within ten hours of the onset of major
symptoms was required. • “Failure to reperfuse” was defined by a second 12-lead ECG
performed 60 minutes after the onset of fibrinolytic therapy showing: Failure of the ST segment elevation in the worst lead (the lead with maximum ST elevation) to have resolved by 50%* and the absence of an accelerated idioventricular rhythm (AIVR) at the time of the 60-minute ECG1
• Any fibrinolytic agent was allowed for trial entry *ST segment measured 80ms after the J point1Sutton et al. Heart 2000;84(2):149-56.
METHODS
Exclusion criteria• Cardiogenic shock, defined by hypotension (systolic BP
90mmHg), oliguria and poor peripheral perfusion with or without pulmonary oedema.
• Patients with confounding features on the pre-treatment ECG, e.g. the presence of bundle branch block configuration or a paced rhythm
• Patients with reinfarction in the same ECG territory within 2 months of an original infarction
• Patients without femoral arterial access• Pregnancy• Patients with significant co-existing pathology (eg. disseminated
malignancy, end-stage respiratory failure) likely to affect prognosis during the follow-up period.
Trial Flow Chart
C o nse rva tive R x
P e rs iste n t S T e lev a tionw itho u t ca rd io g en ic sho ck
C a rd iog en ic S ho ck
C o nse rva tive R x Im m ed ia te co ron ary a ng io gra phyR e scu e P C I i f in d ica ted
R a nd om isa tio n 1 :1
"F a i le d rep er fus ion " 1 h r a fte r R x in i t ia tion
R x : A ny f ib r in o ly tic a ge n tA sp ir in
S T E M IP resen ta tio n w ith in 10 hrs o f pa in
Early crossover for shock only
MERLIN Results: 30 days
0
10
20
30
40
50%
Primary endpoint Composite secondary endpoint
Rescue Conservative
p=0.7
p=0.02
0
5
10
15
20
25
30%
Dea
th
ReM
I
Str
oke
Unp
lann
ed
reva
sc CCF
P=0.7 P=0.3 P=0.03
P=0.0004
P=0.3
MERLIN Conclusions
No mortality benefit Increased risk of stroke and bleeding Reductions in
Unplanned revascularisation 6.5 v 20.1% p<0.01Reinfarction 7.2 v 10.4% ns
REACT
JCUH Shock Survival (n=113)Sutton AGC et al, Heart in press
0 50 100 150 2000
25
50
75
100
% survival
Days
SHOCK Trial - 1 year survival Hochman JS JAMA 2001
0102030405060708090
100
0 2 4 6 8 10 12
Months
% a
live ERV
IMS
Post-MERLIN Strategy
August 2002 – Operator Discretion August 2003 – “Czech Protocol” February 2004 – Open Primary PCI
Participation in Finesse and Assent 4 studies affects some patients
Prague-2 30 day Mortality Eur Heart J 2003;24:94
0
2
4
6
8
10
12
14
16
All Patients 0 - 3 Hours 3 - 12 Hours
Tx
PCI
P=0.12
P<0.02
JCUH “Czech” AMI PCI Protocol
Contraindication to thrombolysis Presentation in, or early shock (if within 12
hours of onset of symptoms) Patients with onset of chest pain >3 hours Patients with previous STEMI Rescue cases to be discussed individually Re-infarction
Age not a contra-indication but comorbidity is
JCUH “Open” AMI PCI Protocol
Patients with chest pain + ST elevation < 12hr Rescue cases to be discussed individually Re-infarction
Age not a contra-indication but comorbidity is
Post-MERLIN September 2002 – August 2004
AMI cases
Primary non-shock
Shock Rescue
(exc shock)
ReMI
Sep 02–Aug 03 113 25 12 21 55
Sep 03-Aug 04 176 84 18 9 50
Sep 03-Feb 04 80 38 11 6 25
Mar 04-Aug 04 96 61 7 3 25
AMI cases
Primary non-shock
Shock Rescue ReMI CCU
Tx
Sep 02–Aug 03 113 25 12 21 55 156
Sep 03-Aug 04 176 84 18 9 50 61
Sep 03-Feb 04 80 38 11 6 25 46
Mar 04-Aug 04 96 61 7 3 25 15
6/12 “Czech Protocol” – 6/12 Open
AMI cases
Primary PCI
Rescue ReMI ReMI Rescue
Czech 09/03-02/04
80/554(14%)
44 (55%)
9(11%)
26(33%)
1(1%)
Open PCI 03/04-08/04
96/604(16%)
66(69%)
5(5%)
22(23%)
3(3%)
09/03-08/04
176 110 14 48 4
Patient Characteristics
Czech (n=80) Open (n=96)
Previous MI 18 (23%) 28 (29%)
Previous PCI 4 (5%) 6 (6%)
Previous CABG 6 (8%) 2 (2%)
Diabetes 13 (16%) 10 (10%)
1 VD 30 (38%) 48 (50%)
2VD 30 (38%) 27 (28%)
3VD 20 (25%) 20 (21%)
Culprit Vessel
Czech Open
LAD 29 39
Cx 12 14
RCA 40 44
LMS 1 0
Grafts 4 1
Multivessel 4 2
Procedure Details
Czech (n=80) Open (n=96)
GpIIbIIIa Antagonist 61 (76%) 84 (88%)
Diagnostic Device 0 0
Thrombus suction 6 (8%) 7 (7%)
X-sizer 3 (4%) 4 (4%)
Percusurge 5 (6%) 2 (2%)
Filter 4 (5%) 1 (1%)
IABP 17 (23%) 16 (17%)
Ventilated pre 2 (3%) 1 (1%)
Complications
Czech Open
No flow/Slow flow 13 (16%) 10 (10%)
Coronary Dissection 10 (13%) 5 (5%)
Coronary Perforation 1 (1%) 3 (3%)
Temp P/M/AVblock 7 (9%) 2 (2%)
DC CV 4 (5%) 3 (3%)
Ventilated during 1 (1%) 1 (1%)
Shock induced 3 (4%) 4 (4%)
TIMI Flows
Czech % Open %
TIMI Pre Post Pre Post
0 69 5 69 3
1 7 0 7 1
2 17 9 13 6
3 7 86 11 90
Procedure Timing
Czech Open
In hours 41% 35%
Out of hours 59% 65%
JCUH AMI PCI Sep 03 – Aug 04 (n (%))
Age < 75 Shock Czech Open
Primary NS 53 (66) 69 (72)
S 7 (9) 5 (5)
Rescue NS 5 (6) 6 (6)
S 3 (4) 2 (2)
Age > 75
Primary NS 9 (11) 13 (14)
S 1 (1) 1 (1)
Rescue NS 2 (3) 0
S 0 0
JCUH AMI PCI Sep 03 – Feb 04 In-Hospital Mortality (n (%))
Age < 75 Shock Czech Death Open Death
Primary NS 53 (66) 0 (0)
S 7 (9) 2 (29)
Rescue NS 5 (6) 0 (0)
S 3 (4) 3 (100)
Age > 75
Primary NS 9 (11) 2 (22)
S 1 (1) 1 (100)
Rescue NS 2 (3) 0 (0)
S 0
JCUH AMI PCI Sep 03 – Aug 04 In-Hospital Mortality (n (%))
Age < 75 Shock Czech Death Open Death
Primary NS 53 (66) 0 (0) 69 (72) 1 (1)
S 7 (9) 2 (29) 5 (5) 1 (20)
Rescue NS 5 (6) 0 (0) 6 (6) 1 (17)
S 3 (4) 3 (100) 2 (2) 1 (50)
Age > 75
Primary NS 9 (11) 2 (22) 13 (14) 1 (8)
S 1 (1) 1 (100) 1 (1) 0 (0)
Rescue NS 2 (3) 0 (0) 0
S 0 0
Czech Protocol In-Hospital Deaths
62yr M, OOHA, Shock o/a 73yr F, Shock, IABP, Temp p/m 62yr M, Rescue shock, IABP, prev CABG 72yr F, Rescue shock, IABP, Temp p/m 70yr F, Rescue shock, IABP 76yr F, ReMI, shock, IABP 83yr M, PEA arrest day 6 76yr M, PEA arrest in CCU ?rupture
Open Protocol In-Hospital Deaths
65yr M – ReMI PCI (+prev MI) on w/l for IHU CABG. 16/5/04 LAD stent successful. 19/5/04 Cx dissection, perforation, IABP, CABG. Died 21/5/04
56yr M – OOHA Transfer occ LAD, Shock, Ventilated + IABP pre-PCI
61yr M – Rescue Shock LAD (CTO RCA) IABP, ventilated
75yr M – Facilitated RCA (3VD) VT arrest day 3 ? Rupture
77yr F – ReMI RCA (3VD), shock, IABP, VSD
JCUH AMI PCI Sep 03 – Aug 04 (n=176)
0
20
40
60
80
100
120
140
Primary -No shock
Primary -Shock
Rescue -No shock
Rescue -Shock
Age < 75Age > 75
AMI PCI Sep 03 – Aug 04 (n=176)In-Hospital Mortality (%)
0
10
20
30
40
50
60
70
80
Primary -No shock
Primary -Shock
Rescue -No shock
Rescue -Shock
Age < 75Age > 75
Conclusions
Primary PCI is feasible for local population In-hospital results are encouraging Post-Merlin practice has changed significantly Tertiary service offered for
– Shock– Reinfarction– Contraindications to thrombolysis– Rescue in selected cases
Angiographically Guided Therapy for AMI
Requirements Motivated Team Cooperation of Ambulance Service
– Telemetered ECG Anaesthetic Support Surgical Support
Questions Widening the net Facilitation Thrombus extraction – Distal protection Shock - ? LNMMA ? Pexelizumab ?Metabolic support Slow flow / No flow IABP Age – What is optimal care for the over 80s?
Audit– Times, ST resolution, Stroke, Follow Up Revasc etc