how to do primary angioplasty “conundrums” dr adrian banning john radcliffe oxford
TRANSCRIPT
How to do primary How to do primary angioplastyangioplasty “Conundrums” “Conundrums”
Dr Adrian Banning John Radcliffe OxfordDr Adrian Banning John Radcliffe Oxford
MY CONFLICTS OF INTEREST ARE
Advisory Boards- Medtronic, Boston, Cordis
Research funding- BostonOxford Live sponsors- Boston, Elli lilly, Edwards
First thoughtFirst thought“Conundrums in PPCI”“Conundrums in PPCI”
Second thoughtSecond thought“Conundrums in PPCI”“Conundrums in PPCI”
What is a What is a “condundrum?”“condundrum?”
A paradoxical, insoluble, or difficult A paradoxical, insoluble, or difficult problem; problem;
How can we improve How can we improve PPCIPPCI
1)1) What can we do in the ambulance? What can we do in the ambulance?
2)2) What can we do in the lab? What can we do in the lab?
3)3) What can we do afterwardsWhat can we do afterwards
Improving PPCIImproving PPCIin the ambulancein the ambulance Optimal primary and Optimal primary and
– secondary preventionsecondary prevention Call to Help “Call to Help “CONUNDRUM”CONUNDRUM”
– Public education Public education Arrive to departArrive to depart
– ECG diagnosisECG diagnosis– Near patient testing?Near patient testing?– Minimise reassurance stopsMinimise reassurance stops
Improving PPCIImproving PPCIin the ambulancein the ambulance
How do we deal with long transfer times?How do we deal with long transfer times?CONUNDRUMCONUNDRUM
Either aEither aComposite lytic strategy?Composite lytic strategy?Enhanced transfer capacity?Enhanced transfer capacity?Per conditioning?Per conditioning?
Has lysis got a role……Has lysis got a role……OpinionOpinion Remember Remember
– The falling incidence of AMIThe falling incidence of AMI– Individual Paramedic experience of lysisIndividual Paramedic experience of lysis– Geographical proximity in most UKGeographical proximity in most UK
So……FORGET LYSISSo……FORGET LYSIS– But if Lytic then direct to HACBut if Lytic then direct to HAC
Reperfusion is a Reperfusion is a complex process complex process
Reperfusion also causes Reperfusion also causes paradoxical tissue injury – eg paradoxical tissue injury – eg myocardial stunning, ‘no myocardial stunning, ‘no reflow’reflow’
It is possible that modulating It is possible that modulating reperfusion injury will improve reperfusion injury will improve the outcomes of reperfusion the outcomes of reperfusion therapies therapies
Mechanism
Circulating mediator – direct effector
Circulating mediator – indirect effector
Circulating mediator – neural pathway
Neural pathway
Systemic effects eg. circulating cells
Distant tissue effects
rIPerC during transfer to primary PCI: Condi trial
AmbulancePatient
ECG
Randomization
Inclusion Criteria
• Symptoms lasting > 30 minutes and < 12 hours
• ST-segment elevation ≥ 0.1 mV in 2 contiguous leads
• Age ≥ 18 years
• Informed consent
Primary Endpoint:Myocardial Salvage Index
Acute scan:Area-at-risk(AAR)
Salvage index =(AAR-FIS)/AAR
One month scan:Final infarct size(FIS)
• Final infarct size at 30 days
• ST-segment resolution
• Troponin T release
• Corrected TIMI Frame Count
• LV function by echocardiography
• MACE at 30 days
Secondary Endpoints
Pre-hospital randomization
n=333
Pre-hospital randomization
n=333
PCI only(n=167)PCI only(n=167)
rIPerC(n=166) rIPerC
(n=166) 22 did not meet inclusion criteria
PCI only(n=145)PCI only(n=145)
rIPerC(n=147)
rIPerC(n=147)
19 did not meet inclusion criteria
110 final infarct size69 with salvage index110 final infarct size
69 with salvage index
20 previous MI
PCI only(n=125)PCI only(n=125)
rIPerC(n=126) rIPerC
(n=126)
21 previous MI
109 final infarct size73 with salvage index109 final infarct size
73 with salvage index
3 dead11 consent withdrawn
1 CABG
3 dead 11 consent withdrawn
3 CABG
p=0.83
Infarct Related Artery
PCI only rIPerC
RCARCA
LADLAD
CX CX
0
.5
1
Primary Endpoint:Myocardial Salvage Index
p=0.033S
alva
ge I
ndex
(m
edia
n [I
QR
])
PCI only rIPerC
0.55
0.75
PCI onlyrIPerC
Bøtker et al.Lancet 2010;373:727-34
0
20
40
Area at Risk Final infarct size Salvage
p=0.97
p=0.10
Scintigraphic Data
% o
f LV
(m
edia
n [IQ
R])
PCI only rIPerC
p=0.037
Bøtker et al.Lancet 2010;373:727-34
Relation Between AAR and FIS
0
20
40
60
0 20 40 60
Difference in slope: 0.16 (0.05; 0.26), p = 0.003
Area at risk (% of LV)
Fin
al in
farc
t siz
e (%
of L
V)
•PCI only•rIPerC
Improving PPCIImproving PPCIin the ambulancein the ambulance
How do we deal with long transfer times?How do we deal with long transfer times?CONUNDRUM ?CONUNDRUM ?
Optimal paramedic antiplatelet treatmentOptimal paramedic antiplatelet treatmentOptimal transferOptimal transferPer-conditioning strategiesPer-conditioning strategiesOptimal performance of HACOptimal performance of HAC
How can we improve How can we improve PPCIPPCI
1)1) What can we do in the ambulance? What can we do in the ambulance?
2)2) What can we do in the lab?What can we do in the lab?
3)3) What can we do afterwardsWhat can we do afterwards
Can we improve PPCICan we improve PPCIin the labin the lab
Optimal pharmacologyOptimal pharmacology
ic Reopro?ic Reopro?
Adjunctive devicesAdjunctive devices
aspiration alone?aspiration alone?
Optimal stent choiceOptimal stent choice
DES vs BMSDES vs BMS
Supporting the recovering ventricleSupporting the recovering ventricle
Can we improve PPCICan we improve PPCIin the labin the lab
Optimal pharmacologyOptimal pharmacology
ic Reopro? Cicero trial. Gu et alic Reopro? Cicero trial. Gu et al
OutcomeOutcome Intracoronary Intracoronary abciximababciximab
Intravenous Intravenous abciximababciximab
pp
Complete ST-segment Complete ST-segment resolution (%)resolution (%)
6464 6262 0.560.56
Myocardial blush grade 2/3 Myocardial blush grade 2/3 (%)(%)
7676 6767 0.020.02
Mean enzymatic infarct size Mean enzymatic infarct size (creatine kinase levels in U/L)(creatine kinase levels in U/L)
12141214 17461746 0.0080.008
Major adverse cardiac events Major adverse cardiac events (%)(%)
5.55.5 6.1 6.1 0.790.79
Do we need a special Do we need a special stent for AMI?stent for AMI? Can we minimise ?Can we minimise ?
– Late acquired malapositionLate acquired malaposition– Downstream embolisation Downstream embolisation
M GuardM Guard StentysStentys
M Guard stent M Guard stent
Stent covered with an ultra-thin, micron-level, flexible Stent covered with an ultra-thin, micron-level, flexible mesh sleeve fabricated by circular knitting. mesh sleeve fabricated by circular knitting.
During stent deployment, the net stretches and slides During stent deployment, the net stretches and slides over the expanding stent struts, creating custom designed over the expanding stent struts, creating custom designed pores parallel to the arterial wall. pores parallel to the arterial wall.
Once in place, MGuard captures embolic debris between Once in place, MGuard captures embolic debris between the fibre net and the arterial wall and isolates the pro-the fibre net and the arterial wall and isolates the pro-thrombotic intima components from the bloodstream. thrombotic intima components from the bloodstream.
Current issues in PCI for ACSUndersizing2 /
Underexpansion3
Undersizing2 / Underexpansion
3
Early and/or late Malapposition
Early and/or late Malapposition
Acute / Sub-Acute
Thrombosis
Acute / Sub-Acute
Thrombosis
Thrombus dissolution1
Thrombus dissolution1Vasodilation1Vasodilation1
Stent recoil4 ?Stent recoil4 ?
1. C. Spaulding, “Clinical Application of a Novel Self-expanding Coronary Stent in AMI” Europ. Cardio 2009;5(2):71-732. Van Werkum J.W. “Predictors of Coronary Stent Thrombosis” JACC 2009 53:16:399-4093. Stéphane Cook and Stephan Windecker, Circulation 2009;119;657-6594. Stéphane Cook, Circulation 2007;115;2426-24345. Renu Virmani, MD, of CVPath Institute (Gaithersburg, MD) in a telephone interview with TCTMD 6. Ozaki Y, Okumura M, Ismail TF, et al. The fate of incomplete stent apposition with drug-eluting
stents: An optical coherence tomography-based natural history study. Eur Heart J. 2010; (31), 1470-1476
Malapposition is a significant risk factor for stent thrombosis3,5
31
Thrombus occurred more often when
there is incomplete stent apposition than
in well-apposed stents (20.6% vs. 2.0%; P < 0.0001)6
STENTYS® Technology
• Nitinol, self-apposing stent (BMS and DES)
• 6F single-wire, rapid exchange, CE-marking
• Disconnectable struts over full length*
32
Disconnectableinterconnector
DisconnectionDisconnectors along the stent
* Except the first and last 2mmProduct not available for sale in the United States
1. Position the STENTYS® stent over the lesion
2. Retract the outer sheath to deploy the stent from distal to proximal
3. The stent is fully deployed in the vessel of the AMI patient with perfect apposition
4. The STENTYS® stent expands with the vessel during vasodilation and as thrombus resolves ensuring perfect apposition.
Deploying a STENTYS® Self-Apposing Stent in an AMI patient
Product not available for sale in the United States
33
Malapposition in a STEMI patient
3 day OCT pictures from the STENTYS® Apposition II Trial
3 day malapposition of a conventional stent Perfect apposition at 3 days of the STENTYS® Self-Apposing Stent
Conventional stent STENTYS® Self-Apposing Stent
Product not available for sale in the United States
34
How can we improve PPCI How can we improve PPCI - the lab- the lab
We don’t always get perfect coronary flowWe don’t always get perfect coronary flow– Late presentationLate presentation– Large thrombus load Large thrombus load “CONUNDRUM”“CONUNDRUM”– ““no reflow” no reflow” “CONUNDRUM”“CONUNDRUM”
pretreatment is the keypretreatment is the key
Hyperbaric oxygen therapy- HOT AMIHyperbaric oxygen therapy- HOT AMI Systematic cooling during AMISystematic cooling during AMI
Reveal- EPO in AMIReveal- EPO in AMI
EPO or matching saline placebo. EPO or matching saline placebo. 68 patients were treated with 60 000 units of EPO and 68 patients were treated with 60 000 units of EPO and
compared with 70 patients randomized to placebo. compared with 70 patients randomized to placebo. Compared with placebo, the administration of EPO Compared with placebo, the administration of EPO
following successful primary or rescue PCI did not following successful primary or rescue PCI did not reduce infarct size, as assessed by MRI at two to six days reduce infarct size, as assessed by MRI at two to six days and at 12 weeks. and at 12 weeks.
No improvement in early or late measurements of left No improvement in early or late measurements of left ventricular remodeling.ventricular remodeling.
In fact, investigators observed a trend toward harm In fact, investigators observed a trend toward harm among older patients, with a larger infarct size among among older patients, with a larger infarct size among those those >>70 years of age treated with EPO.70 years of age treated with EPO.
How can we improve How can we improve PPCIPPCI
1)1) What can we do in the ambulance? What can we do in the ambulance?
2)2) What can we do in the lab? What can we do in the lab?
3)3) What can we do afterwards?What can we do afterwards?
How can we improve How can we improve PPCIPPCI
What can we do afterwards?What can we do afterwards?
Risk assesment of those patients with Risk assesment of those patients with
Multi- vessel disease Multi- vessel disease “CONUNDRUM”“CONUNDRUM”
Severe LV impairmentSevere LV impairment
Integrated early rehabilitationIntegrated early rehabilitation
Effective smoking cessation Effective smoking cessation Prolonged drug compliance in those at highest riskProlonged drug compliance in those at highest risk
How can we improve How can we improve PPCI- the POLITICSPPCI- the POLITICS
Reperfusion of Acute Myocardial Infarction in Carolina Emergency
Departments – Emergency Response (RACE-ER) Project
on behalf of RACE Coordinators, Nurses, Physicians, Paramedics, and Administrators
Regional approach to overcoming systematic
barriers
1) Increase reperfusion rate
2) Increase speed of reperfusion
RACEPilot
RACE65 hospitals
RACE - ER119 hospitals
2003 2006 2007 2008 20092005
Objectives
Transfer: First Door to Device Times(For hospitals with designated transfer strategy)
(85, 127)
(93, 155)
(91, 153)
(93, 155)
(94, 145)
(89, 134)
p=0.0008
(85, 127)
(93, 155)
(91, 153)
(93, 155)
(94, 145)
(89, 134)
Outcomes, In-hospital
Pre Post
n 1067 1179
Death 5.8% 5.7%Death, no shock# 3.4% 2.6%Death, shock # 29.3%34.8%
Bleeding 6.8% 5.1%Shock after admission 6.3% 5.9%CHF 6.5% 8.1%Stroke 1.7% 1.2%Re-infarction 0.9% 0.9%
# shock at presentation
Mortality
BMJ Feb 2008BMJ Feb 2008
…treatment delays can be reduced by prehospital diagnosis and direct transfer to a high volume catheter lab
Nearest centre isnt Nearest centre isnt always quickest accessalways quickest access
Ht attack Ht attack
centrecentrelablab
Nearest centre isnt Nearest centre isnt always quickest always quickest treatmenttreatment
30 mins30 mins
DTB 30 minsDTB 30 mins
Total 60 minsTotal 60 mins
Ht attack Ht attack
centrecentrelablab
10 mins10 mins
DTB 60 minsDTB 60 mins
Total 70 minsTotal 70 mins
MINAP - without the 3 centres with n>400Door to Balloon Time vs No. of PPCI 2007/2008
0
20
40
60
80
100
120
0 100 200 300 400 500 600
Number of Primary Angioplasties 2007/2008
Med
ian
Do
or
to B
allo
on
Tim
e (m
inu
tes)
r = -0.5195% CI of r = -0.73 to -0.20p = 0.002Slope = -9.5 secs/n
How can we improve How can we improve PPCI- the politicsPPCI- the politics
Hospitals receiving PPCI ptsHospitals receiving PPCI pts– 9-5 Mon-Fri 9-5 Mon-Fri – No 24/7 cardiology on-callNo 24/7 cardiology on-call– Door to balloon 2x HAC timeDoor to balloon 2x HAC time– Centre geographically in oneCentre geographically in one
place claims to be somewhere else!place claims to be somewhere else!
CONUNDRUM!!!CONUNDRUM!!!
HAC Door to balloonHAC Door to balloon
In 2012 ALL HACs should be aiming for In 2012 ALL HACs should be aiming for mean/median Door to balloon <45 minsmean/median Door to balloon <45 mins
Ultimate target for all centers 30 minsUltimate target for all centers 30 mins
Getting the best from Getting the best from PPCI ? - conclusionsPPCI ? - conclusions Define optimal management during transferDefine optimal management during transfer
– Network strategyNetwork strategy– Drugs in the ambulanceDrugs in the ambulance– Pre/postconditioning?Pre/postconditioning?
Define optimal lab managementDefine optimal lab management– DevicesDevices– drugsdrugs
Devise mechanical support strategies to facilitate Devise mechanical support strategies to facilitate recoveryrecovery
Rationalise the politics to help sustainability.Rationalise the politics to help sustainability.