how to do primary angioplasty “conundrums” dr adrian banning john radcliffe oxford

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.