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Why we need a consensus document on cardiogenic shock? ACCA Masterclass 2017 Holger Thiele
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Page 1: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Why we need a consensus document on cardiogenic shock?

ACCA Masterclass 2017

Holger Thiele

Page 2: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Cardiogenic Shock – STEMI Guidelines

Steg et al. Eur Heart J.2012;33:2569-2619

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Cardiogenic Shock – CHF Guidelines

Ponikowski et al. Eur Heart J. 2016;37:2129–2200

Page 4: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Austrian/German

S3-Guideline Cardiogenic Shock

Werdan et al. Dtsch Ärzteblatt Int 2012;109:343-351

Page 5: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

AHA Scientific Statement

Diepen et al. Circulation 2017; in press

Contemporary Management of Cardiogenic Shock – A Scientific Statement

Sean van Diepen MD MSc1; Jason N. Katz, MD, MHS2; Nancy M. Albert PhD3; Timothy D. Henry MD4; Alice K Jacobs MD5; Navin K. Kapur MD6; Ahmet Kilic, MD7; Venu Menon MD8; E. Magnus Ohman, MD9; Nancy K. Sweitzer MD PhD10; Holger Thiele MD11; Jeffrey B. Washam PhamD12; Mauricio G. Cohen MD13

Page 6: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Trial n/N n/NRelative Risk

95% CI

Relative Risk

95% CI

0 0.5 1 2 3

Randomized Trials in Cardiogenic Shock

Follow-up

Revascularization (PCI/CABG)

SHOCK

SMASH

Total

81/152

22/32

103/184

100/150

18/23

118/173

1 year30 days

Early revascularization

better

Medical treatment

better

0.75 1.5 2.50.25Thiele et al. Eur Heart J 2015;36:1223-1230

0.72 (0.54;0.95)

0.87 (0.66;1.29)

0.82 (0.69;0.97)

Page 7: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Revascularization Rate – Registry Data

70

47 5054

0

10

20

30

40

50

60

70

80

Switzerland

(Jeger)

GRACE France

(USIK, Fast-

MI)

USA

(Goldberg)

Rev

ascu

lari

zati

on

rat

e (%

)

Page 8: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Catecholamine Use in Europe

0 10 20 30 40 50

Austria

Belgium

Finland

France

Germany

Greece

Italy

Netherlands

Portugal

Spain

Switzerland

Sweden

UK

Sakr et al. Crit Care Med.2006; 34:589–597

N=1058 with shock

% of patients % of patients

NorepinephrineDopamine

0 10 20 30 40 50

Austria

Belgium

Finland

France

Germany

Greece

Italy

Netherlands

Portugal

Spain

Switzerland

Sweden

UK

Page 9: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Catecholamines in Cardiogenic Shock

De Backer et al. NEJM 2010;362:779-789

P=0.03

Days after randomization0 4 8 12 16 20 24 28

Pro

ba

bili

ty o

f su

rviv

al 1.0

0.8

0.6

0.4

0.2

0.0

Norepinephrine

Dopamine

Subgroup of 280 Patients

Page 10: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Trial n/N n/NRelative Risk

95% CI

Relative Risk

95% CI

0 0.5 1 2 3

Randomized Trials in Cardiogenic ShockFollow-up

Revascularization (PCI/CABG)

SHOCK

SMASH

Total

81/152

22/32

103/184

100/150

18/23

118/173

1 year30 days

Early revascularization

better

Medical treatment

better

0.75 1.5 2.50.25Thiele et al. Eur Heart J 2015;36:1223-1230

0.72 (0.54;0.95)

0.87 (0.66;1.29)

0.82 (0.69;0.97)

0.75 (0.55;0.93)64/145 50/13528 days

Norepinephrine

betterDopamine

better

Vasopressors

SOAP-2 (CS Subgruppe)

Page 11: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

E.34 For inotropic support in infarct related CS Dobutamine should be used.

E.35 Norepinephrine should be used in particular in the initial phase of CS,

when no extended hemodynamic monitoring is available, in combination with

dobutamine to esnure adequate perfusion pressure.

E.36 Levosimendane and PDE-inhibitors may be used in catecholamine

refractary. E.39 Dopamine should not be used.

German/Austrian S3-GuidelineInotropes and vasoactive drugs

Werdan et al. Dtsch Arztebl Int. 2012;109:343-351

Page 12: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Catecholamines - GermanyIABP Control P-Value

Catecholamine; n/total (%)

Dopamine

Norepinephrine

Epinephrine

Dobutamine

15/298 (5.0)

220/298 (73.8)

76/298 (25.5)

160/298 (53.7)

11/297 (3.7)

222/297 (74.8)

80/297 (26.9)

156/297 (52.5)

0.43

0.80

0.69

0.78

Catecholamine dose (μg/kg/min); median

(IQR)

Dopamine

Norepinephrine

Epinephrine

Dobutamine

4.1 (2.9-7.7)

0.3 (0.1-1.2)

0.3 (0.1-1.3)

10.2 (4.9-20.6)

4.2 (3.6-8.3)

0.4 (0.1-1.1)

0.3 (0.2-1.4)

9.0 (4.8-17.6)

0.76

0.73

0.59

0.25

Thiele et al. NEJM 2012;367:1287-1296

Page 13: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Currently Available Percutaneous Devices

Thiele et al. Eur Heart J 2015;36:1223-1230

Blumenstein et al. EuroIntervention 2016;epub

HeartMate PHP

Page 14: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Mo

rtal

ity

(%)

Time after randomization (days)

P=0.92; log-rank testRelative risk 0.96; 95% CI 0.79-1.17; P=0.69; Chi2-Test

Primary Study Endpoint (30-Day Mortality)

Control 41.3%IABP 39.7%

0

10

20

30

40

50

0 5 10 15 20 25 30

Thiele et al. NEJM 2012;367:1287-1296

Page 15: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Mortality 12-Month Follow-up

Control

IABP

0%

10%

20%

30%

40%

50%

60%

0 30 60 90 120 150 180 210 240 270 300 330 360 390 420

Mort

alit

y

Days after randomization

P=0.94; log-rank testRelative risk 1.02; 95% CI 0.88-1.19

12-Month

Mortality

49.2%

48.7%

6-Month

Mortality

30-day

Mortality

41.3%

39.7%

51.8%

51.4%

301 181 171 165 161 159 154 152 149 147 146 144 136 45 21

299 174 166 165 159 154 154 152 147 147 146 144 140 55 29

No. at risk

IABP

Control

Thiele et al. Lancet 2013;382:1638-1645

Page 16: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

ESC Guidelines 2012 - 2014 - 2016IABP in cardiogenic shock

ESC

Class IC → IIb B → III

Windecker et al. Eur Heart J. 2014;35:2541-2619Roffi et al. Eur Heart J. 2016;37:267-315

Ponikowski et al. Eur Heart J.2016;37:2129–2200

Page 17: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

IABP + Other Devices Use

Sandhu et al. Circulation 2015;132:1243-1251

IABP

No

mechanical

support

Mechanical

support

Cath PCI US Registry: 76474 patients with PCI and cardiogenic shock

Page 18: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Hospital Variation in IABP + MCS Use

Sandhu et al. Circulation 2015;132:1243-1251

Cath PCI US Registry: 76474 patients with PCI and cardiogenic shock

Page 19: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

0 0.5 1 2 3

Randomized Trials in Cardiogenic Shock

0.75 1.5 2.50.25Thiele et al. Eur Heart J 2015;36:1223-1230

Page 20: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

IMPRESS-IN-SEVERE-SHOCK

Ouweneel et al. JACC 2017;69;278-287

Impella CP versus IABPPrimary endpoint – 30-day mortality

Page 21: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Impella CP versus IABPArterial Lactate

IMPRESS-IN-SEVERE-SHOCK

Ouweneel et al. JACC 2017;69;278-287

Page 22: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Actual Metaanalysis

Thiele et al. Submitted

Mortality, N=148

Page 23: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Actual MetaanalysisHemodynamic parameters + arterial lactate

Thiele et al. Submitted

Page 24: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Complications

Actual Metaanalysis

Thiele et al. Submitted

Page 25: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

What happens if we use LVAD/ECMO in all?

50-60% survival without device

40-50% do not survive

100% Device use

Death with/without

device ~25%?

Anoxic brain death, sepsis

etc.

Cohort A50-60%

Cohort B15-25% Cohort C

25%

Device NO

Device YES!

Device NO

Page 26: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

ECMO Complications

Leipzig/Lübeck ECMO Registry

Variable All patients (n=83)

Overall transfusions, n (%) 67 (81.0%)

RPB 9.5 ± 10.6

Death from device 3 (5.3%)

Use of antibiotics, n (%) 73 (88.0%)

Pneumonia, n (%) 32 (40.0%)

Septic constellation, n (%) 13 (16.2%)

Access site complication 25 (31.3%)

de Waha et al. EuroIntervention 2016;111:1363-1371

Page 27: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

IABP-SHOCK II Score – Mortality Prediction

Poess et al. JACC 2017; in press

Page 28: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

IABP-SHOCK II Score – Mortality Prediction

IABP-SHOCK II Cohort CardSHOCK Validation Cohort

Poess et al. JACC 2017; in press

Page 29: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

How to Prevent MODS?

Zeymer and Thiele. JACC 2017; 69:288-290

MODS

prevention/

therapy

Optimal timing (early versus late, futile situation?)

Optimal

Support(Flow 2-7 l/min)

Prevention of

device-complications (device malfunction, limb ischemia,

hemolysis, bleeding, infection/inflammation)

Mechanical support device?

Page 30: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Anterior STEMI + Cardiogenic Shock

Page 31: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Multivessel PCI in ACS?

II IIa IIb IIII IIII IIIIII

III IIa IIb IIIIIIIII

STEMI, no Shock

STEMI, Shock

Steg et al. Eur Heart J. 2012;33:2569-2619

III IIa IIb IIIIIIIII

II IIa IIb IIII IIII IIIIII

2012 2014

Windecker et al. Eur Heart J. 2014;35:2541-2619

Page 32: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Webb et al. J Am Coll Cardiol 2003;42:1380-1386.van der Schaaf et al. Am J Cardiol 2010;105:955-959Cavender et al. Am J Cardiol 2009;104:507-513Bauer et al. Am J Cardiol 2012;109:941-946Zeymer et al. EuroIntervention 2014;epubCavender et al. J Invasive Cardiol 2013;25:218-224

0

10

20

30

40

50

60

70

Webb

van der S

chaaf

Cavender

Bauer

Zeymer

CavenderYang

Mylotte

MV-PCI

Culprit only (+ staged PCI)P<0.05

P<0.05P<0.05

P=n.s.

P=n.s.

N=74 N=161 N=3087 N=336 N=735

P=0.04

N=199

Mylotte et al. JACC CV Intv 2013;6:115-125

Yang et al. Crit Care Med. 2014;47:17-25

P=n.s.P=0.008

Multivessel PCI or Culprit Lesion Only PCI

Page 33: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Multivessel PCI Use in Clinical Practice

37

27

10,8

24,3

13

23,5

0

5

10

15

20

25

30

35

40

IABP-

SHOCK II

Bauer (EHS-

PCI)

Cavender

(US

Registry)

Park

(Corea)

Webb

(SHOCK)

Zeymer

(ALKK)

Page 34: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Treatment Algorithm Cardiogenic Shock

Thiele et al. Eur Heart J 2015;36:1223-1230

Page 35: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Open Issues in Cardiogenic Shock

• Revascularization strategy (PCI vs CABG, PCI culprit only vs MV-PCI?)

• Access site (radial vs femoral?)

• Antiplatelet therapy (ASA, Clopi, Prasugrel, Ticagrelor, Cangrelor, GpIIb/IIIa-Inh.?)

• Ventilation strategy

• Optimal blood glucose

• Transfusion strategy (liberal vs. restrictive use)

• Mechanical complications (when to do surgery/intervention?)

• Optimal inotrope

• Levosimendan

• MCS (when, which, how, weaning time point?)

• Etc., etc., etc.

Page 36: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

80 57 45

600

55

302398

0

100

200

300

400

500

600

700

SHO

CK

TRIU

MPH

SMA

SH

PRA

GU

E -7

TAC

TICS

IABP-S

HO

CK

I

IABP-S

HO

CK

II

CU

LPRIT

-SH

OC

K

N P

atients

Patient Inclusion in Cardiogenic Shock Trials

Sto

p –

no

effe

ct

Sto

p s

low

re

cru

itm

en

t

Un

de

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we

red

Surr

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Page 37: Why we need a consensus document on …...Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI 0 0.5 1 2 3 Randomized Trials in Cardiogenic Shock Follow-up Revascularization (PCI/CABG)

Thank you for your attention

[email protected]


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