Why we need a consensus document on cardiogenic shock? ACCA - - PowerPoint PPT Presentation

Why we need a consensus document on cardiogenic shock?

ACCA Masterclass 2017

Holger Thiele

Cardiogenic Shock – STEMI Guidelines

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

Cardiogenic Shock – CHF Guidelines

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

Austrian/German S3-Guideline Cardiogenic Shock

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

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

Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI

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 year 30 days

Early revascularization better Medical treatment better

0.75 1.5 2.5 0.25

Thiele 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)

Revascularization Rate – Registry Data

70 47 50 54 10 20 30 40 50 60 70 80 Switzerland (Jeger) GRACE France (USIK, Fast- MI) USA (Goldberg)

Revascularization rate (%)

Catecholamine Use in Europe

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

Norepinephrine Dopamine

10 20 30 40 50

Austria Belgium Finland France Germany Greece Italy Netherlands Portugal Spain Switzerland Sweden UK

Catecholamines in Cardiogenic Shock

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

P=0.03 Days after randomization 0 4 8 12 16 20 24 28 Probability of survival 1.0 0.8 0.6 0.4 0.2 0.0 Norepinephrine Dopamine Subgroup of 280 Patients

Trial n/N n/N Relative Risk 95% CI Relative Risk 95% CI

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 year 30 days

Early revascularization better Medical treatment better

0.75 1.5 2.5 0.25

Thiele 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 50/135 28 days

Norepinephrine better Dopamine better

Vasopressors SOAP-2 (CS Subgruppe)

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-Guideline

Inotropes and vasoactive drugs

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

Catecholamines - Germany

IABP 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

Currently Available Percutaneous Devices

Thiele et al. Eur Heart J 2015;36:1223-1230 Blumenstein et al. EuroIntervention 2016;epub

HeartMate PHP

Mortality (%) Time after randomization (days) P=0.92; log-rank test Relative 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% 10 20 30 40 50 5 10 15 20 25 30

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

Mortality 12-Month Follow-up

Control IABP

0% 10% 20% 30% 40% 50% 60% 30 60 90 120 150 180 210 240 270 300 330 360 390 420

Mortality Days after randomization

P=0.94; log-rank test Relative 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

ESC Guidelines 2012 - 2014 - 2016

IABP in cardiogenic shock ESC

Class IC → IIb B → III

Windecker et al. Eur Heart J. 2014;35:2541-2619 Roffi et al. Eur Heart J. 2016;37:267-315 Ponikowski et al. Eur Heart J.2016;37:2129–2200

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

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

0.5 1 2 3

Randomized Trials in Cardiogenic Shock

0.75 1.5 2.5 0.25

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

IMPRESS-IN-SEVERE-SHOCK Ouweneel et al. JACC 2017;69;278-287

Impella CP versus IABP

Primary endpoint – 30-day mortality

Impella CP versus IABP

Arterial Lactate

IMPRESS-IN-SEVERE-SHOCK Ouweneel et al. JACC 2017;69;278-287

Actual Metaanalysis

Thiele et al. Submitted

Mortality, N=148

Actual Metaanalysis

Hemodynamic parameters + arterial lactate

Thiele et al. Submitted

Complications

Actual Metaanalysis

Thiele et al. Submitted

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 A 50-60% Cohort B 15-25% Cohort C

25%

Device NO Device YES! Device NO

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

IABP-SHOCK II Score – Mortality Prediction

Poess et al. JACC 2017; in press

IABP-SHOCK II Score – Mortality Prediction

IABP-SHOCK II Cohort CardSHOCK Validation Cohort

Poess et al. JACC 2017; in press

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?

Anterior STEMI + Cardiogenic Shock

Multivessel PCI in ACS?

I I IIa IIb III I III I III III I I I IIa IIb III I I I I I I

STEMI, no Shock STEMI, Shock

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

I I I IIa IIb III I I I I I I I I IIa IIb III I III I III III

2012 2014

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

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

10 20 30 40 50 60 70 W e b b v a n d e r S c h a a f C a v e n d e r B a u e r Z e y m e r C a v e n d e r Y a n g M y l

• t

t e MV-PCI Culprit only (+ staged PCI)

P<0.05 P<0.05 P<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

Multivessel PCI Use in Clinical Practice

37 27 10,8 24,3 13 23,5 5 10 15 20 25 30 35 40 IABP- SHOCK II Bauer (EHS- PCI) Cavender (US Registry) Park (Corea) Webb (SHOCK) Zeymer (ALKK)

Treatment Algorithm Cardiogenic Shock

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

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.

80 57 45 600 55 302 398 100 200 300 400 500 600 700 SHOCK TRIUMPH SMASH PRAGUE -7 TACTICS IABP-SHOCK I IABP-SHOCK II CULPRIT-SHOCK

N Patients

Patient Inclusion in Cardiogenic Shock Trials

Stop – no effect Stop slow recruitment Underpowered Surrogate endpoint

706

Stop – slow recruitment

Thank you for your attention

holger.thiele@uksh.de