percutaneous circulatory support. iabp, impella and beyond

Percutaneous circulatory support. IABP, Impella and beyond

Holger ThieleMedical Clinic II (Cardiology/Angiology/Intensive Care)

University Heart Center of Lübeck, Germany

Disclosures

Funding:German Research FoundationGerman Heart Research Foundation German Cardiac SocietyEUArbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte

Consulting:None

Speaker Honoraria:Lilly, Astra Zeneca, Daiichi Sankyo, Boehringer Ingelheim, Maquet Cardiovascular, Medicines Company

In-hospital Mortality

Aissaoui et al. Eur Heart J 2012; 33:2535–2543

USIK 1995, USIC 2000, FAST-MI France National Registry

1995 2000 2005

9080706050403020100

Dea

th a

fter 3

0 da

ys (%

)

8.7(7.5-10.0) 4.2

(3.4-5.1)3.6

(3.0-4.4)

51(44-59)

63(56-70)

70(62-77)

ShockNo Shock

Trial n/N n/NRelative Risk

95% CIRelative Risk95% CI

0 0.5 1 2 3

Randomized Trials in Cardiogenic ShockFollow-up

Revascularization (PCI/CABG) SHOCK SMASH Total

81/152 22/32103/184

100/150 18/23118/173

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)

„Stunned“ Myocardium

Partial stenosis Reperfusion

Hours Hours

7 Days

N=5

Control 0 1 2 3 4 5 0 24 48 72

100

70

50

30

% o

f con

trol

**

** ****

**

**P<0,05 vs. control

Matsuzaki et al. Circulation 1983;68:170-178

IABP History

History: 1962 Animal trials

Moulopoulos et al, Am Heart J 1962;63:669-675

1968 1. clinical description in shock Kantrowitz et al, JAMA 1968;203:135-140

1973 Hemodynamic effects, mortality unchangedScheidt et al, NEJM 1973;288:979-984

> 40 years > 1 Million patients treated, low complication rate, Benchmark registry Ferguson et al, JACC 2001;38:1456-1462

GuidelinesIABP in STEMI complicated by cardiogenic shock

Class 1B → IIa B

ACC/AHA

ESC

Class IC → IIb B

Antman et al. Circulation 2004;110:82-292O’Gara et al. Circulation. 2013;127:e362-e425Van de Werf et al. Eur Heart J 2008;29:2909-2945Steg et al. Eur Heart J.2012;33:2569-2619

Sjauw et al. Eur Heart J 2009;30:459-468

Mortality IABP vs IABP - Metaanalysis

-1 -0.5 0.5 10

No IABP betterIABP better

30-Day MortalityRisk Difference

IABPn/N

No IABPn/N

Trial

-0.18 (-0.20 to -0.16)Total

ThrombolysisStomel

Kovack

BengtsonWaksman

GUSTO-1SHOCK registry

NRMI-2 TT

28/51

10/2748/9911/20

30/62220/439

1068/2180

1415/2878

10/1313/19

58/10117/21

146/248300/417

2346/3501

2890/4320

-0.11 (-0.13 to -0.09)Total 2488/5146 3332/5283

Total 1049/2234 0.06 (0.03 to 0.10)

Primary PCINRMI-2 PCIAMC CS

956/2035

93/199401/955

26/93427/1048

-0.29 (-0,47 to -0.12)

No reperfusion

24/34

24/34

15/15

15/15

Moloupoulos

Total

0

1

2

3

4

5

6

7

8

9

P=0.43

P=0.12

P=0.06

P=0.32 P=0.32 P=0.37

Baseline 8 h 16 h 24 h 32 h 40 h 48 h

Ser

um la

ctat

e (m

mol

/l)

P=0.09

ControlIABP

Serum Lactate

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

Mor

talit

y (%

)

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

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

Mor

talit

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-MonthMortality

30-dayMortality

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



0 0.5 1 2 3



81/152 22/32103/184

100/150 18/23118/173

1 year30 days



0.75 1.5 2.50.25

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 daysNorepinephrinebetter

Dopamine better

Vasopressors SOAP-2 (CS subgroup)

0.33 (0.11;0.97)5/16 10/1630 daysLevosimendanbetter

Controlbetter

Inotropes Unverzagt et al.

Gp IIb/IIIa-Inhibitors PRAGUE-7. In-hospital 15/40 13/40 1.15 (0.59;2.27)

Up-stream Abciximabbetter

Standard treatmentbetter

30 days30 days

7/19 6/21

IABPbetter


1.28 (0.45;3.72)0.96 (0.79-1.17)0.98 (0.81;1.18)

119/3001

123/298126/319 129/319

IABP IABP-SHOCK I IABP-SHOCK II Total

30 days30 days30 days

97/201 24/59 4/15125/275

76/180 7/20 10/1593/215

1.14 (0.91;1.45)1.16 (0.59;2.69)0.40 (0.13;1.05)1.05 (0.85;1.29)

NO-synthase inhibition better

Placebobetter

NO-Synthase-Inh. TRIUMPH SHOCK II Cotter et al. Total

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

ESC Revascularization Guidelines 2014IABP in cardiogenic shock

ESC

Class IC → IIb B → III

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

LVAD/ECMO or IABP?

Bleeding Invasiveness

+ -

Implantation procedure

LVAD

Hemodynamic Support Better LV-unloading

Costs

Currently Available Percutaneous Devices


Technical Parameters

Currently Available Percutaneous Devices


LVAD or IABP?

Cheng et al. Eur Heart J 2009;30:2102-2108

HemodynamicsLVAD

MW ± SDIABP

MW ± SDCardiac Index

Mean differenceP (Heterogeneity) = 0.22

R2=34.0%Thiele et alBurkhoff et alSeyfarth et alPooled

-2 -1 0 1 2LVAD betterIABP better

0.55 (0.23 – 0.87)0.16 (-0.14 - 0.46)0.36 (-0.11 - 0.88)0.35 (0.09 - 0.61)

2.3±0.6 1.8±0.42.2±0.6 2.1±0.22.2±0.6 1.8±0.7

LVAD betterIABP better

LVADMW ± SD

IABPMW ± SD

Mean arterial pressuremean difference

P (Heterogeneity) = 0.10R2=55.9%

Thiele et alBurkhoff et alSeyfarth et alPooled

-50 -25 0 25 50

5.5 (-2.9 – 13.9)18.6 (9.4 – 27.9)16.0 (0.5 – 31.5)

12.8 (3.6 – 22.0)

76±10 70±1691±16 72±1287±16 71±22

16±5 22±716±4 25±319±5 20±6

LVADMW ± SD

IABPMW ± SD

PCWPMean difference

P (Heterogeneity) = 0.01R2=76.6%

Thiele et alBurkhoff et alSeyfarth et alPooled

-20 -10 0 10 20LVAD betterIABP better

-5.6 (-9.2 – 2.1)

-8.4 (-11.0 – 5.8)-1.0 (-5.2 – 3.2)-5.3 (-9.4 to -1.2)

LVAD or IABP - MortalityIndividual patient-based meta-analysis

0 5 10 15 20 25 300

20

40

60

80

100

Pro

babi

lity

of s

urvi

val (

%)

Days after randomization

IABP

LVAD

P=n.s.

Thiele et al. Eur Heart J 2010;31:1828–1835

LVAD oder IABP?Complications

Cheng et al. Eur Heart J 2009;30:2102-2108

LVADn/N

IABPn/N

Limb IschemiaRelative Risk P (heterogeneity)=0.38

R2=0%

Thiele et al

Burkhoff et al

Seyfarth et al

Pooled

0.0001 0.01 1 100 10000IABP betterLVAD better

14.32 (0.87 – 235.4)

1.47 (0.31 – 6.95)

3.00 (0.13 – 67.51)

2.59 (0.75 – 8.97)

7/21 0/20

4/19 2/14

1/13 0/13

12/53 2/47

LVADn/N

IABPn/N

BleedingRelative Risk P (heterogeneity)=0.73

R2=0%

Thiele et al

Burkhoff et al

Pooled


2.26 (1.30 – 3.94)

2.95 (0.74 – 11.80)

2.35 (1.40 – 3.93)

19/21 8/20

8/19 2/14

27/40 10/34

LVADn/N

IABPn/N

Fever or SepsisRelative Risk P (heterogeneity)=0.10

R2=62.1%

Thiele et al

Burkhoff et al

Pooled


1.62 (1.00 – 2.63)

0.59 (0.19 – 1.80)

1.11 (0.43 – 2.90)

17/21 10/20

4/19 5/14

21/40 15/34



0 0.5 1 2 3



81/152 22/32103/184

100/150 18/23118/173

1 year30 days



0.75 1.5 2.50.25

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 daysNorepinephrinebetter

Dopamine better

Vasopressors SOAP-2 (CS subgroup)

0.33 (0.11;0.97)5/16 10/1630 daysLevosimendanbetter

Controlbetter

Inotropes Unverzagt et al.

Gp IIb/IIIa-Inhibitors PRAGUE-7. In-hospital 15/40 13/40 1.15 (0.59;2.27)

Up-stream Abciximabbetter


30 days30 days

7/19 6/21

IABPbetter


1.28 (0.45;3.72)0.96 (0.79-1.17)0.98 (0.81;1.18)

119/3001

123/298126/319 129/319

IABP IABP-SHOCK I IABP-SHOCK II Total


97/201 24/59 4/15125/275

76/180 7/20 10/1593/215

1.14 (0.91;1.45)1.16 (0.59;2.69)0.40 (0.13;1.05)1.05 (0.85;1.29)

NO-synthase inhibition better

Placebobetter

NO-Synthase-Inh. TRIUMPH SHOCK II Cotter et al. Total


9/21 9/19 6/1324/53

9/20 5/14 6/1320/47

0.95 (0.48;1.90)1.33 (0.57-3.10)1.00 (0.44-2.29)1.06 (0.68-1.66)

IABP better

LVAD Thiele et al. Burkhoff et al. Seyfarth et al. Total LVAD better


Sheu et al. Crit Care Med 2010;38:1810-1817

ECMO - EvidenceHistorical control without ECMO; 1993 – 2002 versus ECMO;

2002 – 2009 retrospective analysis

Log-rank p=0.003

0 10 20 30 (Days)

100

80

60

40

20

0Follow-up

At risk(n)

ECMO 46 32 31 28No ECMO 25 7 7 7

Tota

l sur

viva

l (%

)With ECMO

No ECMO

Time after ECMO-Implantation (years)

Tota

l sur

viva

l (%

)

0 1 2 3 4

100

80

60

40

20

0

No. at risk 87 27 18 10 5

Beurtheret et al. Eur Heart J 2013;34:112-120

ECMO for Transfer from Non-tertiary Centers

Mortality in patients > 62 years: 100%Mortalität in patients with resuscitation: 100%

Impella in Clinical PracticeEUROSHOCK Registry;

N=120 patients with cardiogenic shock complicating AMI

Lauten et al. Circ Heart Fail 2013;6:23-30

Recent Registry DataNational Trends USA 2004-2011

Stretch et al. JACC 2014;64:1407-1415

Guidelines and Percutaneous LVAD

Revascularization guidelines and STEMI-guidelines

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

I IIa IIb III

CLVAD may considered for circulatory support in refractory cardiogenic shock

I IIa IIb III

B Routine use

Windecker et al. Eur Heart J. 2014;31:2501-2555

•Lactate > 2.5 mmol/l

•Hemodynamics SBP < 100 mmHg or Vasopressors

• LV-EF < 35%

Standard treatment Vasopressors Inotropics Mechanical ventilation +/- IABP pre PCI +/- IABP pre PCI (n=180)(n=180)

Acute MI (STEMI < 36 h)

Shock

PCI (CABG)

Inclusion criteria

Randomization

Standard treatment Vasopressors Inotropics Mechanical ventilation + Impella CP pre PCI (n=180)

DanShock Trial

Primary Endpoint:Total Mortality

Treatment Algorithm Cardiogenic Shock

No stabilization

Short-term percutaneous mechanical support (IIb/C)

Revascularization (IB)Inotropes/Vasopressors (IIa/C + IIb/B)

FluidsVentilation

Weaning

Stabilization

Assessment neurology +endorgan function

Age, comorbidities?

Cardiogenic shock complicating infarction

Invasive Angiography (IB)Echocardiography (IC) or Levocardiography

Myocardial dysfunction

Recovery cardiac function

Mechanical complication

No recovery cardiac function

Weaning

Severe neurological deficit Normal neurological function

Weaning Long-term surgical mechanical support

Bridge-to recovery Bridge-to transplant

Destination therapy

Ventricular septal defect

Free wall ruptureMitral regurgitation

Mitral repair/replacement (IC)

Surgical closure(IC)

Surgical (IC)/Inter-ventional closure (IIb/C)

IABP (IIa/C)

Revascularization (IB)Inotropes/Vasopressors (IIa/C + IIb/B)

FluidsVentilation


Who Needs an LVAD?

Mortality40%

Cardiogenic shock post AMI100%

Survival without Device 60%

LVAD

Mortality 100%

Neurologic function ↓Futility

LVAD (5,5%) IABP-SHOCK II?

Survival 31%?Mortality 69%

100% LVAD

How to Prevent MODS?


Cardiogenic Shock - Guidelines

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

N P

atie

nts

Patient Inclusion in Cardiogenic Shock Trials

Sto

p –

no e

ffect

Sto

p sl

ow re

crui

tmen

t

Und

erpo

wer

ed

Sur

roga

te e

ndpo

int

706

Sto

p –

slow

recr

uitm

ent

Thank you for your attention

[email protected]

percutaneous circulatory support. iabp, impella and beyond

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