1. circulatory support in cardiogenic shock
Complementary role of percutaneous and surgical
circulatory support in cardiogenic shock
Introduction and objectives
Holger Thiele
Medical Clinic II (Cardiology/Angiology/Intensive Care)
University of Lübeck, Germany

2. Disclosures
Funding:
German Research Foundation German Heart Research Foundation German Cardiac Society EU
Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte Terumo
Lilly
Maquet Cardiovascular Teleflex Medical
Consulting:
Maquet Cardiovascular, Lilly Speaker Honoraria:
Lilly, Astra Zeneca, Daiichi Sankyo, Boehringer Ingelheim, Maquet
Cardiovascular, Medicines Company

3. In-hospital Mortality
USIK 1995, USIC 2000, FAST-MI France National Registry 90 80 70 60 50 40 30 20 10
Shock
No Shock 70
(62-77) 63
(56-70)
Death after 30 days (%) 51
(44-59)
8.7
4.2
( )
3.6
( )
( )
1995
2000
2005
Aissaoui et al. Eur Heart J 2012; 33:2535–2543

4. Randomized Trials in Cardiogenic Shock
Relative Risk 95% CI
Relative Risk 95% CI
Trial
Revascularization (PCI/CABG)
Follow-up
n/N
n/N
SHOCK SMASH
Total
1-year 30 days
76/152
22/32
103/184
83/149
18/23
117/172
0.80 (0.66;0.98)
0.87 (0.66;1.29)
0.82 (0.70;0.98)
Early revascularization better
Medical therapy better
Thiele et al. Eur Heart J 2010; 31,1828–1835

5. Class 1B → IIa B Class IC → IIb B Guidelines
IABP in STEMI complicated by cardiogenic shock
Class 1B → IIa B
Class IC → IIb B
Antman et al. Circulation 2004;110:82-292
O’Gara et al. Circulation. 2013;127:e362-e425 Van de Werf et al. Eur Heart J 2008;29: Steg et al. Eur Heart J.2012;33:

6. Ethical Problems There are no controlled trials on parachute jumping
Umbrellas protect from rain
– randomized trials useless

7. Ethical Problems

8. Primary Study Endpoint (30-Day Mortality)50
Control
41.3%
39.7% 40
IABP
Mortality (%) 30 20
P=0.92; log-rank test
Relative risk 0.96; 95% CI ; P=0.69; Chi2-Test 10 5 25 30
Time after randomization (days)
Thiele et al. NEJM 2012;367:

9. Mortality 12-Month Follow-up
P=0.94; log-rank test
Relative risk 1.02; 95% CI
30-day
6-Month 12-Month
Mortality Mortality
Mortality
60%
IABP
51.8%
48.7%
Control
50%
41.3%
51.4%
49.2%
Mortality
40%
39.7%
30%
20%
10% 0%
No. at risk
Days after randomization
IABP
301
181
171
165
161
159
154
152
149
147
146
144
136 45 21
Control
299
174
166
140 55 29
Thiele et al. Lancet 2013;382:

10. Class IC → IIb B → III ESC Revascularization Guidelines 2014
IABP in cardiogenic shock
Class IC → IIb B → III

11. Currently Available Percutaneous Devices
IABP
Impella
TandemHeart
Mini-ECLS (ECMO)
2.5
3.5 (CP)
5.0

12. ECMO for Transfer from Non-tertiary Centers
100
Mortality in patients> 62 years: 100%
Mortality in patients with resuscitation: 100%
Mortality in patients > 62 years: 100%
Mortalität in patients with resuscitation: 100% 80 60 40 20
Total survival (%)
No. at risk 87 1 27 2 18 3 10 4 5
Time after ECMO-Implantation (years)
Beurtheret et al. Eur Heart J 2013;34:

13. Cardiogenic Shock - Guidelines
Steg et al. Eur Heart J.2012;33:

14. Patient Inclusion in Cardiogenic Shock Trials
Stop – no effect
Stop – slow recruitment
Stop slow recruitment
706
700
600
500
400
300
200
100
Surrogate endpoint
600
Underpowered
398
N Patients
302 55 80 57 45
SHOCK
SMASH
TRIUMPH
TACTICS
PRAGUE -7
IABP-SHOCK I
IABP-SHOCK II
CULPRIT-SHOCK

15. Thank you for your attention

16. Randomized Trials in Cardiogenic Shock
Relative Risk 95% CI
Relative Risk 95% CI
Trial
Revascularization (PCI/CABG) SHOCK
Follow-up
n/N
n/N
1-year
76/152
83/149
0.80 (0.66;0.98)
SMASH
Total
30 days
22/32
103/184
18/23
117/172
0.87 (0.66;1.29)
0.82 (0.70;0.98)
Early revascularization
Medical treatment better
better
Catecholamines
SOAP II (CS Subgroup)
28 days
64/145
50/135
Norepinephrine better
0.75 (0.55;0.93)
Dopamine better
Glycoprotein IIb/IIIa-Inhibitors PRAGUE-7
NO Synthase Inhibitors TRIUMPH
SHOCK-2
Cotter et al
Total
In-hospital
15/40
13/40
1.15 (0.59;2.27)
Up-stream Abciximab
Standard treatment better
better
30 days
97/201
24/59
4/15
125/275
76/180
7/20
10/15
93/215
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
Placebo better
IABP
IABP-SHOCK I IABP-SHOCK II
Total
better
30 Tage
7/19
119/300
126/319
6/21
123/298
129/319
1.28 (0.45;3.72)
0.96 (0.79;1.17)
0.98 (0.81;1.18)
IABP
better
Standard treatment better
Updated Thiele et al. Eur Heart J 2010; 31:1828–1835

17. How to Prevent MODS? Optimal Timing MODS Prevention Optimal Support
Optimal prevention/ Management of potential Device-complications
(i.e. Device malfunction, Hemolysis, Infection)