Faculty Disclosure
Company
Nature of Affiliation
Unlabeled Product
Usage
HeartWare
Employee
None
Abiomed
Educational Grant
None
Mortality (%)
80
PCI (p<0.01)
70
Thrombolysis (p<0.01)
70
IABP (p<0.01)
60
CABG
60
50
50
% 40
% 40
30
30
20
20
10
10
0
0
1997
1999
2001
2003
2005
1997
1999
2001
2003
2005
SHOCK Trial
Proportion Alive
1.0
30 days
Log-Rank p = .024
0.8
0.6
ERV (N=152)
0.4
0.2
IMS (N=150)
0.0
0
Estimated In-Hospital
Mortality (%)
Thiele
Burkhoff
Seyfarth
et al.
et al.
et al.
TandemHeart
TandemHeart
Impella LP25
IABP
IABP
IABP
41
33
26
Single-centre
Multi-centre
Two-centre
Yes
Yes
Yes
Drawing
Not reported
Not reported
Sealed envelopes
Not reported
Not reported
Not possible
Not possible
Not possible
Complete follow-up
Complete follow-up
Complete follow-up
Envelopes
Concealment of
allocation
Blinding
Handling of
patient attrition
* Not reported whether the envelopes were opaque and sequentially numbered.
IABP, intra-aortic balloon pump; LVAD, left ventricular assist device.
Hemodynamics
LVAD
IABP
Cardiac index
Mean + SD Mean + SD Mean Difference
P(heterogeneity) = 0.22
l2 = 34.0%
Thiele et al.
Burkoff et al.
2.3 + 0.6
1.8 + 0.4
0.55 (0.23-0.87)
2.2 + 0.6
2.1 + 0.2
0.16 (-0.14-0.46)
Seyfarth et al.
2.2 + 0.6
1.8 + 0.7
0.35 (-0.16-0.88)
Pooled
0.35 (0.09-0.61)
-2
Thiele et al.
-1
Favors IABP
1
Favors LVAD
LVAD
IABP Mean Arterial Pressure
Mean + SD Mean + SD Mean Difference
76 + 10
70 + 16
P(heterogeneity) = 0.10
l2 = 55.9%
0.55 (-2.9-13.9)
Burkoff et al.
91 + 16
72 + 12
18.6 (9.4-27.9)
Seyfarth et al.
87 + 18
71 + 22
16.0 (0.5-31.5)
12.8 (3.6-22.0)
Pooled
-50
-25
Favors IABP
25
Favors LVAD
50
LVAD
IABP Pulmonary wedge pressure P(heterogeneity) = 0.01
Mean + SD Mean + SD
Mean Difference
l2 = 76.6%
Thiele et al.
16 + 5
22 + 7
Burkoff et al.
16 + 4
25 + 3
Seyfarth et al.
19 + 5
20 + 6
-1.0 (-5.2-3.2)
-5.3 (-9.4 to -1.2)
Pooled
-20
-10
Favors LVAD
10
Favors IABP
20
30 Day Mortality
LVAD
n/N
IABP
n/N
30-day Mortality
Relative Risk
P(heterogeneity) = 0.83
l2 = 0%
Thiele et al.
9/21
9/20
0.95 (0.48-1.90)
Burkhoff et al.
9/19
5/14
1.33 (0.57-3.10)
Seyfarth et al.
6/13
6/13
1.00 (0.44-2.29)
24/53
20/47
1.06 (0.68-1.66)
Pooled
0.1
1
Favors LVAD
10
Favors IABP
Follow-up
n/N
Revascularization (PCI/CABG)
SHOCK
SMASH
Total
1-year
30 days
76/152
22/32
103/184
Relative Risk
95% CI
n/N
0.80 (0.66;0.98)
0.87 (0.66;1.29)
0.82 (0.70;0.98)
83/149
18/23
117/172
Early revascularization
better
Catecholamines
SOAP II (CS Subgroup)
28 days
64/145
NO Synthase Inhibitors
TRIUMPH
SHOCK-2
Cotter et al
Total
IABP
IABP-SHOCK I
LVAD
Thiele et al
Burkhoff et al
Seyfarth et al
Total
In-hospital
15/40
0.75 (0.55;0.93)
97/201
24/59
4/15
125/275
1.15 (0.59;2.27)
7/19
1.14 (0.91;1.45)
1.16 (0.59;2.69)
0.40 (0.13;1.05)
1.05 (0.85;1.29)
9/21
9/19
6/13
24/53
Placebo
better
6/21
1.28 (0.45;3.72)
IABP
better
30 days
30 days
30 days
Standard treatment
better
76/180
7/20
10/15
93/215
NO Synthase inhibition
better
30 days
Dopamine
better
13/40
Up-stream Abciximab
better
30 days
30 days
30 days
Medical treatment
better
50/135
Norepinephrine
better
Glycoprotein IIb/IIIa-Inhibitors
PRAGUE-7
Relative Risk
95% CI
9/20
5/14
6/13
20/47
LVAD
better
Standard treatment
better
IABP
better
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-Shock-II Trial
DSMB:
Kurt Huber
Ferenc Follath
Bernhard Maisch
Johannes Haerting
Steering committee:
Holger Thiele
Karl Werdan
Uwe Zeymer
Gerhard Schuler
Support +
Patronage:
IABP Shock-II
Primary Study Endpoint (30-Day Mortality)
50
Mortality (%)
Control
41.3%
39.7%
40
IABP
30
20
10
0
0
10
15
20
25
30
IABP Shock-II
Primary Study Endpoint (30-Day Mortality)
Thiele et al, Lancet, Volume 382, Issue 9905, 2013, 1638 - 1645
16
ACCF/AHA/SCAI [3-6]
Class IIa [B]
Therapy /
Device
Mechanism
Medical Management
Inotropes /
Pressors
IABP
Aortic Pressure
Augmentation
Counterpulsation
Impella
2.5/4.0/5.0
LA -> AO flow
RA -> AO flow
LV -> AO flow
17
LV Pressure (mmHg)
150
125
100
75
50
25
0
25
50
75
100
125
LV Volume (ml)
150
18
19
Contractility
Ees
Ees
LV Pressure (mmHg)
150
125
100
75
50
25
0
50
100
LV Volume (ml)
150
20
CPO = SW*HR
MAP*SV*HR
SW
Determinants of
Myocardial Oxygen Consumption
PVA = PE+SW
Heart Rate
SW
PE
Left Ventricular Volume
Contractility
21
23
Hemodynamic principles
provide important insights into
different forms of mechanical
circulatory support (MCS) in
various clinical settings
24
25
Harvi
Interactive, simulation-based
textbook for the iPad
(for iPad 2, 3, mini)
26