Table 1. Summary of MCS complication rates reported in randomized trials and comparative observational studies of acute MCS in CS.
AKI, acute kidney injury; AMICS, acute myocardial infarction complicated by cardiogenic shock; CS, cardiogenic shock; CVA, cerebrovascular accident; GI, gastrointestinal; GU, genitourinary; HgB, hemoglobin; IABP, intra-aortic balloon pump; MCS, mechanical circulatory support; n.s., not significant; OR, odds ratio; PCI, percutaneous coronary intervention; pRBCs, packed red blood cells; RU, rectal ulcer; TIA, transient ischemic attack; VA-ECMO, veno-arterial extracorporeal membrane oxygenation.
| Study | Comparison | Major bleeding | Stroke | AKI | Limb ischemia | Hemolysis | Sepsis | Death | Perspective |
|---|---|---|---|---|---|---|---|---|---|
| Thiele
et al.
(IABP-SHOCK- II) 4 |
Life-threatening
or severe and moderate bleeding as defined by GUSTO criteria |
New
neurologic symptoms in conjunction with signs of ischemia or hemorrhage on head CT |
x |
Peripheral
ischemic vascular complication requiring surgical or interventional management |
x |
Sepsis with
clinical signs of infection and elevated procalcitonin levels |
30-day
mortality |
• Poorly defined
controls No definition of shock severity • Wide range of timing for IABP support initiation • No hemodynamic guidance for management of shock • 1-year and 6- year mortality also assessed and showed no difference |
|
| IABP
(n = 301) |
Life-threatening:
3.3% Moderate: 17.3% |
0.7% (2/300) | - | 4.3% (13/300) | - | 15.6% (47/300) | 39.70% | ||
| Medical therapy
(n = 299) |
Life-
threatening: 4.4% Moderate: 16.4% |
1.7% (5/298) | - | 3.4% (10/298) | - | 20.5% (61/298) | 41.30% | ||
| P value | 0.51 | 0.28 | - | 0.53 | - | 0.15 | 0.69 | ||
| Thiele et al. 16 |
Major bleeding
requiring transfusion of blood components |
CVA with
neurological dysfunction |
x |
Lower extremity
ischemia requiring surgical or interventional action |
x |
Elevated body
temperature >38.5°C |
30-day
mortality |
• Surrogate primary
endpoint • Not sufficiently powered to assess mortality • AMICS only • MCS implantation was prior or post PCI |
|
| IABP
(n = 20) |
40% (8/20) | Not reported | - | 0% (0/20) | - | 50% (10/20) | 45% | ||
| Tandem (n =
21) |
90.5% (19/21) | Not reported | - | 33.3% (7/21) | - | 81% (17/21) | 43% | ||
| P value | 0.002 | - | - | 0.009 | - | 0.08 | 0.86 | ||
| Burkhoff
et al. 17 |
Bleeding |
Neurologica
dysfunction |
Renal
dysfunction |
Distal leg ischemia |
Plasma free Hgb >40
mg/dL two or more measurements taken 8 hours apart |
Systemic infection
or sepsis |
30-day
mortality |
• Surrogate primary
endpoint • Trial ended prematurely • Did not exclude patients with IABP already placed at time of enrollment |
|
| IABP
(n = 14) |
14.3% (2/14) | 50% (7/14) | 21.4% (3/14) | 14.3% (2/14) | 7.1% (1/14) | 35.7% (5/14) | 64% | ||
| Tandem (n =
19) |
42.1% (8/19) | 31.6% (6/19) | 21.5% (4/19) | 21.5% (4/19) | 5.3% (1/19) | 21% (4/19) | 53% | ||
| P value | 0.13 | 0.47 | 0.99 | 0.99 | 0.99 | 0.44 | n.s | ||
| Seyfarth
et al. (ISAR- SHOCK) 18 |
Units of pRBCs
administered per patient |
Survival
without neurologic deficit |
x |
Acute limb ischemia
requiring surgery |
Time course of free
HgB |
x |
30-day
mortality |
• Not powered fo
mortality • AMICS only • Impella 2.5 does not provide complete support and may not be an appropriate comparison to IABP • Definition of major bleeding makes it difficult to compare to other studies • Safety outcomes were not well reported • Outcomes of patients who died prior to intervention were included in analysis |
|
| IABP
(n = 13) |
1.2 U | 30.8% (4/13) | - | 0% (0/13) | - | - | 46.20% | ||
| Impella 2.5 (n
= 12) |
2.6 U | 50% (6/12) | - | 8.3% (1/12) | - | - | 50% | ||
| P value | 0.18 | Not reported | - | Not reported | - | - | Not
reported |
||
| Ouweneel
et al. (IMPRESS) 19 |
Serum Hgb
drop of 5 g/dL or transfusion of two units of pRBCs or surgery to control bleeding |
Any stroke
confirmed by neurologist and CT scan |
x |
Major bleed at
arterial access site requiring device extraction or thrombotic occlusion of femoral artery or limb ischemia requiring device extraction or need for vascular surgery to correct vascular complication |
Evidence of clinically
relevant hemolysis requiring device extraction |
x |
30-day
mortality |
• Underpowered due
to poor estimation of true mortality rate • Study cohort not appropriate for treatment evaluation; single MCS intervention alone is unlikely to benefit severe CS patients • No safety p values reported so difficult to assess comparison |
|
| IABP
(n = 24) |
8.3% (2/24) | 4.2% (1/24) | - | 0% (0/24) | 0% (0/24) | - | 50% | ||
| Impella CP (n
= 24) |
33.3% (8/24) | 4.2% (1/24) | - | 4.2% (1/24) | 33.3% (8/24) | - | 45.80% | ||
| P value | Not reported | Not reported | - | Not reported | Not reported | - | 0.92 | ||
| Bochaton
et al. (IMPELLA- STIC) 20 |
Major bleeding
requiring transfusion |
x | x | Limb complication | x | Sepsis |
30-day
mortality |
• Severely inadequate
sample size due to slow enrollment • Compounding effect of having IABP in both arms • Vague definitions of safety outcomes |
|
| IABP
(n = 6) |
0% (0/6) | - | - | 0% (0/6) | - | 50% (3/6) | 0% | ||
| IABP + Impella
5.0 (n = 6) |
83.3% (5/6) | - | - | 33.3% (2/6) | - | 83.3% (5/6) | 33.30% | ||
| P value | 0.02 | - | - | 0.46 | - | 0.59 | 0.46 | ||
| Schrage et al. 24 |
Life-threatening
or severe and moderate bleeding as defined by GUSTO criteria |
New
neurologic symptoms in conjunction with signs of ischemia or hemorrhage on head CT |
x |
Peripheral
ischemic vascular complication requiring surgical or interventional management |
x |
Sepsis with
clinical signs of infection and elevated procalcitonin levels |
30-day
mortality |
• Non-randomized study
• Included Impella 2.5 and Impella CP • Only 38.1% of Impellas were implanted prior to PCI • Poorly defined control group |
|
| No Impella (n =
237) |
Life-
threatening: 3.0% Moderate: 16.9% |
2.5% (6/237) | - | 3.8% (9/237) | - | 19.4% (46/237) | 46.40% | ||
| Impella 2.5/CP
(n = 237) |
Life-
threatening: 8.4% Moderate: 20.3% |
2.5% (6/237) | - | 9.7% (23/237) | - | 30.8% (73/237) | 48.50% | ||
| P value | Life-
threatening: <0.01 Moderate: 0.32 |
0.76 | - | 0.01 | - | <0.01 | 0.64 | ||
| Amin et al. 25 |
Bleeding
event requiring transfusion |
Ischemic
stroke, hemorrhagic stroke, intracerebral hemorrhage, or TIA |
AKI | x | x | x |
In-hospital
mortality |
• Observational study
• Did not control for many parameters that may affect association with mortality • Only reported ORs, no absolute values to assess actual effect |
|
| Impella (4,782)
versus IABP (43,524), propensity matched |
OR: 1.10
(1.0–1.21) |
OR: 1.34
(1.18–1.53) |
OR: 1.08
(1.0–1.17) |
- | - | - | OR: 1.24
(1.13–1.36) |
||
| Dhruva et al. 26 |
Hgb drop <3 g/
dL, transfusion of whole blood or pRBCs, procedural intervention to treat bleeding, or transfusion of whole blood or packed red blood, or suspected GI, GU, RP, or other bleed |
x | x | x | x | x |
In-hospital
mortality |
• Observational study
• Crude imputation of missing registry data • Patients with multiple PCIs included in study and not accounted for • Minimal safety outcome assessment • Did not control for many parameters that may affect association with mortality |
|
| Impella (n =
1,680) |
31.3%
(526/1,680) |
- | - | - | - | - | 45.0% | ||
| IABP (n = 1680) | 16.0%
(268/1,680) |
- | - | - | - | - | 34.1% | ||
| P value | <0.001 | - | - | - | - | - | <0.001 | ||
| IABP (n
= 7,805) |
14.5% | - | - | - | - | - | 28.6% | ||
| No device (n =
7,805) |
11.0% | - | - | - | - | - | 26.5% | ||
| P value | <0.001 | - | - | - | - | - | 0.002 | ||
| Brunner
et al. (ECLS- SHOCK) 21 |
Life-
threatening, severe, or moderate bleeding |
Stroke | x |
Peripheral
ischemic vascular complication |
x | Sepsis |
30-day
mortality |
Study is not well
described, particularly control group definition, and may not be an appropriate comparator |
|
| No MCS (21) | 14.3% (3/21) | 4.8% (1/21) | - | 0% (0/21) | - | 33.3% (7/21) | 19% | ||
| VA-ECMO (21) | 19.0% (4/21) | 4.8% (1/21) | - | 9.5% (2/21) | - | 42.9% (9/21) | 33.30% | ||
| P value | 1.0 | 1.0 | - | 0.49 | - | 0.75 | 0.37 |