Abiomed Impella 2.5, Instructions For Use Manual

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6.29 Impella
®
System for Use During Cardiogenic Shock
Table 6. 7 Site-reported adverse events (to discharge) by classification
In-Hospital Adverse
Events
Impella 5.0/LD
Patients
(n=24)
AB5000 Patients
(n=79)
p-value
Death
50.00% (12/24) 84.81% (67/79) 0.002
CVA/Stroke 4.17% (1/24) 20.25% (16/79) 0.112
TIA 0.00% (0/24) 2.53% (2/79) 1.000
Acute Renal
Dysfunction/Failure
41.67% (10/24) 29.11% (23/79) 0.318
Hemolysis 8.33% (2/24) 6.33% (5/79) 0.663
Acute Hepatic Failure 16.67% (4/24) 18.99% (15/79) 1.000
Bleeding
45.83% (11/24) 41.77% (33/79) 0.815
Infection 37.50% (9/24) 22.78% (18/79) 0.187
Supraventricular
Arrhythmia
12.50% (3/24) 7.59% (6/79) 0.432
Respiratory
Dysfunction/Failure
33.33% (8/24) 17.72% (14/79) 0.153
Sepsis 4.17% (1/24) 0.00% (0/79) 0.068
Multi System Organ
Failure
8.33% (2/24) 35.44% (28/79) 0.010
Other
29.17% (7/24) 45.57% (36/79) 0.167
CVA: Cerebrovascular accident; TIA: Transient Ischemic Attack
In addition, the rates of site-reported in-hospital adverse events, which were captured in both
registry CRFs, were compared. The results of this comparison are provided in Table 6.
7 . Of
note is that multi-system organ failure was lower in the Impella Registry PCCS group and
stroke also numerically lower compared with the AB5000 benchmark cohort. The other site-
reported adverse events including bleeding, hemolysis and infection were comparable between
the two cohorts. Given the clinical presentation of these patients (all undergoing major cardiac
surgery), similar bleeding and infection rates are expected.
Overall, Abiomed’s benchmark analysis revealed that post-cardiotomy patients in the Impella
Registry are comparable with the post-cardiotomy patients treated with the AB5000 device.
Although the devices provided similar amount of circulatory support, it appears that the patients
in the Impella Registry had better outcomes than the patients in the AB5000 Registry.
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