Abiomed Impella 2.5, Инструкция по эксплуатации

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6.13 Impella
®
System for Use During Cardiogenic Shock
AB5000 is the most potent device. For this comparison, the longer duration of support and the
invasiveness of the AB5000 likely increases the risk of device related morbidities as the support
is extended. These issues can result in serious complications culminating in death events.
Therefore, a potential benefit of the higher hemodynamic support of a surgical VAD is offset by
the high complication rates that impair outcomes.
In addition, to assess overall safety of use of the Impella devices, the rates of site-reported in-
hospital adverse events were compared. The results of this comparison are provided in Table 6.4.
There are several noteworthy differences between the Impella and AB5000 safety profile.
• The cerebral vascular accident (CVA) and stroke events were significantly higher in
AB5000 cohort compared to the Impella devices, which could be explained by the
longer duration of support with the AB5000, and its much larger blood contacting
device surface area and areas of stasis in the device that interact with the patient
blood compared to the Impella device.
• The bleeding rates differed among the groups. For Impella 5.0/LD group, only 4
patients underwent percutaneous coronary intervention, with the remainder receiving
surgical revascularization (i.e., a CABG procedure). As a result, the bleeding rates were
similar between the Impella 5.0/LD and AB5000. These were mainly surgical bleeding.
However, the bleeding rates for Impella 2.5 and Impella CP, which were placed
percutaneously in AMICS patients undergoing PCI, were much lower compared to the
other two groups. There were no device-related bleeding events reported.
• There were also differences in the infection rates, with higher incidence in the
Impella 5.0/LD and AB5000 groups. Although infections were reported more
frequently for the Impella 5.0/LD, this most likely due to more rigorous contemporary
process of reporting adverse events, including all infections (urinary tract infections,
streptococcus throat, etc.) in the Impella Registry. None of the infections was
determined to be related to the device.
Table 6. 5 Site-reported adverse events (to discharge) by classification
Adverse Events
Impella
2.5
(n=189)
Impella
CP
(n=111)
Impella
5.0/LD
(n=24)
AB5000/
BVS/AB
(n=115)
p-value
Death 55.03%
(104/189)
54.05%
(60/111)
50.00%
(12/24)
69.57%
(80/115)
0.036
CVA/Stroke
2.65%
(5/189)
3.60%
(4/111)
4.17% (1/24) 21.74%
(25/115)
<.001
TIA
0.00%
(0/189)
0.00%
(0/111)
0.00%
(0/24)
5.22%
(6/115)
0.002
Acute Renal
Dysfunction
27.51%
(52/189)
31.53%
(35/111)
41.67%
(10/24)
25.22%
(29/115)
0.355
Hemolysis 8.47%
(16/189)
10.81%
(12/111)
8.33%
(2/24)
10.43%
(12/115)
0.900
Acute Hepatic
Failure
10.58%
(20/189)
16.22%
(18/111)
12.50%
(3/24)
11.30%
(13/115)
0.516
Bleeding
19.58%
(37/189)
17.12%
(19/111)
41.67%
(10/24)
37.39%
(43/115)
<.001
Infection 17.46%
(33/189)
13.51%
(15/111)
50.00%
(12/24)
26.96%
(31/115)
<.001
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