Abiomed Impella 2.5, Инструкция по эксплуатации

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6.14 Instructions for Use & Clinical Reference Manual (US)
Table 6. 5 Site-reported adverse events (to discharge) by classification (continued)
Adverse Events
Impella
2.5
(n=189)
Impella
CP
(n=111)
Impella
5.0/LD
(n=24)
AB5000/
BVS/AB
(n=115)
p-value
MSOF
1.59%
(3/189)
0.00%
(0/111)
4.17% (1/24) 18.26%
(21/115)
<.001
Respiratory
Dysfunction/Failure
10.05%
(19/189)
14.41%
(16/111)
41.67%
(10/24)
22.61%
(26/115)
<.001
Supraventricular
Arrhythmia
5.82%
(11/189)
6.31%
(7/111)
16.67%
(4/24)
7.83%
(9/115)
0.253
Other
19.58%
(37/189)
18.02%
(20/111)
41.67%
(10/24)
27.83%
(32/115)
0.032
CVA: Cerebrovascular accident; TIA: Transient Ischemic Attack; MSOF: Multi System Organ
Failure
Overall, the benchmark analysis reveals that AMICS patients in the Impella Registry had better
outcomes to discharge than the patients in the AB5000 Registry. This is likely due to the
increased risk with mortality and morbidity associated with a prolonged support and
invasiveness that comes with the AB5000 technology. The comparison also showed that the
rates of complications were lower in the U.S. Impella Registry cohort. This may have been a
result of the less invasive approach for insertion and operation, shorter duration of support, ease
of use to allow earlier mobilization of patients and a reduced ICU and hospital stay.
HEMODYNAMIC EFFECTIVENESS RESULTS
The Impella Catheters directly unload the left ventricle (LV) and propel blood forward, from
the left ventricle into the aorta, in a manner most consistent with normal physiology. Impella
provides both an active forward flow
2,3
, and systemic aortic pressure (AOP) contribution,
1,2,4
leading to an effective increase in mean arterial pressure (MAP) and overall cardiac power
output (CPO).
1,5
Combined with LV unloading, Impella support reduces end-diastolic volume and
pressure (EDV, EDP)
1,2
and augments peak coronary flow,
1,2,6,7
leading to a favorable alteration
of the balance of myocardial oxygen supply and demand. This cascade of hemodynamic effects
has been described in the literature
8
and validated in computational modeling and a variety of
pre-clinical and clinical studies.
1-7
As initial clinical evidence of the hemodynamic benefits of Impella support, results from a clinical
trial with the Impella 5.0 and Impella LD are provided. The study, RECOVER I, was an FDA-
approved prospective, single-arm study that evaluated the safety, hemodynamic benefit and
feasibility for the Impella 5.0 and the Impella LD in a post-cardiotomy settings. As part of the
study, hemodynamic data was collected at baseline and over time to evaluate the robustness of
the hemodynamic support with the Impella 5.0 and Impella LD devices in patients experiencing
hemodynamic compromise/cardiogenic shock post cardiac surgery. Cardiac output (CO), cardiac
index (CI), mean arterial pressure (MAP), cardiac power output (CPO), cardiac power index
(CPI) and pulmonary artery diastolic blood pressure (PAd) measurements were collected. The
data collected showed an immediate improvement of the hemodynamics of PCCS patients post
device implant, as shown in Figure 6.13. In addition, concomitantly, as patients’ hemodynamics
improved, a rapid and sustained weaning of inotropic and pressor support was also observed, as
given Figure 6.14.