Abiomed Impella 2.5, Инструкция по эксплуатации

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6.10 Instructions for Use & Clinical Reference Manual (US)
ADDITIONAL ANALYIS OF THE IMPELLA REGISTRY DATA
An additional analysis of different subsets of the Impella Registry patients was provided. The
analysis was completed to attempt to evaluate a potential benefit of Impella in a subgroup of the
Impella Registry patients, which would be similar to patients selected in prior randomized AMICS
RCTs. This was accomplished by dividing the Impella Registry into two groups, a “RCT group”
or a group who may have qualified for an AMICS RCT that has been conducted (i.e., SHOCK
trial) and a group of “salvage” patients, who would typically be excluded from an AMICS RCT.
Specifically, the “salvage patient population” included patients who presented with anoxic
brain injury prior to implant, out of hospital cardiac arrest and those who were transferred from
outlying hospital. These higher risk patients would usually be excluded from RCTs because of
the time delay in providing care or severity of the insult that makes the shock irreversible despite
effective hemodynamic support. The RCT subgroup consisted of 111 patients and the “salvage”
subgroup was made up of the remaining 209 patients:
The overall 30-day survival results (Kaplan-Meier curve estimates) for the two subgroups
described above are shown in Figure 6.8. As expected, the “salvage” group of patients has
poorer outcomes than the RCT group, which is more representative of patients chosen for
AMICS RCTs.
In addition, the outcomes data for both 30-day survival and survival to discharge are provided
in Figures 6.9 and 6.10, respectively, for each Impella device. Interestingly, there appears to be
a trend (most noticeable for the RCT group) for an incremental improvement in outcomes with
increased flow (from Impella 2.5 to Impella 5.0/LD). This trend reinforces the principle
1
that an
increase in the amount of support (CPO) affects outcomes in patients in whom the cardiogenic
shock condition is still reversible.
Figure 6.8 Outcomes between Impella Registry subgroups: Patients likely to be eligible
for RCTs vs. Patients likely to be excluded from RCTs (“salvage” patients)