Abiomed Impella 2.5, Инструкция по эксплуатации

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6.25 Impella
®
System for Use During Cardiogenic Shock
Failure to Wean (PCCS-FW). In the other analysis, Classification B, which was specifically
requested by FDA, the patients were categorized in three (3) different groups, to evaluate
separately patients that received Impella before, during the operating time (during the surgical
procedure) and after the surgery. The groups included in each category are shown in Figure
Figure 6.20 Groups used for each classification analysis
For Classification A, the overall results (Kaplan-Meier curve estimates) for survival (to 30 days)
for the patients are shown in Figure 6.21. Figures 6.22 and 6.23 give the results for the different
devices used. The results show that high-risk patients in whom hemodynamic support is
initiated early prior to surgery (LCOS group) tend to do better than those without support prior
to surgery and who develop cardiogenic shock post-weaning from CPB or those who cannot
wean from CPB.
Figure 6.21 Kaplan-Meier curve for 30-day survival using Classification A (all patients)
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6.20.