Impella® RP with the Automated Impella® Controller
6.9
In conclusion, the use of Impella RP device improved patient hemodynamics while providing ventricular
unloading in the combined cohorts. The level of support was sufficient to restore the hemodynamics of
these sick patients to a normal range.
Decreased use of inotropes during support
The use of inotropes showed an initial increase on support then generally trended down over time
during Impella RP support, as shown in Figure 6.4.
Figure 6.4 Use of inotropes during Impella RP support
OTHER RELEVANT CLINICAL FINDINGS
Safety:
•
Vascular complication
There were no reported vascular complications in the venous system related to use of the
large bore sheath provided with the Impella RP pump.
•
Integrity of Cardiac and Valvular Structures
A comprehensive echocardiographic safety analysis on echocardiographic images acquired at
different time points before, during and after Impella RP support performed by the
Echocardiography Core Laboratory showed no evidence of any structural damage to the right
ventricular chamber, tricuspid or pulmonary valves, or cordae or papillary muscles.
Effectiveness:
•
Right Ventricular Function
There were 21 patients who had paired echocardiographic images for analysis of right
ventricular function. The majority of these patients showed global (versus regional) dysfunction
prior to use of the Impella RP device. In 90% of the patients (19/21), there was either an
improvement or maintenance of right ventricular function post device placement, as shown in
Figure 6.5.
