Actions to take:
1.
Reduce the P-level to P-2 until imaging is available.
2.
Under fluoroscopic or echocardiographic guidance, determine the
Impella Catheter position.
3.
Return to preferred P-level and confirm positioning with imaging.
LOW NATIVE HEART PULSATILITY−IMPELLA 2.5,
IMPELLA CP, IMPELLA CP WITH SMARTASSIST AND
IMPELLA 5.5 WITH SMARTASSIST
When a patient has poor native ventricular function, the placement signal
may remain pulsatile; however, the amplitude will be dampened.
In a situation of low native heart pulsatility, the Automated Impella
Controller may not be able to determine the catheter position. You may see
the following indication on the home screen:
Impella Position Unknown
Actions to take: Assess cardiac function.
IMPELLA CATHETER OUTLET AREA ON OR NEAR
AORTIC VALVE
If the Impella Catheter outlet area is on or near the aortic valve, the
catheter may be too deep in the ventricle.
Actions to take:
1.
Assess and adjust Impella Catheter position under fluoroscopic or
echocardiographic guidance.
2.
If unsuccessful, reduce the P-level to P-2 and gently pull the
catheter back 2 cm to see if the condition resolves.
For Impella CP with SmartAssist, or Impella 5.5 with SmartAssist catheters,
you may see the following indication on the home screen:
Placement Signal Low
Actions to take:
1.
Assess cardiac function.
2.
If patient's diastolic pressures are greater than 30 mmHg for
the Impella CP with SmartAssist, or 26 for the Impella 5.5 with
SmartAssist, confirm Impella position with imaging and reposition
as needed.
CATHETER POSITION WRONG−IMPELLA 5.0 OR LD
If the Impella 5.0 or LD Catheter is fully in the ventricle or fully in the aorta,
the following alarm will appear:
Impella Position Wrong
The Impella 5.0 or Impella LD System cannot differentiate between these
two conditions. In this situation, the placement screen will appear as shown
in Figure 30.
Figure 30. Impella 5.0 Catheter Position Wrong (similar for Impella LD)
30
Actions to take:
1.
Reduce the P-Level to P-2 until imaging is available.
2.
Reposition Impella Catheter under fluoroscopic or
echocardiographic guidance.
3.
Return to preferred P-Level and confirm positioning with imaging.
LOW NATIVE HEART PULSATILITY−IMPELLA 5.0,
IMPELLA LD
When a patient has poor native ventricular function, the placement signal
may remain pulsatile; however, the amplitude will be dampened and both
the minimum and maximum values will be greater than zero because the
aortic valve does not open and the Impella 5.0 or Impella LD Catheter
raises the aortic blood pressure above the ventricular pressure during
systole.
In a situation of low native heart pulsatility, the Automated Impella
Controller may not be able to determine the catheter position. You may see
the following indication on the home screen:
Impella Position Unknown
Notice that the flow rate is displayed in yellow in the lower-left corner of
the screen, indicating that the patient may not be getting the benefit of
the displayed flow rate.
Actions to take:
1.
Assess cardiac function.
2.
If needed, confirm catheter position with echocardiography.
IMPELLA 5.0 OR IMPELLA LD CATHETER OUTLET AREA
ON OR NEAR AORTIC VALVE
If the Impella 5.0 or Impella LD Catheter outlet area is on or near the aortic
valve, the catheter may be too deep in the ventricle. The following alarm
appears:
Impella Outflow Blocked
In this situation, the Impella Outflow Blocked warning appears as shown
in Figure 31.
Figure 31. Impella 5.0 Catheter Outlet Area on or near Aortic Valve
(similar for Impella LD)
Actions to take:
1.
Assess and adjust Impella 5.0 or Impella LD Catheter position
under fluoroscopic or echocardiographic guidance, if available.
2.
If fluoroscopic or echocardiographic guidance is not available,
reduce the P-level to P-2 and gently pull the catheter back 2 cm to
see if the condition resolves.
User Manual