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AIR DETECTED ALERT
During any of the purge system processes above, the controller automatically
monitors for air in the system. If air is detected in the system, the controller
provides an alert to disconnect the luer, as shown below. Once the luer is
disconnected, the controller automatically de-airs the purge system.
PATIENT WEANING
Weaning the patient from the Impella Catheter is at the discretion of the
physician. The Impella 5.5
with SmartAssist
®
days of use. However, weaning could be delayed beyond the normal use for
temporary support as an unintended consequence of continued instability of
the patient's hemodynamics. Inability to wean the patient from the device
within a reasonable time frame should result in consideration of a more
durable form of left ventricular support. The LVEDP/CO Trend can be used
while weaning. Refer to the Automated Impella Controller Instructions for
Use document for more information.
The following weaning instructions are provided as guidance only.
RAPID WEANING
1.
Initiate rapid weaning by decreasing catheter P-level in 2-level steps
at intervals of several minutes (for example, P-6 to P-4 to P-2). Do
NOT decrease P-level to below P-2 until just before removing the
catheter from the ventricle.
2.
When the P-level has been reduced to P-2, maintain the patient on
P-2 support for at least 10 minutes before discontinuing circulatory
support.
3.
If the patient's hemodynamics remain stable, decrease the P-level
to P-1, pull the catheter into the aorta, and stop the motor by
decreasing the P-level to P-0.
4.
Explant the catheter.
5.
Follow institutional guidelines for arterial closure.
6.
Disconnect the connector cable from the Automated Impella
Controller and turn the controller off by pressing the power switch on
the side of the controller for 3 seconds.
14
has been approved for ≤ 29
®
SLOW WEANING
1.
Initiate slow weaning by decreasing catheter P-level in 2-level steps
over time as cardiac function allows (for example, P-6 to P-4 to P-2).
Do NOT decrease P-level to below P-2 until just before removing the
catheter from the ventricle.
2.
When the P-level has been reduced to P-2, maintain the patient on
P-2 support until the patient's hemodynamics remain stable before
discontinuing circulatory support.
3.
If the patient's hemodynamics remain stable, decrease the P-level to
P-1, pull the catheter into the aorta, and stop the motor by decreasing
the P-level to P-0.
4.
Explant the catheter.
5.
Follow institutional guidelines for arterial closure.
6.
Disconnect the connector cable from the Automated Impella
Controller and turn the controller off by pressing the power switch on
the side of the controller for 3 seconds.
REMOVING THE IMPELLA 5.5
SMARTASSIST
CATHETER
®
The Impella Catheter can be removed after weaning when the introducer is
still in place or when the catheter is secured with the repositioning sheath.
REMOVING THE IMPELLA CATHETER WITH THE INTRODUCER
IN PLACE
1.
Remove the Impella Catheter through the introducer.
2.
Wait until ACT drops below 150 seconds.
3.
When ACT is below 150 seconds, remove the introducer.
REMOVING THE IMPELLA CATHETER SECURED WITH THE
REPOSITIONING UNIT
1.
When ACT is below 150 seconds, remove the Impella Catheter and
repositioning unit together (the catheter will not come through the
repositioning unit).
VASCULAR GRAFT CLOSURE
When closing the vascular graft, consider individual patient characteristics
and select the strategy most consistent with an optimal clinical result. The
entire vascular graft can be removed if indicated, but it is not mandatory to
do so. Graft closure options include:
• Amputating the vascular graft and sewing the small end-to-side
remnant closed by hand
• Using a vascular stapler to close the graft near the surface of the
aorta
• Removing the complete graft with local patch closure, if necessary
OPERATING THE IMPELLA 5.5 WITH
SMARTASSIST CATHETER WITHOUT
HEPARIN IN THE PURGE SOLUTION
The Impella Catheter is designed to be operated with a purge solution that
contains heparin or sodium hydrogen carbonate to maintain the patency of
the Impella catheter's purge system.
The Impella Catheter has not been tested with any alternative anticoagulants,
such as direct thrombin inhibitors, in the purge solution. Use of alternative
anticoagulants may reduce the longevity or performance of the Impella
catheter.
WITH
®
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