Abiomed Automated Impella Controller Manual Del Usuario página 27

OPERATING THE IMPELLA CATHETER
WITHOUT HEPARIN IN THE PURGE
SOLUTION
The Impella Catheter is designed to be operated with a purge solution that
contains heparin. Operation of the system without heparin in the purge
solution has not been tested. In the event that a patient is intolerant to
heparin, due to heparin-induced thrombocytopenia (HIT) or bleeding,
physicians should use their clinical judgment to assess the risks versus
benefits of operating the Impella System without heparin.
If it is in the best interest of the patient to operate the system without
heparin, the dextrose solution is still required, and physicians should
consider systemic delivery of an alternative anticoagulant. The Impella
Catheter has not been tested with any alternative anticoagulants in the
purge solution. Use of alternative anticoagulants may reduce the longevity
or performance of the Impella catheter.
Table Guide for Managing Hemolysis in Various Circumstances
Condition Controller Indicators
Impella inlet area in • "Impella Flow Reduced" or
close proximity to "Suction" alarms
intraventricular wall • Lower than expected flows
Wrong pump position • Position alarms with higher than
expected flows
• "Impella Flow Reduced" or
"Suction" alarms with lower than
expected flows
• Pump outlet blocked alarms
Higher than needed • There may be no controller
P-Level setting indicators
• "Impella Flow Reduced" or
"Suction" alarms
Inadequate filling • Position alarms
volume • "Impella Flow Reduced" or
"Suction" alarms
• Lower than expected flows
Pre-existing patient N/A
conditions or other
medical procedures
Note on imaging: All imaging technology represents the anatomy in two dimensions (2D). It is not possible to assess the interactions
between the catheter and the intraventricular anatomy that occur in three dimensions (3D). Abiomed strongly recommends that the catheter
be repositioned, even if the imaging view shows correct position.
Automated Impella Controller
HEMOLYSIS
When blood is pumped, it is subjected to mechanical forces. Depending
on the strength of the blood cells and the amount of force applied, the
cells may be damaged, allowing hemoglobin to enter the plasma. Pumping
forces can be generated by a variety of medical procedures including heart
lung bypass, hemodialysis, or ventricular assist device (VAD) support.
Patient conditions—including catheter position, pre-existing medical
conditions, and small left ventricular volumes—may also play a role in
patient susceptibility to hemolysis.
Hemolysis should be monitored during support. Patients who develop high
levels of hemolysis may show signs of decreased hemoglobin levels, dark
or blood-colored urine, and in some cases, acute renal failure. Plasma-free
hemoglobin (PfHgb) is the best indicator to confirm whether a patient is
exposed to an unacceptable level of hemolysis.
Management technique may differ depending on the underlying cause of
hemolysis. The following table provides guidance for various circumstances.
Clinical Indicators Management
Imaging (see note) • Reposition the catheter by rotating or moving the catheter into
or out of the ventricle slightly. Either or both of these actions
could help move the inlet of the catheter away from the
intraventricular wall.
• If repositioning will be delayed, reduce the P-level if tolerated
by patient hemodynamics. Return to the previous P-level after
repositioning.
• Reassess position after flow rate has returned to desired target
value.
Imaging (see note) • Reposition the catheter by rotating or moving the catheter into
or out of the ventricle slightly. Either or both of these actions
could help move the inlet of the catheter away from the
intraventricular wall.
• If repositioning will be delayed, reduce the P-level to P-2.
Return to the previous P-level after repositioning.
• Reassess position after flow rate has returned to desired target
value.
• Normal hemodynamics • Reduce P-level until patient pressure starts to drop.
• Native recovery • Slowly increase P-level.
• Low CVP • Reduce the P-level if tolerated by patient hemodynamics.
• Low PCWP • Correct I and O balance.
• Low AOP • Consider giving volume; additional volume will expand the end
• High PA pressures systolic ventricular volume.
• Right heart failure • Reduce PA pressure.
• High urine output • Improve right heart function.
• Increased bleeding or chest
tube drainage
• Patient past medical history
• Current procedures or
treatments
27