Abiomed Automated Impella Controller Manual De Usuario página 24

PATIENT MANAGEMENT OVERVIEW
The following section addresses left-heart support with Impella 2.5, Impella
CP, Impella CP with SmartAssist, Impella LD, Impella 5.0, or Impella 5.5
with SmartAssist heart pumps only. Please refer to the Impella RP User
Manual for right-heart support. The information and instructions in this
section are not intended to supersede established medical procedures
concerning patient care. Best practices−as determined by the medical
community−should always be observed. In each case, the clinician must
determine whether the application of information provided is appropriate
for the particular clinical setting.
PATIENT SELECTION FOR LEFT-
VENTRICULAR SUPPORT
INITIAL PATIENT DECISION: PCI VS. CABG
Per the ESC/EACTS guidelines, there should be an initial overall decision
around patient selection relative to the index procedure being CABG or
PCI. The PCI indication is a medical decision and should be made by a heart
team according to institution standards, current practice of medicine, and
societal ESC/EACTS guidelines. This involves a multidisciplinary approach
composed of clinical or non-invasive cardiologists, cardiac surgeons, and
interventional cardiologists, as well as anaesthetists and other specialists, if
deemed necessary.
Impella Patient Decision
For the use of the Impella 2.5 and the Impella CP, the patient would be
deemed an appropriate candidate for high-risk PCI as defined by the
inclusion/exclusion criteria contained in the heart pump's IFU.
GENERAL PATIENT CARE CONSIDERATIONS
• Use knee immobilizer as needed to maintain access site straight.
• Access site management should be done in accordance with hospital
protocol, using aseptic technique.
• Assess access site for bleeding and hematoma.
• Monitor pedal pulses.
• To prevent the purge tubing from kinking, do not allow the red
Impella plug to hang freely from the catheter and do not bend the
catheter near the red Impella plug.
• Consider attaching the red Impella plug and catheter to a short
armboard to prevent the catheter from kinking near the plug.
• When transferring a patient with the device in place: Be careful not
to pull on the Impella Catheter when transferring a patient from one
bed to another.
- Do not raise the head of the bed to higher than a 30-degree
angle.
- Use care when moving or turning a patient; the Impella Catheter
may move out of position and cause a positioning alarm.
- ACT 160-180 seconds
RIGHT HEART FAILURE
Caregivers should monitor patients being supported by the left-ventricular
Impella Catheter for signs of right heart failure:
• Reduced output from the Impella Catheter
• Suction alarms
• Elevated filling pressures (CVP)
• Signs of liver failure
• Elevated pulmonary pressures
If the patient is exhibiting signs of right heart failure, the clinical team
should assess the need for a more durable form of support.
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USE OF ECHOCARDIOGRAPHY FOR
POSITIONING IMPELLA CATHETER IN THE
LEFT VENTRICLE
BACKGROUND
Echocardiography is a commonly used tool for evaluating the position of
the Impella Catheter relative to the aortic valve and other intraventricular
structures post-placement. The best echocardiographic views for
positioning the Impella Catheter in the left ventricle are a long axis
transesophageal echocardiogram (TEE) or a parasternal long axis
transthoracic echocardiogram (TTE). These long axis views allow you to
see both the aortic valve and Impella Catheter inlet area.
Evaluate the position of the Impella Catheter if the Automated Impella
Controller displays position alarms or if you observe lower than expected
flows or signs of hemolysis. If the catheter does not appear to be correctly
positioned, initiate steps to reposition it. The following illustrations
identify the structures you would expect to see in transesophageal
echocardiography (top) and transthoracic echocardiography (bottom).
In these illustrations, the Impella Catheter is positioned correctly; however,
these depictions are stylized. In actual echocardiograms, the pigtail and
inlet and outlet areas may not be seen as distinctly.
The graphics in this section depict the Impella 2.5 Catheter, but are
representative of positioning for the Impella CP, Impella CP with
SmartAssist, and Impella 5.0 catheters, as well. Positioning for the Impella
LD and Impella 5.5 Catheters would also look similar, but without the
pigtail.
LA
Mitral valve
Location of mitral
chordae
Papillary
muscle
LV
Figure 8. Transesophageal Echocardiogram (TEE) of Impella
Catheter
Impella® Catheter
RV
inlet area
Papillary
muscle
LV
Location of
mitral chordae
Figure 9. Transthoracic Echocardiogram (TTE) of Impella
Catheter
Impella® Catheter
outlet area
Aortic valve
RV
Impella® Catheter
inlet area
Septum
Impella® Catheter
outlet area
Aorta
LA
Mitral valve
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