Abiomed Impella 2.5, Instructions For Use Manual

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5.14 Instructions for Use & Clinical Reference Manual (US)
To backload the catheter without the EasyGuide lumen
10.
Wet the cannula with sterile water and backload the catheter onto the placement
guidewire. One or two people can load the catheter on the guidewire.
One-person technique
a.
Advance the guidewire into the Impella
®
Catheter and stabilize the cannula
between the fingers as shown in Figure 5.17. This prevents pinching of the inlet
area. The guidewire must exit the outlet area on the inner radius of the cannula
and align with the straight black line on the catheter as shown in Figure 5.17. The
cannula can be hyperextended as necessary to ensure the guidewire exits on the
inner radius of the cannula.
Two-person technique
b.
The scrub assistant can help stabilize the catheter by holding the catheter proximal
to the motor. This will allow the implanting physician to visualize the inner radius.
The guidewire must exit the outlet area on the inner radius of the cannula and
align with the straight black line on the catheter, as shown in Figure 5.17. The
physician can focus on advancing the guidewire and, if the cannula needs to be
hyperextended, the scrub assistant is available to assist.
Figure 5.17 Loading the Catheter on the Guidewire without the EasyGuide Lumen and
Aligning the Placement Guidewire
11.
Advance the catheter through the hemostatic valve into the femoral artery
(see Figure 5.18) and along the placement guidewire and across the aortic valve using
a fixed-wire technique. Follow the catheter under fluoroscopy as it is advanced across
the aortic valve, positioning the inlet area of the catheter 3.5 cm below the aortic
valve annulus and in the middle of the ventricular chamber, free from the mitral valve
chordae. Be careful not to coil the guidewire in the left ventricle.
10. 10.
Wet the cannula with sterile water and backload the catheter onto the placement
guidewire. One or two people can load the catheter on the guidewire.
Avoid Damaging Inlet
Area
During placement of the
Impella
® Catheter, take care
to avoid damage to the
inlet area while holding the
catheter and loading the
placement guidewire.
a. a.
Advance the guidewire into the Impella
®
Catheter and stabilize the cannula
between the fingers as shown in Figure 5.17. This prevents pinching of the inlet
area. The guidewire must exit the outlet area on the inner radius of the cannula
and align with the straight black line on the catheter as shown in Figure 5.17. The
cannula can be hyperextended as necessary to ensure the guidewire exits on the
inner radius of the cannula.
Impella
®
Catheter Use in
Open Heart Surgery
If the Impella ® Catheter
is used in the OR as part
of open heart surgery,
manipulation may be
performed only at the access
site. Direct manipulation
of the catheter assembly
through the aorta or ventricle
may result in serious damage
to the Impella
®
Catheter and
serious injury to the patient.
b. b.
The scrub assistant can help stabilize the catheter by holding the catheter proximal
to the motor. This will allow the implanting physician to visualize the inner radius.
The guidewire must exit the outlet area on the inner radius of the cannula and
align with the straight black line on the catheter, as shown in Figure 5.17. The
physician can focus on advancing the guidewire and, if the cannula needs to be
hyperextended, the scrub assistant is available to assist.
Positioning in Small
Hearts
If a patient has a smaller than
normal ventricular cavity, the
proper placement of the inlet
area of the catheter may be
3 cm (rather than 3.5 cm)
from the aortic valve.
11. 11.
Advance the catheter through the hemostatic valve into the femoral artery
(see Figure 5.18) and along the placement guidewire and across the aortic valve using
a fixed-wire technique. Follow the catheter under fluoroscopy as it is advanced across
the aortic valve, positioning the inlet area of the catheter 3.5 cm below the aortic
valve annulus and in the middle of the ventricular chamber, free from the mitral valve
chordae. Be careful not to coil the guidewire in the left ventricle.