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7.
Insert a diagnostic catheter (Abiomed recommends a 6 Fr AL1 or
Multipurpose without side holes or 4–5 Fr pigtail with or without
side holes) over a 0.035 inch diagnostic guidewire into the
introducer and advance it into the left ventricle.
Figure 1.10
8.
Remove the 0.035 inch diagnostic guidewire, leaving the diagnostic
catheter in the ventricle. Form a curve or bend on the end of the
0.018 inch, 260 cm placement guidewire. Place the shaping tool
just distal to the weld separating the shaping ribbon from the body
of the placement guidewire. Bend the shaping ribbon against the
tool, using minimal force. Do NOT use a shaping tool with a sharp
tip or edge. Do NOT pull the shaping tool along the length of the
shaping ribbon as this could strip the coil off the guidewire and
cause it to unfurl and separate. Inspect the coil and guidewire for
damage after shaping and before using.
9.
Advance the placement guidewire into the apex of the left ventricle.
10. Remove the diagnostic catheter.
11. Slide the repositioning sheath towards the red pump plug prior
to insertion.
To backload the catheter using the EasyGuide lumen
12. Insert the placement guidewire into the red EasyGuide lumen at
the tip of the pigtail. (Once you remove the EasyGuide lumen
from the Impella Catheter, do not attempt to reinsert it. If
the catheter does not have a red EasyGuide lumen, follow
the procedure outlined in step 13.)
a. Advance the guidewire until it exits the red lumen near the
label.
b. Remove the EasyGuide lumen by gently pulling the label while
holding the Impella Catheter.
c. If you suspect that a portion of the red lumen remains in the
catheter, do NOT use the Impella Catheter. Measure red lumen
length using catheter markings (intact length is between 21.5
cm and 22.5 cm).
d. Skip to step 14 if the catheter is successfully backloaded on the
guidewire.
Figure 1.11
To backload the catheter without the EasyGuide lumen
13. 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.
6
One-person technique
a.
Advance the guidewire into the Impella Catheter and stabilize
the cannula between the fingers as shown in figure above. 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 below. The
cannula can be hyperextended as necessary to ensure the guide-
wire 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 below. The
physician can focus on advancing the guidewire and, if the cannula
needs to be hyperextended, the scrub assistant is available to assist.
Figure 1.12
14. Advance the catheter through the hemostatic valve into the femoral
artery 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.
15. Remove the placement guidewire.
16. Confirm position with fluoroscopy and confirm that an aortic
waveform is displayed on the Automated Impella Controller.
POSITIONING AND STARTING THE
IMPELLA CATHETER
When the Impella Catheter is not correctly placed, there is no effective
unloading of the ventricle. The patient may not be benefiting from the flow
rate shown on the controller.
1.
Reconfirm that the placement guidewire has been removed. Also
reconfirm that the controller displays an aortic waveform and the
radiopaque marker band is located at the aortic valve.
2.
Press the START IMPELLA soft button. Press the YES soft button
to confirm after wire is removed. The Impella will start in AUTO and
automatically increase the flow rate over 30 seconds.
3.
Once the controller has begun to run in AUTO, pressing the FLOW
CONTROL soft button again opens the FLOW CONTROL menu
with options for AUTO, and P-levels ranging from P-0 to P-9.
4.
Wait 30 seconds for flow to reach its maximum value, then confirm
correct and stable placement. Evaluate the catheter position in
the aortic arch and remove any excess slack. The catheter should
align against the lesser curvature of the aorta rather than the
greater curvature. Verify placement with fluoroscopy and with the
placement screen.
5.
Reposition the catheter as necessary under fluoroscopy.
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