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18. Using heavy silk suture, secure the graft around the blue suture hub so
that the position of the Impella Catheter can still be adjusted. Remove
the vascular clamp adjacent to the axillary artery.
19. The wound should be closed over the trimmed graft with the end of the
blue suture hub clearly visible. Anchor the hub securely to the skin.
20. If there is slack in the catheter, remove the excess slack. Verify placement
with fluoroscopy and with the placement signal. If the Impella 5.5
Catheter advances too far into the left ventricle and the controller
displays a ventricular waveform rather than an aortic waveform, follow
steps a-c below.
a) Pull the catheter back until an aortic waveform is present on the
placement screen.
b) When the aortic waveform is present, pull the catheter back an
additional 3cm for Impella 5.5 with SmartAssist. (The distance
between adjacent markings on the catheter is 1 cm.)
c) The catheter should now be positioned correctly.
21. Pull the yellow pin from the catheter anchor to secure the catheter in
place. Discard the yellow pin. Extend the sterile sleeve to maximum
length and secure the end closest to the red Impella plug by tightening
the anchoring ring.
ALTERNATE INSERTION TECHNIQUE USING A SIDEARM
GRAFT & SILICONE PLUGS
1.
After exposing the axillary artery and making the incision as described in
the steps above, prepare a polyester fiber woven vascular graft (10 mm)
by beveling the end of the graft at least 60 degree angle.
2.
Tighten the distal and proximal vessel loops to control bleeding.
3.
Attach the vascular graft using the standard end-to-side anastomosis
4.
Assess the anastomosis for hemostasis.
5.
Attach a standard 6 Fr introducer to the distal end of the graft.
6.
Remove the vascular clamp on the graft and insert a 0.035 inch
diagnostic guidewire with a 4–6 Fr diagnostic catheter into the
introducer, taking care to center the wire and catheter in the center of
the hemostatic valve. Advance the guidewire and catheter into the left
ventricle.
7.
Remove the diagnostic guidewire and exchange it for the supplied 0.018
inch placement guidewire.
8.
Tighten the vessel loops to control bleeding and remove the 6 Fr
introducer.
9.
Moisten the Impella 5.5 Catheter and push one of the silicone plugs onto
the catheter shaft adjacent to the Impella 5.5 Catheter motor.
10. Backload the Impella 5.5 Catheter onto the 0.018 inch guidewire (as
described in the steps in previous step 11).
11. With the graft held at the base, place the Impella 5.5 Catheter into the
open end of the graft up to the level of the silicone plug.
12. Secure umbilical tape around the silicone plug.
8
13. Loosen both vessel loops and advance the Impella 5.5 Catheter along
the guidewire into the left ventricle until it is properly positioned.
To prevent device failure, do not start the Impella 5.5 Catheter until
the placement guidewire has been removed.
Do NOT remove the Impella 5.5 Catheter over the length of the
placement guidewire.
14. Remove the guidewire.
15. Place a soft-jawed clamp at the anastomosis and remove the silicone
plug.
16. Trim any excess graft and slide the repositioning sheath into position.
17. Using a heavy silk tie or umbilical tape, secure the graft around the blue
hub of the repositioning sheath.
18. Close the wound over the trimmed graft with the end of the blue suture
hub clearly visible. The steering catheter for the Impella 5.5 can be
manipulated if needed by unsecuring the repositioning unit and moving
the catheter in or out.
19. If there is slack in the catheter, remove the excess slack. Verify placement
with fluoroscopy and with the placement signal. If the Impella 5.5
Catheter advances too far into the left ventricle and the controller
displays a ventricular waveform rather than an aortic waveform, follow
steps a-c below.
a) Pull the catheter back until an aortic waveform is present on the
placement screen.
b) When the aortic waveform is present, pull the catheter back an
additional 3cm for Impella 5.5 with SmartAssist. (The distance
between adjacent markings on the catheter is 1 cm.)
c) The catheter should now be positioned correctly.
20. Pull the yellow pin from the catheter anchor to secure the catheter in
place. Discard the yellow pin. Extend the sterile sleeve to maximum
length and secure the end closest to the red Impella
the anchoring ring.
DIRECT AORTIC INSERTION WITH
AXILLARY INTRODUCER
NOTE – Proper surgical procedures and techniques are the
responsibility of the medical professional. The described
procedure is furnished for information purposes only. Each
physician must evaluate the appropriateness of the procedure
based on his or her medical training and experience, the type of
procedure, and the type of systems used.
Avoid manual compression of the inlet, outlet, or sensor areas of the
cannula assembly.
Do NOT kink or clamp the Impella Catheter with anything other than a soft
jaw vascular clamp. Do NOT kink or clamp the peel-away introducer.
Handle with care. The Impella 5.5 Catheter can be damaged during
removal from packaging, preparation, insertion, and removal. Do NOT
bend, pull, or place excess pressure on the catheter or mechanical
components at any time.
The Impella 5.5 Catheter is surgically inserted when there is access to the
ascending aorta through a sternotomy or thoracotomy. Transesophageal
echocardiography (TEE) is required to guide placement.
plug by tightening
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