Abiomed Impella 5.5 Manuel Utilisateur page 13

20. 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 anastomosis.
21. 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.
22. 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.
23. 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 DIRECT AORTIC INSERTION TECHNIQUE WITH
SILICONE PLUGS
An incision larger than 6 mm may allow the front plug to advance into
the aorta.
1.
Using the supplied sterile incision template for positioning, place a
sidebiter clamp on the aorta at least 7 cm above the valve plane. An
incision too close to the aortic valve annulus could result in the catheter
outlet area in the graft rather than the aorta.
2.
Make an incision (or punch) no larger than 6 mm at the insertion site on
the ascending aorta. The incision must be ≤ 6 mm in length to prevent
the front silicone plug from advancing into the aorta through the
incision.
3. Attach the polyester fiber woven vascular graft (10 mm diameter, length
depending on strategy (minimum length = 20 cm)) to the aorta using
the standard end-to-side anastomosis, beveling the graft at least 60°.
Externalize graft to the desired exit point.
4. Administer heparin and achieve ACT of at least 250 seconds. NOTE:
Maintaining ACT at or above 250 seconds will help prevent a thrombus
from entering the catheter and causing a sudden stop on startup. *If the
patient is receiving a GP IIb-IIIa inhibitor, the Impella 5.5 Catheter can be
inserted when ACT is 200 or above.
5. When the anastomosis is complete, place a clamp at the distal end of
the graft and then release the proximal clamp at the base of the graft.
Examine the suture line for leaks and reclamp the graft at the base.
6.
Moisten the Impella 5.5 Catheter and push both silicone plugs up against
the motor housing as shown below.
Impella 5.5 Catheter with Silicone Plugs
7.
With the graft clamped at the base, place the Impella 5.5 Catheter into
the open end of the graft up to the level of the rear plug.
Impella 5.5 ® with SmartAssist ® Circulatory Support System
8.
When the catheter is in position, secure a tourniquet around the rear
silicone plug. Tighten the tourniquet sufficiently to control bleeding
around the rear plug while still allowing the catheter to slide through the
plug.
9. Release the clamp and advance the Impella 5.5 Catheter into the aorta.
10. If the patient is on cardiopulmonary bypass (CPB), allow the heart to fill
by restricting the return flow to the bypass machine and reducing CPB
flow to a minimum setting, as long as acceptable physiologic systemic
flow is maintained.
11. As soon as the motor housing has passed into the aorta, use a ligature to
loosely secure the front silicone plug flush to the graft. The silicone plug
should be in the most proximal portion of the graft. NOTE: There should
be no movement of the front silicone plug within the graft; however, the
catheter shaft should move without resistance within the plug. When
securing the front silicone plug to the graft, do not penetrate the silicone
plug too deeply as this could cause damage to the Impella 5.5 Catheter.
12. While the catheter is being advanced in the aorta, the initial placement
signal has the characteristics of an aortic placement signal. Do not allow
the front plug to advance beyond the base of the graft.
13. To aid in passing the catheter through the aortic valve, apply slight
pressure to the posterior aspect of the aortic valve to produce temporary
aortic insufficiency.
14. Continue advancing across the aortic valve using fluoroscopic and/or
TEE guidance to properly position the cannula bend at the aortic valve
annulus, placing inlet approximately 5 cm deep into the ventricle. Initiate
Impella Catheter Support as described later in this section.
15. Trim any excess graft and slide the blue suture hub into the graft. NOTE:
The hub should be at the skin level and the length of the remaining graft
material should be just long enough to secure the graft around the blue
suture hub with all of the graft buried beneath the skin.
16. 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 anastomosis.
17. 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.
18. If there is slack in the catheter, remove the excess slack. Verify placement
with fluoroscopy/TEE 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.
19. 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.
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