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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.
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.
10
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.
POSITIONING AND STARTING THE
IMPELLA 5.5
WITH SMARTASSIST
®
CATHETER
When the Impella 5.5 with SmartAssist Catheter is not correctly placed, there
is no effective unloading of the ventricle (hydraulic short circuit). The patient
may not be benefiting from the flow rate shown on the controller.
Retrograde flow will occur across the aortic valve if the flow rate of
the Impella Catheter is less than 0.5 L/min.
1.
Reconfirm that the placement guidewire has been removed and
Confirm that the controller displays a pulsatile waveform and the
cannula bend at the aortic valve annulus, placing inlet approximately
5 cm deep into ventricle. (See step 6 if the controller displays a
ventricular waveform.)
2.
Press START IMPELLA soft button to open the P-level menu. Turn
the selector knob to increase the P-level from P-0 to P-2.
3.
Press the selector knob to select the new P-level. Increase the P-level
to P-9 to confirm correct and stable placement.
4.
Evaluate the catheter position in the aortic arch. If there is slack in the
catheter, press and hold the anchor button, remove the excess slack, and
release the anchor button. The catheter should align against the lesser
curvature of the aorta rather than the greater curvature. Verify placement
with fluoroscopy and with the placement signal screen. Note: When
repositioning the catheter ensure there is enough slack in the anti-
contamination sleeve to allow for easy movement of the catheter.
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