Abiomed Impella 5.5 Manuel Utilisateur page 12

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.
INSERTION PREPARATION
1.
Using the supplied sterile incision template for positioning, place a
sidebiter clamp on the aorta at least 7 cm above the valvular 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) at the insertion site on the ascending aorta.
NOTE: If using the silicone plugs rather than the axillary introducer, the
incision must be ≤ 6 mm in diameter 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 exit strategy (minimum length = 20 cm)) to the aorta using
the standard end-to-side anastomosis, beveling the graft to accomodate
the exit strategy. Externalize graft to the desired exit point.
4.
Clamp the graft with a vascular clamp just above the anastomosis and
assess for hemostasis at the anastomosis.
5.
Insert the introducer into the graft and secure it with one (1) or two (2)
provided graft locks. To place the graft lock, open it and place it between
the retainers and the hub on the introducer to prevent the introducer
from sliding out of the graft.
8
6.
Secure the graft lock by pressing both the outside tabs together. When
fully closed, the graft lock provides hemostasis. If hemostasis is not
achieved, make sure to press the two tabs together to fully close the
graft lock as shown above. The graft lock cannot be damaged by over
closing. NOTE: The graft may also be secured over the introducer using
heavy sutures or umbilical tape.
NOTE: If usage of a guidewire is desired insert it at this point. Otherwise
7. 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.
8. Remove the protective sleeve on the provided 8 Fr silicone-coated
® plug by tightening
lubrication dilator, being careful to avoid getting silicone on your hands.
Insert the dilator into the introducer to coat the hemostatic valve with
silicone oil to facilitate insertion of the Impella Catheter through the
hemostatic valve assembly. Once fully inserted, remove the dilator.
9.
Clamp the graft with a vascular clamp just above the anastomosis to
avoid blood loss through the pump cannula during insertion through the
valve.
10. Insert the Impella Catheter through the introducer into the graft such that
the entire pump cannula and motor housing resides in the graft and only
the catheter shaft is seen exiting the valve.
11. Remove the vascular clamp and continue inserting the Impella Catheter
into the aorta.
12. 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.
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. Clamp the graft adjacent to the ascending aorta with a soft jawed
vascular clamp or have an assistant apply digital pressure to control
bleeding at the base of the graft so that the introducer can be removed
and the graft shortened. NOTE: To ensure the soft jaw vascular clamp is
completely sealing over the graft and the 9 Fr catheter, open the sidearm
flush valve on the introducer and verify blood is not leaking from the
system.
16. Slide the repositioning sheath back to the red Impella plug.
17. To remove the introducer, release the graft lock by pressing the two
adjacent long tabs together as shown above and remove it from the
graft.
18. Slide the introducer fully out of the graft prior to peeling it away. To peel
the introducer off the catheter shaft, crack the hub by applying pressure
to the thumb tabs and then peel the introducer off the catheter. NOTE:
When breaking the hemostatic valve in the sheath hub, the valve may
stretch before separating.
a. Grasp the two "wings" and bend back until the valve assembly
19. 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.
proceed to step 7.
comes apart. Continue to peel the two wings until the introducer is
completely separated from the catheter shaft.
User Manual