Abiomed Impella 5.5, Руководство пользователя

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7 Impella 5.5
®
with SmartAssist
®
Circulatory Support System
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 a stiff 0.018 inch
placement guidewire. With the 0.018 inch placement guidewire properly
positioned in the left ventricle, remove the diagnostic catheter.
8.
Administer heparin per institutional protocol. When the ACT is greater
than or equal to 250 seconds, remove the dilator.
9.
Remove the protective sleeve on the provided 8 Fr silicone-coated
lubrication dilator, being careful to avoid getting silicone on your hands.
Insert the dilator into the introducer over the 0.018 inch placement
guidewire 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, keeping the 0.018 inch placement
guidewire in place.
10.
Clamp the graft with a vascular clamp just above the anastomosis to
avoid blood loss through the pump cannula during insertion through the
valve.
11.
While maintaining guidewire position, backload the Impella Catheter
onto the 0.018 inch placement guidewire and advance the catheter over
the guidewire 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.
12.
Remove the vascular clamp and continue inserting the Impella Catheter
into the aorta. Continue advancing across the aortic valve using
fluoroscopic imaging to properly position the cannula bend at the aortic
valve annulus, placing inlet approximately 5 cm deep into ventricle.
Remove the placement guidewire and initiate Impella Catheter support
as described later in this section.
13.
Clamp the graft adjacent to the axillary artery 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.
14.
Slide the repositioning sheath back to the red Impella plug.
NOTE:
For the 23F x 6cm peel-away introducer, it may be necessary to
pull the introducer over the repositioning sheath to remove the peel-away
completely from the artery
15.
To remove the introducer, release the graft lock by pressing the two
adjacent long tabs together as shown below and remove it from the
graft.
Releasing the Graft Lock
16.
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 sheath 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
comes apart. Continue to peel the two wings until the introducer is
completely separated from the catheter shaft.
17.
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.
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.
Attach the anticontamination sleeve to the blue suture hub. Lock the
anchoring ring in place by turning it clockwise. Secure the catheter
shaft in place by tightening the Tuohy-Borst. 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 Dacron
®
vascular graft (10 mm x 20 cm) by
beveling the end of the graft at a 45 to 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
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