Abiomed Impella 5.5 Manuel Utilisateur page 10

Do NOT kink or clamp the white portion of the Impella Catheter with cm
markings with anything other than a soft jaw vascular clamp.
Do NOT kink or clamp the peel-away introducer.
Proper positioning of the Impella Catheter is extremely important and it is
worthwhile to take extra time when positioning the catheter.
Take care to insert the guidewire with diagnostic catheter into the middle
of the hemostatic valve of the introducer to avoid tearing the valve.
When inserting the Impella Catheter into the introducer, take care to
insert it straight into the center of the introducer valve.
Be sure that the stopcock on the peel-away introducer is always kept in the
closed position. Significant bleed back can result if the stopcock is open.
The following steps describe the recommended technique for axillary artery
insertion of the Impella 5.5 with SmartAssist
®
1. Isolate and expose the axillary artery and obtain control via proximal and
distal vessel loops.
2.
Attach a 10 mm diameter vascular graft to the axillary artery using a
standard end-to-side anastomosis. NOTE: Abiomed recommends using
at least a 60 degree bevel on the end of the graft to facilitate passage of
the rigid motor housing into the artery.
3.
Clamp the graft with a vascular clamp just above the anastomosis and
loosen the vessel loops to allow blood to flow into the graft to assess for
hemostasis at the anastomosis.
4.
Insert the introducer into the graft and secure it with a provided graft
lock. 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. Correct positioning of the second graft lock is illustrated
below.
Introducer, Graft Lock, and Graft
Correct Positioning If Second Graft Lock Required
6
Catheter.
®
5.
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 below. 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.
Closing the Graft Lock
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 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.
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
User Manual