Abiomed Impella 5.0 Gebrauchsanweisung Seite 13

1cm
Catheter (with marking) Outlet Sensor
One-person technique
a. Advance the placement guidewire into the Impella
the fingers. This prevents pinching of the inlet area. The placement guidewire must exit the outlet
area on the inner radius of the cannula, and align with the straight black line on the catheter. The
catheter can be hyperextended as necessary to ensure the placement guidewire exits on the inner
radius of the cannula.
Two-person technique
b. The scrub assistant can help stabilize the catheter by holding the catheter proximal to the motor.
This will allow the implanting physician to visualize the inner radius. The placement guidewire must
exit the outlet area on the inner radius of the catheter and align with the straight black line on the
catheter. The physician can focus on advancing the placement guidewire and, if the cannula needs
to be hyperextended, the scrub assistant is available to assist.
7.
Make a transverse incision at the guidewire for the 21 Fr catheter. Use U-stitches instead of purse string
sutures to avoid stenosis of the vessel after explantation.
8.
Administer heparin and achieve ACT of at least 250 seconds.
9.
Insert the catheter into the vessel and advance along the 0.018 inch placement guidewire until resistance
is met at the proximal vessel loop.
10. Loosen the proximal vessel loop and advance the catheter into the vessel. When the motor housing is
entirely past the proximal vessel loop, temporarily tighten the loop to control bleeding.
11. Advance the repositioning sheath, located on the catheter shaft, through the incision and into the
femoral artery until bleeding is controlled. Secure the sheath outside of the vessel using the supplied
suture loop.
12. Stabilize the guidewire and repositioning sheath and advance the catheter through the sheath. Follow
the catheter under fluoroscopy as it is advanced into the left ventricle. (Refer to the following page of this
manual for information about waveforms displayed on the controller during placement.)
13. When the catheter is correctly positioned, slightly loosen the proximal vessel loop and remove the
0.018 inch guidewire. Leave at least 2 to 3 cm of the repositioning sheath inside the vessel.
14. Tighten the prepared U-stitches to seal the sheath.
15. Loosen the distal vessel loop. Then loosen the proximal vessel loop.
POSITIONING AND STARTING THE IMPELLA
1.
Confirm purge fluid is exiting the Impella Catheter.
2.
While the catheter is being advanced in the aorta, the initial placement signal is flat. The inlet area of the
catheter has not passed the aortic valve.
3. Gently advance the catheter forward until a pulsatile waveform is present on the placement signal
screen. This signal is generated when the inlet area of the catheter crosses the aortic valve.
4. Confirm that the controller displays a pulsatile waveform and the inlet area of the Impella
is approximately 3.5 cm below the aortic valve.
Impella 5.0 S/N: 123456
2016-07-22 10:09
60
-20 10 sec.
5. Press the START IMPELLA soft button.
Impella ® 5.0 Circulatory Support System
Inlet Pigtail Guidewire
® 5.0 Catheter and stabilize the cannula between
AIC S/N: IC4186 AIC V5.1
Placement
Signal
(mmHg)
35/2
(17)
5.0 CATHETER
®
5.0 Catheter
®
GP IIb-IIIa Inhibitors
If the patient is receiving a
GP IIb-IIIa inhibitor, the Impella
®
5.0 Catheter can be inserted
when ACT is 200 or above.
Do NOT Touch Inlet or
Outlet Areas
While feeding the Impella 5.0
®
Catheter through the femoral
artery, hold the device at the
cannula or motor housing. Do
NOT touch the inlet area or the
outlet area.
Maintaining ACT
After insertion of the catheter
(and until explant), ACT should
be maintained at 160 to 180
seconds.
Importance of Proper
Impella ® 5.0 Catheter
Placement
When the Impella 5.0 Catheter
®
is not correctly placed, there is
no effective unloading of the
ventricle (hydraulic short circuit).
The patient may not be profiting
from the flow rate shown on the
controller.
Confirming Differential
Pressure Sensor Zero
If the lower value of the
differential pressure signal is not
within 6 mmHg of 0 when the
Impella ® 5.0 Catheter is in place
across the aortic valve, zero the
differential pressure sensor.
Check Positioning at P-9
When the P-level is increased to
P-9, the Impella ® 5.0 Catheter
has a tendency to be drawn into
the ventricle. Check positioning
at P9 to ensure proper placement
throughout the P-level setting
range.
11