Abiomed Impella 5.0 Manual Del Usuario página 8

INSERTING AND STARTING THE
IMPELLA 5.0 CATHETER
®
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. This describes the
femoral insertion procedure. For using the Axillary Insertion
Kit please consult the Axillary insertion Kit User Manual. If the
Impella Catheter is used in the OR as part of open heart surgery,
manipulation may be performed only at the access site. Direct
manipulation of the catheter assembly through the aorta or
ventricle may result in serious damage to the Impella Catheter and
serious injury to the patient.
When using a pigtail diagnostic catheter with side holes, ensure
that the guidewire exits the end of the catheter and not the side
hole. To do so, magnify the area one to two times as the guidewire
begins to exit the pigtail.
During placement of the Impella Catheter, take care to avoid
damage to the inlet area while holding the catheter and loading
the placement guidewire.
1. Identify the femoral artery and perform a cut-down of 3 to 5 cm.
2.
Expose the femoral artery. Wrap vessel loops, one distal and one
proximal to the subsequent point of incision, one and a half times
around the artery. Make the vessel loops as far apart as possible.
Guidewire U-Stitches
Distal Vessel Loop
3.
To prepare the repositioning sheath, remove the luer plug at the end
of the sidearm tube and flush the tube with 0.9% NaCl solution.
Place the luer plug back in the sidearm tube and secure the plug.
4.
Make the incision as close as possible to the distal loop. Insert a 6 Fr
diagnostic catheter with no side holes (Abiomed recommends a 6 Fr
AL1 or Multipurpose without side holes or 5 Fr pigtail without side
holes) over a diagnostic 0.035 inch or 0.038 inch guidewire into the
left ventricle.
5. Remove the diagnostic guidewire and exchange it for the supplied
0.018 inch placement guidewire.
6. Hold tension on the proximal vessel loop to prevent bleeding.
Straighten the blue pigtail and thread it over the 0.018 inch placement
guidewire. Wet the cannula with sterile water and backload the
catheter onto the placement guidewire. One or two people can load
the catheter on the guidewire.
1cm
Catheter (with marking) Outlet Sensor
6
Femoral Artery Proximal Vessel Loop
Inlet Pigtail Guidewire
One-person technique
a. Advance the placement guidewire into the Impella 5.0 Catheter
and stabilize the cannula between 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.
User Manual