Abiomed Impella 2.5, Инструкция по эксплуатации

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5.16 Instructions for Use & Clinical Reference Manual (US)
WIRELESS INSERTION OF THE IMPELLA
®
2.5 CATHETER
OVERVIEW
Physicians should exercise special care when inserting the Impella
®
Catheter
in patients with known or suspected unrepaired abdominal aortic aneurysm or
significant descending thoracic aortic aneurysm or dissection of the ascending,
transverse, or descending aorta.
Physicians have developed a wireless technique as an alternative to the standard insertion
method for the Impella
®
2.5 Catheter. This technique eliminates several of the steps in the
traditional insertion method.
WIRELESS INSERTION TECHNIQUE
1.
Place a 13 Fr introducer in the usual manner.
2. Administer heparin. When the ACT is above 250 seconds, remove the 13 Fr dilator.
3.
Straighten the pigtail at the end of the Impella
®
2.5 Catheter by hand and advance it
through the hemostatic valve. Advance the catheter in small steps to avoid kinking.
4.
Track the catheter through the descending aorta using fluoroscopy. Maintain the pigtail
curve on the medial aspect of the aorta closer to the spine.
5.
When the pigtail reaches the aortic valve, rest the pigtail against the medial cusp and
continue to advance it until the catheter begins to prolapse.
6. Pull back while turning the catheter clockwise, allowing it to advance (“pop”) across
the aortic valve.
7.
If the catheter fails to advance across the valve, pull back, twist 45°, and repeat the
process.
RECOMMENDATIONS FOR HANDLING THE IMPELLA
®
2.5 CATHETER
During wireless insertion of the Impella ® 2.5 Catheter, avoid twisting the catheter more than
360°. Doing so will tangle the connector cable and purge tubing. To reduce the likelihood of
twisting or stressing the clear sidearm, ensure that the clear sidearm is clipped to the connector
cable and is rotating with the red Impella plug. When in the initial set-up configuration, carefully
inspect the catheter for kinking. In this configuration, occlusion alarms will not sound.
If the Impella ® 2.5 Catheter must be removed from the patient, carefully rinse the catheter with
heparinized saline solution to prevent blood from clotting on it when it is exposed to air. Use a
new, clean basin to ensure the catheter will not come in contact with any loose fibers that could
interfere with the operation of the motor.
Wireless Insertion
The Impella
®
2.5 Catheter
must be visualized at all times.
Do NOT apply excessive
force on the catheter when
advancing it across the
aortic valve. The spring
characteristics and robust
catheter design should make
it easy for the catheter to
cross the aortic valve and
move into position.
1. 1.
Place a 13 Fr introducer in the usual manner.
2. 2. Administer heparin. When the ACT is above 250 seconds, remove the 13 Fr dilator.
3. 3.
Straighten the pigtail at the end of the Impella
®
2.5 Catheter by hand and advance it
through the hemostatic valve. Advance the catheter in small steps to avoid kinking.
4. 4.
Track the catheter through the descending aorta using fluoroscopy. Maintain the pigtail
curve on the medial aspect of the aorta closer to the spine.
5. 5.
When the pigtail reaches the aortic valve, rest the pigtail against the medial cusp and
continue to advance it until the catheter begins to prolapse.
6. 6. Pull back while turning the catheter clockwise, allowing it to advance (“pop”) across
the aortic valve.
7. 7.
If the catheter fails to advance across the valve, pull back, twist 45°, and repeat the
process.
Unsuccessful Wireless
Insertion
Persistent unsuccessful
attempts at wireless insertion
of the Impella
®
2.5 Catheter
will require reverting to the
standard wired procedure.