Abiomed Impella 2.5, Instructions For Use Manual

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5.52 Instructions for Use & Clinical Reference Manual (US)
7.
With the guidewire anchored and pressure applied to the access site, completely
remove the Impella
®
Catheter and repositioning sheath together.
EXPLANTING THE IMPELLA
®
LD CATHETER
PREPARATION FOR EXPLANT
1.
Gain exposure and clear access to the ascending aorta insertion site, the Dacron ®
vascular graft, and the sites at which the silicone plugs are secured to the graft.
2.
Complete the weaning procedure at P-2 as described previously.
3. Undo the penetrating suture from the front silicone plug and remove the suture entirely.
4.
Remove the ligature from the rear silicone plug and remove the plug from the end of
the vascular graft.
5.
Maintaining distal control digitally, remove the final circumferential ligature from the
front silicone plug.
6.
Allow controlled bleed-back through the graft to clear any residual thrombus from the
lumen of the graft.
PULLING THE IMPELLA
®
LD CATHETER INTO THE ASCENDING AORTA
Perform the following steps under the guidance of transesophageal echocardiography (TEE).
1.
Immediately prior to pulling the Impella ® LD Catheter across the aortic valve, reduce the
P-level to P-1.
2.
Carefully pull the Impella ® LD Catheter back through the aortic valve and into the
ascending aorta. Depending on the level of the insertion site, a portion of the catheter
may be pulled through the aortotomy and into the vascular graft.
3. Immediately reduce the P-level to P-0 after the Impella
®
LD Catheter crosses the aortic
valve and enters the ascending aorta.
4.
Gently pull the Impella
®
LD Catheter completely through the aortotomy and into the
vascular graft.
5.
Close the graft.
VASCULAR GRAFT CLOSURE
When closing the vascular graft, consider individual patient characteristics and select the
strategy most consistent with an optimal clinical result. The entire vascular graft can be removed
if indicated, but it is not mandatory to do so. Graft closure options include:
• Amputating the vascular graft and sewing the small end-to-side remnant closed by hand
• Using a vascular stapler to close the graft near the surface of the aorta
• Removing the complete graft with local patch closure, if necessary
Retrograde Flow
To avoid retrograde flow,
do
NOT
reduce the P-level
below P-2 while the Impella
®
LD Catheter is in the left
ventricle.
Catheter Removal
The Impella
®
LD Catheter
should only be removed when
the P-level is set to P-0.