Outflow Graft Attachment; Pump Implantation Preparation; Left Ventricle (Lv) Apex Cannulation - HeartWare Ventricular Assist System Instructions For Use Manual

Figure 68: Strain relief over outflow graft
Figure 69: Stretch outflow graft over pump
outflow conduit
Figure 70: Rotate clamp screw to inner side of
outflow conduit
Ventricular Assist System

14.3 Outflow Graft Attachment

Examine the outflow graft package. It must be unopened and without visible damage.
1)
WARNING: Gel impregnated polyester vascular prostheses should not be implanted in patients who exhibit
sensitivity to polyester or materials of bovine origin.
2) Open the package aseptically, talking care not to contaminate the sterile graft.
Pass the outflow graft onto the sterile field.
3)
CAUTION:
The foil pouch and outer tray are not sterile. Only the innermost tray may be introduced to the sterile field.
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DO NOT preclot. Gelweave prostheses are sealed grafts and must not be preclotted.
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The Gelweave prostheses must be implanted within one month after removal from the foil pouch.
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CAUTION: Outflow graft attachment to the pump should be performed by a surgeon, physician's assistant or
surgical assistant trained in the procedure.
4) Slide the strain relief over the outflow graft (Figure 68). Next, stretch the outflow graft over the HVAD
conduit (Figure 69). Hemostats can be used to assist with the procedure. Verify that the outflow graft is not kinked or
twisted. If necessary reattach graft if kinking or twisting occurs.
CAUTION: Excessive tension or force should be avoided as it will damage the polyester fibers and the gelatin
impregnation.
5) Loosen the graft clamp screw and place the graft clamp over the lip of the HVAD
the clamp screw is on the outflow conduit and attached to the graft clamp.
Tighten the clamp screw slightly with the hex driver, then rotate the strain relief so that clamp screw is located on the
6)
inner side of the outflow conduit (Figure 70). Finish tightening the clamp screw until resistance is met.
Rotate the strain relief so that the clamp screw is located on the inner side of the outflow conduit to avoid
◗ ◗
tissue irritation or damage.
DO NOT use excessive force when tightening the clamp screw because this could damage the graft clamp
◗ ◗
or the graft clamp screw. Replace components if required.
7) Gently pull on the outflow graft to verify secure placement of the graft clamp to the outflow conduit.
8) Inspect the outflow graft and strain relief for any kinks or twisting. Reattach the outflow graft if necessary.
9) Clamp the HVAD Pump outflow graft with a vascular clamp and wrap it all in a clean towel.
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14.4 Pump Implantation Preparation

Make a standard median sternotomy incision.
1)
2) Open the pericardium to expose and access the LV apex.
Consider a transesophageal echocardiography (TEE) prior to placing the patient on cardiopulmonary bypass to assess
3)
for a patent foramen ovale (PFO). If present, correct the defect prior to HVAD
4) Consider flooding the field with CO

14.5 Left Ventricle (LV) Apex Cannulation

Elevate the LV apex.
1)
Select the insertion site for the HVAD
2)
pointing to the mitral valve and parallel to the interventricular septum. Evaluate where the HVAD
implanted. If it appears it will directly contact adjacent rigid structures such as the chest wall consider placing the pump
on the diaphragmatic surface, opening the left pleural space, or wrapping it in a sheet of PTFE.
CAUTION: Optimal inflow cannula position is toward the mitral valve and parallel to the interventricular
septum.
Attach the sewing ring to the myocardium using 8-12 pledgeted, double-armed polypropylene sutures. Use felt
3)
strips or a felt ring for reinforcement if necessary.
CAUTION:
Position the sewing ring to permit access to its screw after cannulation.
WARNING
when appropriate to reduce residual intracardiac air during surgery.
2
Pump inflow cannula. It should be anterior to the LV apex with the inflow cannula
®
® Pump outflow
® Pump outflow conduit. Verify that
Pump implantation.
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® Pump will sit when
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Instructions For Use 25