10
7.3.1 Baseline Parameters
Step Procedure
1 Perform a supra-aortic angiogram with fluoroscopic view perpendicular to the aortic valve.
2
Evaluate the distance of the left and right coronary ostia from the aortic annulus in relation to the valve
frame height.
3 Introduce a pacemaker (PM) lead until its distal end is positioned in the right ventricle.
4 Set the stimulation parameters to obtain 1:1 capture, and test pacing.
7.3.2 Valvuloplasty
Refer to Edwards Balloon Catheter Instructions for Use (IFU) for information on device
preparation and handling.
Note: Rapid ventricular pacing should be performed when using the Edwards Balloon Catheter for
valvuloplasty prior to aortic transcatheter valve implantation.
After placement of the balloon at the intended site, begin rapid ventricular pacing. Once the systolic blood
pressure has decreased to 50 mmHg or below, balloon inflation can commence.
CAUTION: Valve implantation should not be carried out if the balloon cannot be fully inflated
during valvuloplasty.
7.3.3 Valve Delivery
Step Procedure
1
Prepare and insert the Edwards eSheath Introducer Set. Refer to the Edwards eSheath Introducer
Set IFU for information on device preparation and handling.
2 Insert the loader into the sheath until the loader stops.
3
Advance the Edwards Commander delivery system, with the Edwards logo facing up, through the
sheath until the valve exits the sheath. Retract the loader to the proximal end of the delivery system.
NOTE: Maintain the proper orientation of the flex catheter (with the Edwards logo facing up)
throughout the procedure.
CAUTION: If accessing femorally or via the iliac, the valve should not be advanced through
the sheath if the sheath tip is not past the aortic bifurcation.
CAUTION: To prevent possible leaflet damage, the valve should not remain in the sheath for
over 5 minutes.
4
In a straight section of the aorta, initiate valve alignment by disengaging the Balloon Lock and pulling
the balloon catheter straight back until part of the Warning Marker is visible. Do not pull past the
Warning Marker.
WARNING: To prevent possible damage to the balloon shaft, ensure that the proximal end of
the balloon shaft is not subjected to bending.
Engage the Balloon Lock.
Use the Fine Adjustment Wheel to position the valve between the valve alignment markers.
CAUTION: Do not turn the Fine Adjustment Wheel if the Balloon Lock is not engaged.
WARNING: Do not position the valve past the distal Valve Alignment Marker. This will prevent
proper valve deployment.
CAUTION: Maintain guidewire position in the left ventricle during valve alignment.
5
Advance the catheter and use the flex wheel, if needed, and cross the aortic valve.
NOTE: Verify the Edwards logo is facing up. The delivery system articulates in a direction
opposite from the flush port.
6
If additional working length is needed, remove the loader by unscrewing the loader cap and peeling
the loader tubing from the delivery system.
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