Edwards Lifesciences SAPIEN 3 Instrucciones De Uso página 7

Step Procedure
12 Attach the loader cap to the loader, re-flush the Flex
Catheter and close the stopcock to the delivery system.
Remove the stylet and flush the guidewire lumen of the
delivery system.
CAUTION: Keep THV hydrated until ready for
implantation to prevent damage to the leaflets
which may impact valve functionality.
WARNING: The physician must verify correct
orientation of the THV prior to its implantation to
prevent the risk of severe patient harm.
7.4 Native Valve Predilation and THV Delivery
Native valve predilation and THV delivery should be performed under local
and/or general anesthesia with hemodynamic monitoring in a
catheterization lab/hybrid operating room with fluoroscopic and
echocardiographic imaging capabilities.
Administer heparin to maintain the ACT at ≥ 250 sec.
CAUTION: Contrast media usage should be monitored to reduce the
risk of renal injury.
Balloon valvuloplasty should be avoided in the treatment of failing
bioprostheses as this may result in embolization of bioprosthesis
material and mechanical disruption of the valve leaflets.
7.4.1 Baseline Parameters
Step Procedure
1 Perform an angiogram with the projection of the valve
perpendicular to the view.
2
For aortic implantation, evaluate the distance of the left and
right coronary ostia from the aortic annulus in relation to
the THV frame height.
3 Introduce a pacemaker (PM) lead and position
appropriately.
4 Set the stimulation parameters to obtain 1:1 capture, and
test pacing.
7.4.2 Native Valve Predilation
Refer to Edwards Transfemoral Balloon Catheter or equivalent Instructions for
Use.
7.4.3 THV Delivery
Step Procedure
1 Prepare the Edwards sheath introducer set per its
instructions for use.
2 If necessary, predilate the vessel.
3 Introduce the sheath per its instructions for use.
4 Insert the loader assembly into the sheath until the loader
stops.
Step Procedure
5 Advance the delivery system until the THV exits the sheath.
CAUTION: For iliofemoral access, the THV should not
be advanced through the sheath if the sheath tip is
not past the bifurcation to minimize the risk of vessel
damage.
CAUTION: The THV should not remain in the sheath for
over 5 minutes as leaflet damage may result and
impact valve functionality.
6 In a straight section of the vasculature, 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.
WARNING: If valve alignment is not performed in a
straight section, there may be difficulties performing
this step which may lead to delivery system damage
and inability to inflate the balloon. Utilizing
alternate fluoroscopic views may help with assessing
curvature of the anatomy. If excessive tension is
experienced during valve alignment, repositioning
the delivery system to a different straight section of
the vasculature and relieving compression (or
tension) in the system will be necessary.
Engage the Balloon Lock.
Utilize the Fine Adjustment Wheel to position the THV
between the Valve Alignment Markers.
Note: Do not turn the Fine Adjustment Wheel if the
Balloon Lock is not engaged.
WARNING: Do not position the THV past the distal
Valve Alignment Marker to minimize the risk of
improper THV deployment or THV embolization.
CAUTION: Maintain guidewire position during valve
alignment to prevent loss of guidewire position.
7 Utilize the Flex wheel to access and cross the valve.
Note: Verify the orientation of the Edwards logo to
ensure proper articulation.
Note: The delivery system articulates in a direction
opposite from the flush port.
8 Disengage the Balloon Lock and retract the tip of the Flex
Catheter to the center of the Triple Marker. Engage the
Balloon Lock.
9 Position the THV with respect to the valve.
10 As necessary, utilize the Flex wheel to adjust the co-axiality
of the THV and the Fine Adjustment Wheel to adjust the
position of the THV.
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