• Balloon catheter per the discretion of the physician
• 20 cc syringe or larger
• 50 cc syringe or larger
• High-pressure 3-way stopcock
• Standard cardiac catheterization lab equipment and supplies, and
access to standard heart valve operating room equipment and supplies
• Fluoroscopy (fixed, mobile or semi-mobile fluoroscopy systems
appropriate for use in percutaneous coronary interventions)
• Transthoracic echocardiography capabilities
• Exchange length 0.035 in (0.89 mm) stiff guidewire
• Temporary pacemaker (PM) and pacing lead, per the discretion of the
physician
• Sterile rinsing basins; physiological saline, heparinized saline, and 15%
diluted radiopaque contrast medium
• Sterile table for THV and accessories preparation
8.2 THV Handling and Preparation
Follow sterile technique during device preparation and implantation.
8.2.1 THV Rinsing Procedure
Before opening the valve jar, carefully examine for evidence of damage
(e.g., a cracked jar or lid, leakage, or broken or missing seals).
CAUTION: If the container is found to be damaged, leaking, without
adequate sterilant, or missing intact seals, the THV must not be used
for implantation, as sterility may be compromised.
1.
Set up two (2) sterile bowls with at least 500 ml of sterile
physiological saline to thoroughly rinse the THV.
2.
Carefully remove the valve/holder assembly from the jar without
touching the tissue. Verify the valve serial identification number with
the number on the jar lid and record in the patient information
documents. Inspect the valve for any signs of damage to the frame
or tissue.
3.
Rinse the THV as follows:
a) Place the valve in the first bowl of sterile, physiological saline. Be
sure the saline solution completely covers the THV and holder.
b) With the valve and holder submerged, slowly agitate (to gently
swirl the valve and holder) back and forth for a minimum of 1
minute.
c) Transfer the THV and holder to the second rinsing bowl of
physiological saline and gently agitate for at least one more
minute. Ensure the rinse solution in the first bowl is not used.
d) The valve should be left in the final rinse solution until needed to
prevent the tissue from drying.
CAUTION: Do not allow the valve to come into contact with the
bottom or sides of the rinse bowl during agitation or swirling in
the rinse solution. Direct contact between the identification tag
and valve is also to be avoided during the rinse procedure. No
other objects should be placed in the rinse bowls. The valve
should be kept hydrated to prevent the tissue from drying.
8.2.2 Prepare the System
Refer to the Edwards sheath, GORE DrySeal Flex Introducer Sheath, and
Balloon Catheter instructions for use for device preparation.
1.
Visually inspect all the components for damage. Ensure the Edwards
COMMANDER delivery system is fully unflexed and the balloon
catheter is fully advanced in the flex catheter.
WARNING: To prevent possible damage to the balloon shaft,
ensure that the proximal end of the balloon shaft is not
subjected to bending.
2.
Flush the flex catheter.
3.
Carefully remove the distal balloon cover from the delivery system.
4.
Remove the stylet from the distal end of the guidewire lumen and
set aside. Flush the guidewire lumen with heparinized saline and
insert the stylet back into the distal end of the guidewire lumen.
Note: Failure to replace the stylet in the guidewire lumen may
result in damage to the lumen during crimping process.
5.
Place the delivery system into the default position and make sure
that the flex catheter tip is covered by the proximal balloon cover.
6.
If using the Edwards provided sheath, unscrew the loader cap from
the loader tube and flush the loader cap. Place the loader cap over
the proximal balloon cover and onto the flex catheter with the inside
of the cap oriented towards the distal tip.
If using the GORE DrySeal Flex Introducer Sheath, proceed to step 7.
7.
Fully advance the balloon catheter in the flex catheter.
Peel off the proximal balloon cover over the blue section of the
balloon shaft.
8.
Attach a 3-way stopcock to the balloon inflation port. Fill a 50 cc or
larger syringe with 15-20 ml of diluted contrast medium and attach
to the 3-way stopcock.
9.
Fill the inflation device provided by Edwards Lifesciences with excess
volume relative to the indicated inflation volume. Lock the inflation
device and attach to the 3-way stopcock.
10. Close 3-way stopcock to the inflation device provided by Edwards
Lifesciences and de-air the system using the 50 cc or larger syringe.
Slowly release the plunger and leave zero-pressure in the system.
WARNING: Ensure there is no residual fluid left in the balloon to
avoid potential difficulty with valve alignment during the
procedure.
11. Close the stopcock to the delivery system. By rotating the knob of
the inflation device provided by Edwards Lifesciences, transfer the
contrast medium into the syringe to achieve the appropriate
volume required to deploy the valve, per the inflation parameters.
12. Close the stopcock to the 50 cc or larger syringe. Remove the
syringe. Verify that the inflation volume is correct and lock the
inflation device provided by Edwards Lifesciences.
CAUTION: Maintain the inflation device provided by Edwards
Lifesciences in the locked position until valve deployment.
8.2.3 Mount and Crimp the THV onto the Delivery System
8.2.3.1 Procedure with Edwards Provided Sheath
1.
Set up two (2) additional sterile bowls with at least 100 ml of sterile
physiological saline to thoroughly rinse the Qualcrimp crimping
accessory.
2.
Completely submerge the Qualcrimp crimping accessory in the first
bowl and gently compress it to ensure complete saline absorption.
Slowly swirl the Qualcrimp crimping accessory for a minimum of
1 minute. Repeat this process in the second bowl.
3.
Remove crimper from packaging.
4.
Rotate the crimper handle until the aperture is fully open.
5.
Remove the valve from the holder and remove the ID tag.
6.
Attach the 2-piece crimp stopper to the base of the crimper and click
into place.
7.
With the crimper in the open position, gently place the valve into the
crimper aperture. Gradually crimp the valve until it fits into the
Qualcrimp crimping accessory.
8.
Place the Qualcrimp crimping accessory over the valve making sure
the valve is parallel to the edge of the Qualcrimp crimping accessory.
9.
Place the valve and Qualcrimp crimping accessory in crimper
aperture. Insert the delivery system coaxially within the valve on the
Valve Crimp Section (2-3 mm distal to the balloon shaft) with the
orientation of the valve on the delivery system with the Inflow (outer
skirt end) of the valve towards the proximal end of the delivery
system.
10. Crimp the valve until it reaches the Qualcrimp stop located on the
2-piece Crimp Stopper.
11. Gently remove the Qualcrimp crimping accessory from the valve.
Remove the Qualcrimp stop from the Final Stop, leaving the Final
Stop in place.
12. Fully crimp the valve until it reaches the Final Stop.
Note: Ensure that the Valve Crimp Section remains coaxial
within the valve.
13. Repeat the full crimp of the valve two more times for a total of three
full crimps.
14. Pull the balloon shaft and lock in default position.
15. Flush the loader with heparinized saline. Immediately advance the
valve into the loader until the tapered tip of the delivery system is
exposed.
CAUTION: To prevent possible leaflet damage, the valve should
not remain fully crimped and/or in the loader for over
15 minutes.
16. Attach the loader cap to the loader, re-flush the delivery system
through the flush port and close the stopcock to the delivery
system.
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