Implanting The Valve; Deploying The Valve; Re-Sheathing The Valve (Optional) - Abbott Portico Gebrauchsanweisung

Remove any remaining air bubbles by gently sliding the leaflet tester from the top to the bottom of each leaflet.
CAUTION: Exercise care to avoid damaging the leaflets with the leaflet tester.
Inspect the valve to ensure that no leaflet tissue is trapped between the stent struts. If leaflet tissue is trapped between the stent
struts, use the narrow end of the leaflet tester to move the leaflets inside of the stent.
Grasp the shaft of the delivery system just below the loading tube while encapsulating the valve. Turn the deployment/re-sheath
wheel opposite the direction of the arrow on the handle until the valve is fully encased in the valve capsule.
NOTE: Ensure the distal end of the valve capsule remains below the black indicator line on the loading tube.
CAUTION: Do not use the device if excess force is required to turn the deployment/re-sheath wheel during
encapsulation.
CAUTION: Do not re-sheath the valve more than two times prior to final valve release. Additional re-sheath attempts may
compromise product performance.
If necessary, turn the micro adjustment wheel in the direction of the arrow to close any gaps between the valve capsule and the
radiopaque tip. Once the gap is closed, turn the micro adjustment wheel opposite the direction arrow, until the wheel stops.
Pour the saline out of the loading funnel.
Slide the loading funnel and loading tube off the distal end of the delivery system.
CAUTION: Inspect the valve capsule to ensure loading was successful. The surface should be smooth and free from
ridges or creases. If a device is found to be incorrectly loaded, replace the valve and delivery system with new
components.
Fill the syringe with sterile isotonic saline, and complete system de-airing as described below:
a. Flush the stability layer.
b. Slide the integrated sheath tip off the stability layer.
c. Flush the integrated sheath.
d. Close the stopcock on the integrated sheath.
e. Slide the integrated sheath up to the valve capsule.
f. Engage the integrated sheath tip onto the valve capsule.
g. Flush the guidewire lumen.

Implanting the Valve

Prepare the access site according to standard practice.
CAUTION: If performing transcatheter valve implantation without an arterial introducer sheath, use a minimum 14F
introducer sheath for balloon aortic valvuloplasty.
CAUTION: For subclavian/axillary procedures, the distance between the annular plane and the integrated sheath distal
tip must be ≥17 cm (6.7") to allow the valve capsule to retract completely during valve deployment.
Predilate the native aortic valve with an appropriate diameter valvuloplasty balloon.

Deploying the Valve

Backload the FlexNav™ delivery system onto an 0.035" (0.89 mm)-compatible guidewire while maintaining position across the
aortic valve.
NOTE: Wipe the radiopaque tip, valve capsule, and integrated sheath with a wet gauze pad to activate the hydrophilic coating.
For transfemoral procedures, advance the distal end of the delivery system through the access site until the integrated sheath
hub meets the access site. If using the integrated sheath, be sure to hold on to both the integrated sheath and the delivery
system shaft, keeping them joined together upon insertion.
Position the delivery system so that the inner shaft marker band is aligned with the native aortic valve annulus plane.
Begin deploying the valve by turning the deployment/re-sheath wheel in the direction of the arrow on the handle. Maintain valve
position during deployment.
NOTE: Position the annulus end of the valve 3 mm (0.12") below the native aortic annulus.
Prior to release, position the fluoro source to ensure the struts at the distal (LVOT) portion of the valve are aligned and confirm
the depth of the implant is approximately 3mm.
NOTE: The deployment/re-sheath wheel will make a clicking sound when it has reached the partial deployment lock. The
deployment mechanism will not re-engage until the deployment lock button is depressed.
CAUTION: Do not depress the deployment lock button until you are ready to fully deploy the valve.
If the valve must be re-positioned, proceed to instructions for re-sheathing the valve.
If proper placement is confirmed, complete valve deployment by pressing the deployment lock button, then turning the
deployment/re-sheath wheel in the direction of the arrow on the handle until the valve capsule is fully retracted.
NOTE: The deployment/re-sheath wheel will make a clicking sound when the valve capsule is fully retracted.
Once the valve is fully deployed, confirm (under fluoroscopy, using orthogonal views) that the retainer tabs have detached from
the delivery system retainer receptacle.

Re-Sheathing the Valve (Optional)

If repositioning is required, fully re-sheath the valve by turning the deployment/re-sheath wheel opposite the direction of the arrow on
the handle. Return to step 3 of "Deploying the Valve."
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