Abbott Tendyne Gebrauchsanweisung Seite 26

wire. With wire in the left ventricle, remove
introducer needle.
WARNING: Do not attempt to re-insert
a partially or completely withdrawn needle.
4. Insert an 8F sheath into the left ventricle and
remove dilator. Insert a balloon tip catheter
over the wire and through the sheath into the
left ventricle. Using the inflated balloon,
establish an entanglement free pathway from
the ventricular access site to the left atrium
leading with the inflated balloon tip catheter.
5. Advance the guide wire across the mitral valve
and into the left atrium. Deflate the balloon
and remove the balloon tipped catheter from
the sheath off the wire. Remove the sheath
from the heart and off the wire. Maintain wire
position in the left atrium.
10.10. Deploying the Valve
1. Run a continuous saline flush through the
Delivery Handle. Confirm that the pressure is
between 150-250 mmHg.
2. Insert the collapsible dilator and sheath
through the myocardium over the 0.035"
(0.89 mm) guide wire.
3. Advance the Delivery Handle using
echocardiography and fluoroscopy guidance to
maintain proper trajectory and to confirm final
sheath depth is above the mitral annulus.
CAUTION: Maintain end of sheath
approximately 1 centimeter (cm) above mitral
annulus to ensure device does not interact with
atrial wall.
4. Deflate the collapsible dilator for at least
5 seconds and remove. If resistance is
encountered, confirm the dilator has fully
deflated. Remove the 0.035" guidewire from
the heart through the hemostasis valve.
5. Stop the flush and evacuate air from the
sheath through the hemostasis adapter side
port.
6. Restart flush.
7. Rotate the Delivery Push Knob – Knob 1 on the
Delivery Handle in the direction indicated by
the arrows to push the valve out of the Loading
Tube into the sheath.
8. Continue rotating Delivery Push Knob – Knob 1
until the indicator line is seen in the Top
TM
IFU, TENDYNE Mitral Valve System
Alignment Window, indicating that the valve is
at the end of the sheath.
Confirm on echo that the valve is at the end of
the sheath.
9. Turn off the flush.
10. Pull the tether taut and tighten the Tether
Retention Knob - Knob 2 at the end of the
Delivery Handle to secure the tether leader.
Use fingertips only. Do not overtighten.
11. Ensure the tip of the sheath is at the level of
the mitral annular plane.
12. Rotate Sheath Retraction Knob - Knob 3 in the
direction indicated by the arrows to retract the
sheath and initiate valve deployment.
CAUTION: Ensure that Delivery Push Knob –
Knob 1 does not rotate.
10.11. Orienting the Valve
1. Ensure that the valve is at the level of the
mitral annulus and that the cuff has been
deployed a sufficient amount to correctly
identify the orientation of the valve A2 cuff.
2. Confirm with echocardiography that the valve
is oriented correctly, ensuring that the raised
anterior aspect (straight segment of the valve)
is radially oriented toward the aortomitral
continuity.
Fluoroscopy may also be used to confirm
orientation, using pre- determined projection
angles from pre-operative CT scan and properly
aligning the A1 radiopaque marker on the
valve.
3. Continue to rotate Sheath Retraction Knob -
Knob 3 in the direction of the arrow until
a hard stop.
4. Rotate Delivery Push Knob – Knob 1 in the
direction opposite the indicator arrow one-half
turn to deploy the valve fully.
5. If the valve needs to be repositioned, use the
Delivery Handle to recapture the valve stem
and nitinol struts by rotating the Sheath
Retraction Knob - Knob 3 in the direction of the
indicator arrows.
CAUTION: Confirm native leaflets are not
captured between the sheath and valve.
6. Once recaptured, push the valve into the left
atrium, reorient radially as needed, re-orient
axially within the annulus and redeploy by
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