COOK Medical Zenith TX2 Gebrauchsanweisung Seite 16

7. Introduce the freshly hydrated delivery system over the wire guide and advance until the desired
graft position is reached. Ensure there is a minimum overlap of two stents (plus the distal uncov-
ered stent).
CAUTION: To avoid twisting the endovascular graft, never rotate the delivery system during
the procedure. Allow the device to conform naturally to the curves and tortuosity of the
vessels.
NOTE: The dilator tip softens at body temperature.
NOTE: To facilitate introduction of the wire guide into the delivery system, it may be necessary to
slightly straighten the delivery system dilator tip.
8. Verify wire guide position in the aortic arch. Ensure correct graft position.
9. Ensure that the Captor Hemostatic Valve on the Flexor Introducer Sheath is turned counter-
clockwise to the open position.
10. Stabilize the grey positioner (delivery system shaft) and withdraw the sheath until the graft is fully
expanded and the valve assembly docks with the control handle.
CAUTION: As the sheath or wire guide is withdrawn, anatomy and graft position may change.
Constantly monitor graft position and perform angiography to check position as necessary.
NOTE: If extreme difficulty is encountered when attempting to withdraw the sheath, place the de-
vice in a less tortuous position which enables the sheath to be retracted. Very carefully withdraw
the sheath until it just begins to retract, and stop instantly. Move back to original position and
continue deployment.
11. Verify graft position and adjust it forward, if necessary. Recheck graft position with angiography.
NOTE: If an angiographic catheter is placed parallel to the stent graft, use this to perform position
angiography.
12. Loosen the safety lock from the green trigger-wire release mechanism. Withdraw the trigger-wire
slowly until the proximal end of the graft opens. (Fig. 11) Withdraw the trigger-wire completely to
release the distal attachment to the introducer.
NOTE: Check to make sure that all trigger-wires are removed prior to withdrawal of the delivery
system.
13. Remove the inner introduction system entirely, leaving the sheath and wire guide in the graft.
CAUTION: To avoid entangling any catheters left in situ, rotate the delivery system during with-
drawal.
14. Close the Captor
direction until it stops.
Distal Extension Molding Balloon Insertion (Optional)
1. Prepare molding balloon as follows and/or per the manufacturer's instructions.
• Flush wire lumen with heparinized saline.
• Remove all air from balloon.
2. In preparation for the insertion of the molding balloon, open the Captor Hemostatic Valve by turn-
ing it counter-clockwise.
3. Advance the molding balloon over the wire guide and through the Captor Hemostatic Valve of the
introduction system to the level of the distal component/distal extension overlap. Maintain proper
sheath positioning.
4. Tighten the Captor Hemostatic Valve around the molding balloon with gentle pressure by turning
it clockwise.
CAUTION: Do not inflate balloon in the aorta outside of graft.
5. Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the
area of the overlap, starting proximally and working in the distal direction.
CAUTION: Confirm complete deflation of balloon prior to repositioning.
6. Withdraw the molding balloon to the distal covered stent and expand.
7. Loosen the Captor Hemostatic Valve, remove the molding balloon and replace it with an angio-
graphic catheter to perform completion angiograms.
8. Tighten the Captor Hemostatic Valve around the angiographic catheter with gentle pressure by
turning it clockwise.
9. Remove or replace all stiff wire guides to allow aorta to resume its natural position.
Final Angiogram
1. Position angiographic catheter just above the level of the endovascular graft. Perform angiogra-
phy to verify correct positioning. Verify patency of arch vessels.
2. Confirm there are no endoleaks or kinks, and verify position of proximal and distal gold radi-
opaque markers. Remove the sheaths, wires and catheters.
3. Repair vessels and close in standard surgical fashion.
11. IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP
11.1 General
• The long-term performance of endovascular grafts has not yet been established. All patients
should be advised that endovascular treatment requires life-long, regular follow-up to assess their
health and performance of their endovascular graft. Patients with specific clinical findings (e.g.,
endoleaks, enlarging aneurysms, or changes in the structure or position of the endovascular graft)
should receive additional follow-up. Patients should be counseled on the importance of adhering to
the follow-up schedule, both during the first year and at yearly intervals thereafter. Patients should
be told that regular and consistent follow-up is a critical part of ensuring the ongoing safety and
effectiveness of endovascular treatment of thoracic aortic aneurysms.
• Physicians should evaluate patients on an individual basis and prescribe their follow-up relative to
the needs and circumstances of each individual patient. The recommended imaging schedule is
presented in Table 12.1. This schedule continues to be the minimum recommendation for patient
follow-up and should be maintained even in the absence of clinical symptoms (e.g., pain, numb-
ness, weakness). Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, or
changes in the structure or position of the stent graft) should receive follow-up at more frequent
intervals.
12 ENGLISH
Hemostatic Valve on the Flexor
®
Introducer Sheath by turning it in a clockwise
®
I-TX2-PRO-FORM-1002-361-02