Imaging Guidelines And Post-Operative Follow-Up; General - COOK Medical Zenith TX2 Instrucciones De Uso

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.
Fig. 9
12. Loosen the safety lock from the green trig-
ger-wire release mechanism. Withdraw the
trigger-wire in a continuous movement until
the proximal end of the graft opens (Fig. 9).
Withdraw the trigger-wire completely to re-
lease 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 introduction system, leaving the
wire guide in the graft.
NOTE: Leave the Zenith TX2 Dissection
Endovascular Graft with Pro-Form and the
Z-Trak Plus Introduction System in place if
intending to use a dissection stent.
11.1.2
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 mold-
ing balloon, open the Captor Hemostatic
Valve by turning it counter-clockwise.
3. Advance the molding balloon over the wire
guide and through the hemostatic valve of
the main body introduction system to the
level of the proximal fixation site. Maintain
proper sheath positioning.
4. Tighten the Captor Hemostatic Valve around
the molding balloon with gentle pressure by
turning it clockwise.
5. Expand the molding balloon with diluted
contrast media (as directed by the manufac-
turer) in the area of the proximal covered
stent, starting proximally and working in the
distal direction.
CAUTION: Do not inflate balloon in aorta
outside of graft. Use caution during molding
within a dissection.
CAUTION: Confirm complete deflation of
balloon prior to repositioning.
6. Open the Captor Hemostatic Valve, remove
the molding balloon and replace it with an
angiographic catheter to perform completion
angiograms.
7. Tighten the Captor Hemostatic Valve around
the angiographic catheter with gentle pres-
sure by turning it clockwise.
8. Remove or replace all stiff wire guides to
allow aorta to resume its natural position.
I-ZDEG-EU-1105-394-02
Final Angiogram
1. Position angiographic catheter just above the
level of the endovascular graft. Perform
angiography to verify correct positioning.
Verify patency of arch vessels and celiac
plexus.
2. Confirm that there are no endoleaks or
kinks, and verify position of proximal and
distal gold radiopaque markers. Remove the
sheaths, wires and catheters.
NOTE: If endoleaks or other problems are
observed, refer to Section 11.2, Ancillary
Devices.
3. Repair vessels and close in standard surgical
fashion.
11.2
Inaccuracies in device size selection or place-
ment, changes or anomalies in patient anatomy,
or procedural complications can require place-
ment of additional endovascular grafts. Regard-
less of the device placed, the basic procedure(s)
will be similar to the maneuvers required and
described previously in this document. It is vital
to maintain wire guide access.
12 IMAGING GUIDELINES AND
POST-OPERATIVE FOLLOW-UP
12.1 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 endovascu-
lar graft and/or stent. Patients with specific clini-
cal findings (e.g., endoleaks, persisting flow in
false lumen or changes in the structure or posi-
tion of the endovascular graft) should receive ad-
ditional 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 dissections.
Physicians should evaluate patients on an in-
dividual basis and prescribe their follow-up
relative to the needs and circumstances of each
individual patient. The recommended imaging
schedule is presented in Table 2. This schedule
continues to be the minimum requirement for
patient follow-up and should be maintained even
in the absence of clinical symptoms (e.g., pain,
numbness, weakness). Patients with specific
clinical findings (e.g., endoleaks, enlarging aneu-
rysms, or changes in the structure or position of
the stent graft or stent) should receive follow-up
at more frequent intervals.
Annual imaging follow-up should include chest
radiographs and both contrast and non-contrast
CT examinations. If renal complications or other
factors preclude the use of image contrast media,
chest radiographs and non-contrast CT may be
used.
• The combination of contrast and non-contrast
CT imaging provides information on endole-
ak, patency, tortuosity, progressive disease,
fixation length, and other morphological
changes.
• The chest radiographs provide information
on device integrity (separation between com-
ponents, stent fracture, and barb separation).
Table 2 lists the minimum requirements for imag-
ing follow-up for patients with the Zenith TX2
Dissection Endovascular Graft with Pro-Form and
the Z-Trak Plus Introduction System. Patients re-
quiring enhanced follow-up should have interim
evaluations.
ENGLISH 11