16
I-ZDEG-EU-1312-394-03
• Appropriate size sheath (e.g., 5.0 French)
• Pigtail flush catheter (often radiopaque-banded sizing catheters; i.e., Cook
Centimeter Sizing CSC-20 catheter)
2. Perform angiography at the appropriate level. If using radiopaque markers,
adjust position as necessary and repeat angiography.
3. Ensure graft system has been flushed and primed with heparinized saline
(appropriate flush solution), and all air has been removed.
4. Give systemic heparin. Flush all catheters and wet all wire guides with a
strong heparin solution. This should be repeated following each exchange.
5. Replace the standard wire guide with a stiff .035 inch, 260/300 cm LESDC
wire guide and advance through the catheter and up to the aortic arch.
6. Remove pigtail flush catheter and sheath.
NoTE: At this stage, the second femoral artery can be accessed for
angiographic catheter placement. Alternatively, a brachial approach may be
considered.
7. Introduce the freshly hydrated introduction system over the wire guide and
advance until the desired graft position is reached.
CaUTIoN: To avoid twisting the endovascular graft, never rotate the
introduction system during the procedure. allow the device to conform
naturally to the curves and tortuosity of the vessels.
NoTE:
The dilator tip will soften at body temperature.
NoTE:
To facilitate introduction of the wire guide into the introduction
system, it may be necessary to slightly straighten the introduction 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 to the open position (fig. 8).
10. Stabilize the gray positioner (introduction 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CaUTIoN: As the sheath is withdrawn, anatomy and graft position may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 device in a less tortuous position that 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 in a continuous movement until the proximal
end of the graft opens (fig. 9). Do not rotate the green trigger-wire knob.
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 introduction 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 molding 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
manufacturer) 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 pressure by turning it clockwise.
8. 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 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,
additional Devices.
3. Repair vessels and close in standard surgical fashion.
11.2 Additional Devices
Inaccuracies in device size selection or placement, changes or anomalies
in patient anatomy, or procedural complications can require placement of
additional endovascular grafts. Regardless 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 POSTOPERATIVE 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 endovascular graft and/or stent. Patients with specific clinical findings (e.g.,
endoleaks, persisting flow in false lumen 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 dissections.
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 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
aneurysms, 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 thoracic device radiographs and both
contrast and non-contrast CT examinations. If renal complications or other
factors preclude the use of image contrast media, thoracic device radiographs
and non-contrast CT may be used.
• The combination of contrast and non-contrast CT imaging provides
information on device migration, endoleak, patency, tortuosity, progressive
disease, fixation length, and other morphological changes.
• The thoracic device radiographs provide information on device integrity
(separation between components and stent fracture).
Table 2 lists the minimum requirements for imaging follow-up for patients with
the Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak
Plus Introduction System. Patients requiring enhanced follow-up should have
interim evaluations.
Table 2 Recommended Imaging Schedule for Endograft Patients
angiogram
CT
(contrast and non-contrast)
Thoracic Device radiographs
Pre-procedure
X
1
Procedural
X
Pre-discharge (within 7 days)
X
2
X
1 month
X
2
X
6 month
X
2
X
12 month (annually thereafter)
X
2
X
1
Imaging should be performed within 6 months before the procedure.
2
If Type I or III endoleak, prompt intervention and additional follow-up post-intervention recommended, See
Section 12.5, additional Surveillance and Treatment.
Table 3 Acceptable Imaging Protocols
Non-contrast
Contrast
IV contrast
No
Yes
Acceptable machines
Spiral capable of > 40 seconds
Spiral capable of > 40 seconds
Injection volume
n/a
150 cc
Injection rate
n/a
> 2.5 cc/sec
Injection mode
n/a
Power
Bolus timing
n/a
Test bolus: Smart Prep, C.A.R.E. or equivalent
Coverage - start
Neck
Subclavian aorta
Coverage - finish
Diaphragm
Profunda femoris origin
Collimation
< 3 mm
< 3 mm
Reconstruction
2.5 mm throughout - soft algorithm
2.5 mm throughout - soft algorithm
Axial DFOV
32 cm
32 cm
Post-injection runs
None
None
12.2 Contrast and Non-Contrast CT Recommendations
• Film sets should include all sequential images at lowest possible slice
thickness (≤ 3 mm). Do NOT perform large slice thickness (> 3 mm) and/or
omit consecutive CT images/film sets, as it prevents precise anatomical and
device comparisons over time.
• All images should include a scale for each film/image. Images should be
arranged no smaller than 20:1 images on 14” x 17” sheets if film is used.
• Both non-contrast and contrast runs are required, with matching or
corresponding table positions.
• Pre-contrast and contrast run slice thickness and interval must match.
• DO NOT change patient orientation or re-landmark patient between non-
contrast and contrast runs.
Non-contrast and contrast enhanced baseline and follow-up imaging are
important for optimal patient surveillance. It is important to follow acceptable
imaging protocols during the CT exam. Table 3 lists examples of acceptable
imaging protocols.
