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NOTE: If di culty is encountered advancing the iliac leg delivery system,
exchange to a more supportive wire guide. In tortuous vessels the anatomy
may alter signi cantly with the introduction of the rigid wires and sheath
systems.
4. Confirm position of distal end of the iliac leg graft. Reposition the
iliac leg graft if necessary to ensure both internal iliac patency and
a minimum overlap of one full iliac leg stent (i.e., proximal stent of
iliac leg graft, maximum overlap of 1.5 stents) within the main body
endovascular graft.
5. To deploy, hold the iliac leg graft in position with the grey positioner
while withdrawing the sheath. (Figures 34a and 34b)
Ensure one stent overlap is maintained.
6. Stop withdrawing the sheath as soon as the distal end of the iliac leg
graft is released.
7. Under fluoroscopy and after verification of iliac leg graft position,
loosen pin vise, retract inner cannula to dock tapered dilator to
grey positioner. Tighten pin vise. Maintain sheath position while
withdrawing grey positioner with secured inner cannula. (Figure 35)
8. Re-check the position of the wire guide.
10.1.11 Distal Bifurcated Body Deployment
1. Remove the safety lock from the white trigger-wire release mechanism.
Withdraw and remove the trigger-wire by sliding the white trigger-wire
release mechanism off the handle and then remove via its slot over the
device inner cannula. (Figure 36)
2. Under fluoroscopy and after verification of iliac leg graft position,
loosen pin vise, retract inner cannula to dock tapered dilator to
grey positioner. Tighten pin vise. Maintain sheath position while
withdrawing grey positioner with secured inner cannula.
3. Re-check the position of the wire guides. Leave sheath and wire guide
in place.
4. Close the Captor Hemostatic Valve on the Flexor introducer sheath by
turning in a clockwise direction until hemostasis is achieved. (Figure 37)
10.1.12 Molding Balloon Insertion
1. Prepare Molding balloon as follows:
• Flush wire lumen with Heparinised 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 distal bifurcated body introduction system to
level of renal arteries. Maintain proper sheath positioning.
NOTE: Captor Hemostatic Valve may be utilized to assist with hemostasis by
turning in a clockwise rotation to the "close" position.
NOTE: Captor Hemostatic Valve should always be in the "open" position
when repositioning of molding balloon.
4. Expand the molding balloon with diluted contrast media (as directed
by the manufacturer) in the area of the suprarenal stent and the
infrarenal neck, starting proximally and working in the distal direction.
(Figure 38)
CAUTION: Prior to molding in the vicinity of any Fenestration stent(s)
confirm that the aortic section of the stent has been flared.
CAUTION: Confirm complete deflation of balloon prior to repositioning.
5. Withdraw the Molding balloon to the ipsilateral limb distal fixation site
and expand.
CAUTION: Do not inflate balloon in iliac vessel outside of graft.
6. Deflate and remove molding balloon. Transfer the molding balloon
onto the contralateral wire guide and into the contralateral iliac leg
Table 11.1 Recommended Imaging Schedule for Endograft Patients
Pre-procedure
Procedural
Pre-discharge (within 7 days)
1 month
3 month
6 month
12 month (annually thereafter)
Imaging should be performed within 6 months before the procedure.
1
2
Duplex ultrasound may be used for those patients experiencing renal failure or who are otherwise unable to undergo contrast enhanced CT scan. With
ultrasound, non-contrast CT is still recommended.
3
Either pre-discharge or 1 month CT recommended.
If Type I or III endoleak, prompt intervention and additional follow-up post-intervention recommended. See Section 11.6, Additional Surveillance and
4
Treatment.
5
Recommended if endoleak reported at pre-discharge or 1 month.
11.2 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 inch x 17 inch sheets if film is used.
• Both non-contrast and contrast runs are required, with matching or corresponding table positions.
• Non-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 11.2 lists examples of acceptable imaging protocols.
IV contrast
Acceptable machines
Injection volume
Injection rate
Injection mode
Bolus timing
Coverage - start
Coverage - nish
Collimation
Reconstruction
Axial DFOV
Post-injection runs
introduction system. Advance molding balloon to the contralateral
limb overlap and expand.
CAUTION: Confirm complete deflation of balloon prior to repositioning.
7. Withdraw the molding balloon to the contralateral iliac leg/vessel distal
fixation and expand. (Figure 38)
CAUTION: Do not inflate balloon in iliac vessel outside of graft.
8. Remove molding balloon and replace it with an angiographic catheter
to perform completion angiograms.
9. Remove or replace all stiff wire guides to allow iliac arteries to resume
their natural position.
Final Angiogram
1. Position angiographic catheter just above the level of the renal arteries.
Perform angiography to verify that the renal arteries are patent and
that there are no endoleaks. Verify patency of internal iliac arteries.
2. Confirm there are no endoleaks or kinks and verify position of proximal
gold radiopaque markers. Remove the sheaths, wires and catheters.
NOTE: If endoleaks or other problems are observed, refer to Section 1.6,
Ancillary Components.
3. Repair vessels and close in standard surgical fashion.
11 IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP
11.1 General
The long-term performance and safety of endovascular grafts has
not yet been established. As a result, life-long, regular follow-up must
be undertaken in all patients to assess the ongoing performance of the
Zenith Fenestrated AAA Endovascular Graft. Patients with speci c clinical
ndings (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 rst 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 e ectiveness of endovascular
treatment of AAAs.
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 11.1.
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 speci c clinical
ndings (e.g., endoleaks, enlarging aneurysms or changes in the structure
or position of the stent graft) should receive follow-up at more frequent
intervals.
Annual imaging follow-up should include abdominal radiographs and both
contrast and non-contrast CT examinations. If renal complications or other
factors preclude the use of image contrast media, abdominal radiographs,
non-contrast CT and duplex ultrasound may be used.
• The combination of contrast and non-contrast CT imaging provides
information on aneurysm diameter change, endoleak, patency, tortuosity,
progressive disease, fixation length and other morphological changes.
• The abdominal radiographs provide information on device integrity
(separation between components, stent fracture and barb separation).
• Duplex ultrasound imaging may provide information on aneurysm
diameter change, endoleak, patency, tortuosity and progressive disease.
In this circumstance, a non-contrast CT should be performed to use in
conjunction with the ultrasound. Ultrasound may be a less reliable and
sensitive diagnostic method compared to CT. Table 11.1 lists the
minimum requirements for imaging follow-up for patients with the
Zenith Fenestrated AAA Endovascular Graft. Patients requiring enhanced
follow-up should have interim evaluations.
Angiogram
(Contrast and non-contrast)
X
1
X
Table 11.2 Acceptable Imaging Protocols
Non-Contrast
No
Spiral capable of >40 seconds
n/a
n/a
n/a
n/a
Diaphragm
Proximal femur
<3 mm
2.5 mm throughout – soft algorithm
32 cm
None
32
CT
Abdominal
Radiographs
X
1
X
2,3,4
X
X
2,3,4
X
X
2,4,5
X
X
2,4
X
X
2,4
Contrast
Yes
Spiral capable of >40 seconds
150 cc
>2.5 cc/sec
Power
Test bolus: SmartPrep, C.A.R.E. or equivalent
1 cm superior to celiac axis
Profunda femoris origin
<3 mm
2.5 mm throughout – soft algorithm
32 cm
None
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