32
10.2.2 Iliac Plugs
Refer to the Zenith AAA Endovascular Graft Ancillary Components or the
Zenith AAA Iliac Plug IFU .
10.2.3 Main Body Extensions
Main body extensions are used for extending the proximal body of an
in
situ
endovascular graft . (
Fig . 40
)
Main Body Extension Preparation/Flush
1 . Remove the inner stylet (from the inner cannula), cannula protector
(from the inner cannula) and dilator tip protector (from the dilator tip) .
Remove the Peel-Away sheath from the back of the hemostatic valve .
(
Fig . 31
) Elevate the distal tip of the system and flush through the
stopcock on the hemostatic valve until fluid emerges from the flushing
groove near the tip of the introducer sheath . (
Fig . 32
) Continue to inject
a full 20 cc of flushing solution through the device . Discontinue injection
and close the stopcock .
NOTE:
Graft flushing solution of heparinized saline is often used .
2 . Attach a syringe with heparinized saline to the hub of the inner cannula .
Flush until fluid exits the dilator tip . (
Fig . 33
)
NOTE:
When flushing system, elevate distal tip of the system to facilitate
removal of air .
3 . Soak sterile gauze pads in saline solution and use them to wipe the
Flexor introducer sheath to activate the hydrophilic coating . Hydrate
both the sheath and the dilator liberally .
Main Body Extension Placement and Deployment
1 . Remove the main body delivery sheath . Use the main body graft wire
guide to introduce the main body extension into the main body .
NOTE:
The main body extension delivery system cannot be introduced
through the main body or iliac leg introducer sheath .
2 . Advance slowly until the main body extension is at the site of the required
intervention . (
Fig . 41
)
3 . Verify the main body extension position to ensure proper sealing and
resistance to migration .
4 . Verify the placement with angiography to ensure that the renal arteries
remain patent and that proper placement is achieved .
CAUTION: Care should be taken not to displace the main body graft
during the placement and deployment of the main body extension .
5 . Deploy the device by withdrawing the sheath while stabilizing the gray
positioner of the delivery system . (
Figs . 35 and 42
) Continue to deploy
the device until the most distal stent is uncovered . Stop withdrawing the
sheath .
6 . Remove the safety lock from the black trigger-wire release mechanism .
Withdraw and remove the trigger-wire by sliding the black trigger-wire
release mechanism off the handle, and then remove via the slot over the
inner cannula . (
Fig . 37
)
7 . Withdraw the tapered tip of the introducer back through the main
body extension graft and delivery system while maintaining wire guide
position . Ensure the main body extension and endovascular graft are
not displaced during withdrawal of the delivery system .
8 . Close the Captor Hemostatic Valve by turning it in a clockwise direction
until it stops . (
Fig . 38
)
Main Body Extension Molding Balloon Insertion
NOTE:
For information on the use of recommended products, refer to the
individual product’s Instructions for Use .
1 . Prepare the molding balloon as follows:
• Flush the wire lumen with heparinized saline.
• Remove all air from the balloon.
CAUTION: The Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon .
2 . Advance the molding balloon over the wire guide and through the
hemostatic valve of the main body introduction system to the level of
the main body extension .
3 . Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure by turning the Captor Hemostatic Valve clockwise .
CAUTION: Do not inflate the balloon in the vessel outside of the graft .
4 . Expand the molding balloon within the proximal segment of the main
body extension and then the most distal segment of the main body
extension using diluted contrast media (as recommended by the
manufacturer) . (
Fig . 43)
CAUTION: Confirm complete deflation of the balloon prior to
repositioning .
5 . Completely deflate and remove the molding balloon, replace it with an
angiographic catheter and perform completion angiograms .
6 . If no other endovascular maneuvers are necessary, remove any sheaths,
wires and catheters . Repair vessels and close in standard surgical
fashion .
11 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP
11.1 General
•
The long-term performance of this endovascular graft has not yet
been established . All patients should be advised that endovascular
treatment requires lifelong, regular follow-up to assess their
health and the 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 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 .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
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 .
• Annual imaging follow-up should include abdominal radiographs and
both contrast and non-contrast CT examinations .
• 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) .
Table 11 .1 .1
lists the minimum imaging follow-up for patients with the
Zenith Alpha Abdominal Endovascular Graft . Patients requiring enhanced
follow-up should have interim evaluations .
Table 11 .1 .1 Recommended Imaging Follow-up Schedule
Pre-op
Intra-op
30-Day
6-Month
12-Month
4
CT Scan
X
1
X
3
X
3
X
3
Abdominal Device X-ray
X
X
X
Angiography
X
2
X
1
Imaging should be performed within 6 months before the procedure.
2
Required only to resolve any uncertainties in anatomical measurements necessary for graft sizing.
3
Duplex ultrasound may be used for those patients experiencing renal failure or who are otherwise unable to undergo contrast enhanced CT scan.
4
Yearly thereafter
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.
It is important to follow acceptable imaging protocols during the CT exam .
Table 11 .2 .1
lists examples of acceptable imaging protocols
