33
11.1.7 Main Body Proximal (Top) Deployment
1. Perform angiography through an angiographic catheter to verify position
of the endovascular graft with respect to the renal arteries. If necessary,
carefully reposition the covered portion of the endovascular graft with
respect to the renal arteries. (Repositioning can only take place over a
small range of distance at this stage.)
NOTE: Ensure patency of renal arteries by confirming that the proximal graft
markers are 2 mm or more below the lowest patent renal artery.
CAUTION: During proximal trigger-wire removal, top cap advancement,
and subsequent suprarenal stent deployment, verify that the position of
the main body wire guide extends just distal to the aortic arch and that
support of the system is maximized.
2. Remove the safety lock from the black trigger-wire release mechanism.
Under fluoroscopy, withdraw and remove the trigger-wire by sliding the
black trigger-wire release mechanism off the handle and then remove via
its slot over the inner cannula. (Fig. 14)
If resistance is felt or system bowing is noticed, the trigger-wire is under
tension. Excessive force may cause the graft position to be altered. If
excessive resistance or delivery system movement is noted, stop and assess
the situation. If unable to remove the black trigger-wire release mechanism
from the top cap, perform the following steps under fluoroscopy:
a. Remove tension on the trigger-wire by loosening the pin vise and
slightly pulling the inner cannula to move the top cap down over the
suprarenal stent. Avoid compressing the Zenith Flex main body.
b. Retighten the pin vise.
c. Remove the black trigger-wire release mechanism.
d. Continue with Step 3 in Section 11.1.7, Main Body Proximal (Top)
Deployment.
NOTE: If still unable to remove the top stent trigger-wire release mechanism
from the top cap, see Section 14.1, Trigger-Wire Release Troubleshooting.
3. Loosen the pin vise. (Fig. 15) Control the position of the graft by
stabilizing the gray positioner of the introducer.
4. Deploy the suprarenal stent by advancing the top cap inner cannula 1 to
2 mm at a time while controlling the position of the main body until the
top stent is fully deployed. (Fig. 16 and 17) Advance the top cap cannula
an additional 1 to 2 cm and then retighten the pin vise to avoid contact
with the deployed suprarenal stent.
NOTE: If unable to fully deploy suprarenal stent by advancing the top
cap inner cannula, see Section 14.2, Suprarenal Stent Deployment
Troubleshooting.
NOTE: Once the barbed suprarenal stent has been deployed, futher attempts
to reposition the graft are not recommended.
WARNING: The Zenith Flex AAA Endovascular Graft incorporates a
suprarenal stent with fixation barbs. Exercise extreme caution when
manipulating interventional devices in the region of the suprarenal
stent.
5. Advance the contralateral wire guide into the thoracic aorta.
11.1.8 Contralateral Iliac Leg Placement and Deployment
CAUTION: Verify that the predetermined contralateral iliac leg is selected
for insertion on the contralateral side of the patient before implantation.
1. Position the image intensifier to show both the contralateral internal iliac
artery and contralateral common iliac artery.
2. Prior to introduction of contralateral iliac leg delivery system, inject
contrast through the contralateral femoral sheath to locate the
contralateral internal iliac artery.
3. Introduce the contralateral iliac leg delivery system into the artery.
Advance slowly until the iliac leg graft overlaps at least one full iliac leg
stent (i.e., proximal stent of iliac leg graft) inside the contralateral limb of
the main body. (Fig. 18) If there is any tendency for the main body graft
to move during this maneuver, hold it in position by stabilizing the gray
positioner on the ipsilateral side.
NOTE: If difficulty is encountered advancing the iliac leg delivery system,
exchange to a more supportive wire guide. In tortuous vessels the anatomy may
alter significantly 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 gray positioner
while withdrawing the sheath. (Fig. 19 and 20) 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 gray positioner.
Tighten pin vise. Maintain sheath position while withdrawing gray
positioner with secured inner cannula. (Fig. 21)
8. Re-check the position of the wire guide.
11.1.9 Main Body Distal (Bottom) Deployment
1. Return to the ipsilateral side.
2. Fully deploy the ipsilateral limb of the main body by withdrawing the sheath
until the most distal stent has expanded. (Fig. 22 and 23) Stop withdrawing
sheath.
NOTE: The distal stent is still secured by the trigger-wire.
3. 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. (Fig. 24)
11.1.10 Docking of Top Cap
1. Loosen the pin vise. (Fig. 25)
2. Secure sheath and inner cannula to avoid any movement of these
components.
3. Advance the gray positioner over the inner cannula until it docks with the
top cap. (Fig. 26, 27 and 28)
NOTE: If resistance occurs, slightly rotate gray positioner and continue to
gently advance.
4. Retighten the pin vise and withdraw the entire top cap and gray
positioner through the graft and through the sheath by pulling on the
inner cannula. (Fig. 29) Leave the sheath and wire guide in place.
NOTE: Maintain position of sheath and wire guide.
5. Close the Captor® Hemostatic Valve on the Flexor® introducer sheath by
turning it in a clockwise direction until it stops. (Fig. 30)
11.1.11 Ipsilateral Iliac Leg Placement and Deployment
NOTE: Ensure the Captor Hemostatic Valve on the introducer sheath is turned
to the open position. (Fig. 31)
1. Utilize the main body graft wire and sheath assembly to introduce the
ipsilateral iliac leg graft. Advance dilator and sheath assembly into the
main body sheath.
NOTE: In tortuous vessels, the position of the internal iliac arteries may alter
significantly with the introduction of the rigid wires and sheath systems.
2. Advance slowly until the ipsilateral iliac leg graft overlaps a minimum
of one full iliac leg stent (i.e., proximal stent of iliac leg graft) inside the
ipsilateral limb of the main body. (Fig. 32)
NOTE: If an overlap of greater than 3 iliac leg stents is required (greater than
2 iliac leg stents for 37 mm and 54 mm leg lengths), it may be necessary to
consider use of a leg extension in the bifurcation area of the opposite side.
3. Confirm position of distal end of the iliac leg graft. Reposition the iliac leg
graft if necessary to ensure internal iliac patency.
4. To deploy, stabilize the iliac leg graft with the gray positioner while
withdrawing the iliac leg sheath. (Fig. 33 and 34) If necessary, withdraw
the main body sheath.
5. Under fluoroscopy and after verification of iliac leg graft position, loosen
pin vise, retract inner cannula to dock tapered dilator to gray positioner.
Tighten pin vise. Maintain sheath position while withdrawing gray
positioner with secured inner cannula. (Fig. 35)
6. Close the Captor Hemostatic Valve on the Flexor® introducer sheath by
turning it in a clockwise direction until it stops.
7. Re-check the position of the wire guides. Leave sheath and wire guides in
place.
11.1.12 Molding Balloon Insertion
1. Prepare molding balloon as follows:
• Flush wire lumen with heparinized saline.
• Remove all air from balloon.
2. In preparation of the insertion of the molding balloon, open the Captor
Hemostatic Valve by turning counterclockwise.
3. Advance the molding balloon over the wire guide and through the Captor
Hemostatic Valve of the main body introduction system to the level of the
renal arteries. Maintain proper sheath position.
4. Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure by turning it clockwise.
CAUTION: Do not inflate balloon in vessel outside of graft.
5. Expand the molding balloon with diluted contrast media (as directed by
the manufacturer) in the area of the most proximal covered stent and the
infrarenal neck, starting proximally and working in the distal direction.
(Fig. 36)
CAUTION: Confirm complete deflation of balloon prior to repositioning.
CAUTION: Captor Hemostatic Valve must be open prior to repositioning
of molding balloon.
6. Withdraw the molding balloon to the ipsilateral limb overlap and expand.
CAUTION: Captor Hemostatic Valve must be open prior to repositioning
of molding balloon.
7. Withdraw the molding balloon to the ipsilateral distal fixation site and
expand.
CAUTION: Do not inflate balloon in vessel outside of graft.
8. Deflate and remove molding balloon. Transfer the molding balloon
onto the contralateral wire guide and into the contralateral iliac leg
introduction system. Advance molding balloon to the contralateral limb
overlap and expand.
CAUTION: Confirm complete deflation of balloon prior to repositioning.
9. Withdraw the molding balloon to the contralateral iliac leg/vessel distal
fixation site and expand. (Fig. 36)
CAUTION: Do not inflate balloon in vessel outside of graft.
10. Remove molding balloon and replace it with an angiographic catheter to
perform completion angiograms.
11. 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 the Suggested
Instructions for Use for the Zenith AAA Endovascular Graft Ancillary
Components.
3. Repair vessels and close in standard surgical fashion.
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 lifelong, 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 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 12.1.
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. 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).
