Vascular Access And Angiography; Placement Of Proximal Devices; Zenith Universal Distal Body Placement; Iliac Leg Graft Or Iliac Device (Contralateral) Placement - COOK Medical Zenith Universal Distal Body Mode D'emploi

3. Attach syringe with heparinised saline to the hub on the inner
cannula. Elevate the tip of the system and ush until uid exits the
dilator tip. Refer to Figure 7.
4. Soak a gauze pad in saline solution and use to wipe Flexor introducer
sheath to activate the hydrophilic coating. Hydrate sheath liberally.

10.5 Vascular Access and Angiography

1. Puncture the selected common femoral arteries using standard
technique with an 18 or 19UT gauge arterial needle. Upon vessel
entry, insert:
Wire guides – standard 0.89 mm (0.035") diameter, 260 cm long, soft
tip Wire Guide
Appropriate size sheaths (e.g., 2.0 mm I.D. (6 Fr) or 2.7 mm I.D. (8 Fr))
Flush catheter (often radiopaque sizing catheters – e.g., Centimetre
Sizing Catheter or straight flush catheter)
2. Perform angiography as needed to identify positions of the coeliac,
SMA, renal arteries, and the aortic bifurcation.
NOTE: If uoroscope angulation is used with an angulated neck it may be
necessary to perform angiograms using various projections.

10.6 Placement of Proximal Devices

1. Implant any proximal grafts (example Zenith t-Branch or Zenith
Fenestrated AAA Endovascular Grafts) as required. Refer to the
Instructions for Use of these devices for preparation and deployment
instructions.

10.7 Zenith Universal Distal Body Placement

1. Ensure the delivery system has been ushed with heparinised saline
and that all air is removed from the system.
2. Give systemic heparin if required. Flush each catheter and/or wipe the
wire guide after any exchange.
NOTE: Monitor the patient's coagulation status throughout the
procedure.
3. A 0.89 mm (0.035") sti wire guide, at least 260 cm long, should be
in place on the ipsilateral side to guide the delivery system into the
aorta. Maintain wire guide position.
4. Before insertion, position delivery system on patient's abdomen
under uoroscopy to assist with orientation and positioning. The side
arm of the haemostatic valve may serve as an external reference to
the contralateral limb radiopaque marker.
5. Advance delivery system over the wire guide until the contralateral
limb is positioned above and slightly anterior to the origin of the
contralateral common iliac. If the contralateral limb radiopaque
marker is not properly aligned, rotate the entire system until it is
correctly positioned half way between a lateral and an anterior
position on the contralateral side.
NOTE: Zenith Universal Distal Body delivery system will not pass through
the sheath used to deliver the proximal body. The proximal body delivery
sheath must be removed prior to insertion of the Zenith Universal Distal
Body delivery system.
CAUTION: Maintain wire guide position during delivery system
insertion.
CAUTION: To avoid any twist in the endovascular graft, during
any rotation of the delivery system, be careful to rotate all of the
components of the system together (from outer sheath to inner
cannula).
6. Verify position of wire guide in the thoracic aorta.
7. Perform an angiogram to verify the position and orientation, including;
The degree of overlap with proximal body (no less than 2 stents)
The position of the contralateral limb (on contralateral side and
slightly anterior) and proximal to the aortic bifurcation.
8. Ensure the Captor Haemostatic Valve is turned to the open position.
NOTE: The Captor Haemostatic Valve must only be turned until it stops
and the open/close marks must be correctly aligned. Do not overturn the
Captor Haemostatic Valve as overturning will damage the valve which
may result in signi cant blood loss.
9. Stabilize the gray positioner (the shaft of the delivery system) and
begin withdrawal of the outer sheath. Deploy the rst two stents by
withdrawing the sheath while monitoring device location. Proceed
with deployment until contralateral limb is fully deployed.
NOTE: Tick marker on the contralateral limb of the distal bifurcated body
is used to determine anterior/posterior orientation of the contralateral
limb. It is not intended to line up with the anterior tick mark on the
proximal body.
10. Advance a contralateral catheter and wire guide into the common
iliac artery to a level below the short contralateral limb and then
manipulate the wire guide into the contralateral limb and into the
Zenith Universal Distal Body. AP and oblique uoroscopic views can
aid in veri cation of device cannulation.
11. Advance an angiographic catheter into the body of the graft. Perform
angiography to con rm correct position inside the Zenith Universal
Distal Body. Advance the catheter to where the proximal end of the
Zenith Universal Distal Body graft is attached to the introducer.
12. Remove the safety lock from the black trigger-wire release
mechanism. Under uoroscopy, withdraw the release mechanism o
the handle to remove the trigger-wire and release the graft's proximal
attachment. Remove via its slot over the inner cannula. Refer to
Figure 8.
NOTE: The distal stent is still secured by the distal trigger-wire.
NOTE: 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.
NOTE: Technical Assistance from a Cook product specialist may be
obtained by contacting your local Cook representative.
CAUTION: During trigger-wire removal and subsequent
deployment, verify that the position of the access wire guide
extends sufficiently into the aortic arch.

10.8 Iliac Leg Graft or iliac device (Contralateral) Placement

1. See IFU of the iliac leg graft or iliac device that has been selected to
be placed in the contralateral side of the Zenith Universal Distal Body
graft.

10.9 Rest of Zenith Universal Distal Body Deployment

1. Withdraw the rest of the Zenith Universal Distal Body sheath to
expose the ipsilateral limb.
2. Remove the safety lock from the white trigger-wire release
mechanism. Withdraw the release mechanism o the handle
to remove the trigger-wire and detach the distal end of the
endovascular graft from the delivery system. Remove via its slot over
the device inner cannula.
3. Remove the grey positioner and dilator tip as one unit by pulling on
the inner cannula. Keep the wire guide and sheath immobilized.
4. Close the Captor valve immediately after removal of the grey
positioner and dilator tip.
NOTE: The Captor Haemostatic Valve must only be turned until it stops
and the open/close marks must be correctly aligned. Do not overturn the
Captor Haemostatic Valve as overturning will damage the valve which
may result in signi cant blood loss.

10.10 Iliac Leg Graft or Iliac Device (Ipsilateral) Placement

See IFU of the iliac leg graft or device that has been selected to be placed
in the ipsilateral side of the Zenith Universal Distal Body graft.

10.11 Final Angiogram

Position an angiographic catheter just above the level of the visceral
arteries. Perform angiography to verify that all the arteries are patent and
that there are no endoleaks. If endoleaks or other problems are observed,
address as appropriate.

10.12 Zenith Universal Distal Body Moulding (Optional)

1. Prepare moulding balloon as follows:
Flush wire lumen with heparinised saline.
Remove all air from balloon.
2. In preparation for the insertion of the moulding balloon, open the
Captor Haemostatic Valve by turning it counter-clockwise.
3. Advance the moulding balloon over the wire guide and through the
haemostatic valve of the delivery system to the level of the overlap.
Maintain proper sheath positioning.
NOTE: Captor Haemostatic Valve may be utilised to assist with
haemostasis by turning in a clockwise rotation to the "close" position.
NOTE: Captor Haemostatic Valve should always be in the "open" position
when repositioning of moulding balloon.
4. Expand the moulding balloon with diluted contrast media (as
directed by the manufacturer) in the area of the overlap between the
proximal device and Zenith Universal Distal Body, starting proximally
and working in the distal direction.
NOTE: Do not in ate the moulding balloon outside the graft.
NOTE: Care should be taken when manipulating a moulding balloon in
the vicinity of the visceral stents (if applicable).
NOTE: Con rm complete de ation of balloon prior to repositioning.
5. Withdraw the moulding balloon to the ipsilateral limb device overlap
site and expand. Withdraw to the distal xation site and expand.
CAUTION: Do not inflate balloon in iliac vessel outside of graft.
6. De ate and remove moulding balloon. Transfer the moulding balloon
onto the contralateral wire guide and into the contralateral iliac leg
delivery system. Advance moulding balloon to the contralateral limb
overlap and expand.
CAUTION: Confirm complete deflation of balloon prior to
repositioning.
7. Withdraw the moulding balloon to the contralateral iliac leg/vessel
distal xation and expand.
CAUTION: Do not inflate balloon in iliac vessel outside of graft.
8. Remove moulding balloon and replace it with an angiographic
catheter to perform completion angiograms.
9. Repair vessels and close access sites in standard surgical fashion.
11 IMAGING GUIDELINES AND POST OPERATIVE FOLLOW UP

11.1 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. 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 AAA and TAAA.
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 imaging follow-up for patients with the
Zenith Universal Distal Body. Patients requiring enhanced follow-up
should have interim evaluations.
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