Main Body Molding Balloon Insertion - Optional; Final Angiogram; Ancillary Devices: Distal Extension; General Use Information - COOK Medical Zenith Alpha Mode D'emploi

10. If the bare stent cannot be fully released from the cap, complete
the deployment procedure and refer to Section 12, RELEASE
TROUBLESHOOTING.
11. Turn the blue rotation handle in the direction of the arrow next to label 3
until a stop is felt and the proximal end of the graft opens. (Fig. 16)
If difficulty is encountered rotating the blue rotation handle, refer to
Section 12, RELEASE TROUBLESHOOTING for instructions on how to
disassemble the blue rotation handle.
12. Remove the inner introduction system entirely, leaving the sheath and wire
guide in place.
13. Close the Captor Hemostatic Valve on the Flexor Introducer Sheath by
turning it to the closed position.
CAUTION: To avoid entangling any catheters left in situ, rotate the
introduction system during withdrawal.
10.1.4 Main Body Molding Balloon Insertion – Optional
1. Prepare the molding balloon as follows and/or per the manufacturer's
instructions:
• Flush the wire lumen with heparinized saline.
• Remove all air from the balloon.
2. In preparation for insertion of the molding balloon, open the Captor
Hemostatic Valve by turning it to the open position. (Fig. 7)
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 seal site. Maintain proper sheath positioning.
4. Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure by turning it to the closed position.
CAUTION: Do not inflate balloon in the aorta outside of the graft.
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: Confirm complete deflation of balloon prior to
repositioning.
6. If applicable, withdraw the molding balloon to the proximal component/
distal component overlap and expand.
7. Withdraw the molding balloon to the distal fixation site and expand.
8. Open the Captor Hemostatic Valve, remove the molding balloon
and replace it with an angiographic catheter to perform completion
angiography.
9. Tighten the Captor Hemostatic Valve around the angiographic catheter
with gentle pressure by turning it clockwise.
10. Remove or replace all stiff wire guides to allow the aorta to resume its
natural position.

10.1.5 Final Angiogram

1. Position angiographic catheter just above the level of the endovascular
graft. Perform angiography to verify correct positioning of the graft. Verify
patency of arch vessels and celiac trunk.
2. In the final angiogram confirm that there are no endoleaks or kinks, that
the proximal and distal gold radiopaque markers are positioned to provide
adequate overlap between components, and that there is sufficient graft
length to maintain over time a minimum of 20 mm in proximal and distal
seal.
NOTE: If endoleaks or other problems are observed (e.g., inadequate seal
length or overlap length), refer to Section 10.2, Ancillary Devices: Distal
Extension.
3. Remove the sheaths, wires, and catheters.
4. Repair vessels and close in standard surgical fashion.

10.2 Ancillary Devices: Distal Extension

General Use Information

Inaccuracies in device size selection or placement, changes or anomalies
in patient anatomy, or procedural complications can require placement of
additional endovascular grafts and extensions. 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.
Standard techniques for placement of arterial access sheaths, guiding catheters,
angiographic catheters, and wire guides should be employed during use of the
Zenith Alpha Thoracic Endovascular Graft ancillary devices.
The Zenith Alpha Thoracic Endovascular Graft ancillary devices are compatible
with .035 inch diameter wire guides. Additional proximal main body
components may be used to extend graft coverage proximally. Distal extensions
are used to extend the distal body of an in situ endovascular graft or to increase
the length of overlap between graft components.

10.2.1 Distal Extension Preparation/Flush

1. Remove the yellow-hubbed inner stylet from the dilator tip. Verify that the
Captor Sleeve is within the Captor Hemostatic Valve; do not remove the
Captor Sleeve. (Fig. 4)
2. Elevate distal tip of system and flush through the hemostatic valve until
fluid exits the tip of the introducer sheath. (Fig. 5) Continue to inject a full
60 mL of flushing solution through the device. Discontinue injection and
close the stopcock on the connecting tube.
NOTE: Graft flushing solution of heparinized saline is often used.
3. Attach a syringe with heparinized saline to the hub on the blue rotation
handle. (Fig. 6) Flush until fluid exits the distal sideports and dilator tip.
4. Soak sterile gauze pads with saline and use to wipe the Flexor Introducer
Sheath to activate the hydrophilic coating. Hydrate both sheath and dilator
liberally.

10.2.2 Placement of the Distal Extension

1. Puncture the selected artery using standard technique with an 18 gage
access needle. Alternatively, use the in situ wire guide that was used
previously for introduction system/graft insertions. Upon vessel entry,
insert:
• Wire guide – (standard .035 inch, 260/300 cm, 15 mm J tip or Bentson).
• Appropriate size sheath (e.g., 5 French).
• Pigtail flush catheter (often radiopaque-banded sizing catheters; e.g.,
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 the graft system has been primed with heparinized saline, and all air
has been removed.
4. Give systemic heparin. Flush all catheters and wire guides with heparinized
saline. Reflush catheters and rewet wire guides after each exchange.
5. Replace the standard wire guide with a stiff .035 inch, 260/300 cm, LESDC
wire guide and advance it through the catheter and up to the aortic arch.
6. Remove the pigtail flush catheter and sheath.
NOTE: At this stage, the second femoral artery can be accessed for flush
catheter placement. Alternatively, consider using a brachial approach.
7. Introduce the freshly hydrated introduction system over the wire guide and
advance until the desired graft position is reached. Ensure that the distal
extension overlaps the distal component by a minimum of three stents
(plus the distal uncovered stent).
CAUTION: To avoid twisting the endovascular graft, never rotate
the introduction system when you introduce it. Allow the device to
conform naturally to the curves and tortuosity of the vessels.
NOTE: The dilator tip softens 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.
24
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 counterclockwise to the open position. (Fig. 7)
10. Stabilize the gray positioner (introduction system shaft) and withdraw the
sheath until the graft is fully expanded and the valve assembly with the
Captor Sleeve docks with the black gripper. (Fig. 8)
CAUTION: As the sheath or wire guide 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. Move back to original position and continue
deployment.
11. Verify graft position and, if necessary, adjust it forward. Recheck graft
position with angiography.
12. While holding the black gripper, turn the black safety-lock knob in the
direction of the arrow until a slight click is felt, indicating that the blue
rotation handle is engaged. (Fig. 9) Make sure the black safety-lock knob is
in the unlocked position.
13. Under fluoroscopy, turn the blue rotation handle in the direction of the
arrow until a stop is felt. (Fig. 10) This indicates that the proximal end of
the graft has opened, and that the distal attachment to the introducer has
been released.
NOTE: If the blue rotation handle stops before completing the rotation,
verify the position of the black safety-lock knob and, if necessary, turn it
counterclockwise to the unlocked position.
NOTE: If the black safety-lock knob is removed from the system after it has
been turned counterclockwise to the unlocked position, the blue rotation
handle will remain engaged. Continue with the procedure.
NOTE: If difficulty is still encountered during rotating the blue rotation
handle, refer to Section 12, RELEASE TROUBLESHOOTING for instructions
on how to disassemble the blue rotation handle.
14. Remove the inner introduction system entirely, leaving the sheath and wire
guide in place.
CAUTION: To avoid entangling any catheters left in situ, rotate the
introduction system during withdrawal.
15. Close the Captor Hemostatic Valve on the Flexor Introducer Sheath by
turning it in a clockwise direction until it stops.
10.2.3 Distal Extension Molding Balloon Insertion – Optional
1. Prepare the molding balloon as follows and/or per the manufacturer's
instructions:
• Flush the wire lumen with heparinized saline.
• Remove all air from the balloon.
2. In preparation for insertion of the molding balloon, open the Captor
Hemostatic Valve by turning it counterclockwise. (Fig. 7)
3. Advance the molding balloon over the wire guide and through the Captor
Hemostatic Valve of the introduction system to the level of the distal
component/distal extension overlap. Maintain proper sheath positioning.
4. Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure by turning it clockwise.
CAUTION: Do not inflate balloon in the aorta outside of the graft.
5. Expand the molding balloon with diluted contrast media (as directed
by the manufacturer) in the area of the overlap, starting proximally and
working in the distal direction.
CAUTION: Confirm complete deflation of balloon prior to
repositioning.
6. Withdraw the molding balloon to the distal fixation site and expand.
7. Loosen the Captor Hemostatic Valve, remove the molding balloon
and replace it with an angiographic catheter to perform completion
angiography.
8. Tighten the Captor Hemostatic Valve around the angiographic catheter
with gentle pressure by turning it clockwise.
9. Remove or replace all stiff wire guides to allow aorta to resume its natural
position.
10.2.4 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 trunk.
2. In the final angiogram confirm that there are no endoleaks or kinks, that
the proximal and distal gold radiopaque markers are positioned to provide
adequate overlap between components, and that there is sufficient graft
length to maintain over time a minimum of 20 mm in proximal and distal
seal.
NOTE: If endoleaks or other problems are observed (e.g., inadequate seal
length or overlap length), refer to Section 10.2, Ancillary Devices: Distal
Extension.
3. Remove the sheaths, wires, and catheters.
4. Repair vessels and close in standard surgical fashion.

11 IMAGING GUIDELINES AND POSTOPERATIVE 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 the
performance of their endovascular graft. Patients with specific clinical
findings (e.g., endoleaks, enlarging aneurysms or ulcers, 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 thoracic aneurysm or ulcer.
• 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 3. 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 ulcers, 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 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 in combination with
transesophageal echocardiography for assessment of endoleak.
• The combination of contrast and non-contrast CT imaging provides
information on device migration, aneurysm diameter or ulcer depth change,
endoleak, patency, tortuosity, progressive disease, fixation length, and other
morphological changes.
• The thoracic device radiographs provide information on device migration
and device integrity (separation between components, stent fracture, and
barb separation) that may or may not be visible on CT depending on the
quality of the scan.
Table 3 lists the minimum requirements for imaging follow-up for patients
with the Zenith Alpha Thoracic Endovascular Graft. Patients requiring enhanced
follow-up should have interim evaluations.