Distal Extension Preparation/Flush; Placement Of The Distal Extension; Distal Extension Molding Balloon Insertion - Optional; Final Angiogram - COOK Medical ZENITH ALPHA Mode D'emploi

Distal Extension Preparation/Flush

1. Remove the yellow-hubbed inner stylet from the dilator tip. Verify that the
Captor Sleeve is inserted in the Captor Hemostatic Valve; do not remove the
Captor Sleeve (fig. 4).
2. Elevate distal tip of system and flush through the hemostatic valve (fig. 5)
until fluid emerges from the tip of the introducer sheath. Continue to inject
a full 60 cc of flushing solution through the device. Discontinue injection
and close stopcock on connecting tube.
NoTE: Graft flushing solution of heparinized saline is often used.
3. Attach syringe with heparinized saline to the hub on the 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.

Placement of the Distal Extension

1. Puncture the selected artery using standard technique with an 18 gage
access needle. Alternatively, use 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
wire guide
• Appropriate size sheath (e.g., 5.0 French)
• Pigtail flush catheter (often radiopaque-banded sizing catheters; i.e.,
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. This should be repeated following each exchange.
5. Replace the standard wire guide with a stiff .035 inch, 260/300 cm – LESDC
wire guide and advance 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, a brachial approach may be considered.
7. Introduce the freshly hydrated introduction system over the wire guide
and advance until the desired graft position is reached. Ensure there is a
minimum overlap of three stents (plus the distal uncovered stent).
CaUTIoN: To avoid twisting the endovascular graft, never rotate
the introduction system during the procedure. 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.
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 counter-clockwise 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 adjust it forward, if necessary. Recheck graft
position with angiography.
12. While holding the black gripper, turn the black safety lock knob in the
direction of the arrow to engage the blue rotation handle (fig. 9).
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 the distal attachment to the introducer has been
released.
NoTE: If difficulty is encountered during rotation of the blue rotation
handle, refer to Section 12 RELEaSE TRoUbLESHooTING for instructions
on how to disassemble the rotation handle.
NoTE: Check to make sure that all release wires are removed prior to
withdrawal of the introduction system.
14. Remove the inner introduction system entire ly, leaving the sheath and wire
guide in the graft.
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.
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.
Table 3 — Recommended Imaging Schedule for Endograft Patients
Pre-procedure
Procedural
1 month
6 month
12 month (annually thereafter)
Imaging should be performed within 6 months before the procedure.
1
2 If Type I or III endoleak, prompt intervention and additional follow-up post-intervention recommended, See Section 11.5, additional Surveillance and Treatment.

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.
20
Distal Extension Molding Balloon Insertion — Optional
1. Prepare molding balloon as follows and/or per the manufacturer's
2. In preparation for insertion of the molding balloon, open the Captor
3. Advance the molding balloon over the wire guide and through the Captor
4. Tighten the Captor Hemostatic Valve around the molding balloon with
5. Expand the molding balloon with diluted contrast media (as directed
6. Withdraw the molding balloon to the distal fixation site and expand.
7. Loosen the Captor Hemostatic Valve, remove the molding balloon
8. Tighten the Captor Hemostatic Valve around the angiographic catheter
9. Remove or replace all stiff wire guides to allow aorta to resume its natural

Final Angiogram

1. Position angiographic catheter just above the level of the endovascular
2. Confirm there are no endoleaks or kinks, and verify position of proximal
3. 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
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 aortic aneurysms and ulcers.
• 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 integrity
(separation between components, stent fracture, and barb separation that
may not be visible on CT) and device migration.
angiogram (contrast and non-contrast)
X
• The same scan parameters, (i.e., spacing, thickness and FOV), should be used
at each follow-up. Do not change the scan table x- or y- coordinates while
scanning.
• Sequences must have matching or corresponding table positions. It is
important to follow acceptable imaging protocols during the CT exam. Table
4 lists examples of acceptable imaging protocols.
instructions.
• Flush the wire lumen with heparinized saline.
• Remove all air from the balloon.
Hemostatic Valve by turning it counter-clockwise (fig. 7).
Hemostatic Valve of the introduction system to the level of the distal
component/distal extension overlap. Maintain proper sheath positioning.
gentle pressure by turning it clockwise.
CaUTIoN: Do not inflate balloon in the aorta outside of the graft.
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.
and replace it with an angiographic catheter to perform completion
angiograms.
with gentle pressure by turning it clockwise.
position.
graft. Perform angiography to verify correct positioning. Verify patency of
arch vessels.
and distal gold radiopaque markers. Remove the sheaths, wires and
catheters.
CT
X 1
X 2
X 2
X 2
Thoracic Device Radiographs
X
X
X
I-ALPHA-TAA-1306-436-01