Patient Preparation; Bifurcated System; Bifurcated Main Body Preparation/Flush; Iliac Leg Preparation/Flush - COOK Medical Zenith Alpha Mode D'emploi

Patient Preparation

1 . Refer to institutional protocols relating to anesthesia, anticoagulation and
monitoring of vital signs .
2 . Position the patient on the imaging table allowing fluoroscopic
visualization from the aortic arch to the femoral bifurcations .
3 . Both common femoral arteries should be prepared using standard
techniques for either surgical or percutaneous access .
10.1 Bifurcated System (Fig. 2)

10.1.1 Bifurcated Main Body Preparation/Flush

1 . Verify that the Captor Sleeve is inserted in the Captor Hemostatic Valve .
Elevate the distal tip of the system and flush through the stopcock on the
Captor Hemostatic Valve until fluid emerges through the flush groove at
the proximal end of the introducer sheath . (Fig . 5a) Continue to inject a
full 20 cc 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 .
2 . Attach a syringe with heparinized saline to the clear hub on the end of
the handle . Flush until fluid exits the dilator tip . (Fig . 6)
NOTE: When flushing the system, elevate the distal end of the system to
facilitate the 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 dilator liberally .

10.1.2 Iliac Leg Preparation/Flush

1 . Remove the Peel-Away sheath from the back of the hemostatic valve .
(Fig . 8) Elevate the distal tip of the system and flush through the
stopcock on the hemostatic valve until fluid emerges through the flush
groove at the proximal end of the introducer sheath . (Fig . 5b) Continue
to inject a full 20 cc 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 .
NOTE: When removing the Peel-Away sheath from the back of the
hemostatic valve, ensure that the delivery system sheath is held stationary
against the dilator tip to limit possible movement .
2 . Attach a syringe with heparinized saline to the black hub on the inner
cannula . Flush until fluid exits the dilator tip . (Fig . 7)
NOTE: When flushing the system, elevate the distal end of the system to
facilitate the removal of air .

10.1.3 Vascular Access and Angiography

1 . Puncture the selected common femoral arteries using standard
technique with an 18 or 19UT gage arterial needle . Upon vessel entry,
insert:
• Wire guides - standard .035 inch diameter, 145 cm long
• Appropriate size sheaths (e .g ., 6 or 8 Fr)
• Flush catheter (often radiopaque sizing catheters - e .g ., Centimeter Sizing
Catheter or straight flush catheter)
2 . Perform angiography to identify level(s) of renals, aortic bifurcation and
iliac bifurcations .
NOTE: If fluoroscope angulation is used with an angulated neck it may be
necessary to perform angiograms using various projections .

10.1.4 Main Body Placement

1 . Ensure the delivery system has been flushed with heparinized saline and
that all air is removed from the system .
2 . Give systemic heparin and check flushing solutions . Flush after each
catheter and/or wire guide exchange .
NOTE: Monitor the patient's coagulation status throughout the procedure .
3 . On the ipsilateral side, replace the J wire with a stiff wire guide (LES)
.035 inch, 260 cm long, and advance through the catheter and up to
the thoracic aorta . Remove the flush catheter and sheath . Maintain wire
guide position .
4 . Before insertion, position the main body delivery system on the patient's
abdomen under fluoroscopy to determine the orientation of the
contralateral limb radiopaque marker . The sidearm of the hemostatic
valve may serve as an external reference to the contralateral limb
radiopaque marker .
5 . Insert the main body delivery system over the wire into the femoral
artery, with attention to sidearm reference .
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 . Advance the delivery system until the four gold radiopaque markers
(which are positioned 2 mm from the most proximal segment of the
graft material) (Fig . 9, Illustration 1) are just inferior to the most inferior
renal orifice .
7 . Verify position of the wire guide in the thoracic aorta . Ensure the graft
system is oriented such that the contralateral limb is positioned above
and anterior to the origin of the contralateral 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 .
• A marker formation of a indicates an anterior position of the short
(contralateral) limb . (Fig . 9, Illustration 4)
• A marker formation of a indicates a posterior position of the short
(contralateral) limb . (Fig . 9, Illustration 5)
l
• A marker formation of a line indicates a lateral position of the short
(contralateral) limb . (Fig . 9, Illustration 6)
8 . Repeat the angiogram to verify the four gold radiopaque markers are
2 mm or more below the most inferior renal orifice .
9 . Ensure the Captor Hemostatic Valve is turned to the open position .
(Fig . 10)
10 . Stabilize the gray positioner (the shaft of the delivery system) while
withdrawing the sheath . Deploy the first two covered stents by
withdrawing the sheath while monitoring device location .
NOTE: The delivery system does not utilize a top cap; however, the stent
graft has a suprarenal stent with barbs . The device should be accurately
positioned before the outer sheath is withdrawn .
11 . Without moving the table, decrease the magnification to check on the
position of the contralateral limb radiopaque marker and location of
renal arteries . Continue withdrawing the sheath until the contralateral
limb is fully deployed . (Fig . 11) Stop withdrawing the sheath .
NOTE: Verify the contralateral limb is at least 5 mm above the aortic
bifurcation and in the desired location for cannulation .
12 . Repeat the angiogram and reposition if necessary .
13 . While holding the black gripper, turn the black safety lock knob 180
degrees in the direction of the arrows . (counter clockwise) . Ensure that
the black safety lock knob is secured in the unlock position . This will
allow you to rotate the blue rotation handle . (Fig . 12)
NOTE: If the black safety lock knob is removed from the system after it
has been turned counterclockwise, the blue rotation handle will still be
functional . Continue with the procedure .
14 . To release the suprarenal bare stent, under fluoroscopy, turn the blue
rotation handle approximately two full rotations in the direction of the
arrow (clockwise) until a stop is felt . (at this point, the safety lock knobs
are aligned) . Rotating the blue handle retracts the wires that tether the
bare proximal stent to the proximal end of the delivery system . (Fig . 13)
NOTE: If the blue rotation handle stops before completing approximately
two full rotations, confirm that the black safety lock knob is in the unlock
position . If it is not, unlock the black safety lock knob and complete Step 14 .
NOTE: Handle system mechanism may be manually overridden; however,
do not attempt any troubleshooting actions before referring to Section 12 .
NOTE: If resistance is felt or system bowing is noticed, the device 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 the stent does not fully release, see Section 12, MAIN BODY

RELEASE TROUBLESHOOTING

CAUTION: During 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 .
NOTE: Once the barbed suprarenal stent has been deployed, further
attempts to reposition the graft are not recommended .
WARNING: The Zenith Alpha Abdominal Endovascular Graft
incorporates a suprarenal stent with fixation barbs . Exercise extreme
caution when manipulating interventional devices in the region of the
suprarenal stent .

10.1.5 Contralateral Iliac Wire Guide Placement

1 . Manipulate wire guide using an angiographic catheter through the open
end of the contralateral limb into the body of the graft . Advance the wire
guide inside the body of the graft and into the thoracic aorta . AP and
oblique fluoroscopic views can aid in verification of device cannulation .
2 . After cannulation of the wire guide, advance the angiographic catheter
over the wire into the body of the endovascular graft . Remove the wire
guide and perform angiography to confirm position . Reinsert the wire
guide inside the body of the graft and into the thoracic aorta . Remove
the angiographic catheter .

10.1.6 Contralateral Iliac Leg Placement and Deployment

NOTE: If using this device in conjunction with the Zenith Spiral-Z AAA
Iliac Leg, refer to the Zenith Spiral-Z AAA Iliac Leg IFU for appropriate
deployment and overlap instructions .
CAUTION: Verify that the contralateral iliac leg is selected .
NOTE: When using a 42 or 59 mm leg graft on the ipsilateral side,
contralateral leg overlap into the contralateral main body limb should be
limited to 16 mm .
1 . Position the image intensifier to show both the contralateral internal iliac
artery and contralateral common iliac artery .
2 . Prior to introduction of the contralateral iliac leg delivery system,
inject contrast through the contralateral femoral sheath to locate the
contralateral internal iliac artery .
3 . Remove the femoral sheath and introduce the contralateral iliac leg
delivery system into the artery . Advance slowly until the zone between
the two proximal gold markers aligns with the gold radiopaque marker
at the bifurcation of the main body graft . This will allow between 16 mm
and 32 mm of overlap between components . (Fig . 14) If there is any
tendency for the main body graft to move during this maneuver, hold it
in position by stabilizing the positioner on the ipsilateral side .
NOTE: On each iliac leg there are three gold markers, as explained below:
Proximal Marker 1
Proximal Marker 2
Distal Marker
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 the distal end of the contralateral iliac leg graft .
Reposition the contralateral iliac leg graft if necessary to ensure both
internal iliac patency and minimum overlap of 2 stents (16 mm) within
the main body endovascular graft .
5 . To deploy, hold the contralateral iliac leg graft in position with the gray
positioner while withdrawing the sheath approximately 10 mm .
(Figs . 15 and 16)
31
Location Graft Overlap
Proximal edge When marker is aligned
with the main body
bifurcation marker, there is
an overlap of 16 mm on the
contralateral side (minimum
recommended overlap)
16 mm from When this marker is
proximal edge aligned with the main body
bifurcation marker, there is
an overlap of 32 mm on the
contralateral side (maximum
recommended overlap)
Distal edge N/A