Final Angiogram; Imaging Guidelines And Post-Operative Follow-Up; General; Contrast And Non-Contrast Ct Recommendations - COOK Medical Zenith Fenestrated AAA Instructions For Use Manual

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 Section 1.6,
Ancillary Components.
3. Repair vessels and close in standard surgical fashion.

11 IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP

11.1 General

The long-term performance and safety of endovascular grafts has
not yet been established. As a result, life-long, regular follow-up must
be undertaken in all patients to assess the ongoing performance of the
Zenith Fenestrated AAA 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 AAAs.
Table 11.1 Recommended Imaging Schedule for Endograft Patients
Pre-procedure
Procedural
Pre-discharge (within 7 days)
1 month
3 month
6 month
12 month (annually thereafter)
Imaging should be performed within 6 months before the procedure.
1
Duplex ultrasound may be used for those patients experiencing renal failure or who are otherwise unable to undergo contrast enhanced CT scan. With
2
ultrasound, non-contrast CT is still recommended.
3 Either pre-discharge or 1 month CT recommended.
4 If Type I or III endoleak, prompt intervention and additional follow-up post-intervention recommended. See Section 11.6, Additional Surveillance and
Treatment.
5 Recommended if endoleak reported at pre-discharge or 1 month.

11.2 Contrast and Non-Contrast CT Recommendations

consecutive CT images/film sets, as it prevents precise anatomical and device comparisons over time.
Non-contrast and contrast enhanced baseline and follow-up imaging are important for optimal patient surveillance. It is important to follow acceptable
imaging protocols during the CT exam. Table 11.2 lists examples of acceptable imaging protocols.
IV contrast
Acceptable machines
Injection volume
Injection rate
Injection mode
Bolus timing
Coverage - start
Coverage - nish
Collimation
Reconstruction
Axial DFOV
Post-injection runs

11.3 Abdominal Radiographs

The following views are required:
30 degree RPO views centered on umbilicus.
subsequent examination.
Ensure entire device is captured on each single image format lengthwise.
If there is any concern about the device integrity (e.g., kinking,
stent breaks, barb separation, relative component migration), it is
recommended to use magnified views. The attending physician should
evaluate films for device integrity (entire device length including
components) using 2-4X magnification visual aid.

11.4 Ultrasound

Ultrasound imaging may be performed in place of contrast CT when
patient factors preclude the use of image contrast media. Ultrasound
may be paired with non-contrast CT. A complete aortic duplex is to be
videotaped for maximum aneurysm diameter, endoleaks, stent patency and
stenosis. Included on the videotape should be the following information as
outlined below:
the proximal aorta demonstrating mesenteric and renal arteries to the
iliac bifurcations to determine if endoleaks are present utilizing color flow
and color power angiography (if accessible).
endoleaks.
be obtained.

11.5 MRI Safety and Compatibility

Non-clinical testing conducted on the standard Zenith AAA Endovascular
Graft has demonstrated that the graft is MR Conditional.
The Zenith Fenestrated AAA Graft contains the same metal as the standard
Zenith AAA device (stainless steel), but also contains a small amount of
Nitinol. It is not expected that this small amount of nitinol would alter the MRI
Conditional rating that was observed for the standard Zenith AAA device.
The standard Zenith AAA Endovascular Graft can be scanned safely under
the following conditions:
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.
information on aneurysm diameter change, endoleak, patency, tortuosity,
progressive disease, fixation length and other morphological changes.
(separation between components, stent fracture and barb separation).
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 requirements for imaging follow-up for patients with the
Zenith Fenestrated AAA Endovascular Graft. Patients requiring enhanced
follow-up should have interim evaluations.
Angiogram (Contrast and non-contrast)
X 1
X
Table 11.2 Acceptable Imaging Protocols
Non-Contrast
No
n/a
n/a
n/a
n/a
Diaphragm
Proximal femur
<3 mm
2.5 mm throughout – soft algorithm
32 cm
None
1.5 Tesla Systems:
for 15 minutes of scanning
In non-clinical testing, the standard Zenith AAA Endovascular Graft produced
a temperature rise of less than or equal to 1.4°C at a maximum whole
body averaged speci c absorption rate (SAR) of 2.8 W/kg, as assessed by
calorimetry for 15 minutes of MR scanning in a 1.5 Tesla static magnetic eld
strength Magnetom, Siemens Medical Magnetom, Numaris/4 Software,
Version Syngo MR 2002B DHHS MR Scanner. The maximum whole body
averaged speci c absorption rate (SAR) was 2.8 W/kg, which corresponds to a
calorimetry measured value of 1.5 W/kg.
3.0 Tesla Systems:
for 15 minutes of scanning
In non-clinical testing, the standard Zenith AAA Endovascular Graft
produced a temperature rise of less than or equal to 1.9°C at a maximum
whole body averaged speci c absorption rate (SAR) of 3.0 W/kg, as
assessed by calorimetry for 15 minutes of MR scanning in a 3.0 Tesla Excite,
GE Electric Healthcare, G3.0-052B Software, MR Scanner. The maximum
whole body averaged speci c absorption rate (SAR) was 3.0 W/kg, which
corresponds to a calorimetry measured value of 2.8 W/kg.
MR image quality of the standard Zenith AAA Endovascular Graft may
be compromised if the area of interest is in the exact same area or within
approximately 20 cm of the device and its lumen, when scanned in
nonclinical testing using the sequence: Fast spin echo, in a 3.0 Tesla static
magnetic eld strength, Excite, GE Electric Healthcare, with G3.0-052B
software, MR system with body radiofrequency coil. Therefore it may be
necessary to optimize MR imaging parameters for this metallic implant.
For all scanners, the image artifact dissipates as the distance from the
device to the area of interest increases. MR scans of the head and neck and
lower extremities may be obtained without image artifact. Image artifact
may be present in scans of the abdominal region and upper extremities,
depending on distance from the device to the area of interest.
NOTE: For the Zenith Fenestrated AAA Graft, the clinical bene t of an MRI
scan should be balanced with the potential risk of the procedure.
33
CT Abdominal
Radiographs
X 1
X
2,3,4 X
X 2,3,4 X
X 2,4,5
X 2,4 X
X 2,4 X
Contrast
Yes
150 cc
Power
Test bolus: SmartPrep, C.A.R.E. or equivalent
1 cm superior to celiac axis
Profunda femoris origin
<3 mm
2.5 mm throughout – soft algorithm
32 cm
None