Ct Recommendations; Abdominal Radiographs; Ultrasound; Mri Safety And Compatibility - COOK Medical Zenith Universal Distal Body Mode D'emploi

Table 11.1 Recommended Imaging Schedule for Endograft Patients
Pre-procedure
Procedural
Pre-discharge (within 7 days)
1 month
6 month
12 month (annually thereafter)
1
Imaging should be performed within 6 months before the procedure.
2
Duplex ultrasound may be used for those patients experiencing renal failure or who are otherwise unable to undergo contrast enhanced CT scan. With 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.

11.2 CT Recommendations

Image 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 sets, as it prevents precise anatomical and device comparisons over time. When using a multiphase scan, the table positions
must match.
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:
Four images: supine-frontal (AP), cross-table lateral, 30 degree LPO and
30 degree RPO views centred on umbilicus
Record the table-to-detector distance and use the same distance at
each 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, relative component migration), it is recommended to use
magni ed views. The attending physician should evaluate images for
device integrity (entire device length including components) using 2-4X
magni cation 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 (NOTE: Imaging
is limited to the abdominal aorta). 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:
Transverse and longitudinal imaging should be obtained of the
abdominal aorta demonstrating the celiac, mesenteric and renal
arteries to the iliac bifurcations to determine if endoleaks are present
utilizing colour flow and colour power Doppler (if accessible)
Spectral analysis confirmation should be performed for any suspected
endoleaks
Transverse and longitudinal imaging of the maximum aneurysm
should be obtained.

11.5 MRI Safety and Compatibility

For MRI safety and compatibility information refer to Section 4.4.

11.6 Additional Surveillance and Treatment

Additional surveillance and possible treatment is recommended for:
Aneurysms with Type I endoleak
Aneurysms with Type III endoleak
Aneurysm enlargement, ≥5 mm of maximum diameter (regardless of
endoleak status)
Migration
Inadequate seal length
Consideration for reintervention or conversion to open repair should
include the attending physician's assessment of an individual patient's
co-morbidities, life expectancy and the patient's personal choices.
Patients should be counselled that subsequent re-interventions
including catheter-based and open surgical conversion are possible
following endograft placement.
Angiogram
X 1
X
Table 11.2 Acceptable Imaging Protocols
Non-Contrast
No
Spiral CT or high performance MDCT
capable of > 40 seconds
n/a
n/a
n/a
n/a
Humeral Head
Proximal femur
<3 mm
2.5 mm throughout – soft algorithm
32 cm
None
17
Abdominal
CT Radiographs
X 1
X 2,3,4 X
X X
2,3,4
X 2,4 X
X X
2,4
Contrast
Yes
Spiral CT or high performance MDCT
capable of > 40 seconds
150 cc
>2.5 cc/sec
Power
Test bolus: SmartPrep, C.A.R.E. or equivalent
Humeral Head
Proximal femur
<3 mm
2.5 mm throughout – soft algorithm
32 cm
None