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. 2017 Jun 9;2017(6):CD010296. doi: 10.1002/14651858.CD010296.pub2

Bendick 2003.

Clinical features and settings Overall population who received a stent composed of 63 male and 6 female participants, mean (± SD) age 72.6 ± 8.7 years (range 58‐87 years);
Type of stents received: not reported. 64 grafts had modular design and 5 grafts had unibody bifurcated design.
Aneurysm diameter: mean (± SD) aneurysm size: 5.6 ± 0.9 cm.
Setting: vascular laboratory.
Participants Included participants were 19 males and one female patient; mean (± SD) age: 74.5 ± 7.6 years; range: 65‐86 years. 18 of these participants had modular graft design and 2 participants had unibody bifurcated graft placed.
Comorbidities: not reported.
Geography: USA.
Study design Unclear. Probably a retrospective study.
Target condition and reference standard(s) Target condition: endoleak.
Definition of endoleak: any endoleaks that were seen with DUS were classified as being related to the stent graft itself (group l), at either proximal or distal attachment sites or at any graft module junctions or secondary to patent aortic branch vessels (group II), such as the inferior mesenteric artery or lumbar arteries, which showed collateral filing and back‐bleeding into the aneurysm sac. Endoleak classified as indeterminate if it could not be definitively identified as being in group I or group II.
Endoleak (absolute n): 8.
Prevalence of endoleak: 40% (8/20).
Reference standard: CT scan.
Image acquisition:
  • delayed dual spiral imaging before and after (60‐s and 120‐s delays) a 175‐200 mL bolus of IV contrast;

  • thickness: multiple axial images with 2‐ to 3‐mm slice thickness with 1.5‐mm reconstruction algorithm throughout the region of interest.


Type of CT scanner: not reported.
Use of contrast: not clearly reported.
Index and comparator tests Index test: CDUS.
Image production: aorta scanned in long axis and in cross‐sectional views from level of diaphragm distally to below attachment sites of iliac limbs of stent graft. Residual aneurysm sac size measured in both anterior‐posterior and transverse dimensions at its widest point, and arterial flow haemodynamics documented throughout stent graft with spectral Doppler velocity measurements. Suspected endoleak further documented for flow characteristics with spectral Doppler velocities.
Type of US: standard DUS scan examination (LOGIQ 700, GE, Milwaukee, WI, USA) with CDI and spectral Doppler velocity measurements
Use of contrast: yes (1‐mL bolus of US scan contrast agent (Optison, Mallinckrodt, St Louis, MO).
Operator: unclear.
Follow‐up No apparent missing data or adverse events.
Notes
  • Overall population who received stent composed of 63 males and 6 females; mean (± SD) age: 72.6 ± 8.7 years: range: 58‐87 years; mean (± SD) aneurysm size: 5.6 ± 0.9 cm. 64 grafts had modular design, and 5 grafts had unibody bifurcated design.

  • Timing of follow‐up examination ranged from 1 to 12 months after graft placement, with a mean (± SD) follow‐up time 5.3 ± 3.0 months.

Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests No Of the whole sample who received stents, 20 participants included. While 10 participants selected at random, remaining 10 participants selected based on participant's habitus or presence of bowel gas.
Acceptable reference standard? 
 All tests Yes Reference standard was CT scan.
Acceptable delay between tests? 
 All tests Yes "All CT angiography were read within a 2‐week period of the duplex ultrasound scan."
Partial verification avoided? 
 All tests Yes All study participants accounted for and results of reference standard reported for all.
Differential verification avoided? 
 All tests Yes All participants who received US subjected to CT scan.
Incorporation avoided? 
 All tests Yes Index test not part of reference standard.
Reference standard results blinded? 
 All tests Yes "The operator was blinded to the results of any previous ultrasound scans and of any prior angiographic or CT angiography studies."
Index test results blinded? 
 All tests Yes All CTA studies read independently for presence or absence of endoleaks.
Relevant clinical information? 
 All tests Yes Yes.
Uninterpretable results reported? 
 All tests Yes "CT angiography identified eight endoleaks and classified two of them into group I and three into group II; three additional posterior sac endoleaks were seen, but their origin was not clearly identified."
Withdrawals explained? 
 All tests Yes No withdrawals occurred.