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

Gurtler 2013.

Clinical features and settings 171 people after EVAR who received 489 CE‐CDUS and 421 MS‐CT examinations during follow‐up. 39 participants withdrawn because of time mismatch between imaging studies. 200 contemporary examination pairs ± 30 days from 132 participants of the 489 CE‐CDUS and 421 MS‐CT examinations matched.
Type of stents received: bi‐iliac or mono‐iliac stent graft.
Aneurysm diameter: not reported.
Setting: department for clinical radiology.
Participants 151 men; mean (± SD) age: 70.4 ± 8.6 years; range: 34‐91 years.
Comorbidities: not reported.
Geography: Germany.
Study design Cross‐sectional study.
Target condition and reference standard(s) Target condition: endoleak.
Definition of endoleak: "An endoleak was defined as an extravasation of contrast between the aneurysm wall and the prosthesis."
Endoleak (absolute n): 87.
Prevalence of endoleak: 43.5% (87/200).
Reference standard: MSCT.
Image acquisition:
  • "the imaged volume included the entire abdominal aorta from its lower thoracic portion and the common and external iliac arteries to the upper femoral arteries. The acquisition direction was craniocaudal;"

  • "images were reconstructed as thin‐slice maximum‐intensity projections with increments of 0.6 mm and slice of 0.75 mm in coronal planes."


Type of CT scanner: Somaton Sensation 16‐, 64‐, or 128‐slice detector MS‐CT scanner (Siemens Medical Systems, Forchheim, Germany).
Use of contrast: "A total of 100 to 120 mL Imeron (Bracco) with an iodine concentration of 350 mg/mL was administered, followed by 50 mL saline (0.9% NaCl)."
Operator: 2 experienced radiologists.
Index and comparator tests Index test: CE‐CDUS.
Image production: transverse and sagittal imaging.
Type of US: ACUSON Sequoia 512 and a ACUSON S2000 (Siemens Healthcare, Erlangen, Germany) using a curved‐array 4‐MHz multi‐frequency transducer.
Use of contrast: "an intravenous bolus injection of 1.0 mL SonoVue, a second‐generation blood pool contrast agent, consisting of stabilized microbubbles of sulfur hexafluoride, was administered into an antecubital vein through an 18‐gauge needle and was followed by a flush of 10 mL saline solution (0.9% NaCl)."
Operator: 1 experienced sonographer.
Follow‐up 39 participants withdrawn because of time mismatch between imaging studies.
Notes
  • Aim of studyto show that CE‐CDUS imaging is as good as MS‐CT in detecting endoleaks and even better than MS‐CT in classifying different endoleak types.

  • Study conducted between February 2006 and February 2011.

  • 2 study participants received new stent grafts during the follow‐up, so total of 173 stents examined.

  • During the follow‐up interval, 97/173 participants (56.1%) showed an endoleak, but 19 of the primary endoleaks sealed spontaneously.

Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Unclear Not clearly stated if the participants were consecutively enrolled.
Acceptable reference standard? 
 All tests Yes Reference standard was MS‐CT scan.
Acceptable delay between tests? 
 All tests Yes "We compared examinations that were performed on the same day or ≤30 days."
Partial verification avoided? 
 All tests Yes All participants received both tests.
Differential verification avoided? 
 All tests Yes All participants who received index test subjected to same reference standard.
Incorporation avoided? 
 All tests Yes Index test not part of reference standard.
Reference standard results blinded? 
 All tests Yes "Radiologists reading one test did not have access to the results of the other test."
Index test results blinded? 
 All tests Yes "Radiologists reading one test did not have access to the results of the other test."
Relevant clinical information? 
 All tests Yes Yes.
Uninterpretable results reported? 
 All tests Yes No apparent uninterpretable data occurred.
Withdrawals explained? 
 All tests Yes "39 patients were withdrawn because of time mismatch between imaging studies."