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

Costa 2013.

Clinical features and settings 40 people within the scope of stents monitoring protocol and risk of endoleaks type II followed from November 2010 to February 2013.
Type of stents received: fenestrated.
Aneurysm diameter (mean ± SD): 55 ± 8 mm in anteroposterior diameter.
Setting: vascular surgery department at the University Hospital of Lyon.
Participants 39 men; age (mean ± SD): 75 ± 8 years.
Comorbidities: smoking habits, hypertension, dyslipidaemia, diabetes, overweight.
Geography: France.
Study design Cross‐sectional study.
Target condition and reference standard(s) Target condition: endoleak.
Definition of endoleak: "Endoleaks (the most common complication) are responsible for feeding the aneurysm sac and is a breaking risk factor. The type I endoleak is a leak at a site proximal or distal attachment, type II is a reflux from the collateral of the aorta, the type III is a defect in the wall of the stent, and Type IV is a result of a porosity of the prosthesis."
Endoleak (absolute n): 19.
Prevalence of endoleak: 31.7% (19/60).
Reference standard: CT.
Image acquisition:
  • "computed tomography of the aortic stent comprised of: a sequence without injection, injection sequence with 120 mL of contrast medium, and a delayed sequence of two minutes after injection;"

  • "the acquisition of the sequence without injection could be performed with a wide collimation (two and one half millimeters), whereas the sequences with injection should be performed with a collimating infra millimeter."


Type of CT scanner: not reported.
Use of contrast: 120 mL of unspecified contrast medium.
Operator: CT performed and interpreted in radiology.
Index and comparator tests Index test: echo‐Doppler with and without contrast injection. Contrast agent used in people at risk of endoleak and had no contraindications to product.
Image production: participants supine.
Type of US: General Electric equipment with a convex abdominal probe (4C‐A) and Siemens Acuson with a convex abdominal probe (C5‐2).
Use of contrast: "The contrast agent used (the only available in France) was the Sonovue Braco Milan. The dose used was that recommended: 2.4 mL bolus followed by washing with 5 ml of isotonic saline."
Operator: echo‐Doppler performed and interpreted by trained vascular physicians.
Follow‐up 3 participants excluded from study because they had contraindication for contrast medium injection (severe pulmonary hypertension, heart failure stage III).
Notes
  • Aim of study was to demonstrate that use of CE‐CDUS by an experienced vascular physician could increase sensitivity of detecting type II endoleaks compared with CTA taken as the gold standard.

  • Study conducted between November 2010 and February 2013.

  • People with type I, III, and IV endoleak associated with type II endoleak not included.

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 CT scan.
Acceptable delay between tests? 
 All tests Yes "The Doppler with and without ultrasound contrast agent injection was made within less than 24 hours and CT less than ten days before or after."
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 "Ultrasound and CT analyzes were performed independently and blindly (vascular doctor did not know the results of the CT scan, and the radiologist did not know the results of echo‐Doppler)."
Index test results blinded? 
 All tests Yes "Ultrasound and CT analyzes were performed independently and blindly (vascular doctor did not know the results of the CT scan, and the radiologist did not know the results of echo‐Doppler)."
Relevant clinical information? 
 All tests Yes Age, gender, risk factors, and comorbidities of the participants reported.
Uninterpretable results reported? 
 All tests Yes No apparent uninterpretable data occurred.
Withdrawals explained? 
 All tests Yes "Three patients were excluded from the study because they had against‐indication for the contrast medium injection (severe pulmonary hypertension, heart failure stage III).