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

Ten Bosch 2010.

Clinical features and settings People who underwent endovascular repair for infrarenal AAA.
Type of stent received: Talent (Medtronic, Minneapolis, MN. USA).
Aneurysm diameter: not reported.
Setting: department of vascular surgery.
Participants 83 participants consecutively enrolled for CEUS and CTA imaging during surveillance after EVAR.
Comorbidities: not reported.
Geography: the Netherlands.
Study design Prospectively enrolled consecutive participants; all had target condition; all received both tests.
Target condition and reference standard(s) Target condition: endoleak.
Definition of endoleak: presence of persistent intrasac flow outside graft. Endoleaks classified as type IA/B, II, III, or IV.
Endoleak (absolute n): unclear.
Prevalence of endoleak: 21.3% (27/127).
Reference standard: triple‐phase (unenhanced and contrast‐enhanced in arterial and delayed phases) CTA.
Image acquisition:
  • images acquired in arterial phase, triggered by contrast medium passing aorta, and in delayed phase 70 s after IV contrast medium injection.


CTA performed from diaphragm to common femoral arteries after continuous IV administration of iodinated contrast agent (Xenetix 300; Laboratoire Andre Guerbet, Aulnaysous Bois, France).
Parameters: high‐speed mode capability, rotation time 0.5 s, table speed 24 mm per rotation, collimation of 1.5 mm, and slice thickness 3 mm.
Type of CT scanner: multidetector 16‐slice spiraI CT scanner (Somatom Sensation; Siemens, Forchheim, Germany).
Use of contrast: yes, iodinated contrast agent (Xenetix 300; Laboratoire Andre Guerbet, Aulnaysous Bois, France).
Index and comparator tests Index test: CDUS.
Image production: continuous real‐time tissue harmonic imaging for endoleak detection performed for 15 minutes during sonographic contrast agent infusion at mechanical index of 0.4‐0.5 and at low acoustic power.
Type of US: 3.5‐MHz curved array transducer (Aloka 550‐5000; Biomedic, Almere, the Netherlands).
Use of contrast: yes, 5 mL SonoVue (Bracco, Milan, Italy) containing 8 μL sulphur hexafluoride microbubbles per millilitre with 55 mL saline solution.
Operator: 3 ("three well trained vascular technicians dedicated to US imaging").
Follow‐up "Seven of the 113 patients were excluded from participation in the study because of severe iodinated contrast allergy (n = 3) or severe renal insufficiency (n = 4), which precluded CT angiography. The remaining 106 patients who were eligible for the study were prospectively enrolled far dual‐modality imaging after consent. Overall, 62 of 189 potential paired examinations were excluded from comparative analysis for one of the following reasons: time interval between CT angiography and US examinations exceeding 30 days as a consequence of logistic problems (n = 53), failure to perform US because of obesity (n = 2) or bowel gas (n = 1), and failure to receive CT angiography as a result of study protocol violation (n = 6)."
Notes
  • "Seven of 113 patients enrolled were excluded from participation in the study because of severe iodinated contrast allergy (n 3) or severe renal insufficiency (n 4), which precluded CT angiography."

  • "Overall, 62 of 189 potential paired examinations were excluded from comparative analysis for one of the following reasons: time interval between CT angiography and US examinations exceeding 30 days as a consequence of logistic problems (n = 53), failure to perform US because of obesity (n = 2) or bowel gas (n = 1), and failure to receive CT angiography as a result of study protocol violation (n = 6)."

  • Aim of study was to investigate accuracy of CEUS as an alternative to CTA in the follow‐up of participants after EVAR with regard to detection of endoleaks and changes in AAA dimensions. Study prospectively enrolled 106 participants.

Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes 106 participants who were eligible were prospectively enrolled for dual‐modality imaging after consent. Overall, 127 of 189 potential paired examinations in 83 participants available for comparative analysis.
Acceptable reference standard? 
 All tests Yes CTA triple‐phase (unenhanced and contrast‐enhanced in arterial and delayed phases) performed.
Acceptable delay between tests? 
 All tests Yes Participants with time interval between CTA and US examinations > 30 days were excluded.
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 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 "Each of the three vascular technicians independently measured AAA sac diameters and reported the presence or absence of endoleak at the end of each contrast‐enhanced US examination; technicians were blinded to the results of CT angiography. AAA dimensions on contrast‐enhanced US were recorded as the means of the three measurements."
Index test results blinded? 
 All tests Yes "Each of the three vascular technicians independently measured AAA sac diameters and reported the presence or absence of endoleak at the end of each contrast‐enhanced US examination; technicians were blinded to the results of CT angiography. AAA dimensions on contrast‐enhanced US were recorded as the means of the three measurements."
Relevant clinical information? 
 All tests Yes Yes.
Uninterpretable results reported? 
 All tests Yes Failure to perform US because of obesity (n = 2) or bowel gas (n = 1), and failure to receive CTA due to study protocol violation (n = 6).
Withdrawals explained? 
 All tests Unclear 7/113 participants enrolled were excluded because of severe iodinated contrast allergy (n = 3) or severe renal insufficiency (n = 4), which precluded CTA.
Overall, 62/189 potential paired examinations were excluded from comparative analysis for 1 of the following reasons: time interval between CTA and US examinations > 30 days as consequence of logistic problems (n = 53), failure to perform US because of obesity (n = 2) or bowel gas (n = 1), and failure to receive CTA due to study protocol violation (n = 6).