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

Clevert 2011.

Clinical features and settings Participants referred to interdisciplinary ultrasound centre (Klinikum Grosshadern, Munich, Germany) for further diagnostic work‐up and follow‐up after EVAR for AAA.
Type of stents received: not reported.
Aneurysm diameter: not reported.
Setting: interdisciplinary ultrasound centre.
Participants 35 consecutive participants; 33 men; mean age: 73 years; range: 54‐83 years.
Comorbidities: not reported.
Geography: Germany.
Study design Retrospective study; consecutively enrolled participants.
Target condition and reference standard(s) Target condition: endoleak (not defined).
Definition of endoleak: no definition provided.
Endoleak (absolute n): 4.
Prevalence of endoleak: 11.4% (4/35).
Reference standard: CTS (not clearly defined); image fusion with CTA.
No further information was reported.
Image acquisition: not reported.
Type of CT scanner: not reported.
Use of contrast: not reported.
Index and comparator tests Index test: CDUS.
Image production:
Type of US: curved array multi‐frequency probe: Siemens ACUSON S2000 (Siemens Healthcare, Erlangen, Germany) system or a GE Logic E9 (GE Healthcare, Milwaukee, WI, USA).
Use of contrast: yes, IV bolus of 1.0 mL of a second‐generation blood pool contrast agent (SonoVue, Bracco, Milan, Italy) consisting of stabilized microbubbles of sulphur hexafluoride, followed by a second bolus injection of 10 mL saline solution (0.9% NaCl).
Operator: US examinations performed by experienced sonographer and were later read by 2 blinded unbiased investigators with > 5 years of clinical US experience in consensus.
Follow‐up No loss to follow‐up, missing data, or adverse events.
Notes
  • Period of enrolment: 15 months.

  • Evaluation of stent graft flow artefacts in CCDS, CE‐CDUS, and image fusion (score 0, 1, 2):

    • score 0 = incomplete flow detection with pronounced overwriting artefacts;

    • score 1 = partial artefacts due to flow overwriting;

    • score 2 = no artefacts with optimal flow detection.

  • In CCDS followed by CE‐CDUS and image fusion, detectability of endoleaks and flow artefacts was evaluated semi‐quantitatively by comparing image sequences in a consensus reading performed by 2 experienced sonographers.

  • Additional image fusion with CTA then performed.

  • Period of follow‐up unclear.

Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants consecutively referred for follow‐up to detect potential endoleaks.
Acceptable reference standard? 
 All tests Yes Reference standard was CTA.
Acceptable delay between tests? 
 All tests Unclear No information provided.
Partial verification avoided? 
 All tests Yes All study participants accounted for and results of CTA reported for all. ("All patients who were sent to our department for further diagnostic work‐up and follow‐up after EVAR, and who did not match any of the exclusion criteria were included in the study. We screened a total of thirty‐five patients. Each patient was examined using all diagnostic ultrasound and CT tools of the study.")
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 Unclear Information not clearly reported.
Index test results blinded? 
 All tests Yes Examiner initially blinded to CT results. US examinations performed by experienced sonographer and later read by 2 blinded unbiased investigators with > 5 years of clinical US experience in consensus.
Relevant clinical information? 
 All tests Yes Yes.
Uninterpretable results reported? 
 All tests Unclear Unclear.
Withdrawals explained? 
 All tests Yes No apparent withdrawal.