Sandford 2006.
Clinical features and settings | People who underwent EVAR were referred to Leicester Royal Infirmary for endoleak follow‐up (over 11‐year period between 30 March 1994 and 8 October 2005). Type of stents received: not reported. Aneurysm diameter: not reported. Setting: department of cardiovascular sciences. |
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Participants | 310 participants who underwent EVAR. No information reported related to age and gender. Comorbidities: not reported. Geography: UK. |
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Study design | Single‐centre, retrospective design, participants consecutively enrolled (all participants received both tests). | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: not described. Endoleak (absolute n): 44 (unclear). Prevalence of endoleak: 18.0% (44/244). Reference standard: contrast CT scan performed using IV contrast and Phillips Secura single‐slice spiral CT. Image acquisition: no details reported. Type of CT scanner: Phillips Secura single‐slice spiral CT. Use of contrast: yes. |
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Index and comparator tests |
Index test: CDUS. Image production: not reported. Type of US: Phillips HDI 5000. Use of contrast: no. Operator: a trained vascular technician. Comparator test: CT scan. Image acquisition: not reported. Type of CT scanner: GE Lightspeed plus 16‐slice scanner (GE Healthcare, Waukesha, WI, USA). Use of contrast: yes, Omnipaque 350 contrast 120 mL (GE Healthcare, Milwaukee, WI, USA). CT scan surveillance performed using GE Lightspeed plus 16‐slice scanner (GE Healthcare, Waukesha, WI, USA) using 2.5‐mm acquisition slice. Omnipaque 350 contrast 120 mL (GE Healthcare, Milwaukee, WI, USA) was injected at rate of 4‐5 mL/s using SmartPrep software (GE Healthcare, Milwaukee, WI, USA). Arterial phase acquisition obtained by a mean delay of 25 s after injection. Delayed phase obtained at 70 s after completion of first scan. CT scan reconstruction used 0.625‐mm format. Index test: colour flow DUSS performed by a trained vascular technician using Phillips HDI 5000 ultrasound machine. No contrast used. If abnormality found on DUSS, or views were inadequate, participants underwent CT scan, using IV contrast and a Phillips Secura single‐slice spiral CT. All participants having undergone concurrent DUSS and CT scans were included in analysis. Concurrent scans defined as having occurred within 6 months of each other. |
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Follow‐up | Follow‐up period: 60 months; however, number of participants eventually lost to follow‐up unclear. | |
Notes | ||
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Imaging was retrospectively reviewed for 310 consecutive patients undergoing endovascular aneurysm repair at a single. Patients were followed up after EVAR in a nurse led clinic and underwent six monthly clinical examination and duplex ultrasound scan |
Acceptable reference standard? All tests | Yes | The reference standard was CT scan |
Acceptable delay between tests? All tests | No | No: concurrent scans were defined as having occurred within 6 months of each other |
Partial verification avoided? All tests | Yes | All study participants are accounted for and results of the reference standard are reported for all |
Differential verification avoided? All tests | Yes | All patients who received the index test were subjected to the same reference standard |
Incorporation avoided? All tests | Yes | The index test was not part of the reference standard |
Reference standard results blinded? All tests | Unclear | Unclear |
Index test results blinded? All tests | Unclear | Unclear |
Relevant clinical information? All tests | Yes | Yes |
Uninterpretable results reported? All tests | Yes | "Of the 1352 CDUS performed, 151 (11%) reported difficult views due to either increased bowel gas or obesity. The proportion of scans which reported poor views was higher immediately post operatively than subsequent scans, affecting 19 of 99 (19%) pre‐discharge scans" |
Withdrawals explained? All tests | Unclear | Unclear |