Perini 2011.
Clinical features and settings | People who underwent EVAR for AAA. Type of stents received: Zenith (Cook Medical, Bloomington, IA, USA), Talent (Medtronic, Santa Rosa, CA, USA), Anaconda (Vascutek, Glasgow, UK), fenestrated endografts (Cook Medical). All cases performed in dedicated operating theatre with OEC 9900 Elite MD Imaging System (GE Healthcare, Salt Lake City, UT, USA). Number of participants for each device not reported. Aneurysm diameter: mean (± SD): 5.5 ± 1.3. cm Setting: vascular surgery department. |
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Participants | 395 participants; basic characteristics not reported. Comorbidities: not reported. Geography: France. |
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Study design | Retrospective study. Recruitment period: January 2006 to December 2010. |
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Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: not reported. Endoleak (absolute n): 99. Prevalence of endoleak: 25.1% (99/395). Reference standard: 64‐slice CT scanner. Image acquisition:
Type of CT scanner: 64‐slice CT scanner (Philips Brilliance 64 CT scanner, Philips Healthcare, Amsterdam, the Netherlands). Use of contrast: yes, 2 types: Iomeron 350 (Bracco SA, Milano, Italy); Omnipaque 350 (Amersham Health, Princeton, NJ, USA). |
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Index and comparator tests |
Index test: CDUS. Image production: typical US examination started with standard B‐mode investigation to measure aneurysm sac diameter (outer wall to outer wall, dimensions recorded as the mean of 3 measurements). Then, blood flows from main body of endograft to femoral arteries analysed with pulse‐wave modality. In setting of fenestrated or multi‐branched endograft, visceral arteries also evaluated (feature not analysed in this study). Type of US: convex 3.5‐MHz probe, a Philips iE33 (Philips Healthcare, Amsterdam, the Netherlands), a Vivid 7 and a Vivid 9 (GE Healthcare, Salt Lake City, UT, USA) equipped with a convex 3.5‐MHz probe. Use of contrast: yes, SonoVue (Bracco, Milan, Italy). Operator:3 angiologists experienced in vascular ultrasonography. |
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Follow‐up | All participants completed follow‐up, and no adverse events recorded during these examinations. | |
Notes | ||
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants represented average patients who after receiving EVAR are exposed to endoleak surveillance. |
Acceptable reference standard? All tests | Yes | Reference standard was CTA. |
Acceptable delay between tests? All tests | Yes | Time interval between the 2 examinations < 15 days. |
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 was part of reference standard. |
Reference standard results blinded? All tests | Yes | CTAs analysed on independent dedicated workstation (Aquarius, TeraRecon, San Matteo, CA, USA) by both vascular surgeons and vascular radiologists (who were blinded to the results of CEUS, if already performed) to determine maximal aortic diameter by centre‐line measurements and to depict and characterise endoleaks. |
Index test results blinded? All tests | Yes | All US scans performed by 3 angiologists experienced in vascular ultrasonography and use of US contrast material who were blinded to CTA findings at time of examination. |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | All data were interpreted. |
Withdrawals explained? All tests | Yes | All participants completed follow‐up, and no adverse events recorded during these examinations. |