Raman 2003.
Clinical features and settings | People who underwent endovascular repair of AAA (between February 1996 and November 2002). Type of stents received: 247 participants received Ancure (Guidant, Menlo Park, CA; USA); 34 received AneuRX (Medtronic, Santa Rosa, CA, USA) endograft. Aneurysm diameter: not reported. Setting: hospital vascular laboratory, University of Pittsburgh Medical Centre. |
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Participants | 281 participants; 246 males, 35 females; mean (± SD) age: 73 ± 7 years; range: 47‐90 years. Comorbidities: not reported. Geography: USA. |
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Study design | Single‐centre, retrospective study (all participants received both tests). | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: perigraft flow into aneurysm sac. Endoleak (absolute n): 35. Prevalence of endoleak: 9.9% (49/494). Reference standard: helical CT. Image acquisition:
Type of CT scanner: helical CT, Lightspeed QXi multi‐detector‐row CT scanner (General Electric Medical Systems, Milwaukee, WI, USA). Use of contrast: yes, type not reported. |
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Index and comparator tests |
Index test: CDUS. Image production: protocol consisted of obtaining longitudinal and transverse views of proximal, mid, and distal aorta and iliac arteries. Peak systolic velocities obtained in graft and then compared with velocities in iliac vessels to assess for presence of limb flow anomalies including stenosis or occlusion. CFD scanning and Doppler interrogation of sac used to rule out presence of perigraft flow. Type of US: 3‐ to 5‐MHz transducers, Acuson 128 XP ultrasound machine (Mountain View, CA, USA). Use of contrast: no. Operator: registered vascular technologist. |
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Follow‐up | No loss to follow‐up, missing data, or adverse events reported ("All CT scans and CDU [CDUS] were technically satisfactory for determination of aneurysm size and presence of endoleak.") | |
Notes |
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Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Retrospective review of all participants who underwent endovascular repair of AAAs between February 1996 and November 2002 and had same‐day CT and CDUS studies. |
Acceptable reference standard? All tests | Yes | Reference standard was helical CT. |
Acceptable delay between tests? All tests | Yes | Yes, participants received same‐day US and CT. |
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 | US scanning technologist and surgeon reviewing tapes were both unaware of results of CT scan during any portion of US scan examination or review. |
Index test results blinded? All tests | Unclear | Unclear. |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | "All CT scans and CDU [CDUS] were technically satisfactory for determination of aneurysm size and presence of endoleak." |
Withdrawals explained? All tests | Yes | No withdrawal reported. |