Arsicot 2014.
Clinical features and settings | 75 consecutive participants treated with EVAR for infrarenal AAA, representing 116 pairs of examinations (3D US and CTA). Type of stents received: Anaconda (Vascutek) 30, Low Profile (Cook) 4, Zenith (Cook) 28, Endurant (Medtronic) 1, Aneurx (Medtronic) 2, Excluder (WL Gore & Associates) 8, Powerlink (Edwards) 2. Aneurysm diameter: not reported. Setting: academic hospital. |
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Participants | 73 men; age (mean ± SD): 76.3 ± 9.2 years. Comorbidities: diabetes (n = 18), dyslipidaemia (n = 67), BMI ≥ 30 kg/m2 (n = 15), renal insufficiency (n = 24), supra‐aortic trunks lesions (n = 19), angina (n = 42), ASA score III‐IV (n = 56). Geography: France. |
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Study design | Retrospective cross‐sectional study; participants consecutively enrolled. | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: not reported. Endoleak (absolute n): 14. Prevalence of endoleak: 29.2% (14/48). Reference standard: CTA. Image acquisition:
Type of CT scanner: Siemens Medical Solutions Inc (Somatom Definition AS+, Malvern). Use of contrast: "The protocol of imagery included an injection of 100 mL of iodised contrast of 250 concentration, with a 5 mL/s flow IV in the upper limb right." Operators: vascular surgeon. |
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Index and comparator tests |
Index test: 3D US Image production: "The examination was carried out by 1 of the 3 vascular sonographers of our institution with a transperitoneal approach. The ultrasound probe was placed over the umbilicus in the longitudinal axis of the infrarenal abdominal aorta, and side electronic scanning allowed a 3D acquisition of the infrarenal aneurysm to the aortic bifurcation." Type of US: Toshiba Aplio XG ultrasound system (Toshiba Medical Systems, Zoetermeer, the Netherlands) equipped with a marketed 3D 3.5‐MHz dedicated probe. Use of contrast: no. Operator: 1 vascular sonographer. |
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Follow‐up | No loss to follow‐up, missing data, or adverse events. | |
Notes |
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Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Patients were consecutively enrolled |
Acceptable reference standard? All tests | Yes | The reference standard was CTA |
Acceptable delay between tests? All tests | No | The average time interval between the achievements of CTA and 3DU for a given patient was 48.18 ± 36.52 days |
Partial verification avoided? All tests | Yes | It appears that all patients that received both tests |
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 is not part of the reference standard |
Reference standard results blinded? All tests | Yes | “Volumetric calculation by CTA was carried out by a single person, vascular surgeon of formation, by data processing of the native sections of the CTA (Siemens Medical Solutions Inc., Somatom Definition AS+, Malvern). He did not know the results of ultrasound measurements of volume” |
Index test results blinded? All tests | Unclear | No description was reported |
Relevant clinical information? All tests | Yes | Yes |
Uninterpretable results reported? All tests | Yes | No apparent uninterpretable data occurred |
Withdrawals explained? All tests | Yes | No explicit report concerning loss to follow‐up, missing data or adverse events |