Abbas 2014.
Clinical features and settings | 23 consecutive participants attending for CTA and 3D CEUS imaging who were thought to have an endoleak following an EVAR. Type of stents received: bifurcated: 87% (n = 20); uni‐iliac: 13% (n = 3). Aneurysm diameter (mean ± SD): CTA measure: 6.6 ± 1.1 cm; US measure: 6.0 ± 0.97 cm. Setting: tertiary referral vascular centre. |
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Participants | 23 participants; 20 men; age (mean ± SD): 77.4 ± 6 years. Comorbidities: not reported. Geography: UK. |
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Study design | Retrospective cross‐sectional study; participants were consecutively enrolled. | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: "The 3D reconstruction enables the operator to view the path of the endoleak. The ability to manoeuvre the 3D reconstruction and view the images in sagittal, coronal, and transverse planes simultaneously without moving the probe, enables the operator to accurately identify if flow is within or outside the aneurysm sac." Endoleak (absolute n): 17. Prevalence of endoleak: 56.7% (17/30). Reference standard: CTA. Image acquisition:
Type of CT scanner: Siemens Sensation (Siemens Medical, Germany). Use of contrast: 100 mL of iodinated contrast medium Omnipaque 240 (iohexol, 240 mg/mL) administered at flow rate of 3 mL/s. Operator: consultant interventional radiologist. |
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Index and comparator tests |
Index test: 3D CE‐CDUS. Image production: with participants supine, AAA and stent‐graft visualized and traced to proximal neck, which was measured in cross‐section and interrogated for potential endoleak using low colour flow velocity or power Doppler colour flow settings. Type of US: Curefab 3D system comprises tracking sensors installed in transducer of a high‐definition duplex Doppler US system (IU22‐C5) and an electromagnetic box. This technology uses motion tracking mini‐GPS with magnetic field emitter and 2 tracking sensors that transform standard 2D CEUS images into high‐definition 3D format (Curefab, Munich, Germany). Use of contrast: yes, "SonoVue, Bracco, Milan, Italy." Operator: all images reviewed by a research fellow and reported by either an accredited vascular or laboratory technologist. Comparator: 2D CE‐CDUS. Image production: with participants supine, AAA and stent‐graft visualized and traced to proximal neck, which was measured in cross‐section and interrogated for potential endoleak using low colour flow velocity or power Doppler colour flow settings. Type of US: DUS instrument (Philips IU22) with C5‐1 curved array transducer. Use of contrast: yes, "SonoVue, Bracco, Milan, Italy." Operator: all images reviewed by research fellow and reported by either an accredited vascular laboratory technologist. |
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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 | Participants consecutively enrolled. |
Acceptable reference standard? All tests | Yes | Reference standard was CTA. |
Acceptable delay between tests? All tests | No | "The interval between paired images was 3.9 ± 2.7 (mean ± SD) weeks. Range: same day to 8 weeks." |
Partial verification avoided? All tests | Yes | Appeared all participants received both tests. |
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 not part of the reference standard. |
Reference standard results blinded? All tests | Unclear | No description provided. |
Index test results blinded? All tests | Unclear | No description provided. |
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. |