Gargiulo 2014.
Clinical features and settings | 22 consecutive participants who underwent fenestrated EVAR follow‐up. Type of stents received: fenestrations were joined to native visceral vessels with a balloon‐expandable covered stent‐graft (Advanta V12, Atrium Medical, Hudson, NH, USA). Aneurysm diameter: mean (± SD) preoperative AAA diameter: 55 ± 7 mm; range: 48‐71 mm. Setting: ultrasound unit. |
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Participants | 21 men; mean (± SD) age: 74 ± 7 years; range: 54‐80 years. Comorbidities: all ASA ≥ III (ASA III/IV: 82%/18%). 5 (23%) participants had BMI ≥ 30 kg/m2. Geography: Italy. |
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Study design | Cross‐sectional study. Participants consecutively enrolled. | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: "Endoleaks were detected and classified according to the White and May classification” (White GH, Yu W, May J, Chaufour X, Stephen MS. Endoleak as a complication of endoluminal grafting of abdominal aortic aneurysms: classification, incidence, diagnosis, and management. Journal of Endovascular Surgery 1997;4(2):152e68). Endoleak (absolute n): 3. Prevalence of endoleak: 14% (3/22). Reference standard: CTA. Image acquisition:
Type of CT scanner: 64‐slice CT scanner (GE Healthcare, Milwaukee, WI, USA). Use of contrast: "Iodinate contrast (100‐130 mL Iomeron 400; Bracco, Milan, Italy) was injected at 4 mL/second for the first 100 mL and 2 mL/second for the last 30 mL. Contrast injection was followed by saline solution (0.9% NaCl) at a rate of 2 mL/second." Operator: "CTA was performed by a radiologist with experience in vascular CTA evaluations (MD)." |
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Index and comparator tests |
Index test: 4D CE‐CDUS. Image production: "The US examination started with B‐mode evaluation of the aorta by live x‐plane imaging where the maximal aneurysm diameter and the stent‐graft were evaluated. The abdominal aorta was scanned from the diaphragm to the iliac arteries and the entire sac was analysed to detect possible colour flow within the aneurysm sac. Then, the blood flow in the visceral and renal arteries was analysed in colour flow and pulse‐wave modes." Type of US: iU22 system, software Q‐Lab (Philips Medical Systems, Bothell, WA, USA). Fully sampled matrix array with frequency 6.0‐1.0 MHz (x6‐1; Philips Medical Systems, Bothell, WA, USA). Use of contrast: "A sulfur hexafluoride‐filled microbubble contrast agent (SonoVue; BR1, Bracco)." Operator: 1 "one investigator (CS) who had more than 10 years of experience in contrast ultrasound and who was blinded to the CTA." |
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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 | Yes | "The interval between the two examinations was always ≤ 30 days." |
Partial verification avoided? All tests | Yes | All participants received both tests. |
Differential verification avoided? All tests | Yes | All participants who received index test were subjected to same reference standard. |
Incorporation avoided? All tests | Yes | Index test not part of reference standard. |
Reference standard results blinded? All tests | Unclear | Not clearly stated if CTA scans were performed before US scans or if reader of CTA scans was blinded to results of the other test. |
Index test results blinded? All tests | Yes | "All US scanning was performed by one investigator […] who was blinded to the CTA." |
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. |