Demirpolat 2011.
Clinical features and settings | People with endovascular repair of AAA. Type of stents received: nitinol‐based grafts. Aneurysm diameter: mean (± SD): 64 6 ± 18.4 mm; range: 37‐103 mm. Participant with smallest aneurysm diameter (37 mm) was treated because of an associated iliac artery aneurysm. Setting: department of radiology. |
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Participants | 29 participants; 26 males; 3 females; mean age: 72.2 years; range: 47‐90 years. Comorbidities: not reported. Geography: Turkey. |
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Study design | Longitudinal study (consecutively selected participants, all received both tests). | |
Target condition and reference standard(s) |
Target condition: type I and II endoleaks. Definition of endoleak: persistence of flow in aneurysm lumen after procedure; persistent flow can lead to increase in diameter of aneurysm, with subsequent risk of rupture. Endoleak (absolute n): 9. Prevalence of endoleak: 35.4% (17/48). Reference standard: CT scan. Image acquisition:
Type of CT scanner: 16‐detector‐row CT scanner (Toshiba Medical Systems, Tochigi‐ken, Japan). Use of contrast: yes, type not specified ("100 ml of nonionic contrast material was injected through an antecubital vein with an automated injector at a rate of 3 ml/sec"). |
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Index and comparator tests |
Index test: CDUS. Image production: "The aneurysm and the stent graft were evaluated in axial and longitudinal planes with B mode and CDUS. The transverse and sagittal outer to outer diameter of the aneurysm at the site of largest diameter was measured in the axial plane perpendicular to the axis of the aorta. The patency of the stent graft and iliac arteries was assessed and perigraft flow was searched for with CDUS. The colour box size was adjusted to encompass the entire aneurysm sac." Type of US: 3 types of duplex scanner, sector or linear scan heads with varying frequencies (9 to 4‐MHz linear or 4 to 1‐MHz sector) (Siemens Sonoline Antares or Siemens Ellegra, Siemens, Erlangen, Germany; or ATL HDI 5000, Advanced Technology Laboratories, Bothell, WA, USA). Use of contrast: no. Operator: a radiologist experienced in DU. |
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Follow‐up | 1 participant dropped out because of violation of study protocol: 1 stroke occurred during the time interval between the 2 investigations. | |
Notes | Data analysis at 48 months. | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Spectrum of participants was representative of participants who will receive test. |
Acceptable reference standard? All tests | Yes | Reference standard was CT scan. |
Acceptable delay between tests? All tests | Yes | CTA and CDUS examinations were performed same day. |
Partial verification avoided? All tests | Yes | Whole sample received reference standard test. |
Differential verification avoided? All tests | Yes | All participants who received US subjected to CT scan. |
Incorporation avoided? All tests | Yes | Index test not part of reference standard. |
Reference standard results blinded? All tests | Yes | "All CTA and CDUS exams were interpreted independently by two radiologists blinded to the results of the other study." |
Index test results blinded? All tests | Yes | "All CTA and CDUS exams were interpreted independently by two radiologists blinded to the results of the other study." |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | No apparent uninterpretable results. |
Withdrawals explained? All tests | Unclear | Insufficient information. |