Gurtler 2013.
Clinical features and settings | 171 people after EVAR who received 489 CE‐CDUS and 421 MS‐CT examinations during follow‐up. 39 participants withdrawn because of time mismatch between imaging studies. 200 contemporary examination pairs ± 30 days from 132 participants of the 489 CE‐CDUS and 421 MS‐CT examinations matched. Type of stents received: bi‐iliac or mono‐iliac stent graft. Aneurysm diameter: not reported. Setting: department for clinical radiology. |
|
Participants | 151 men; mean (± SD) age: 70.4 ± 8.6 years; range: 34‐91 years. Comorbidities: not reported. Geography: Germany. |
|
Study design | Cross‐sectional study. | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: "An endoleak was defined as an extravasation of contrast between the aneurysm wall and the prosthesis." Endoleak (absolute n): 87. Prevalence of endoleak: 43.5% (87/200). Reference standard: MSCT. Image acquisition:
Type of CT scanner: Somaton Sensation 16‐, 64‐, or 128‐slice detector MS‐CT scanner (Siemens Medical Systems, Forchheim, Germany). Use of contrast: "A total of 100 to 120 mL Imeron (Bracco) with an iodine concentration of 350 mg/mL was administered, followed by 50 mL saline (0.9% NaCl)." Operator: 2 experienced radiologists. |
|
Index and comparator tests |
Index test: CE‐CDUS. Image production: transverse and sagittal imaging. Type of US: ACUSON Sequoia 512 and a ACUSON S2000 (Siemens Healthcare, Erlangen, Germany) using a curved‐array 4‐MHz multi‐frequency transducer. Use of contrast: "an intravenous bolus injection of 1.0 mL SonoVue, a second‐generation blood pool contrast agent, consisting of stabilized microbubbles of sulfur hexafluoride, was administered into an antecubital vein through an 18‐gauge needle and was followed by a flush of 10 mL saline solution (0.9% NaCl)." Operator: 1 experienced sonographer. |
|
Follow‐up | 39 participants withdrawn because of time mismatch between imaging studies. | |
Notes |
|
|
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Unclear | Not clearly stated if the participants were consecutively enrolled. |
Acceptable reference standard? All tests | Yes | Reference standard was MS‐CT scan. |
Acceptable delay between tests? All tests | Yes | "We compared examinations that were performed on the same day or ≤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 subjected to same reference standard. |
Incorporation avoided? All tests | Yes | Index test not part of reference standard. |
Reference standard results blinded? All tests | Yes | "Radiologists reading one test did not have access to the results of the other test." |
Index test results blinded? All tests | Yes | "Radiologists reading one test did not have access to the results of the other test." |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | No apparent uninterpretable data occurred. |
Withdrawals explained? All tests | Yes | "39 patients were withdrawn because of time mismatch between imaging studies." |