Cantisani 2011.
Clinical features and settings | People who had undergone EVAR for AAA. Type of stents received: EVAR devices employed were Excluder (WL Gore & Associates, Flagstaff, AZ, USA) in 50 participants, Talent (Medtronic, Santa Rosa, CA, USA) in 55, Powerlink (Endologix, Irvine, CA, USA) in 12, and Jomed (Jomed International AB, Helsingborg, Sweden) in 6. Aneurysm diameter (mean ± SD): 5.4 ± 0.5 cm; range 3.9‐8.7 cm. Setting: vascular laboratory. |
|
Participants | 123 participants; 92 males and 31 females; mean (± SD) age: 63.0 ± 7.3 years; who had undergone EVAR for AAA; aneurysm baseline mean (± SD) diameter: 5.4 ± 0.5 cm; range 3.9‐8.7 cm. Comorbidities: not reported. Geography: Italy. |
|
Study design | Prospective, observational (cross‐sectional) study. | |
Target condition and reference standard(s) |
Target condition: aneurysm sac size, attachment and integrity of prosthesis, and presence and type of any endoleak. Definition of endoleak: incomplete exclusion of aneurysm sac from circulation. Endoleak (absolute n): 24. Prevalence of endoleak: 22.2% (24/108). Reference standard: CTA. Image acquisition:
Type of CT scanner: Somaton Sensation (Siemens Medical Solutions, Erlangen, Germany). Use of contrast: non‐ionic contrast media: Iomeron, Bracco, Milan, Italy, flow 4 mL/s. |
|
Index and comparator tests |
Index test: CDUS. Image production: 3‐ to 5‐MHz probe, with longitudinal and transversal scans with participant lying in dorsal or lateral position. Aneurysm sac size measured in both anterior‐posterior and transverse dimensions at widest point and mean of these measurements used for purposes of study. Arterial flow haemodynamics documented throughout stent graft with spectral Doppler velocity measurements. CE‐CDUS: 3‐ to 5‐MHz probe and with low mechanical index (varying from 0.06 to 0.10; about 35‐45 kPa), with real‐time tissue harmonic imaging and contrast harmonic imaging (pulse subtraction). Type of US: Aplio XV (Toshiba Vx, Zoetermeer, the Netherlands) and Technos MPX US (ESAOTE Biomedica, Genoa, Italy). Use of contrast: yes; second‐generation contrast agent (SonoVue, Bracco, Milan, Italy) consisting of sulphur hexafluoride gas microbubbles in a phospholipid membrane. Operator: 2 radiologists with 20 and 10 years of experience in this particular field. |
|
Follow‐up | 15 participants excluded: 8 participants not undergo MRA (2 with claustrophobia; 6 had pace‐maker); 3 because of renal failure; 1 participant because of the allergy to iodine; 3 because of presence of severe comorbidity (heart failure and severe pulmonary disease). | |
Notes |
|
|
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants consecutively enrolled for follow‐up to detect potential endoleaks. |
Acceptable reference standard? All tests | Yes | CTA used to detect target disease. |
Acceptable delay between tests? All tests | Yes | CDUS and CE‐CDUS performed on same day, and, within 1 week, CTA and MRA. |
Partial verification avoided? All tests | Yes | All study participants accounted for and results of reference standard reported for all. |
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 | "The radiologists were blinded to the results of any previous examination." |
Index test results blinded? All tests | Yes | Index test performed before reference standard. |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | Yes. |
Withdrawals explained? All tests | Yes | 15 participants excluded from study because of the following reasons: 8 participants could not undergo MRA (2 with claustrophobia; 6 had pace‐maker); 3 participants because of renal failure, 1 participant because of allergy to iodine, and 3 because of presence of severe comorbidity (heart failure and severe pulmonary disease). |