Pages 2001.
Clinical features and settings | People with infrarenal AAA who received EVAR. In 41 of these participants (21.6%), anatomical findings were compatible with stent‐graft placement. Type of stents received: not reported. Aneurysm diameter: mean (± SD) preoperative aneurysmal diameter determined by CT scan: 55 ± 9 mm; range: 40‐90 mm. Proximal neck of aneurysm located below renal arteries in all cases. Maximum proximal neck diameter 28 mm and minimal length 15 mm. Setting: unclear (department of surgery or department of radiology). |
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Participants | 41 participants; 39 men; mean age: 71 years; range: 50‐83 years. Comorbidities: not reported. Geography: France. |
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Study design | Prospectively consecutively enrolled study. Whole sample of participants who received stent considered. Recruitment period: November 1996 to September 1999. |
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Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: persistent blood flow or uptake of contrast between the stem graft and walls of the aneurysmal sac.
Endoleak (absolute n): 17. Prevalence of endoleak: 26.6% (29/109). Reference standard: spiral CT scan. Image acquisition:
Type of CT scanner: Somatom Plus S system (Siemens, Erlongen, Germany). Use of contrast: not reported. |
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Index and comparator tests |
Index test: CDUS. Image production: abdominal aorta visualized from celiac trunk to hypogastric arteries first in transverse plane and then in longitudinal plane in B‐mode and colour Doppler mode. Continuous spectral analysis performed if colour Doppler findings suggested presence of an endoleak. Type of US: 3.5‐MHz curved array transducer, Apogee 800PLUS ultrasound system (ATL, Philips, Eindhoven, the Netherlands). Use of contrast: no. Operator: 3 qualified angiologists. |
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Follow‐up | No loss to follow‐up, missing data, or adverse events. Uninterpretable data reported. | |
Notes | Postoperative surveillance included plain abdominal roentgenography, CT scan, and CDUS. Procedures performed prior to discharge and at 3, 6, 12, 24, and 30 months. | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Participants represented average patients who after receiving EVAR are exposed to endoleak surveillance. |
Acceptable reference standard? All tests | Yes | Reference standard was CT scan. |
Acceptable delay between tests? All tests | Unclear | Not reported. |
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 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 | CT scan and CDUS examination performed by different operators at different locations. Second operator had no knowledge of results of first examination. CT scans and videotaped CDUS procedures reviewed by independent radiologist. |
Index test results blinded? All tests | Yes | CT scan and CDUS examination performed by different operators at different locations. Second operator had no knowledge of results of first examination. CT scans and videotaped CDUS procedures reviewed by independent radiologist. |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | "In six cases, B‐mode images were uninterpretable because of the presence of intestinal gas. In 55 cases, spectral study was necessary to confirm or deny suspicion of an endoleak based on colour Doppler findings." |
Withdrawals explained? All tests | Yes | No apparent dropouts observed. |