AbuRahma 2005.
Clinical features and settings | 178 participants treated with aortic stent grafts for AAA. Type of stents received: 86 Ancure (Guidant Corporation, USA), 55 AneuRx (Medtronic,USA), and 37 Excluder (WL Gore & Associates, USA). Aneurysm diameter: not reported. Setting: vascular laboratory. |
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Participants | 156 men; mean age: 74 years; range: 49‐89 years. Comorbidities: not reported. Geography: USA. |
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Study design | Cross‐sectional study; participants were consecutively enrolled; all participants were without the target condition at the start of study. | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: "An endoleak was determined using CT scans based on extravasation of contrast between the prosthesis and the aneurysm wall; by CDUS, endoleak was indicated by flow and spectral signals outside the prosthesis. Primary or early endoleak occurred within 30 days of the procedure; late endoleak referred to leaks observed beyond 30 days postoperatively." Endoleak (absolute n): 34. Prevalence of endoleak: 9.3% (34/367). Reference standard: helical CT imaging. Image acquisition:
Type of CT scanner: Philips Medical Systems, Inc (Shelton, CT, USA). Use of contrast: Optiray 350 (125 mL; Mallinkrodt Medical, USA). |
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Index and comparator tests |
Index test: CDUS. Image production: transverse and anteroposterior images obtained from level of suprarenal aorta above graft to distal iliac or femoral arteries. Type of US: HDI 5000 scanner, ATL‐Philips, USA. Use of contrast: no. Operator: registered vascular technologist and board‐certified vascular surgeon. |
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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 CT scan. |
Acceptable delay between tests? All tests | Yes | "CT and CDUS scans were considered concurrent if they were done within 7 days." |
Partial verification avoided? All tests | Yes | Appeared all participants that 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 | Reference standard performed before CDUS. |
Index test results blinded? All tests | Yes | "Neither the registered vascular technologist nor the reviewing surgeon was aware of the CT results during any portion of the CDUS examination." |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | No apparent uninterpretable data ("no delayed imaging was performed to detect questionable endoleaks"). |
Withdrawals explained? All tests | Yes | No explicit report concerning loss to follow‐up, missing data, or adverse events. |