Costa 2013.
Clinical features and settings | 40 people within the scope of stents monitoring protocol and risk of endoleaks type II followed from November 2010 to February 2013. Type of stents received: fenestrated. Aneurysm diameter (mean ± SD): 55 ± 8 mm in anteroposterior diameter. Setting: vascular surgery department at the University Hospital of Lyon. |
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Participants | 39 men; age (mean ± SD): 75 ± 8 years. Comorbidities: smoking habits, hypertension, dyslipidaemia, diabetes, overweight. Geography: France. |
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Study design | Cross‐sectional study. | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: "Endoleaks (the most common complication) are responsible for feeding the aneurysm sac and is a breaking risk factor. The type I endoleak is a leak at a site proximal or distal attachment, type II is a reflux from the collateral of the aorta, the type III is a defect in the wall of the stent, and Type IV is a result of a porosity of the prosthesis." Endoleak (absolute n): 19. Prevalence of endoleak: 31.7% (19/60). Reference standard: CT. Image acquisition:
Type of CT scanner: not reported. Use of contrast: 120 mL of unspecified contrast medium. Operator: CT performed and interpreted in radiology. |
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Index and comparator tests |
Index test: echo‐Doppler with and without contrast injection. Contrast agent used in people at risk of endoleak and had no contraindications to product. Image production: participants supine. Type of US: General Electric equipment with a convex abdominal probe (4C‐A) and Siemens Acuson with a convex abdominal probe (C5‐2). Use of contrast: "The contrast agent used (the only available in France) was the Sonovue Braco Milan. The dose used was that recommended: 2.4 mL bolus followed by washing with 5 ml of isotonic saline." Operator: echo‐Doppler performed and interpreted by trained vascular physicians. |
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Follow‐up | 3 participants excluded from study because they had contraindication for contrast medium injection (severe pulmonary hypertension, heart failure stage III). | |
Notes |
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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 CT scan. |
Acceptable delay between tests? All tests | Yes | "The Doppler with and without ultrasound contrast agent injection was made within less than 24 hours and CT less than ten days before or after." |
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 | "Ultrasound and CT analyzes were performed independently and blindly (vascular doctor did not know the results of the CT scan, and the radiologist did not know the results of echo‐Doppler)." |
Index test results blinded? All tests | Yes | "Ultrasound and CT analyzes were performed independently and blindly (vascular doctor did not know the results of the CT scan, and the radiologist did not know the results of echo‐Doppler)." |
Relevant clinical information? All tests | Yes | Age, gender, risk factors, and comorbidities of the participants reported. |
Uninterpretable results reported? All tests | Yes | No apparent uninterpretable data occurred. |
Withdrawals explained? All tests | Yes | "Three patients were excluded from the study because they had against‐indication for the contrast medium injection (severe pulmonary hypertension, heart failure stage III). |