Ten Bosch 2010.
Clinical features and settings | People who underwent endovascular repair for infrarenal AAA. Type of stent received: Talent (Medtronic, Minneapolis, MN. USA). Aneurysm diameter: not reported. Setting: department of vascular surgery. |
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Participants | 83 participants consecutively enrolled for CEUS and CTA imaging during surveillance after EVAR. Comorbidities: not reported. Geography: the Netherlands. |
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Study design | Prospectively enrolled consecutive participants; all had target condition; all received both tests. | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: presence of persistent intrasac flow outside graft. Endoleaks classified as type IA/B, II, III, or IV. Endoleak (absolute n): unclear. Prevalence of endoleak: 21.3% (27/127). Reference standard: triple‐phase (unenhanced and contrast‐enhanced in arterial and delayed phases) CTA. Image acquisition:
CTA performed from diaphragm to common femoral arteries after continuous IV administration of iodinated contrast agent (Xenetix 300; Laboratoire Andre Guerbet, Aulnaysous Bois, France). Parameters: high‐speed mode capability, rotation time 0.5 s, table speed 24 mm per rotation, collimation of 1.5 mm, and slice thickness 3 mm. Type of CT scanner: multidetector 16‐slice spiraI CT scanner (Somatom Sensation; Siemens, Forchheim, Germany). Use of contrast: yes, iodinated contrast agent (Xenetix 300; Laboratoire Andre Guerbet, Aulnaysous Bois, France). |
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Index and comparator tests |
Index test: CDUS. Image production: continuous real‐time tissue harmonic imaging for endoleak detection performed for 15 minutes during sonographic contrast agent infusion at mechanical index of 0.4‐0.5 and at low acoustic power. Type of US: 3.5‐MHz curved array transducer (Aloka 550‐5000; Biomedic, Almere, the Netherlands). Use of contrast: yes, 5 mL SonoVue (Bracco, Milan, Italy) containing 8 μL sulphur hexafluoride microbubbles per millilitre with 55 mL saline solution. Operator: 3 ("three well trained vascular technicians dedicated to US imaging"). |
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Follow‐up | "Seven of the 113 patients were excluded from participation in the study because of severe iodinated contrast allergy (n = 3) or severe renal insufficiency (n = 4), which precluded CT angiography. The remaining 106 patients who were eligible for the study were prospectively enrolled far dual‐modality imaging after consent. Overall, 62 of 189 potential paired examinations were excluded from comparative analysis for one of the following reasons: time interval between CT angiography and US examinations exceeding 30 days as a consequence of logistic problems (n = 53), failure to perform US because of obesity (n = 2) or bowel gas (n = 1), and failure to receive CT angiography as a result of study protocol violation (n = 6)." | |
Notes |
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Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | 106 participants who were eligible were prospectively enrolled for dual‐modality imaging after consent. Overall, 127 of 189 potential paired examinations in 83 participants available for comparative analysis. |
Acceptable reference standard? All tests | Yes | CTA triple‐phase (unenhanced and contrast‐enhanced in arterial and delayed phases) performed. |
Acceptable delay between tests? All tests | Yes | Participants with time interval between CTA and US examinations > 30 days were excluded. |
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 | "Each of the three vascular technicians independently measured AAA sac diameters and reported the presence or absence of endoleak at the end of each contrast‐enhanced US examination; technicians were blinded to the results of CT angiography. AAA dimensions on contrast‐enhanced US were recorded as the means of the three measurements." |
Index test results blinded? All tests | Yes | "Each of the three vascular technicians independently measured AAA sac diameters and reported the presence or absence of endoleak at the end of each contrast‐enhanced US examination; technicians were blinded to the results of CT angiography. AAA dimensions on contrast‐enhanced US were recorded as the means of the three measurements." |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | Failure to perform US because of obesity (n = 2) or bowel gas (n = 1), and failure to receive CTA due to study protocol violation (n = 6). |
Withdrawals explained? All tests | Unclear | 7/113 participants enrolled were excluded because of severe iodinated contrast allergy (n = 3) or severe renal insufficiency (n = 4), which precluded CTA. Overall, 62/189 potential paired examinations were excluded from comparative analysis for 1 of the following reasons: time interval between CTA and US examinations > 30 days as consequence of logistic problems (n = 53), failure to perform US because of obesity (n = 2) or bowel gas (n = 1), and failure to receive CTA due to study protocol violation (n = 6). |