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. 2017 Jun 9;2017(6):CD010296. doi: 10.1002/14651858.CD010296.pub2

Giannoni 2007.

Clinical features and settings Participants who received endovascular grafts for infrarenal aortic aneurysms; 13 aortic and 17 aortoiliac aneurysms, all previously treated in Department of Vascular Surgery.
Type of stents received: 24 participants received Excluder (WL Gore & Associates, Flagstaff, AZ, USA); 3 received Vanguard (Boston Scientific, Natik, MA, USA); and 3 received Talent (Medtronic, Minneapolis, MN, USA).
Aneurysm diameter: mean (±SD) transverse diameter: 53.19 ± 15.69 mm on contrast CT‐scan.
Setting: division of vascular surgery.
Participants 30 consecutive people; mean (± SD) age: 74.4 ± 5.4 years; range: 65‐84 years; BMI 22‐38 kg/m2.
Comorbidities: not reported.
Geography: Italy.
Study design Cross‐sectional study; consecutively selected participants; all received both tests.
Target condition and reference standard(s) Target condition: type II endoleaks.
Definition of endoleak: persisting flow from patent lumbar or mesenteric arteries within aneurysm sac and outside endograft.
Endoleak (absolute n): 7.
Prevalence of endoleak: 24.1% (7/29).
Reference standard: contrast CT scan performed with delayed triphasic sequences. No further information provided.
Image acquisition: not reported.
Type of CT scanner: Somatom Sensation Cardiac 64 (Siemens, Munich, Germany).
Use of contrast: not reported.
Index and comparator tests Index test: CDUS.
Image production: not reported.
Type of US: convex probe (3‐4 MHz), equipped for Cadence CPS software (Sequoia Acuson Siemens, Mountain View, CA, USA).
Use of contrast: echo‐contrast solution (Sono Vue, Bracco, Italy) injected in bolus by hand into antecubital vein and immediately followed by 10 mL of saline solution.
Operator:> 1 ("The US examinations were performed by vascular doctors dedicated to US imaging (MD), blinded to the results of CT angiography.")
Follow‐up "One patient dropped out because of violation of the study protocol: a stroke occurred in the time interval between the two investigations."
Notes  
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 Yes "No more than 15 days elapsed between the two examinations."
Partial verification avoided? 
 All tests Yes All participants received both tests except 1 who dropped‐out due to occurrence of stroke.
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 US examinations performed by vascular doctors dedicated to US imaging, blinded to results of CTA.
Index test results blinded? 
 All tests Yes US examinations performed by vascular doctors dedicated to US imaging, blinded to results of CTA.
Relevant clinical information? 
 All tests Yes Yes.
Uninterpretable results reported? 
 All tests Yes "In one patient in which both investigations detected the increase of the diameter of aneurysm sac, CPS US (Video 1) (Fig. 2) demonstrated the type II endoleak not confirmed to CT‐scan (Fig. 3). The angiography disclosed a low flow type II endoleak from a lumbar artery."
Withdrawals explained? 
 All tests Yes "One patient dropped out because of violation of the study protocol: a stroke occurred in the time interval between the two investigations."