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

Cantisani 2011.

Clinical features and settings People who had undergone EVAR for AAA.
Type of stents received: EVAR devices employed were Excluder (WL Gore & Associates, Flagstaff, AZ, USA) in 50 participants, Talent (Medtronic, Santa Rosa, CA, USA) in 55, Powerlink (Endologix, Irvine, CA, USA) in 12, and Jomed (Jomed International AB, Helsingborg, Sweden) in 6.
Aneurysm diameter (mean ± SD): 5.4 ± 0.5 cm; range 3.9‐8.7 cm.
Setting: vascular laboratory.
Participants 123 participants; 92 males and 31 females; mean (± SD) age: 63.0 ± 7.3 years; who had undergone EVAR for AAA; aneurysm baseline mean (± SD) diameter: 5.4 ± 0.5 cm; range 3.9‐8.7 cm.
Comorbidities: not reported.
Geography: Italy.
Study design Prospective, observational (cross‐sectional) study.
Target condition and reference standard(s) Target condition: aneurysm sac size, attachment and integrity of prosthesis, and presence and type of any endoleak.
Definition of endoleak: incomplete exclusion of aneurysm sac from circulation.
Endoleak (absolute n): 24.
Prevalence of endoleak: 22.2% (24/108).
Reference standard: CTA.
Image acquisition:
  • CTA performed with 64‐slice CT scanner. Triple‐phase CT protocol carried out with an unenhanced, an arterial (with bolus‐tracking), and a delayed phase at 120s;

  • thickness: 1.2 mm; reconstruction with soft kernel algorithm (B30), 1.5 and 3 mm with 1.5 of recon increment.


Type of CT scanner: Somaton Sensation (Siemens Medical Solutions, Erlangen, Germany).
Use of contrast: non‐ionic contrast media: Iomeron, Bracco, Milan, Italy, flow 4 mL/s.
Index and comparator tests Index test: CDUS.
Image production: 3‐ to 5‐MHz probe, with longitudinal and transversal scans with participant lying in dorsal or lateral position. Aneurysm sac size measured in both anterior‐posterior and transverse dimensions at widest point and mean of these measurements used for purposes of study. Arterial flow haemodynamics documented throughout stent graft with spectral Doppler velocity measurements.
CE‐CDUS: 3‐ to 5‐MHz probe and with low mechanical index (varying from 0.06 to 0.10; about 35‐45 kPa), with real‐time tissue harmonic imaging and contrast harmonic imaging (pulse subtraction).
Type of US: Aplio XV (Toshiba Vx, Zoetermeer, the Netherlands) and Technos MPX US (ESAOTE Biomedica, Genoa, Italy).
Use of contrast: yes; second‐generation contrast agent (SonoVue, Bracco, Milan, Italy) consisting of sulphur hexafluoride gas microbubbles in a phospholipid membrane.
Operator: 2 radiologists with 20 and 10 years of experience in this particular field.
Follow‐up 15 participants excluded: 8 participants not undergo MRA (2 with claustrophobia; 6 had pace‐maker); 3 because of renal failure; 1 participant because of the allergy to iodine; 3 because of presence of severe comorbidity (heart failure and severe pulmonary disease).
Notes
  • MRA also used as a comparator test.

  • DSA performed in case of contradictory results at different modalities. Cases positive for endoleak and considered for possible reintervention also underwent DSA study and were eventually treated.

  • MRA examinations conducted on 1.5‐T scanner (Magnetom Avanto, Siemens Medical System, Erlangen, Germany).

  • Specific definitions for types of endoleaks not provided.

Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Participants consecutively enrolled for follow‐up to detect potential endoleaks.
Acceptable reference standard? 
 All tests Yes CTA used to detect target disease.
Acceptable delay between tests? 
 All tests Yes CDUS and CE‐CDUS performed on same day, and, within 1 week, CTA and MRA.
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 US subjected to CT scan.
Incorporation avoided? 
 All tests Yes Index test not part of reference standard.
Reference standard results blinded? 
 All tests Yes "The radiologists were blinded to the results of any previous examination."
Index test results blinded? 
 All tests Yes Index test performed before reference standard.
Relevant clinical information? 
 All tests Yes Yes.
Uninterpretable results reported? 
 All tests Yes Yes.
Withdrawals explained? 
 All tests Yes 15 participants excluded from study because of the following reasons: 8 participants could not undergo MRA (2 with claustrophobia; 6 had pace‐maker); 3 participants because of renal failure, 1 participant because of allergy to iodine, and 3 because of presence of severe comorbidity (heart failure and severe pulmonary disease).