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

Raman 2003.

Clinical features and settings People who underwent endovascular repair of AAA (between February 1996 and November 2002).
Type of stents received: 247 participants received Ancure (Guidant, Menlo Park, CA; USA); 34 received AneuRX (Medtronic, Santa Rosa, CA, USA) endograft.
Aneurysm diameter: not reported.
Setting: hospital vascular laboratory, University of Pittsburgh Medical Centre.
Participants 281 participants; 246 males, 35 females; mean (± SD) age: 73 ± 7 years; range: 47‐90 years.
Comorbidities: not reported.
Geography: USA.
Study design Single‐centre, retrospective study (all participants received both tests).
Target condition and reference standard(s) Target condition: endoleak.
Definition of endoleak: perigraft flow into aneurysm sac.
Endoleak (absolute n): 35.
Prevalence of endoleak: 9.9% (49/494).
Reference standard: helical CT.
Image acquisition:
  • CT scans obtained with 2.5‐mm slice thickness throughout scan, which started 1 cm above celiac axis and ended at femoral bifurcation;

  • thickness: 2.5 mm.


Type of CT scanner: helical CT, Lightspeed QXi multi‐detector‐row CT scanner (General Electric Medical Systems, Milwaukee, WI, USA).
Use of contrast: yes, type not reported.
Index and comparator tests Index test: CDUS.
Image production: protocol consisted of obtaining longitudinal and transverse views of proximal, mid, and distal aorta and iliac arteries. Peak systolic velocities obtained in graft and then compared with velocities in iliac vessels to assess for presence of limb flow anomalies including stenosis or occlusion. CFD scanning and Doppler interrogation of sac used to rule out presence of perigraft flow.
Type of US: 3‐ to 5‐MHz transducers, Acuson 128 XP ultrasound machine (Mountain View, CA, USA).
Use of contrast: no.
Operator: registered vascular technologist.
Follow‐up No loss to follow‐up, missing data, or adverse events reported ("All CT scans and CDU [CDUS] were technically satisfactory for determination of aneurysm size and presence of endoleak.")
Notes
  • Of the 281 participants, 97 had been enrolled in a phase II Food and Drug Administration protocol. Follow‐up of these participants included same‐day US, CT, and abdominal radiograph in first postoperative month, then at 6 and 12 months, and yearly thereafter. The other participants underwent simultaneous studies, usually only at 1‐month postoperative visit. Participants who underwent routine EVAR with commercial endografts underwent same‐day studies only 30 days postoperatively. Residual follow‐up with CT scans only at same intervals as protocol participants.

  • 494 postoperative same‐day CT scans and CDUS scans obtained (mean ± SD: 3.8 ± 1.4 per participant; range: 1 to 7) over 1‐ to 72‐month follow‐up period (mean (± SD): 34.6 ± 2 months).

Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Yes Retrospective review of all participants who underwent endovascular repair of AAAs between February 1996 and November 2002 and had same‐day CT and CDUS studies.
Acceptable reference standard? 
 All tests Yes Reference standard was helical CT.
Acceptable delay between tests? 
 All tests Yes Yes, participants received same‐day US and CT.
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 US scanning technologist and surgeon reviewing tapes were both unaware of results of CT scan during any portion of US scan examination or review.
Index test results blinded? 
 All tests Unclear Unclear.
Relevant clinical information? 
 All tests Yes Yes.
Uninterpretable results reported? 
 All tests Yes "All CT scans and CDU [CDUS] were technically satisfactory for determination of aneurysm size and presence of endoleak."
Withdrawals explained? 
 All tests Yes No withdrawal reported.