Parent 2002.
Clinical features and settings | People of Norfolk Surgical Group who underwent endovascular graft repair of AAA. Type of stents received: EVT‐EGS/Guidant ‐ Ancure product (Menlo Park, CA, USA) used in all cases. Bifurcated endograft: 63 participants, tube endograft: 12 participants, aortoiliac endograft in 8 participants. Aneurysm diameter: not reported. Setting: unclear. |
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Participants | 83 participants; age and gender not reported. Comorbidities: not reported. Geography: USA. |
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Study design | Retrospective study. | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: absence of perigraft flow from the source vessel identified with prior study results. Endoleak (absolute n): 23. Prevalence of endoleak: 27.7% (23/83). Reference standard: CT scan. Image acquisition:
Type of CT scanner: not reported. Use of contrast: yes, 120 mL Omnipaque 350 (Nycomed, Inc, Princeton, NJ, USA). |
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Index and comparator tests |
Index test: CDUS. Image production: CDUS scan evidence of endoleak required identification of perigraft Doppler scan signals with colour flow and confirmed with spectral analysis and mapping of blood flow pattern. In addition, characterization of Doppler scan spectral analysis as biphasic, monophasic, or bidirectional (to/fro) obtained from CDUS scan studies. Type of US: not reported. Use of contrast: no. Operator: unclear. |
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Follow‐up | 8 examinations suboptimal because of gassy abdomen or large abdominal girth. | |
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 CTA. |
Acceptable delay between tests? All tests | Unclear | Information reported unclear although authors reported that CDUS and CT scan examinations were scheduled within 30 days and at 3, 6, and 12 months after surgery and then annually thereafter. |
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 was part of reference standard. |
Reference standard results blinded? All tests | Unclear | No information provided. |
Index test results blinded? All tests | Unclear | No information provided. |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | 8 examinations suboptimal because of gassy abdomen or large abdominal girth. |
Withdrawals explained? All tests | Yes | 42 (51%) participants never had an endoleak at any time in follow‐up period with CT and CDUS scan studies. Remaining 41 (49%) participants with endoleaks identified at any time in follow‐up period form basis of this analysis. |