Thompson 1998.
Clinical features and settings | 20 people who received endovascular grafts for infrarenal aortic aneurysms. Type of stent received: 6 aortic tube endografts (Endovascular Technologies EGS, Menlo Park, CA, USA), 3 bifurcated systems (Stentor; Mintec, Freeport, Bahamas), and 11 tapered aorto‐uni‐iliac graft. Aneurysm diameter: median transverse diameter: 5.2 cm; range: 4.8‐7.3 cm measured by CT. Setting: department of surgery. |
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Participants | Median age: 72 years; range: 68‐84 years; median aneurysm diameter: 5.2 cm; range: 4.8‐7.3 cm measured by CT; 5.0 cm; range: 4.3‐7.0 cm measured by duplex imaging; median follow‐up: 14 months; range: 6‐31 months. Comorbidities: not reported. Geography: UK. |
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Study design | All participants who had a technically successful EVAR were entered into a standard prospective surveillance programme at 3, 6, 12, 18, and 24 months following repair. | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: to presence or absence of flow within aneurysm sac. Endoleak (absolute n):75. Prevalence of endoleak: 15.9% (49/494). Reference standard: contrast CT scan. Image acquisition:
Type of CT scanner: Siemens HiQ scanner (Munich, Germany). Use of contrast: yes (type unclear). |
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Index and comparator tests |
Index test: CDUS. Image production: "Duplex imaging was performed with the patient supine using a 3.5 MHz curved linear array transducer, HDI Ultramark 9 (ATL, Letchworth, UK). Colour Doppler ultrasonography was utilized to image flow within the graft, and any flow disturbance was noted. Endoleaks were specifically sought with the colour Doppler set to detect low flow." Type of US: 3.5‐MHz curved linear array transducer, HDI Ultramark 9 (ATL, Letchworth, UK). Use of contrast: no. Operator: 2 ("Diagnostic imaging was performed by investigators.") |
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Follow‐up | Unclear. | |
Notes | ||
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Up to December 1996, EVAR was attempted in 48 participants, with primary success in 43. 20 of these participants followed for ≥ 6 months and formed group for study. Median age: 72 years; range: 68‐84 years; median aneurysm diameter: 5.2 cm; range: 4.8‐7.3 cm as measured by CT and 5.0 cm; range: 4.3‐7.0 cm as measured by duplex imaging; median follow‐up: 14; range: 6‐31 months. |
Acceptable reference standard? All tests | Yes | Reference standard was CT scan. |
Acceptable delay between tests? All tests | Yes | Yes: CT and US examinations performed on same day. |
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 | "Diagnostic imaging was performed by investigators (G.F. and T.H.) who were blinded of the result from the other imaging technique and previous scans." |
Index test results blinded? All tests | Unclear | "Diagnostic imaging was performed by investigators (G.F. and T.H.) who were blinded of the result from the other imaging technique and previous scans." |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Unclear | Unclear. |
Withdrawals explained? All tests | Yes | No withdrawals. |