d'Audiffret 2001.
Clinical features and settings | People with AAA who underwent endoluminal exclusion with commercially available endoprosthesis and had a minimum follow‐up of 6 months. Type of stents received: devices included Mintec system (n = 7), Vanguard system (n = 56), Endovascular Technology (n = 11), Aneuryx (n = 2), Talent (n = 1), and Stenford system (n = 12). Prosthesis configurations were aortic tube grafts (n = 3), aorto‐uni‐iliac (n = 5), and bifurcated grafts (n = 81). Aneurysm diameter: mean aneurysm diameter: 53.2 mm; range: 45‐80 mm on preoperative CT. Setting: department of vascular medicine. |
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Participants | 89 participants; mean (± SD) age: 70 ± 5 years; female: 6, male: 83; ASA classification 1: 2, 2: 37, 3: 40, 4: 10. Comorbidities: risk factors: ischaemic heart disease 50 (56.2%), previous myocardial infarction 17 (19.2%), obesity 28 (31.3%), smoking 43 (49%), hypertension 53 (59.4%), pulmonary disease 25 (29%), diabetes mellitus 8 (9%), renal impairment 10 (11%), and hyperlipidaemia 27 (30.3%). Geography: France. |
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Study design | Retrospective study with consecutively selected participants ("A total of 89 patients were followed up with serial CT and DUS at 1, 3, 6, 12, and 24 months after endoluminal treatment. Special attention was directed toward the presence of endoleaks and aneurysm diameter evolution.") | |
Target condition and reference standard(s) |
Target condition: endoleak. Definition of endoleak: presence of contrast between graft and arterial wall of aneurysm. Endoleak (absolute n): 32. Prevalence of endoleak: 36.0% (32/89). Reference standard: helical CT Twin scanner. Image acquisition:
Type of CT scanner: helical Elscint CT Twin scanner (Picker Marconi, Chatenay‐Malabry, France). Use of contrast: yes, type of contrast not reported ("100 to 150 mL of nonionic contrast agent"). |
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Index and comparator tests |
Index test: CDUS. Image production: "The aorta from the renal to the distal iliac arteries was examined with B‐mode imaging. The largest anteroposterior and transverse diameters were measured and recorded. Colour flow sampling within the aneurysm sac, outside the endoprosthesis, was used to detect endoleaks. When flow was detected, a Doppler waveform analysis completed the investigation." Type of US: 3.5‐MHz probe Esaote which included Doppler flow velocity measurement, CDUS, power Doppler, and B‐mode US (AU 4; Biomedica, Genoa, Italy). Use of contrast: no. Operator: physicians certified in vascular medicine and US. |
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Follow‐up | No loss to follow‐up, missing data, or adverse events. | |
Notes | Secondary objective included value of transverse diameter preoperatively and at each follow‐up examination and variations of diameter from preoperative to latest available examination. | |
Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Spectrum of participants was representative of participants who receive test. |
Acceptable reference standard? All tests | Yes | CTs performed with helical Elscint CT Twin scanner. |
Acceptable delay between tests? All tests | Yes | "Comparisons were performed when both examinations were done within a 1‐month interval." |
Partial verification avoided? All tests | Yes | After device implantation, participants followed up with serial CT and DUS at 1, 3, 6, 12, 18, and 24 months, then yearly. Current analysis performed on first 89 participants who underwent endoluminal exclusion and had minimum follow‐up of 6 months. |
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 | No | "The physicians performing the DU [DUS] or the CT may have been aware of the results of the examination, which was done first." |
Index test results blinded? All tests | No | "The physicians performing the DU or the CT may have been aware of the results of the examination, which was done first." |
Relevant clinical information? All tests | Yes | Yes. |
Uninterpretable results reported? All tests | Yes | "One false positive leak was detected with duplex ultrasound. The patient had an arteriogram that did not confirm the endoleak. The most likely explanation was a flow artefact due to the high position of a contralateral graft limb into the main graft body." |
Withdrawals explained? All tests | Unclear | No apparent withdrawal occurred. |