Why the study?
What proportion of patients with abdominal aortic aneurysm are anatomically suitable for EVAR according to current IFUs, and do low-profile delivery systems increase suitability?
What proportion of patients with abdominal aortic aneurysm are anatomically suitable for EVAR according to current IFUs, and do low-profile delivery systems increase suitability?
Less than half of AAA patients are anatomically suitable for EVAR based on current IFUs, but low-profile delivery systems could increase suitability to up to 60%.
Current IFU criteria limit EVAR suitability to under half of AAA patients; this cross-sectional analysis leaves open whether low-profile systems expand real-world eligibility.
The aim of the study was to evaluate the anatomic suitability for endovascular abdominal aneurysm repair (EVAR) according to instructions for use (IFUs) of three commercially available bifurcated stent graft devices and explore the possible benefits of low-profile delivery systems. Computed tomography scans of 241 patients with abdominal aortic aneurysm (AAA) were evaluated for suitability of Zenith Flex(®), Gore Excluder(®) and Endurant(®) bifurcated stent graft systems according to their IFUs. The most common exclusion criteria and possible benefits of smaller diameter delivery systems were analyzed. When choosing the most suitable graft model for each patient, the overall suitability was 49.4%. By brand, the suitability was 28.6% for Zenith(®), 25.7% for Gore Excluder(®) and 48.1% for Endurant(®). By step wise accepting iliac diameters of ≥6 mm, ≥5 mm and ≥4 mm the overall suitability increased to 56.7, 58.9 and 60.2%, respectively (P < 0.001). Diameters below 4 mm had no additional effect on suitability as combinations of other anatomical features, with or without narrow iliacs, accounted for the remaining excluding factors. In conclusion, Less than half of patients with AAAs are suitable for EVAR according to current IFUs. Low-profile delivery systems may allow for endovascular treatment in up to 60% of patients.
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Kristmundsson et al. (2013) studied this question.
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