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Structural implications of fenestrated stent graft misalignment.

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Misaligned fenestrations in fenestrated stent grafts for abdominal aortic aneurysms can compromise treatment. Both Anaconda and Zenith devices showed reduced performance at higher misalignment angles in an in vitro study.

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Area of Science:

  • Biomedical Engineering
  • Vascular Surgery
  • Medical Device Technology

Background:

  • Endovascular aneurysm repair (EVAR) is a minimally invasive treatment for abdominal aortic aneurysms (AAAs).
  • Fenestrated stent grafts are necessary for AAAs involving visceral arteries, requiring precise fenestration alignment.
  • In vitro evaluation is crucial for understanding device performance under simulated physiological conditions.

Purpose of the Study:

  • To assess the structural impact of fenestration misalignment on luminal patency and aortic neck apposition.
  • To compare the performance of Anaconda and Zenith fenestrated stent grafts under varying degrees of misalignment.
  • To identify critical misalignment angles that compromise device integrity and sealing.

Main Methods:

  • Utilized a custom apparatus to test Anaconda and Zenith fenestrated stent grafts.
  • Evaluated stent grafts at 10° increments of misalignment, up to 80°.
  • Measured luminal cross-sectional area and proximal aortic neck apposition at each interval.

Main Results:

  • Anaconda stent grafts showed a linear decrease in luminal patency with increasing misalignment (P < 0.0001).
  • Zenith stent grafts exhibited reduced luminal patency at misalignments ≥40° (P < 0.0001) and compromised aortic neck apposition at ≥30°, indicating potential type Ia endoleaks.
  • Both devices demonstrated adverse effects at extreme angles, with Anaconda showing luminal narrowing and Zenith showing loss of apposition.

Conclusions:

  • Both Anaconda and Zenith fenestrated stent grafts are susceptible to adverse structural changes at high misalignment angles.
  • Luminal narrowing is a concern for Anaconda devices, while type Ia endoleaks are a risk for Zenith devices at significant misalignments.
  • At low angles of misalignment, both stent graft types appear to perform comparably.