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Zenith abdominal aortic aneurysm endovascular graft
Roy K Greenberg1, Timothy A M Chuter, Richard P Cambria
1Department of Vascular and Cardiothoracic Surgery and Biomedical Engineering, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. greenbr@ccf.org
Journal of Vascular Surgery
|May 20, 2008
Summary
The Zenith endovascular graft demonstrates long-term durability and safety, with low risks of death or rupture. Continued surveillance is essential due to late endoleaks and potential sac enlargement.
Area of Science:
- Vascular Surgery
- Endovascular Interventions
- Medical Device Technology
Background:
- The Zenith endovascular graft is a device used for treating abdominal aortic aneurysms.
- Long-term safety and efficacy data are crucial for endovascular aneurysm repair (EVAR) devices.
Purpose of the Study:
- To assess the 5-year safety and efficacy of the Zenith endovascular graft in a US multicenter trial.
- To evaluate outcomes stratified by patient risk (standard vs. high) and assess device-specific complications.
Main Methods:
- A prospective multicenter trial enrolled patients into open surgery (control) or Zenith endovascular graft (endovascular) arms.
- Patients were followed for up to 5 years, with risk stratification into high- and standard-risk groups.
- Key outcomes included mortality, rupture, conversion, endoleaks, secondary interventions, sac enlargement, and suboptimal endovascular results (SER).
Main Results:
- At 5 years, survival estimates were 83% (standard-risk) and 61% (high-risk); aneurysm-related death was 2-4%.
- Freedom from rupture was high (99.6-100%). Cumulative risks of conversion, limb occlusion, migration, or component separation were ≤3%.
- Late endoleaks occurred in 12-15%, leading to secondary interventions in 20-25% of patients. SER was linked to advanced age and internal iliac artery occlusion.
Conclusions:
- The Zenith endovascular graft shows favorable middle- and long-term durability.
- Aneurysm-related death and rupture risks are low, with uncommon device integrity issues.
- Long-term surveillance is necessary to monitor late endoleaks and potential sac growth, though sequelae remain uncertain.
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