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Long-term durability of Zenith endovascular graft for AAA
Robert J. Feezor, MD, Adam W. Beck, MD, Thomas S. Huber, MD, PhD, Salvatore T. Scali, MD.
University of Florida, Gainesville, FL, USA.
Objectives: Trial evidence indicated that infrarenal endovascular aneurysm repair (EVAR) using the Zenith® endovascular device (Cook Medical, Bloomington, IN) is safe and effective. Clinical trials provide 5 year data, but clinical practice has evolved and longer-term data is lacking. We sought to determine the outcomes of patients treated with Zenith devices with ≥ 5 years of clinical and radiographic follow-up.
Methods: A prospective endovascular database was queried for patients who underwent endovascular repair of an infrarenal aortic aneurysm (EVAR) using a Zenith® device at a single institution. Patients with clinical and radiographic follow-up greater than 60 months were included and outcomes were analyzed. Life-tables were used to estimate clinical end-points.
Results: Of 307 patients who underwent Zenith® EVAR >5 years ago, 47(15%) had clinical and radiographic follow-up beyond 5 years after implantation. Mean age(±standard deviation) was 70±6 years, and 36(77%) were men. Median follow-up was 77 months(IQR, 67-86). Median aneurysm sac regression was 18%(IQR 6-30%). Only 6(13%) increased in size, all associated with an endoleak. There were no cases of endograft migration or operative conversion. There was one immediate type-Ia and one delayed Ib endoleak. Fourteen patients(30%) had an endoleak at any point during follow-up, and 12(26%) were type-II. Five patients(11%) had an endoleak on the most recent CT, all of which were type-II. Ten patients (21%) underwent revision at a median of 35 months after implantation(range 0 to 67 months). The 5- and 10-year estimated freedom from any reintervention were 83±5% and 78±6%, respectively (Figure). Thirty-five(74%) patients experienced the “ideal” outcome of no repeat interventions and cessation of AAA growth.
Conclusions: In appropriately selected patients, implantation of the Zenith® EVAR to treat infrarenal aortic aneurysms is effective and durable, with an acceptably low rate of re-intervention and high rate of sustained aneurysm sac regression. 
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