Clinical Performance of the Low Profile Zenith Alpha Abdominal Endovascular Graft: 2 Year Results from the ZEPHYR Registry

OBJECTIVE: The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported. METHODS: The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with non-ruptured abdominal aortic aneurysm with a maximum diameter = 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of = 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients were included in 14 sites across Germany, Belgium, and the Netherlands. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion. RESULTS: A total of 347 patients were included in the ZEPHYR registry. Median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1 year, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant cause for secondary interventions was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1 year, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariate and multivariate Cox regression analyses could not identify any independent predictor for limb complications. CONCLUSION: While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is concerning. The manufacturer's instructions for use should be closely followed. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.