A Canadian postmarket study of the Zenith Alpha Abdominal Endovascular Graft.
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OBJECTIVE: To evaluate the performance of the low-profile Zenith Alpha Abdominal Endovascular Graft in a Canadian postmarket setting. METHODS: A prospective, multicenter, nonrandomized, postmarket study was conducted at five sites in Canada between May 2017 and June 2018. Patients were treated for abdominal aortic or aortoiliac aneurysms using the Zenith Alpha Abdominal Endovascular Graft and followed for 2 years after the initial procedure in accordance with each institution's standard of care. RESULTS: A total of 100 patients (mean age, 75.2 ± 7.4 years,; 88% male; 16% with aortoiliac aneurysms) were treated. Technical success was achieved in 99% of patients (98/99). One patient was excluded from the technical success end point owing to missing data. The single technical failure was due to partial coverage of the left renal artery by the main body graft. The mean follow-up duration was 635.9 ± 213.6 days. Device success through the 2-year follow-up was achieved in 86.9% of patients (86/99). Overall, nine deaths occurred; none were related to the study device or the procedure. No patient required conversion to open surgery. Through follow-up, four patients experienced a type I endoleak. There were no instances of type III or IV endoleaks. One case of aneurysm rupture (related to type Ib endoleak and retrograde migration of an iliac leg graft) was treated successfully with angioplasty, coil embolization, and iliac graft extension. Eight patients experienced aneurysm growth of >5 mm throughout follow-up. Iliac leg graft occlusions occurred in five patients. In total, 14 patients required 15 secondary interventions (SIs). Iliac leg graft-related SIs were performed in seven patients, for device occlusion (n = 3), kink or compression (n = 2), stenosis (n = 2), or nonocclusive thrombus (n = 3). Other reasons for SIs included type II endoleak (n = 8), type Ib endoleak (n = 2), iliac artery dissection (n = 1), abdominal aortic aneurysm rupture (n = 1), and partial coverage of the left renal artery (n = 1). CONCLUSIONS: The Zenith Alpha Abdominal Endovascular Graft demonstrates high rates of technical success, no open conversions, and no aneurysm -related mortality after abdominal aortic or aortoiliac aneurysm repair. Type I endoleak rates were low. These outcomes support the safety and performance of the Zenith Alpha Abdominal Endovascular Graft.
