Longer-Term Durability of Zenith Alpha Stent Graft Evaluated in Study

November 20, 2017—A study published by Giovanni F. Torsello, MD, et al in the Journal of Vascular Surgery (JVS; 2017;66:1638–1643) investigated the longer-term durability of the Zenith Alpha thoracic stent graft (Cook Medical) after thoracic endovascular aortic repair.

Researchers retrospectively analyzed data collected from all patients treated for thoracic aortic aneurysms or penetrating aortic ulcers and had CTA-based follow-up ≥ 12 months. The primary endpoint was ongoing clinical success, with stent graft migration and fracture as secondary endpoints.

As summarized in JVS, between August 2010 and October 2015, 70 consecutive patients were treated in a single center with the Zenith Alpha stent graft. Ongoing clinical success was 87.1% in patients with CTA-based follow-up of 22.3 ± 15.9 months. There were three cases of type Ia endoleak (4.3%), two cases of type Ib endoleak (2.9%), and one case of aneurysm sac enlargement (1.4%). One case (1.4%) required reintervention for a combined type Ia and type II endoleak. No type III or type IV endoleak was detected.

No stent fractures were reported, and there was one case of distal stent graft migration. There were no conversions to open repair and no ruptures or intraoperative deaths. Five patients died postoperatively (7.1%). All-cause mortality was 17.1% at 76 months.

According to the study results, the Zenith Alpha stent graft appears to maintain favorable results in a longer time frame with a low incidence of aneurysm sac growth and migration. The study investigators advised that multicenter prospective trials are needed to validate these data.