International Study Evaluates Cook Medical's Zenith Alpha TEVAR Device

August 11, 2015—Karl A. Illig, MD, et al published 1-year outcomes from a study evaluating the safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical) for the treatment of descending thoracic aortic aneurysms and large ulcers. The investigators concluded that early outcomes after Zenith Alpha implantation appear promising and suggest expanded thoracic endovascular aortic repair applicability in patients with smaller access vessels. They advised that longer-term follow-up is ongoing. The study is available online ahead of print in the Journal of Vascular Surgery.
 
According to the investigators, the Zenith Alpha device, with a 16- to 20-F delivery system, was developed to address vascular access issues associated with larger-profile devices and to increase conformability in tortuous anatomy. 

This prospective, nonrandomized, multicenter study was conducted in Europe, Japan, and the United States. The main anatomical inclusion criteria included proximal neck seal zone ≥ 20 mm, aortic arch radius ≥ 20 mm, and a neck diameter of 15 to 42 mm. Patients were evaluated preprocedure, predischarge, and postdischarge at 1, 6, and 12 months and yearly through 5 years.

As summarized in the Journal of Vascular Surgery, the study enrolled 110 patients (58 men and 42 women; mean age, 72 ± 10 years) for the treatment of descending thoracic aortic aneurysms (n = 90) or ulcers (n = 20) between March 2010 and January 2013. Access was percutaneous in 36% (40 of 110) of patients. The study device was successfully implanted in all but two patients (both due to an inability to gain access or advance to the target treatment site). There were no 30-day mortalities.

The investigators found that five deaths occurred at ≤ 1 year (only one was aneurysm-related by independent adjudication), resulting in a 95% freedom from all-cause mortality and a 99% freedom from thoracoabdominal aneurysm-related mortality. At one or more time points ≤ 1 year, type I endoleak (all distal) was observed in four patients, type III endoleak in two patients, and aneurysm growth in four patients. Five patients experienced stroke at ≤ 1 year (two were procedure-related). No aortic rupture, paraplegia, paralysis, or permanent spinal cord injury were observed at ≤ 1 year, reported the investigators in the Journal of Vascular Surgery.