Initial clinical experience with the Zenith alpha stent-graft

Area of Science:

• Vascular Surgery
• Endovascular Interventions
• Medical Device Technology

Background:

• Endovascular aortic repair (EVAR) is a common treatment for thoracic aortic pathologies.
• The Zenith TX-2 stent-graft has been a standard device for these procedures.
• Newer devices are continually developed to improve outcomes and expand treatment options.

Purpose of the Study:

• To evaluate the safety and short-term efficacy of the Zenith Alpha stent-graft for endovascular repair of the thoracic aorta.
• To compare the Zenith Alpha stent-graft with the existing Zenith TX-2 stent-graft in a contemporary patient cohort.

Main Methods:

• A prospective study comparing 33 patients treated with the Zenith Alpha (group ZA) and 34 patients treated with the Zenith TX-2 (group TX).
• Patients were treated between August 2010 and May 2014 for thoracic aortic pathologies.
• Outcomes assessed included technical success, endoleaks, mortality, access vessel complications, and patient anatomy (iliac tortuosity, access vessel diameter).

Main Results:

• Technical success rates were similar between groups (93.9% ZA vs. 91.2% TX).
• No significant differences in type I endoleaks or need for open conversion were observed.
• Group ZA had a higher proportion of patients with previous endograft failures (18% vs. 0%) and more challenging access vessel anatomy (smaller diameter, higher tortuosity).
• A trend towards increased 30-day mortality in group ZA (6% vs. 0%) was noted, though not statistically significant (p=0.07).

Conclusions:

• The Zenith Alpha stent-graft demonstrates comparable safety and efficacy to the Zenith TX-2 for thoracic aortic endovascular repair.
• The Zenith Alpha is a viable option for patients with complex access vessel morphology, including those with prior endograft interventions.
• Further investigation is warranted to fully understand the 30-day mortality trend observed in the Zenith Alpha group.