Experience with the Stentor endograft at four Italian centers

Area of Science:

• Vascular Surgery
• Endovascular Interventions
• Medical Device Technology

Background:

• Abdominal aortic aneurysms (AAAs) pose significant health risks.
• Endovascular aneurysm repair (EVAR) offers a less invasive treatment option.
• Early endograft devices required evaluation for efficacy and safety.

Purpose of the Study:

• To evaluate the outcomes of endovascular abdominal aortic aneurysm (AAA) exclusion using the Stentor device in an Italian multicenter trial.
• To assess the technical feasibility and early clinical success of the Stentor endograft.
• To identify complications and challenges associated with the Stentor device implantation.

Main Methods:

• A prospective multicenter trial enrolled 66 patients with infrarenal AAAs between April 1995 and July 1996.
• Patients underwent endovascular exclusion using the Stentor device, with both tubular and bifurcated grafts utilized.
• Outcomes, including technical success, vascular complications, endoleaks, and mortality, were recorded and analyzed.

Main Results:

• Sixty (91%) endograft procedures were completed successfully, with 4 conversions and 1 termination due to technical issues.
• Six (9.1%) vascular complications occurred, including one fatal pulmonary embolism (1.5% mortality).
• Clinical success at 30 days was 86.3%; however, late complications included graft limb thrombosis and secondary endoleaks requiring intervention.

Conclusions:

• The Stentor device demonstrated technical feasibility for AAA exclusion but presented challenges, particularly with bifurcated graft limb deployment.
• Deployment issues and endoleaks impacted the overall success rate, necessitating further device refinement.
• The study's conclusion was influenced by the introduction of second-generation endografts, highlighting the evolving nature of EVAR technology.