Third- versus Second-Generation Stent Graft for Endovascular Aneurysm Repair: A Device-Specific Analysis

Area of Science:

• Vascular Surgery
• Medical Devices
• Endovascular Interventions

Background:

• Endovascular aneurysm repair (EVAR) is a common treatment for abdominal aortic aneurysms.
• The Excluder endograft has undergone generational improvements to enhance procedural efficiency and patient outcomes.
• Comparing different generations of endografts is crucial for optimizing EVAR techniques.

Purpose of the Study:

• To compare the procedural and long-term outcomes of the second-generation Excluder (ExSP) with the third-generation Excluder (ExC3) endografts.
• To evaluate intraprocedural data, including procedure time, fluoroscopy duration, and radiation dose.
• To assess the efficacy of the C3 delivery system in complex EVAR cases.

Main Methods:

• Retrospective single-center comparative study of elective EVAR procedures using Excluder endografts from May 2008 to December 2015.
• Patients were categorized based on the endograft generation used (ExSP vs. ExC3).
• Subgroup analysis of complex procedures was performed according to International Standards, with preliminary and primary endpoints focusing on early/mid-term outcomes and procedural data, respectively.

Main Results:

• The study included 64 patients (24 ExSP, 40 ExC3) with a mean follow-up of 31.6 months.
• The ExC3 group presented with more risk factors, comorbidities, and unfavorable anatomy.
• Significantly shorter procedure duration (120 vs. 151 min overall, 129 vs. 173 min complex) and reduced fluoroscopy time/radiation exposure (24,084 vs. 32,548 cGy/cm² overall, 26,770 vs. 41,104 cGy/cm² complex) were observed with ExC3.

Conclusions:

• The third-generation C3 Excluder significantly reduces procedural time and radiation exposure compared to the second-generation ExSP device.
• EVAR outcomes with the C3 Excluder are comparable to the previous generation, even in patients with higher comorbidity and anatomical complexity.
• Further long-term follow-up studies are warranted to fully assess the performance of the C3 Excluder.