Reintervention Rate after Treatment with the INCRAFT AAA Ultra-Low-Profile Stent Graft System

Area of Science:

• Vascular Surgery
• Endovascular Aneurysm Repair
• Medical Device Outcomes

Background:

• The INCRAFT stent graft system is an ultra-low-profile endograft for infrarenal aortic aneurysms.
• Postmarketing investigations were mandated due to observed device-related complications.
• This study analyzes mid-term outcomes in a real-world INCRAFT endograft patient cohort.

Purpose of the Study:

• To evaluate the mid-term safety and efficacy of the INCRAFT stent graft system.
• To assess reintervention rates, technical success, and mortality associated with INCRAFT endografts.
• To identify complications such as endoleaks, stent fractures, and endograft migration.

Main Methods:

• A consecutive series of patients treated with INCRAFT endografts from February 2015 to December 2022 were analyzed.
• Safety and outcome endpoints followed Society for Vascular Surgery reporting standards.
• Key outcomes included reinterventions, mortality, endoleaks, stent fractures, and migration.

Main Results:

• Eighty patients (76 ± 7 years) were included, with 91% undergoing percutaneous procedures.
• Mean follow-up was 37 months; no aortic or procedure-related mortality occurred.
• Reinterventions were needed in 31% of patients, primarily for limb issues (23%) and type II endoleaks (14%).

Conclusions:

• The INCRAFT stent graft system demonstrated safe and successful treatment of infrarenal aortic aneurysms.
• A significant rate of reinterventions was necessary for endograft patency and aneurysm growth control.
• Long-term surveillance is crucial for patients treated with this ultra-low-profile endograft.