Five-Year Results for Abdominal Aortic Aneurysm Repair with the GORE® EXCLUDER® Device: Insights from the Gore Global Registry for Endovascular Aortic Treatment (GREAT).

BACKGROUND

The early postoperative benefits of endovascular aneurysm repair (EVAR) have been well established but questions remain regarding its durability at mid-term and long-term time points. Long-term results in real-world use of EVAR outside of randomized trial data are limited. This study used the Global Registry for Endovascular Aortic Treatment registry to explore the 5-year outcomes with the GORE EXCLUDER device in real-world clinical circumstances.

METHODS

All patients within the Global Registry for Endovascular Aortic Treatment registry who underwent an infrarenal abdominal aortic aneurysm repair with the GORE EXCLUDER device were included in this study. Baseline characteristics and demographic information of the cohort were collected. End points included mortality (all-cause and aneurysm-related), serious endoleaks, aneurysm sac diameter, endograft integrity (fracture, compression, migration), post-EVAR aortic rupture, device-related reintervention, conversion to open repair, graft explantation, and major adverse cardiovascular events.

RESULTS

A total of 3,216 patients were included in this analysis. The cohort reflected a significantly comorbid population with 46% of patients reaching a Charlson Comorbidity Index score of ≥5. Follow-up at 5 years was 60% of eligible participants. The freedom from aortic-related mortality was at 98.8% and overall survival was 71.2%. Postoperative major adverse cardiovascular events occurred in 49 (1.5%) patients. Device-related intervention through 5 years was 7.2% and the overall serious endoleak rate was 6.8%. Less than 1% of patients required an open conversion/revision and aortic rupture following device placement occurred in 15 (0.5%) patients. Aneurysm sac regression was achieved in 58.1% of patients at 5 years, and stability/absence of growth was observed in 83.6% at 5 years.

CONCLUSIONS

This study supports the durability of the GORE EXCLUDER device through 5 years with negligible incidence of graft integrity compromise and low aortic/device-related reintervention rates. Furthermore, the efficacy of the device is highlighted with low aortic-related mortality and high sac regression/stability diameter through 5 years.