Five-year outcomes of the GORE EXCLUDER Iliac Branch Endoprosthesis in real-world registry settings.

OBJECTIVE

This study reports midterm outcomes for the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) for patients enrolled in the Global Registry for Endovascular Aortic Treatment (GREAT).

METHODS

Retrospective analysis of the prospective, multicenter GREAT registry (NCT01658787) evaluated a total of 94 patients who received the IBE as part of routine clinical practice.

RESULTS

The all-cause mortality rate among patients treated with IBE in the GREAT registry at 5 years was 14.3%, the cumulative mortality rate was 23.4%, and aortic-related mortality was 1.1%. The cumulative reintervention rate was 16.0% through 5 years including a device-related reintervention rate of 15.0%. Freedom from all-cause mortality and aortic-related mortality at 5 years was 68.7% (57.4%-77.6%) and 98.8% (91.8%-99.8%), respectively. Freedom from any reintervention and from device- or procedure-related reintervention through 5 years was 80.6% (69.7%-88.0%) and 82.2% (71.5%-89.1%), respectively. The cumulative rate of an endoleak through 5 years was 12.8%. Most endoleaks were type II (7.4%) and type IB (6.4%). Type III endoleaks were uncommon (2.1%), and no type IV endoleaks were reported. With regard to device integrity events, there was only a single instance of migration reported in 5 years. Aortic rupture was rare, with a rate of 1.1%. Patency-related adverse events were uncommon, with a cumulative incidence of 3.2% through 5 years with most events occurring during the first 2 years of follow-up.

CONCLUSIONS

Our findings indicate that the GORE EXCLUDER IBE was associated with low rates of aortic-related mortality, aortic rupture, reintervention, endograft migration or fracture, aneurysm growth, and endoleak in a real-world setting. Midterm outcomes observed in this real-world registry were comparable to those reported in a more restrictive investigational device exemption trial.