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.