Five-year pivotal trial outcomes of the Gore Excluder conformable endoprosthesis implanted in abdominal aortic aneurysms with short non-angulated infrarenal seal zones.

Abstract

Objective: The GORE EXCLUDER Conformable Abdominal Aortic Aneurysm Endoprosthesis with Active Control System (EXCC) is approved in the United States (U.S.) for treatment of AAAs and highly angulated (≤90°) and short (≥10 mm) infrarenal aortic proximal seal zones (necks). Reported here are the 5-year outcomes of the EXCC U.S. pivotal clinical trial in the short, non-angulated cohort (SNA).

Methods: The EXCC investigational device exemption prospective pivotal trial short neck sub-study across 31 sites included patients with infrarenal necks measuring ≥10 mm length and ≤60° angulation. Five-year outcomes assessed by Core lab and adjudicated by independent review committee included patient safety (mortality, reintervention, rupture, conversion to open repair), device effectiveness (freedom from endoleak, migration, fracture, erosion, occlusion), and freedom from aneurysm sac expansion in the SNA cohort and subpopulations of patients with neck length of ≥10 mm to <15 mm and ≥15 mm.

Results: The EXCC device was implanted in 80 SNA patients, of which 23 (29%) had <15 mm neck length and 57 (71%) had ≥15 mm. Patients were a mean age of 73.5 ± 8.1 years, 93.8% White, and had a mean body mass index of 29.5 ± 5.1 kg/m². At 5 years, 15 patients died, 12 were lost to follow-up, and for 47 of the 53 remaining patients, 5-year follow-up data was available. The mean maximum abdominal aortic aneurysm (AAA) diameter was 57.7 mm (range, 42.5-82.7 mm), and the mean infrarenal aortic angle was 35.7° (range, 3°-59°). Through 5 years, no aneurysm-related mortality, conversion to open repair, obstruction, occlusion, erosion, migration, or type I or type III endoleaks were reported. AAA expansion ≥5 mm occurred in eight patients (10.3%). Nine patients (11.3%) underwent reintervention, predominantly embolization for type II endoleak. One patient (1.3%) experienced an AAA rupture. In patients with a ≥10 mm to <15 mm seal zone vs a ≥15 mm seal zone, differences in AAA expansion (9.5% vs 10.5%) or reinterventions (8.7% vs 12.3%) were not significant (P = 1.0).

Conclusions: The 5-year outcomes of the EXCC U.S. pivotal trial demonstrate excellent patient safety and device effectiveness endpoints. There is complete absence of aneurysm-related mortality, conversion to open repair, significant endoleak, or device occlusion/migration. Reinterventions and AAA sac expansion are infrequent and do not differ between short or standard infrarenal seal zone lengths. The EXCC device is safe and effective through 5 years for AAA necks measuring ≥10 mm length and ≤60° angulation.