The new C3 Gore Excluder stent-graft: single-center experience with 100 patients.

ABSTRACT

OBJECTIVES: To present results from the first 100 patients treated with the new C3 Gore Excluder stent-graft in a single institution. METHODS: All patients treated with the C3 Excluder stent-graft between August 2010 and July 2013 in our institution were included. Patient demographics, treatment indication, need for intraoperative stent-graft repositioning, immediate technical success, survival, endoleak and migration rate, and need for reintervention during follow-up were analyzed. RESULTS: A total of 100 patients (86% male, mean age 71.1 ± 9.3 years) were enrolled. Elective abdominal aortic aneurysm (AAA) was the most common indication for treatment (n = 90), followed by common iliac artery aneurysm (n = 5), ruptured AAA (n = 2), type Ia endoleak (n = 1), and type IV endoleak (n = 1) after prior EVAR, and penetrating aortic ulcer (n = 1). Technical success was achieved in 98 patients. In two patients a small type I endoleak persisted at completion angiography, but had disappeared at the first control computed tomography angiogram. Stent-graft repositioning after initial deployment was required in 49 patients, almost equally distributed for level and contralateral gate reorientation. Exact positioning of the proximal trunk was achieved in 98 patients, with the remaining two cases within 5 mm of the intended location. Adverse events related to repositioning maneuvers were noticed in two cases. Mean follow-up duration was 12.2 ± 9.4 months (range 0-36 months). Eight patients died, none from aneurysm related causes. Cumulative patient survival was 96.2 ± 2.1% at 1 year, and 84 ± 6.1% at 2 years, respectively. No migration, or type I or III endoleak was detected during follow-up. Estimated freedom from reintervention was 96 ± 2.4% at 1 year, and 91 ± 5.2% at 2 years, respectively. CONCLUSIONS: The new C3 Excluder stent-graft provides excellent short-term outcomes and offers important advantages in terms of stent-graft repositioning to achieve high proximal deployment accuracy. Longer follow-up is required to confirm improved long-term outcome compared with the previous generation Excluder stent-graft.