Multicenter European Registry for Patients with AAA Undergoing EVAR Evaluating the Performance of the 36-mm-Diameter Endurant Stent-Graft.
- 2017
Available online from MWHC library: 1997 - present, Available in print through MWHC library: 1996 - 2006
CONCLUSION: The use of the largest diameter Endurant stent-graft device emerges as a reasonable option for EVAR treatment of AAA featuring a large-diameter proximal neck. Assessment of a larger group of patients followed in the long term will be necessary for a more definitive statement on such strategy. INTRODUCTION: The use of and results with the Endurant stent-graft have been reported extensively. However, there has been little if any focus placed on performance and outcomes when a 36-mm-diameter device is used. METHODS: Data were collected and retrospectively analyzed on EVAR patients treated with a 36-mm-diameter Endurant device at 3 European academic vascular centers between 2007 and 2015. Primary endpoints were the absence of type Ia endoleak in the early and mid-term follow-up period, and aneurysm sac stabilization or shrinkage. Secondary endpoints were 30-day mortality, overall survival and secondary interventions. Subgroup analysis of outcomes in the on-label (ONL) versus off-label (OFL) device use cohorts was also performed. RESULTS: Seventy-three patients were included in the study. Mean follow-up was 30.1 +/- 16.2 months. Mean aortic neck diameter was 29.5 +/- 1.9. Primary technical success was achieved in 69 patients (94.5%). Five patients (6.8%) were found to have developed a type Ia endoleak, 3 during the first month, and the other 2 at 2 years. Overall EVAR-related mortality was 4.1% (n = 3). Subgroup analysis focused on the OFL cohort (n = 44) versus the ONL patients (n = 29). Two of the OFL patients (4.5%) had a type Ia endoleak, and 3 (10.3%) in the ONL group.