Long-term results after standard endovascular aneurysm repair with the Endurant and Excluder stent grafts

Abstract

Objective: Many endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts.Methods: Patients undergoing standard endovascular repair from July 2004 to December 2011 in a single institution with the Endurant or the Low-Porosity Excluder endografts were eligible. Only patients treated for intact degenerative abdominal infrarenal aneurysms were included. All measurements were performed on center-lumen line reconstructions obtained on dedicated software. The primary end point was primary clinical success, defined as clinical success without the need for an additional or secondary surgical or endovascular procedure. Neck-related events (a composite of type IA endoleak, neck-related secondary intervention, or migration of >5 mm), neck morphology changes, renal function, and overall survival were secondary end points.Results: The study included 277 patients (156 Endurants; 121 Excluders). The median follow-up was 5.8 years (range, 0.1-12.4 years) and did not differ between groups (P ¼ .18). Patients treated with the Endurant stent graft had wider (neck diameter of >28 mm, 27.3% vs 1.7% [P < .001]; neck diameter of 27 mm, [interquartile range (IQR), 24-29 mm] for Endurant and 24 mm [IQR, 22-25 mm] for Excluder; P < .001) and more angulated necks (b-angle of >60 , 26.7% vs 12.5%; P ¼ .004). Oversizing was greater in the Endurant group (16% [IQR, 12%-22%] vs 13% [IQR, 8%-17%], respectively; P < .001). Patients were treated outside device instructions for use regarding proximal neck: 16.7% in the Endurant and 17.3% in the Excluder group (P ¼ .720). The 7-year primary clinical success was 54.7% for the Endurant and 58.1% for the Excluder groups (P ¼ .53). Freedom from neck-related events at 7 years was 76.7% for the Endurant and 78.8% for Excluder group (P ¼ .94). The Endurant stent graft (hazard ratio [HR], 2.7; 95% confidence interval [CI], 1.3-5.8; P ¼ .009) was an independent predictor of significant renal function decline. Neck dilatation was greater in Endurant-implanted patients (13% [95% CI, 2%-22%] vs 4% [95% CI, 0%-10%]; P < .001). Overall survival at 7 years was 61.4% in the Endurant and 50.3% (n ¼ 50; standard error, 0.047) in the Excluder group (P ¼ .39).Conclusions: This study reveals that durable and sustainable results can be obtained with either of these late generation devices. This finding suggests that careful planning and a tailored device selection taking into account the patient's anatomy are more relevant determinants than the graft model itself to obtain clinical success. The Endurant endoprosthesis seems to be associated with a higher rate of neck dilatation and faster decrease in the estimate...

The Impact of Endograft Selection on Outcomes Following Treatment Outside of Instructions for Use (IFU) in Endovascular Abdominal Aortic Aneurysm Repair (EVAR)

“…A later design (the Endurant IIs) included a three-piece design, although this was only made available in 2014. It is not included in this analysis, as inclusion in the ENGAGE registry ended in 2011 [8].…”

“…Two of the most widely utilized endoprostheses are the Endurant (Medtronic Vascular Inc, Dublin, Ireland), and the Excluder (W. L. Gore & Associates, Flagstaff, Arizona). Each device has different accepted thresholds for these morphologic features as expressed in their instructions for use (IFU) [8]. The variation in thresholds for device application is likely impacted by the site of proximal stent fixation; Endurant is a suprarenal device as compared to Excluder, an infrarenal device.…”

Aneurysm Volumes After Endovascular Repair of Ruptured vs Intact Aortic Aneurysms: A Retrospective Observational Study

“…According to a recent publication from our group, there seems to be no difference in volume variation between the abovementioned stent-grafts. 18 rEVAR patients also do not seem to be at greater risk for late complications compared with iEVAR patients. Even though the authors did not assess reinterventions or secondary interventions in the current study, a previous paper reported a greater but not significantly increased need for reinterventions in the rEVAR group.…”

Endograft platform does not influence aortic neck dilatation after infrarenal endovascular aneurysm repair with primary endostapling

“…20 Excess oversizing is implicated in eventual neck failure and type I endoleakage and is to be avoided; 2 the higher oversizing noted with SS devices in the current study was largely due to the need to size for nonparallel necks. Both SS 21 and NT 4,22 platforms have been associated with AND, but no study has undertaken a comparative study in this context particularly when adjunct EAs are used.…”