Improved effectiveness of the repositionable GORE EXCLUDER AAA endoprosthesis featuring the C3 delivery system compared with the original GORE EXCLUDER AAA endoprosthesis for within the instructions for use treatment of aortoiliac aneurysms

Objective

To compare two endograft types, the original GORE EXCLUDER AAA endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) with the repositionable GORE EXCLUDER featuring the C3 delivery system, which allows repositioning of the proximal part of the graft to achieve accurate placement in relation to the renal arteries, in unselected patients with aortoiliac aneurysms. In a second nested, substudy we investigated the relative effect of the standard Gore and Gore Dryseal introducer sheaths on intraoperative transfusion needs.

Methods

We retrospectively analyzed prospectively collected information. The primary composite outcome measure was the intraoperative misdeployment or migration of the endograft's main body, proximally or distally to the renals (leading to technical failure or requiring either placement of aortic cuff extenders or conversion to open repair). Secondary outcome measures included the composite long-term event of rupture and/or type I/III endoleak.

Results

A total of 313 consecutive patients (303 males; median age, 73 years) had either an original GORE EXCLUDER device (n = 174) or the new device (n = 139) placed between 2004 and 2011 and 2011 and 2017, respectively, to treat an infrarenal aortoiliac aneurysm or an isolated common iliac artery aneurysm. The primary composite outcome measure occurred more often in patients who had the original GORE EXCLUDER device placed (10.9% vs 3.6% for the new device; odds ratio, 0.30; 95% confidence interval, 0.11-0.84; P = .016), confirmed by multivariate logistic regression analysis. This difference between the two groups was exclusively driven by distal misdeployment or migration of the endograft (10.3% vs 2.9% for the new device; P = .01), mostly requiring aortic extender placement. Intraoperative blood transfusion rates were lower in patients who had the GORE Dryseal introducer sheath used (1.1% vs 18.9% for the original GORE introducer sheath; OR, 0.05; 95% confidence interval, 0.006-0.35; P < .001). At a mean follow-up of 1.7 years (maximum, 13 years), 11 patients developed the composite event. On univariate Cox analysis, significant predictors included female gender (P = .003), absence of dyslipidemia (P = .023), the primary outcome measure (P = .006), and failure to cannulate (P = .009), but not device type or other variables. On multivariate Cox regression, female gender (hazard ratio, 37; P < .001), chronic obstructive pulmonary disease (hazard ratio, 3.99; P = .045), the primary outcome measure of the study (hazard ratio, 8.9; P = .002), and failure to cannulate (hazard ratio, 43; P = .003) were all independent predictors.

Conclusions

Our study has demonstrated that the repositionable GORE EXCLUDER has important safety characteristics compared with the original device and equivalent long-term effectiveness. Additional benefit was obtained with the use of the Gore Dryseal introducer sheath.