Mid-Term Outcomes of the Iliac Branch Endoprosthesis with Standardized Combinations of Bridging Stent-Grafts for Endovascular Treatment of Aortoiliac Disease with or Without Co-existing Hypogastric Aneurysms (The HYPROTECT Study).

PURPOSE

To evaluate retrospectively the 2-year outcomes of the Gore Excluder Iliac Branch Endoprosthesis (IBE) in patients with and without coexisting hypogastric artery (HA) aneurysms in a large contemporary multicentric European experience using dedicated bridging devices.

METHODS

The study included all consecutive patients treated at participating institutions with the Gore Excluder IBE device who received a covered stent (i.e., stent-graft) from the same manufacturer. Technical success was defined as deployment of endografts with complete exclusion of the aneurysm(s), patency of target vessels, and absence of type 1 and 3 endoleak. Assessment of follow-up outcomes included freedom from HA branch instability defined as the composite cumulative endpoint of any HA branch-related complication.

RESULTS

A total of 437 patients were included for analysis from 22 European vascular surgery centers. Patients were categorized into two subgroups: subgroup A (n = 269) if they did not have concomitant hypogastric aneurysms, otherwise they were categorized into subgroup B (n = 168). Finally, 78 (18%) had bilateral IBE with a total of 515 IBE included in the study. Balloon expandable stents were deployed in 19 (6.3%) subgroup A patients compared with 46 (21.7%,) in subgroup B, p < .001. The two-year estimate for freedom of HA branch instability was significantly higher for patients in group A as compared with patients in group B (94% vs. 90%, p = .045). At univariate regression, the number of stent-grafts used was associated with higher risk of iliac branch instability (p = .021), while in multivariate regression for the use of more than 2 bridging stent-grafts the risk of instability increased by 2.35 times.

CONCLUSIONS

This large contemporary European multicentric experience with the use of the Gore Excluder IBE in patients with or without associated HA aneurysms shows satisfactory mid-term outcomes when the device is used in conjunction with both self-expandable and balloon-expanding stent-grafts from the same manufacturer. Although primary patency of the iliac branch was as high as 90%, caution and strict follow-up must be exercised when multiple bridging stent-grafts are used over longer distances.