Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry ( ClinicalTrials.gov; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27–86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease.

Objective The objective of this study is to report the medium-term results of GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE, W. L. Gore & Associates, Flagstaff, Ariz) for the treatment of aortoiliac aneurysms by using the GALIBER registry. Methods Patients with aortoiliac or isolated common iliac/hypogastric aneurysms treated with Iliac Branch Endoprosthesis device between January 2014 and May 2019 were prospectively collected from 5 centers. Demographic, clinical, and radiologic data were extracted from electronic databases. Technical success was defined as successful implantation of the Iliac Branch Endoprosthesis device with exclusion of aortoiliac aneurysm, as well as patency of Iliac Branch Endoprosthesis in the follow-up. Iliac Branch Endoprosthesis patency was evaluated by Doppler ultrasound and/or computed tomography based on the protocol of each participant center. Follow-up was 731 days +/− 499. Results Between January 2014 and May 2019, 105 iliac arteries were treated with GORE® IBE device, in 81 patients (79 men, two women; mean age 71, range 52–91). Only seven patients (8.6%) were symptomatic. 60 patients (74%) had aortic and iliac enlargement. Thirty-three patients presented bilateral iliac aneurysms (40.7%): In twenty-four (29.6%) patients, an Iliac Branch Endoprosthesis device was implanted in both sides, and in nine patients (11.1%), one Iliac Branch Endoprosthesis was used with the embolization of the contralateral hypogastric artery. Technical success was achieved in the 99% (104/105 iliac branch device implanted). There were no procedural deaths or type I or III intraoperative endoleaks observed. During the follow-up (range 55–1789 days), 28 (34.5%) type II endoleaks were observed and one (1.2%) type Ia was observed. The patency of the hypogastric arteries treated with the iliac branch device was 98.1% during the follow-up (range 55–1789 days). In 30% of the patients with contralateral hypogastric embolization, some kind of complications was observed in the embolizated side: one developed ischemic colitis and two buttock claudication. Conclusions Preservation of internal iliac artery with the Iliac Branch Endoprosthesis device can be performed safely with excellent technical success and good medium-term patency rates. These results support hypogastric preservation whenever possible to prevent ischemic complications.

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