One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System

Abstract

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.

Keywords: aortic arch pathologies; chronic dissection; complications; conformability; endograft; endoleak; reintervention; stent-graft; thoracic aortic aneurysm; thoracic aortic aneurysms; thoracic endovascular aortic repair; type B aortic dissection.

Figure 1.

A 54-year-old man with multiple comorbidities had a type B aortic dissection diagnosed in 2013 (4 years prior). (A) The last computed tomography angiogram (CTA) showed aneurysm growth to 6 cm maximum diameter in the descending thoracic aorta. (B) After angiography, a TGM 45-45-20E CTAG device was placed just distal to the left subclavian artery. (C) After deployment, a bird-beak configuration (white arrow) was detected. (D) The angulation control mechanism was used for a more complete apposition to the inner aortic curvature. In total, 3 devices were implanted, leaving the celiac trunk patent. (E) In the control CTA scan 12 months later, the stent-graft was aligned with the aorta and the aneurysm sac had shrunk.