Dissected Aorta Repair Through Stent Implantation trial: Canadian results

Abstract

Objectives: We describe the Canadian results of the Ascyrus Medical Dissection Stent (AMDS), a novel partially uncovered aortic arch hybrid graft implanted antegrade during hypothermic circulatory arrest to promote true lumen expansion and enhance aortic remodeling.

Methods: From March 2017 to February 2018, 16 consecutive patients (66 ± 12 years; 38% female) presented with acute type A aortic dissections and underwent emergent surgical aortic repair with AMDS implantation. All patients presented with DeBakey I aortic dissection, with evidence of malperfusion in 50% (n = 8) of patients. All cases were performed under hypothermic circulatory arrest with an additional average duration for AMDS implantation time of 2.1 minutes.

Results: All 16 device implantations were successful. Overall 30-day mortality was 6.3% (n = 1) and stroke occurred in 6.3% (n = 1) of cases. There was no incidence of device-related aortic injury or aortic arch branch vessel occlusion. During the follow-up period, 12 patients had completed at least 1 postoperative computed tomography scan. At initial follow-up computed tomography scan, complete or partial thrombosis, and remodeling of the aortic arch occurred in 91.7% of cases (n = 11/12) and in the proximal descending thoracic aorta, complete or partial thrombosis, and remodeling occurred in 91.7% (n = 11/12).

Conclusions: Preliminary results suggest that the AMDS is a safe, feasible and reproducible adjunct to current surgical approaches for acute DeBakey I aortic dissection repair. Further, the AMDS manages malperfusion and promotes early positive remodeling in the aortic arch and distal dissected segments, with favorable FL closure rates at follow-up. Ongoing follow-up will provide additional insight into the long-term effects of the AMDS.

Keywords: aortic dissection; endovascular.