Dissected Aorta Repair Through Stent Implantation trial: Canadian results

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.