Dissected Aorta Repair Through Stent Implantation trial: Canadian results

J Thorac Cardiovasc Surg. 2019 May;157(5):1763-1771. doi: 10.1016/j.jtcvs.2018.09.120. Epub 2018 Oct 26.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Video-Audio Media

MeSH terms

  • Acute Disease
  • Aged
  • Aortic Aneurysm, Thoracic / diagnostic imaging
  • Aortic Aneurysm, Thoracic / physiopathology
  • Aortic Aneurysm, Thoracic / surgery*
  • Aortic Dissection / diagnostic imaging
  • Aortic Dissection / physiopathology
  • Aortic Dissection / surgery*
  • Blood Vessel Prosthesis Implantation / adverse effects
  • Blood Vessel Prosthesis Implantation / instrumentation*
  • Blood Vessel Prosthesis*
  • Canada
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Postoperative Complications / etiology
  • Prospective Studies
  • Prosthesis Design
  • Stents*
  • Time Factors
  • Treatment Outcome
  • Vascular Remodeling