Three-year outcomes of the Dissected Aorta Repair Through Stent Implantation trial

Abstract

ObjectiveThe study objective was to evaluate the clinical and radiographic outcomes of the Ascyrus Medical Dissection Stent in a prospective, nonrandomized, international study (Dissected Aorta Repair Through Stent Implantation) of patients with acute DeBakey type I aortic dissection. MethodsThe Ascyrus Medical Dissection Stent was used in combination with the standard surgical management of acute DeBakey type I aortic dissection I to treat patients with (56.5%, 26/46) and without (43.5%, 20/46) preoperative clinical and radiographic malperfusion. All patients had a primary entry tear in the ascending aorta, and 97.8% (45/46) were treated with a hemiarch repair. Median follow-up was 3 years. ResultsAll 47 patients underwent emergency surgical repair with successful Ascyrus Medical Dissection Stent implantation. One patient was excluded from analysis due to use in iatrogenic dissection. Overall mortality at 30 days and 3 years was 13.0% (6/46) and 21.7% (10/46), respectively. Overall new stroke rate at 30 days was 15.2% (7/46). No devices were explanted at any time during the 3-year median follow-up. At 3 years, the total aortic diameter in zones 0, 1, and 2 decreased or remained stable in 91.7%, 72.7%, and 75.0%, respectively. The false lumen was completely or partially thrombosed in 90.5% in zone 0, 60.0% in zone 1, and 68.2% in zone 2 at 3 years. ConclusionsThe use of the Ascyrus Medical Dissection Stent in the treatment of acute DeBakey type I aortic dissection I holds promise as a simple technology that enables repair of the aortic arch and proximal descending aorta, while promoting positive aortic remodeling. Ongoing follow-up of the Dissected Aorta Repair Through Stent Implantation trial will provide long-term, prospective, clinical outcomes and radiographic data on positive remodeling of the aortic arch.