Midterm Outcomes of the Dissected Aorta Repair Through Stent Implantation Trial

Background: The intimal flap at the distal aortic anastomosis after standard aortic dissection repair creates distal anastomotic new entry, leading to false lumen (FL) pressurization and true lumen (TL) collapse and resulting in increased mortality, malperfusion, aortic growth, and reinterventions. The Ascyrus Medical Dissection Stent (AMDS; Ascyrus Medical, Boca Raton, FL) is a hybrid prosthesis that seals and depressurizes the FL at the distal anastomosis while expanding and pressurizing the TL. Methods: The Dissected Aorta Repair Through Stent Implantation trial is a prospective, nonrandomized, international type A dissection trial where patients with acute DeBakey I dissections were enrolled between March 2017 and January 2019. Forty-seven patients were enrolled (median age, 62.5; 67.4% men) with a median follow-up of 631 days. Results: All patients underwent emergent surgical repair with successful AMDS implantation. One patient was excluded because of use in iatrogenic dissection. Overall mortality at 30 days and 1 year was 13.0% (6/46) and 19.6% (9/46), whereas new strokes occurred in 6.5% (3/46). Over 95% of vessel malperfusions resolved because of AMDS-induced TL expansion, including 3 patients with preoperative paralysis. Positive remodeling of the aortic arch occurred in 100% of cases with complete obliteration or thrombosis of the FL in 74%. In the proximal descending thoracic aorta positive remodeling occurred in 77% and complete obliteration or FL thrombosis in 53% of cases. Conclusions: AMDS facilitates single-stage management of malperfusion and induces positive remodeling of the aortic arch through effective sealing of the distal anastomotic FL, depressurization of the FL with expansion, and pressurization of the TL. Importantly the use of AMDS is safe and reproducible.