EMBARGOED UNTIL 8:30 AM, May 16, 2022
Newswise — Boston, MA (May 16, 2022) - The dissected aorta repair through stent implantation trial (DARTS) evaluated clinical and radiographic outcomes of the Ascyrus Medical Dissection Stent (AMDS) in a prospective, non-randomized, international study of patients with acute DeBakey type I aortic dissection (ATAD I).
The AMDS is an adjunct to standard surgical repair. It is a hybrid prosthesis that seals and depressurizes the false lumen (FL) at the distal anastomosis, while expanding and pressurizing the true lumen (TL) to treat and prevent malperfusion and induce positive remodeling. The AMDS was used in combination with the standard surgical management of ATAD I to treat patients with and without pre-operative clinical and radiographic malperfusion.
Forty-seven patients were enrolled in the DARTS trial between March 2017 and January 2019. All of the patients had a primary entry tear in the ascending aorta, and 97.8% were treated with a hemiarch repair. All 47 underwent emergent surgical repair with successful AMDS transplantation.
The patients were evaluated at 30 days, one year, and three years. Overall mortality was 13.0% at 30-days, 19.6% at one year, and 21.7% at three years, with no strokes recorded after one year. No devices were explanted, and no device-related reinterventions occurred at any time during the three-year median follow-up. Independent analysis evaluated computed tomography angiography (CTA) of the AMDS up to four years post-procedure. The total aortic diameter in the aortic arch remained stable or decreased in size in 82.6% of patients. Supra-aortic vessel patency at the last follow-up was 100%.
Author Sabin Bozso, MD, of the University of Alberta Hospital concludes that “the AMDS is a safe, time-efficient, and reproducible addition to standard-of-care surgical therapy in ATAD I. The use of the AMDS in the treatment of ATAD I holds promise as a simple technology that enables repair of the aortic arch and proximal descending aorta, while promoting positive aortic remodeling. The rates of secondary procedures following treatment with AMDS compare favorably with published literature. Ongoing follow-up of the DARTS trial will provide long-term, prospective, clinical outcomes and radiographic data on positive remodeling of the aortic arch.”
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Presented by Sabin Bozso, MD, May 16, 2022, at the AATS 102nd Annual Meeting
ABOUT THE AMERICAN ASSOCIATION FOR THORACIC SURGERY (AATS)
The American Association for Thoracic Surgery (AATS) is an international organization that encourages, promotes, and stimulates the scientific investigation of cardiothoracic surgery. Founded in 1917 by a respected group of the earliest pioneers in the field, its original mission was to “foster the evolution of an interest in surgery of the Thorax.” Today, the AATS is the premiere association for cardiothoracic surgeons in the world and works to continually enhance the ability of cardiothoracic surgeons to provide the highest quality of patient care. Its more than 1,500 members have a proven record of distinction within the specialty and have made significant contributions to the care and treatment of cardiothoracic disease. Visit www.aats.org to learn more.
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