One-Year Results of Novel Aortic Arch Hybrid Prosthesis for Repair of Acute DeBakey Type I Dissection With Malperfusion: PERSEVERE Study

The PERSEVERE study evaluated one-year outcomes of the AMDS Hybrid Prosthesis for acute DeBakey Type I aortic dissection with malperfusion. This prospective, single-arm trial enrolled 93 patients across 26 US sites between July 2022 and May 2023. Primary endpoints included major adverse events including mortality, stroke, renal failure requiring dialysis, myocardial infarction, and distal anastomotic new entry tears (DANE). Through one-year, mortality was 20.4 percent (compared to 42.7 percent in the reference cohort), with minimal events occurring beyond 30 days and no postoperative DANE tears. Secondary outcomes showed 96 percent freedom from unanticipated aortic reoperation and 100 percent arch patency. Positive aortic remodeling demonstrated total aortic diameter stabilization (100 percent in Zone 1, 98 percent in Zone 2, and 73 percent in Zone 3), true lumen expansion (96 percent, 94 percent, and 70 percent respectively), and false lumen thrombosis (91 percent, 92 percent, and 88 percent respectively). The authors conclude that the AMDS device provides encouraging outcomes with reduced mortality and favorable aortic remodeling in this high-risk population.