A novel hybrid prosthesis for open repair of acute DeBakey type I dissection with malperfusion: Early results from the PERSEVERE trial

Abstract

BACKGROUND: Outcomes after hemiarch repair for acute DeBakey type I aortic dissection (ADTI) remain unfavorable, with high rates of major adverse events and negative aortic remodeling. The PERSEVERE study evaluates the safety and effectiveness of the AMDS Hybrid prosthesis, a novel bare metal stent, in patients presenting with preoperative malperfusion. METHODS: PERSEVERE is a prospective single-arm investigational study conducted at 26 sites in the United States. Ninety-three patients underwent ADTI aortic dissection repair with AMDS implantation. The 30-day primary endpoints are a composite rate of 4 major adverse events and the rate of distal anastomotic new entry tears. The secondary endpoints include aortic remodeling. RESULTS: Clinical malperfusion was documented in 76 patients (82%); only radiographic malperfusion, in 17 (18%). The median follow-up in the 93 patients was 5.6 months. Within 30 days, 9 patients died (9.7%), 10 patients (10.8%) experienced new disabling stroke, and 18 patients (19.4%) had new-onset renal failure requiring ≥1 dialysis treatment. There were no cases of myocardial infarction. The composite rate of major adverse events (27%) was lower than that reported in the reference cohort (58%). There were no distal anastomotic new entry tears. Technical success was achieved in 99% of patients. Early remodeling indicated total aortic diameter stability, true lumen expansion, and false lumen reduction in the treated aortic segment. CONCLUSIONS: Early results show significant reductions in major adverse events and distal anastomotic new entry tears, successfully meeting both primary endpoints. The technical success rate was high. AMDS can be used safely in patients with ADTI dissection with malperfusion.