A Novel Hybrid Prosthesis for Open Repair of Acute DeBakey Type I Dissection with Malperfusion: Early Results from the PERSEVERE Trial.

Outcomes after hemiarch repair for acute DeBakey Type I aortic dissection remain unfavorable, with high rates of major adverse events and negative aortic remodeling. The PERSEVERE study evaluates safety and effectiveness of the AMDS Hybrid prosthesis, a novel bare metal stent, in patients presenting with pre-operative malperfusion. PERSEVERE is a prospective, single arm, investigational study conducted at 26 sites in the United States. Ninety-three patients underwent acute DeBakey Type I aortic dissection repair with AMDS implantation. The 30-day primary endpoints are composite rate of 4 major adverse events and rate of distal anastomotic new entry tears. The secondary endpoints include aortic remodeling. Clinical malperfusion was documented in 76 patients (82%), with the remaining having only radiographic malperfusion. Median follow-in 93 patients was 5.6 months. Within 30-days, there were 9 deaths (9.7%), 11 patients (11.8%) with new disabling stroke, 18 patients (19.4%) with new onset renal failure requiring ≥ 1 dialysis treatment, and no myocardial infarction. The composite rate of major adverse events (28%) was less than 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. Early results show significant reduction 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 acute DeBakey type I dissection with malperfusion.

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.