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

BACKGROUND

High rates of major adverse events and negative aortic remodeling are common after hemiarch repair for acute DeBakey type I aortic dissection. The ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection (PERSEVERE; NCT05174767) study evaluated 1-year outcomes with the AMDS Hybrid Prosthesis i(Artivion, Inc) n patients with malperfusion.

METHODS

PERSEVERE is a prospective, single arm study. Primary end point events of mortality, new disabling stroke, new renal failure requiring dialysis, myocardial infarction, and rate of distal anastomotic new entry (DANE) tears were assessed through 1 year. Reoperation, aortic patency, and changes in aortic remodeling, including total aortic growth, true lumen expansion, and false lumen thrombosis, were also reported.

RESULTS

Of 93 enrolled patients, 63 (68%) completed 1-year follow-up, and 56 patients had a computed tomographic angiogram. Through 1 year, 19 (20%) patients died, 11 (12%) had new disabling strokes, 19 (20%) required dialysis, and 2 (2%) had a myocardial infarction; most events Occurred within 30 days. DANE was not documented in any postoperative computed tomographic angiograms. Freedom from unanticipated aortic reoperations and occlusion in the arch was 96% (89 of 93) and 100% (91 of 91), respectively. Freedom from total aortic growth at 1 year was 100% in zone 1, 98.2% in zone 2, and 73.2% in zone 3. In zones 1 to 3, true lumen expansion occurred in 96%, 94%, and 70% of patients, respectively. In zones 1 to 3, false lumen thrombosis occurred in 91%, 92%, and 88% of patients, respectively.

CONCLUSIONS

The 1-year outcomes with the AMDS Hybrid Prosthesis are encouraging, with lower than observed mortality, limited primary events after 30 days, and the absence of DANE. There is evidence of positive aortic remodeling. Follow-up is ongoing.