Hybrid Arch Stent Graft in the Treatment of Acute and Chronic Aortic Pathologies: Interim Results from an Asia-Pacific Multi-center study.

Abstract

NEOS-APAC is an observational, prospective, multicenter post-market study in Asia Pacific to demonstrate the safety and clinical performance of the E-vita OPEN NEO for frozen elephant treatment (FET) of aneurysms or dissections. This article reports the first interim results until 3-6 months. Overall, 114 patients were enrolled in ten Asia Pacific sites between August 2021 - February 2024. Of those, 112 (mean age 59±11 years, 81% male) underwent device placement. Of these, 98% reached discharge and 90% 3-6 months follow-up. The E-vita OPEN NEO was implanted per treating physician discretion and per the Instructions For Use. The 112 patients were distributed among three different indications (34%/7% acute/subacute aortic dissection, 26% chronic aortic dissection and 33% thoracic aortic aneurysm). The 30-day mortality (primary endpoint) was 1.8% and all-cause mortality was 3.6% until 180 days. None of the deaths were evaluated as device-related. At discharge technical success was achieved in 97.3% and treatment success reached 95.0% at 3-6 months. Secondary endpoints included 0% aortic-related death or rupture and 0% loss of device integrity at 3-6 months. Patients experienced 0.9% new disabling stroke, 0.9% new paraplegia and 1.8% new paraparesis until discharge, and 3.0%, 2.0% and 2.0% until 3-6 months, respectively. No patients had renal failure. The NEOS-APAC study yields promising early follow-up results with a low 30-day mortality rate and low main secondary safety outcome rates, which compare favorably to literature. The results demonstrate safe and effective treatment with the E-vita OPEN NEO in the Asia Pacific clinical setting.