Results from the Italian Nexus aRCH endovascular repair registry for endovascular aortic arch repair

Abstract

Objective: The aim of this study is to evaluate the safety, efficacy, and clinical outcomes of endovascular aortic arch repair using the Nexus and Nexus Duo endograft systems.

Methods: A multicenter, retrospective study with prospectively collected data was conducted as part of the Italian Nexus Aortic aRCH Endovascular Repair Registry (INARCHER) between 2019 and 2024. Nexus platforms include an off-the-shelf bimodular single branch endograft and a custom-made double-branch device. Patients who underwent endovascular aortic arch repair with the Nexus and Nexus Duo endograft systems at participating centers were included. The study addressed both aortic arch aneurysm and dissection. Data collection included baseline patient characteristics, procedural details, and follow-up results. The primary endpoints were early (30 days) major adverse events, major stroke, and mortality. Secondary endpoints included the need for device-related reintervention and the device-related endoleak.

Results: We collected 31 cases from 11 centers. The mean age was 73.4 ± 7.32 years, and 77.4% were male. Thirteen patients had a degenerative aneurysm, three had a pseudoaneurysm after prior surgical repair, two had penetrating aortic ulcers, and 13 had an aortic dissection (subacute, n = 1; chronic, n = 12). Prior ascending aorta replacement was present in 15 cases (48.4%). Seven patients (22.6%) received urgent treatment. Twenty-five cases were treated with complete supra-aortic trunks debranching and Nexus, six cases with left subclavian artery-left common carotid artery debranching and Nexus Duo. The mean operative time was 230 ± 73 minutes. Technical success was achieved in 97% of procedures owing to one case of type IA endoleak. Perioperative mortality was 6.5%, related to a massive pulmonary embolism and a cardiac arrest. Major strokes occurred in 6.5%. The major adverse event rate was 22.6%. The mean follow-up period was 29.7 ± 24.9 months. Beyond 30 days, there was no aortic-related mortality, and freedom from related reintervention was 97% (95% confidence interval, 91%-100%).

Conclusions: The use of the Nexus and Nexus Duo endograft systems appears to be a safe option for the treatment of aortic arch dissection and aneurysm, with complication rates consistent with existing literature for such high-complexity cases. Endovascular aortic arch repair remains a challenging procedure with non-negligible neurologic complication, requiring ongoing improvements to enhance patient outcomes.

Keywords: Aneurysm; Aortic arch; Endovascular; Off-the-shelf.