Technical tips and clinical experience with the Nexus Endospan arch branch stent-graft.

Abstract

Aortic arch pathologies are commonly treated by open surgery which is still the gold standard. Patients that are unfit for surgery can be effectively treated mini-invasively with novel endovascular endograft specifically designed for the arch. Endovascular technology has remarkably improved in recent years and is a valid alternative option for the treatment of aortic arch. Available endografts on the market include fenestrated and branched (single, double, or triple). Most endograft designed for the aortic arch are custom-made and production time could be limiting. The aim of this study is to report our experience with the only single branch bi-modular off-the shelf device available on the market specifically designed for aortic arch aneurysms and dissections. We perform endovascular treatment of the arch in a multidisciplinary team together with dedicated anesthesiologist team, interventional cardiologists, and cardiac surgeons. Prior to the implantation of the endograft, a debranching procedure must be made to redirect the blood from brachiocephalic trunk (BCT) to the left common carotid artery and left subclavian artery. A through and through system from the right axillary artery to the femoral artery is required to deploy the main module. The ascending module is delivered over an extra stiff guidewire placed in the left ventricle. Molding of the endografts is performed with kissing balloon in rapid pacing. We performed 8 cases. Six of them came to our attention for residual dissection and has already been treated with ascending aorta replacement. Mean aortic diameter was 63 mm. All patients required complete debranching of the supra-aortic vessel and received a right common carotid -left subclavian artery bypass with reimplantation of the left common carotid artery on the graft. Timing of the debranching was a few days before the endovascular procedure in 76% of cases. Technical success of the endovascular intervention occurred in 100% of cases. In 2 cases the target supra-aortic trunk for the deployment of the main module BCT branch was the left subclavian artery with no adverse event related to this variation. No intraoperative adjunctive maneuvers have been registered, left subclavian artery have been embolized during the procedure in 5 cases. No access complications have been reported. We experienced 1 case of major stroke with permanent neurological impairments that lead to worsening of clinical condition and death at 6 months. No cardiological adverse event have been registered. Two cases of type 2 endoleak have been reported and required reintervention with embolization of the LSA. At 1 year follow-up no aorta-related adverse event has been reported. The use of this off-the-shelf device for the treatment of aortic arch pathologies requiring total debranching of the supra-aortic vessels seems to be safe and effective. Preliminary results are promising despite available data are insufficient and further data collection is mandatory.