Total Aortic Arch Endograft – FIM Study

Background: Conventional surgical or hybrid repair of aortic arch aneurysms carries substantial risk of mortality and morbidity. Currently, there are no endovascular dedicated devices for off-the-shelf aortic arch repair. This is the first report of the Nexus aortic arch endograft FIM study.

Methods: 13 patient (Europe and Canada) were enrolled in the FIM study of the Nexus™ (Endospan Ltd.) arch endograft (as of December 2015). Preprocedural planning and training were performed on a patient specific elastomeric model. The device was implanted over a brachio-iliac through & through wire technique, with modular extensions to ascending aorta. Pre-procedural results and up to 1 year follow up will be presented.

Results: Successful implantation of the modular graft was achieved in 100% of patients. Type I/III endoleaks were seen in one patient. There were 2 mortality cases, four cases of CVA (all recovered completely), and one patient had spinal cord ischemia with transient paraplegia. There was no graft migration or side branches occlusion

Conclusion: This novel designed arch endograft has the potential to provide the next evolutionary step towards an off-the-shelf, pure endovascular solution as a first-line intervention for major aortic arch lesions. Long term follow-up is required.