Background: Conventional surgical or hybrid repair of aortic arch aneurysms carries substantial risk of mortality and morbidity. Early experience with custom made branched arch endografts showed promising results, although availability and production time limit their widespread use. Consequently, many patients remain untreated. Currently, there are no off-the-shelf branched aortic arch endografts. This preclinical study is the first report of an off-the-shelf modular aortic arch endograft, with a novel Z shape design addresses the unique procedural and long term challenges with complete endovascular therapy for aortic arch pathologies.
Methods: Sixteen pigs (7 acute, 9 chronic) underwent endovascular implantation of the Nexus™ (Endospan Ltd.) arch endograft over a brachio-iliac through & through wire technique, with modular extensions to ascending aorta and LCC. Aggregate follow-up period was 481 days.
Results: Successful implantation of the modular graft was achieved in 100% of animals. Mean procedural time was 90±30 Min. Mean pressure gradient between ascending aorta and cranial vessels was 0±2 mmHg. All chronic animals recovered well. Long term follow up demonstrated no graft migration or side branch occlusion/stenosis.
Conclusion: the 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. The integrated brachial intra-procedural latching and Brachiocephalic artery placement of a proximal (cranial) end of the main prosthesis provides the cornerstone for increased intra-procedural and long term endograft fixation.
