Preclinical testing of a novel tandem endo-Wheat delivery system

BACKGROUND: Endovascular repair of pathology affecting the proximal aorta is an area of active innovation. Physician-modified composite valve-graft devices have successfully been implemented to repair the aortic root, but several technical challenges remain. While treatment of aortic root pathology requires complete seal at the level of the sinuses of Valsalva and bridging stents into the coronary arteries ("endo-Bentall"), aortic dissection originating above the sinotubular junction can be addressed in principle via a procedure analogous to surgical aortic valve replacement and separate graft replacement of the ascending aorta ("endo-Wheat"). Here, we report the technical description and preclinical assessment of a novel fenestrated endograft, and delivery system intended for tandem use with a balloon-expandable aortic valve prosthesis. METHODS: A novel endo-Wheat device and sheath system were fabricated following iterative design refinements. Laboratory-based testing was performed using a 3D-printed phantom of a thoracoabdominal aorta with an acute type A aortic dissection. RESULTS: This endo-Wheat system is designed to enable coronary artery perfusion through via aortic root fenestrations while establishing a seal at the sinotubular junction. We demonstrated techinical feasibility with tandem delivery of the fenestrated endograft and balloon-expandable TEVAR in rapid succession. We identify technical challenges with the implementation of this system and subsequent design modifications. CONCLUSIONS: We conclude that this device may provide a reliable, off-the-shelf solution for treatment of acute type A aortic dissection in poor operative candidates.