Experimental Evaluation of a Large Fenestrated Physician-Modified Endo-Wheat Using a Cadaveric Model

Acute type A dissection are treated with open surgery. When patients are not eligible, few therapeutic solutions remain. Endovascular approaches are currently under development. The objective of this experimental study was to evaluate the feasibility and reproducibility of a physician-modified fenestrated endo-wheat device for endovascular aortic root repair, and to refine both the device and the deployment technique.

The endo-wheat module consists of a thoracic stent graft and a nitinol valve. A standard configuration was developed based on computed tomography angiography analysis from patients with acute type A aortic dissection. The stent graft was modified to cover only one valve cusp and then sutured to the valve. Visibility was enhanced using one linear and 2 lateral radiopaque markers on the covered cusp. The cadaveric models included the heart, ascending aorta, aortic arch, and a portion of the descending thoracic aorta. All procedures were performed on a pulsatile benchtop flow model. Following each procedure, the ascending aorta was opened to assess the positioning and patency of the coronary ostia.

Twelve procedures were completed. Successful deployment of the endo-wheat module into the aortic valve and ascending aorta was achieved in all cases. Neither the coronary arteries nor the brachiocephalic trunk were covered. The average time required to modify the module was 19 min. The left axillary artery emerged as a suitable access route, providing excellent maneuverability and precision during deployment. Macroscopic inspection revealed no damage to the customized stent grafts.

The endo-wheat module and its associated deployment technique are feasible and reproducible for endovascular aortic root repair in a cadaveric model.