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

Area of Science:

• Cardiovascular Surgery
• Medical Device Engineering
• Endovascular Interventions

Background:

• Aortic root pathologies require innovative repair strategies.
• Endovascular approaches offer minimally invasive alternatives to open surgery.
• The fenestrated endo-wheat device presents a novel option for aortic root repair.

Purpose of the Study:

• To assess the feasibility and reproducibility of a physician-modified fenestrated endo-wheat device for endovascular aortic root repair.
• To refine the device and its deployment technique.
• To evaluate the safety and efficacy of the endo-wheat module in a cadaveric model.

Main Methods:

• A fenestrated endo-wheat module comprising a thoracic stent graft and nitinol valve was developed.
• The stent graft was modified to cover a single valve cusp and sutured to the valve.
• Procedures were performed on cadaveric models using a pulsatile flow system, with assessment of coronary ostia patency.

Main Results:

• Successful deployment of the endo-wheat module was achieved in all 12 procedures.
• No coverage of coronary arteries or brachiocephalic trunk was observed.
• The left axillary artery provided excellent access, and module modification averaged 19 minutes.

Conclusions:

• The physician-modified fenestrated endo-wheat device and deployment technique are feasible and reproducible.
• This approach demonstrates potential for endovascular aortic root repair.
• Further investigation may lead to advancements in aortic valve interventions.