A Universal Delivery System for Percutaneous Heart Valve Implantation

Area of Science:

• Cardiovascular Medicine
• Biomedical Engineering
• Medical Devices

Background:

• Transcatheter heart valve implantation is an advancing alternative to surgical valve replacement.
• Current delivery systems are often specific to particular valves and stent types.
• A need exists for a universally applicable delivery system for diverse transcatheter valve implants.

Purpose of the Study:

• To develop a universally applicable delivery system (DS) for various transcatheter heart valves.
• To design a DS compatible with both balloon-expandable and self-expandable stents.
• To ensure the DS is feasible for use with multiple vascular access routes.

Main Methods:

• A novel DS was designed and manufactured in five different diameters.
• The DS incorporated a dual-material sheath (soft polymer outer, stainless steel spring inner) to balance flexibility and rigidity.
• Implantations of tissue-engineered and pericardial pulmonary valves, along with polymeric and balloon-expandable stents, were performed in experimental sheep models.

Main Results:

• An initial implantation success rate of 70.5% was achieved with the developed DS.
• Following refinement, the success rate improved significantly to 83.3%.
• The primary cause of failed implantations was identified as inadequate prosthesis sizing, not DS malfunction.

Conclusions:

• The developed universally applicable delivery system demonstrates significant potential for transcatheter heart valve implantation.
• The innovative sheath design effectively addresses the mechanical challenges of delivering diverse valve and stent configurations.
• Further improvements in prosthesis sizing are crucial for maximizing the success rates of transcatheter valve procedures.