DEVELOPMENT OF TAILOR-MADE SEMILUNAR TRANSCATHETER HEART VALVES

Objectives: Transcatheter heart valve implantation is a young and innovative technology offering a novel form of treatment to patients previously classified as "no-option patients", due to comorbidities preventing open heart surgery associated with surgical valve replacement. Initial clinical results of transcatheter aortic and pulmonary valve replacement demonstrate promising results but also reveal the need for improvement Factors which require technological development are repositionability and anchoring of prostheses to prevent device migration. Since suturing the valve into place is not possible in a transcatheter implantation, anchoring must be achieved through optimal anatomical fit. Methods: The diversity of pathological morphologies of the left and right ventricular outflow tract in patients indicated for transcatheter heart valve surgery leads to poor anatomical fit paravalvular leakage or prosthesis migration. This study presents a new strategy for designing and manufacturing transcatheter heart valves in a system referred to as the "custom assembly kit". In this system, the prosthesis is composed of up to three components, one base valve element, having three leaflets, as well as proximal and distal anchoring elements. These three components can be assembled according to the anatomicy of a specific patient anatomy and provide optimized anchoring to prevent valve migration. Results: CAD designs and early prototypes of the concept demonstrate its feasibility. Excellent anatomical fit of the device is achieved by offering different diameters and geometries for the anchoring elements to connect to the base valve element. The assembled device offers the best possible prosthesis for a given pathological valve and outflow tract morphology. The design and development of this device are performed in close collaboration between biomedical engineers and cardiologists to ensure optimal mechanical durability, longevity and anatomical fit. Conclusions: This system represents the next step in transcatheter heart valve technology and will be further developed to form a marketable device.