ABSTRACT
SPECIAL ISSUES AND FUTURE DEVELOPMENTS There are multiple new concepts under scientific as well as clinical evaluation designed to provide new features overcoming some of the shortcomings of the first-generation techniques. Only two already clinically tested devices are mentioned in the following:
The SADRA Lotus valve, for example, is a self-expanding device providing the ability of correcting and repositioning the valve prosthesis before releasing and permanently seating the device. The user is able to verify functionality and anchoring properties as well as the position of the device in relationship to the coronary arteries, the native aortic valve, and the mitral apparatus before final implantation (48) (Fig. 42.19). As opposed to the “one-shot” release of the balloon-expandable techniques, this technology of repositioning aims to offer a more controlled way of device deployment. Once the device is in correct position, a locking mechanism stabilizes the system. In addition, to avoid a paravalvular leak, a sealing membrane is attached to the outside of the prosthesis filling out paravalvular gaps. The fist-in-man study using the SADRA Lotus valve is currently ongoing.
