Why the study?
Do newer generation fully repositionable, re-sheathable, and retrievable TAVI prostheses improve clinical outcomes compared to currently available technology in high surgical risk and inoperable patients with severe symptomatic AS?
Do newer generation fully repositionable, re-sheathable, and retrievable TAVI prostheses improve clinical outcomes compared to currently available technology in high surgical risk and inoperable patients with severe symptomatic AS?
Newer generation TAVI devices with repositionable, re-sheathable, and retrievable features are expected to overcome the limitations of current devices and reduce adverse procedural outcomes.
Supports hypothesis of benefit from repositionable TAVI designs; leaves open randomized confirmation before practice change in high-risk severe AS.
Transcatheter aortic valve implantation (TAVI) is a great alternative treatment option in high surgical risk and inoperable patients with severe symptomatic aortic stenosis (AS). TAVI is a rapidly emerging technique with a constantly expanding body of evidence. However, the devices, which are commercially available and are currently used widely, have several major limitations. In particular, the inability to reposition/ retrieve/ resheath valves, in addition to several patient selection and procedural limitations, such as the occurrence of moderate to severe paravalvular regurgitation (PVR), the risk of annular rupture, atrioventricular (AV) conduction abnormalities with subsequent pacemaker requirement, vascular complications and associated bleeding, coronary ostial obstruction by the valve, stroke, as well as complex delivery processes, are expected to be overcome with the newer generation valves. Consequently, a number of new transcatheter valve choices have been developed either for clinical study or are in the pipeline, that it is hoped to bring meaningful clinical outcomes compared with the currently commercially available technology. Early data on design modifications have shown significant reductions in adverse outcomes from TAVI.
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Kariori et al. (2014) studied this question.