Why the study?
Despite CE mark approval for transfemoral implantation in aortic regurgitation and aortic stenosis, limited and no published post-approval data were available for the JenaValve system.
The JenaValve system offers a unique anchorage mechanism suitable for both aortic stenosis and regurgitation, with promising early safety data but requiring further long-term studies.
Transcatheter aortic valve replacement is a valuable alternative technique to surgery and the spectrum of therapy continues to evolve. The JenaValve Pericaridal transcatheter aortic valve replacement System allows prosthesis fixation in a native, noncalcified aortic annulus with a unique paper clip-like anchorage mechanism. The low rate of paravalvular leakage and permanent pacemaker implantation emphasizes the further widespread use of the JenaValve – despite the limited data available. In May 2021, a CE mark for the transfemoral implantation in both aortic regurgitation and aortic stenosis was granted. However, no data have been published so far. The ongoing ALIGN trials are expected to provide the pending long-term data. Lay abstract There is a wide variety of valve systems to treat aortic valve disease. This review summarizes the previously published data of the JenaValve system. Thanks to unique characteristics, this valve can be used either for aortic stenosis or regurgitation. Early data are promising with a low complication rate. Further studies are required to assess long-term results.
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Poschner et al. (2021) studied this question.
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