In vitro implantation of a new transcatheter prosthesis in mitral valve position

Abstract

Aim. The study was designed to focus on the evaluation of in vitro implantation of a new transcatheter mitral bioprosthesis. Methods. A prototype of the first domestic self-expanding transcatheter bioprosthesis “Solertis” was tested by implanting it in the position of a native mitral valve of isolated pig heart by using transatrial access. Results. A correct orientation of the atrial and ventricular elements of the bioprosthesis and reliable circular coverage/adaptation of the annular part of the stent, which provide stable fixation of the prosthesis in a mitral position without left ventricular outflow tract obstruction, were determined. The function of the prosthesis during saline load test was adequate and without paraprosthetic regurgitation. Conclusion. The prototype of “Solertis” self-expanding transcatheter bioprosthesis demonstrated its efficiency for the native mitral valve replacement in vitro. The study results allow for proceeding to the next stage of preclinical testing—in vivo investigation.Received 5 December 2017. Accepted 20 December 2017. Published online 28 December 2017.Funding: The study was carried out with the support of a grant of the Russian Science Foundation (16-15-10315).Conflict of interest: The authors declare no conflict of interest.Author contributionsConception and study design: I.Yu. ZhuravlevaData collection and analysis: D.P. DemidovDrafting the article: R.M. SharifulinArticle editing: A.V. Bogachev-Prokophiev, A.M. KaraskovFinal approval of the version to be published: A.V. Bogachev-Prokophiev, I.Yu. Zhuravleva, R.M. Sharifulin, D.P. Demidov, A.M. Karaskov