Early clinical and hemodynamic results of transcatheter aortic valve implantation using the “MedLab-KT” prosthesis

Abstract

Background. The obvious expansion of mini-invasive technologies is looming large in surgical treatment of heart diseases. Hundreds of thousands of transcatheter aortic valve replacement procedures have been performed in the world today. The improvement in quality and the increase in life expectancy in cohorts of patients who until recently have been considered inoperable are now routinely achievable. A significant limitation of this method for Russian clinics is the absence of domestic transcatheter implantable prosthetic heart valves on the market. During the last five years, such devices have been developed at “MedEng” (Penza, Russia) scientific and production enterprise. We present the first Russian transcatheter aortic valve prosthesis, its leaflets made of polytetrafluoroethylene, components of the delivery system and implantation, as well as the hospital outcomes of clinical trials. Aim. To evaluate the clinical and hemodynamic results of transcatheter aortic valve implantation using a “MedLab-KT” prosthesis during hospital stay.Methods. A prospective study included 54 patients who underwent transcatheter repair of the aortic valve using a “MedLab-KT” prosthesis. To evaluate the frequency of complications, myocardial infarction, strokes, bleeding, deaths during hospital stay and gradient indices on the prosthesis, postoperative ultrasound examination data were obtained and analyzed. Results. The results are comparable with those achieved by using the foreign models known from literature. Conclusion. The clinical and hemodynamic results of using the “MedLab-KT” aortic valve prosthesis can be considered as satisfactory. Funding: The study had no sponsorship. Conflict of interest: The authors declare no conflict of interest. Authors’ contributionConception and study design: V.V. Bazylev, E.V. Rosseykin, A.B. VoevodinData collection and analysis: A.B. Voevodin, A.S. ZakharovaStatistical analysis: A.B. VoevodinDrafting the article: A.B. VoevodinCritical revision of the article: A.B. VoevodinFinal approval of the version to be published: V.V. Bazylev, A.B. Voevodin, A.S. Zakharova, E.V. Rosseykin ORCID IDV.V. Bazylev, https://orcid.org/0000-0001-6089-9722A.B. Voevodin, https://orcid.org/0000-0002-7078-1274A.S. Zakharova, https://orcid.org/0000-0001-7239-2945E.V. Rosseykin, https://orcid.org/0000-0003-0784-2246