Key result
MedLab-KT TAVR shows ~14% mortality and no significant regurgitation in high-risk patients.
Why the study?
Until recently, there were no transcatheter prostheses produced within Russia, prompting the evaluation of the first domestic transcatheter aortic valve prosthesis MedLab-KT.
Observational (n=7)
Initial clinical experience with the Russian-made MedLab-KT transcatheter aortic valve prosthesis in 7 high-risk patients demonstrated procedural feasibility with no significant paraprosthetic regurgitation, though 1 death and 1 myocardial infarction occurred.
Initial MedLab-KT TAVR use feasible in high-risk patients; leaves open safety, durability, and need for larger trials.
Aim. Transcatheter aortic valve replacement in patients with high and extremely high risk has become a routine procedure in many cardiac surgery clinics. Until recently, there were no transcatheter prostheses produced within Russia. This article analyzes the results of applying the first domestic transcatheter aortic valve prosthesis MedLabKT. Material and methods. In the period from June 2018 to October 2018, 7 operations of transcatheter aortic valve replacement were made using the MedLabKT prosthesis. In all cases, implantation was performed by transapical access. Results. We noted one death. In all cases, paraprosthetic regurgitation was not registrated or was not significant. There are no cases of dislocation of the prosthesis. There were no complications associated with access. In one case, implantation was complicated by myocardial infarction. Conclusion. The first experience of implantation demonstrated the efficacy and safety of using the MedLabLT prosthesis for transcatheter aortic valve replacement. The analysis of longterm results is required.
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Bogachev-Prokofiev et al. (2018) conducted an observational in Aortic valve disease requiring replacement (n=7). MedLab-KT transcatheter aortic valve prosthesis was evaluated on Safety and efficacy (including death, paraprosthetic regurgitation, dislocation, and complications). Transcatheter aortic valve replacement using the MedLab-KT prosthesis in 7 high-risk patients resulted in 1 death (14.3%) and 1 myocardial infarction (14.3%), with no significant regurgitation.
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