Key result
MedLab-KT TAVR in high-risk patients shows no significant paraprosthetic regurgitation despite early adverse events.
Why the study?
Transcatheter aortic valve replacement has become routine in high-risk patients, but no transcatheter prostheses were previously produced within Russia.
Is the MedLab-KT prosthesis safe and effective for transcatheter aortic valve replacement?
Observational (n=7)
Is the MedLab-KT prosthesis safe and effective for transcatheter aortic valve replacement?
Initial experience with the Russian-made MedLab-KT transcatheter aortic valve prosthesis demonstrates feasibility, though with some early complications (1 death, 1 MI in 7 patients).
Early MedLab-KT experience supports procedural feasibility in high-risk patients; leaves open durability, safety, and comparative outcomes pending 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 (n=7). MedLab-KT transcatheter aortic valve prosthesis was evaluated on Safety and efficacy (death, paraprosthetic regurgitation, dislocation, access complications). Transcatheter aortic valve replacement using the MedLab-KT prosthesis in 7 high-risk patients resulted in 1 death, 1 myocardial infarction, and no significant paraprosthetic regurgitation.
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