Mid-term results of open transaortic implantation of the «MedLab-CT» prosthesis: prospective clinical study

Aim. To evaluate the mid-term clinical and hemodynamic results of open transaortic implantation of the balloon-expandable prosthesis «MedLab-CT» in patients with high surgical risk.

Material and methods. The study included 41 patients (mean age 65.7±11.7 years) who underwent open implantation of the «MedLab-CT» (MedInzh, Russia) aortic valve (AV) prosthesis under cardiopulmonary bypass and cardioplegia, belonging to the cohort of high surgical risk according to the data EuroSCORE II scale, with critical symptomatic aortic stenosis, high functional class according to the classification of the New York Heart Association (NYHA). All studied patients had clinical indications for transcatheter AV replacement, however, given the concomitant surgical pathology of the heart (critical multivessel coronary artery disease unsuitable for endovascular treatment and/or damage to other valves), as well as the morphological features of the aortic root («low» location coronary artery ostia relative to the annulus fibrosus of the AV, large calcifications of the coronary cusps according to computed tomography, with a high risk of ostium occlusion), they were denied a minimally invasive procedure. The incidence of adverse clinical events and hemodynamic parameters of the AV prosthesis in the medium-term period were assessed.

Results. The average follow-up period was 13.1 months, the maximum was 3 years. Mortality – 2.4% (n=1), there were no cases of stroke. The average gradient in the long-term period on AK «MedLab-CT» is 8.5±3.1 mm Hg. Paravalvular regurgitation above grade 2 and transvalvular regurgitation were not detected. Thus, no cases of dysfunction of the aortic prosthesis were noted.

Conclusion. In the medium term, satisfactory clinical and hemodynamic results of open implantation of the «MedLab-CT» balloon-expandable prosthesis were obtained in high surgical risk patients.