Immediate and midterm outcomes of transcatheter aortic valve replacement using MEDLAB CT polymeric heart valve

Aim: To assess the immediate and mid-term outcomes of transapical and transfemoral aortic valve replacement using polymeric heart valve MedLAB CT.

Methods: A total of 319 patients with aortic valve disease admitted to the Federal Center for Cardiovascular Surgery (Penza) for elective cardiac surgery were enrolled in a prospective single-center study. The mean age of the patients was 73.3±4 years. All recruited patients were evaluated as high and medium risk for cardiac surgery with the mean EuroSCORE II of 6.27%. All surgeries were performed in a hybrid operating room under combined endotracheal anesthesia. The size of the valves was selected by the surgeon based on EchoCG findings, CT images of the aortic root, and intraoperative aortography. The endpoints were death from any cause and clinically significant cerebral stroke. Hemodynamic parameters were assessed according to echocardiography: the mean AV gradient, the effective orifice area, the severity of postoperative regurgitation.

Results: A total of 450 transapical and 8 transfemoral aortic valve replacement using polymeric heart valve MedLAB CT were performed. 29 (6%) patients died in the in-hospital period. Five (1%) patients had stroke. There were no cases of myocardial infarction. Acute kidney injury was diagnosed in eight (2%) patients. Eleven (2.4%) patients required pacemaker implantation. There were no cases of clinically significant aortic regurgitation in the early postoperative period. Four patients required repeat open aortic valve surgery within the same hospitalization. The mean AV gradient following surgery was 5.55±2.24, the peak – 11.29±4.46 mmHg. The effective orifice area was 2.27±0.60 cm². 80 patients died within the 8-years follow-up period. The mortality rate was 18.3% and the survival rate was 71.3% within 84 months.

Conclusion: The safety and effectiveness of the MedLAB CT polymeric heart valve prosthesis with PTFE leaflets are not inferior, but even superior in terms of several parameters to biological TAVR. TAVR via transapical and transfemoral access using MedLAB CT is a safe and effective procedure with favorable immediate and mid-term outcomes.

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