Technical features of a self-expandable prosthetic valve for the treatment of pulmonary valve disease

Background. Balloon-expandable prostheses authorized for transcatheter pulmonary valve replacement in the Russian Federation have a barrel-shaped frame, which requires pre-stenting of a native right ventricular outflow tract or a conduit. This increases procedure duration, complicates implantation technique, and increases operation costs. Aim. To develop a self-expandable pulmonary valve model for transcatheter replacement and prepare it for preclinical trials. Methods. The model of a self-expandable pulmonary valve bioprothesis for transcatheter replacement made of nitinol was developed. The leaflets and the lining of the frame were made of porcine pericardium and assembled manually. Radial force testing was performed; valve loading into the delivery system was also tested. Results. According to the results of the tests, the valve biomaterial and the suture sites were not damaged after compression. In 2022, initial preclinical tests are scheduled to determine viability of the implanted valves at 6 and 12 months after surgery, and the rate of calcification for this observation period is to be assessed as well. Conclusion. By optimizing the design of the support frame, we improved the transcatheter model of the biological valve with satisfactory results at the initial stage of preclinical trials.