Key result
A newly developed self-expandable pulmonary valve bioprosthesis made of nitinol and porcine pericardium showed no damage to biomaterial or suture sites after compression testing.
Why the study?
Authorized balloon-expandable prostheses require pre-stenting of the right ventricular outflow tract or conduit, increasing procedure duration, complexity, and costs.
A novel self-expandable pulmonary valve bioprosthesis showed satisfactory mechanical integrity during initial bench testing, paving the way for in vivo preclinical trials.
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. Received 22 April 2022. Revised 5 May 2022. Accepted 11 May 2022. Funding: This work is supported by a grant of the Russian Science Foundation (project No. 21-75-10041). Conflict of interest: Authors declare no conflict of interest. Contribution of the authorsConception and study design: K.A. Rzaeva, T.P. Timchenko, A.N. Arkhipov, N.R. NichayData collection and analysis: A.V. Voitov, N.R. NichayDrafting the article: K.A. Rzaeva, A.V. GorbatykhCritical revision of the article: I.Yu. Zhuravleva, I.A. Soynov, A.V. Bogachev-ProkophievFinal approval of the version to be published: K.A. Rzaeva, T.P. Timchenko, I.Yu. Zhuravleva, A.N. Arkhipov, A.V. Gorbatykh, A.V. Voitov, N.R. Nichay, A.V. Bogachev-Prokophiev, I.A. Soynov
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Rzaeva et al. (2022) studied Pulmonary valve disease. Self-expandable pulmonary valve bioprosthesis was evaluated on Valve biomaterial and suture site integrity after compression. A newly developed self-expandable pulmonary valve bioprosthesis made of nitinol and porcine pericardium showed no damage to biomaterial or suture sites after compression testing.
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