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

Q4 Medicine

Patologiya krovoobrashcheniya i kardiokhirurgiya Pub Date : 2022-09-30 DOI:10.21688/1681-3472-2022-3-85-90

K. Rzaeva, T. Timchenko, I. Zhuravleva, A. Arkhipov, A. Gorbatykh, A. Voitov, N. Nichay, A. Bogachev-Prokophiev, I. Soynov

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Abstract

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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背景。俄罗斯联邦批准用于经导管肺瓣膜置换术的可膨胀气球假体具有桶形框架，需要预先植入天然右心室流出道或导管。这增加了手术时间，使植入技术复杂化，并增加了手术成本。的目标。目的:建立经导管置换术用自膨胀肺瓣膜模型，为临床前试验做准备。建立了镍钛诺生物假体经导管置换术用自膨胀肺瓣膜模型。小叶和框架的衬里是由猪心包和手工组装。进行径向力测试;并对输送系统的阀负载进行了测试。根据试验结果，瓣膜生物材料和缝合部位在压缩后未受到损伤。2022年，计划进行初步临床前试验，以确定术后6个月和12个月植入瓣膜的活力，并评估这一观察期的钙化率。通过优化支撑架的设计，我们改进了经导管生物瓣膜模型，在临床前试验初期取得了满意的效果。2022年4月22日收到。2022年5月5日修订。2022年5月11日接受。基金资助:本工作由俄罗斯科学基金资助(项目号21-75-10041)。利益冲突:作者声明无利益冲突。作者贡献。研究构思与设计:K.A. Rzaeva, T.P. Timchenko, A.N. Arkhipov, N.R. nichai资料收集与分析:A.V. Voitov, N.R. nichai论文撰写:K.A. Rzaeva, A.V. gorbatyh论文关键修改:i.u yu。朱拉夫列娃，a . a .索伊诺夫，A.V.博加切夫-普罗科菲耶夫最终批准出版的版本: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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