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经心室肺动脉瓣植入术的临床前试验:心包与主动脉猪瓣置于自扩张支架上的比较。

A preclinical trial of perventricular pulmonary valve implantation: Pericardial versus aortic porcine valves mounted on self-expandable stent.

机构信息

Department of Thoracic and Cardiovascular Surgery, Yonsei University Severance Hospital, Seoul, Korea.

Department of Radiology, Seoul National University Hospital, Seoul, Korea.

出版信息

Artif Organs. 2021 May;45(5):E89-E100. doi: 10.1111/aor.13845. Epub 2020 Dec 6.

DOI:10.1111/aor.13845
PMID:33090503
Abstract

Perventricular pulmonary valve implantation (PPVI) of a xenograft valve can be a less invasive technique that avoids cardiopulmonary bypass in patients who require pulmonary valve replacement. We compared the hemodynamics, durability, and histologic changes between two different xenogenic valves (pericardial vs. aortic valve porcine xenografts) implanted into the pulmonary valve position using a PPVI technique and evaluated the safety and efficacy of PPVI as a preclinical study. In 18 sheep, pericardial (group porcine pericardial [PP], n = 9) or aortic valve (group porcine aortic valve [PAV], n = 9) xenogenic porcine valves manufactured as a stented valve were implanted using a PPVI technique. The porcine tissues were decellularized, alpha-galactosidase treated, fixed with glutaraldehyde after space-filler treatment, and detoxified to improve durability. Hemodynamic and immunohistochemical studies were performed after the implantation; radiologic and histologic studies were performed after a terminal procedure. All stented valves were positioned properly after the implantation, and echocardiography and cardiac catheterization demonstrated good hemodynamic state and function of the valves. All the anti-α-Gal IgM and IgG titers were below 0.3 optical density. Computed tomography of extracted valves demonstrated no significant differences in the degree of calcification between the two groups (P = .927). Microscopic findings revealed a minimal amount of calcification and no significant infiltration of macrophage or T-cell in both groups, regardless of the implantation duration. The PPVI is a feasible technique. Both stented valves made of PP and PAV showed no significant differences in hemodynamic profile, midterm durability, and degree of degenerative dystrophic calcification.

摘要

经皮室间隔肺动脉瓣植入术(PPVI)是一种微创技术,可避免需要肺动脉瓣置换的患者进行体外循环。我们比较了两种不同的异种生物瓣(心包瓣与主动脉瓣猪异种移植物)经 PPVI 技术植入肺动脉瓣位置后的血流动力学、耐久性和组织学变化,并评估了 PPVI 的安全性和有效性,作为一项临床前研究。在 18 只绵羊中,使用 PPVI 技术植入心包(猪心包组 [PP],n = 9)或主动脉瓣(猪主动脉瓣组 [PAV],n = 9)异种猪生物瓣。制造的支架瓣膜。将猪组织去细胞化,用 α-半乳糖苷酶处理,用戊二醛固定后进行空间填充处理,并进行解毒处理以提高耐久性。植入后进行血流动力学和免疫组织化学研究;进行终端程序后进行放射学和组织学研究。所有支架瓣膜在植入后均定位正确,超声心动图和心导管检查显示瓣膜具有良好的血流动力学状态和功能。所有抗-α-Gal IgM 和 IgG 滴度均低于 0.3 光密度。提取瓣膜的计算机断层扫描显示两组之间钙化程度无显著差异(P = 0.927)。无论植入时间如何,两组的微观发现均显示出最小程度的钙化和巨噬细胞或 T 细胞的无显著浸润。PPVI 是一种可行的技术。由 PP 和 PAV 制成的两种支架瓣膜在血流动力学特征、中期耐久性和退行性营养不良性钙化程度方面均无显著差异。

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