北京生物醫(yī)學工程

經(jīng)導管瓣膜瓣中瓣模式下流體力學性能體外測試及評價

Hydrodynamic performance testing and evaluation of the transcatheter heart valve in valve-in-valve model

作者：劉麗萬辰杰柯林楠王春仁

單位：中國食品藥品檢定研究院（北京 102629） <p>通信作者：王春仁。E-mail:[email protected]</p> <p> </p>

關(guān)鍵詞：經(jīng)導管瓣中瓣；經(jīng)導管瓣膜；生物瓣膜；穩(wěn)態(tài)前向流實驗；穩(wěn)態(tài)反向泄漏實驗；脈動流實驗

分類號：R318.01

出版年·卷·期（頁碼）：2021·40·4（393-399）

摘要：

目的隨著生物瓣膜毀損病例的增加，越來越多的經(jīng)導管瓣膜作為瓣中瓣被應(yīng)用于二次瓣膜置換手術(shù)，但其流體力學性能鮮有報道。本文將經(jīng)導管瓣膜安裝在生物瓣膜內(nèi)形成瓣中瓣結(jié)構(gòu)，并對其流體力學性能進行體外測試及評價。方法將經(jīng)導管瓣膜（23 mm、27 mm、29 mm）分別安裝在對應(yīng)規(guī)格生物瓣膜（23 mm、27 mm、29 mm）中形成瓣中瓣，進行穩(wěn)態(tài)前向流實驗、穩(wěn)態(tài)反向泄漏實驗、脈動流實驗，對其流體力學性能進行評價，并與同規(guī)格生物瓣膜流體力學性能進行對比。結(jié)果穩(wěn)態(tài)前向流實驗中，同一規(guī)格的經(jīng)導管瓣中瓣跨瓣壓差隨著前向流量的增大而增大。穩(wěn)態(tài)反向泄漏實驗中，同一規(guī)格的經(jīng)導管瓣中瓣泄露量隨著反向壓力的增大而增大。脈動流實驗中，經(jīng)導管瓣中瓣和生物瓣膜的平均跨瓣壓差、返流百分比和有效瓣口面積變化趨勢相同的。對于同一規(guī)格的經(jīng)導管瓣中瓣和生物瓣膜，隨著心輸出量的增加，跨瓣壓差增大，返流百分比減小，有效瓣口面積增大；在同一心輸出量下，隨著經(jīng)導管瓣中瓣和生物瓣膜規(guī)格的增大，跨瓣壓差減小，返流百分比增大，有效瓣口面積增大。結(jié)論經(jīng)導管瓣中瓣體外脈動流性能指標滿足YY/T1449.3-2016標準中經(jīng)導管瓣膜的性能要求，且其脈動流性能與同規(guī)格生物瓣膜相比無明顯差異。該經(jīng)導管瓣中瓣具有良好的血流動力學性能。

Objective With the increase of bioprosthetic valve damage cases, Valve in valve - transcatheter heart valves(ViV-THV) are used in secondary valve replacement. But there are few reports on its hydrodynamic performance . In this paper, the transcatheter heart valves is installed in the bioprostheticl valve to form a valve- in-valve model, and its hydrodynamic performance is tested and evaluated in vitro. Methods Transcatheter heart valves (23mm, 27mm and 29mm) were respectively installed in bioprosthetic valves(23mm, 27mm and 29mm) as ViV-THV. The steady forward-flow testing，the steady back-flow leakage testing and pulsatile-flow testing were carried out to evaluate the hydrodynamic properties of the ViV-THV, and the hydrodynamic properties were compared with bioprosthetic valves. Results In the steady forward-flow testing, the pressure gradients of ViV-THV increased with the increase of the forward flow rate. In the steady back-flow leakage testing, the leakage volume of the ViV-THV increased with the increase of the reverse pressure. In the pulsatile-flow testing, the mean pressure gradients, the paravalvular leakage and the effective orifice area had the same trend with the bioprosthetic valves. With the increase of cardiac output, the mean pressure gradients increased, the paravalvular leakage decreased and the effective orifice increased for the same size of ViV-THV and bioprosthetic valve. Under the same cardiac output, the mean pressure gradients decreased, the paravalvular leakage increased and the effective orifice area increased with the increase of the size of the ViV-THV and bioprosthetic valve. Conclusions Hydrodynamic performance of the ViV-THV were in line with the YY /T 1449.3-2016 standards, and there were no significant difference with the same size bioprosthetic valve. The transcatheter heart valve prostheses performed well in the described valve-in-valve settings.

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