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三种心脏主动脉生物假体的一年血流动力学性能:一项随机对照临床试验。

One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial.

作者信息

Montero-Cruces Lourdes, Carnero-Alcázar Manuel, Reguillo-Lacruz Fernando José, Cobiella-Carnicer Francisco Javier, Pérez-Camargo Daniel, Campelos-Fernández Paula, Maroto-Castellanos Luis Carlos

机构信息

Department of Cardiac Surgery, Cardiovascular Institute, Hospital Clínico San Carlos, 28940 Madrid, Spain.

出版信息

J Clin Med. 2021 Nov 16;10(22):5340. doi: 10.3390/jcm10225340.

Abstract

BACKGROUND

We aimed to compare 1 year the hemodynamic in-vivo performance of three biological aortic prostheses (Carpentier Perimount Magna Ease, Crown PRT, and Trifecta).

METHODS

The sample used in this study comes from the "BEST-VALVE" clinical trial, which is a phase IV single-blinded randomized clinical trial with the three above-mentioned prostheses.

RESULTS

154 patients were included. Carpentier Perimount Magna Ease ( = 48, 31.2%), Crown PRT ( = 51, 32.1%) and Trifecta ( = 55, 35.7%). One year after the surgery, the mean aortic gradient and the peak aortic velocity was 17.5 (IQR 11.3-26) and 227.1 (IQR 202.0-268.8) for Carpentier Perimount Magna Ease, 21.4 (IQR 14.5-26.7) and 237.8 (IQR 195.9-261.9) for Crown PRT, and 13 (IQR 9.6-17.8) and 209.7 (IQR 176.5-241.4) for Trifecta, respectively. Pairwise comparisons demonstrated improved mean gradients and maximum velocity of Trifecta as compared to Crown PRT. Among patients with nominal prosthesis sizes ≤ 21, the mean and peak aortic gradient was higher for Crown PRT compared with Trifecta, and in patients with an aortic annulus measured with metric Hegar dilators less than or equal to 22 mm.

CONCLUSIONS

One year after surgery, the three prostheses presented a different hemodynamic performance, being Trifecta superior to Crown PRT.

摘要

背景

我们旨在比较三种生物主动脉瓣假体(Carpentier Perimount Magna Ease、Crown PRT和Trifecta)1年的体内血流动力学性能。

方法

本研究中使用的样本来自“BEST-VALVE”临床试验,这是一项针对上述三种假体的IV期单盲随机临床试验。

结果

共纳入154例患者。Carpentier Perimount Magna Ease组48例(31.2%),Crown PRT组51例(32.1%),Trifecta组55例(35.7%)。术后1年,Carpentier Perimount Magna Ease组的平均主动脉压差和主动脉峰值流速分别为17.5(四分位间距11.3 - 26)和227.1(四分位间距202.0 - 268.8),Crown PRT组为21.4(四分位间距14.5 - 26.7)和237.8(四分位间距195.9 - 261.9),Trifecta组为13(四分位间距9.6 - 17.8)和209.7(四分位间距176.5 - 241.4)。两两比较显示,与Crown PRT相比,Trifecta的平均压差和最大流速有所改善。在标称假体尺寸≤21的患者中,Crown PRT的平均和峰值主动脉压差高于Trifecta,且在使用公制Hegar扩张器测量主动脉瓣环小于或等于22 mm的患者中也是如此。

结论

术后1年,三种假体呈现出不同的血流动力学性能,Trifecta优于Crown PRT。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/17cb/8625181/334f03044bea/jcm-10-05340-g001.jpg

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