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新型 St Jude Trifecta 与 Carpentier-Edwards Perimount Magna 和 Magna Ease 主动脉生物瓣比较:是否具有血液动力学优势?

The new St Jude Trifecta versus Carpentier-Edwards Perimount Magna and Magna Ease aortic bioprosthesis: is there a hemodynamic superiority?

机构信息

Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Hospital Essen, Essen, Germany.

Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Hospital Essen, Essen, Germany.

出版信息

J Thorac Cardiovasc Surg. 2014 May;147(5):1553-60. doi: 10.1016/j.jtcvs.2013.05.045. Epub 2013 Jul 16.

Abstract

OBJECTIVES

The Trifecta valve (St Jude Medical, St Paul, Minn) is a new bioprosthetic heart valve designed for supra-annular aortic valve replacement. We compared the hemodynamic performance of the Trifecta against the Perimount-Magna and Magna-Ease valve prostheses (Edwards Lifesciences, Irvine, Calif) in a nonrandomized, observational, single-center study.

METHODS

A total of 346 consecutive patients with aortic valve disease underwent aortic valve replacement between January 2003 and November 2011, with implantation of the Trifecta (group 1, n = 121), the Perimount-Magna (group 2, n = 126), or the Magna Ease bioprosthesis (group 3, n = 99). Clinical and hemodynamic data were prospectively recorded and compared. Hemodynamic performance was evaluated by transthoracic echocardiography, including mean pressure gradient (MPG) and aortic valve area (AVA) at baseline, discharge, and 6-month follow-up. A multivariate model of covariance analysis was constructed to further compare the primary study end points of MPG and AVA at 6-month follow-up.

RESULTS

For all valve sizes, unadjusted MPGs did not differ (P = .08), but AVAs differed (P < .001) between groups at 6-month follow-up. After final adjustment by a multivariate model of covariance analysis, neither the MPGs (P = .16) nor the AVAs (P = .92) at 6 months postoperatively were influenced by the type of prosthesis used.

CONCLUSIONS

The present observational study is the first to compare the new Trifecta valve with well-established supra-annular aortic valve bioprostheses from a hemodynamic perspective. Although mean pressure gradients and aortic valve areas seem to be advantageous at 6-month follow-up with the new Trifecta valve, after multivariate covariance analysis, no influence of prosthesis type on mean pressure gradient or aortic valve area could be demonstrated.

摘要

目的

Trifecta 瓣膜(美国明尼苏达州圣保罗市圣犹达医疗公司)是一种新型生物瓣,用于主动脉瓣上方环上替换。我们在一项非随机、观察性、单中心研究中,比较了 Trifecta 瓣膜与 Perimount-Magna 和 Magna-Ease 瓣膜在血流动力学性能方面的差异。

方法

2003 年 1 月至 2011 年 11 月,共有 346 例主动脉瓣疾病患者接受了主动脉瓣置换术,其中植入 Trifecta 瓣膜(第 1 组,n=121)、Perimount-Magna 瓣膜(第 2 组,n=126)或 Magna Ease 生物瓣(第 3 组,n=99)。前瞻性记录并比较临床和血流动力学数据。通过经胸超声心动图评估血流动力学性能,包括基线、出院时和 6 个月随访时的平均压力梯度(MPG)和主动脉瓣面积(AVA)。构建协方差分析的多变量模型,进一步比较 6 个月随访时 MPG 和 AVA 的主要研究终点。

结果

对于所有瓣膜尺寸,未调整的 MPG 无差异(P=0.08),但 6 个月随访时各组的 AVA 不同(P<0.001)。经多变量协方差分析最终调整后,术后 6 个月时 MPG(P=0.16)和 AVA(P=0.92)均不受所使用的瓣膜类型影响。

结论

本观察性研究首次从血流动力学角度比较了新型 Trifecta 瓣膜与成熟的主动脉瓣上方环上生物瓣。尽管新型 Trifecta 瓣膜在 6 个月随访时平均压力梯度和主动脉瓣面积似乎具有优势,但经过多变量协方差分析后,未能证明瓣膜类型对平均压力梯度或主动脉瓣面积有影响。

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