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心脏手术期间血液吸附效果的性别差异——一项REMOVE试验的事后分析

Sex differences on the effect of hemoadsorption during cardiac surgery - A REMOVE trial post-hoc analysis.

作者信息

Caldonazo Tulio, Doenst Torsten, Fazzini Luca, Kirov Hristo, Hagel Stefan, Lehmann Thomas, Saha Shekhar, Boburg Rodrigo Sandoval, Freiburger Sebastian, Rustenbach Christian Jörg, Marin-Cuartas Mateo, Diab Mahmoud

机构信息

Department of Cardiothoracic Surgery, Friedrich-Schiller-University Jena, Jena, Germany.

Department of Cardiothoracic Surgery, Friedrich-Schiller-University Jena, Jena, Germany.

出版信息

Int J Cardiol. 2025 Sep 15;435:133371. doi: 10.1016/j.ijcard.2025.133371. Epub 2025 May 23.

DOI:10.1016/j.ijcard.2025.133371
PMID:40414542
Abstract

OBJECTIVES

Multi-organ failure is one of the leading causes of mortality after cardiac surgery for infective endocarditis (IE). Although the randomized evidence does not support the use of hemoadsorption during cardiac surgery for IE, observational studies suggest a beneficial effect in selected patient groups. We aimed to analyze the effect of sex differences on hemoadsorption in patients with IE.

METHODS

This is a post-hoc analysis of the REMOVE-trial that randomized patients with IE who underwent cardiac surgery with hemoadsorption using CytoSorb® or control. The primary endpoint was variation of Sequential Organ Failure Assessment (ΔSOFA), defined as the difference between the mean total postoperative and baseline SOFA score within 24 h of surgery. The secondary endpoints were 30-day mortality and other usual postoperative outcomes.

RESULTS

Among 282 patients, 73 (25.9 %) were females (38 and 35 patients in the hemoadsorption and control group, respectively) and 209 (74.1 %) were males (98 and 111 patients in the hemoadsorption and control group, respectively). The overall ΔSOFA did not differ significantly between the intervention groups in both female and male subgroups (MD: -2.13, 95 % CI -5.20 to 0.93, p = 0.163; MD: 0.31, 95 % CI -0.91 to 1.53, p = 0.612, respectively) and neither did 30-day mortality (HR = 0.54, 95 % CI 0.23 to 1.24, p = 0.132; HR 1.17, 95 % CI 0.61 to 2.21, p = 0.634, respectively). No significant differences were observed concerning the other secondary outcomes.

CONCLUSION

The intraoperative use of hemoadsorption was not associated with reduction of postoperative organ dysfunction, 30-day mortality, or other major clinical endpoints in both sex subgroups.

摘要

目的

多器官功能衰竭是感染性心内膜炎(IE)心脏手术后的主要死亡原因之一。尽管随机对照证据不支持在IE心脏手术期间使用血液吸附,但观察性研究表明其对特定患者群体有益。我们旨在分析性别差异对IE患者血液吸附的影响。

方法

这是对REMOVE试验的事后分析,该试验将接受使用CytoSorb®进行血液吸附的心脏手术的IE患者随机分为试验组或对照组。主要终点是序贯器官衰竭评估(ΔSOFA)的变化,定义为术后24小时内术后平均总SOFA评分与基线SOFA评分之差。次要终点是30天死亡率和其他常见的术后结局。

结果

在282例患者中,73例(25.9%)为女性(血液吸附组和对照组分别为38例和35例),209例(74.1%)为男性(血液吸附组和对照组分别为98例和111例)。在女性和男性亚组中,干预组之间的总体ΔSOFA均无显著差异(MD:-2.13,95%CI -5.20至0.93,p = 0.163;MD:0.31,95%CI -0.91至1.53,p = 0.612),30天死亡率也无显著差异(HR = 0.54,95%CI 0.23至1.24,p = 0.132;HR 1.17,95%CI 0.61至2.21,p = 0.634)。其他次要结局也未观察到显著差异。

结论

在两个性别亚组中,术中使用血液吸附均与术后器官功能障碍、30天死亡率或其他主要临床终点的降低无关。

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