[Hemoperfusion in anesthesia and intensive care medicine: benefits, risks, and evidence for different systems].

Die Anaesthesiologie Pub Date : 2023-12-01 Epub Date: 2023-09-14 DOI:10.1007/s00101-023-01341-w
Caroline Gräfe, Lorenz Weidhase, Uwe Liebchen, Markus A Weigand, Christina Scharf
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Abstract

Background: Hemoperfusion is a technique for the extracorporeal elimination of endogenous and exogenous toxins and harmful mediators by adsorption. It can be used as a stand-alone device, as part of a heart-lung machine or extracorporeal membrane oxygenation (ECMO) or, as is currently the case, integrated into a kidney replacement procedure. In the meantime, various suppliers offer devices with different technologies.

Objective: The aim of this work was to evaluate the benefits, risks and evidence of the different systems, how they work and for which indications they are approved in Germany.

Method: To achieve this goal, a narrative assessment of the existing literature and guidelines for different indications was performed. The focus was on in vivo studies.

Results: In principle, a distinction must be made in adsorption techniques between pure adsorption and the combination as adsorption and kidney replacement therapy. The adsorbers available in Germany include Cytosorb®, HA-330, Seraph®-100 and Toraymyxin. Combined procedures (adsorption and kidney replacement) are offered with coupled plasma filtration and adsorption (CPFA) and oXiris®. Most adsorbers have been developed for cytokine and endotoxin removal in patients with sepsis; however, to date, no randomized controlled trial (RCT) has demonstrated a survival benefit when using hemoperfusion. Therefore, the S3 guidelines for treatment of sepsis and the surviving sepsis campaign guidelines advise against its routine use. When the corona pandemic began, hemoperfusion was considered as a promising therapeutic approach. Cytosorb®, Seraph®-100, and oXiris® received emergency approval by the FDA to be used in critically ill patients with COVID-19, so questions arose about the appropriateness and importance of its use; however, the data generated did not show positive results, so its use cannot be recommended routinely either. In addition, they are not mentioned as a treatment option in the current guidelines. The use of adsorption procedures in patients with liver failure and rhabdomyolysis has only been rudimentarily studied, so any evidence is currently lacking. The only adsorber that has CE approval in Germany for both applications is Cytosorb®. In the next few years, studies will have to follow that investigate the efficacy and thus either justify or refute the use in clinical routine. Hemoperfusion procedures are used in the heart-lung machine as part of cardiac surgery for either cytokine or anticoagulant adsorption. No congruent data are available to support the use for the elimination of cytokines. If emergency cardiac surgery is required in a patient with pre-existing anticoagulation, hemoperfusion procedures can be used to prevent bleeding complications. Cytosorb® has CE approval for this indication. All available techniques are nonselective adsorption processes, so that adsorption of known and unknown substances can occur. Unintentional adsorption of drugs, such as various anti-infective agents is a relevant risk, especially when used in patients with sepsis.

Discussion: Various adsorption systems can eliminate different known and unknown substances. Currently, there is a lack of evidence for all indications and systems to justify their routine use except in clinical trials. Future clinical trials should evaluate the potential benefits but also dangers, so that in the meantime the routine use can be justified or a recommendation against the use can be given.

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[麻醉和重症监护医学中的血液灌流:不同系统的益处、风险和证据]。
背景:血液灌流是一种体外吸附清除内源性和外源性毒素和有害介质的技术。它可以作为一个独立的设备,作为心肺机或体外膜氧合(ECMO)的一部分,或者像目前的情况一样,集成到肾脏替代手术中。与此同时,不同的供应商提供不同技术的设备。目的:这项工作的目的是评估不同系统的益处、风险和证据,它们是如何工作的,以及它们在德国被批准用于哪些适应症。方法:为了达到这一目标,对现有文献和不同适应症的指南进行了叙述性评估。重点是体内研究。结果:原则上,在吸附技术上必须区分纯吸附和联合吸附与肾脏替代疗法。德国提供的吸附剂包括Cytosorb®,HA-330, Seraph®-100和Toraymyxin。联合程序(吸附和肾脏置换)提供耦合血浆过滤和吸附(CPFA)和oXiris®。大多数吸附剂已被开发用于脓毒症患者的细胞因子和内毒素去除;然而,到目前为止,还没有随机对照试验(RCT)证明使用血液灌流可以提高生存率。因此,S3脓毒症治疗指南和存活脓毒症运动指南建议不要常规使用。当冠状病毒大流行开始时,血液灌流被认为是一种有希望的治疗方法。Cytosorb®、Seraph®-100和oXiris®获得FDA紧急批准用于COVID-19危重患者,因此出现了关于其使用的适当性和重要性的问题;然而,所产生的数据并没有显示出积极的结果,因此也不能推荐常规使用。此外,在目前的指南中,它们并没有作为一种治疗选择被提及。在肝功能衰竭和横纹肌溶解患者中使用吸附程序仅进行了初步研究,因此目前缺乏任何证据。唯一在德国获得CE认证的吸附剂是Cytosorb®。在接下来的几年里,研究将继续调查其疗效,从而证明或反驳其在临床常规中的应用。作为心脏手术的一部分,血液灌流在心肺机中用于细胞因子或抗凝血剂的吸附。没有一致的数据可用于支持消除细胞因子的使用。如果患者已经存在抗凝,需要紧急心脏手术,可以使用血液灌流手术来预防出血并发症。Cytosorb®已获得CE批准用于该适应症。所有可用的技术都是非选择性吸附过程,因此可以发生已知和未知物质的吸附。药物(如各种抗感染药物)的无意吸附是一个相关的风险,特别是在败血症患者中使用时。讨论:各种吸附系统可以消除不同的已知和未知物质。目前,除了临床试验外,缺乏所有适应症和系统的证据来证明其常规使用的合理性。未来的临床试验应该评估潜在的益处和危险,以便在此期间可以证明常规使用是合理的,或者可以给出反对使用的建议。
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