Riescher-Tuczkiewicz Alix, Caldwell Stephen H, Kamath Patrick S, Villa Erica, Rautou Pierre-Emmanuel
Université Paris-Cité, Inserm, Centre de recherche sur l'inflammation, UMR 1149, Paris, France.
Division of Gastroenterology & Hepatology, University of Virginia Health System, Charlottesville, VA 22908, USA.
JHEP Rep. 2023 Dec 19;6(3):100986. doi: 10.1016/j.jhepr.2023.100986. eCollection 2024 Mar.
BACKGROUND & AIMS: Despite several recent international guidelines, no consensus exists on the bleeding risk nor haemostatic parameter thresholds that define the safety of invasive procedures in patients with cirrhosis. The aim of this study was to establish a position paper on the bleeding risk associated with invasive procedures in patients with cirrhosis among the experts involved in various guidelines.
All experts involved in recent guidelines on the management of invasive procedures in patients with cirrhosis were invited to classify 80 procedures as "high risk" or "low risk" with respect to bleeding. Procedures were considered high risk when the estimated risk of major bleeding was 1.5% or more, or when even minor bleeding might lead to significant morbidity or death. The experts were also asked to choose safety thresholds for laboratory test values at which elective invasive procedures could be safely performed. The predetermined threshold considered as "consensus" was ≥75% agreement.
Fifty-two experts participated in the study. Out of 80 procedures, a consensus opinion was reached for 52 procedures (65%): 17 procedures were classified as "high risk", primarily interventional endoscopic procedures, percutaneous organ biopsies, or procedures involving the central nervous system; and 35 as "low risk", primarily "diagnostic" procedures. The lowest platelet counts at which performance of a low-risk procedure or a high-risk procedure/surgery were deemed acceptable were 30 × 10/L and 50 × 10/L, respectively. Experts did not believe that international normalised ratio should be considered before performing low-risk procedures; 71% also indicated that it should not be considered before performing high-risk procedures.
This experience-based classification may be helpful to refine future study designs and to guide clinical decision making regarding invasive procedures in patients with cirrhosis.
Several risk classifications and management guidelines for invasive procedures in patients with cirrhosis have been proposed, but with conflicting recommendations. By providing a position paper, based on the opinion of a broad panel of experts, on the bleeding risk associated with 52 invasive procedures in patients with cirrhosis, this survey will help to provide a framework for future study design. The consensus on platelet count, international normalised ratio, fibrinogen and activated partial thromboplastin time identified in this survey will inform physicians regarding the laboratory test values considered acceptable by the experts prior to the performance of an elective invasive procedure in patients with cirrhosis.
尽管近期有多项国际指南,但对于肝硬化患者侵入性操作的出血风险以及界定操作安全性的止血参数阈值,目前尚无共识。本研究的目的是在参与各项指南制定的专家中,就肝硬化患者侵入性操作相关的出血风险制定一份立场文件。
邀请所有参与近期肝硬化患者侵入性操作管理指南制定的专家,将80项操作按出血风险分为“高风险”或“低风险”。当估计大出血风险为1.5%或更高,或即使轻微出血也可能导致严重发病或死亡时,该操作被视为高风险。专家们还被要求选择实验室检查值的安全阈值,在该阈值下可安全进行择期侵入性操作。被视为“共识”的预定阈值为≥75%的一致意见。
52位专家参与了本研究。在80项操作中,52项操作(65%)达成了共识意见:17项操作被归类为“高风险”,主要是介入性内镜操作、经皮器官活检或涉及中枢神经系统的操作;35项为“低风险”,主要是“诊断性”操作。低风险操作或高风险操作/手术被认为可接受的最低血小板计数分别为30×10⁹/L和50×10⁹/L。专家们认为在进行低风险操作前不应考虑国际标准化比值;71%的专家还表示在进行高风险操作前也不应考虑该指标。
这种基于经验的分类可能有助于完善未来的研究设计,并指导肝硬化患者侵入性操作的临床决策。
已经提出了几种针对肝硬化患者侵入性操作的风险分类和管理指南,但建议相互矛盾。通过基于广泛专家意见提供一份关于肝硬化患者52项侵入性操作相关出血风险的立场文件,本次调查将有助于为未来的研究设计提供一个框架。本次调查中确定的关于血小板计数、国际标准化比值、纤维蛋白原和活化部分凝血活酶时间的共识,将告知医生在为肝硬化患者进行择期侵入性操作前专家认为可接受的实验室检查值。