Liver Unit, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Research, Universitat Autònoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain.
Gastroenterology Unit, AORN A. Cardarelli, Naples, Italy.
Clin Gastroenterol Hepatol. 2018 Jan;16(1):132-139.e8. doi: 10.1016/j.cgh.2017.04.042. Epub 2017 May 10.
BACKGROUND & AIMS: Early placement of a transjugular intrahepatic portosystemic shunts (TIPS) is considered the treatment of choice for patients with acute variceal bleeding (AVB) and cirrhosis who have a high risk of death (Child-Pugh class B with active bleeding at endoscopy or Child-Pugh class C). It has been proposed that patients of Child-Pugh class B, even with active bleeding, should not be considered high risk. Alternative criteria have been proposed for identification of high-risk patients, such as Child-Pugh class C with plasma level of creatinine of 1 mg/dL or more (ChildC-C1) and a model for end-stage liver disease (MELD) score of 19 or more. We analyzed outcomes of a large cohort of patients with AVB who received the standard of care at different centers to validate these systems of risk stratification.
We performed an observational study of 915 patients with liver cirrhosis and AVB who received standard treatment (drugs, antibiotics, and endoscopic ligation, with TIPS as the rescue treatment), over different time periods between 2006 and 2014 in Canada and Europe. All patients were followed until day 42 (week 6) after index AVB or death. Child-Pugh and MELD scores were calculated at time of hospital admission. The primary outcome was mortality 6 weeks after index AVB among patients who met the early TIPS criteria (Child-Pugh class B with active bleeding at endoscopy or Child-Pugh class C), MELD19 criteria (patients with MELD scores of 19 or more), and ChildC-C1 criteria.
Among 915 patients with AVB, 18% died within 6 weeks. Among the 523 patients who met the early TIPS criteria, 17% died within 6 weeks. All 3 rules discriminated patients at high risk of death from those with low risk: 28.3% of the patients classified as high risk by the early TIPS criteria died whereas only 7.0% of patients classified as low risk died; 46.0% of patients classified as high risk by the MELD19 criteria died vs 8.1% of patients classified as low risk; 51.9% of patients classified as high risk by the ChildC-C1 criteria died compared with 10.9% of patients classified as low risk. Mortality was significantly lower among patients with Child-Pugh class B (11.7%) than with Child-Pugh class C (35.6%) (P ≤ .001). Mortality was similar between patients with Child-Pugh class B cirrhosis with or without active bleeding (11.7%). Patients with Child-Pugh class A cirrhosis or MELD scores of 11 or less had low mortality (2%-4%), patients with Child-Pugh class B cirrhosis or MELD scores of 12 to 18 had intermediate mortality (10%-12%), and patients with Child-Pugh class C cirrhosis or MELD scores of 19 or more had high mortality (22%-46%).
Patients with Child-Pugh class B cirrhosis and AVB who receive standard therapy, regardless of the presence of active bleeding, have 3-fold lower mortality than patients with Child-Pugh C cirrhosis and might not need TIPS. Patients with Child-Pugh class C and/or MELD scores of 19 or more should be considered at high risk of death. These findings might help refine criteria for early TIPS.
对于有发生死亡高风险（Child-Pugh 分级 B 级且内镜下有活动性出血，或 Child-Pugh 分级 C 级）的急性静脉曲张出血（AVB）和肝硬化患者，早期放置经颈静脉肝内门体分流术（TIPS）被认为是首选治疗方法。有人提出，即使有活动性出血，Child-Pugh 分级 B 级的患者也不应被视为高风险。已经提出了替代标准来识别高危患者，例如 Child-Pugh 分级 C 级，同时伴有肌酐血浆水平 1mg/dL 或更高（ChildC-C1）和终末期肝病模型（MELD）评分 19 或更高。我们分析了在不同中心接受 AVB 标准治疗的大量患者的结局，以验证这些风险分层系统。
我们对 2006 年至 2014 年期间在加拿大和欧洲不同时间接受标准治疗（药物、抗生素和内镜结扎，TIPS 作为抢救治疗）的 915 例肝硬化伴 AVB 患者进行了一项观察性研究。所有患者均随访至 AVB 指数后第 42 天（第 6 周）或死亡。入院时计算 Child-Pugh 和 MELD 评分。主要结局是符合早期 TIPS 标准（内镜下有活动性出血的 Child-Pugh 分级 B 级或 Child-Pugh 分级 C 级）、MELD19 标准（MELD 评分 19 或更高）和 ChildC-C1 标准的患者在 AVB 指数后 6 周的死亡率。
在 915 例 AVB 患者中，18%在 6 周内死亡。在符合早期 TIPS 标准的 523 例患者中，17%在 6 周内死亡。所有 3 种规则都能区分高死亡率风险的患者和低死亡率风险的患者：符合早期 TIPS 标准的患者中，28.3%的患者为高风险，而只有 7.0%的患者为低风险；符合 MELD19 标准的患者中，46.0%为高风险，而 8.1%为低风险；符合 ChildC-C1 标准的患者中，51.9%为高风险，而 10.9%为低风险。Child-Pugh 分级 B 级（11.7%）患者的死亡率明显低于 Child-Pugh 分级 C 级（35.6%）（P ≤.001）。Child-Pugh 分级 B 级肝硬化患者（11.7%）与 Child-Pugh 分级 B 级肝硬化且有或无活动性出血患者（11.7%）的死亡率相似。Child-Pugh 分级 A 级肝硬化或 MELD 评分 11 或更低的患者死亡率较低（2%-4%），Child-Pugh 分级 B 级肝硬化或 MELD 评分 12-18 的患者死亡率中等（10%-12%），Child-Pugh 分级 C 级肝硬化或 MELD 评分 19 或更高的患者死亡率较高（22%-46%）。
接受标准治疗的 Child-Pugh 分级 B 级肝硬化伴 AVB 患者，无论是否存在活动性出血，其死亡率均较 Child-Pugh 分级 C 级肝硬化患者低 3 倍，可能不需要 TIPS。Child-Pugh 分级 C 级和/或 MELD 评分 19 或更高的患者应被视为高死亡风险。这些发现可能有助于完善早期 TIPS 的标准。
