目的:在中国患者中使用Viatorr支架的经颈静脉肝内门体分流术(TIPS)的中长期疗效和安全性数据有限。本研究旨在评估Viatorr支架插入后5年死亡率和明显肝性脑病(OHE)的发生率,并构建预测TIPS术后OHE的模型。
方法:纳入了2016年8月至2019年12月在我们机构接受Viatorr支架插入的123例患者,并以70/30的比例随机分为训练和验证队列。患者随访至死亡或随访结束日期(12月31日,2021)。主要终点是全因死亡率,次要终点是OHE,静脉曲张再出血,复发性腹水和分流功能障碍。
结果:1-,2-,3-,4年和5年累积生存率为92.4%,87.9%,85.3%,80.2%和80.2%,分别。TIPS术后OHE和Child-Pugh分级是独立的预后因素。静脉曲张再出血的发生率,复发性腹水,分流功能障碍和TIPS术后OHE为9.1%,14.3%,5.3%和28.0%,分别。预测TIPS后OHE的列线图变量包括年龄,糖尿病和腹水等级。训练和验证队列中时间依赖性受试者操作特征(ROC)曲线下面积(AUC)分别为0.806和0.751。决策曲线分析(DCA)在训练和验证队列中均显示出良好的净收益。
结论:TIPS后OHE和Child-Pugh分级是肝硬化患者早期死亡的独立预后因素,因此,我们构建了一个简单方便的TIPS术后OHE预测模型,用于术前识别高危患者.
Data on medium- and long-term efficacy and safety of Transjugular intrahepatic portosystemic shunt (TIPS) using Viatorr stents in Chinese patients are limited. This study aimed to evaluate the 5-year mortality and the incidence of overt hepatic encephalopathy (OHE) after Viatorr stent insertion, and construct a model to predict post-TIPS OHE preoperatively.
One hundred thirty-two patients undergoing Viatorr stent insertion in our institution between August 2016 and December 2019 were included, and randomly divided into training and validation cohort at a 70/30 ratio. Patients were followed up until death or the end date of follow-up (December 31st, 2021). The primary end point was all-cause mortality, and the secondary end points were OHE, variceal rebleeding, recurrent ascites and shunt dysfunction.
The 1-, 2-, 3-, 4- and 5-year cumulative survival rates were 92.4%, 87.9%, 85.3%, 80.2% and 80.2%, respectively. Post-TIPS OHE and Child-Pugh grade were independent prognostic factors. The rates of variceal rebleeding, recurrent ascites, shunt dysfunction and post-TIPS OHE were 9.1%, 14.3%, 5.3% and 28.0%, respectively. The variables of nomogram predicting post-TIPS OHE included age, diabetes and ascites grade. The area under time-dependent receiver operation characteristic (ROC) curve (AUC) in training and validation cohort were 0.806 and 0.751, respectively. The decision curve analysis (DCA) showed good net benefit both in training and validation cohort.
Post-TIPS OHE and Child-Pugh grade are independent prognostic factors for early mortality in cirrhosis patients, thus we construct a simple and convenient prediction model for post-TIPS OHE to identify high-risk patients preoperatively.