Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China.
Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China.
Clin Gastroenterol Hepatol. 2021 Sep;19(9):1959-1966.e3. doi: 10.1016/j.cgh.2021.04.033. Epub 2021 Apr 24.
This article systemically describes the landscape of peroral endoscopic myotomy (POEM)-related adverse events (AEs) and compares the different grading systems; and establishes and validates a combined risk factor model and a simplified risk-scoring system to predict POEM-related major AEs.
A total of 3135 patients with achalasia treated with POEM were included and the AEs were systemically described and graded. A predictive model and risk-scoring system was developed using logistic regression and then internally validated using bootstrapping approaches.
A total of 258 out of 3135 patients, accounting for 8.23% of the total patients, presented with 297 AEs. According to Clavien-Dindo grading, 175 (67.83%), 23 (8.91%), 56 (21.71%), 4 (1.55%), and 0 (0.00%) patients were graded as grade I-V, respectively. By American Society of Gastrointestinal Endoscopy lexicon, 175 (67.83%) patients were classified with mild AE, 66 (25.58%) were classified with moderate AE, and 17 (6.59%) were classified with severe AE, respectively. Sixty-eight (2.17%) patients were classified with major AE. Air insufflation, selective myotomy, mucosal injury, and long operation time were selected into the predictive model with an area under the curve of 0.795. They were assigned with scores of 18, 5, 3, and 5 in the risk-scoring system, respectively. By applying the risk scoring system, patients with higher scores had higher rates of major AEs. The model showed little evidence for overfitting and was well-calibrated.
Based on a systematic landscape analysis, POEM is a safe procedure with low rates of severe AEs. Our prediction model and risk-scoring system demonstrated good performance in predicting major AEs.
本文系统地描述了经口内镜下肌切开术（POEM）相关不良事件（AE）的现状，并比较了不同的分级系统；建立并验证了一个联合风险因素模型和简化的评分系统，以预测 POEM 相关的主要 AE。
共纳入 3135 例贲门失弛缓症患者接受 POEM 治疗，系统地描述和分级 AE。使用逻辑回归建立预测模型和评分系统，然后使用 bootstrap 方法进行内部验证。
共有 258 例（8.23%）患者发生 297 例 AE。根据 Clavien-Dindo 分级，175 例（67.83%）、23 例（8.91%）、56 例（21.71%）、4 例（1.55%）和 0 例（0.00%）患者分别为 I-V 级。根据美国胃肠内镜学会词汇表，175 例（67.83%）患者为轻度 AE，66 例（25.58%）为中度 AE，17 例（6.59%）为重度 AE。68 例（2.17%）患者为主要 AE。气腹、选择性肌切开术、黏膜损伤和手术时间长被选入预测模型，曲线下面积为 0.795。在评分系统中，它们的得分分别为 18、5、3 和 5。根据风险评分系统，得分较高的患者发生主要 AE 的概率更高。该模型具有很好的预测性能，没有过度拟合的迹象，并且校准良好。
基于系统的现状分析，POEM 是一种安全的手术，严重 AE 发生率低。我们的预测模型和评分系统在预测主要 AE 方面表现出良好的性能。
