PMID- 33905769
OWN - NLM
STAT- MEDLINE
DCOM- 20210909
LR  - 20230205
IS  - 1542-7714 (Electronic)
IS  - 1542-3565 (Linking)
VI  - 19
IP  - 9
DP  - 2021 Sep
TI  - Landscape of Adverse Events Related to Peroral Endoscopic Myotomy in 3135 
      Patients and a Risk-Scoring System to Predict Major Adverse Events.
PG  - 1959-1966.e3
LID - S1542-3565(21)00467-5 [pii]
LID - 10.1016/j.cgh.2021.04.033 [doi]
AB  - BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
CI  - Copyright (c) 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.
FAU - Liu, Xinyang
AU  - Liu X
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Yao, Lu
AU  - Yao L
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Cheng, Jing
AU  - Cheng J
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Xu, Meidong
AU  - Xu M
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Chen, Shiyao
AU  - Chen S
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Zhong, Yunshi
AU  - Zhong Y
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - He, Mengjiang
AU  - He M
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Chen, Weifeng
AU  - Chen W
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Zhang, Yiqun
AU  - Zhang Y
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Qin, Wenzheng
AU  - Qin W
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Hu, Jianwei
AU  - Hu J
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Cai, Mingyan
AU  - Cai M
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Yao, Liqing
AU  - Yao L
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China.
FAU - Zhou, Pinghong
AU  - Zhou P
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China. Electronic address: zhou.pinghong@zs-hospital.sh.cn.
FAU - Li, Quanlin
AU  - Li Q
AD  - Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan 
      University, Shanghai, China. Electronic address: li.quanlin@zs-hospital.sh.cn.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210424
PL  - United States
TA  - Clin Gastroenterol Hepatol
JT  - Clinical gastroenterology and hepatology : the official clinical practice journal 
      of the American Gastroenterological Association
JID - 101160775
SB  - IM
CIN - Clin Gastroenterol Hepatol. 2023 Jan;21(1):234-235. PMID: 35085826
MH  - Endoscopy, Gastrointestinal
MH  - *Esophageal Achalasia/diagnosis/surgery
MH  - Esophageal Sphincter, Lower
MH  - Humans
MH  - *Myotomy/adverse effects
MH  - *Natural Orifice Endoscopic Surgery/adverse effects
MH  - Risk Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adverse Events
OT  - Clinical Prediction
OT  - POEM
EDAT- 2021/04/28 06:00
MHDA- 2021/09/10 06:00
CRDT- 2021/04/27 20:10
PHST- 2020/12/24 00:00 [received]
PHST- 2021/04/14 00:00 [revised]
PHST- 2021/04/19 00:00 [accepted]
PHST- 2021/04/28 06:00 [pubmed]
PHST- 2021/09/10 06:00 [medline]
PHST- 2021/04/27 20:10 [entrez]
AID - S1542-3565(21)00467-5 [pii]
AID - 10.1016/j.cgh.2021.04.033 [doi]
PST - ppublish
SO  - Clin Gastroenterol Hepatol. 2021 Sep;19(9):1959-1966.e3. doi: 
      10.1016/j.cgh.2021.04.033. Epub 2021 Apr 24.