PMID- 27609778
OWN - NLM
STAT- MEDLINE
DCOM- 20171011
LR  - 20220311
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
VI  - 85
IP  - 4
DP  - 2017 Apr
TI  - Early adverse events of per-oral endoscopic myotomy.
PG  - 708-718.e2
LID - S0016-5107(16)30539-9 [pii]
LID - 10.1016/j.gie.2016.08.033 [doi]
AB  - BACKGROUND AND AIMS: The recently developed technique of per-oral endoscopic 
      myotomy (POEM) has been shown to be effective for the therapy of esophageal 
      motility disorders. Limited information is available about POEM adverse events 
      (AEs). METHODS: POEM was performed on 241 patients (58% male; mean age, 47.4 +/- 
      16.4 years) under general anesthesia over 61 months. The main outcome was the 
      rate of intra- and post-procedural AEs. Post-procedural checks comprised clinical 
      and laboratory examinations and endoscopy, with further follow-ups performed at 
      3, 6, and 12 months. RESULTS: Of the 241 procedures, 238 were successfully 
      completed (mean procedure time, 100.2 +/- 39.5 min). Reasons for abortion were 
      excessive submucosal fibrosis preventing submucosal tunneling. Three patients had 
      severe procedural-related AEs (SAE rate, 1.2%); 1 case of pneumothorax required 
      intra-procedural drainage, and 2 patients had delayed SAEs (1 ischemic gastric 
      cardia perforation and 1 hemothorax, both leading to surgery). The overall rate 
      of minor AEs was 31.1%, mainly prolonged intra-procedural bleeding (>15 min 
      hemostasis) and defects of the mucosa overlying the tunnel; none led to 
      clinically relevant signs or symptoms. Patients experiencing any AE had a 
      significantly prolonged hospital stay (P = .037) and a trend toward prolonged 
      procedure time (P = .094). Neck/upper thoracic emphysema and free abdominal air 
      were noted in 31.5% and 35.7%, respectively (95.3% drained), but without relevant 
      sequelae. CONCLUSIONS: POEM has a low rate of SAEs; minor AEs are more frequent 
      but lack a consistent definition. Therefore, based on our experience and 
      literature analysis, we suggest a classification of AEs for POEM. (Clinical 
      trials registration number: NCT01405417.).
CI  - Copyright (c) 2017. Published by Elsevier Inc.
FAU - Werner, Yuki B
AU  - Werner YB
AD  - Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, 
      Hamburg, Germany; Department of Gastronterology, University Hospital 
      Hamburg-Eppendorf, Hamburg, Germany.
FAU - von Renteln, Daniel
AU  - von Renteln D
AD  - Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, 
      Hamburg, Germany.
FAU - Noder, Tania
AU  - Noder T
AD  - Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, 
      Hamburg, Germany.
FAU - Schachschal, Guido
AU  - Schachschal G
AD  - Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, 
      Hamburg, Germany.
FAU - Denzer, Ulrike W
AU  - Denzer UW
AD  - Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, 
      Hamburg, Germany.
FAU - Groth, Stefan
AU  - Groth S
AD  - Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, 
      Hamburg, Germany.
FAU - Nast, Jan F
AU  - Nast JF
AD  - Department of Gastronterology, University Hospital Hamburg-Eppendorf, Hamburg, 
      Germany.
FAU - Kersten, Jan F
AU  - Kersten JF
AD  - Department of Medical Biometry and Epidemiology, University Hospital 
      Hamburg-Eppendorf, Hamburg, Germany.
FAU - Petzoldt, Martin
AU  - Petzoldt M
AD  - Department of Anaesthesiology, University Hospital Hamburg-Eppendorf, Hamburg, 
      Germany.
FAU - Adam, Gerhard
AU  - Adam G
AD  - Department of Diagnostic and Interventional Radiology, University Hospital 
      Hamburg-Eppendorf, Hamburg, Germany.
FAU - Mann, Oliver
AU  - Mann O
AD  - Department of General and Abdominal Surgery, University Hospital 
      Hamburg-Eppendorf, Hamburg, Germany.
FAU - Repici, Alessandro
AU  - Repici A
AD  - Digestive Endoscopy Unit, Humanitas Research Hospital and Humanitas University, 
      Milan, Italy.
FAU - Hassan, Cesare
AU  - Hassan C
AD  - Endoscopy Unit, Nuovo Regina Margherita Hospital, Rome, Italy.
FAU - Rosch, Thomas
AU  - Rosch T
AD  - Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, 
      Hamburg, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT01405417
PT  - Journal Article
DEP - 20160905
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
SB  - IM
CIN - Gastrointest Endosc. 2017 Apr;85(4):719-721. PMID: 28317687
CIN - Gastrointest Endosc. 2017 Apr;85(4):870. PMID: 28317698
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Loss, Surgical
MH  - Cardia
MH  - Endoscopy, Digestive System/adverse effects/*methods
MH  - Esophageal Achalasia/*surgery
MH  - Esophageal Motility Disorders/surgery
MH  - Esophageal Sphincter, Lower/*surgery
MH  - Female
MH  - Hemothorax/epidemiology/etiology
MH  - Humans
MH  - Intraoperative Complications/*epidemiology/etiology
MH  - Ischemia/epidemiology/etiology
MH  - Length of Stay
MH  - Male
MH  - Middle Aged
MH  - Natural Orifice Endoscopic Surgery/adverse effects/*methods
MH  - Pneumothorax/epidemiology/etiology
MH  - Postoperative Complications/*epidemiology/etiology
MH  - Stomach Diseases/epidemiology/etiology
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2016/09/10 06:00
MHDA- 2017/10/12 06:00
CRDT- 2016/09/10 06:00
PHST- 2016/03/31 00:00 [received]
PHST- 2016/08/25 00:00 [accepted]
PHST- 2016/09/10 06:00 [pubmed]
PHST- 2017/10/12 06:00 [medline]
PHST- 2016/09/10 06:00 [entrez]
AID - S0016-5107(16)30539-9 [pii]
AID - 10.1016/j.gie.2016.08.033 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2017 Apr;85(4):708-718.e2. doi: 10.1016/j.gie.2016.08.033. 
      Epub 2016 Sep 5.