Early adverse events of per-oral endoscopic myotomy.
OBJECTIVE
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.).
Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany; Department of Gastronterology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Yuki B
YB
Werner
Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Daniel
D
von Renteln
Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Tania
T
Noder
Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Guido
G
Schachschal
Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Ulrike W
UW
Denzer
Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Stefan
S
Groth
Department of Gastronterology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Jan F
JF
Nast
Department of Medical Biometry and Epidemiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Jan F
JF
Kersten
Department of Anaesthesiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Martin
M
Petzoldt
Department of Diagnostic and Interventional Radiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Gerhard
G
Adam
Department of General and Abdominal Surgery, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Oliver
O
Mann
Digestive Endoscopy Unit, Humanitas Research Hospital and Humanitas University, Milan, Italy.
Alessandro
A
Repici
Endoscopy Unit, Nuovo Regina Margherita Hospital, Rome, Italy.
Cesare
C
Hassan
Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Thomas
T
Rösch
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016063:Blood Loss, Surgical; D002299:Cardia; D016145:Endoscopy, Digestive System / Q000009:adverse effects / Q000379:methods*; D004931:Esophageal Achalasia / Q000601:surgery*; D015154:Esophageal Motility Disorders / Q000601:surgery; D049630:Esophageal Sphincter, Lower / Q000601:surgery*; D005260:Female; D006491:Hemothorax / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D007431:Intraoperative Complications / Q000453:epidemiology* / Q000209:etiology; D007511:Ischemia / Q000453:epidemiology / Q000209:etiology; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D057605:Natural Orifice Endoscopic Surgery / Q000009:adverse effects / Q000379:methods*; D011030:Pneumothorax / Q000453:epidemiology / Q000209:etiology; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology; D013272:Stomach Diseases / Q000453:epidemiology / Q000209:etiology; D016896:Treatment Outcome; D055815:Young Adult