Yuki B Werner1, Daniel von Renteln2, Tania Noder2, Guido Schachschal2, Ulrike W Denzer2, Stefan Groth2, Jan F Nast3, Jan F Kersten4, Martin Petzoldt5, Gerhard Adam6, Oliver Mann7, Alessandro Repici8, Cesare Hassan9, Thomas Rösch2. 1. Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany; Department of Gastronterology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 2. Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 3. Department of Gastronterology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 4. Department of Medical Biometry and Epidemiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 5. Department of Anaesthesiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 6. Department of Diagnostic and Interventional Radiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 7. Department of General and Abdominal Surgery, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 8. Digestive Endoscopy Unit, Humanitas Research Hospital and Humanitas University, Milan, Italy. 9. Endoscopy Unit, Nuovo Regina Margherita Hospital, Rome, Italy.
Abstract
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.).
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.).
Authors: Dagmar Simkova; Jan Mares; Zuzana Vackova; Tomas Hucl; Petr Stirand; Eva Kieslichova; Ondrej Ryska; Julius Spicak; Sylvia Drazilova; Eduard Veseliny; Jan Martinek Journal: Surg Endosc Date: 2022-09-28 Impact factor: 3.453
Authors: Jan Friso Nast; Christoph Berliner; Thomas Rösch; Daniel von Renteln; Tania Noder; Guido Schachschal; Stefan Groth; Harald Ittrich; Jan F Kersten; Gerhard Adam; Yuki B Werner Journal: Surg Endosc Date: 2018-03-15 Impact factor: 4.584
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