OBJECTIVES: The safety of peroral endoscopic myotomy (POEM) is still debated since comprehensive analysis of adverse events (AEs) associated with the procedure in large multicenter cohort studies has not been performed. To study (1) the prevalence of AEs and (2) factors associated with occurrence of AEs in patients undergoing POEM. METHODS: Patients who underwent POEM at 12 tertiary-care centers between 2009 and 2015 were included in this case-control study. Cases were defined by the occurrence of any AE related to the POEM procedure. Control patients were selected for each AE case by matching for age, gender, and disease classification (achalasia type I and II vs. type III/spastic esophageal disorders). RESULTS: A total of 1,826 patients underwent POEM. Overall, 156 AEs occurred in 137 patients (7.5%). A total of 51 (2.8%) inadvertent mucosotomies occurred. Mild, moderate, and severe AEs had a frequency of 116 (6.4%), 31 (1.7%), and 9 (0.5%), respectively. Multivariate analysis demonstrated that sigmoid-type esophagus (odds ratio (OR) 2.28, P=0.05), endoscopist experience <20 cases (OR 1.98, P=0.04), use of a triangular tip knife (OR 3.22, P=0.05), and use of an electrosurgical current different than spray coagulation (OR 3.09, P=0.02) were significantly associated with the occurrence of AEs. CONCLUSIONS: This large study comprehensively assessed the safety of POEM and highly suggests POEM as a relatively safe procedure when performed by experts at tertiary centers with an overall 7.5% prevalence of AEs. Severe AEs are rare. Sigmoid-type esophagus, endoscopist experience, type of knife, and current used can be considered as predictive factors of AE occurrence.
OBJECTIVES: The safety of peroral endoscopic myotomy (POEM) is still debated since comprehensive analysis of adverse events (AEs) associated with the procedure in large multicenter cohort studies has not been performed. To study (1) the prevalence of AEs and (2) factors associated with occurrence of AEs in patients undergoing POEM. METHODS:Patients who underwent POEM at 12 tertiary-care centers between 2009 and 2015 were included in this case-control study. Cases were defined by the occurrence of any AE related to the POEM procedure. Control patients were selected for each AE case by matching for age, gender, and disease classification (achalasia type I and II vs. type III/spastic esophageal disorders). RESULTS: A total of 1,826 patients underwent POEM. Overall, 156 AEs occurred in 137 patients (7.5%). A total of 51 (2.8%) inadvertent mucosotomies occurred. Mild, moderate, and severe AEs had a frequency of 116 (6.4%), 31 (1.7%), and 9 (0.5%), respectively. Multivariate analysis demonstrated that sigmoid-type esophagus (odds ratio (OR) 2.28, P=0.05), endoscopist experience <20 cases (OR 1.98, P=0.04), use of a triangular tip knife (OR 3.22, P=0.05), and use of an electrosurgical current different than spray coagulation (OR 3.09, P=0.02) were significantly associated with the occurrence of AEs. CONCLUSIONS: This large study comprehensively assessed the safety of POEM and highly suggests POEM as a relatively safe procedure when performed by experts at tertiary centers with an overall 7.5% prevalence of AEs. Severe AEs are rare. Sigmoid-type esophagus, endoscopist experience, type of knife, and current used can be considered as predictive factors of AE occurrence.
Authors: Peter B Cotton; Glenn M Eisen; Lars Aabakken; Todd H Baron; Matt M Hutter; Brian C Jacobson; Klaus Mergener; Albert Nemcek; Bret T Petersen; John L Petrini; Irving M Pike; Linda Rabeneck; Joseph Romagnuolo; John J Vargo Journal: Gastrointest Endosc Date: 2010-03 Impact factor: 9.427
Authors: Mouen A Khashab; Ahmed A Messallam; Manabu Onimaru; Ezra N Teitelbaum; Michael B Ujiki; Matthew E Gitelis; Rani J Modayil; Eric S Hungness; Stavros N Stavropoulos; Mohamad H El Zein; Hironari Shiwaku; Rastislav Kunda; Alessandro Repici; Hitomi Minami; Philip W Chiu; Jeffrey Ponsky; Vivek Kumbhari; Payal Saxena; Amit P Maydeo; Haruhiro Inoue Journal: Gastrointest Endosc Date: 2015-01-26 Impact factor: 9.427
Authors: Daniel Von Renteln; Karl-Hermann Fuchs; Paul Fockens; Peter Bauerfeind; Melina C Vassiliou; Yuki B Werner; Gerald Fried; Wolfram Breithaupt; Henriette Heinrich; Albert J Bredenoord; Jan F Kersten; Tessa Verlaan; Michael Trevisonno; Thomas Rösch Journal: Gastroenterology Date: 2013-05-09 Impact factor: 22.682
Authors: Rym El Khoury; Ezra N Teitelbaum; Joel M Sternbach; Nathaniel J Soper; Carla B Harmath; John E Pandolfino; Peter J Kahrilas; Eric S Hungness Journal: Surg Endosc Date: 2015-10-20 Impact factor: 4.584
Authors: Ahmed M Sharata; Christy M Dunst; Radu Pescarus; Eran Shlomovitz; Aaron J T Wille; Kevin M Reavis; Lee L Swanström Journal: J Gastrointest Surg Date: 2014-09-03 Impact factor: 3.452