PMID- 28534521 OWN - NLM STAT- MEDLINE DCOM- 20170825 LR - 20220318 IS - 1572-0241 (Electronic) IS - 0002-9270 (Linking) VI - 112 IP - 8 DP - 2017 Aug TI - Comprehensive Analysis of Adverse Events Associated With Per Oral Endoscopic Myotomy in 1826 Patients: An International Multicenter Study. PG - 1267-1276 LID - 10.1038/ajg.2017.139 [doi] AB - 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. FAU - Haito-Chavez, Yamile AU - Haito-Chavez Y AD - Division of Gastroenterology and Hepatology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. FAU - Inoue, Haruhiro AU - Inoue H AD - Digestive Diseases Center, Showa University Koto-Toyosu Hospital, Tokyo, Japan. FAU - Beard, Kristin W AU - Beard KW AD - The Oregon Clinic, Oregon, Oregon, USA. FAU - Draganov, Peter V AU - Draganov PV AD - Division of Gastroenterology and Hepatology, University of Florida College of Medicine, Gainesville, Florida, USA. FAU - Ujiki, Michael AU - Ujiki M AD - Department of Surgery, NorthShore University Health System, Evanston, Illinois, USA. FAU - Rahden, Burkhard H A AU - Rahden BHA AD - Department of General, Visceral, Vascular and Pediatric Surgery, University Medical Center, Wirzburg, Germany. FAU - Desai, Pankaj N AU - Desai PN AD - Surat Institute of Digestive Sciences, Surat, India. FAU - Pioche, Mathieu AU - Pioche M AD - Universite de Lyon and Hospices Civils de Lyon, Digestive Physiology, E Herriot Hospital, Lyon, France. FAU - Hayee, Bu AU - Hayee B AD - Department of Gastroenterology, King's College Hospital NHS Foundation Trust, London, UK. FAU - Haji, Amyn AU - Haji A AD - Department of Gastroenterology, King's College Hospital NHS Foundation Trust, London, UK. FAU - Saxena, Payal AU - Saxena P AD - Department of Gastroenterology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia. FAU - Reavis, Kevin AU - Reavis K AD - The Oregon Clinic, Oregon, Oregon, USA. FAU - Onimaru, Manabu AU - Onimaru M AD - Digestive Diseases Center, Showa University Koto-Toyosu Hospital, Tokyo, Japan. FAU - Balassone, Valerio AU - Balassone V AD - Digestive Diseases Center, Showa University Koto-Toyosu Hospital, Tokyo, Japan. FAU - Nakamura, Jun AU - Nakamura J AD - Digestive Diseases Center, Showa University Koto-Toyosu Hospital, Tokyo, Japan. FAU - Hata, Yoshitaka AU - Hata Y AD - Digestive Diseases Center, Showa University Koto-Toyosu Hospital, Tokyo, Japan. FAU - Yang, Dennis AU - Yang D AD - Division of Gastroenterology and Hepatology, University of Florida College of Medicine, Gainesville, Florida, USA. FAU - Pannu, Davinderbir AU - Pannu D AD - Division of Gastroenterology and Hepatology, University of Florida College of Medicine, Gainesville, Florida, USA. FAU - Abbas, Ali AU - Abbas A AD - Division of Gastroenterology and Hepatology, University of Florida College of Medicine, Gainesville, Florida, USA. FAU - Perbtani, Yaseen B AU - Perbtani YB AD - Division of Gastroenterology and Hepatology, University of Florida College of Medicine, Gainesville, Florida, USA. FAU - Patel, Lava Y AU - Patel LY AD - Department of Surgery, NorthShore University Health System, Evanston, Illinois, USA. FAU - Filser, Jorg AU - Filser J AD - Department of General, Visceral, Vascular and Pediatric Surgery, University Medical Center, Wirzburg, Germany. FAU - Roman, Sabine AU - Roman S AD - Universite de Lyon and Hospices Civils de Lyon, Digestive Physiology, E Herriot Hospital, Lyon, France. FAU - Rivory, Jerome AU - Rivory J AD - Universite de Lyon and Hospices Civils de Lyon, Digestive Physiology, E Herriot Hospital, Lyon, France. FAU - Mion, Francois AU - Mion F AD - Universite de Lyon and Hospices Civils de Lyon, Digestive Physiology, E Herriot Hospital, Lyon, France. FAU - Ponchon, Thierry AU - Ponchon T AD - Universite de Lyon and Hospices Civils de Lyon, Digestive Physiology, E Herriot Hospital, Lyon, France. FAU - Perretta, Silvana AU - Perretta S AD - Department of Gastrointestinal and Endocrine Surgery, University of Strasbourg, Strasbourg, France. FAU - Wong, Vivien AU - Wong V AD - Department of Gastrointestinal and Endocrine Surgery, University of Strasbourg, Strasbourg, France. FAU - Maselli, Roberta AU - Maselli R AD - Gastroenterology, Humanitas Clinical and Research Hospital, IRCCS, Rozzano, Italy. FAU - Ngamruengphong, Saowanee AU - Ngamruengphong S AD - Division of Gastroenterology and Hepatology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. FAU - Chen, Yen-I AU - Chen YI AD - Division of Gastroenterology and Hepatology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. FAU - Bukhari, Majidah AU - Bukhari M AD - Division of Gastroenterology and Hepatology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. FAU - Hajiyeva, Gulara AU - Hajiyeva G AD - Division of Gastroenterology and Hepatology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. FAU - Ismail, Amr AU - Ismail A AD - Division of Gastroenterology and Hepatology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. FAU - Pieratti, Renata AU - Pieratti R AD - Division of Gastroenterology and Hepatology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. FAU - Kumbhari, Vivek AU - Kumbhari V AD - Division of Gastroenterology and Hepatology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. FAU - Galdos-Cardenas, Gerson AU - Galdos-Cardenas G AD - The International Health Department-Global Disease Epidemiology and Control-The Johns Hopkins School of Public Health, Baltimore, Maryland, USA. FAU - Repici, Alessandro AU - Repici A AD - Gastroenterology, Humanitas Clinical and Research Hospital, IRCCS, Rozzano, Italy. FAU - Khashab, Mouen A AU - Khashab MA AD - Division of Gastroenterology and Hepatology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20170523 PL - United States TA - Am J Gastroenterol JT - The American journal of gastroenterology JID - 0421030 SB - IM MH - Adult MH - Aged MH - Case-Control Studies MH - Cohort Studies MH - Endoscopy/*adverse effects MH - Esophageal Achalasia/*surgery MH - Female MH - Humans MH - Incidence MH - Male MH - Middle Aged MH - Postoperative Complications/*epidemiology MH - Treatment Outcome EDAT- 2017/05/24 06:00 MHDA- 2017/08/26 06:00 CRDT- 2017/05/24 06:00 PHST- 2016/10/08 00:00 [received] PHST- 2017/03/02 00:00 [accepted] PHST- 2017/05/24 06:00 [pubmed] PHST- 2017/08/26 06:00 [medline] PHST- 2017/05/24 06:00 [entrez] AID - ajg2017139 [pii] AID - 10.1038/ajg.2017.139 [doi] PST - ppublish SO - Am J Gastroenterol. 2017 Aug;112(8):1267-1276. doi: 10.1038/ajg.2017.139. Epub 2017 May 23.