Peroral endoscopic myotomy safety data

The safety profile of a therapeutic procedure is almost more important than its efficacy. This concept is particularly true for those developing procedures, like Peroral Endoscopic Myotomy (POEM), which are supposed to mimic and reproduce what is usually done by a surgical operation that is recognized as the therapeutic gold standard. The first human POEM was performed in 2008 in Japan. Since then, few groups of investigators have begun to perform POEM and have published their preliminary experiences. The published results are encouraging, demonstrating good results of safety and efficacy. Pneumoperitoneum, pneumomediastinum, small perforations of the mucosal flap, and mild bleeding are very frequent events during POEM, but should not be considered as significant complications, because they are self-limited or can be managed during the procedure, and do not substantially alter the postoperative course. Few significant complications have been reported in the literature including aspiration pneumonia, mediastinal hematoma, delayed hemorrhage, pneumothorax, esophageal perforation, peritonitis, and dehiscence of the esophageal closure. No mortality has been reported to date. Analysis of the published series confirms the excellent safety profile of the POEM procedure. Some clinical points appear to be of significant importance, in terms of safety, especially the use of carbon dioxide instead of room air for insufflation and meticulous hemostasis during the procedure. Thorough cleaning of the esophagus and antibiotic prophylaxis may play significant roles in the prevention of infections. © 2013 Elsevier Inc.