title: Multicenter study on the safety of bariatric endoscopy.
abstract: BACKGROUND
  Bariatric endoscopy includes a series of specific techniques focused on the management of obese patients. As a quality criterion, safety as expressed by a minimal incidence of serious complications is required in addition to efficacy.
  
  
  METHODS
  A descriptive, retrospective, multicenter review of the experience recorded at seven hospitals included in the Grupo Español de Endoscopia Bariátrica (GETTEMO) in order to document the incidence, cause, and resolution (including legal consequences) of serious complications reported for each bariatric technique, and according to endoscopist expertise.
  
  
  RESULTS
  In all, 6,771 bariatric endoscopic procedures were collected, wherein 57 serious complications (0.84%) were identified. Balloons: Orbera®-Medsil®, 5/5,589; Spatz2® (older model): 44/225; Heliosphere®: 1/70; Obalon®: 0/107. Sutures: POSE®, 5/679; sleeve gastroplasty with Apollo® system: 0/55. Prostheses: Endobarrier®: 2/46. All complications were resolved with medical/endoscopic management except for five cases (0.07%) that required surgery. A single lawsuit occurred (esophageal perforation with Spatz2® balloon), which had a favorable outcome. There was no mortality, and apparently no differences were found according to endoscopist expertise level.
  
  
  CONCLUSIONS
  In our multicenter experience, bariatric endoscopy may be considered as a safe procedure (0.84% of serious complications in all). However, some devices may induce a higher proportion of complications, such as 19.55% for Spatz2® balloons (already replaced) or 4.34% for Endobarrier® sleeves (at the upper limit of accepted safety), although our experience with the latter is limited. All complications were resolved with conservative medical management, and only exceptionally required surgery (0.07%). No technique-related mortality was seen, and only one lawsuit occurred. Further evolutionary studies are required on the novel endoscopic techniques presently emerging to authenticate our results.
authors.affiliation: Aparato Digestivo, Gastrodex. Hospital Universitario Quiron Dexeus, España.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Espinet Coll
authors.affiliation: Clínica Diagonal. , España.
authors.forename: Javier
authors.initials: J
authors.lastname: Nebreda Durán
authors.affiliation: Hospital Madrid San Chinarro, España.
authors.forename: Gontrand
authors.initials: G
authors.lastname: López-Nava Breviere
authors.affiliation: Hospitales Viamed Montecanal de Aragón, España.
authors.forename: Julio
authors.initials: J
authors.lastname: Ducóns García
authors.affiliation: Clínica Arenal y Hospital San Agustín. , España.
authors.forename: Manuel
authors.initials: M
authors.lastname: Rodríguez-Téllez
authors.affiliation: Clínica Mompía y Hospital Universitario Marqués de Valdecilla. , España.
authors.forename: Javier
authors.initials: J
authors.lastname: Crespo García
authors.affiliation: Complejo Hospitalario de Navarra., España.
authors.forename: Carlos
authors.initials: C
authors.lastname: Marra-López Valenciano
mesh_terms: D050110:Bariatric Surgery / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D016099:Endoscopy, Gastrointestinal / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D009765:Obesity / Q000601:surgery*; D061214:Patient Safety / Q000706:statistics & numerical data*; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology / Q000628:therapy; D012189:Retrospective Studies; D016896:Treatment Outcome