GUIDELINE Adverse events of upper GI endoscopy This is one of a series of statements discussing the use of lications rely on self-reporting, and most reported data GI endoscopy in common clinical situations. The Stan- collected only from the immediate periprocedure period, dards of Practice Committee of the American Society for thus the rate of late adverse events and mortality may be Gastrointestinal Endoscopy (ASGE) prepared this text. underestimated.8,9 Major adverse events related to diag- In preparing this document, a search of the medical liter- nostic UGI endoscopy are rare and include cardiopulmo- ature was performed by using PubMed. Additional refer- nary adverse events, infection, perforation, and bleeding. ences were obtained from the bibliographies of the identi- Adverse events of ERCP and EUS are discussed in separate fied articles and from recommendations of expert ASGE documents.10,11 consultants. When few or no data exist from well-designed prospective trials, emphasis is given to results of large series and reports from recognized experts. This document is ADVERSE EVENTS ASSOCIATED WITH based on a critical review of the available data and expert DIAGNOSTIC UGI ENDOSCOPY consensus at the time that the document was drafted. Further controlled clinical studies may be needed to clar- Cardiopulmonary adverse events ify aspects of this document. This document may be re- Most UGI procedures in the United States and Europe vised as necessary to account for changes in technology, are performed with patients under sedation (moderate or 12 new data, or other aspects of clinical practice. deep). Cardiopulmonary adverse events related to seda- This document is intended to be an educational device tion and analgesia account for as much as 60% of UGI 1-4,7 to provide information that may assist endoscopists in endoscopy adverse events. The rate of cardiopulmo- providing care to patients. This document is not a rule and nary adverse events in large, national studies is between 1 1-4,6,7 should not be construed as establishing a legal standard of in 170 and 1 in 10,000. Reported adverse events range care or as encouraging, advocating, requiring, or discour- from minor incidents, such as changes in oxygen satura- aging any particular treatment. Clinical decisions in any tion or heart rate, to significant adverse events such as particular case involve a complex analysis of the patient’s aspiration pneumonia, respiratory arrest, myocardial in- condition and available courses of action. Therefore, clin- farction, stroke, and shock. Patient-related risk factors for ical considerations may lead an endoscopist to take a cardiopulmonary adverse events include preexisting course of action that varies from this document. cardiopulmonary disease, advanced age, American So- ciety of Anesthesiologists class III or higher, and an Upper GI (UGI) endoscopy is commonly performed increased modified Goldman score.13,14 Procedure- and carries a low risk of adverse events. Large series report related risk factors for hypoxemia include difficulty with adverse event rates of 1 in 200 to 1 in 10,000 and mortality intubating the esophagus, a prolonged procedure, and a rates ranging from none to 1 in 2000.1-6 Data collected patient in the prone position.7,8,15,16 For a detailed dis- from the Clinical Outcomes Research Initiative database cussion and specific recommendations, the reader is show a cardiopulmonary event rate of 1 in 170 and a referred to the ASGE document “Sedation and Anesthe- mortality rate of 1 in 10,000 from among 140,000 UGI sia in GI Endoscopy”17 and the “American Society of endoscopic procedures.7 The variability in rates of adverse Anesthesiology Practice Guidelines for Sedation and events may be attributed to the method of data collection, Analgesia by Nonanesthesiologists.”18 patient populations, duration of follow-up, and definitions of adverse events. Some authors include minor incidents, such as transient hypoxemia or self-limited bleeding as Infectious adverse events adverse events, whereas others report only significant ad- Infectious adverse events of diagnostic UGI endoscopy verse events that prevent completion of the procedure or can result from either the procedure itself or failure to result in hospitalization.8 Additionally, the majority of pub- follow guidelines for the reprocessing and use of endo- scopic devices and accessories.19,20 Transient bacteremia as a result of diagnostic UGI endoscopy has been reported at rates as high as 8%, but the frequency of infectious Copyright © 2012 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 endocarditis and other clinical sequelae is extremely 21,22 http://dx.doi.org/10.1016/j.gie.2012.03.252 low. Current American Heart Association and ASGE guidelines do not recommend antibiotic prophylaxis with www.giejournal.org Volume 76, No. 4 : 2012 GASTROINTESTINAL ENDOSCOPY 707 Adverse events of upper GI endoscopy diagnostic UGI endoscopy solely to prevent infectious propriate, placement of an endotracheal tube for airway endocarditis.20,23 protection. Although the incidence of bacteremia with UGI dilation ranges from 12% to 22%, infectious sequelae Perforation are rare.47 Therefore, antibiotic prophylaxis is not Prospective, multicenter registries report perforation recommended.20 rates of 1 in 2500 to 1 in 11,000.4,24 Factors predisposing to Dilation of esophageal strictures. The most com- perforation include the presence of anterior cervical os- mon adverse events of esophageal dilation are perforation teophytes, Zenker’s diverticulum, esophageal stricture, and bleeding. Wire-guided bougie dilation or through-the- malignancies of the UGI tract, and duodenal divertic- scope balloon dilation may have lower risks of adverse ula.24,25 Perforation of the esophagus is associated with a events than blind passage of dilators.42 Randomized trials mortality rate between 2% and 36%.26-29 Early identifica- suggest that wire-guided polyvinyl dilators and through- tion and expeditious management of a perforation have the-scope balloons have similar rates of both efficacy and been shown to decrease associated morbidity and adverse events.41,44,48,49 mortality.29,30 The rate of perforation after esophageal dilation for esophageal rings and simple peptic strictures is lower than Bleeding that of certain high-risk lesions. Dilation of complex stric- Clinically significant bleeding is a rare adverse event of tures (angulated, multiple, or long) with Maloney dilators diagnostic UGI endoscopy.31 Mallory-Weiss tears occur in may be associated with a 2% to 10% risk of perforation50,51 less than 0.5% of diagnostic UGI endoscopic procedures so wire-guided or balloon dilation is likely a safer alterna- and usually are not associated with significant bleeding.32 tive.42 Dilation of caustic strictures, which tend to be long Bleeding may be more likely in individuals with thrombo- and angulated, is associated with a higher rate of adverse cytopenia and/or coagulopathy.1 The minimum threshold events.52,53 Dilation of eosinophilic esophagitis is associ- platelet count for the performance of diagnostic UGI en- ated with a high incidence of mucosal tears, but only 1 doscopy has not been established. UGI endoscopy with perforation was identified in a systematic review of 671 biopsy was shown to be safe in 1 study of adults with solid dilations for eosinophilic esophagitis.54 The risk of perfo- malignancies and platelet counts greater than 20,000/mL.33 ration resulting from dilation of malignant strictures of the Two case series of UGI endoscopy with or without biop- esophagus is approximately 10%55,56 and is associated sies in children with platelet counts greater than with increasing dilator diameter.56-59 Radiation-induced 50,000/mL reported no bleeding adverse events.34,35 How- strictures have also been reported to have a high rate of ever, a larger study of 198 UGI endoscopies in children dilation-related adverse events,60 but this risk may be re- after stem cell transplantation demonstrated that the risk of lated to the presence of malignancy rather than the effect bleeding requiring red blood cell transfusions after UGI of radiation.61 endoscopic biopsies was 4% despite a minimum platelet Pain is the most common symptom related to perfora- count of 50,000/mL.36 Four of these 8 patients were found tion.25,26,62,63 Fever, crepitus, pleuritic chest pain, leukocy- to have duodenal hematomas. Thus, some authors have tosis, and pleural effusion may also be present. Perforation concluded that diagnostic UGI endoscopy can be per- with associated air dissection may be diagnosed by plain formed when the platelet level is 20,000/mL or greater and radiography of the neck and/or chest, but such findings that a threshold of 50,000/mL should be considered before may be absent immediately after perforation.64 If a perfo- performing biopsies.37-40 ration is suspected, contrast esophagography should be performed, usually beginning with water-soluble con- ADVERSE EVENTS OF ENDOSCOPIC trast.65 If the site of perforation cannot be determined but INTERVENTIONS suspicion remains high, a barium esophagram or CT scan of the chest is indicated. A CT scan with oral contrast is Adverse events of UGI dilation sensitive for the site of perforation and for more subtle Data from randomized trials and large case series sug- findings such as minute amounts of air or fluid.66 gest that the overall rate of dilation adverse events is The approach to the patient with perforation depends between 0.1% and 0.4%.1,41-44 The most common