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Advances in Endoscopy ADVANCES IN ENDOSCOPY Current Developments in Diagnostic and Therapeutic Endoscopy Endoscopy Section Editor: Todd H. Baron, MD Endoscopic Approaches for the Treatment of Gastroesophageal Reflux Disease Ronnie Fass, MD Professor of Medicine, Case Western Reserve University Medical Director, Digestive Health Center Director, Division of Gastroenterology and Hepatology Head, Esophageal and Swallowing Center MetroHealth Medical Center Cleveland, Ohio G&H When should endoscopic therapy, rather Restech), the transoral incisionless fundoplication (TIF, than surgical therapy, be considered for the EndoGastric Solutions) procedure, and the Medigus treatment of gastroesophageal reflux disease? Ultrasonic Surgical Endostapler (MUSE, Medigus) pro- cedure. RF Endoscopic therapy for the treatment of gastroesoph- ageal reflux disease (GERD) has been in a great position G&H How are these procedures performed? for the last decade because fewer patients are interested in chronic medical therapy with proton pump inhibitors RF The Stretta procedure uses an endoluminal approach (PPIs) due to the potential for adverse events. Similarly, to deliver low-power, temperature-controlled, radiofre- more patients are looking for alternatives to antireflux quency energy into the gastroesophageal junction. A surgery because of concerns about potential short- and 4-channel radiofrequency generator and an esophageal long-term complications. Candidates for endoscopic catheter with a bougie tip with an expanded basket are therapy are those who exhibit typical symptoms of used to deploy 4 needle electrodes. The TIF procedure GERD, such as heartburn and regurgitation, and have employs the Esophyx Z device to create an anterior full- low-grade erosive esophagitis (Los Angeles Grades A and thickness fundoplication, constructing a valve 3 to 5 cm B), endoscopy negative with abnormal esophageal acid in length and 200 to 300 degrees in circumference. The exposure, a hiatal hernia smaller than 3 cm in size, and MUSE procedure also creates an anterior full-thickness at least a partial response to PPI treatment. Patients with fundoplication using a modified endoscope that incor- poor compliance with medical therapy, a desire to dis- porates a miniature camera, an ultrasound probe, and a continue medical therapy, or a preference for nonmedi- stapler on its tip. cal, nonsurgical therapy who are not interested in anti- reflux surgery and who meet the aforementioned criteria G&H How effective are endoscopic should be considered for endoscopic therapy for GERD. approaches compared with the use of PPIs or surgical therapy? G&H What endoscopic therapies are available for the treatment of GERD? RF Not many studies have compared the efficacy of endoscopic procedures to PPIs or surgical fundoplication. RF The currently used endoscopic therapies include an In a randomized, small sample trial, the TIF procedure endoscopic radiofrequency ablation procedure (Stretta, was compared to PPI therapy and was shown to control Gastroenterology & Hepatology Volume 15, Issue 10 October 2019 555 patients’ GERD symptoms and provide similar improve- G&H What are the most common adverse ment in esophageal acid exposure in the short term (6 events associated with endoscopic therapy? Endoscopy months). However, at 12 months, the TIF procedure How can complications be managed or normalized esophageal acid exposure in only 29% of the prevented? patients, and 61% of patients returned to PPIs. In a larger randomized, controlled trial, the TIF procedure was com- RF The complication rate of the TIF procedure ranges pared to PPI therapy in patients with GERD. Although between 3% and 10%. Major complications are uncom- both groups experienced a similar reduction in GERD- mon and may include bleeding, perforation, pneumo- related symptoms, patients in the TIF group demonstrat- thorax, mediastinal abscess, and mucosal tear. Addition- ed a significantly better control of regurgitation. al side effects include dysphagia, chest pain, sore throat, The MUSE procedure was compared to laparoscop- and bloating. Reports of complications after the MUSE ic fundoplication in a very small number of patients. procedure have been limited to very few studies. Major Those in the MUSE group had a longer procedure time complications may affect approximately 6% of patients and lengthier stay in the hospital. Additionally, more and include pneumothorax, esophageal leak, pneumo- patients used PPIs and fewer reported improvement in mediastinum, and bleeding. Minor adverse events may GERD health-related quality of life at 6 months post- affect up to 22% of patients and include dysphagia, chest procedure than did patients in the laparoscopic fundo- pain, and sore throat. Adverse events of the Stretta pro- plication group. cedure occur at a rate of approximately 1% and include When compared with antireflux surgery, the Stretta mucosal lacerations, erosions, prolonged gastroparesis, procedure showed similar control of GERD symptoms bleeding, pleural effusion, pneumonia, and mediastinal and reduction in PPI use, but had less effect on improv- inflammation. ing the typical GERD symptoms and had a higher rate Although complications from gastrointestinal pro- of repeat intervention after 3 years. cedures, including endoscopic therapy, are many times inevitable, steps should be taken to reduce them and G&H What are the main benefits and improve their outcome. Careful patient selection is piv- challenges associated with treating GERD via otal to improve clinical outcome and minimize adverse an endoscopic approach? events. Operators of the procedure should be well trained, highly experienced, provided with all the equipment and RF Presently, endoscopic procedures have a unique staff needed to perform the procedure, and have suffi- position in GERD management. There is a marked cient patient volume to ensure performance of the tech- decline in the number of surgical fundoplications per- nique on a regular basis. Major adverse events should be formed annually in the United States at a time when identified early, and proper therapy should be instituted more patients are interested in alternatives to chronic as soon as possible. Endoscopic or surgical interventions PPI treatment. The main benefit of endoscopic therapy may be needed in a very small subset of patients. is that it provides patients who cannot or do not wish to take chronic PPI treatment with a therapeutic option G&H How common is symptom recurrence, besides surgical intervention. Additional benefits are and are repeat interventions likely, with that these endoscopic approaches are outpatient proce- endoscopic therapy? dures, are less expensive than surgical intervention, are relatively safe, are effective at controlling GERD symp- RF Very few studies have prospectively investigated dif- toms, and can improve health-related quality of life. ferent data points that evaluated symptom recurrence The current challenges of endoscopic therapy over time, preventing clinicians from better assessing the include durability of the intervention, a lack of normal- durability of the procedures. In addition, symptomatic ization of esophageal acid exposure in most patients, and response may decrease over time following endoscopic a limited effect on healing erosive esophagitis as well as intervention without necessarily complete symptom lower esophageal sphincter basal pressure. Candidates recurrence. Of the patients undergoing the TIF pro- for endoscopic therapy are carefully selected and need cedure, after 1 year, between 15% and 58% reported to meet rigorous inclusion criteria. Endoscopic therapy having GERD symptoms. In the case of the MUSE should be performed by expert endoscopists who rou- procedure, approximately 27% of patients demon- tinely perform the procedures, with surgery as backup. strated GERD symptoms 2 years postprocedure. With Lastly, reimbursement of endoscopic therapy has been the Stretta procedure, which has the longest follow-up a great challenge and has somewhat limited the use of evaluation (>10 years), up to 42% of the patients dem- these procedures in clinical practice. onstrated GERD symptoms. 556 Gastroenterology & Hepatology Volume 15, Issue 10 October 2019 For both the TIF and the MUSE procedures, recur- the greater and lesser curvature, mucosal resection fol- rence of symptoms is either managed conservatively lowed by plication, and submucosal injection of a bio- with medical therapy or with surgical fundoplication. In compatible substance. Endoscopy the case of the Stretta procedure, symptom recurrence may also be treated with endoscopic intervention. G&H What are the priorities of research in this field? G&H In whom are these endoscopic approaches contraindicated? RF Durability assessment of all endoscopic procedures is still needed, especially for the TIF and MUSE tech- RF Endoscopic therapy should be avoided in morbidly niques. The value of these procedures in patients with obese patients; those who have scleroderma, a history of atypical and extraesophageal manifestations of GERD esophageal or gastric surgery, a major esophageal motor or in unique clinical scenarios, such as post–peroral disorder (eg, achalasia, jackhammer esophagus, absent endoscopic myotomy and post–sleeve gastrectomy, also contractility, distal esophageal spasm, and esophagogas- requires further research. tric junction outflow obstruction), an esophageal stric- ture, Barrett esophagus, or esophageal or gastric varices; Dr Fass serves as an advisor to Ironwood Pharmaceuticals, and in pregnant
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