Daryl Ramai1,2, Alexandra Shapiro2, Mohamed Barakat3, Antonio Facciorusso4, Adriane Dull2, Saurabh Chandan5, Douglas G Adler6. 1. Division of Gastroenterology & Hepatology, University of Utah Health, Salt Lake City, UT, USA. 2. Department of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA. 3. Division of Gastroenterology, The Brooklyn Hospital Center, Brooklyn, NY, USA. 4. Section of Gastroenterology, Department of Medical Sciences, University of Foggia, 71122, Foggia, Italy. 5. Division of Gastroenterology & Hepatology, CHI Health Creighton University Medical Center, Omaha, NE, USA. 6. Center for Advanced Therapeutic Endoscopy (CATE), Porter Adventist Hospital/PEAK Gastroenterology, Denver, CO, USA. dougraham2001@gmail.com.
Abstract
BACKGROUND: Transoral incisionless fundoplication (TIF) has been used for treating chronic gastroesophageal reflux disease (GERD) refractory to medical therapy. We aim to investigate the complications associated with TIF using a national database. METHODS: We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2011 through Jan 2021. RESULTS: During the study period, approximately 95 event cases reported to the FDA. Approximately 131 patient complications were identified. The number of adverse events declined from 2011 to 2016 (R2 = 0.96) but increased from 2016 to 2020 (R2 = 0.99). The most common adverse event was perforation (19.8%), followed by laceration 17.6%, bleeding (9.2%), and pleural effusion (9.2%). The most common patient complications were treated using endoscopic clips (12.3%), chest tube or drain insertion (12.3%), use of endoscopic retriever device (11.1%), esophageal stent (8.6%), and emergent or open surgery (11.1%). CONCLUSIONS: Adverse events from TIF range from mild to severe. Further research is needed to develop approaches aimed at reducing patient risks.
BACKGROUND: Transoral incisionless fundoplication (TIF) has been used for treating chronic gastroesophageal reflux disease (GERD) refractory to medical therapy. We aim to investigate the complications associated with TIF using a national database. METHODS: We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2011 through Jan 2021. RESULTS: During the study period, approximately 95 event cases reported to the FDA. Approximately 131 patient complications were identified. The number of adverse events declined from 2011 to 2016 (R2 = 0.96) but increased from 2016 to 2020 (R2 = 0.99). The most common adverse event was perforation (19.8%), followed by laceration 17.6%, bleeding (9.2%), and pleural effusion (9.2%). The most common patient complications were treated using endoscopic clips (12.3%), chest tube or drain insertion (12.3%), use of endoscopic retriever device (11.1%), esophageal stent (8.6%), and emergent or open surgery (11.1%). CONCLUSIONS: Adverse events from TIF range from mild to severe. Further research is needed to develop approaches aimed at reducing patient risks.