TY - JOUR
T1 - Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease
T2 - a MAUDE database analysis
AU - Ramai, Daryl
AU - Shapiro, Alexandra
AU - Barakat, Mohamed
AU - Facciorusso, Antonio
AU - Dull, Adriane
AU - Chandan, Saurabh
AU - Adler, Douglas G.
N1 - Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2022/7
Y1 - 2022/7
N2 - 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.
AB - 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.
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U2 - 10.1007/s00464-021-08851-x
DO - 10.1007/s00464-021-08851-x
M3 - Article
C2 - 34750704
AN - SCOPUS:85118535735
VL - 36
SP - 4956
EP - 4959
JO - Surgical Endoscopy
JF - Surgical Endoscopy
SN - 0930-2794
IS - 7
ER -