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Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease: a MAUDE database analysis

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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.

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Authors and Affiliations

  1. Division of Gastroenterology & Hepatology, University of Utah Health, Salt Lake City, UT, USA

    Daryl Ramai

  2. Department of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA

    Daryl Ramai, Alexandra Shapiro & Adriane Dull

  3. Division of Gastroenterology, The Brooklyn Hospital Center, Brooklyn, NY, USA

    Mohamed Barakat

  4. Section of Gastroenterology, Department of Medical Sciences, University of Foggia, 71122, Foggia, Italy

    Antonio Facciorusso

  5. Division of Gastroenterology & Hepatology, CHI Health Creighton University Medical Center, Omaha, NE, USA

    Saurabh Chandan

  6. Center for Advanced Therapeutic Endoscopy (CATE), Porter Adventist Hospital/PEAK Gastroenterology, Denver, CO, USA

    Douglas G. Adler

Authors
  1. Daryl Ramai
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  2. Alexandra Shapiro
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  3. Mohamed Barakat
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  4. Antonio Facciorusso
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  5. Adriane Dull
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  6. Saurabh Chandan
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  7. Douglas G. Adler
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Corresponding author

Correspondence to Douglas G. Adler.

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Disclosures

Drs. Daryl Ramai, Alexandra Shapiro, Mohamed Barakat, Antonio Facciorusso, Adriane Dull, Saurabh Chandan, and Douglas G. Adler have no conflicts of interest or financial ties to disclose.

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Ramai, D., Shapiro, A., Barakat, M. et al. Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease: a MAUDE database analysis. Surg Endosc 36, 4956–4959 (2022). https://doi.org/10.1007/s00464-021-08851-x

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  • DOI: https://doi.org/10.1007/s00464-021-08851-x

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