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Transoral incisionless fundoplication for recurrent symptoms after laparoscopic fundoplication

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Abstract

Background

Revision of a failed laparoscopic fundoplication carries higher risk of complication and lower chance of success compared to the original surgery. Transoral incisionless fundoplication (TIF) may be an endoscopic alternative for select GERD patients without need of a moderate/large hiatal hernia repair. The aim of this study was to assess feasibility, efficacy, and safety of TIF 2.0 after failed laparoscopic Nissen or Toupet fundoplication (TIFFF).

Methods

This is a multicenter retrospective cohort study of patients who underwent TIFFF between September 2017 and December 2020 using TIF 2.0 technique (EsophyX Z/Z+) performed by gastroenterologists and surgeons. Patients were included if they had (1) recurrent GERD symptoms, (2) pathologic reflux based upon pH testing or Grade C/D esophagitis or Barrett’s esophagus, and (3) hiatal hernia ≤ 2 cm. The primary outcome was improvement in GERD Health-Related Quality of Life (GERD-HRQL) post-TIFFF. The TIFFF cohort was also compared to a similar surgical re-operative cohort using propensity score matching.

Results

Twenty patients underwent TIFFF (median 4.1 years after prior fundoplication) and mean GERD-HRQL score improved from 24.3 ± 22.9 to 14.75 ± 21.6 (p = 0.014); mean Reflux Severity Index (RSI) score improved from 14.1 ± 14.6 to 9.1 ± 8.0 (p = 0.046) with 8/10 (80%) of patients with normal RSI (< 13) post-TIF. Esophagitis healed in 78% of patients. PPI use decreased from 85 to 55% with 8/20 (45%) patients off of PPI. Importantly, mean acid exposure time decreased from 12% ± 17.8 to 0.8% ± 1.1 (p = 0.028) with 9/9 (100%) of patients with normalized pH post-TIF. There were no statistically significant differences in clinical efficacy outcomes between TIFFF and surgical revision, but TIFFF had significantly fewer late adverse events.

Conclusion

Endoscopic rescue with TIF is a safe and efficacious alternative to redo laparoscopic surgery in symptomatic patients with appropriate anatomy and objective evidence of persistent or recurrent reflux.

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Abbreviations

BMI:

Body mass index

GERD:

Gastroesophageal reflux disease

GERD-HRQL:

GERD Health-Related Quality of Life

LNF:

Laparoscopic Nissen fundoplication

PPI:

Proton pump inhibitor

RSI:

Reflux Symptom Index

TIF:

Transoral incisionless fundoplication

TIFF:

Transoral incisionless fundoplication after failed fundoplication

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Acknowledgements

TIF Research Consortium: Cheguevara Afaneh, Daniella Assis, Christy Dunst, Jon Gabrielsen, Olaya Brewer Gutierrez, Glen Ihde, Harshit Khara, Jennifer Kolb, Michael Marohn, Jason Samarasena, and Erik Wilson.

Funding

This investigator-initiated study was supported in part by the Johns Hopkins Heartburn Center (TIF Registry) and Endogastric Solutions. Endogastric Solutions was not involved in the design, conduct, or analysis of the data and preparation of the manuscript.

Author information

Author notes

  1. Gaurav Ghosh and Alyssa Y. Choi are co-first authors.

Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, New York-Presbyterian Hospital/Weill Cornell Medicine, 1283 York Ave, 9th Floor, New York, NY, 10065, USA

    Gaurav Ghosh & Reem Sharaiha

  2. HH Chao Comprehensive Digestive Disease Center, University of California Irvine Medical Center, Orange, CA, USA

    Alyssa Y. Choi & Kenneth J. Chang

  3. Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, MD, USA

    Mohamad Dbouk & Marcia Irene Canto

  4. Department of Surgery, New York-Presbyterian Hospital/Weill Cornell Medicine, New York, NY, USA

    Jacques Greenberg & Rasa Zarnegar

  5. Northern Nevada Medical Group, Fallon, NV, USA

    Michael Murray

  6. Fox Valley Surgical Associates, Affinity Health Systems, Appleton, WI, USA

    Peter Janu

  7. Center for Interventional Gastroenterology at UTHealth, McGovern Medical School, UTHealth, Houston, TX, USA

    Nirav Thosani

  8. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA

    Barham K. Abu Dayyeh

  9. Department of Gastroenterology and Nutrition, Geisinger Medical Center, Danville, PA, USA

    David Diehl

  10. Department of Surgery, University of California Irvine Medical Center, Orange, CA, USA

    Ninh T. Nguyen

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  1. Gaurav Ghosh
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Consortia

the TIF Research Consortium

Contributions

GG and AC participated in the study conception and design; JG, RZ, MM, PJ, NT, BKA, DD, NTN, and KC participated in the acquisition of data; GG participated in the analysis of data; GG and MD participated in the interpretation of data; GG and AC participated in the drafting of manuscript; DD, MD, and RZ participated in the revision of manuscript; MC and RS participated in the final revision and approval of manuscript.

Corresponding author

Correspondence to Gaurav Ghosh.

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Disclosures

Michael Murray is a Consultant for Endogastric solutions. Peter Janu is a Consultant and speaker in Endogastric Solutions, Ethicon, J&J, and Olympus. Barham K. Abu-Dayyeh is a Consultant for Endogenex, Endo-TAGSS, Metamodix, and BFKW; receives Consulting and grant/research support from USGI, Cairn Diagnostics, Aspire Bariatrics, and Boston Scientific; speaker in Olympus and Johnson and Johnson; and receives Speaker and rant/research support from Medtronic and Endogastric solutions and research support from Apollo Endosurgery, and Spatz Medical. David Diehl is a Consultant and speaker for Olympus, Boston Scientific, Cook Medical, Cernostics, GI Supply, Lumendi, Microtek, Actuated Medical, and Pentax. Rasa Zarnegar is a Consultant for Bard. Ninh T. Nguyen is a Speaker for Endogastric Solutions and Olympus. Kenneth J. Chang is a Consultant for Apollo, Boston Scientific, Cook Medical, Erbe, Endogastric Solutions, Mauna Kea, Medtronic, Olympus, Ovesco Endoscopy, and Pentax. Marcia Irene Canto receives research grant from Endogastric Solutions. Reem Sharaiha is a Consultant for Boston scientific, Olympus, and Cook Medical. Drs. Gaurav Ghosh, Alyssa Choi, Mohamad Dbouk, Jacques Greenberg, and Nirav Thosani have no conflicts of interest or financial ties to disclose.

Ethical approval

Granted for this study by each center’s respective Institutional Review Board.

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The members of TIF Research Consortium have been listed in acknowledgements.

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Ghosh, G., Choi, A.Y., Dbouk, M. et al. Transoral incisionless fundoplication for recurrent symptoms after laparoscopic fundoplication. Surg Endosc 37, 3701–3709 (2023). https://doi.org/10.1007/s00464-023-09880-4

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