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Magnet-assist endoscopic augmentation of the lower esophageal sphincter for treatment of gastroesophageal reflux disease: cadaveric and survival studies in a porcine model (with video)

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Abstract

Background

Augmentation of the lower esophageal sphincter (LES) is the primary goal of both surgical and endoscopic therapies for gastroesophageal reflux disease (GERD). The feasibility, efficacy, safety, and reversibility of a newly developed endotherapy for GERD using intraluminal magnets referred to as a magnet closure device (MCD) were evaluated.

Methods

This study involved nine cadaveric and six survival pigs. The MCD consisted of a ring neodymium magnet attached to a 2–0 polypropylene suture and suture anchor. The MCD was deployed onto the esophageal wall at the region of the LES using an endoscopic suturing device. Two to three MCDs were placed on opposing walls to induce closure of the esophageal lumen. LES pressures were measured using high-resolution manometry at the index procedure (baseline and immediately post-MCD placement) and at survival endoscopy. Endoscopic removal of the devices was performed followed by necropsy at week 2.

Results

MCDs were successfully deployed in all cadaveric (n = 22) and survival animals (n = 12). In cadavers, 20/22 (91%) sutures were full-thickness with no adjacent organ injury. In survival animals, mean LES pressure increased from 8.4 mmHg (baseline) to 32.4 mmHg immediately post-procedure (p < 0.01). No clinically significant adverse events occurred. Repeat endoscopy at two weeks showed intact MCDs in 4/6 (67%) animals with significant increase in median LES pressure (n = 4, 24.0 mmHg versus 7.4 mmHg [baseline], p < 0.05). Endoscopic removal of MCDs was successfully achieved.

Conclusions

Endoscopic augmentation of the LES using a new MCD was feasible, safe and reversible with significantly increased LES pressures recorded. Future studies are needed to enhance durability. These preliminary results on a reversible technique are promising and may represent an attractive alternative to endoluminal GERD therapy.

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Abbreviations

GERD:

Gastroesophageal reflux disease

PPI:

Proton pump inhibitor

LES:

Lower esophageal sphincter

MCD:

Magnet closure device

NdFeB:

Neodymium iron boron

EGJ:

Esophagogastric junction

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Acknowledgement

This study was supported by a grant from the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN (Grant No: UL1TR002377).

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Authors and Affiliations

  1. Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA

    Akira Dobashi, Jodie L. Deters, Charles A. Miller, Crystal J. Lavey & Elizabeth Rajan

  2. Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan

    Akira Dobashi

Authors
  1. Akira Dobashi
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  2. Jodie L. Deters
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  3. Charles A. Miller
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  4. Crystal J. Lavey
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  5. Elizabeth Rajan
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Contributions

Study design, endoscopic procedure, data analysis, manuscript drafting: AD. Study design, data analysis and manuscript revision: ER. Manuscript review and data acquisition: JLD, CAM, CJL.

Corresponding author

Correspondence to Elizabeth Rajan.

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Disclosures

Akira Dobashi has intellectual property with Medtronic related to the magnet traction device. Elizabeth Rajan is a consultant of Medtronic and has intellectual property with Medtronic related to the magnet traction device. Jodie Deters, Charles Miller, Crystal Lavey have no conflicts of interest or financial ties to disclose.

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Endoscopic augmentation of the lower esophageal sphincter using a new magnet closure device(MCD) (MP4 25087 kb)

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Dobashi, A., Deters, J.L., Miller, C.A. et al. Magnet-assist endoscopic augmentation of the lower esophageal sphincter for treatment of gastroesophageal reflux disease: cadaveric and survival studies in a porcine model (with video). Surg Endosc 35, 4478–4484 (2021). https://doi.org/10.1007/s00464-020-07954-1

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  • DOI: https://doi.org/10.1007/s00464-020-07954-1

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