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Endoscopic full-thickness plication for the treatment of GERD: Five-year long-term multicenter results

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Abstract

Background

The Plicator™ (NDO Surgical, Inc., Mansfield, MA) endoscopically places a full-thickness permanent suture to augment the antireflux barrier. At 3-years post-treatment, published results demonstrated a reduction in subjects’ gastroesophageal reflux disease (GERD) symptoms and related medication use.

Aim

To evaluate the Plicator’s safety and durability of effect at improving GERD symptoms at 5-years post-treatment.

Methods

A total of 33 chronic GERD sufferers across seven sites were followed for approximately 5 years (median follow-up: 59 months, range 50–65 months) after receiving a single full-thickness plication approximately 1 cm below the gastroesophageal (GE) junction in the anterior gastric cardia. At baseline, 30 out of 33 subjects required daily proton-pump inhibitor (PPI) therapy.

Results

Of the subjects who were PPI dependent prior to treatment 67% (20/30) remained off daily PPI therapy at 60 months and 5-year median GERD health-related quality-of-life (HRQL) scores show significant improvement from baseline off-meds scores (10 versus 19, p < 0.001). Additionally, 50% (16/32) of subjects achieved ≥ 50% score improvement in GERD-HRQL. No new adverse events were identified and all device-related events occurred acutely. These results were comparable to the results seen at 36 months follow-up.

Conclusions

Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 5-years post procedure with no long-term adverse events post treatment.

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Acknowledgments

Grant Support: supported by NDO Surgical, Inc., Mansfield, MA USA

Author information

Authors and Affiliations

  1. Beth Israel Deaconess Medical Center, 330 Brookline Avenue, DA-501, Boston, MA, 02215, USA

    Douglas Pleskow & Anthony Lembo

  2. Dartmouth Hitchcock Medical Center, Lebanon, NH, USA

    Richard Rothstein

  3. Virginia Mason Medical Center, Seattle, WA, USA

    Richard Kozarek

  4. Lenox Hill Hospital, New York, NY, USA

    Gregory Haber

  5. Mayo Clinic, Rochester, MN, USA

    Christopher Gostout

  6. Cedars Sinai Medical Center, Los Angeles, CA, USA

    Simon Lo

  7. Medical University of South Carolina, Charleston, SC, USA

    Robert Hawes

Authors
  1. Douglas Pleskow
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  2. Richard Rothstein
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  3. Richard Kozarek
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  4. Gregory Haber
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  5. Christopher Gostout
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  6. Simon Lo
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  7. Robert Hawes
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  8. Anthony Lembo
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Corresponding author

Correspondence to Anthony Lembo.

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Pleskow, D., Rothstein, R., Kozarek, R. et al. Endoscopic full-thickness plication for the treatment of GERD: Five-year long-term multicenter results. Surg Endosc 22, 326–332 (2008). https://doi.org/10.1007/s00464-007-9667-0

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  • DOI: https://doi.org/10.1007/s00464-007-9667-0

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