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

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Abstract

Background

The purpose of the present study was to assess the long-term safety and durability of effect for endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux disease (GERD). The Plicator (NDO Surgical, Inc., Mansfield, MA) used delivers a transmural suture through the gastric cardia to restructure the antireflux barrier. Published reports have shown the Plicator procedure to be effective in reducing GERD symptoms and medication use at 1 year post-plication.

Methods

Twenty-nine patients with chronic heartburn requiring maintenance daily anti-secretory therapy were treated at five sites. Patients received a single full-thickness plication in the gastric cardia 1cm below the gastroesophageal junction (GE) junction. Re-treatments were not permitted. Patients were evaluated at baseline for GERD symptoms and medication use. Intermediate (12 month) and long-term subject follow-up (median follow-up: 36.4 months; range, 31.2–43.9 months) were completed to evaluate procedure safety and durability of effect.

Results

Twenty-nine patients completed the 12-month and 36-month follow-up. All procedure-related adverse events occurred acutely, and no new events were observed during extended follow-up. At 36-months post-procedure, 57% (16/28) of baseline proton pump inhibitor (PPI)-dependent patients remained off daily PPI therapy. Treatment effect remained stable from 12- to 36-months, with 21/29 patients off daily PPI at 12 months compared to 17/29 patients at 36-months. Median GERD- Health Related Quality of Life (HRQL) scores remained significantly improved at 36 months versus baseline off-meds scores (8 versus 19, p < 0.001). In addition, the proportion of patients achieving ≥ 50% improvement in GERD-HRQL score was consistent from 12 months (59%) to 36 months (55%).

Conclusions

Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 3-years post-procedure. Treatment effect is stable from 1 to 3 years, and there are no long-term procedural adverse effects.

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Acknowledgments

This work was supported by a grant from NDO Surgical, Inc., Mansfield, MA, USA.

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Authors and Affiliations

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

    D. Pleskow & A. Lembo

  2. Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive, Lebanon, New Hampshire, 03756, USA

    R. Rothstein

  3. Virginia Mason Medical Center, 904 7th Avenue, Seattle, Washington, 98104, USA

    R. Kozarek

  4. Lenox Hill Hospital, 100 East 77th Street, New York, New York, 10021, USA

    G. Haber

  5. Mayo Clinic, 200 First Street, SW, Rochester, Minnesota , 55905, USA

    C. Gostout

Authors
  1. D. Pleskow
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  2. R. Rothstein
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  3. R. Kozarek
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  4. G. Haber
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  5. C. Gostout
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  6. A. Lembo
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Corresponding author

Correspondence to A. Lembo.

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Pleskow, D., Rothstein, R., Kozarek, R. et al. Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results. Surg Endosc 21, 439–444 (2007). https://doi.org/10.1007/s00464-006-9121-8

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  • DOI: https://doi.org/10.1007/s00464-006-9121-8

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