Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: Final results of open-label prospective trial

Leonardo Rodríguez, Patricia Rodriguez, Beatriz Gómez, Juan C. Ayala, Jorge Saba, Alberto Perez-Castilla, Manoel Galvao Neto, Michael D. Crowell

Research output: Contribution to journalArticle

44 Citations (Scopus)

Abstract

Background: Electrical stimulation of the lower esophageal sphincter (LES) improves LES pressure without interfering with LES relaxation. The aim of this open-label pilot trial was to evaluate the safety and efficacy of long-term LES stimulation using a permanently implanted LES stimulator in patients with gastroesophageal reflux disease (GERD). Methods: GERD patients who were at least partially responsive to proton pump inhibitors (PPI) with abnormal esophageal pH, hiatal hernia ≤3 cm, and esophagitis ≤LA grade C were included. Bipolar stitch electrodes were placed in the LES and an IPG was placed in a subcutaneous pocket. Electrical stimulation was delivered at 20 Hz, 215 μs, 3-8 mA in 30 min sessions. The number and timing of sessions was tailored to each patient's GERD profile. Patients were evaluated using GERD-HRQL, daily symptom and medication diaries, SF-12, esophageal pH, and high-resolution manometry. Results: 24 patients (mean age = 53 years, SD = 12 years; 14 men) were implanted; 23 completed their 6-month evaluation. Median GERD-HRQL scores at 6 months was 2.0 (IQR = 0-5.5) and was significantly better than both baseline on-PPI [9.0 (range = 6.0-10.0); p < 0.001] and off-PPI [23 (21-25); p < 0.001] GERD-HRQL. Median% 24-h esophageal pH < 4.0 at baseline was 10.1 and improved to 5.1 at 6 months (p < 0.001). At their 6-month follow-up, 91 % (21/23) of the patients were off PPI and had significantly better median GERD-HRQL on LES stimulation compared to their on-PPI GERD-HRQL at baseline (9.0 vs. 2.0; p < 0.001). There were no unanticipated implantation- or stimulation-related adverse events or untoward sensation due to stimulation. There were no reports of treatment-related dysphagia, and manometric swallow was also unaffected. Conclusions: Electrical stimulation of the LES is safe and effective for treating GERD. There is a significant and sustained improvement in GERD symptoms, esophageal pH, and reduction in PPI usage without any side effects with the therapy. Furthermore, the therapy can be optimized to address an individual patient's disease.

Original languageEnglish (US)
Pages (from-to)1083-1092
Number of pages10
JournalSurgical Endoscopy and Other Interventional Techniques
Volume27
Issue number4
DOIs
StatePublished - Apr 2013

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Electric Stimulation Therapy
Lower Esophageal Sphincter
Gastroesophageal Reflux
Proton Pump Inhibitors
Electric Stimulation
Hiatal Hernia
Esophagitis
Manometry
Deglutition
Deglutition Disorders
Electrodes
Therapeutics

Keywords

  • Electrical stimulation
  • GERD
  • Refractory GERD
  • Surgical treatment

ASJC Scopus subject areas

  • Surgery

Cite this

Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD : Final results of open-label prospective trial. / Rodríguez, Leonardo; Rodriguez, Patricia; Gómez, Beatriz; Ayala, Juan C.; Saba, Jorge; Perez-Castilla, Alberto; Galvao Neto, Manoel; Crowell, Michael D.

In: Surgical Endoscopy and Other Interventional Techniques, Vol. 27, No. 4, 04.2013, p. 1083-1092.

Research output: Contribution to journalArticle

Rodríguez, Leonardo ; Rodriguez, Patricia ; Gómez, Beatriz ; Ayala, Juan C. ; Saba, Jorge ; Perez-Castilla, Alberto ; Galvao Neto, Manoel ; Crowell, Michael D. / Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD : Final results of open-label prospective trial. In: Surgical Endoscopy and Other Interventional Techniques. 2013 ; Vol. 27, No. 4. pp. 1083-1092.
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abstract = "Background: Electrical stimulation of the lower esophageal sphincter (LES) improves LES pressure without interfering with LES relaxation. The aim of this open-label pilot trial was to evaluate the safety and efficacy of long-term LES stimulation using a permanently implanted LES stimulator in patients with gastroesophageal reflux disease (GERD). Methods: GERD patients who were at least partially responsive to proton pump inhibitors (PPI) with abnormal esophageal pH, hiatal hernia ≤3 cm, and esophagitis ≤LA grade C were included. Bipolar stitch electrodes were placed in the LES and an IPG was placed in a subcutaneous pocket. Electrical stimulation was delivered at 20 Hz, 215 μs, 3-8 mA in 30 min sessions. The number and timing of sessions was tailored to each patient's GERD profile. Patients were evaluated using GERD-HRQL, daily symptom and medication diaries, SF-12, esophageal pH, and high-resolution manometry. Results: 24 patients (mean age = 53 years, SD = 12 years; 14 men) were implanted; 23 completed their 6-month evaluation. Median GERD-HRQL scores at 6 months was 2.0 (IQR = 0-5.5) and was significantly better than both baseline on-PPI [9.0 (range = 6.0-10.0); p < 0.001] and off-PPI [23 (21-25); p < 0.001] GERD-HRQL. Median{\%} 24-h esophageal pH < 4.0 at baseline was 10.1 and improved to 5.1 at 6 months (p < 0.001). At their 6-month follow-up, 91 {\%} (21/23) of the patients were off PPI and had significantly better median GERD-HRQL on LES stimulation compared to their on-PPI GERD-HRQL at baseline (9.0 vs. 2.0; p < 0.001). There were no unanticipated implantation- or stimulation-related adverse events or untoward sensation due to stimulation. There were no reports of treatment-related dysphagia, and manometric swallow was also unaffected. Conclusions: Electrical stimulation of the LES is safe and effective for treating GERD. There is a significant and sustained improvement in GERD symptoms, esophageal pH, and reduction in PPI usage without any side effects with the therapy. Furthermore, the therapy can be optimized to address an individual patient's disease.",
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T2 - Final results of open-label prospective trial

AU - Rodríguez, Leonardo

AU - Rodriguez, Patricia

AU - Gómez, Beatriz

AU - Ayala, Juan C.

AU - Saba, Jorge

AU - Perez-Castilla, Alberto

AU - Galvao Neto, Manoel

AU - Crowell, Michael D.

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N2 - Background: Electrical stimulation of the lower esophageal sphincter (LES) improves LES pressure without interfering with LES relaxation. The aim of this open-label pilot trial was to evaluate the safety and efficacy of long-term LES stimulation using a permanently implanted LES stimulator in patients with gastroesophageal reflux disease (GERD). Methods: GERD patients who were at least partially responsive to proton pump inhibitors (PPI) with abnormal esophageal pH, hiatal hernia ≤3 cm, and esophagitis ≤LA grade C were included. Bipolar stitch electrodes were placed in the LES and an IPG was placed in a subcutaneous pocket. Electrical stimulation was delivered at 20 Hz, 215 μs, 3-8 mA in 30 min sessions. The number and timing of sessions was tailored to each patient's GERD profile. Patients were evaluated using GERD-HRQL, daily symptom and medication diaries, SF-12, esophageal pH, and high-resolution manometry. Results: 24 patients (mean age = 53 years, SD = 12 years; 14 men) were implanted; 23 completed their 6-month evaluation. Median GERD-HRQL scores at 6 months was 2.0 (IQR = 0-5.5) and was significantly better than both baseline on-PPI [9.0 (range = 6.0-10.0); p < 0.001] and off-PPI [23 (21-25); p < 0.001] GERD-HRQL. Median% 24-h esophageal pH < 4.0 at baseline was 10.1 and improved to 5.1 at 6 months (p < 0.001). At their 6-month follow-up, 91 % (21/23) of the patients were off PPI and had significantly better median GERD-HRQL on LES stimulation compared to their on-PPI GERD-HRQL at baseline (9.0 vs. 2.0; p < 0.001). There were no unanticipated implantation- or stimulation-related adverse events or untoward sensation due to stimulation. There were no reports of treatment-related dysphagia, and manometric swallow was also unaffected. Conclusions: Electrical stimulation of the LES is safe and effective for treating GERD. There is a significant and sustained improvement in GERD symptoms, esophageal pH, and reduction in PPI usage without any side effects with the therapy. Furthermore, the therapy can be optimized to address an individual patient's disease.

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