TY - JOUR
T1 - Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD
T2 - long-term 3-year results
AU - Rodríguez, Leonardo
AU - Rodriguez, Patricia A.
AU - Gómez, Beatrice
AU - Netto, Manoel Galvao
AU - Crowell, Michael D.
AU - Soffer, Edy
N1 - Funding Information:
Study SponsorâEndoStim BV, The Hague, Netherlands, provided funding for the trial. Prof. Michael D Crowell is a consultant for EndoStim Inc. and the chair of its data monitoring committee. Prof. Edy Soffer is a stock holder in EndoStim Inc. Leonardo RodrÃguez, Patricia A Rodriguez, Beatrice Gómez, Manoel Galvao Netto, or their immediate family have no financial relationship with the sponsor that would constitute a conflict of interest.
Publisher Copyright:
© 2015, The Author(s).
PY - 2016/7/1
Y1 - 2016/7/1
N2 - Background: Electrical stimulation of the lower esophageal sphincter (LES) has been shown to improve outcomes in patients with gastroesophageal reflux disease (GERD) at 2 years. The aim of the study was to evaluate the safety and efficacy of LES stimulation in the same cohort at 3 years. Methods: GERD patients with partial response to PPI, with % 24-h esophageal pH < 4.0 for >5 %, with hiatal hernia <3 cm and with esophagitis ≤LA grade C were treated with LES stimulation in an open-label 2-year trial. All patients were on fixed stimulation parameter of 20 Hz, 220 μs, 5 mA delivered in twelve, 30-min sessions. After completing the 2-year open-label study, they were offered enrollment into a multicenter registry trial and were evaluated using GERD-HRQL, symptom diaries and pH testing at their 3-year follow-up. Results: Fifteen patients completed their 3-year evaluation [mean (SD) age = 56.1 (9.7) years; men = 8] on LES stimulation. At 3 years, there was a significant improvement in their median (IQR) GERD-HRQL on electrical stimulation compared to both their on PPI [9 (6–10) vs. 1 (0–2), p = 0.001] and off PPI [22 (21–24) vs. 1 (0–2), p < 0.001]. Median 24-h distal esophageal acid exposure was significantly reduced from [10.3 (7.5–11.6) % at baseline vs. 3 (1.9–4.5) %, p < 0.001] at 3 years. Seventy-three % (11/15) patients had normalized their distal esophageal acid exposure at 3 years. Remaining four patients had improved their distal esophageal acid exposure by 39–48 % from baseline. All but four patients reported cessation of regular PPI use (>50 % of days with PPI use); three had normal esophageal pH at 3 years. There were no unanticipated device- or stimulation-related adverse events or untoward sensation reported during the 2- to 3-year follow-up. Conclusion: LES-EST is safe and effective for treating patients with GERD over long-term, 3-year duration. There was a significant and sustained improvement in esophageal acid exposure and reduction in GERD symptoms and PPI use. Further, no new GI side effects or adverse events were reported.
AB - Background: Electrical stimulation of the lower esophageal sphincter (LES) has been shown to improve outcomes in patients with gastroesophageal reflux disease (GERD) at 2 years. The aim of the study was to evaluate the safety and efficacy of LES stimulation in the same cohort at 3 years. Methods: GERD patients with partial response to PPI, with % 24-h esophageal pH < 4.0 for >5 %, with hiatal hernia <3 cm and with esophagitis ≤LA grade C were treated with LES stimulation in an open-label 2-year trial. All patients were on fixed stimulation parameter of 20 Hz, 220 μs, 5 mA delivered in twelve, 30-min sessions. After completing the 2-year open-label study, they were offered enrollment into a multicenter registry trial and were evaluated using GERD-HRQL, symptom diaries and pH testing at their 3-year follow-up. Results: Fifteen patients completed their 3-year evaluation [mean (SD) age = 56.1 (9.7) years; men = 8] on LES stimulation. At 3 years, there was a significant improvement in their median (IQR) GERD-HRQL on electrical stimulation compared to both their on PPI [9 (6–10) vs. 1 (0–2), p = 0.001] and off PPI [22 (21–24) vs. 1 (0–2), p < 0.001]. Median 24-h distal esophageal acid exposure was significantly reduced from [10.3 (7.5–11.6) % at baseline vs. 3 (1.9–4.5) %, p < 0.001] at 3 years. Seventy-three % (11/15) patients had normalized their distal esophageal acid exposure at 3 years. Remaining four patients had improved their distal esophageal acid exposure by 39–48 % from baseline. All but four patients reported cessation of regular PPI use (>50 % of days with PPI use); three had normal esophageal pH at 3 years. There were no unanticipated device- or stimulation-related adverse events or untoward sensation reported during the 2- to 3-year follow-up. Conclusion: LES-EST is safe and effective for treating patients with GERD over long-term, 3-year duration. There was a significant and sustained improvement in esophageal acid exposure and reduction in GERD symptoms and PPI use. Further, no new GI side effects or adverse events were reported.
KW - Electrical stimulation
KW - Esophageal acid
KW - GERD
KW - Lower esophageal sphincter
KW - Outcomes
KW - Treatment
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U2 - 10.1007/s00464-015-4539-5
DO - 10.1007/s00464-015-4539-5
M3 - Article
C2 - 26487200
AN - SCOPUS:84944930974
SN - 0930-2794
VL - 30
SP - 2666
EP - 2672
JO - Surgical endoscopy
JF - Surgical endoscopy
IS - 7
ER -